(4) Situations where the initial pediatric study 
plan under section 505B(e) of such Act (21 U.S.C. 
355c(e)) includes a plan to study the drug or bio-
logical product in all relevant pediatric age groups. 
(5) Consideration of how the Secretary of 
Health and Human Services will balance the unique 
scientific challenges of rare disease drug develop-
ment with the need for improved pediatric labeling 
of drugs and biological products for indications for 
which orphan designation has been granted under 
section 526 of such Act (21 U.S.C. 360bb). 
(6) Applicability of real-world evidence in the 
fulfillment of requirements under section 505B of 
such Act (21 U.S.C. 355c). 
(7) Consideration of input received from the 
public meeting set forth in subsection (d). 
(d) PUBLIC MEETING.—The Secretary shall— 
(1) not later than 1 year after the date of en-
actment of this Act, hold a public meeting to inform 
the final guidance to be issued under subsection 
(b)(2); and 
(2) publish prior notice of such meeting in the 
Federal Register. 
(e) GAO STUDY.—Not later than 4 years after the 
date of enactment of this Act, the Comptroller General 
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of the United States shall submit to the Committee on 
Energy and Commerce and the Committee on Ways and 
Means of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate 
a report that— 
(1) addresses the impacts of this Act on— 
(A) rare disease drug development in the 
United States; and 
(B) the increased availability of pediatric 
information on drugs and biological products 
for indications for which orphan designation 
has been granted under section 526 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bb); and 
(2) includes— 
(A) the findings of a survey of companies 
of varying sizes engaged in the development of 
orphan drugs; and 
(B) input from patient groups and medical 
provider associations. 
(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit requirements for investiga-
tions, as described in section 505B(a)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)), of 
molecularly targeted pediatric cancer drugs for which or-
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phan designation has been granted under section 526 of 
such Act (21 U.S.C. 360bb). 
SEC. 3. REAUTHORIZING THE 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 in paragraph (1) by 
striking ‘‘$25,000,000 for each of fiscal years 2023 
through 2027’’ and inserting ‘‘$50,000,000 for each of fis-
cal years 2023 through 2027’’. 
SEC. 4. ENSURING COMPLETION OF PEDIATRIC STUDY RE-
QUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(2)) is 
amended by striking ‘‘(except that the drug or biological 
product shall not be subject to action under section 303)’’. 
(b) 
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’’. 
(c) TRANSITION RULE.—The Secretary of Health 
and Human Services shall take no enforcement actions 
under section 303 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 333) for failures described in section 
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505B(d) of such Act (21 U.S.C. 355c(d)) before the date 
this is 180 days after the date of enactment of this Act. 
SEC. 5. 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 assessment 
of the appropriateness of deferrals and deferral ex-
tensions granted for such products and an evalua-
tion of compliance with deadlines provided for in 
such deferrals 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 for failure to comply with require-
ments under section 505B of such Act, including for 
each penalty, settlement, or payment the name of 
the drug, the sponsor thereof, and the amount of the 
penalty, settlement, or payment imposed.’’. 
Æ 
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