{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 900 sorted by section_id", "rows": [["10:10:5.0.2.5.37.0.16.1", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.1 Purpose and scope.", "DOE", "", "", "", "(a) Pursuant to section 216(h) of the Federal Power Act (16 U.S.C. 824p(h)), the Department of Energy (DOE) establishes the Coordinated Interagency Transmission Authorizations and Permits Program (CITAP Program) under this part to coordinate the review and processes related to Federal authorizations necessary to site a proposed electric transmission facility. Pursuant to section 216(h)(4)(A), this part establishes the mechanism by which DOE will set prompt and binding intermediate milestones and ultimate deadlines for the processes related to deciding whether to issue such authorizations. In addition, as the lead agency and in collaboration with any National Environmental Policy Act (NEPA) joint lead agency and in consultation with the relevant Federal entities, as applicable, DOE will prepare a single environmental review document, which will be designed to serve the needs of all relevant Federal agencies and inform all Federal authorization decisions on the proposed electric transmission project.\n\n(b) This part provides a process for the timely submission of information needed for Federal decisions related to authorizations for siting proposed electric transmission projects. This part seeks to ensure that these projects are developed consistent with the nation's environmental laws, including laws that address endangered and threatened species, critical habitats, and cultural and historic properties. This part provides a framework, called the Integrated Interagency Pre-Application (IIP) Process, by which DOE will coordinate submission of materials necessary for Federal authorizations and related environmental reviews required under Federal law to site proposed electric transmission facilities, and integrates the IIP Process into the CITAP Program.\n\n(c) This part describes the timing and procedures for the IIP Process, which should be initiated prior to a project proponent's submission of any application for a required Federal authorization. The IIP Process provides for timely and focused pre-application meetings with relevant Federal and non-Federal entities. In addition, the IIP Process facilitates early identification of potential siting constraints and opportunities. The IIP Process promotes thorough and consistent stakeholder engagement by a project proponent. At the close-out of each IIP Process, DOE will establish the schedule for all Federal reviews and authorizations required to site a proposed electric transmission facility, in coordination with the relevant Federal entities.\n\n(d) This part improves the Federal permitting process by facilitating the early submission, compilation, and documentation of information needed for coordinated review by relevant Federal entities under the National Environmental Policy Act (42 U.S.C. 4321  et seq. ). This part also facilitates expeditious action on necessary Federal authorizations by ensuring that relevant Federal entities coordinate their consideration of those applications and by providing non-Federal entities the opportunity to coordinate their non-Federal permitting and environmental reviews with the reviews of the relevant Federal entities.\n\n(e) This part facilitates improved and earlier coordination of and consultation between relevant Federal entities, relevant non-Federal entities, and others pursuant to section 106 of the National Historic Preservation Act (54 U.S.C. 306108) (NHPA) and its implementing regulations found at 36 CFR part 800. Under this part, DOE may determine it has an undertaking with the potential to affect historic properties and may, at that time, authorize a project proponent, as a CITAP applicant, to initiate section 106 consultation for the undertaking consistent with 36 CFR 800.2(c)(4). Prior to that determination, this part requires project proponents to gather initial information and make recommendations relevant to the section 106 process to the extent possible. This part also establishes DOE as lead for the section 106 process, consistent with DOE's role as lead or joint lead agency for purposes of NEPA, in order to maximize opportunities for coordination between the NEPA and section 106 processes. Federal entities remain responsible for government-to-government consultation with Indian Tribes (and government-to-sovereign consultation in the context of Native Hawaiian relations) and for any findings and determinations required by and reserved to Federal agencies in 36 CFR part 800.\n\n(f) This part applies only to qualifying projects as defined by \u00a7 900.2.\n\n(g) Participation in the IIP Process does not alter any requirements to obtain necessary Federal authorizations for proposed electric transmission projects. Nor does this part alter any responsibilities of the relevant Federal entities for environmental review or consultation under applicable law.\n\n(h) The Director may waive any requirement imposed on a project proponent under this part if, in the Director's discretion, the Director determines that the requirement is unnecessary, duplicative, or impracticable under the circumstances relevant to the proposed electric transmission project. Where the principal project developer is itself a Federal entity that would be otherwise expected to prepare an environmental review document for the project, the Director shall consider modifications to the requirements under this part as may be necessary under the circumstances."], ["10:10:5.0.2.5.37.0.16.10", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.10 Consolidated administrative docket.", "DOE", "", "", "", "(a) DOE shall maintain a consolidated docket of:\n\n(1) All information that DOE distributes to or receives from the project proponent, relevant Federal entities, and relevant non-Federal entities related to the Integrated Interagency Pre-Application (IIP) Process, including:\n\n(i) The IIP initiation request, review meeting request, and close-out meeting request required by \u00a7\u00a7 900.5, 900.8, and 900.9;\n\n(ii) The IIP Process final meeting summaries required by \u00a7\u00a7 900.5, 900.8 and 900.9;\n\n(iii) The IIP Process final resource reports developed under \u00a7 900.6;\n\n(iv) The final project-specific schedule developed under \u00a7\u00a7 900.7 and 900.8;\n\n(v) Other documents submitted by the project proponent as part of the IIP Process or provided to the project proponent as part of the IIP Process, including but not limited to maps, publicly available data, and other supporting documentation; and\n\n(vi) Communications between any relevant Federal or non-Federal entity and the project proponent regarding the IIP Process; and\n\n(2) All information assembled and used by relevant Federal entities as the basis for Federal authorizations and related reviews following completion of the IIP Process.\n\n(b) Federal entities should include DOE in all communications with the project proponent related to the IIP Process for the proposed electric transmission project.\n\n(c) DOE shall make the consolidated docket available, as appropriate, to the NEPA joint lead agency selected under \u00a7 900.11; any relevant Federal or non-Federal entity responsible for issuing an authorization for the proposed project; and any consulting parties per section 106 of the NHPA, consistent with 36 CFR part 800. DOE shall exclude or redact privileged documents, as appropriate.\n\n(d) Where necessary and appropriate, DOE may require a project proponent to contract with a qualified record-management consultant to compile a contemporaneous docket on behalf of all participating agencies. Any such contractor shall operate at the direction of DOE, and DOE shall retain responsibility and authority over the content of the docket.\n\n(e) Upon request, any member of the public will be provided materials included in the docket, excluding any materials protected as CEII or otherwise required or allowed to be withheld under the Freedom of Information Act."], ["10:10:5.0.2.5.37.0.16.11", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.11 NEPA lead agency and selection of NEPA joint lead agency.", "DOE", "", "", "", "(a) For a proposed electric transmission project that is accepted for the Integrated Interagency Pre-Application (IIP) Process under \u00a7 900.5, DOE shall serve as the NEPA lead agency to prepare an environmental review document to serve the needs of all relevant Federal entities. A NEPA joint lead agency to prepare the environmental review document may also be designated pursuant to this section, no later than by the IIP Process review meeting.\n\n(b) The NEPA joint lead agency, if any, shall be the Federal entity with the most significant interest in the management of Federal lands or waters that would be traversed or affected by the proposed project. DOE shall make this determination in consultation with all Federal entities that manage Federal lands or waters traversed or affected by the proposed project. For a proposed project that would traverse lands managed by both the USDA and the DOI, DOE will request that USDA and DOI determine the appropriate NEPA joint lead agency, if any."], ["10:10:5.0.2.5.37.0.16.12", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.12 Environmental review.", "DOE", "", "", "", "(a) After the Integrated Interagency Pre-Application (IIP) Process close-out meeting, and after receipt of a relevant application for a Federal authorization or permit in accordance with the final project-specific schedule, DOE and any NEPA joint lead agency selected under \u00a7 900.11 shall prepare an environmental review document for the proposed electric transmission project designed to serve the needs of all relevant Federal entities.\n\n(b) When preparing the environmental review document, DOE and any NEPA joint lead agency shall:\n\n(1) Consider the materials developed throughout the IIP Process; and\n\n(2) Consult with relevant Federal entities and relevant non-Federal entities.\n\n(c) DOE, in consultation with any NEPA joint lead agency, is expected to be responsible for:\n\n(1) Identifying, contracting with, directing, supervising, and arranging for the payment of contractors, as appropriate, to draft the environmental review document; and\n\n(2) Publishing the environmental review document and any related documents.\n\n(d) Each Federal entity or non-Federal entity that is responsible for issuing a separate Federal authorization for the proposed project shall:\n\n(1) Identify all information and analysis needed to make the authorization decision; and\n\n(2) Identify all alternatives that need to be included, including a preferred alternative, with respect to the authorization.\n\n(e) DOE and any NEPA joint lead agency, in consultation with relevant Federal entities, shall identify the full scope of alternatives for analysis, including the no action alternative.\n\n(f) To the maximum extent permitted under law, relevant Federal entities shall use the environmental review document as the basis for all Federal authorization decisions on the proposed project. DOE and the relevant Federal entities shall issue, except where inappropriate or inefficient, a joint decision document, which will include the determination by the Secretary of a duration for each land use authorization issued on the proposed project.\n\n(g) For all proposed projects, DOE shall serve as lead agency for consultation under the Endangered Species Act (50 CFR 402.07) and section 106 of the NHPA (36 CFR 800.2(a)(2)) unless the relevant Federal entities designate otherwise. DOE shall coordinate these consultation processes with the Federal agency with the most significant interest in the management of Federal lands or waters that would be traversed or affected by the proposed project or the designated lead agency."], ["10:10:5.0.2.5.37.0.16.13", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.13 Severability.", "DOE", "", "", "", "The provisions of this part are separate and severable from one another. Should a court hold any provision(s) to be stayed or invalid, such action shall not affect any other provision of this part and the remaining provisions shall remain in effect."], ["10:10:5.0.2.5.37.0.16.2", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.2 Definitions.", "DOE", "", "", "", "As used in this part:\n\nAnalysis area  means a geographical area established for a resource report at the IIP Process initial meeting and modified at the IIP Process review meeting, if applicable.\n\nAuthorization  means any license, permit, approval, finding, determination, or other administrative decision required under Federal, Tribal, State, or local law to site a proposed electric transmission facility, including special use authorization, certifications, opinions, or other approvals.\n\nCommunities of Interest  means the following communities that could be affected by a proposed electric transmission project: disadvantaged communities; rural communities; Tribal communities; indigenous communities; geographically proximate communities; communities with environmental justice concerns; and energy communities.\n\nDirector  means the Director of the DOE Grid Deployment Office, that person's delegate, or another DOE official designated to perform the functions of this part by the Secretary of Energy.\n\nFederal authorization  means any authorization required under Federal law.\n\nFederal entity  means any Federal agency or department.\n\nIndian Tribe  has the same meaning as provided by 25 U.S.C. 5304(e).\n\nMitigation approach  means an approach that applies a conceptual plan to identify appropriate measures to avoid, minimize, or compensate for potential impacts to resources from a proposed electric transmission project, consistent with 40 CFR 1508.1(s) or any successor regulation. A mitigation approach identifies the needs and baseline conditions of targeted resources, potential impacts from the proposed project, cumulative impacts of past and reasonably foreseeable future disturbances to those resources, and future disturbance trends, then uses this information to identify priorities for measures across the relevant area. Such an approach includes full consideration of the conditions of additionality (meaning that the benefits of a compensatory mitigation measure improve upon the baseline conditions in a manner that is demonstrably new and would not have occurred without the mitigation measure) and durability (meaning that the effectiveness of a mitigation measure is sustained for the duration of the associated direct and indirect impacts).\n\nMOU signatory agency  means a Federal entity that has entered into the currently effective memorandum of understanding (MOU) under section 216(h)(7)(B)(i) of the Federal Power Act, such as the interagency MOU executed in May 2023, titled \u201cMemorandum of Understanding among the U.S. Department of Agriculture, Department of Commerce, Department of Defense, Department of Energy, the Environmental Protection Agency, the Council on Environmental Quality, the Federal Permitting Improvement Steering Council, Department of the Interior, and the Office of Management and Budget Regarding Facilitating Federal Authorizations for Electric Transmission Facilities.\u201d\n\nNEPA joint lead agency  means the Federal entity designated under \u00a7 900.11.\n\nNon-Federal entity  means an Indian Tribe, multi-State governmental entity, State agency, or local government agency.\n\nParticipating agencies  means:\n\n(1) The Department of Agriculture (USDA);\n\n(2) The Department of Commerce;\n\n(3) The Department of Defense (DOD);\n\n(4) The Department of Energy;\n\n(5) The Environmental Protection Agency (EPA);\n\n(6) The Council on Environmental Quality;\n\n(7) The Office of Management and Budget;\n\n(8) The Department of the Interior (DOI);\n\n(9) The Federal Permitting Improvement Steering Council (FPISC);\n\n(10) Other agencies and offices as the Secretary of Energy may from time to time invite to participate; and\n\n(11) The following independent agencies, to the extent consistent with their statutory authority and obligations, and determined by the chair or executive director of each agency, as appropriate:\n\n(i) The Federal Energy Regulatory Commission (FERC); and\n\n(ii) The Advisory Council on Historic Preservation.\n\nPotentially affected landowner  means an owner of a real property interest that is potentially affected directly ( e.g.,  crossed or used) or indirectly ( e.g.,  changed in use) by a project right-of-way, potential route, or proposed ancillary or access site, as identified in \u00a7 900.6.\n\nProject area  means the area located between the two end points of the proposed electric transmission facility containing the study corridors selected by the project proponent for in-depth consideration for the proposed project and the immediate surroundings of the end points of the proposed facility. The project area does not necessarily coincide with \u201cpermit area,\u201d \u201carea of potential effect,\u201d \u201caction area,\u201d or other terms specific to a certain type of regulatory review.\n\nProject proponent  means a person or entity who initiates the IIP Process in anticipation of seeking a Federal authorization for a proposed electric transmission project.\n\nQualifying project  means:\n\n(1) A proposed electric transmission line and its attendant facilities:\n\n(i) That will either be a high-voltage (230 kV or above) line or a regionally or nationally significant line, as determined by DOE based upon relevant factors, including but not limited to, reduction in congestion costs for generating and delivering energy, mitigation of weather and variable generation uncertainty, and enhanced diversity of supply;\n\n(ii) Which is expected to be used, in whole or in part, for the transmission of electric energy in interstate or international commerce for sale at wholesale;\n\n(iii) Which is expected to require preparation of an environmental impact statement (EIS) pursuant to NEPA to inform an agency decision on a Federal authorization;\n\n(iv) Which is not proposed for authorization under section 8(p) of the Outer Continental Shelf Lands Act (43 U.S.C. 1337(p));\n\n(v) Which is not seeking a construction or modification permit from FERC pursuant to section 216(b) of the Federal Power Act (16 U.S.C. 824p(b)); and\n\n(vi) Which will not be wholly located within the Electric Reliability Council of Texas interconnection; or\n\n(2) Any other proposed electric transmission facility that is approved by the Director under the process set out in \u00a7 900.3.\n\nRelevant Federal entity  means a Federal entity with jurisdictional interests that may have an effect on a proposed electric transmission project, that is responsible for issuing a Federal authorization for the proposed project, that has relevant expertise with respect to environmental and other issues pertinent to or potentially affected by the proposed project, or that provides funding for the proposed project. The term includes participating agencies. The term includes a Federal entity with either permitting or non-permitting authority; for example, those entities with which consultation or review must be completed before a project may commence, such as DOD for an examination of military test, training, or operational impacts.\n\nRelevant non-Federal entity  means a non-Federal entity with relevant expertise or jurisdiction within the project area, that is responsible for issuing an authorization for the proposed electric transmission project, that has relevant expertise with respect to environmental and other issues pertinent to or potentially affected by the proposed project, or that provides funding for the proposed project. The term includes an entity with either permitting or non-permitting authority, such as an Indian Tribe, Native Hawaiian Organization, or State or Tribal Historic Preservation Office with whom consultation must be completed in accordance with section 106 of the NHPA prior to approval of a permit, right-of-way, or other authorization required for a Federal authorization.\n\nRoute  means an area along a linear path within which a proposed electric transmission facility could be sited that is:\n\n(1) Wide enough to allow minor adjustments in the alignment of the proposed facility to avoid sensitive features or to accommodate potential engineering constraints; and\n\n(2) Narrow enough to allow detailed study.\n\nStakeholder  means any relevant non-Federal entity, interested non-governmental organization, potentially affected landowner, or other interested person or organization.\n\nStudy corridor  means a contiguous area (not to exceed one mile in width) within the project area where potential routes or route segments may be considered for further study. A study corridor does not necessarily coincide with \u201cpermit area,\u201d \u201carea of potential effect,\u201d \u201caction area,\u201d or other defined terms of art that are specific to types of regulatory review."], ["10:10:5.0.2.5.37.0.16.3", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.3 Applicability to other projects.", "DOE", "", "", "", "(a) Following the procedures set out in this section, the Director may determine that a proposed electric transmission facility that does not meet the description of a  qualifying project  under paragraph (1) of the definition in \u00a7 900.2 is a  qualifying project  under paragraph (2) of the definition.\n\n(b) A requestor seeking DOE assistance under this part for a proposed electric transmission facility that does not meet the description of a  qualifying project  under paragraph (1) of the definition in \u00a7 900.2 must file a request for coordination with the Director. The request must contain:\n\n(1) The legal name of the requester; its principal place of business; and the name, title, and mailing address of the person or persons to whom communications concerning the request for coordination are to be addressed;\n\n(2) A concise description of the proposed facility sufficient to explain its scope and purpose;\n\n(3) A list of anticipated relevant Federal entities involved in the proposed facility; and\n\n(4) A list of anticipated relevant non-Federal entities involved in the proposed facility, including any agency serial or docket numbers for pending applications.\n\n(c) Not later than 30 calendar days after the date that the Director receives a request under this section, the Director, in consultation with the relevant Federal entities, will determine if the proposed electric transmission facility is a qualifying project under this part and will notify the project proponent in writing of one of the following:\n\n(1) If accepted, that the proposed facility is a qualifying project and the project proponent must submit an initiation request as set forth under \u00a7 900.5; or\n\n(2) If not accepted, that the proposed facility is not a qualifying project, a justification of that determination, and an indication that the project proponent must follow the procedures of each relevant Federal entity that has jurisdiction over the proposed facility without DOE performing a coordinating function.\n\n(d) In making the determination whether a proposed electric transmission facility is a qualifying project, the Director may consider:\n\n(1) Whether the proposed facility would benefit from CITAP Program coordination;\n\n(2) Whether the proposed facility would result in reduced congestion costs for generating and delivering energy;\n\n(3) Whether the proposed facility would result in mitigation of weather and variable generation uncertainty;\n\n(4) Whether the proposed facility would result in an enhanced diversity of supply; and\n\n(5) Any other relevant factors, as determined by the Director.\n\n(e) For a proposed facility that is seeking a construction or modification permit pursuant to section 216(b) of the Federal Power Act, DOE may only consider a request for assistance under this section if the request under paragraph (b) of this section is consistent with Delegation Order No. S1-DEL-FERC-2006 or any similar, subsequent delegation that the Secretary may order.\n\n(f) At the discretion of the MOU signatory agencies, this section may be applied to a proposed electric transmission facility proposed for authorization under section 8(p) of the Outer Continental Shelf Lands Act, if the proposed authorization is independent of any generation project.\n\n(g) This section does not apply to:\n\n(1) A proposed electric transmission facility proposed to be authorized under section 8(p) of the Outer Continental Shelf Lands Act in conjunction with a generation project; or\n\n(2) A proposed electric transmission facility wholly located within the Electric Reliability Council of Texas interconnection."], ["10:10:5.0.2.5.37.0.16.4", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.4 Purpose and scope of IIP Process.", "DOE", "", "", "", "(a) The Integrated Interagency Pre-Application (IIP) Process is intended for a project proponent who has identified potential study corridors or potential routes and the proposed locations of any intermediate substations for a proposed electric transmission project. To the extent possible, the project proponent should use the following criteria to identify potential study corridors and potential routes:\n\n(1) Potential environmental, visual, historic, cultural, economic, social, or health effects or harm based on the proposed project or proposed siting, and anticipated constraints (for instance, pole height and corridor width based on line capacity to improve safety and resiliency of the project);\n\n(2) Potential cultural resources, sacred sites, and historic properties that may be eligible for or listed in the National Register of Historic Places;\n\n(3) Areas under (or potentially under) special protection by State or Federal statute and areas subject to a Federal entity or non-Federal entity decision that could potentially increase the time needed for project evaluation and siting a transmission line route. Such areas may include, but are not limited to, properties or sites that may be of traditional religious or cultural importance to Indian Tribes, National Scenic and Historic Trails, National Landscape Conservation System units managed by the Bureau of Land Management (BLM), Land and Water Conservation Fund lands, National Wildlife Refuges, national monuments, National Historic Landmarks, units of the National Park System, national marine sanctuaries, and marine national monuments;\n\n(4) Opportunities to site potential routes through designated corridors, previously disturbed lands, and lands with existing infrastructure as a means of potentially reducing impacts and known conflicts as well as the time needed for affected Federal land managers to evaluate an application for a Federal authorization if the route is sited through such areas ( e.g.,  colocation with existing infrastructure or location on previously disturbed lands, in energy corridors designated by the Department of the Interior or the Department of Agriculture under section 503 of the Federal Land Policy and Management Act (Pub. L. 94-579) or section 368 of the Energy Policy Act of 2005 (Pub. L. 109-58), existing rights-of-way, National Interest Electric Transmission Corridors designated under Federal Power Act section 216(a), or utility corridors identified in a land management plan);\n\n(5) Potential constraints caused by impacts on military test, training, and operational missions, including impacts on installations, ranges, and airspace;\n\n(6) Potential constraints caused by impacts on the United States' aviation system;\n\n(7) Potential constraints caused by impacts to navigable waters of the United States; and\n\n(8) Potential avoidance, minimization, offsetting, and compensatory (onsite and offsite) measures, developed through a mitigation approach to reduce or offset the potential impact of the proposed project to resources requiring mitigation.\n\n(b) Participation in the IIP Process is a prerequisite for the coordination provided by DOE between relevant Federal entities, relevant non-Federal entities, and the project proponent.\n\n(c) The IIP Process ensures early interaction between the project proponents, relevant Federal entities, and relevant non-Federal entities to enhance early understanding by those entities. Through the IIP Process, the project proponent will provide relevant Federal entities and relevant non-Federal entities with a clear description of the proposed electric transmission project, the project proponent's siting process, and the environmental and community setting being considered by the project proponent for siting the proposed electric transmission facility; and will coordinate with relevant Federal entities to develop resource reports that will serve as inputs, as appropriate, into the relevant Federal analyses and facilitate early identification of project issues.\n\n(d) The IIP Process is an iterative process anchored by three meetings: the initial meeting, review meeting, and close-out meeting. These meetings, defined in \u00a7\u00a7 900.5, 900.8 and 900.9, are milestones in the process and do not preclude any additional meetings or communications between the project proponent and the relevant Federal entities. The iterative nature of the process is provided for in procedures for evaluating the completeness of submitted materials and the suitability of materials for the relevant Federal entities' decision-making before each milestone.\n\n(e) DOE, in exercising its responsibilities under this part, will communicate regularly with FERC, electric reliability organizations and electric transmission organizations approved by FERC, relevant Federal entities, and project proponents. DOE will use information technologies to provide opportunities for relevant Federal entities to participate remotely.\n\n(f) DOE, in exercising its responsibilities under this part, will to the maximum extent practicable and consistent with Federal law, coordinate the IIP Process with any relevant non-Federal entities. DOE will use information technologies to provide opportunities and reduce burdens for relevant non-Federal entities to participate remotely.\n\n(g) The Director may at any time require the project proponent to provide additional information necessary to resolve issues raised by the IIP Process.\n\n(h) Pursuant to 10 CFR 1004.11, any person submitting information during the IIP Process that the person believes to be confidential and exempt by law from public disclosure should submit two well-marked copies, one marked \u201cconfidential\u201d that includes all the information believed to be confidential, and one marked \u201cnon-confidential\u201d with the information believed to be confidential deleted or redacted. DOE will make its own determination about the confidential status of the information and treat it according to its determination, in accordance with applicable law. The project proponent must request confidential treatment for all material filed with DOE containing non-public location, character, and ownership information about cultural resources.\n\n(i) Pursuant to 10 CFR 1004.13, any person submitting information during the IIP Process that the person believes might contain Critical Electric Infrastructure Information (CEII) should submit a request for CEII designation of information."], ["10:10:5.0.2.5.37.0.16.5", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.5 Initiation of IIP Process.", "DOE", "", "", "", "(a)  Initiation request.  A project proponent shall submit an initiation request to DOE. The project proponent may decide when to submit the initiation request. The initiation request must include, based on best available information:\n\n(1) A summary of the proposed electric transmission project, as described by paragraph (b) of this section;\n\n(2) Associated maps, geospatial information, and studies (provided in electronic format), as described by paragraph (c) of this section;\n\n(3) A project participation plan, as described by paragraph (d) of this section; and\n\n(4) A statement regarding the proposed project's status pursuant to Title 41 of the Fixing America's Surface Transportation Act (FAST-41) (42 U.S.C. 4370m-2(b)(2)), as described by paragraph (e) of this section.\n\n(b)  Summary of the proposed project.  The summary of the proposed electric transmission project may not exceed 10 single-spaced pages unless the project proponent requests a waiver of the page limit, including a rationale for the waiver, and DOE grants the waiver. The summary must include:\n\n(1) The following information:\n\n(i) The project proponent's legal name and principal place of business;\n\n(ii) The project proponent's contact information and designated point(s) of contact;\n\n(iii) Whether the project proponent is an individual, partnership, corporation, or other entity and, if applicable, the State laws under which the project proponent is organized or authorized; and\n\n(iv) If the project proponent resides or has its principal office outside the United States, documentation related to designation by irrevocable power of attorney of an agent residing within the United States;\n\n(2) A statement of the project proponent's interests and objectives;\n\n(3) To the extent available, copies of or links to:\n\n(i) Any regional electric transmission planning documents, regional reliability studies, regional congestion or other related studies that relate to the proposed project or the need for the proposed project; and\n\n(ii) Any relevant interconnection requests;\n\n(4) A description of potential study corridors and routes identified by the project proponent and a brief description of the evaluation criteria and methods used by the project proponent to identify and develop those corridors and routes;\n\n(5) A brief description of the proposed project, including end points, voltage, ownership, intermediate substations if applicable, and, to the extent known, any information about constraints or flexibility with respect to the proposed project;\n\n(6) Identification of any environmental and engineering firms and sub-contractors under contract to develop the proposed project;\n\n(7) The project proponent's proposed schedule for filing necessary Federal and State applications, construction start date, and planned in-service date, assuming receipt of all necessary authorizations; and\n\n(8) A list of anticipated relevant Federal entities and relevant non-Federal entities, including contact information for each Federal agency, State agency, Indian Tribe, or multi-State entity that is responsible for or has a role in issuing an authorization or environmental review for the proposed project.\n\n(c)  Maps, geospatial information, and studies.  The initiation request must include maps, geospatial information, and studies in support of the information provided in the summary of the proposed project under paragraph (b) of this section. Maps must be of sufficient detail to identify the study corridors and potential routes. Project proponents must provide the maps, information, and studies as electronic data files that may be readily accessed by relevant Federal entities and relevant non-Federal entities. The maps, information, and studies described in this paragraph (c) must include:\n\n(1) Location maps and plot plans to scale showing all major components, including a description of zoning and site availability for any permanent facilities; cultural resource location information in these materials should be submitted in accordance with \u00a7 900.4(h);\n\n(2) A map of the project area showing potential study corridors and potential routes;\n\n(3) Existing data or studies relevant to the summary of the proposed project; and\n\n(4) Citations identifying sources, data, and analyses used to develop the summary of the proposed project.\n\n(d)  Project participation plan.  The project participation plan, which may not exceed 10, single-spaced pages, summarizes the outreach that the project proponent conducted prior to submission of the initiation request, and describes the project proponent's planned outreach to communities of interest going forward. A supplemental appendix may be submitted to provide sufficient detail in addition to the narrative elements. The project participation plan must include:\n\n(1) A summary of prior outreach to communities of interest and stakeholders including:\n\n(i) A description of what work already has been done, including stakeholder and community outreach and public engagement, as well as any entities and organizations interested in the proposed electric transmission project;\n\n(ii) A list of environmental, engineering, public affairs, other contractors or consultants employed by the proponent to facilitate public outreach;\n\n(iii) A description of any materials provided to the public, such as environmental surveys or studies;\n\n(iv) A description of the communities of interest identified and the process by which they were identified;\n\n(v) A general description of the real property interests that would be impacted by the proposed project and the rights that the owners of those property interests would have under State law; and\n\n(vi) A summary of comments received during these previous engagement activities, issues identified by stakeholders, communities of interest (including various resource issues, differing project alternative study corridors or routes, and revisions to routes), and responses provided to commenters, if applicable; and\n\n(2) A public engagement plan, which must:\n\n(i) Describe the project proponent's outreach plan and status of those activities, including planned future activities corresponding to each of the items or issues identified in paragraphs (d)(1)(i) through (vi) of this section, specifying the planned dates or frequency;\n\n(ii) Describe the manner in which the project proponent will reach out to communities of interest about potential mitigation of concerns;\n\n(iii) Describe planned outreach activities during the permitting process, including efforts to identify, and engage, individuals with limited English proficiency and linguistically isolated communities, and provide accommodations for individuals with accessibility needs; and\n\n(iv) Discuss the specific tools and actions used by the project proponent to facilitate public communications and public information, including whether the project proponent will have a readily accessible, easily identifiable, single point of contact.\n\n(e)  FAST-41 statement.  The FAST-41 statement required under paragraph (a) of this section must specify the status of the proposed electric transmission project pursuant to FAST-41 at the time of submission of the initiation request. The statement must either:\n\n(1) State that the project proponent has sought FAST-41 coverage pursuant to 42 U.S.C. 4370m-2(a)(1); and state whether the Executive Director of the FPISC has created an entry on the Permitting Dashboard for the project as a covered project pursuant to 42 U.S.C. 4370m-2(b)(2)(A); or\n\n(2) State that the project proponent elected not to apply to be a FAST-41 covered project at this time.\n\n(f)  Initiation request determination.  Not later than 20 calendar days after the date that DOE receives an initiation request, DOE shall:\n\n(1) Determine whether the initiation request meets the requirements of this section and, if not previously determined under \u00a7 900.3, whether the proposed electric transmission facility is a qualifying project;\n\n(2) Identify the relevant Federal entities and relevant non-Federal entities and provide each with an electronic copy of the initiation request; and\n\n(3) Give notice to the project proponent and relevant Federal and non-Federal entities of DOE's determinations under paragraph (f)(1) of this section.\n\n(g)  Deficiencies.  If DOE determines under paragraph (f)(1) of this section that the initiation request does not meet the requirements of this section, DOE must provide the reasons for that finding and a description of how the project proponent may, if applicable, address any deficiencies in the initiation request so that DOE may reconsider its determination. If DOE determines under paragraph (f)(1) of this section that the proposed electric transmission facility is not a qualifying project, DOE must provide a justification for the determination and the project proponent may file a request for coordination with the Director as provided in \u00a7 900.3. A project to site a proposed electric transmission facility that is not a qualifying project is not eligible for participation in the IIP Process.\n\n(h)  Initial meeting.  If a project proponent submits a valid initiation request, DOE, in consultation with the identified relevant Federal entities, shall convene the IIP Process initial meeting with the project proponent and all relevant Federal entities notified by DOE under paragraph (f) of this section as soon as practicable and no later than 15 calendar days after the date that DOE provides notice under paragraph (f) that the initiation request meets the requirements of this section. DOE shall also invite relevant non-Federal entities to participate in the initial meeting. During the initial meeting:\n\n(1) DOE and the relevant Federal entities shall discuss with the project proponent the IIP Process, Federal authorization process, related environmental reviews, any arrangements for the project proponent to contribute funds to DOE to cover costs incurred by DOE and the relevant Federal entities in the IIP Process (in accordance with 42 U.S.C. 7278), any requirements for entering into cost recovery agreements, and paying for third-party contractors under DOE's supervision, where applicable;\n\n(2) DOE will identify any Federal applications that must be submitted during the IIP Process, to enable relevant Federal entities to begin work on the review process, and those applications that will be submitted after the IIP Process. All application submittal timelines will be accounted for in the project-specific schedule described in \u00a7 900.7;\n\n(3) DOE will establish all analysis areas necessary for the completion of resource reports required under \u00a7 900.6;\n\n(4) The project proponent shall describe the proposed electric transmission project and the contents of the initiation request;\n\n(5) DOE and the relevant Federal entities, along with any relevant non-Federal entities who choose to participate, will review the information provided by the project proponent and publicly available information, discuss the study corridors and potential routes identified by the project proponent, discuss the evaluation criteria and methods used to identify those corridors and routes and, to the extent possible and based on agency expertise and experience, identify any additional criteria for adding or modifying potential routes and study corridors;\n\n(6) DOE and the relevant Federal entities will discuss, based on available information provided by the project proponent, any surveys and studies that may be required for potential routes and completion of the resource reports, including biological (including threatened and endangered species or avian, aquatic, and terrestrial species and aquatic habitats of concern), visual, cultural, economic, social, health, and historic surveys and studies.\n\n(i)  Feedback to project proponent.  Feedback provided to the project proponent under paragraph (h) of this section does not constitute a commitment by any relevant Federal entity to approve or deny a Federal authorization request, nor does the IIP Process limit agency discretion regarding NEPA review.\n\n(j)  Draft initial meeting summary.  Not later than 10 calendar days after the initial meeting, DOE shall:\n\n(1) Prepare a draft initial meeting summary that includes a summary of the meeting discussion, a description of key issues and information gaps identified during the meeting, and any requests for more information from relevant Federal entities and relevant non-Federal entities; and\n\n(2) Convey the draft summary to the project proponent, relevant Federal entities, and any relevant non-Federal entities that participated in the meeting.\n\n(k)  Corrections.  The project proponent and entities that received the draft initial meeting summary under paragraph (j) of this section will have 10 calendar days following receipt of the draft initial meeting summary to review the draft and provide corrections to DOE.\n\n(l)  Final summary.  Not later than 10 calendar days following the close of the 10-day review period under paragraph (k) of this section, DOE shall:\n\n(1) Prepare a final initial meeting summary by incorporating received corrections, as appropriate;\n\n(2) Add the final summary to the consolidated administrative docket described by \u00a7 900.10; and\n\n(3) Provide an electronic copy of the summary to all relevant Federal entities, relevant non-Federal entities, and the project proponent."], ["10:10:5.0.2.5.37.0.16.6", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.6 Project proponent resource reports.", "DOE", "", "", "", "(a)  Preparation and submission.  The project proponent shall prepare and submit to DOE the 13 project proponent resource reports described in this section. The project proponent may submit the resource reports at any time before requesting a review meeting under \u00a7 900.8 and shall, at the direction of DOE, revise resource reports in response to comments received from relevant Federal entities and relevant non-Federal entities during the Integrated Interagency Pre-Application (IIP) Process.\n\n(b)  Content.  Each resource report must include concise descriptions, based on the best available scientific and commercial information, of the known existing environment and major site conditions. The detail of each resource report must be commensurate with the complexity of the proposal and its potential for environmental impacts. Each topic in each resource report must be addressed or its omission justified. If any resource report topic is not addressed at the time the applicable resource report is filed or its omission is not addressed, the report must explain why the topic is missing. If material required for one resource report is provided in another resource report or in another exhibit, it may be incorporated by reference. If outside material is reasonably available for review and comment, a resource report may incorporate that material by reference by including a citation to the material and a brief summary of the material. Consistent with \u00a7\u00a7 900.1(h) and 900.4(g), the Director may modify the requirements of this section to reflect differences in onshore and offshore environments and uses.\n\n(c)  Requirements for IIP Process progression.  Failure of the project proponent to provide at least the required initial or revised content will prevent progress through the IIP Process to the IIP Process review or close-out meetings, unless the Director determines that the project proponent has provided an acceptable reason for the item's absence and an acceptable timeline for filing it. Failure to file within the accepted timeline will prevent further progress in the IIP Process.\n\n(d)  General requirements.  As appropriate, each resource report shall:\n\n(1) Address conditions or resources that might be directly or indirectly affected by the proposed electric transmission project;\n\n(2) Identify environmental effects expected to occur as a result of the proposed project;\n\n(3) Identify the potential effects of construction, operation (including maintenance and malfunctions), and termination of the proposed project, as well as potential cumulative effects resulting from existing or reasonably foreseeable projects;\n\n(4) Identify measures proposed to enhance the environment or to avoid, minimize, or compensate for potential adverse effects of the proposed project; and\n\n(5) Provide a list of publications, reports, and other literature or communications, including agency communications, that were cited or relied upon to prepare each report.\n\n(e)  Federal responsibility.  The resource reports prepared by the project proponent under this section do not supplant the requirements under existing environmental laws related to the information required for Federal authorization or consultation processes. The relevant Federal entities shall independently evaluate the information submitted and shall be responsible for the accuracy, scope, and contents of all Federal authorization decision documents and related environmental reviews.\n\n(f)  Resource Report 1\u2014General project description.  This report should describe all expected facilities associated with the project, special construction and operation procedures, construction timetables, future plans for related construction, and permits, authorizations, and consultations that are expected to be required for proposed project. Resource Report 1 must:\n\n(1) Describe and provide location maps of all facilities to be constructed, modified, abandoned, replaced, or removed, including facilities related to construction and operational support activities and areas such as maintenance bases, staging areas, communications towers, power lines, and new access roads (roads to be built or modified), as well as any existing infrastructure proposed to be used for the project ( e.g.,  connections to existing substations and transmission, and existing access roads);\n\n(2) Describe specific generation resources that are known or reasonably foreseen to be developed or interconnected as a result of the proposed electric transmission project, if any;\n\n(3) Identify facilities constructed by other entities that are related to the proposed project ( e.g.,  fiber optic cables) and where those facilities would be located;\n\n(4) Provide the following information for each facility described under paragraphs (f)(1) through (3) of this section:\n\n(i) A brief description of the facility, including, as appropriate, ownership, land requirements, megawatt size, construction status, and an update of the latest status of Federal, State, and local permits and approvals; and\n\n(ii) Current topographic maps showing the location of the facility;\n\n(5) Provide any communications with the appropriate State Historic Preservation Offices (SHPOs) and Tribal Historic Preservation Offices (THPOs) regarding cultural and historic resources in the project area;\n\n(6) To the extent known, identify the permits, authorizations, and consultations that are expected to be required for proposed project, including consultation under section 106 of the NHPA, consultation under section 7 of the Endangered Species Act of 1973 (Pub. L. 93-205, as amended, 16 U.S.C. 1531  et seq. ), consistency determinations under the Coastal Zone Management Act (CZMA), and permits under the Clean Water Act (33 U.S.C. 1251  et seq. ) (CWA);\n\n(7) Describe any developments in obtaining authorizations and permits or completing required consultations for the proposed project and identify environmental mitigation requirements specified in any permit or proposed in any permit application to the extent not specified elsewhere in this resource report or another resource report;\n\n(8) If the project includes abandonment of certain facilities, rights-of-way, or easements, identify and describe the following:\n\n(i) facilities, rights-of-way, or easements that the project proponent plans to abandon;\n\n(ii) how the facilities, rights-of-way, or easements would be abandoned;\n\n(iii) how the abandoned facilities, rights-of-way, and easements would be restored;\n\n(iv) the owner of the facilities, rights-of-way, or easement after abandonment;\n\n(v) the party responsible for the abandoned facilities, rights-of-way, or easement;\n\n(vi) whether landowners were or are expected to be given the opportunity to request that the abandoned facilities on their property, including foundations and below ground components, be removed; and\n\n(vii) landowners whose preferences regarding abandoned facility removal the project proponent does not intend to honor and reasons why the project proponent does not intend to honor those preferences;\n\n(9) Provide construction timetables and describe, by milepost, proposed construction and restoration methods to be used in areas of rugged topography, residential areas, active croplands, sites where the proposed project would be located parallel to and under roads, and sites where explosives may be used;\n\n(10) Describe estimated workforce requirements for the proposed project, including the number of construction spreads, average workforce requirements for each construction spread, estimated duration of construction from initial clearing to final restoration, and number of personnel to be hired to operate the proposed project;\n\n(11) Describe reasonably foreseeable plans for future expansion of facilities related to the project, including additional land requirements and the compatibility of those plans with the current proposal;\n\n(12) Provide the names and mailing addresses of all potentially affected landowners identified by the project proponent, identify which potentially affected landowners have been notified by the project proponent, and describe the methodology used to identify potentially affected landowners;\n\n(13) Summarize the proposed mitigation approach anticipated by the project proponent to reduce the potential impacts of the proposed project to resources warranting or requiring mitigation; and\n\n(14) Describe how the proposed project will reduce capacity constraints and congestion on the transmission system, meet unmet demand, or connect generation resources (including the expected type of generation, if known) to load, as appropriate.\n\n(g)  Resource Report 2\u2014Water use and quality.  This report should describe water resources that may be impacted by the proposed project, describe the potential impacts on these resources, and describe the measures taken to avoid and minimize adverse effects to such water resources, where appropriate. Resource Report 2 must:\n\n(1) Identify surface water resources, including perennial waterbodies, intermittent streams, ephemeral waterbodies, municipal water supply or watershed areas, specially designated surface water protection areas and sensitive waterbodies, floodplains, and wetlands, that would be crossed by a potential route;\n\n(2) For each surface water resource that would be crossed by a potential route, identify the approximate width of the crossing, State water quality classifications, any known potential pollutants present in the water or sediments, and any downstream potable water intake sources within the applicable analysis area;\n\n(3) Describe typical staging area requirements at surface water resource crossings and identify and describe each potential surface water crossing where staging areas are likely to be more extensive and could require a mitigation approach to address potential impacts to the water resource;\n\n(4) Provide two copies of floodplain and National Wetland Inventory (NWI) maps or, if not available, appropriate State wetland maps clearly showing the study corridors or potential routes and mileposts;\n\n(5) For each wetland crossing, identify the milepost of the crossing, the wetland classification specified by the USFWS, and the length of the crossing, and describe, by milepost, wetland crossings as determined by field delineations using the current Federal methodology;\n\n(6) For each floodplain crossing, identify the mileposts, acres of floodplains affected, flood elevation, and basis for determining that elevation;\n\n(7) Describe and provide data supporting the expected impact of the proposed project on surface and groundwater resources;\n\n(8) Describe and provide data supporting proposed avoidance and minimization measures as well as protection or enhancement measures that would reduce the potential for adverse impacts to surface and groundwater resources, and discuss any potential compensation expected to be provided for remaining unavoidable impacts to water resources due to the proposed project;\n\n(9) Identify the location of known public and private groundwater supply wells or springs within the applicable analysis area;\n\n(10) Identify locations of EPA or State-designated principal-source aquifers and wellhead protection areas crossed by a potential route;\n\n(11) Discuss the results of any coordination with relevant Federal entities or non-Federal entities related to CWA permitting and include any written correspondence that resulted from the coordination; and\n\n(12) Indicate whether the project proponent expects that a water quality certification (under section 401 of the CWA) will be required for any potential routes.\n\n(h)  Resource Report 3\u2014Fish, wildlife, and vegetation.  This report should identify and describe potential impacts to aquatic and terrestrial habitats, wildlife, and plants from the proposed project and discuss potential avoidance, minimization, or compensation measures, and enhancement or protection measures to reduce adverse impacts to these resources. Resource Report 3 must:\n\n(1) Describe aquatic habitats that occur in the applicable analysis area, including commercial and recreational warmwater, coldwater, and saltwater fisheries and associated significant habitats such as spawning or rearing areas, estuaries, and other essential fish habitats;\n\n(2) Describe terrestrial habitats that occur in the project area, including wetlands, typical wildlife habitats, and rare, unique, or otherwise significant habitats;\n\n(3) Identify fish, wildlife, and plants that may be affected by the proposed project, including species that have commercial, recreational, or aesthetic value and that may be affected by the proposed project;\n\n(4) Describe and provide the acreage of vegetation cover types that would be affected by the proposed project, including unique ecosystems or communities such as remnant prairie or old-growth forest, or significant individual plants, such as old-growth specimen trees;\n\n(5) Describe the impact of the proposed project on aquatic and terrestrial habitats, including potential loss and fragmentation;\n\n(6) Describe the potential impact of the proposed project on Federally listed, candidate, or proposed endangered or threatened species, State, Tribal, and local species of concern, and those species' habitats, including the possibility of a major alteration to ecosystems or biodiversity;\n\n(7) Describe the potential impact of maintenance, clearing, and treatment of the applicable analysis area on fish, wildlife, and plant life;\n\n(8) Identify all Federally listed, candidate, or proposed endangered or threatened species that may be affected by the proposed project and proposed or designated critical habitats that potentially occur in the applicable analysis area;\n\n(9) Identify all State, Tribal, and local species of concern that may be affected by the proposed project;\n\n(10) Identify all known and potential bald and golden eagle nesting and roosting sites, migratory bird flyways, and any sites important to migratory bird breeding, feeding, and sheltering within the applicable analysis areas. These identifications should coincide with the USFWS's most current range and location maps at the time this resource report is submitted;\n\n(11) Discuss the results of any discussions conducted by the proponent to date with relevant Federal entities or relevant non-Federal entities related to fish, wildlife, and vegetation resources, and include any written correspondence that resulted from the discussions;\n\n(12) Include the results of any appropriate surveys that have already been conducted, as well as plans and protocols for future surveys. If potentially suitable habitat is present, species-specific surveys may be required;\n\n(13) If present, identify all Federally designated essential fish habitat (EFH) that occurs in the applicable analysis area and provide:\n\n(i) Information on all EFH, as identified by the pertinent Federal fishery management plans, which may be adversely affected by potential routes;\n\n(ii) The results of discussions with National Marine Fisheries Service; and\n\n(iii) Any resulting EFH assessments that were evaluated, and EFH Conservation Recommendations that were provided by the National Marine Fisheries Service;\n\n(14) Describe potential avoidance, minimization, or compensation measures, and enhancement or protection measures to address adverse effects described in paragraphs (h)(5), (6), and (7) of this section;\n\n(15) Describe anticipated site-specific mitigation approaches for fisheries, wildlife (including migration corridors and seasonal areas of use), grazing, and plant life;\n\n(16) Describe proposed measures to avoid and minimize incidental take of Federally listed and candidate species and species of concern, including eagles and migratory birds; and\n\n(17) Include copies of any correspondence not otherwise provided pursuant to this paragraph (h) containing recommendations from appropriate Federal, State, and local fish and wildlife agencies to avoid or limit impact on wildlife, fish, fisheries, habitats, and plants, and the project proponent's response to those recommendations.\n\n(i)  Resource Report 4\u2014Cultural resources.  This report should describe the location of known cultural and historic resources, previous surveys and listings of cultural and historic resources, the potential effects that construction, operation, and maintenance of the proposed project will have on those resources, and initial recommendations for avoidance and minimization measures to address potential effects to those resources. The information provided in Resource Report 4 will contribute to the satisfaction of DOE's and relevant Federal entities' obligations under section 106 of the NHPA.\n\n(1) Resource Report 4 must contain:\n\n(i) A summary of known cultural and historic resources in the applicable analysis area including but not limited to those listed or eligible for listing on the National Register of Historic Places, such as properties of religious and cultural significance to Indian Tribes, and any material remains of past human life or activities that are of an archeological interest;\n\n(ii) A description of potential effects that construction, operation, and maintenance of the proposed project will have on resources identified in paragraph (i)(1)(i) of this section;\n\n(iii) Documentation of the project proponent's initial communications and engagement, including preliminary outreach and coordination, with Indian Tribes, indigenous peoples, THPOs, SHPOs, communities of interest, and other entities having knowledge of, interest regarding, or an understanding about the resources identified in paragraph (i)(1)(i) of this section and any written comments from SHPOs, THPOs, other Tribal historic preservation offices or governments, or others, as appropriate and available;\n\n(iv) Recommended avoidance and minimization measures to address potential effects of the proposed project;\n\n(v) Any relevant existing surveys or listings of cultural and historic resources in the affected environment; and\n\n(vi) Recommendations for any additional surveys needed; and\n\n(vii) A description, by milepost, of any area that has not been surveyed due to a denial of access by landowners.\n\n(2) The project proponent must update this report with the results of any additional surveys that the project proponent chooses to undertake, as identified in in paragraph (i)(1)(vi) of this section, after the initial submission of this report.\n\n(3) The project proponent must request confidential treatment for all material filed with DOE containing non-public location, character, and ownership information about cultural resources in accordance with \u00a7 900.4(h).\n\n(j)  Resource Report 5\u2014Socioeconomics.  This report should identify and quantify the impacts of constructing and operating the proposed project on the demographics and economics of communities in the applicable analysis area, including minority and underrepresented communities. Resource Report 5 must:\n\n(1) Describe the socioeconomic resources that may be affected in the applicable analysis area;\n\n(2) Describe the positive and adverse socioeconomic impacts of the proposed project;\n\n(3) Evaluate the impact of any substantial migration of people into the applicable analysis area on governmental facilities and services and describe plans to reduce the impact on the local infrastructure;\n\n(4) Describe on-site labor requirements during construction and operation, including projections of the number of construction personnel who currently reside within the applicable analysis area, who would commute daily to the site from outside the analysis area, or who would relocate temporarily within the analysis area;\n\n(5) Determine whether existing affordable housing within the applicable analysis area is sufficient to meet the needs of the additional population; and\n\n(6) Describe the number and types of residences and businesses that would be displaced by the proposed project, procedures to be used to acquire these properties, and types and amounts of relocation assistance payments.\n\n(k)  Resource Report 6\u2014Tribal interests.  This report must identify the Indian Tribes and indigenous communities that may be affected by the construction, operation, and maintenance of the project facilities, including those Indian Tribes and indigenous communities that may attach religious and cultural significance to cultural resources within the project area. In developing this report, the project proponent should consider both Indian Tribes with contemporary presence in the project area and Indian Tribes with historic connections to the area. To the extent Indian Tribes and indigenous communities are willing to communicate and share resource information, this report must discuss the potential impacts of project construction, operation, and maintenance on Indian Tribes and Tribal interests. This discussion must include impacts to sacred sites and Treaty rights, impacts related to enumerated resources and areas identified in the resource reports listed in this section (for instance, water rights, access to property, wildlife and ecological resources, etc.), and set forth available information on any additional, relevant traditional cultural and religious resources that could be affected by the proposed electric transmission project that are not already addressed. This resource report should acknowledge existing relationships between adjacent and underlying Federal land management agencies and the Indian Tribes. In developing this report, the project proponent should engage the Federal land manager early to leverage existing relationships. Specific site or property locations, the disclosure of which may create a risk of harm, theft, or destruction of archaeological or Native American cultural resources and information which would violate any Federal law, including section 9 of the Archaeological Resources Protection Act of 1979 (Pub. L. 96-95, as amended) (16 U.S.C. 470hh) and section 304 of the NHPA (54 U.S.C. 307103), should be submitted consistent with \u00a7 900.4(h). The project proponent must request confidential treatment for all material filed with DOE containing non-public location, character, and ownership information about Tribal resources in accordance with \u00a7 900.4(h).\n\n(l)  Resource Report 7\u2014Communities of Interest.  This report must summarize best available information about the presence of communities of interest. The resource report must identify and describe the potential impacts of constructing, operating, and maintaining the proposed electric transmission project on communities of interest; and describe any proposed mitigation approaches for such impacts or community concerns. The report must include a discussion of any disproportionate and/or adverse human health or environmental impacts to communities of interest.\n\n(m)  Resource Report 8\u2014Geological resources and hazards.  This report should describe geological resources that might be directly or indirectly affected by the proposed electric transmission project and methods to reduce those effects. The report should also describe geological hazards that could place project facilities at risk and methods proposed to mitigate those risks. Resource Report 8 must:\n\n(1) Describe geological resources in the applicable analysis area that are currently or potentially exploitable, if relevant;\n\n(2) Identify, by milepost, existing and potential geological hazards and areas of nonroutine geotechnical concern in the applicable analysis area, such as high seismicity areas, active faults, and areas susceptible to soil liquefaction; planned, active, and abandoned mines; karst terrain (including significant caves protected under the Federal Cave Resources Protection Act (Pub. L. 100-691, as amended) (16 U.S.C. 4301  et seq. )); and areas of potential ground failure, such as subsidence, slumping, and land sliding;\n\n(3) Discuss the risks posed to the proposed project from each hazard or area of nonroutine geotechnical concern identified in paragraph (m)(2) of this section;\n\n(4) Describe how the proposed project would be located or designed to avoid or minimize adverse effects to geological resources and reduce risk to project facilities, including geotechnical investigations and monitoring that would be conducted before, during, and after construction;\n\n(5) Discuss the potential for blasting to affect structures and the measures to be taken to remedy such effects; and\n\n(6) Specify methods to be used to prevent project-induced contamination from mines or from mine tailings along the right-of-way and discuss whether the proposed project would hinder mine reclamation or expansion efforts.\n\n(n)  Resource Report 9\u2014Soil resources.  This report should describe the soils that could be crossed by the proposed electric transmission project, the potential effect on those soils, and the proposed mitigation approach for those effects. Resource Report 9 must:\n\n(1) List, by milepost, the soil associations that would be crossed by each potential route and describe the erosion potential, fertility, and drainage characteristics of each association;\n\n(2) For the applicable analysis area:\n\n(i) List the soil series within the area and the percentage of the area comprised of each series;\n\n(ii) List the percentage of each series which would be permanently disturbed;\n\n(iii) Describe the characteristics of each soil series; and\n\n(iv) Indicate which soil units are classified as prime or unique farmland by the USDA, Natural Resources Conservation Service;\n\n(3) Identify potential impacts from: soil erosion due to water, wind, or loss of vegetation; soil compaction and damage to soil structure resulting from movement of construction vehicles; wet soils and soils with poor drainage that are especially prone to structural damage; damage to drainage tile systems due to movement of construction vehicles and trenching activities; and interference with the operation of agricultural equipment due to the probability of large stones or blasted rock occurring on or near the surface as a result of construction;\n\n(4) Identify, by milepost, cropland and residential areas where loss of soil fertility due to trenching and backfilling could occur; and\n\n(5) Describe the proposed mitigation approach to reduce the potential for adverse impact to soils or agricultural productivity.\n\n(o)  Resource Report 10\u2014Land use, recreation, and aesthetics.  This report should describe the existing uses of land that may be impacted by the proposed project, and changes to those land uses and impacts to inhabitants and users that would occur if the proposed electric transmission project is approved. Resource Report 10 must:\n\n(1) Describe the width and acreage requirements of all construction and permanent rights-of-way required for project construction, operation, and maintenance;\n\n(2) List existing rights-of-way that would be co-located with or adjacent to the proposed rights-of-way (including temporary construction lines), and any required utility coordination, permits, and fees that would be associated as a result;\n\n(3) Identify, preferably by diagrams, existing rights-of-way that are expected to be used for any portion of the construction or operational right-of-way, the overlap, and how much additional width is expected to be required;\n\n(4) Identify the total amount of land to be purchased or leased for each project facility, the amount of land that would be disturbed for construction, operation, and maintenance of the facility, and the use of the remaining land not required for project operation and maintenance, if any;\n\n(5) Identify the size of typical staging areas and expanded work areas, such as those at railroad, road, and waterbody crossings, and the size and location of all construction materials storage yards and access roads;\n\n(6) Identify, by milepost, the existing use of:\n\n(i) Lands crossed by or adjacent to each project facility; and\n\n(ii) Lands on which a project facility is expected to be located;\n\n(7) Describe:\n\n(i) Planned development within the applicable analysis area that is either included in a master plan or on file with the local planning board or the county;\n\n(ii) The time frame (if available) for such development; and\n\n(iii) Proposed coordination to minimize impacts on land use due to such development;\n\n(8) Identify areas within applicable analysis areas that:\n\n(i) Are owned or controlled by Federal, State or local agencies, or private preservation groups;\n\n(ii) Are directly affected by the proposed project or any project facilities or operational sites; and\n\n(iii) Have special designations not otherwise mentioned in other resource reports.\n\n(iv) Examples of such specially designated areas under this provision may include but are not limited to sugar maple stands, orchards and nurseries, landfills, hazardous waste sites, nature preserves, conservation or agricultural lands subject to conservation or agricultural easements or restrictions, game management areas, remnant prairie, old-growth forest, national or State forests, parks, designated natural, recreational or scenic areas, registered natural landmarks, and areas managed by Federal entities under existing land use plans as Visual Resource Management Class I or Class II areas;\n\n(9) Identify Indian Tribes and indigenous communities that may be affected by the proposed project;\n\n(10) Describe Tribal and indigenous community resources lands, interests, and established treaty rights that may be affected by the proposed project;\n\n(11) Identify properties within the project area which may hold cultural or religious significance for Indian Tribes and indigenous communities, regardless of whether the property is on or off of any Federally recognized Indian reservation;\n\n(12) Identify resources within the applicable analysis area that are included in, or are designated for study for inclusion in, if available: the National Wild and Scenic Rivers System (16 U.S.C. 1271), the National Wildlife Refuge System (16 U.S.C. 668dd), the National Wilderness Preservation System (16 U.S.C. 1131), the National Trails System (16 U.S.C. 1241-1251), the National Park System (54 U.S.C. 100101-120104), National Historic Landmarks (NHLs), National Natural Landmarks (NNLs), Land and Water Conservation Fund (LWCF) acquired Federal lands, LWCF State Assistance Program sites and the Federal Lands to Parks (FLP) program lands, or a wilderness area designated under the Wilderness Act (16 U.S.C. 1131-1136); or the National Marine Sanctuary System, including national marine sanctuaries (16 U.S.C. 1431-1445c-1.) and Marine National Monuments as designated under authority by the Antiquities Act (54 U.S.C. 320301-320303) or by Congress; National Forests and Grasslands (16 U.S.C. 1609  et seq ); and lands in easement programs managed by the Natural Resource Conservation Service or the U.S. Forest Service (16 U.S.C. 3865,  et seq. );\n\n(13) Indicate whether the project proponent will need to submit a CZMA Federal consistency certification to State coastal management program(s) for the project, as required by NOAA's Federal consistency regulations at 15 CFR part 930, subpart D;\n\n(14) Describe the impacts the proposed project will have on:\n\n(i) Present uses of land in the applicable analysis area, including commercial uses, mineral resource uses, and recreational uses,\n\n(ii) Public health and safety;\n\n(iii) Federal, State, and Tribal scientific survey, research, and observation activities;\n\n(iv) Sensitive resources and critical habitats;\n\n(v) The aesthetic value of the land and its features; and\n\n(vi) Federal, State or Tribal access limitations.\n\n(15) Describe any temporary or permanent restrictions on land use that would result from the proposed project.\n\n(16) Describe the proposed mitigation approach intended to address impacts described in paragraphs (o)(12) and (13) of this section, as well as protection and enhancement of existing land use;\n\n(17) Provide a proposed operations and maintenance plan for vegetation management, including management of noxious and invasive species;\n\n(18) Describe the visual characteristics of the lands and waters affected by the proposed project. Components of this description include a description of how permanent project facilities will impact the visual character of proposed project right-of-way and surrounding vicinity, and measures proposed to lessen these impacts. Project proponents are encouraged to supplement the text description with visual aids;\n\n(19) Identify, by milepost, all residences and buildings near the proposed electric transmission facility construction right-of-way, and identify the distance of the residence or building from the edge of the right-of-way and provide survey drawings or alignment sheets to illustrate the location of the proposed facility in relation to the buildings;\n\n(20) List all dwellings and related structures, commercial structures, industrial structures, places of worship, hospitals, nursing homes, schools, or other structures normally inhabited by humans or intended to be inhabited by humans on a regular basis within the applicable analysis area and provide a general description of each habitable structure and its distance from the centerline of the proposed project. In cities, towns, or rural subdivisions, houses can be identified in groups, and the report must provide the number of habitable structures in each group and list the distance from the centerline to the closest habitable structure in the group;\n\n(21) List all known commercial AM radio transmitters located within the applicable analysis area and all known FM radio transmitters, microwave relay stations, or other similar electronic installations located within the analysis area; provide a general description of each installation and its distance from the centerline of the proposed project; and locate all installations on a routing map; and\n\n(22) List all known private airstrips within the applicable analysis area and all airports registered with the Federal Aviation Administration (FAA) with at least one runway more than 3,200 feet in length that are located within the analysis area. Indicate whether any transmission structures will exceed a 100:1 horizontal slope (one foot in height for each 100 feet in distance) from the closest point of the closest runway. List all airports registered with the FAA having no runway more than 3,200 feet in length that are located within the analysis area. Indicate whether any transmission structures will exceed a 50:1 horizontal slope from the closest point of the closest runway. List all heliports located within the analysis area. Indicate whether any transmission structures will exceed a 25:1 horizontal slope from the closest point of the closest landing and takeoff area of the heliport. Provide a general description of each private airstrip, registered airport, and registered heliport, and state the distance of each from the centerline of the proposed transmission line. Locate all airstrips, airports, and heliports on a routing map.\n\n(23) Information made available under paragraphs (o)(9), (10), and (11) must be submitted consistent with \u00a7 900.4(h), including information regarding specific site or property locations, the disclosure of which will create a risk of harm, theft, or destruction of archaeological or Native American cultural resources and information which would violate any Federal law, including section 9 of the Archaeological Resources Protection Act of 1979 (Pub. L. 96-95, as amended) (16 U.S.C. 470hh) and section 304 of the NHPA (54 U.S.C. 307103).\n\n(p)  Resource Report 11\u2014Air quality and noise effects.  This report should identify the effects of the proposed electric transmission project on the existing air quality and noise environment and describe proposed measures to mitigate the effects. Resource Report 11 must:\n\n(1) Describe the existing air quality in the applicable analysis area, indicate if any project facilities are located within a designated nonattainment or maintenance area under the Clean Air Act (42 U.S.C. 7401  et seq. ), and provide the distance from the project facilities to any Class I area in the project area;\n\n(2) Estimate emissions from the proposed project and the corresponding impacts on air quality and the environment;\n\n(i) Estimate the reasonably foreseeable emissions, including greenhouse gas emissions, from construction, operation, and maintenance of the project facilities (such as emissions from tailpipes, equipment, fugitive dust, open burning, and substations) expressed in tons per year; include supporting calculations, emissions factors, fuel consumption rates, and annual hours of operation;\n\n(ii) Estimate the reasonably foreseeable change in greenhouse gas emissions from the existing, proposed, and reasonably foreseeable generation resources identified in Resource Report 1 (see paragraph (f) of this section) that may connect to the proposed project or interconnect as a result of the proposed project, if any, as well as any other modeled air emissions impacts;\n\n(iii) For each designated nonattainment or maintenance area, provide a comparison of the emissions from construction, operation, and maintenance of the proposed project with the applicable General Conformity thresholds (40 CFR part 93);\n\n(iv) Identify the corresponding impacts on communities and the environment in the applicable analysis area from the estimated emissions;\n\n(v) Describe any proposed mitigation measures to control emissions identified under this section; and\n\n(vi) Estimate the reasonably foreseeable effect of the proposed project on indirect emissions;\n\n(3) Describe existing noise levels at noise-sensitive areas in the applicable analysis area, such as schools, hospitals, residences, and any areas covered by relevant State or local noise ordinances;\n\n(i) Report existing noise levels as the a-weighted decibel (dBA) Leq (day), Leq (night), and Ldn (day-night sound level) and include the basis for the data or estimates;\n\n(ii) Include a plot plan that identifies the locations and duration of noise measurements, the time of day, weather conditions, wind speed and direction, engine load, and other noise sources present during each measurement; and\n\n(iii) Identify any noise regulations that may be applicable to the proposed project;\n\n(4) Estimate the impact of the proposed project on the noise environment;\n\n(i) Provide a quantitative estimate of the impact of transmission line operation on noise levels at the edge of the proposed right-of-way, including corona, insulator, and Aeolian noise; and provide a quantitative estimate of the impact of operation of proposed substations and appurtenant project facilities on noise levels at nearby noise-sensitive areas, including discrete tones;\n\n(A) Include step-by-step supporting calculations or identify the computer program used to model the noise levels, the input and raw output data and all assumptions made when running the model, far-field sound level data for maximum facility operation (either from the manufacturer or from far-field sound level data measured from similar project facilities in service elsewhere) and the source of the data;\n\n(B) Include sound pressure levels for project facilities, dynamic insertion loss for structures, and sound attenuation from the project facilities to the edge of the right-of-way or to nearby noise-sensitive areas (as applicable);\n\n(ii) Describe the impact of proposed construction activities, including any nighttime construction, on the noise environment; estimate the impact of any horizontal directional drilling, pile driving, or blasting on noise levels at nearby noise-sensitive areas and include supporting assumptions and calculations;\n\n(5) Based on noise estimates, indicate whether the proposed project will comply with applicable noise regulations and whether noise attributable to any proposed substation or appurtenant facility will exceed permissible levels at any pre-existing noise-sensitive area;\n\n(6) Based on noise estimates, determine whether any wildlife-specific noise thresholds may have an impact on the proposed project, such as those thresholds specific to avian species that may be relevant in significant wildlife areas, if appropriate; and\n\n(7) Describe measures, and manufacturer's specifications for equipment, proposed to mitigate noise effects and impacts to air quality, including emission control systems, installation of filters, mufflers, or insulation of piping and buildings, and orientation of equipment away from noise-sensitive areas.\n\n(q)  Resource Report 12\u2014Alternatives.  This report should describe the range of study corridors that were considered as alternatives during the planning, identification, and design of the proposed electric transmission project and compare the environmental impacts of such corridors and the routes contained in those corridors. This analysis may inform the relevant Federal entities' subsequent analysis of their alternatives during the NEPA process. Resource Report 12 must:\n\n(1) Identify all study corridors and routes contained within those corridors. The report must identify the location of the corridors on maps of sufficient scale to depict their location and relationship to the proposed project, and the relationship of the proposed electric transmission facility to existing rights-of-way;\n\n(2) Discuss the \u201cno action\u201d alternative and the potential for accomplishing the proponent's proposed objectives using alternative means;\n\n(3) Discuss design and construction methods considered by the project proponent;\n\n(4) Identify all the alternative study corridors and routes the project proponent considered in the initial screening for the proposed project but did not recommend for further study and the reasons why the proponent chose not to examine such alternatives.\n\n(5) For alternative study corridors and routes recommended for more in-depth consideration, the report must:\n\n(i) Describe the potential impacts to cultural and historic resources for each alternative;\n\n(ii) Describe the environmental characteristics of each alternative, provide comparative tables showing the differences in environmental characteristics for the alternatives, and include an analysis of the potential relative environmental impacts for each alternative;\n\n(iii) Provide an explanation of the costs to construct, operate, and maintain each alternative, the potential for each alternative to meet project deadlines, and technological and procedural constraints in developing the alternatives; and\n\n(iv) Demonstrate whether and how environmental benefits and costs were weighed against economic benefits and costs to the public.\n\n(r)  Resource Report 13\u2014Reliability, resilience, and safety.  This report should describe the impacts that would result from a failure of the proposed electric transmission facility, the measures, procedures, and features that would reduce the risk of failure, and measures in place to reduce impacts and protect the public if a failure did occur. Resource Report 13 must:\n\n(1) Discuss events that could result in a failure of the proposed facility, including accidents, intentional destructive acts, and natural catastrophes (accounting for the likelihood of relevant natural catastrophes resulting from climate change);\n\n(2) Describe the reasonably foreseeable impacts that would result from a failure of the proposed electric transmission facility, including hazards to the public, environmental impacts, and service interruptions;\n\n(3) Describe the operational measures, procedures, and design features of the proposed project that would reduce the risk of facility failure;\n\n(4) Describe measures proposed to protect the public from failure of the proposed facility (including coordination with local agencies);\n\n(5) Discuss contingency plans for maintaining service or reducing downtime;\n\n(6) Describe measures used to exclude the public from hazardous areas, measures used to minimize problems arising from malfunctions and accidents (with estimates of probability of occurrence), and identify standard procedures for protecting services and public safety during maintenance and breakdowns; and\n\n(7) Describe improvements to reliability likely to result from the proposed project."], ["10:10:5.0.2.5.37.0.16.7", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.7 Standard and project-specific schedules.", "DOE", "", "", "", "(a) DOE shall publish, and update from time to time, a standard schedule that identifies the steps generally needed to complete decisions on all Federal environmental reviews and authorizations for a proposed electric transmission project. The standard schedule will include recommended timing for each step so as to allow final decisions on all Federal authorizations within two years of the publication of a notice of intent to prepare an environmental review document under \u00a7 900.9 or as soon as practicable thereafter, considering the requirements of relevant Federal laws, and the need for robust analysis of proposed project impacts, early and meaningful consultation with potentially affected Indian Tribes and engagement with stakeholders and communities of interest.\n\n(b) During the Integrated Interagency Pre-Application (IIP) Process, DOE, in coordination with any NEPA joint lead agency and relevant Federal entities, shall prepare a project-specific schedule that is informed by the standard schedule prepared under paragraph (a) of this section and that establishes prompt and binding intermediate milestones and ultimate deadlines for the review of, and Federal authorization decisions relating to, a proposed electric transmission project, accounting for relevant statutory requirements, the potential route, reasonable alternative potential routes, if any, the need to assess and address any impacts to military testing, training, and operations, and other factors particular to the specific proposed project, including the need for early and meaningful consultation with potentially affected Indian Tribes and engagement with stakeholders and communities of interest. DOE may revise the project-specific schedule as needed to satisfy applicable statutory requirements, allow for engagement with stakeholders and communities of interest, and account for delays caused by the actions or inactions of the project proponent."], ["10:10:5.0.2.5.37.0.16.8", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.8 IIP Process review meeting.", "DOE", "", "", "", "(a) An Integrated Interagency Pre-Application (IIP) Process review meeting is required for each proposed electric transmission project utilizing the IIP Process and may only be held after the project proponent submits a review meeting request to DOE. The project proponent may submit the request at any time following submission of the initial resource reports required under \u00a7 900.6. The review meeting request must include:\n\n(1) A summary table of changes made to the proposed project since the IIP Process initial meeting, including potential environmental and community benefits from improved siting or design;\n\n(2) Maps of potential routes and study corridors, including the proposed line, substations, and other infrastructure, as applicable, with at least as much detail as required for the initiation request described by \u00a7 900.5 and as modified in response to early stakeholder input and outreach and feedback from relevant Federal entities and relevant non-Federal entities;\n\n(3) If known, a schedule for completing any upcoming field resource surveys, as appropriate;\n\n(4) A conceptual plan for implementation and monitoring of proposed mitigation measures to avoid, minimize, or compensate for effects of the proposed project, consistent with 40 CFR 1508.1(s) or any successor regulation. This may include compensatory mitigation measures (offsite and onsite);\n\n(5) An updated public engagement plan described in \u00a7 900.5(d)(2), reflecting actions undertaken since the project proponent submitted the initiation request and input received from relevant Federal entities and relevant non-Federal entities;\n\n(6) A listing of:\n\n(i) The dates on which the project proponent filed applications or requests for Federal authorizations and the dates on which the project proponent filed revisions to previously filed applications or requests; and\n\n(ii) Estimated dates for filing remaining applications or requests for Federal authorization;\n\n(7) Estimated dates that the project proponent will file requests for authorizations and consultations with relevant non-Federal entities; and\n\n(8) A proposed duration for each Federal land use authorization expected to be required for the proposed project, commensurate with the anticipated use of the proposed electric transmission facility.\n\n(b) Not later than 10 calendar days after the date that DOE receives the review meeting request, DOE shall provide relevant Federal entities and relevant non-Federal entities with materials included in the request and the initial resource reports submitted under \u00a7 900.6 via electronic means.\n\n(c) Not later than 60 calendar days after the date that DOE receives the review meeting request, DOE shall:\n\n(1) Determine whether the meeting request meets the requirements of paragraph (a) of this section and whether the initial resource reports are sufficiently detailed; and\n\n(2) Give notice to the project proponent and relevant Federal and non-Federal entities of DOE's determinations under paragraph (c)(1) of this section.\n\n(d) If DOE determines under paragraph (c)(1) of this section that the meeting request does not meet the requirements of paragraph (a) of this section or that the initial resource reports are not sufficiently detailed, DOE must provide the reasons for that finding and a description of how the project proponent may address any deficiencies in the meeting request or resource reports so that DOE may reconsider its determination.\n\n(e) Not later than 15 calendar days after the date that DOE provides notice to the project proponent under paragraph (c) of this section that the review meeting request and initial resource reports have been accepted, DOE shall convene the review meeting with the project proponent and the relevant Federal entities. All relevant non-Federal entities participating in the IIP Process shall also be invited.\n\n(f) During the IIP Process review meeting:\n\n(1) The relevant Federal entities shall discuss, and modify if needed, the analysis areas used in the initial resource reports;\n\n(2) Relevant Federal entities shall identify any remaining issues of concern, known information gaps or data needs, and potential issues or conflicts that could impact the time it will take the relevant Federal entities to process applications for Federal authorizations for the proposed electric transmission project;\n\n(3) Relevant non-Federal entities may identify remaining issues of concern, information needs, and potential issues or conflicts for the project;\n\n(4) The participants shall discuss the project proponent's updates to the siting process to date, including stakeholder outreach activities, resultant stakeholder input, and project proponent response to stakeholder input;\n\n(5) Led by DOE, all relevant Federal entities shall discuss statutory and regulatory standards that must be met to make decisions for Federal authorizations required for the proposed project;\n\n(6) Led by DOE, all relevant Federal entities shall describe the process for, and estimated time to complete, required Federal authorizations and, where possible, the anticipated cost ( e.g.,  processing and monitoring fees and land use fees);\n\n(7) Led by DOE, all relevant Federal entities shall describe their expectations for complete applications for Federal authorizations for the proposed project;\n\n(8) Led by DOE, all relevant Federal entities shall identify necessary updates to the initial resource reports that must be made before conclusion of the IIP Process, or, as necessary, following conclusion of the IIP Process; and\n\n(9) DOE shall present the proposed project-specific schedule developed under \u00a7 900.7.\n\n(g) Not later than 10 calendar days after the review meeting, DOE shall:\n\n(1) Prepare a draft review meeting summary that includes a summary of the meeting discussion, a description of key issues and information gaps identified during the meeting, and any requests for more information from relevant Federal entities and relevant non-Federal entities; and\n\n(2) Convey the draft summary to the project proponent, relevant Federal entities, and any non-Federal entities that participated in the meeting.\n\n(h) The project proponent and entities that received the draft review meeting summary under paragraph (g) of this section will have 10 calendar days following receipt of the draft to review the draft and provide corrections to DOE.\n\n(i) Not later than 10 calendar days following the close of the 10-day review period under paragraph (h) of this section, DOE shall:\n\n(1) Prepare a final review meeting summary incorporating received corrections, as appropriate;\n\n(2) Add the final summary to the consolidated administrative docket described by \u00a7 900.10; and\n\n(3) Provide an electronic copy of the summary to the relevant Federal entities, relevant non-Federal entities, and the project proponent.\n\n(j) Not later than 10 calendar days following the close of the 10-day review period under paragraph (h) of this section, DOE shall:\n\n(1) determine whether the project proponent has developed the scope of its proposed project and alternatives sufficiently for DOE to determine that there exists an undertaking for purposes of section 106 of the NHPA; and\n\n(2) if the scope is sufficiently developed, initiate consultation with SHPOs, THPOs, and others consistent with 36 CFR 800.2(c)(4), which may include authorizing a project proponent, as a CITAP applicant, to initiate section 106 consultation and providing appropriate notifications.\n\n(k) After the review meeting and before the IIP Process close-out meeting described by \u00a7 900.9 the project proponent shall revise resource reports submitted under \u00a7 900.6 based on feedback from relevant Federal entities and relevant non-Federal entities received during the review meeting and based on any updated surveys conducted since the initial meeting."], ["10:10:5.0.2.5.37.0.16.9", 10, "Energy", "III", "", "900", "PART 900\u2014COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES", "", "", "", "\u00a7 900.9 IIP Process close-out meeting.", "DOE", "", "", "", "(a) An Integrated Interagency Pre-Application (IIP) Process close-out meeting concludes the IIP Process for a proposed electric transmission project and may only be held after the project proponent submits a close-out meeting request to DOE. The project proponent may submit the request at any time following the submission of the updated resource reports as required under \u00a7 900.8. The close-out meeting request shall include:\n\n(1) A summary table of changes made to the proposed project during the IIP Process, including potential environmental and community benefits from improved siting or design;\n\n(2) A description of all changes made to the proposed project since the review meeting, including a summary of changes made to the updated resource reports in response to the concerns raised during the review meeting;\n\n(3) A final public engagement plan, as described in \u00a7 900.5(d)(2);\n\n(4) Requests for Federal authorizations for the proposed project; and\n\n(5) An updated estimated timeline of filing requests for all other authorizations and consultations with non-Federal entities.\n\n(b) Not later than 10 calendar days after the date that DOE receives the close-out meeting request, DOE shall provide relevant Federal entities and relevant non-Federal entities with materials included in the request and any updated resource reports submitted under \u00a7 900.6 via electronic means.\n\n(c) Not later than 60 calendar days after the date that DOE receives the close-out meeting request, DOE shall:\n\n(1) Determine whether the meeting request meets the requirements of paragraph (a) of this section and whether the updated resource reports are sufficiently detailed; and\n\n(2) Give notice to the project proponent and relevant Federal and non-Federal entities of DOE's determinations under paragraph (c)(1) of this section.\n\n(d) If DOE determines that the meeting request does not meet the requirements of paragraph (a) of this section or that the updated resource reports are not sufficiently detailed, DOE must provide the reasons for that finding and a description of how the project proponent may address any deficiencies in the meeting request or resource reports so that DOE may reconsider its determination.\n\n(e) Not later than 15 calendar days after the date that DOE provides notice to the project proponent under paragraph (c) of this section that the close-out meeting request and updated resource reports have been accepted, DOE shall convene the close-out meeting with the project proponent and all relevant Federal entities. All relevant non-Federal entities participating in the IIP Process shall also be invited.\n\n(f) The IIP Process close-out meeting concludes the IIP Process. During the close-out meeting:\n\n(1) The participants shall discuss the project proponent's updates to the siting process to date, including stakeholder outreach activities, resultant stakeholder input, and project proponent response to stakeholder input; and\n\n(2) DOE shall present the final project-specific schedule.\n\n(g) Not later than 10 calendar days after the close-out meeting, DOE shall:\n\n(1) Prepare a draft close-out meeting summary; and\n\n(2) Convey the draft summary to the project proponent, relevant Federal entities, and any non-Federal entities that participated in the meeting.\n\n(h) The project proponent and entities that received the draft close-out meeting summary under paragraph (g) of this section will have 10 calendar days following receipt of the draft to review the draft and provide corrections to DOE.\n\n(i) Not later than 10 calendar days following the close of the 10-day review period under paragraph (h) of this section, DOE shall:\n\n(1) Prepare a final close-out meeting summary by incorporating received corrections, as appropriate;\n\n(2) Add the final summary to the consolidated administrative docket described by \u00a7 900.10;\n\n(3) Provide an electronic copy of the summary to all relevant Federal entities, relevant non-Federal entities, and the project proponent; and\n\n(4) In the event that the proposed project is not identified as a covered project pursuant to \u00a7 900.5(e), notify the FPISC Executive Director that the proposed project ought to be included on the FPISC Dashboard as a transparency project.\n\n(j) DOE and any NEPA joint lead agency shall issue a Notice of Intent to prepare an environmental review document for the proposed project within 90 days of the later of the IIP Process close-out meeting or the receipt of a complete application for a Federal authorization for which NEPA review will be required, as consistent with the final project-specific schedule.\n\n(k) DOE shall issue, for each Federal land use authorization for a proposed electric transmission facility, a preliminary duration determination commensurate with the anticipated use of the proposed facility."], ["20:20:4.0.4.3.1.0.117.1", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.1 Basis.", "JBEA", "", "", "", "This statement is issued by the Joint Board for the Enrollment of Actuaries (the Joint Board) pursuant to the requirement of section 552 of title 5 of the United States Code that every agency shall publish in the  Federal Register  a description of its central and field organization."], ["20:20:4.0.4.3.1.0.117.2", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.2 Establishment.", "JBEA", "", "", "", "The Joint Board has been established by the Secretary of Labor and the Secretary of the Treasury pursuant to section 3041 of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1241). Bylaws of the Board have been issued by the two Secretaries. \n 1\n\n1  Copy filed with the Office of the Federal Register. Copies may also be obtained from the Executive Director of the Board."], ["20:20:4.0.4.3.1.0.117.3", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.3 Composition.", "JBEA", "", "", "[81 FR 8833, Feb. 23, 2016]", "Pursuant to the Bylaws, the Joint Board consists of three members appointed by the Secretary of the Treasury and two members appointed by the Secretary of Labor. The Board elects a Chairman and a Secretary from among the Department of the Treasury and the Department of Labor members. The Pension Benefit Guaranty Corporation may designate a non-voting representative to sit with, and participate in, the discussions of the Board. All decisions of the Board are made by simple majority vote."], ["20:20:4.0.4.3.1.0.117.4", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.4 Meetings.", "JBEA", "", "", "", "The Joint Board meets on the call of the Chairman at such times as are necessary in order to consider matters requiring action. Minutes are kept of each meeting by the Secretary."], ["20:20:4.0.4.3.1.0.117.5", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.5 Staff.", "JBEA", "", "", "", "(a) The Executive Director advises and assists the Joint Board directly in carrying out its responsibilities under the Act and performs such other functions as the Board may delegate to him.\n\n(b) Members of the staffs of the Departments of the Treasury and of Labor, by arrangement with the Joint Board, perform such services as may be appropriate in assisting the Board in the discharge of its responsibilities."], ["20:20:4.0.4.3.1.0.117.6", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.6 Offices.", "JBEA", "", "", "", "The Joint Board does not maintain offices separate from those of the Departments of the Treasury and Labor. Its post office address is Joint Board for the Enrollment of Actuaries, c/o Department of the Treasury, Washington, D.C. 20220."], ["20:20:4.0.4.3.1.0.117.7", 20, "Employees' Benefits", "VIII", "", "900", "PART 900\u2014STATEMENT OF ORGANIZATION", "", "", "", "\u00a7 900.7 Delegations of authority.", "JBEA", "", "", "", "As occasion warrants, the Joint Board may delegate functions to the Chairman or the Executive Director, including the authority to receive applications and to give notice of actions. Any such delegation of authority is conferred by resolution of the Board."], ["21:21:8.0.1.2.36.1.1.1", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.1 Scope.", "FDA", "", "", "", "The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part establishes procedures whereby an entity can apply to become a Food and Drug Administration (FDA)-approved accreditation body to accredit facilities to be eligible to perform screening or diagnostic mammography services. Subpart A further establishes requirements and standards for accreditation bodies to ensure that all mammography facilities under the jurisdiction of the United States are adequately and consistently evaluated for compliance with national quality standards for mammography. Subpart B of this part establishes minimum national quality standards for mammography facilities to ensure safe, reliable, and accurate mammography. The regulations set forth in this part do not apply to facilities of the Department of Veterans Affairs."], ["21:21:8.0.1.2.36.1.1.2", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.2 Definitions.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 32407, June 17, 1999; 67 FR 5467, Feb. 6, 2002; 88 FR 15168, Mar. 10, 2023]", "The following definitions apply to subparts A, B, and C of this part:\n\n(a)  Accreditation body  or  body  means an entity that has been approved by FDA under \u00a7 900.3(d) to accredit mammography facilities.\n\n(b)  Action limits  or  action levels  means the minimum and maximum values of a quality assurance measurement that can be interpreted as representing acceptable performance with respect to the parameter being tested. Values less than the minimum or greater than the maximum action limit or level indicate that corrective action must be taken by the facility. Action limits or levels are also sometimes called control limits or levels.\n\n(c)  Adverse event  means an undesirable experience associated with mammography activities within the scope of 42 U.S.C. 263b. Adverse events include but are not limited to:\n\n(1) Poor image quality;\n\n(2) Failure to send mammography reports within 30 days to the referring healthcare provider or in a timely manner to the self-referred patient; and\n\n(3) Use of personnel that do not meet the applicable requirements of \u00a7 900.12(a).\n\n(d)  Air kerma  means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy). For X-rays with energies less than 300 kiloelectron volts (keV), 1 Gy = 100 rad. In air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of exposure.\n\n(e)  Breast implant  means a prosthetic device implanted in the breast.\n\n(f)  Calendar quarter  means any one of the following time periods during a given year: January 1 through March 31, April 1 through June 30, July 1 through September 30, or October 1 through December 31.\n\n(g)  Category I  means medical educational activities that have been designated as Category I by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization.\n\n(h)  Certificate  means the certificate described in \u00a7 900.11(a).\n\n(i)  Certification  means the process of approval of a facility by FDA or a certification agency to provide mammography services.\n\n(j)  Clinical image  means a mammogram.\n\n(k)  Consumer  means an individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient ( e.g.,  family member or referring healthcare provider).\n\n(l)  Continuing education unit  or  continuing education credit  means one contact hour of training.\n\n(m)  Contact hour  means an hour of training received through direct instruction.\n\n(n)  Direct instruction  means:\n\n(1) Face-to-face interaction between instructor(s) and student(s), as when the instructor provides a lecture, conducts demonstrations, or reviews student performance; or\n\n(2) The administration and correction of student examinations by an instructor(s) with subsequent feedback to the student(s).\n\n(o)  Direct supervision  means that:\n\n(1) During joint interpretation of mammograms, the supervising interpreting physician reviews, discusses, and confirms the diagnosis of the physician being supervised and signs the resulting report before it is entered into the patient's records; or\n\n(2) During the performance of a mammography examination or survey of the facility's equipment and quality assurance program, the supervisor is present to observe and correct, as needed, the performance of the individual being supervised who is performing the examination or conducting the survey.\n\n(p)  Established operating level  means the value of a particular quality assurance parameter that has been established as an acceptable normal level by the facility's quality assurance program.\n\n(q)  Facility  means a hospital, outpatient department, clinic, radiology practice, mobile unit, office of a physician, or other facility that conducts mammography activities, including the following: Operation of equipment to produce a mammogram, processing of the mammogram, initial interpretation of the mammogram, and maintaining viewing conditions for that interpretation. This term does not include a facility of the Department of Veterans Affairs.\n\n(r)  First allowable time  means the earliest time a resident physician is eligible to take the diagnostic radiology boards from an FDA-designated certifying body. The \u201cfirst allowable time\u201d may vary with the certifying body.\n\n(s)  FDA  means the Food and Drug Administration.\n\n(t)  Interim regulations  means the regulations entitled \u201cRequirements for Accrediting Bodies of Mammography Facilities\u201d (58 FR 67558-67565) and \u201cQuality Standards and Certification Requirements for Mammography Facilities\u201d (58 FR 67565-67572), published by FDA on December 21, 1993, and amended on September 30, 1994 (59 FR 49808-49813). These regulations established the standards that had to be met by mammography facilities in order to lawfully operate between October 1, 1994, and April 28, 1999.\n\n(u)  Interpreting physician  means a licensed physician who interprets mammograms and who meets the requirements set forth in \u00a7 900.12(a)(1).\n\n(v)  Kerma  means the sum of the initial energies of all the charged particles liberated by uncharged ionizing particles in a material of given mass.\n\n(w)  Laterality  means the designation of either the right or left breast.\n\n(x)  Lead interpreting physician  means the interpreting physician assigned the general responsibility for ensuring that a facility's quality assurance program meets all of the requirements of \u00a7 900.12(d) through (f). The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the facility.\n\n(y)  Mammogram  means a radiographic image produced through mammography.\n\n(z)  Mammographic modality  means a technology, within the scope of 42 U.S.C. 263b, for radiography of the breast. Examples are screen-film mammography, full field digital mammography, and digital breast tomosynthesis.\n\n(aa)  Mammography  means radiography of the breast, but, for the purposes of this part, does not include:\n\n(1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures;\n\n(2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter; or\n\n(3) Computed tomography of the breast.\n\n(bb)  Mammography equipment evaluation  means an onsite assessment of mammography unit or image processor performance by a medical physicist for the purpose of making a preliminary determination as to whether the equipment meets all of the applicable standards in \u00a7 900.12(b) and (e).\n\n(cc)  Mammography medical outcomes audit  means a systematic collection of mammography results and the comparison of those results with outcomes data.\n\n(dd)  Mammography unit  or  units  means an assemblage of components for the production of X-rays for use during mammography, including, at a minimum: An X-ray generator, an X-ray control, a tube housing assembly, a beam limiting device, and the supporting structures for these components.\n\n(ee)  Mean optical density  means the average of the optical densities measured using phantom thicknesses of 2, 4, and 6 centimeters with values of kilovolt peak (kVp) clinically appropriate for those thicknesses.\n\n(ff)  Medical physicist  means a person trained in evaluating the performance of mammography equipment and facility quality assurance programs and who meets the qualifications for a medical physicist set forth in \u00a7 900.12(a)(3).\n\n(gg)  MQSA  means the Mammography Quality Standards Act.\n\n(hh)  Multi-reading  means two or more physicians, at least one of whom is an interpreting physician, interpreting the same mammogram.\n\n(ii)  Patient  means any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a healthcare provider or is self-referred.\n\n(jj)  Phantom  means a test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer.\n\n(kk)  Phantom image  means a radiographic image of a phantom.\n\n(ll)  Physical science  means physics, chemistry, radiation science (including medical physics and health physics), and engineering.\n\n(mm)  Positive mammogram  means a mammogram that has an overall assessment of findings that are either \u201csuspicious\u201d or \u201chighly suggestive of malignancy.\u201d\n\n(nn)  Provisional certificate  means the provisional certificate described in \u00a7 900.11(b)(2).\n\n(oo)  Qualified instructor  means an individual whose training and experience adequately prepares him or her to carry out specified training assignments. Interpreting physicians, radiologic technologists, or medical physicists who meet the requirements of \u00a7 900.12(a) would be considered qualified instructors in their respective areas of mammography. Other examples of individuals who may be qualified instructors for the purpose of providing training to meet the regulations of this part include, but are not limited to, instructors in a post-high school training institution and manufacturer's representatives.\n\n(pp)  Quality control technologist  means an individual meeting the requirements of \u00a7 900.12(a)(2) who is responsible for those quality assurance responsibilities not assigned to the lead interpreting physician or to the medical physicist.\n\n(qq)  Radiographic equipment  means X-ray equipment used for the production of static X-ray images.\n\n(rr)  Radiologic technologist  means an individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements set forth in \u00a7 900.12(a)(2).\n\n(ss)  Serious adverse event  means an adverse advent that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner.\n\n(tt)  Serious complaint  means a report of a serious adverse event.\n\n(uu)  Standard breast  means a 4.2 centimeter (cm) thick compressed breast consisting of 50 percent glandular and 50 percent adipose tissue.\n\n(vv)  Survey  means an onsite physics consultation and evaluation of a facility quality assurance program performed by a medical physicist.\n\n(ww)  Time cycle  means the film development time.\n\n(xx)  Traceable to a national standard  means an instrument is calibrated at either the National Institute of Standards and Technology (NIST) or at a calibration laboratory that participates in a proficiency program with NIST at least once every 2 years and the results of the proficiency test conducted within 24 months of calibration show agreement within \u00b13 percent of the national standard in the mammography energy range.\n\n(yy)  Review physician  means a physician who, by meeting the requirements set out in \u00a7 900.4(c)(5), is qualified to review clinical images on behalf of the accreditation body.\n\n(zz)  Certification agency  means a State that has been approved by FDA under \u00a7 900.21 to certify mammography facilities.\n\n(aaa)  Performance indicators  mean the measures used to evaluate the certification agency's ability to conduct certification, inspection, and compliance activities.\n\n(bbb)  Authorization  means obtaining approval from FDA to utilize new or changed State regulations or procedures during the issuance, maintenance, and withdrawal of certificates by the certification agency."], ["21:21:8.0.1.2.36.1.1.3", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.3 Application for approval as an accreditation body.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 85 FR 18443, Apr. 2, 2020]", "(a)  Eligibility.  Private nonprofit organizations or State agencies capable of meeting the requirements of this subpart A may apply for approval as accreditation bodies.\n\n(b)  Application for initial approval.  (1) An applicant seeking initial FDA approval as an accreditation body shall inform the Division of Mammography Quality Standards, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993, Attn: Program Management Branch, of its desire to be approved as an accreditation body and of its requested scope of authority.\n\n(2) Following receipt of the request, FDA will provide the applicant with additional information to aid in submission of an application for approval as an accreditation body.\n\n(3) The applicant shall furnish to FDA, at the address in \u00a7 900.3(b)(1), three copies of an application containing the following information, materials, and supporting documentation:\n\n(i) Name, address, and phone number of the applicant and, if the applicant is not a State agency, evidence of nonprofit status (i.e., of fulfilling Internal Revenue Service requirements as a nonprofit organization);\n\n(ii) Detailed description of the accreditation standards the applicant will require facilities to meet and a discussion substantiating their equivalence to FDA standards required under \u00a7 900.12;\n\n(iii) Detailed description of the applicant's accreditation review and decisionmaking process, including:\n\n(A) Procedures for performing accreditation and reaccreditation clinical image review in accordance with \u00a7 900.4(c), random clinical image reviews in accordance with \u00a7 900.4(f), and additional mammography review in accordance with \u00a7 900.12(j);\n\n(B) Procedures for performing phantom image review;\n\n(C) Procedures for assessing mammography equipment evaluations and surveys;\n\n(D) Procedures for initiating and performing onsite visits to facilities;\n\n(E) Procedures for assessing facility personnel qualifications;\n\n(F) Copies of the accreditation application forms, guidelines, instructions, and other materials the applicant will send to facilities during the accreditation process, including an accreditation history form that requires each facility to provide a complete history of prior accreditation activities and a statement that all information and data submitted in the application is true and accurate, and that no material fact has been omitted;\n\n(G) Policies and procedures for notifying facilities of deficiencies;\n\n(H) Procedures for monitoring corrections of deficiencies by facilities;\n\n(I) Policies and procedures for suspending or revoking a facility's accreditation;\n\n(J) Policies and procedures that will ensure processing of accreditation applications and renewals within a timeframe approved by FDA and assurances that the body will adhere to such policies and procedures; and\n\n(K) A description of the applicant's appeals process for facilities contesting adverse accreditation status decisions.\n\n(iv) Education, experience, and training requirements for the applicant's professional staff, including reviewers of clinical or phantom images;\n\n(v) Description of the applicant's electronic data management and analysis system with respect to accreditation review and decision processes and the applicant's ability to provide electronic data in a format compatible with FDA data systems;\n\n(vi) Resource analysis that demonstrates that the applicant's staffing, funding, and other resources are adequate to perform the required accreditation activities;\n\n(vii) Fee schedules with supporting cost data;\n\n(viii) Statement of policies and procedures established to avoid conflicts of interest or the appearance of conflicts of interest by the applicant's board members, commissioners, professional personnel (including reviewers of clinical and phantom images), consultants, administrative personnel, and other representatives of the applicant;\n\n(ix) Statement of policies and procedures established to protect confidential information the applicant will collect or receive in its role as an accreditation body;\n\n(x) Disclosure of any specific brand of imaging system or component, measuring device, software package, or other commercial product used in mammography that the applicant develops, sells, or distributes;\n\n(xi) Description of the applicant's consumer complaint mechanism;\n\n(xii) Satisfactory assurances that the applicant shall comply with the requirements of \u00a7 900.4; and\n\n(xiii) Any other information as may be required by FDA.\n\n(c)  Application for renewal of approval.  An approved accreditation body that intends to continue to serve as an accreditation body beyond its current term shall apply to FDA for renewal or notify FDA of its plans not to apply for renewal in accordance with the following procedures and schedule:\n\n(1) At least 9 months before the date of expiration of a body's approval, the body shall inform FDA, at the address given in \u00a7 900.3(b)(1), of its intent to seek renewal.\n\n(2) FDA will notify the applicant of the relevant information, materials, and supporting documentation required under \u00a7 900.3(b)(3) that the applicant shall submit as part of the renewal procedure.\n\n(3) At least 6 months before the date of expiration of a body's approval, the applicant shall furnish to FDA, at the address in \u00a7 900.3(b)(1), three copies of a renewal application containing the information, materials, and supporting documentation requested by FDA in accordance with \u00a7 900.3(c)(2).\n\n(4) No later than July 28, 1998, any accreditation body approved under the interim regulations published in the  Federal Register  of December 21, 1993 (58 FR 67558), that desires to continue to serve as an accreditation body under the final regulations shall apply for renewal of approval in accordance with the procedures set forth in paragraphs (c)(1) through (c)(3) of this section.\n\n(5) Any accreditation body that does not plan to renew its approval shall so notify FDA at the address given in paragraph (b)(1) of this section at least 9 months before the expiration of the body's term of approval.\n\n(d)  Rulings on applications for initial and renewed approval.  (1) FDA will conduct a review and evaluation to determine whether the applicant substantially meets the applicable requirements of this subpart and whether the accreditation standards the applicant will require facilities to meet are substantially the same as the quality standards published under subpart B of this part.\n\n(2) FDA will notify the applicant of any deficiencies in the application and request that those deficiencies be rectified within a specified time period. If the deficiencies are not rectified to FDA's satisfaction within the specified time period, the application for approval as an accreditation body may be rejected.\n\n(3) FDA shall notify the applicant whether the application has been approved or denied. That notification shall list any conditions associated with approval or state the bases for any denial.\n\n(4) The review of any application may include a meeting between FDA and representatives of the applicant at a time and location mutually acceptable to FDA and the applicant.\n\n(5) FDA will advise the applicant of the circumstances under which a denied application may be resubmitted.\n\n(6) If FDA does not reach a final decision on a renewal application in accordance with this paragraph before the expiration of an accreditation body's current term of approval, the approval will be deemed extended until the agency reaches a final decision on the application, unless an accreditation body does not rectify deficiencies in the application within the specified time period, as required in paragraph (d)(2) of this section.\n\n(e)  Relinquishment of authority.  An accreditation body that decides to relinquish its accreditation authority before expiration of the body's term of approval shall submit a letter of such intent to FDA, at the address in \u00a7 900.3(b)(1), at least 9 months before relinquishing such authority.\n\n(f)  Transfer of records.  An accreditation body that does not apply for renewal of accreditation body approval, is denied such approval by FDA, or relinquishes its accreditation authority and duties before expiration of its term of approval, shall:\n\n(1) Transfer facility records and other related information as required by FDA to a location and according to a schedule approved by FDA.\n\n(2) Notify, in a manner and time period approved by FDA, all facilities accredited or seeking accreditation by the body that the body will no longer have accreditation authority.\n\n(g)  Scope of authority.  An accreditation body's term of approval is for a period not to exceed 7 years. FDA may limit the scope of accreditation authority."], ["21:21:8.0.1.2.36.1.1.4", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.4 Standards for accreditation bodies.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 64 FR 32407, June 17, 1999; 88 FR 15168, Mar. 10, 2023]", "(a)  Code of conduct and general responsibilities.  The accreditation body shall accept the following responsibilities in order to ensure safe and accurate mammography at the facilities it accredits and shall perform these responsibilities in a manner that ensures the integrity and impartiality of accreditation body actions.\n\n(1)(i) When an accreditation body receives or discovers information that suggests inadequate image quality, or upon request by FDA, the accreditation body shall review a facility's clinical images or other aspects of a facility's practice to assist FDA in determining whether or not the facility's practice poses a serious risk to human health. Such reviews are in addition to the evaluation an accreditation body performs as part of the initial accreditation or renewal process for facilities.\n\n(ii) If review by the accreditation body demonstrates that a problem does exist with respect to image quality or other aspects of a facility's compliance with quality standards, or upon request by FDA, the accreditation body shall require or monitor corrective actions, or suspend or revoke accreditation of the facility.\n\n(2) The accreditation body shall inform FDA as soon as possible but in no case longer than 2 business days after becoming aware of equipment or practices that pose a serious risk to human health.\n\n(3) The accreditation body shall establish and administer a quality assurance (QA) program that has been approved by FDA in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section. Such quality assurance program shall:\n\n(i) Include requirements for clinical image review and phantom image review;\n\n(ii) Ensure that clinical and phantom images are evaluated consistently and accurately; and\n\n(iii) Specify the methods and frequency of training and evaluation for clinical and phantom image reviewers, and the bases and procedures for removal of such reviewers.\n\n(4) The accreditation body shall establish measures that FDA has approved in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the body's behalf. Such individuals who review clinical or phantom images under the provisions of paragraphs (c) and (d) of this section or who visit facilities under the provisions of paragraph (f) of this section shall not review clinical or phantom images from or visit a facility with which such individuals maintain a relationship, or when it would otherwise be a conflict of interest for them to do so, or when they have a bias in favor of or against the facility.\n\n(5) The accreditation body may require specific equipment performance or design characteristics that FDA has approved. However, no accreditation body shall require, either explicitly or implicitly, the use of any specific brand of imaging system or component, measuring device, software package, or other commercial product as a condition for accreditation by the body, unless FDA determines that it is in the best interest of public health to do so.\n\n(i) Any representation, actual or implied, either orally, in sales literature, or in any other form of representation, that the purchase or use of a particular product brand is required in order for any facility to be accredited or certified under \u00a7 900.11(b), is prohibited, unless FDA approves such representation.\n\n(ii) Unless FDA has approved the exclusive use and promotion of a particular commercial product in accordance with this section, all products produced, distributed, or sold by an accreditation body or an organization that has a financial or other relationship with the accreditation body that may be a conflict of interest or have the appearance of a conflict of interest with the body's accreditation functions, shall bear a disclaimer stating that the purchase or use of such products is not required for accreditation or certification of any facility under \u00a7 900.11(b). Any representations about such products shall include a similar disclaimer.\n\n(6)(i) When an accreditation body denies accreditation to a facility, the accreditation body shall notify the facility in writing and explain the bases for its decision. The notification shall also describe the appeals process available from the accreditation body for the facility to contest the decision.\n\n(ii) If a facility has failed to become accredited after three consecutive attempts, no accreditation body shall accept an application for accreditation from the facility for a period of 1 year from the date of the most recent accreditation failure.\n\n(7) No accreditation body may establish requirements that preclude facilities from being accredited under \u00a7 900.11(b) by any other accreditation body, or require accreditation by itself under MQSA if another accreditation body is available to a facility.\n\n(8) The accreditation body shall obtain FDA authorization for any changes it proposes to make in any standards that FDA has previously accepted under \u00a7 900.3(d).\n\n(9) An accreditation body shall establish procedures to protect confidential information it collects or receives in its role as an accreditation body.\n\n(i) Nonpublic information collected from facilities for the purpose of carrying out accreditation body responsibilities shall not be used for any other purpose or disclosed, other than to FDA or its duly designated representatives, including State agencies, without the consent of the facility;\n\n(ii) Nonpublic information that FDA or its duly designated representatives, including State agencies, share with the accreditation body concerning a facility that is accredited or undergoing accreditation by that body shall not be further disclosed except with the written permission of FDA.\n\n(b)  Monitoring facility compliance with quality standards.  (1) The accreditation body shall require that each facility it accredits meet standards for the performance of quality mammography that are substantially the same as those in this subpart and in subpart B of this part.\n\n(2) The accreditation body shall notify a facility regarding equipment, personnel, and other aspects of the facility's practice that do not meet such standards and advise the facility that such equipment, personnel, or other aspects of the practice should not be used by the facility for activities within the scope of part 900.\n\n(3) The accreditation body shall specify the actions that facilities shall take to correct deficiencies in equipment, personnel, and other aspects of the practice to ensure facility compliance with applicable standards.\n\n(4) If deficiencies cannot be corrected to ensure compliance with standards or if a facility is unwilling to take corrective actions, the accreditation body shall immediately so notify FDA, and shall suspend or revoke the facility's accreditation in accordance with the policies and procedures described under \u00a7 900.3(b)(3)(iii)(I).\n\n(c)  Clinical image review for accreditation and reaccreditation \u2014(1)  Frequency of review.  The accreditation body shall review clinical images from each facility accredited by the body at least once every 3 years.\n\n(2)  Requirements for clinical image attributes.  The accreditation body shall use the following attributes for all clinical image reviews, unless FDA has approved other attributes:\n\n(i)  Positioning.  Sufficient breast tissue shall be imaged to ensure that cancers are not likely to be missed because of inadequate positioning.\n\n(ii)  Compression.  Compression shall be applied in a manner that minimizes the potential obscuring effect of overlying breast tissue and motion artifact.\n\n(iii)  Exposure level.  Exposure level shall be adequate to visualize breast structures. Images shall be neither underexposed nor overexposed.\n\n(iv)  Contrast.  Image contrast shall permit differentiation of subtle tissue density differences.\n\n(v)  Sharpness.  Margins of normal breast structures shall be distinct and not blurred.\n\n(vi)  Noise.  Noise in the image shall not obscure breast structures or suggest the appearance of structures not actually present.\n\n(vii)  Artifacts.  Artifacts due to lint, processing, scratches, and other factors external to the breast shall not obscure breast structures or suggest the appearance of structures not actually present.\n\n(viii)  Examination identification.  Each image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:\n\n(A) Name of the patient and an additional patient identifier.\n\n(B) Date of examination.\n\n(C)  View and laterality.  This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by FDA in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section shall be used to identify view and laterality.\n\n(D)  Facility name and location.  At a minimum, the location shall include the city, State, and zip code of the facility.\n\n(E) Technologist identification.\n\n(F) Cassette/screen identification.\n\n(G) Mammography unit identification, if there is more than one unit in the facility.\n\n(3)  Scoring of clinical images.  Accreditation bodies shall establish and administer a system for scoring clinical images using all attributes specified in paragraphs (c)(2)(i) through (c)(2)(viii) of this section or an alternative system that FDA has approved in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section. The scoring system shall include an evaluation for each attribute.\n\n(i) The accreditation body shall establish and employ criteria for acceptable and nonacceptable results for each of the 8 attributes as well as an overall pass-fail system for clinical image review that has been approved by FDA in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section.\n\n(ii) All clinical images submitted by a facility to the accreditation body shall be reviewed independently by two or more review physicians.\n\n(4)  Selection of clinical images for review.  Unless otherwise specified by FDA, the accreditation body shall require that for each mammography unit in the facility:\n\n(i) The facility shall submit craniocaudal (CC) and mediolateral oblique (MLO) views from two mammographic examinations that the facility produced during a time period specified by the accreditation body;\n\n(ii) Clinical images submitted from one such mammographic examination for each unit shall be of dense breasts (predominance of glandular tissue) and the other shall be of fat-replaced breasts (predominance of adipose tissue);\n\n(iii) All clinical images submitted shall be images that the facility's interpreting physician(s) interpreted as negative or benign.\n\n(iv) If the facility has no clinical images meeting the requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this section, it shall so notify the accreditation body, which shall specify alternative clinical image selection methods that do not compromise care of the patient.\n\n(5)  Review physicians.  Accreditation bodies shall ensure that all of their review physicians:\n\n(i) Meet the interpreting physician requirements specified in \u00a7 900.12(a)(1) and meet such additional requirements as have been established by the accreditation body and approved by FDA;\n\n(ii) Are trained and evaluated in the clinical image review process, for the types of clinical images to be evaluated by a review physician, by the accreditation body before designation as review physicians and periodically thereafter; and\n\n(iii) Clearly document their findings and reasons for assigning a particular score to any clinical image and provide information to the facility for use in improving the attributes for which significant deficiencies were identified.\n\n(6)  Image management.  The accreditation body's QA program shall include a tracking system to ensure the security and return to the facility of all clinical images received and to ensure completion of all clinical image reviews by the body in a timely manner. The accreditation body shall return all clinical images to the facility within 60 days of their receipt by the body, with the following exceptions:\n\n(i) If the clinical images are needed earlier by the facility for clinical purposes, the accreditation body shall cooperate with the facility to accommodate such needs.\n\n(ii) If a review physician identifies a suspicious abnormality on an image submitted for clinical image review, the accreditation body shall ensure that this information is provided to the facility and that the clinical images are returned to the facility. Both shall occur no later than 10-business days after identification of the suspected abnormality.\n\n(7)  Notification of unsatisfactory image quality.  If the accreditation body determines that the clinical images received from a facility are of unsatisfactory quality, the body shall notify the facility of the nature of the problem and its possible causes.\n\n(d)  Phantom image review for accreditation and reaccreditation \u2014(1)  Frequency of review.  The accreditation body shall review phantom images from each facility accredited by the body at least once every 3 years.\n\n(2)  Requirements for the phantom used.  The accreditation body shall require that each facility submit for review phantom images that the facility produced using a phantom and methods of use specified by the body and approved by FDA in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section.\n\n(3)  Scoring phantom images.  The accreditation body shall use a system for scoring phantom images that has been approved by FDA in accordance with \u00a7 900.3(b) and (d) or paragraph (a)(8) of this section.\n\n(4)  Phantom images selected for review.  For each mammography unit in the facility, the accreditation body shall require the facility to submit phantom images that the facility produced during a time period specified by the body.\n\n(5)  Phantom image reviewers.  Accreditation bodies shall ensure that all of their phantom image reviewers:\n\n(i) Meet the requirements specified in \u00a7 900.12(a)(3) or alternative requirements established by the accreditation body and approved by FDA in accordance with \u00a7 900.3 or paragraph (a)(8) of this section;\n\n(ii) Are trained and evaluated in the phantom image review process, for the types of phantom images to be evaluated by a phantom image reviewer, by the accreditation body before designation as phantom image reviewers and periodically thereafter; and\n\n(iii) Clearly document their findings and reasons for assigning a particular score to any phantom image and provide information to the facility for use in improving its phantom image quality with regard to the significant deficiencies identified.\n\n(6)  Image management.  The accreditation body's QA program shall include a tracking system to ensure the security of all phantom images received and to ensure completion of all phantom image reviews by the body in a timely manner. All phantom images that result in a failure of accreditation shall be returned to the facility.\n\n(7)  Notification measures for unsatisfactory image quality.  If the accreditation body determines that the phantom images received from a facility are of unsatisfactory quality, the body shall notify the facility of the nature of the problem and its possible causes.\n\n(e)  Reports of mammography equipment evaluation, surveys, and quality control.  The following requirements apply to all facility equipment covered by the provisions of subparts A and B:\n\n(1) The accreditation body shall require every facility applying for accreditation to submit:\n\n(i) With its initial accreditation application, a mammography equipment evaluation that was performed by a medical physicist no earlier than 6 months before the date of application for accreditation by the facility. Such evaluation shall demonstrate compliance of the facility's equipment with the requirements in \u00a7 900.12(e).\n\n(ii) Prior to accreditation, a survey that was performed no earlier than 6 months before the date of application for accreditation by the facility. Such survey shall assess the facility's compliance with the facility standards referenced in paragraph (b) of this section.\n\n(2) The accreditation body shall require that all facilities undergo an annual survey to ensure continued compliance with the standards referenced in paragraph (b) of this section and to provide continued oversight of facilities' quality control programs as they relate to such standards. The accreditation body shall require for all facilities that:\n\n(i) Such surveys be conducted annually;\n\n(ii) Facilities take reasonable steps to ensure that they receive reports of such surveys within 30 days of survey completion; and\n\n(iii) Facilities submit the results of such surveys and any other information that the body may require to the body at least annually.\n\n(3) The accreditation body shall review and analyze the information required in this section and use it to identify necessary corrective measures for facilities and to determine whether facilities should remain accredited by the body.\n\n(f)  Accreditation body onsite visits and random clinical image reviews.  The accreditation body shall conduct onsite visits and random clinical image reviews of a sample of facilities to monitor and assess their compliance with standards established by the body for accreditation. The accreditation body shall submit annually to FDA, at the address given in \u00a7 900.3(b)(1), 3 copies of a summary report describing all facility assessments the body conducted under the provisions of this section for the year being reported.\n\n(1)  Onsite visits \u2014(i)  Sample size.  Annually, each accreditation body shall visit at least 5 percent of the facilities it accredits. However, a minimum of 5 facilities shall be visited, and visits to no more than 50 facilities are required, unless problems identified in paragraph (f)(1)(i)(B) of this section indicate a need to visit more than 50 facilities.\n\n(A) At least 50 percent of the facilities visited shall be selected randomly.\n\n(B) Other facilities visited shall be selected based on problems identified through State or FDA inspections, serious complaints received from consumers or others, a previous history of noncompliance, or any other information in the possession of the accreditation body, inspectors, or FDA.\n\n(C) Before, during, or after any facility visit, the accreditation body may require that the facility submit to the body for review clinical images, phantom images, or any other information relevant to applicable standards in this subpart and in subpart B of this part.\n\n(ii)  Visit plan.  The accreditation body shall conduct facility onsite visits according to a visit plan that has been approved by FDA in accordance with \u00a7 900.3(d) or paragraph (a)(8) of this section, unless otherwise directed by FDA in particular circumstances. At a minimum, such a plan shall provide for:\n\n(A) Assessment of overall clinical image QA activities of the facility;\n\n(B) Review of facility documentation to determine if appropriate mammography reports are sent to patients and providers as required;\n\n(C) Selection of a sample of clinical images for clinical image review by the accreditation body. Clinical images shall be selected in a manner specified by the accreditation body and approved by FDA that does not compromise care of the patient as a result of the absence of the selected images from the facility;\n\n(D) Verification that the facility has a medical audit system in place and is correlating films and pathology reports for positive cases;\n\n(E) Verification that personnel specified by the facility are the ones actually performing designated personnel functions;\n\n(F) Verification that equipment specified by the facility is the equipment that is actually being used to perform designated equipment functions;\n\n(G) Verification that a consumer complaint mechanism is in place and that the facility is following its procedures; and\n\n(H) Review of all factors related to previously identified concerns or concerns identified during that visit.\n\n(2)  Clinical image review for random sample of facilities \u2014(i)  Sample size.  In addition to conducting clinical image reviews for accreditation and reaccreditation for all facilities, the accreditation body shall conduct clinical image reviews annually for a randomly selected sample as specified by FDA, but to include at least 3 percent of the facilities the body accredits. Accreditation bodies may count toward this random sample requirement all facilities selected randomly for the onsite visits described in paragraph (f)(1)(i)(A) of this section. Accreditation bodies shall not count toward the random sample requirement any facilities described in paragraph (f)(1)(i)(B) of this section that were selected for a visit because of previously identified concerns.\n\n(ii)  Random clinical image review.  In performing clinical image reviews of the random sample of facilities, accreditation bodies shall evaluate the same attributes as those in paragraph (c) of this section for review of clinical images for accreditation and reaccreditation.\n\n(iii) Accreditation bodies should not schedule random clinical image reviews at facilities that have received notification of the need to begin the accreditation renewal process or that have completed the accreditation renewal process within the previous 6 months.\n\n(iv)  Selection of the random sample of clinical images for clinical image review by the accreditation body.  Clinical images shall be selected in a manner, specified by the accreditation body and approved by FDA under \u00a7 900.3(d) or paragraph (a)(8) of this section, that does not compromise care of the patient as a result of the absence of the selected images from the facility.\n\n(g)  Consumer complaint mechanism.  The accreditation body shall develop and administer a written and documented system, including timeframes, for collecting and resolving serious consumer complaints that could not be resolved at a facility. Such system shall have been approved by FDA in accordance with\u00a7 900.3(d) or paragraph (a)(8) of this section. Accordingly, all accreditation bodies shall:\n\n(1) Provide a mechanism for all facilities it accredits to file serious unresolved complaints with the accreditation body;\n\n(2) Maintain a record of every serious unresolved complaint received by the body on all facilities it accredits for a period of at least 3 years from the date of receipt of each such complaint;\n\n(h)  Reporting and recordkeeping.  All reports to FDA specified in paragraphs (h)(1) through (h)(4) of this section shall be prepared and submitted in a format and medium prescribed by FDA and shall be submitted to a location and according to a schedule specified by FDA. The accreditation body shall:\n\n(1) Collect and submit to FDA the information required by 42 U.S.C. 263b(d) for each facility when the facility is initially accredited and at least annually when updated, in a manner and at a time specified by FDA.\n\n(2) Accept applications containing the information required in 42 U.S.C. 263b(c)(2) for provisional certificates and in \u00a7 900.11(b)(3) for extension of provisional certificates, on behalf of FDA, and notify FDA of the receipt of such information;\n\n(3) Submit to FDA the name, identifying information, and other information relevant to 42 U.S.C. 263b and specified by FDA for any facility for which the accreditation body denies, suspends, or revokes accreditation, and the reason(s) for such action;\n\n(4) Submit to FDA an annual report summarizing all serious complaints received during the previous calendar year, their resolution status, and any actions taken in response to them;\n\n(5) Provide to FDA other information relevant to 42 U.S.C. 263b and required by FDA about any facility accredited or undergoing accreditation by the body.\n\n(i)  Fees.  Fees charged to facilities for accreditation shall be reasonable. Costs of accreditation body activities that are not related to accreditation functions under 42 U.S.C. 263b are not recoverable through fees established for accreditation.\n\n(1) The accreditation body shall make public its fee structure, including those factors, if any, contributing to variations in fees for different facilities.\n\n(2) At FDA's request, accreditation bodies shall provide financial records or other material to assist FDA in assessing the reasonableness of accreditation body fees. Such material shall be provided to FDA in a manner and time period specified by the agency."], ["21:21:8.0.1.2.36.1.1.5", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.5 Evaluation.", "FDA", "", "", "", "FDA shall evaluate annually the performance of each accreditation body. Such evaluation shall include an assessment of the reports of FDA or State inspections of facilities accredited by the body as well as any additional information deemed relevant by FDA that has been provided by the accreditation body or other sources or has been required by FDA as part of its oversight initiatives. The evaluation shall include a determination of whether there are major deficiencies in the accreditation body's performance that, if not corrected, would warrant withdrawal of the approval of the accreditation body under the provisions of \u00a7 900.6."], ["21:21:8.0.1.2.36.1.1.6", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.6 Withdrawal of approval.", "FDA", "", "", "", "If FDA determines, through the evaluation activities of \u00a7 900.5, or through other means, that an accreditation body is not in substantial compliance with this subpart, FDA may initiate the following actions:\n\n(a)  Major deficiencies.  If FDA determines that an accreditation body has failed to perform a major accreditation function satisfactorily, has demonstrated willful disregard for public health, has violated the code of conduct, has committed fraud, or has submitted material false statements to the agency, FDA may withdraw its approval of that accreditation body.\n\n(1) FDA shall notify the accreditation body of the agency's action and the grounds on which the approval was withdrawn.\n\n(2) An accreditation body that has lost its approval shall notify facilities accredited or seeking accreditation by it that its approval has been withdrawn. Such notification shall be made within a time period and in a manner approved by FDA.\n\n(b)  Minor deficiencies.  If FDA determines that an accreditation body has demonstrated deficiencies in performing accreditation functions and responsibilities that are less serious or more limited than the deficiencies in paragraph (a) of this section, FDA shall notify the body that it has a specified period of time to take particular corrective measures directed by FDA or to submit to FDA for approval the body's own plan of corrective action addressing the minor deficiencies. FDA may place the body on probationary status for a period of time determined by FDA, or may withdraw approval of the body as an accreditation body if corrective action is not taken.\n\n(1) If FDA places an accreditation body on probationary status, the body shall notify all facilities accredited or seeking accreditation by it of its probationary status within a time period and in a manner approved by FDA.\n\n(2) Probationary status shall remain in effect until such time as the body can demonstrate to the satisfaction of FDA that it has successfully implemented or is implementing the corrective action plan within the established schedule, and that the corrective actions have substantially eliminated all identified problems.\n\n(3) If FDA determines that an accreditation body that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, FDA may withdraw approval of the accreditation body. The accreditation body shall notify all facilities accredited or seeking accreditation by it of its loss of FDA approval, within a time period and in a manner approved by FDA.\n\n(c)  Reapplication by accreditation bodies that have had their approval withdrawn.  (1) A former accreditation body that has had its approval withdrawn may submit a new application for approval if the body can provide information to FDA to establish that the problems that were grounds for withdrawal of approval have been resolved.\n\n(2) If FDA determines that the new application demonstrates that the body satisfactorily has addressed the causes of its previous unacceptable performance, FDA may reinstate approval of the accreditation body.\n\n(3) FDA may request additional information or establish additional conditions that must be met by a former accreditation body before FDA approves the reapplication.\n\n(4) FDA may refuse to accept an application from a former accreditation body whose approval was withdrawn because of fraud or willful disregard of public health."], ["21:21:8.0.1.2.36.1.1.7", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7 900.7 Hearings.", "FDA", "", "", "", "(a) Opportunities to challenge final adverse actions taken by FDA regarding approval or reapproval of accreditation bodies, withdrawal of approval of accreditation bodies, or rejection of a proposed fee for accreditation shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter.\n\n(b) A facility that has been denied accreditation is entitled to an appeals process from the accreditation body. The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with \u00a7 900.3(d) or \u00a7 900.4(a)(8).\n\n(c) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeals process may appeal to FDA for reconsideration in accordance with \u00a7 900.15."], ["21:21:8.0.1.2.36.1.1.8", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "A", "Subpart A\u2014Accreditation", "", "\u00a7\u00a7 900.8-900.9 [Reserved]", "FDA", "", "", "", ""], ["21:21:8.0.1.2.36.2.1.1", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.10 Applicability.", "FDA", "", "", "", "The provisions of subpart B are applicable to all facilities under the regulatory jurisdiction of the United States that provide mammography services, with the exception of the Department of Veterans Affairs."], ["21:21:8.0.1.2.36.2.1.2", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.11 Requirements for certification.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 83 FR 13864, Apr. 2, 2018; 88 FR 15168, Mar. 10, 2023]", "(a)  General.  After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in \u00a7 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA.\n\n(b)  Application \u2014(1)  Certificates.  (i) In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by FDA. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1).\n\n(ii) Following the agency's receipt of the accreditation body's decision to accredit a facility, or an equivalent decision by another entity designated by FDA, the agency may issue a certificate to the facility, or renew an existing certificate, if the agency determines that the facility has satisfied the requirements for certification or recertification.\n\n(2)  Provisional certificates.  (i) A new facility beginning operation after October 1, 1994, is eligible to apply for a provisional certificate. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive a provisional certificate, a facility must meet the requirements of 42 U.S.C. 263b(c)(4) and submit the necessary information to an approved accreditation body or other entity designated by FDA.\n\n(ii) Following the agency's receipt of the accreditation body's decision that a facility has submitted the required information, FDA may issue a provisional certificate to a facility upon determination that the facility has satisfied the requirements of \u00a7 900.11(b)(2)(i). A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a 90-day extension of the provisional certificate.\n\n(3)  Extension of provisional certificate.  (i) To apply for a 90-day extension to a provisional certificate, a facility shall submit to its accreditation body, or other entity designated by FDA, a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.\n\n(ii) The accreditation body shall forward the request, with its recommendation, to FDA within 2 business days after receipt.\n\n(iii) FDA may issue a 90-day extension for a provisional certificate upon determination that the extension meets the criteria set forth in 42 U.S.C. 263b(c)(2).\n\n(iv) There can be no renewal of a provisional certificate beyond the 90-day extension.\n\n(c)  Reinstatement policy.  A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be considered to be a new facility and thereby be eligible for a provisional certificate.\n\n(1) Unless prohibited from reinstatement under \u00a7 900.11(c)(4), a facility applying for reinstatement shall:\n\n(i) Contact an FDA-approved accreditation body or other entity designated by FDA to determine the requirements for reapplication for accreditation;\n\n(ii) Fully document its history as a previously provisionally certified or certified mammography facility, including the following information:\n\n(A) Name and address of the facility under which it was previously provisionally certified or certified;\n\n(B) Name of previous owner/lessor;\n\n(C) FDA facility identification number assigned to the facility under its previous certification; and\n\n(D) Expiration date of the most recent FDA provisional certificate or certificate; and\n\n(iii) Justify application for reinstatement of accreditation by submitting to the accreditation body or other entity designated by FDA, a corrective action plan that details how the facility has corrected deficiencies that contributed to the lapse of, denial of renewal, or revocation of its certificate.\n\n(2) FDA may issue a provisional certificate to the facility if:\n\n(i) The accreditation body or other entity designated by FDA notifies the agency that the facility has adequately corrected, or is in the process of correcting, pertinent deficiencies; and\n\n(ii) FDA determines that the facility has taken sufficient corrective action since the lapse of, denial of renewal, or revocation of its previous certificate.\n\n(3) After receiving the provisional certificate, the facility may lawfully resume performing mammography services while completing the requirements for certification.\n\n(4) If a facility's certificate was revoked on the basis of an act described in 42 U.S.C. 263b(i)(1), as implemented by \u00a7 900.14(a), no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years of the date of revocation."], ["21:21:8.0.1.2.36.2.1.3", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.12 Quality standards.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 63 FR 56558, Oct. 22, 1998; 64 FR 18333, Apr. 14, 1999; 64 FR 32408, June 17, 1999; 65 FR 43690, July 14, 2000; 88 FR 15168, Mar. 10, 2023]", "(a)  Personnel.  The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities:\n\n(1)  Interpreting physicians.  All physicians interpreting mammograms shall meet the following qualifications:\n\n(i)  Initial qualifications.  Unless the exemption in paragraph (a)(1)(iii)(A) of this section applies, before beginning to interpret mammograms independently, the interpreting physician shall:\n\n(A) Be licensed to practice medicine in a State;\n\n(B)( 1 ) Be certified in an appropriate specialty area by a body determined by FDA to have procedures and requirements adequate to ensure that physicians certified by the body are competent to interpret radiological procedures, including mammography; or\n\n( 2 ) Have had at least 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography. The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of paragraph (a)(1) of this section;\n\n(C) Have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography. All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution; and\n\n(D) Unless the exemption in paragraph (a)(1)(iii)(B) of this section applies, have interpreted or multi-read at least 240 mammographic examinations within the 6-month period immediately prior to the date that the physician qualifies as an interpreting physician. This interpretation or multi-reading shall be under the direct supervision of an interpreting physician.\n\n(ii)  Continuing experience and education.  All interpreting physicians shall maintain their qualifications by meeting the following requirements:\n\n(A) Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have interpreted or multi-read at least 960 mammographic examinations during the 24 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in-between the two. The facility will choose one of these dates to determine the 24-month period.\n\n(B) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the 36 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice; and\n\n(C) Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.\n\n(D) Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph (a)(1)(ii)(B) of this section, even if the course is taught multiple times during the previous 36 months.\n\n(iii)  Exemptions.  (A) Those physicians who qualified as interpreting physicians under paragraph (a)(1) of this section of FDA's interim regulations prior to April 28, 1999, are considered to have met the initial requirements of paragraph (a)(1)(i) of this section. They may continue to interpret mammograms provided they continue to meet the licensure requirement of paragraph (a)(1)(i)(A) of this section and the continuing experience and education requirements of paragraph (a)(1)(ii) of this section.\n\n(B) Physicians who have interpreted or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician in any 6-month period during the last 2 years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from paragraph (a)(1)(i)(D) of this section.\n\n(iv)  Reestablishing qualifications.  Interpreting physicians who fail to maintain the required continuing experience or continuing education requirements shall reestablish their qualifications before resuming the independent interpretation of mammograms, as follows:\n\n(A) Interpreting physicians who fail to meet the continuing experience requirements of paragraph (a)(1)(ii)(A) of this section shall:\n\n( 1 ) Interpret or multi-read at least 240 mammographic examinations under the direct supervision of an interpreting physician, or\n\n( 2 ) Interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician's total up to 960 examinations for the prior 24 months, whichever is less.\n\n( 3 ) The interpretations required under paragraph (a)(1)(iv)(A)( 1 ) or (a)(1)(iv)(A)( 2 ) of this section shall be done within the 6 months immediately prior to resuming independent interpretation.\n\n(B) Interpreting physicians who fail to meet the continuing education requirements of paragraph (a)(1)(ii)(B) of this section shall obtain a sufficient number of additional category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.\n\n(2)  Radiologic technologists.  All mammographic examinations shall be performed by radiologic technologists who meet the following general requirements, mammography requirements, and continuing education and experience requirements:\n\n(i)  General requirements.  (A) Be licensed to perform general radiographic procedures in a State; or\n\n(B) Have general certification from one of the bodies determined by FDA to have procedures and requirements adequate to ensure that radiologic technologists certified by the body are competent to perform radiologic examinations; and\n\n(ii)  Mammography requirements.  Have, prior to April 28, 1999, qualified as a radiologic technologist under paragraph (a)(2) of this section of FDA's interim regulations of December 21, 1993, or completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. The hours of documented training shall include, but not necessarily be limited to:\n\n(A) Training in breast anatomy and physiology, positioning and compression, quality assurance/quality control techniques, imaging of patients with breast implants;\n\n(B) The performance of a minimum of 25 examinations under the direct supervision of an individual qualified under paragraph (a)(2) of this section; and\n\n(C) At least 8 hours of training in each mammography modality to be used by the technologist in performing mammography exams; and\n\n(iii)  Continuing education requirements.  (A) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 36-month period.\n\n(B) Units earned through teaching a specific course can be counted only once towards the 15 required in paragraph (a)(2)(iii)(A) of this section, even if the course is taught multiple times during the previous 36 months.\n\n(C) At least six of the continuing education units required in paragraph (a)(2)(iii)(A) of this section shall be related to each mammographic modality used by the technologist.\n\n(D)  Requalification.  Radiologic technologists who fail to meet the continuing education requirements of paragraph (a)(2)(iii)(A) of this section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography. The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed.\n\n(E) Before a radiologic technologist may begin independently performing mammographic examinations using a mammographic modality other than one of those for which the technologist received training under paragraph (a)(2)(ii)(C) of this section, the technologist shall have at least 8 hours of continuing education units in the new modality.\n\n(iv)  Continuing experience requirements.  (A) Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed or of April 28, 1999, whichever is later, the radiologic technologist shall have performed a minimum of 200 mammography examinations during the 24 months immediately preceding the date of the facility's annual inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility will choose one of these dates to determine the 24-month period.\n\n(B)  Requalification.  Radiologic technologists who fail to meet the continuing experience requirements of paragraph (a)(2)(iv)(A) of this section shall perform a minimum of 25 mammography examinations under the direct supervision of a qualified radiologic technologist, before resuming the performance of unsupervised mammography examinations.\n\n(3)  Medical physicists.  All medical physicists conducting surveys of mammography facilities and providing oversight of the facility quality assurance program under paragraph (e) of this section shall meet the following:\n\n(i)  Initial qualifications.  (A) Be State licensed or approved or have certification in an appropriate specialty area by one of the bodies determined by FDA to have procedures and requirements to ensure that medical physicists certified by the body are competent to perform physics survey; and\n\n(B)( 1 ) Have a masters degree or higher in a physical science from an accredited institution, with no less than 20 semester hours or equivalent (e.g., 30 quarter hours) of college undergraduate or graduate level physics;\n\n( 2 ) Have 20 contact hours of documented specialized training in conducting surveys of mammography facilities; and\n\n( 3 ) Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 10 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. After April 28, 1999, experience conducting surveys must be acquired under the direct supervision of a medical physicist who meets all the requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section; or\n\n(ii)  Alternative initial qualifications.  (A) Have qualified as a medical physicist under paragraph (a)(3) of this section of FDA's interim regulations and retained that qualification by maintenance of the active status of any licensure, approval, or certification required under the interim regulations; and\n\n(B) Prior to the April 28, 1999, have:\n\n( 1 ) A bachelor's degree or higher in a physical science from an accredited institution with no less than 10 semester hours or equivalent of college undergraduate or graduate level physics,\n\n( 2 ) Forty contact hours of documented specialized training in conducting surveys of mammography facilities and,\n\n( 3 ) Have the experience of conducting surveys of at least 1 mammography facility and a total of at least 20 mammography units. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement. The training and experience requirements must be met after fulfilling the degree requirement.\n\n(iii)  Continuing qualifications.  (A) Continuing education. Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section were completed, the medical physicist shall have taught or completed at least 15 continuing education units in mammography during the 36 months immediately preceding the date of the facility's annual inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility shall choose one of these dates to determine the 36-month period. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once towards the required 15 units in a 36-month period, even if the course is taught multiple times during the 36 months.\n\n(B)  Continuing experience.  Following the second anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28, 1999, whichever is later, the medical physicist shall have surveyed at least two mammography facilities and a total of at least six mammography units during the 24 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two. The facility shall choose one of these dates to determine the 24-month period. No more than one survey of a specific facility within a 10-month period or a specific unit within a period of 60 days can be counted towards this requirement.\n\n(C) Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours of training in surveying units of the new mammographic modality.\n\n(iv)  Reestablishing qualifications.  Medical physicists who fail to maintain the required continuing qualifications of paragraph (a)(3)(iii) of this section may not perform the MQSA surveys without the supervision of a qualified medical physicist. Before independently surveying another facility, medical physicists must reestablish their qualifications, as follows:\n\n(A) Medical physicists who fail to meet the continuing educational requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous 3 years.\n\n(B) Medical physicists who fail to meet the continuing experience requirement of paragraph (a)(3)(iii)(B) of this section shall complete a sufficient number of surveys under the direct supervision of a medical physicist who meets the qualifications of paragraphs (a)(3)(i) and (a)(3)(iii) of this section to bring their total surveys up to the required two facilities and six units in the previous 24 months. No more than one survey of a specific unit within a period of 60 days can be counted towards the total mammography unit survey requirement.\n\n(4)  Retention of personnel records.  Facilities shall maintain records of training and experience relevant to their qualification under MQSA for personnel who work or have worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors. Records of personnel no longer employed by the facility must be maintained for no less than 24 months from the date of the departure of an employee, and these records must be available for review at the time of any annual inspection occurring during those 24 months. The facility shall provide copies of these personnel records to current interpreting physicians, radiologic technologists, and medical physicists upon their request. Facilities must provide personnel records to former employees if the former employees communicate their request within 24 months of the date of their departure. If it has been greater than 24 months and the facility has maintained those records, the facility must provide those records to former employees upon request. Before a facility closes or ceases to provide mammography services, it must make arrangements for access by current and former personnel to their MQSA personnel records. This access may be provided by the permanent transfer of these records to the personnel or the transfer of the records to a facility or other entity that will provide access to these records for no less than 24 months from the date of facility closure or cessation of mammography services.\n\n(b)  Equipment.  Regulations published under \u00a7\u00a7 1020.30, 1020.31, and 900.12(e) of this chapter that are relevant to equipment performance should also be consulted for a more complete understanding of the equipment performance requirements.\n\n(1)  Prohibited equipment.  Radiographic equipment designed for general purpose or special nonmammography procedures shall not be used for mammography. This prohibition includes systems that have been modified or equipped with special attachments for mammography. This requirement supersedes the implied acceptance of such systems in \u00a7 1020.31(f)(3) of this chapter.\n\n(2)  General.  All radiographic equipment used for mammography shall be specifically designed for mammography and shall be certified pursuant to \u00a7 1010.2 of this chapter as meeting the applicable requirements of \u00a7\u00a7 1020.30 and 1020.31 of this chapter in effect at the date of manufacture.\n\n(i) All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use.\n\n(ii) A mammography unit that is converted from one mammographic modality to another is considered a new unit at the facility under this part and must, prior to clinical use, undergo a mammography equipment evaluation demonstrating compliance with applicable requirements. The facility must also follow its accreditation body's procedures for applying for accreditation of that unit.\n\n(3)  Motion of tube-image receptor assembly.  (i) The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.\n\n(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of this section shall not fail in the event of power interruption.\n\n(4)  Image receptor sizes.  (i) Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 \u00d7 24 centimeters (cm) and 24 \u00d7 30 cm.\n\n(ii) Systems using screen-film image receptors shall be equipped with moving grids matched to all image receptor sizes provided.\n\n(iii) Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.\n\n(5)  Light fields.  For any mammography system with a light beam that passes through the x-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 foot candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.\n\n(6)  Magnification.  (i) Systems used to perform noninterventional problem solving procedures shall have radiographic magnification capability available for use by the operator.\n\n(ii) Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.\n\n(7)  Focal spot selection.  (i) When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.\n\n(ii) When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.\n\n(iii) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.\n\n(8)  Compression.  All mammography systems shall incorporate a compression device.\n\n(i)  Application of compression.  Effective October 28, 2002, each system shall provide:\n\n(A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and\n\n(B) Fine adjustment compression controls operable from both sides of the patient.\n\n(ii)  Compression paddle.  (A) Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for \u201cspot compression\u201d) may be provided. Such compression paddles for special purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section.\n\n(B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.\n\n(C) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements.\n\n(D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.\n\n(E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.\n\n(9)  Technique factor selection and display.  (i) Manual selection of milliampere seconds (mAs) or at least one of its component parts (milliapere (mA) and/or time) shall be available.\n\n(ii) The technique factors (peak tube potential in kilovolt (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated.\n\n(iii) Following AEC mode use, the system shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be displayed as mA and time.\n\n(10)  Automatic exposure control.  (i) Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, e.g., grid, nongrid; magnification, nonmagnification; and various target-filter combinations.\n\n(ii) The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue.\n\n(A) The size and available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle.\n\n(B) The selected position of the detector shall be clearly indicated.\n\n(iii) The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.\n\n(11)  Film.  For facilities using screen-film units, the facility shall use x-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography. For facilities using hardcopy prints of digital images for transfer, retention, or final interpretation purposes, the facility shall use a type of film designated by the film manufacturer as appropriate for these purposes and compatible with the printer being used.\n\n(12)  Intensifying screens.  The facility shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen's spectral output as specified by the manufacturer.\n\n(13)  Film processing solutions.  For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.\n\n(14)  Lighting.  The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians.\n\n(15)  Film masking devices.  Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility.\n\n(16)  Equipment\u2014other modalities.  Systems with image receptor modalities other than screen-film shall demonstrate compliance with quality standards by successful results of quality assurance testing as specified under paragraph (e)(6) of this section.\n\n(c)  Medical records and mammography reports \u2014(1)  Contents and terminology.  Each facility shall prepare a written report of the results of each mammographic examination performed under its certificate. The mammographic examination presented for interpretation must be in the original mammographic modality in which it was performed, and must not consist of digital images produced through copying or digitizing hardcopy original images. The mammography report shall include the following information:\n\n(i) The name of the patient and an additional patient identifier;\n\n(ii) Date of examination, facility name, and location. At a minimum, the location shall include the city, State, ZIP code, and telephone number of the facility;\n\n(iii) The name of the interpreting physician who interpreted the mammogram;\n\n(iv) Overall final assessment of findings, classified in one of the following categories (the assessment statement is only the word or phrase within the quotation marks):\n\n(A) \u201cNegative.\u201d Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be documented and addressed);\n\n(B) \u201cBenign.\u201d Also a normal result, with benign findings present, but no evidence of malignancy (if the interpreting physician is aware of clinical findings or symptoms, despite the benign assessment, these shall be documented and addressed);\n\n(C) \u201cProbably Benign.\u201d Finding(s) has a high probability of being benign;\n\n(D) \u201cSuspicious.\u201d Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;\n\n(E) \u201cHighly Suggestive of Malignancy.\u201d Finding(s) has a high probability of being malignant;\n\n(F) \u201cKnown Biopsy-Proven Malignancy.\u201d Reserved for known malignancies being mammographically evaluated for definitive therapy; and\n\n(G) \u201cPost-Procedure Mammogram for Marker Placement.\u201d Reserved for a post-procedure mammogram used to confirm the deployment and position of a breast tissue marker.\n\n(v) In cases where no final assessment category can be assigned due to incomplete work-up, one of the following classification statements shall be assigned as an assessment and reasons why no final assessment can be made shall be stated by the interpreting physician.\n\n(A) \u201cIncomplete: Need additional imaging evaluation.\u201d Reserved for examinations where additional imaging needs to be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given; or\n\n(B) \u201cIncomplete: Need prior mammograms for comparison.\u201d Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a followup report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained.\n\n(vi) Overall assessment of breast density, classified in one of the following categories:\n\n(A) \u201cThe breasts are almost entirely fatty.\u201d\n\n(B) \u201cThere are scattered areas of fibroglandular density.\u201d\n\n(C) \u201cThe breasts are heterogeneously dense, which may obscure small masses.\u201d\n\n(D) \u201cThe breasts are extremely dense, which lowers the sensitivity of mammography.\u201d\n\n(vii) Recommendations made to the healthcare provider about what additional actions, if any, should be taken. All clinical questions raised by the referring healthcare provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.\n\n(2)  Communication of mammography results to the patients.  Each facility shall provide each patient a summary of the mammography report written in lay terms within 30 calendar days of the mammographic examination which shall, at a minimum, include the name of the patient; the name, address, and telephone number of the facility performing the mammographic examination; and an assessment of breast density as described in paragraphs (c)(2)(iii) and (iv) of this section. If the assessment of the mammography report is \u201cSuspicious\u201d or \u201cHighly Suggestive of Malignancy,\u201d the facility shall provide the patient a summary of the mammography report written in lay language within 7 calendar days of the final interpretation of the mammograms.\n\n(i) Patients who do not name a healthcare provider to receive the mammography report shall be sent the report described in paragraph (c)(1) of this section within 30 days, in addition to the written notification of results in lay terms. If the assessment of the mammography report is \u201cSuspicious\u201d or \u201cHighly Suggestive of Malignancy,\u201d the facility shall send this report to the patient within 7 calendar days of the final interpretation of the mammograms.\n\n(ii) Each facility that accepts patients who do not have a healthcare provider shall maintain a system for referring such patients to a healthcare provider when clinically indicated, which shall include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy.\n\n(iii) If the mammography report identifies the patient's breast density as \u201cThe breasts are almost entirely fatty\u201d or \u201cThere are scattered areas of fibroglandular density,\u201d the lay summary shall include the statement \u201cBreast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.\u201d\n\n(iv) If the mammography report identifies the breast density as \u201cThe breasts are heterogeneously dense, which may obscure small masses\u201d or \u201cThe breasts are extremely dense, which lowers the sensitivity of mammography,\u201d the lay summary shall include the statement \u201cBreast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.\u201d\n\n(3)  Communication of mammography results to health care providers.  When the patient has a referring health care provider or the patient has named a health care provider, the facility shall:\n\n(i) Provide a written report of the mammography examination, including the items listed in paragraph (c)(1) of this section, to that health care provider as soon as possible, but no later than 30 days from the date of the mammography examination; and\n\n(ii) If the assessment is \u201cSuspicious\u201d or \u201cHighly Suggestive of Malignancy,\u201d the facility shall provide a written report of the mammographic examination, including the items listed in paragraph (c)(1) of this section, to the referring healthcare provider, or if the referring healthcare provider is unavailable, to a responsible designee of the referring healthcare provider within 7 calendar days of the final interpretation of the mammograms.\n\n(4)  Recordkeeping.  Each facility that performs mammograms:\n\n(i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain the original mammograms and mammography reports in a permanent medical record of the patient for the longest of the following: a period of not less than 5 years, a period of not less than 10 years if no additional mammograms of the patient are performed at the facility, or a period, if any, mandated by State or local law. Facilities shall implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained in retrievable form in the mammographic modality in which they were produced. They cannot be produced by copying or digitizing hardcopy originals.\n\n(ii) Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Transfer of the mammograms and mammography reports must take place within 15 calendar days of the facility receiving such request. The transferred mammograms must be in the mammographic modality in which they were produced, and cannot be produced by copying or digitizing hardcopy originals. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically;\n\n(iii) Shall upon request by, or on behalf of, the patient, provide copies of mammograms and copies of mammogram reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Release of the copies must take place within 15 calendar days of the facility receiving such request. For digital mammograms or digital breast tomosynthesis, if the copies are being released for final interpretation purposes, the facility must be able to provide the recipient with digital images electronically;\n\n(iv) Any fee charged to the patients for providing the services in paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the documented costs associated with this service; and\n\n(v) Before a facility closes or ceases to provide mammography services, it must make arrangements for access by patients and healthcare providers to their mammographic records. This access may be provided by the permanent transfer of mammographic records to the patient or the patient's healthcare provider or the transfer of the mammographic records to a facility or other entity that will provide access to patients and healthcare providers. Access to the records must be provided by such other facility or entity for the remainder of the time periods specified in paragraph (c)(4)(i) of this section. If a facility ceases to perform mammography but continues to operate as a medical entity, and is able to satisfy the recordkeeping requirements of paragraphs (c)(4)(i) through (iv) of this section, it may choose to continue to retain the medical records rather than transfer them to another facility, unless such a transfer is requested by, or on behalf of, the patient. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.\n\n(5)  Mammographic image identification.  Each mammographic image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:\n\n(i) Name of patient and an additional patient identifier.\n\n(ii) Date of examination.\n\n(iii)  View and laterality.  This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by FDA in accordance with \u00a7 900.3(b) or \u00a7 900.4(a)(8) shall be used to identify view and laterality.\n\n(iv)  Facility name and location.  At a minimum, the location shall include the city, State, and zip code of the facility.\n\n(v) Technologist identification.\n\n(vi) Cassette/screen identification.\n\n(vii) Mammography unit identification, if there is more than one unit in the facility.\n\n(d)  Quality assurance\u2014general.  Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity, and accuracy of mammography services performed at the facility.\n\n(1)  Responsible individuals.  Responsibility for the quality assurance program and for each of its elements shall be assigned to individuals who are qualified for their assignments and who shall be allowed adequate time to perform these duties.\n\n(i)  Lead interpreting physician.  The facility shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program meets all requirements of paragraphs (d) through (f) of this section. No other individual shall be assigned or shall retain responsibility for quality assurance tasks unless the lead interpreting physician has determined that the individual's qualifications for, and performance of, the assignment are adequate.\n\n(ii)  Interpreting physicians.  All interpreting physicians interpreting mammograms for the facility shall:\n\n(A) Follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality, and\n\n(B) Participate in the facility's medical outcomes audit program.\n\n(iii)  Medical physicist.  Each facility shall have the services of a medical physicist available to survey mammography equipment and oversee the equipment-related quality assurance practices of the facility. At a minimum, the medical physicist(s) shall be responsible for performing the surveys and mammography equipment evaluations and providing the facility with the reports described in paragraphs (e)(9) and (e)(10) of this section.\n\n(iv)  Quality control technologist.  Responsibility for all individual tasks within the quality assurance program not assigned to the lead interpreting physician or the medical physicist shall be assigned to a quality control technologist(s). The tasks are to be performed by the quality control technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the quality control technologist shall ensure that the tasks are completed in such a way as to meet the requirements of paragraph (e) of this section.\n\n(2)  Quality assurance records.  The lead interpreting physician, quality control technologist, and medical physicist shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the correction actions), safety, protection, and employee qualifications to meet assigned quality assurance tasks are properly maintained and updated. These quality control records shall be kept for each test specified in paragraphs (e) and (f) of this section until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the quality assurance requirements or until the test has been performed two additional times at the required frequency, whichever is longer.\n\n(e)  Quality assurance\u2014equipment \u2014(1)  Daily quality control tests.  Film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be performed on each day that clinical films are processed before any clinical films are processed that day. The test shall include an assessment of base plus fog density, mid-density, and density difference, using the mammography film used clinically at the facility.\n\n(i) The base plus fog density shall be within + 0.03 of the established operating level.\n\n(ii) The mid-density shall be within \u00b10.15 of the established operating level.\n\n(iii) The density difference shall be within \u00b10.15 of the established operating level.\n\n(2)  Weekly quality control tests.  Facilities with screen-film systems shall perform an image quality evaluation test, using an FDA-approved phantom, at least weekly.\n\n(i) The optical density of the film at the center of an image of a standard FDA-accepted phantom shall be at least 1.20 when exposed under a typical clinical condition.\n\n(ii) The optical density of the film at the center of the phantom image shall not change by more than \u00b10.20 from the established operating level.\n\n(iii) The phantom image shall achieve at least the minimum score established by the accreditation body and accepted by FDA in accordance with \u00a7 900.3(d) or \u00a7 900.4(a)(8).\n\n(iv) The density difference between the background of the phantom and an added test object, used to assess image contrast, shall be measured and shall not vary by more than \u00b10.05 from the established operating level.\n\n(3)  Quarterly quality control tests.  Facilities with screen-film systems shall perform the following quality control tests at least quarterly:\n\n(i)  Fixer retention in film.  The residual fixer shall be no more than 5 micrograms per square cm.\n\n(ii)  Repeat analysis.  If the total repeat or reject rate changes from the previously determined rate by more than 2.0 percent of the total films included in the analysis, the reason(s) for the change shall be determined. Any corrective actions shall be recorded and the results of these corrective actions shall be assessed.\n\n(4)  Semiannual quality control tests.  Facilities with screen-film systems shall perform the following quality control tests at least semiannually:\n\n(i)  Darkroom fog.  The optical density attributable to darkroom fog shall not exceed 0.05 when a mammography film of the type used in the facility, which has a mid-density of no less than 1.2 OD, is exposed to typical darkroom conditions for 2 minutes while such film is placed on the counter top emulsion side up. If the darkroom has a safelight used for mammography film, it shall be on during this test.\n\n(ii)  Screen-film contact.  Testing for screen-film contact shall be conducted using 40 mesh copper screen. All cassettes used in the facility for mammography shall be tested.\n\n(iii)  Compression device performance.  (A) A compression force of at least 111 newtons (25 pounds) shall be provided.\n\n(B) Effective October 28, 2002, the maximum compression force for the initial power drive shall be between 111 newtons (25 pounds) and 200 newtons (45 pounds).\n\n(5)  Annual quality control tests.  Facilities with screen-film systems shall perform the following quality control tests at least annually:\n\n(i)  Automatic exposure control performance.  (A) The AEC shall be capable of maintaining film optical density within \u00b10.30 of the mean optical density when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility. If this requirement cannot be met, a technique chart shall be developed showing appropriate techniques (kVp and density control settings) for different breast thicknesses and compositions that must be used so that optical densities within \u00b10.30 of the average under phototimed conditions can be produced.\n\n(B) After October 28, 2002, the AEC shall be capable of maintaining film optical density (OD) within \u00b10.15 of the mean optical density when thickness of a homogeneous material is varied over a range of 2 to 6 cm and the kVp is varied appropriately for such thicknesses over the kVp range used clinically in the facility.\n\n(C) The optical density of the film in the center of the phantom image shall not be less than 1.20.\n\n(ii)  Kilovoltage peak (kVp) accuracy and reproducibility.  (A) The kVp shall be accurate within \u00b15 percent of the indicated or selected kVp at:\n\n( 1 ) The lowest clinical kVp that can be measured by a kVp test device;\n\n( 2 ) The most commonly used clinical kVp;\n\n( 3 ) The highest available clinical kVp, and\n\n(B) At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.02.\n\n(iii)  Focal spot condition.  Until October 28, 2002, focal spot condition shall be evaluated either by determining system resolution or by measuring focal spot dimensions. After October 28, 2002, facilities shall evaluate focal spot condition only by determining the system resolution.\n\n(A)  System resolution.  ( 1 ) Each X-ray system used for mammography, in combination with the mammography screen-film combination used in the facility, shall provide a minimum resolution of 11 Cycles/millimeter (mm) (line-pairs/mm) when a high contrast resolution bar test pattern is oriented with the bars perpendicular to the anode-cathode axis, and a minimum resolution of 13 line-pairs/mm when the bars are parallel to that axis.\n\n( 2 ) The bar pattern shall be placed 4.5 cm above the breast support surface, centered with respect to the chest wall edge of the image receptor, and with the edge of the pattern within 1 cm of the chest wall edge of the image receptor.\n\n( 3 ) When more than one target material is provided, the measurement in paragraph (e)(5)(iii)(A) of this section shall be made using the appropriate focal spot for each target material.\n\n( 4 ) When more than one SID is provided, the test shall be performed at SID most commonly used clinically.\n\n( 5 ) Test kVp shall be set at the value used clinically by the facility for a standard breast and shall be performed in the AEC mode, if available. If necessary, a suitable absorber may be placed in the beam to increase exposure times. The screen-film cassette combination used by the facility shall be used to test for this requirement and shall be placed in the normal location used for clinical procedures.\n\n(B)  Focal spot dimensions.  Measured values of the focal spot length (dimension parallel to the anode cathode axis) and width (dimension perpendicular to the anode cathode axis) shall be within the tolerance limits specified in table 1.\n\nTable 1\n\n(iv)  Beam quality and half-value layer (HVL).  The HVL shall meet the specifications of \u00a7 1020.30(m)(1) of this chapter for the minimum HVL. These values, extrapolated to the mammographic range, are shown in table 2. Values not shown in table 2 may be determined by linear interpolation or extrapolation.\n\nTable 2\n\n(v)  Breast entrance air kerma and AEC reproducibility.  The coefficient of variation for both air kerma and mAs shall not exceed 0.05.\n\n(vi)  Dosimetry.  The average glandular dose delivered during a single cranio-caudal view of an FDA-accepted phantom simulating a standard breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The dose shall be determined with technique factors and conditions used clinically for a standard breast.\n\n(vii)  X-ray field/light field/image receptor/compression paddle alignment.  (A) All systems shall have beam-limiting devices that allow the entire chest wall edge of the x-ray field to extend to the chest wall edge of the image receptor and provide means to assure that the x-ray field does not extend beyond any edge of the image receptor by more than 2 percent of the SID.\n\n(B) If a light field that passes through the X-ray beam limitation device is provided, it shall be aligned with the X-ray field so that the total of any misalignment of the edges of the light field and the X-ray field along either the length or the width of the visually defined field at the plane of the breast support surface shall not exceed 2 percent of the SID.\n\n(C) The chest wall edge of the compression paddle shall not extend beyond the chest wall edge of the image receptor by more than one percent of the SID when tested with the compression paddle placed above the breast support surface at a distance equivalent to standard breast thickness. The shadow of the vertical edge of the compression paddle shall not be visible on the image.\n\n(viii)  Uniformity of screen speed.  Uniformity of screen speed of all the cassettes in the facility shall be tested and the difference between the maximum and minimum optical densities shall not exceed 0.30. Screen artifacts shall also be evaluated during this test.\n\n(ix)  System artifacts.  System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations used clinically.\n\n(x)  Radiation output.  (A) The system shall be capable of producing a minimum output of 4.5 mGy air kerma per second (513 milli Roentgen (mR) per second) when operating at 28 kVp in the standard mammography (moly/moly) mode at any SID where the system is designed to operate and when measured by a detector with its center located 4.5 cm above the breast support surface with the compression paddle in place between the source and the detector. After October 28, 2002, the system, under the same measuring conditions shall be capable of producing a minimum output of 7.0 mGy air kerma per second (800 mR per second) when operating at 28 kVp in the standard (moly/moly) mammography mode at any SID where the system is designed to operate.\n\n(B) The system shall be capable of maintaining the required minimum radiation output averaged over a 3.0 second period.\n\n(xi)  Decompression.  If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, the system shall be tested to confirm that it provides:\n\n(A) An override capability to allow maintenance of compression;\n\n(B) A continuous display of the override status; and\n\n(C) A manual emergency compression release that can be activated in the event of power or automatic release failure.\n\n(6)  Quality control tests\u2014other modalities.  For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.\n\n(7)  Mobile units.  The facility shall verify that mammography units used to produce mammograms at more than one location meet the requirements in paragraphs (e)(1) through (e)(6) of this section. In addition, at each examination location, before any examinations are conducted, the facility shall verify satisfactory performance of such units using a test method that establishes the adequacy of the image quality produced by the unit.\n\n(8)  Use of test results.  (i) After completion of the tests specified in paragraphs (e)(1) through (e)(7) of this section, the facility shall compare the test results to the corresponding specified action limits; or, for nonscreen-film modalities, to the manufacturer's recommended action limits; or, for post-move, preexamination testing of mobile units, to the limits established in the test method used by the facility.\n\n(ii) If the test results fall outside of the action limits, the source of the problem shall be identified and corrective actions shall be taken:\n\n(A) Before any further examinations are performed or any films are processed using a component of the mammography system that failed any of the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;\n\n(B) Within 30 days of the test date for all other tests described in paragraph (e) of this section.\n\n(9)  Surveys.  (i) At least once a year, each facility shall undergo a survey by a medical physicist or by an individual under the direct supervision of a medical physicist. At a minimum, this survey shall include the performance of tests to ensure that the facility meets the quality assurance requirements of the annual tests described in paragraphs (e)(5) and (e)(6) of this section and the weekly phantom image quality test described in paragraph (e)(2) of this section.\n\n(ii) The results of all tests conducted by the facility in accordance with paragraphs (e)(1) through (e)(7) of this section, as well as written documentation of any corrective actions taken and their results, shall be evaluated for adequacy by the medical physicist performing the survey.\n\n(iii) The medical physicist shall prepare a survey report that includes a summary of this review and recommendations for necessary improvements.\n\n(iv) The survey report shall be sent to the facility within 30 days of the date of the survey.\n\n(v) The survey report shall be dated and signed by the medical physicist performing or supervising the survey. If the survey was performed entirely or in part by another individual under the direct supervision of the medical physicist, that individual and the part of the survey that individual performed shall also be identified in the survey report.\n\n(10)  Mammography equipment evaluations.  Additional evaluations of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is disassembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.\n\n(11)  Facility cleanliness.  (i) The facility shall establish and implement adequate protocols for maintaining darkroom, screen, and view box cleanliness.\n\n(ii) The facility shall document that all cleaning procedures are performed at the frequencies specified in the protocols.\n\n(12)  Calibration of air kerma measuring instruments.  Instruments used by medical physicists in their annual survey to measure the air kerma or air kerma rate from a mammography unit shall be calibrated at least once every 2 years and each time the instrument is repaired. The instrument calibration must be traceable to a national standard and calibrated with an accuracy of \u00b16 percent (95 percent confidence level) in the mammography energy range.\n\n(13)  Infection control.  Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials. This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:\n\n(i) Comply with all applicable Federal, State, and local regulations pertaining to infection control; and\n\n(ii) Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or\n\n(iii) If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.\n\n(f)  Quality assurance-mammography medical outcomes audit.  Each facility shall establish and maintain a mammography medical outcomes audit program to followup positive mammographic assessments and to correlate pathology results with the interpreting physician's findings. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms.\n\n(1)  General requirements.  For the purposes of these audit requirements, a mammographic examination consisting of routine views of an asymptomatic patient shall be termed a screening mammogram, while a mammographic examination consisting of individualized views of a patient with breast symptoms, physical signs of breast disease, or abnormal findings on a screening mammogram shall be termed a diagnostic mammogram. Each facility shall establish a system to collect and review outcome data for all mammographic examinations performed, including followup on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. In addition, for cases of breast cancer among patients imaged at the facility that subsequently become known to the facility, the facility shall promptly initiate followup on surgical and/or pathology results and review of the mammographic examinations taken prior to the diagnosis of a malignancy. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians and, at a minimum, shall consist of a determination of the following:\n\n(i) Positive predictive value\u2014percent of patients with positive mammograms who are diagnosed with breast cancer within 1 year of the date of the mammographic examination.\n\n(ii) Cancer detection rate\u2014of the patients initially examined with screening mammograms who receive an assessment of \u201cIncomplete: Need additional imaging evaluation,\u201d \u201cSuspicious,\u201d or \u201cHighly Suggestive of Malignancy\u201d on the screening mammogram or on a subsequent diagnostic mammogram, the number of patients who are diagnosed with breast cancer within 1 year of the date of the initial screening mammogram, expressed arithmetically as a ratio per 1,000 patients.\n\n(iii) Recall rate\u2014percentage of screening mammograms given an assessment of \u201cIncomplete: Need additional imaging evaluation.\u201d\n\n(2)  Frequency of audit analysis.  The facility's first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified, or 12 months after April 28, 1999, whichever date is the latest. This audit analysis shall be completed within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every 12 months.\n\n(3)  Audit interpreting physician.  Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results and for notifying other interpreting physicians of their results and the facility aggregate results. If followup actions are taken, the audit interpreting physician shall also be responsible for documenting the nature of the followup.\n\n(4) The records and data required to demonstrate compliance with the requirements in paragraphs (f)(1) through (3) of this section must be retained until the annual inspection that follows the facility's analysis of that information.\n\n(g)  Mammographic procedure and techniques for mammography of patients with breast implants.  (1) Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic exam.\n\n(2) Except where contraindicated, or unless modified by a physician's directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.\n\n(h)  Consumer complaint mechanism.  Each facility shall:\n\n(1) Establish a written and documented system for collecting and resolving consumer complaints;\n\n(2) Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received;\n\n(3) Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction;\n\n(4) Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body.\n\n(i)  Clinical image quality.  Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility's accreditation body.\n\n(j)  Additional mammography review and patient and referring provider notification.  (1) If FDA or the State certification agency believes that mammographic quality at a facility has been compromised and may present a significant risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA or the State certification agency, for review by the accreditation body or the State certification agency. This additional mammography review will help FDA or the State certification agency determine whether the facility is in compliance with this section and whether there is a need to notify affected patients, their referring physicians or other healthcare providers, and/or the public that there is a significant risk to human health.\n\n(2) Based on the results of the additional mammography review, the facility's failure to comply with the terms of the additional mammography review, or other information, FDA or the State certification agency may determine that the quality of mammography performed by a facility, whether or not certified under \u00a7 900.11, was so inconsistent with the quality standards established in this part as to present a significant risk to human health. FDA or the State certification agency may require such a facility to notify all patients who received mammograms at the facility or those patients who are determined to be at risk due to the quality of their mammography, and their referring physicians or other healthcare providers, of the deficiencies and resulting potential harm, appropriate remedial measures, and such other relevant information as FDA or the State certification agency may require. Such notification shall occur within a timeframe and in a manner specified by FDA or the State certification agency. If the facility is unable or unwilling to perform such notification, FDA or the State certification agency may notify patients and their referring physicians or other healthcare providers individually or through the mass media."], ["21:21:8.0.1.2.36.2.1.4", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.13 Revocation of accreditation and revocation of accreditation body approval.", "FDA", "", "", "", "(a)  FDA action following revocation of accreditation.  If a facility's accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility's certificate shall no longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography.\n\n(b)  Withdrawal of FDA approval of an accreditation body.  (1) If FDA withdraws approval of an accreditation body under \u00a7 900.6, the certificates of facilities previously accredited by such body shall remain in effect for up to 1 year from the date of the withdrawal of approval, unless FDA determines, in order to protect human health or because the accreditation body fraudulently accredited facilities, that the certificates of some or all of the facilities should be revoked or suspended or that a shorter time period should be established for the certificates to remain in effect.\n\n(2) After 1 year from the date of withdrawal of approval of an accreditation body, or within any shorter period of time established by the agency, the affected facilities must obtain accreditation from another accreditation body, or from another entity designated by FDA."], ["21:21:8.0.1.2.36.2.1.5", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.14 Suspension or revocation of certificates.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997. Republished and corrected at 62 FR 60614, Nov. 10, 1997, as amended at 88 FR 15171, Mar. 10, 2023]", "(a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with part 16 of this chapter, that the facility, owner, operator, or any employee of the facility:\n\n(1) Has been guilty of misrepresentation in obtaining the certificate;\n\n(2) Has failed to comply with the standards of \u00a7 900.12;\n\n(3) Has failed to comply with reasonable requests of FDA, the State certification agency, or the accreditation body for records, information, reports, or materials, including clinical images for an additional mammography review under \u00a7 900.12(j), that FDA or the State certification agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of \u00a7 900.12;\n\n(4) Has refused a reasonable request of a duly designated FDA inspector, State inspector, or accreditation body representative for permission to inspect the facility or the operations and pertinent records of the facility;\n\n(5) Has violated or aided and abetted in the violation of any provision of or regulation issued pursuant to 42 U.S.C. 263b;\n\n(6) Has failed to comply with prior sanctions imposed by FDA or the State certification agency under 42 U.S.C. 263b(h), including a directed plan of correction or a patient and referring physician notification; or\n\n(7) Has failed to comply with requests of current or former facility personnel for records of their training or experience relevant to their qualification under MQSA, in violation of \u00a7 900.12(a)(4).\n\n(b) FDA may suspend the certificate of a facility before holding a hearing if FDA makes a finding described in paragraph (a) of this section and also determines that;\n\n(1) The failure to comply with required standards presents a serious risk to human health;\n\n(2) The refusal to permit inspection makes immediate suspension necessary; or\n\n(3) There is reason to believe that the violation or aiding and abetting of the violation was intentional or associated with fraud.\n\n(c) If FDA suspends a certificate in accordance with paragraph (b) of this section:\n\n(1) The agency shall provide the facility with an opportunity for an informal hearing under part 16 of this chapter not later than 60 days from the effective date of this suspension;\n\n(2) The suspension shall remain in effect until the agency determines that:\n\n(i) Allegations of violations or misconduct were not substantiated;\n\n(ii) Violations of required standards have been corrected to the agency's satisfaction; or\n\n(iii) The facility's certificate is revoked in accordance with paragraph (d) of this section;\n\n(d) After providing a hearing in accordance with paragraph (c)(1) of this section, the agency may revoke the facility's certificate if the agency determines that the facility:\n\n(1) Is unwilling or unable to correct violations that were the basis for suspension; or\n\n(2) Has engaged in fraudulent activity to obtain or continue certification."], ["21:21:8.0.1.2.36.2.1.6", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.15 Appeals of adverse accreditation or reaccreditation decisions that preclude certification or recertification.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18443, Apr. 2, 2020; 88 FR 15171, Mar. 10, 2023]", "(a) The appeals procedures described in this section are available only for adverse accreditation or reaccreditation decisions that preclude certification or recertification by FDA. Agency decisions to suspend or revoke certificates that are already in effect will be handled in accordance with \u00a7 900.14.\n\n(b) Upon learning that a facility has failed to become accredited or reaccredited, FDA will notify the facility that the agency is unable to certify that facility without proof of accreditation.\n\n(c) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body, in accordance with \u00a7 900.7. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from FDA.\n\n(d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body's appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498.\n\n(1) References to the Centers for Medicare and Medicaid Services in 42 CFR part 498 should be read as the Division of Mammography Quality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug Administration.\n\n(2) References to the Appeals Council of the Social Security Administration in 42 CFR part 498 should be read as references to the Departmental Appeals Board.\n\n(3) In accordance with the procedures set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP.\n\n(i) A facility must request reconsideration by DMQS within 60 days of the accreditation body's adverse appeals decision, at the following address: Food and Drug Administration, Center for Devices and Radiological Health, Division of Mammography Quality Standards, Attn: Facility Accreditation Review Committee, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002.\n\n(ii) The request for reconsideration shall include three copies of the following records:\n\n(A) The accreditation body's original denial of accreditation.\n\n(B) All information the facility submitted to the accreditation body as part of the appeals process;\n\n(C) A copy of the accreditation body's adverse appeals decision; and\n\n(D) A statement of the basis for the facility's disagreement with the accreditation body's decision.\n\n(iii) DMQRP will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498.\n\n(4) A facility that is dissatisfied with DMQRP's decision following reconsideration is entitled to a formal hearing in accordance with procedures set forth in subpart D of 42 CFR part 498.\n\n(5) Either the facility or FDA may request review of the hearing officer's decision. Such review will be conducted by the Departmental Appeals Board in accordance with subpart E of 42 CFR part 498.\n\n(6) A facility cannot perform mammography services while an adverse accreditation decision is being appealed."], ["21:21:8.0.1.2.36.2.1.7", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.16 Appeals of denials of certification.", "FDA", "", "", "", "(a) The appeals procedures described in this section are available only to facilities that are denied certification by FDA after they have been accredited by an approved accreditation body. Appeals for facilities that have failed to become accredited are governed by the procedures set forth in \u00a7 900.15.\n\n(b) FDA may deny the application if the agency has reason to believe that:\n\n(1) The facility will not be operated in accordance with standards established under \u00a7 900.12;\n\n(2) The facility will not permit inspections or provide access to records or information in a timely fashion; or\n\n(3) The facility has been guilty of misrepresentation in obtaining the accreditation.\n\n(c)(1) If FDA denies an application for certification by a faciity that has received accreditation from an approved accreditation body, FDA shall provide the facility with a statement of the grounds on which the denial is based.\n\n(2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of \u00a7 900.15(d)."], ["21:21:8.0.1.2.36.2.1.8", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.17 [Reserved]", "FDA", "", "", "", ""], ["21:21:8.0.1.2.36.2.1.9", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "B", "Subpart B\u2014Quality Standards and Certification", "", "\u00a7 900.18 Alternative requirements for \u00a7 900.12 quality standards.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020; 88 FR 45067, July 14, 2023]", "(a)  Criteria for approval of alternative standards.  Upon application by a qualified party as defined in paragraph (b) of this section, FDA may approve an alternative to a quality standard under \u00a7 900.12, when the agency determines that:\n\n(1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and\n\n(2) The proposed alternative:\n\n(i) Is too limited in its applicability to justify an amendment to the standard; or\n\n(ii) Offers an expected benefit to human health that is so great that the time required for amending the standard would present an unjustifiable risk to the human health; and\n\n(3) The granting of the alternative is in keeping with the purposes of 42 U.S.C. 263b.\n\n(b)  Applicants for alternatives.  (1) Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of \u00a7 900.12.\n\n(2) Federal agencies and State governments that are not accreditation bodies may apply for alternatives to the standards of \u00a7 900.12(a).\n\n(3) Manufacturers and assemblers of equipment used for mammography may apply for alternatives to the standards of \u00a7 900.12(b) and (e).\n\n(c)  Applications for approval of an alternative standard.  An application for approval of an alternative standard or for an amendment or extension of the alternative standard shall be submitted in an original and two copies to the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality Standards, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002. The application for approval of an alternative standard shall include the following information:\n\n(1) Identification of the original standard for which the alternative standard is being proposed and an explanation of why the applicant is proposing the alternative;\n\n(2) A description of the manner in which the alternative is proposed to deviate from the original standard;\n\n(3) A description, supported by data, of the advantages to be derived from such deviation;\n\n(4) An explanation, supported by data, of how such a deviation would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard;\n\n(5) The suggested period of time that the proposed alternative standard would be in effect; and\n\n(6) Such other information required by the Director to evaluate and act on the application.\n\n(d)  Ruling on applications.  (1) FDA may approve or deny, in whole or in part, a request for approval of an alternative standard or any amendment or extension thereof, and shall inform the applicant in writing of this action. The written notice shall state the manner in which the requested alternative standard differs from the agency standard and a summary of the reasons for approval or denial of the request. If the request is approved, the written notice shall also include the effective date and the termination date of the approval and a summary of the limitations and conditions attached to the approval and any other information that may be relevant to the approved request. Each approved alternative standard shall be assigned an identifying number.\n\n(2) Notice of an approved request for an alternative standard or any amendment or extension thereof shall be placed in the public docket file in the Dockets Management Staff and may also be in the form of a notice published in the  Federal Register.  The notice shall state the name of the applicant, a description of the published agency standard, and a description of the approved alternative standard, including limitations and conditions attached to the approval of the alternative standard.\n\n(3) Summaries of the approval of alternative standards, including information on their nature and number, shall be provided to the National Mammography Quality Assurance Advisory Committee.\n\n(4) All applications for approval of alternative standards and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications shall be available for public disclosure in the Dockets Management Staff, excluding patient identifiers and confidential commercial information.\n\n(e)  Amendment or extension of an alternative standard.  An application for amending or extending approval of an alternative standard shall include the following information:\n\n(1) The approval number and the expiration date of the alternative standard;\n\n(2) The amendment or extension requested and the basis for the amendment or extension; and\n\n(3) An explanation, supported by data, of how such an amendment or extension would ensure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.\n\n(f)  Applicability of the alternative standards.  (1) Except as provided in paragraphs (f)(2) and (f)(3) of this section, any approval of an alternative standard, amendment, or extension may be implemented only by the entity to which it was granted and under the terms under which it was granted. Other entities interested in similar or identical approvals must file their own application following the procedures of paragraph (c) of this section.\n\n(2) When an alternative standard is approved for a manufacturer of equipment, any facility using that equipment will also be covered by the alternative standard.\n\n(3) The agency may extend the alternative standard to other entities when FDA determines that expansion of the approval of the alternative standard would be an effective means of promoting the acceptance of measures to improve the quality of mammography. All such determinations will be publicized by appropriate means.\n\n(g)  Withdrawal of approval of alternative requirements.  FDA shall amend or withdraw approval of an alternative standard whenever the agency determines that this action is necessary to protect the human health or otherwise is justified by \u00a7 900.12. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification of the applicant when FDA determines that such action is necessary to prevent an imminent health hazard."], ["21:21:8.0.1.2.36.3.1.1", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.20 Scope.", "FDA", "", "", "", "The regulations set forth in this part implement the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part establishes procedures whereby a State can apply to become a FDA-approved certification agency to certify facilities within the State to perform mammography services. Subpart C of this part further establishes requirements and standards for State certification agencies to ensure that all mammography facilities under their jurisdiction are adequately and consistently evaluated for compliance with quality standards at least as stringent as the national quality standards established by FDA."], ["21:21:8.0.1.2.36.3.1.2", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.21 Application for approval as a certification agency.", "FDA", "", "", "[62 FR 55976, Oct. 28, 1997; 62 FR 60614, Nov. 10, 1997, as amended at 75 FR 20916, Apr. 22, 2010; 85 FR 18444, Apr. 2, 2020]", "(a)  Eligibility.  State agencies may apply for approval as a certification agency if they have standards at least as stringent as those of \u00a7 900.12, qualified personnel, adequate resources to carry out the States as Certifiers' responsibilities, and the authority to enter into a legal agreement with FDA to accept these responsibilities.\n\n(b)  Application for approval.  (1) An applicant seeking FDA approval as a certification agency shall inform the Food and Drug Administration, Center for Devices and Radiological Health, Director, Division of Mammography Quality Standards, Attn: Program Management Branch, 10903 New Hampshire Ave., Bldg. 66, Rm. 3621, Silver Spring, MD 20993-0002, in writing, of its desire to be approved as a certification agency.\n\n(2) Following receipt of the written request, FDA will provide the applicant with additional information to aid in the submission of an application for approval as a certification agency.\n\n(3) The applicant shall furnish to FDA, at the address in paragraph (b)(1) of this section, three copies of an application containing the following information, materials, and supporting documentation:\n\n(i) Name, address, and phone number of the applicant;\n\n(ii) Detailed description of the mammography quality standards the applicant will require facilities to meet and, for those standards different from FDA's quality standards, information substantiating that they are at least as stringent as FDA standards under \u00a7 900.12;\n\n(iii) Detailed description of the applicant's review and decisionmaking process for facility certification, including:\n\n(A) Policies and procedures for notifying facilities of certificate denials and expirations;\n\n(B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities;\n\n(C) Policies and procedures for suspending or revoking a facility's certification;\n\n(D) Policies and procedures that will ensure processing certificates within a timeframe approved by FDA;\n\n(E) A description of the appeals process for facilities contesting adverse certification status decisions;\n\n(F) Education, experience, and training requirements of the applicant's professional and supervisory staff;\n\n(G) Description of the applicant's electronic data management and analysis system;\n\n(H) Fee schedules;\n\n(I) Statement of policies and procedures established to avoid conflict of interest;\n\n(J) Description of the applicant's mechanism for handling facility inquiries and complaints;\n\n(K) Description of a plan to ensure that certified mammography facilities will be inspected according to MQSA (42 U.S.C. 263b) and procedures and policies for notifying facilities of inspection deficiencies;\n\n(L) Policies and procedures for monitoring and enforcing the correction of facility deficiencies discovered during inspections or by other means;\n\n(M) Policies and procedures for additional mammography review and for requesting such reviews from accreditation bodies;\n\n(N) Policies and procedures for patient notification;\n\n(O) If a State has regulations that are more stringent than those of \u00a7 900.12, an explanation of how adverse actions taken against a facility under the more stringent regulations will be distinguished from those taken under the requirements of \u00a7 900.12; and\n\n(P) Any other information that FDA identifies as necessary to make a determination on the approval of the State as a certification agency.\n\n(c)  Rulings on applications for approval.  (1) FDA will conduct a review and evaluation to determine whether the applicant substantially meets the applicable requirements of this subpart and whether the certification standards the applicant will require facilities to meet are the quality standards published under subpart B of this part or at least as stringent as those of subpart B.\n\n(2) FDA will notify the applicant of any deficiencies in the application and request that those deficiencies be corrected within a specified time period. If the deficiencies are not corrected to FDA's satisfaction within the specified time period, FDA may deny the application for approval as a certification agency.\n\n(3) FDA shall notify the applicant whether the application has been approved or denied. The notification shall list any conditions associated with approval or state the bases for any denial.\n\n(4) The review of any application may include a meeting between FDA and representatives of the applicant at a time and location mutually acceptable to FDA and the applicant.\n\n(5) FDA will advise the applicant of the circumstances under which a denied application may be resubmitted.\n\n(d)  Scope of authority.  FDA may limit the scope of certification authority delegated to the State in accordance with MQSA."], ["21:21:8.0.1.2.36.3.1.3", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.22 Standards for certification agencies.", "FDA", "", "", "", "The certification agency shall accept the following responsibilities in order to ensure quality mammography at the facilities it certifies and shall perform these responsibilities in a manner that ensures the integrity and impartiality of the certification agency's actions:\n\n(a)  Conflict of interest.  The certification agency shall establish and implement measures that FDA has approved in accordance with \u00a7 900.21(b) to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the certification agency's behalf.\n\n(b)  Certification and inspection responsibilities.  Mammography facilities shall be certified and inspected in accordance with statutory and regulatory requirements that are at least as stringent as those of MQSA and this part.\n\n(c)  Compliance with quality standards.  The scope, timeliness, disposition, and technical accuracy of completed inspections and related enforcement activities shall ensure compliance with facility quality standards required under \u00a7 900.12.\n\n(d)  Enforcement actions.  (1) There shall be appropriate criteria and processes for the suspension and revocation of certificates.\n\n(2) There shall be prompt investigation of and appropriate enforcement action for facilities performing mammography without certificates.\n\n(e)  Appeals.  There shall be processes for facilities to appeal inspection findings, enforcement actions, and adverse certification decision or adverse accreditation decisions after exhausting appeals to the accreditation body.\n\n(f)  Additional mammography review.  There shall be a process for the certification agency to request additional mammography review from accreditation bodies for issues related to mammography image quality and clinical practice. The certification agency should request additional mammography review only when it believes that mammography quality at a facility has been compromised and may present a serious risk to human health.\n\n(g)  Patient notification.  There shall be processes for the certification agency to conduct, or cause to be conducted, patient notifications should the certification agency determine that mammography quality has been compromised to such an extent that it may present a serious risk to human health.\n\n(h)  Electronic data transmission.  There shall be processes to ensure the timeliness and accuracy of electronic transmission of inspection data and facility certification status information in a format and timeframe determined by FDA.\n\n(i)  Changes to standards.  A certification agency shall obtain FDA authorization for any changes it proposes to make in any standard that FDA has previously accepted under \u00a7 900.21 before requiring facilities to comply with the changes as a condition of obtaining or maintaining certification."], ["21:21:8.0.1.2.36.3.1.4", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.23 Evaluation.", "FDA", "", "", "", "FDA shall evaluate annually the performance of each certification agency. The evaluation shall include the use of performance indicators that address the adequacy of program performance in certification, inspection, and enforcement activities. FDA will also consider any additional information deemed relevant by FDA that has been provided by the certification body or other sources or has been required by FDA as part of its oversight mandate. The evaluation also shall include a review of any changes in the standards or procedures in the areas listed in \u00a7\u00a7 900.21(b) and 900.22 that have taken place since the original application or the last evaluation, whichever is most recent. The evaluation shall include a determination of whether there are major deficiencies in the certification agency's regulations or performance that, if not corrected, would warrant withdrawal of the approval of the certification agency under the provisions of \u00a7 900.24, or minor deficiencies that would require corrective action."], ["21:21:8.0.1.2.36.3.1.5", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.24 Withdrawal of approval.", "FDA", "", "", "", "If FDA determines, through the evaluation activities of \u00a7 900.23, or through other means, that a certification agency is not in substantial compliance with this subpart, FDA may initiate the following actions:\n\n(a)  Major deficiencies.  If, after providing notice and opportunity for corrective action, FDA determines that a certification agency has demonstrated willful disregard for public health, has committed fraud, has failed to provide adequate resources for the program, has submitted material false statements to the agency, has failed to achieve the MQSA goals of quality mammography and access, or has performed or failed to perform a delegated function in a manner that may cause serious risk to human health, FDA may withdraw its approval of that certification agency. The certification agency shall notify, within a time period and in a manner approved by FDA, all facilities certified or seeking certification by it that it has been required to correct major deficiencies.\n\n(1) FDA shall notify the certification agency of FDA's action and the grounds on which the approval was withdrawn.\n\n(2) A certification agency that has lost its approval shall notify facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, that its approval has been withdrawn. Such notification shall be made within a timeframe and in a manner approved by FDA.\n\n(b)  Minor deficiencies.  If FDA determines that a certification agency has demonstrated deficiencies in performing certification functions and responsibilities that are less serious or more limited than the deficiencies in paragraph (a) of this section, including failure to follow the certification agency's own procedures and policies as approved by FDA, FDA shall notify the certification agency that it has a specified period of time to take particular corrective measures as directed by FDA or to submit to FDA for approval the certification agency's own plan of corrective action addressing the minor deficiencies. If the approved corrective actions are not being implemented satisfactorily or within the established schedule, FDA may place the agency on probationary status for a period of time determined by FDA, or may withdraw approval of the certification agency.\n\n(1) If FDA places a certification agency on probationary status, the certification agency shall notify all facilities certified or seeking certification by it of its probationary status within a time period and in a manner approved by FDA.\n\n(2) Probationary status shall remain in effect until such time as the certification agency can demonstrate to the satisfaction of FDA that it has successfully implemented or is implementing the corrective action plan within the established schedule, and that the corrective actions have substantially eliminated all identified problems, or\n\n(3) If FDA determines that a certification agency that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, FDA may withdraw approval of the certification agency. The certification agency shall notify all facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, of its loss of FDA approval, within a timeframe and in a manner approved by FDA.\n\n(c)  Transfer of records.  A certification agency that has its approval withdrawn shall transfer facility records and other related information as required by FDA to a location and according to a schedule approved by FDA."], ["21:21:8.0.1.2.36.3.1.6", 21, "Food and Drugs", "I", "I", "900", "PART 900\u2014MAMMOGRAPHY", "C", "Subpart C\u2014States as Certifiers", "", "\u00a7 900.25 Hearings and appeals.", "FDA", "", "", "", "(a) Opportunities to challenge final adverse actions taken by FDA regarding approval of certification agencies or withdrawal of approval of certification agencies shall be communicated through notices of opportunity for informal hearings in accordance with part 16 of this chapter.\n\n(b) A facility that has been denied certification is entitled to an appeals process from the certification agency. The appeals process shall be specified in writing by the certification agency and shall have been approved by FDA in accordance with \u00a7\u00a7 900.21 and 900.22."], ["7:7:8.1.1.1.1.1.2.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.1 Words in the singular form.", "AMS", "", "", "", "Words in this subpart in the singular form shall be deemed to import the plural, and vice versa, as the case may demand."], ["7:7:8.1.1.1.1.1.2.10", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.10 Certification of the transcript.", "AMS", "", "", "", "The judge shall notify the hearing clerk of the close of a hearing as soon as possible thereafter and of the time for filing written arguments, briefs, proposed findings and proposed conclusions, and shall furnish the hearing clerk with such other information as may be necessary. As soon as possible after the hearing, the judge shall transmit to the hearing clerk an original and three copies of the transcript of the testimony and the original and all copies of the exhibits not already on file in the office of the hearing clerk. He shall attach to the original transcript of testimony his certificate stating that, to the best of his knowledge and belief, the transcript is a true transcript of the testimony given at the hearing except in such particulars as he shall specify; and that the exhibits transmitted are all the exhibits as introduced at the hearing with such exceptions as he shall specify. A copy of such certificate shall be attached to each of the copies of the transcript of testimony. In accordance with such certificate the hearing clerk shall note upon the official record copy, and cause to be noted on other copies, of the transcript each correction detailed therein by adding or crossing out (but without obscuring the text as originally transcribed) at the appropriate place any words necessary to make the same conform to the correct meaning, as certified by the judge. The hearing clerk shall obtain and file certifications to the effect that such corrections have been effected in copies other than the official record copy."], ["7:7:8.1.1.1.1.1.2.11", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.11 Copies of the transcript.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 67 FR 10829, Mar. 11, 2002]", "(a) During the period in which the proceeding has an active status in the Department, a copy of the transcript and exhibits shall be kept on file in the office of the hearing clerk, where it shall be available for examination during official hours of business. Thereafter said transcript and exhibits shall be made available by the hearing clerk for examination during official hours of business after prior request and reasonable notice to the hearing clerk.\n\n(b) Transcripts of hearings shall be made available to any person at actual cost of duplication."], ["7:7:8.1.1.1.1.1.2.12", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.12 Administrator's recommended decision.", "AMS", "", "", "", "(a)  Preparation.  As soon as practicable following the termination of the period allowed for the filing of written arguments or briefs and proposed findings and conclusions the Administrator shall file with the hearing clerk a recommended decision.\n\n(b)  Contents.  The Administrator's recommended decision shall include: (1) A preliminary statement containing a description of the history of the proceedings, a brief explanation of the material issues of fact, law, or discretion presented on the record, and proposed findings and conclusions with respect to such issues as well as the reasons or basis therefor; (2) a ruling upon each proposed finding or conclusion submitted by interested persons, and (3) an appropriate proposed marketing agreement or marketing order effectuating his recommendations.\n\n(c)  Exceptions to recommended decision.  Immediately following the filing of his recommended decision, the Administrator shall give notice thereof, and opportunity to file exceptions thereto by publication in the  Federal Register.  Within a period of time specified in such notice any interested person may file with the hearing clerk exceptions to the Administrator's proposed marketing agreement or marketing order, or both, as the case may be, and a brief in support of such exceptions. Such exceptions shall be in writing, shall refer, where practicable, to the related pages of the transcript and may suggest appropriate changes in the proposed marketing agreement or marketing order.\n\n(d)  Omission of recommended decision.  The procedure provided in this section may be omitted only if the Secretary finds on the basis of the record that due and timely execution of his functions imperatively and unavoidably requires such omission."], ["7:7:8.1.1.1.1.1.2.13", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.13 Submission to Secretary.", "AMS", "", "", "", "Upon the expiration of the period allowed for filing exceptions or upon request of the Secretary, the hearing clerk shall transmit to the Secretary the record of the proceeding. Such record shall include: All motions and requests filed with the hearing clerk and rulings thereon; the certified transcript; any proposed findings or conclusions or written arguments or briefs that may have been filed; the Administrator's recommended decision, if any, and such exceptions as may have been filed."], ["7:7:8.1.1.1.1.1.2.14", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.13a Decision by Secretary.", "AMS", "", "", "", "After due consideration of the record, the Secretary shall render a decision. Such decision shall become a part of the record and shall include: (a) A statement of his findings and conclusions, as well as the reasons or basis therefor, upon all the material issues of fact, law or discretion presented on the record, (b) a ruling upon each proposed finding and proposed conclusion not previously ruled upon in the record, (c) a ruling upon each exception filed by interested persons and (d) either (1) a denial of the proposal to issue a marketing agreement or marketing order or (2) a marketing agreement and, if the findings upon the record so warrant, a marketing order, the provisions of which shall be set forth directly or by reference, regulating the handling of the commodity or product in the same manner and to the same extent as such marketing agreement, which order shall be complete except for its effective date and any determinations to be made under \u00a7 900.14(b) or \u00a7 900.14(c):  Provided,  That such marketing order shall not be executed, issued, or made effective until and unless the Secretary determines that the requirements of \u00a7 900.14(b) or \u00a7 900.14(c) have been met."], ["7:7:8.1.1.1.1.1.2.15", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.14 Execution and issuance of marketing agreements and marketing orders.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 53 FR 15659, May 3, 1988; 88 FR 82231, Nov. 24, 2023]", "(a)  Execution and issuance of marketing agreement.  If the Secretary has approved a marketing agreement, as provided in \u00a7 900.13a, the Administrator shall cause copies thereof to be distributed for execution by the handlers eligible to become parties thereto. If and when such number of the handlers as the Secretary shall deem sufficient shall have executed the agreement, the Secretary shall execute the agreement. After execution of a marketing agreement, such agreement shall be filed with the hearing clerk, and notice thereof, together with notice of the effective date, shall be given by publication in the  Federal Register.  The marketing agreement shall not become effective less than 30 days after its publication in the  Federal Register,  unless the Secretary, upon good cause found and published with the agreement, fixes an earlier effective date therefor:  Provided,  That no marketing agreement shall become effective as to any person signatory thereto before either (1) it has been filed with the Office of the Federal Register, or (2) such person has received actual notice that the Secretary has executed the agreement and the effective date of the marketing agreement.\n\n(b)  Issuance of marketing order with marketing agreement.  Whenever, as provided in paragraph (a) of this section, the Secretary executes a marketing agreement, and handlers also have executed the same as provided in section 8c(8) of the Act, he shall, if he finds that it will tend to effectuate the purposes of the Act, issue and make effective the marketing order, if any, which was filed as a part of his decision pursuant to \u00a7 900.13a:  Provided,  That the issuance of such order shall have been approved or favored by producers as required by section 8c(8) of the act.\n\n(c)  Issuance of marketing order without marketing agreement.  If, despite the failure or refusal of handlers to sign the marketing agreement, as provided in section 8c(8) of the Act, the Secretary makes the determinations required under section 8c(9) of the Act, the Secretary shall issue and make effective the marketing order, if any, which was filed as a part of his decision pursuant to \u00a7 900.13a.\n\n(d)  Effective date of marketing order.  No marketing order shall become effective less than 30 days after its publication in the  Federal Register,  unless the Secretary, upon good cause found and published with the order, fixes an earlier effective date therefor:  Provided,  That no marketing order shall become effective as to any person sought to be charged thereunder before either (1) it has been filed with the Office of the Federal Register, or (2) such person has received actual notice of the issuance and terms of the marketing order.\n\n(e)  Notice of issuance.  After issuance of a marketing order, such order shall be filed with the hearing clerk, and notice thereof, together with notice of the effective date, shall be given by publication in the  Federal Register.  (7 U.S.C. 610(c).)"], ["7:7:8.1.1.1.1.1.2.16", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.15 Filing; extensions of time; effective date of filing; and computation of time.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 30 FR 254, Jan. 9, 1965; 67 FR 10829, Mar. 11, 2002]", "(a)  Filing, number of copies.  Except as is provided otherwise in this subpart, all documents or papers required or authorized by the foregoing provisions of this subpart to be filed with the hearing clerk shall be filed in quadruplicate. Any document or paper, so required or authorized to be filed with the hearing clerk, shall, during the course of an oral hearing, be filed with the presiding officer. The provisions of this subpart concerning filing with the hearing clerk of hearing notices, recommended and final decisions, marketing agreements and orders, and all documents described in \u00a7 900.17 shall be met by filing a true copy thereof with the hearing clerk.\n\n(b)  Extensions of time.  The time for the filing of any document or paper required or authorized by the foregoing provisions of this subpart to be filed may be extended by the judge before the record is certified by the judge or by the Administrator (after the record is so certified by the judge but before it is transmitted to the Secretary), or by the Secretary (after the record is transmitted to the Secretary) upon request filed, and if, in the judgment of the judge, Administrator, or the Secretary, as the case may be, there is good reason for the extension. All rulings made pursuant to this paragraph shall be filed with the hearing clerk.\n\n(c)  Effective date of filing.  Any document or paper required or authorized in this subpart to be filed shall be deemed to be filed at the time it is received by the Hearing Clerk.\n\n(d)  Computation of time.  Each day, including Saturdays, Sundays, and legal public holidays, shall be included in computing the time allowed for filing any document or paper: Provided, That when the time for filing a document or paper expires on a Saturday, Sunday, or legal public holiday, the time allowed for filing the document or paper shall be extended to include the following business day."], ["7:7:8.1.1.1.1.1.2.17", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.16 Ex parte communications.", "AMS", "", "", "[42 FR 10833, Feb. 24, 1977]", "(a) At no stage of the proceeding following the issuance of a notice of hearing and prior to the issuance of the Secretary's decision therein shall an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding discuss ex parte the merits of the proceeding with any person having an interest in the proceeding or with any representative of such person:  Provided,  That procedural matters and status reports shall not be included within this limitation; and  Provided further,  That an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding may discuss the merits of the proceeding with such a person if all parties known to be interested in the proceeding have been given notice and an opportunity to participate. A memorandum of any such discussion shall be included in the record of the proceeding.\n\n(b) No person interested in the proceeding shall make or knowingly cause to be made to an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding an ex parte communication relevant to the merits of the proceeding except as provided in paragraph (a) of this section.\n\n(c) If an employee of the Department who is or may reasonably be expected to be involved in the decisional process of the proceeding receives or makes a communication prohibited by this section, the Department shall place on the public record of the proceeding:\n\n(1) All such written communications;\n\n(2) Memoranda stating the substance of all such oral communications; and\n\n(3) All written responses, and memoranda stating the substance of all oral responses thereto.\n\n(d) Upon receipt of a communication knowingly made or knowingly caused to be made by a party in violation of this section, the Department may, to the extent consistent with the interest of justice and the policy of the underlying statute, take whatever steps are deemed necessary to nullify the effect of such communication.\n\n(e) For the purposes of this section,  ex parte communication  means an oral or written communication not on the public record with respect to which reasonable prior notice to all interested parties is not given, but which shall not include requests for status reports (including requests on procedural matters) on any proceeding."], ["7:7:8.1.1.1.1.1.2.18", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.17 Additional documents to be filed with hearing clerk.", "AMS", "", "", "", "In addition to the documents or papers required or authorized by the foregoing provisions of this subpart to be filed with the hearing clerk, the hearing clerk shall receive for filing and shall have custody of all papers, reports, records, orders, and other documents which relate to the administration of any marketing agreement or marketing order and which the Secretary is required to issue or to approve."], ["7:7:8.1.1.1.1.1.2.19", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.18 Hearing before Secretary.", "AMS", "", "", "", "The Secretary may act in the place and stead of a judge in any proceeding under this subpart. When he so acts the hearing clerk shall transmit the record to the Secretary at the expiration of the period provided for the filing of proposed findings of fact, conclusions and orders, and the Secretary shall thereupon, after due consideration of the record, issue his final decision in the proceeding:  Provided,  That he may issue a tentative decision in which event the parties shall be afforded an opportunity to file exceptions before the issuance of the final decision."], ["7:7:8.1.1.1.1.1.2.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.2 Definitions.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 26 FR 7796, Aug. 22, 1961; 28 FR 579, Jan. 23, 1963; 37 FR 8059, Apr. 25, 1972; 38 FR 29798, Oct. 29, 1973; 67 FR 10829, Mar. 11, 2002; 82 FR 58098, Dec. 11, 2017]", "As used in this subpart, the terms as defined in the act shall apply with equal force and effect. In addition, unless the context otherwise requires:\n\n(a) The term  Act  means Public Act No. 10, 73 Congress (48 Stat. 31), as amended and as reenacted and amended by the Agricultural Marketing Agreement Act of 1937 (50 Stat. 246), as amended.\n\n(b) The term  Department  means the United States Department of Agriculture.\n\n(c) The term  Secretary  means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act for the Secretary.\n\n(d) The term  judge  means any administrative law judge appointed pursuant to 5 U.S.C. 3105 or any presiding official appointed by the Secretary, and assigned to conduct the proceeding.\n\n(e) The term  Administrator  means the Administrator of the Agricultural Marketing Service or any officer or employee of the Department to whom authority has been delegated or may hereafter be delegated to act for the Administrator.\n\n(f) [Reserved]\n\n(g) The term  Federal Register  means the publication provided for by the act of July 26, 1935 (49 Stat. 500), and acts supplementary thereto and amendatory thereof.\n\n(h) The term  hearing  means that part of the proceeding which involves the submission of evidence.\n\n(i) The term  marketing agreement  means any marketing agreement or any amendment thereto which may be entered into pursuant to section 8b of the act.\n\n(j) The term  marketing order  means any order or any amendment thereto which may be issued pursuant to section 8c of the act, and after notice and hearing as required by said section.\n\n(k) The term  proceeding  means a proceeding upon the basis of which a marketing agreement may be entered into or a marketing order may be issued.\n\n(l) The term  hearing clerk  means the hearing clerk, United States Department of Agriculture, Washington, DC."], ["7:7:8.1.1.1.1.1.2.3", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.3 Proposals.", "AMS", "", "", "", "(a) A marketing agreement or a marketing order may be proposed by the Secretary or by any other person. If any person other than the Secretary proposes a marketing agreement or marketing order, he shall file with the Administrator a written application, together with at least four copies of the proposal, requesting the Secretary to hold a hearing upon the proposal. Upon receipt of such proposal, the Administrator shall cause such investigation to be made and such consideration thereof to be given as, in his opinion, are warranted. If the investigation and consideration lead the Administrator to conclude that the proposed marketing agreement or marketing order will not tend to effectuate the declared policy of the act, or that for other proper reasons a hearing should not be held on the proposal, he shall deny the application, and promptly notify the applicant of such denial, which notice shall be accompanied by a brief statement of the grounds for the denial.\n\n(b) If the investigation and consideration lead the Administrator to conclude that the proposed marketing agreement or marketing order will tend to effectuate the declared policy of the act, or if the Secretary desires to propose a marketing agreement or marketing order, he shall sign and cause to be served a notice of hearing, as provided in this subpart."], ["7:7:8.1.1.1.1.1.2.4", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.4 Institution of proceeding.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 83 FR 52944, Oct. 19, 2018; 85 FR 41174, July 9, 2020; 88 FR 82231, Nov. 24, 2023]", "(a)  Filing and contents of the notice of hearing.  The proceeding shall be instituted by filing the notice of hearing with the hearing clerk. The notice of hearing shall contain a reference to the authority under which the marketing agreement or marketing order is proposed; shall define the scope of the hearing as specifically as may be practicable; shall describe any alternative procedures established pursuant to paragraph (d) of this section; shall contain either the terms or substance of the proposed marketing agreement or marketing order or a description of the subjects and issues involved and shall state the industry, area, and class of persons to be regulated, the time and place of such hearing, and the place where copies of such proposed marketing agreement or marketing order may be obtained or examined. The time of the hearing shall not be less than 15 days after the date of publication of the notice in the  Federal Register,  as provided in this subpart, unless the Administrator shall determine that an emergency exists which requires a shorter period of notice, in which case the period of notice shall be that which the Administrator may determine to be reasonable in the circumstances: Provided, That, in the case of hearings on amendments to marketing agreements or marketing orders, the time of the hearing may be less than 15 days but shall not be less than 3 days after the date of publication of the notice in the  Federal Register .\n\n(b)  Giving notice of hearing and supplemental publicity.  (1) The Administrator shall give or cause to be given notice of hearing in the following manner:\n\n(i) By publication of the notice of hearing in the  Federal Register ;\n\n(ii) By mailing a true copy of the notice of hearing, using a postal or other delivery service or electronic communication, to each of the persons known to the Administrator to be interested therein;\n\n(iii) By issuing a press release containing the complete text or a summary of the contents of the notice of hearing and making the same available to such newspapers in the area proposed to be subjected to regulation as reasonably will tend to bring the notice to the attention of the persons interested therein;\n\n(iv) By forwarding copies of the notice of hearing addressed to the governors of such of the several States of the United States and to executive heads of such of the Territories and possessions of the United States as the Administrator, having due regard for the subject matter of the proposal and the public interest, shall determine, should be notified.\n\n(2) Legal notice of the hearing shall be deemed to be given if notice is given in the manner provided by paragraph (b)(1)(i) of this section; and failure to give notice in the manner provided in paragraph (b)(1)(ii), (iii), and (iv) of this section shall not affect the legality of the notice.\n\n(c)  Record of notice and supplemental publicity.  There shall be filed with the hearing clerk or submitted to the judge at the hearing an affidavit or certificate of the person giving the notice provided in paragraph (b)(1) (iii) and (iv) of this section. In regard to the provisions relating to mailing in paragraph (b)(1)(ii) of this section, a determination by the Administrator that such provisions have been complied with shall be filed with the hearing clerk or submitted to the judge at the hearing. In the alternative, if notice is not given in the manner provided in paragraph (b)(1)(ii), (iii), and (iv) of this section there shall be filed with the hearing clerk or submitted to the judge at the hearing a determination by the Administrator that such notice is impracticable, unnecessary, or contrary to the public interest with a brief statement of the reasons for such determination. Determinations by the Administrator as herein provided shall be final.\n\n(d)  Alternative procedures.  The Administrator may establish alternative procedures for the proceeding that are in addition to or in lieu of one or more procedures in this subpart, provided that the procedures are consistent with 5 U.S.C. 556 and 557. The alternative procedures must be described in the notice of hearing, as required in paragraph (a) of this section."], ["7:7:8.1.1.1.1.1.2.5", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.5 Docket number.", "AMS", "", "", "", "Each proceeding, immediately following its institution, shall be assigned a docket number by the hearing clerk and thereafter the proceeding may be referred to by such number."], ["7:7:8.1.1.1.1.1.2.6", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.6 Judges.", "AMS", "", "", "", "(a)  Assignment.  No judge who has any pecuniary interest in the outcome of a proceeding shall serve as judge in such proceeding.\n\n(b)  Powers of judges.  Subject to review by the Secretary, as provided elsewhere in this subpart, the judge, in any proceeding, shall have power to:\n\n(1) Rule upon motions and requests;\n\n(2) Change the time and place of hearing, and adjourn the hearing from time to time or from place to place;\n\n(3) Administer oaths and affirmations and take affidavits;\n\n(4) Examine and cross-examine witnesses and receive evidence;\n\n(5) Admit or exclude evidence;\n\n(6) Hear oral argument on facts or law;\n\n(7) Do all acts and take all measures necessary for the maintenance of order at the hearing and the efficient conduct of the proceeding.\n\n(c)  Who may act in absence of judge.  In case of the absence of the judge or his inability to act, the powers and duties to be performed by him under this part in connection with a proceeding may, without abatement of the proceeding unless otherwise ordered by the Secretary, be assigned to any other judge.\n\n(d)  Disqualification of judge.  The judge may at any time withdraw as judge in a proceeding if he deems himself to be disqualified. Upon the filing by an interested person in good faith of a timely and sufficient affidavit of personal bias or disqualification of a judge, the Secretary shall determine the matter as a part of the record and decision in the proceeding, after making such investigation or holding such hearings, or both, as he may deem appropriate in the circumstances."], ["7:7:8.1.1.1.1.1.2.7", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.7 Motions and requests.", "AMS", "", "", "", "(a)  General.  All motions and requests shall be filed with the hearing clerk, except that those made during the course of the hearing may be filed with the judge or may be stated orally and made a part of the transcript. Except as provided in \u00a7 900.15(b) such motions and requests shall be addressed to, and ruled on by, the presiding officer if made prior to his certification of the transcript pursuant to \u00a7 900.10 or by the Secretary if made thereafter.\n\n(b)  Certification to Secretary.  The judge may in his discretion submit or certify to the Secretary for decision any motion, request, objection, or other question addressed to the judge."], ["7:7:8.1.1.1.1.1.2.8", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.8 Conduct of the hearing.", "AMS", "", "", "[25 FR 5907, June 28, 1960, as amended at 37 FR 1103, Jan. 25, 1972; 85 FR 41174, July 9, 2020]", "(a)  Time and place.  The hearing shall be held at the time and place fixed in the notice of hearing, unless the judge shall have changed the time or place, in which event the judge shall file with the hearing clerk a notice of such change, which notice shall be given in the same manner as provided in \u00a7 900.4 (relating to the giving of notice of the hearing):  Provided,  That, if the change in time or place of hearing is made less than 5 days prior to the date previously fixed for the hearing, the judge, either in addition to or in lieu of causing the notice of the change to be given, shall announce, or cause to be announced, the change at the time and place previously fixed for the hearing.\n\n(b)  Appearances \u2014(1)  Right to appear.  At the hearing, any interested person shall be given an opportunity to appear, either in person or through his authorized counsel or representative, and to be heard with respect to matters relevant and material to the proceeding, provided that such interested person complies with any alternative procedures included in the hearing notice pursuant to\u00a7  900.4. Any interested person who desires to be heard in person at any hearing under these rules shall, before proceeding to testify, state his name, address, and occupation. If any such person is appearing through a counsel or representative, such person or such counsel or representative shall, before proceeding to testify or otherwise to participate in the hearing, state for the record the authority to act as such counsel or representative, and the names and addresses and occupations of such person and such counsel or representative. Any such person or such counsel or representative shall give such other information respecting his appearance as the judge may request.\n\n(2)  Debarment of counsel or representative.  Wherever, while a proceeding is pending before him, the judge finds that a person, acting as counsel or representative for any person participating in the proceeding, is guilty of unethical or unprofessional conduct, the judge may order that such person be precluded from further acting as counsel or representative in such proceeding. An appeal to the Secretary may be taken from any such order, but the proceeding shall not be delayed or suspended pending disposition of the appeal:  Provided,  That the judge may suspend the proceeding for a reasonable time for the purpose of enabling the client to obtain other counsel or other representative. In case the judge has ordered that a person be precluded from further acting as counsel or representative in the proceeding, the presiding officer, within a reasonable time thereafter shall submit to the Secretary a report of the facts and circumstances surrounding such order and shall recommend what action the Secretary should take respecting the appearance of such person as counsel or representative in other proceedings before the Secretary. Thereafter the Secretary may, after notice and an opportunity for hearing, issue such order, respecting the appearance of such person as counsel or representative in proceedings before the Secretary, as the Secretary finds to be appropriate.\n\n(3)  Failure to appear.  If any interested person fails to appear at the hearing, he shall be deemed to have waived the right to be heard in the proceeding.\n\n(c)  Order of procedure.  (1) The judge shall, at the opening of the hearing prior to the taking of testimony, have noted as part of the record the notice of hearing as filed with the Office of the Federal Register and the affidavit or certificate of the giving of notice or the determination provided for in \u00a7 900.4(c).\n\n(2) Evidence shall then be received with respect to the matters specified in the notice of the hearing in such order as the judge shall announce.\n\n(d)  Evidence \u2014(1)  In general.  The hearing shall be publicly conducted, and the testimony given at the hearing shall be reported verbatim.\n\n(i) Every witness shall, before proceeding to testify, be sworn or make affirmation. Cross-examination shall be permitted to the extent required for a full and true disclosure of the facts.\n\n(ii) When necessary, in order to prevent undue prolongation of the hearing, the judge may limit the number of times any witness may testify to the same matter or the amount of corroborative or cumulative evidence.\n\n(iii) The judge shall, insofar as practicable, exclude evidence which is immaterial, irrelevant, or unduly repetitious, or which is not of the sort upon which responsible persons are accustomed to rely.\n\n(2)  Objections.  If a party objects to the admission or rejection of any evidence or to any other ruling of the judge during the hearing, he shall state briefly the grounds of such objection, whereupon an automatic exception will follow if the objection is overruled by the judge. The transcript shall not include argument or debate thereon except as ordered by the judge. The ruling of the judge on any objection shall be a part of the transcript. Only objections made before the judge may subsequently be relied upon in the proceeding.\n\n(3)  Proof and authentication of official records or documents.  An official record or document, when admissible for any purpose, shall be admissible as evidence without the production of the person who made or prepared the same. Such record or document shall, in the discretion of the judge, be evidenced by an official publication thereof or by a copy attested by the person having legal custody thereof and accompanied by a certificate that such person has the custody.\n\n(4)  Exhibits.  All written statements, charts, tabulations, or similar data offered in evidence at the hearing shall, after identification by the proponent and upon satisfactory showing of the authenticity, relevancy, and materiality of the contents thereof, be numbered as exhibits and received in evidence and made a part of the record. Such exhibits shall be submitted in quadruplicate and in documentary form. In case the required number of copies is not made available, the judge shall exercise his discretion as to whether said exhibits shall, when practicable, be read in evidence or whether additional copies shall be required to be submitted within a time to be specified by the judge. If the testimony of a witness refers to a statute, or to a report or document (including the record of any previous hearing) the judge, after inquiry relating to the identification of such statute, report, or document, shall determine whether the same shall be produced at the hearing and physically be made a part of the evidence as an exhibit, or whether it shall be incorporated into the evidence by reference. If relevant and material matter offered in evidence is embraced in a report or document (including the record of any previous hearing) containing immaterial or irrelevant matter, such immaterial or irrelevant matter shall be excluded and shall be segregated insofar as practicable, subject to the direction of the presiding officer.\n\n(5)  Official notice.  Official notice may be taken of such matters as are judicially noticed by the courts of the United States and of any other matter of technical, scientific or commercial fact of established character:  Provided,  That interested persons shall be given adequate notice, at the hearing or subsequent thereto, of matters so noticed and shall be given adequate opportunity to show that such facts are inaccurate or are erroneously noticed.\n\n(6)  Offer of proof.  Whenever evidence is excluded from the record, the party offering such evidence may make an offer of proof, which shall be included in the transcript. The offer of proof shall consist of a brief statement describing the evidence to be offered. If the evidence consists of a brief oral statement or of an exhibit, it shall be inserted into the transcript in toto. In such event, it shall be considered a part of the transcript if the Secretary decides that the judge's ruling in excluding the evidence was erroneous. The judge shall not allow the insertion of such evidence in toto if the taking of such evidence will consume a considerable length of time at the hearing. In the latter event, if the Secretary decides that the judge erred in excluding the evidence, and that such error was substantial, the hearing shall be reopened to permit the taking of such evidence."], ["7:7:8.1.1.1.1.1.2.9", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "A", "Subpart A\u2014Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders", "", "\u00a7 900.9 Oral and written arguments.", "AMS", "", "", "", "(a)  Oral argument before judge.  Oral argument before the judge shall be in the discretion of the judge. Such argument, when permitted, may be limited by the judge to any extent that he finds necessary for the expeditious disposition of the proceeding and shall be reduced to writing and made part of the transcript.\n\n(b)  Briefs, proposed findings and conclusions.  The judge shall announce at the hearing a reasonable period of time within which interested persons may file with the hearing clerk proposed findings and conclusions, and written arguments or briefs, based upon the evidence received at the hearing, citing, where practicable, the page or pages of the transcript of the testimony where such evidence appears. Factual material other than that adduced at the hearing or subject to official notice shall not be alluded to therein, and, in any case, shall not be considered in the formulation of the marketing agreement or marketing order. If the person filing a brief desires the Secretary to consider any objection made by such person to a ruling of the judge, as provided in \u00a7 900.8(d), he shall include in the brief a concise statement concerning each such objection, referring where practicable, to the pertinent pages of the transcript."], ["7:7:8.1.1.1.1.10.2.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.400 General.", "AMS", "", "", "", "Referenda for the purpose of ascertaining whether the issuance by the Secretary of Agriculture of a marketing order to regulate the handling of any fruit, vegetable, or nut, or product thereof, or the continuance or termination of such an order, is approved or favored by producers or processors shall, unless supplemented or modified by the Secretary, be conducted in accordance with this subpart."], ["7:7:8.1.1.1.1.10.2.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.401 Definitions.", "AMS", "", "", "[30 FR 15414, Dec. 15, 1965, as amended at 37 FR 8059, Apr. 25, 1972]", "(a)  Act  means Public Act No. 10, 73d Congress (48 Stat. 31), as amended, and as reenacted and amended by the Agricultural Marketing Agreement Act of 1937 (50 Stat. 246), as amended (7 U.S.C. 601-674).\n\n(b)  Secretary  means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead; and  Department  means the United States Department of Agriculture.\n\n(c)  Administrator  means the Administrator of the Agricultural Marketing Service, with power to redelegate, or any officer or employee of the Department to whom authority has been delegated or may hereafter be delegated to act in his stead.\n\n(d)  Order  means the marketing order (including an amendatory order) with respect to which the Secretary has directed that a referendum be conducted.\n\n(e)  Referendum agent  means the individual or individuals designated by the Secretary to conduct the referendum.\n\n(f)  Representative period  means the period designated by the Secretary pursuant to section 8c of the act (7 U.S.C. 608c).\n\n(g)  Person  means any individual, partnership, corporation, association, or other business unit. For the purpose of this definition, the term  partnership  includes (1) a husband and wife who have title to, or leasehold interest in, land as tenants in common, joint tenants, tenants by the entirety, or, under community property laws, as community property, and (2) so-called  joint ventures,  wherein one or more parties to the agreement, informal or otherwise, contributed capital and others contribute labor, management, equipment, or other services, or any variation of such contributions by two or more parties, so that it results in the growing of the commodity for market and the authority to transfer title to the commodity so produced.\n\n(h)  Producer  means any person defined as a producer in the order who: (1) Owns and farms land, resulting in his ownership of the commodity produced thereon; (2) Rents and farms land, resulting in his ownership of all or a portion of the commodity produced thereon; or (3) Owns land which he does not farm and, as rental for such land, obtains the ownership of a portion of the commodity produced thereon. Ownership of, or leasehold interest in, land and the acquisition, in any manner other than as hereinbefore set forth, of legal title to the commodity grown thereon shall not be deemed to result in such owners or lessees becoming producers."], ["7:7:8.1.1.1.1.10.2.3", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.402 Voting.", "AMS", "", "", "", "(a) Each person who is a producer, as defined in this subpart, at the time of the referendum and who also was a producer during the representative period, shall be entitled to only one vote in the referendum, except that: (1) In a landlord-tenant relationship, where in each of the parties is a producer, each such producer shall be entitled to one vote in the referendum; and (2) a cooperative association of producers, bona fide engaged in marketing the commodity or product thereof proposed to be regulated, or in rendering services for or advancing the interest of the producers of such commodity or product, may, if it elects to do so, vote, both by number and total volume, for the producers who are members of, stockholders in, or under contract with such association.\n\n(b) Whenever, as required by the act, processors vote on the issuance of an order, each processor who is engaged in canning or freezing within the production area of the commodity covered by the order shall be entitled to vote in the referendum the quantity of such commodity canned or frozen within the production area for market by him during the representative period determined by the Secretary.\n\n(c) Proxy voting is not authorized but an officer or employee of a corporate producer, processor or cooperative association, or an administrator, executor or trustee of a producing estate may cast a ballot on behalf of such producer, processor, estate, or cooperative association. Any individual so voting in a referendum shall certify that he is an officer or employee of the producer, processor, or cooperative association, or an administrator, executor, or trustee of a producing estate, and that he has the authority to take such action. Upon request of the referendum agent, the individual shall submit adequate evidence of such authority.\n\n(d) Each producer, cooperative association of producers, and processor entitled to vote in a referendum shall be entitled to cast one ballot in the referendum. Each producer, cooperative association of producers, and processor casting more than one ballot with conflicting votes shall thereby invalidate all ballots cast by such producer, cooperative association of producers, or processor in such referendum."], ["7:7:8.1.1.1.1.10.2.4", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.403 Instructions.", "AMS", "", "", "", "The referendum agent shall conduct the referendum, in the manner herein provided, under supervision of the Administrator. The Administrator may prescribe additional instructions, not inconsistent with the provisions hereof, to govern the procedure to be followed by the referendum agent. Such agent shall:\n\n(a) Determine the time of commencement and termination of the period of the referendum, and the time prior to which all ballots must be cast.\n\n(b) Determine whether ballots may be cast by mail, at polling places, at meetings of producers or processors, or by any combination of the foregoing.\n\n(c) Provide ballots and related material to be used in the referendum. Ballot material shall provide for recording essential information for ascertaining:\n\n(1) Whether the person voting, or on whose behalf the vote is cast, is an eligible voter, and\n\n(2) The total volume (i) produced for market during the representative period, or (ii) canned or frozen for market during the representative period.\n\n(d) Give reasonable advance notice of the referendum (1) by utilizing without advertising expense available media of public information (including, but not being limited to, press and radio facilities) serving the production area, announcing the dates, places, or methods of voting, eligibility requirements, and other pertinent information, and (2) by such other means as said agent may deem advisable.\n\n(e) Make available to producers and the aforesaid cooperative associations which indicate to the agent their intentions to vote, and to processors when required, instructions on voting, appropriate ballot and certification forms, and, except in the case of a referendum on the termination or continuance of an order, the text of the proposed order and a summary of its terms and conditions:  Provided,  That no person who claims to be qualified to vote shall be refused a ballot.\n\n(f) If ballots are to be cast by mail, cause all the material specified in paragraph (e) of this section to be mailed to each producer (and processor when required) whose name and address is known to the referendum agent.\n\n(g) If ballots are to be cast at polling places or meetings, determine the necessary number of polling or meeting places, designate them, announce the time of each meeting or the hours during which each polling place will be open, provide the material specified in paragraph (e) of this section, and provide for appropriate custody of ballot forms and delivery to the referendum agent of ballots cast.\n\n(h) At the conclusion of the referendum, canvass the ballots, tabulate the results, and, except as otherwise directed, report the outcome to the Administrator and promptly thereafter submit the following:\n\n(1) All ballots received by the agent and appointees, together with a certificate to the effect that the ballots forwarded are all of the ballots cast and received by such persons during the referendum period;\n\n(2) A list of all challenged ballots deemed to be invalid; and\n\n(3) A tabulation of the results of the referendum and a report thereon, including a detailed statement explaining the method used in giving publicity to the referendum and showing other information pertinent to the manner in which the referendum was conducted."], ["7:7:8.1.1.1.1.10.2.5", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.404 Subagents.", "AMS", "", "", "", "The referendum agent may appoint any person or persons deemed necessary or desirable to assist said agent in performing his functions hereunder. Each person so appointed may be authorized by said agent to perform, in accordance with the requirements herein set forth, any or all of the following functions (which, in the absence of such appointment, shall be performed by said agent):\n\n(a) Give public notice of the referendum in the manner specified herein;\n\n(b) Preside at a meeting where ballots are to be cast or as poll officer at a polling place;\n\n(c) Distribute ballots and the aforesaid texts to producers (and to processors when required) and receive any ballots which are cast; and\n\n(d) Record the name and address of each person receiving a ballot from, or casting a ballot with, said subagent and inquire into the eligibility of such person to vote in the referendum."], ["7:7:8.1.1.1.1.10.2.6", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.405 Ballots.", "AMS", "", "", "", "The referendum agent and his appointees shall accept all ballots cast; but, should they, or any of them, deem that a ballot should be challenged for any reason, said agent or appointee shall endorse above his signature, on said ballot, a statement to the effect that such ballot was challenged, by whom challenged, the reasons therefor, the results of any investigations made with respect thereto, and the disposition thereof. Invalid ballots shall not be counted."], ["7:7:8.1.1.1.1.10.2.7", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.406 Referendum report.", "AMS", "", "", "", "Except as otherwise directed, the Administrator shall prepare and submit to the Secretary a report on results of the referendum, the manner in which it was conducted, the extent and kind of public notice given, and other information pertinent to analysis of the referendum and its results."], ["7:7:8.1.1.1.1.10.2.8", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "J", "Subpart J\u2014Procedure for the Conduct of Referenda in Connection With Marketing Orders for Fruits, Vegetables, and Nuts Pursuant to the Agricultural Marketing Agreement Act of 1937, as Amended", "", "\u00a7 900.407 Confidential information.", "AMS", "", "", "", "All ballots cast and the contents thereof (whether or not relating to the identity of any person who voted or the manner in which any person voted) and all information furnished to, compiled by, or in possession of, the referendum agent shall be treated as confidential."], ["7:7:8.1.1.1.1.11.2.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "K", "Subpart K\u2014Public Information", "", "\u00a7 900.500 General.", "AMS", "", "", "[40 FR 20267, May 9, 1975]", "This subpart is issued in accordance with the regulations of the Secretary of Agriculture in part 1, subpart A, of subtitle A of this title (7 CFR 1.1 through 1.16), and appendix A thereto, implementing the Freedom of Information Act (5 U.S.C. 552). The Secretary's regulations, as implemented by the regulations of this subpart, govern the availability of records of AMS to the public."], ["7:7:8.1.1.1.1.11.2.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "K", "Subpart K\u2014Public Information", "", "\u00a7 900.501 Public inspection and copying.", "AMS", "", "", "[44 FR 39151, July 5, 1979]", "(a) Facilities for public inspection and copying of the indexes and materials required to be made available under \u00a7 1.2(a) of this title will be provided by AMS during normal information should be made to the Freedom of Information Act Officer at the following address:\n\nFreedom of Information Act Officer, Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250.\n\nFreedom of Information Act Officer, Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250.\n\n(b) Copies of such material may be obtained in person or by mail. Applicable fees for copies will be charged in accordance with the regulations prescribed by the Director, Office of Operations and Finance, USDA."], ["7:7:8.1.1.1.1.11.2.3", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "K", "Subpart K\u2014Public Information", "", "\u00a7 900.502 Indexes.", "AMS", "", "", "[44 FR 39151, July 5, 1979]", "Pursuant to the regulations in \u00a7 1.4(b) of this title, AMS will maintain and make available for public inspection and copying current indexes of all material required to be made available in \u00a7 1.2(a) of this title. Notice is hereby given that publication of these indexes is unnecessary and impractical, since the material is voluminous and does not change often enough to justify the expense of publication."], ["7:7:8.1.1.1.1.11.2.4", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "K", "Subpart K\u2014Public Information", "", "\u00a7 900.503 Request for records.", "AMS", "", "", "[44 FR 39151, July 5, 1979, as amended at 88 FR 82231, Nov. 24, 2023]", "(a) Requests for records under 5 U.S.C. 552(a)(3) shall be made in accordance with \u00a7 1.3(a) of this title. Authority to make determinations regarding initial requests in accordance with \u00a7 1.4(c) of this title is delegated to the Freedom of Information Act Officer of AMS. Requests should be submitted to the FOIA Officer at the following address:\n\nFreedom of Information Act Officer (FOIA Request). Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250.\n\nFreedom of Information Act Officer (FOIA Request). Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250.\n\n(b) The request shall identify each record with reasonable specificity as prescribed in \u00a7 1.3 of this title.\n\n(c) The FOIA Officer is authorized to receive requests and to exercise the authority to\n\n(1) Make determinations to grant requests or deny initial requests,\n\n(2) Extend the administrative deadline,\n\n(3) Make discretionary release of exempt records, and\n\n(4) Make determinations regarding charges pursuant to the fee schedule."], ["7:7:8.1.1.1.1.11.2.5", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "K", "Subpart K\u2014Public Information", "", "\u00a7 900.504 Appeals.", "AMS", "", "", "[40 FR 20267, May 9, 1975]", "Any person whose request under \u00a7 900.503 above is denied shall have the right to appeal such denial in accordance with \u00a7 1.3(e) of this title. Appeals shall be addressed to the Administrator, Agricultural Marketing Service, U.S. Department of Agriculture, Washington, DC 20250."], ["7:7:8.1.1.1.1.12.3.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "L", "Subpart L\u2014Information Collection", "", "\u00a7 900.600 General.", "AMS", "", "", "[63 FR 10492, Mar. 4, 1998]", "This subpart shall contain such requirements as pertain to the information collection provisions under the Paperwork Reduction Act of 1995."], ["7:7:8.1.1.1.1.12.3.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "L", "Subpart L\u2014Information Collection", "", "\u00a7 900.601 OMB control numbers assigned pursuant to the Paperwork Reduction Act.", "AMS", "", "", "[63 FR 10492, Mar. 4, 1998, as amended at 88 FR 82231, Nov. 24, 2023]", "(a)  Purpose.  This section collects and displays the control numbers assigned to information collection requirements by the Office of Management and Budget contained in 7 CFR parts 905 through 998 under the Paperwork Reduction Act of 1995.\n\n(b)  Display.\n\nTable 1 to Paragraph ( b )"], ["7:7:8.1.1.1.1.13.3.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "M", "Subpart M\u2014Assessment of Exemptions", "", "\u00a7 900.700 Exemption from assessments.", "AMS", "", "", "[80 FR 82020, Dec. 31, 2015, as amended at 88 FR 82232, Nov. 24, 2023]", "(a) This section specifies criteria for identifying persons eligible to obtain an exemption from the portion of the assessment used to fund marketing promotion activities under a marketing order and the procedures for applying for such an exemption under 7 CFR parts 905, 906, 915, 922, 923, 925, 927, 929, 930, 932, 948, 955, 956, 958, 959, 966, 981, 982, 984, 985, 987, 989, 993, and such other parts (included in 7 CFR parts 905 through 998) covering marketing orders for fruits, vegetables, and specialty crops as may be established or amended to include market promotion. For the purposes of this section, the term \u201cassessment period\u201d means fiscal period, fiscal year, crop year, or marketing year as defined under these parts; the term \u201cmarketing promotion\u201d means marketing research and development projects or marketing promotion, including paid advertising designed to assist, improve, or promote the marketing, distribution, or consumption of the applicable commodity.\n\n(b) A handler who operates under an approved National Organic Program (7 CFR part 205) (NOP) organic handling system plan and is subject to assessments under a part or parts specified in paragraph (a) of this section may be exempt from the portion of the assessment applicable to marketing promotion, including paid advertising, provided that:\n\n(1) Only agricultural commodities certified as \u201corganic\u201d or \u201c100 percent organic\u201d (as defined in the NOP) are eligible for exemption;\n\n(2) The exemption shall apply to all certified \u201corganic\u201d or \u201c100 percent organic\u201d (as defined in the NOP) products of a handler regardless of whether the agricultural commodity subject to the exemption is handled by a person that also handles conventional or nonorganic agricultural products of the same agricultural commodity as that for which the exemption is claimed;\n\n(3) The handler maintains a valid certificate of organic operation as issued under the Organic Foods Production Act of 1990 (7 U.S.C. 6501-6522)(OFPA) and the NOP regulations issued under OFPA (7 CFR part 205);\n\n(4) Any handler so exempted shall continue to be obligated to pay assessments under such part or parts specified that are associated with any agricultural products that do not qualify for an exemption under this section; and\n\n(5) For exempted products, any handler so exempted shall be obligated to pay the portion of the assessment associated with the other authorized activities under such part or parts other than marketing promotion, including paid advertising.\n\n(c)  Assessment exemption application.  (1) To be exempt from paying assessments for these purposes under a part or parts listed in paragraph (a) of this section, the handler shall submit an application to the board or committee established under the applicable part or parts prior to or during the assessment period. This application, Form SC-649, \u201cCertified Organic Handler Application for Exemption from Market Promotion Assessments Paid Under Federal Marketing Orders,\u201d shall include:\n\n(i) The date, applicable committee or board, and Federal marketing order number;\n\n(ii) The applicant's full name, company name, address, telephone and fax numbers, and email address;\n\n(iii) Certification that the applicant maintains a valid certificate of organic operation under the OFPA and the NOP;\n\n(iv) Certification that the applicant handles or markets organic products eligible to be labeled \u201corganic\u201d or \u201c100 percent organic\u201d under the NOP;\n\n(v) Certification that the applicant is otherwise subject to assessments under the Federal marketing order program for which the exemption is requested;\n\n(vi) The number of organic certified producers for whom they handle or market product (including the applicant);\n\n(vii) A requirement that the applicant attach a copy of their certificate of organic operation and all applicable producer certificates of organic operation issued by a USDA-accredited certifying agent under the OFPA and the NOP;\n\n(viii) Certification, as evidenced by signature and date, that all information provided by the applicant is true; and\n\n(ix) Such other information as the committee or board may require, with the approval of the Secretary.\n\n(2) The handler shall file the application with the committee or board, prior to or during the applicable assessment period, and annually thereafter, as long as the handler continues to be eligible for the exemption. If the person complies with the requirements of this section and is eligible for an assessment exemption, the committee or board will approve the exemption request and provide written notification of such to the applicant within 30 days. If the application is disapproved, the committee or board will provide written notification of the reason(s) for such disapproval within the same timeframe.\n\n(3) The exemption will apply at the beginning of the next assessable period following notification of approval of the assessment exemption, in writing, by the committee or board.\n\n(d)  Assessment exemption calculation.  (1) The applicable assessment rate for any handler approved for an exemption shall be computed by dividing the committee's or board's estimated non-marketing promotion expenditures by the committee's or board's estimated total expenditures approved by the Secretary and applying that percentage to the assessment rate applicable to all persons for the assessment period. The modified assessment rate shall then be applied to the quantity of certified \u201corganic\u201d or \u201c100 percent organic\u201d products handled under an approved organic assessment exemption as provided in paragraph (c)(2) of this section. Products handled not subject to an approved organic assessment exemption shall be assessed at the assessment rate applicable to all persons for the assessment period. The committee's or board's estimated non-marketing promotion expenditures shall exclude the direct costs of marketing promotion and the portion of committee's or board's administrative and overhead costs ( e.g.,  salaries, supplies, printing, equipment, rent, contractual expenses, and other applicable costs) to support and administer the marketing promotion activities.\n\n(2) If a committee or board does not plan to conduct any market promotion activities in a fiscal year, the committee or board may submit a certification to that effect to the Secretary, and as long as no assessments for such fiscal year are used for marketing promotion projects, or the administration of projects are funded by a previous fiscal period's assessments, the committee or board may assess all handlers, regardless of their organic status, the full assessment rate applicable to the assessment period.\n\n(3) For each assessment period, the Secretary shall review the portion of the assessment rate applicable to marketing promotion for persons eligible for an exemption and, if appropriate, approve the assessment rate.\n\n(4) When the requirements of this section for exemption no longer apply to a handler, the handler shall inform the committee or board within 30 days and pay the full assessment on all remaining assessable product for all committee or board assessments from the date the handler no longer is eligible to the end of the assessment period.\n\n(5) Within 30 days following the applicable assessment period, the committee or board shall re-compute the applicable assessment rate for handlers exempt under this section based on the actual expenditures incurred during the applicable assessment period. The Secretary shall review, and if appropriate, approve any change in the portion of the assessment rate for market promotion applicable to exempt handlers, and authorize adjustments for any overpayments or collection of underpayments."], ["7:7:8.1.1.1.1.2.2.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.20 Words in the singular form.", "AMS", "", "", "", "Words in this subpart in the singular form shall be deemed to import the plural, and vice versa, as the case may demand."], ["7:7:8.1.1.1.1.2.2.10", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.29 Deadline for filing exceptions to recommended decisions.", "AMS", "", "", "", "In a Federal milk marketing agreement or order amendatory proceeding, exceptions to a recommended decision under \u00a7 900.12 shall be filed with the hearing clerk not later than 60 days after publication of the recommended decision in the  Federal Register,  unless otherwise specified in that decision."], ["7:7:8.1.1.1.1.2.2.11", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.30 Deadline for issuance of Secretary's (final) decisions.", "AMS", "", "", "", "A Secretary's (final) decision under \u00a7 900.13a to a proposed amendment on marketing agreement or order shall be issued not later than 60 days after the deadline for submission of exceptions to the recommended decision."], ["7:7:8.1.1.1.1.2.2.12", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.31 Electronic submission of hearing documents.", "AMS", "", "", "", "To the extent practicable, all documents filed with the hearing clerk in a proceeding to amend a Federal milk marketing agreement or order shall also be submitted electronically to the Dairy Programs, Agricultural Marketing Service, USDA. All documents should reference the docket number of the proceeding. Instructions for electronic filing will be provided in the notice of action plan referred to in \u00a7 900.23 of this subpart, at the amendatory hearing, and in each  Federal Register  publication regarding the amendatory proceeding."], ["7:7:8.1.1.1.1.2.2.13", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.32 Informal rulemaking.", "AMS", "", "", "", "USDA may elect to use informal rulemaking procedures under 553 of Title 5, United States Code, to amend Federal milk marketing agreements and orders, other than provisions that directly affect milk prices. In making this determination, consideration shall be given to:\n\n(a) The nature and complexity of the proposal;\n\n(b) The potential regulatory and economic impacts on affected entities; and\n\n(c) Any other relevant matters."], ["7:7:8.1.1.1.1.2.2.14", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.33 Industry assessments.", "AMS", "", "", "", "If the Secretary determines it is necessary to improve or expedite an amendatory formal rulemaking proceeding to amend a Federal milk marketing agreement or order, USDA may impose an assessment on pooled milk to supplement appropriated funds for the procurement of such services, including but not limited to, court reporters, hearing examiners, legal counsel, hearing venue and associated travel for USDA officials. Only the milk pooled in the particular marketing area that stands to be affected by proposals heard at the amendatory proceeding may be assessed. The assessments shall be subject to the provisions of \u00a7 1000.85 (7 CFR 1000.85) concerning assessments for order administration, including the provision that assessments shall not exceed $.005 per hundredweight of milk for any given month."], ["7:7:8.1.1.1.1.2.2.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.21 Definitions.", "AMS", "", "", "", "As used in this subpart, the terms as defined in the Act and in \u00a7 900.2 of this part shall apply."], ["7:7:8.1.1.1.1.2.2.3", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.22 Proposal submission requirements.", "AMS", "", "", "", "When a person other than the Secretary makes a proposal to amend a Federal milk marketing agreement or order under \u00a7 900.3 of this part, the proposal shall address the following, to the extent applicable:\n\n(a) Explain the proposal. What is the disorderly marketing condition that the proposal is intended to address?\n\n(b) What is the purpose of the proposal?\n\n(c) Describe the current Federal order requirements or industry practices relative to the proposal.\n\n(d) Describe the expected impact on the industry, including on producers and handlers, and on consumers. Explain/Quantify.\n\n(e) What are the expected effects on small businesses as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612)? Explain/Quantify.\n\n(f) How would adoption of the proposal increase or decrease costs to producers, handlers, others in the marketing chain, consumers, the Market Administrator offices and/or the Secretary? Explain/Quantify.\n\n(g) Would a pre-hearing information session be helpful to explain the proposal?"], ["7:7:8.1.1.1.1.2.2.4", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.23 Procedures following receipt of a proposal.", "AMS", "", "", "", "Within 30 days of receipt of a proposal to amend a Federal milk marketing agreement order under \u00a7 900.3 of this part, USDA shall either: Issue a notice providing an action plan and expected timeframes for the different steps in the formal rulemaking process for completion of the hearing not more than 120 days after the date of the issuance of the notice; request additional information from the person submitting the proposal to be used in deciding whether a hearing will be held. If the information requested is not received within a specified timeframe, the request shall be denied; or deny the request. Notice of the action plan will be made on the Dairy Programs, AMS Web site and through program releases to interested persons."], ["7:7:8.1.1.1.1.2.2.5", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.24 Pre-hearing information sessions.", "AMS", "", "", "", "A pre-hearing information session may be held by the Secretary in response to any proposals received under \u00a7 900.3 of this part. Any person proposing an amendment to a Federal milk marketing agreement or order may request that a pre-hearing information session be held. A person submitting a proposal shall have up to 3 calendar days to modify or withdraw his or her proposal prior to the publication of a notice of hearing."], ["7:7:8.1.1.1.1.2.2.6", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.25 Advance submission of testimony.", "AMS", "", "", "", "Any person proposing an amendment to a Federal milk marketing agreement or order under \u00a7 900.3 of this part, when participating as a witness, shall make copies of his or her testimony, if prepared as an exhibit, and any other exhibits available to USDA officials before the start of the hearing on the person's day of appearance. Individual dairy farmers shall not be subject to this requirement."], ["7:7:8.1.1.1.1.2.2.7", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.26 Requesting USDA data for use at an amendatory hearing.", "AMS", "", "", "", "Requests for preparation of USDA data to be used at a Federal milk marketing agreement or order amendatory proceeding must be received by USDA at least 10 days before the beginning of the hearing. If an amendatory hearing is announced with less than 10 days before the start of the hearing, requests for data must be submitted within 2 days following publication of the notice of hearing in the  Federal Register."], ["7:7:8.1.1.1.1.2.2.8", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.27 Deadline for filing post-hearing briefs and corrections to transcript.", "AMS", "", "", "", "(a) Under \u00a7 900.10 of this part, the period of time for interested persons to file corrections to the transcript of testimony at a Federal milk marketing agreement or order amendatory proceeding shall be no more than 30 days after the hearing record is available.\n\n(b) Under \u00a7 900.9(b) of this part, the period of time after the completion of a Federal milk marketing agreement or order amendatory hearing for interested persons to file proposed findings and conclusions, and written arguments or briefs, shall be no more than 60 days after completion of the amendatory hearing."], ["7:7:8.1.1.1.1.2.2.9", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "B", "Subpart B\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders", "", "\u00a7 900.28 Deadline for issuance of recommended decisions or tentative final decisions.", "AMS", "", "", "", "In a Federal milk marketing agreement or order amendatory proceeding, USDA shall issue a recommended decision under \u00a7 900.12 or, when applicable, a tentative final decision, not later than 90 days after the deadline for submission of proposed findings and conclusions, and written arguments or briefs."], ["7:7:8.1.1.1.1.3.2.1", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.36 Words in the singular form.", "AMS", "", "", "", "Words in this subpart in the singular form shall be deemed to import the plural, and vice versa, as the case may demand."], ["7:7:8.1.1.1.1.3.2.2", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.37 Definitions.", "AMS", "", "", "", "As used in this subpart, the terms as defined in the Act and in \u00a7 900.2 of this part shall apply."], ["7:7:8.1.1.1.1.3.2.3", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.38 Pre-hearing information sessions.", "AMS", "", "", "", "A pre-hearing information session concerning a proposal to amend a fruit, vegetable or nut marketing agreement or order may be held either prior or subsequent to submission of a proposal under \u00a7 900.3 of this part. Such sessions may be held by a marketing agreement or order committee or board or by the Secretary."], ["7:7:8.1.1.1.1.3.2.4", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.39 Proposal submission requirements.", "AMS", "", "", "", "When a person other than the Secretary makes a proposal to amend a fruit, vegetable or nut marketing agreement or order under \u00a7 900.3 of this part, the proposal shall address the following, to the extent applicable:\n\n(a) The purpose of the proposal;\n\n(b) The problem the proposal is designed to address with explanation and quantification;\n\n(c) The current requirements or industry practices relative to the proposal;\n\n(d) The expected impact on the industry, including producers, handlers, and on consumers;\n\n(e) In the case of marketing orders, an explanation, including supporting information and data, of how the proposal would tend to improve returns to producers, and in the case of marketing agreements, how the proposal impacts the signatories to the agreement;\n\n(f) The expected effects on small businesses as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612);\n\n(g) A description and quantification of whether the proposal would increase or decrease costs to producers, handlers, or others in the marketing chain, and to consumers, marketing order committees and boards and/or the Secretary;\n\n(h) A description of how the proposal would be implemented; and\n\n(i) A description, including quantification, of how compliance with the proposal would be effected."], ["7:7:8.1.1.1.1.3.2.5", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.40 Written testimony and USDA data request requirements.", "AMS", "", "", "", "In addition to the provisions of \u00a7 900.8(b)(4), witnesses at an amendatory fruit, vegetable or nut formal rulemaking hearing shall make, to the extent practicable, at least 8 copies of their testimony, if prepared as an exhibit, and any other exhibits available to USDA before testimony is given on the day of appearance at the hearing. Industry requests for preparation of USDA data for a rulemaking hearing should be made at least 10 days prior to the beginning of the hearing."], ["7:7:8.1.1.1.1.3.2.6", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.41 Electronic document submission standards.", "AMS", "", "", "", "To the extent practicable, all documents filed with the hearing clerk in a proceeding to amend a fruit, vegetable or nut marketing agreement or order shall also be submitted electronically to the Agricultural Marketing Service, Fruit and Vegetable Programs, USDA. All documents should reference the docket number of the proceeding. Instructions for electronic filing shall be provided at the amendatory formal rulemaking hearing and in each  Federal Register  publication regarding the amendatory proceeding."], ["7:7:8.1.1.1.1.3.2.7", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.42 Industry assessments.", "AMS", "", "", "", "If the Secretary determines it is necessary to improve or expedite an amendatory fruit, vegetable or nut formal rulemaking proceeding, costs associated with improving or expediting the proceeding may be charged to the committees or boards. Such costs shall be paid with assessments from the handlers regulated under the marketing order to be amended or on signatories to the marketing agreement subject to amendment. Such assessments may supplement funds for costs associated with, but not limited to, court reporters, hearing examiners, legal counsel, hearing venue and associated travel for USDA officials."], ["7:7:8.1.1.1.1.3.2.8", 7, "Agriculture", "IX", "", "900", "PART 900\u2014GENERAL REGULATIONS", "C", "Subpart C\u2014Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders", "", "\u00a7 900.43 Use of informal rulemaking.", "AMS", "", "", "", "(a) Notwithstanding the provisions of \u00a7\u00a7 900.1 through 900.18, and 900.36 through 900.42 of this part, the Secretary may determine that informal rulemaking procedures under \u00a7 553 of Title 5, United States Code be used to amend fruit, vegetable or nut marketing agreements and marketing orders. 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