HR 4369 RFS
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Centers of 
Excellence in Advanced and Continuous Pharmaceutical 
Manufacturing Act of 2021’’. 
SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN AD-
VANCED 
AND 
CONTINUOUS 
PHARMA-
CEUTICAL MANUFACTURING. 
(a) IN GENERAL.—Section 3016 of the 21st Century 
Cures Act (21 U.S.C. 399h) is amended to read as follows: 
‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN AD-
VANCED 
AND 
CONTINUOUS 
PHARMA-
CEUTICAL MANUFACTURING. 
‘‘(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs— 
‘‘(1) shall solicit and, beginning not later than 
one year after the date of enactment of the National 
Centers of Excellence in Advanced and Continuous 
Pharmaceutical Manufacturing Act of 2021, receive 
requests from institutions of higher education, or 
consortia of institutions of higher education, to be 
designated as a National Center of Excellence in Ad-
vanced and Continuous Pharmaceutical Manufac-
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turing (in this section referred to as a ‘National 
Center of Excellence’) to support the advancement, 
development, and implementation of advanced and 
continuous pharmaceutical manufacturing; and 
‘‘(2) shall so designate not more than 5 institu-
tions of higher education or consortia of such insti-
tutions that— 
‘‘(A) request such designation; and 
‘‘(B) meet the criteria specified in sub-
section (c). 
‘‘(b) REQUEST FOR DESIGNATION.—A request for 
designation under subsection (a) shall be made to the Sec-
retary at such time, in such manner, and containing such 
information as the Secretary may require. Any such re-
quest shall include a description of how the institution of 
higher education, or consortium of institutions of higher 
education, meets or plans to meet each of the criteria spec-
ified in subsection (c). 
‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 
criteria specified in this subsection with respect to an in-
stitution of higher education, or consortium of institutions 
of higher education, are that the institution or consortium 
has, as of the date of the submission of a request under 
subsection (a) by such institution or consortium— 
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‘‘(1) physical and technical capacity for re-
search, development, implementation, and dem-
onstration of advanced and continuous pharma-
ceutical manufacturing; 
‘‘(2) manufacturing knowledge-sharing net-
works with other institutions of higher education, 
large and small pharmaceutical manufacturers, ge-
neric and nonprescription manufacturers, contract 
manufacturers, and other relevant entities; 
‘‘(3) proven capacity to design, develop, imple-
ment, and demonstrate new, highly effective tech-
nologies for use in advanced and continuous phar-
maceutical manufacturing; 
‘‘(4) a track record for creating, preserving, 
and transferring knowledge with respect to advanced 
and continuous pharmaceutical manufacturing; 
‘‘(5) the proven ability to facilitate training of 
an adequate future workforce for research on, and 
implementation of, advanced and continuous phar-
maceutical manufacturing; and 
‘‘(6) experience in participating in and leading 
advanced and continuous pharmaceutical manufac-
turing technology partnerships with other institu-
tions of higher education, large and small pharma-
ceutical manufacturers, generic and nonprescription 
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manufacturers, contract manufacturers, and other 
relevant entities— 
‘‘(A) to support companies seeking to im-
plement advanced and continuous pharma-
ceutical manufacturing in the United States; 
‘‘(B) to support Federal agencies with 
technical assistance and employee training, 
which may include regulatory and quality met-
ric guidance as applicable, and hands-on train-
ing, for advanced and continuous pharma-
ceutical manufacturing; 
‘‘(C) with respect to advanced and contin-
uous pharmaceutical manufacturing, to orga-
nize and conduct research and development ac-
tivities needed to create new and more effective 
technology, develop and share knowledge, create 
intellectual property, and maintain technological 
leadership; 
‘‘(D) to develop best practices for design-
ing and implementing advanced and continuous 
pharmaceutical manufacturing processes; and 
‘‘(E) to assess and respond to the national 
workforce needs for advanced and continuous 
pharmaceutical manufacturing, including the 
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development and implementing of training pro-
grams. 
‘‘(d) TERMINATION
OF DESIGNATION.—The Sec-
retary may terminate the designation of any National Cen-
ter of Excellence designated under this section if the Sec-
retary 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 ter-
mination, the Secretary shall provide written notice to the 
National Center of Excellence, including the rationale for 
such termination. 
‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi-
tion of designation as a National Center of Excellence 
under this section, the Secretary shall require that an in-
stitution of higher education or consortium of institutions 
of higher education enter into an agreement with the Sec-
retary under which the institution or consortium agrees— 
‘‘(1) to collaborate directly with the Food and 
Drug Administration to publish the reports required 
by subsection (g); 
‘‘(2) to share data with the Food and Drug Ad-
ministration regarding best practices and research 
generated through the funding under subsection (f); 
‘‘(3) to develop, along with industry partners 
(which may include large and small biopharma-
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ceutical manufacturers, generic and nonprescription 
manufacturers, and contract research organizations 
or contract manufacturers that carry out drug devel-
opment and manufacturing activities) and another 
institution or consortium designated under this sec-
tion, if any, a roadmap for developing an advanced 
and continuous pharmaceutical manufacturing work-
force; 
‘‘(4) to develop, along with industry partners 
and other institutions or consortia of such institu-
tions designated under this section, a roadmap for 
strengthening existing, and developing new, relation-
ships with other institutions of higher education or 
consortia thereof; and 
‘‘(5) to provide an annual report to the Food 
and Drug Administration regarding the institution’s 
or consortium’s activities under this section, includ-
ing a description of how the institution or consor-
tium continues to meet and make progress on the 
criteria specified in subsection (c). 
‘‘(f) FUNDING.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
funding, through grants, contracts, or cooperative 
agreements, to the National Centers of Excellence 
designated under this section for the purpose of 
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