I
119THCONGRESS
1
STSESSION H. R. 1262
To amend the Federal Food, Drug, and Cosmetic Act with respect to
molecularly targeted pediatric cancer investigations, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY12, 2025
Mr. M
CCAUL(for himself, Mr. BILIRAKIS, Mrs. DINGELL, Ms. SCHRIER, Mrs.
H
ARSHBARGER, Ms. MATSUI, Mr. CRENSHAW, Ms. CASTORof Florida,
Mr. K
ELLYof Pennsylvania, Mrs. TRAHAN, and Mr. WEBERof Texas)
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with
respect to molecularly targeted pediatric cancer investiga-
tions, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3
(a) S
HORTTITLE.—This Act may be cited as the 4
‘‘Give Kids a Chance Act of 2025’’. 5
(b) T
ABLE OFCONTENTS.—The table of contents for 6
this Act is as follows: 7
Sec. 1. Short title; table of contents.
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Sec. 2. Research into pediatric uses of drugs; additional authorities of Food
and Drug Administration regarding molecularly targeted can-
cer drugs.
Sec. 3. Ensuring completion of pediatric study requirements.
Sec. 4. FDA report on PREA enforcement.
Sec. 5. Extension of authority to issue priority review vouchers to encourage
treatments for rare pediatric diseases.
Sec. 6. Limitations on exclusive approval or licensure of orphan drugs.
Sec. 7. Program for pediatric studies of drugs.
Sec. 8. Organ Procurement and Transplantation Network.
Sec. 9. Establishment of Abraham Accords Office within Food and Drug Ad-
ministration.
SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDI-
1
TIONAL AUTHORITIES OF FOOD AND DRUG 2
ADMINISTRATION REGARDING MOLECU-3
LARLY TARGETED CANCER DRUGS. 4
(a) I
NGENERAL.— 5
(1) A
DDITIONAL ACTIVE INGREDIENT FOR AP -6
PLICATION DRUG; LIMITATION REGARDING NOVEL - 7
COMBINATION APPLICATION DRUG .—Section 8
505B(a)(3) of the Federal Food, Drug, and Cos-9
metic Act (21 U.S.C. 355c(a)(3)) is amended— 10
(A) by redesignating subparagraphs (B) 11
and (C) as subparagraphs (C) and (D), respec-12
tively; and 13
(B) by striking subparagraph (A) and in-14
serting the following: 15
‘‘(A) I
N GENERAL.—For purposes of para-16
graph (1)(B), the investigation described in this 17
paragraph is a molecularly targeted pediatric 18
cancer investigation of— 19
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‘‘(i) the drug or biological product for 1
which the application referred to in such 2
paragraph is submitted; or 3
‘‘(ii) such drug or biological product 4
used in combination with— 5
‘‘(I) an active ingredient of a 6
drug or biological product— 7
‘‘(aa) for which an approved 8
application under section 505(j) 9
under this Act or under section 10
351(k) of the Public Health 11
Service Act is in effect; and 12
‘‘(bb) that is determined by 13
the Secretary, after consultation 14
with the applicant, to be part of 15
the standard of care for treating 16
a pediatric cancer; or 17
‘‘(II) an active ingredient of a 18
drug or biological product— 19
‘‘(aa) for which an approved 20
application under section 505(b) 21
of this Act or section 351(a) of 22
the Public Health Service Act to 23
treat an adult cancer is in effect 24
and is held by the same person 25
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submitting the application under 1
paragraph (1)(B); and 2
‘‘(bb) that is directed at a 3
molecular target that the Sec-4
retary determines to be substan-5
tially relevant to the growth or 6
progression of a pediatric cancer. 7
‘‘(B) A
DDITIONAL REQUIREMENTS .— 8
‘‘(i) D
ESIGN OF INVESTIGATION .—A 9
molecularly targeted pediatric cancer inves-10
tigation referred to in subparagraph (A) 11
shall be designed to yield clinically mean-12
ingful pediatric study data that is gathered 13
using appropriate formulations for each 14
age group for which the study is required, 15
regarding dosing, safety, and preliminary 16
efficacy to inform potential pediatric label-17
ing. 18
‘‘(ii) L
IMITATION.—An investigation 19
described in subparagraph (A)(ii) may be 20
required only if the drug or biological 21
product for which the application referred 22
to in paragraph (1)(B) contains either— 23
‘‘(I) a single new active ingre-24
dient; or 25
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‘‘(II) more than one active ingre-1
dient, if an application for the com-2
bination of active ingredients has not 3
previously been approved but each ac-4
tive ingredient is in a drug product 5
that has been previously approved to 6
treat an adult cancer. 7
‘‘(iii) R
ESULTS OF ALREADY -COM-8
PLETED PRECLINICAL STUDIES OF APPLI -9
CATION DRUG.—With respect to an inves-10
tigation required pursuant to paragraph 11
(1)(B), the Secretary may require the re-12
sults of any completed preclinical studies 13
relevant to the initial pediatric study plan 14
be submitted to the Secretary at the same 15
time that the initial pediatric study plan 16
required under subsection (e)(1) is sub-17
mitted. 18
‘‘(iv) R
ULE OF CONSTRUCTION RE -19
GARDING INACTIVE INGREDIENTS .—With 20
respect to a combination of active ingredi-21
ents referred to in subparagraph (A)(ii), 22
such subparagraph shall not be construed 23
as addressing the use of inactive ingredi-24
ents with such combination.’’. 25
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(2) DETERMINATION OF APPLICABLE REQUIRE -1
MENTS.—Section 505B(e)(1) of the Federal Food, 2
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 3
amended by adding at the end the following: ‘‘The 4
Secretary shall determine whether subparagraph (A) 5
or (B) of subsection (a)(1) applies with respect to an 6
application before the date on which the applicant is 7
required to submit the initial pediatric study plan 8
under paragraph (2)(A).’’. 9
(3) C
LARIFYING APPLICABILITY .—Section 10
505B(a)(1) of the Federal Food, Drug, and Cos-11
metic Act (21 U.S.C. 355c(a)(1)) is amended by 12
adding at the end the following: 13
‘‘(C) R
ULE OF CONSTRUCTION .—No appli-14
cation that is subject to the requirements of 15
subparagraph (B) shall be subject to the re-16
quirements of subparagraph (A), and no appli-17
cation (or supplement to an application) that is 18
subject to the requirements of subparagraph 19
(A) shall be subject to the requirements of sub-20
paragraph (B).’’. 21
(4) C
ONFORMING AMENDMENTS .—Section 22
505B(a) of the Federal Food, Drug, and Cosmetic 23
Act (21 U.S.C. 355c(a)) is amended— 24
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(A) in paragraph (3)(C), as redesignated 1
by paragraph (1)(A) of this subsection, by 2
striking ‘‘investigations described in this para-3
graph’’ and inserting ‘‘investigations referred to 4
in subparagraph (A)’’; and 5
(B) in paragraph (3)(D), as redesignated 6
by paragraph (1)(A) of this subsection, by 7
striking ‘‘the assessments under paragraph 8
(2)(B)’’ and inserting ‘‘the assessments re-9
quired under paragraph (1)(A)’’. 10
(b) G
UIDANCE.—The Secretary of Health and 11
Human Services, acting through the Commissioner of 12
Food and Drugs, shall— 13
(1) not later than 12 months after the date of 14
enactment of this Act, issue draft guidance on the 15
implementation of the amendments made by sub-16
section (a); and 17
(2) not later than 12 months after closing the 18
comment period on such draft guidance, finalize 19
such guidance. 20
(c) A
PPLICABILITY.—The amendments made by this 21
section apply with respect to any application under section 22
505(b) of the Federal Food, Drug, and Cosmetic Act (21 23
U.S.C. 355(b)) and any application under section 351(a) 24
of the Public Health Service Act (42 U.S.C. 262(a)), that 25
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is submitted on or after the date that is 3 years after the 1
date of enactment of this Act. 2
(d) R
EPORTS TOCONGRESS.— 3
(1) S
ECRETARY OF HEALTH AND HUMAN SERV -4
ICES.—Not later than 6 years after the date of en-5
actment of this Act, the Secretary of Health and 6
Human Services shall submit to the Committee on 7
Energy and Commerce of the House of Representa-8
tives and the Committee on Health, Education, 9
Labor, and Pensions of the Senate a report on the 10
Secretary’s efforts, in coordination with industry, to 11
ensure implementation of the amendments made by 12
subsection (a). 13
(2) GAO
STUDY AND REPORT.— 14
(A) S
TUDY.—Not later than 8 years after 15
the date of enactment of this Act, the Comp-16
troller General of the United States shall con-17
duct a study of the effectiveness of requiring 18
assessments and investigations described in sec-19
tion 505B of the Federal Food, Drug, and Cos-20
metic Act (21 U.S.C. 355c), as amended by 21
subsection (a), in the development of drugs and 22
biological products for pediatric cancer indica-23
tions, including consideration of any benefits to, 24
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or burdens on, pediatric cancer drug develop-1
ment. 2
(B) F
INDINGS.—Not later than 10 years 3
after the date of enactment of this Act, the 4
Comptroller General shall submit to the Com-5
mittee on Energy and Commerce of the House 6
of Representatives and the Committee on 7
Health, Education, Labor, and Pensions of the 8
Senate a report containing the findings of the 9
study conducted under subparagraph (A). 10
SEC. 3. ENSURING COMPLETION OF PEDIATRIC STUDY RE-11
QUIREMENTS. 12
(a) E
QUALACCOUNTABILITY FOR PEDIATRICSTUDY 13
R
EQUIREMENTS.—Section 505B(d) of the Federal Food, 14
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-15
ed— 16
(1) in paragraph (1), by striking ‘‘Beginning 17
270’’ and inserting ‘‘N
ONCOMPLIANCE LETTER .— 18
Beginning 270’’; 19
(2) in paragraph (2)— 20
(A) by striking ‘‘The drug or’’ and insert-21
ing ‘‘E
FFECT OF NONCOMPLIANCE .—The drug 22
or’’; and 23
(B) by striking ‘‘(except that the drug or 24
biological product shall not be subject to action 25
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under section 303)’’ and inserting ‘‘(except that 1
the drug or biological product shall be subject 2
to action under section 303 only if such person 3
demonstrated a lack of due diligence in satis-4
fying the applicable requirement)’’; and 5
(3) by adding at the end the following: 6
‘‘(3) L
IMITATION.—The Secretary shall not 7
issue enforcement actions under section 303 for fail-8
ures under this subsection in the case of a drug or 9
biological product that is no longer marketed.’’. 10
(b) D
UEDILIGENCE.—Section 505B(d) of the Fed-11
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 12
as amended by subsection (a), is further amended by add-13
ing at the end the following: 14
‘‘(4) D
UE DILIGENCE.—Before the Secretary 15
may conclude that a person failed to submit or oth-16
erwise meet a requirement as described in the mat-17
ter preceding paragraph (1), the Secretary shall— 18
‘‘(A) issue a noncompliance letter pursuant 19
to paragraph (1); 20
‘‘(B) provide such person with a 45-day 21
period beginning on the date of receipt of such 22
noncompliance letter to respond in writing as 23
set forth in such paragraph; and 24
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‘‘(C) after reviewing such written response, 1
determine whether the person demonstrated a 2
lack of due diligence in satisfying such require-3
ment.’’. 4
(c) C
ONFORMING AMENDMENTS.—Section 5
303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 6
(21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505– 7
1’’ and inserting ‘‘505–1, or 505B’’. 8
(d) T
RANSITIONRULE.—The Secretary of Health 9
and Human Services may take enforcement action under 10
section 303 of the Federal Food, Drug, and Cosmetic Act 11
(21 U.S.C. 333) only for failures described in section 12
505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 13
or after the date that is 180 days after the date of enact-14
ment of this Act. 15
SEC. 4. FDA REPORT ON PREA ENFORCEMENT. 16
Section 508(b) of the Food and Drug Administration 17
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 18
amended— 19
(1) in paragraph (11), by striking the semicolon 20
at the end and inserting ‘‘, including an evaluation 21
of compliance with deadlines provided for in defer-22
rals and deferral extensions;’’; 23
(2) in paragraph (15), by striking ‘‘and’’ at the 24
end; 25
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(3) in paragraph (16), by striking the period at 1
the end and inserting ‘‘; and’’; and 2
(4) by adding at the end the following: 3
‘‘(17) a listing of penalties, settlements, or pay-4
ments under section 303 of the Federal Food, Drug, 5
and Cosmetic Act (21 U.S.C. 353) for failure to 6
comply with requirements under such section 505B, 7
including, for each penalty, settlement, or payment, 8
the name of the drug, the sponsor thereof, and the 9
amount of the penalty, settlement, or payment im-10
posed; and’’. 11
SEC. 5. EXTENSION OF AUTHORITY TO ISSUE PRIORITY RE-12
VIEW VOUCHERS TO ENCOURAGE TREAT-13
MENTS FOR RARE PEDIATRIC DISEASES. 14
(a) E
XTENSION.—Paragraph (5) of section 529(b) of 15
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 16
360ff(b)) is amended by striking ‘‘December 20, 2024, un-17
less’’ and all that follows through the period at the end 18
and inserting ‘‘September 30, 2029.’’. 19
(b) U
SERFEEPAYMENT.—Section 529(c)(4) of the 20
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21
360ff(c)(4)) is amended by striking subparagraph (A) and 22
inserting the following: 23
‘‘(A) I
N GENERAL.—The priority review 24
user fee required by this subsection shall be due 25
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upon the submission of a human drug applica-1
tion under section 505(b)(1) or section 351(a) 2
of the Public Health Service Act for which the 3
priority review voucher is used. All other user 4
fees associated with the human drug application 5
shall be due as required by the Secretary or 6
under applicable law.’’. 7
(c) GAO R
EPORT ONEFFECTIVENESS OFRAREPE-8
DIATRICDISEASEPRIORITYVOUCHERAWARDS IN 9
I
NCENTIVIZINGRAREPEDIATRICDISEASEDRUGDEVEL-10
OPMENT.— 11
(1) GAO
STUDY.— 12
(A) S
TUDY.—The Comptroller General of 13
the United States shall conduct a study of the 14
effectiveness of awarding rare pediatric disease 15
priority vouchers under section 529 of the Fed-16
eral Food, Drug, and Cosmetic Act (21 U.S.C. 17
360ff), as amended by subsection (a), in the de-18
velopment of human drug products that treat or 19
prevent rare pediatric diseases (as defined in 20
such section 529). 21
(B) C
ONTENTS OF STUDY .—In conducting 22
the study under subparagraph (A), the Comp-23
troller General shall examine the following: 24
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(i) The indications for each drug or 1
biological product that— 2
(I) is the subject of a rare pedi-3
atric disease product application (as 4
defined in section 529 of the Federal 5
Food, Drug, and Cosmetic Act (21 6
U.S.C. 360ff)) for which a priority re-7
view voucher was awarded; and 8
(II) was approved under section 9
505 of the Federal Food, Drug, and 10
Cosmetic Act (42 U.S.C. 355) or li-11
censed under section 351 of the Pub-12
lic Health Service Act (42 U.S.C. 13
262). 14
(ii) Whether, and to what extent, an 15
unmet need related to the treatment or 16
prevention of a rare pediatric disease was 17
met through the approval or licensure of 18
such a drug or biological product. 19
(iii) The size of the company to which 20
a priority review voucher was awarded 21
under section 529 of the Federal Food, 22
Drug, and Cosmetic Act (21 U.S.C. 360ff) 23
for such a drug or biological product. 24
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(iv) The value of such priority review 1
voucher if transferred. 2
(v) Identification of each drug for 3
which a priority review voucher awarded 4
under such section 529 was used. 5
(vi) The size of the company using 6
each priority review voucher awarded 7
under such section 529. 8
(vii) The length of the period of time 9
between the date on which a priority re-10
view voucher was awarded under such sec-11
tion 529 and the date on which it was 12
used. 13
(viii) Whether, and to what extent, an 14
unmet need related to the treatment or 15
prevention of a rare pediatric disease was 16
met through the approval under section 17
505 of the Federal Food, Drug, and Cos-18
metic Act (42 U.S.C. 355) or licensure 19
under section 351 of the Public Health 20
Service Act (42 U.S.C. 262) of a drug for 21
which a priority review voucher was used. 22
(ix) Whether, and to what extent, 23
companies were motivated by the avail-24
ability of priority review vouchers under 25
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section 529 of the Federal Food, Drug, 1
and Cosmetic Act (21 U.S.C. 360ff) to at-2
tempt to develop a drug for a rare pedi-3
atric disease. 4
(x) Whether, and to what extent, pedi-5
atric review vouchers awarded under such 6
section were successful in stimulating de-7
velopment and expedited patient access to 8
drug products for treatment or prevention 9
of a rare pediatric disease that wouldn’t 10
otherwise take place without the incentive 11
provided by such vouchers. 12
(xi) The impact of such priority re-13
view vouchers on the workload, review 14
process, and public health prioritization ef-15
forts of the Food and Drug Administra-16
tion. 17
(xii) Any other incentives in Federal 18
law that exist for companies developing 19
drugs or biological products described in 20
clause (i). 21
(2) R
EPORT ON FINDINGS .—Not later than 5 22
years after the date of the enactment of this Act, the 23
Comptroller General of the United States shall sub-24
mit to the Committee on Energy and Commerce of 25
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the House of Representatives and the Committee on 1
Health, Education, Labor, and Pensions of the Sen-2
ate a report containing the findings of the study 3
conducted under paragraph (1). 4
SEC. 6. LIMITATIONS ON EXCLUSIVE APPROVAL OR LICEN-5
SURE OF ORPHAN DRUGS. 6
(a) I
NGENERAL.—Section 527 of the Federal Food, 7
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended— 8
(1) in subsection (a), in the matter following 9
paragraph (2), by striking ‘‘same disease or condi-10
tion’’ and inserting ‘‘same approved use or indica-11
tion within such rare disease or condition’’; 12
(2) in subsection (b)— 13
(A) in the matter preceding paragraph (1), 14
by striking ‘‘same rare disease or condition’’ 15
and inserting ‘‘same approved use or indication 16
for which such 7-year period applies to such al-17
ready approved or licensed drug’’; and 18
(B) in paragraph (1), by inserting ‘‘, relat-19
ing to the approved use or indication,’’ after 20
‘‘the needs’’; 21
(3) in subsection (c)(1), by striking ‘‘same rare 22
disease or condition as the already approved drug’’ 23
and inserting ‘‘same use or indication for which the 24
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already approved or licensed drug was approved or 1
licensed’’; and 2
(4) by adding at the end the following: 3
‘‘(f) A
PPROVEDUSE ORINDICATIONDEFINED.—In 4
this section, the term ‘approved use or indication’ means 5
the use or indication approved under section 505 of this 6
Act or licensed under section 351 of the Public Health 7
Service Act for a drug designated under section 526 for 8
a rare disease or condition.’’. 9
(b) A
PPLICATION OFAMENDMENTS.—The amend-10
ments made by subsection (a) shall apply with respect to 11
any drug designated under section 526 of the Federal 12
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-13
less of the date on which the drug was so designated, and 14
regardless of the date on which the drug was approved 15
under section 505 of such Act (21 U.S.C. 355) or licensed 16
under section 351 of the Public Health Service Act (42 17
U.S.C. 262). 18
SEC. 7. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 19
Section 409I(d)(1) of the Public Health Service Act 20
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 21
and all that follows through the period at the end and 22
inserting ‘‘section, $25,000,000 for each of fiscal years 23
2025 through 2027.’’. 24
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SEC. 8. ORGAN PROCUREMENT AND TRANSPLANTATION 1
NETWORK. 2
Section 372 of the Public Health Service Act (42 3
U.S.C. 274) is amended— 4
(1) in subsection (b)(2)— 5
(A) by moving the margins of subpara-6
graphs (M) through (O) 2 ems to the left; 7
(B) in subparagraph (A)— 8
(i) in clause (i), by striking ‘‘, and’’ 9
and inserting ‘‘; and’’; and 10
(ii) in clause (ii), by striking the 11
comma at the end and inserting a semi-12
colon; 13
(C) in subparagraph (C), by striking 14
‘‘twenty-four-hour telephone service’’ and in-15
serting ‘‘24-hour telephone or information tech-16
nology service’’; 17
(D) in each of subparagraphs (B) through 18
(M), by striking the comma at the end and in-19
serting a semicolon; 20
(E) in subparagraph (N), by striking 21
‘‘transportation, and’’ and inserting ‘‘transpor-22
tation;’’; 23
(F) in subparagraph (O), by striking the 24
period and inserting a semicolon; and 25
(G) by adding at the end the following: 26
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‘‘(P) encourage the integration of elec-1
tronic health records systems through applica-2
tion programming interfaces (or successor tech-3
nologies) among hospitals, organ procurement 4
organizations, and transplant centers, including 5
the use of automated electronic hospital refer-6
rals and the grant of remote, electronic access 7
to hospital electronic health records of potential 8
donors by organ procurement organizations, in 9
a manner that complies with the privacy regula-10
tions promulgated under the Health Insurance 11
Portability and Accountability Act of 1996, at 12
part 160 of title 45, Code of Federal Regula-13
tions, and subparts A, C, and E of part 164 of 14
such title (or any successor regulations); and 15
‘‘(Q) consider establishing a dashboard to 16
display the number of transplants performed, 17
the types of transplants performed, the number 18
and types of organs that entered the Organ 19
Procurement and Transplantation Network sys-20
tem and failed to be transplanted, and other 21
appropriate statistics, which should be updated 22
more frequently than annually.’’; and 23
(2) by adding at the end the following: 24
‘‘(d) R
EGISTRATIONFEES.— 25
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•HR 1262 IH
‘‘(1) IN GENERAL.—The Secretary may collect 1
registration fees from any member of the Organ 2
Procurement and Transplantation Network for each 3
transplant candidate such member places on the list 4
described in subsection (b)(2)(A)(i). Such registra-5
tion fees shall be collected and distributed only to 6
support the operation of the Organ Procurement 7
and Transplantation Network. Such registration fees 8
are authorized to remain available until expended. 9
‘‘(2) C
OLLECTION.—The Secretary may collect 10
the registration fees under paragraph (1) directly or 11
through awards made under subsection (b)(1)(A). 12
‘‘(3) D
ISTRIBUTION.—Any amounts collected 13
under this subsection shall— 14
‘‘(A) be credited to the currently applicable 15
appropriation, account, or fund of the Depart-16
ment of Health and Human Services as discre-17
tionary offsetting collections; and 18
‘‘(B) be available, only to the extent and in 19
the amounts provided in advance in appropria-20
tions Acts, to distribute such fees among 21
awardees described in subsection (b)(1)(A). 22
‘‘(4) T
RANSPARENCY.—The Secretary shall— 23
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‘‘(A) promptly post on the website of the 1
Organ Procurement and Transplantation Net-2
work— 3
‘‘(i) the amount of registration fees 4
collected under this subsection from each 5
member of the Organ Procurement and 6
Transplantation Network; and 7
‘‘(ii) a list of activities such fees are 8
used to support; and 9
‘‘(B) update the information posted pursu-10
ant to subparagraph (A), as applicable for each 11
calendar quarter for which fees are collected 12
under paragraph (1). 13
‘‘(5) GAO
REVIEW.—Not later than 2 years 14
after the date of enactment of this subsection, the 15
Comptroller General of the United States shall, to 16
the extent data are available— 17
‘‘(A) conduct a review concerning the ac-18
tivities under this subsection; and 19
‘‘(B) submit to the Committee on Health, 20
Education, Labor, and Pensions and the Com-21
mittee on Finance of the Senate and the Com-22
mittee on Energy and Commerce of the House 23
of Representatives, a report on such review, in-24
cluding related recommendations, as applicable. 25
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‘‘(6) SUNSET.—The authority to collect reg-1
istration fees under paragraph (1) shall expire on 2
the date that is 3 years after the date of enactment 3
of the Give Kids a Chance Act of 2025.’’. 4
SEC. 9. ESTABLISHMENT OF ABRAHAM ACCORDS OFFICE 5
WITHIN FOOD AND DRUG ADMINISTRATION. 6
(a) I
NGENERAL.—Chapter X of the Federal Food, 7
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-8
ed by adding at the end the following: 9
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 10
‘‘(a) I
NGENERAL.—The Secretary, acting through 11
the Commissioner of Food and Drugs, shall establish with-12
in the Food and Drug Administration an office, to be 13
known as the Abraham Accords Office, to be headed by 14
a director. 15
‘‘(b) O
FFICE.—Not later than two years after the 16
date of enactment of this section, the Secretary shall— 17
‘‘(1) in consultation with the governments of 18
Abraham Accords countries, as well as appropriate 19
United States Government diplomatic and security 20
personnel— 21
‘‘(A) select the location of the Abraham 22
Accords Office in an Abraham Accords country; 23
and 24
‘‘(B) establish such office; and 25
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•HR 1262 IH
‘‘(2) assign to such office such personnel of the 1
Food and Drug Administration as the Secretary de-2
termines necessary to carry out the functions of 3
such office. 4
‘‘(c) D
UTIES.—The Secretary, acting through the Di-5
rector of the Abraham Accords Office, shall— 6
‘‘(1) after the Abraham Accords Office is estab-7
lished— 8
‘‘(A) as part of the Food and Drug Admin-9
istration’s work to strengthen the international 10
oversight of regulated commodities, provide 11
technical assistance to regulatory partners in 12
Abraham Accords countries on strengthening 13
regulatory oversight and converging regulatory 14
requirements for the oversight of regulated 15
products, including good manufacturing prac-16
tices and other issues relevant to manufacturing 17
medical products that are regulated by the 18
Food and Drug Administration; and 19
‘‘(B) facilitate interactions between the 20
Food and Drug Administration and interested 21
parties in Abraham Accords countries, including 22
by sharing relevant information regarding 23
United States regulatory pathways with such 24
parties, and facilitate feedback on the research, 25
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•HR 1262 IH
development, and manufacturing of products 1
regulated in accordance with this Act; and 2
‘‘(2) carry out other functions and activities as 3
the Secretary determines to be necessary to carry 4
out this section. 5
‘‘(d) A
BRAHAMACCORDSCOUNTRYDEFINED.—In 6
this section, the term ‘Abraham Accords country’ means 7
a country identified by the Department of State as having 8
signed the Abraham Accords Declaration. 9
‘‘(e) N
ATIONALSECURITY.—Nothing in this section 10
shall be construed to require any action inconsistent with 11
a national security recommendation provided by the Fed-12
eral Government.’’. 13
(b) R
EPORT TOCONGRESS.— 14
(1) I
N GENERAL.—Not later than 3 years after 15
the date of enactment of this Act, the Secretary of 16
Health and Human Services shall submit to the 17
Congress a report on the Abraham Accords Office, 18
including— 19
(A) an evaluation of how the Office has ad-20
vanced progress toward conformance with Food 21
and Drug Administration regulatory require-22
ments by manufacturers in the Abraham Ac-23
cords countries; 24
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•HR 1262 IH
(B) a numerical count of parties that the 1
Office has helped facilitate interactions or feed-2
back pursuant to section 1015(c)(1)(B) of the 3
Federal Food, Drug, and Cosmetic Act (as 4
added by subsection (a)); 5
(C) a summary of technical assistance pro-6
vided to regulatory partners in Abraham Ac-7
cords countries pursuant to subparagraph (A) 8
of such section 1015(c)(1); and 9
(D) recommendations for increasing and 10
improving coordination between the Food and 11
Drug Administration and entities in Abraham 12
Accords countries. 13
(2) A
BRAHAM ACCORDS COUNTRY DEFINED .— 14
In this subsection, the term ‘‘Abraham Accords 15
country’’ has the meaning given such term in section 16
1015(d) of the Federal Food, Drug, and Cosmetic 17
Act (as added by subsection (a)). 18
Æ
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