SEC. 2. ADVANCED MANUFACTURING TECHNOLOGIES PRO-
GRAM. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. ADVANCED MANUFACTURING TECHNOLOGIES 
PROGRAM. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the Securing America’s Medicine 
Cabinet Act of 2021, the Secretary shall continue in effect 
the program to evaluate and approve new drug manufac-
turing technologies that are included in an application, or 
supplement to an application, for a drug under subsection 
(b) or (j) of section 505 of this Act or for a biological 
product submitted under subsection (a) or (k) of section 
351 of the Public Health Service Act. 
‘‘(b) DESIGNATION.—The Secretary shall designate a 
method of manufacturing a drug as an advanced manufac-
turing technology under this section if the drug manufac-
turer demonstrates that such technology is likely to— 
‘‘(1) prevent or resolve a drug shortage; 
‘‘(2) maintain an adequate supply of critical 
medications for national emergencies; or 
‘‘(3) promote the adoption of innovative ap-
proaches to drug product design and manufacturing. 
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‘‘(c) CONSULTATION.—If the Secretary designates a 
method of manufacturing as an advanced manufacturing 
technology under this section, the Secretary shall take ac-
tions to expedite the development and implementation of 
such method of manufacture for purposes of approval of 
the application under subsection (c) or (j) of section 505 
of this Act or subsection (a) or (k) of section 351 of the 
Public Health Service Act, which may include, as appro-
priate— 
‘‘(1) holding meetings between the sponsor of 
the application and appropriate Food and Drug Ad-
ministration staff throughout the development of the 
technology; 
‘‘(2) providing timely advice to, and interactive 
communication with, the sponsor regarding the de-
velopment of the technology; and 
‘‘(3) involving senior managers and experienced 
staff of the Food and Drug Administration, as ap-
propriate, in a collaborative, cross-disciplinary review 
of the method of manufacturing. 
‘‘(d) EVALUATION
OF
AN ADVANCED MANUFAC-
TURING TECHNOLOGY.— 
‘‘(1) PACKAGE.—A sponsor who receives des-
ignation of an advanced manufacturing technology 
under this section shall provide the Secretary with a 
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package of scientific evidence supporting the imple-
mentation of the advanced manufacturing technology 
in a particular context-of-use. 
‘‘(2) EVALUATION.—Within 90 days of receiv-
ing the package, the Secretary shall determine 
whether a designated advanced manufacturing tech-
nology is validated for the proposed context of use 
based on the scientific merit the supporting evidence 
provided by the sponsor. 
‘‘(3) EFFECT OF APPROVAL.—Upon approval, 
the same sponsor may rely upon the advanced man-
ufacturing technology for use across multiple manu-
facturing product lines within the same context-of- 
use without having to re-submit data to the Sec-
retary validating the underlying technology. 
‘‘(e) IMPLEMENTATION AND REPORTING.— 
‘‘(1) PUBLIC
MEETING.—The Secretary shall 
publish in the Federal Register a notice of a public 
meeting to be held no later than 1 year after the 
date of enactment of the Securing America’s Medi-
cine Cabinet Act of 2021 to discuss and obtain input 
and recommendations from stakeholders regarding 
the goals and scope of, and a suitable framework 
and procedures and requirements for, the program 
under this section. 
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‘‘(2) 
PROGRAM
GUIDANCE.—The 
Secretary 
shall— 
‘‘(A) not later than 1 year after the date 
of enactment of the Securing America’s Medi-
cine Cabinet Act of 2021, issue draft guidance 
regarding the goals and implementation of the 
program under this section; and 
‘‘(B) not later than 2 years after the date 
of enactment of the Securing America’s Medi-
cine Cabinet Act of 2021, issue final guidance 
with respect to the implementation of such pro-
gram. 
‘‘(3) REPORT.—The Secretary shall make avail-
able on the internet website of the Food and Drug 
Administration an annual report on the progress of 
the program under this section.’’. 
SEC. 3. NATIONAL CENTER OF EXCELLENCE IN ADVANCED 
PHARMACEUTICAL MANUFACTURING. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
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‘‘SEC. 1015. NATIONAL CENTER OF EXCELLENCE IN AD-
VANCED 
PHARMACEUTICAL 
MANUFAC-
TURING. 
‘‘(a) IN GENERAL.—The Secretary shall designate in-
stitutions of higher education as National Centers of Ex-
cellence in Advanced Pharmaceutical Manufacturing, in-
cluding continuous pharmaceutical manufacturing. 
‘‘(b) ELIGIBILITY.—To be eligible for designation 
under subsection (a) an entity shall— 
‘‘(1) be an institution of higher education; 
‘‘(2) demonstrate— 
‘‘(A) the physical and technical capacity 
for research and development of advanced phar-
maceutical manufacturing; 
‘‘(B) a record of transferring scientific 
knowledge to the marketplace; 
‘‘(C) scalable manufacturing knowledge, 
which may be through collaborations of other 
institutions of higher education, biopharma-
ceutical manufacturers, or other entities; 
‘‘(D) the ability to train a future workforce 
for research on and implementation of advanced 
pharmaceutical manufacturing; and 
‘‘(E) the ability to support Federal agen-
cies with technical assistance for advanced 
pharmaceutical technologies, with an emphasis 
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on creating a secure national pharmaceutical 
stockpile and the ability to rapidly address drug 
shortages; and 
‘‘(3) submit an application to the Secretary at 
such time, in such form, and in such manner as the 
Secretary may require. 
‘‘(c) TERMINATION.—The Secretary may terminate 
the designation of an entity designated under subsection 
(a) upon a determination that the entity no longer meets 
the requirements of subsection (b). 
‘‘(d) ANNUAL REPORT.—Not later than 1 year after 
the date on which the first designation is made under sub-
section (a), and annually thereafter, the Secretary shall 
submit a report to Congress on the activities of the entities 
designated under such subsection. 
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $100,000,000 for the period of fiscal years 2022 
through 2025.’’. 
Æ 
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