TRANSPLANT Act of 2020

II 116TH CONGRESS 2D SESSION S. 4672 To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes. IN THE SENATE OF THE UNITED STATES SEPTEMBER 23, 2020 Mr. REED (for himself, Mr. BURR, Ms. SMITH, and Mr. SCOTT of South Caro- lina) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes. 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 ‘‘Timely ReAuthoriza- 4 tion of Necessary Stem-cell Programs Lends Access to 5 Needed Therapies Act of 2020’’ or the ‘‘TRANSPLANT 6 Act of 2020’’. 7 VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 4672 IS SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 1 TRANSPLANTATION PROGRAM. 2 (a) ADVISORY COUNCIL MEETINGS.—Subsection (a) 3 of section 379 of the Public Health Service Act (42 U.S.C. 4 274k) is amended by adding at the end the following new 5 paragraph: 6 ‘‘(7) The Advisory Council shall meet not less 7 frequently than 2 times per year.’’. 8 (b) INCREASING COLLECTION.— 9 (1) TECHNICAL CLARIFICATION.—Effective as 10 if included in the enactment of Public Law 114–104 11 (the Stem Cell Therapeutic and Research Reauthor- 12 ization Act of 2015), the amendment to section 13 379(d)(2)(B) of the Public Health Service Act (42 14 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public 15 Law 114–104 is amended— 16 (A) by inserting ‘‘through’’ before ‘‘remote 17 collection,’’; and 18 (B) by inserting ‘‘goal of increasing collec- 19 tions of high quality’’ before ‘‘cord blood 20 units,’’. 21 (2) TECHNICAL UPDATE.—Subparagraph (B) 22 of section 379(d)(2) of the Public Health Service 23 Act (42 U.S.C. 274k(d)(2)) is amended by striking 24 the second and third sentences in such subpara- 25 graph. 26 VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 4672 IS (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec- 1 tion 379 of the Public Health Service Act (42 U.S.C. 2 274k) is amended by adding at the end the following: 3 ‘‘(o) PERIODIC REVIEW OF STATE OF SCIENCE.— 4 ‘‘(1) REVIEW.—The Secretary, in consultation 5 with the Director of the National Institutes of 6 Health, the Commissioner of Food and Drugs, the 7 Administrator of the Health Resources and Services 8 Administration, the Advisory Council, and other 9 stakeholders, where appropriate given relevant ex- 10 pertise, shall conduct a review of the state of the 11 science of using adult stem cells and birth tissue 12 products to develop new types of therapies for pa- 13 tients, for the purpose of considering the potential 14 inclusion of such new types of therapies in the Pro- 15 gram. 16 ‘‘(2) RECOMMENDATIONS.—Not later than 17 June 30, 2023, and every 3 years thereafter, the 18 Secretary shall— 19 ‘‘(A) complete the review required by para- 20 graph (1); and 21 ‘‘(B) informed by such review, submit to 22 the Committee on Health, Education, Labor, 23 and Pensions of the Senate and the Committee 24 on Energy and Commerce of the House of Rep- 25 VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 4672 IS resentatives recommendations on the appro- 1 priateness of the inclusion of new types of 2 therapies in the Program.’’. 3 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 4 379B of the Public Health Service Act (42 U.S.C. 274m) 5 is amended by striking ‘‘$33,000,000 for fiscal year 2015 6 and $30,000,000 for each of fiscal years 2016 through 7 2020’’ and inserting ‘‘$30,000,000 for each of fiscal years 8 2021 through 2025’’. 9 SEC. 3. CORD BLOOD INVENTORY. 10 Subsection (g) of section 2 of the Stem Cell Thera- 11 peutic and Research Act of 2005 (42 U.S.C. 274k note) 12 is amended to read as follows: 13 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 14 carry out this section, there is authorized to be appro- 15 priated $23,000,000 for each of fiscal years 2021 through 16 2025.’’. 17 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI- 18 CINE. 19 (a) NATIONAL INSTITUTES OF HEALTH.—Section 20 402 of the Public Health Service Act (42 U.S.C. 282) is 21 amended by adding at the end the following: 22 ‘‘(o) REGENERATIVE MEDICINE.—The Director of 23 NIH shall, as appropriate, continue to consult with the 24 directors of relevant institutes and centers of the National 25 VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 4672 IS Institutes of Health, other relevant experts from such in- 1 stitutes and centers, and relevant experts within the Food 2 and Drug Administration, to further the field of regenera- 3 tive medicine using adult stem cells, including autologous 4 stem cells, therapeutic tissue engineering products, human 5 cell and tissue products, human gene therapies, and ge- 6 netically modified cells.’’. 7 (b) GAO REPORT.—Not later than 2 years after the 8 date of enactment of this Act, the Comptroller General 9 of the United States shall submit to the Committee on 10 Health, Education, Labor, and Pensions of the Senate and 11 the Committee on Energy and Commerce of the House 12 of Representatives a report that assesses the workforce re- 13 lated to the C.W. Bill Young Cell Transplantation Pro- 14 gram established under section 379 of the Public Health 15 Service Act (42 U.S.C. 274k). The report shall include— 16 (1) an overview of the current employment lev- 17 els, in both commercial and academic settings, for— 18 (A) positions necessary for the collection 19 and transplantation of stem cell therapeutics, 20 including bone marrow and cord blood; and 21 (B) positions in the field of regenerative 22 medicine using adult stem cells and related to 23 product development; 24 VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 4672 IS (2) the identification of gaps, if any, in the pro- 1 jected workforce capacity for— 2 (A) positions described in paragraph 3 (1)(A); and 4 (B) the field of regenerative medicine using 5 adult stem cells, including workforce gaps re- 6 lated to the development of new cellular thera- 7 pies using adult stem cells; 8 (3) an overview of the availability of training 9 programs related to the development, refinement, 10 and utilization of adult stem cells, including training 11 on good manufacturing practices for such activities, 12 and the performance of such programs; and 13 (4) recommendations, if any, for improving the 14 workforce capacity related to— 15 (A) the positions described in paragraph 16 (1)(A); or 17 (B) the field of regenerative medicine using 18 adult stem cells. 19 Æ VerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S4672.IS S4672 pbinns on DSKJLVW7X2PROD with BILLS