I
119THCONGRESS
1
STSESSION H. R. 1108
To amend the Public Health Service Act to direct the Secretary of Health
and Human Services to develop a plan to improve the development
and distribution of diagnostic tests during a public health emergency,
and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY7, 2025
Mrs. M
ILLER-MEEKS(for herself, Ms. SCHRIER, Mr. CRENSHAW, and Mr.
C
ARSON) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
A BILL
To amend the Public Health Service Act to direct the Sec-
retary of Health and Human Services to develop a plan
to improve the development and distribution of diagnostic
tests during a public health emergency, and for other
purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Diagnostics Testing 4
Preparedness Plan Act of 2025’’. 5
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SEC. 2. IMPROVING DEVELOPMENT AND DISTRIBUTION OF 1
DIAGNOSTIC TESTS. 2
Section 319B of the Public Health Service Act (42 3
U.S.C. 247d–2) is amended to read as follows: 4
‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-5
TION OF DIAGNOSTIC TESTS. 6
‘‘(a) D
IAGNOSTICTESTINGPREPAREDNESSPLAN.— 7
The Secretary shall develop, make publicly available, and 8
update a plan for the rapid development, validation, au-9
thorization, manufacture, procurement, and distribution 10
of diagnostic tests, and for rapid scaling of testing capac-11
ity, in response to chemical, biological, radiological, or nu-12
clear threats, including emerging infectious diseases, for 13
which a public health emergency is declared under section 14
319, or that has significant potential to cause such a pub-15
lic health emergency. 16
‘‘(b) P
URPOSES.—The purpose of the plan under sub-17
section (a) shall be to— 18
‘‘(1) facilitate the development and utilization 19
of diagnostic tests; 20
‘‘(2) describe the processes for the rapid devel-21
opment, validation, authorization, manufacture, pro-22
curement, and distribution of diagnostic tests, and 23
for rapid scaling of testing capacity; and 24
‘‘(3) facilitate coordination and collaboration 25
among public and private entities to improve the 26
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rapid development and utilization of diagnostic test-1
ing during a public health emergency. 2
‘‘(c) C
ONSIDERATIONS.—The plan under subsection 3
(a) shall take into consideration— 4
‘‘(1) domestic capacity, including any such ca-5
pacity established through partnerships with public 6
and private entities pursuant to subsection (e), to 7
support the development, validation, manufacture, 8
procurement, and distribution of tests, and the rapid 9
scaling of testing capacity; 10
‘‘(2) novel technologies and platforms that— 11
‘‘(A) may be used to improve testing capa-12
bilities, including— 13
‘‘(i) high-throughput laboratory 14
diagnostics; 15
‘‘(ii) point-of-care diagnostics; and 16
‘‘(iii) rapid at-home diagnostics; 17
‘‘(B) improve the accessibility of diagnostic 18
tests; and 19
‘‘(C) facilitate the development and manu-20
facture of diagnostic tests; 21
‘‘(3) medical supply needs related to testing, in-22
cluding diagnostic testing, equipment, supplies, and 23
component parts, and any potential vulnerabilities 24
related to the availability of such medical supplies 25
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and related planning needs, consistent with section 1
2811(b)(4)(J); 2
‘‘(4) strategies for the rapid and efficient dis-3
tribution of tests locally, regionally, or nationwide 4
and appropriate scaling of laboratory testing capac-5
ity; and 6
‘‘(5) assessment of such strategies through 7
drills and operational exercises carried out under 8
section 2811(b)(4)(G), as appropriate. 9
‘‘(d) C
OORDINATION.—To inform the development 10
and update of the plan under subsection (a), and in car-11
rying out activities to implement such plan, the Secretary 12
shall coordinate with industry, such as device manufactur-13
ers, clinical and reference laboratories, and medical prod-14
uct distributors, States, local governmental entities, In-15
dian Tribes and Tribal organizations, and other relevant 16
public and private entities. 17
‘‘(e) C
APACITYBUILDING.—The Secretary may con-18
tract with public and private entities, as appropriate, to 19
increase domestic capacity in the rapid development, vali-20
dation, authorization, manufacture, procurement, and dis-21
tribution of diagnostic tests, as appropriate, to State, 22
local, and Tribal health departments and other appro-23
priate entities for immediate public health response activi-24
ties to address an infectious disease with respect to which 25
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a public health emergency is declared under section 319, 1
or that has significant potential to cause such a public 2
health emergency. 3
‘‘(f) D
EADLINES FORPLAN.— 4
‘‘(1) P
UBLIC RELEASE.—Not later than one 5
year after the date of enactment of the Diagnostics 6
Testing Preparedness Plan Act of 2025, the Sec-7
retary shall publicly release the plan developed under 8
subsection (a). 9
‘‘(2) U
PDATES.—The Secretary shall update 10
such plan not less frequently than once every 3 years 11
after the date of the initial public release of the 12
plan.’’. 13
Æ
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