II 

116TH CONGRESS 

2D SESSION H. R. 4764 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 1, 2020 

Received 

AN ACT 

To reauthorize the Stem Cell Therapeutic and Research Act 

of 2005, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Timely ReAuthoriza3 tion of Necessary Stem-cell Programs Lends Access to 

4 Needed Therapies Act of 2020’’ or the ‘‘TRANSPLANT 

5 Act of 2020’’. 

6 SEC. 2. REAUTHORIZATION OF THE C.W. BILL YOUNG CELL 

7 TRANSPLANTATION PROGRAM. 

8 (a) ADVISORY COUNCIL MEETINGS.—Subsection (a) 

9 of section 379 of the Public Health Service Act (42 U.S.C. 

10 274k) is amended by adding at the end the following new 

11 paragraph: 

12 ‘‘(7) The Secretary shall convene the Advisory 

13 Council at least two times each calendar year.’’. 

14 (b) INCREASING COLLECTION.— 

15 (1) TECHNICAL CLARIFICATION.—Effective as 

16 if included in the enactment of Public Law 114–104 

17 (the Stem Cell Therapeutic and Research Reauthor18 ization Act of 2015), the amendment to section 

19 379(d)(2)(B) of the Public Health Service Act (42 

20 U.S.C. 274k(d)(2)(B)) in section 2(a)(2) of Public 

21 Law 114–104 is amended by inserting ‘‘goal of in22 creasing collections of high quality’’ before ‘‘cord 

23 blood units,’’. 

24 (2) ELIMINATING DEADWOOD.—Subparagraph 

25 (B) of section 379(d)(2) of the Public Health Serv26 ice Act (42 U.S.C. 274k(d)(2)) is amended by strikVerDate Sep 11 2014 23:02 Jan 04, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4764.RDS H4764

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1 ing the second and third sentences in such subpara2 graph. 

3 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec4 tion 379 of the Public Health Service Act (42 U.S.C. 

5 274k) is amended by adding at the end the following new 

6 subsection: 

7 ‘‘(o) PERIODIC REVIEW OF STATE OF SCIENCE.— 

8 ‘‘(1) REVIEW.—Not less than every two years, 

9 the Secretary, in consultation with the Director of 

10 the National Institutes of Health, the Commissioner 

11 of Food and Drugs, the Administrator of the Health 

12 Resources and Services Administration, the Advisory 

13 Council, and other stakeholders, where appropriate 

14 given relevant expertise, shall conduct a review of 

15 the state of the science of using adult stem cells and 

16 birthing tissues to develop new types of therapies for 

17 patients, for the purpose of considering the potential 

18 inclusion of such new types of therapies in the Pro19 gram. 

20 ‘‘(2) RECOMMENDATIONS.—Not later than 

21 June 30, 2024, the Secretary shall— 

22 ‘‘(A) complete the second review required 

23 by paragraph (1); and 

24 ‘‘(B) informed by such review, submit to 

25 the Committee on Health, Education, Labor, 


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1 and Pensions of the Senate and the Committee 

2 on Energy and Commerce of the House of Rep3 resentatives recommendations on the appro4 priateness of the inclusion of new types of 

5 therapies in the Program.’’. 

6 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

7 379B of the Public Health Service Act (42 U.S.C. 274m) 

8 is amended by striking ‘‘$33,000,000 for fiscal year 2015 

9 and $30,000,000 for each of fiscal years 2016 through 

10 2020’’ and inserting ‘‘$30,000,000 for each of fiscal years 

11 2021 through 2025’’. 

12 SEC. 3. CORD BLOOD INVENTORY. 

13 Subsection (g) of section 2 of the Stem Cell Thera14 peutic and Research Act of 2005 (42 U.S.C. 274k note) 

15 is amended to read as follows: 

16 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To 

17 carry out this section, there is authorized to be appro18 priated $23,000,000 for each of fiscal years 2021 through 

19 2025.’’. 

20 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI21 CINE. 

22 Section 402 of the Public Health Service Act (42 

23 U.S.C. 282) is amended by adding at the end the fol24 lowing: 


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1 ‘‘(o) REGENERATIVE MEDICINE.—The Director of 

2 NIH shall, as appropriate, continue to consult with the 

3 directors of relevant institutes and centers of the National 

4 Institutes of Health, other relevant experts from such in5 stitutes and centers, and relevant experts within the Food 

6 and Drug Administration, to further the field of regenera7 tive medicine using adult stem cells, including autologous 

8 stem cells, therapeutic tissue engineering products, human 

9 cell and tissue products, human gene therapies, and ge10 netically modified cells.’’. 

11 SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORK12 FORCE. 

13 Not later than 2 years after the date of enactment 

14 of this Act, the Comptroller General of the United States 

15 shall submit to the Committee on Health, Education, 

16 Labor, and Pensions of the Senate and the Committee on 

17 Energy and Commerce of the House of Representatives 

18 a report that assesses the national blood stem cell work19 force, including those related to the C.W. Bill Young Cell 

20 Transplantation Program established under section 379 of 

21 the Public Health Service Act (42 U.S.C. 274k). The re22 port shall include— 

23 (1) an overview of the current employment lev24 els, in both commercial and academic settings, for— 


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1 (A) positions necessary for the collection 

2 and transplantation of stem cell therapeutics, 

3 including bone marrow and cord blood; 

4 (B) positions in the field of regenerative 

5 medicine using adult stem cells and related to 

6 product development; and 

7 (C) Federal funding for extramural stem 

8 cell programs; 

9 (2) an overview of the current employment lev10 els in Federal stem cell programs, including the 

11 scope of, staffing models of, and vacancies within 

12 such programs; 

13 (3) the identification of gaps, if any, in the pro14 jected workforce capacity for— 

15 (A) positions described in paragraph 

16 (1)(A); and 

17 (B) the field of regenerative medicine using 

18 adult stem cells, including workforce gaps re19 lated to the development of new cellular thera20 pies using adult stem cells; 

21 (4) an overview of the availability of training 

22 programs related to the development, refinement, 

23 and utilization of adult stem cells, including training 

24 on good manufacturing practices for such activities, 

25 and the performance of such programs; and 


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1 (5) recommendations, if any, for improving the 

2 workforce capacity related to— 

3 (A) the positions described in paragraph 

4 (1)(A); or 

5 (B) the field of regenerative medicine using 

6 adult stem cells. 

Passed the House of Representatives September 30, 

2020. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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