21 U.S.C. § 399i — Food and Drug Administration Working

Page 717 TITLE 21—FOOD AND DRUGS § 399i Congress on the role of the Food and Drug Ad- ministration in supporting advanced and con- tinuous pharmaceutical manufacturing, in- cluding— (A) a national framework of principles re- lated to the implementation of advanced and continuous pharmaceutical manufacturing; (B) a plan for the development of Federal regulations and guidance to support and fa- cilitate the incorporation of advanced or continuous manufacturing into the develop- ment of pharmaceuticals; (C) a plan for development of Federal regu- lations or guidance related to the review of advanced and continuous pharmaceutical manufacturing, including how such manu- facturing practices may be incorporated into the review of medical product applications; and (D) a summary of relevant feedback re- lated to improving advanced and continuous pharmaceutical manufacturing solicited from the public, which may include other in- stitutions of higher education, nonprofit or- ganizations, and large and small pharma- ceutical manufacturers, including generic and nonprescription manufacturers, and con- tract manufacturers, and other relevant en- tities. (h) Definitions In this section: (1) Advanced and continuous pharmaceutical manufacturing The term ‘‘advanced and continuous phar- maceutical manufacturing’’ refers to a method of pharmaceutical manufacturing, or a com- bination of pharmaceutical manufacturing methods— (A) that incorporates a novel technology, or uses an established technique or tech- nology in a new or innovative way, that en- hances drug quality or improves the manu- facturing process for a drug, including proc- esses that may apply to advanced therapies and the production of biological products, such as cell and gene therapies; or (B) for which the input materials are con- tinuously fed into and transformed within the process, and the output materials are continuously removed from the system, uti- lizing an integrated manufacturing process that consists of a series of 2 or more simul- taneous unit operations. (2) Biological product The term ‘‘biological product’’ has the meaning given such term in section 262(i) of title 42. (3) Drug The term ‘‘drug’’ has the meaning given such term in section 321(g) of this title. (4) Institution of higher education The term ‘‘institution of higher education’’ has the meaning given such term in section 1001(a) of title 20. (5) Secretary The term ‘‘Secretary’’ means the Secretary of Health and Human Services. (i) Authorization of appropriations (1) In general There is authorized to be appropriated to carry out this section $100,000,000 for the pe- riod of fiscal years 2023 through 2027. (2) Federal administrative expenses Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evalua- tion. (Pub. L. 114–255, div. A, title III, § 3016, Dec. 13, 2016, 130 Stat. 1095; Pub. L. 117–328, div. FF, title III, § 3204(a), Dec. 29, 2022, 136 Stat. 5815.) Editorial Notes REFERENCES IN TEXT This Act, referred to in subsec. (f)(3), is Pub. L. 114–255, Dec. 13, 2016, 130 Stat. 1033, known as the 21st Century Cures Act. For complete classification of this Act to the Code, see Short Title of 2016 Amendment note set out under section 201 of Title 42, The Public Health and Welfare, and Tables. CODIFICATION Section was enacted as part of the 21st Century Cures Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. AMENDMENTS 2022—Pub. L. 117–328 amended section generally. Prior to amendment, section related to grants for studying continuous drug manufacturing. Statutory Notes and Related Subsidiaries TRANSITION RULE Pub. L. 117–328, div. FF, title III, § 3204(b), Dec. 29, 2022, 136 Stat. 5819, provided that: ‘‘Section 3016 of the 21st Century Cures Act (21 U.S.C. 399h), as in effect on the day before the date of the enactment of this section [Dec. 29, 2022], shall apply with respect to grants award- ed under such section before such date of enactment.’’ § 399i. Food and Drug Administration Working Capital Fund (a) In general There is hereby established in the Treasury of the United States a Working Capital Fund (the Fund) to be administered by the Food and Drug Administration (FDA), without fiscal year limi- tation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the pur- chase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, the needs of the FDA and requisitions of other Government Offices, and (2) such other services as the Commissioner of the FDA, subject to re- view by the Secretary of Health and Human Services, determines may be performed more ad- vantageously as central services. The Fund shall be reimbursed from applicable discretionary re- sources, notwithstanding any otherwise applica- ble purpose limitations, available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated Page 718 TITLE 21—FOOD AND DRUGS § 451 or actual charges for personal services, mate- rials, equipment, information technology, and other expenses. Charges for equipment and in- formation technology shall include costs associ- ated with maintenance, repair, and depreciation (including improvement and replacement). (b) Appropriations Of any discretionary resources appropriated in this Act for fiscal year 2018 for ‘‘Department of Health and Human Services, Food and Drug Ad- ministration, Salaries and Expenses’’, not to ex- ceed $5,000,000 of amounts available as of Sep- tember 30 may be transferred to and merged with the Fund established under subsection (a), notwithstanding any otherwise applicable pur- pose limitations. (c) Emergency funds excluded No amounts may be transferred pursuant to this section that are designated by the Congress as an emergency requirement pursuant to a con- current resolution on the budget or the Bal- anced Budget and Emergency Deficit Control Act of 1985. (Pub. L. 115–141, div. A, title VII, § 722, Mar. 23, 2018, 132 Stat. 387.) Editorial Notes REFERENCES IN TEXT This Act, referred to in subsec. (b), is div. A of Pub. L. 115–141, Mar. 23, 2018, 132 Stat. 351, known as the Ag- riculture, Rural Development, Food and Drug Adminis- tration, and Related Agencies Appropriations Act, 2018. For complete classification of this Act to the Code, see Tables. The Balanced Budget and Emergency Deficit Control Act of 1985, referred to in subsec. (c), is title II of Pub. L. 99–177, Dec. 12, 1985, 99 Stat. 1038, which enacted chapter 20 (§ 900 et seq.) and sections 654 to 656 of Title 2, The Congress, amended sections 602, 622, 631 to 642, and 651 to 653 of Title 2, sections 1104 to 1106, and 1109 of Title 31, Money and Finance, and section 911 of Title 42, The Public Health and Welfare, repealed section 661 of Title 2, enacted provisions set out as notes under section 900 of Title 2 and section 911 of Title 42, and amended provisions set out as a note under section 621 of Title 2. For complete classification of this Act to the Code, see Short Title note set out under section 900 of Title 2 and Tables. CODIFICATION Section was enacted as part of the Agriculture, Rural Development, Food and Drug Administration, and Re- lated Agencies Appropriations Act, 2018, and also as part of the Consolidated Appropriations Act, 2018, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter. CHAPTER 10—POULTRY AND POULTRY PRODUCTS INSPECTION Sec. 451. Congressional statement of findings. 452. Congressional declaration of policy. 453. Definitions. 454. Federal and State cooperation in develop- ment and administration of State poultry product inspection programs. 455. Inspection in official establishments. 456. Operation of premises, facilities and equip- ment. 457. Labeling and container standards. 458. Prohibited acts. 459. Compliance by all establishments. Sec. 460. Miscellaneous activities subject to regula- tion. 461. Offenses and punishment. 462. Reporting of violations; notice; opportunity to present views. 463. Rules and regulations. 464. Exemptions. 465. Limitations upon entry of poultry products and other materials into official establish- ments. 466. Imports. 467. Inspection services. 467a. Administrative detention; duration; pending judicial proceedings; notification of govern- ment authorities; release; removal of offi- cial marks. 467b. Seizure and condemnation. 467c. Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plain- tiff; subpenas. 467d. Administration and enforcement; applica- bility of penalty provisions; conduct of in- quiries; power and jurisdiction of courts. 467e. Non-Federal jurisdiction of federally regu- lated matters; prohibition of additional or different requirements for establishments with inspection services and as to marking, labeling, packaging, and ingredients; rec- ordkeeping and related requirements; con- current jurisdiction over distribution for human food purposes of adulterated or mis- branded and imported articles; other mat- ters. 467f. Federal Food, Drug, and Cosmetic Act appli- cations. 468. Cost of inspection; overtime. 469. Authorization of appropriations. 470. Omitted. 471. Safe Meat and Poultry Inspection Panel. 472. Interstate shipment of poultry inspected by Federal and State agencies for certain small establishments. 473. Grants for improvements to meat and poultry facilities to allow for interstate shipment. § 451. Congressional statement of findings Poultry and poultry products are an impor- tant source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of con- sumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or mis- branded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to con- sumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdic- tions as contemplated by this chapter are appro- priate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.