National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020

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 designa- tion of institutions of higher education that provide re- search, data, and leadership on continuous manufac- turing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes. VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 2 HR 4866 RFS Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘National Centers of 4 Excellence in Continuous Pharmaceutical Manufacturing 5 Act of 2020’’. 6 SEC. 2. NATIONAL CENTERS OF EXCELLENCE IN CONTIN- 7 UOUS PHARMACEUTICAL MANUFACTURING. 8 (a) IN GENERAL.—Section 3016 of the 21st Century 9 Cures Act (21 U.S.C. 399h) is amended to read as follows: 10 ‘‘SEC. 3016. NATIONAL CENTERS OF EXCELLENCE IN CON- 11 TINUOUS PHARMACEUTICAL MANUFAC- 12 TURING. 13 ‘‘(a) IN GENERAL.—The Secretary of Health and 14 Human Services, acting through the Commissioner of 15 Food and Drugs— 16 ‘‘(1) shall solicit and, beginning not later than 17 one year after the date of enactment of the National 18 Centers of Excellence in Continuous Pharmaceutical 19 Manufacturing Act of 2020, receive requests from 20 institutions of higher education to be designated as 21 a National Center of Excellence in Continuous Phar- 22 maceutical Manufacturing (in this section referred to 23 as a ‘National Center of Excellence’) to support the 24 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 3 HR 4866 RFS advancement and development of continuous manu- 1 facturing; and 2 ‘‘(2) shall so designate any institution of higher 3 education that— 4 ‘‘(A) requests such designation; and 5 ‘‘(B) meets the criteria specified in sub- 6 section (c). 7 ‘‘(b) REQUEST FOR DESIGNATION.—A request for 8 designation under subsection (a) shall be made to the Sec- 9 retary at such time, in such manner, and containing such 10 information as the Secretary may require. Any such re- 11 quest shall include a description of how the institution of 12 higher education meets or plans to meet each of the cri- 13 teria specified in subsection (c). 14 ‘‘(c) CRITERIA FOR DESIGNATION DESCRIBED.—The 15 criteria specified in this subsection with respect to an in- 16 stitution of higher education are that the institution has, 17 as of the date of the submission of a request under sub- 18 section (a) by such institution— 19 ‘‘(1) physical and technical capacity for re- 20 search and development of continuous manufac- 21 turing; 22 ‘‘(2) manufacturing knowledge-sharing net- 23 works with other institutions of higher education, 24 large and small pharmaceutical manufacturers, ge- 25 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 4 HR 4866 RFS neric and nonprescription manufacturers, contract 1 manufacturers, and other entities; 2 ‘‘(3) proven capacity to design and demonstrate 3 new, highly effective technology for use in contin- 4 uous manufacturing; 5 ‘‘(4) a track record for creating and transfer- 6 ring knowledge with respect to continuous manufac- 7 turing; 8 ‘‘(5) the potential to train a future workforce 9 for research on and implementation of advanced 10 manufacturing 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 manufac- 16 turers, and other entities— 17 ‘‘(A) to support companies with continuous 18 manufacturing in the United States; 19 ‘‘(B) to support Federal agencies with 20 technical assistance, which may include regu- 21 latory and quality metric guidance as applica- 22 ble, for advanced manufacturing and continuous 23 manufacturing; 24 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 5 HR 4866 RFS ‘‘(C) with respect to continuous manufac- 1 turing, to organize and conduct research and 2 development activities needed to create new and 3 more effective technology, capture and dissemi- 4 nate expertise, create intellectual property, and 5 maintain technological leadership; 6 ‘‘(D) to develop best practices for design- 7 ing continuous manufacturing; and 8 ‘‘(E) to assess and respond to the work- 9 force needs for continuous manufacturing, in- 10 cluding the development of training programs if 11 needed. 12 ‘‘(d) TERMINATION OF DESIGNATION.—The Sec- 13 retary may terminate the designation of any National Cen- 14 ter of Excellence designated under this section if the Sec- 15 retary determines such National Center of Excellence no 16 longer meets the criteria specified in subsection (c). Not 17 later than 60 days before the effective date of such a ter- 18 mination, the Secretary shall provide written notice to the 19 National Center of Excellence, including the rationale for 20 such termination. 21 ‘‘(e) CONDITIONS FOR DESIGNATION.—As a condi- 22 tion of designation as a National Center of Excellence 23 under this section, the Secretary shall require that an in- 24 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 6 HR 4866 RFS stitution of higher education enter into an agreement with 1 the Secretary under which the institution agrees— 2 ‘‘(1) to collaborate directly with the Food and 3 Drug Administration to publish the reports required 4 by subsection (g); 5 ‘‘(2) to share data with the Food and Drug Ad- 6 ministration regarding best practices and research 7 generated through the funding under subsection (f); 8 ‘‘(3) to develop, along with industry partners 9 (which may include large and small biopharma- 10 ceutical manufacturers, generic and nonprescription 11 manufacturers, and contract manufacturers) and an- 12 other institution or institutions designated under 13 this section, if any, a roadmap for developing a con- 14 tinuous manufacturing workforce; 15 ‘‘(4) to develop, along with industry partners 16 and other institutions designated under this section, 17 a roadmap for strengthening existing, and devel- 18 oping new, relationships with other institutions; and 19 ‘‘(5) to provide an annual report to the Food 20 and Drug Administration regarding the institution’s 21 activities under this section, including a description 22 of how the institution continues to meet and make 23 progress on the criteria listed in subsection (c). 24 ‘‘(f) FUNDING.— 25 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 7 HR 4866 RFS ‘‘(1) IN GENERAL.—The Secretary shall award 1 funding, through grants, contracts, or cooperative 2 agreements, to the National Centers of Excellence 3 designated under this section for the purpose of 4 studying and recommending improvements to contin- 5 uous manufacturing, including such improvements 6 as may enable the Centers— 7 ‘‘(A) to continue to meet the conditions 8 specified in subsection (e); and 9 ‘‘(B) to expand capacity for research on, 10 and development of, continuing manufacturing. 11 ‘‘(2) CONSISTENCY WITH FDA MISSION.—As a 12 condition on receipt of funding under this sub- 13 section, a National Center of Excellence shall agree 14 to consider any input from the Secretary regarding 15 the use of funding that would— 16 ‘‘(A) help to further the advancement of 17 continuous manufacturing through the National 18 Center of Excellence; and 19 ‘‘(B) be relevant to the mission of the 20 Food and Drug Administration. 21 ‘‘(3) 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. 25 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 8 HR 4866 RFS ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 1 this section shall be construed as precluding a Na- 2 tional Center for Excellence designated under this 3 section from receiving funds under any other provi- 4 sion of this Act or any other Federal law. 5 ‘‘(g) ANNUAL REVIEW AND REPORTS.— 6 ‘‘(1) ANNUAL REPORT.—Beginning not later 7 than one year after the date on which the first des- 8 ignation is made under subsection (a), and annually 9 thereafter, the Secretary shall— 10 ‘‘(A) submit to Congress a report describ- 11 ing the activities, partnerships and collabora- 12 tions, Federal policy recommendations, previous 13 and continuing funding, and findings of, and 14 any other applicable information from, the Na- 15 tional Centers of Excellence designated under 16 this section; and 17 ‘‘(B) make such report available to the 18 public in an easily accessible electronic format 19 on the website of the Food and Drug Adminis- 20 tration. 21 ‘‘(2) REVIEW OF NATIONAL CENTERS OF EX- 22 CELLENCE AND POTENTIAL DESIGNEES.—The Sec- 23 retary shall periodically review the National Centers 24 of Excellence designated under this section to ensure 25 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 9 HR 4866 RFS that such National Centers of Excellence continue to 1 meet the criteria for designation under this section. 2 ‘‘(3) REPORT ON LONG-TERM VISION OF FDA 3 ROLE.—Not later than 2 years after the date on 4 which the first designation is made under subsection 5 (a), the Secretary, in consultation with the National 6 Centers of Excellence designated under this section, 7 shall submit a report to the Congress on the long- 8 term vision of the Department of Health and 9 Human Services on the role of the Food and Drug 10 Administration in supporting continuous manufac- 11 turing, including— 12 ‘‘(A) a national framework of principles re- 13 lated to the implementation and regulation of 14 continuous manufacturing; 15 ‘‘(B) a plan for the development of Federal 16 regulations and guidance for how advanced 17 manufacturing and continuous manufacturing 18 can be incorporated into the development of 19 pharmaceuticals and regulatory responsibilities 20 of the Food and Drug Administration; and 21 ‘‘(C) appropriate feedback solicited from 22 the public, which may include other institutions, 23 large and small biopharmaceutical manufactur- 24 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 10 HR 4866 RFS ers, generic and nonprescription manufacturers, 1 and contract manufacturers. 2 ‘‘(h) DEFINITIONS.—In this section: 3 ‘‘(1) ADVANCED MANUFACTURING.—The term 4 ‘advanced manufacturing’ means an approach for 5 the manufacturing of pharmaceuticals that incor- 6 porates novel technology, or uses an established 7 technique or technology in a new or innovative way 8 (such as continuous manufacturing where the input 9 materials are continuously transformed within the 10 process by two or more unit operations) that en- 11 hances drug quality or improves the manufacturing 12 process. 13 ‘‘(2) CONTINUOUS MANUFACTURING.—The 14 term ‘continuous manufacturing’— 15 ‘‘(A) means a process where the input ma- 16 terials are continuously fed into and trans- 17 formed within the process, and the processed 18 output materials are continuously removed from 19 the system; and 20 ‘‘(B) consists of an integrated process that 21 consists of a series of two or more unit oper- 22 ations. 23 ‘‘(3) INSTITUTION OF HIGHER EDUCATION.— 24 The term ‘institution of higher education’ has the 25 VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS 11 HR 4866 RFS meaning given such term in section 101(a) of the 1 Higher Education Act of 1965 (20 U.S.C. 1001(a)). 2 ‘‘(4) SECRETARY.—The term ‘Secretary’ means 3 the Secretary of Health and Human Services, acting 4 through the Commissioner of Food and Drugs.’’. 5 (b) TRANSITION RULE.—Section 3016 of the 21st 6 Century Cures Act (21 U.S.C. 399h), as in effect on the 7 day before the date of the enactment of this section, shall 8 apply with respect to grants awarded under such section 9 before such date of enactment. 10 Passed the House of Representatives September 21, 2020. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 03:54 Sep 23, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4866.RFS H4866 pamtmann on DSKBC07HB2PROD with BILLS