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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— 
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‘‘(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-
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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 
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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 
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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-
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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: 
CHERYL L. JOHNSON, 
Clerk. 
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