Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1108 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1108
5	5	To amend the Public Health Service Act to direct the Secretary of Health
6	6	and Human Services to develop a plan to improve the development
7	7	and distribution of diagnostic tests during a public health emergency,
8	8	and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	FEBRUARY7, 2025
11	11	Mrs. M
12	12	ILLER-MEEKS(for herself, Ms. SCHRIER, Mr. CRENSHAW, and Mr.
13	13	C
14	14	ARSON) introduced the following bill; which was referred to the Com-
15	15	mittee on Energy and Commerce
16	16	A BILL
17	17	To amend the Public Health Service Act to direct the Sec-
18	18	retary of Health and Human Services to develop a plan
19	19	to improve the development and distribution of diagnostic
20	20	tests during a public health emergency, and for other
21	21	purposes.
22	22	Be it enacted by the Senate and House of Representa-1
23	23	tives of the United States of America in Congress assembled, 2
24	24	SECTION 1. SHORT TITLE. 3
25	25	This Act may be cited as the ‘‘Diagnostics Testing 4
26	26	Preparedness Plan Act of 2025’’. 5
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29	29	•HR 1108 IH
30	30	SEC. 2. IMPROVING DEVELOPMENT AND DISTRIBUTION OF 1
31	31	DIAGNOSTIC TESTS. 2
32	32	Section 319B of the Public Health Service Act (42 3
33	33	U.S.C. 247d–2) is amended to read as follows: 4
34	34	‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-5
35	35	TION OF DIAGNOSTIC TESTS. 6
36	36	‘‘(a) D
37	37	IAGNOSTICTESTINGPREPAREDNESSPLAN.— 7
38	38	The Secretary shall develop, make publicly available, and 8
39	39	update a plan for the rapid development, validation, au-9
40	40	thorization, manufacture, procurement, and distribution 10
41	41	of diagnostic tests, and for rapid scaling of testing capac-11
42	42	ity, in response to chemical, biological, radiological, or nu-12
43	43	clear threats, including emerging infectious diseases, for 13
44	44	which a public health emergency is declared under section 14
45	45	319, or that has significant potential to cause such a pub-15
46	46	lic health emergency. 16
47	47	‘‘(b) P
48	48	URPOSES.—The purpose of the plan under sub-17
49	49	section (a) shall be to— 18
50	50	‘‘(1) facilitate the development and utilization 19
51	51	of diagnostic tests; 20
52	52	‘‘(2) describe the processes for the rapid devel-21
53	53	opment, validation, authorization, manufacture, pro-22
54	54	curement, and distribution of diagnostic tests, and 23
55	55	for rapid scaling of testing capacity; and 24
56	56	‘‘(3) facilitate coordination and collaboration 25
57	57	among public and private entities to improve the 26
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60	60	•HR 1108 IH
61	61	rapid development and utilization of diagnostic test-1
62	62	ing during a public health emergency. 2
63	63	‘‘(c) C
64	64	ONSIDERATIONS.—The plan under subsection 3
65	65	(a) shall take into consideration— 4
66	66	‘‘(1) domestic capacity, including any such ca-5
67	67	pacity established through partnerships with public 6
68	68	and private entities pursuant to subsection (e), to 7
69	69	support the development, validation, manufacture, 8
70	70	procurement, and distribution of tests, and the rapid 9
71	71	scaling of testing capacity; 10
72	72	‘‘(2) novel technologies and platforms that— 11
73	73	‘‘(A) may be used to improve testing capa-12
74	74	bilities, including— 13
75	75	‘‘(i) high-throughput laboratory 14
76	76	diagnostics; 15
77	77	‘‘(ii) point-of-care diagnostics; and 16
78	78	‘‘(iii) rapid at-home diagnostics; 17
79	79	‘‘(B) improve the accessibility of diagnostic 18
80	80	tests; and 19
81	81	‘‘(C) facilitate the development and manu-20
82	82	facture of diagnostic tests; 21
83	83	‘‘(3) medical supply needs related to testing, in-22
84	84	cluding diagnostic testing, equipment, supplies, and 23
85	85	component parts, and any potential vulnerabilities 24
86	86	related to the availability of such medical supplies 25
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89	89	•HR 1108 IH
90	90	and related planning needs, consistent with section 1
91	91	2811(b)(4)(J); 2
92	92	‘‘(4) strategies for the rapid and efficient dis-3
93	93	tribution of tests locally, regionally, or nationwide 4
94	94	and appropriate scaling of laboratory testing capac-5
95	95	ity; and 6
96	96	‘‘(5) assessment of such strategies through 7
97	97	drills and operational exercises carried out under 8
98	98	section 2811(b)(4)(G), as appropriate. 9
99	99	‘‘(d) C
100	100	OORDINATION.—To inform the development 10
101	101	and update of the plan under subsection (a), and in car-11
102	102	rying out activities to implement such plan, the Secretary 12
103	103	shall coordinate with industry, such as device manufactur-13
104	104	ers, clinical and reference laboratories, and medical prod-14
105	105	uct distributors, States, local governmental entities, In-15
106	106	dian Tribes and Tribal organizations, and other relevant 16
107	107	public and private entities. 17
108	108	‘‘(e) C
109	109	APACITYBUILDING.—The Secretary may con-18
110	110	tract with public and private entities, as appropriate, to 19
111	111	increase domestic capacity in the rapid development, vali-20
112	112	dation, authorization, manufacture, procurement, and dis-21
113	113	tribution of diagnostic tests, as appropriate, to State, 22
114	114	local, and Tribal health departments and other appro-23
115	115	priate entities for immediate public health response activi-24
116	116	ties to address an infectious disease with respect to which 25
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119	119	•HR 1108 IH
120	120	a public health emergency is declared under section 319, 1
121	121	or that has significant potential to cause such a public 2
122	122	health emergency. 3
123	123	‘‘(f) D
124	124	EADLINES FORPLAN.— 4
125	125	‘‘(1) P
126	126	UBLIC RELEASE.—Not later than one 5
127	127	year after the date of enactment of the Diagnostics 6
128	128	Testing Preparedness Plan Act of 2025, the Sec-7
129	129	retary shall publicly release the plan developed under 8
130	130	subsection (a). 9
131	131	‘‘(2) U
132	132	PDATES.—The Secretary shall update 10
133	133	such plan not less frequently than once every 3 years 11
134	134	after the date of the initial public release of the 12
135	135	plan.’’. 13
136	136	Æ
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