(b) CONTENTS.—The initial action plan published 
under subsection (a) shall— 
(1) identify appropriate representation from 
within the Food and Drug Administration to be re-
sponsible for implementation of such action plan; 
(2) include elements to facilitate— 
(A) interactions and collaboration between 
the Food and Drug Administration, including 
the review centers thereof, and stakeholders in-
cluding patients, sponsors, and the external bio-
medical research community; 
(B) consideration of cross-cutting clinical 
and regulatory policy issues, including consist-
ency of regulatory advice and decisionmaking; 
(C) identification of key regulatory science 
and policy issues critical to advancing develop-
ment of safe and effective drugs; and 
(D) enhancement of collaboration and en-
gagement of the relevant centers and offices of the 
Food and Drug Administration with other oper-
ating divisions within the Department of Health 
and Human Services, the Partnership, and the 
broader neurodegenerative disease community; 
and 
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(3) be subject to revision, as determined appro-
priate by the Secretary of Health and Human Serv-
ices. 
SEC. 5. FDA RARE NEURODEGENERATIVE DISEASE GRANT 
PROGRAM. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall award 
grants and contracts to public and private entities to cover 
the costs of research on, and development of interventions 
intended to prevent, diagnose, mitigate, treat, or cure, 
amyotrophic 
lateral 
sclerosis 
and 
other 
rare 
neurodegenerative diseases in adults and children, includ-
ing costs incurred with respect to the development and crit-
ical evaluation of tools, methods, and processes— 
(1) to characterize such neurodegenerative dis-
eases and their natural history; 
(2) to identify molecular targets for such 
neurodegenerative diseases; and 
(3) to increase efficiency and productivity of 
clinical development of therapies, including through— 
(A) the use of master protocols and adaptive 
and add-on clinical trial designs; and 
(B) efforts to establish new or leverage exist-
ing clinical trial networks. 
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SEC. 6. GAO REPORT. 
Not later than 4 years after the date of the enactment 
of this Act, the Comptroller General of the United States 
shall submit to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Senate a 
report containing— 
(1) with respect to grants awarded under the 
program established under section 2— 
(A) an analysis of what is known about the 
impact of such grants on research or development 
related to the prevention, diagnosis, mitigation, 
treatment, or cure of amyotrophic lateral scle-
rosis; and 
(B) data concerning such grants, includ-
ing— 
(i) the number of grants awarded; 
(ii) the participating entities to whom 
grants were awarded; 
(iii) the value of each such grant; 
(iv) a description of the research each 
such grant was used to further; 
(v) the number of patients who received 
expanded access to an investigational drug 
to prevent, diagnose, mitigate, treat, or cure 
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amyotrophic lateral sclerosis under each 
grant; 
(vi) whether the investigational drug 
that was the subject of such a grant was ap-
proved by the Food and Drug Administra-
tion; and 
(vii) the average number of days be-
tween when a grant application is sub-
mitted and when a grant is awarded; and 
(2) with respect to grants awarded under the 
program established under section 5— 
(A) an analysis of what is known about the 
impact of such grants on research or development 
related to the prevention, diagnosis, mitigation, 
treatment, or cure of amyotrophic lateral scle-
rosis; 
(B) an analysis of what is known about 
how such grants increased efficiency and produc-
tivity of the clinical development of therapies, 
including through the use of clinical trials that 
operated with common master protocols, or had 
adaptive or add-on clinical trial designs; and 
(C) data concerning such grants, includ-
ing— 
(i) the number of grants awarded; 
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(ii) the participating entities to whom 
grants were awarded; 
(iii) the value of each such grant; 
(iv) a description of the research each 
such grant was used to further; and 
(v) whether the investigational drug 
that was the subject of such a grant received 
approval by the Food and Drug Adminis-
tration. 
SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 
For purposes of carrying out this Act, there are author-
ized to be appropriated $100,000,000 for each of fiscal years 
2022 through 2026. 
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Union Calendar No. 148 
117TH CONGRESS 
1ST SESSION 
H. R. 3537 
[Report No. 117–207] 
A BILL 
To direct the Secretary of Health and Human 
Services to support research on, and expanded 
access to, investigational drugs for amyotrophic 
lateral sclerosis, and for other purposes. 
DECEMBER 8, 2021 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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