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 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 2021’’ or the ‘‘TRANSPLANT 

7 Act of 2021’’. 


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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 Secretary shall convene the Advisory 

8 Council at least 2 times each calendar 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 by inserting ‘‘goal of in17 creasing collections of high quality’’ before ‘‘cord 

18 blood units,’’. 

19 (2) ELIMINATING DEADWOOD.—Subparagraph 

20 (B) of section 379(d)(2) of the Public Health Serv21 ice Act (42 U.S.C. 274k(d)(2)) is amended by strik22 ing the second and third sentences in such subpara23 graph. 

24 (c) PERIODIC REVIEW OF STATE OF SCIENCE.—Sec25 tion 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 subsection: 

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

4 ‘‘(1) REVIEW.—Not less frequently than every 

5 2 years, the Secretary, in consultation with the Di6 rector of the National Institutes of Health, the Com7 missioner of Food and Drugs, the Administrator of 

8 the Health Resources and Services Administration, 

9 the Advisory Council, and other stakeholders, where 

10 appropriate given relevant expertise, shall conduct a 

11 review of the state of the science of using adult stem 

12 cells and birthing tissues to develop new types of 

13 therapies for patients, for the purpose of considering 

14 the potential inclusion of such new types of therapies 

15 in the Program. 

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

17 June 30, 2025, the Secretary shall— 

18 ‘‘(A) complete the second review required 

19 by paragraph (1); and 

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

21 the Committee on Health, Education, Labor, 

22 and Pensions of the Senate and the Committee 

23 on Energy and Commerce of the House of Rep24 resentatives recommendations on the approVerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288

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1 priateness of the inclusion of new types of 

2 therapies in the Program.’’. 

3 (d) AUTHORIZATION OF APPROPRIATIONS.—Section 

4 379B of the Public Health Service Act (42 U.S.C. 274m) 

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

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

7 2020’’ and inserting ‘‘$31,000,000 for each of fiscal years 

8 2022 through 2026’’. 

9 SEC. 3. CORD BLOOD INVENTORY. 

10 Subsection (g) of section 2 of the Stem Cell Thera11 peutic and Research Act of 2005 (42 U.S.C. 274k note) 

12 is amended to read as follows: 

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

14 carry out this section, there is authorized to be appro15 priated $23,000,000 for each of fiscal years 2022 through 

16 2026.’’. 

17 SEC. 4. ADVANCING THE FIELD OF REGENERATIVE MEDI18 CINE. 

19 Section 402 of the Public Health Service Act (42 

20 U.S.C. 282) is amended by adding at the end the fol21 lowing: 

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

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

24 directors of relevant institutes and centers of the National 

25 Institutes of Health, other relevant experts from such inVerDate Sep 11 2014 23:29 Feb 26, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S288.IS S288

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1 stitutes and centers, and relevant experts within the Food 

2 and Drug Administration, to further the field of regenera3 tive medicine using adult stem cells, including autologous 

4 stem cells, therapeutic tissue engineering products, human 

5 cell and tissue products, human gene therapies, and ge6 netically modified cells.’’. 

7 SEC. 5. GAO REPORT ON REGENERATIVE MEDICINE WORK8 FORCE. 

9 Not later than 2 years after the date of enactment 

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

11 shall submit to the Committee on Health, Education, 

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

13 Energy and Commerce of the House of Representatives 

14 a report that assesses a specialized health care workforce 

15 in the field of regenerative medicine. The report shall in16 clude— 

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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