708 
SEC. 613. HOSPITAL PREPAREDNESS PROGRAM. 
(a) INCREASING PARTICIPATION BY EMS IN THE 
HOSPITAL PREPAREDNESS PROGRAM.— 
(1) IN GENERAL.—Section 319C–2 of the Pub-
lic Health Service Act (42 U.S.C. 247d–3b) is 
amended— 
(A) in subsection (b)(1)(A)— 
(i) in clause (iii)(III), by striking ‘‘; 
and’’ and inserting a semicolon; and 
(ii) by striking clause (iv) and insert-
ing the following: 
‘‘(iv) one or more emergency medical 
service organizations; and 
‘‘(v) to the extent practicable, one or 
more emergency management organiza-
tions; and’’; and 
(B) in subsection (g)(1)— 
(i) by striking ‘‘(1) LOCAL RESPONSE 
CAPABILITIES’’ and inserting: 
‘‘(1) LOCAL RESPONSE CAPABILITIES.— 
‘‘(A) PROGRAM COORDINATION.—’’; 
(ii) by striking ‘‘extent practicable, 
ensure’’ and inserting the following: ‘‘ex-
tent practicable— 
‘‘(i) ensure’’; 
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(iii) by striking the period and insert-
ing ‘‘; and’’; and 
(iv) by adding at the end the fol-
lowing: 
‘‘(ii) seek to increase participation of 
eligible entities described in subsection 
(b)(1)(A) with lower participation rates 
relative to other eligible entities, such as 
emergency medical services organizations 
and health care facilities in underserved 
areas.’’. 
(2) 
PREFERENCES.—Section 
319C– 
2(d)(1)(A)(iii) of the Public Health Service Act (42 
U.S.C. 247d–3b(d)(1)(A)(iii)) is amended by strik-
ing ‘‘subsection (b)(1)(A)(ii)’’ and inserting ‘‘clauses 
(ii) and (iv) of subsection (b)(1)(A)’’. 
(b) IMPROVING MEDICAL READINESS AND RESPONSE 
CAPABILITIES.—Section 319C–2 of the Public Health 
Service Act (42 U.S.C. 247d–3b) is amended— 
(1) in subsection (b)(2)— 
(A) in subparagraph (A), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (B), by striking the 
period and inserting ‘‘; and’’; and 
(C) by inserting at the end the following: 
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‘‘(C) designate a lead entity to administer such 
award and support coordination between entities de-
scribed in this subsection.’’; 
(2) in subsection (g)(1), as amended by sub-
section (a)(1)(B), by adding at the end the fol-
lowing: 
‘‘(B) REGIONAL OPERATIONS.—An eligible 
entity shall establish and maintain, or leverage 
an existing, capability to enable coordination of 
regional medical operations, which may include 
systems to facilitate information sharing and 
coordination, within a coalition described under 
subsection 
(b)(1)(A) 
and, 
as 
appropriate, 
among multiple coalitions that are in close geo-
graphic proximity to each other.’’; and 
(3) in subsection (j)(1)— 
(A) in subparagraph (A), by striking ‘‘for 
each of fiscal years 2019 through 2023’’ and 
inserting ‘‘for each of fiscal years 2025 and 
2026, to remain available through December 
31, 2026’’; and 
(B) in subparagraph (B)(iii), by striking 
‘‘September 30, 2023’’ and inserting ‘‘Decem-
ber 31, 2026’’. 
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SEC. 614. FACILITIES AND CAPACITIES OF THE CENTERS 
FOR DISEASE CONTROL AND PREVENTION TO 
COMBAT 
PUBLIC 
HEALTH 
SECURITY 
THREATS. 
Section 319D(h) of the Public Health Service Act (42 
U.S.C. 247d–4(h)) is amended— 
(1) in paragraph (1), by striking ‘‘$25,000,000 
for each of fiscal years 2022 and 2023’’ and insert-
ing ‘‘$40,000,000 for each of fiscal years 2025 and 
2026’’, to remain available through December 31, 
2026; and 
(2) in paragraph (2), by striking ‘‘2022 and 
2023’’ and inserting ‘‘2025 and 2026, to remain 
available through December 31, 2026’’. 
SEC. 615. PILOT PROGRAM TO SUPPORT STATE MEDICAL 
STOCKPILES. 
(a) IN GENERAL.—Section 319F–2(i) of the Public 
Health Service Act (42 U.S.C. 247d–6b(i)) is amended— 
(1) in paragraph (2)(B)(i)— 
(A) in subclause (I), by striking ‘‘and 
2024’’ and inserting ‘‘through 2025’’; and 
(B) in subclause (II), by striking ‘‘2025’’ 
and inserting ‘‘2026’’; 
(2) in paragraph (4)— 
(A) in subparagraph (G), by striking ‘‘; 
and’’ at the end and inserting a semicolon; 
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(B) by redesignating subparagraph (H) as 
subparagraph (I); 
(C) by inserting after subparagraph (G) 
the following: 
‘‘(H) facilitate the sharing of best practices 
among States within a consortia of States in re-
ceipt of funding related to establishing and 
maintaining a stockpile of medical products; 
and’’; and 
(D) in subparagraph (I), as so redesig-
nated, by striking ‘‘State efforts’’ and inserting 
‘‘State or regional efforts’’; 
(3) by redesignating paragraphs (5) through 
(9) as paragraphs (6) through (10), respectively; 
(4) by inserting after paragraph (4) the fol-
lowing: 
‘‘(5) COORDINATION.—An entity in receipt of 
an award under paragraph (1), in carrying out the 
activities under this subsection, shall coordinate with 
appropriate health care entities, health officials, and 
emergency management officials within the jurisdic-
tion of such State or States.’’; and 
(5) in paragraph (10), as so redesignated, by 
striking ‘‘$3,500,000,000 for each of fiscal years 
2023 and 2024’’ and inserting ‘‘$3,365,000,000 for 
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fiscal year 2025, and $3,265,000,000 for fiscal year 
2026’’. 
(b) GAO REPORT.—Section 2409(b) of the PRE-
VENT Pandemics Act (Public Law 117–328) is amend-
ed— 
(1) in paragraph (2), by striking ‘‘; and’’ and 
inserting a semicolon; 
(2) in paragraph (3), by striking the period and 
inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(4) the impact of any regional stockpiling ap-
proaches carried out under subsection (i)(1) of sec-
tion 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b).’’. 
SEC. 616. ENHANCING DOMESTIC WASTEWATER SURVEIL-
LANCE FOR PATHOGEN DETECTION. 
(a) IN GENERAL.—Title III of the Public Health 
Service Act is amended by inserting after section 317V 
(42 U.S.C. 247b–24) the following: 
‘‘SEC. 317W. WASTEWATER SURVEILLANCE FOR PATHOGEN 
DETECTION. 
‘‘(a) WASTEWATER SURVEILLANCE SYSTEM.—The 
Secretary, acting through the Director of the Centers for 
Disease Control and Prevention and in coordination with 
other Federal departments and agencies, shall award 
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grants, contracts, or cooperative agreements to eligible en-
tities to establish, maintain, or improve activities related 
to the detection and monitoring of infectious diseases 
through wastewater for public health emergency prepared-
ness and response purposes. 
‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 
an award under this section, an entity shall— 
‘‘(1) be a State, Tribal, or local health depart-
ment, or a partnership between such a health de-
partment and other public and private entities; and 
‘‘(2) submit to the Secretary an application at 
such time, in such manner, and containing such in-
formation as the Secretary may reasonably require, 
which shall include— 
‘‘(A) a description of activities proposed to 
be carried out pursuant to an award under sub-
section (a); 
‘‘(B) factors such entity proposes to use to 
select wastewater sampling sites; 
‘‘(C) factors such entity proposes to use to 
determine whether a response to findings from 
such wastewater sampling may be warranted, 
and a plan for responding, as appropriate, con-
sistent with applicable plans developed by such 
entity pursuant to section 319C–1; 
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‘‘(D) a plan to sustain such wastewater 
surveillance activities described in such applica-
tion following the conclusion of the award pe-
riod; and 
‘‘(E) any additional information the Sec-
retary may require. 
‘‘(c) CONSIDERATION.—In making awards under sub-
section (a), the Secretary may give priority to eligible enti-
ties that have submitted an application that— 
‘‘(1) details plans to provide public access to 
deidentified data generated through such wastewater 
surveillance activities in a manner that allows for 
comparison to such data generated by other recipi-
ents of an award under subsection (a); and 
‘‘(2) provides an assessment of community 
needs related to ongoing infectious disease moni-
toring, including estimates of the incidence and 
prevalence of infectious diseases that can be detected 
in wastewater and availability, at the time of the ap-
plication, of other forms of infectious disease detec-
tion in the jurisdiction. 
‘‘(d) USE OF FUNDS.—An eligible entity shall, as ap-
propriate, use amounts awarded under this section to— 
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‘‘(1) establish or enhance existing capacity and 
capabilities to conduct wastewater sampling, testing, 
and related analysis; 
‘‘(2) conduct wastewater surveillance, as appro-
priate, in areas or facilities with increased risk of in-
fectious disease outbreaks and limited ability to uti-
lize other forms of infectious disease detection, such 
as at individual facilities, institutions, and locations 
in rural areas or areas in which wastewater is not 
treated through the relevant local utility of the juris-
diction; and 
‘‘(3) implement projects that use evidence-based 
or innovative practices to conduct wastewater sur-
veillance activities. 
‘‘(e) PARTNERSHIPS.—In carrying out activities 
under this section, eligible entities shall identify opportuni-
ties to partner with other public or private entities to le-
verage relevant capabilities maintained by such entities, 
as appropriate and consistent with this section. 
‘‘(f) TECHNICAL ASSISTANCE.—The Secretary, in 
consultation with the heads of other applicable Federal 
agencies and departments, as appropriate, shall provide 
technical assistance to recipients of awards under this sec-
tion to facilitate the planning, development, and imple-
mentation of activities described in subsection (d). 
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‘‘(g) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there is authorized to be appro-
priated $20,000,000 for each of fiscal years 2025 and 
2026, to remain available through December 31, 2026.’’. 
(b) WASTEWATER SURVEILLANCE RESEARCH.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) shall continue to conduct or sup-
port research on the use of wastewater surveillance 
to detect and monitor emerging infectious diseases, 
which may include— 
(A) research to improve the efficiency and 
effectiveness of wastewater sample collection 
and analysis and increase the sensitivity and 
specificity of wastewater testing methods; and 
(B) implementation and development of 
evidence-based practices to facilitate the esti-
mation of the incidence and prevalence of infec-
tious disease within a community. 
(2) NON-DUPLICATION OF EFFORT.—The Sec-
retary shall ensure that activities carried out under 
this subsection do not unnecessarily duplicate efforts 
of other agencies and offices within the Department 
of Health and Human Services related to wastewater 
surveillance. 
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SEC. 617. REAUTHORIZATION OF MOSQUITO ABATEMENT 
FOR SAFETY AND HEALTH PROGRAM. 
Section 317S of the Public Health Service Act (42 
U.S.C. 247b–21) is amended— 
(1) in subsection (a)(3)(A), by striking ‘‘sub-
section (b)(3)’’ and inserting ‘‘subsection (b)(4)’’; 
(2) in subsection (b)— 
(A) 
by 
redesignating 
paragraphs 
(3) 
through (6) as paragraphs (4) through (7), re-
spectively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) CONSIDERATIONS.—The Secretary may 
consider the use of innovative and novel technology 
for mosquito prevention and control in making 
grants under paragraph (1).’’; 
(3) by amending subsection (d) to read as fol-
lows: 
‘‘(d) USES OF FUNDS.—Amounts appropriated under 
subsection (f) may be used by the Secretary to provide 
training and technical assistance with respect to the plan-
ning, development, and operation of assessments and 
plans under subsection (a) and control programs under 
subsection (b). The Secretary may provide such training 
and technical assistance directly or through awards of 
grants or contracts to public and private entities.’’; and 
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(4) in subsection (f)(1), by striking ‘‘2019 
through 2023’’ and inserting ‘‘2025 and 2026, to re-
main available through December 31, 2026’’. 
Subtitle B—Federal Planning and 
Coordination 
SEC. 621. ALL-HAZARDS EMERGENCY PREPAREDNESS AND 
RESPONSE. 
Section 2811 of the Public Health Service Act (42 
U.S.C. 300hh–10) is amended— 
(1) in subsection (b)— 
(A) in paragraph (3)— 
(i) by striking ‘‘Oversee advanced re-
search, development, and procurement’’ 
and inserting the following: 
‘‘(A) IN GENERAL.—Oversee advanced re-
search, development, procurement, and replen-
ishment’’; and 
(ii) by adding at the end the fol-
lowing: 
‘‘(B) 
DEVELOPMENT
OF
REQUIRE-
MENTS.—Lead the development and approval, 
and, on a routine basis, the review and update, 
of requirements for such countermeasures and 
products, including related capabilities, to in-
form the advanced research, development, pro-
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720 
curement, and replenishment decisions of the 
Secretary.’’; 
(B) in paragraph (4)— 
(i) in subparagraph (F)— 
(I) in the matter preceding clause 
(i), by striking ‘‘and in consultation 
with the Secretary of Homeland Secu-
rity,’’; and 
(II) in clause (i), by inserting 
‘‘enhance’’ after ‘‘capabilities and’’; 
(ii) in subparagraph (G)— 
(I) in the matter preceding clause 
(i), by inserting ‘‘the Office of Pan-
demic Preparedness and Response 
Policy,’’ after ‘‘Veterans Affairs,’’; 
(II) in clause (i), by striking 
‘‘based on’’ and inserting ‘‘based on— 
’’; 
(III) in clause (ii), by striking ‘‘; 
and’’ at the end and inserting a semi-
colon; 
(IV) in clause (iii), by striking 
the period and inserting ‘‘; and’’; and 
(V) by adding at the end the fol-
lowing: 
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‘‘(iv) that include, as appropriate, par-
ticipation by relevant industry, academia, 
professional societies, and other stake-
holders.’’; 
(iii) in subparagraph (H)— 
(I) by inserting ‘‘and the Direc-
tor of the Office of Pandemic Pre-
paredness and Response Policy’’ after 
‘‘Security Affairs’’; and 
(II) by inserting ‘‘and medical 
product and supply capacity planning 
pursuant to subparagraph (J), includ-
ing discussion of any relevant identi-
fied supply chain vulnerabilities’’ be-
fore the period at the end; 
(iv) in subparagraph (I), by inserting 
‘‘the Director of the Office of Pandemic 
Preparedness and Response Policy,’’ after 
‘‘Security Affairs,’’; and 
(v) in subparagraph (J)(i), in the 
matter preceding subclause (I), by insert-
ing ‘‘(including ancillary medical supplies 
and components of medical products, such 
as active pharmaceutical ingredients, key 
starting materials, medical device compo-
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nents, testing kits, reagents, and other 
testing supplies)’’ after ‘‘supply needs’’; 
and 
(C) in paragraph (7)— 
(i) in the matter preceding subpara-
graph (A), by inserting ‘‘and the require-
ments developed pursuant to paragraph 
(3)(B)’’ after ‘‘subsection (d)’’; 
(ii) by redesignating subparagraphs 
(E) and (F) as subparagraphs (F) and 
(G), respectively; and 
(iii) by inserting after subparagraph 
(D) the following: 
‘‘(E) include a professional judgment of 
anticipated budget needs for each future fiscal 
year accounted for in such plan to account for 
the full range of anticipated medical counter-
measure needs and life-cycle costs to address 
such priorities and requirements;’’; 
(2) in subsection (d)— 
(A) by amending paragraph (1) to read as 
follows: 
‘‘(1) IN GENERAL.—Not later than March 15, 
2020, and biennially thereafter, the Assistant Sec-
retary for Preparedness and Response shall develop 
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723 
and submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Com-
mittee on Energy and Commerce of the House of 
Representatives a coordinated strategy for medical 
countermeasures to address chemical, biological, ra-
diological, and nuclear threats, informed by the re-
quirements 
developed 
pursuant 
to 
subsection 
(b)(3)(B). Not later than 180 days after the submis-
sion of such strategy to such committees, the Assist-
ant Secretary for Preparedness and Response shall 
submit an accompanying implementation plan to 
such committees. In developing such a strategy and 
plan, the Assistant Secretary for Preparedness and 
Response shall consult with the Public Health Emer-
gency Medical Countermeasures Enterprise estab-
lished under section 2811–1. Such strategy and plan 
shall be known as the Public Health Emergency 
Medical Countermeasures Enterprise Strategy and 
Implementation Plan.’’; and 
(B) in paragraph (2), in the matter pre-
ceding subparagraph (A), by inserting ‘‘strategy 
and’’ before ‘‘plan’’; and 
(3) in subsection (f)— 
(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by inserting ‘‘, includ-
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724 
ing such agents that are an emerging infectious 
disease’’ after ‘‘become a pandemic’’; and 
(B) in paragraph (2)(A), by striking 
‘‘$250,000,000 for each of fiscal years 2019 
through 2023’’ and inserting ‘‘$335,000,000 
for each of fiscal years 2025 and 2026, to re-
main available through December 31, 2026’’. 
SEC. 622. NATIONAL HEALTH SECURITY STRATEGY. 
Section 2802 of the Public Health Service Act (42 
U.S.C. 300hh–1) is amended— 
(1) in subsection (a)(3)— 
(A) by striking ‘‘In 2022, the’’ and insert-
ing ‘‘The’’; and 
(B) by inserting ‘‘, maintaining, and sus-
taining’’ after ‘‘establishing’’; and 
(2) in subsection (b)— 
(A) in paragraph (2)— 
(i) in subparagraph (A), by inserting 
‘‘that support interagency coordination and 
availability of information, as appropriate’’ 
before the period; 
(ii) in subparagraph (B), by inserting 
‘‘rapid testing,’’ after ‘‘and supplies,’’; 
(B) in paragraph (3)— 
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(i) in the matter preceding subpara-
graph (A), by inserting ‘‘and blood banks’’ 
after ‘‘dental health facilities’’; 
(ii) in subparagraph (C), by inserting 
‘‘and current capacity of facilities within 
such systems, as applicable’’ before the pe-
riod; and 
(iii) in subparagraph (D), by inserting 
‘‘and other medical products and medical 
supplies consistent with the activities car-
ried out under section 2811(b)(4)(J)’’ be-
fore the period; 
(C) in paragraph (5), by inserting ‘‘appli-
cable federally funded activities and’’ after ‘‘(in-
cluding’’; 
(D) in paragraph (8)— 
(i) in subparagraph (A), by inserting 
‘‘public health and medical’’ before ‘‘activi-
ties’’; and 
(ii) in subparagraph (B), by striking 
‘‘familiarity with’’ and inserting ‘‘under-
standing of, and coordination between,’’; 
(E) by redesignating paragraphs (9) and 
(10) as paragraphs (10) and (12), respectively; 
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(F) by inserting after paragraph (8) the 
following: 
‘‘(9) OTHER
SETTINGS.—Supporting Federal, 
State, local, and Tribal coordination and planning 
with respect to facilities in which there is an in-
creased risk of infectious disease outbreaks, includ-
ing such facilities that address the needs of at-risk 
individuals, in the event of a public health emer-
gency declared under section 319.’’; 
(G) by inserting after subparagraph (10), 
as so redesignated, the following: 
‘‘(11) OTHER
HAZARDS.—Assessing current 
and potential health security threats from natural 
disasters with respect to public health and medical 
preparedness and response.’’; 
(H) by inserting after paragraph (12), as 
so redesignated, the following: 
‘‘(13) CYBERSECURITY RESILIENCY OF HEALTH 
CARE SYSTEMS.—Consistent with the requirements 
of section 2218 of the Homeland Security Act of 
2002, strengthening the ability of States, local com-
munities, and Tribal communities to prepare for, re-
spond to, and be resilient against cybersecurity 
vulnerabilities or cybersecurity attacks that affect 
public health and health information technology, and 
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727 
encouraging health care facilities to use recognized 
security practices meeting or exceeding the ap-
proaches established under section 405(d) of the Cy-
bersecurity Act of 2015.’’; and 
(I) by striking ‘‘tribal’’ each place it ap-
pears and inserting ‘‘Tribal’’. 
SEC. 623. IMPROVING DEVELOPMENT AND DISTRIBUTION 
OF DIAGNOSTIC TESTS. 
Section 319B of the Public Health Service Act (42 
U.S.C. 247d–2) is amended to read as follows: 
‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-
TION OF DIAGNOSTIC TESTS. 
‘‘(a) DIAGNOSTIC TESTING PREPAREDNESS PLAN.— 
The Secretary shall develop, make publicly available, not 
later than 1 year after the date of enactment of the Pan-
demic and All-Hazards Preparedness and Response Act, 
and update not less frequently than every 3 years there-
after, a plan for the rapid development, validation, author-
ization, manufacture, procurement, and distribution of di-
agnostic tests, and for rapid scaling of testing capacity, 
in response to chemical, biological, radiological, or nuclear 
threats, including emerging infectious diseases, for which 
a public health emergency is declared under section 319, 
or that has significant potential to cause such a public 
health emergency. 
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‘‘(b) PURPOSES.—The purpose of the plan under sub-
section (a) shall be to— 
‘‘(1) facilitate the development and utilization 
of diagnostic tests; 
‘‘(2) describe the processes for the rapid devel-
opment, validation, authorization, manufacture, pro-
curement, and distribution of diagnostic tests, and 
for rapid scaling of testing capacity; and 
‘‘(3) facilitate coordination and collaboration 
among public and private entities to improve the 
rapid development and utilization of diagnostic test-
ing during a public health emergency. 
‘‘(c) CONSIDERATIONS.—The plan under subsection 
(a) shall take into consideration— 
‘‘(1) domestic capacity, including any such ca-
pacity established through partnerships with public 
and private entities pursuant to subsection (e), to 
support the development, validation, manufacture, 
procurement, and distribution of tests, and the rapid 
scaling of testing capacity; 
‘‘(2) novel technologies and platforms that— 
‘‘(A) may be used to improve testing capa-
bilities, including— 
‘‘(i) 
high-throughput 
laboratory 
diagnostics; 
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‘‘(ii) point-of-care diagnostics; and 
‘‘(iii) rapid at-home diagnostics; 
‘‘(B) improve the accessibility of diagnostic 
tests; and 
‘‘(C) facilitate the development and manu-
facture of diagnostic tests; 
‘‘(3) medical supply needs related to testing, in-
cluding diagnostic testing, equipment, supplies, and 
component parts, and any potential vulnerabilities 
related to the availability of such medical supplies 
and related planning needs, consistent with section 
2811(b)(4)(J); 
‘‘(4) strategies for the rapid and efficient dis-
tribution of tests locally, regionally, or nationwide 
and appropriate scaling of laboratory testing capac-
ity; and 
‘‘(5) assessment of such strategies through 
drills and operational exercises carried out under 
section 2811(b)(4)(G), as appropriate. 
‘‘(d) COORDINATION.—To inform the development 
and update of the plan under subsection (a), and in car-
rying out activities to implement such plan, the Secretary 
shall coordinate with industry, such as device manufactur-
ers, clinical and reference laboratories, and medical prod-
uct distributors, States, local governmental entities, In-
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dian Tribes and Tribal organizations, and other relevant 
public and private entities. 
‘‘(e) CAPACITY BUILDING.—The Secretary may con-
tract with public and private entities, as appropriate, to 
increase domestic capacity in the rapid development, vali-
dation, authorization, manufacture, procurement, and dis-
tribution of diagnostic tests, as appropriate, to State, 
local, and Tribal health departments and other appro-
priate entities for immediate public health response activi-
ties to address an infectious disease with respect to which 
a public health emergency is declared under section 319, 
or that has significant potential to cause such a public 
health emergency.’’. 
SEC. 624. COMBATING ANTIMICROBIAL RESISTANCE. 
(a) IN GENERAL.—Section 319E of the Public 
Health Service Act (42 U.S.C. 247d–5) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by inserting ‘‘and ac-
tivities’’ after ‘‘Federal programs’’; 
(B) in paragraph (2)— 
(i) by striking ‘‘public health constitu-
encies, manufacturers, veterinary and med-
ical professional societies and others’’ and 
inserting ‘‘the Advisory Council described 
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in subsection (b) and relevant public and 
private entities’’; and 
(ii) by inserting ‘‘, pursuant to para-
graph (4),’’ after ‘‘comprehensive plan’’; 
(C) by amending paragraph (3) to read as 
follows: 
‘‘(3) AGENDA.—The task force described in 
paragraph (1) shall consider factors the Secretary 
considers appropriate, including factors to— 
‘‘(A) slow the emergence of resistant bac-
teria and fungi and prevent the spread of re-
sistant infections; 
‘‘(B) strengthen activities to combat resist-
ance with respect to zoonotic diseases; 
‘‘(C) advance development and use of rapid 
and innovative capabilities, including diagnostic 
tests, for identification and characterization of 
resistant bacteria and fungi; 
‘‘(D) accelerate basic and applied research 
and 
development 
for 
new 
antibiotics, 
antifungals, and other related therapeutics and 
vaccines; and 
‘‘(E) support international collaboration 
and capacities for antimicrobial-resistance pre-
vention, detection, and control.’’; 
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(D) by redesignating paragraph (4) as 
paragraph (5); 
(E) by inserting after paragraph (3) the 
following: 
‘‘(4) ACTION PLAN.—Not later than October 1, 
2026, and every 5 years thereafter, the task force 
described in paragraph (1) shall develop and submit 
to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of 
the Senate and the Committee on Energy and Com-
merce and the Committee on Appropriations of the 
House of Representatives a plan regarding Federal 
programs and activities to combat antimicrobial re-
sistance, including measurable outcomes, as appro-
priate, informed by— 
‘‘(A) the agenda described in paragraph 
(3); 
‘‘(B) input provided by the Advisory Coun-
cil described in subsection (b); and 
‘‘(C) input from other relevant stake-
holders provided pursuant to paragraph (2).’’; 
(2) by redesignating subsections (b) through (o) 
as subsections (c) through (p), respectively; 
(3) by inserting after subsection (a) the fol-
lowing: 
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‘‘(b) ADVISORY COUNCIL.— 
‘‘(1) IN
GENERAL.—The Secretary may con-
tinue the Presidential Advisory Council on Com-
bating Antibiotic-Resistant Bacteria, referred to in 
this subsection as the ‘Advisory Council’. 
‘‘(2) DUTIES.—The Advisory Council shall ad-
vise and provide information and recommendations 
to the Secretary, acting through the Task Force es-
tablished under subsection (a), regarding Federal 
programs and activities intended to reduce or com-
bat antimicrobial-resistant bacteria or fungi that 
may present a public health threat and improve ca-
pabilities to prevent, diagnose, mitigate, or treat 
such resistance. Such advice, information, and rec-
ommendations may be related to improving Federal 
efforts related to factors described in subsection 
(a)(3) and other topics related to antimicrobial re-
sistance, as appropriate. 
‘‘(3) MEETINGS AND COORDINATION.— 
‘‘(A) MEETINGS.—The Advisory Council 
shall meet not less frequently than biannually 
and, to the extent practicable, in coordination 
with meetings of the task force established 
under subsection (a). 
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‘‘(B) 
COORDINATION.—The 
Advisory 
Council shall, to the greatest extent practicable, 
coordinate activities carried out by the Council 
with the task force established under subsection 
(a). 
‘‘(4) FACA.—Chapter 10 of title 5, United 
States Code, shall apply to the activities and duties 
of the Advisory Council. 
‘‘(5) SUNSET.— 
‘‘(A) IN GENERAL.—The Advisory Council 
under this subsection shall terminate on De-
cember 31, 2026. 
‘‘(B) EXTENSION
OF
ADVISORY
COUN-
CIL.—Not later than October 1, 2026, the Sec-
retary shall submit to the Committee on 
Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives a report 
that includes a recommendation on whether the 
Advisory Council should be extended, and iden-
tifying whether there are other committees, 
councils, or task forces that have overlapping or 
similar duties to that of the Advisory Council, 
and whether such committees, councils, or task 
forces should be combined, restructured, or 
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eliminated, including with respect to the task 
force established under subsection (a).’’; and 
(4) in subsection (n), as so redesignated, by 
striking ‘‘(f) through (j)’’ and inserting ‘‘(g) through 
(k)’’. 
(b) CONFORMING AMENDMENT.—Section 505 of the 
Pandemic and All-Hazards Preparedness and Advancing 
Innovation Act of 2019 (42 U.S.C. 247d–5 note; Public 
Law 116–22) is amended by striking subsection (a) and 
all that follows through ‘‘Not later’’ in subsection (e) and 
inserting the following: 
‘‘Not later’’. 
SEC. 625. STRATEGIC NATIONAL STOCKPILE AND MATE-
RIAL THREATS. 
Section 319F–2 of the Public Health Service Act (42 
U.S.C. 247d–6b) is amended— 
(1) in subsection (a)— 
(A) in paragraph (2)— 
(i) in subparagraph (A), by inserting 
‘‘Such review shall include a description of 
how the Secretary manages and mitigates 
risks associated with gaps between current 
inventory levels and stockpiling goals, 
prioritizes such risks, and tracks progress 
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toward mitigation of such risks.’’ after the 
first sentence; and 
(ii) in subparagraph (B)(i), by amend-
ing subclause (IV) to read as follows: 
‘‘(IV) the emergency health secu-
rity threat or threats such counter-
measure procurement is intended to 
address, including— 
‘‘(aa) whether such procure-
ment is consistent with meeting 
emergency health security needs 
associated with such threat or 
threats; and 
‘‘(bb) in the case of a coun-
termeasure that addresses a bio-
logical agent, whether such agent 
has an increased likelihood to be-
come resistant to, more resistant 
to, 
or 
evade, 
such 
counter-
measure relative to other avail-
able medical countermeasures;’’; 
(B) in paragraph (3)— 
(i) in subparagraph (B), by striking 
‘‘are followed, regularly reviewed, and up-
dated with respect to such stockpile’’ and 
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inserting ‘‘with respect to such stockpile 
are followed, regularly reviewed, and up-
dated to reflect best practices’’; 
(ii) in subparagraph (I), by inserting 
‘‘, through a standard operating proce-
dure,’’ after ‘‘ensure’’; 
(iii) by redesignating subparagraphs 
(H) through (K) as subparagraphs (I) 
through (L), respectively; 
(iv) by inserting after subparagraph 
(G) the following: 
‘‘(H) utilize tools to enable the timely and 
accurate tracking of the contents of the stock-
pile throughout the deployment of such con-
tents, including tracking of the location and ge-
ographic distribution and utilization of such 
contents;’’; 
(v) in subparagraph (K), as so redes-
ignated, by striking ‘‘; and’’ at the end and 
inserting a semicolon; 
(vi) in subparagraph (L), as so redes-
ignated, by striking the period and insert-
ing ‘‘; and’’; and 
(vii) by adding at the end the fol-
lowing: 
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‘‘(M) communicate to relevant vendors re-
garding modifications, renewals, extensions, or 
terminations of contracts, or the intent to exer-
cise options for such contracts, within 30 days, 
as practicable, of such determination, including 
through the development of a contract notifica-
tion process.’’; 
(C) in paragraph (5)(B), in the matter 
preceding clause (i), by inserting ‘‘, which may 
accompany the review required under paragraph 
(2),’’ after ‘‘Representatives a report’’; and 
(D) in paragraph (6)(A)— 
(i) by redesignating clauses (viii) 
through (x) as clauses (ix) through (xi), re-
spectively; and 
(ii) by inserting after clause (vii) the 
following: 
‘‘(viii) with respect to any change in 
the Federal organizational management of 
the stockpile, an assessment and compari-
son of any differences in the processes and 
operations resulting from such change, in-
cluding— 
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‘‘(I) planning for potential coun-
termeasure deployment, distribution, 
or dispensing capabilities; 
‘‘(II) organizational structure; 
‘‘(III) communication with rel-
evant stakeholders related to procure-
ment decisions; 
‘‘(IV) processes related to pro-
curement, deployment, and use of 
stockpiled countermeasures; 
‘‘(V) communication and coordi-
nation with the Public Health Emer-
gency Medical Countermeasures En-
terprise and other related Federal en-
tities; 
‘‘(VI) 
inventory 
management; 
and 
‘‘(VII) availability and use of re-
sources for such activities;’’; and 
(2) 
in 
subsection 
(c)(2)(C), 
by 
striking 
‘‘promptly’’ and inserting ‘‘, not later than 60 days 
after each such determination,’’; 
(3) 
in 
subsection 
(f)(1), 
by 
striking 
‘‘$610,000,000 for each of fiscal years 2019 through 
2021, and $750,000,000 for each of fiscal years 
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740 
2022 and 2023’’ and inserting ‘‘$1,100,000,000 for 
fiscal year 2025, and $1,210,000,000 for fiscal year 
2026’’; and 
(4) in subsection (g)(1), by striking ‘‘2019 
through 2028’’ and inserting ‘‘2025 through 2034’’. 
SEC. 
626. 
MEDICAL 
COUNTERMEASURES 
FOR 
VIRAL 
THREATS WITH PANDEMIC POTENTIAL. 
Section 319L of the Public Health Service Act (42 
U.S.C. 247d–7e) is amended— 
(1) in subsection (c)— 
(A) in paragraph (4)— 
(i) in subparagraph (D)— 
(I) in clause (ii), by striking ‘‘; 
and’’ and inserting a semicolon; and 
(II) by redesignating clause (iii) 
as clause (iv); and 
(III) by inserting after clause (ii) 
the following: 
‘‘(iii) research and development of 
medical countermeasures for priority virus 
families that have significant potential to 
cause a pandemic, including such counter-
measures that take either pathogen-specific 
or pathogen-agnostic approaches, and plat-
form technologies to improve the develop-
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741 
ment and manufacture of such medical 
countermeasures; and’’; and 
(ii) in subparagraph (F)(ii), by insert-
ing ‘‘or priority virus families and other 
viral pathogens that pose a threat due to 
their significant potential to cause a pan-
demic,’’ after ‘‘pandemic influenza,’’; and 
(B) in paragraph (5), by adding at the end 
the following: 
‘‘(I) NOTIFICATION.—In awarding con-
tracts, grants, cooperative agreements, or other 
transactions under this section, the Secretary 
shall communicate to relevant vendors regard-
ing modifications, renewals, extensions, or ter-
minations of contracts, including through the 
development of a contract notification process, 
within 30 days of such determination, as prac-
ticable.’’; 
(2) 
in 
subsection 
(d)(2), 
by 
striking 
‘‘$611,700,000 for each of fiscal years 2019 through 
2023’’ and inserting ‘‘$950,000,000 for each of fis-
cal years 2025 and 2026’’; and 
(3) in subsection (e)(1), by amending subpara-
graph (D) to read as follows: 
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‘‘(D) SUNSET.—This paragraph shall cease 
to have force or effect after December 31, 
2026.’’. 
SEC. 627. PUBLIC HEALTH EMERGENCY MEDICAL COUN-
TERMEASURES ENTERPRISE. 
Section 2811–1 of the Public Health Service Act (42 
U.S.C. 300hh–10a) is amended— 
(1) in subsection (b)— 
(A) by redesignating paragraph (11) as 
paragraph (13); 
(B) by inserting after paragraph (10) the 
following: 
‘‘(11) The Director of the Biomedical Advanced 
Research and Development Authority. 
‘‘(12) The Director of the Strategic National 
Stockpile.’’; and 
(C) in paragraph (13), as so redesignated, 
by striking ‘‘the Director of the Biomedical Ad-
vanced Research and Development Authority, 
the Director of the Strategic National Stock-
pile, the Director of the National Institute of 
Allergy and Infectious Diseases,’’ and inserting 
‘‘the Director of the National Institute of Al-
lergy and Infectious Diseases’’; and 
(2) in subsection (c)— 
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(A) in paragraph (1)— 
(i) by redesignating subparagraph (D) 
as subparagraph (E); and 
(ii) by inserting after subparagraph 
(C) the following: 
‘‘(D) Assist the Secretary in developing 
strategies for appropriate and evidence-based 
allocation and distribution of countermeasures 
to jurisdictions, in a manner that supports the 
availability and use of such countermeasures, 
for public health and medical preparedness and 
response needs.’’; 
(B) in paragraph (2), by inserting ‘‘rel-
evant stakeholders, including industry,’’ after 
‘‘consider input from’’; and 
(C) by adding at the end the following: 
‘‘(3) INFORMATION
SHARING.—The Secretary 
shall, as appropriate and in a manner that does not 
compromise national security, communicate and 
share information related to recommendations made 
and strategies developed under paragraph (1) with 
relevant stakeholders, including industry and State, 
local, and Tribal public health departments.’’. 
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744 
SEC. 628. FELLOWSHIP AND TRAINING PROGRAMS. 
Section 317G of the Public Health Service Act (42 
U.S.C. 247b–8) is amended— 
(1) by striking ‘‘The Secretary,’’ and inserting 
the following: 
‘‘(a) IN GENERAL.—The Secretary,’’; and 
(2) by adding at the end the following: 
‘‘(b) NONCOMPETITIVE CONVERSION.— 
‘‘(1) IN
GENERAL.—The Secretary may non-
competitively convert an individual who has com-
pleted an epidemiology, surveillance, or laboratory 
fellowship or training program under subsection (a) 
to a career-conditional appointment without regard 
to the provisions of subchapter I of chapter 33 of 
title 5, United States Code, provided that such indi-
vidual meets qualification requirements for the ap-
pointment.’’. 
SEC. 629. REGIONAL BIOCONTAINMENT RESEARCH LAB-
ORATORIES. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall make awards to establish or maintain, as 
applicable, not fewer than 12 regional biocontainment lab-
oratories, for purposes of— 
(1) conducting biomedical research to support 
public health and medical preparedness for, and 
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rapid response to, biological agents, including emerg-
ing infectious diseases; 
(2) ensuring the availability of surge capacity 
for purposes of responding to such biological agents; 
(3) supporting information sharing between, 
and the dissemination of findings to, researchers and 
other relevant individuals to facilitate collaboration 
between industry and academia; and 
(4) providing, as appropriate and applicable, 
technical assistance and training to researchers and 
other relevant individuals to support the biomedical 
research workforce in improving the management 
and mitigation of safety and security risks in the 
conduct of research involving such biological agents. 
(b) REQUIREMENTS.—As a condition of receiving a 
grant under this section, a regional biocontainment labora-
tory shall agree to such oversight activities as the Sec-
retary determines appropriate, including periodic meetings 
with relevant officials of the Department of Health and 
Human Services, facility inspections, and other activities 
as necessary and appropriate to ensure compliance with 
the terms and conditions of such award. 
(c) WORKING GROUP.—The Secretary shall establish 
a Working Group, consisting of a representative from each 
entity in receipt of an award under subsection (a). The 
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Working Group shall make recommendations to the Sec-
retary in administering awards under this section, for pur-
poses of— 
(1) improving the quality and consistency of ap-
plicable procedures and practices within laboratories 
funded pursuant to subsection (a); and 
(2) ensuring coordination, as appropriate, of 
federally funded activities carried out at such labora-
tories. 
(d) DEFINITION.—In this section, the term ‘‘regional 
biocontainment laboratory’’ means a Biosafety or Animal 
Biosafety Level–3 and Level–2 facility located at an insti-
tution in the United States that is designated by the Sec-
retary to carry out the activities described in subsection 
(a). 
(e) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
$52,000,000 for each of fiscal years 2025 and 2026, to 
remain available through December 31, 2026. 
(f) ADMINISTRATIVE EXPENSES.—Of the amount 
available to carry out this section for a fiscal year, the 
Secretary may use not more than 5 percent for the admin-
istrative expenses of carrying out this section, including 
expenses related to carrying out subsection (c). 
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(g) REPORT TO CONGRESS.—Not later than 1 year 
after the date of the enactment of this Act, and biannually 
thereafter, the Secretary, in consultation with the heads 
of applicable Federal departments and agencies shall re-
port to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on— 
(1) the activities and accomplishments of the 
regional biocontainment laboratories; 
(2) any published or disseminated research 
findings based on research conducted in such labora-
tories in the applicable year; 
(3) oversight activities carried out by the Sec-
retary pursuant to subsection (b); 
(4) activities undertaken by the Secretary to 
take into consideration the capacity and capabilities 
of the network of regional biocontainment labora-
tories in activities to prepare for and respond to bio-
logical agents, which may include leveraging such ca-
pacity and capabilities to support the Laboratory 
Response Network, as applicable and appropriate; 
(5) plans for the maintenance and sustainment 
of federally funded activities conducted at the re-
gional biocontainment laboratories, consistent with 
the strategy required under section 2312 of the 
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PREVENT Pandemics Act (Public Law 117–328); 
and 
(6) activities undertaken by the Secretary to co-
ordinate with the heads of other relevant Federal de-
partments and agencies to ensure that work carried 
out by each such facility on behalf of the Secretary 
and such other relevant heads is prioritized, is com-
plementary to the work carried out by other such fa-
cilities and other relevant federally funded activities, 
and avoids unnecessary duplication. 
SEC. 629A. LIMITATION RELATED TO COUNTRIES OF CON-
CERN CONDUCTING CERTAIN RESEARCH. 
Section 2315(c) of the PREVENT Pandemics Act 
(42 U.S.C. 6627) is amended to read as follows: 
‘‘(c) LIMITATIONS ON COUNTRIES OF CONCERN CON-
DUCTING CERTAIN RESEARCH.— 
‘‘(1) IN GENERAL.—The Secretary of Health 
and Human Services (referred to in this subsection 
as the ‘Secretary’) shall not fund research that may 
reasonably be anticipated to involve the creation, 
transfer, and use of enhanced pathogens of pan-
demic potential or biological agents or toxins listed 
pursuant to section 351A(a)(1) of the Public Health 
Service Act if such research is conducted by a for-
eign entity at a facility located in a country that is 
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determined to be a country of concern as defined in 
paragraph (2). 
‘‘(2) COUNTRIES OF CONCERN.— 
‘‘(A) DEFINITION.—For purposes of this 
subsection, a ‘country of concern’ means the 
People’s Republic of China, the Democratic 
People’s Republic of Korea, the Russian Fed-
eration, the Islamic Republic of Iran, and any 
other country as determined pursuant to sub-
paragraph (B). 
‘‘(B) ADDITIONAL
COUNTRIES.—The Di-
rector of National Intelligence (referred to in 
this subsection as the ‘Director’) shall, in con-
sultation with the Secretary, add additional 
countries of concern for purposes of paragraph 
(1), only if— 
‘‘(i) the Director determines that evi-
dence exists that a country has malicious 
intent related to the creation, enhance-
ment, transfer, or use of pathogens of pan-
demic potential or biological agents or tox-
ins 
listed 
pursuant 
to 
such 
section 
351A(a)(1); and 
‘‘(ii) in a manner that does not com-
promise national security, the Director 
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provides such evidence in a report sub-
mitted to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate 
and the Committee on Energy and Com-
merce of the House of Representatives. 
‘‘(C) LIMITATION.—Paragraph (1) shall 
not take effect with respect to a country of con-
cern identified under subparagraph (B) until 
the date that is 15 days after the date on which 
the Director submits the report described in 
subparagraph (B)(ii). 
‘‘(3) CLARIFICATION.— 
‘‘(A) IN
GENERAL.—The requirement of 
paragraph (1) may be waived by the President 
for the duration of the initial response to an 
outbreak of a novel emerging infectious disease 
if the President determines that such require-
ment impedes the ability of the Federal Govern-
ment to immediately respond to such outbreak. 
‘‘(B) NOTIFICATION.—The President shall 
notify such committees of Congress not later 
than 48 hours after exercising the waiver under 
subparagraph (A), and shall provide updates to 
such committees related to the use of such 
waiver every 15 days thereafter. 
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‘‘(4) SUNSET.—The limitation under this sub-
section shall expire on December 31, 2026.’’. 
Subtitle C—Addressing the Needs 
of All Individuals 
SEC. 631. IMPROVING ACCESS TO CERTAIN PROGRAMS. 
(a) PROCEDURES RELATED TO THE TRANSITION OF 
CERTAIN CLAIMS.— 
(1) PROCEDURES
FOR
CORRECTING
SUBMIS-
SIONS.— 
(A) 
REQUESTS
INITIALLY
SUBMITTED 
UNDER SECTION 319F–4.— 
(i) IN GENERAL.—In the case of a re-
quest for compensation submitted under 
section 319F–4 of the Public Health Serv-
ice Act (42 U.S.C. 247d–6e) for an injury 
or death related to a medical product for 
active immunization to prevent coronavirus 
disease 2019 that the Secretary determines 
to be ineligible pursuant to subsection 
(b)(4)(B) of such section 319F–4, the Sec-
retary shall, not later than 30 days after 
such determination, notify the individual 
submitting the request of such determina-
tion. 
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(ii) SUBMISSION
OF
PETITION.—An 
individual who receives a notification de-
scribed in clause (i) shall be eligible to sub-
mit a petition to the United States Court 
of Federal Claims under section 2111 of 
the Public Health Service Act (42 U.S.C. 
300aa–11) with respect to the same med-
ical product administration claimed in the 
request submitted under section 319F–4 of 
such Act (42 U.S.C. 247d–6e), provided 
such petition is submitted not later than 
the later of— 
(I) 1 year after receiving such 
notification under clause (i); or 
(II) the last date on which the 
individual otherwise would be eligible 
to submit a petition relating to such 
injury, as specified in section 2116 of 
such Act (42 U.S.C. 300aa–16). 
(iii) ELIGIBILITY.—To be eligible to 
submit a petition in accordance with clause 
(ii), the petitioner shall have submitted the 
request that was determined to be ineli-
gible as described in clause (i) not later 
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than the applicable deadline for filing a pe-
tition under such section 2116. 
(B) 
REQUESTS
INITIALLY
SUBMITTED 
UNDER SECTION 2111.— 
(i) IN GENERAL.—If a special master 
determines that— 
(I) a petition submitted under 
section 2111 of the Public Health 
Service Act (42 U.S.C. 300aa–11) re-
lated to a medical product for active 
immunization to prevent coronavirus 
disease 2019 that is ineligible for the 
program under subtitle 2 of title XXI 
of the Public Health Service Act (42 
U.S.C. 300aa–10 et seq.) because it 
relates to a medical product adminis-
tered at a time when the medical 
product was not included in the table 
under section 2114 of such Act (42 
U.S.C. 300aa–14); and 
(II) the medical product was ad-
ministered when it was a covered 
countermeasure subject to a declara-
tion under section 319F–3(b) of such 
Act (42 U.S.C. 247d–6d(b)), 
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the special master shall, not later than 30 
days after such determination, notify the 
petitioner of such determination. 
(ii) SUBMISSION
OF
REQUEST.—An 
individual who receives a notification de-
scribed in clause (i) shall be eligible to sub-
mit a request for compensation under sec-
tion 319F–4(b) of the Public Health Serv-
ice Act (42 U.S.C. 247d–6e(b)) with re-
spect to the same medical product adminis-
tration claimed in the petition submitted 
under section 2111 of such Act (42 U.S.C. 
300aa–11)— 
(I) not later than 1 year after re-
ceiving such notification; or 
(II) in the case that the notifica-
tion is issued after judicial review of 
the petition under subsection (e) or 
(f) of section 2112 of such Act (42 
U.S.C. 300aa–12), not later than 1 
year after the judgment of the United 
States Court of Federal Claims or the 
mandate is issued by the United 
States Court of Appeals for the Fed-
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755 
eral Circuit pursuant to such sub-
section (e) or (f). 
(iii) ELIGIBILITY.—To be eligible to 
submit a request for compensation in ac-
cordance with clause (ii), the individual 
submitting the request shall have sub-
mitted the petition under section 2111 of 
the Public Health Service Act (42 U.S.C. 
300aa–11) that was determined to be ineli-
gible not later than 1 year after the date 
of administration of the medical product. 
(2) CHANGES TO CERTAIN PROGRAMS.— 
(A) SECTION 319F–4.—Section 319F–4 of 
the Public Health Service Act (42 U.S.C. 
247d–6e) is amended— 
(i) in subsection (b)(4)— 
(I) by striking ‘‘Except as pro-
vided’’ and inserting the following: 
‘‘(A) IN GENERAL.—Except as provided’’; 
and 
(II) by adding at the end the fol-
lowing: 
‘‘(B) EXCLUSION OF INJURIES ELIGIBLE 
FOR
PETITION
UNDER
TITLE
XXI.—Notwith-
standing any other provision of this section, no 
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756 
individual may be eligible for compensation 
under this section with respect to a vaccine 
that, at the time it was administered, was in-
cluded in the Vaccine Injury Table under sec-
tion 2114.’’; and 
(ii) in subsection (d)(3)— 
(I) by striking ‘‘This section’’ 
and inserting the following: 
‘‘(A) IN GENERAL.—This section’’; and 
(II) by adding at the end the fol-
lowing: 
‘‘(B) EXHAUSTION OF REMEDIES.—A cov-
ered individual shall not be considered to have 
exhausted remedies as described in paragraph 
(1), nor be eligible to seek remedy under section 
319F–3(d), unless such individual has provided 
to the Secretary all supporting documentation 
necessary to facilitate the determinations re-
quired under subsection (b)(4).’’. 
(B) TITLE XXI.—Title XXI of the Public 
Health Service Act (42 U.S.C. 300aa–1 et seq.) 
is amended— 
(i) in section 2111(a)(2)(A) (42 
U.S.C. 300aa–11(a)(2)(A)), in the matter 
preceding clause (i), by inserting ‘‘con-
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taining the information required under 
subsection (c)’’ after ‘‘unless a petition’’; 
(ii) in section 2112(d) (42 U.S.C. 
300aa–12(d))— 
(I) by adding at the end of para-
graph (1) the following: ‘‘Such des-
ignation shall not occur until the peti-
tioner has filed all materials required 
under section 2111(c).’’; and 
(II) in paragraph (3)(A)(ii), by 
striking ‘‘the petition was filed’’ and 
inserting ‘‘on which the chief special 
master makes the designation pursu-
ant to paragraph (1)’’; 
(iii) in section 2114(e) (42 U.S.C. 
300aa–14(e)), by adding at the end the 
following: 
‘‘(4) 
LICENSURE
REQUIREMENT.—Notwith-
standing paragraphs (2) and (3), the Secretary may 
not revise the Vaccine Injury Table to include a vac-
cine for which the Centers for Disease Control and 
Prevention has issued a recommendation for routine 
use in children or pregnant women until at least one 
application for such vaccine has been approved 
under section 351. Upon such revision of the Vac-
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cine Injury Table, all vaccines in a vaccine category 
on the Vaccine Injury Table, including vaccines au-
thorized under emergency use pursuant to section 
564 of the Federal Food, Drug, and Cosmetic Act, 
shall be considered included in the Vaccine Injury 
Table.’’; and 
(iv) in section 2116 (42 U.S.C. 
300aa–16), by adding at the end the fol-
lowing: 
‘‘(d) CLARIFICATION.—Notwithstanding subsections 
(a) and (b), an injury or death related to a vaccine admin-
istered at a time when the vaccine was a covered counter-
measure subject to a declaration under section 319F–3(b) 
shall not be eligible for compensation under the Pro-
gram.’’. 
(b) ACCELERATING INJURY COMPENSATION PRO-
GRAM ADMINISTRATION AND ENSURING PROGRAM INTEG-
RITY.— 
(1) PETITIONS
FOR
COMPENSATION.—Section 
2111(a)(2)(A)(i) of the Public Health Service Act 
(42 U.S.C. 300aa–11(a)(2)(A)(i)) is amended— 
(A) in subclause (I), by striking ‘‘, and’’ 
and inserting a semicolon; 
(B) in subclause (II)— 
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(i) by moving the margin 2 ems to the 
right; and 
(ii) by striking ‘‘, or’’ and inserting ‘‘; 
and’’; and 
(C) by adding at the end the following: 
‘‘(III) the judgment described in subclause 
(I) does not result from a petitioner’s motion to 
dismiss the case; or’’. 
(2) DETERMINATION OF GOOD FAITH.—Section 
2115(e)(1) of the Public Health Service Act (42 
U.S.C. 300aa–15(e)(1)) is amended by adding at the 
end the following: ‘‘When making a determination of 
good faith under this paragraph, the special master 
or court may consider whether the petitioner dem-
onstrated an intention to obtain compensation on 
such petition and was not merely seeking to satisfy 
the exhaustion requirement under section 2121(b).’’. 
(c) EXTENSION
OF DEADLINES
TO SUBMIT RE-
QUESTS FOR COMPENSATION FOR CERTAIN INJURIES.— 
(1) IN GENERAL.—With respect to claims filed 
under section 319F–4 of the Public Health Service 
Act (42 U.S.C. 247d–6e) alleging a covered injury 
caused by the administration or use of a covered 
countermeasure pursuant to a declaration under sec-
tion 319F–3(b) of such Act (42 U.S.C. 247d–6d(b)) 
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relating to coronavirus disease 2019, the following 
shall apply: 
(A) Notwithstanding the filing deadline ap-
plicable under such section 319F–4, the claim 
shall be filed within 3 years of the administra-
tion or use of the covered countermeasure, or 1 
year after the date of enactment of this Act, 
whichever is later, and, if a claim filed under 
such section 319F–4 with respect to such ad-
ministration or use was filed before the date of 
enactment of this Act and denied on the basis 
of having not been filed within the time period 
required under subsection (b)(4) of such section 
319F–4, such claim may be refiled pursuant to 
this subparagraph. 
(B) With respect to a claim relating to the 
administration of a medical product for active 
immunization to prevent coronavirus disease 
2019 such a claim may be filed under the such 
section 319F–4 only if the administration of 
such vaccine occurred prior to the addition of 
the vaccine to the Vaccine Injury Table under 
section 2114 of the Public Health Service Act 
(42 U.S.C. 300aa–14). 
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761 
SEC. 632. SUPPORTING AT-RISK INDIVIDUALS DURING 
EMERGENCY RESPONSES. 
(a) TECHNICAL ASSISTANCE FOR AT-RISK INDIVID-
UALS AND DISASTERS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’) may provide appropriate technical as-
sistance to States, localities, Tribes, and other appli-
cable entities related to addressing the unique needs 
and considerations of at-risk individuals, as defined 
in section 2802(b)(4) of the Public Health Service 
Act (42 U.S.C. 300hh–1(b)(4)), in the event of a 
public health emergency declared by the Secretary 
pursuant to section 319 of the Public Health Service 
Act (42 U.S.C. 247d). 
(2) TECHNICAL
ASSISTANCE.—The technical 
assistance described in paragraph (1) shall include— 
(A) developing, identifying, evaluating, and 
disseminating evidence-based or evidence-in-
formed strategies to improve health and address 
other near-term or long-term outcomes for at- 
risk individuals related to public health emer-
gencies, including by addressing such unique 
needs and considerations in carrying out public 
health and medical activities to prepare for, re-
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762 
spond to, and recover from, such public health 
emergencies; and 
(B) assisting applicable entities, through 
contracts or cooperative agreements, as appro-
priate, in the implementation of such evidence- 
based strategies. 
(3) CONSULTATION.—In carrying out activities 
under paragraph (2), the Secretary shall take into 
consideration relevant findings and recommendations 
of, and, as appropriate, consult with, the National 
Advisory Committee on Individuals with Disabilities 
and Disasters established under section 2811C of 
the Public Health Service Act (42 U.S.C. 300hh– 
10d), the National Advisory Committee on Children 
and Disasters under section 2811A of such Act (42 
U.S.C. 300hh–10b), and the National Advisory 
Committee on Seniors and Disasters under section 
2811B of such Act (42 U.S.C. 300hh–10c). 
(b) CRISIS STANDARDS OF CARE.—Not later than 2 
years after the date of enactment of this Act, the Sec-
retary, acting through the Director of the Office for Civil 
Rights of the Department of Health and Human Services, 
shall issue guidance to States and localities on the develop-
ment or modification of State and local crisis standards 
of care for use during the response to a public health 
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763 
emergency declared by the Governor of a State or by the 
Secretary under section 319 of the Public Health Service 
Act (42 U.S.C. 247d), or a major disaster or emergency 
declared by the President under section 401 or 501, re-
spectively, of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5170, 5191) to en-
sure that such standards of care are consistent with the 
nondiscrimination requirements of section 504 of the Re-
habilitation Act of 1973 (29 U.S.C. 794), title II of the 
Americans with Disabilities Act of 1990 (42 U.S.C. 12131 
et seq.), and the Age Discrimination Act of 1975 (42 
U.S.C. 6101 et seq.). 
SEC. 633. NATIONAL ADVISORY COMMITTEES. 
(a) NATIONAL ADVISORY COMMITTEE ON CHILDREN 
AND DISASTERS.—Subsection (g) of section 2811A of the 
Public Health Service Act (42 U.S.C. 300hh–10b) is 
amended to read as follows: 
‘‘(g) SUNSET.— 
‘‘(1) IN
GENERAL.—The Advisory Committee 
shall terminate on December 31, 2026. 
‘‘(2) EXTENSION OF ADVISORY COMMITTEE.— 
Not later than October 1, 2025, the Secretary shall 
submit to Congress a recommendation on whether 
the Advisory Committee should be extended beyond 
the date described in paragraph (1).’’. 
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764 
(b) NATIONAL ADVISORY COMMITTEE ON SENIORS 
AND DISASTERS.—Section 2811B of the Public Health 
Service Act (42 U.S.C. 300hh–10c) is amended— 
(1) in subsection (d)— 
(A) in paragraph (1)— 
(i) by inserting ‘‘and departments’’ 
after ‘‘agencies’’; and 
(ii) by striking ‘‘17 members’’ and in-
serting ‘‘25 members’’; and 
(B) in paragraph (2)— 
(i) by striking subparagraphs (J) and 
(K); 
(ii) by redesignating subparagraphs 
(A) through (I) and (L) as clauses (i) 
through (x), respectively, and adjusting the 
margins accordingly; 
(iii) by inserting before clause (i), as 
so redesignated, the following: 
‘‘(B) FEDERAL
MEMBERS.—The Federal 
members shall include the following:’’; and 
(iv) by inserting before subparagraph 
(B), as so designated, the following: 
‘‘(A) NON-FEDERAL MEMBERS.—The Sec-
retary in consultation with such other heads of 
agencies and departments as may be appro-
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priate, shall appoint to the Advisory Committee 
under paragraph (1) at least 13 individuals, in-
cluding the following: 
‘‘(i) At least 3 non-Federal health 
care providers with expertise in geriatric 
medical disaster planning, preparedness, 
response, or recovery. 
‘‘(ii) At least 3 representatives of 
State, local, territorial, or Tribal agencies 
with expertise in geriatric disaster plan-
ning, preparedness, response, or recovery. 
‘‘(iii) At least 2 non-Federal profes-
sionals with training in gerontology, such 
as social workers, scientists, human serv-
ices specialists, or other non-medical pro-
fessionals, with experience in disaster plan-
ning, preparedness, response, or recovery 
among other adults.’’; and 
(2) by amending subsection (g) to read as fol-
lows: 
‘‘(g) SUNSET.—The Advisory Committee shall termi-
nate on December 31, 2026.’’. 
(c) NATIONAL ADVISORY COMMITTEE ON INDIVID-
UALS
WITH
DISABILITIES
AND
DISASTERS.—Section 
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2811C of the Public Health Service Act (42 U.S.C. 
300hh–10d) is amended— 
(1) by redesignating subsections (c) through (g) 
as subsections (d) through (h), respectively; 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 
may provide advice and recommendations to the Secretary 
with respect to individuals with disabilities and the med-
ical and public health grants and cooperative agreements 
as applicable to preparedness and response activities 
under this title and title III.’’; 
(3) in subsection (d), as so redesignated— 
(A) in paragraph (1), by striking ‘‘17 
members’’ and inserting ‘‘25 members’’; 
(B) in paragraph (2)— 
(i) by striking subparagraphs (K) 
through (M); 
(ii) by redesignating subparagraphs 
(A) through (J) as clauses (i) through (x), 
respectively, and adjusting the margins ac-
cordingly; 
(iii) by inserting before clause (i), as 
so redesignated, the following: 
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‘‘(B) FEDERAL
MEMBERS.—The Federal 
members shall include the following:’’; 
(iv) by adding at the end of subpara-
graph (B), as so designated, the following: 
‘‘(xi) Representatives of such other 
Federal agencies as the Secretary deter-
mines necessary to fulfill the duties of the 
Advisory Committee.’’; and 
(v) by inserting before subparagraph 
(B), as so designated, the following: 
‘‘(A) NON-FEDERAL MEMBERS.—The Sec-
retary in consultation with such other heads of 
agencies and departments as may be appro-
priate, shall appoint to the Advisory Committee 
under paragraph (1) at least 13 individuals, in-
cluding the following: 
‘‘(i) At least 4 non-Federal health 
care professionals with expertise in dis-
ability accessibility before, during, and 
after disasters, medical and mass care dis-
aster planning, preparedness, response, or 
recovery. 
‘‘(ii) At least 3 representatives of 
State, local, Tribal, or territorial agencies 
with expertise in disaster planning, pre-
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768 
paredness, response, or recovery for indi-
viduals with disabilities. 
‘‘(iii) At least 4 individuals with a dis-
ability with expertise in disaster planning, 
preparedness, response, or recovery for in-
dividuals with disabilities. 
‘‘(iv) Other members as the Secretary 
determines appropriate, of whom— 
‘‘(I) at least one such member 
shall represent a local, State, or na-
tional organization with expertise in 
individuals with disabilities; 
‘‘(II) at least one such member 
shall be an individual with a dis-
ability; and 
‘‘(III) at least one such member 
shall be an individual with expertise in 
the needs of housing services, includ-
ing during the response to, and recov-
ery from, disasters.’’; and 
(C) by adding at the end the following: 
‘‘(3) CONSIDERATION.—In appointing members, 
including the Chair, to the Committee under this 
subsection, the Secretary may give consideration to 
disability status.’’; and 
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(4) by amending subsection (h), as so redesig-
nated, to read as follows: 
‘‘(h) SUNSET.—The Advisory Committee shall termi-
nate on December 31, 2026.’’. 
SEC. 634. NATIONAL ACADEMIES STUDY ON PRIZES. 
(a) IN GENERAL.—Not later than 90 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall seek to enter into an agreement 
with the National Academies of Sciences, Engineering, 
and Medicine (referred to in this section as the ‘‘National 
Academies’’) to conduct a study to examine— 
(1) alternative models for directly funding, or 
stimulating investment in, biomedical research and 
development that delink research and development 
costs from the prices of drugs, including the pro-
gressive replacement of patents and regulatory 
exclusivities on new drugs with a combination of ex-
panded support for research and innovation prizes to 
reward the successful development of drugs or 
achievement of related milestones; 
(2) the dollar amount of innovation prizes for 
different stages of research and development of dif-
ferent classes or types of drugs, and total annual 
funding, that would be necessary to stimulate invest-
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ment sufficient to achieve such successful drug de-
velopment and related milestones; 
(3) the relative effectiveness and efficiency of 
such alternative models in stimulating innovation, 
compared to the status quo that includes patents 
and regulatory exclusivities; 
(4) strategies to implement such alternative 
models described in paragraph (1), including a 
phased transition; and 
(5) the anticipated economic and societal im-
pacts of such alternative models, including an as-
sessment of impact on— 
(A) the number and variety of new drugs 
that would be developed, approved, and mar-
keted in the United States, including such new 
drugs intended to prevent, diagnose, or treat a 
rare disease or condition; 
(B) the rate at which new drugs would be 
developed, approved, and marketed in the 
United States; 
(C) access to medication; 
(D) health outcomes; 
(E) average lifespan and disease burden in 
the United States; 
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(F) the number of manufacturers that 
would be seeking approval for a drug or bring-
ing a drug to market for the first time; 
(G) Federal discretionary and mandatory 
spending; and 
(H) public and private insurance markets. 
(b) REQUIREMENTS.—In conducting the study pursu-
ant to subsection (a), the National Academies shall hold 
not fewer than 2 public listening sessions to solicit feed-
back from interested parties, including representatives of 
academia, professional societies, patient advocates, public 
health organizations, relevant Federal departments and 
agencies, drug developers, representatives of other rel-
evant industries, and subject matter experts. 
(c) REPORT.—Not later than 2 years after the agree-
ment under subsection (a), the National Academies shall 
submit to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the 
Senate and the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives a report on the study conducted pursuant to 
subsection (a). 
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Subtitle D—Additional 
Reauthorizations 
SEC. 641. MEDICAL COUNTERMEASURE PRIORITY REVIEW 
VOUCHER. 
Section 565A(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb–4a) is amended by striking 
‘‘October 1, 2023’’ and inserting ‘‘December 31, 2026’’. 
SEC. 642. EPIDEMIC INTELLIGENCE SERVICE. 
Section 317F(c)(2) of the Public Health Service Act 
(42 U.S.C. 247b–7(c)(2)) is amended by striking ‘‘2019 
through 2023’’ and inserting ‘‘2025 and 2026, to remain 
available through December 31, 2026’’. 
SEC. 643. MONITORING AND DISTRIBUTION OF CERTAIN 
MEDICAL COUNTERMEASURES. 
Section 319A(e) of the Public Health Service Act (42 
U.S.C. 247d–1(e)) is amended by striking ‘‘2019 through 
2023’’ and inserting ‘‘2025 and 2026, to remain available 
through December 31, 2026’’. 
SEC. 644. REGIONAL HEALTH CARE EMERGENCY PRE-
PAREDNESS AND RESPONSE SYSTEMS. 
Section 319C–3 of the Public Health Service Act (42 
U.S.C. 247d–3c) is amended— 
(1) in subsection (b)(3), by striking ‘‘under 
the’’ and all that follows through ‘‘such Act)’’ and 
inserting ‘‘under law’’; and 
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(2) in subsection (e)(2), by striking ‘‘September 
30, 2023’’ and inserting ‘‘December 31, 2026’’. 
SEC. 645. EMERGENCY SYSTEM FOR ADVANCE REGISTRA-
TION 
OF 
VOLUNTEER 
HEALTH 
PROFES-
SIONALS. 
(1) IN GENERAL.—Section 319I of the Public 
Health Service Act (42 U.S.C. 247d–7b) is amend-
ed— 
(A) in subsection (a), by striking ‘‘Not 
later than 12 months after the date of enact-
ment of the Pandemic and All-Hazards Pre-
paredness Act, the Secretary shall link existing 
State verification systems to maintain a single 
national interoperable network of systems,’’ and 
inserting ‘‘The Secretary shall continue to 
maintain a single national interoperable net-
work of verification systems,’’ and 
(B) in subsection (k), by striking ‘‘2019 
through 2023’’ and inserting ‘‘2025 and 2026, 
to remain available through December 31, 
2026’’. 
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SEC. 646. ENSURING COLLABORATION AND COORDINATION 
IN MEDICAL COUNTERMEASURE DEVELOP-
MENT. 
Section 319L–1(b) of the Public Health Service Act 
(42 U.S.C. 247d–7f(b)) is amended by striking ‘‘Decem-
ber 31, 2024’’ and inserting ‘‘December 31, 2026’’. 
SEC. 647. MILITARY AND CIVILIAN PARTNERSHIP FOR 
TRAUMA READINESS. 
Section 1291(g) of the Public Health Service Act (42 
U.S.C. 300d–91(g)) is amended by striking ‘‘2019 
through 2023’’ and inserting ‘‘2025 and 2026, to remain 
available through December 31, 2026’’. 
SEC. 648. NATIONAL DISASTER MEDICAL SYSTEM. 
Section 2812 of the Public Health Service Act (42 
U.S.C. 300hh–11) is amended— 
(1) in subsection (c)(4)(B), by striking ‘‘Decem-
ber 31, 2024’’ and inserting ‘‘December 31, 2026’’; 
and 
(2) in subsection (g), by striking ‘‘$57,400,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$65,900,000 for each of fiscal years 2025 
and 2026, to remain available through December 31, 
2026’’. 
SEC. 649. VOLUNTEER MEDICAL RESERVE CORPS. 
Section 2813(i) of the Public Health Service Act (42 
U.S.C. 300hh–15(i)) is amended by striking ‘‘2019 
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through 2023’’ and inserting ‘‘2025 through 2026, to re-
main available through December 31, 2026’’. 
SEC. 649A. EPIDEMIOLOGY-LABORATORY CAPACITY. 
Section 2821(b) of the Public Health Service Act (42 
U.S.C. 300hh–31(b)) is amended, in the matter preceding 
paragraph (1), by striking ‘‘2019 through 2023’’ and in-
serting ‘‘2025 and 2026, to remain available through De-
cember 31, 2026’’. 
TITLE VII—PUBLIC HEALTH 
PROGRAMS 
SEC. 701. ACTION FOR DENTAL HEALTH. 
Section 340G(f) of the Public Health Service Act (42 
U.S.C. 256g(f)) is amended by striking ‘‘$13,903,000 for 
each of fiscal years 2019 through 2023’’ and inserting 
‘‘$15,000,000 for each of fiscal years 2025 through 2029, 
to remain available until expended’’. 
SEC. 702. PREEMIE. 
(a) RESEARCH RELATING TO PRETERM LABOR AND 
DELIVERY AND THE CARE, TREATMENT, AND OUTCOMES 
OF PRETERM AND LOW BIRTHWEIGHT INFANTS.— 
(1) IN
GENERAL.—Section 3(e) of the Pre-
maturity Research Expansion and Education for 
Mothers who deliver Infants Early Act (42 U.S.C. 
247b–4f(e)) is amended by striking ‘‘fiscal years 
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2019 through 2023’’ and inserting ‘‘fiscal years 
2025 through 2029’’. 
(2) TECHNICAL CORRECTION.—Effective as if 
included in the enactment of the PREEMIE Reau-
thorization Act of 2018 (Public Law 115–328), sec-
tion 2 of such Act is amended, in the matter pre-
ceding paragraph (1), by striking ‘‘Section 2’’ and 
inserting ‘‘Section 3’’. 
(b) INTERAGENCY WORKING GROUP.—Section 5(a) 
of the PREEMIE Reauthorization Act of 2018 (Public 
Law 115–328) is amended by striking ‘‘The Secretary of 
Health and Human Services, in collaboration with other 
departments, as appropriate, may establish’’ and inserting 
‘‘Not later than 18 months after the date of the enactment 
of the Health Improvements, Extenders, and Reauthoriza-
tions Act, the Secretary of Health and Human Services, 
in collaboration with other departments, as appropriate, 
shall establish’’. 
(c) STUDY ON PRETERM BIRTHS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into appropriate ar-
rangements 
with 
the 
National 
Academies 
of 
Sciences, Engineering, and Medicine under which 
the National Academies shall— 
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(A) not later than 30 days after the date 
of enactment of this Act, convene a committee 
of experts in maternal health to study pre-
mature births in the United States; and 
(B) upon completion of the study under 
subparagraph (A)— 
(i) approve by consensus a report on 
the results of such study; 
(ii) include in such report— 
(I) an assessment of each of the 
topics listed in paragraph (2); 
(II) the analysis required by 
paragraph (3); and 
(III) the raw data used to de-
velop such report; and 
(iii) not later than 24 months after 
the date of enactment of this Act, transmit 
such report to— 
(I) the Secretary of Health and 
Human Services; 
(II) the Committee on Energy 
and Commerce of the House of Rep-
resentatives; and 
(III) the Committee on Finance 
and the Committee on Health, Edu-
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cation, Labor, and Pensions of the 
Senate. 
(2) ASSESSMENT TOPICS.—The topics listed in 
this subsection are each of the following: 
(A) The financial costs of premature birth 
to society, including— 
(i) an analysis of stays in neonatal in-
tensive care units and the cost of such 
stays; 
(ii) long-term costs of stays in such 
units to society and the family involved 
post-discharge; and 
(iii) health care costs for families 
post-discharge from such units (such as 
medications, therapeutic services, co-pay-
ments for visits, and specialty equipment). 
(B) The factors that impact preterm birth 
rates. 
(C) Opportunities for earlier detection of 
premature birth risk factors, including— 
(i) opportunities to improve maternal 
and infant health; and 
(ii) opportunities for public health 
programs to provide support and resources 
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for parents in-hospital, in non-hospital set-
tings, and post-discharge. 
(3) ANALYSIS.—The analysis required by this 
subsection is an analysis of— 
(A) targeted research strategies to develop 
effective drugs, treatments, or interventions to 
bring at-risk pregnancies to term; 
(B) State and other programs’ best prac-
tices with respect to reducing premature birth 
rates; and 
(C) precision medicine and preventative 
care approaches starting early in the life course 
(including during pregnancy) with a focus on 
behavioral and biological influences on pre-
mature birth, child health, and the trajectory of 
such approaches into adulthood. 
SEC. 703. PREVENTING MATERNAL DEATHS. 
(a) MATERNAL MORTALITY REVIEW COMMITTEE.— 
Section 317K(d) of the Public Health Service Act (42 
U.S.C. 247b–12(d)) is amended— 
(1) in paragraph (1)(A), by inserting ‘‘(includ-
ing obstetricians and gynecologists)’’ after ‘‘clinical 
specialties’’; and 
(2) in paragraph (3)(A)(i)— 
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(A) in subclause (I), by striking ‘‘as appli-
cable’’ and inserting ‘‘if available’’; and 
(B) in subclause (III), by striking ‘‘, as ap-
propriate’’ and inserting ‘‘and coordinating with 
death certifiers to improve the collection of 
death record reports and the quality of death 
records, including by amending cause-of-death 
information on a death certificate, as appro-
priate’’. 
(b) BEST PRACTICES RELATING TO THE PREVEN-
TION OF MATERNAL MORTALITY.—Section 317K of the 
Public Health Service Act (42 U.S.C. 247b–12) is amend-
ed— 
(1) by redesignating subsections (e) and (f) as 
subsections (f) and (g), respectively; and 
(2) by inserting after subsection (d) the fol-
lowing: 
‘‘(e) BEST PRACTICES RELATING TO THE PREVEN-
TION OF MATERNAL MORTALITY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall, in consultation with 
the Administrator of the Health Resources and Serv-
ices Administration, disseminate to hospitals, State 
professional society groups, and perinatal quality 
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collaboratives, best practices on how to prevent ma-
ternal mortality and morbidity that consider and re-
flect best practices identified through other relevant 
Federal maternal health programs. 
‘‘(2) 
FREQUENCY.—The 
Secretary, 
acting 
through the Director of the Centers for Disease 
Control and Prevention, shall disseminate the best 
practices referred to in paragraph (1) not less than 
once per fiscal year.’’. 
(c) EXTENSION.—Subsection (g) of section 317K of 
the Public Health Service Act (42 U.S.C. 247b–12), as 
redesignated by subsection (b), is amended by striking 
‘‘$58,000,000 for each of fiscal years 2019 through 2023’’ 
and inserting ‘‘$100,000,000 for each of fiscal years 2025 
through 2029’’. 
SEC. 704. SICKLE CELL DISEASE PREVENTION AND TREAT-
MENT. 
(a) IN GENERAL.—Section 1106(b) of the Public 
Health Service Act (42 U.S.C. 300b–5(b)) is amended— 
(1) in paragraph (1)(A)(iii), by striking ‘‘pre-
vention and treatment of sickle cell disease’’ and in-
serting ‘‘treatment of sickle cell disease and the pre-
vention and treatment of complications of sickle cell 
disease’’; 
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(2) in paragraph (2)(D), by striking ‘‘preven-
tion and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the preven-
tion and treatment of complications of sickle cell dis-
ease’’; 
(3) in paragraph (3)— 
(A) in subparagraph (A), by striking 
‘‘enter into a contract with’’ and inserting 
‘‘make a grant to, or enter into a contract or 
cooperative agreement with,’’; and 
(B) in subparagraph (B), in each of 
clauses (ii) and (iii), by striking ‘‘prevention 
and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the 
prevention and treatment of complications of 
sickle cell disease’’; and 
(4) in paragraph (6), by striking ‘‘$4,455,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$8,205,000 for each of fiscal years 2025 
through 2029’’. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that further research should be undertaken to ex-
pand the understanding of the causes of, and to find cures 
for, heritable blood disorders, including sickle cell disease. 
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SEC. 705. TRAUMATIC BRAIN INJURIES. 
(a) THE BILL PASCRELL, JR., NATIONAL PROGRAM 
FOR TRAUMATIC BRAIN INJURY SURVEILLANCE
AND 
REGISTRIES.— 
(1) PREVENTION
OF
TRAUMATIC
BRAIN
IN-
JURY.—Section 393B of the Public Health Service 
Act (42 U.S.C. 280b–1c) is amended— 
(A) in subsection (a), by inserting ‘‘and 
prevalence’’ after ‘‘incidence’’; 
(B) in subsection (b)— 
(i) in paragraph (1), by inserting 
‘‘and reduction of associated injuries and 
fatalities’’ before the semicolon; 
(ii) in paragraph (2), by inserting 
‘‘and related risk factors’’ before the semi-
colon; and 
(iii) in paragraph (3)— 
(I) in the matter preceding sub-
paragraph (A), by striking ‘‘2020’’ 
each place it appears and inserting 
‘‘2030’’; and 
(II) in subparagraph (A)— 
(aa) in clause (i), by striking 
‘‘; and’’ and inserting a semi-
colon; 
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(bb) by redesignating clause 
(ii) as clause (iv); 
(cc) by inserting after clause 
(i) the following: 
‘‘(ii) populations at higher risk of 
traumatic brain injury, including popu-
lations whose increased risk is due to occu-
pational or circumstantial factors; 
‘‘(iii) causes of, and risk factors for, 
traumatic brain injury; and’’; and 
(dd) in clause (iv), as so re-
designated, by striking ‘‘arising 
from traumatic brain injury’’ and 
inserting ‘‘, which may include 
related mental health and other 
conditions, arising from trau-
matic brain injury, including’’; 
and 
(C) in subsection (c), by inserting ‘‘, and 
other relevant Federal departments and agen-
cies’’ before the period at the end. 
(2) NATIONAL
PROGRAM
FOR
TRAUMATIC 
BRAIN INJURY SURVEILLANCE AND REGISTRIES.— 
Section 393C of the Public Health Service Act (42 
U.S.C. 280b–1d) is amended— 
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(A) by amending the section heading to 
read as follows: ‘‘THE BILL PASCRELL, JR., 
NATIONAL
PROGRAM
FOR
TRAUMATIC 
BRAIN INJURY SURVEILLANCE AND REG-
ISTRIES’’; 
(B) in subsection (a)— 
(i) in the matter preceding paragraph 
(1), by inserting ‘‘to identify populations 
that may be at higher risk for traumatic 
brain injuries, to collect data on the causes 
of, and risk factors for, traumatic brain in-
juries,’’ after ‘‘related disability,’’; 
(ii) in paragraph (1), by inserting ‘‘, 
including the occupation of the individual, 
when relevant to the circumstances sur-
rounding the injury’’ before the semicolon; 
and 
(iii) in paragraph (4), by inserting 
‘‘short- and long-term’’ before ‘‘outcomes’’; 
(C) by striking subsection (b); 
(D) by redesignating subsection (c) as sub-
section (b); 
(E) in subsection (b), as so redesignated, 
by inserting ‘‘and evidence-based practices to 
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identify and address concussion’’ before the pe-
riod at the end; and 
(F) by adding at the end the following: 
‘‘(c) AVAILABILITY
OF INFORMATION.—The Sec-
retary, acting through the Director of the Centers for Dis-
ease Control and Prevention, shall make publicly available 
aggregated information on traumatic brain injury and 
concussion described in this section, including on the 
website of the Centers for Disease Control and Prevention. 
Such website, to the extent feasible, shall include aggre-
gated information on populations that may be at higher 
risk for traumatic brain injuries and strategies for pre-
venting or reducing risk of traumatic brain injury that are 
tailored to such populations.’’. 
(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 394A of the Public Health Service Act (42 
U.S.C. 280b–3) is amended— 
(A) in subsection (a), by striking ‘‘1994, 
and’’ and inserting ‘‘1994,’’; and 
(B) in subsection (b), by striking ‘‘2020 
through 2024’’ and inserting ‘‘2025 through 
2029’’. 
(b) STATE GRANT PROGRAMS.— 
(1) STATE GRANTS FOR PROJECTS REGARDING 
TRAUMATIC
BRAIN
INJURY.—Section 1252 of the 
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Public Health Service Act (42 U.S.C. 300d–52) is 
amended— 
(A) in subsection (b)(2)— 
(i) by inserting ‘‘, taking into consid-
eration populations that may be at higher 
risk for traumatic brain injuries’’ after 
‘‘outreach programs’’; and 
(ii) 
by 
inserting 
‘‘Tribal,’’ 
after 
‘‘State,’’; 
(B) in subsection (c), by adding at the end 
the following: 
‘‘(3) MAINTENANCE OF EFFORT.—With respect 
to activities for which a grant awarded under sub-
section (a) is to be expended, a State or American 
Indian consortium shall agree to maintain expendi-
tures of non-Federal amounts for such activities at 
a level that is not less than the level of such expendi-
tures maintained by the State or American Indian 
consortium for the fiscal year preceding the fiscal 
year for which the State or American Indian consor-
tium receives such a grant. 
‘‘(4) WAIVER.—The Secretary may, upon the 
request of a State or American Indian consortium, 
waive not more than 50 percent of the matching 
fund amount under paragraph (1), if the Secretary 
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determines that such matching fund amount would 
result in an inability of the State or American In-
dian consortium to carry out the purposes under 
subsection (a). A waiver provided by the Secretary 
under this paragraph shall apply only to the fiscal 
year involved.’’; 
(C) in subsection (e)(3)(B)— 
(i) by striking ‘‘(such as third party 
payers, State agencies, community-based 
providers, schools, and educators)’’; and 
(ii) by inserting ‘‘(such as third party 
payers, State agencies, community-based 
providers, schools, and educators)’’ after 
‘‘professionals’’; 
(D) in subsection (h), by striking para-
graphs (1) and (2) and inserting the following: 
‘‘(1) AMERICAN INDIAN CONSORTIUM; STATE.— 
The terms ‘American Indian consortium’ and ‘State’ 
have the meanings given such terms in section 1253. 
‘‘(2) TRAUMATIC BRAIN INJURY.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the term ‘traumatic brain injury’— 
‘‘(i) means an acquired injury to the 
brain; 
‘‘(ii) may include— 
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‘‘(I) brain injuries caused by an-
oxia due to trauma; and 
‘‘(II) damage to the brain from 
an internal or external source that re-
sults in infection, toxicity, surgery, or 
vascular disorders not associated with 
aging; and 
‘‘(iii) does not include brain dysfunc-
tion caused by congenital or degenerative 
disorders, or birth trauma. 
‘‘(B) REVISIONS
TO
DEFINITION.—The 
Secretary may revise the definition of the term 
‘traumatic brain injury’ under this paragraph, 
as the Secretary determines necessary, after 
consultation with States and other appropriate 
public or nonprofit private entities.’’; and 
(E) in subsection (i), by striking ‘‘2020 
through 2024’’ and inserting ‘‘2025 through 
2029’’. 
(2) STATE GRANTS FOR PROTECTION AND AD-
VOCACY SERVICES.—Section 1253(l) of the Public 
Health Service Act (42 U.S.C. 300d–53(l)) is 
amended by striking ‘‘2020 through 2024’’ and in-
serting ‘‘2025 through 2029’’. 
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(c) REPORT TO CONGRESS.—Not later than 2 years 
after the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this Act as 
the ‘‘Secretary’’) shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House 
of Representatives a report that contains— 
(1) an overview of populations who may be at 
higher risk for traumatic brain injury, such as indi-
viduals affected by domestic violence or sexual as-
sault and public safety officers as defined in section 
1204 of the Omnibus Crime Control and Safe 
Streets Act of 1968 (34 U.S.C. 10284); 
(2) an outline of existing surveys and activities 
of the Centers for Disease Control and Prevention 
on traumatic brain injuries and any steps the agency 
has taken to address gaps in data collection related 
to such higher risk populations, which may include 
leveraging surveys such as the National Intimate 
Partner and Sexual Violence Survey to collect data 
on traumatic brain injuries; 
(3) an overview of any outreach or education ef-
forts to reach such higher risk populations; and 
(4) any challenges associated with reaching 
such higher risk populations. 
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(d) STUDY ON LONG-TERM SYMPTOMS OR CONDI-
TIONS RELATED TO TRAUMATIC BRAIN INJURY.— 
(1) IN GENERAL.—The Secretary, in consulta-
tion with stakeholders and the heads of other rel-
evant Federal departments and agencies, as appro-
priate, shall conduct, either directly or through a 
contract with a nonprofit private entity, a study to— 
(A) examine the incidence and prevalence 
of long-term or chronic symptoms or conditions 
in individuals who have experienced a traumatic 
brain injury; 
(B) examine the evidence base of research 
related to the chronic effects of traumatic brain 
injury across the lifespan; 
(C) examine any correlations between trau-
matic brain injury and increased risk of other 
conditions, such as dementia and mental health 
conditions; 
(D) assess existing services available for 
individuals with such long-term or chronic 
symptoms or conditions; and 
(E) identify any gaps in research related to 
such long-term or chronic symptoms or condi-
tions of individuals who have experienced a 
traumatic brain injury. 
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(2) PUBLIC REPORT.—Not later than 2 years 
after the date of enactment of this Act, the Sec-
retary shall— 
(A) submit to the Committee on Energy 
and Commerce of the House of Representatives 
and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report de-
tailing the findings, conclusions, and rec-
ommendations of the study described in para-
graph (1); and 
(B) in the case that such study is con-
ducted directly by the Secretary, make the re-
port described in subparagraph (A) publicly 
available on the website of the Department of 
Health and Human Services. 
SEC. 706. LIFESPAN RESPITE CARE. 
(a) DEFINITION OF FAMILY CAREGIVER.—Section 
2901(5) of the Public Health Service Act (42 U.S.C. 
300ii(5)) is amended by striking ‘‘unpaid adult’’ and in-
serting ‘‘unpaid individual’’. 
(b) FUNDING.—Section 2905 of the Public Health 
Service Act (42 U.S.C. 300ii–4) is amended by striking 
‘‘fiscal years 2020 through fiscal year 2024’’ and inserting 
‘‘fiscal years 2025 through 2029’’. 
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SEC. 707. DR. LORNA BREEN HEALTH CARE PROVIDER PRO-
TECTION. 
(a) DISSEMINATION OF BEST PRACTICES.— Section 
2 of the Dr. Lorna Breen Health Care Provider Protection 
Act (Public Law 117–105) is amended by striking ‘‘2 
years’’ and inserting ‘‘5 years’’. 
(b) EDUCATION AND AWARENESS INITIATIVE EN-
COURAGING USE OF MENTAL HEALTH AND SUBSTANCE 
USE DISORDER SERVICES BY HEALTH CARE PROFES-
SIONALS.—Section 3 of the Dr. Lorna Breen Health Care 
Provider Protection Act (Public Law 117–105) is amend-
ed— 
(1) in subsection (b), by inserting ‘‘and annu-
ally thereafter,’’ after ‘‘of this Act,’’; and 
(2) in subsection (c), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2025 through 2029’’. 
(c) PROGRAMS
TO
PROMOTE
MENTAL
HEALTH 
AMONG THE HEALTH PROFESSIONAL WORKFORCE.—The 
second section 764 of the Public Health Service Act (42 
U.S.C. 294t), as added by section 4 of the Dr. Lorna 
Breen Health Care Provider Protection Act (Public Law 
117–105), is amended— 
(1) by redesignating such section 764 as section 
764A; 
(2) in subsection (a)(3)— 
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(A) by striking ‘‘to eligible entities in’’ and 
inserting ‘‘to eligible entities that— 
‘‘(A) are in’’; 
(B) by striking the period and inserting ‘‘; 
or’’; and 
(C) by adding at the end the following: 
‘‘(B) have a focus on the reduction of ad-
ministrative burden on health care workers.’’; 
(3) in subsection (c), by inserting ‘‘not less 
than’’ after ‘‘period of’’; and 
(4) in subsection (f), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2025 through 2029’’. 
SEC. 708. GABRIELLA MILLER KIDS FIRST RESEARCH. 
(a) FUNDING FOR THE PEDIATRIC RESEARCH INI-
TIATIVE.— 
(1) IN GENERAL.—The Public Health Service 
Act (42 U.S.C. 201 et seq.) is amended— 
(A) in section 402A(a)(2) (42 U.S.C. 
282a(a)(2))— 
(i) in the heading— 
(I) by striking ‘‘10-YEAR’’; and 
(II) by striking ‘‘THROUGH COM-
MON FUND’’; 
(ii) by striking ‘‘to the Common 
Fund’’ and inserting ‘‘to the Division of 
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Program 
Coordination, 
Planning, 
and 
Strategic Initiatives’’; 
(iii) by striking ‘‘10-Year’’; 
(iv) by striking ‘‘and reserved under 
subsection (c)(1)(B)(i) of this section’’; 
and 
(v) by striking ‘‘2014 through 2023’’ 
and inserting ‘‘2025 through 2031’’; 
(B) in each of paragraphs (1)(A) and 
(2)(C) of section 402A(c) (42 U.S.C. 282a(c)), 
by striking ‘‘section 402(b)(7)(B)’’ and insert-
ing ‘‘section 402(b)(7)(B)(i)’’; and 
(C) in section 402(b)(7)(B)(ii) (42 U.S.C. 
282(b)(7)(B)(ii)), by striking ‘‘the Common 
Fund’’ and inserting ‘‘the Division of Program 
Coordination, Planning, and Strategic Initia-
tives’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
9008(i)(2) of the Internal Revenue Code of 1986 
(26 U.S.C. 9008(i)(2)) is amended by striking ‘‘10- 
Year’’. 
(b) COORDINATION OF NIH FUNDING FOR PEDI-
ATRIC RESEARCH.— 
(1) SENSE OF CONGRESS.—It is the sense of 
the Congress that the Director of the National Insti-
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796 
tutes of Health should continue to oversee and co-
ordinate research that is conducted or supported by 
the National Institutes of Health for research on pe-
diatric cancer and other pediatric diseases and con-
ditions, including through the Pediatric Research 
Initiative Fund. 
(2) 
AVOIDING
DUPLICATION.—Section 
402(b)(7)(B)(ii) of the Public Health Service Act 
(42 U.S.C. 282(b)(7)(B)(ii)) is amended by inserting 
‘‘and shall prioritize, as appropriate, such pediatric 
research that does not duplicate existing research 
activities of the National Institutes of Health’’ be-
fore ‘‘; and’’. 
(c) REPORT ON PROGRESS AND INVESTMENTS IN PE-
DIATRIC RESEARCH.—Not later than 5 years after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report that— 
(1) details pediatric research projects and ini-
tiatives receiving funds allocated pursuant to section 
402(b)(7)(B)(ii) of the Public Health Service Act 
(42 U.S.C. 282(b)(7)(B)(ii)); and 
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(2) summarizes advancements made in pediatric 
research with funds allocated pursuant to such sec-
tion. 
SEC. 709. SCREENS FOR CANCER. 
(a) NATIONAL BREAST
AND CERVICAL CANCER 
EARLY DETECTION PROGRAM.—Title XV of the Public 
Health Service Act (42 U.S.C. 300k et seq.) is amended— 
(1) in section 1501 (42 U.S.C. 300k)— 
(A) in subsection (a)— 
(i) in paragraph (2), by striking ‘‘the 
provision of appropriate follow-up services 
and support services such as case manage-
ment’’ and inserting ‘‘that appropriate fol-
low-up services are provided’’; 
(ii) in paragraph (3), by striking 
‘‘programs for the detection and control’’ 
and inserting ‘‘for the prevention, detec-
tion, and control’’; 
(iii) in paragraph (4), by striking ‘‘the 
detection and control’’ and inserting ‘‘the 
prevention, detection, and control’’; 
(iv) in paragraph (5)— 
(I) by striking ‘‘monitor’’ and in-
serting ‘‘ensure’’; and 
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(II) by striking ‘‘; and’’ and in-
serting a semicolon; 
(v) by redesignating paragraph (6) as 
paragraph (9); 
(vi) by inserting after paragraph (5) 
the following: 
‘‘(6) to enhance appropriate support activities 
to increase breast and cervical cancer screenings, 
such as navigation of health care services, implemen-
tation of evidence-based or evidence-informed strate-
gies to increase breast and cervical cancer screening 
in health care settings, and facilitation of access to 
health care settings; 
‘‘(7) to reduce disparities in breast and cervical 
cancer incidence, morbidity, and mortality, including 
in populations with higher than average rates; 
‘‘(8) to improve access to breast and cervical 
cancer screening and diagnostic services and reduce 
related barriers, including factors that relate to neg-
ative health outcomes; and’’; and 
(vii) in paragraph (9), as so redesig-
nated, by striking ‘‘through (5)’’ and in-
serting ‘‘through (8)’’; and 
(B) by striking subsection (d); 
(2) in section 1503 (42 U.S.C. 300m)— 
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(A) in subsection (a)— 
(i) in paragraph (1), by striking 
‘‘that, initially’’ and all that follows 
through the semicolon and inserting ‘‘that 
appropriate breast and cervical cancer 
screening and diagnostic services are pro-
vided consistent with relevant evidence- 
based recommendations; and’’; 
(ii) by striking paragraphs (2) and 
(4); 
(iii) by redesignating paragraph (3) as 
paragraph (2); and 
(iv) in paragraph (2), as so redesig-
nated, by striking ‘‘; and’’ and inserting a 
period; and 
(B) by striking subsection (d); 
(3) in section 1508(b) (42 U.S.C. 300n–4(b))— 
(A) by striking ‘‘1 year after the date of 
the enactment of the National Breast and Cer-
vical Cancer Early Detection Program Reau-
thorization of 2007, and annually thereafter,’’ 
and inserting ‘‘2 years after the date of enact-
ment of the Health Improvements, Extenders, 
and Reauthorizations Act, and every 5 years 
thereafter,’’; 
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800 
(B) by striking ‘‘Labor and Human Re-
sources’’ and inserting ‘‘Health, Education, 
Labor, and Pensions’’; and 
(C) by striking ‘‘preceding fiscal year’’ and 
inserting ‘‘preceding 2 fiscal years in the case 
of the first report after the date of enactment 
of the Health Improvements, Extenders, and 
Reauthorizations Act and preceding 5 fiscal 
years for each report thereafter’’; and 
(4) in section 1510(a) (42 U.S.C. 300n–5(a))— 
(A) by striking ‘‘2011, and’’ and inserting 
‘‘2011,’’; and 
(B) by inserting ‘‘, and $235,500,000 for 
each of fiscal years 2025 through 2029’’ before 
the period at the end before the period at the 
end. 
(b) GAO STUDY.—Not later than September 30, 
2027, the Comptroller General of the United States shall 
report to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on the work 
of the National Breast and Cervical Cancer Early Detec-
tion Program, including— 
(1) an estimate of the number of individuals eli-
gible for services provided under such program; 
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801 
(2) a summary of trends in the number of indi-
viduals served through such program; and 
(3) an assessment of any factors that may be 
driving the trends identified under paragraph (2), 
including any barriers to accessing breast and cer-
vical cancer screenings provided by such program. 
SEC. 710. DEONDRA DIXON INCLUDE PROJECT. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 409K. DOWN SYNDROME RESEARCH. 
‘‘(a) IN GENERAL.—The Director of NIH shall carry 
out a program of research, training, and investigation re-
lated to Down syndrome to be known as the ‘INvestigation 
of Co-occurring conditions across the Lifespan to Under-
stand Down syndromE Project’ or the ‘INCLUDE 
Project’. 
‘‘(b) PROGRAM ELEMENTS.—The program under 
subsection (a) shall include— 
‘‘(1) high-risk, high reward research on the ef-
fects of trisomy 21 on human development and 
health; 
‘‘(2) promoting research for participants with 
Down syndrome across the lifespan, including cohort 
studies to facilitate improved understanding of 
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802 
Down syndrome and co-occurring conditions and de-
velopment of new interventions; 
‘‘(3) expanding the number of clinical trials 
that are inclusive of, or expressly for, participants 
with Down syndrome, including novel biomedical and 
pharmacological interventions and other therapies 
designed to promote or enhance activities of daily 
living; 
‘‘(4) research on the biological mechanisms in 
individuals with Down syndrome pertaining to struc-
tural, functional, and behavioral anomalies and dys-
function as well as stunted growth; 
‘‘(5) supporting research to improve diagnosis 
and treatment of conditions co-occurring with Down 
syndrome, including the identification of biomarkers 
related to risk factors, diagnosis, and clinical re-
search and therapeutics; 
‘‘(6) research on the causes of increased preva-
lence, and concurrent treatment, of co-occurring con-
ditions, such as Alzheimer’s disease and related de-
mentias and autoimmunity, in individuals with Down 
syndrome; and 
‘‘(7) research, training, and investigation on im-
proving the quality of life of individuals with Down 
syndrome and their families. 
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‘‘(c) COORDINATION; PRIORITIZING NONDUPLICA-
TIVE RESEARCH.—The Director of NIH shall ensure 
that— 
‘‘(1) the programs and activities of the insti-
tutes and centers of the National Institutes of 
Health relating to Down syndrome and co-occurring 
conditions are coordinated, including through the 
Office of the Director of NIH and priority-setting 
reviews conducted pursuant to section 402(b)(3); 
and 
‘‘(2) such institutes and centers, prioritize, as 
appropriate, Down syndrome research that does not 
duplicate existing research activities of the National 
Institutes of Health. 
‘‘(d) CONSULTATION
WITH
STAKEHOLDERS.—In 
carrying out activities under this section, the Director of 
NIH shall, as appropriate and to the maximum extent fea-
sible, consult with relevant stakeholders, including patient 
advocates, to ensure that such activities take into consid-
eration the needs of individuals with Down syndrome. 
‘‘(e) BIENNIAL REPORTS TO CONGRESS.— 
‘‘(1) IN GENERAL.—The Director of NIH shall 
submit, on a biennial basis, to the Committee on 
Energy and Commerce and the Subcommittee on 
Labor, Health and Human Services, Education, and 
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Related Agencies of the Committee on Appropria-
tions of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions 
and the Subcommittee on Labor, Health and 
Human Services, Education, and Related Agencies 
of the Committee on Appropriations of the Senate, 
a report that catalogs the research conducted or 
supported under this section. 
‘‘(2) CONTENTS.—Each report under para-
graph (1) shall include— 
‘‘(A) identification of the institute or cen-
ter involved; 
‘‘(B) a statement of whether the research 
is or was being carried out directly by such in-
stitute or center or by multiple institutes and 
centers; and 
‘‘(C) identification of any resulting real- 
world evidence that is or may be used for clin-
ical research and medical care for patients with 
Down syndrome.’’. 
SEC. 711. IMPROVE INITIATIVE. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.), as amended by section 710, is 
further amended by adding at the end the following: 
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805 
‘‘SEC. 409L. IMPROVE INITIATIVE. 
‘‘(a) IN GENERAL.—The Director of the National In-
stitutes of Health shall carry out a program of research 
to improve health outcomes to be known as the Imple-
menting a Maternal health and PRegnancy Outcomes Vi-
sion for Everyone Initiative (referred to in this section as 
the ‘Initiative’). 
‘‘(b) OBJECTIVES.—The Initiative shall— 
‘‘(1) advance research to— 
‘‘(A) reduce preventable causes of maternal 
mortality and severe maternal morbidity; 
‘‘(B) reduce health disparities related to 
maternal health outcomes, including such dis-
parities associated with medically underserved 
populations; and 
‘‘(C) improve health for pregnant and 
postpartum women before, during, and after 
pregnancy; 
‘‘(2) use an integrated approach to understand 
the factors, including biological, behavioral, and 
other factors, that affect maternal mortality and se-
vere maternal morbidity by building an evidence 
base for improved outcomes in specific regions of the 
United States; and 
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‘‘(3) target health disparities associated with 
maternal mortality and severe maternal morbidity 
by— 
‘‘(A) implementing and evaluating commu-
nity-based interventions for disproportionately 
affected women; and 
‘‘(B) identifying risk factors and the un-
derlying biological mechanisms associated with 
leading causes of maternal mortality and severe 
maternal morbidity in the United States. 
‘‘(c) SUNSET.—The authority under this section shall 
expire on September 30, 2029.’’. 
SEC. 712. ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK. 
Section 372 of the Public Health Service Act (42 
U.S.C. 274) is amended— 
(1) in subsection (b)(2)— 
(A) by moving the margins of subpara-
graphs (M) through (O) 2 ems to the left; 
(B) in subparagraph (A)— 
(i) in clause (i), by striking ‘‘, and’’ 
and inserting ‘‘; and’’; and 
(ii) in clause (ii), by striking the 
comma at the end and inserting a semi-
colon; 
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807 
(C) in subparagraph (C), by striking 
‘‘twenty-four-hour telephone service’’ and in-
serting ‘‘24-hour telephone or information tech-
nology service’’; 
(D) in each of subparagraphs (B) through 
(M), by striking the comma at the end and in-
serting a semicolon; 
(E) in subparagraph (N), by striking 
‘‘transportation, and’’ and inserting ‘‘transpor-
tation;’’; 
(F) in subparagraph (O), by striking the 
period and inserting a semicolon; and 
(G) by adding at the end the following: 
‘‘(P) encourage the integration of elec-
tronic health records systems through applica-
tion programming interfaces (or successor tech-
nologies) among hospitals, organ procurement 
organizations, and transplant centers, including 
the use of automated electronic hospital refer-
rals and the grant of remote, electronic access 
to hospital electronic health records of potential 
donors by organ procurement organizations, in 
a manner that complies with the privacy regula-
tions promulgated under the Health Insurance 
Portability and Accountability Act of 1996, at 
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808 
part 160 of title 45, Code of Federal Regula-
tions, and subparts A, C, and E of part 164 of 
such title (or any successor regulations); and 
‘‘(Q) consider establishing a dashboard to 
display the number of transplants performed, 
the types of transplants performed, the number 
and types of organs that entered the Organ 
Procurement and Transplantation Network sys-
tem and failed to be transplanted, and other 
appropriate statistics, which should be updated 
more frequently than annually.’’; and 
(2) by adding at the end the following: 
‘‘(d) REGISTRATION FEES.— 
‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ 
Procurement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registra-
tion fees shall be collected and distributed only to 
support the operation of the Organ Procurement 
and Transplantation Network. Such registration fees 
are authorized to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect 
the registration fees under paragraph (1) directly or 
through awards made under subsection (b)(1)(A). 
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809 
‘‘(3) DISTRIBUTION.—Any amounts collected 
under this subsection shall— 
‘‘(A) be credited to the currently applicable 
appropriation, account, or fund of the Depart-
ment of Health and Human Services as discre-
tionary offsetting collections; and 
‘‘(B) be available, only to the extent and in 
the amounts provided in advance in appropria-
tions Acts, to distribute such fees among 
awardees described in subsection (b)(1)(A). 
‘‘(4) TRANSPARENCY.—The Secretary shall— 
‘‘(A) promptly post on the website of the 
Organ Procurement and Transplantation Net-
work— 
‘‘(i) the amount of registration fees 
collected under this subsection from each 
member of the Organ Procurement and 
Transplantation Network; and 
‘‘(ii) a list of activities such fees are 
used to support; and 
‘‘(B) update the information posted pursu-
ant to subparagraph (A), as applicable for each 
calendar quarter for which fees are collected 
under paragraph (1). 
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‘‘(5) GAO REVIEW.—Not later than 2 years 
after the date of enactment of this subsection, the 
Comptroller General of the United States shall, to 
the extent data are available— 
‘‘(A) conduct a review concerning the ac-
tivities under this subsection; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House 
of Representatives, a report on such review, in-
cluding related recommendations, as applicable. 
‘‘(6) SUNSET.—The authority to collect reg-
istration fees under paragraph (1) shall expire on 
the date that is 3 years after the date of enactment 
of the Health Improvements, Extenders, and Reau-
thorizations Act.’’. 
SEC. 713. HONOR OUR LIVING DONORS. 
(a) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—Section 377 of the Public Health Service Act 
(42 U.S.C. 274f) is amended— 
(1) by redesignating subsections (c) through (f) 
as subsections (d) through (g), respectively; 
(2) by inserting after subsection (b) the fol-
lowing: 
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‘‘(c) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—The recipient of a grant under this section, in 
providing reimbursement to a donating individual through 
such grant, shall not give any consideration to the income 
of the organ recipient.’’; and 
(3) in subsection (f), as so redesignated— 
(A) in paragraph (1), by striking ‘‘sub-
section 
(c)(1)’’ 
and 
inserting 
‘‘subsection 
(d)(1)’’; and 
(B) in paragraph (2), by striking ‘‘sub-
section 
(c)(2)’’ 
and 
inserting 
‘‘subsection 
(d)(2)’’. 
(b) REMOVAL OF EXPECTATION OF PAYMENTS BY 
ORGAN
RECIPIENTS.—Section 377(e) of the Public 
Health Service Act (42 U.S.C. 274f(e)), as redesignated 
by section 2(1), is amended— 
(1) in paragraph (1), by adding ‘‘or’’ at the 
end; 
(2) in paragraph (2), by striking ‘‘; or’’ and in-
serting a period; and 
(3) by striking paragraph (3). 
(c) ANNUAL REPORT.—Section 377 of the Public 
Health Service Act (42 U.S.C. 274f), as amended by sec-
tions 2 and 3, is amended by adding at the end the fol-
lowing: 
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‘‘(h) ANNUAL REPORT.—Not later than December 31 
of each year, beginning in Fiscal Year 2026, the Secretary 
shall— 
‘‘(1) prepare, submit to the Congress, and make 
public a report on whether grants under this section 
provided adequate funding during the preceding fis-
cal year to reimburse all donating individuals par-
ticipating in the grant program under this section 
for all qualifying expenses; and 
‘‘(2) include in each such report— 
‘‘(A) the estimated number of all donating 
individuals participating in the grant program 
under this section who did not receive reim-
bursement for all qualifying expenses during 
the preceding fiscal year; and 
‘‘(B) the total amount of funding that is 
estimated to be necessary to fully reimburse all 
donating individuals participating in the grant 
program under this section for all qualifying ex-
penses.’’. 
SEC. 714. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 
and all that follows through the period at the end and 
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inserting ‘‘section, $25,000,000 for each of fiscal years 
2025 through 2027.’’. 
TITLE VIII—FOOD AND DRUG 
ADMINISTRATION 
Subtitle A—Give Kids a Chance 
SEC. 801. RESEARCH INTO PEDIATRIC USES OF DRUGS; AD-
DITIONAL AUTHORITIES OF FOOD AND DRUG 
ADMINISTRATION 
REGARDING 
MOLECU-
LARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.— 
(1) ADDITIONAL ACTIVE INGREDIENT FOR AP-
PLICATION DRUG; LIMITATION REGARDING NOVEL- 
COMBINATION
APPLICATION
DRUG.—Section 
505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended— 
(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is a molecularly targeted pediatric 
cancer investigation of— 
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‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product 
used in combination with— 
‘‘(I) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
351(k) of the Public Health 
Service Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary, after consultation 
with the applicant, to be part of 
the standard of care for treating 
a pediatric cancer; or 
‘‘(II) an active ingredient of a 
drug or biological product— 
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of 
the Public Health Service Act to 
treat an adult cancer is in effect 
and is held by the same person 
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submitting the application under 
paragraph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each 
age group for which the study is required, 
regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological 
product for which the application referred 
to in paragraph (1)(B) contains either— 
‘‘(I) a single new active ingre-
dient; or 
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‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
tive ingredient is in a drug product 
that has been previously approved to 
treat an adult cancer. 
‘‘(iii) RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLI-
CATION DRUG.—With respect to an inves-
tigation required pursuant to paragraph 
(1)(B), the Secretary may require the re-
sults of any completed preclinical studies 
relevant to the initial pediatric study plan 
be submitted to the Secretary at the same 
time that the initial pediatric study plan 
required under subsection (e)(1) is sub-
mitted. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING
INACTIVE
INGREDIENTS.—With 
respect to a combination of active ingredi-
ents referred to in subparagraph (A)(ii), 
such subparagraph shall not be construed 
as addressing the use of inactive ingredi-
ents with such combination.’’. 
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(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) applies with respect to an 
application before the date on which the applicant is 
required to submit the initial pediatric study plan 
under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(1)) is amended by 
adding at the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of 
subparagraph (B) shall be subject to the re-
quirements of subparagraph (A), and no appli-
cation (or supplement to an application) that is 
subject to the requirements of subparagraph 
(A) shall be subject to the requirements of sub-
paragraph (B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)) is amended— 
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(A) in paragraph (3)(C), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘investigations described in this para-
graph’’ and inserting ‘‘investigations referred to 
in subparagraph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘the assessments under paragraph 
(2)(B)’’ and inserting ‘‘the assessments re-
quired under paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) not later than 12 months after the date of 
enactment of this Act, issue draft guidance on the 
implementation of the amendments made by sub-
section (a); and 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize 
such guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262(a)), that 
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is submitted on or after the date that is 3 years after the 
date of enactment of this Act. 
(d) REPORTS TO CONGRESS.— 
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 6 years after the date of en-
actment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
Secretary’s efforts, in coordination with industry, to 
ensure implementation of the amendments made by 
subsection (a). 
(2) GAO STUDY AND REPORT.— 
(A) STUDY.—Not later than 8 years after 
the date of enactment of this Act, the Comp-
troller General of the United States shall con-
duct a study of the effectiveness of requiring 
assessments and investigations described in sec-
tion 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C.355c), as amended by sub-
section (a), in the development of drugs and bi-
ological products for pediatric cancer indica-
tions, including consideration of any benefits to, 
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or burdens on, pediatric cancer drug develop-
ment. 
(B) FINDINGS.—Not later than 10 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate a report containing the findings of the 
study conducted under subparagraph (A). 
SEC. 802. ENSURING COMPLETION OF PEDIATRIC STUDY 
REQUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-
ed— 
(1) in paragraph (1), by striking ‘‘Beginning 
270’’ and inserting ‘‘NONCOMPLIANCE
LETTER.— 
Beginning 270’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘The drug or’’ and insert-
ing ‘‘EFFECT OF NONCOMPLIANCE.—The drug 
or’’; and 
(B) by striking ‘‘(except that the drug or 
biological product shall not be subject to action 
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under section 303)’’ and inserting ‘‘(except that 
the drug or biological product shall be subject 
to action under section 303 only if such person 
demonstrated a lack of due diligence in satis-
fying the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not 
issue enforcement actions under section 303 for fail-
ures under this subsection in the case of a drug or 
biological product that is no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 
as amended by subsection (a), is further amended by add-
ing at the end the following: 
‘‘(4) DUE
DILIGENCE.—Before the Secretary 
may conclude that a person failed to submit or oth-
erwise meet a requirement as described in the mat-
ter preceding paragraph (1), the Secretary shall— 
‘‘(A) issue a noncompliance letter pursuant 
to paragraph (1); 
‘‘(B) provide such person with a 45-day 
period beginning on the date of receipt of such 
noncompliance letter to respond in writing as 
set forth in such paragraph; and 
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‘‘(C) after reviewing such written response, 
determine whether the person demonstrated a 
lack of due diligence in satisfying such require-
ment.’’. 
(c) 
CONFORMING
AMENDMENTS.—Section 
303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505– 
1’’ and inserting ‘‘505–1, or 505B’’. 
(d) TRANSITION RULE.—The Secretary of Health 
and Human Services may take enforcement action under 
section 303 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333) only for failures described in section 
505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 
or after the date that is 180 days after the date of enact-
ment of this Act. 
SEC. 803. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration 
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 
amended— 
(1) in paragraph (11), by striking the semicolon 
at the end and inserting ‘‘, including an evaluation 
of compliance with deadlines provided for in defer-
rals and deferral extensions;’’; 
(2) in paragraph (15), by striking ‘‘and’’ at the 
end; 
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(3) in paragraph (16), by striking the period at 
the end and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or pay-
ments under section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353) for failure to 
comply with requirements under such section 505B, 
including, for each penalty, settlement, or payment, 
the name of the drug, the sponsor thereof, and the 
amount of the penalty, settlement, or payment im-
posed; and’’. 
SEC. 804. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 
REVIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(b)) is amended by striking ‘‘December 20, 2024, un-
less’’ and all that follows through the period at the end 
and inserting ‘‘September 30, 2029.’’. 
(b) USER FEE PAYMENT.—Section 529(c)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(c)(4)) is amended by striking subparagraph (A) and 
inserting the following: 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
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upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351(a) 
of the Public Health Service Act for which the 
priority review voucher is used. All other user 
fees associated with the human drug application 
shall be due as required by the Secretary or 
under applicable law.’’. 
(c) GAO REPORT ON EFFECTIVENESS OF RARE PE-
DIATRIC
DISEASE
PRIORITY
VOUCHER
AWARDS
IN 
INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-
OPMENT.— 
(1) GAO STUDY.— 
(A) STUDY.—The Comptroller General of 
the United States shall conduct a study of the 
effectiveness of awarding rare pediatric disease 
priority vouchers under section 529 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the de-
velopment of human drug products that treat or 
prevent rare pediatric diseases (as defined in 
such section 529). 
(B) CONTENTS OF STUDY.—In conducting 
the study under subparagraph (A), the Comp-
troller General shall examine the following: 
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(i) The indications for each drug or 
biological product that— 
(I) is the subject of a rare pedi-
atric disease product application (as 
defined in section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff)) for which a priority re-
view voucher was awarded; and 
(II) was approved under section 
505 of the Federal Food, Drug, and 
Cosmetic Act (42 U.S.C. 355) or li-
censed under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 
262). 
(ii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
met through the approval or licensure of 
such a drug or biological product. 
(iii) The size of the company to which 
a priority review voucher was awarded 
under section 529 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff) 
for such a drug or biological product. 
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(iv) The value of such priority review 
voucher if transferred. 
(v) Identification of each drug for 
which a priority review voucher awarded 
under such section 529 was used. 
(vi) The size of the company using 
each priority review voucher awarded 
under such section 529. 
(vii) The length of the period of time 
between the date on which a priority re-
view voucher was awarded under such sec-
tion 529 and the date on which it was 
used. 
(viii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
met through the approval under section 
505 of the Federal Food, Drug, and Cos-
metic Act (42 U.S.C. 355) or licensure 
under section 351 of the Public Health 
Service Act (42 U.S.C. 262) of a drug for 
which a priority review voucher was used. 
(ix) Whether, and to what extent, 
companies were motivated by the avail-
ability of priority review vouchers under 
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section 529 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ff) to at-
tempt to develop a drug for a rare pedi-
atric disease. 
(x) Whether, and to what extent, pedi-
atric review vouchers awarded under such 
section were successful in stimulating de-
velopment and expedited patient access to 
drug products for treatment or prevention 
of a rare pediatric disease that wouldn’t 
otherwise take place without the incentive 
provided by such vouchers. 
(xi) The impact of such priority re-
view vouchers on the workload, review 
process, and public health prioritization ef-
forts of the Food and Drug Administra-
tion. 
(xii) Any other incentives in Federal 
law that exist for companies developing 
drugs or biological products described in 
clause (i). 
(2) REPORT ON FINDINGS.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall sub-
mit to the Committee on Energy and Commerce of 
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the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report containing the findings of the study 
conducted under paragraph (1). 
SEC. 805. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-
CENSURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved use or indica-
tion within such rare disease or condition’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ 
and inserting ‘‘same approved use or indication 
for which such 7-year period applies to such al-
ready approved or licensed drug’’; and 
(B) in paragraph (1), by inserting ‘‘, relat-
ing to the approved use or indication,’’ after 
‘‘the needs’’; 
(3) in subsection (c)(1), by striking ‘‘same rare 
disease or condition as the already approved drug’’ 
and inserting ‘‘same use or indication for which the 
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already approved or licensed drug was approved or 
licensed’’; and 
(4) by adding at the end the following: 
‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 
this section, the term ‘approved use or indication’ means 
the use or indication approved under section 505 of this 
Act or licensed under section 351 of the Public Health 
Service Act for a drug designated under section 526 for 
a rare disease or condition.’’. 
(b) APPLICATION OF AMENDMENTS.—The amend-
ments made by subsection (a) shall apply with respect to 
any drug designated under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-
less of the date on which the drug was so designated, and 
regardless of the date on which the drug was approved 
under section 505 of such Act (21 U.S.C. 355) or licensed 
under section 351 of the Public Health Service Act (42 
U.S.C. 262). 
Subtitle B—United States-Abraham 
Accords Cooperation and Security 
SEC. 811. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 
WITHIN FOOD AND DRUG ADMINISTRATION. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
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‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall establish with-
in the Food and Drug Administration an office, to be 
known as the Abraham Accords Office, to be headed by 
a director. 
‘‘(b) OFFICE.—Not later than 2 years after the date 
of enactment of this section, the Secretary shall— 
‘‘(1) in consultation with the governments of 
Abraham Accords countries, as well as appropriate 
United States Government diplomatic and security 
personnel— 
‘‘(A) select the location of the Abraham 
Accords Office in an Abraham Accords country; 
and 
‘‘(B) establish such office; and 
‘‘(2) assign to such office such personnel of the 
Food and Drug Administration as the Secretary de-
termines necessary to carry out the functions of 
such office. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of the Abraham Accords Office, shall— 
‘‘(1) after the Abraham Accords Office is estab-
lished— 
‘‘(A) as part of the Food and Drug Admin-
istration’s work to strengthen the international 
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oversight of regulated commodities, provide 
technical assistance to regulatory partners in 
Abraham Accords countries on strengthening 
regulatory oversight and converging regulatory 
requirements for the oversight of regulated 
products, including good manufacturing prac-
tices and other issues relevant to manufacturing 
medical products that are regulated by the 
Food and Drug Administration; and 
‘‘(B) facilitate interactions between the 
Food and Drug Administration and interested 
parties in Abraham Accords countries, including 
by sharing relevant information regarding 
United States regulatory pathways with such 
parties, and facilitate feedback on the research, 
development, and manufacturing of products 
regulated in accordance with this Act; and 
‘‘(2) carry out other functions and activities as 
the Secretary determines to be necessary to carry 
out this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In 
this section, the term ‘Abraham Accords country’ means 
a country identified by the Department of State as having 
signed the Abraham Accords Declaration. 
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‘‘(e) NATIONAL SECURITY.—Nothing in this section 
shall be construed to require any action inconsistent with 
a national security recommendation provided by the Fed-
eral Government.’’. 
(b) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the 
Congress a report on the Abraham Accords Office, 
including— 
(A) an evaluation of how the Office has ad-
vanced progress toward conformance with Food 
and Drug Administration regulatory require-
ments by manufacturers in the Abraham Ac-
cords countries; 
(B) a numerical count of parties that the 
Office has helped facilitate interactions or feed-
back pursuant to section 1015(c)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)); 
(C) a summary of technical assistance pro-
vided to regulatory partners in Abraham Ac-
cords countries pursuant to subparagraph (A) 
of such section 1015(c)(1); and 
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(D) recommendations for increasing and 
improving coordination between the Food and 
Drug Administration and entities in Abraham 
Accords countries. 
(2) ABRAHAM ACCORDS COUNTRY DEFINED.— 
In this subsection, the term ‘‘Abraham Accords 
country’’ has the meaning given such term in section 
1015(d) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)). 
TITLE IX—LOWERING 
PRESCRIPTION DRUG COSTS 
SEC. 901. OVERSIGHT OF PHARMACY BENEFIT MANAGE-
MENT SERVICES. 
(a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of 
the Public Health Service Act (42 U.S.C. 300gg et seq.) 
is amended— 
(1) in part D (42 U.S.C. 300gg–111 et seq.), 
by adding at the end the following new section: 
‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 
PHARMACY BENEFIT MANAGEMENT SERV-
ICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after the date that is 30 months after the date of enact-
ment of this section (referred to in this subsection and 
subsection (b) as the ‘effective date’), a group health plan 
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or a health insurance issuer offering group health insur-
ance coverage, or an entity providing pharmacy benefit 
management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or 
renewal of a contract, entered into on or after the effective 
date, with an applicable entity unless such applicable enti-
ty agrees to— 
‘‘(1) not limit or delay the disclosure of infor-
mation to the group health plan (including such a 
plan offered through a health insurance issuer) in 
such a manner that prevents an entity providing 
pharmacy benefit management services on behalf of 
a group health plan or health insurance issuer offer-
ing group health insurance coverage from making 
the reports described in subsection (b); and 
‘‘(2) provide the entity providing pharmacy ben-
efit management services on behalf of a group health 
plan or health insurance issuer relevant information 
necessary to make the reports described in sub-
section (b). 
‘‘(b) REPORTS.— 
‘‘(1) IN GENERAL.—For plan years beginning 
on or after the effective date, in the case of any con-
tract between a group health plan or a health insur-
ance issuer offering group health insurance coverage 
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offered in connection with such a plan and an entity 
providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension 
or renewal of such a contract, entered into on or 
after the effective date, the entity providing phar-
macy benefit management services on behalf of such 
a group health plan or health insurance issuer, not 
less frequently than every 6 months (or, at the re-
quest of a group health plan, not less frequently 
than quarterly, and under the same conditions, 
terms, and cost of the semiannual report under this 
subsection), shall submit to the group health plan a 
report in accordance with this section. Each such re-
port shall be made available to such group health 
plan in plain language, in a machine-readable for-
mat, and as the Secretary may determine, other for-
mats. Each such report shall include the information 
described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes 
of paragraph (1), the information described in this 
paragraph is, with respect to drugs covered by a 
group health plan or group health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan during each reporting 
period— 
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‘‘(A) in the case of a group health plan 
that is offered by a specified large employer or 
that is a specified large plan, and is not offered 
as health insurance coverage, or in the case of 
health insurance coverage for which the election 
under paragraph (3) is made for the applicable 
reporting period— 
‘‘(i) a list of drugs for which a claim 
was filed and, with respect to each such 
drug on such list— 
‘‘(I) the contracted compensation 
paid by the group health plan or 
health insurance issuer for each cov-
ered drug (identified by the National 
Drug Code) to the entity providing 
pharmacy benefit management serv-
ices or other applicable entity on be-
half of the group health plan or health 
insurance issuer; 
‘‘(II) the contracted compensa-
tion paid to the pharmacy, by any en-
tity providing pharmacy benefit man-
agement services or other applicable 
entity on behalf of the group health 
plan or health insurance issuer, for 
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each covered drug (identified by the 
National Drug Code); 
‘‘(III) for each such claim, the 
difference between the amount paid 
under subclause (I) and the amount 
paid under subclause (II); 
‘‘(IV) the proprietary name, es-
tablished name or proper name, and 
National Drug Code; 
‘‘(V) for each claim for the drug 
(including original prescriptions and 
refills) and for each dosage unit of the 
drug for which a claim was filed, the 
type of dispensing channel used to 
furnish the drug, including retail, mail 
order, or specialty pharmacy; 
‘‘(VI) with respect to each drug 
dispensed, for each type of dispensing 
channel (including retail, mail order, 
or specialty pharmacy)— 
‘‘(aa) whether such drug is a 
brand name drug or a generic 
drug, and— 
‘‘(AA) in the case of a 
brand name drug, the whole-
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sale acquisition cost, listed 
as cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(BB) in the case of a 
generic drug, the average 
wholesale price, listed as 
cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(bb) the total number of— 
‘‘(AA) 
prescription 
claims 
(including 
original 
prescriptions and refills); 
‘‘(BB) participants and 
beneficiaries for whom a 
claim for such drug was 
filed through the applicable 
dispensing channel; 
‘‘(CC) dosage units and 
dosage units per fill of such 
drug; and 
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‘‘(DD) days supply of 
such drug per fill; 
‘‘(VII) the net price per course of 
treatment or single fill, such as a 30- 
day supply or 90-day supply to the 
plan or coverage after rebates, fees, 
alternative discounts, or other remu-
neration received from applicable enti-
ties; 
‘‘(VIII) the total amount of out- 
of-pocket spending by participants 
and beneficiaries on such drug, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage, or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(IX) the total net spending on 
the drug; 
‘‘(X) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
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rebates, fees, alternative discounts, or 
other remuneration; 
‘‘(XI) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of such drug or spending 
on such drug; and 
‘‘(XII) to the extent feasible, in-
formation on the total amount of re-
muneration for such drug, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer), to the partici-
pants and beneficiaries enrolled in 
such plan or coverage; 
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‘‘(ii) a list of each therapeutic class 
(as defined by the Secretary) for which a 
claim was filed under the group health 
plan or health insurance coverage during 
the reporting period, and, with respect to 
each such therapeutic class— 
‘‘(I) the total gross spending on 
drugs in such class before rebates, 
price 
concessions, 
alternative 
dis-
counts, or other remuneration from 
applicable entities; 
‘‘(II) the net spending in such 
class after such rebates, price conces-
sions, alternative discounts, or other 
remuneration from applicable entities; 
‘‘(III) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
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‘‘(bb) that is related to utili-
zation of drugs or drug spending; 
‘‘(IV) the average net spending 
per 30-day supply and per 90-day 
supply by the plan or by the issuer 
with respect to such coverage and its 
participants and beneficiaries, among 
all drugs within the therapeutic class 
for which a claim was filed during the 
reporting period; 
‘‘(V) the number of participants 
and beneficiaries who filled a prescrip-
tion for a drug in such class, includ-
ing the National Drug Code for each 
such drug; 
‘‘(VI) if applicable, a description 
of the formulary tiers and utilization 
mechanisms (such as prior authoriza-
tion or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket 
spending under the plan or coverage 
by participants and beneficiaries, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
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843 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(iii) with respect to any drug for 
which gross spending under the group 
health plan or health insurance coverage 
exceeded $10,000 during the reporting pe-
riod or, in the case that gross spending 
under the group health plan or coverage 
exceeded $10,000 during the reporting pe-
riod with respect to fewer than 50 drugs, 
with respect to the 50 prescription drugs 
with the highest spending during the re-
porting period— 
‘‘(I) a list of all other drugs in 
the same therapeutic class as such 
drug; 
‘‘(II) if applicable, the rationale 
for the formulary placement of such 
drug in that therapeutic category or 
class, selected from a list of standard 
rationales established by the Sec-
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retary, in consultation with stake-
holders; and 
‘‘(III) any change in formulary 
placement compared to the prior plan 
year; and 
‘‘(iv) in the case that such plan or 
issuer (or an entity providing pharmacy 
benefit management services on behalf of 
such plan or issuer) has an affiliated phar-
macy or pharmacy under common owner-
ship, including mandatory mail and spe-
cialty home delivery programs, retail and 
mail auto-refill programs, and cost sharing 
assistance incentives funded by an entity 
providing pharmacy benefit services— 
‘‘(I) an explanation of any ben-
efit design parameters that encourage 
or require participants and bene-
ficiaries in the plan or coverage to fill 
prescriptions at mail order, specialty, 
or retail pharmacies; 
‘‘(II) the percentage of total pre-
scriptions dispensed by such phar-
macies to participants or beneficiaries 
in such plan or coverage; and 
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‘‘(III) a list of all drugs dis-
pensed by such pharmacies to partici-
pants or beneficiaries enrolled in such 
plan or coverage, and, with respect to 
each drug dispensed— 
‘‘(aa) the amount charged, 
per dosage unit, per 30-day sup-
ply, or per 90-day supply (as ap-
plicable) to the plan or issuer, 
and to participants and bene-
ficiaries; 
‘‘(bb) the median amount 
charged to such plan or issuer, 
and the interquartile range of the 
costs, per dosage unit, per 30- 
day supply, and per 90-day sup-
ply, including amounts paid by 
the 
participants 
and 
bene-
ficiaries, when the same drug is 
dispensed by other pharmacies 
that are not affiliated with or 
under common ownership with 
the entity and that are included 
in the pharmacy network of such 
plan or coverage; 
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‘‘(cc) the lowest cost per 
dosage unit, per 30-day supply 
and per 90-day supply, for each 
such drug, including amounts 
charged to the plan or coverage 
and to participants and bene-
ficiaries, that is available from 
any pharmacy included in the 
network of such plan or coverage; 
and 
‘‘(dd) the net acquisition 
cost per dosage unit, per 30-day 
supply, and per 90-day supply, if 
such drug is subject to a max-
imum price discount; and 
‘‘(B) with respect to any group health 
plan, including group health insurance coverage 
offered in connection with such a plan, regard-
less of whether the plan or coverage is offered 
by a specified large employer or whether it is a 
specified large plan— 
‘‘(i) a summary document for the 
group health plan that includes such infor-
mation described in clauses (i) through (iv) 
of subparagraph (A), as specified by the 
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Secretary through guidance, program in-
struction, or otherwise (with no require-
ment of notice and comment rulemaking), 
that the Secretary determines useful to 
group health plans for purposes of select-
ing pharmacy benefit management serv-
ices, such as an estimated net price to 
group health plan and participant or bene-
ficiary, a cost per claim, the fee structure 
or reimbursement model, and estimated 
cost per participant or beneficiary; 
‘‘(ii) a summary document for plans 
and issuers to provide to participants and 
beneficiaries, which shall be made available 
to participants or beneficiaries upon re-
quest to their group health plan (including 
in the case of group health insurance cov-
erage offered in connection with such a 
plan), that— 
‘‘(I) contains such information 
described in clauses (iii), (iv), (v), and 
(vi), as applicable, as specified by the 
Secretary through guidance, program 
instruction, or otherwise (with no re-
quirement of notice and comment 
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848 
rulemaking) that the Secretary deter-
mines useful to participants or bene-
ficiaries in better understanding the 
plan or coverage or benefits under 
such plan or coverage; 
‘‘(II) contains only aggregate in-
formation; and 
‘‘(III) states that participants 
and beneficiaries may request specific, 
claims-level information required to be 
furnished under subsection (c) from 
the group health plan or health insur-
ance issuer; and 
‘‘(iii) with respect to drugs covered by 
such plan or coverage during such report-
ing period— 
‘‘(I) the total net spending by the 
plan or coverage for all such drugs; 
‘‘(II) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; and 
‘‘(III) to the extent feasible, in-
formation on the total amount of re-
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muneration for such drugs, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer) to participants 
and beneficiaries; 
‘‘(iv) amounts paid directly or indi-
rectly in rebates, fees, or any other type of 
compensation 
(as 
defined 
in 
section 
408(b)(2)(B)(ii)(dd)(AA) of the Employee 
Retirement Income Security Act) to bro-
kerage firms, brokers, consultants, advi-
sors, or any other individual or firm, for— 
‘‘(I) the referral of the group 
health plan’s or health insurance 
issuer’s business to an entity pro-
viding pharmacy benefit management 
services, including the identity of the 
recipient of such amounts; 
‘‘(II) consideration of the entity 
providing pharmacy benefit manage-
ment services by the group health 
plan or health insurance issuer; or 
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‘‘(III) the retention of the entity 
by the group health plan or health in-
surance issuer; 
‘‘(v) an explanation of any benefit de-
sign parameters that encourage or require 
participants and beneficiaries in such plan 
or coverage to fill prescriptions at mail 
order, specialty, or retail pharmacies that 
are affiliated with or under common own-
ership with the entity providing pharmacy 
benefit management services under such 
plan or coverage, including mandatory mail 
and specialty home delivery programs, re-
tail and mail auto-refill programs, and 
cost-sharing assistance incentives directly 
or indirectly funded by such entity; and 
‘‘(vi) total gross spending on all drugs 
under the plan or coverage during the re-
porting period. 
‘‘(3) OPT-IN FOR GROUP HEALTH INSURANCE 
COVERAGE OFFERED BY A SPECIFIED LARGE EM-
PLOYER OR THAT IS A SPECIFIED LARGE PLAN.—In 
the case of group health insurance coverage offered 
in connection with a group health plan that is of-
fered by a specified large employer or is a specified 
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large plan, such group health plan may, on an an-
nual basis, for plan years beginning on or after the 
date that is 30 months after the date of enactment 
of this section, elect to require an entity providing 
pharmacy benefit management services on behalf of 
the health insurance issuer to submit to such group 
health plan a report that includes all of the informa-
tion described in paragraph (2)(A), in addition to 
the information described in paragraph (2)(B). 
‘‘(4) PRIVACY REQUIREMENTS.— 
‘‘(A) IN
GENERAL.—An entity providing 
pharmacy benefit management services on be-
half of a group health plan or a health insur-
ance issuer offering group health insurance cov-
erage shall report information under paragraph 
(1) in a manner consistent with the privacy reg-
ulations promulgated under section 13402(a) of 
the Health Information Technology for Eco-
nomic and Clinical Health Act and consistent 
with the privacy regulations promulgated under 
the Health Insurance Portability and Account-
ability Act of 1996 in part 160 and subparts A 
and E of part 164 of title 45, Code of Federal 
Regulations (or successor regulations) (referred 
to in this paragraph as the ‘HIPAA privacy 
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852 
regulations’) and shall restrict the use and dis-
closure of such information according to such 
privacy regulations and such HIPAA privacy 
regulations. 
‘‘(B) ADDITIONAL REQUIREMENTS.— 
‘‘(i) IN
GENERAL.—An entity pro-
viding pharmacy benefit management serv-
ices on behalf of a group health plan or 
health insurance issuer offering group 
health insurance coverage that submits a 
report under paragraph (1) shall ensure 
that such report contains only summary 
health information, as defined in section 
164.504(a) of title 45, Code of Federal 
Regulations (or successor regulations). 
‘‘(ii) RESTRICTIONS.—In carrying out 
this subsection, a group health plan shall 
comply with section 164.504(f) of title 45, 
Code of Federal Regulations (or a suc-
cessor regulation), and a plan sponsor shall 
act in accordance with the terms of the 
agreement described in such section. 
‘‘(C) RULE OF CONSTRUCTION.— 
‘‘(i) Nothing in this section shall be 
construed to modify the requirements for 
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the creation, receipt, maintenance, or 
transmission of protected health informa-
tion under the HIPAA privacy regulations. 
‘‘(ii) Nothing in this section shall be 
construed to affect the application of any 
Federal or State privacy or civil rights law, 
including the HIPAA privacy regulations, 
the Genetic Information Nondiscrimination 
Act of 2008 (Public Law 110–233) (in-
cluding the amendments made by such 
Act), the Americans with Disabilities Act 
of 1990 (42 U.S.C. 12101 et sec), section 
504 of the Rehabilitation Act of 1973 (29 
U.S.C. 794), section 1557 of the Patient 
Protection and Affordable Care Act (42 
U.S.C. 18116), title VI of the Civil Rights 
Act of 1964 (42 U.S.C. 2000d), and title 
VII of the Civil Rights Act of 1964 (42 
U.S.C. 2000e). 
‘‘(D) WRITTEN NOTICE.—Each plan year, 
group health plans, including with respect to 
group health insurance coverage offered in con-
nection with a group health plan, shall provide 
to each participant or beneficiary written notice 
informing the participant or beneficiary of the 
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requirement for entities providing pharmacy 
benefit management services on behalf of the 
group health plan or health insurance issuer of-
fering group health insurance coverage to sub-
mit reports to group health plans under para-
graph (1), as applicable, which may include in-
corporating such notification in plan documents 
provided to the participant or beneficiary, or 
providing individual notification. 
‘‘(E) LIMITATION
TO
BUSINESS
ASSOCI-
ATES.—A group health plan receiving a report 
under paragraph (1) may disclose such informa-
tion only to the entity from which the report 
was received or to that entity’s business associ-
ates as defined in section 160.103 of title 45, 
Code of Federal Regulations (or successor regu-
lations) or as permitted by the HIPAA privacy 
regulations. 
‘‘(F) CLARIFICATION REGARDING PUBLIC 
DISCLOSURE
OF
INFORMATION.—Nothing in 
this section shall prevent an entity providing 
pharmacy benefit management services on be-
half of a group health plan or health insurance 
issuer offering group health insurance coverage, 
from placing reasonable restrictions on the pub-
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lic disclosure of the information contained in a 
report described in paragraph (1), except that 
such plan, issuer, or entity may not— 
‘‘(i) restrict disclosure of such report 
to the Department of Health and Human 
Services, the Department of Labor, or the 
Department of the Treasury; or 
‘‘(ii) prevent disclosure for the pur-
poses of subsection (c), or any other public 
disclosure requirement under this section. 
‘‘(G) LIMITED
FORM
OF
REPORT.—The 
Secretary shall define through rulemaking a 
limited form of the report under paragraph (1) 
required with respect to any group health plan 
established by a plan sponsor that is, or is af-
filiated with, a drug manufacturer, drug whole-
saler, or other direct participant in the drug 
supply chain, in order to prevent anti-competi-
tive behavior. 
‘‘(5) STANDARD FORMAT AND REGULATIONS.— 
‘‘(A) IN
GENERAL.—Not later than 18 
months after the date of enactment of this sec-
tion, the Secretary shall specify through rule-
making a standard format for entities providing 
pharmacy benefit management services on be-
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half of group health plans and health insurance 
issuers offering group health insurance cov-
erage, to submit reports required under para-
graph (1). 
‘‘(B) 
ADDITIONAL
REGULATIONS.—Not 
later than 18 months after the date of enact-
ment of this section, the Secretary shall, 
through rulemaking, promulgate any other final 
regulations necessary to implement the require-
ments of this section. In promulgating such 
regulations, the Secretary shall, to the extent 
practicable, align the reporting requirements 
under this section with the reporting require-
ments under section 2799A–10. 
‘‘(c) REQUIREMENT TO PROVIDE INFORMATION TO 
PARTICIPANTS OR BENEFICIARIES.—A group health plan, 
including with respect to group health insurance coverage 
offered in connection with a group health plan, upon re-
quest of a participant or beneficiary, shall provide to such 
participant or beneficiary— 
‘‘(1) the summary document described in sub-
section (b)(2)(B)(ii); and 
‘‘(2) the information described in subsection 
(b)(2)(A)(i)(III) with respect to a claim made by or 
on behalf of such participant or beneficiary. 
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‘‘(d) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall enforce 
this section. The enforcement authority under this 
subsection shall apply only with respect to group 
health plans (including group health insurance cov-
erage offered in connection with such a plan) to 
which the requirements of subparts I and II of part 
A and part D apply in accordance with section 2722, 
and with respect to entities providing pharmacy ben-
efit management services on behalf of such plans 
and applicable entities providing services on behalf 
of such plans. 
‘‘(2) FAILURE TO PROVIDE INFORMATION.—A 
group health plan, a health insurance issuer offering 
group health insurance coverage, an entity providing 
pharmacy benefit management services on behalf of 
such a plan or issuer, or an applicable entity pro-
viding services on behalf of such a plan or issuer 
that violates subsection (a); an entity providing 
pharmacy benefit management services on behalf of 
such a plan or issuer that fails to provide the infor-
mation required under subsection (b); or a group 
health plan that fails to provide the information re-
quired under subsection (c), shall be subject to a 
civil monetary penalty in the amount of $10,000 for 
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each day during which such violation continues or 
such information is not disclosed or reported. 
‘‘(3) FALSE INFORMATION.—A health insurance 
issuer, an entity providing pharmacy benefit man-
agement services, or a third party administrator pro-
viding services on behalf of such issuer offered by a 
health insurance issuer that knowingly provides false 
information under this section shall be subject to a 
civil monetary penalty in an amount not to exceed 
$100,000 for each item of false information. Such 
civil monetary penalty shall be in addition to other 
penalties as may be prescribed by law. 
‘‘(4) PROCEDURE.—The provisions of section 
1128A of the Social Security Act, other than sub-
sections (a) and (b) and the first sentence of sub-
section (c)(1) of such section shall apply to civil 
monetary penalties under this subsection in the 
same manner as such provisions apply to a penalty 
or proceeding under such section. 
‘‘(5) WAIVERS.—The Secretary may waive pen-
alties under paragraph (2), or extend the period of 
time for compliance with a requirement of this sec-
tion, for an entity in violation of this section that 
has made a good-faith effort to comply with the re-
quirements in this section. 
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‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to permit a health insurance issuer, 
group health plan, entity providing pharmacy benefit man-
agement services on behalf of a group health plan or 
health insurance issuer, or other entity to restrict disclo-
sure to, or otherwise limit the access of, the Secretary to 
a report described in subsection (b)(1) or information re-
lated to compliance with subsections (a), (b), (c), or (d) 
by such issuer, plan, or entity. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE ENTITY.—The term ‘applica-
ble entity’ means— 
‘‘(A) an applicable group purchasing orga-
nization, drug manufacturer, distributor, whole-
saler, rebate aggregator (or other purchasing 
entity designed to aggregate rebates), or associ-
ated third party; 
‘‘(B) any subsidiary, parent, affiliate, or 
subcontractor of a group health plan, health in-
surance issuer, entity that provides pharmacy 
benefit management services on behalf of such 
a plan or issuer, or any entity described in sub-
paragraph (A); or 
‘‘(C) such other entity as the Secretary 
may specify through rulemaking. 
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‘‘(2) APPLICABLE GROUP PURCHASING ORGANI-
ZATION.—The term ‘applicable group purchasing or-
ganization’ means a group purchasing organization 
that is affiliated with or under common ownership 
with an entity providing pharmacy benefit manage-
ment services. 
‘‘(3) CONTRACTED COMPENSATION.—The term 
‘contracted compensation’ means the sum of any in-
gredient cost and dispensing fee for a drug (inclusive 
of the out-of-pocket costs to the participant or bene-
ficiary), or another analogous compensation struc-
ture that the Secretary may specify through regula-
tions. 
‘‘(4) GROSS
SPENDING.—The term ‘gross 
spending’, with respect to prescription drug benefits 
under a group health plan or health insurance cov-
erage, means the amount spent by a group health 
plan or health insurance issuer on prescription drug 
benefits, calculated before the application of rebates, 
fees, alternative discounts, or other remuneration. 
‘‘(5) NET SPENDING.—The term ‘net spending’, 
with respect to prescription drug benefits under a 
group health plan or health insurance coverage, 
means the amount spent by a group health plan or 
health insurance issuer on prescription drug bene-
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fits, calculated after the application of rebates, fees, 
alternative discounts, or other remuneration. 
‘‘(6) PLAN SPONSOR.—The term ‘plan sponsor’ 
has the meaning given such term in section 3(16)(B) 
of the Employee Retirement Income Security Act of 
1974. 
‘‘(7) REMUNERATION.—The term ‘remunera-
tion’ has the meaning given such term by the Sec-
retary through rulemaking, which shall be reevalu-
ated by the Secretary every 5 years. 
‘‘(8) SPECIFIED LARGE EMPLOYER.—The term 
‘specified large employer’ means, in connection with 
a group health plan (including group health insur-
ance coverage offered in connection with such a 
plan) established or maintained by a single em-
ployer, with respect to a calendar year or a plan 
year, as applicable, an employer who employed an 
average of at least 100 employees on business days 
during the preceding calendar year or plan year and 
who employs at least 1 employee on the first day of 
the calendar year or plan year. 
‘‘(9) SPECIFIED LARGE PLAN.—The term ‘spec-
ified large plan’ means a group health plan (includ-
ing group health insurance coverage offered in con-
nection with such a plan) established or maintained 
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by a plan sponsor described in clause (ii) or (iii) of 
section 3(16)(B) of the Employee Retirement In-
come Security Act of 1974 that had an average of 
at least 100 participants on business days during 
the preceding calendar year or plan year, as applica-
ble. 
‘‘(10) WHOLESALE
ACQUISITION
COST.—The 
term ‘wholesale acquisition cost’ has the meaning 
given such term in section 1847A(c)(6)(B) of the 
Social Security Act.’’; and 
(2) in section 2723 (42 U.S.C. 300gg–22)— 
(A) in subsection (a)— 
(i) in paragraph (1), by inserting 
‘‘(other than section 2799A–11)’’ after 
‘‘part D’’; and 
(ii) in paragraph (2), by inserting 
‘‘(other than section 2799A–11)’’ after 
‘‘part D’’; and 
(B) in subsection (b)— 
(i) in paragraph (1), by inserting 
‘‘(other than section 2799A–11)’’ after 
‘‘part D’’; 
(ii) in paragraph (2)(A), by inserting 
‘‘(other than section 2799A–11)’’ after 
‘‘part D’’; and 
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(iii) in paragraph (2)(C)(ii), by insert-
ing ‘‘(other than section 2799A–11)’’ after 
‘‘part D’’. 
(b) EMPLOYEE RETIREMENT INCOME SECURITY ACT 
OF 1974.— 
(1) IN GENERAL.—Subtitle B of title I of the 
Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1021 et seq.) is amended— 
(A) in subpart B of part 7 (29 U.S.C. 
1185 et seq.), by adding at the end the fol-
lowing: 
‘‘SEC. 726. OVERSIGHT OF ENTITIES THAT PROVIDE PHAR-
MACY BENEFIT MANAGEMENT SERVICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after the date that is 30 months after the date of enact-
ment of this section (referred to in this subsection and 
subsection (b) as the ‘effective date’), a group health plan 
or a health insurance issuer offering group health insur-
ance coverage, or an entity providing pharmacy benefit 
management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or 
renewal of a contract, entered into on or after the effective 
date, with an applicable entity unless such applicable enti-
ty agrees to— 
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‘‘(1) not limit or delay the disclosure of infor-
mation to the group health plan (including such a 
plan offered through a health insurance issuer) in 
such a manner that prevents an entity providing 
pharmacy benefit management services on behalf of 
a group health plan or health insurance issuer offer-
ing group health insurance coverage from making 
the reports described in subsection (b); and 
‘‘(2) provide the entity providing pharmacy ben-
efit management services on behalf of a group health 
plan or health insurance issuer relevant information 
necessary to make the reports described in sub-
section (b). 
‘‘(b) REPORTS.— 
‘‘(1) IN GENERAL.—For plan years beginning 
on or after the effective date, in the case of any con-
tract between a group health plan or a health insur-
ance issuer offering group health insurance coverage 
offered in connection with such a plan and an entity 
providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension 
or renewal of such a contract, entered into on or 
after the effective date, the entity providing phar-
macy benefit management services on behalf of such 
a group health plan or health insurance issuer, not 
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less frequently than every 6 months (or, at the re-
quest of a group health plan, not less frequently 
than quarterly, and under the same conditions, 
terms, and cost of the semiannual report under this 
subsection), shall submit to the group health plan a 
report in accordance with this section. Each such re-
port shall be made available to such group health 
plan in plain language, in a machine-readable for-
mat, and as the Secretary may determine, other for-
mats. Each such report shall include the information 
described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes 
of paragraph (1), the information described in this 
paragraph is, with respect to drugs covered by a 
group health plan or group health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan during each reporting 
period— 
‘‘(A) in the case of a group health plan 
that is offered by a specified large employer or 
that is a specified large plan, and is not offered 
as health insurance coverage, or in the case of 
health insurance coverage for which the election 
under paragraph (3) is made for the applicable 
reporting period— 
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‘‘(i) a list of drugs for which a claim 
was filed and, with respect to each such 
drug on such list— 
‘‘(I) the contracted compensation 
paid by the group health plan or 
health insurance issuer for each cov-
ered drug (identified by the National 
Drug Code) to the entity providing 
pharmacy benefit management serv-
ices or other applicable entity on be-
half of the group health plan or health 
insurance issuer; 
‘‘(II) the contracted compensa-
tion paid to the pharmacy, by any en-
tity providing pharmacy benefit man-
agement services or other applicable 
entity on behalf of the group health 
plan or health insurance issuer, for 
each covered drug (identified by the 
National Drug Code); 
‘‘(III) for each such claim, the 
difference between the amount paid 
under subclause (I) and the amount 
paid under subclause (II); 
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‘‘(IV) the proprietary name, es-
tablished name or proper name, and 
National Drug Code; 
‘‘(V) for each claim for the drug 
(including original prescriptions and 
refills) and for each dosage unit of the 
drug for which a claim was filed, the 
type of dispensing channel used to 
furnish the drug, including retail, mail 
order, or specialty pharmacy; 
‘‘(VI) with respect to each drug 
dispensed, for each type of dispensing 
channel (including retail, mail order, 
or specialty pharmacy)— 
‘‘(aa) whether such drug is a 
brand name drug or a generic 
drug, and— 
‘‘(AA) in the case of a 
brand name drug, the whole-
sale acquisition cost, listed 
as cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
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‘‘(BB) in the case of a 
generic drug, the average 
wholesale price, listed as 
cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(bb) the total number of— 
‘‘(AA) 
prescription 
claims 
(including 
original 
prescriptions and refills); 
‘‘(BB) participants and 
beneficiaries for whom a 
claim for such drug was 
filed through the applicable 
dispensing channel; 
‘‘(CC) dosage units and 
dosage units per fill of such 
drug; and 
‘‘(DD) days supply of 
such drug per fill; 
‘‘(VII) the net price per course of 
treatment or single fill, such as a 30- 
day supply or 90-day supply to the 
plan or coverage after rebates, fees, 
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alternative discounts, or other remu-
neration received from applicable enti-
ties; 
‘‘(VIII) the total amount of out- 
of-pocket spending by participants 
and beneficiaries on such drug, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage, or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(IX) the total net spending on 
the drug; 
‘‘(X) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; 
‘‘(XI) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
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counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of such drug or spending 
on such drug; and 
‘‘(XII) to the extent feasible, in-
formation on the total amount of re-
muneration for such drug, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer), to the partici-
pants and beneficiaries enrolled in 
such plan or coverage; 
‘‘(ii) a list of each therapeutic class 
(as defined by the Secretary) for which a 
claim was filed under the group health 
plan or health insurance coverage during 
the reporting period, and, with respect to 
each such therapeutic class— 
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‘‘(I) the total gross spending on 
drugs in such class before rebates, 
price 
concessions, 
alternative 
dis-
counts, or other remuneration from 
applicable entities; 
‘‘(II) the net spending in such 
class after such rebates, price conces-
sions, alternative discounts, or other 
remuneration from applicable entities; 
‘‘(III) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities— 
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of drugs or drug spending; 
‘‘(IV) the average net spending 
per 30-day supply and per 90-day 
supply by the plan or by the issuer 
with respect to such coverage and its 
participants and beneficiaries, among 
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all drugs within the therapeutic class 
for which a claim was filed during the 
reporting period; 
‘‘(V) the number of participants 
and beneficiaries who filled a prescrip-
tion for a drug in such class, includ-
ing the National Drug Code for each 
such drug; 
‘‘(VI) if applicable, a description 
of the formulary tiers and utilization 
mechanisms (such as prior authoriza-
tion or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket 
spending under the plan or coverage 
by participants and beneficiaries, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(iii) with respect to any drug for 
which gross spending under the group 
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health plan or health insurance coverage 
exceeded $10,000 during the reporting pe-
riod or, in the case that gross spending 
under the group health plan or coverage 
exceeded $10,000 during the reporting pe-
riod with respect to fewer than 50 drugs, 
with respect to the 50 prescription drugs 
with the highest spending during the re-
porting period— 
‘‘(I) a list of all other drugs in 
the same therapeutic class as such 
drug; 
‘‘(II) if applicable, the rationale 
for the formulary placement of such 
drug in that therapeutic category or 
class, selected from a list of standard 
rationales established by the Sec-
retary, in consultation with stake-
holders; and 
‘‘(III) any change in formulary 
placement compared to the prior plan 
year; and 
‘‘(iv) in the case that such plan or 
issuer (or an entity providing pharmacy 
benefit management services on behalf of 
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such plan or issuer) has an affiliated phar-
macy or pharmacy under common owner-
ship, including mandatory mail and spe-
cialty home delivery programs, retail and 
mail auto-refill programs, and cost sharing 
assistance incentives funded by an entity 
providing pharmacy benefit services— 
‘‘(I) an explanation of any ben-
efit design parameters that encourage 
or require participants and bene-
ficiaries in the plan or coverage to fill 
prescriptions at mail order, specialty, 
or retail pharmacies; 
‘‘(II) the percentage of total pre-
scriptions dispensed by such phar-
macies to participants or beneficiaries 
in such plan or coverage; and 
‘‘(III) a list of all drugs dis-
pensed by such pharmacies to partici-
pants or beneficiaries enrolled in such 
plan or coverage, and, with respect to 
each drug dispensed— 
‘‘(aa) the amount charged, 
per dosage unit, per 30-day sup-
ply, or per 90-day supply (as ap-
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plicable) to the plan or issuer, 
and to participants and bene-
ficiaries; 
‘‘(bb) the median amount 
charged to such plan or issuer, 
and the interquartile range of the 
costs, per dosage unit, per 30- 
day supply, and per 90-day sup-
ply, including amounts paid by 
the 
participants 
and 
bene-
ficiaries, when the same drug is 
dispensed by other pharmacies 
that are not affiliated with or 
under common ownership with 
the entity and that are included 
in the pharmacy network of such 
plan or coverage; 
‘‘(cc) the lowest cost per 
dosage unit, per 30-day supply 
and per 90-day supply, for each 
such drug, including amounts 
charged to the plan or coverage 
and to participants and bene-
ficiaries, that is available from 
any pharmacy included in the 
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network of such plan or coverage; 
and 
‘‘(dd) the net acquisition 
cost per dosage unit, per 30-day 
supply, and per 90-day supply, if 
such drug is subject to a max-
imum price discount; and 
‘‘(B) with respect to any group health 
plan, including group health insurance coverage 
offered in connection with such a plan, regard-
less of whether the plan or coverage is offered 
by a specified large employer or whether it is a 
specified large plan— 
‘‘(i) a summary document for the 
group health plan that includes such infor-
mation described in clauses (i) through (iv) 
of subparagraph (A), as specified by the 
Secretary through guidance, program in-
struction, or otherwise (with no require-
ment of notice and comment rulemaking), 
that the Secretary determines useful to 
group health plans for purposes of select-
ing pharmacy benefit management serv-
ices, such as an estimated net price to 
group health plan and participant or bene-
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877 
ficiary, a cost per claim, the fee structure 
or reimbursement model, and estimated 
cost per participant or beneficiary; 
‘‘(ii) a summary document for plans 
and issuers to provide to participants and 
beneficiaries, which shall be made available 
to participants or beneficiaries upon re-
quest to their group health plan (including 
in the case of group health insurance cov-
erage offered in connection with such a 
plan), that— 
‘‘(I) contains such information 
described in clauses (iii), (iv), (v), and 
(vi), as applicable, as specified by the 
Secretary through guidance, program 
instruction, or otherwise (with no re-
quirement of notice and comment 
rulemaking) that the Secretary deter-
mines useful to participants or bene-
ficiaries in better understanding the 
plan or coverage or benefits under 
such plan or coverage; 
‘‘(II) contains only aggregate in-
formation; and 
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‘‘(III) states that participants 
and beneficiaries may request specific, 
claims-level information required to be 
furnished under subsection (c) from 
the group health plan or health insur-
ance issuer; and 
‘‘(iii) with respect to drugs covered by 
such plan or coverage during such report-
ing period— 
‘‘(I) the total net spending by the 
plan or coverage for all such drugs; 
‘‘(II) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; and 
‘‘(III) to the extent feasible, in-
formation on the total amount of re-
muneration for such drugs, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
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