I 

115TH CONGRESS 

2D SESSION H. R. 5568 

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 

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 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 2018’’. 


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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 this section, 

13 receive requests from institutions of higher edu14 cation to be designated as a National Center of Ex15 cellence in Continuous Pharmaceutical Manufac16 turing (in this section referred to as a ‘National 

17 Center of Excellence’) to support the advancement 

18 and development of continuous manufacturing; and 

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

20 education that— 

21 ‘‘(A) requests such designation; and 

22 ‘‘(B) meets the criteria specified in sub23 section (c). 

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

25 designation under subsection (a) shall be made to the Sec26 retary at such time, in such manner, and such information 


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1 as the Secretary may require. Any such request shall in2 clude a description of how the institution of higher edu3 cation meets or plans to meet each of the criteria specified 

4 in subsection (c). 

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

6 criteria specified in this subsection with respect to an in7 stitution of higher education are that the institution has, 

8 as of the date of the submission of a request under sub9 section (a) by such institution— 

10 ‘‘(1) physical and technical capacity for re11 search and development of continuous manufac12 turing; 

13 ‘‘(2) scalable manufacturing knowledge-sharing 

14 networks with other institutions of higher education, 

15 large and small biopharmaceutical manufacturers, 

16 generic and nonprescription manufacturers, contract 

17 manufacturers, and other entities; 

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

19 new, highly effective technology for use in contin20 uous manufacturing; 

21 ‘‘(4) a track record for creating and transfer22 ring knowledge with respect to continuous manufac23 turing; 


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

2 for research on and implementation of continuous 

3 manufacturing; and 

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

5 continuous manufacturing technology partnership 

6 with other institutions of higher education, large and 

7 small biopharmaceutical manufacturers, generic and 

8 nonprescription manufacturers, contract manufac9 turers, and other entities— 

10 ‘‘(A) to support companies with continuous 

11 manufacturing in the United States; 

12 ‘‘(B) to support Federal agencies with 

13 technical assistance for continuous manufac14 turing; 

15 ‘‘(C) with respect to continuous manufac16 turing, to organize and conduct research and 

17 development activities needed to create new and 

18 more effective technology, capture and dissemi19 nate expertise, create intellectual property, and 

20 maintain technological leadership; 

21 ‘‘(D) to standardize systems and ap22 proaches for designing continuous manufac23 turing; and 

24 ‘‘(E) to develop a plan to establish a con25 tinuous manufacturing workforce. 


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1 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec2 retary may terminate the designation of any National Cen3 ter of Excellence designated under this section if the Sec4 retary determines such National Center of Excellence no 

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

6 later than 60 days before the effective date of such a ter7 mination, the Secretary shall provide written notice to the 

8 National Center of Excellence, including the rationale for 

9 such termination. 

10 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi11 tion of designation as a National Center of Excellence 

12 under this section, the Secretary shall require that an in13 stitution of higher education enter into an agreement with 

14 the Secretary under which the institution agrees— 

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

16 Drug Administration to publish the reports required 

17 by subsection (g); 

18 ‘‘(2) to share data with the Food and Drug Ad19 ministration regarding best practices and research 

20 generated through the funding under subsection (f); 

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

22 and Drug Administration regarding the institution’s 

23 activities under this section; and 

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

25 and another institution or institutions designated 


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

2 a continuous manufacturing workforce. 

3 ‘‘(f) FUNDING.— 

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

5 funding to the National Centers of Excellence des6 ignated under this section for the purpose of study7 ing and recommending improvements to continuous 

8 manufacturing, including such improvements as may 

9 enable the Centers— 

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

11 specified in subsection (e); 

12 ‘‘(B) to submit reports under subsection 

13 (e)(3); and 

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

15 and development of, continuing manufacturing. 

16 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

17 There are authorized to be appropriated to carry out 

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

19 years 2019 through 2023. 

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

21 this section shall be construed as precluding a Na22 tional Center for Excellence designated under this 

23 section from receiving funds under any other provi24 sion of this Act or any other Federal law. 

25 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 


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

2 than one year after the date on which the first des3 ignation is made under subsection (a), and annually 

4 thereafter, the Secretary shall— 

5 ‘‘(A) submit to Congress a report describ6 ing the activities, partnerships and collabora7 tions, Federal policy recommendations, previous 

8 and continuing funding, and findings of, and 

9 any other applicable information from, the Na10 tional Centers of Excellence designated under 

11 this section; and 

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

13 public in an easily accessible electronic format 

14 on the website of the Food and Drug Adminis15 tration. 

16 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EX17 CELLENCE AND POTENTIAL DESIGNEES.—The Sec18 retary shall periodically review the National Centers 

19 of Excellence designated under this section to ensure 

20 that such National Centers of Excellence continue to 

21 meet the criteria for designation under this section. 

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

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

24 which the first designation is made under subsection 

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


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1 Centers of Excellence designated under this section, 

2 shall submit a report to the Congress on the long3 term vision of the Department of Health and 

4 Human Services on the role of the Food and Drug 

5 Administration in supporting continuous manufac6 turing, including— 

7 ‘‘(A) a national framework of principles re8 lated to the implementation and regulation of 

9 continuous manufacturing; and 

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

11 regulations and guidance for how continuous 

12 manufacturing can be incorporated into the de13 velopment, review, and approval process for 

14 drugs and biological products. 

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

16 ‘‘(1) BIOLOGICAL PRODUCT.—The term ‘bio17 logical product’ has the meaning given such term in 

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

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

20 ‘‘(2) CONTINUOUS MANUFACTURING.—The 

21 term ‘continuous manufacturing’— 

22 ‘‘(A) means a process where the input ma23 terials are continuously fed into and trans24 formed within the process, and the processed 


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1 output materials are continuously removed from 

2 the system; and 

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

4 consists of a series of two or more unit oper5 ations. 

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

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

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

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

10 The term ‘institution of higher education’ has the 

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

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

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

14 the Secretary of Health and Human Services, acting 

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

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

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

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

19 apply with respect to grants awarded under such section 

20 before such date of enactment. 

Æ 


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