In the Senate of the United States, 

December 11, 2020. 

Resolved, That the bill from the House of Representatives (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: 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Timely ReAuthorization 

3 of Necessary Stem-cell Programs Lends Access to Needed 

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

5 2020’’. 

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

7 TRANSPLANTATION PROGRAM. 

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

9 section 379 of the Public Health Service Act (42 U.S.C. 
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1 274k) is amended by adding at the end the following new 

2 paragraph: 

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

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

5 (b) INCREASING COLLECTION.— 

6 (1) TECHNICAL CLARIFICATION.—Effective as if 

7 included in the enactment of Public Law 114–104 

8 (the Stem Cell Therapeutic and Research Reauthor9 ization Act of 2015), the amendment to section 

10 379(d)(2)(B) of the Public Health Service Act (42 

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

12 Law 114–104 is amended by inserting ‘‘goal of in13 creasing collections of high quality’’ before ‘‘cord blood 

14 units,’’. 

15 (2) ELIMINATING DEADWOOD.—Subparagraph 

16 (B) of section 379(d)(2) of the Public Health Service 

17 Act (42 U.S.C. 274k(d)(2)) is amended by striking the 

18 second and third sentences in such subparagraph. 

19 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec20 tion 379 of the Public Health Service Act (42 U.S.C. 274k) 

21 is amended by adding at the end the following new sub22 section: 

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

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

25 the Secretary, in consultation with the Director of the 
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1 National Institutes of Health, the Commissioner of 

2 Food and Drugs, the Administrator of the Health Re3 sources and Services Administration, the Advisory 

4 Council, and other stakeholders, where appropriate 

5 given relevant expertise, shall conduct a review of the 

6 state of the science of using adult stem cells and birth7 ing tissues to develop new types of therapies for pa8 tients, for the purpose of considering the potential in9 clusion of such new types of therapies in the Program. 

10 ‘‘(2) RECOMMENDATIONS.—Not later than June 

11 30, 2024, the Secretary shall— 

12 ‘‘(A) complete the second review required by 

13 paragraph (1); and 

14 ‘‘(B) informed by such review, submit to the 

15 Committee on Health, Education, Labor, and 

16 Pensions of the Senate and the Committee on 

17 Energy and Commerce of the House of Rep18 resentatives recommendations on the appro19 priateness of the inclusion of new types of thera20 pies in the Program.’’. 

21 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

22 379B of the Public Health Service Act (42 U.S.C. 274m) 

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

24 and $30,000,000 for each of fiscal years 2016 through 2020’’ 
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1 and inserting ‘‘$30,000,000 for each of fiscal years 2021 

2 through 2025’’. 

3 SEC. 3. CORD BLOOD INVENTORY. 

4 Subsection (g) of section 2 of the Stem Cell Therapeutic 

5 and Research Act of 2005 (42 U.S.C. 274k note) is amended 

6 to read as follows: 

7 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—To carry 

8 out this section, there is authorized to be appropriated 

9 $23,000,000 for each of fiscal years 2021 through 2025.’’. 

10 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI11 CINE. 

12 Section 402 of the Public Health Service Act (42 

13 U.S.C. 282) is amended by adding at the end the following: 

14 ‘‘(o) REGENERATIVE MEDICINE.—The Director of NIH 

15 shall, as appropriate, continue to consult with the directors 

16 of relevant institutes and centers of the National Institutes 

17 of Health, other relevant experts from such institutes and 

18 centers, and relevant experts within the Food and Drug Ad19 ministration, to further the field of regenerative medicine 

20 using adult stem cells, including autologous stem cells, 

21 therapeutic tissue engineering products, human cell and tis22 sue products, human gene therapies, and genetically modi23 fied cells.’’. 
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1 SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORK2 FORCE. 

3 Not later than 2 years after the date of enactment of 

4 this Act, the Comptroller General of the United States shall 

5 submit to the Committee on Health, Education, Labor, and 

6 Pensions of the Senate and the Committee on Energy and 

7 Commerce of the House of Representatives a report that as8 sesses a specialized health care workforce in the field of re9 generative medicine. The report shall include— 

10 (1) an overview of the current employment levels, 

11 in both commercial and academic settings, for— 

12 (A) positions necessary for the collection 

13 and transplantation of stem cell therapeutics, in14 cluding bone marrow and cord blood; and 

15 (B) positions in the field of regenerative 

16 medicine using adult stem cells and related to 

17 product development; 

18 (2) the identification of gaps, if any, in the pro19 jected workforce capacity for— 

20 (A) positions described in paragraph 

21 (1)(A); and 

22 (B) the field of regenerative medicine using 

23 adult stem cells, including workforce gaps related 

24 to the development of new cellular therapies 

25 using adult stem cells; 
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1 (3) an overview of the availability of training 

2 programs related to the development, refinement, and 

3 utilization of adult stem cells, including training on 

4 good manufacturing practices for such activities, and 

5 the performance of such programs; and 

6 (4) recommendations, if any, for improving the 

7 workforce capacity related to— 

8 (A) the positions described in paragraph 

9 (1)(A); or 

10 (B) the field of regenerative medicine using 

11 adult stem cells. 

Attest: 

Secretary. 

116TH CONGRESS 

2D SESSION H.R. 4764 

AMENDMENT