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 Carolina) 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. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Timely ReAuthoriza5 tion of Necessary Stem-cell Programs Lends Access to 

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

7 Act of 2020’’. 


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

2 TRANSPLANTATION PROGRAM. 

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

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

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

6 paragraph: 

7 ‘‘(7) The Advisory Council shall meet not less 

8 frequently than 2 times per year.’’. 

9 (b) INCREASING COLLECTION.— 

10 (1) TECHNICAL CLARIFICATION.—Effective as 

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

12 (the Stem Cell Therapeutic and Research Reauthor13 ization Act of 2015), the amendment to section 

14 379(d)(2)(B) of the Public Health Service Act (42 

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

16 Law 114–104 is amended— 

17 (A) by inserting ‘‘through’’ before ‘‘remote 

18 collection,’’; and 

19 (B) by inserting ‘‘goal of increasing collec20 tions of high quality’’ before ‘‘cord blood 

21 units,’’. 

22 (2) TECHNICAL UPDATE.—Subparagraph (B) 

23 of section 379(d)(2) of the Public Health Service 

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

25 the second and third sentences in such subpara26 graph. 


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1 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec2 tion 379 of the Public Health Service Act (42 U.S.C. 

3 274k) is amended by adding at the end the following: 

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

5 ‘‘(1) REVIEW.—The Secretary, in consultation 

6 with the Director of the National Institutes of 

7 Health, the Commissioner of Food and Drugs, the 

8 Administrator of the Health Resources and Services 

9 Administration, the Advisory Council, and other 

10 stakeholders, where appropriate given relevant ex11 pertise, shall conduct a review of the state of the 

12 science of using adult stem cells and birth tissue 

13 products to develop new types of therapies for pa14 tients, for the purpose of considering the potential 

15 inclusion of such new types of therapies in the Pro16 gram. 

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

18 June 30, 2023, and every 3 years thereafter, the 

19 Secretary shall— 

20 ‘‘(A) complete the review required by para21 graph (1); and 

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

23 the Committee on Health, Education, Labor, 

24 and Pensions of the Senate and the Committee 

25 on Energy and Commerce of the House of RepVerDate Sep 11 2014 23:15 Oct 10, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4672.IS S4672

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1 resentatives recommendations on the appro2 priateness of the inclusion of new types of 

3 therapies in the Program.’’. 

4 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

5 379B of the Public Health Service Act (42 U.S.C. 274m) 

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

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

8 2020’’ and inserting ‘‘$30,000,000 for each of fiscal years 

9 2021 through 2025’’. 

10 SEC. 3. CORD BLOOD INVENTORY. 

11 Subsection (g) of section 2 of the Stem Cell Thera12 peutic and Research Act of 2005 (42 U.S.C. 274k note) 

13 is amended to read as follows: 

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

15 carry out this section, there is authorized to be appro16 priated $23,000,000 for each of fiscal years 2021 through 

17 2025.’’. 

18 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI19 CINE. 

20 (a) NATIONAL INSTITUTES OF HEALTH.—Section 

21 402 of the Public Health Service Act (42 U.S.C. 282) is 

22 amended by adding at the end the following: 

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

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

25 directors of relevant institutes and centers of the National 


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1 Institutes of Health, other relevant experts from such in2 stitutes and centers, and relevant experts within the Food 

3 and Drug Administration, to further the field of regenera4 tive medicine using adult stem cells, including autologous 

5 stem cells, therapeutic tissue engineering products, human 

6 cell and tissue products, human gene therapies, and ge7 netically modified cells.’’. 

8 (b) GAO REPORT.—Not later than 2 years after the 

9 date of enactment of this Act, the Comptroller General 

10 of the United States shall submit to the Committee on 

11 Health, Education, Labor, and Pensions of the Senate and 

12 the Committee on Energy and Commerce of the House 

13 of Representatives a report that assesses the workforce re14 lated to the C.W. Bill Young Cell Transplantation Pro15 gram established under section 379 of the Public Health 

16 Service Act (42 U.S.C. 274k). The report shall include— 

17 (1) an overview of the current employment lev18 els, in both commercial and academic settings, for— 

19 (A) positions necessary for the collection 

20 and transplantation of stem cell therapeutics, 

21 including bone marrow and cord blood; and 

22 (B) positions in the field of regenerative 

23 medicine using adult stem cells and related to 

24 product development; 


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1 (2) the identification of gaps, if any, in the pro2 jected workforce capacity for— 

3 (A) positions described in paragraph 

4 (1)(A); and 

5 (B) the field of regenerative medicine using 

6 adult stem cells, including workforce gaps re7 lated to the development of new cellular thera8 pies using adult stem cells; 

9 (3) an overview of the availability of training 

10 programs related to the development, refinement, 

11 and utilization of adult stem cells, including training 

12 on good manufacturing practices for such activities, 

13 and the performance of such programs; and 

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

15 workforce capacity related to— 

16 (A) the positions described in paragraph 

17 (1)(A); or 

18 (B) the field of regenerative medicine using 

19 adult stem cells. 

Æ 


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