TRANSPLANT Act of 2020

In the Senate of the United States, December 11, 2020. Resolved, That the bill from the House of Representa- tives (H.R. 4764) entitled ‘‘An Act to reauthorize the Stem Cell Therapeutic and Research Act of 2005, and for other purposes.’’, do pass with the following AMENDMENT: Strike all after the enacting clause and insert the following: SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Timely ReAuthorization 2 of Necessary Stem-cell Programs Lends Access to Needed 3 Therapies Act of 2020’’ or the ‘‘TRANSPLANT Act of 4 2020’’. 5 SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 6 TRANSPLANTATION PROGRAM. 7 (a) ADVISORY COUNCIL MEETINGS.—Subsection (a) of 8 section 379 of the Public Health Service Act (42 U.S.C. 9 2 † HR 4764 EAS 274k) is amended by adding at the end the following new 1 paragraph: 2 ‘‘(7) The Secretary shall convene the Advisory 3 Council at least two times each calendar year.’’. 4 (b) INCREASING COLLECTION.— 5 (1) TECHNICAL CLARIFICATION.—Effective as if 6 included in the enactment of Public Law 114–104 7 (the Stem Cell Therapeutic and Research Reauthor- 8 ization Act of 2015), the amendment to section 9 379(d)(2)(B) of the Public Health Service Act (42 10 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public 11 Law 114–104 is amended by inserting ‘‘goal of in- 12 creasing collections of high quality’’ before ‘‘cord blood 13 units,’’. 14 (2) ELIMINATING DEADWOOD.—Subparagraph 15 (B) of section 379(d)(2) of the Public Health Service 16 Act (42 U.S.C. 274k(d)(2)) is amended by striking the 17 second and third sentences in such subparagraph. 18 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec- 19 tion 379 of the Public Health Service Act (42 U.S.C. 274k) 20 is amended by adding at the end the following new sub- 21 section: 22 ‘‘(o) PERIODIC REVIEW OF STATE OF SCIENCE.— 23 ‘‘(1) REVIEW.—Not less than every two years, 24 the Secretary, in consultation with the Director of the 25 3 † HR 4764 EAS National Institutes of Health, the Commissioner of 1 Food and Drugs, the Administrator of the Health Re- 2 sources and Services Administration, the Advisory 3 Council, and other stakeholders, where appropriate 4 given relevant expertise, shall conduct a review of the 5 state of the science of using adult stem cells and birth- 6 ing tissues to develop new types of therapies for pa- 7 tients, for the purpose of considering the potential in- 8 clusion of such new types of therapies in the Program. 9 ‘‘(2) RECOMMENDATIONS.—Not later than June 10 30, 2024, the Secretary shall— 11 ‘‘(A) complete the second review required by 12 paragraph (1); and 13 ‘‘(B) informed by such review, submit to the 14 Committee on Health, Education, Labor, and 15 Pensions of the Senate and the Committee on 16 Energy and Commerce of the House of Rep- 17 resentatives recommendations on the appro- 18 priateness of the inclusion of new types of thera- 19 pies in the Program.’’. 20 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 21 379B of the Public Health Service Act (42 U.S.C. 274m) 22 is amended by striking ‘‘$33,000,000 for fiscal year 2015 23 and $30,000,000 for each of fiscal years 2016 through 2020’’ 24 4 † HR 4764 EAS and inserting ‘‘$30,000,000 for each of fiscal years 2021 1 through 2025’’. 2 SEC. 3. CORD BLOOD INVENTORY. 3 Subsection (g) of section 2 of the Stem Cell Therapeutic 4 and Research Act of 2005 (42 U.S.C. 274k note) is amended 5 to read as follows: 6 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 7 out this section, there is authorized to be appropriated 8 $23,000,000 for each of fiscal years 2021 through 2025.’’. 9 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI- 10 CINE. 11 Section 402 of the Public Health Service Act (42 12 U.S.C. 282) is amended by adding at the end the following: 13 ‘‘(o) REGENERATIVE MEDICINE.—The Director of NIH 14 shall, as appropriate, continue to consult with the directors 15 of relevant institutes and centers of the National Institutes 16 of Health, other relevant experts from such institutes and 17 centers, and relevant experts within the Food and Drug Ad- 18 ministration, to further the field of regenerative medicine 19 using adult stem cells, including autologous stem cells, 20 therapeutic tissue engineering products, human cell and tis- 21 sue products, human gene therapies, and genetically modi- 22 fied cells.’’. 23 5 † HR 4764 EAS SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORK- 1 FORCE. 2 Not later than 2 years after the date of enactment of 3 this Act, the Comptroller General of the United States shall 4 submit to the Committee on Health, Education, Labor, and 5 Pensions of the Senate and the Committee on Energy and 6 Commerce of the House of Representatives a report that as- 7 sesses a specialized health care workforce in the field of re- 8 generative medicine. The report shall include— 9 (1) an overview of the current employment levels, 10 in both commercial and academic settings, for— 11 (A) positions necessary for the collection 12 and transplantation of stem cell therapeutics, in- 13 cluding bone marrow and cord blood; and 14 (B) positions in the field of regenerative 15 medicine using adult stem cells and related to 16 product development; 17 (2) the identification of gaps, if any, in the pro- 18 jected workforce capacity for— 19 (A) positions described in paragraph 20 (1)(A); and 21 (B) the field of regenerative medicine using 22 adult stem cells, including workforce gaps related 23 to the development of new cellular therapies 24 using adult stem cells; 25 6 † HR 4764 EAS (3) an overview of the availability of training 1 programs related to the development, refinement, and 2 utilization of adult stem cells, including training on 3 good manufacturing practices for such activities, and 4 the performance of such programs; and 5 (4) recommendations, if any, for improving the 6 workforce capacity related to— 7 (A) the positions described in paragraph 8 (1)(A); or 9 (B) the field of regenerative medicine using 10 adult stem cells. 11 Attest: Secretary. 116TH CONGRESS 2D SESSION H.R. 4764 AMENDMENT