I 
115TH CONGRESS 
2D SESSION 
H. R. 5568 
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 
APRIL 18, 2018 
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 2018’’. 
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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 this section, 
receive requests from institutions of higher edu-
cation to be designated as a National Center of Ex-
cellence in Continuous Pharmaceutical Manufac-
turing (in this section referred to as a ‘National 
Center of Excellence’) to support the advancement 
and development of continuous manufacturing; 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 such information 
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as the Secretary may require. Any such request shall in-
clude a description of how the institution of higher edu-
cation meets or plans to meet each of the criteria 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) scalable manufacturing knowledge-sharing 
networks with other institutions of higher education, 
large and small biopharmaceutical manufacturers, 
generic 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; 
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‘‘(5) the potential to train a future workforce 
for research on and implementation of continuous 
manufacturing; and 
‘‘(6) the potential to participate in and lead a 
continuous manufacturing technology partnership 
with other institutions of higher education, large and 
small biopharmaceutical 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 for continuous manufac-
turing; 
‘‘(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 standardize systems and ap-
proaches for designing continuous manufac-
turing; and 
‘‘(E) to develop a plan to establish a con-
tinuous manufacturing workforce. 
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