IB 
Union Calendar No. 413 
116TH CONGRESS 
2D SESSION 
H. R. 4866 
[Report No. 116–513] 
To amend the 21st Century Cures Act to provide for designation of institu-
tions of higher education that provide research, data, and leadership 
on continuous manufacturing as National Centers of Excellence in Con-
tinuous Pharmaceutical Manufacturing, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 28, 2019 
Mr. PALLONE (for himself and Mr. GUTHRIE) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
SEPTEMBER 17, 2020 
Additional sponsor: Ms. SPANBERGER 
SEPTEMBER 17, 2020 
Reported with an amendment; committed to the Committee of the Whole 
House on the State of the Union and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on October 28, 2019] 
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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 Ex-
cellence 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 in-
stitutions of higher education to be designated as a 
National Center of Excellence in Continuous Pharma-
ceutical Manufacturing (in this section referred to as 
a ‘National Center of Excellence’) to support the ad-
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vancement and development of continuous manufac-
turing; 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 des-
ignation under subsection (a) shall be made to the Secretary 
at such time, in such manner, and containing such infor-
mation as the Secretary may require. Any such request 
shall include a description of how the institution of higher 
education meets or plans to meet each of the criteria speci-
fied in subsection (c). 
‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 
criteria specified in this subsection with respect to an insti-
tution of higher education are that the institution has, as 
of the date of the submission of a request under subsection 
(a) by such institution— 
‘‘(1) physical and technical capacity for research 
and development of continuous manufacturing; 
‘‘(2) manufacturing knowledge-sharing networks 
with other institutions of higher education, large and 
small pharmaceutical manufacturers, generic and 
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nonprescription manufacturers, contract manufactur-
ers, and other entities; 
‘‘(3) proven capacity to design and demonstrate 
new, highly effective technology for use in continuous 
manufacturing; 
‘‘(4) a track record for creating and transferring 
knowledge with respect to continuous manufacturing; 
‘‘(5) the potential to train a future workforce for 
research on and implementation of advanced manu-
facturing 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 manufactur-
ers, and other entities— 
‘‘(A) to support companies with continuous 
manufacturing in the United States; 
‘‘(B) to support Federal agencies with tech-
nical assistance, which may include regulatory 
and quality metric guidance as applicable, for 
advanced manufacturing and continuous manu-
facturing; 
‘‘(C) with respect to continuous manufac-
turing, to organize and conduct research and de-
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velopment 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 designing 
continuous manufacturing; and 
‘‘(E) to assess and respond to the workforce 
needs for continuous manufacturing, including 
the development of training programs if needed. 
‘‘(d) TERMINATION OF DESIGNATION.—The Secretary 
may terminate the designation of any National Center of 
Excellence designated under this section if the Secretary de-
termines 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 termination, the Sec-
retary shall provide written notice to the National Center 
of Excellence, including the rationale for such termination. 
‘‘(e) CONDITIONS FOR DESIGNATION.—As a condition 
of designation as a National Center of Excellence under this 
section, the Secretary shall require that an institution of 
higher education enter into an agreement with the Sec-
retary under which the institution agrees— 
‘‘(1) to collaborate directly with the Food and 
Drug Administration to publish the reports required 
by subsection (g); 
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‘‘(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 contin-
uous manufacturing workforce; 
‘‘(4) to develop, along with industry partners 
and other institutions designated under this section, 
a roadmap for strengthening existing, and developing 
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.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
funding, through grants, contracts, or cooperative 
agreements, to the National Centers of Excellence des-
ignated under this section for the purpose of studying 
and recommending improvements to continuous man-
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ufacturing, including such improvements as may en-
able 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 subsection, 
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 con-
tinuous 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. 
‘‘(4) RULE OF CONSTRUCTION.—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. 
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‘‘(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 describing 
the activities, partnerships and collaborations, 
Federal policy recommendations, previous and 
continuing funding, and findings of, and any 
other applicable information from, the National 
Centers of Excellence designated under this sec-
tion; and 
‘‘(B) make such report available to the pub-
lic in an easily accessible electronic format on 
the website of the Food and Drug Administra-
tion. 
‘‘(2) REVIEW OF NATIONAL CENTERS OF EXCEL-
LENCE AND POTENTIAL DESIGNEES.—The Secretary 
shall periodically review the National Centers of Ex-
cellence 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 
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(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 Serv-
ices on the role of the Food and Drug Administration 
in supporting continuous manufacturing, 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-
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 incorporates 
novel technology, or uses an established technique or 
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technology in a new or innovative way (such as con-
tinuous manufacturing where the input materials are 
continuously transformed within the process by two 
or more unit operations) that enhances drug quality 
or improves the manufacturing process. 
‘‘(2) CONTINUOUS MANUFACTURING.—The term 
‘continuous manufacturing’— 
‘‘(A) means a process where the input mate-
rials are continuously fed into and transformed 
within the process, and the processed output ma-
terials are continuously removed from the sys-
tem; 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 meaning 
given such term in section 101(a) of the Higher Edu-
cation 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 Cen-
tury Cures Act (21 U.S.C. 399h), as in effect on the day 
before the date of the enactment of this section, shall apply 
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with respect to grants awarded under such section before 
such date of enactment. 
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Union Calendar No. 413 
116TH CONGRESS 
2D SESSION 
H. R. 4866 
[Report No. 116–513] 
A BILL 
To amend the 21st Century Cures Act to provide 
for designation of institutions of higher education 
that provide research, data, and leadership on 
continuous manufacturing as National Centers of 
Excellence in Continuous Pharmaceutical Manu-
facturing, and for other purposes. 
SEPTEMBER 17, 2020 
Reported with an amendment; committed to the Com-
mittee of the Whole House on the State of the Union 
and ordered to be printed 
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