sources, foundations, and private individuals; 
and 
(4) provides an assurance that the entity will 
not accept funding for a Partnership project from 
any organization that manufactures or distributes 
products regulated by the Food and Drug Adminis-
tration unless the entity provides assurances in its 
agreement with the Secretary that the results of the 
project will not be influenced by any source of fund-
ing. 
(c) GIFTS.— 
(1) IN GENERAL.—The Partnership may solicit 
and accept gifts, grants, and other donations, estab-
lish accounts, and invest and expend funds in sup-
port of pre-competitive research and research associ-
ated with phase 3 clinical trials conducted with re-
spect to investigational drugs that are the subjects 
of expanded access applications under section 561 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb). 
(2) USE.—In addition to any amounts appro-
priated for purposes of carrying out this section, the 
Partnership may use, without further appropriation, 
any funds derived from a gift, grant, or other dona-
tion accepted pursuant to paragraph (1). 
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SEC. 4. ALS AND OTHER RARE NEURODEGENERATIVE DIS-
EASE ACTION PLAN. 
(a) IN GENERAL.—Not later than 6 months after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall publish on the website of the De-
partment of Health and Human Services an action plan 
describing actions the Food and Drug Administration in-
tends to take during the 5-year period following publica-
tion of the plan with respect to program enhancements, 
policy development, regulatory science initiatives, and 
other appropriate initiatives to— 
(1) foster the development of safe and effective 
drugs that improve or extend, or both, the lives of 
people living with amyotrophic lateral sclerosis and 
other rare neurodegenerative diseases as quickly as 
possible; and 
(2) facilitate access to investigational drugs for 
amyotrophic 
lateral 
sclerosis 
and 
other 
rare 
neurodegenerative diseases. 
(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— 
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(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 decision making; 
(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 by staff of the relevant centers of the 
Food and Drug Administration and other rel-
evant offices of the Food and Drug Administra-
tion with other operating divisions within the 
Department of Health and Human Services, the 
Partnership, and the broader neurodegenerative 
disease community; and 
(3) be subject to revision, as determined appro-
priate by the Secretary of Health and Human Serv-
ices. 
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SEC. 5. FDA RARE NEURODEGENERATIVE DISEASE GRANT 
PROGRAM. 
The Secretary of Health and Human Services shall 
use funds made available under section 6 to award grants 
and contracts to public and private entities to cover the 
costs of research on, and development of interventions in-
tended to prevent, diagnose, mitigate, treat, or cure, 
amyotrophic lateral sclerosis and other rare life-threat-
ening or severely debilitating neurodegenerative diseases 
in adults and children, including costs incurred with re-
spect to the development and critical 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 advanc-
ing rational therapeutic development and working to 
establish new or leverage existing clinical trial net-
works. 
SEC. 6. AUTHORIZATION OF APPROPRIATIONS. 
For purposes of carrying out this Act, there are au-
thorized to be appropriated $100,000,000 for each of fis-
cal years 2022 through 2026. 
Æ 
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