470 
(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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471 
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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472 
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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473 
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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474 
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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475 
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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476 
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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477 
(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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478 
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 such sec-
tion 319F–4 only if the administration of such 
vaccine occurred prior to the addition of the 
vaccine to the Vaccine Injury Table under sec-
tion 2114 of the Public Health Service Act (42 
U.S.C. 300aa–14). 
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479 
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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480 
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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481 
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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482 
(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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483 
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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484 
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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485 
‘‘(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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486 
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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487 
(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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488 
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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489 
(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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490 
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 ‘‘March 
31, 2025’’ 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 ‘‘March 
31, 2025’’ 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. 650. 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 Lower Costs for Everyday Americans 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— 
(A) not later than 30 days after the date 
of enactment of this Act, convene a committee 
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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-
cation, Labor, and Pensions of the 
Senate. 
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(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 
for parents in-hospital, in non-hospital set-
tings, and post-discharge. 
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(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)— 
(A) in subclause (I), by striking ‘‘as appli-
cable’’ and inserting ‘‘if available’’; and 
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(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 
collaboratives, best practices on how to prevent ma-
ternal mortality and morbidity that consider and re-
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499 
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’’; 
(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-
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502 
‘‘(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— 
(A) by amending the section heading to 
read as follows: ‘‘THE BILL PASCRELL, JR., 
NATIONAL
PROGRAM
FOR
TRAUMATIC 
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503 
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 
identify and address concussion’’ before the pe-
riod at the end; and 
(F) by adding at the end the following: 
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‘‘(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 
Public Health Service Act (42 U.S.C. 300d–52) is 
amended— 
(A) in subsection (b)(2)— 
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505 
(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 
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 
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506 
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— 
‘‘(I) brain injuries caused by an-
oxia due to trauma; and 
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‘‘(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’’. 
(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 
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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. 
(d) STUDY ON LONG-TERM SYMPTOMS OR CONDI-
TIONS RELATED TO TRAUMATIC BRAIN INJURY.— 
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509 
(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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510 
(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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511 
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. CONFORMING AMENDMENT TO INTERNAL REV-
ENUE CODE OF 1986. 
Section 9008(i)(2) of the Internal Revenue Code of 
1986 (26 U.S.C. 9008(i)(2)) is amended by striking ‘‘10– 
Year’’. 
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 
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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)— 
(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); 
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(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,’’; 
(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))— 
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(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; 
(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: 
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‘‘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 
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-
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518 
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. 
‘‘(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 
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‘‘(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 
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— 
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‘‘(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: 
‘‘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; 
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‘‘(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 
‘‘(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.’’. 
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522 
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; 
(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: 
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‘‘(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 
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.— 
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‘‘(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). 
‘‘(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— 
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‘‘(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). 
‘‘(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. 
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‘‘(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: 
‘‘(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)’’. 
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527 
(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: 
‘‘(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 
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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 
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 
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529 
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— 
‘‘(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 
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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 
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 
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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 
‘‘(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 
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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.’’. 
(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: 
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‘‘(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— 
(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— 
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(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 
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). 
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535 
(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, 
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, 
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536 
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 
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: 
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537 
‘‘(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 
‘‘(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. 
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538 
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; 
(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. 
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539 
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 
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-
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540 
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: 
(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 
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541 
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. 
(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-
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542 
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 
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. 
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543 
(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 
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 
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544 
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 
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 
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545 
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: 
‘‘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 
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