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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 10:10:5.0.2.5.37.0.16.1 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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. (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. (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… | |||||||
| 10:10:5.0.2.5.37.0.16.10 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 900.10 Consolidated administrative docket. | DOE | (a) DOE shall maintain a consolidated docket of: (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: (i) The IIP initiation request, review meeting request, and close-out meeting request required by §§ 900.5, 900.8, and 900.9; (ii) The IIP Process final meeting summaries required by §§ 900.5, 900.8 and 900.9; (iii) The IIP Process final resource reports developed under § 900.6; (iv) The final project-specific schedule developed under §§ 900.7 and 900.8; (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 (vi) Communications between any relevant Federal or non-Federal entity and the project proponent regarding the IIP Process; and (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. (b) Federal entities should include DOE in all communications with the project proponent related to the IIP Process for the proposed electric transmission project. (c) DOE shall make the consolidated docket available, as appropriate, to the NEPA joint lead agency selected under § 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. (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 a… | |||||||
| 10:10:5.0.2.5.37.0.16.11 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 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. (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—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 900.11 shall prepare an environmental review document for the proposed electric transmission project designed to serve the needs of all relevant Federal entities. (b) When preparing the environmental review document, DOE and any NEPA joint lead agency shall: (1) Consider the materials developed throughout the IIP Process; and (2) Consult with relevant Federal entities and relevant non-Federal entities. (c) DOE, in consultation with any NEPA joint lead agency, is expected to be responsible for: (1) Identifying, contracting with, directing, supervising, and arranging for the payment of contractors, as appropriate, to draft the environmental review document; and (2) Publishing the environmental review document and any related documents. (d) Each Federal entity or non-Federal entity that is responsible for issuing a separate Federal authorization for the proposed project shall: (1) Identify all information and analysis needed to make the authorization decision; and (2) Identify all alternatives that need to be included, including a preferred alternative, with respect to the authorization. (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. (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. (g) For all proposed proj… | |||||||
| 10:10:5.0.2.5.37.0.16.13 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 900.2 Definitions. | DOE | As used in this part: Analysis 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. Authorization 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. Communities 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. Director 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. Federal authorization means any authorization required under Federal law. Federal entity means any Federal agency or department. Indian Tribe has the same meaning as provided by 25 U.S.C. 5304(e). Mitigation 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 demo… | |||||||
| 10:10:5.0.2.5.37.0.16.3 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 900.2 is a qualifying project under paragraph (2) of the definition. (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 § 900.2 must file a request for coordination with the Director. The request must contain: (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; (2) A concise description of the proposed facility sufficient to explain its scope and purpose; (3) A list of anticipated relevant Federal entities involved in the proposed facility; and (4) A list of anticipated relevant non-Federal entities involved in the proposed facility, including any agency serial or docket numbers for pending applications. (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: (1) If accepted, that the proposed facility is a qualifying project and the project proponent must submit an initiation request as set forth under § 900.5; or (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. (d) In making the determination whether a propo… | |||||||
| 10:10:5.0.2.5.37.0.16.4 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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: (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); (2) Potential cultural resources, sacred sites, and historic properties that may be eligible for or listed in the National Register of Historic Places; (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; (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 … | |||||||
| 10:10:5.0.2.5.37.0.16.5 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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: (1) A summary of the proposed electric transmission project, as described by paragraph (b) of this section; (2) Associated maps, geospatial information, and studies (provided in electronic format), as described by paragraph (c) of this section; (3) A project participation plan, as described by paragraph (d) of this section; and (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. (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: (1) The following information: (i) The project proponent's legal name and principal place of business; (ii) The project proponent's contact information and designated point(s) of contact; (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 (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; (2) A statement of the project proponent's interests and objectives; (3) To the extent available, copies of or links to: (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 (ii) Any relevant interconnection req… | |||||||
| 10:10:5.0.2.5.37.0.16.6 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 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. (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 §§ 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. (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 timel… | |||||||
| 10:10:5.0.2.5.37.0.16.7 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 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. (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—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 900.6. The review meeting request must include: (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; (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 § 900.5 and as modified in response to early stakeholder input and outreach and feedback from relevant Federal entities and relevant non-Federal entities; (3) If known, a schedule for completing any upcoming field resource surveys, as appropriate; (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); (5) An updated public engagement plan described in § 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; (6) A listing of: (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 (ii) Estimated dates for filing remaining applications or requests for Federal authorization; (7) Estimated dates that the project proponent will file requests for authorizations and consultations… | |||||||
| 10:10:5.0.2.5.37.0.16.9 | 10 | Energy | III | 900 | PART 900—COORDINATION OF FEDERAL AUTHORIZATIONS FOR ELECTRIC TRANSMISSION FACILITIES | § 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 § 900.8. The close-out meeting request shall include: (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; (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; (3) A final public engagement plan, as described in § 900.5(d)(2); (4) Requests for Federal authorizations for the proposed project; and (5) An updated estimated timeline of filing requests for all other authorizations and consultations with non-Federal entities. (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 § 900.6 via electronic means. (c) Not later than 60 calendar days after the date that DOE receives the close-out meeting request, DOE shall: (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 (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. (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 an… | |||||||
| 20:20:4.0.4.3.1.0.117.1 | 20 | Employees' Benefits | VIII | 900 | PART 900—STATEMENT OF ORGANIZATION | § 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—STATEMENT OF ORGANIZATION | § 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. 1 1 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—STATEMENT OF ORGANIZATION | § 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—STATEMENT OF ORGANIZATION | § 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—STATEMENT OF ORGANIZATION | § 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. (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—STATEMENT OF ORGANIZATION | § 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—STATEMENT OF ORGANIZATION | § 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—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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: (a) Accreditation body or body means an entity that has been approved by FDA under § 900.3(d) to accredit mammography facilities. (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. (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: (1) Poor image quality; (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 (3) Use of personnel that do not meet the applicable requirements of § 900.12(a). (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. (e) Breast implant means a prosthetic device implanted in the breast. (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. (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. (h) Certificate means the certificate described in § 900.11(a). (i) Certification means the process of approval of a facility by FDA or a certif… | |||
| 21:21:8.0.1.2.36.1.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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. (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. (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. (3) The applicant shall furnish to FDA, at the address in § 900.3(b)(1), three copies of an application containing the following information, materials, and supporting documentation: (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); (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 § 900.12; (iii) Detailed description of the applicant's accreditation review and decisionmaking process, including: (A) Procedures for performing accreditation and reaccreditation clinical image review in accordance with § 900.4(c), random clinical image reviews in accordance with § 900.4(f), and additional mammography review in accordance with § 900.12(j); (B) Procedures for performing phantom image review; (C) Procedures for assessing mammography equipment evaluations and surveys; (D) Procedures for initiating and performing onsite visits to facilities; (E) Procedures for assessing facility personnel qualifications; (F) Copies of the accreditation appl… | |||
| 21:21:8.0.1.2.36.1.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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. (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. (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. (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. (3) The accreditation body shall establish and administer a quality assurance (QA) program that has been approved by FDA in accordance with § 900.3(d) or paragraph (a)(8) of this section. Such quality assurance program shall: (i) Include requirements for clinical image review and phantom image review; (ii) Ensure that clinical and phantom images are evaluated consistently and accurately; and (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. (4) The accreditation body shall establish measures that FDA has approved in accordance with § 900.3(d) or paragraph (a)(8) of this sect… | |||
| 21:21:8.0.1.2.36.1.1.5 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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 § 900.6. | ||||
| 21:21:8.0.1.2.36.1.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 900.6 Withdrawal of approval. | FDA | If FDA determines, through the evaluation activities of § 900.5, or through other means, that an accreditation body is not in substantial compliance with this subpart, FDA may initiate the following actions: (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. (1) FDA shall notify the accreditation body of the agency's action and the grounds on which the approval was withdrawn. (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. (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. (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. (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 esta… | ||||
| 21:21:8.0.1.2.36.1.1.7 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | § 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. (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 § 900.3(d) or § 900.4(a)(8). (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 § 900.15. | ||||
| 21:21:8.0.1.2.36.1.1.8 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | A | Subpart A—Accreditation | §§ 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—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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 § 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA. (b) Application —(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). (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. (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. (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 § 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. (3) Extension of provisiona… | |||
| 21:21:8.0.1.2.36.2.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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: (1) Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications: (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: (A) Be licensed to practice medicine in a State; (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 ( 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; (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 in… | |||
| 21:21:8.0.1.2.36.2.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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. (b) Withdrawal of FDA approval of an accreditation body. (1) If FDA withdraws approval of an accreditation body under § 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. (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—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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: (1) Has been guilty of misrepresentation in obtaining the certificate; (2) Has failed to comply with the standards of § 900.12; (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 § 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 § 900.12; (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; (5) Has violated or aided and abetted in the violation of any provision of or regulation issued pursuant to 42 U.S.C. 263b; (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 (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 § 900.12(a)(4). (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; (1) The failure to comply with required standards presents a serious risk to human health; (2) The refusal to permit inspection makes immediate suspension necessary; or (3) There is reason to believe that the violation o… | |||
| 21:21:8.0.1.2.36.2.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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 § 900.14. (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. (c) A facility that has been denied accreditation or reaccreditation is entitled to an appeals process from the accreditation body, in accordance with § 900.7. A facility must avail itself of the accreditation body's appeal process before requesting reconsideration from FDA. (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. (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. (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. (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. (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, Silve… | |||
| 21:21:8.0.1.2.36.2.1.7 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 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 § 900.15. (b) FDA may deny the application if the agency has reason to believe that: (1) The facility will not be operated in accordance with standards established under § 900.12; (2) The facility will not permit inspections or provide access to records or information in a timely fashion; or (3) The facility has been guilty of misrepresentation in obtaining the accreditation. (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. (2) A facility that has been denied accreditation may request reconsideration and appeal of FDA's determination in accordance with the applicable provisions of § 900.15(d). | ||||
| 21:21:8.0.1.2.36.2.1.8 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.17 [Reserved] | FDA | |||||
| 21:21:8.0.1.2.36.2.1.9 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | B | Subpart B—Quality Standards and Certification | § 900.18 Alternative requirements for § 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 § 900.12, when the agency determines that: (1) The proposed alternative standard will be at least as effective in assuring quality mammography as the standard it proposes to replace, and (2) The proposed alternative: (i) Is too limited in its applicability to justify an amendment to the standard; or (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 (3) The granting of the alternative is in keeping with the purposes of 42 U.S.C. 263b. (b) Applicants for alternatives. (1) Mammography facilities and accreditation bodies may apply for alternatives to the quality standards of § 900.12. (2) Federal agencies and State governments that are not accreditation bodies may apply for alternatives to the standards of § 900.12(a). (3) Manufacturers and assemblers of equipment used for mammography may apply for alternatives to the standards of § 900.12(b) and (e). (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: (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; (2) A description of the manner in which the alternative is proposed to deviate from the original standard; (3) A description, supported by data, of the a… | |||
| 21:21:8.0.1.2.36.3.1.1 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 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—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 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 § 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. (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. (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. (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: (i) Name, address, and phone number of the applicant; (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 § 900.12; (iii) Detailed description of the applicant's review and decisionmaking process for facility certification, including: (A) Policies and procedures for notifying facilities of certificate denials and expirations; (B) Procedures for monitoring and enforcement of the correction of deficiencies by facilities; (C) Policies and procedures for suspending or revoking a facility's certification; (D) Policies and procedures that will ensure processing certificates within a timeframe approved by FDA; (E) A description of the appeals process for facilities contesting adve… | |||
| 21:21:8.0.1.2.36.3.1.3 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 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: (a) Conflict of interest. The certification agency shall establish and implement measures that FDA has approved in accordance with § 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. (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. (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 § 900.12. (d) Enforcement actions. (1) There shall be appropriate criteria and processes for the suspension and revocation of certificates. (2) There shall be prompt investigation of and appropriate enforcement action for facilities performing mammography without certificates. (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. (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. (g) Patient notification. There shall be processes for the certification agency t… | ||||
| 21:21:8.0.1.2.36.3.1.4 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 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 §§ 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 § 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—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 900.24 Withdrawal of approval. | FDA | If FDA determines, through the evaluation activities of § 900.23, or through other means, that a certification agency is not in substantial compliance with this subpart, FDA may initiate the following actions: (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. (1) FDA shall notify the certification agency of FDA's action and the grounds on which the approval was withdrawn. (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. (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… | ||||
| 21:21:8.0.1.2.36.3.1.6 | 21 | Food and Drugs | I | I | 900 | PART 900—MAMMOGRAPHY | C | Subpart C—States as Certifiers | § 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. (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 §§ 900.21 and 900.22. | ||||
| 7:7:8.1.1.1.1.1.2.1 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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. (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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 § 900.14(b) or § 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 § 900.14(b) or § 900.14(c) have been met. | |||||
| 7:7:8.1.1.1.1.1.2.15 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 § 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. (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 § 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. (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 s… | ||||
| 7:7:8.1.1.1.1.1.2.16 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 § 900.17 shall be met by filing a true copy thereof with the hearing clerk. (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. (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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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. (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: (1) All such written communications; (2) Memoranda stating the substance of all such oral communications; and (3) All written responses, and memoranda stating the substance of all oral responses thereto. (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 … | ||||
| 7:7:8.1.1.1.1.1.2.18 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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: (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. (b) The term Department means the United States Department of Agriculture. (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. (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. (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. (f) [Reserved] (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. (h) The term hearing means that part of the proceeding which involves the submission of evidence. (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. (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. (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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 . (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: (i) By publication of the notice of hearing in the Federal Register ; (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; (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 s… | ||||
| 7:7:8.1.1.1.1.1.2.5 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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: (1) Rule upon motions and requests; (2) Change the time and place of hearing, and adjourn the hearing from time to time or from place to place; (3) Administer oaths and affirmations and take affidavits; (4) Examine and cross-examine witnesses and receive evidence; (5) Admit or exclude evidence; (6) Hear oral argument on facts or law; (7) Do all acts and take all measures necessary for the maintenance of order at the hearing and the efficient conduct of the proceeding. (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. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 § 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 § 900.10 or by the Secretary if made thereafter. (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—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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 § 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. (b) Appearances —(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§ 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. (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 m… | ||||
| 7:7:8.1.1.1.1.1.2.9 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | A | Subpart A—Procedural Requirements Governing Proceedings Pertaining to Marketing Agreements and Marketing Orders | § 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. (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 § 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—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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). (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. (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. (d) Order means the marketing order (including an amendatory order) with respect to which the Secretary has directed that a referendum be conducted. (e) Referendum agent means the individual or individuals designated by the Secretary to conduct the referendum. (f) Representative period means the period designated by the Secretary pursuant to section 8c of the act (7 U.S.C. 608c). (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. (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 thereo… | ||||
| 7:7:8.1.1.1.1.10.2.3 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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. (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. (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. (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 process… | |||||
| 7:7:8.1.1.1.1.10.2.4 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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: (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. (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. (c) Provide ballots and related material to be used in the referendum. Ballot material shall provide for recording essential information for ascertaining: (1) Whether the person voting, or on whose behalf the vote is cast, is an eligible voter, and (2) The total volume (i) produced for market during the representative period, or (ii) canned or frozen for market during the representative period. (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. (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. (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 requi… | |||||
| 7:7:8.1.1.1.1.10.2.5 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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): (a) Give public notice of the referendum in the manner specified herein; (b) Preside at a meeting where ballots are to be cast or as poll officer at a polling place; (c) Distribute ballots and the aforesaid texts to producers (and to processors when required) and receive any ballots which are cast; and (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—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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—GENERAL REGULATIONS | J | Subpart J—Procedure 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 | § 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—GENERAL REGULATIONS | K | Subpart K—Public Information | § 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—GENERAL REGULATIONS | K | Subpart K—Public Information | § 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 § 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: Freedom of Information Act Officer, Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250. Freedom of Information Act Officer, Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250. (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—GENERAL REGULATIONS | K | Subpart K—Public Information | § 900.502 Indexes. | AMS | [44 FR 39151, July 5, 1979] | Pursuant to the regulations in § 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 § 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—GENERAL REGULATIONS | K | Subpart K—Public Information | § 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 § 1.3(a) of this title. Authority to make determinations regarding initial requests in accordance with § 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: Freedom of Information Act Officer (FOIA Request). Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250. Freedom of Information Act Officer (FOIA Request). Agricultural Marketing Service, United States Department of Agriculture, Washington, DC 20250. (b) The request shall identify each record with reasonable specificity as prescribed in § 1.3 of this title. (c) The FOIA Officer is authorized to receive requests and to exercise the authority to (1) Make determinations to grant requests or deny initial requests, (2) Extend the administrative deadline, (3) Make discretionary release of exempt records, and (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—GENERAL REGULATIONS | K | Subpart K—Public Information | § 900.504 Appeals. | AMS | [40 FR 20267, May 9, 1975] | Any person whose request under § 900.503 above is denied shall have the right to appeal such denial in accordance with § 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—GENERAL REGULATIONS | L | Subpart L—Information Collection | § 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—GENERAL REGULATIONS | L | Subpart L—Information Collection | § 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. (b) Display. Table 1 to Paragraph ( b ) | ||||
| 7:7:8.1.1.1.1.13.3.1 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | M | Subpart M—Assessment of Exemptions | § 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 “assessment period” means fiscal period, fiscal year, crop year, or marketing year as defined under these parts; the term “marketing promotion” 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. (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: (1) Only agricultural commodities certified as “organic” or “100 percent organic” (as defined in the NOP) are eligible for exemption; (2) The exemption shall apply to all certified “organic” or “100 percent organic” (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; (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); (4) A… | ||||
| 7:7:8.1.1.1.1.2.2.1 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 900.30 Deadline for issuance of Secretary's (final) decisions. | AMS | A Secretary's (final) decision under § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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: (a) The nature and complexity of the proposal; (b) The potential regulatory and economic impacts on affected entities; and (c) Any other relevant matters. | |||||
| 7:7:8.1.1.1.1.2.2.14 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 900.21 Definitions. | AMS | As used in this subpart, the terms as defined in the Act and in § 900.2 of this part shall apply. | |||||
| 7:7:8.1.1.1.1.2.2.3 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 900.3 of this part, the proposal shall address the following, to the extent applicable: (a) Explain the proposal. What is the disorderly marketing condition that the proposal is intended to address? (b) What is the purpose of the proposal? (c) Describe the current Federal order requirements or industry practices relative to the proposal. (d) Describe the expected impact on the industry, including on producers and handlers, and on consumers. Explain/Quantify. (e) What are the expected effects on small businesses as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612)? Explain/Quantify. (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. (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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 900.25 Advance submission of testimony. | AMS | Any person proposing an amendment to a Federal milk marketing agreement or order under § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 900.27 Deadline for filing post-hearing briefs and corrections to transcript. | AMS | (a) Under § 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. (b) Under § 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—GENERAL REGULATIONS | B | Subpart B—Supplemental Procedural Requirements Governing Proceedings to Amend Federal Milk Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 900.37 Definitions. | AMS | As used in this subpart, the terms as defined in the Act and in § 900.2 of this part shall apply. | |||||
| 7:7:8.1.1.1.1.3.2.3 | 7 | Agriculture | IX | 900 | PART 900—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 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 § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 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 § 900.3 of this part, the proposal shall address the following, to the extent applicable: (a) The purpose of the proposal; (b) The problem the proposal is designed to address with explanation and quantification; (c) The current requirements or industry practices relative to the proposal; (d) The expected impact on the industry, including producers, handlers, and on consumers; (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; (f) The expected effects on small businesses as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612); (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; (h) A description of how the proposal would be implemented; and (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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 900.40 Written testimony and USDA data request requirements. | AMS | In addition to the provisions of § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 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—GENERAL REGULATIONS | C | Subpart C—Supplemental Procedural Requirements Governing Proceedings to Amend Fruit, Vegetable and Nut Marketing Agreements and Marketing Orders | § 900.43 Use of informal rulemaking. | AMS | (a) Notwithstanding the provisions of §§ 900.1 through 900.18, and 900.36 through 900.42 of this part, the Secretary may determine that informal rulemaking procedures under § 553 of Title 5, United States Code be used to amend fruit, vegetable or nut marketing agreements and marketing orders. In making this determination, consideration shall be given to: (1) The nature and complexity of the proposal; (2) The potential regulatory and economic impacts on affected entities; and (3) Any other relevant matters. |
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CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);