IIB 
116TH CONGRESS 
2D SESSION 
H. R. 4866 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 22, 2020 
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
AN ACT 
To amend the 21st Century Cures Act to provide for designa-
tion of institutions of higher education that provide re-
search, data, and leadership on continuous manufac-
turing as National Centers of Excellence in Continuous 
Pharmaceutical Manufacturing, and for other purposes. 
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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 Continuous Pharmaceutical Manufacturing 
Act of 2020’’. 
SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN CONTIN-
UOUS PHARMACEUTICAL 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 CON-
TINUOUS 
PHARMACEUTICAL 
MANUFAC-
TURING. 
‘‘(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 Continuous Pharmaceutical 
Manufacturing Act of 2020, receive requests from 
institutions of higher education to be designated as 
a National Center of Excellence in Continuous Phar-
maceutical Manufacturing (in this section referred to 
as a ‘National Center of Excellence’) to support the 
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advancement and development of continuous manu-
facturing; and 
‘‘(2) shall so designate any institution of higher 
education that— 
‘‘(A) requests such designation; and 
‘‘(B) meets 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 meets or plans to meet each of the cri-
teria specified in subsection (c). 
‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 
criteria specified in this subsection with respect to an in-
stitution of higher education are that the institution has, 
as of the date of the submission of a request under sub-
section (a) by such institution— 
‘‘(1) physical and technical capacity for re-
search and development of continuous manufac-
turing; 
‘‘(2) manufacturing knowledge-sharing net-
works with other institutions of higher education, 
large and small pharmaceutical manufacturers, ge-
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neric and nonprescription manufacturers, contract 
manufacturers, and other entities; 
‘‘(3) proven capacity to design and demonstrate 
new, highly effective technology for use in contin-
uous manufacturing; 
‘‘(4) a track record for creating and transfer-
ring knowledge with respect to continuous manufac-
turing; 
‘‘(5) the potential to train a future workforce 
for research on and implementation of advanced 
manufacturing and continuous manufacturing; and 
‘‘(6) experience in participating in and leading 
a continuous manufacturing technology partnership 
with other institutions of higher education, large and 
small pharmaceutical manufacturers, generic and 
nonprescription manufacturers, contract manufac-
turers, and other entities— 
‘‘(A) to support companies with continuous 
manufacturing in the United States; 
‘‘(B) to support Federal agencies with 
technical assistance, which may include regu-
latory and quality metric guidance as applica-
ble, for advanced manufacturing and continuous 
manufacturing; 
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‘‘(C) with respect to continuous manufac-
turing, to organize and conduct research and 
development activities needed to create new and 
more effective technology, capture and dissemi-
nate expertise, create intellectual property, and 
maintain technological leadership; 
‘‘(D) to develop best practices for design-
ing continuous manufacturing; and 
‘‘(E) to assess and respond to the work-
force needs for continuous manufacturing, in-
cluding the development of training programs if 
needed. 
‘‘(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 60 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-
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stitution of higher education enter into an agreement with 
the Secretary under which the institution 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 manufacturers) and an-
other institution or institutions designated under 
this section, if any, a roadmap for developing a con-
tinuous manufacturing workforce; 
‘‘(4) to develop, along with industry partners 
and other institutions designated under this section, 
a roadmap for strengthening existing, and devel-
oping new, relationships with other institutions; and 
‘‘(5) to provide an annual report to the Food 
and Drug Administration regarding the institution’s 
activities under this section, including a description 
of how the institution continues to meet and make 
progress on the criteria listed in subsection (c). 
‘‘(f) FUNDING.— 
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‘‘(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 contin-
uous manufacturing, including such improvements 
as may enable the Centers— 
‘‘(A) to continue to meet the conditions 
specified in subsection (e); and 
‘‘(B) to expand capacity for research on, 
and development of, continuing manufacturing. 
‘‘(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 
continuous manufacturing through the National 
Center of Excellence; and 
‘‘(B) be relevant to the mission of the 
Food and Drug Administration. 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $80,000,000 for the period of fiscal 
years 2021 through 2025. 
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‘‘(4) 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; and 
‘‘(B) 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 
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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 continuous manufac-
turing, including— 
‘‘(A) a national framework of principles re-
lated to the implementation and regulation of 
continuous manufacturing; 
‘‘(B) a plan for the development of Federal 
regulations and guidance for how advanced 
manufacturing and continuous manufacturing 
can be incorporated into the development of 
pharmaceuticals and regulatory responsibilities 
of the Food and Drug Administration; and 
‘‘(C) appropriate feedback solicited from 
the public, which may include other institutions, 
large and small biopharmaceutical manufactur-
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ers, generic and nonprescription manufacturers, 
and contract manufacturers. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) ADVANCED MANUFACTURING.—The term 
‘advanced manufacturing’ means an approach for 
the manufacturing of pharmaceuticals that incor-
porates novel technology, or uses an established 
technique or technology in a new or innovative way 
(such as continuous manufacturing where the input 
materials are continuously transformed within the 
process by two or more unit operations) that en-
hances drug quality or improves the manufacturing 
process. 
‘‘(2) 
CONTINUOUS
MANUFACTURING.—The 
term ‘continuous manufacturing’— 
‘‘(A) means a process where the input ma-
terials are continuously fed into and trans-
formed within the process, and the processed 
output materials are continuously removed from 
the system; and 
‘‘(B) consists of an integrated process that 
consists of a series of two or more unit oper-
ations. 
‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 
The term ‘institution of higher education’ has the 
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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.’’. 
(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. 
Passed the House of Representatives September 21, 
2020. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
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