The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs-
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.
To be eligible to receive a designation under this section, an institution of higher education or consortium of institutions of higher education shall include in its request for designation a description of the institution's or consortium's-
The Secretary may terminate the designation of any National Center of Excellence designated 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 provide written notice to the National Center of Excellence, including the rationale for such termination.
As a condition of designation as a National Center of Excellence under this section, the Secretary shall require that an institution of higher education or consortium of institutions of higher education enter into an agreement with the Secretary under which the institution or consortium agrees-
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 purposes of supporting the advanced research on, and development and implementation of, advanced and continuous pharmaceutical manufacturing, and recommending improvements to advanced and continuous pharmaceutical manufacturing, including-
As a condition on receipt of funding under this subsection, a National Center of Excellence shall consider any input from the Secretary regarding the use of funding related to-
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.
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-
An entity receiving a grant under this section shall, not later than 1 year after receiving such grant, and annually thereafter for the duration of the grant period, submit to the Secretary a summary of programs and activities funded under the grant.
The Secretary shall periodically review the National Centers of Excellence designated under this section to ensure that such National Centers of Excellence continue to meet the criteria for designation under this section.
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 Congress on the role of the Food and Drug Administration in supporting advanced and continuous pharmaceutical manufacturing, including-
In this section:
The term "advanced and continuous pharmaceutical manufacturing" refers to a method of pharmaceutical manufacturing, or a combination of pharmaceutical manufacturing methods-
The term "biological product" has the meaning given such term in section 262(i) of title 42.
The term "drug" has the meaning given such term in section 321(g) of this title.
The term "institution of higher education" has the meaning given such term in section 1001(a) of title 20.
The term "Secretary" means the Secretary of Health and Human Services.
There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027.
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 evaluation.
21 U.S.C. § 399h
EDITORIAL NOTES
REFERENCES IN TEXTThis Act, referred to in subsec. (f)(3), is Pub. L. 114-255, 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.
CODIFICATIONSection 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.
AMENDMENTS2022- 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 awarded under such section before such date of enactment."