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Union Calendar No. 413 

116TH CONGRESS 

2D SESSION H. R. 4866 

[Report No. 116–513] 

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 

SEPTEMBER 17, 2020 

Additional sponsor: Ms. SPANBERGER

SEPTEMBER 17, 2020 

Reported with an amendment; committed to the Committee of the Whole 

House on the State of the Union and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on October 28, 2019] 


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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. 


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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 Ex5 cellence in Continuous Pharmaceutical Manufacturing Act 

6 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 Food 

16 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 in21 stitutions of higher education to be designated as a 

22 National Center of Excellence in Continuous Pharma23 ceutical Manufacturing (in this section referred to as 

24 a ‘National Center of Excellence’) to support the adVerDate Sep 11 2014 00:32 Sep 18, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H4866.RH H4866

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1 vancement and development of continuous manufac2 turing; 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 des9 ignation under subsection (a) shall be made to the Secretary 

10 at such time, in such manner, and containing such infor11 mation as the Secretary may require. Any such request 

12 shall include a description of how the institution of higher 

13 education meets or plans to meet each of the criteria speci14 fied in subsection (c). 

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

16 criteria specified in this subsection with respect to an insti17 tution of higher education are that the institution has, as 

18 of the date of the submission of a request under subsection 

19 (a) by such institution— 

20 ‘‘(1) physical and technical capacity for research 

21 and development of continuous manufacturing; 

22 ‘‘(2) manufacturing knowledge-sharing networks 

23 with other institutions of higher education, large and 

24 small pharmaceutical manufacturers, generic and 


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1 nonprescription manufacturers, contract manufactur2 ers, and other entities; 

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

4 new, highly effective technology for use in continuous 

5 manufacturing; 

6 ‘‘(4) a track record for creating and transferring 

7 knowledge with respect to continuous manufacturing; 

8 ‘‘(5) the potential to train a future workforce for 

9 research on and implementation of advanced manu10 facturing and continuous manufacturing; and 

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

12 a continuous manufacturing technology partnership 

13 with other institutions of higher education, large and 

14 small pharmaceutical manufacturers, generic and 

15 nonprescription manufacturers, contract manufactur16 ers, and other entities— 

17 ‘‘(A) to support companies with continuous 

18 manufacturing in the United States; 

19 ‘‘(B) to support Federal agencies with tech20 nical assistance, which may include regulatory 

21 and quality metric guidance as applicable, for 

22 advanced manufacturing and continuous manu23 facturing; 

24 ‘‘(C) with respect to continuous manufac25 turing, to organize and conduct research and deVerDate Sep 11 2014 00:32 Sep 18, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H4866.RH H4866

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1 velopment activities needed to create new and 

2 more effective technology, capture and dissemi3 nate expertise, create intellectual property, and 

4 maintain technological leadership; 

5 ‘‘(D) to develop best practices for designing 

6 continuous manufacturing; and 

7 ‘‘(E) to assess and respond to the workforce 

8 needs for continuous manufacturing, including 

9 the development of training programs if needed. 

10 ‘‘(d) TERMINATION OF DESIGNATION.—The Secretary 

11 may terminate the designation of any National Center of 

12 Excellence designated under this section if the Secretary de13 termines such National Center of Excellence no longer meets 

14 the criteria specified in subsection (c). Not later than 60 

15 days before the effective date of such a termination, the Sec16 retary shall provide written notice to the National Center 

17 of Excellence, including the rationale for such termination. 

18 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condition 

19 of designation as a National Center of Excellence under this 

20 section, the Secretary shall require that an institution of 

21 higher education enter into an agreement with the Sec22 retary under which the institution agrees— 

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

24 Drug Administration to publish the reports required 

25 by subsection (g); 


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1 ‘‘(2) to share data with the Food and Drug Ad2 ministration regarding best practices and research 

3 generated through the funding under subsection (f); 

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

5 (which may include large and small biopharma6 ceutical manufacturers, generic and nonprescription 

7 manufacturers, and contract manufacturers) and an8 other institution or institutions designated under this 

9 section, if any, a roadmap for developing a contin10 uous manufacturing workforce; 

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

12 and other institutions designated under this section, 

13 a roadmap for strengthening existing, and developing 

14 new, relationships with other institutions; and 

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

16 and Drug Administration regarding the institution’s 

17 activities under this section, including a description 

18 of how the institution continues to meet and make 

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

20 ‘‘(f) FUNDING.— 

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

22 funding, through grants, contracts, or cooperative 

23 agreements, to the National Centers of Excellence des24 ignated under this section for the purpose of studying 

25 and recommending improvements to continuous manVerDate Sep 11 2014 00:32 Sep 18, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H4866.RH H4866

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1 ufacturing, including such improvements as may en2 able the Centers— 

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

4 specified in subsection (e); and 

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

6 and development of, continuing manufacturing. 

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

8 condition on receipt of funding under this subsection, 

9 a National Center of Excellence shall agree to consider 

10 any input from the Secretary regarding the use of 

11 funding that would— 

12 ‘‘(A) help to further the advancement of con13 tinuous manufacturing through the National 

14 Center of Excellence; and 

15 ‘‘(B) be relevant to the mission of the Food 

16 and Drug Administration. 

17 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

18 There is authorized to be appropriated to carry out 

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

20 years 2021 through 2025. 

21 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

22 section shall be construed as precluding a National 

23 Center for Excellence designated under this section 

24 from receiving funds under any other provision of 

25 this Act or any other Federal law. 


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1 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 

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

3 than one year after the date on which the first des4 ignation is made under subsection (a), and annually 

5 thereafter, the Secretary shall— 

6 ‘‘(A) submit to Congress a report describing 

7 the activities, partnerships and collaborations, 

8 Federal policy recommendations, previous and 

9 continuing funding, and findings of, and any 

10 other applicable information from, the National 

11 Centers of Excellence designated under this sec12 tion; and 

13 ‘‘(B) make such report available to the pub14 lic in an easily accessible electronic format on 

15 the website of the Food and Drug Administra16 tion. 

17 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EXCEL18 LENCE AND POTENTIAL DESIGNEES.—The Secretary 

19 shall periodically review the National Centers of Ex20 cellence designated under this section to ensure that 

21 such National Centers of Excellence continue to meet 

22 the criteria for designation under this section. 

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

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

25 which the first designation is made under subsection 


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1 (a), the Secretary, in consultation with the National 

2 Centers of Excellence designated under this section, 

3 shall submit a report to the Congress on the long-term 

4 vision of the Department of Health and Human Serv5 ices on the role of the Food and Drug Administration 

6 in supporting continuous manufacturing, including— 

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

9 continuous manufacturing; 

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

11 regulations and guidance for how advanced 

12 manufacturing and continuous manufacturing 

13 can be incorporated into the development of 

14 pharmaceuticals and regulatory responsibilities 

15 of the Food and Drug Administration; and 

16 ‘‘(C) appropriate feedback solicited from the 

17 public, which may include other institutions, 

18 large and small biopharmaceutical manufactur19 ers, generic and nonprescription manufacturers, 

20 and contract manufacturers. 

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

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

23 ‘advanced manufacturing’ means an approach for the 

24 manufacturing of pharmaceuticals that incorporates 

25 novel technology, or uses an established technique or 


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1 technology in a new or innovative way (such as con2 tinuous manufacturing where the input materials are 

3 continuously transformed within the process by two 

4 or more unit operations) that enhances drug quality 

5 or improves the manufacturing process. 

6 ‘‘(2) CONTINUOUS MANUFACTURING.—The term 

7 ‘continuous manufacturing’— 

8 ‘‘(A) means a process where the input mate9 rials are continuously fed into and transformed 

10 within the process, and the processed output ma11 terials are continuously removed from the sys12 tem; and 

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

14 consists of a series of two or more unit oper15 ations. 

16 ‘‘(3) INSTITUTION OF HIGHER EDUCATION.—The 

17 term ‘institution of higher education’ has the meaning 

18 given such term in section 101(a) of the Higher Edu19 cation Act of 1965 (20 U.S.C. 1001(a)). 

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

21 the Secretary of Health and Human Services, acting 

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

23 (b) TRANSITION RULE.—Section 3016 of the 21st Cen24 tury Cures Act (21 U.S.C. 399h), as in effect on the day 

25 before the date of the enactment of this section, shall apply 


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1 with respect to grants awarded under such section before 

2 such date of enactment. 


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Union Calendar No. 413 

116TH CONGRESS 

2D SESSION H. R. 4866 

[Report No. 116–513] 

A BILL 

To amend the 21st Century Cures Act to provide 

facturing, and for other purposes. Excellence in Continuous Pharmaceutical Manucontinuous manufacturing as National Centers of that provide research, data, and leadership on for designation of institutions of higher education 

SEPTEMBER 17, 2020 

Reported with an amendment; committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union 


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