21 U.S.C. § 399h — National Centers of Excellence in Ad-

Page 715 TITLE 21—FOOD AND DRUGS § 399h (4) development of programs and enhance- ment of strategies to recruit, train, and pro- vide continuing education opportunities for the personnel of the Centers with expertise re- lated to the major disease area of focus of the Institute; (5) enhancement of the interactions of the Centers with patients, sponsors, and the exter- nal biomedical community regarding the major disease area of focus of the Institute; and (6) facilitation of the collaborative relation- ships of the Centers with other agencies with- in the Department of Health and Human Serv- ices regarding the major disease area of focus of the Institute. (b) Public process The Secretary shall provide a period for public comment during the time that each Institute is being implemented. (c) Timing The Secretary shall establish at least one In- stitute under subsection (a) before the date that is 1 year after December 13, 2016. (d) Termination of Institutes The Secretary may terminate any Institute established pursuant to this section if the Sec- retary determines such Institute is no longer benefitting the public health. Not less than 60 days prior to so terminating an Institute, the Secretary shall provide public notice, including the rationale for such termination. (June 25, 1938, ch. 675, § 1014, as added Pub. L. 114–255, div. A, title III, § 3073(a), Dec. 13, 2016, 130 Stat. 1136.) § 399h. National Centers of Excellence in Ad- vanced and Continuous Pharmaceutical Manufacturing (a) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs— (1) may, to support the advancement, devel- opment, and implementation of advanced and continuous pharmaceutical manufacturing— (A) solicit requests for designation as Na- tional Centers of Excellence in Advanced and Continuous Pharmaceutical Manufac- turing (in this section referred to as a ‘‘Na- tional Center of Excellence’’); (B) beginning not later than one year after December 29, 2022, designate as National Centers of Excellence institutions of higher education or consortia of institutions of higher education that— (i) request such designation; and (ii) meet the eligibility criteria specified in subsection (c); and (C) award grants to such institutions or consortia of institutions; and (2) shall so designate not more than 5 insti- tutions of higher education or consortia of such institutions. (b) Request for designation A request for designation under subsection (a) shall be made to the Secretary at such time, in such manner, and containing such information as the Secretary may require. (c) Eligibility criteria for designation To be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher edu- cation shall include in its request for designa- tion a description of the institution’s or consor- tium’s— (1) physical capacity and technical capabili- ties to conduct advanced research on, and to develop and implement, advanced and contin- uous pharmaceutical manufacturing; (2) collaboration or partnerships with other institutions of higher education, nonprofit or- ganizations, and large and small pharma- ceutical manufacturers, including generic and nonprescription manufacturers, contract man- ufacturers, and other relevant entities; (3) proven capacity to design, develop, imple- ment, and demonstrate new, highly effective technologies for use in advanced and contin- uous pharmaceutical manufacturing; (4) proven ability to facilitate training of a qualified workforce for advanced research on, and development and implementation of, ad- vanced and continuous pharmaceutical manu- facturing; and (5)(A) experience in participating in and leading advanced and continuous pharma- ceutical manufacturing technology partner- ships with other institutions of higher edu- cation, nonprofit organizations, and large and small pharmaceutical manufacturers, includ- ing generic and nonprescription manufactur- ers, contract manufacturers, and other rel- evant entities to— (i) support the implementation of ad- vanced or continuous pharmaceutical manu- facturing for companies manufacturing or seeking to manufacture in the United States; (ii) support Federal agencies with tech- nical assistance and workforce training, which may include regulatory and quality metric guidance as applicable, and hands-on training, for advanced and continuous phar- maceutical manufacturing; (iii) organize and conduct advanced re- search and development activities, with re- spect to advanced or continuous pharma- ceutical manufacturing, needed to develop new and more effective technology, and to develop and support technological leader- ship; (iv) develop best practices for designing, developing, and implementing advanced and continuous pharmaceutical manufacturing processes; and (v) identify and assess workforce needs for advanced and continuous pharmaceutical manufacturing, and address such workforce needs, which may include the development and implementing of training programs; or (B) a plan, to be implemented within 2 years, to establish partnerships described in subpara- graph (A). (d) Termination of designation The Secretary may terminate the designation of any National Center of Excellence designated Page 716 TITLE 21—FOOD AND DRUGS § 399h under this section if the Secretary determines such National Center of Excellence no longer meets the criteria specified in subsection (c). Not later than 90 days before the effective date of such a termination, the Secretary shall pro- vide written notice to the National Center of Excellence, including the rationale for such ter- mination. (e) Conditions for designation As a condition of designation as a National Center of Excellence under this section, the Sec- retary shall require that an institution of higher education or consortium of institutions of high- er education enter into an agreement with the Secretary under which the institution or consor- tium agrees— (1) to collaborate directly with the Food and Drug Administration to publish the reports re- quired by subsection (g); (2) to share data with the Food and Drug Ad- ministration regarding best practices and re- search generated through the funding under subsection (f); (3) to develop, along with industry partners (which may include large and small pharma- ceutical manufacturers, including generic and nonprescription manufacturers, and contract research organizations or contract manufac- turers that carry out drug development and manufacturing activities) and another institu- tion or consortium designated under this sec- tion, if any, a strategic plan for developing an advanced and continuous pharmaceutical manufacturing workforce; (4) to develop, along with industry partners and other institutions or consortia of such in- stitutions designated under this section, a strategic plan for strengthening existing, and developing new, partnerships with other insti- tutions of higher education or consortia there- of, or nonprofit organizations; and (5) to provide an annual report to the Food and Drug Administration regarding the des- ignee’s activities under this section, including a description of how the designee continues to meet and make progress on the criteria speci- fied in subsection (c). (f) Funding (1) In general The Secretary shall award funding, through grants, contracts, or cooperative agreements, to the entities designated as National Centers of Excellence under this section for the pur- poses of supporting the advanced research on, and development and implementation of, ad- vanced and continuous pharmaceutical manu- facturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including— (A) expanding capacity for advanced re- search on, and development of, advanced and continuous pharmaceutical manufacturing; and (B) implementing advanced research ca- pacity and capabilities in advanced and con- tinuous pharmaceutical manufacturing suit- able for accelerating the development of drug products needed to respond to public health threats, mitigate or prevent drug shortages, address drug quality issues and supply chain disruptions, and other cir- cumstances with respect to which the Sec- retary may determine the rapid development of new products or new manufacturing proc- esses may be appropriate. (2) Consistency with FDA mission As a condition on receipt of funding under this subsection, a National Center of Excel- lence shall consider any input from the Sec- retary regarding the use of funding related to— (A) best practices to increase, and provide for the advancement of, advanced and con- tinuous pharmaceutical manufacturing through the National Center of Excellence; and (B) the extent to which activities con- ducted by the National Center of Excellence are consistent with the mission of the Food and Drug Administration. (3) Rule of construction Nothing in this section shall be construed as precluding a National Center for Excellence designated under this section from receiving funds under any other provision of this Act or any other Federal law. (g) Annual review and reports (1) Annual report to Congress Beginning not later than one year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall— (A) submit to Congress a report describing the activities, partnerships and collabora- tions, Federal policy recommendations, pre- vious and continuing funding, and findings of, and any other applicable information from, the National Centers of Excellence designated under this section; (B) include in such report an accounting of the Federal administrative expenses de- scribed in subsection (i)(2) over the reporting period; and (C) make such report available to the pub- lic in an easily accessible electronic format on the website of the Food and Drug Admin- istration. (2) Center of Excellence report An entity receiving a grant under this sec- tion shall, not later than 1 year after receiving such grant, and annually thereafter for the du- ration of the grant period, submit to the Sec- retary a summary of programs and activities funded under the grant. (3) Periodic review The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such Na- tional Centers of Excellence continue to meet the criteria for designation under this section. (4) Additional report to Congress Not later than 1 year after the date on which the first designation is made under subsection (a), the Secretary, in consultation with the National Centers of Excellence designated under this section, shall submit a report to the 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