IIB 

116TH CONGRESS 

2D SESSION H. R. 4866 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 22, 2020 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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. 


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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 2020’’. 

7 SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN CONTIN8 UOUS PHARMACEUTICAL MANUFACTURING. 

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

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

11 ‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CON12 TINUOUS PHARMACEUTICAL MANUFAC13 TURING. 

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

15 Human Services, acting through the Commissioner of 

16 Food and Drugs— 

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

18 one year after the date of enactment of the National 

19 Centers of Excellence in Continuous Pharmaceutical 

20 Manufacturing Act of 2020, receive requests from 

21 institutions of higher education to be designated as 

22 a National Center of Excellence in Continuous Phar23 maceutical Manufacturing (in this section referred to 

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


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1 advancement and development of continuous manu2 facturing; and 

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

4 education that— 

5 ‘‘(A) requests such designation; and 

6 ‘‘(B) meets the criteria specified in sub7 section (c). 

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

9 designation under subsection (a) shall be made to the Sec10 retary at such time, in such manner, and containing such 

11 information as the Secretary may require. Any such re12 quest shall include a description of how the institution of 

13 higher education meets or plans to meet each of the cri14 teria specified in subsection (c). 

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

16 criteria specified in this subsection with respect to an in17 stitution of higher education are that the institution has, 

18 as of the date of the submission of a request under sub19 section (a) by such institution— 

20 ‘‘(1) physical and technical capacity for re21 search and development of continuous manufac22 turing; 

23 ‘‘(2) manufacturing knowledge-sharing net24 works with other institutions of higher education, 

25 large and small pharmaceutical manufacturers, geVerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866

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1 neric and nonprescription manufacturers, contract 

2 manufacturers, and other entities; 

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

4 new, highly effective technology for use in contin5 uous manufacturing; 

6 ‘‘(4) a track record for creating and transfer7 ring knowledge with respect to continuous manufac8 turing; 

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

10 for research on and implementation of advanced 

11 manufacturing and continuous manufacturing; and 

12 ‘‘(6) experience in participating in and leading 

13 a continuous manufacturing technology partnership 

14 with other institutions of higher education, large and 

15 small pharmaceutical manufacturers, generic and 

16 nonprescription manufacturers, contract manufac17 turers, and other entities— 

18 ‘‘(A) to support companies with continuous 

19 manufacturing in the United States; 

20 ‘‘(B) to support Federal agencies with 

21 technical assistance, which may include regu22 latory and quality metric guidance as applica23 ble, for advanced manufacturing and continuous 

24 manufacturing; 


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1 ‘‘(C) with respect to continuous manufac2 turing, to organize and conduct research and 

3 development activities needed to create new and 

4 more effective technology, capture and dissemi5 nate expertise, create intellectual property, and 

6 maintain technological leadership; 

7 ‘‘(D) to develop best practices for design8 ing continuous manufacturing; and 

9 ‘‘(E) to assess and respond to the work10 force needs for continuous manufacturing, in11 cluding the development of training programs if 

12 needed. 

13 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec14 retary may terminate the designation of any National Cen15 ter of Excellence designated under this section if the Sec16 retary determines such National Center of Excellence no 

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

18 later than 60 days before the effective date of such a ter19 mination, the Secretary shall provide written notice to the 

20 National Center of Excellence, including the rationale for 

21 such termination. 

22 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi23 tion of designation as a National Center of Excellence 

24 under this section, the Secretary shall require that an inVerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866

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1 stitution of higher education enter into an agreement with 

2 the Secretary under which the institution agrees— 

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

4 Drug Administration to publish the reports required 

5 by subsection (g); 

6 ‘‘(2) to share data with the Food and Drug Ad7 ministration regarding best practices and research 

8 generated through the funding under subsection (f); 

9 ‘‘(3) to develop, along with industry partners 

10 (which may include large and small biopharma11 ceutical manufacturers, generic and nonprescription 

12 manufacturers, and contract manufacturers) and an13 other institution or institutions designated under 

14 this section, if any, a roadmap for developing a con15 tinuous manufacturing workforce; 

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

17 and other institutions designated under this section, 

18 a roadmap for strengthening existing, and devel19 oping new, relationships with other institutions; and 

20 ‘‘(5) to provide an annual report to the Food 

21 and Drug Administration regarding the institution’s 

22 activities under this section, including a description 

23 of how the institution continues to meet and make 

24 progress on the criteria listed in subsection (c). 

25 ‘‘(f) FUNDING.— 


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

2 funding, through grants, contracts, or cooperative 

3 agreements, to the National Centers of Excellence 

4 designated under this section for the purpose of 

5 studying and recommending improvements to contin6 uous manufacturing, including such improvements 

7 as may enable the Centers— 

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

9 specified in subsection (e); and 

10 ‘‘(B) to expand capacity for research on, 

11 and development of, continuing manufacturing. 

12 ‘‘(2) CONSISTENCY WITH FDA MISSION.—As a 

13 condition on receipt of funding under this sub14 section, a National Center of Excellence shall agree 

15 to consider any input from the Secretary regarding 

16 the use of funding that would— 

17 ‘‘(A) help to further the advancement of 

18 continuous manufacturing through the National 

19 Center of Excellence; and 

20 ‘‘(B) be relevant to the mission of the 

21 Food and Drug Administration. 

22 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

23 There is authorized to be appropriated to carry out 

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

25 years 2021 through 2025. 


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1 ‘‘(4) 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 consultation 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; 

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

17 regulations and guidance for how advanced 

18 manufacturing and continuous manufacturing 

19 can be incorporated into the development of 

20 pharmaceuticals and regulatory responsibilities 

21 of the Food and Drug Administration; and 

22 ‘‘(C) appropriate feedback solicited from 

23 the public, which may include other institutions, 

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1 ers, generic and nonprescription manufacturers, 

2 and contract manufacturers. 

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

4 ‘‘(1) ADVANCED MANUFACTURING.—The term 

5 ‘advanced manufacturing’ means an approach for 

6 the manufacturing of pharmaceuticals that incor7 porates novel technology, or uses an established 

8 technique or technology in a new or innovative way 

9 (such as continuous manufacturing where the input 

10 materials are continuously transformed within the 

11 process by two or more unit operations) that en12 hances drug quality or improves the manufacturing 

13 process. 

14 ‘‘(2) CONTINUOUS MANUFACTURING.—The 

15 term ‘continuous manufacturing’— 

16 ‘‘(A) means a process where the input ma17 terials are continuously fed into and trans18 formed within the process, and the processed 

19 output materials are continuously removed from 

20 the system; and 

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

22 consists of a series of two or more unit oper23 ations. 

24 ‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 

25 The term ‘institution of higher education’ has the 


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

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

3 ‘‘(4) SECRETARY.—The term ‘Secretary’ means 

4 the Secretary of Health and Human Services, acting 

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

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

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

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

9 apply with respect to grants awarded under such section 

10 before such date of enactment. 

Passed the House of Representatives September 21, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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