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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6705 Introduced in House (IH)]

<DOC>

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Effective Screening and Testing for 
Tuberculosis Act''.

SEC. 2. TREATMENT OF CERTAIN TESTS FOR TUBERCULOSIS AS BREAKTHROUGH 
              DEVICES.

    The Secretary of Health and Human Services shall treat a device as 
a breakthrough device eligible for expedited development and priority 
review under section 515B of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360e-3) if it is a new and innovative donor screening test 
with heightened sensitivity to effectively screen human cell, tissue, 
and cellular and tissue-based product donors for evidence of active or 
latent tuberculosis infection.

SEC. 3. REQUIRING CERTAIN ESTABLISHMENTS THAT PERFORM DONOR SCREENING 
              OR TESTING TO SCREEN OR TEST FOR ACTIVE AND LATENT 
              TUBERCULOSIS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall promulgate 
regulations revising part 1271 of title 21, Code of Federal 
Regulations, including sections 1271.75 and 1271.85, and any other 
applicable regulations, to require--
            (1) an establishment that performs donor screening to 
        screen for active and latent tuberculosis; and
            (2) an establishment that performs donor testing to test 
        for active and latent tuberculosis.
    (b) Regulations.--The Secretary of Health and Human Services 
shall--
            (1) not later than 1 year after the date of enactment of 
        this Act, propose the regulations required by subsection (a);
            (2) not later than 3 months after the close of the comment 
        period for such proposed regulations, promulgate such 
        regulations as final; and
            (3) not later than 6 months after the date such regulations 
        are promulgated as final, begin implementation of such 
        regulations.
    (c) Definitions.--In this section, the terms ``establishment that 
performs donor screening'' and ``establishment that performs donor 
testing'' have the meanings given to such terms under part 1271 of 
title 21, Code of Federal Regulations.

SEC. 4. GUIDANCE ON CURRENT GOOD TISSUE PRACTICE AND ADDITIONAL 
              REQUIREMENTS FOR MANUFACTURERS OF HUMAN CELLS, TISSUES, 
              AND CELLULAR AND TISSUE-BASED PRODUCTS.

    Not later than 6 months after the date of enactment of this Act, 
the Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, and in coordination with the Director 
of the Centers for Disease Control and Prevention, shall--
            (1) review the guidance titled ``Guidance for Industry--
        Current Good Tissue Practice (CGTP) and Additional Requirements 
        for Manufacturers of Human Cells, Tissues, and Cellular and 
        Tissue-Based Products (HCT/Ps)'' (December 2011); and
            (2) issue an updated version of such guidance.

SEC. 5. COMPLIANCE WITH CUTGO.

    No additional funds are authorized to be appropriated to carry out 
this Act, and this Act shall be carried out using amounts otherwise 
available for such purpose.
                                 <all>
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