I 
116TH CONGRESS 
1ST SESSION H. R. 4866 
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 
A BILL 
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. 
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 2019’’. 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
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 
180 days after the date of enactment of the National 
Centers of Excellence in Continuous Pharmaceutical 
Manufacturing Act of 2019, 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 
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). 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(3) to provide an annual report to the Food 
and Drug Administration regarding the institution’s 
activities under this section; and 
‘‘(4) to develop, along with industry partners 
and another institution or institutions designated 
under this section, if any, a roadmap for developing 
a continuous manufacturing workforce. 
‘‘(f) FUNDING.— 
‘‘(1) IN GENERAL.—The Secretary shall award 
funding to the National Centers of Excellence des-
ignated under this section for the purpose of study-
ing and recommending improvements to continuous 
manufacturing, including such improvements as may 
enable the Centers— 
‘‘(A) to continue to meet the conditions 
specified in subsection (e); 
‘‘(B) to submit reports under subsection 
(e)(3); and 
‘‘(C) to expand capacity for research on, 
and development of, continuing manufacturing. 
‘‘(2) 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. 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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; 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 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
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 collaboration 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; and 
‘‘(B) a plan for the development of Federal 
regulations and guidance for how continuous 
manufacturing can be incorporated into the de-
velopment, review, and approval process for 
drugs and biological products. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) BIOLOGICAL
PRODUCT.—The term ‘bio-
logical product’ has the meaning given such term in 
section 351(i) of the Public Health Service Act (42 
U.S.C. 262(i)). 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(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) DRUG.—The term ‘drug’ has the meaning 
given such term in section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321). 
‘‘(4) 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)). 
‘‘(5) 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 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS
apply with respect to grants awarded under such section 
before such date of enactment. 
Æ 
VerDate Sep 11 2014 
03:53 Nov 01, 2019
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6301
E:\BILLS\H4866.IH
H4866
pamtmann on DSKBC07HB2PROD with BILLS