TRANSPLANT Act of 2021

II 117TH CONGRESS 1ST SESSION S. 288 To reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes. IN THE SENATE OF THE UNITED STATES FEBRUARY 8, 2021 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 2021’’ or the ‘‘TRANSPLANT 6 Act of 2021’’. 7 VerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 288 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 Secretary shall convene the Advisory 7 Council at least 2 times each calendar 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 by inserting ‘‘goal of in- 16 creasing collections of high quality’’ before ‘‘cord 17 blood units,’’. 18 (2) ELIMINATING DEADWOOD.—Subparagraph 19 (B) of section 379(d)(2) of the Public Health Serv- 20 ice Act (42 U.S.C. 274k(d)(2)) is amended by strik- 21 ing the second and third sentences in such subpara- 22 graph. 23 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec- 24 tion 379 of the Public Health Service Act (42 U.S.C. 25 VerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 288 IS 274k) is amended by adding at the end the following new 1 subsection: 2 ‘‘(o) PERIODIC REVIEW OF STATE OF SCIENCE.— 3 ‘‘(1) REVIEW.—Not less frequently than every 4 2 years, the Secretary, in consultation with the Di- 5 rector of the National Institutes of Health, the Com- 6 missioner of Food and Drugs, the Administrator of 7 the Health Resources and Services Administration, 8 the Advisory Council, and other stakeholders, where 9 appropriate given relevant expertise, shall conduct a 10 review of the state of the science of using adult stem 11 cells and birthing tissues to develop new types of 12 therapies for patients, for the purpose of considering 13 the potential inclusion of such new types of therapies 14 in the Program. 15 ‘‘(2) RECOMMENDATIONS.—Not later than 16 June 30, 2025, the Secretary shall— 17 ‘‘(A) complete the second review required 18 by paragraph (1); and 19 ‘‘(B) informed by such review, submit to 20 the Committee on Health, Education, Labor, 21 and Pensions of the Senate and the Committee 22 on Energy and Commerce of the House of Rep- 23 resentatives recommendations on the appro- 24 VerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 288 IS priateness of the inclusion of new types of 1 therapies in the Program.’’. 2 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 3 379B of the Public Health Service Act (42 U.S.C. 274m) 4 is amended by striking ‘‘$33,000,000 for fiscal year 2015 5 and $30,000,000 for each of fiscal years 2016 through 6 2020’’ and inserting ‘‘$31,000,000 for each of fiscal years 7 2022 through 2026’’. 8 SEC. 3. CORD BLOOD INVENTORY. 9 Subsection (g) of section 2 of the Stem Cell Thera- 10 peutic and Research Act of 2005 (42 U.S.C. 274k note) 11 is amended to read as follows: 12 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 13 carry out this section, there is authorized to be appro- 14 priated $23,000,000 for each of fiscal years 2022 through 15 2026.’’. 16 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI- 17 CINE. 18 Section 402 of the Public Health Service Act (42 19 U.S.C. 282) is amended by adding at the end the fol- 20 lowing: 21 ‘‘(o) REGENERATIVE MEDICINE.—The Director of 22 NIH shall, as appropriate, continue to consult with the 23 directors of relevant institutes and centers of the National 24 Institutes of Health, other relevant experts from such in- 25 VerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 288 IS stitutes and centers, and relevant experts within the Food 1 and Drug Administration, to further the field of regenera- 2 tive medicine using adult stem cells, including autologous 3 stem cells, therapeutic tissue engineering products, human 4 cell and tissue products, human gene therapies, and ge- 5 netically modified cells.’’. 6 SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORK- 7 FORCE. 8 Not later than 2 years after the date of enactment 9 of this Act, the Comptroller General of the United States 10 shall submit to the Committee on Health, Education, 11 Labor, and Pensions of the Senate and the Committee on 12 Energy and Commerce of the House of Representatives 13 a report that assesses a specialized health care workforce 14 in the field of regenerative medicine. The report shall in- 15 clude— 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 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 288 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 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S288.IS S288 pamtmann on DSKBC07HB2PROD with BILLS