{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 700 sorted by section_id", "rows": [["15:15:2.1.3.2.1.1.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "A", "Subpart A\u2014Purpose", "", "\u00a7 700.1 Purpose of this part.", "BIS", "", "", "[79 FR 47563, Aug. 14, 2014, as amended at 89 FR 58970, July 22, 2024]", "This part implements the Defense Priorities and Allocations System (DPAS) that is administered by the Department of Commerce, Bureau of Industry and Security. The DPAS implements the priorities and allocations authority of the Defense Production Act (50 U.S.C. 4501  et seq. ), delegated to the Department of Commerce under Executive Order 13603, including use of that authority to support emergency preparedness activities pursuant to Title VI of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121  et seq. ), and the priorities authority of the Selective Service Act and related statutes, all with respect to industrial resources. The DPAS establishes procedures for the placement, acceptance, and performance of priority rated contracts and orders (other than contracts of employment) and for the allocation of materials, services, and facilities for approved programs. The guidance and procedures in this part are generally consistent with the guidance and procedures provided in other regulations issued under Executive Order 13603 authority."], ["15:15:2.1.3.2.1.10.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.70 General provisions.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, June 11, 1998; 79 FR 47570, Aug. 14, 2014; 89 FR 58976, July 22, 2024]", "(a) Compliance actions may be taken for any reason necessary or appropriate to the enforcement or the administration of the Defense Production Act, the Selective Service Act and related statutes, this part, or an official action. Such actions include audits, investigations, or other inquiries.\n\n(b) Willful violation of any of the provisions of Title I or section 705 of the Defense Production Act, this part, or an official action of the Department of Commerce, is a criminal act, punishable as provided in sections 103 and 705 of the Defense Production Act."], ["15:15:2.1.3.2.1.10.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.71 Audits and investigations.", "BIS", "", "", "[79 FR 47570, Aug. 14, 2014, as amended at 89 FR 58976, July 22, 2024]", "(a) Audits and investigations are official actions involving the examination of books, records, documents, other writings, and information to ensure that the provisions of the Defense Production Act, the Selective Service Act and related statutes, and this part have been properly followed. An audit or investigation may also include interviews and a systems evaluation to detect problems or failures in the implementation of this part.\n\n(b) When undertaking an audit, investigation, or other inquiry, the Department of Commerce shall:\n\n(1) Define the scope and purpose in the official action given to the person under investigation, and\n\n(2) Have ascertained that the information sought or other adequate and authoritative data are not available from any Federal or other responsible agency.\n\n(c) In administering this part, the Department of Commerce may issue the following documents, which constitute official actions:\n\n(1)  Administrative subpoenas.  An administrative subpoena requires a person to appear as a witness before an official designated by the Department of Commerce to testify under oath on matters of which that person has knowledge relating to the enforcement or the administration of the Defense Production Act, the Selective Service Act and related statutes, or this part. An administrative subpoena may also require the production of books, papers, records, documents and physical objects or property.\n\n(2)  Demand for information.  A demand for information requires a person to furnish to a duly authorized representative of the Department of Commerce any information necessary or appropriate to the enforcement or the administration of the Defense Production Act, the Selective Service Act, or this part.\n\n(3)  Inspection authorizations.  An inspection authorization requires a person to permit a duly authorized representative of the Department of Commerce to interview the person's employees or agents, to inspect books, records, documents, other writings and information in the person's possession or control at the place where that person usually keeps them, and to inspect a person's property when such interviews and inspections are necessary or appropriate to the enforcement or the administration of the Defense Production Act, the Selective Service Act, or this part.\n\n(d) The production of books, records, documents, other writings and information will not be required at any place other than where they are usually kept if, prior to the return date specified in the administrative subpoena or demand for information, a duly authorized official of the Department of Commerce is furnished with copies of such material that are certified under oath to be true copies. As an alternative, a person may enter into a stipulation with a duly authorized official of the Department of Commerce as to the content of the material.\n\n(e) An administrative subpoena, demand for information, or inspection authorization shall include the name, title or official position of the person to be served, the evidence sought to be adduced, and its general relevance to the scope and purpose of the audit, investigation, or other inquiry. If employees or agents are to be interviewed; if books, records, documents, other writings, or information are to be produced; or if property is to be inspected; the administrative subpoena, demand for information, or inspection authorization will describe them with particularity.\n\n(f) Service of documents shall be made in the following manner:\n\n(1) Service of a demand for information or inspection authorization shall be made personally, or by certified mail\u2014return receipt requested at the person's last known address. Service of an administrative subpoena shall be made personally. Personal service may also be made by leaving a copy of the document with someone at least 18 years of age at the person's last known dwelling or place of business.\n\n(2) Service upon other than an individual may be made by serving a partner, corporate officer, or a managing or general agent authorized by appointment or by law to accept service of process. If an agent is served, a copy of the document shall be mailed to the person named in the document.\n\n(3) Any individual 18 years of age or older may serve an administrative subpoena, demand for information, or inspection authorization. When personal service is made, the individual making the service shall prepare an affidavit as to the manner in which service was made and the identity of the person served, and return the affidavit, and in the case of subpoenas, the original document, to the issuing officer. In case of failure to make service, the reasons for the failure shall be stated on the original document."], ["15:15:2.1.3.2.1.10.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.72 Compulsory process.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, June 11, 1998; 67 FR 45633, July 10, 2002; 71 FR 39528, July 13, 2006; 79 FR 47570, Aug. 14, 2014]", "(a) If a person refuses to permit a duly authorized representative of the Department of Commerce to have access to any premises or source of information necessary to the administration or enforcement of the Defense Production Act or this part, the Department of Commerce may seek compulsory process. Compulsory process means the institution of appropriate legal action, including  ex parte  application for an inspection warrant or its equivalent, in any forum of appropriate jurisdiction.\n\n(b) Compulsory process may be sought in advance of an audit, investigation, or other inquiry, if, in the judgment of the Director of the Office of Strategic Industries and Economic Security, U.S. Department of Commerce, in consultation with the Chief Counsel for Industry and Security, U.S. Department of Commerce, there is reason to believe that a person will refuse to permit an audit, investigation, or other inquiry, or that other circumstances exist which make such process desirable or necessary."], ["15:15:2.1.3.2.1.10.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.73 Notification of failure to comply.", "BIS", "", "", "[79 FR 47570, Aug. 14, 2014]", "(a) At the conclusion of an audit, investigation, or other inquiry, or at any other time, the Department of Commerce may inform the person in writing where compliance with the requirements of the Defense Production Act, the Selective Service Act and related statutes, or this part were not met.\n\n(b) In cases where the Department of Commerce determines that failure to comply with the provisions of the Defense Production Act, the Selective Service Act and related statutes, or this part was inadvertent, the person may be informed in writing of the particulars involved and the corrective action to be taken. Failure to take corrective action may then be construed as a willful violation of the Defense Production Act, this part, or an official action."], ["15:15:2.1.3.2.1.10.1.5", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.74 Violations, penalties, and remedies.", "BIS", "", "", "[79 FR 47571, Aug. 14, 2014, as amended at 89 FR 58976, July 22, 2024]", "(a) Willful violation of the provisions of Title I or sections 705 or 707 of the Defense Production Act, the priorities provisions of the Selective Service Act and related statutes or this part is a crime and upon conviction, a person may be punished by fine or imprisonment, or both as provided in sections 103 and 705 of the Defense Production Act and in section 468(f) of the Selective Service Act.\n\n(b) The government may also seek an injunction from a court of appropriate jurisdiction to prohibit the continuance of any violation of, or to enforce compliance with, the Defense Production Act, this part, or an official action.\n\n(c) In order to secure the effective enforcement of the Defense Production Act, this part, and official actions, the following are prohibited (see section 704 of the Defense Production Act; see  e.g.,  sections 2 and 371 of Title 18 United States Code):\n\n(1) No person may solicit, influence or permit another person to perform any act prohibited by, or to omit any act required by, the Defense Production Act, this part, or an official action.\n\n(2) No person may conspire or act in concert with any other person to perform any act prohibited by, or to omit any act required by, the Defense Production Act, this part, or an official action.\n\n(3) No person shall deliver any item if the person knows or has reason to believe that the item will be accepted, redelivered, held, or used in violation of the Defense Production Act, this part, or an official action. In such instances, the person must immediately notify the Department of Commerce that, in accordance with this section, delivery has not been made."], ["15:15:2.1.3.2.1.10.1.6", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "J", "Subpart J\u2014Compliance", "", "\u00a7 700.75 Compliance conflicts.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, June 11, 1998]", "If compliance with any provision of the Defense Production Act, the Selective Service Act and related statutes, this regulation, or an official action would prevent a person from filling a rated order or from complying with another provision of the Defense Production Act, this regulation, or an official action, the person must immediately notify the Department of Commerce for resolution of the conflict."], ["15:15:2.1.3.2.1.11.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Adjustments, Exceptions, and Appeals", "", "\u00a7 700.80 Adjustments or exceptions.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, 31925, June 11, 1998; 79 FR 47571, Aug. 14, 2014; 89 FR 58976, July 22, 2024]", "(a) A person may submit a request to the Office of Strategic Industries and Economic Security, U.S. Department of Commerce, for an adjustment or exception on the ground that:\n\n(1) A provision of this part or an official action results in an undue or exceptional hardship on that person not suffered generally by others in similar situations and circumstances; or\n\n(2) The consequence of following a provision of this part or an official action is contrary to the intent of the Defense Production Act, the Selective Service Act and related statutes, or this part.\n\n(b) Each request for adjustment or exception must be in writing and contain a complete statement of all the facts and circumstances related to the provision of this part or official action from which adjustment is sought and a full and precise statement of the reasons why relief should be provided.\n\n(c) The submission of a request for adjustment or exception shall not relieve any person from the obligation of complying with the provisions of this part or official action in question while the request is being considered unless such interim relief is granted in writing by the Office of Strategic Industries and Economic Security. The Office of Strategic Industries and Economic Security shall respond to requests for adjustment of or exceptions to compliance with the provisions of this part or an official action within twenty-five (25) days, not including Saturdays, Sundays or Government holidays, of the date of receipt.\n\n(d) A decision of the Office of Strategic Industries and Economic Security under this section may be appealed to the Assistant Secretary for Export Administration, U.S. Department of Commerce. (For information on the appeal procedure, see \u00a7 700.81.)"], ["15:15:2.1.3.2.1.11.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "K", "Subpart K\u2014Adjustments, Exceptions, and Appeals", "", "\u00a7 700.81 Appeals.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31925, June 11, 1998; 71 FR 39528, July 13, 2006; 79 FR 47571, Aug. 14, 2014; 89 FR 58976, July 22, 2024]", "(a) Any person who has had a request for adjustment or exception denied by the Office of Strategic Industries and Economic Security under \u00a7 700.80, may appeal to the Assistant Secretary for Export Administration, Department of Commerce, who shall review and reconsider the denial. Such appeals should be submitted to the Office of the Assistant Secretary for Export Administration, Bureau of Industry and Security, Department of Commerce, Room 3886, Washington, DC 20230, Ref: DPAS Appeals.\n\n(b) Appeals of denied requests for exceptions from or adjustments to compliance with the provisions of this part or an official action must be received by the Assistant Secretary for Export Administration no later than forty-five (45) days after receipt of a written notice of denial from the Office of Strategic Industries and Economic Security. After this forty-five (45) day period, an appeal may be accepted at the discretion of the Assistant Secretary for Export Administration.\n\n(c) Each appeal must be in writing and contain a complete statement of all the facts and circumstances related to the action appealed from and a full and precise statement of the reasons the decision should be modified or reversed.\n\n(d) In addition to the written materials submitted in support of an appeal, an appellant may request, in writing, an opportunity for an informal hearing. This request may be granted or denied at the discretion of the Assistant Secretary for Export Administration.\n\n(e) When a hearing is granted, the Assistant Secretary for Export Administration may designate an employee of the Department of Commerce to conduct the hearing and to prepare a report. The hearing officer shall determine all procedural questions and impose such time or other limitations deemed reasonable. In the event that the hearing officer decides that a printed transcript is necessary, all expenses shall be borne by the appellant.\n\n(f) When determining an appeal, the Assistant Secretary for Export Administration may consider all information submitted during the appeal as well as any recommendations, reports, or other relevant information and documents available to the Department of Commerce, or consult with any other persons or groups.\n\n(g) The submission of an appeal under this section shall not relieve any person from the obligation of complying with the provisions of this part or official action in question while the appeal is being considered, unless such relief is granted in writing by the Assistant Secretary for Export Administration.\n\n(h) The decision of the Assistant Secretary for Export Administration shall be made within a reasonable time after receipt of the appeal and shall be the final administrative action. It shall be issued to the appellant in writing with a statement of the reasons for the decision."], ["15:15:2.1.3.2.1.12.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "L", "Subpart L\u2014Miscellaneous Provisions", "", "\u00a7 700.90 Protection against claims.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47571, Aug. 14, 2014]", "A person shall not be held liable for damages or penalties for any act or failure to act resulting directly or indirectly from compliance with any provision of this part, or an official action, notwithstanding that such provision or action shall subsequently be declared invalid by judicial or other competent authority."], ["15:15:2.1.3.2.1.12.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "L", "Subpart L\u2014Miscellaneous Provisions", "", "\u00a7 700.91 Records and reports.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, 31925, June 11, 1998; 79 FR 47571, Aug. 14, 2014]", "(a) Persons are required to make and preserve for at least three years, accurate and complete records of any transaction covered by this part (OMB control number 0694-0053) or an official action.\n\n(b) Records must be maintained in sufficient detail to permit the determination, upon examination, of whether each transaction complies with the provisions of this part or any official action. However, this part does not specify any particular method or system to be used.\n\n(c) Records required to be maintained by this part must be made available for examination on demand by duly authorized representatives of the Department of Commerce as provided in \u00a7 700.71.\n\n(d) In addition, persons must develop, maintain, and submit any other records and reports to the Department of Commerce that may be required for the administration of the Defense Production Act, the Selective Service Act and related statutes, and this part.\n\n(e) Section 705(d) of the Defense Production Act provides that information obtained under this section which the President deems confidential, or with reference to which a request for confidential treatment is made by the person furnishing such information, shall not be published or disclosed unless the President determines that the withholding of this information is contrary to the interest of the national defense. Information required to be submitted to the Department of Commerce in connection with the enforcement or administration of the Act, this part, or an official action, is deemed to be confidential under section 705(d) of the Act and shall not be published or disclosed except as required by law."], ["15:15:2.1.3.2.1.12.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "L", "Subpart L\u2014Miscellaneous Provisions", "", "\u00a7 700.92 Applicability of this part and official actions.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47571, Aug. 14, 2014]", "(a) This part and all official actions, unless specifically stated otherwise, apply to transactions in any state, territory, or possession of the United States and the District of Columbia.\n\n(b) This part and all official actions apply not only to deliveries to other persons but also include deliveries to affiliates and subsidiaries of a person and deliveries from one branch, division, or section of a single entity to another branch, division, or section under common ownership or control.\n\n(c) This part and its schedules shall not be construed to affect any administrative actions taken by the Department of Commerce, or any outstanding contracts or orders placed pursuant to any of the regulations, orders, schedules or delegations of authority under the Defense Materials System and Defense Priorities System previously issued by the Department of Commerce. Such actions, contracts, or orders shall continue in full force and effect under this part unless modified or terminated by proper authority.\n\n(d) The repeal of any provision of this part, orders, schedules and delegations of authority of the Defense Materials System (DMS) and Defense Priorities System (DPS) shall not have the effect to release or extinguish any penalty or liability incurred under the DMS/DPS. The DMS/DPS shall be treated as still remaining in force for the purpose of sustaining any action for the enforcement of such penalty or liability."], ["15:15:2.1.3.2.1.12.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "L", "Subpart L\u2014Miscellaneous Provisions", "", "\u00a7 700.93 Communications.", "BIS", "", "", "[89 FR 58976, July 22, 2024]", "General communications concerning this part, including how to obtain copies of this part, explanatory information, and requests for guidance or clarification, may be addressed to the Office of Strategic Industries and Economic Security, Room 3876, Department of Commerce, 1401 Constitution Ave. NW, Washington, DC 20230, Ref: DPAS; Telephone (202) 482-3634, email  DPAS@bis.doc.gov.  Request for special priorities assistance under \u00a7 700.50, adjustments or exceptions under \u00a7 700.80, or appeals under \u00a7 700.81, must be submitted in the manner specified in those sections."], ["15:15:2.1.3.2.1.2.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7 700.2 Introduction.", "BIS", "", "", "[89 FR 58970, July 22, 2024]", "(a) Certain national defense and energy programs (including military, emergency preparedness, homeland security, and critical infrastructure protection and restoration activities) may be eligible for priorities and allocations support as determined by a Determination Department.\n\n(b) The Department of Commerce administers the DPAS and may exercise priorities and allocations authority to ensure the timely delivery of industrial resources to meet approved program requirements.\n\n(c) The Department of Commerce has delegated authority to place priority ratings on contracts or orders necessary or appropriate to promote the national defense to certain government agencies that issue such contracts or orders. Such delegations include authority to authorize recipients of rated orders to place ratings on contracts or orders to contractors, subcontractors, and suppliers. Schedule I to this part includes a list of agencies to which the Department of Commerce has delegated authority. The Department of Commerce is also listed as an agency for programs where its authorization is necessary to place rated orders."], ["15:15:2.1.3.2.1.2.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7 700.3 Priority ratings and rated orders.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31921, June 11, 1998; 79 FR 47563, Aug. 14, 2014; 89 FR 58970, July 22, 2024]", "(a) Rated orders are identified by a priority rating, which consists of a rating symbol (DO or DX), and a program identification symbol. Rated orders take precedence over all unrated orders as necessary to meet required delivery dates. Rating symbols indicate the level of priority. Among rated orders, DX rated orders take precedence over DO rated orders. Program identification symbols indicate which approved program is attributed to the rated order.\n\n(b) Persons receiving rated orders must give them preferential treatment as required by this part.\n\n(c) All rated orders must be scheduled to the extent possible to ensure delivery by the required delivery date.\n\n(d) Persons who receive rated orders must in turn place rated orders with their suppliers for the industrial resources they need to fill the orders. This provision ensures that suppliers will give priority treatment to rated orders from contractor to subcontractor to suppliers throughout the procurement chain.\n\n(e) Persons may place a priority rating on orders only when they are in receipt of a rated order, have been explicitly authorized to do so by the Department of Commerce or a Delegate Agency, or are otherwise permitted to do so by this part."], ["15:15:2.1.3.2.1.2.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "B", "Subpart B\u2014Overview", "", "\u00a7\u00a7 700.4-700.7 [Reserved]", "BIS", "", "", "", ""], ["15:15:2.1.3.2.1.3.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "C", "Subpart C\u2014Definitions", "", "\u00a7 700.8 Definitions.", "BIS", "", "", "[79 FR 47564, Aug. 14, 2014, as amended at 89 FR 58970, July 22, 2024]", "The definitions in this section apply throughout this part:\n\nAllocation.  The control of the distribution of materials, services or facilities for a purpose deemed necessary or appropriate to promote the national defense.\n\nAllocation order.  An official action to control the distribution of materials, services, or facilities for a purpose deemed necessary or appropriate to promote the national defense.\n\nAllotment.  An official action that specifies the maximum quantity of a material, service, or facility authorized for a specific use to promote the national defense.\n\nApproved program.  A program determined in writing as necessary or appropriate for priorities and allocations support to promote the national defense by the Secretary of Defense, the Secretary of Energy, or the Secretary of Homeland Security, under the authority of the Defense Production Act and Executive Order 13603, or the Selective Service Act and Executive Order 12742.\n\nConstruction.  The erection, addition, extension, or alteration of any building, structure, or project, using materials or products which are to be an integral and permanent part of the building, structure, or project. Construction does not include maintenance and repair.\n\nCritical infrastructure.  Any systems and assets, whether physical or cyber-based, so vital to the United States that the degradation or destruction of such systems and assets would have a debilitating impact on national security, including, but not limited to, national economic security and national public health or safety.\n\nDefense Production Act.  The Defense Production Act of 1950, as amended (50 U.S.C. 4501  et seq. ).\n\nDelegate Agency.  A government agency authorized by delegation from the Department of Commerce to place priority ratings on contracts or orders needed to support approved programs.\n\nDetermination Department.  Any of the three Federal departments whose head is delegated authority by the President under section 202 of Executive Order 13603 to determine in writing that a program is necessary or appropriate to promote the national defense (referred to as \u201capproved program\u201d):\n\n(1) The Secretary of Defense with respect to military production and construction, military assistance to foreign nations, military use of civil transportation, stockpiles managed by the Department of Defense, space, and directly related activities;\n\n(2) The Secretary of Energy with respect to energy production and construction, distribution and use, and directly related activities; and\n\n(3) The Secretary of Homeland Security with respect to all other national defense programs, including civil defense and continuity of Government.\n\nDirective.  An official action which requires a person to take or refrain from taking certain actions in accordance with its provisions.\n\nEmergency preparedness.  All activities and measures designed or undertaken to prepare for or minimize the effects of a hazard upon the civilian population, to deal with the immediate emergency conditions which would be created by the hazard, and to effectuate emergency repairs to, or the emergency restoration of, vital utilities and facilities destroyed or damaged by the hazard. Emergency preparedness includes the following:\n\n(1) Measures to be undertaken in preparation for anticipated hazards (including the establishment of appropriate organizations, operational plans, and supporting agreements, the recruitment and training of personnel, the conduct of research, the procurement and stockpiling of necessary materials and supplies, the provision of suitable warning systems, the construction or preparation of shelters, shelter areas, and control centers, and, when appropriate, the nonmilitary evacuation of the civilian population);\n\n(2) Measures to be undertaken during a hazard (including the enforcement of passive defense regulations prescribed by duly established military or civil authorities, the evacuation of personnel to shelter areas, the control of traffic and panic, and the control and use of lighting and civil communications); and\n\n(3) Measures to be undertaken following a hazard (including activities for firefighting, rescue, emergency medical, health and sanitation services, monitoring for specific dangers of special weapons, unexploded bomb reconnaissance, essential debris clearance, emergency welfare measures, and immediately essential emergency repair or restoration of damaged vital facilities).\n\nFacilities.  The term includes all types of buildings, structures, or other improvements to real property (but excluding farms, churches or other houses of worship, and private dwelling houses), and services relating to the use of any such building, structure, or other improvement.\n\nHazard.  An emergency or disaster resulting from:\n\n(1) A natural disaster, or\n\n(2) An accidental or man-caused event.\n\nHomeland security.  Includes efforts:\n\n(1) To prevent terrorist attacks within the United States;\n\n(2) To reduce the vulnerability of the United States to terrorism;\n\n(3) To minimize damage from a terrorist attack in the United States; and\n\n(4) To recover from a terrorist attack in the United States.\n\nIndustrial resources.  All materials, services, and facilities, including construction materials, the authority for which has not been delegated to other agencies under Executive Order 13603. This term may also be referred to as \u201citem\u201d in this part.\n\nMaintenance and repair and/or operating supplies (MRO).  (1)  Maintenance  is the upkeep necessary to continue any plant, facility, or equipment in working condition.\n\n(2)  Repair  is the restoration of any plant, facility, or equipment to working condition when it has been rendered unsafe or unfit for service by wear and tear, damage, or failure of parts.\n\n(3)  Operating supplies  are any items carried as operating supplies according to a person's established accounting practice. Operating supplies may include hand tools and expendable tools, jigs, dies, fixtures used on production equipment, lubricants, cleaners, chemicals and other expendable items.\n\n(4) MRO does not include items produced or obtained for sale to other persons or for installation upon or attachment to the property of another person, or items required for the production of such items; items needed for the replacement of any plant, facility, or equipment; or items for the improvement of any plant, facility, or equipment by replacing items which are still in working condition with items of a new or different kind, quality, or design.\n\nMaterials.  Includes:\n\n(1) Any raw materials (including minerals, metals, and advanced processed materials), commodities, articles, components (including critical components), products, and items of supply; and\n\n(2) Any technical information or services ancillary to the use of any such materials, commodities, articles, components, products, or items.\n\nNational defense.  Programs for military and energy production or construction, military or critical infrastructure assistance to any foreign nation, homeland security, stockpiling, space, and any directly related activity. Such term includes emergency preparedness activities conducted pursuant to Title VI of The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121  et seq. ) and critical infrastructure protection and restoration.\n\nOfficial action.  An action taken by the Department of Commerce under the authority of the Defense Production Act, the Selective Service Act and related statutes, and this part. Such actions include the issuance of rating authorizations, directives, letters of understanding, demands for information, inspection authorizations, administrative subpoenas, and allocation orders.\n\nPerson.  Any individual, corporation, partnership, association, or any other organized group of persons, or legal successor or representative thereof; or any authorized State or local government or agency thereof; and for purposes of administration of this part, includes the United States Government and any authorized foreign government or international organization or agency thereof, delegated authority as provided in this part.\n\nPriorities authority.  The authority of the Department of Commerce, pursuant to section 101 of the Defense Production Act, to require priority performance of contracts and orders (other than contracts of employment) for industrial resources for use in approved programs.\n\nPriority rating.  An identifying code, consisting of the rating symbol and the program identification symbol, assigned by the Department of Commerce, a Delegate Agency, or authorized person and placed on all rated orders.\n\nProduction equipment.  Any item of capital equipment used in producing materials or furnishing services that has a unit acquisition cost of $2,500 or more, an anticipated service life in excess of one year, and the potential for maintaining its integrity as a capital item.\n\nProgram identification symbols.  Abbreviations used to indicate which approved program is supported by a rated order.\n\nRated order.  A prime contract, a subcontract, or a purchase order in support of an approved program issued in accordance with the provisions of this part.\n\nResource Department.  Any of the six Federal departments whose head is delegated authority by the President under section 201 of Executive Order 13603 to require acceptance and priority performance of contracts or orders (other than contracts of employment) to promote the national defense over performance of any other contracts or orders, and to allocate materials, services, and facilities as deemed necessary or appropriate to promote the national defense (referred to as \u201capproved program\u201d):\n\n(1) The Secretary of Agriculture with respect to food resources, food resource facilities, livestock resources, veterinary resources, plant health resources, and the domestic distribution of farm equipment and commercial fertilizer;\n\n(2) The Secretary of Energy with respect to all forms of energy;\n\n(3) The Secretary of Health and Human Services with respect to health resources;\n\n(4) The Secretary of Transportation with respect to all forms of civil transportation;\n\n(5) The Secretary of Defense with respect to water resources; and\n\n(6) The Secretary of Commerce with respect to all other materials, services, and facilities, including construction materials (referred to as \u201cindustrial resources\u201d).\n\nSelective Service Act.  Section 18 of the Selective Service Act of 1948 (50 U.S.C. 3816).\n\nServices.  Includes any effort that is needed for or incidental to:\n\n(1) The development, production, processing, distribution, delivery, or use of an industrial resource or a critical technology item;\n\n(2) The construction of facilities; or\n\n(3) Other national defense programs and activities.\n\nSet-aside.  An official action that requires a person to reserve materials, services, or facilities capacity in anticipation of the receipt of rated orders.\n\nStafford Act.  Title VI (Emergency Preparedness) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, as amended (42 U.S.C. 5121  et seq. ).\n\nWorking day.  Any day that the recipient of an order is open for business."], ["15:15:2.1.3.2.1.4.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.10 Authority.", "BIS", "", "", "[79 FR 47565, Aug. 14, 2014, as amended at 89 FR 58971, July 22, 2024]", "(a)  Delegations to the Department of Commerce.  The priorities and allocations authorities of the President under Title I of the Defense Production Act with respect to industrial resources have been delegated to the Secretary of Commerce under Executive Order 13603 of March 16, 2012 (3 CFR, 2012 Comp., p. 225). The priorities authorities of the President under the Selective Service Act and related statutes with respect to industrial resources have also been delegated to the Secretary of Commerce under Executive Order 12742 of January 8, 1991 (3 CFR, 1991 Comp. 309).\n\n(b)  Delegations by the Department of Commerce.  The Department of Commerce has authorized the Delegate Agencies to assign priority ratings to orders for industrial resources needed for use in approved programs.\n\n(c)  Jurisdiction limitations.  (1) The priorities and allocations authority for certain items have been delegated under Executive Order 13603, other executive orders, or Interagency Memoranda of Understanding between other agencies. Unless otherwise agreed to by the concerned agencies, the provisions of this part are not applicable to:\n\n(i) Food resources, food resource facilities, livestock resources, veterinary resources, plant health resources, and the domestic distribution of farm equipment and commercial fertilizer (delegated to the Department of Agriculture);\n\n(ii) All forms of energy (delegated to the Department of Energy);\n\n(iii) Health resources (delegated to the Department of Health and Human Services);\n\n(iv) All forms of civil transportation (delegated to the Department of Transportation); and\n\n(v) Water resources (delegated to the Department of Defense/U.S. Army Corps of Engineers).\n\n(2) The priorities and allocations authority set forth in this part may not be applied to communications services subject to Executive Order 13618 of July 6, 2012\u2014Assignment of National Security and Emergency Preparedness Communications Functions (3 CFR, 2012 Comp., p. 273)."], ["15:15:2.1.3.2.1.4.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.11 Priority ratings.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31922, June 11, 1998; 71 FR 39528, July 13, 2006; 79 FR 47565, Aug. 14, 2014; 89 FR 58971, July 22, 2024]", "(a)  Levels of priority.  (1) There are two levels of priority established by this regulation, identified by the rating symbols \u201cDO\u201d and \u201cDX.\u201d\n\n(2) All DO rated orders have equal priority with each other and take preference over unrated orders. All DX rated orders have equal priority with each other and take preference over DO rated orders and unrated orders. (For resolution of conflicts among rated orders of equal priority, see \u00a7 700.14(c).)\n\n(3) In addition, a Directive issued by Commerce takes preference over any DX rated order, DO rated order, or unrated order, as stipulated in the Directive. (For a full discussion of Directives, see \u00a7 700.62.)\n\n(b)  Program identification symbols.  Program identification symbols indicate which approved program is being supported by a rated order. The list of approved programs and their identification symbols is found in schedule I to this part. For example, A1 identifies defense aircraft programs and A7 signifies defense electronic and communications equipment programs. Program identification symbols, in themselves, do not connote any priority.\n\n(c)  Priority ratings.  A priority rating consists of the rating symbol\u2014DO and DX\u2014and the program identification symbol, such as A1, A7, or N1. Thus, a contract for the production of an aircraft will contain a DO-A1 or DX-A1 priority rating. A contract for a radar set will contain a DO-A7 or DX-A7 priority rating."], ["15:15:2.1.3.2.1.4.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.12 Elements of a rated order.", "BIS", "", "", "[79 FR 47565, Aug. 14, 2014, as amended at 89 FR 58971, July 22, 2024]", "(a)  Elements required for all rated orders.  (1) The appropriate priority rating and program identification symbol ( e.g.,  DO-A1, DX-A2, DO-N1).\n\n(2) A required delivery date or dates. The words \u201cimmediately\u201d or \u201cas soon as possible\u201d do not constitute a delivery date. When a \u201crequirements contract,\u201d \u201cbasic ordering agreement,\u201d \u201cprime vendor contract,\u201d or similar procurement document bearing a priority rating contains no specific delivery date or dates, but provides for the furnishing of items from time-to-time or within a stated period against specific purchase orders, such as \u201ccalls,\u201d \u201crequisitions,\u201d and \u201cdelivery orders,\u201d the purchase orders supporting such contracts or agreements must specify a required delivery date or dates and are to be considered as rated as of the date of their receipt by the supplier and not as of the date of the original procurement document.\n\n(3) The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of an individual authorized to sign rated orders for the person placing the order. The signature, manual or digital, certifies that the rated order is authorized under this part and that the requirements of this part are being followed.\n\n(4) A statement that reads in substance: \u201cThis is a rated order certified for national defense use and you are required to follow all the provisions of the Defense Priorities and Allocations System regulation (15 CFR part 700).\u201d\n\n(b)  Additional element required for certain emergency preparedness rated orders.  If a rated order is placed for the purpose of emergency preparedness requirements and expedited action is necessary or appropriate to meet these requirements, the following statement must be included in the order: \u201cThis rated order is placed for the purpose of emergency preparedness. It must be accepted or rejected within [Insert a time limit no less than the minimum applicable time limit specified in \u00a7 700.13(d)(2)].\u201d"], ["15:15:2.1.3.2.1.4.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.13 Acceptance and rejection of rated orders.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31922, June 11, 1998; 70 FR 10864, Mar. 7, 2005; 79 FR 47565, Aug. 14, 2014; 89 FR 58972, July 22, 2024]", "(a)  Mandatory acceptance.  (1) Except as otherwise specified in this section, a person shall accept every rated order received and must fill such orders regardless of any other rated or unrated orders that have been accepted.\n\n(2) A person shall not discriminate against rated orders in any manner such as by charging higher prices or by imposing different terms and conditions than for comparable unrated orders.\n\n(b)  Mandatory rejection.  Unless otherwise directed by Commerce:\n\n(1) A person shall not accept a rated order for delivery on a specific date if unable to fill the order by that date. However, the person must inform the customer of the earliest date on which delivery can be made and offer to accept the order on the basis of that date. Scheduling conflicts with previously accepted lower rated or unrated orders are not sufficient reason for rejection under this section.\n\n(2) A person shall not accept a DO rated order for delivery on a date which would interfere with delivery of any previously accepted DO or DX rated orders. However, the person must offer to accept the order based on the earliest delivery date otherwise possible.\n\n(3) A person shall not accept a DX rated order for delivery on a date which would interfere with delivery of any previously accepted DX rated orders, but must offer to accept the order based on the earliest delivery date otherwise possible.\n\n(4) If a person is unable to fill all the rated orders of equal priority status received on the same day, the person must accept, based upon the earliest delivery dates, only those orders which can be filled, and reject the other orders. For example, a person must accept order A requiring delivery on December 15 before accepting order B requiring delivery on December 31. However, the person must offer to accept the rejected orders based on the earliest delivery dates otherwise possible.\n\n(c)  Optional rejection.  Unless otherwise directed by Commerce, rated orders may be rejected in any of the following cases as long as a supplier does not discriminate among customers:\n\n(1) If the person placing the order is unwilling or unable to meet regularly established terms of sale or payment;\n\n(2) If the order is for an item not supplied or for a service not performed;\n\n(3) If the order is for an item produced, acquired, or provided only for the supplier's own use for which no orders have been filled for two years prior to the date of receipt of the rated order. If, however, a supplier has sold some of these items, the supplier is obligated to accept rated orders up to that quantity or portion of production, whichever is greater, sold within the past two years;\n\n(4) If the person placing the rated order, other than the U.S. Government, makes the item or performs the service being ordered;\n\n(5) If acceptance of a rated order or performance against a rated order would violate any other regulation, official action, or order of the Department of Commerce issued under the authority of the Defense Production Act or the Selective Service Act and related statutes (see \u00a7 700.75).\n\n(d)  Customer notification requirements.  (1) Except as provided in paragraph (d)(2) of this section, a person must accept or reject a rated order in writing (hard copy), or in electronic format, within fifteen (15) working days after receipt of a DO rated order and within ten (10) working days after receipt of a DX rated order. If the order is rejected, the person must give reasons in writing or electronically for the rejection.\n\n(2) If a rated order is placed for the purpose of emergency preparedness requirements and expedited action is necessary or appropriate to meet these requirements and the order includes the statement set forth in \u00a7 700.12(b), a person must accept or reject the rated order and transmit the acceptance or rejection in writing or in an electronic format within the time specified in the rated order. The minimum times for acceptance or rejection that such orders may specify are six (6) hours after receipt of the order if the order is issued by an authorized person in response to a hazard that has occurred, or twelve (12) hours after receipt if the order is issued by an authorized person to prepare for an imminent hazard.\n\n(3) If a person has accepted a rated order and subsequently finds that shipment or performance will be delayed, the person must notify the customer immediately, give the reasons for the delay, and advise of a new shipment or performance date. If notification is given verbally, written (hard copy) or electronic confirmation must be provided within one (1) working day of the verbal notice."], ["15:15:2.1.3.2.1.4.1.5", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.14 Preferential scheduling.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31922, June 11, 1998; 79 FR 47566, Aug. 14, 2014; 89 FR 58972, July 22, 2024]", "(a) A person must schedule operations, including the acquisition of all needed production items, in a timely manner to satisfy the delivery requirements of each rated order. Modifying production or delivery schedules is necessary only when required delivery dates for rated orders cannot otherwise be met.\n\n(b) DO rated orders must be given production preference over unrated orders, if necessary to meet required delivery dates, even if this requires the diversion of items being processed or ready for delivery against unrated orders. Similarly, DX rated orders must be given preference over DO rated orders and unrated orders.\n\n(c)  Conflicting rated orders.  (1) If a person finds that delivery or performance against any accepted rated orders conflicts with the delivery or performance against other accepted rated orders of equal priority status, the person shall give preference to the conflicting orders in the sequence in which they are to be delivered or performed (not to the receipt dates). If the conflicting rated orders are scheduled to be delivered or performed on the same day, the person shall give preference to those orders which have the earliest receipt dates.\n\n(2) If a person is unable to resolve rated order delivery or performance conflicts under this section, the person should promptly seek special priorities assistance as provided in subpart H of this part. If the person's customer objects to the rescheduling of delivery or performance of a rated order, the customer should promptly seek special priorities assistance as provided in subpart H of this part. For any rated order against which delivery or performance will be delayed, the person must notify the customer as provided in \u00a7 700.13(d)(3).\n\n(d) If a person is unable to purchase needed production items in time to fill a rated order by its required delivery date, the person must fill the rated order by using inventoried production items. A person who uses inventoried items to fill a rated order may replace those items with the use of a rated order as provided in \u00a7 700.17(b)."], ["15:15:2.1.3.2.1.4.1.6", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.15 Extension of priority ratings.", "BIS", "", "", "[89 FR 58972, July 22, 2024]", "(a) A person must use rated orders with suppliers to obtain industrial resources needed to fill a rated order. All elements of a rated order outlined in section 700.12 must be included on the rated order. The person must use the priority rating indicated on the customer's rated order, except as otherwise provided in this part (see \u00a7 700.17) or as directed by the Department of Commerce.\n\nExample:  \n\n\n \n If a person is in receipt of a rated order with a priority rating of DO-A3 for a navigation system and needs to purchase semiconductors for its manufacture, that person must use a DO-A3 priority rating to obtain the needed semiconductors.\n\nExample:\n\nIf a person is in receipt of a rated order with a priority rating of DO-A3 for a navigation system and needs to purchase semiconductors for its manufacture, that person must use a DO-A3 priority rating to obtain the needed semiconductors.\n\n(b) The required elements of a rated order outlined in \u00a7 700.12 must be included on each successive order placed to obtain industrial resources needed to fill a customer's rated order. Therefore, the inclusion of the rating will continue from contractor to subcontractor to supplier throughout the entire supply chain.\n\n(c) A person must use rated orders with suppliers to obtain industrial resources needed to fill an emergency preparedness rated order. That person must require acceptance or rejection, and transmission of that acceptance or rejection by the supplier within the time limit stated in the rated order that is being filled."], ["15:15:2.1.3.2.1.4.1.7", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.16 Changes or cancellations of priority ratings and rated orders.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47566, Aug. 14, 2014; 89 FR 58972, July 22, 2024]", "(a) The priority rating on a rated order may be changed or cancelled by:\n\n(1) An official action of the Department of Commerce; or\n\n(2) Written notification from the person who placed the rated order (including a Delegate Agency).\n\n(b) If an unrated order is amended so as to make it a rated order, or a DO rating is changed to a DX rating, the supplier must give the appropriate preferential treatment to the order as of the date the change is received by the supplier.\n\n(c) An amendment to a rated order that significantly alters a supplier's original production or delivery schedule shall constitute a new rated order as of the date of its receipt. The supplier must accept or reject the amended order according to the provisions of \u00a7 700.13.\n\n(d) The following amendments do not constitute a new rated order: a change in shipping destination; a reduction in the total amount of the order; an increase in the total amount of the order which has negligible impact upon deliveries; a minor variation in size or design (prior to the start of production); or a change which is agreed upon between the supplier and the customer.\n\n(e) A person must cancel any rated orders that the person (or a predecessor in interest) has placed with suppliers or cancel the priority ratings on those orders if the person no longer needs the items in those orders to fill a rated order.\n\n(f) A person adding a rating to an unrated order, or changing or cancelling a priority rating must promptly notify all suppliers to whom the order was sent of the addition, change or cancellation."], ["15:15:2.1.3.2.1.4.1.8", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.17 Use of rated orders.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31923, June 11, 1998; 79 FR 47566, Aug. 14, 2014; 89 FR 58972, July 22, 2024]", "(a) A person must use rated orders to obtain:\n\n(1) Items which will be physically incorporated into other items to fill rated orders, including that portion of such items normally consumed, or converted into scrap or by-products, in the course of processing;\n\n(2) Containers or other packaging materials required to make delivery of the finished items against rated orders;\n\n(3) Services, other than contracts of employment, needed to fill rated orders; and\n\n(4) MRO needed to produce the finished items to fill rated orders. However, for MRO, the priority rating used must contain the program identification symbol H7 along with the rating symbol contained on the customer's rated order. For example, a person in receipt of a rated order with a priority rating of DO-A3 rated order, who needs MRO, would place a rated order with a priority rating of DO-H7 rated order with the person's supplier.\n\n(b) A person may use a rated order to replace inventoried items (including finished items) if such items were used to fill rated orders, as follows:\n\n(1) The order must be placed within ninety (90) days of the date of use of the inventory.\n\n(2) A DO rating symbol and the program identification symbol indicated on the customer's rated order must be used on the order. A DX rating symbol may not be used even if the inventory was used to fill a DX rated order.\n\n(3) If the priority ratings on rated orders from one customer or several customers contain different program identification symbols, the rated orders may be combined. In this case, the program identification symbol H1 must be used (i.e., DO-H1).\n\n(c) A person may combine DX and DO rated orders from one customer or several customers if the items covered by each level of priority are identified separately and clearly. If different program identification symbols are indicated on those rated orders of equal priority, the person must use the program identification symbol H1 (i.e., DO-H1 or DX-H1).\n\n(d)  Combining rated and unrated orders.  (1) A person may combine rated and unrated order quantities on one purchase order provided that:\n\n(i) The rated quantities are separately and clearly identified; and\n\n(ii) The elements of a rated order, as required by \u00a7 700.12, are included on the order with the statement required in \u00a7 700.12(a)(4) modified to read in substance: \u201cThis purchase order contains rated order quantities certified for national defense use, and you are required to follow all the provisions of the Defense Priorities and Allocations System regulation (15 CFR part 700) as it pertains to the rated quantities.\u201d\n\n(2) A supplier must accept or reject the rated portion of the purchase order as provided in \u00a7 700.13 and give preferential treatment only to the rated quantities as required by this part. This part may not be used to give preferential treatment to the unrated portion of the order.\n\n(3) Any supplier who believes that rated and unrated orders are being combined in a manner contrary to the intent of this regulation or in a fashion that causes undue or exceptional hardship may submit a request for adjustment or exception under \u00a7 700.80.\n\n(e) A person may place a rated order for the minimum commercially procurable quantity even if the quantity needed to fill a rated order is less than that minimum. However, a person must combine rated orders as provided in paragraph (c) of this section, if possible, to obtain minimum procurable quantities.\n\n(f) A person is not required to place a priority rating on an order for less than $125,000, or one half of the Simplified Acquisition Threshold (as established in the Federal Acquisition Regulation (FAR)) (see FAR section 2.101), whichever amount is greater, provided that delivery can be obtained in a timely fashion without the use of the priority rating."], ["15:15:2.1.3.2.1.4.1.9", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "D", "Subpart D\u2014Industrial Priorities", "", "\u00a7 700.18 Limitations on placing rated orders.", "BIS", "", "", "[79 FR 47566, Aug. 14, 2014, as amended at 89 FR 58972, July 22, 2024]", "(a)  General limitations.  (1) A person may not place a rated order pursuant to this part unless the person is in receipt of a rated order, has been explicitly authorized to do so by the Department of Commerce or a Delegate Agency or is otherwise permitted to do so by this part.\n\n(2) Rated orders may not be used to obtain:\n\n(i) Delivery on a date earlier than needed;\n\n(ii) A greater quantity of the item than needed, except to obtain a minimum procurable quantity;\n\n(iii) Items in advance of the receipt of a rated order, except as specifically authorized by the Department of Commerce (see \u00a7 700.51(c) for information on obtaining authorization for a priority rating in advance of a rated order); or\n\n(iv) Any of the following items unless specific priority rating authority has been obtained from a Delegate Agency or the Department of Commerce:\n\n(A) Items for plant improvement, expansion, or construction, unless they will be physically incorporated into a construction project covered by a rated order; or\n\n(B) Production or construction equipment or items to be used for the manufacture of production equipment (for information on requesting priority rating authority, see \u00a7 700.51).\n\n(v) Any items related to the development of chemical or biological warfare capabilities or the production of chemical or biological weapons, unless such development or production has been authorized by the President or the Secretary of Defense.\n\n(3) Separate rated orders may not be placed solely for obtaining minimum procurable quantities on each order if the minimum procurable quantity would be sufficient to cover more than one rated order.\n\n(b)  Specific item limitations.  Notwithstanding any authorization or requirement to place a rated order stated elsewhere in this part, no person may place a rated order to obtain the following items unless such order is authorized by an official action of the Department of Commerce.\n\n(1) Copper raw materials.\n\n(2) Crushed stone.\n\n(3) Gravel.\n\n(4) Sand.\n\n(5) Scrap.\n\n(6) Slag.\n\n(7) Steam heat, central.\n\n(8) Waste paper."], ["15:15:2.1.3.2.1.5.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Industrial Priorities for Energy Programs", "", "\u00a7 700.20 Use of priority ratings.", "BIS", "", "", "", "(a) Section 101(c) of the Defense Production Act authorizes the use of priority ratings for projects which maximize domestic energy supplies.\n\n(b) Projects which maximize domestic energy supplies include those which maintain or further domestic energy exploration, production, refining, and transportation; maintain or further the conservation of energy; or are involved in the construction or maintenance of energy facilities."], ["15:15:2.1.3.2.1.5.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "E", "Subpart E\u2014Industrial Priorities for Energy Programs", "", "\u00a7 700.21 Application for priority rating authority.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014, as amended at 89 FR 58972, July 22, 2024]", "(a) For projects believed to maximize domestic energy supplies, a person may request priority rating authority for scarce, critical, and essential supplies of materials, equipment, and services (related to the production of materials or equipment, or the installation, repair, or maintenance of equipment) by submitting a request to the Department of Energy. Further information may be obtained from the Department of Energy, Office of Cybersecurity, Energy Security, and Emergency Response, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (202) 586-8100; Email:  askcr@hq.doe.gov.\n\n(b) If the Department of Energy notifies the Department of Commerce that the project maximizes domestic energy supplies and that the materials, equipment, or services are critical and essential, the Department of Commerce will determine whether the items in question are scarce, and, if they are scarce, whether there is a need to use the priorities authority.\n\n(1) Scarcity implies an unusual difficulty in obtaining the materials, equipment, or services in a time frame consistent with the timely completion of the energy project. In determining scarcity, the Department of Commerce may consider factors such as the following:\n\n(i) Value and volume of material or equipment shipments;\n\n(ii) Consumption of material and equipment;\n\n(iii) Volume and market trends of imports and exports;\n\n(iv) Domestic and foreign sources of supply;\n\n(v) Normal levels of inventories;\n\n(vi) Rates of capacity utilization;\n\n(vii) Volume of new orders; and\n\n(viii) Lead times for new orders.\n\n(2) In finding whether there is a need to use the priorities authority, the Department of Commerce may consider alternative supply solutions and other measures.\n\n(c) After the Department of Commerce has conducted its analysis, it will advise the Department of Energy whether the two findings have been satisfied. If the findings are satisfied, the Department of Commerce will authorize the Department of Energy to grant the use of a priority rating to the applicant.\n\n(d) Schedule I to this part includes a list of approved programs to support the maximization of domestic energy supplies. A Department of Energy regulation setting forth the procedures and criteria used by the Department of Energy in making its determination and findings is published in 10 CFR part 216."], ["15:15:2.1.3.2.1.6.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.30 Policy.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014]", "(a) Allocation orders will:\n\n(1) Be used only when there is insufficient supply of a material, service, or facility to satisfy national defense requirements through the use of the priorities authority or when the use of the priorities authority would cause a severe and prolonged disruption in the supply of materials, services, or facilities available to support normal U.S. economic activities; and\n\n(2) Not be used to ration materials or services at the retail level.\n\n(b) Allocation orders, when used, will be distributed equitably among the suppliers of the materials, services, or facilities being allocated and not require any person to relinquish a disproportionate share of the civilian market."], ["15:15:2.1.3.2.1.6.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.31 General procedures.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014, as amended at 89 FR 58972, July 22, 2024]", "Before the Department of Commerce uses its allocations authority to address a supply problem within its resource jurisdiction, it will develop a plan that includes:\n\n(a) A copy of the written determination made in accordance with section 202 of Executive Order 13603, that the program or programs that would be supported by the allocation action are necessary or appropriate to promote the national defense;\n\n(b) A detailed description of the situation to include any unusual events or circumstances that have created the requirement for an allocation action;\n\n(c) A statement of the specific objective(s) of the allocation action;\n\n(d) A list of the materials, services, or facilities to be allocated;\n\n(e) A list or description of the sources of the materials, services, or facilities that will be subject to the allocation action;\n\n(f) A detailed description of the provisions that will be included in the allocation orders, including the type(s) of allocation orders, the percentages or quantity of capacity or output to be allocated for each purpose, the relationship with previously or subsequently received priority rated and unrated contracts and orders, and the duration of the allocation action ( e.g.,  anticipated start and end dates);\n\n(g) An evaluation of the impact of the proposed allocation action on the civilian market; and\n\n(h) Proposed actions, if any, to mitigate disruptions to civilian market operations."], ["15:15:2.1.3.2.1.6.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.32 Controlling the general distribution of a material in the civilian market.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014]", "No allocation action by the Department of Commerce may be used to control the general distribution of a material in the civilian market unless the conditions of paragraphs (a), (b), and (c) of this section are met.\n\n(a) The Secretary has made a written finding that:\n\n(1) Such material is a scarce and critical material essential to the national defense, and\n\n(2) The requirements of the national defense for such material cannot otherwise be met without creating a significant dislocation of the normal distribution of such material in the civilian market to such a degree as to create appreciable hardship.\n\n(b) The Secretary has submitted the finding for the President's approval through the Assistant to the President and National Security Advisor and the Assistant to the President for Homeland Security and Counterterrorism.\n\n(c) The President has approved the finding.\n\n(d) In this section, the term, \u201cSecretary\u201d means the Secretary of Commerce or his or her designee."], ["15:15:2.1.3.2.1.6.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.33 Types of allocation orders.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014, as amended at 89 FR 58973, July 22, 2024]", "There are three types of allocation orders available for communicating allocation actions.\n\n(a)  Set-aside.  A set-aside is an official action that requires a person to reserve materials, services, or facilities capacity in anticipation of the receipt of rated orders.\n\n(b)  Directive.  A directive is an official action that requires a person to take or refrain from taking certain actions in accordance with its provisions. For example, a directive can require a person to: stop or reduce production of an item; prohibit the use of selected materials, services, or facilities; or divert the use of materials, services, or facilities from one purpose to another.\n\n(c)  Allotment.  An allotment is an official action that specifies the maximum quantity of a material, service, or facility authorized for a specific use to promote the national defense."], ["15:15:2.1.3.2.1.6.1.5", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.34 Elements of an allocation order.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014, as amended at 89 FR 58973, July 22, 2024]", "Allocation orders may be issued directly to the affected persons or by constructive notice to the parties through publication in the  Federal Register.  This section describes the elements that each order must include.\n\n(a)  Elements to be included in all allocation orders.  (1) A detailed description of the required allocation action(s), including its relationship to previously or subsequently received DX rated orders, DO rated orders, and unrated orders.\n\n(2) Specific start and end calendar dates for each required allocation action.\n\n(b)  Elements to be included in orders issued directly to affected persons.  (1) A statement that reads in substance: \u201cThis is an allocation order certified for national defense use. [Insert the name of the person receiving the order] is required to comply with this order, in accordance with the provisions of the Defense Priorities and Allocations System regulation (15 CFR part 700).\u201d\n\n(2) The written signature on a manually placed order, or the digital signature or name on an electronically placed order, of an authorized official or employee of the Department of Commerce.\n\n(c)  Elements to be included in an allocation order issued by constructive notice through publication in the   Federal Register.  (1) A statement that reads in substance: \u201cThis is an allocation order certified for national defense use. [Insert the name(s) of the person(s) to whom the order applies or a description of the class of persons to whom the order applies] is (are) required to comply with this order, in accordance with the provisions of the Defense Priorities and Allocations System regulation (15 CFR part 700).\u201d\n\n(2) The order must be signed by an authorized official or employee of the Department of Commerce."], ["15:15:2.1.3.2.1.6.1.6", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.35 Mandatory acceptance of an allocation order.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014]", "(a) Except as otherwise specified in this section, a person shall accept and comply with every allocation order received.\n\n(b) A person shall not discriminate against an allocation order in any manner such as by charging higher prices for materials, services, or facilities covered by the order or by imposing terms and conditions for contracts and orders involving allocated materials, services, or facilities that differ from the person's terms and conditions for contracts and orders for the materials, services, or facilities prior to receiving the allocation order.\n\n(c) If a person is unable to comply fully with the required action(s) specified in an allocation order, the person must notify the Office of Strategic Industries and Economic Security immediately, explain the extent to which compliance is possible, and give the reasons why full compliance is not possible. If notification is given verbally, written or electronic confirmation must be provided within one working day. Such notification does not release the person from complying with the order to the fullest extent possible, until the person is notified by the Department of Commerce that the order has been changed or cancelled."], ["15:15:2.1.3.2.1.6.1.7", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "F", "Subpart F\u2014Allocation Actions", "", "\u00a7 700.36 Changes or cancellations of allocation orders.", "BIS", "", "", "[79 FR 47567, Aug. 14, 2014]", "An allocation order may be changed or cancelled by an official action from the Department of Commerce. Notice of such changes or cancellations may be provided directly to persons to whom the order being cancelled or modified applies or constructive notice may be provided by publication in the  Federal Register."], ["15:15:2.1.3.2.1.8.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.50 General provisions.", "BIS", "", "", "[89 FR 58973, July 22, 2024]", "(a) Once a priority rating has been authorized pursuant to this part, further action by the Department of Commerce generally is not needed. However, it is anticipated that from time-to-time problems will occur. In this event, a person should immediately contact the appropriate contract administration officer or the Department of Commerce for guidance or assistance. Special priorities assistance is a service provided to alleviate problems that do arise.\n\n(1) If additional formal aid is needed for a rated order placed by a Delegate Agency, special priorities assistance should be sought from the Delegate Agency through the contract administration officer. If the Delegate Agency is unable to resolve the problem or to authorize the use of a priority rating and believes additional assistance is warranted, the Delegate Agency may forward the request to the Department of Commerce for action.\n\n(2) If additional formal aid is needed for a rated order placed by other authorized persons, special priorities assistance should be sought from the Department of Commerce.\n\n(b) Special priorities assistance may be provided for any reason consistent with this part, such as assisting in obtaining timely deliveries of items needed to satisfy rated orders or authorizing the use of priority ratings on orders to obtain items not otherwise ratable under this part. If the Department of Commerce is unable to resolve the problem or to authorize the use of a priority rating and believes additional assistance is warranted, the Department of Commerce may forward the request to another agency, identified in \u00a7 700.10(c), as appropriate, for action.\n\n(c) A request for special priorities assistance must be submitted on Form BIS-999 (OMB control number 0694-0057) to the local contract administration representative or to the Department of Commerce. Form BIS-999 may be obtained from the Delegate Agency representative or from the Department of Commerce. A sample Form BIS-999 is attached at appendix I. A fillable Form BIS-999 may be obtained on the following website:  https://www.bis.doc.gov/."], ["15:15:2.1.3.2.1.8.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.51 Requests for priority rating authority.", "BIS", "", "", "[89 FR 58973, July 22, 2024]", "(a) If a rated order is likely to be delayed because a person is unable to obtain items not normally rated under this part, the person may request the authority to use a priority rating in ordering the needed items. Examples of items for which priority ratings may be authorized include:\n\n(1) Production or construction equipment;\n\n(2) Computers when not used as production items; and\n\n(3) Expansion, rebuilding or replacing plant facilities.\n\n(b) If a person does not have priority rating authority under this part from a Delegate Agency or the Department of Commerce and is unable to ensure the timely delivery of industrial resources, the person may request the authority to use a priority rating in ordering the needed items.\n\n(1) A request for priority rating authority under this part must be submitted on Form BIS-999 to the Department of Commerce (see \u00a7 700.50(c) for information on Form BIS-999).\n\n(2) A request for priority rating authority under this part may be used only to support approved programs (see \u00a7 700.55, \u00a7 700.57, and \u00a7 700.58 for information on requesting a determination by the appropriate Determination Department that the request supports a program that is necessary or appropriate to promote the national defense).\n\n(c)  Rating authority for production or construction equipment.  (1) A request for priority rating authority for production or construction equipment must be submitted to the appropriate Delegate Agency or the Department of Commerce. Requests in support of Department of Defense approved programs should be submitted to the Department of Defense on Department of Defense Form DD 691. All other requests should be submitted on Form BIS-999. If the Delegate Agency is unable to resolve the problem or authorize the use of a priority rating, the Delegate Agency may forward the request to the Department of Commerce for action.\n\n(2) When the use of a priority rating is authorized for the procurement of production or construction equipment, a rated order may be used either to purchase or to lease such equipment. However, in the latter case, the equipment may be leased only from a person engaged in the business of leasing such equipment or from a person willing to lease rather than sell.\n\n(d)  Rating authority in advance of a rated prime contract.  (1) In certain cases and upon specific request, the Department of Commerce, in order to promote the national defense, may authorize a person to place a priority rating on an order to a supplier in advance of the issuance of a rated prime contract. In these instances, the person requesting advance rating authority must obtain sponsorship of the request from the appropriate Delegate Agency or those authorized by the Department of Commerce to priority rate the prime contract. The person shall also assume any business risk associated with the placing of rated orders if these orders have to be cancelled in the event the rated prime contract is not issued.\n\n(2) The person must state the following in the request: \u201cIt is understood that the authorization of a priority rating in advance of our receiving a rated prime contract and our use of that priority rating with our suppliers in no way commits the Department of Commerce or any other government agency to enter into a contract or order or to expend funds. Further, we understand that the Federal Government shall not be liable for any cancellation charges, termination costs, or other damages that may accrue if a rated prime contract is not eventually placed and, as a result, we must subsequently cancel orders placed with the use of the priority rating authorized as a result of this request.\u201d\n\n(3) In reviewing requests for rating authority in advance of a rated prime contract, the Department of Commerce will consider, among other things, the following criteria:\n\n(i) The probability that the prime contract will be awarded;\n\n(ii) The impact of the resulting rated orders on suppliers and on other authorized programs;\n\n(iii) Whether the contractor is the sole source;\n\n(iv) Whether the item being produced has a long lead time; and\n\n(v) The time period for which the rating is being requested.\n\n(4) The Department of Commerce may require periodic reports on the use of the rating authority granted under paragraph (c) of this section.\n\n(5) If a rated prime contract is not issued, the person shall promptly notify all suppliers who have received rated orders pursuant to the advanced rating authority that the priority rating on those orders is cancelled."], ["15:15:2.1.3.2.1.8.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.52 Examples of assistance.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 89 FR 58974, July 22, 2024]", "(a) While special priorities assistance may be provided for any reason in support of this regulation and an approved program (see \u00a7 700.55, \u00a7 700.57, \u00a7 700.58, and Schedule I of this part), it is usually provided in situations where:\n\n(1) A person is experiencing difficulty in obtaining delivery against a rated order by the required delivery date;\n\n(2) A person cannot locate a supplier for an item needed to fill a rated order; or\n\n(3) A person is experiencing difficulty in obtaining delivery for an unrated order by the required delivery date.\n\n(b) Other examples of special priorities assistance include:\n\n(1) Ensuring that rated orders receive preferential treatment by suppliers;\n\n(2) Resolving production or delivery conflicts between various rated orders;\n\n(3) Assisting in placing rated orders with suppliers;\n\n(4) Verifying the urgency of rated orders; and\n\n(5) Determining the validity of rated orders."], ["15:15:2.1.3.2.1.8.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.53 Criteria for assistance.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47568, Aug. 14, 2014; 89 FR 58974, July 22, 2024]", "Requests for special priorities assistance should be timely,  i.e.,  the request has been submitted promptly and enough time exists for the Determination Department, Delegate Agency, or the Department of Commerce to effect a meaningful resolution to the problem, and must establish that:\n\n(a) There is an urgent need for the item; and\n\n(b) The applicant has made a reasonable effort to resolve the problem."], ["15:15:2.1.3.2.1.8.1.5", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.54 Instances where assistance will not be provided.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 63 FR 31924, June 11, 1998; 79 FR 47568, Aug. 14, 2014; 89 FR 58974, July 22, 2024]", "Special priorities assistance is provided at the discretion of the Determination Departments, Delegate Agencies, and the Department of Commerce when it is determined that such assistance is warranted to meet the objectives of this regulation. Examples where assistance may not be provided include situations when a person is attempting to:\n\n(a) Secure a price advantage;\n\n(b) Obtain delivery prior to the time required to fill a rated order;\n\n(c) Gain competitive advantage;\n\n(d) Disrupt an industry apportionment program in a manner designed to provide a person with an unwarranted share of scarce items; or\n\n(e) Overcome a supplier's regularly established terms of sale or conditions of doing business."], ["15:15:2.1.3.2.1.8.1.6", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.55 Requests for determination that program within the United States is necessary or appropriate to promote the national defense.", "BIS", "", "", "[89 FR 58974, July 22, 2024]", "(a)  Homeland security, emergency response, and critical infrastructure protection and restoration assistance programs within the United States.  Any person requesting priority rating authority or requiring assistance in obtaining rated items under this part supporting homeland security, emergency preparedness, and critical infrastructure protection and restoration related activities should submit a request for a determination in writing that the request supports a program that is necessary or appropriate to promote the national defense (referred to as \u201capproved program\u201d) to the Office of Policy and Program Analysis, Federal Emergency Management Agency, Department of Homeland Security, 500 C Street SW, Washington, DC 20472; Telephone: (202) 212-2900; Fax: (202) 646-4601; Email:  FEMA-DPA@fema.dhs.gov,  website:  https://www.fema.gov/disaster/defense-production-act.\n\n(b)  Military production and construction, military use of civil transportation, stockpiles managed by the Department of Defense, space, and directly related activities within the United States.  Any person requesting priority rating authority or requiring assistance under this part in obtaining rated items supporting military production and construction, military use of civil transportation, stockpiles managed by the Department of Defense, space, and directly related activities should submit a request for a determination in writing that the request supports a program that is necessary or appropriate to promote the national defense (referred to as \u201capproved program\u201d) to the Department of Defense DPA Title I Lead in the Office of the Assistant Secretary of Defense for Industrial Base Policy, 3330 Defense Pentagon, Room 3B854, Washington, DC 20301; Telephone: (703) 697-0051; Fax: (703) 695-4885; Email:  osd.pentagon.ousd-a-s.mbx.indpol-dpa-title-i@mail.mil;  website:  https://www.businessdefense.gov/.\n\n(c)  Energy production and construction, distribution and use, and directly related activities within the United States.  Any person requesting priority rating authority or requiring assistance under this part in obtaining rated items supporting energy production and construction, distribution and use, and directly related activities should submit a request for a determination in writing that the request supports a program that is necessary or appropriate to promote the national defense (referred to as \u201capproved program\u201d) to the Department of Energy, Office of Cybersecurity, Energy Security, and Emergency Response, 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (202) 586-8100; Email:  askcr@hq.doe.gov."], ["15:15:2.1.3.2.1.8.1.7", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.56 Military assistance programs with Canada.", "BIS", "", "", "[79 FR 47568, Aug. 14, 2014, as amended at 89 FR 58974, July 22, 2024]", "(a) To promote military assistance to Canada, this section provides for authorizing priority ratings to persons in Canada to obtain items in the United States in support of approved programs. Although priority ratings have no legal authority outside of the United States, this section also provides information on how persons in the United States may obtain informal assistance in Canada in support of approved programs.\n\n(b) The joint United States-Canadian military arrangements for the defense of North America and the integrated nature of the United States and Canadian defense industries require close coordination and the establishment of a means to provide mutual assistance to the defense industries located in both countries.\n\n(c) The Department of Commerce coordinates with Public Works and Government Services Canada on all matters of mutual concern relating to the administration of this part.\n\n(d) Any person in the United States ordering defense items in Canada in support of an approved program should inform the Canadian supplier that the items being ordered are to be used to fill a rated order. The Canadian supplier should be informed that if production materials are needed from the United States by the Canadian supplier or the Canadian supplier's vendor to fill the order, the Canadian supplier or vendor should contact Public Works and Government Services Canada for authority to place rated orders in the United States: Public Works and Government Services Canada, Acquisitions Branch, Business Management Directorate, Phase 3, Place du Portage, 0B2-103, 11 Laurier Street, Gatineau, Quebec, K1A 0S5, Canada; Telephone: (819) 420-7200; Fax: (819) 997-9776, or electronically at  TPSGC.PAPrioritesdedefense-APDefencePriorities.PWGSC@tpsgc-pwgsc.gc.ca.\n\n(e) Any person in Canada producing defense items for the Canadian government may also obtain priority rating authority for items to be purchased in the United States by applying to Public Works and Government Services Canada, Acquisitions Branch, Business Management Directorate, in accordance with its procedures.\n\n(f) Persons in Canada needing special priorities assistance in obtaining defense items in the United States may apply to Public Works and Government Services Canada, Acquisitions Branch, Business Management Directorate, for such assistance. Public Works and Government Services Canada will forward appropriate requests to the Department of Commerce.\n\n(g) Any person in the United States requiring assistance in obtaining items in Canada must submit a request to the Office of Strategic Industries and Economic Security, U.S. Department of Commerce on Form BIS-999. The Department of Commerce will forward appropriate requests to Public Works and Government Services Canada."], ["15:15:2.1.3.2.1.8.1.8", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.57 Military assistance programs with other nations and international organizations.", "BIS", "", "", "[79 FR 47568, Aug. 14, 2014, as amended at 80 FR 50762, Aug. 21, 2015; 89 FR 58975, July 22, 2024]", "(a)  Scope.  To promote military assistance to foreign nations and international organizations (for example, the North Atlantic Treaty Organization or the United Nations), this section provides for authorizing priority ratings to persons in foreign nations or international organizations to obtain items in the United States in support of approved programs. Although priority ratings have no legal authority outside of the United States, this section also provides information on how persons in the United States may obtain informal assistance in foreign nations that are signatories to bilateral security of supply arrangements with the Department of Defense. These foreign nations include Australia, Estonia, Denmark, Finland, Israel, Italy, Japan, Latvia, Lithuania, The Netherlands, Norway, Republic of Korea, Singapore, Spain, Sweden, and the United Kingdom. The most current security of supply arrangement information, including an up-to-date list of countries, may be found on the following website:  https://www.businessdefense.gov/security-of-supply.html.\n\n(b)  Foreign nations and international organizations.  (1) Any person in a foreign nation other than Canada, or any person in an international organization, requiring assistance in obtaining items in the United States or priority rating authority for items to be purchased in the United States, should submit a request for such assistance or priority rating authority to: the Department of Defense DPA Title I Lead in the Office of the Assistant Secretary of Defense for Industrial Base Policy, 3330 Defense Pentagon, Room 3B854, Washington, DC 20301; Telephone: (703) 697-0051; Fax: (703) 695-4885; Email:  osd.pentagon.ousd-a-s.mbx.indpol-dpa-title-i@mail.mil,  website:  https://www.businessdefense.gov/.\n\n(i) If the end product is being acquired by a U.S. Government agency, the request should be submitted to the Department of Defense DPA Title I Lead through the U.S. contract administration representative.\n\n(ii) If the end product is being acquired by a foreign nation or international organization, the request must be sponsored prior to its submission to the Department of Defense DPA Title I Lead by the government of the foreign nation or the international organization that will use the end product.\n\n(2) If the Department of Defense endorses the request, it will be forwarded to the Department of Commerce for appropriate action.\n\n(c)  Requesting assistance in foreign nations that are signatories to bilateral security of supply arrangements.  (1) The Department of Defense has entered into bilateral security of supply arrangements with several foreign nations that allow the Department of Defense to request the priority delivery for Department of Defense contracts, subcontracts, and orders from companies in these countries. These countries include Australia, Denmark, Estonia, Finland, Israel, Italy, Japan, Latvia, Lithuania, The Netherlands, Norway, Republic of Korea, Singapore, Spain, Sweden, and the United Kingdom. The most current security of supply arrangement information, including an up-to-date list of countries, may be found on the following website:  https://www.businessdefense.gov/security-of-supply.html.\n\n(2) Any person in the United States requiring assistance in obtaining the priority delivery of a contract, subcontract, or order in foreign nations that are signatories to bilateral security of supply arrangements with the Department of Defense should contact the Department of Defense DPA Title I Lead in the Office of the Assistant Secretary of Defense for Industrial Base Policy for assistance.\n\n(3) Persons in foreign nations that are signatories to bilateral security of supply arrangements with the Department of Defense should request assistance in accordance with paragraph (b)(1) of this section."], ["15:15:2.1.3.2.1.8.1.9", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "H", "Subpart H\u2014Special Priorities Assistance", "", "\u00a7 700.58 Critical infrastructure assistance programs to foreign nations and international organizations.", "BIS", "", "", "[89 FR 58975, July 22, 2024]", "(a)  Scope.  To promote critical infrastructure assistance to foreign nations, this section provides for authorizing priority ratings to persons in foreign nations or international organizations (for example, the North Atlantic Treaty Organization or the United Nations) to obtain items in the United States in support of approved programs.\n\n(b)  Foreign nations or international organizations.  (1) Any person in a foreign nation or representing an international organization requiring assistance in obtaining items under this part to be purchased in the United States for support of critical infrastructure protection and restoration should submit a request for priority rating authority on Form BIS-999 to the Department of Commerce (see \u00a7 700.50(c) for information on Form BIS-999).\n\n(2) Any person in a foreign nation or representing an international organization requesting priority rating authority or requiring assistance in obtaining rated items under this part in support of critical infrastructure protection and restoration related activities should submit a request for a determination in writing that the request supports a program that is necessary or appropriate to promote the national defense to the Office of Policy and Program Analysis, Federal Emergency Management Agency, Department of Homeland Security, 500 C Street SW, Washington, DC 20472; Telephone: (202) 212-2900; Fax: (202) 646-4601; Email:  FEMA-DPA@fema.dhs.gov,  website:  https://www.fema.gov/disaster/defense-production-act."], ["15:15:2.1.3.2.1.9.1.1", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Official Actions", "", "\u00a7 700.60 General provisions.", "BIS", "", "", "[79 FR 47569, Aug. 14, 2014]", "(a) The Department of Commerce may, from time-to-time, take specific official actions to implement or enforce the provisions of this part.\n\n(b) Some of these official actions (rating authorizations and letters of understanding) are discussed in this subpart. Official actions that pertain to compliance (administrative subpoenas, demands for information, and inspection authorizations) are discussed in \u00a7 700.71(c). Directives are discussed in \u00a7 700.62."], ["15:15:2.1.3.2.1.9.1.2", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Official Actions", "", "\u00a7 700.61 Rating authorizations.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47570, Aug. 14, 2014; 89 FR 58975, July 22, 2024]", "(a) A rating authorization is an official action granting specific priority rating authority that:\n\n(1) Permits a person to place a priority rating on an order for an item, such as an item not normally ratable under this regulation; or\n\n(2) Authorizes a person to modify a priority rating on a specific order or series of contracts or orders.\n\n(b) To request priority rating authority, see \u00a7 700.51."], ["15:15:2.1.3.2.1.9.1.3", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Official Actions", "", "\u00a7 700.62 Directives.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47570, Aug. 14, 2014]", "(a) A directive is an official action which requires a person to take or refrain from taking certain actions in accordance with its provisions.\n\n(b) A person must comply with each directive issued. However, a person may not use or extend a directive to obtain any items from a supplier, unless expressly authorized to do so in the directive.\n\n(c) Directives take precedence over all DX rated orders, DO rated orders, and unrated orders previously or subsequently received, unless a contrary instruction appears in the directive."], ["15:15:2.1.3.2.1.9.1.4", 15, "Commerce and Foreign Trade", "VII", "A", "700", "PART 700\u2014DEFENSE PRIORITIES AND ALLOCATIONS SYSTEM", "I", "Subpart I\u2014Official Actions", "", "\u00a7 700.63 Letters of understanding.", "BIS", "", "", "[49 FR 30414, July 30, 1984. Redesignated at 54 FR 601, Jan. 9, 1989, as amended at 79 FR 47570, Aug. 14, 2014; 89 FR 58976, July 22, 2024]", "(a) A letter of understanding is an official action that may be issued in resolving special priorities assistance cases to reflect an agreement reached by all parties ( e.g.,  the Department of Commerce, the Determination Department, the Delegate Agency, the supplier, the customer).\n\n(b) A letter of understanding is not used to alter scheduling between rated orders, to authorize the use of priority ratings, to impose restrictions under this regulation, or to take other official actions. Rather, letters of understanding are used to confirm production or shipping schedules which do not require modifications to other rated orders."], ["21:21:7.0.1.2.10.1.1.1", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 700.3 Definitions.", "FDA", "", "", "[39 FR 10054, Mar. 15, 1974, as amended at 46 FR 38073, July 24, 1981]", "As used in this subchapter:\n\n(a) The term  act  means the Federal Food, Drug, and Cosmetic Act.\n\n(b) The term  cosmetic product  means a finished cosmetic the manufacture of which has been completed. Any cosmetic product which is also a drug or device or component thereof is also subject to the requirements of Chapter V of the act.\n\n(c) The term  flavor  means any natural or synthetic substance or substances used solely to impart a taste to a cosmetic product.\n\n(d) The term  fragrance  means any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product.\n\n(e) The term  ingredient  means any single chemical entity or mixture used as a component in the manufacture of a cosmetic product.\n\n(f) The term  proprietary ingredient  means any cosmetic product ingredient whose name, composition, or manufacturing process is protected from competition by secrecy, patent, or copyright.\n\n(g) The term  chemical description  means a concise definition of the chemical composition using standard chemical nomenclature so that the chemical structure or structures of the components of the ingredient would be clear to a practicing chemist. When the composition cannot be described chemically, the substance shall be described in terms of its source and processing.\n\n(h) The term  cosmetic raw material  means any ingredient, including an ingredient that is a mixture, which is used in the manufacture of a cosmetic product for commercial distribution and is supplied to a cosmetic product manufacturer, packer, or distributor by a cosmetic raw material manufacturer or supplier.\n\n(i) The term  commercial distribution  of a cosmetic product means annual gross sales in excess of $1,000 for that product.\n\n(j)  Establishment  means a place of business where cosmetic products are manufactured or packaged.\n\n(k) The term  manufacture  of a cosmetic product means the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.\n\n(l) The term  packaging  of a cosmetic product means filling or labeling the product container, including changing the immediate container or label (but excluding changing other labeling) at any point in the distribution of the cosmetic product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.\n\n(m) The term  all business trading names used by the establishment  means any name which is used on a cosmetic product label and owned by the cosmetic product manufacturer or packer, but is different from the principal name under which the cosmetic product manufacturer or packer is registered.\n\n(n) The definitions and interpretations contained in sections 201, 601, and 602 of the act shall be applicable to such terms when used in the regulations in this subchapter.\n\n(o)  System of commercial distribution  of a cosmetic product means any distribution outside the establishment manufacturing the product, whether for sale, to promote future sales (including free samples of the product), or to gage consumer acceptance through market testing, in excess of $1,000 in cost of goods.\n\n(p)  Filed screening procedure  means a procedure that is:\n\n(1) On file with the Food and Drug Administration and subject to public inspection;\n\n(2) Designed to determine that there is a reasonable basis for concluding that an alleged injury did not occur in conjunction with the use of the cosmetic product; and\n\n(3) Which is subject, upon request by the Food and Drug Administration, to an audit conducted by the Food and Drug Administration at reasonable times and, where an audit is conducted, such audit shows that the procedure is consistently being applied and that the procedure is not disregarding reportable information.\n\n(q)  Reportable experience  means an experience involving any allergic reaction, or other bodily injury, alleged to be the result of the use of a cosmetic product under the conditions of use prescribed in the labeling of the product, under such conditions of use as are customary or reasonably foreseeable for the product or under conditions of misuse, that has been reported to the manufacturer, packer, or distributor of the product by the affected person or any other person having factual knowledge of the incident, other than an alleged experience which has been determined to be unfounded or spurious when evaluated by a filed screening procedure."], ["21:21:7.0.1.2.10.2.1.1", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.11 Cosmetics containing bithionol.", "FDA", "", "", "", "(a) Bithionol has been used to some extent as an antibacterial agent in cosmetic preparations such as detergent bars, shampoos, creams, lotions, and bases used to hide blemishes. New evidence of clinical experience and photopatch tests indicate that bithionol is capable of causing photosensitivity in man when used topically and that in some instances the photosensitization may persist for prolonged periods as severe reactions without further contact with sensitizing articles. Also, there is evidence to indicate that bithionol may produce cross-sensitization with other commonly used chemicals such as certain halogenated salicylanilides and hexachlorophene. It is, therefore, the view of the Food and Drug Administration that bithionol is a deleterious substance which may render any cosmetic product that contains it injurious to users. Accordingly, any cosmetic containing bithionol is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.\n\n(b) Regulatory proceedings may be initiated with respect to any cosmetic preparation containing bithionol shipped within the jurisdiction of the act after March 15, 1968."], ["21:21:7.0.1.2.10.2.1.10", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.27 Use of prohibited cattle materials in cosmetic products.", "FDA", "", "", "[70 FR 53068, Sept. 7, 2005, as amended at 71 FR 59668, Oct. 11, 2006; 73 FR 20794, Apr. 17, 2008; 81 FR 5596, Feb. 3, 2016; 81 FR 14732, Mar. 18, 2016]", "(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply to such terms when used in this part. The following definitions also apply:\n\n(1)  Prohibited cattle materials  mean specified risk materials, small intestine of all cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). Prohibited cattle materials do not include the following:\n\n(i) Tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, gelatin, hides and hide-derived products, and milk and milk products, and\n\n(ii) Cattle materials inspected and passed from a country designated under paragraph (e) of this section.\n\n(2)  Inspected and passed  means that the product has been inspected and passed for human consumption by the appropriate regulatory authority, and at the time it was inspected and passed, it was found to be not adulterated.\n\n(3)  Mechanically separated (MS) (Beef)  means a meat food product that is finely comminuted, resulting from the mechanical separation and removal of most of the bone from attached skeletal muscle of cattle carcasses and parts of carcasses that meets the specifications contained in 9 CFR 319.5, the U.S. Department of Agriculture regulation that prescribes the standard of identity for MS (Species).\n\n(4)  Nonambulatory disabled cattle  means cattle that cannot rise from a recumbent position or that cannot walk, including, but not limited to, those with broken appendages, severed tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.\n\n(5)  Specified risk material  means the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older and the tonsils and distal ileum of the small intestine of all cattle.\n\n(6)  Tallow  means the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues. Tallow must be produced from tissues that are not prohibited cattle materials or must contain no more than 0.15 percent insoluble impurities as determined by the method entitled \u201cInsoluble Impurities\u201d (AOCS Official Method Ca 3a-46), American Oil Chemists' Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from AOCS ( http://www.aocs.org ) 2211 W. Bradley Ave. Champaign, IL 61821. Copies may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to  http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.\n\n(7)  Tallow derivative  means any chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.\n\n(8)  Gelatin  means a product that has been obtained by the partial hydrolysis of collagen derived from hides, connective tissue, and/or bone bones of cattle and swine. Gelatin may be either Type A (derived from an acid-treated precursor) or Type B (derived from an alkali-treated precursor) that has gone through processing steps that include filtration and sterilization or an equivalent process in terms of infectivity reduction.\n\n(b)  Requirements.  (1) No cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials.\n\n(2) The small intestine is not considered prohibited cattle material if the distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine, as measured from the caeco-colic junction and progressing proximally towards the jejunum, or by a procedure that the establishment can demonstrate is equally effective in ensuring complete removal of the distal ileum.\n\n(c)  Records.  (1) Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.\n\n(2) Records must be retained for 2 years after the date they were created.\n\n(3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location.\n\n(4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location.\n\n(5) Records required by this section and existing records relevant to compliance with this section must be available to FDA for inspection and copying.\n\n(6) When filing entry with U.S. Customs and Border Protection, the importer of record of a cosmetic manufactured from, processed with, or otherwise containing, cattle material must affirm that the cosmetic was manufactured from, processed with, or otherwise contains, cattle material and must affirm that the cosmetic was manufactured in accordance with this section. If a cosmetic is manufactured from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle material.\n\n(7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in \u00a7 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.\n\n(d)  Adulteration.  Failure of a manufacturer or processor to operate in compliance with the requirements of paragraph (b) or (c) of this section renders a cosmetic adulterated under section 601(c) of the act.\n\n(e)  Process for designating countries.  A country seeking designation must send a written request to the Director, Office of the Center Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration, at the address designated in 21 CFR 5.1100. The request shall include information about a country's bovine spongiform encephalopathy (BSE) case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether specified risk materials, the small intestine of cattle except as provided in paragraph (b)(2) of this section, material from nonambulatory disabled cattle, or MS (Beef) from cattle from the country should be considered prohibited cattle materials. FDA shall respond in writing to any such request and may impose conditions in granting any such request. A country designation granted by FDA under this paragraph will be subject to future review by FDA, and may be revoked if FDA determines that it is no longer appropriate."], ["21:21:7.0.1.2.10.2.1.11", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.35 Cosmetics containing sunscreen ingredients.", "FDA", "", "", "[64 FR 27693, May 21, 1999]", "(a) A product that includes the term \u201csunscreen\u201d in its labeling or in any other way represents or suggests that it is intended to prevent, cure, treat, or mitigate disease or to affect a structure or function of the body comes within the definition of a drug in section 201(g)(1) of the act. Sunscreen active ingredients affect the structure or function of the body by absorbing, reflecting, or scattering the harmful, burning rays of the sun, thereby altering the normal physiological response to solar radiation. These ingredients also help to prevent diseases such as sunburn and may reduce the chance of premature skin aging, skin cancer, and other harmful effects due to the sun when used in conjunction with limiting sun exposure and wearing protective clothing. When consumers see the term \u201csunscreen\u201d or similar sun protection terminology in the labeling of a product, they expect the product to protect them in some way from the harmful effects of the sun, irrespective of other labeling statements. Consequently, the use of the term \u201csunscreen\u201d or similar sun protection terminology in a product's labeling generally causes the product to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses (e.g., as a color additive or to protect the color of the product). To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term \u201csunscreen\u201d or similar sun protection terminology anywhere in its labeling, the term must be qualified by describing the cosmetic benefit provided by the sunscreen ingredient.\n\n(b) The qualifying information required under paragraph (a) of this section shall appear prominently and conspicuously at least once in the labeling in conjunction with the term \u201csunscreen\u201d or other similar sun protection terminology used in the labeling. For example: \u201cContains a sunscreen\u2014to protect product color.\u201d"], ["21:21:7.0.1.2.10.2.1.2", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.13 Use of mercury compounds in cosmetics including use as skinbleaching agents in cosmetic preparations also regarded as drugs.", "FDA", "", "", "", "(a) Mercury-containing cosmetic preparations have been represented for many years as skin-bleaching agents or as preparations to remove or prevent freckles and/or brown spots (so-called age spots). Preparations intended for such use are regarded as drugs as well as cosmetics. In addition to such use as skin-bleaching agents, mercury compounds have also been widely used as preservatives in cosmetics such as hand and body creams and lotions; hair shampoos, hair sets and rinses, hair straighteners, hair coloring, and other preparations; bath oils, bubble bath, and other bath preparations; makeup; antiperspirants and deodorants; and eye-area cosmetics.\n\n(b) The toxicity of mercury compounds is extensively documented in scientific literature. It is well known that mercury compounds are readily absorbed through the unbroken skin as well as through the lungs by inhalation and by intestinal absorption after ingestion. Mercury is absorbed from topical application and is accumulated in the body, giving rise to numerous adverse effects. Mercury is a potent allergen and sensitizer, and skin irritation is common after topical application. Cosmetic preparations containing mercury compounds are often applied with regularity and frequency for prolonged periods. Such chronic use of mercury-containing skin-bleaching preparations has resulted in the accumulation of mercury in the body and the occurrence of severe reactions. Recently it has also been determined that microorganisms in the environment can convert various forms of mercury into highly toxic methyl mercury which has been found in the food supply and is now considered to be a serious environmental problem.\n\n(c) The effectiveness of mercury-containing preparations as skin-bleaching agents is questionable. The Food and Drug Administration has not been provided with well controlled studies to document the effectiveness of these preparations. Although mercurial preservatives are recognized as highly effective, less toxic and satisfactory substitutes are available except in the case of certain eye-area cosmetics.\n\n(d) Because of the known hazards of mercury, its questionable efficacy as a skin-bleaching agent, and the availability of effective and less toxic nonmercurial preservatives, there is no justification for the use of mercury in skin-bleaching preparations or its use as a preservative in cosmetics, with the exception of eye-area cosmetics for which no other effective and safe nonmercurial preservative is available. The continued use of mercurial preservatives in such eye-area cosmetics is warranted because mercury compounds are exceptionally effective in preventing  Pseudomonas  contamination of cosmetics and  Pseudomonas  infection of the eye can cause serious injury, including blindness. Therefore:\n\n(1) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-9 (issued May 13, 1939) and concludes that any product containing mercury as a skin-bleaching agent and offered for sale as skin-bleaching, beauty, or facial preparation is misbranded within the meaning of sections 502(a), 502(f)(1) and (2), and 502(j), and may be a new drug without approval in violation of section 505 of the Federal Food, Drug, and Cosmetic Act. Any such preparation shipped within the jurisdiction of the Act after January 5, 1973 will be the subject of regulatory action.\n\n(2) The Food and Drug Administration withdraws the opinion expressed in trade correspondence TC-412 (issued Feb. 11, 1944) and will regard as adulterated within the meaning of section 601(a) of the Act any cosmetic containing mercury unless the cosmetic meets the conditions of paragraph (d)(2) (i) or (ii) of this section.\n\n(i) It is a cosmetic containing no more than a trace amount of mercury and such trace amount is unavoidable under conditions of good manufacturing practice and is less than 1 part per million (0.0001 percent), calculated as the metal; or\n\n(ii) It is a cosmetic intended for use only in the area of the eye, it contains no more than 65 parts per million (0.0065 percent) of mercury, calculated as the metal, as a preservative, and there is no effective and safe nonmercurial substitute preservative available for use in such cosmetic."], ["21:21:7.0.1.2.10.2.1.3", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.14 Use of vinyl chloride as an ingredient, including propellant of cosmetic aerosol products.", "FDA", "", "", "[39 FR 30830, Aug. 26, 1974]", "(a) Vinyl chloride has been used as an ingredient in cosmetic aerosol products including hair sprays. Where such aerosol products are used in the confines of a small room, as is often the case, the level of vinyl chloride to which the individual may be exposed could be significantly in excess of the safe level established in connection with occupational exposure. Evidence indicates that vinyl chloride inhalation can result in acute toxicity, manifested by dizziness, headache, disorientation, and unconsciousness where inhaled at high concentrations. Studies also demonstrate carcinogenic effects in animals as a result of inhalation exposure to vinyl chloride. Furthermore, vinyl chloride has recently been linked to liver disease, including liver cancer, in workers engaged in the polymerization of vinyl chloride. It is the view of the Commissioner that vinyl chloride is a deleterious substance which may render any cosmetic aerosol product that contains it as an ingredient injurious to users. Accordingly, any cosmetic aerosol product containing vinyl chloride as an ingredient is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.\n\n(b) Any cosmetic aerosol product containing vinyl chloride as an ingredient shipped within the jurisdiction of the Act is subject to regulatory action."], ["21:21:7.0.1.2.10.2.1.4", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products.", "FDA", "", "", "[40 FR 50531, Oct. 30, 1975]", "(a) Halogenated salicylanilides (tribromsalan (TBS,3,4\u2032,5-tribromosalicylanilide), dibromsalan (DBS,4\u20325-dibromosalicylanilide), metabromsalan (MBS, 3,5-dibromosalicylanilide) and 3,3\u2032,4,5\u2032-tetrachlorosalicylanilide (TCSA)) have been used as antimicrobial agents for a variety of purposes in cosmetic products. These halogenated salicylanilides are potent photosensitizers and cross-sensitizers and can cause disabling skin disorders. In some instances, the photosensitization may persist for prolonged periods as a severe reaction without further exposure to these chemicals. Safer alternative antimicrobial agents are available.\n\n(b) These halogenated salicylanilides are deleterious substances which render any cosmetic that contains them injurious to users. Therefore, any cosmetic product that contains such a halogenated salicylanilide as an ingredient at any level for any purpose is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.\n\n(c) Any cosmetic product containing these halogenated salicylanilides as an ingredient that is initially introduced into interstate commerce after December 1, 1975, that is not in compliance with this section is subject to regulatory action."], ["21:21:7.0.1.2.10.2.1.5", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.16 Use of aerosol cosmetic products containing zirconium.", "FDA", "", "", "[42 FR 41376, Aug. 16, 1977]", "(a) Zirconium-containing complexes have been used as an ingredient in cosmetics and/or cosmetics that are also drugs, as, for example, aerosol antiperspirants. Evidence indicates that certain zirconium compounds have caused human skin granulomas and toxic effects in the lungs and other organs of experimental animals. When used in aerosol form, some zirconium will reach the deep portions of the lungs of users. The lung is an organ, like skin, subject to the development of granulomas. Unlike the skin, the lung will not reveal the presence of granulomatous changes until they have become advanced and, in some cases, permanent. It is the view of the Commissioner that zirconium is a deleterious substance that may render any cosmetic aerosol product that contains it injurious to users.\n\n(b) Any aerosol cosmetic product containing zirconium is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act.\n\n(c) Any such cosmetic product introduced in interstate commerce after September 15, 1977 is subject to regulatory action."], ["21:21:7.0.1.2.10.2.1.6", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.18 Use of chloroform as an ingredient in cosmetic products.", "FDA", "", "", "[41 FR 26845, June 29, 1976]", "(a) Chloroform has been used as an ingredient in cosmetic products. Recent information has become available associating chloroform with carcinogenic effects in animals. Studies conducted by the National Cancer Institute have demonstrated that the oral administration of chloroform to mice and rats induced hepatocellular carcinomas (liver cancer) in mice and renal tumors in male rats. Scientific literature indicates that chloroform is absorbed from the gastrointestinal tract, through the respiratory system, and through the skin. The Commissioner concludes that, on the basis of these findings, chloroform is a deleterious substance which may render injurious to users any cosmetic product that contains chloroform as an ingredient.\n\n(b) Any cosmetic product containing chloroform as an ingredient is adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic Act. Any cosmetic product containing chloroform in residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient, is not, for the purpose of this section, considered to contain chloroform as an ingredient."], ["21:21:7.0.1.2.10.2.1.7", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.19 Use of methylene chloride as an ingredient of cosmetic products.", "FDA", "", "", "[54 FR 27342, June 29, 1989]", "(a) Methylene chloride has been used as an ingredient of aerosol cosmetic products, principally hair sprays, at concentrations generally ranging from 10 to 25 percent. In a 2-year animal inhalation study sponsored by the National Toxicology Program, methylene chloride produced a significant increase in benign and malignant tumors of the lung and liver of male and female mice. Based on these findings and on estimates of human exposure from the customary use of hair sprays, the Food and Drug Administration concludes that the use of methylene chloride in cosmetic products poses a significant cancer risk to consumers, and that the use of this ingredient in cosmetic products may render these products injurious to health.\n\n(b) Any cosmetic product that contains methylene chloride as an ingredient is deemed adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal Food, Drug, and Cosmetic Act."], ["21:21:7.0.1.2.10.2.1.8", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.23 Chlorofluorocarbon propellants.", "FDA", "", "", "[43 FR 11317, Mar. 17, 1978]", "The use of chlorofluorocarbons in cosmetics as propellants in self-pressurized containers is prohibited as provided in \u00a7 2.125 of this chapter."], ["21:21:7.0.1.2.10.2.1.9", 21, "Food and Drugs", "I", "G", "700", "PART 700\u2014GENERAL", "B", "Subpart B\u2014Requirements for Specific Cosmetic Products", "", "\u00a7 700.25 Tamper-resistant packaging requirements for cosmetic products.", "FDA", "", "", "[47 FR 50451, Nov. 5, 1982; 48 FR 1707, Jan. 14, 1983; 48 FR 11427, Mar. 18, 1983, as amended at 48 FR 16664, Apr. 19, 1983; 48 FR 37624, Aug. 19, 1983]", "(a)  General.  Because most cosmetic liquid oral hygiene products and vaginal products are not now packaged in tamper-resistant retail packages, there is the opportunity for the malicious adulteration of those cosmetic products with health risks to individuals who unknowingly purchase adulterated products and with loss of consumer confidence in the security of cosmetic product packages. The Food and Drug Administration has the authority and responsibility under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-resistant packaging of cosmetic liquid oral hygiene products or products used vaginally that will improve the packaging security and help assure the safety of those products. Such a cosmetic product for retail sale that is not packaged in a tamper-resistant package or that is not properly labeled under this section is adulterated under section 601 of the act or misbranded under section 602 of the act, or both.\n\n(b)  Requirement for tamper-resistant package.  Each manufacturer and packer who packages a cosmetic liquid oral hygiene product or vaginal product for retail sale shall package the product in a tamper-resistant package, if this product is accessible to the public while held for sale. A tamper-resistant package is one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of substitution of a tamper-resistant feature after tampering, the indicator or barrier to entry is required to be distinctive by design (e.g., an aerosol product container) or by the use of an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the term \u201cdistinctive by design\u201d means the packaging cannot be duplicated with commonly available materials or through commonly available processes. For purposes of this section, the term \u201caerosol product\u201d means a product which depends upon the power of a liquified or compressed gas to expel the contents from the container. A tamper-resistant package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-resistant feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.\n\n(c)  Labeling.  Each retail package of a cosmetic product covered by this section, except aerosol products as defined in paragraph (b) of this section, is required to bear a statement that is prominently placed so that consumers are alerted to the specific tamper-resistant feature of the package. The labeling statement is also required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-resistant feature chosen to meet the requirement in paragraph (b) of this section is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling statement on a bottle with a shrink band could say \u201cFor your protection, this bottle has an imprinted seal around the neck.\u201d\n\n(d)  Requests for exemptions from packaging and labeling requirements.  A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under \u00a7 10.30 of this chapter and should be clearly identified on the envelope as a \u201cRequest for Exemption from Tamper-resistant Rule.\u201d The petition is required to contain the following:\n\n(1) The name of the product.\n\n(2) The reasons that the product's compliance with the tamper-resistant packaging or labeling requirements of this section is unnecessary or cannot be achieved.\n\n(3) A description of alternative steps that are available, or that the petitioner has already taken, to reduce the likelihood that the product will be the subject of malicious adulteration.\n\n(4) Other information justifying an exemption.\n\nThis information collection requirement has been approved by the Office of Management and Budget under number 0910-0149.\n\n(e)  Effective date.  Cosmetic products covered by this section are required to comply with the requirements of this section on the dates listed below except to the extent that a product's manufacturer or packer has obtained an exemption from a packaging or labeling requirement.\n\n(1)  Initial effective date for packaging requirements.  (i) The packaging requirement in paragraph (b) of this section is effective on Feburary 7, 1983 for each affected cosmetic product (except vaginal tablets) packaged for retail sale on or after that date, except for the requirement in paragraph (b) of this section for a distinctive indicator or barrier to entry.\n\n(ii) The packaging requirement in paragraph (b) of this section is effective on May 5, 1983 for each cosmetic product that is a vaginal tablet packaged for retail sale on or after that date.\n\n(2)  Initial effective date for labeling requirements.  The requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design and the requirement in paragraph (c) of this section for a labeling statement are effective on May 5, 1983 for each affected cosmetic product packaged for retail sale on or after that date, except that the requirement for a specific label reference to any identifying characteristic is effective on February 6, 1984 for each affected cosmetic product packaged for retail sale on or after that date.\n\n(3)  Retail level effective date.  The tamper-resistant packaging requirement of paragraph (b) of this section is effective February 6, 1984 for each affected cosmetic product held for sale on or after that date that was packaged for retail sale before May 5, 1983. This does not include the requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design. Products packaged for retail sale after May 5, 1983, as required to be in compliance with all aspects of the regulations without regard to the retail level effective date."], ["24:24:4.1.1.1.1.0.1.1", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.100 Purpose.", "HUD", "", "", "", "The requirements of this part augment the requirements of section 802 of the National Affordable Housing Act of 1990 (approved November 28, 1990, Public Law 101-625) (42 U.S.C. 8011), (hereinafter, section 802), as amended by the Housing and Community Development Act of 1992 (Public Law 102-550, approved October 28, 1992), which authorizes the Congregate Housing Services Program (hereinafter, CHSP or Program)."], ["24:24:4.1.1.1.1.0.1.10", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.145 Cost distribution.", "HUD", "", "", "", "(a)  General.  (1) Grantees, the Secretary concerned, and participants shall all contribute to the cost of providing supportive services according to section 802(i)(A)(i). Grantees must contribute at least 50 percent of program cost, participants must contribute fees that in total are at least 10 percent of program cost, and the Secretary concerned will provide funds in an amount not to exceed 40 percent.\n\n(2) Section 802(i)(1)(B)(ii) creates a cost-sharing provision between grantee and the Secretary concerned if total participant fees collected over a year are less than 10 percent of total program cost. This provision is subject to availability of appropriated grant funds. If funds are not available, the grantee must assume the funding shortfall.\n\n(b)  Prohibition on substitution of funds and maintenance of existing supportive services.  Grantees shall maintain existing funding for and provision of supportive services prior to the application date, as set forth in section 802(i)(1)(D). The grantee shall ensure that the activities provided to the project under a CHSP grant will be in addition to, and not in substitution for, these previously existing services. The value of these services do not qualify as matching funds. Such services must be maintained either for the time the participant remains in CHSP, or for the duration of CHSP grant. The grantee shall certify compliance with this paragraph to the Secretary concerned.\n\n(c)  Eligible matching funds.  (1) All sources of matching funds must be directly related to the types of supportive services prescribed by the PAC or used for administration of CHSP.\n\n(2) Matching funds may include:\n\n(i) Cash (which may include funds from Federal, State and local governments, third party contributions, available payments authorized under Medicaid for specific individuals in CHSP, Community Development Block Grants or Community Services Block Grants, Older American Act programs or excess residual funds with the approval of the Secretary concerned),\n\n(ii) The imputed dollar value of other agency or third party-provided direct services or staff who will work with or provide services to program participants; these services must be justified in the application to assure that they are the new or expanded services of CHSP necessary to keep the program participants independent. If services are provided by the state, Indian tribe, unit of general local government, or local nonprofit housing sponsor, IHA, PHA, or for-profit or not-for-profit owner, any salary paid to staff from governmental sources to carry out the program of the grantee and any funds paid to residents employed by the Program (other than from amounts under a contract under section 700.155) is allowable match.\n\n(iii) In-kind items (these are limited to 10 percent of the 50 percent matching amount), such as the current market value of donated common or office space, utility costs, furniture, material, supplies, equipment and food used in direct provision of services. The applicant must provide an explanation for the estimated donated value of any item listed.\n\n(iv) The value of services performed by volunteers to CHSP, at the rate of $5.00 an hour.\n\n(d)  Limitation.  (1) The following are not eligible for use as matching funds:\n\n(i) PHA operating funds;\n\n(ii) CHSP funds;\n\n(iii) Section 8 funds other than excess residual receipts;\n\n(iv) Funds under section 14 of the U.S. Housing Act of 1937, unless used for service coordination or case management; and\n\n(v) Comprehensive grant funds unless used for service coordination or case management;\n\n(2) Local government contributions are limited by section 802(i)(1)(E).\n\n(e)  Annual review of match.  The Secretary concerned will review the infusion of matching funds annually, as part of the program or budget review. If there are insufficient matching funds available to meet program requirements at any point after grant start-up, or at any time during the term of the grant ( i.e.,  if matching funds from sources other than program participant fees drop below 50 percent of total supportive services cost), the Secretary concerned may decrease the federal grant share of supportive services funds accordingly."], ["24:24:4.1.1.1.1.0.1.11", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.150 Program participant fees.", "HUD", "", "", "", "(a)  Eligible program participants.  The grantee shall establish fees consistent with section 700.145(a). Each program participant shall pay CHSP fees as stated in paragraphs (d) and (e) of this section, up to a maximum of 20 percent of the program participant's adjusted income. Consistent with section 802(d)(7)(A), the Secretary concerned shall provide for the waiver of fees for individuals who are without sufficient income to provide for any payment.\n\n(b)  Fees shall include:  (1) Cash contributions of the program participant;\n\n(2) Food Stamps; and\n\n(3) Contributions or donations to other eligible programs acceptable as matching funds under section 700.145(c).\n\n(c)  Older Americans Act programs.  No fee may be charged for any meals or supportive services under CHSP if that service is funded under an Older Americans Act Program.\n\n(d)  Meals fees:  (1) For full meal services, the fees for residents receiving more than one meal per day, seven days per week, shall be reasonable and shall equal between 10 and 20 percent of the adjusted income of the project resident, or the cost of providing the services, whichever is less.\n\n(2) The fees for residents receiving meal services less frequently than as described in paragraph (d)(1) of this section shall be in an amount equal to 10 percent of the adjusted income of the project resident, or the cost of providing the services, whichever is less.\n\n(e)  Other service fees.  The grantee may also establish fees for other supportive services so that the total fees collected from all participants for meals and other services is at least 10 percent of the total cost of CHSP. However, no program participants may be required to pay more than 20 percent of their adjusted incomes for any combination of services.\n\n(f)  Other residents and nonresidents.  Fees shall be established for residents of eligible housing projects (other than eligible project residents) and for nonresidents who receive meals and other services from CHSP under section 700.125(a). These fees shall be in an amount equal to the cost of providing the services."], ["24:24:4.1.1.1.1.0.1.12", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.155 Grant agreement and administration.", "HUD", "", "", "", "(a)  General.  HUD will enter into grant agreements with grantees, to provide congregate services for program participants in eligible housing projects, in order to meet the purposes of CHSP.\n\n(b)  Term of grant agreement and reservation of amount.  A grant will be for a term of five years and the Secretary concerned shall reserve a sum equal to the total approved grant amount for each grantee. Grants will be renewable at the expiration of a term, subject to the availability of funds and conformance with the regulations in this part, except as otherwise provided in section 700.160.\n\n(c)  Monitoring of project sites by governmental units.  States, Indian tribes, and units of general local government with a grant covering multiple projects shall monitor, review, and evaluate Program performance at each project site for compliance with CHSP regulations and procedures, in such manner as prescribed by HUD or RHS.\n\n(d)  Reports.  Each grantee shall submit program and fiscal reports and program budgets to the Secretary concerned in such form and at such times, as the Secretary concerned requires.\n\n(e)  Enforcement.  The Secretary concerned will enforce the obligations of the grantee under the agreement through such action as may be necessary, including terminating grants, recapturing grant funds, and imposing sanctions.\n\n(1) These actions may be taken for:\n\n(i) A grantee's non-compliance with the grant agreement or HUD or RHS regulations;\n\n(ii) Failure of the grantee to provide supportive services within 12 months of execution of the grant agreement.\n\n(2) Sanctions include but are not limited to the following:\n\n(i) Temporary withholding of reimbursements or extensions or renewals under the grant agreement, pending correction of deficiencies by the grantee;\n\n(ii) Setting conditions in the contract;\n\n(iii) Termination of the grant;\n\n(iv) Substitution of grantee; and\n\n(v) Any other action deemed necessary by the Secretary concerned.\n\n(f)  Renewal of grants.  Subject to the availability of funding, satisfactory performance, and compliance with the regulations in this part:\n\n(1) Grantees funded initially under this part shall be eligible to receive continued, non-competitive renewals after the initial five-year term of the grant.\n\n(2) Grantees will receive priority funding and grants will be renewed within time periods prescribed by the Secretary concerned.\n\n(g)  Use of Grant Funds.  If during any year, grantees use less than the annual amount of CHSP funds provided to them for that year, the excess amount can be carried forward for use in later years."], ["24:24:4.1.1.1.1.0.1.13", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.160 Eligibility and priority for 1978 Act recipients.", "HUD", "", "", "", "Grantees funded initially under 42 U.S.C. 8001 shall be eligible to receive continued, non-competitive funding subject to its availability. These grantees will be eligible to receive priority funding under this part if they comply with the regulations in this part and with the requirements of any NOFA issued in a particular fiscal year."], ["24:24:4.1.1.1.1.0.1.14", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.165 Evaluation of Congregate Housing Services Programs.", "HUD", "", "", "", "(a) Grantees shall submit annually to the Secretary concerned, a report evaluating the impact and effectiveness of CHSPs at the grant sites, in such form as the Secretary concerned shall require.\n\n(b) The Secretaries concerned shall further review and evaluate the performance of CHSPs at these sites and shall evaluate the Program as a whole.\n\n(c) Each grantee shall submit a certification with its application, agreeing to cooperate with and to provide requested data to the entity responsible for the Program's evaluation, if requested to do so by the Secretary concerned."], ["24:24:4.1.1.1.1.0.1.15", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.170 Reserve for supplemental adjustment.", "HUD", "", "", "", "The Secretary concerned may reserve funds subject to section 802(o). Requests to utilize supplemental funds by the grantee shall be transmitted to the Secretary concerned in such form as may be required."], ["24:24:4.1.1.1.1.0.1.16", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.175 Other Federal requirements.", "HUD", "", "", "[61 FR 42943, 42949, Aug. 19, 1996, as amended at 80 FR 75940, Dec. 7, 2015]", "In addition to the Federal Requirements set forth in 24 CFR part 5, the following requirements apply to grant recipient organizations in this program:\n\n(a)  Uniform administrative requirements, cost principles, and audit requirements for Federal awards.  The policies, guidelines, and requirements in 2 CFR part 200, including the audit requirements described in subpart F, apply to the acceptance and use of assistance under this program.\n\n(b)  Conflict of interest.  In addition to the conflict of interest requirements in 2 CFR 200.112 (for all recipients and subrecipients); 200.317 (for recipients and subrecipients that are States); and 200.318(c) and 200.319(a)(5) (for recipients and subrecipients that are not States), no person who is an employee, agent, consultant, officer, or elected or appointed official of the applicant, and who exercises or has exercised any function or responsibilities with respect to activities assisted with CHSP grant funds, or who is in a position to participate in a decision-making process or gain inside information with regard to such activities, may obtain a personal or financial interest or benefit from the activity, or have an interest in any contract, subcontract, or agreement with respect thereto, or any proceeds thereunder, either for himself or herself or for those with whom he or she has family or business ties during his or her tenure, or for one year thereafter. CHSP employees may receive reasonable salary and benefits.\n\n(c)  Disclosures required by Reform Act.  Section 102(c) of the HUD Reform Act of 1989 (42 U.S.C. 3545(c)) requires disclosure concerning other government assistance to be made available with respect to the Program and parties with a pecuniary interest in CHSP and submission of a report on expected sources and uses of funds to be made available for CHSP. Each applicant shall include information required by 24 CFR part 12 on form HUD-2880 \u201cApplicant/Recipient Disclosure/Update Report,\u201d as required by the  Federal Register  Notice published on January 16, 1992, at 57 FR 1942.\n\n(d)  Nondiscrimination and equal opportunity.  (1) The fair housing poster regulations (24 CFR part 110) and advertising guidelines (24 CFR part 109);\n\n(2) The Affirmative Fair Housing Marketing Program requirements of 24 CFR part 200, subpart M, and the implementing regulations at 24 CFR part 108; and\n\n(3) Racial and ethnic collection requirements\u2014Recipients must maintain current data on the race, ethnicity and gender of program applicants and beneficiaries in accordance with section 562 of the Housing and Community Development Act of 1987 and section 808(e)(6) of the Fair Housing Act.\n\n(e)  Environmental requirements.  Support services, including the operating and administrative expenses described in section 700.115(a), are categorically excluded from the requirements of the National Environmental Policy Act (NEPA) of 1969. These actions, however, are not excluded from individual compliance requirements of other environmental statutes, Executive Orders, and agency regulations where appropriate. When the responsible official determines that any action under this part may have an environmental effect because of extraordinary circumstances, the requirements of NEPA shall apply."], ["24:24:4.1.1.1.1.0.1.2", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.105 Definitions.", "HUD", "", "", "", "In addition to the definitions in section 802(k), the following definitions apply to CHSP:\n\nActivity of Daily Living (ADL)  means an activity regularly necessary for personal care.\n\n(1) The minimum requirements of ADLs include:\n\n(i) Eating (may need assistance with cooking, preparing or serving food, but must be able to feed self);\n\n(ii) Dressing (must be able to dress self, but may need occasional assistance);\n\n(iii) Bathing (may need assistance in getting in and out of the shower or tub, but must be able to wash self);\n\n(iv) Grooming (may need assistance in washing hair, but must be able to take care of personal appearance);\n\n(v) Getting in and out of bed and chairs, walking, going outdoors, using the toilet; and\n\n(vi) Household management activities (may need assistance in doing housework, grocery shopping or laundry, or getting to and from one location to another for activities such as going to the doctor and shopping, but must be mobile. The mobility requirement does not exclude persons in wheelchairs or those requiring mobility devices.)\n\n(2) Each of the Activities of Daily Living noted in paragraph (1) of this definition includes a requirement that a person must be able to perform at a specified minimal level ( e.g.,  to satisfy the eating ADL, the person must be able to feed himself or herself). The determination of whether a person meets this minimal level of performance must include consideration of those services that will be performed by a person's spouse, relatives or other attendants to be provided by the individual. For example, if a person requires assistance with cooking, preparing or serving food plus assistance in feeding himself or herself, the individual would meet the minimal performance level and thus satisfy the eating ADL, if a spouse, relative or attendant provides assistance with feeding the person. Should such assistance become unavailable at any time, the owner is not obligated at any time to provide individualized services beyond those offered to the resident population in general. The Activities of Daily Living analysis is relevant only with regard to determination of a person's eligibility to receive  supportive services  paid for by CHSP and is not a determination of eligibility for occupancy;\n\nAdjusted income  means adjusted income as defined in 24 CFR parts 813 or 913.\n\nApplicant  means a State, Indian tribe, unit of general local government, public housing authority (PHA), Indian housing authority (IHA) or local nonprofit housing sponsor. A State, Indian tribe, or unit of general local government may apply on behalf of a local nonprofit housing sponsor or a for-profit owner of eligible housing for the elderly.\n\nArea agency on aging  means the single agency designated by the State Agency on Aging to administer the program described in Title III of the Older Americans Act of 1965 (45 CFR chapter 13).\n\nAssistant Secretary  means the HUD Assistant Secretary for Housing-Federal Housing Commissioner or the HUD Assistant Secretary for Public and Indian Housing.\n\nCase management  means implementing the processes of: establishing linkages with appropriate agencies and service providers in the general community in order to tailor the needed services to the program participant; linking program participants to providers of services that the participant needs; making decisions about the way resources are allocated to an individual on the basis of needs; developing and monitoring of case plans in coordination with a formal assessment of services needed; and educating participants on issues, including, but not limited to, supportive service availability, application procedures and client rights.\n\nEligible housing for the elderly  means any eligible project including any building within a mixed-use project that was designated for occupancy by elderly persons, or persons with disabilities at its inception or, although not so designated, for which the eligible owner or grantee gives preference in tenant selection (with HUD approval) for all units in the eligible project (or for a building within an eligible mixed-use project) to eligible elderly persons, persons with disabilities, or temporarily disabled individuals. For purposes of this part, this term does not include projects assisted under the Low-Rent Housing Homeownership Opportunity program (Turnkey III (24 CFR part 905, subpart G)).\n\nEligible owner  means an owner of an eligible housing project.\n\nExcess residual receipts  mean residual receipts of more than $500 per unit in the project which are available and not committed to other uses at the time of application to HUD for CHSP. Such receipts may be used as matching funds and may be spent down to a minimum of $500/unit.\n\nFor-profit owner of eligible housing for the elderly  means an owner of an eligible housing project in which some part of the project's earnings lawfully inure to the benefit of any private shareholder or individual.\n\nGrantee  or  Grant recipient  means the recipient of funding under CHSP. Grantees under this Program may be states, units of general local government, Indian tribes, PHAs, IHAs, and local nonprofit housing sponsors.\n\nLocal nonprofit housing sponsor  means an owner or borrower of eligible housing for the elderly; no part of the net earnings of the owning organization shall lawfully inure to the benefit of any shareholder or individual.\n\nNonprofit  includes a public housing agency as that term is defined in section 3(b)(6) of the United States Housing Act of 1937.\n\nPerson with disabilities  means a household composed of one or more persons, at least one of whom is an adult who has a disability.\n\n(1) A person shall be considered to have a disability if such person is determined under regulations issued by the Secretary to have a physical, mental, or emotional impairment which:\n\n(i) Is expected to be of long-continued and indefinite duration;\n\n(ii) Substantially impedes his or her ability to live independently; and\n\n(iii) Is of such a nature that the person's ability could be improved by more suitable housing conditions.\n\n(2) A person shall also be considered to have a disability if the person has a developmental disability as defined in section 102(5) of the Developmental Disabilities Assistance and Bill of Rights Act (42 U.S.C. 6001-7). Notwithstanding the preceding provisions of this paragraph, the terms \u201cperson with disabilities\u201d or \u201ctemporarily disabled\u201d include two or more persons with disabilities living together, one or more such persons living with another person who is determined (under regulations prescribed by the Secretary of HUD) to be essential to their care or well-being, and the surviving member or members of any household where at least one or more persons was an adult with a disability who was living, in a unit assisted under this section, with the deceased member of the household at the time of his or her death.\n\nProgram participant  (participant) means any project resident as defined in section 802(e)(1) who is formally accepted into CHSP, receives CHSP services, and resides in the eligible housing project served by CHSP grant.\n\nQualifying supportive services  means those services described in section 802(k)(16). Under this Program, \u201chealth-related services\u201d mean non-medical supervision, wellness programs, preventive health screening, monitoring of medication consistent with state law, and non-medical components of adult day care. The Secretary concerned may also approve other requested supportive services essential for achieving and maintaining independent living.\n\nRural Housing Service  (RHS) means a credit agency for rural housing and rural development in the U.S. Department of Agriculture (USDA).\n\nSecretary concerned  means (1) The Secretary of Housing and Urban Development, with respect to eligible federally assisted housing administered by HUD; and\n\n(2) The Secretary of Agriculture with reference to programs administered by the Administrator of the Rural Housing Service.\n\nService coordinator  means CHSP staff person responsible for coordinating Program services as described in section 700.130.\n\nService provider  means a person or organization licensed or otherwise approved in writing by a State or local agency ( e.g.,  Department of Health, Department of Human Services or Welfare) to provide supportive services.\n\nState agency  means the State or an agency or instrumentality of the State.\n\nState agency on aging  means the single agency designated by the Governor to administer the program described in Title III of the Older Americans Act of 1965 (See 45 CFR part 13)."], ["24:24:4.1.1.1.1.0.1.3", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.110 Announcement of fund availability, application process and selection.", "HUD", "", "", "", "(a)  Notice of funding availability.  A Notice of Funding Availability (NOFA) will be published periodically in the  Federal Register  by the Secretary concerned containing the amounts of funds available, allocation or distribution of funds available among eligible applicant groups, where to obtain and submit applications, the deadline for submissions, and further explanation of the selection criteria, review and selection process. The Secretary concerned will designate the maximum allowable size for grants.\n\n(b)  Selection criteria  are set forth in section 802(h)(1) and shall include additional criteria specified by the Secretary concerned."], ["24:24:4.1.1.1.1.0.1.4", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.115 Program costs.", "HUD", "", "", "[61 FR 42943, 42949, Aug. 19, 1996, as amended at 80 FR 75940, Dec. 7, 2015]", "(a)  Allowable costs.  (1) Allowable costs for direct provision of supportive services includes the provision of supportive services and others approved by the Secretary concerned for:\n\n(i) Direct hiring of staff, including a service coordinator;\n\n(ii) Supportive service contracts with third parties;\n\n(iii) Equipment and supplies (including food) necessary to provide services;\n\n(iv) Operational costs of a transportation service ( e.g.,  mileage, insurance, gasoline and maintenance, driver wages, taxi or bus vouchers);\n\n(v) Purchase or leasing of vehicles;\n\n(vi) Direct and indirect administrative expenses for administrative costs such as annual fiscal review and audit, telephones, postage, travel, professional education, furniture and equipment, and costs associated with self evaluation or assessment (not to exceed one percent of the total budget for the activities approved); and\n\n(vii) States, Indian tribes and units of general local government with more than one project included in the grant may receive up to 1% of the total cost of the grant for monitoring the projects.\n\n(2) Allowable costs shall be reasonable, necessary and recognized as expenditures in compliance with 2 CFR part 200, subpart E.\n\n(b)  Nonallowable costs.  (1) CHSP funds may not be used to cover expenses related to any grantee program, service, or activity existing at the time of application to CHSP.\n\n(2) Examples of nonallowable costs under the program are:\n\n(i) Capital funding (such as purchase of buildings, related facilities or land and certain major kitchen items such as stoves, refrigerators, freezers, dishwashers, trash compactors or sinks);\n\n(ii) Administrative costs that represent a non-proportional share of costs charged to the Congregate Housing Services Program for rent or lease, utilities, staff time;\n\n(iii) Cost of supportive services other than those approved by the Secretary concerned;\n\n(iv) Modernization, renovation or new construction of a building or facility, including kitchens;\n\n(v) Any costs related to the development of the application and plan of operations before the effective date of CHSP grant award;\n\n(vi) Emergency medical services and ongoing and regular care from doctors and nurses, including but not limited to administering medication, purchase of medical supplies, equipment and medications, overnight nursing services, and other institutional forms of service, care or support;\n\n(vii) Occupational therapy and vocational rehabilitation services; or\n\n(viii) Other items defined as unallowable costs elsewhere in this part, in CHSP grant agreement, and 2 CFR part 200, subpart E.\n\n(c)  Administrative cost limitation.  Grantees are subject to the limitation in section 802(j)(4)."], ["24:24:4.1.1.1.1.0.1.5", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.120 Eligible supportive services.", "HUD", "", "", "", "(a) Supportive services or funding for such services may be provided by state, local, public or private providers and CHSP funds. A CHSP under this section shall provide meal and other qualifying services for program participants (and other residents and nonresidents, as described in \u00a7 700.125(a)) that are coordinated on site.\n\n(b) Qualifying supportive services are those listed in section 802(k)(16) and in section 700.105.\n\n(c) Meal services shall meet the following guidelines:\n\n(1)  Type of service.  At least one meal a day must be served in a group setting for some or all of the participants; if more than one meal a day is provided, a combination of a group setting and carry-out meals may be utilized.\n\n(2)  Hot meals.  At least one meal a day must be hot. A hot meal for the purpose of this program is one in which the principal food item is hot at the time of serving.\n\n(3)  Special menus.  Grantees shall provide special menus as necessary for meeting the dietary needs arising from the health requirements of conditions such as diabetes and hypertension. Grantees should attempt to meet the dietary needs of varying religious and ethnic backgrounds.\n\n(4)  Meal service standards.  Grantees shall plan for and provide meals which are wholesome, nutritious, and each of which meets a minimum of one-third of the minimum daily dietary allowances as established by the Food and Nutrition Board of the National Academy of Sciences-National Research Council (or State or local standards, if these standards are higher). Grantees must have an annual certification, prepared and signed by a registered dietitian, which states that each meal provided under CHSP meets the minimum daily dietary allowances.\n\n(5)  Food stamps and agricultural commodities.  In providing meal services grantees must apply for and use food stamps and agricultural commodities as set forth in section 802(d)(2)(A).\n\n(6)  Preference for nutrition providers:  In contracting for or otherwise providing for meal services grantees must follow the requirements of section 802(d)(2)(B). These requirements do not preclude a grantee or owner from directly preparing and providing meals under its own auspices."], ["24:24:4.1.1.1.1.0.1.6", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.125 Eligibility for services.", "HUD", "", "", "", "(a)  Participants, other residents, and nonresidents.  Such individuals are eligible either to participate in CHSP or to receive CHSP services, if they qualify under section 802(e)(1), (4) and (5). Under this paragraph, temporarily disabled persons are also eligible.\n\n(b)  Economic need.  In providing services under CHSP, grantees shall give priority to very low income individuals, and shall consider their service needs in selecting program participants."], ["24:24:4.1.1.1.1.0.1.7", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.130 Service coordinator.", "HUD", "", "", "", "(a) Each grantee must have at least one service coordinator who shall perform the responsibilities listed in section 802(d)(4).\n\n(b) The service coordinator shall comply with the qualifications and standards required by the Secretary concerned. The service coordinator shall be trained in the subject areas set forth in section 802(d)(4), and in any other areas required by the Secretary concerned.\n\n(c) The service coordinator may be employed directly by the grantee, or employed under a contract with a case management agency on a fee-for-service basis, and may serve less than full-time. The service coordinator or the case management agency providing service coordination shall not provide supportive services under a CHSP grant or have a financial interest in a service provider agency which intends to provide services to the grantee for CHSP.\n\n(d) The service coordinator shall:\n\n(1) Provide general case management and referral services to all potential participants in CHSP. This involves intake screening, upon referral from the grantee of potential program participants, and preliminary assessment of frailty or disability, using a commonly accepted assessment tool. The service coordinator then will refer to the professional assessment committee (PAC) those individuals who appear eligible for CHSP;\n\n(2) Establish professional relationships with all agencies and service providers in the community, and develop a directory of providers for use by program staff and program participants;\n\n(3) Refer proposed participants to service providers in the community, or those of the grantee;\n\n(4) Serve as staff to the PAC;\n\n(5) Complete, for the PAC, all paperwork necessary for the assessment, referral, case monitoring and reassessment processes;\n\n(6) Implement any case plan developed by the PAC and agreed to by the program participant;\n\n(7) Maintain necessary case files on each program participant, containing such information and kept in such form as HUD and RHS shall require;\n\n(8) Provide the necessary case files to PAC members upon request, in connection with PAC duties;\n\n(9) Monitor the ongoing provision of services from community agencies and keep the PAC and the agency providing the supportive service informed of the progress of the participant;\n\n(10) Educate grant recipient's program participants on such issues as benefits application procedures (e.g. SSI, food stamps, Medicaid), service availability, and program participant options and responsibilities;\n\n(11) Establish volunteer support programs with service organizations in the community;\n\n(12) Assist the grant recipient in building informal support networks with neighbors, friends and family; and\n\n(13) Educate other project management staff on issues related to \u201caging-in-place\u201d and services coordination, to help them to work with and assist other persons receiving housing assistance through the grantee.\n\n(e) The service coordinator shall tailor each participant's case plan to the individual's particular needs. The service coordinator shall work with community agencies, the grantee and third party service providers to ensure that the services are provided on a regular, ongoing, and satisfactory basis, in accordance with the case plan approved by the PAC and the participant.\n\n(f) Service coordinators shall not serve as members of the PAC."], ["24:24:4.1.1.1.1.0.1.8", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.135 Professional assessment committee.", "HUD", "", "", "", "(a)  General.  (1) A professional assessment committee (PAC), as described in this section, shall recommend services appropriate to the functional abilities and needs of each eligible project resident. The PAC shall be either a voluntary committee appointed by the project management or an agency in the community which provides assessment services and conforms to section 802(e)(3)(A) and (B). PAC members are subject to the conflict of interest provisions in section 700.175(b).\n\n(2) The PAC shall utilize procedures that ensure that the process of determining eligibility of individuals for congregate services affords individuals fair treatment, due process, and a right of appeal of the determination of eligibility, and shall ensure the confidentiality of personal and medical records.\n\n(3) The dollar value of PAC members' time spent on regular assessments after initial approval of program participants may be counted as match. If a community agency discharges the duties of the PAC, staff time is counted as its imputed value, and if the members are volunteers, their time is counted as volunteer time, according to sections 700.145(c)(2) (ii) and (iv).\n\n(b)  Duties of the PAC.  The PAC is required to:\n\n(1) Perform a formal assessment of each potential elderly program participant to determine if the individual is frail. To qualify as frail, the PAC must determine if the elderly person is deficient in at least three ADLs, as defined in section 700.105. This assessment shall be based upon the screening done by the service coordinator, and shall include a review of the adequacy of the informal support network ( i.e.,  family and friends available to the potential participant to assist in meeting the ADL needs of that individual), and may include a more in-depth medical evaluation, if necessary;\n\n(2) Determine if non-elderly disabled individuals qualify under the definition of person with disabilities under section 700.105. If they do qualify, this is the acceptance criterion for them for CHSP. Persons with disabilities do not require an assessment by the PAC;\n\n(3) Perform a regular assessment and updating of the case plan of all participants;\n\n(4) Obtain and retain information in participant files, containing such information and maintained in such form, as HUD or RHS shall require;\n\n(5) Replace any members of the PAC within 30 days after a member resigns. A PAC shall not do formal assessments if its membership drops below three, or if the qualified medical professional leaves the PAC and has not been replaced.\n\n(6) Notify the grantee or eligible owner and the program participants of any proposed modifications to PAC procedures, and provide these parties with a process and reasonable time period in which to review and comment, before adoption of a modification;\n\n(7) Provide assurance of nondiscrimination in selection of CHSP participants, with respect to race, religion, color, sex, national origin, familial status or type of disability;\n\n(8) Provide complete confidentiality of information related to any individual examined, in accordance with the Privacy Act of 1974;\n\n(9) Provide all formal information and reports in writing.\n\n(c)  Prohibitions relating to the PAC.  (1) At least one PAC member shall not have any direct or indirect relationship to the grantee.\n\n(2) No PAC member may be affiliated with organizations providing services under the grant.\n\n(3) Individuals or staff of third party organizations that act as PAC members may not be paid with CHSP grant funds.\n\n(d)  Eligibility and admissions.  (1) Before selecting potential program participants, each grantee (with PAC assistance) shall develop a CHSP application form. The information in the individual's application is crucial to the PAC's ability to determine the need for further physical or psychological evaluation.\n\n(2) The PAC, upon completion of a potential program participant's initial assessment, must make a recommendation to the service coordinator for that individual's acceptance or denial into CHSP.\n\n(3) Once a program participant is accepted into CHSP, the PAC must provide a supportive services case plan for each participant. In developing this plan, the PAC must take into consideration the participant's needs and wants. The case plan must provide the minimum supportive services necessary to maintain independence.\n\n(e)  Transition-out procedures.  The grantee or PAC must develop procedures for providing for an individual's transition out of CHSP to another setting. Transition out is based upon the degree of supportive services needed by an individual to continue to live independently. If a program participant leaves the program, but wishes to retain supportive services, he or she may do so, as long as he or she continues to live in an eligible project, pays the full cost of services provided, and management agrees (section 802(e)(4) and (5)). A participant can be moved out of CHSP if he or she:\n\n(1) Gains physical and mental health and is able to function without supportive services, even if only for a short time (in which case readmission, based upon reassessment to determine the degree of frailty or the disability, is acceptable);\n\n(2) Requires a higher level of care than that which can be provided under CHSP; or\n\n(3) Fails to pay services fees.\n\n(f)  Procedural rights of participants.  (1) The PAC must provide an informal process that recognizes the right to due process of individuals receiving assistance. This process, at a minimum, must consist of:\n\n(i) Serving the participant with a written notice containing a clear statement of the reasons for termination;\n\n(ii) A review of the decision, in which the participant is given the opportunity to present written or oral objections before a person other than the person (or a subordinate of that person) who made or approved the termination decision; and\n\n(iii) Prompt written notification of the final decision to the participant.\n\n(2) Procedures must ensure that any potential or current program participant, at the time of initial or regular assessment, has the option of refusing offered services and requesting other supportive services as part of the case planning process.\n\n(3) In situations where an individual requests additional services, not initially recommended by the PAC, the PAC must make a determination of whether the request is legitimately a needs-based service that can be covered under CHSP subsidy. Individuals can pay for services other than those recommended by the PAC as long as the additional services do not interfere with the efficient operation of the program."], ["24:24:4.1.1.1.1.0.1.9", 24, "Housing and Urban Development", "VII", "", "700", "PART 700\u2014CONGREGATE HOUSING SERVICES PROGRAM", "", "", "", "\u00a7 700.140 Participatory agreement.", "HUD", "", "", "", "(a) Before actual acceptance into CHSP, potential participants must work with the PAC and the service coordinator in developing supportive services case plans. A participant has the option of accepting any of the services under the case plan.\n\n(b) Once the plan is approved by the PAC and the program participant, the participant must sign a participatory agreement governing the utilization of the plan's supportive services and the payment of supportive services fees. The grantee annually must renegotiate the agreement with the participant."], ["28:28:2.0.5.5.1.1.127.1", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.10 General provisions.", "", "", "", "", "(a)  Purpose and scope.  The subpart contains the regulations of the Office of Independent Counsel implementing the Privacy Act of 1974, 5 U.S.C. 552a. The regulations apply to all records that are contained in systems of records maintained by the Office of Independent Counsel and that are retrieved by an individual's name or personal identifier. These regulations set forth the procedures by which an individual may seek access under the Privacy Act to records pertaining to him, may request correction of such records, or may seek an accounting of disclosures of such records by the office.\n\n(b)  Transfer of law-enforcement records.  The head of the Office, or his designee, is authorized to make written requests under 5 U.S.C. 552a(b)(7) for transfer of records maintained by other agencies that are necessary to carry out an authorized law-enforcement activity of the Office.\n\n(c)  Definitions.  As used in this subpart, the following terms shall have the following meanings:\n\n(1)  Agency  has the meaning given in 5 U.S.C. 551(1) and 5 U.S.C. 552a(a)(1).\n\n(2)  Record  has the same meaning given in 5 U.S.C. 552(a)(4).\n\n(3)  Request for access  means a request made pursuant to 5 U.S.C. 552a(d)(1).\n\n(4)  Request for correction  means a request made pursuant to 5 U.S.C. 552a(d)(2).\n\n(5)  Request for an accounting  means a request made pursuant to 5 U.S.C. 552a(c)(3).\n\n(6)  Requester  means an individual who makes either a request for access, a request for correction, or a request for an accounting.\n\n(7)  System of records  means a group of any group of any records under the control of the Office from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to that individual."], ["28:28:2.0.5.5.1.1.127.10", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.19 Preservation of records.", "", "", "", "", "The Office shall preserve all correspondence relating to the requests it receives under this subpart, and all records processed pursuant to such requests, until such time as the destruction of such correspondence and records is authorized pursuant to title 44 of the U.S. Code. Under no circumstances shall records be destroyed while they are the subject of a pending request for access, appeal, or lawsuit under the Act."], ["28:28:2.0.5.5.1.1.127.11", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.20 Requests for correction of records.", "", "", "", "", "(a)  How made.  Unless a record is exempted from correction and amendment, an individual may submit a request for correction of a record pertaining to him. A request for correction must be made in writing. The request must identify the particular record in question, state the correction sought, and set forth the justification for the correction. Both the envelope and the request for correction itself must be clearly marked: \u201cPrivacy Act Correction Request.\u201d\n\n(b)  Initial determination.  Within 10 working days of receiving a request for correction, the Office shall notify the requester whether his request will be granted or denied, in whole or in part. If the Office grants the request for correction in whole or in part, it shall advise the requester of his right to obtain a copy of the corrected record, in releasable form, upon request. If the Office denies the request for correction in whole or in part, it shall notify the requester in writing of the denial. The notice of denial shall state the reason or reasons for the denial and advise the requester of his right to appeal.\n\n(c)  Appeals.  When a request for correction is denied in whole or in part, the requester may appeal the denial to Independent Counsel within 30 days of his receipt of the notice denying his request. An appeal to Independent Counsel shall be made in writing, shall set forth the specific item of information sought to be corrected, and shall include any documentation said to justify the correction. An appeal shall be addressed to the Office of Independent Counsel, suite 701 West, 555 Thirteenth Street, NW., Washington, DC 20004. Both the envelope and the letter of appeal itself must be clearly marked: \u201cPrivacy Act Correction Appeal.\u201d\n\n(d)  Determination on appeal.  Independent Counsel, or his designee, shall decide all appeals from denials or requests to correct records. All such appeals shall be decided within 30 working days of receipt of the appeal, unless there is good cause to extend this period. If the denial of a request is affirmed on appeal, the requester shall be so notified in writing and advised of\u2014\n\n(1) The reason or reasons the denial has been affirmed,\n\n(2) The requester's right to file a Statement of Disagreement, as provided in paragraph (e) of this section, and\n\n(3) The requester's right to obtain judicial review of the denial in the United States District Court for the judicial district in which the requester resides or has his principal place of business, the judicial district in which the record is located, or the District of Columbia.\n\nIf the denial is reversed on appeal, the requester shall be so notified and the request for correction shall be remanded to the Office for processing in accordance with the decision on appeal.\n\n(e)  Statements of disagreement.  A requester whose appeal under this section is denied shall have the right to file a Statement of Disagreement with the Office of Independent Counsel, Suite 701 West, 555 Thirteenth Street, NW., Washington, DC 20004, within 30 days of receiving notice of denial of his appeal. Statements of disagreement may not exceed one typed page per fact disputed. Statements exceeding this limit shall be returned to the requester for condensation. Upon receipt of a statement of disagreement under this section, Independent Counsel, or his designee, shall have the statement included in the system of records in which the disputed record is maintained and shall have the disputed record marked so as to indicate\u2014\n\n(1) That a statement of disagreement has been filed, and\n\n(2) Where in the system of records the statement of disagreement may be found.\n\n(f)  Notices of correction or disagreement.  Within 30 working days of the correction of a record, the Office shall advise all agencies to which it previously disclosed the record that the record has been corrected. Whenever an individual has filed a statement of disagreement, the Office shall append a copy of the statement to the disputed record whenever the record is disclosed. The Office may also append to the disputed record any written statement it has made giving the Office's reasons for denying the request to correct the record."], ["28:28:2.0.5.5.1.1.127.12", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.21 Records not subject to correction.", "", "", "", "", "The following records are not subject to correction or amendment as provided in \u00a7 700.20:\n\n(a) Transcripts of testimony given under oath or written statements made under oath;\n\n(b) Transcripts of grand jury proceedings, judicial proceedings, or quasi-judicial proceedings that constitute the official record of such proceedings;\n\n(c) Presentence records that are the property of the courts, but may be maintained by the Office in a system of records; and\n\n(d) Records duly exempted from correction pursuant to 5 U.S.C. 552a(j) or 552a(k) by notice published in the  Federal Register."], ["28:28:2.0.5.5.1.1.127.13", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.22 Request for accounting of record disclosures.", "", "", "", "", "(a) An individual may request the Office to provide him with an accounting of those other agencies to which the Office has disclosed the record, and the date, nature, and purpose of each disclosure. A request for an accounting must be made in writing and must identify the particular record for which the accounting is requested. The request also must be addressed to the Office and both the envelope and the request itself must clearly be marked: \u201cPrivacy Act Accounting Request.\u201d\n\n(b) The Office shall not be required to provide an accounting to an individual to the extent that the accounting relates to\u2014\n\n(1) Records for which no accounting must be kept pursuant to 5 U.S.C. 552a(c)(1),\n\n(2) Disclosures of records to law-enforcement agencies for lawful law-enforcement activities, pursuant to written requests from such law-enforcement agencies specifying records sought and the law-enforcement activities for which the records are sought, under 5 U.S.C. 552a (c)(3) and (b)(7), or\n\n(3) Records for which an accounting need not be disclosed pursuant to 5 U.S.C. 552a (j) or (k).\n\n(c) A denial of a request for an accounting may be appealed to Independent Counsel in the same manner as a denial of a request for access, with both the envelope and the letter of appeal itself clearly marked: \u201cPrivacy Act Accounting Appeal.\u201d"], ["28:28:2.0.5.5.1.1.127.14", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.23 Notice of subpoenas and emergency disclosures.", "", "", "", "", "(a)  Subpoenas.  When records pertaining to an individual are subpoenaed by a grand jury, court, or quasi-judicial authority, the official served with the subpoena shall be responsible for ensuring that written notice of its service is forwarded to the individual. Notice shall be provided within 10 working days of the service of the subpoena or, in the case of a grand jury subpoena, within 10 working days of its becoming a matter of public record. Notice shall be mailed to the last known address of the individual and shall contain the following information: The date the subpoena is returnable, the court or quasi-judicial authority to which it is returnable, the name and number of the case of proceeding, and the nature of the records sought. Notice of the service of a subpoena is not required if the system of records has been exempted from the notice requirement of 5 U.S.C. 552a(e)(8), pursuant to 5 U.S.C. 552a(j), by a Notice of Exemption published in the  Federal Register.\n\n(b)  Emergency disclosures.  If the record of an individual has been disclosed to any person under compelling circumstances affecting the health or safety of any person, as described in 5 U.S.C. 552a(b)(8), the individual to whom the record pertains shall be notified of the disclosure at his last known address within 10 working days. The notice of such disclosure shall be in writing and shall state the nature of the information disclosed, the person or agency to whom it was disclosed, the date of disclosure, and the compelling circumstances justifying the disclosure. The officer who made or authorized the disclosure shall be responsible for providing such notification."], ["28:28:2.0.5.5.1.1.127.15", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.24 Security of systems of records.", "", "", "", "", "(a) The Office Administrator or Security Officer shall be responsible for issuing regulations governing the security of systems of records. To the extent that such regulations govern the security of automated systems of records, the regulations shall be consistent with the guidelines developed by the National Bureau of Standards.\n\n(b) The Office shall establish administrative and physical controls to prevent unauthorized access to its systems of records, to prevent the unauthorized disclosure of records, and to prevent the unauthorized disclosure of records, and to prevent the physical damage or destruction of records. The stringency of such controls shall reflect the sensitivity of the records the controls protect. At a minimum, however, the Office's administrative and physical controls shall ensure that\u2014\n\n(1) Records are protected from public view,\n\n(2) The area in which records are kept is supervised during business hours to prevent unauthorized persons from having access to the records, and\n\n(3) Records are inaccessible to unauthorized persons outside of business hours.\n\n(c) The Office shall establish rules restricting access to records to only those individuals within the Office who must have access to such records in order to perform their duties. The Office also shall adopt procedures to prevent the accidental disclosure of records or the accidental granting of access to records."], ["28:28:2.0.5.5.1.1.127.16", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.25 Use and collection of social security numbers.", "", "", "", "", "(a) Each system manager of a system of records that utilizes Social Security numbers as a method of identification without statutory authorization, or authorization by regulation adopted prior to January 1, 1975, shall take steps to revise the system to avoid future collection and use of the Social Security numbers.\n\n(b) The Office shall take such measures as are necessary to ensure that employees authorized to collect information from individuals are advised that individuals may not be required to furnish Social Security numbers without statutory or regulatory authorization and that individuals who are requested to provide Social Security numbers voluntarily must be advised that furnishing the number is not required and that no penalty or denial of benefits will flow from the refusal to provide it."], ["28:28:2.0.5.5.1.1.127.17", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.26 Employee standards of conduct.", "", "", "", "", "(a) The Office shall inform its employees of the provisions of the Privacy Act, including the Act's civil liability and criminal penalty provisions. The Office also shall notify its employees that they have a duty to\u2014\n\n(1) Protect the security of records,\n\n(2) Assure the accuracy, relevance, timeliness, and completeness of records,\n\n(3) Avoid the unauthorized disclosure, either verbal or written, of records, and\n\n(4) Ensure that the Office maintains no system of records without public notice.\n\n(b) Except to the extent that the Privacy Act permits such activities, an employee of the Office of Independent Counsel shall:\n\n(1) Not collect information of a personal nature from individuals unless the employee is authorized to collect such information to perform a function or discharge a responsibility of the Office;\n\n(2) Collect from individuals only that information that is necessary to the performance of the functions or to the discharge of the responsibilities of the Office;\n\n(3) Collect information about an individual directly from that individual, whenever practicable;\n\n(4) Inform each individual from whom information is collected of\u2014\n\n(i) The legal authority that authorizes the Office to collect such information,\n\n(ii) The principal purposes for which the Office intends to use the information,\n\n(iii) The routine uses the Office may make of the information, and\n\n(iv) The effects upon the individual of not furnishing the information;\n\n(5) Maintain all records that are used by the agency in making any determination about any individual with such accuracy, relevance, timeliness, and completeness as to assure fairness to the individual in the determination;\n\n(6) Except as to disclosures to an agency or pursuant to 5 U.S.C. 552a(b)(2), make reasonable efforts, prior to disseminating any record about an individual, to assure that such records are accurate, relevant, timely, and complete;\n\n(7) Maintain no record concerning an individual's religious or political beliefs or activities, or his membership in associations or organizations, unless\u2014\n\n(i) The individual has volunteered such information for his own benefit,\n\n(ii) A statute expressly authorizes the Office to collect, maintain, use or disseminate the information, or\n\n(iii) The individual's beliefs, activities, or membership are pertinent to and within the scope of an authorized law-enforcement or correctional activity;\n\n(8) Notify the head of the Office of the existence or development of any system of records that has not been disclosed to the public;\n\n(9) When required by the Act, maintain an accounting in the prescribed form of all disclosures of records by the Office to agencies or individuals whether verbally or in writing;\n\n(10) Disclose no record to anyone, except within the Office, for any use, unless authorized by the Act;\n\n(11) Maintain and use records with care to prevent the inadvertent disclosure of a record to anyone; and\n\n(12) Notify the head of the Office of any record that contains information that the Act or the foregoing provisions of this paragraph do not permit the Office to maintain.\n\n(c) Not less than once a year, the head of each Office shall review the systems of records maintained by that Office to ensure that the Office is in compliance with the provisions of the Privacy Act."], ["28:28:2.0.5.5.1.1.127.18", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.27 Other rights and services.", "", "", "", "", "Nothing in this subpart shall be construed to entitle any person, as of right, to any service or to the disclosure of any record to which such person is not entitled under 5 U.S.C. 552a."], ["28:28:2.0.5.5.1.1.127.2", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.11 Request for access to records.", "", "", "", "", "(a)  Procedure for making requests for access to records.  An individual may request access to a record about him by appearing in person or by writing the Office. A requester in need of guidance in defining his request may write to the FOIA/PA Officer, Office of Independent Counsel, suite 701 West, 555 Thirteenth Street, NW., Washington, DC 20004. Both the envelope and the request itself should be marked: \u201cPrivacy Act Request.\u201d\n\n(b)  Description of records sought.  A request for access to records must describe the records sought in sufficient detail to enable Office personnel to locate the system of records containing the record with a reasonable amount of effort. Whenever possible, a request for access should describe the nature of the records sought, the date of the record or the period in which the record was compiled, and the name or identifying number of the system of records in which the requester believes the record is kept.\n\n(c)  Agreement to pay fees.  The filing of a request for access to a record under this subpart shall be deemed to constitute an agreement to pay all applicable fees charged under \u00a7 700.17 up to $25.00. The Office shall confirm this agreement in its letter of acknowledgment to the requesters. When filing a request, a requester may specify a willingness to pay a greater amount, if applicable.\n\n(d)  Verification of identity.  Any individual who submits a request for access to records must verify his identity in one of the following ways, unless the notice published in the  Federal Register  describing the relevant system of records provides otherwise.\n\n(1) Any requester making a request in writing must state in his request his full name, current address, and date and place of birth. In addition, a requester must provide with his request an example of his signature, which shall be notarized. In order to facilitate the identification and location of the requested records, a requester may also, at his option, include in his request his Social Security number.\n\n(2) Any requester submitting a request in person may provide to the Office a form of Official photographic identification, such as a passport or an identification badge. If a requester is unable to produce a form of photographic identification, he may provide to the Office two or more acceptable forms of identification (such as a driver's license or credit card) bearing his name and address.\n\n(e)  Verification of guardianship.  The parent or guardian of a minor (or the guardian of a person judicially determined to be incompetent) who submits a request for access to the records of the minor or incompetent must establish:\n\n(1) His own identity and the identity of the subject of the record, as required in paragraph (d) of this section,\n\n(2) That he is the parent or guardian of the subject of the record, which may be proved by providing a copy of the subject's birth certificate showing parentage or by providing a court order establishing the guardianship, and\n\n(3) That he seeks to act on behalf of the subject of the record."], ["28:28:2.0.5.5.1.1.127.3", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.12 Responses to requests for access to records.", "", "", "", "", "(a)  Authority to grant or deny requests.  The head of the Office, or his designee, is authorized to grant or deny any request for access to a record.\n\n(b)  Initial action by the Office.  When the Office receives a request for access to a record in its possession, the Office shall promptly determine whether another Government agency is better able to determine whether the record is exempt, to any extent, from access. If the Office determines that it is the agency best able to determine whether the record is exempt, to any extent, from access, then the Office shall respond to the request. If the Office determines that it is not the agency best able to determine whether the record is exempt from access, the Office shall respond to the request, after consulting with the agency best able to determine whether the record is exempt from access. Under ordinary circumstances, the agency that generated or originated a requested record shall be presumed to be the agency best able to determine whether the record is exempt from access. However, nothing in this section shall prohibit the agency that generated or originated a requested record from consulting with the Office, if the agency that generated or originated the requested record determines that the Office has an interest in the requested record or the information contained therein.\n\n(c)  Law-enforcement information.  Whenever a request for access is made for a record containing information that relates to an investigation of a possible violation of criminal law or to a criminal law-enforcement proceeding and that was generated or originated by another agency, the Office shall consult with that other agency, as appropriate.\n\n(d)  Classified information.  Whenever a request for access is made for a record containing information that has been classified, or that may be eligible for classification, by another agency under the provision of Executive Order 12356 or any other Executive order concerning the classification of records, the Office shall refer the responsibilities for responding to the request to the agency that classified the information or should consider the information for classification. Whenever a record contains information that has been derivatively classified by the Office because it contains information classified by another agency, the Office shall refer the responsibility for responding to the request to the agency that classified the underlying information; however, such referral shall extend only to the information classified by the other agency.\n\n(e)  Agreements regarding consultations.  No provision of this section shall preclude formal or informal agreements between the Office and another agency, to eliminate the need for consultations concerning requests or classes of requests.\n\n(f)  Date for determining responsive records.  In determining records responsive to a request for access, the Office ordinarily will include only those records within the Office's possession and control as of the date of its receipt of the request."], ["28:28:2.0.5.5.1.1.127.4", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.13 Form and content of Office responses.", "", "", "", "", "(a)  Form of notice granting request for access.  After the Office has made a determination to grant a request for access in whole or in part, the Office shall so notify the requester in writing. The notice shall describe the manner in which access to the record will be granted and shall inform the requester of any fees to be charged in accordance with \u00a7 700.17.\n\n(b)  Form of notice denying request for access.  When the Office denies a request for access in whole or in part it shall so notify the requester in writing. The notice shall be signed by the head of the Office, or his designee, and shall include:\n\n(1) The name and title or position of the person responsible for the denial;\n\n(2) A brief statement of the reason or reasons for the denial, including the Privacy Act exemption or exemptions that the Office has relied upon in denying the request and a brief explanation of the manner in which the exemption or exemptions apply to each record withheld; and\n\n(3) A statement that the denial may be appealed under \u00a7 700.18(a) and a description of the requirements of that subsection.\n\n(c)  Record cannot be located or has been destroyed.  If a requested record cannot be located from the information supplied, or is known or believed to have been destroyed or otherwise disposed of, the Office shall so notify the requester in writing.\n\n(d)  Medical records.  When an individual requests medical records pertaining to himself that are not otherwise exempt from individual access, the Office may advise the individual that the records will be provided only to a physician, designated by the individual, who requests the records and establishes his identity in writing. The designated physician shall determine which records should be provided to the individual and which records should not be disclosed to the individual because of possible harm to the individual or another person."], ["28:28:2.0.5.5.1.1.127.5", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.14 Classified information.", "", "", "", "", "In processing a request for access to a record containing information that is classified or classifiable under Executive Order 12356 or any other Executive order concerning the classification of records, the Office shall review the information to determine whether it warrants classification. Information that does not warrant classification shall not be withheld from a requester on the basis of 5 U.S.C. 552a(k)(1). The Office shall, upon receipt of any appeal involving classified or classifiable information, take appropriate action to ensure compliance with the provisions of Executive Order 12356."], ["28:28:2.0.5.5.1.1.127.6", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.15 Records in exempt systems of records.", "", "", "", "", "(a)  Law-enforcement records exempted under subsections (j)(2) and (k)(2).  Before denying a request by an individual for access to a law-enforcement record that has been exempted from access pursuant to 5 U.S.C. 552a(k)(2), the Office must review the requested record to determine whether information in the record has been used or is being used to deny the individual any right, privilege, or benefit for which he would otherwise be eligible or to which he would otherwise be entitled under federal law. If so, the Office shall notify the requester of the existence of the record and disclose such information to the requester, except to the extent that the information would identify a confidential source. In cases when disclosure of information in a law-enforcement record could reasonably be expected to identify a confidential source, the record shall not be disclosed to the requester unless the Office is able to delete from such information all material that would identify the confidential source.\n\n(b)  Employee background investigations.  When a requester requests access to a record pertaining to a background investigation and the record has been exempted from access pursuant to 5 U.S.C. 552a(k)(5), the record shall not be disclosed to the requester unless the Office is able to delete from such record all information that would identify a confidential source."], ["28:28:2.0.5.5.1.1.127.7", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.16 Access to records.", "", "", "", "", "(a)  Manner of access.  The Office, once it has made a determination to grant a request for access, shall grant the requester access to the requested record by\u2014\n\n(1) Providing the requester with a copy of the record or\n\n(2) Making the record available for inspection by the requester at a reasonable time and place.\n\nThe Office shall in either case charge the requester applicable fees in accordance with the provisions of \u00a7 700.17. If the Office provides access to a record by making the record available for inspection by the requester, the manner of such inspection shall not unreasonably disrupt the operations of the Office.\n\n(b)  Accompanying person.  A requester appearing in person to review his records may be accompanied by another individual of his own choosing. Both the requester and the accompanying person shall be required to sign a form stating that the Office of Independent Counsel is authorized to disclose the record in the presence of both individuals."], ["28:28:2.0.5.5.1.1.127.8", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.17 Fees for access to records.", "", "", "", "", "(a)  When charged.  The Office shall charge fees pursuant to 5 U.S.C. 552a(f)(5) for the copying of records to afford access to individuals unless the Office, in its discretion, waives or reduces the fees for good cause shown. The Office shall charge fees only at the rate of $0.10 per page. For materials other than paper copies, the Office may charge the direct costs of reproduction, but only if the requester has been notified of such costs before they are incurred. Fees shall not be charged when they would amount, in the aggregate, for one request or for a series of related requests, to less than $3.00. However, the Office may, in its discretion, increase the amount of this minimum fee.\n\n(b)  Notice of estimated fees in excess of $25.  When the Office determines or estimates that the fees to be charged under this section may amount to more than $25, the Office shall notify the requester as soon as practicable of the actual or estimated amount of the fee, unless the requester has indicated in advance his willingness to pay a fee as high as that anticipated. (If only a portion of the fee can be estimated readily, the Office shall advise the requester that the estimated fee may be only a portion of the total fee.) When the estimated fee exceeds $25 and the Office has so notified the requester, the Office will be deemed not to have received the request for access to records until the requester has agreed to pay the anticipated fee. A notice to a requester pursuant to this paragraph shall offer him the opportunity to confer with Office personnel with the object of reformulating his request to meet his needs at a lower cost.\n\n(c)  Form of payment.  Requesters must pay fees by check or money order made payable to the Treasury of the United States.\n\n(d)  Advance deposits.  (1) When the estimated fee chargeable under this section exceeds $25, the Office may require a requester to make an advance deposit of 25 percent of the estimated fee or an advance payment of $25, whichever is greater.\n\n(2) When a requester has previously failed to pay a fee charged under this part, the requester must pay the Office the full amount owed and make an advance deposit of the full amount of any estimated fee before the Office shall be required to process a new or pending request for access from that requester."], ["28:28:2.0.5.5.1.1.127.9", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "A", "Subpart A\u2014Protection of Privacy and Access to Individual Records Under the Privacy Act of 1974", "", "\u00a7 700.18 Appeals from denials of access.", "", "", "", "", "(a)  Appeals to Independent Counsel.  When the Office denies in whole or part a request for access to records, the requester may appeal the denial to Independent Counsel within 30 days of his receipt of the notice denying his request. An appeal to Independent Counsel shall be made in writing, addressed to the Office of Independent Counsel, suite 701 West, 555 Thirteenth Street, NW., Washington, DC 20004. Both the envelope and the letter of appeal itself must be clearly marked: \u201cPrivacy Act Appeal.\u201d\n\n(b)  Action on appeals.  Unless Independent Counsel otherwise directs, he or his designee shall act on all appeals under this section, except that: A denial of a request for access by Independent Counsel, or his designee, shall constitute the final action of the Office on that request.\n\n(c)  Form of action on appeal.  The disposition of an appeal shall be in writing. A decision affirming in whole or in part the denial of a request for access shall include a brief statement of the reason or reasons for the affirmance, including each Privacy Act exemption relied upon and its relation to each record withheld, and a statement that judicial review of the denial is available in the United States District Court for the judicial district in which the requester resides or has his principal place of business, the judicial district in which the requested records are located, or the District of Columbia. If the denial of a request for access is reversed on appeal, the requester shall be so notified and the request shall be processed promptly in accordance with the decision on appeal."], ["28:28:2.0.5.5.1.2.127.1", 28, "Judicial Administration", "VII", "", "700", "PART 700\u2014PRODUCTION OR DISCLOSURE OF MATERIAL OR INFORMATION OF THE OFFICE OF INDEPENDENT COUNSEL", "B", "Subpart B\u2014Exemption of the Office of Independent Counsel's Systems of Records Under the Privacy Act", "", "\u00a7 700.31 Exemption of the Office of Independent Counsel's systems of records\u2014limited access.", "", "", "", "", "(a) The following system of records is exempt from 5 U.S.C. 552a(c) (3) and (4); (d); (e)(1), (2) and (3); (e)(4) (G), (H) and (I); (e) (5) and (8); (f); and (g):\n\n(1) General Files System of the Office of Independent Counsel (OIC/001).\n\n(1) General Files System of the Office of Independent Counsel (OIC/001).\n\nThese exemptions apply only to the extent that information in the system is subject to exemption pursuant to 5 U.S.C. 552a (j)(2), (k)(1), (k)(2), and (k)(5).\n\n(b) Exemptions from the particular subsections are justified for the following reasons:\n\n(1) From subsection (c)(3) because making available to a record subject the accounting of disclosures from records concerning him/her would reveal investigative interest on the part of the Office of Independent Counsel as well as the recipient agency. This would permit record subjects to impede the investigation, e.g., destroy evidence, intimidate potential witnesses, or flee the area to avoid inquiries or apprehension by law-enforcement personnel. Moreover, the release of the accounting of disclosures made under subsection (b) of the Act, including those disclosures permitted under the routine uses published for these systems would permit the subject of an investigation of an actual or potential criminal, civil or regulatory violation to determine whether he is the subject of an investigation or to obtain valuable information concerning the nature of the investigation, material compiled during the investigation, and the identity of witnesses and informants. Disclosure of the accounting would, therefore, present a serious impediment to law enforcement. In addition, disclosure of the accounting would amount to notice to the individual of the existence of a record; such notice requirement under subsection (f)(1) of the Act is specifically exempted for this system of records.\n\n(2) From subsection (c)(4) because an exemption is being claimed under subsection (d) of the Act. This system is exempt from the access provisions of subsection (d) pursuant to subsections (j) and (k) of the Privacy Act. Subsection (c)(4), therefore, is inapplicable to this system of records.\n\n(3) From subsection (d) because the records contained in this system relate to official federal investigations. Individual access to these records contained in this system would inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation, of the existence of that investigation, of the nature and scope of the information and evidence obtained as to his activities, of the identities of witnesses and informants, or would provide information that could enable the subject to avoid detection or apprehension. These factors would present a serious impediment to effective law enforcement because they could prevent the successful completion of the investigation, reveal confidential informants, endanger the physical safety of witnesses or informants, and lead to the improper influencing of witnesses, the destruction of evidence, or the fabrication of testimony. Individual access also could constitute an unwarranted invasion of the personal privacy of third parties who are involved in an investigation. Amendment of the records would interfere with ongoing criminal-law enforcement proceedings and impose an impossible administrative burden.\n\n(4) From subsections (e) (1) and (5) because, in the course of criminal or other law-enforcement investigation, cases and matters, the Office of Independent Counsel may occasionally obtain information concerning actual or potential violations of law that are not strictly within its authority or jurisdiction, or may compile information, the accuracy of which is unclear or which is not strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate and necessary to retain all information that may aid in establishing patterns of criminal activity. Moreover, it would impede the specific investigative process if it were necessary to ensure the relevance, accuracy, timeliness and completeness of all information obtained. In particular, this would restrict the ability of trained investigators, intelligence analysts, and government attorneys to exercise their judgment in reporting on information and investigations.\n\n(5) From subsection (e)(2) because, in a criminal or other law-enforcement investigation, the requirement that information be collected to the greatest extent possible from the subject individual would present a serious impediment to law enforcement. In such circumstances, the subject of the investigation or prosecution would be informed of the existence of the investigation and would therefore be able to avoid detection, apprehension, or legal obligations or duties, as well as to influence witnesses improperly, to destroy evidence, or to fabricate testimony.\n\n(6) From subsection (e)(3) because compliance with the requirements of this subsection during the course of an investigation could impede the information-gathering process, thus hampering the investigation. Furthermore, such requirements could compromise the existence of a confidential investigation or reveal the identity of witnesses or confidential informants.\n\n(7) From subsections (e)(4) (G) and (H) because this system is exempt from the individual-access provisions of subsection (d) pursuant to subsections (j) and (k) of the Privacy Act.\n\n(8) From subsection (e)(4)(I) because the categories of sources of records in this system have been published in the  Federal Register  in broad generic terms in the belief that this is all that subsection (e)(4)(I) of the Act requires. In the event, however, that this subsection should be interpreted to require more detail as to the identity of sources of the records in these systems, exemption from this provision is necessary in order to protect the confidentiality of the sources of criminal and other law-enforcement information. Such exemption is further necessary to protect the privacy and physical safety of witnesses and informants.\n\n(9) From subsection (e)(8) because the individual-notice requirements of subsection (e)(8) could present a serious impediment to law enforcement through interference with the Office of Independent Counsel's ability to issue subpoenas and the disclosure of its investigative techniques and procedures.\n\n(10) From subsection (f) because this system is exempt from the individual-access provisions of subsection (d) pursuant to subsections (j) and (k) of the Privacy Act. Furthermore, such notice to an individual would be detrimental to the successful conduct and/or completion of an investigation or prosecution pending or future.\n\n(11) From subsection (g) because this system is exempt from the individual-access and amendment provisions of subsection (d) and the provisions of subsection (f) pursuant to subsections (j) and (k) of the Privacy Act.\n\n(c) The following system of records is exempt from 5 U.S.C. 552a(c) (3) and (4), (d), (e) (1), (2) and (3), (e)(4), (G), (H) and (I); (e) (5) and (8); (f) and (g):\n\n(1) Freedom of Information Act/Privacy Act Files (OIC/002). These exemptions apply to the extent that information in this system is subject to exemption pursuant to 5 U.S.C. 552a(j)(2), (k)(1), (k)(2,) and (k)(5).\n\n(1) Freedom of Information Act/Privacy Act Files (OIC/002). These exemptions apply to the extent that information in this system is subject to exemption pursuant to 5 U.S.C. 552a(j)(2), (k)(1), (k)(2,) and (k)(5).\n\n(d) Because this system contains Office of Independent Counsel criminal law-enforcement investigatory records, exemptions from the particular subsections are justified for the following reasons:\n\n(1) From subsection (c)(3) because the release of the disclosure accounting would permit the subject(s) of criminal investigations under investigation or in litigation to obtain valuable information concerning the nature of that investigation, matter or case and present a serious impediment to law-enforcement activities.\n\n(2) From subsection (c)(4) because an exemption is being claimed for subsection (d) of the Act, rendering this subsection inapplicable to the extent that this system of records is exempted from subsection (d).\n\n(3) From subsection (d) because access to the records contained in this system would inform the subject of criminal investigation or case of the existence of such, and provide the subject with information that might enable him to avoid detection, apprehension or legal obligations, and present a serious impediment to law enforcement and other civil remedies. Amendment of the records would interfere with ongoing criminal law-enforcement proceedings and impose an impossible administrative burden.\n\n(4) From subsection (e)(1) because in the courses of criminal investigations, matters or cases, the Office of Independent Counsel often obtains information concerning the violation of laws other than those relating to an active case, matter, or investigation. In the interests of effective law enforcement and criminal litigation, it is necessary that the Office of Independent Counsel retain this information since it can aid in establishing patterns of activity and provide valuable leads for future cases that may be brought within the Office of Independent Counsel.\n\n(5) From subsection (e)(2) because collecting information to the greatest extent possible from the subject individual of a criminal investigation or prosecution would present a serious impediment to law enforcement. In such circumstances, the subject of the investigation would be placed on notice of the existence of the investigation and would therefore be able to avoid detection, apprehension, or legal obligations and duties.\n\n(6) From subsection (e)(3) because providing individuals supplying information with a form stating the requirements of subsection (e)(3) would constitute a serious impediment to law enforcement. In those circumstances, it could compromise the existence of a confidential investigation, reveal the identity of confidential sources of information, and endanger the life and physical safety of confidential informants.\n\n(7) From subsection (e)(4) (G), (H) and (I) because this system of records is exempt from the individual-access and amendment provisions of subsection (d) and the rules provisions of subsection (f).\n\n(8) From subsection (e)(5) because, in the collection of information for law-enforcement purposes, it is impossible to determine in advance what information is accurate, relevant, timely, and complete. With the passage of time, seemingly irrelevant or untimely information may acquire new significance as further investigation brings new details to light and the accuracy of such information can only be determined in a court of law. The restrictions of subsection (e)(5) would inhibit the ability of trained investigators and intelligence analysts to exercise their judgment in reporting on investigations and impede the development of intelligence necessary for effective law enforcement.\n\n(9) From subsection (e)(8) because the individual-notice requirements of subsection (e)(8) could present a serious impediment to law enforcement, i.e., this could interfere with the Office of Independent Counsel's ability to issue subpoenas and could reveal investigative techniques and procedures.\n\n(10) From subsection (f) because this system has been exempted from the individual-access and amendment provisions of subsection (d).\n\n(11) From subsection (g) because the records in this system are generally compiled for law-enforcement purposes and are exempt from the individual-access and amendment provisions of subsections (d) and (f), this rendering subsection (g) inapplicable."], ["40:40:33.0.1.1.1.1.1.1", 40, "Protection of Environment", "I", "R", "700", "PART 700\u2014GENERAL", "A", "Subpart A\u2014Addresses", "", "\u00a7 700.17 Addresses for the Office of Pollution Prevention and Toxics.", "EPA", "", "", "", "The official addresses, unless otherwise noted, are as follows:\n\n(a)  Correspondence and non-docket materials \u2014(1)  United States Postal Service mailing address.  Office of Pollution Prevention and Toxics (7401M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.\n\n(2)  Hand/courier delivery address.  Office of Pollution Prevention and Toxics, Environmental Protection Agency, EPA East Bldg., 1201 Constitution Ave. NW., Washington, DC 20004. This is not a mailing address. You must make arrangements with the person receiving your delivery.\n\n(b)  Office of Pollution Prevention and Toxics Docket (OPPT Docket) \u2014(1)  Electronic docket address.  Publicly available docket materials are available in the electronic docket at  http://www.regulations.gov.  Although listed in the docket index at regulations.gov, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only at the OPPT Docket.\n\n(2)  Physical location.  Environmental Protection Agency Docket Center (EPA/DC), Environmental Protection Agency, EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The telephone number for the OPPT Docket is (202) 566-0280. This is not a mailing address. For instructions on visiting the docket, go to  http://www.epa.gov/dockets/contacts.htm.\n\n(3)  United States Postal Service mailing address.  Document Control Office (7407M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.\n\n(4)  Hand/courier delivery address.  Document Control Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, EPA East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC. Deliveries are only accepted between 8:30 a.m. and 4 p.m., and special arrangements should be made for deliveries of boxed information. The telephone number for the Document Control Office is (202) 564-8930."], ["40:40:33.0.1.1.1.3.1.1", 40, "Protection of Environment", "I", "R", "700", "PART 700\u2014GENERAL", "C", "Subpart C\u2014Fees", "", "\u00a7 700.40 Purpose and applicability.", "EPA", "", "", "[83 FR 52713, Oct. 17, 2018]", "(a)  Purpose.  The purpose of this subpart is to establish and collect fees from manufacturers and processors to defray part of EPA's cost of administering the Toxic Substances Control Act (15 U.S.C. 2601-2692), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182).\n\n(b)  Applicability.  This subpart applies to all manufacturers who are required to submit information under section 4 of the Act, who submit certain notices and exemption requests to EPA under section 5 of the Act, who manufacture a chemical substance that is subject to a risk evaluation under TSCA section 6(b)(4) of the Act, and who process a chemical substance that is the subject of a Significant New Use Notice (SNUN) or Test Market Exemption (TME) under section 5 of the Act and who are required to submit information under section 4 of the Act related to a SNUN submission.\n\n(c)  Effective date.  After October 18, 2018, all persons specified in \u00a7 700.45 and paragraph (a) of this section must comply with this subpart."], ["40:40:33.0.1.1.1.3.1.2", 40, "Protection of Environment", "I", "R", "700", "PART 700\u2014GENERAL", "C", "Subpart C\u2014Fees", "", "\u00a7 700.41 Radon user fees.", "EPA", "", "", "[59 FR 13177, Mar. 18, 1994]", "User fees relating to radon proficiency programs authorized under the Toxic Substances Control Act appear at 40 CFR part 195."], ["40:40:33.0.1.1.1.3.1.3", 40, "Protection of Environment", "I", "R", "700", "PART 700\u2014GENERAL", "C", "Subpart C\u2014Fees", "", "\u00a7 700.43 Definitions applicable to this subpart.", "EPA", "", "", "[53 FR 31252, Aug. 17, 1988, as amended at 62 FR 17931, Apr. 11, 1997; 83 FR 52713, Oct. 17, 2018; 89 FR 12974, Feb. 21, 2024]", "Definitions in section 3 of the Act (15 U.S.C. 2602), as well as definitions contained in \u00a7\u00a7 704.3, 720.3, 723.175(b), 725.3, and 790.3 of this chapter, apply to this subpart unless otherwise specified in this section. In addition, the following definitions apply:\n\nConsolidated microbial commercial activity notice  or  consolidated MCAN  means any MCAN submitted to EPA that covers more than one microorganism (each being assigned a separate MCAN number by EPA) as a result of a prenotice agreement with EPA.\n\nConsolidated premanufacture notice  or  consolidated PMN  means any PMN submitted to EPA that covers more than one chemical substance (each being assigned a separate PMN number by EPA) as a result of a prenotice agreement with EPA ( See  48 FR 21734).\n\nConsortium  means an association of manufacturers and/or processors who have made an agreement to jointly split the cost of applicable fees.\n\nEnforceable consent agreement  means a consent agreement used by EPA to accomplish testing where a consensus exists among EPA and interested parties (as identified in \u00a7 790.22(b)(2)) concerning the need for and scope of testing under section 4 of the Act.\n\nEPA-initiated risk evaluation  means any risk evaluation conducted pursuant to section 6(b)(4)(C)(i) of the Act.\n\nExemption notice  means any notice submitted to EPA under \u00a7 723.175 of this chapter.\n\nFinal product  means a new chemical substance (as \u201cnew chemical substance\u201d is defined in \u00a7 720.3 of this chapter) that is manufactured by a person for distribution in commerce, or for use by the person other than as an intermediate.\n\nJoint submitters  mean two or more persons who submit a TSCA section 5 notice together.\n\nManufacturer-requested risk evaluation  means any chemical substance risk evaluation conducted at the request of one or more manufacturers of that chemical substance pursuant to section 6(b)(4)(C)(ii) of the Act.\n\nMicrobial commercial activity notice  or  MCAN  means any notice for microorganisms submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with subpart D of part 725 of this chapter.\n\nPerson  means a manufacturer or processor.\n\nPremanufacture notice  or  PMN  means any notice submitted to EPA pursuant to section 5(a)(1)(A) of the Act in accordance with part 720 of this chapter or \u00a7 723.250 of this chapter.\n\nPrincipal sponsor  means a person who assumes primary responsibility for the direction of study, the payment of fees to EPA, and for oral and written communication with EPA.\n\nProduction volume  means manufactured (including imported) amount in pounds.\n\nRisk evaluation  means any risk evaluation conducted pursuant to section 6(b) of the Act.\n\nSection 5 notice  means any PMN, consolidated PMN, intermediate PMN, significant new use notice, exemption notice, exemption application, any MCAN or consolidated MCAN submitted under section 5 of the Act.\n\nSignificant new use notice  or  SNUN  means any notice submitted to EPA pursuant to section 5(a)(1)(B) of the Act in accordance with part 721 of this chapter.\n\nSmall business concern  means a manufacturer or processor who meets the size standards identified in the following table. The number of employees indicates the maximum allowed for a manufacturer or processor to be considered small. If the North American Industry Classification System (NAICS) code of a manufacturer or processor is not represented in the table, it will be considered small if it has 500 or fewer employees. When calculating the number of employees, a manufacturer or processor must include the employees of all of its \u201cparent companies\u201d (if any) and all companies it \u201cowns or controls,\u201d as defined by 40 CFR 704.3. The number of employees are calculated as the average number of people employed for each pay period of the business' latest 12 calendar months, regardless of hours worked or temporary status.\n\nSmall quantities solely for research and development  (or \u201csmall quantities solely for purposes of scientific experimentation or analysis or chemical research on, or analysis of, such substance or another substance, including such research or analysis for the development of a product\u201d) means quantities of a chemical substance manufactured (including imported), or processed or proposed to be manufactured (including imported), or processed solely for research and development that are not greater than reasonably necessary for such purposes.\n\nTest order  means an order to develop information pursuant to section 4(a) of the Act.\n\nTest rule  refers to a regulation requiring the development of information pursuant to section 4(a) of the Act."], ["40:40:33.0.1.1.1.3.1.4", 40, "Protection of Environment", "I", "R", "700", "PART 700\u2014GENERAL", "C", "Subpart C\u2014Fees", "", "\u00a7 700.45 Fee payments.", "EPA", "", "", "[83 FR 52714, Oct. 17, 2018, as amended at 89 FR 12974, Feb. 21, 2024]", "(a)  Persons who must pay fees.  (1) Manufacturers submitting a TSCA section 5 notice to EPA shall remit for each such notice the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section.\n\n(2) Manufacturers and processors of chemical substances and mixtures required to submit information for these chemical substances and mixtures under a TSCA section 4(a) test order or enforceable consent agreement, or manufacturers of chemical substances and mixtures required to submit information for these chemical substance and mixtures under a TSCA section 4(a) test rule, shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. Manufacturers of a chemical substance subject to a test rule under TSCA section 4(a) are exempted from fee payment requirements in this section, if they meet one or more of the exemptions under this paragraphs (a)(2)(i) through (v) of this section on or after the certification cutoff date identified in paragraph (b)(6) of this section and do not conduct manufacturing outside of those exemptions after the certification cutoff dates or if they meet the exemptions under paragraph (a)(2)(vi) of this section for the five-year period preceding publication of the preliminary list and do not conduct manufacturing outside of that exemption during the five-year period preceding publication of the preliminary list; and the exemptions are only available if the manufacturer will meet one or more of the exemptions in this paragraph (a)(2)(i) through (vi) in the successive five years; and will not conduct manufacturing outside of the exemptions in paragraphs (a)(2)(i) through (v) of this section in the successive five years or will meet the exemption in paragraph (a)(2)(vi) of this section in the successive five years:\n\n(i) Import articles containing that chemical substance;\n\n(ii) Produce that chemical substance as a byproduct that is not later used for commercial purposes or distributed for commercial use;\n\n(iii) Manufacture that chemical substance as an impurity as defined in 40 CFR 704.3;\n\n(iv) Manufacture that chemical substance as a non-isolated intermediate as defined in 40 CFR 704.3;\n\n(v) Manufacture small quantities of that chemical substance solely for research and development, as defined in 40 CFR 700.43; or\n\n(vi) Manufacture that chemical substance in quantities below a 1,100 lbs annual production volume as described in \u00a7 700.43, unless all manufacturers of that chemical substance manufacture that chemical in quantities below a 1,100 lbs annual production volume as defined in \u00a7 700.43, in which case this exemption is not applicable.\n\n(3) Manufacturers of a chemical substance that is subject to a risk evaluation under section 6(b) of the Act, shall remit for each such chemical risk evaluation the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section. Manufacturers of a chemical substance subject to risk evaluation under section 6(b) of the Act are exempted from fee payment requirements in this section, if they meet one or more of the exemptions under paragraphs (a)(3)(i) through (v) of this section on or after the certification cutoff date identified in paragraph (b)(6)(i) of this section and do not conduct manufacturing outside of those exemptions after the certification cutoff dates or if they meet the exemptions under paragraph (a)(3)(vi) of this section for the five-year period preceding publication of the preliminary list and do not conduct manufacturing outside of that exemption during the five-year period preceding publication of the preliminary list; and the exemptions are only available if the manufacturer will meet one or more of the exemptions in paragraphs (a)(3)(i) through (vi) of this section in the successive five years and will not conduct manufacturing outside of the exemptions in paragraphs (a)(3)(i) through (v) of this section in the successive five years or will meet the exemption in paragraph (a)(3)(vi) of this section in the successive five years:\n\n(i) Import articles containing that chemical substance;\n\n(ii) Produce that chemical substance as a byproduct that is not later used for commercial purposes or distributed for commercial use;\n\n(iii) Manufacture that chemical substance as an impurity as defined in 40 CFR 704.3;\n\n(iv) Manufacture that chemical substance as a non-isolated intermediate as defined in 40 CFR 704.3;\n\n(v) Manufacture small quantities of that chemical substance solely for research and development, as defined in \u00a7 700.43; or\n\n(vi) manufacture that chemical substance in quantities below a 2,500 lbs annual production volume as described in \u00a7 700.43, unless all manufacturers of that chemical substance manufacture that chemical in quantities below a 2,500 lbs annual production volume as defined in \u00a7 700.43, in which case this exemption is not applicable.\n\n(4) Processors submitting a SNUN or TME under TSCA section 5 to EPA shall remit for each such notice the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section.\n\n(5) Processors of chemical substances and mixtures subject to a TSCA section 4(a) test rule, test order, or enforceable consent agreement in association with a SNUN submission referenced in paragraph (a)(4) of this section shall remit for each such test rule, order, or enforceable consent agreement the applicable fee identified in paragraph (c) of this section in accordance with the procedures in paragraphs (f) and (g) of this section.\n\n(b)  Identifying manufacturers subject to fees \u2014(1)  In general.  For purposes of identifying manufacturers subject to fees for section 4 test rules and section 6 EPA-initiated risk evaluations, EPA will publish a preliminary list of manufacturers identified through a review of data sources described in paragraph (b)(2) of this subsection; provide an opportunity for public comment; and publish a final list specifying the manufacturers responsible for payment.\n\n(2)  Data sources.  To compile the preliminary list, EPA will rely on information submitted to the Agency (such as the information submitted under sections 5(a), 8(a), 8(b), and to the Toxics Release Inventory) as well as other information available to the Agency, including publicly available information or information submitted to other agencies to which EPA has access. To be able to include the most recent CDR data and to account for annual or other typical fluctuations in manufacturing, EPA will use the five most recent years of data submitted or available to the Agency to develop the preliminary list.\n\n(3)  Publication of preliminary list.  (i) For risk evaluations initiated by EPA under section 6, the preliminary list will be published at the time of final designation of the chemical substance as a High-Priority Substance.\n\n(ii) For test rules under section 4, the preliminary list will be published with the proposed test rule.\n\n(4)  Public comment period.  Following publication of the preliminary list, EPA will provide a period of public comment that is no less than 30 days.\n\n(5)  Self-identification.  All manufacturers other than those listed in paragraphs (a)(2)(i) through (iii) and (a)(3)(i) through (iii) of this section who have manufactured (including imported) the chemical substance in the previous five years must submit notice to EPA, irrespective of whether they are included in the preliminary list specified in paragraph (b)(3) of this section. The notice must be submitted electronically via EPA's Central Data Exchange (CDX), the Agency's electronic reporting portal, using the Chemical Information Submission System (CISS) reporting tool, and must contain the following information:\n\n(i)  Contact information.  The name and address of the submitting company, the name and address of the authorized official for the submitting company, and the name and telephone number of a person who will serve as technical contact for the submitting company and who will be able to answer questions about the information submitted by the company to EPA.\n\n(ii)  Certification of cessation.  If a manufacturer has manufactured in the five-year period preceding publication of the preliminary list but has ceased manufacture prior to the certification cutoff dates identified in paragraph (b)(6) of this section and will not manufacture the substance again in the successive five years, the manufacturer may submit a certification statement attesting to these facts. If EPA receives such a certification statement from a manufacturer, the manufacturer will not be included in the final list of manufacturers described in paragraph (b)(7) of this section and will not be obligated to pay the fee under this section.\n\n(iii)  Certification of no manufacture.  If a manufacturer is identified on the preliminary list but has not manufactured the chemical in the five-year period preceding publication of the preliminary list, the manufacturer may submit a certification statement attesting to these facts. If EPA receives such a certification statement from a manufacturer, the manufacturer will not be included in the final list of manufacturers described in paragraph (b)(7) of this section and will not be obligated to pay the fee under this section.\n\n(iv)  Certification of meeting exemption.  If a manufacturer is identified on the preliminary list and exclusively meets one or more of the exemptions as described in paragraph (a)(2) or (a)(3) of this section, the manufacturer must submit a certification statement attesting to these facts in order to not be included in the final list of manufacturers described in paragraph (b)(7) of this section. If a manufacturer is not on a preliminary list and exclusively meets one or more of the exemptions as described in paragraph (a)(2) or (a)(3) of this section, the manufacturer may submit a certification statement attesting to these facts. If EPA receives such a certification statement from a manufacturer, the manufacturer will not be included in the final list of manufacturers described in paragraph (b)(7) of this section and will not be obligated to pay the fee under this section, unless all manufacturers of that chemical substance meet the exemption as described in (a)(2)(vi) or (a)(3)(vi) of this section.\n\n(v)  Production volume.  If a manufacturer has not submitted certification of cessation, as described in paragraph (b)(5)(ii) of this section, or certification of no manufacture, as described in paragraph (b)(5)(iii) of this section, for purposes of identifying manufacturers subject to fees for TSCA section 6 EPA-initiated risk evaluations and does not meet one or more of the exemptions in paragraph (a)(3)(i) through (v) of this section, the manufacturer must submit their production volume as defined in 40 CFR 700.43 for the applicable substance for the three calendar years prior to publication of the preliminary list. Only production volume reported to EPA prior to the final list being published will be used in determining fees described in \u00a7 700.45(f).\n\n(6)  Certification cutoff date.  (i) For a section 6 EPA-initiated risk evaluation, the cutoff date for purposes of paragraph (b)(5)(ii) of this section is the day prior to initiation of the prioritization process for the applicable chemical substance.\n\n(ii) For a section 4 test rule, the cutoff date for purposes of paragraph (b)(5)(ii) of this section is the day prior to publication of the proposed test rule for the applicable chemical substance.\n\n(7)  Publication of final list.  EPA expects to publish a final list of manufacturers to identify the specific manufacturers subject to the applicable fee. This list will indicate if additional manufacturers self-identified pursuant to paragraph (b)(5) of this section, if other manufacturers were identified through credible public comment, and if manufacturers submitted certification of cessation, no manufacture, or meeting exemption pursuant to paragraph (b)(5)(ii), (iii), or (iv) of this section. The final list will be published no later than concurrently with the final scope document for risk evaluations initiated by EPA under TSCA section 6, and with the final test rule for test rules under TSCA section 4. EPA may modify the list after the publication of the final list.\n\n(8)  Effect of final list.  Manufacturers who are listed on the final list are subject to the applicable fee identified in paragraph (c) of this section.\n\n(9)  Identifying manufacturers for other fee categories.  For Section 4 Test Orders and enforceable consent agreements, and Section 6 Manufacturer-Requested Risk Evaluations, EPA will not conduct the identification process described in paragraphs (b)(1) through (8) of this section, as manufacturers self-identify through a submission or are already otherwise known to Agency. However, those manufacturers are required to provide an information submission to EPA for the purposes of fee administration. The notice must be submitted electronically via the Agency's electronic reporting software ( e.g.,  Central Data Exchange (CDX)) and must contain the manufacturers: Full name, address, telephone number and email address. Timing of this submission must be as follows:\n\n(i) For section 4 test orders and enforceable consent agreements, the informational submission in this paragraph (b)(9) must be provided within 30 days following notification from EPA.\n\n(ii) For section 6 manufacturer-requested risk evaluations, the informational submission in this paragraph (b)(9) is required as part of the procedural process for making such requests, and must be completed at the time of making the request.\n\n(10)  Recordkeeping.  After April 22, 2024:\n\n(i) All manufacturers other than those listed in paragraph (a)(2)(i) through (v) or (a)(3)(i) through (v) of this section must maintain production volume records related to compliance with paragraph (b)(5)(v) of this section. These records must be maintained for a period of five years from the date notice is submitted pursuant to paragraph (b)(5) of this section.\n\n(ii) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(iv) or (a)(3)(iv) of this section must maintain manufacturing and other business records related to compliance with the exemption criteria described in paragraph (a)(2)(iv) or (a)(3)(iv) of this section, respectively. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section.\n\n(iii) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(v) or (a)(3)(v) of this section must maintain manufacturing and other business records related to compliance with the exemption criteria described in paragraph (a)(2)(v) or (a)(3)(v) of this section, respectively, such as production volume, plans of study, information from research and development notebooks, study reports, or notice solely for research and development use. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section.\n\n(iv) Those manufacturers that are exempt from fee payment requirements pursuant to paragraph (a)(2)(vi) or (a)(3)(vi) of this section must maintain production volume records related to compliance with the exemption criteria described in paragraph (a)(2)(vi) or (a)(3)(vi) of this section, respectively. These records must be maintained for a period of five years from the date the notice is submitted pursuant to paragraph (b)(5) of this section.\n\n(c) Fees for the 2024, 2025, and 2026 fiscal years. Persons shall remit fee payments to EPA as follows:\n\n(1)  Small business concerns.  Small business concerns shall remit fees as follows:\n\n(i)  Premanufacture notice and consolidated premanufacture notice.  Persons shall remit a fee totaling $6,480 for each premanufacture notice (PMN) or consolidated PMN submitted in accordance with part 720 of this chapter.\n\n(ii)  Significant new use notice.  Persons shall remit a fee totaling $6,480 for each significant new use notice (SNUN) submitted in accordance with part 721 of this chapter.\n\n(iii)  Exemption application.  Persons shall remit a fee totaling $2,180 for each of the following exemption requests submitted under TSCA section 5:\n\n(A)  Low releases and low exposures exemption  or  LoREX  request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with \u00a7 723.50(a)(1)(ii) of this chapter.\n\n(B)  Low volume exemption  or  LVE  request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with \u00a7 723.50(a)(1)(i) of this chapter.\n\n(C)  Test marketing exemption  or  TME  application submitted to EPA pursuant to section 5 of the Act in accordance with \u00a7\u00a7 725.300 through 725.355 of this chapter.\n\n(D)  TSCA experimental release application  or  TERA  application submitted to EPA pursuant to section 5 of the Act for research and development activities involving microorganisms in accordance with \u00a7\u00a7 725.200 through 725.260 of this chapter.\n\n(E)  Tier II exemption  application submitted to EPA pursuant to section 5 of the Act in accordance with \u00a7\u00a7 725.428 through 725.455 of this chapter.\n\n(iv)  Instant photographic film article exemption notice.  Persons shall remit a fee totaling $2,180 for each instant photographic film article exemption notice submitted in accordance with \u00a7 723.175 of this chapter.\n\n(v)  Microbial commercial activity notice  and  consolidated microbial commercial activity notice.  Persons shall remit a fee totaling $6,480 for each microbial commercial activity notice (MCAN) or consolidated MCAN submitted in accordance with \u00a7\u00a7 725.25 through 725.36 of this chapter.\n\n(vi) Persons shall remit a total of twenty percent of the applicable fee under paragraph (c)(2)(vi), (vii) or (viii) of this section for a test rule, test order, or enforceable consent agreement.\n\n(vii) Persons shall remit a total fee of twenty percent of the applicable fee under paragraphs (c)(2)(ix) of this section for an EPA-initiated risk evaluation.\n\n(viii) Persons shall remit the total fee under paragraph (c)(2)(x) or (xi) of this section, as applicable, for a manufacturer-requested risk evaluation.\n\n(2)  Others.  Persons other than small business concerns shall remit fees as follows:\n\n(i)  PMN  and  consolidated PMN.  Persons shall remit a fee totaling $37,000 for each PMN or consolidated PMN submitted in accordance with part 720 of this chapter.\n\n(ii)  SNUN.  Persons shall remit a fee totaling $37,000 for each significant new use notice submitted in accordance with part 721 of this chapter.\n\n(iii)  Exemption applications.  Persons shall remit a fee totaling $10,870 for each of the following exemption requests, and modifications to previous exemption requests, submitted under section 5 of the Act:\n\n(A)  Low releases and low exposures exemption  or  LoREX  request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with \u00a7 723.50(a)(1)(ii) of this chapter.\n\n(B)  Low volume exemption  or  LVE  request submitted to EPA pursuant to section 5(a)(1) of the Act in accordance with \u00a7 723.50(a)(1)(i) of this chapter.\n\n(C)  Test marketing exemption  or  TME  application submitted to EPA pursuant to section 5 of the Act in accordance with \u00a7\u00a7 725.300 through 725.355 of this chapter, unless the submitting company has graduated from EPA's Sustainable Futures program, in which case this exemption fee is waived.\n\n(D)  TSCA experimental release application  or  TERA  application submitted to EPA pursuant to section 5 of the Act for research and development activities involving microorganisms in accordance with \u00a7\u00a7 725.200 through 725.260 of this chapter.\n\n(E)  Tier II exemption  application submitted to EPA pursuant to section 5 of the Act in accordance with \u00a7\u00a7 725.428 through 725.455 of this chapter.\n\n(iv)  Instant photographic film article exemption notice.  Persons shall remit a fee totaling $10,870 for each exemption notice submitted in accordance with \u00a7  723.175 of this chapter.\n\n(v)  MCAN and consolidated MCAN.  Persons shall remit a fee totaling $37,000 for each MCAN or consolidated MCAN submitted in accordance with \u00a7\u00a7  725.25 through 725.36 of this chapter.\n\n(vi)  Test rule.  Persons shall remit a fee totaling $50,000 for each test rule.\n\n(vii)  Test order.  Persons shall remit a fee totaling $25,000 for each test order.\n\n(viii)  Enforceable consent agreement.  Persons shall remit a fee totaling $50,000 for each enforceable consent agreement.\n\n(ix)  EPA-initiated chemical risk evaluation.  Persons shall remit a fee totaling $4,287,000.\n\n(x)  Manufacturer-requested risk evaluation of a Work Plan Chemical.  Persons shall remit an initial fee of $1,414,924, a second payment of $1,414,924, and final payment to total 50% of the actual costs of this activity, in accordance with the procedures in paragraph (g) of this section. The final payment amount will be determined by EPA, and invoice issued to the requesting manufacturer.\n\n(xi)  Manufacturer-requested risk evaluation of a non-work plan chemical.  Persons shall remit an initial fee of $2,829,847, a second payment of $2,829,847, and final payment to total 100% of the actual costs of the activity, in accordance with the procedures in paragraph (g) of this section. The final payment amount will be determined by EPA, and invoice issued to the requesting manufacturer.\n\n(d)  Fees for 2026 fiscal year and beyond.  (1) Fees for the 2026 and later fiscal years will be adjusted on a three-year cycle by multiplying the fees in paragraph (c) of this section by the current PPI index value with a base year of 2024 using the following formula:\n\nFA = F \u00d7 I\n\nWhere:\n \n FA = the inflation-adjusted future year fee amount.\n \n F = the fee specified in paragraph (c) of this section.\n \n I = Producer Price Index for Chemicals and Allied Products inflation value with 2024 as a base year.\n\nWhere:\n\nFA = the inflation-adjusted future year fee amount.\n\nF = the fee specified in paragraph (c) of this section.\n\nI = Producer Price Index for Chemicals and Allied Products inflation value with 2024 as a base year.\n\n(2) Updated fee amounts for PMNs, SNUNs, MCANs, exemption notices, exemption applications, and manufacturer-requested risk evaluation requests apply to submissions received by the Agency on or after October 1 of every three-year fee adjustment cycle beginning in fiscal year 2024 (October 1, 2023). Updated fee amounts also apply to test rules, test orders, enforceable consent agreements and EPA-initiated risk evaluations that are \u201cnoticed\u201d on or after October 1 of every three-year fee adjustment cycle, beginning in fiscal year 2026.\n\n(3) The Agency will initiate public consultation through notice-and-comment rulemaking prior to making fee adjustments beyond inflation. If it is determined that no additional adjustment is necessary beyond for inflation, EPA will provide public notice of the inflation-adjusted fee amounts through posting to the Agency's web page by the beginning of each three-year fee adjustment cycle (October 1, 2026, October 1, 2029, etc.). If the Agency determines that adjustments beyond inflation are necessary, EPA will provide public notice of that determination and the process to be followed to make those adjustments.\n\n(e)  No fee required.  Persons are exempt from remitting any fee for Tier I exemption submissions under \u00a7 725.424 and polymer exemption reports submitted under \u00a7 723.250 of this chapter.\n\n(f)  Multiple parties, including joint submitters and consortia.  (1) Joint submitters of a TSCA section 5 notice are required to remit the applicable fee identified in paragraph (c) of this section for each section 5 notice submitted. Only one fee is required for each submission, regardless of the number of joint submitters for that notice. To qualify for the fee identified in paragraph (c)(1) of this section, each joint submitter of a TSCA section 5 notice must qualify as a small business concern under \u00a7 700.43 of this chapter.\n\n(2) Any consortium formed to split the cost of the applicable fee under section 4 of the Act is required to remit the appropriate fee identified in paragraph (c) of this section for each test rule, test order, or enforceable consent agreement regardless of the number of manufacturers and/or processors in that consortium. For the consortium to qualify for the fee identified in paragraph (c)(1) of this section, each person in the consortium must qualify as a small business concern under \u00a7 700.43 of this chapter. Failure to submit fee payment pursuant to this paragraph, or to provide notice of failure to reach agreement pursuant to paragraph (f)(2)(v) of this section constitutes a violation by each consortium member.\n\n(i) The consortium must identify a principal sponsor and provide notification to EPA that a consortium has formed. The notification must be accomplished within 90 days of the publication date of a test rule under section 4 of the Act, or within 90 days of the effective date of a test order under section 4 of the Act, or within 90 days of the signing of an enforceable consent agreement under section 4 of the Act. EPA may permit additional entities to join an existing consortium after the expiration of the notification period if the principal sponsor provides updated notification.\n\n(ii) Notification must be submitted electronically via the Agency's electronic reporting software\u2014Central Data Exchange (CDX)\u2014and include the following information:\n\n(A) Full name, address, telephone number and signature of principal sponsor;\n\n(B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium.\n\n(iii) It is up to the consortium to determine how fees will be split among the persons in the consortium.\n\n(iv) Consortia are strongly encouraged to set lower fees for small business concerns participating in the consortium.\n\n(v) If a consortium is unable to come to terms on how fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the end of the notification period in paragraph (f)(2)(i) of this section.\n\n(vi) If a consortium provides notice to EPA under paragraph (f)(2)(v) of this section that they failed to reach agreement on payment, EPA will assess fees to all persons as individuals described under paragraph (f)(4) of this section.\n\n(3) Any consortium formed to split the cost of the applicable fee supporting a risk evaluation under section 6(b) of the Act is required to remit the appropriate fee identified in paragraph (c) of this section for each risk evaluation, regardless of the number of manufacturers in that consortium. For the consortium to qualify for the fee identified in paragraph (c)(1)(vii) of this section, each person in the consortium must qualify as a small business concern under \u00a7 700.43 of this chapter. Failure to provide notice or submit fee payment pursuant to this paragraph (f)(3) constitutes a violation by each consortium member.\n\n(i) Notification must be provided to EPA that a consortium has formed. The notification must be accomplished within 90 days of the publication of the final scope of a chemical risk evaluation under section 6(b)(4)(D) of the Act or within 90 days of EPA providing notification to a manufacturer that a manufacturer-requested risk evaluation has been granted. EPA may permit additional entities to join an existing consortium after the expiration of the notification period if the principal sponsor provides updated notification.\n\n(ii) Notification must be submitted electronically via the Agency's electronic reporting software\u2014Central Data Exchange (CDX)\u2014and include the following information:\n\n(A) Full name, address, telephone number and signature of principal sponsor;\n\n(B) Name(s) and contact information for each manufacturer and/or processor associating with the consortium.\n\n(iii) It is up to the consortium to determine how fees will be split among the persons in the consortium.\n\n(iv) Consortia are strongly encouraged to set lower fees for small business concerns participating in the consortium.\n\n(v) If a consortium is unable to come to terms on how fees will be split among the persons in the consortium, the principal sponsor must notify EPA in writing before the end of the notification period in paragraph (f)(3)(i) of this section.\n\n(vi) If a consortium provides notice to EPA under paragraph (f)(3)(v) of this section that they failed to reach agreement on payment, EPA will assess fees to all persons as individuals as described under paragraph (f)(4) of this section.\n\n(4) If multiple persons are subject to fees triggered by section 4 or 6(b) of the Act and no consortium is formed, EPA will determine the portion of the total applicable fee to be remitted by each person subject to the requirement.\n\n(i) Each person's share of the applicable fees triggered by section 4 of the Act specified in paragraph (c) of this section shall be in proportion to the total number of manufacturers and/or processors of the chemical substance, with lower fees for small businesses:\n\nWhere:\n \n P s  = the portion of the fee under paragraph (c) of this section that is owed by a person who qualifies as a small business concern under \u00a7 700.43 of this chapter.\n \n P o  = the portion of the fee owed by a person other than a small business concern.\n \n F = the total fee required under paragraph (c) of this section.\n \n M t  = the total number of persons subject to the fee requirement.\n \n M s  = the number of persons subject to the fee requirement who qualify as a small business concern.\n\nWhere:\n\nP s  = the portion of the fee under paragraph (c) of this section that is owed by a person who qualifies as a small business concern under \u00a7 700.43 of this chapter.\n\nP o  = the portion of the fee owed by a person other than a small business concern.\n\nF = the total fee required under paragraph (c) of this section.\n\nM t  = the total number of persons subject to the fee requirement.\n\nM s  = the number of persons subject to the fee requirement who qualify as a small business concern.\n\n(ii) Each person's share of the applicable fees triggered by section 6(b) of the Act specified in paragraph (c) of this section shall be in proportion to the total number of manufacturers and their reported production volume as described in \u00a7 700.45(b)(v) of the chemical substance, with lower fees for small businesses:\n\n(iii) Remaining manufacturers ( i.e.,  those that do not qualify as a small business concern) are then ranked in ascending order (from lowest to highest) based on reported production volume as described in \u00a7 700.45(b)(v). Each remaining manufacturer is assigned a number with 1 for lowest production volume, 2 for second lowest production volume, etc.\n\nTable 1 to Paragraph  (f)(4)(iii) \u2014Example of Placing Manufacturers That Do Not Qualify as a Small Business Concern in Ascending Order\n\nWhere:\n \n P s  = the portion of the fee under paragraph (c) of this section that is owed by a person who qualifies as a small business concern under \u00a7 700.43 of this chapter.\n \n P \u226520th  = the portion of the fee owed by a person other than a small business concern in the top 20th percentile.\n \n P <20th  = the portion of the fee owed by a person other than a small business concern not in the top 20th percentile.\n \n F = the total fee required under paragraph (c) of this section.\n \n M t  = the total number of persons subject to the fee requirement.\n \n M s  = the number of persons subject to the fee requirement who qualify as a small business concern.\n \n N 20th  = The assigned number as illustrated in Table 1 to the manufacturer(s) with a production volume as described in 700.45(b)(v) at which the manufacturers with production volume greater than or equal to are in the top 20th percentile.\n \n M \u226520th  = the total number of persons with production volume as described in 700.45(b)(v) greater than or equal to the manufacturer(s) with a production volume as N 20th .\n \n M <20th  = the total number of persons with production volume as described in 700.45(b)(v) less than the manufacturer(s) with a production volume as N 20th .\n \n F o  = the total fee required under paragraph (c) of this section by all person(s) other than a small business concern.\n\nWhere:\n\nP s  = the portion of the fee under paragraph (c) of this section that is owed by a person who qualifies as a small business concern under \u00a7 700.43 of this chapter.\n\nP \u226520th  = the portion of the fee owed by a person other than a small business concern in the top 20th percentile.\n\nP <20th  = the portion of the fee owed by a person other than a small business concern not in the top 20th percentile.\n\nF = the total fee required under paragraph (c) of this section.\n\nM t  = the total number of persons subject to the fee requirement.\n\nM s  = the number of persons subject to the fee requirement who qualify as a small business concern.\n\nN 20th  = The assigned number as illustrated in Table 1 to the manufacturer(s) with a production volume as described in 700.45(b)(v) at which the manufacturers with production volume greater than or equal to are in the top 20th percentile.\n\nM \u226520th  = the total number of persons with production volume as described in 700.45(b)(v) greater than or equal to the manufacturer(s) with a production volume as N 20th .\n\nM <20th  = the total number of persons with production volume as described in 700.45(b)(v) less than the manufacturer(s) with a production volume as N 20th .\n\nF o  = the total fee required under paragraph (c) of this section by all person(s) other than a small business concern.\n\n(iv) In the event there are three or less manufacturers identified for a chemical substance, EPA will distribute the fee evenly among those three or less fee payers, regardless of production volume.\n\n(v) In the event the number assigned to the top 20th percentile is not an integer, EPA will round to the nearest integer to determine the manufacturer(s) with the reported production volume as described in \u00a7 700.45(b)(v) greater than or equal to the top 20th percentile.\n\n(vi) In the event multiple manufacturers report the same production volume as described in \u00a7 700.45(b)(v) and are greater than or equal to the top 20th percentile, EPA will include all manufacturers with that same production volume in the fee calculation for the top 20th percentile group.\n\n(5) If multiple persons are subject to fees triggered by section 4 of the Act and some inform EPA of their intent to form a consortium while others choose not to associate with the consortium, EPA will take the following steps to allocate fee amounts:\n\n(i) Count the total number of manufacturers, including the number of manufacturers within any consortia; divide the total fee amount by the total number of manufacturers; and allocate equally on a per capita basis to generate a base fee;\n\n(ii) Provide all small businesses who are either not associated with a consortium, or associated with an all- small business consortium, with an 80% discount from the base fee referenced previously;\n\n(iii) Calculate the total remaining fee and total number of remaining manufacturers by subtracting out the discounted fees and the number of small businesses identified;\n\n(iv) Reallocate the remaining fee across those remaining individuals and groups in equal amounts, counting each manufacturer in a consortium as one person; and\n\n(v) Inform consortia and individuals of their requisite fee amount. Small businesses in a successfully-formed consortium, other than a consortium of all small businesses, will not be afforded the 80% discount by EPA, but consortia managers are strongly encouraged to provide a discount for small business concerns.\n\n(6) If multiple persons are subject to fees triggered by section 6(b) of the Act and some inform EPA of their intent to form a consortium while others choose not to associate with the consortium, EPA will take the following steps to allocate fee amounts:\n\n(i) Count the total number of manufacturers, including the number of manufacturers within any consortia; divide the total fee amount by the total number of manufacturers; and allocate equally on a per capita basis to generate a base fee;\n\n(ii) Provide all small businesses who are either not associated with a consortium, or associated with an all-small business consortium, with an 80% discount from the base fee referenced previously;\n\n(iii) Calculate the total remaining fee and total number of remaining manufacturers by subtracting out the discounted fees and the number of small businesses identified;\n\n(iv) Place remaining manufacturers in ascending order (from lowest to highest) based on reported production volume as described in \u00a7 700.45(b)(v). Assign each remaining manufacturer a number with 1 for lowest production volume, 2 for second lowest production volume, etc.;\n\n(v) Determine the manufacturer(s) in the top 20th percentile by multiplying the total number of remaining manufacturers by 0.8. then comparing that number to the manufacturer(s) with that assigned number as described in paragraph (f)(6)(iv) of this section;\n\n(vi) Reallocate 80% of the total remaining fee evenly across that manufacturer(s) with a production volume amount equal to or larger than that manufacturer(s) (the top 20th percentile), counting each manufacturer in a consortium as one person;\n\n(vii) Reallocate the remaining fee evenly across the remaining manufacturers, counting each manufacturer in a consortium as one person; and\n\n(viii) Inform consortia and individuals of their requisite fee amount. Small businesses in a successfully formed consortium, other than a consortium of all small businesses, will not be afforded the 80% discount by EPA, but consortia managers are strongly encouraged to provide a discount for small business concerns.\n\n(g)  Remittance procedure \u2014(1)  Electronic payment.  Each remittance under this section shall be paid electronically in U.S. dollars, using one of the electronic payment methods supported by the Department of the Treasury's  Pay.gov  online electronic payment service, or any applicable additional or successor online electronic payment service offered by the Department of Treasury.\n\n(2)  Fees incurred prior to  October 18, 2018. Timing of payment for fees incurred between October 1, 2018 and October 18, 2018. Fees required by paragraph (c) of this section for which the fee-triggering action or event occurred between October 1, 2018, and October 18, 2018 shall be paid in response to invoices EPA will send within 30 days of October 18, 2018.\n\n(3)  Fees incurred after  October 18, 2018. Timing of payment for fees incurred after October 18, 2018. Fees required by paragraph (c) of this section for which the fee-triggering action or event occurred after October 18, 2018 shall be paid at the following time:\n\n(i)  Test orders and test rules.  The applicable fee specified in paragraph (c) of this section shall be paid in full not later than 180 days after the effective date of a test rule or test order under section 4 of the Act.\n\n(ii)  Enforceable  c onsent agreements.  The applicable fee specified in paragraph (c) of this section shall be paid in full not later than 120 days after the signing of an enforceable consent agreement under section 4 of the Act.\n\n(iii)  Section 5 notice.  The applicable fee specified in paragraph (c) of this section shall be paid in full immediately upon submission of a TSCA section 5 notice.\n\n(iv)  Risk evaluations.  (A) For EPA-initiated risk evaluations, the applicable fee specified in paragraph (c) of this section shall be paid in two installments, with the first payment of 50% due 180 days after publishing the final scope of a risk evaluation and the second payment for the remainder of the fee due 545 days after publishing the final scope of a risk evaluation under section 6(b)(4)(D) of the Act.\n\n(B) For manufacturer-requested risk evaluations under section 6(b)(4)(C)(ii) of the Act, the applicable fees specified in paragraph (c) of this section shall be paid as follows:\n\n( 1 ) The applicable fee specified in paragraph (c) of this section shall be paid in three installments. The first payment shall be due no later than 180 days after EPA provides the submitting manufacture(s) notice that it has granted the request.\n\n( 2 ) The second payment shall be due no later than 545 days after EPA provides the submitting manufacturer(s) notice that it has granted the request.\n\n( 3 ) The final payment shall be due no later than 30 days after EPA publishes the final risk evaluation.\n\n(4)  Payment identity.  (i) Persons who submit a TSCA section 5 notice shall place an identifying number and a payment identity number on the front page of each TSCA section 5 notice submitted. The identifying number must include the letters \u201cTS\u201d followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a \u201c Pay.gov \u201d transaction number used to transmit the fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one TSCA section 5 notice, the person shall include the name of the submitter and a new TS number for each TSCA section 5 notice to which the remittance applies, and the amount of the remittance that applies to each notice.\n\n(ii) Persons who are required to submit a letter of intent to conduct testing per \u00a7 790.45 of this chapter shall place a payment identity number on the front page of each letter submitted. The identifying number must include the letters \u201cTS\u201d followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a \u201c Pay.gov \u201d transaction number used to transmit the fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one letter of intent to conduct testing, the person shall include the name of the submitter and a new TS number for each letter of intent to conduct testing to which the remittance applies, and the amount of the remittance that applies to each letter of intent.\n\n(iii) Persons who sign an enforceable consent agreement per \u00a7 790.60 of this chapter shall place a payment identity number within the contents of the signed agreement. The identifying number must include the letters \u201cTS\u201d followed by a combination of 6 numbers (letters may be substituted for some numbers). The payment identity number may be a \u201c Pay.gov \u201d transaction number used to transmit the fee. The same TS number and the submitter's name must appear on the corresponding fee remittance under this section. If a remittance applies to more than one enforceable consent agreement, the party or parties shall include the name of the submitter(s) and a new TS number for each enforceable consent agreement to which the remittance applies, and the amount of the remittance that applies to each enforceable consent agreement.\n\n(5)  Small business certification.  (i) Each person who remits the fee identified in paragraph (c)(1) of this section for a PMN, consolidated PMN, or SNUN shall insert a check mark for the statement, \u201cThe company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $6,480 in accordance with 40 CFR 700.45(c).\u201d under \u201cCERTIFICATION\u201d on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).\n\n(ii) Each person who remits the fee identified in paragraph (c)(1) of this section for a LVE, LoREX, TERA, TME, or Tier II exemption request under TSCA section 5 shall insert a check mark for the statement, \u201cThe company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $2,180 in accordance with 40 CFR 700.45(c).\u201d in the exemption application.\n\n(iii) Each person who remits the fee identified in paragraph (c)(1) of this section for an exemption notice under \u00a7 723.175 of this chapter shall include the words, \u201cThe company or companies identified in this notice is/are a small business concern under 40 CFR 700.43 and has/have remitted a fee of $2,180 in accordance with 40 CFR 700.45(c).\u201d in the certification required in \u00a7 723.175(i)(1)(x) of this chapter.\n\n(iv) Each person who remits the fee identified in paragraph (c)(1) of this section for a MCAN or consolidated MCAN for a microorganism shall insert a check mark for the statement, \u201cThe company named in part 1, section A is a small business concern under 40 CFR 700.43 and has remitted a fee of $6,480 in accordance with 40 CFR 700.45(c).\u201d in the certification required in \u00a7 725.25(b) of this chapter.\n\n(6)  Payment certification statement.  (i) Each person who remits a fee identified in paragraph (c)(2) of this section for a PMN, consolidated PMN, or SNUN shall insert a check mark for the statement, \u201cThe company named in part 1, section A has remitted the fee of $37,000 specified in 40 CFR 700.45(c).\u201d under \u201cCERTIFICATION\u201d on page 2 of the Premanufacture Notice for New Chemical Substances (EPA Form 7710-25).\n\n(ii) Each person who remits a fee identified in paragraph (c)(2) of this section for a LVE, LoREX, TERA, TME, or Tier II exemption request under TSCA section 5 shall insert a check mark for the statement, \u201cThe company named in part 1, section A has remitted the fee of $10,870 specified in 40 CFR 700.45(c).\u201d in the exemption application.\n\n(iii) Each person who remits the fee identified in paragraph (c)(2) of this section for an exemption notice under \u00a7 723.175 of this chapter shall include the words, \u201cThe company or companies identified in this notice has/have remitted a fee of $10,870 in accordance with 40 CFR 700.45(c).\u201d in the certification required in \u00a7 723.175(i)(1)(x) of this chapter.\n\n(iv) Each person who remits the fee identified in paragraph (c)(2) of this section for a MCAN for a microorganism shall insert a check mark for the statement, \u201cThe company named in part 1, section A has remitted the fee of $37,000 in accordance with 40 CFR 700.45(c).\u201d in the certification required in \u00a7 725.25(b) of this chapter.\n\n(h)  Full fee refunds.  EPA will refund, in totality, any fee paid for a section 5 notice whenever the Agency determines:\n\n(1) That the chemical substance that is the subject of a PMN, consolidated PMN, exemption request, or exemption notice, is not a new chemical substance as of the date of submission of the notice,\n\n(2) In the case of a SNUN, that the notice was not required,\n\n(3) That as of the date of submission of the notice: The microorganism that is the subject of a MCAN or consolidated MCAN is not a new microorganism; nor is the use involving the microorganism a significant new use; or\n\n(4) When the Agency fails to make a determination on a notice by the end of the applicable notice review period under \u00a7 720.75 or \u00a7 725.50 of this chapter, unless the Agency determines that the submitter unduly delayed the process, or\n\n(5) When the Agency fails to approve, or deny an exemption request within the applicable period under \u00a7 720.38(d), \u00a7 723.50(g), or \u00a7 725.50(b) of this chapter, unless the Agency determines that the submitter unduly delayed the process.\n\n(i)  Partial fee refunds.  (1) If a TSCA section 5 notice is withdrawn during the first 10 business days after the beginning of the applicable review period under \u00a7 720.75(a) of this chapter, the Agency will refund all but 25% of the fee as soon as practicable.\n\n(2) Once withdrawn, any future submission related to the TSCA section 5 notice must be submitted as a new notice.\n\n(3) If EPA determines that the initial payment for a manufacturer-requested risk evaluation exceed the applicable fee in paragraph (c) of this section, EPA will refund the difference."]], "truncated": false, "filtered_table_rows_count": 104, "expanded_columns": [], "expandable_columns": [], "columns": ["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"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select section_id, title_number, 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