II 

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. 

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 ‘‘Promoting Access to 

5 Critical Countermeasures by Ensuring Specimen Samples 

6 to Diagnostics Act’’ or the ‘‘Promoting ACCESS to 

7 Diagnostics Act’’. 


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•S 3496 IS

1 SEC. 2. ACCESSING SPECIMEN SAMPLES AND DIAGNOSTIC 

2 TESTS. 

3 (a) IMPROVING RESEARCH AND DEVELOPMENT OF

4 MEDICAL COUNTERMEASURES FOR NOVEL PATHO5 GENS.— 

6 (1) SAMPLE ACCESS.—Not later than 1 year 

7 after the date of enactment of this Act, the Sec8 retary of Health and Human Services (referred to in 

9 this subsection as the ‘‘Secretary’’) shall make pub10 licly available policies and procedures related to pub11 lic and private entities accessing specimens of, or 

12 specimens containing, pathogens or suitable surro13 gates for, or alternatives to, such pathogens as the 

14 Secretary determines appropriate to support public 

15 health preparedness and response activities or bio16 medical research for purposes of the development 

17 and validation, as applicable, of medical products to 

18 address emerging infectious diseases and for use to 

19 otherwise respond to emerging infectious diseases. 

20 Such policies and procedures shall take into account, 

21 as appropriate, any applicable existing Federal re22 sources. 

23 (2) GUIDANCE.—The Secretary shall issue 

24 guidance regarding the procedures for carrying out 

25 paragraph (1), including— 


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•S 3496 IS

1 (A) the method for requesting such sam2 ples; 

3 (B) considerations for sample availability 

4 and use of suitable surrogates or alternatives to 

5 such pathogens, as appropriate, including appli6 cable safeguard and security measures; and 

7 (C) information required to be provided in 

8 order to receive such samples or suitable surro9 gates or alternatives. 

10 (b) EARLIER DEVELOPMENT OF DIAGNOSTIC

11 TESTS.—Title III of the Public Health Service Act is 

12 amended by inserting after section 319A (42 U.S.C. 

13 247d–1) the following: 

14 ‘‘SEC. 319B. EARLIER DEVELOPMENT OF DIAGNOSTIC 

15 TESTS. 

16 ‘‘The Secretary may contract with public and private 

17 entities, as appropriate, to increase capacity in the rapid 

18 development, validation, manufacture, and dissemination 

19 of diagnostic tests, as appropriate, to State, local, and 

20 Tribal health departments and other appropriate entities 

21 for immediate public health response activities to address 

22 emerging infectious diseases that have significant poten23 tial to cause a public health emergency.’’. 

Æ 


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