II 118TH CONGRESS 1ST SESSION S. 1441 To establish a Center for Biomedical Innovation and Development in order to accelerate innovation and development of advanced medical counter- measure products. IN THE SENATE OF THE UNITED STATES MAY 4, 2023 Mr. CORNYN (for himself and Mr. KAINE) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish a Center for Biomedical Innovation and Devel- opment in order to accelerate innovation and develop- ment of advanced medical countermeasure products. 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 ‘‘Accelerating Bio- 4 medical Innovation Act’’. 5 VerDate Sep 11 2014 03:06 May 13, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1441.IS S1441 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1441 IS SEC. 2. CENTER FOR BIOMEDICAL INNOVATION AND DE- 1 VELOPMENT PROGRAM. 2 Title III of the Public Health Service Act (42 U.S.C. 3 241 et seq.) is amended by inserting after section 319L– 4 1 the following: 5 ‘‘SEC. 319L–2. CENTER FOR BIOMEDICAL INNOVATION AND 6 DEVELOPMENT PROGRAM. 7 ‘‘(a) ESTABLISHMENT OF CONSORTIUM.—Not later 8 than 1 year after the date of enactment of this section, 9 the Secretary shall establish a consortium of not fewer 10 than 3 institutions of higher education (as defined in sec- 11 tion 101 of the Higher Education Act), to accelerate inno- 12 vation and development of advanced medical counter- 13 measure products, including biological products and de- 14 vices, selected by the Biomedical Advanced Research and 15 Development Agency (referred to in this section as 16 ‘BARDA’). Such consortium shall be known as the Center 17 for Biomedical Innovation and Development (referred to 18 in this section as the ‘Center’). 19 ‘‘(b) SELECTION OF PARTICIPATING INSTITU- 20 TIONS.—In selecting institutions of higher education to 21 participate in the Center under subsection (a), the Sec- 22 retary shall— 23 ‘‘(1) select eligible institutions that have— 24 ‘‘(A) expertise and capabilities in current 25 good manufacturing practices, as defined in 26 VerDate Sep 11 2014 03:06 May 13, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1441.IS S1441 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1441 IS part 117 of title 21 Code of Federal Regula- 1 tions (or successor regulations); 2 ‘‘(B) experience in technology innovation, 3 including advanced manufacturing technologies, 4 that may assist in countermeasure and ad- 5 vanced research and development; 6 ‘‘(C) facilities with flexible and adaptable 7 advanced process development capabilities; and 8 ‘‘(D) other relevant qualifications, as de- 9 termined by the Secretary; 10 ‘‘(2) select at least one institution with the ca- 11 pability to handle secure and classified information, 12 as appropriate; and 13 ‘‘(3) prioritize institutions most likely to aid in 14 the advancement and innovation of the medical 15 countermeasure products, the manufacturing proc- 16 esses for such products, and the execution and de- 17 sign of clinical trials. 18 ‘‘(c) CENTER ACTIVITIES.—The Center established 19 under subsection (a) shall assist public and private entities 20 in accelerating nonclinical research discoveries with re- 21 spect to medical countermeasures through advanced devel- 22 opment and clinical trials. The activities of the Center may 23 include— 24 VerDate Sep 11 2014 03:06 May 13, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1441.IS S1441 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1441 IS ‘‘(1) advanced process development and pilot 1 manufacturing to support clinical trials; 2 ‘‘(2) technical assistance; 3 ‘‘(3) contract award management; 4 ‘‘(4) referral and coordination with potential 5 manufacturing partners; 6 ‘‘(5) regulatory assistance; 7 ‘‘(6) technology transfer; and 8 ‘‘(7) program management. 9 ‘‘(d) ELIGIBLE PRODUCTS.—A drug or device (in- 10 cluding a combination of one or more drugs or devices) 11 is eligible for consideration and referral by the Director 12 of BARDA to the Center if such drug or device incor- 13 porates a novel technology, or uses an established tech- 14 nique or technology in a novel way, that will substan- 15 tially— 16 ‘‘(1) further development of a drug or device of 17 interest; 18 ‘‘(2) fulfil an unmet need; or 19 ‘‘(3) develop the manufacturing process for a 20 drug or device. 21 ‘‘(e) INTERNATIONAL COORDINATION.—The Director 22 of BARDA, in collaboration with the Assistant Secretary 23 for Global Affairs and the Center established under sub- 24 section (a), shall coordinate, as appropriate, with inter- 25 VerDate Sep 11 2014 03:06 May 13, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1441.IS S1441 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1441 IS national partners to enhance global health security by en- 1 couraging other initiatives, similar to the program de- 2 scribed in subsection (a), under which international ad- 3 vanced development networks support an expanded world- 4 wide strategy for vaccine, drug, device, and other counter- 5 measure research, development, and manufacturing.’’. 6 Æ VerDate Sep 11 2014 03:06 May 13, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S1441.IS S1441 pbinns on DSKJLVW7X2PROD with $$_JOB