I 

118TH CONGRESS 

1ST SESSION H. R. 6705 

To require the Secretary of Health and Human Services to treat certain 

tests for tuberculosis as breakthrough devices eligible for expedited development and priority review, to require certain establishments that perform donor screening or testing to screen or test for active and latent 

tuberculosis, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 11, 2023 

Mr. MOOLENAAR (for himself, Mrs. DINGELL, and Mr. CORREA) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL 

To require the Secretary of Health and Human Services 

to treat certain tests for tuberculosis as breakthrough 

devices eligible for expedited development and priority 

review, to require certain establishments that perform 

donor screening or testing to screen or test for active 

and latent tuberculosis, 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 ‘‘Effective Screening 

5 and Testing for Tuberculosis Act’’. 


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•HR 6705 IH

1 SEC. 2. TREATMENT OF CERTAIN TESTS FOR TUBER2 CULOSIS AS BREAKTHROUGH DEVICES. 

3 The Secretary of Health and Human Services shall 

4 treat a device as a breakthrough device eligible for expe5 dited development and priority review under section 515B 

6 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 360e–3) if it is a new and innovative donor screening test 

8 with heightened sensitivity to effectively screen human 

9 cell, tissue, and cellular and tissue-based product donors 

10 for evidence of active or latent tuberculosis infection. 

11 SEC. 3. REQUIRING CERTAIN ESTABLISHMENTS THAT PER12 FORM DONOR SCREENING OR TESTING TO 

13 SCREEN OR TEST FOR ACTIVE AND LATENT 

14 TUBERCULOSIS. 

15 (a) IN GENERAL.—The Secretary of Health and 

16 Human Services, acting through the Commissioner of 

17 Food and Drugs, shall promulgate regulations revising 

18 part 1271 of title 21, Code of Federal Regulations, includ19 ing sections 1271.75 and 1271.85, and any other applica20 ble regulations, to require— 

21 (1) an establishment that performs donor 

22 screening to screen for active and latent tuber23 culosis; and 

24 (2) an establishment that performs donor test25 ing to test for active and latent tuberculosis. 


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•HR 6705 IH

1 (b) REGULATIONS.—The Secretary of Health and 

2 Human Services shall— 

3 (1) not later than 1 year after the date of en4 actment of this Act, propose the regulations required 

5 by subsection (a); 

6 (2) not later than 3 months after the close of 

7 the comment period for such proposed regulations, 

8 promulgate such regulations as final; and 

9 (3) not later than 6 months after the date such 

10 regulations are promulgated as final, begin imple11 mentation of such regulations. 

12 (c) DEFINITIONS.—In this section, the terms ‘‘estab13 lishment that performs donor screening’’ and ‘‘establish14 ment that performs donor testing’’ have the meanings 

15 given to such terms under part 1271 of title 21, Code of 

16 Federal Regulations. 

17 SEC. 4. GUIDANCE ON CURRENT GOOD TISSUE PRACTICE 

18 AND ADDITIONAL REQUIREMENTS FOR MAN19 UFACTURERS OF HUMAN CELLS, TISSUES, 

20 AND CELLULAR AND TISSUE-BASED PROD21 UCTS. 

22 Not later than 6 months after the date of enactment 

23 of this Act, the Secretary of Health and Human Services, 

24 acting through the Commissioner of Food and Drugs, and 


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•HR 6705 IH

1 in coordination with the Director of the Centers for Dis2 ease Control and Prevention, shall— 

3 (1) review the guidance titled ‘‘Guidance for In4 dustry—Current Good Tissue Practice (CGTP) and 

5 Additional Requirements for Manufacturers of 

6 Human Cells, Tissues, and Cellular and Tissue7 Based Products (HCT/Ps)’’ (December 2011); and 

8 (2) issue an updated version of such guidance. 

9 SEC. 5. COMPLIANCE WITH CUTGO. 

10 No additional funds are authorized to be appro11 priated to carry out this Act, and this Act shall be carried 

12 out using amounts otherwise available for such purpose. 

Æ 


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