II 

118TH CONGRESS 

1ST SESSION S. 2672 

To require the Secretary of Health and Human Services to develop a strategic 

framework to improve the development and distribution of diagnostic 

tests in response to chemical, biological, radiological, or nuclear threats. 

IN THE SENATE OF THE UNITED STATES 

JULY 27, 2023 

Ms. SMITH (for herself and Ms. COLLINS) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To require the Secretary of Health and Human Services 

to develop a strategic framework to improve the development and distribution of diagnostic tests in response 

to chemical, biological, radiological, or nuclear threats. 

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 ‘‘Improving Develop5 ment and Distribution of Diagnostic Tests Act’’. 


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1 SEC. 2. IMPROVING DEVELOPMENT AND DISTRIBUTION OF 

2 DIAGNOSTIC TESTS. 

3 Section 319B of the Public Health Service Act (42 

4 U.S.C. 247d–2) is amended to read as follows: 

5 ‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU6 TION OF DIAGNOSTIC TESTS. 

7 ‘‘(a) FRAMEWORK.—The Secretary shall develop, 

8 make publicly available not later than 1 year after the date 

9 of enactment of the Improving Development and Distribu10 tion of Diagnostic Tests Act, and update not less fre11 quently than every 3 years thereafter, a strategic frame12 work for the rapid development, validation, authorization, 

13 manufacture, procurement, and distribution of diagnostic 

14 tests, and for rapid scaling of testing capacity, in response 

15 to chemical, biological, radiological, or nuclear threats, in16 cluding infectious diseases for which a public health emer17 gency is declared under section 319, or that has signifi18 cant potential to cause such a public health emergency. 

19 Such strategic framework shall take into consideration— 

20 ‘‘(1) domestic capacity, including any such ca21 pacity established through partnerships with public 

22 and private entities pursuant to subsection (c), to 

23 support the development, validation, authorization, 

24 manufacture, procurement, and distribution of tests; 

25 ‘‘(2) novel technologies and platforms that may 

26 be used to improve testing capabilities, including 


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1 high-throughput laboratory diagnostics, and point2 of-care diagnostics, and any such technologies to im3 prove the accessibility of such tests, and facilitate 

4 the development and manufacture of diagnostic 

5 tests; 

6 ‘‘(3) medical supply needs related to testing, in7 cluding diagnostic testing, equipment, supplies, and 

8 component parts, and any potential vulnerabilities 

9 related to the availability of such medical supplies 

10 and related planning, consistent with section 

11 2811(b)(4)(J); 

12 ‘‘(4) strategies for the rapid and efficient dis13 tribution of tests locally, regionally, or nationwide 

14 and scaling laboratory testing capacity; and 

15 ‘‘(5) assessing such strategies through drills 

16 and operational exercises carried out under section 

17 2811(b)(4)(G), as appropriate. 

18 ‘‘(b) COORDINATION.—To inform the development 

19 and update of the framework under subsection (a), and 

20 in carrying out activities to implement such framework, 

21 the Secretary shall coordinate with industry, States, local 

22 governmental entities, Indian Tribes and Tribal organiza23 tions, Urban Indian organizations, and other relevant pub24 lic and private entities. 


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1 ‘‘(c) CAPACITY BUILDING.—The Secretary may con2 tract with public and private entities, as appropriate, to 

3 increase domestic capacity in the rapid development, vali4 dation, authorization, manufacture, procurement, and dis5 tribution of diagnostic tests, as appropriate, to State, 

6 local, and Tribal health departments and other appro7 priate entities for immediate public health response activi8 ties to address an infectious disease with respect to which 

9 a public health emergency is declared under section 319, 

10 or that has significant potential to cause such a public 

11 health emergency.’’. 

Æ 


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