sion studies and expanded access programs spe-
cific to rare diseases or conditions. 
(2) CONSULTATION.—The contract under para-
graph (1) shall provide for consultation with relevant 
stakeholders, including— 
(A) rare disease or condition patients; and 
(B) patient groups that— 
(i) represent rare disease or condition 
patients; and 
(ii) have international patient out-
reach. 
(3) REPORT.—The contract under paragraph 
(1) shall provide for— 
(A) not later than 2 years after the date 
of enactment of this Act— 
(i) the completion of the study under 
paragraph (1); and 
(ii) the submission of a report on the 
results of such study to the Congress; and 
(B) the inclusion in the report under sub-
paragraph (A)(ii) of recommendations for 
changes to the processes and authorities of the 
Food and Drug Administration to facilitate de-
velopment of, and access to, treatments for rare 
diseases or conditions. 
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(4) PUBLIC AVAILABILITY.—The contract under 
paragraph (1) shall provide for the appropriate enti-
ty referred to in paragraph (1) to make the report 
under paragraph (3) available to the public, includ-
ing by posting the report on the website of the ap-
propriate entity. 
(c) PUBLIC MEETING.— 
(1) IN GENERAL.—Not later than December 31, 
2023, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and 
Drugs, shall convene one or more public meetings to 
solicit input from stakeholders regarding the ap-
proaches described in paragraph (2). 
(2) APPROACHES.—The public meeting or 
meetings under paragraph (1) shall address ap-
proaches to increasing and improving engagement 
with rare disease or condition patients, groups rep-
resenting such patients, rare disease or condition ex-
perts, and experts on small population studies, in 
order to improve the understanding with respect to 
rare diseases or conditions of— 
(A) patient burden; 
(B) treatment options; and 
(C) side effects of treatments, including— 
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(i) comparing the side effects of treat-
ments; and 
(ii) understanding the risks of side ef-
fects relative to the health status of the pa-
tient and the progression of the disease or 
condition. 
(3) PUBLIC DOCKET.—The Secretary of Health 
and Human Services shall establish a public docket 
to receive written comments related to the ap-
proaches addressed during each public meeting 
under paragraph (1). Such public docket shall re-
main open for 60 days following the date of each 
such public meeting. 
(4) REPORTS.—Not later than 180 days after 
each public meeting under paragraph (1), the Com-
missioner of Food and Drugs shall develop and pub-
lish on the website of the Food and Drug Adminis-
tration a report on— 
(A) the approaches discussed at the public 
meeting; and 
(B) any related recommendations. 
(d) CONSULTATION
ON
THE SCIENCE
OF SMALL 
POPULATION STUDIES.—Section 569(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8(b)) 
is amended by adding at the end the following: 
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