I 

116TH CONGRESS 

1ST SESSION H. R. 4866 

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 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 designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous 

Pharmaceutical Manufacturing, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Centers of 

5 Excellence in Continuous Pharmaceutical Manufacturing 

6 Act of 2019’’. 


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1 SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN CONTIN2 UOUS PHARMACEUTICAL MANUFACTURING. 

3 (a) IN GENERAL.—Section 3016 of the 21st Century 

4 Cures Act (21 U.S.C. 399h) is amended to read as follows: 

5 ‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CON6 TINUOUS PHARMACEUTICAL MANUFAC7 TURING. 

8 ‘‘(a) IN GENERAL.—The Secretary of Health and 

9 Human Services, acting through the Commissioner of 

10 Food and Drugs— 

11 ‘‘(1) shall solicit and, beginning not later than 

12 180 days after the date of enactment of the National 

13 Centers of Excellence in Continuous Pharmaceutical 

14 Manufacturing Act of 2019, receive requests from 

15 institutions of higher education to be designated as 

16 a National Center of Excellence in Continuous Phar17 maceutical Manufacturing (in this section referred to 

18 as a ‘National Center of Excellence’) to support the 

19 advancement and development of continuous manu20 facturing; and 

21 ‘‘(2) shall so designate any institution of higher 

22 education that— 

23 ‘‘(A) requests such designation; and 

24 ‘‘(B) meets the criteria specified in sub25 section (c). 


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1 ‘‘(b) REQUEST FOR DESIGNATION.—A request for 

2 designation under subsection (a) shall be made to the Sec3 retary at such time, in such manner, and containing such 

4 information as the Secretary may require. Any such re5 quest shall include a description of how the institution of 

6 higher education meets or plans to meet each of the cri7 teria specified in subsection (c). 

8 ‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 

9 criteria specified in this subsection with respect to an in10 stitution of higher education are that the institution has, 

11 as of the date of the submission of a request under sub12 section (a) by such institution— 

13 ‘‘(1) physical and technical capacity for re14 search and development of continuous manufac15 turing; 

16 ‘‘(2) scalable manufacturing knowledge-sharing 

17 networks with other institutions of higher education, 

18 large and small biopharmaceutical manufacturers, 

19 generic and nonprescription manufacturers, contract 

20 manufacturers, and other entities; 

21 ‘‘(3) proven capacity to design and demonstrate 

22 new, highly effective technology for use in contin23 uous manufacturing; 


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1 ‘‘(4) a track record for creating and transfer2 ring knowledge with respect to continuous manufac3 turing; 

4 ‘‘(5) the potential to train a future workforce 

5 for research on and implementation of continuous 

6 manufacturing; and 

7 ‘‘(6) the potential to participate in and lead a 

8 continuous manufacturing technology partnership 

9 with other institutions of higher education, large and 

10 small biopharmaceutical manufacturers, generic and 

11 nonprescription manufacturers, contract manufac12 turers, and other entities— 

13 ‘‘(A) to support companies with continuous 

14 manufacturing in the United States; 

15 ‘‘(B) to support Federal agencies with 

16 technical assistance for continuous manufac17 turing; 

18 ‘‘(C) with respect to continuous manufac19 turing, to organize and conduct research and 

20 development activities needed to create new and 

21 more effective technology, capture and dissemi22 nate expertise, create intellectual property, and 

23 maintain technological leadership; 


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1 ‘‘(D) to standardize systems and ap2 proaches for designing continuous manufac3 turing; and 

4 ‘‘(E) to develop a plan to establish a con5 tinuous manufacturing workforce. 

6 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec7 retary may terminate the designation of any National Cen8 ter of Excellence designated under this section if the Sec9 retary determines such National Center of Excellence no 

10 longer meets the criteria specified in subsection (c). Not 

11 later than 60 days before the effective date of such a ter12 mination, the Secretary shall provide written notice to the 

13 National Center of Excellence, including the rationale for 

14 such termination. 

15 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi16 tion of designation as a National Center of Excellence 

17 under this section, the Secretary shall require that an in18 stitution of higher education enter into an agreement with 

19 the Secretary under which the institution agrees— 

20 ‘‘(1) to collaborate directly with the Food and 

21 Drug Administration to publish the reports required 

22 by subsection (g); 

23 ‘‘(2) to share data with the Food and Drug Ad24 ministration regarding best practices and research 

25 generated through the funding under subsection (f); 


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1 ‘‘(3) to provide an annual report to the Food 

2 and Drug Administration regarding the institution’s 

3 activities under this section; and 

4 ‘‘(4) to develop, along with industry partners 

5 and another institution or institutions designated 

6 under this section, if any, a roadmap for developing 

7 a continuous manufacturing workforce. 

8 ‘‘(f) FUNDING.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall award 

10 funding to the National Centers of Excellence des11 ignated under this section for the purpose of study12 ing and recommending improvements to continuous 

13 manufacturing, including such improvements as may 

14 enable the Centers— 

15 ‘‘(A) to continue to meet the conditions 

16 specified in subsection (e); 

17 ‘‘(B) to submit reports under subsection 

18 (e)(3); and 

19 ‘‘(C) to expand capacity for research on, 

20 and development of, continuing manufacturing. 

21 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

22 There is authorized to be appropriated to carry out 

23 this subsection $80,000,000 for the period of fiscal 

24 years 2021 through 2025. 


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1 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 

2 this section shall be construed as precluding a Na3 tional Center for Excellence designated under this 

4 section from receiving funds under any other provi5 sion of this Act or any other Federal law. 

6 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 

7 ‘‘(1) ANNUAL REPORT.—Beginning not later 

8 than one year after the date on which the first des9 ignation is made under subsection (a), and annually 

10 thereafter, the Secretary shall— 

11 ‘‘(A) submit to Congress a report describ12 ing the activities, partnerships and collabora13 tions, Federal policy recommendations, previous 

14 and continuing funding, and findings of, and 

15 any other applicable information from, the Na16 tional Centers of Excellence designated under 

17 this section; and 

18 ‘‘(B) make such report available to the 

19 public in an easily accessible electronic format 

20 on the website of the Food and Drug Adminis21 tration. 

22 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EX23 CELLENCE AND POTENTIAL DESIGNEES.—The Sec24 retary shall periodically review the National Centers 

25 of Excellence designated under this section to ensure 


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1 that such National Centers of Excellence continue to 

2 meet the criteria for designation under this section. 

3 ‘‘(3) REPORT ON LONG-TERM VISION OF FDA

4 ROLE.—Not later than 2 years after the date on 

5 which the first designation is made under subsection 

6 (a), the Secretary, in collaboration with the National 

7 Centers of Excellence designated under this section, 

8 shall submit a report to the Congress on the long9 term vision of the Department of Health and 

10 Human Services on the role of the Food and Drug 

11 Administration in supporting continuous manufac12 turing, including— 

13 ‘‘(A) a national framework of principles re14 lated to the implementation and regulation of 

15 continuous manufacturing; and 

16 ‘‘(B) a plan for the development of Federal 

17 regulations and guidance for how continuous 

18 manufacturing can be incorporated into the de19 velopment, review, and approval process for 

20 drugs and biological products. 

21 ‘‘(h) DEFINITIONS.—In this section: 

22 ‘‘(1) BIOLOGICAL PRODUCT.—The term ‘bio23 logical product’ has the meaning given such term in 

24 section 351(i) of the Public Health Service Act (42 

25 U.S.C. 262(i)). 


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1 ‘‘(2) CONTINUOUS MANUFACTURING.—The 

2 term ‘continuous manufacturing’— 

3 ‘‘(A) means a process where the input ma4 terials are continuously fed into and trans5 formed within the process, and the processed 

6 output materials are continuously removed from 

7 the system; and 

8 ‘‘(B) consists of an integrated process that 

9 consists of a series of two or more unit oper10 ations. 

11 ‘‘(3) DRUG.—The term ‘drug’ has the meaning 

12 given such term in section 201 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 321). 

14 ‘‘(4) INSTITUTION OF HIGHER EDUCATION.— 

15 The term ‘institution of higher education’ has the 

16 meaning given such term in section 101(a) of the 

17 Higher Education Act of 1965 (20 U.S.C. 1001(a)). 

18 ‘‘(5) SECRETARY.—The term ‘Secretary’ means 

19 the Secretary of Health and Human Services, acting 

20 through the Commissioner of Food and Drugs.’’. 

21 (b) TRANSITION RULE.—Section 3016 of the 21st 

22 Century Cures Act (21 U.S.C. 399h), as in effect on the 

23 day before the date of the enactment of this section, shall 


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1 apply with respect to grants awarded under such section 

2 before such date of enactment. 

Æ 


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