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-
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—
‘‘(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
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
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-
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
studying and recommending improvements to ad-
vanced and continuous pharmaceutical manufac-
turing, including such improvements as may enable 
the Centers— 
‘‘(A) to continue to meet the conditions 
specified in subsection (e); 
‘‘(B) to expand capacity for research on, 
and development of, advanced and continuous 
pharmaceutical manufacturing; and 
‘‘(C) to implement research infrastructure 
in advanced and continuous pharmaceutical 
manufacturing suitable for accelerating the de-
velopment of drug products needed to respond 
to emerging medical threats, such as emerging 
drug shortages, quality issues disrupting the 
supply chain, epidemics and pandemics, and 
other such situations requiring the rapid devel-
opment of new products or new manufacturing 
processes. 
‘‘(2) CONSISTENCY WITH FDA MISSION.—As a 
condition on receipt of funding under this sub-
section, a National Center of Excellence shall agree 
to consider any input from the Secretary regarding 
the use of funding that would—
‘‘(A) help to further the advancement of 
advanced and continuous pharmaceutical manu-
facturing through the National Center of Excel-
lence; and 
‘‘(B) be relevant to the mission of the 
Food and Drug Administration. 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed as precluding a Na-
tional Center for Excellence designated under this 
section from receiving funds under any other provi-
sion of this Act or any other Federal law. 
‘‘(g) ANNUAL REVIEW AND REPORTS.— 
‘‘(1) ANNUAL
REPORT.—Beginning not later 
than one year after the date on which the first des-
ignation is made under subsection (a), and annually 
thereafter, the Secretary shall— 
‘‘(A) submit to Congress a report describ-
ing the activities, partnerships and collabora-
tions, Federal policy recommendations, previous 
and continuing funding, and findings of, and 
any other applicable information from, the Na-
tional 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 
public in an easily accessible electronic format 
on the website of the Food and Drug Adminis-
tration. 
‘‘(2) REVIEW OF NATIONAL CENTERS OF EX-
CELLENCE AND POTENTIAL DESIGNEES.—The Sec-
retary 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. 
‘‘(3) REPORT ON LONG-TERM VISION OF FDA 
ROLE.—Not later than 2 years 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 long- 
term vision of the Department of Health and 
Human Services on the role of the Food and Drug 
Administration in supporting advanced and contin-
uous pharmaceutical manufacturing, including— 
‘‘(A) a national framework of principles re-
lated to the implementation and regulation of
advanced and continuous pharmaceutical manu-
facturing; 
‘‘(B) a plan for the development of Federal 
regulations and guidance for how advanced and 
continuous pharmaceutical manufacturing can 
be incorporated into the development of phar-
maceuticals and regulatory responsibilities of 
the Food and Drug Administration; 
‘‘(C) a plan for development of Federal 
regulations or guidance for how advanced and 
continuous pharmaceutical manufacturing will 
be reviewed by the Food and Drug Administra-
tion; and 
‘‘(D) appropriate feedback solicited from 
the public, which may include other institutions 
of higher education, large and small biopharma-
ceutical 
manufacturers, 
generic 
and 
non-
prescription manufacturers, and contract manu-
facturers. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) ADVANCED.—The term ‘advanced’, with 
respect to pharmaceutical manufacturing, refers to 
an approach that incorporates novel technology, or 
uses an established technique or technology in a new
or innovative way, that enhances drug quality or im-
proves the performance of a manufacturing process. 
‘‘(2) CONTINUOUS.—The term ‘continuous’, 
with respect to pharmaceutical manufacturing, re-
fers to a process— 
‘‘(A) where the input materials are con-
tinuously fed into and transformed within the 
process, and the processed output materials are 
continuously removed from the system; and 
‘‘(B) that consists of an integrated process 
that consists of a series of two or more simulta-
neous unit operations. 
‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 
The term ‘institution of higher education’ has the 
meaning given such term in section 101(a) of the 
Higher Education Act of 1965 (20 U.S.C. 1001(a)). 
‘‘(4) SECRETARY.—The term ‘Secretary’ means 
the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs. 
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There is authorized to be 
appropriated to carry out this section $100,000,000 
for the period of fiscal years 2022 through 2026. 
‘‘(2) FEDERAL ADMINISTRATIVE EXPENSES.— 
Of the amounts made available to carry out this sec-
tion for a fiscal year, the Secretary shall not use 
more than eight percent for Federal administrative 
expenses, including training, technical assistance, re-
porting, and evaluation.’’. 
(b) TRANSITION RULE.—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, shall 
apply with respect to grants awarded under such section 
before such date of enactment. 
(c) CLERICAL AMENDMENT.—The item relating to 
section 3016 in the table of contents in section 1(b) of 
the 21st Century Cures Act (Public Law 114-255) is 
amended to read as follows: 
‘‘Sec. 3016. National Centers of Excellence in Advanced and Continuous Phar-
maceutical Manufacturing.’’. 
Passed the House of Representatives October 19, 
2021. 
Attest: 
Clerk.
117TH CONGRESS 
1ST SESSION 
H. R. 4369 
AN ACT 
To amend the 21st Century Cures Act to provide 
for designation of institutions of higher education 
that provide research, data, and leadership on 
advanced and continuous pharmaceutical manu-
facturing as National Centers of Excellence in 
Advanced and Continuous Pharmaceutical Manu-
facturing, and for other purposes.