Title: Promoting ACCESS to Diagnostics Act
Policy area: Health

Summary:
Promoting Access to Critical Countermeasures by Ensuring Specimen Samples to Diagnostics Act or the Promoting ACCESS to Diagnostics Act
This bill directs the Department of Health and Human Services (HHS) to support the development of medical products and diagnostic tests for emerging infectious diseases.
Specifically, HHS must develop policies and procedures governing access by public and private entities to samples of pathogens (or suitable surrogates). The samples may be used for preparedness and response activities, developing medical products for emerging infectious diseases, and similar purposes.
Additionally, HHS may contract with public and private entities to increase the capacity to rapidly develop, validate, and disseminate diagnostic tests to health departments and other entities to respond to emerging infectious diseases with significant potential to cause a public health emergency.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3496 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 3496

  To improve research and development of medical countermeasures for 
                            novel pathogens.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             January 13 (legislative day, January 10), 2022

 Mr. Braun (for himself and Mr. Kaine) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To improve research and development of medical countermeasures for 
                            novel pathogens.

    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 ``Promoting Access to Critical 
Countermeasures by Ensuring Specimen Samples to Diagnostics Act'' or 
the ``Promoting ACCESS to Diagnostics Act''.

SEC. 2. ACCESSING SPECIMEN SAMPLES AND DIAGNOSTIC TESTS.

    (a) Improving Research and Development of Medical Countermeasures 
for Novel Pathogens.--
            (1) Sample access.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this subsection as the ``Secretary'') 
        shall make publicly available policies and procedures related 
        to public and private entities accessing specimens of, or 
        specimens containing, pathogens or suitable surrogates for, or 
        alternatives to, such pathogens as the Secretary determines 
        appropriate to support public health preparedness and response 
        activities or biomedical research for purposes of the 
        development and validation, as applicable, of medical products 
        to address emerging infectious diseases and for use to 
        otherwise respond to emerging infectious diseases. Such 
        policies and procedures shall take into account, as 
        appropriate, any applicable existing Federal resources.
            (2) Guidance.--The Secretary shall issue guidance regarding 
        the procedures for carrying out paragraph (1), including--
                    (A) the method for requesting such samples;
                    (B) considerations for sample availability and use 
                of suitable surrogates or alternatives to such 
                pathogens, as appropriate, including applicable 
                safeguard and security measures; and
                    (C) information required to be provided in order to 
                receive such samples or suitable surrogates or 
                alternatives.
    (b) Earlier Development of Diagnostic Tests.--Title III of the 
Public Health Service Act is amended by inserting after section 319A 
(42 U.S.C. 247d-1) the following:

``SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC TESTS.

    ``The Secretary may contract with public and private entities, as 
appropriate, to increase capacity in the rapid development, validation, 
manufacture, and dissemination of diagnostic tests, as appropriate, to 
State, local, and Tribal health departments and other appropriate 
entities for immediate public health response activities to address 
emerging infectious diseases that have significant potential to cause a 
public health emergency.''.
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