II 

117TH CONGRESS 

1ST SESSION S. 2589 

To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership 

on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 3, 2021 

Mrs. BLACKBURN (for herself and Mr. MENENDEZ) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 advanced and 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 ‘‘Securing America’s 

5 Medicine Cabinet Act of 2021’’. 


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1 SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN AD2 VANCED AND CONTINUOUS PHARMA3 CEUTICAL MANUFACTURING. 

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

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

6 ‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN AD7 VANCED AND CONTINUOUS PHARMA8 CEUTICAL MANUFACTURING. 

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

10 Human Services, acting through the Commissioner of 

11 Food and Drugs— 

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

13 one year after the date of enactment of the Securing 

14 America’s Medicine Cabinet Act of 2021, receive re15 quests from institutions of higher education, or con16 sortia of institutions of higher education, to be des17 ignated as a National Center of Excellence in Ad18 vanced and Continuous Pharmaceutical Manufac19 turing (in this section referred to as a ‘National 

20 Center of Excellence’) to support the advancement, 

21 development, and implementation of advanced and 

22 continuous pharmaceutical manufacturing; and 

23 ‘‘(2) shall so designate not more than 5 institu24 tions of higher education or consortia of such insti25 tutions that— 

26 ‘‘(A) request such designation; and 


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1 ‘‘(B) meet the criteria specified in sub2 section (c). 

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

4 designation under subsection (a) shall be made to the Sec5 retary at such time, in such manner, and containing such 

6 information as the Secretary may require. Any such re7 quest shall include a description of how the institution of 

8 higher education, or consortium of institutions of higher 

9 education, meets or plans to meet each of the criteria spec10 ified in subsection (c). 

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

12 criteria specified in this subsection with respect to an in13 stitution of higher education, or consortium of institutions 

14 of higher education, are that the institution or consortium 

15 has, as of the date of the submission of a request under 

16 subsection (a) by such institution or consortium— 

17 ‘‘(1) physical and technical capacity for re18 search, development, implementation, and dem19 onstration of advanced and continuous pharma20 ceutical manufacturing; 

21 ‘‘(2) manufacturing knowledge-sharing net22 works with other institutions of higher education, 

23 large and small pharmaceutical manufacturers, ge24 neric and nonprescription manufacturers, contract 

25 manufacturers, and other relevant entities; 


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1 ‘‘(3) proven capacity to design, develop, imple2 ment, and demonstrate new, highly effective tech3 nologies for use in advanced and continuous phar4 maceutical manufacturing; 

5 ‘‘(4) a track record for creating, preserving, 

6 and transferring knowledge with respect to advanced 

7 and continuous pharmaceutical manufacturing; 

8 ‘‘(5) the proven ability to facilitate training of 

9 an adequate future workforce for research on, and 

10 implementation of, advanced and continuous phar11 maceutical manufacturing; and 

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

13 advanced and continuous pharmaceutical manufac14 turing technology partnerships with other institu15 tions of higher education, large and small pharma16 ceutical manufacturers, generic and nonprescription 

17 manufacturers, contract manufacturers, and other 

18 relevant entities— 

19 ‘‘(A) to support companies seeking to im20 plement advanced and continuous pharma21 ceutical manufacturing in the United States; 

22 ‘‘(B) to support Federal agencies with 

23 technical assistance and employee training, 

24 which may include regulatory and quality met25 ric guidance as applicable, and hands-on trainVerDate Sep 11 2014 16:14 Aug 04, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2589.IS S2589

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1 ing, for advanced and continuous pharma2 ceutical manufacturing; 

3 ‘‘(C) with respect to advanced and contin4 uous pharmaceutical manufacturing, to orga5 nize and conduct research and development ac6 tivities needed to create new and more effective 

7 technology, develop and share knowledge, create 

8 intellectual property, and maintain technological 

9 leadership; 

10 ‘‘(D) to develop best practices for design11 ing and implementing advanced and continuous 

12 pharmaceutical manufacturing processes; and 

13 ‘‘(E) to assess and respond to the national 

14 workforce needs for advanced and continuous 

15 pharmaceutical manufacturing, including the 

16 development and implementing of training pro17 grams. 

18 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec19 retary may terminate the designation of any National Cen20 ter of Excellence designated under this section if the Sec21 retary determines such National Center of Excellence no 

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

23 later than 90 days before the effective date of such a ter24 mination, the Secretary shall provide written notice to the 


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1 National Center of Excellence, including the rationale for 

2 such termination. 

3 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi4 tion of designation as a National Center of Excellence 

5 under this section, the Secretary shall require that an in6 stitution of higher education or consortium of institutions 

7 of higher education enters into an agreement with the Sec8 retary under which the institution or consortium agrees— 

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

10 Drug Administration to publish the reports required 

11 by subsection (g); 

12 ‘‘(2) to share data with the Food and Drug Ad13 ministration regarding best practices and research 

14 generated through the funding under subsection (f); 

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

16 (which may include large and small biopharma17 ceutical manufacturers, generic and nonprescription 

18 manufacturers, and contract research organizations 

19 or contract manufacturers that carry out drug devel20 opment and manufacturing activities) and another 

21 institution or consortium designated under this sec22 tion, if any, a roadmap for developing an advanced 

23 and continuous pharmaceutical manufacturing work24 force; 


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

2 and other institutions or consortia of such institu3 tions designated under this section, a roadmap for 

4 strengthening existing, and developing new, relation5 ships with other institutions of higher education or 

6 consortia thereof; and 

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

8 and Drug Administration regarding the institution’s 

9 or consortium’s activities under this section, includ10 ing a description of how the institution or consor11 tium continues to meet and make progress on the 

12 criteria specified in subsection (c). 

13 ‘‘(f) FUNDING.— 

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

15 funding, through grants, contracts, or cooperative 

16 agreements, to the National Centers of Excellence 

17 designated under this section for the purpose of 

18 studying and recommending improvements to ad19 vanced and continuous pharmaceutical manufac20 turing, including such improvements as may enable 

21 the Centers— 

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

23 specified in subsection (e); 


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

2 and development of, advanced and continuous 

3 pharmaceutical manufacturing; and 

4 ‘‘(C) to implement research infrastructure 

5 in advanced and continuous pharmaceutical 

6 manufacturing suitable for accelerating the de7 velopment of drug products needed to respond 

8 to emerging medical threats, such as emerging 

9 drug shortages, quality issues disrupting the 

10 supply chain, epidemics and pandemics, and 

11 other such situations requiring the rapid devel12 opment of new products or new manufacturing 

13 processes. 

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

15 condition on receipt of funding under this sub16 section, a National Center of Excellence shall agree 

17 to consider any input from the Secretary regarding 

18 the use of funding that would— 

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

20 advanced and continuous pharmaceutical manu21 facturing through the National Center of Excel22 lence; and 

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

24 Food and Drug Administration. 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

2 There is authorized to be appropriated to carry out 

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

4 years 2022 through 2026. 

5 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

6 this section shall be construed as precluding a Na7 tional Center for Excellence designated under this 

8 section from receiving funds under any other provi9 sion of this Act or any other Federal law. 

10 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 

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

12 than one year after the date on which the first des13 ignation is made under subsection (a), and annually 

14 thereafter, the Secretary shall— 

15 ‘‘(A) submit to Congress a report describ16 ing the activities, partnerships and collabora17 tions, Federal policy recommendations, previous 

18 and continuing funding, and findings of, and 

19 any other applicable information from, the Na20 tional Centers of Excellence designated under 

21 this section; and 

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

23 public in an easily accessible electronic format 

24 on the website of the Food and Drug Adminis25 tration. 


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1 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EX2 CELLENCE AND POTENTIAL DESIGNEES.—The Sec3 retary shall periodically review the National Centers 

4 of Excellence designated under this section to ensure 

5 that such National Centers of Excellence continue to 

6 meet the criteria for designation under this section. 

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

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

9 which the first designation is made under subsection 

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

11 Centers of Excellence designated under this section, 

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

13 vision of the Department of Health and Human 

14 Services on the role of the Food and Drug Adminis15 tration in supporting advanced and continuous phar16 maceutical manufacturing, including— 

17 ‘‘(A) a national framework of principles re18 lated to the implementation and regulation of 

19 advanced and continuous pharmaceutical manu20 facturing; 

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

22 regulations and guidance for how advanced and 

23 continuous pharmaceutical manufacturing can 

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1 maceuticals and regulatory responsibilities of 

2 the Food and Drug Administration; 

3 ‘‘(C) a plan for development of Federal 

4 regulations or guidance for how advanced and 

5 continuous pharmaceutical manufacturing will 

6 be reviewed by the Food and Drug Administra7 tion; and 

8 ‘‘(D) appropriate feedback solicited from 

9 the public, which may include other institutions 

10 of higher education, large and small biopharma11 ceutical manufacturers, generic and non12 prescription manufacturers, and contract manu13 facturers. 

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

15 ‘‘(1) ADVANCED.—The term ‘advanced’, with 

16 respect to pharmaceutical manufacturing, refers to 

17 an approach that incorporates novel technology, or 

18 uses an established technique or technology in a new 

19 or innovative way, that enhances drug quality or im20 proves the performance of a manufacturing process. 

21 ‘‘(2) CONTINUOUS.—The term ‘continuous’, 

22 with respect to pharmaceutical manufacturing, re23 fers to a process— 

24 ‘‘(A) where the input materials are con25 tinuously fed into and transformed within the 


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1 process, and the processed output materials are 

2 continuously removed from the system; and 

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

4 that consists of a series of two or more simulta5 neous unit operations. 

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

7 The term ‘institution of higher education’ has the 

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

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

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

11 the Secretary of Health and Human Services, acting 

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

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

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

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

16 apply with respect to grants awarded under such section 

17 before such date of enactment. 

Æ 


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