of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or 
cure amyotrophic lateral sclerosis. 
(2) The term ‘‘participating clinical trial’’ 
means a phase 3 clinical trial conducted pursuant to 
an exemption under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or 
section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)) to investigate a drug intended to pre-
vent, diagnose, mitigate, treat, or cure amyotrophic 
lateral sclerosis. 
(3) The term ‘‘participating clinical trial site’’ 
means a health care facility, or network of facilities, 
at which patients participating in a participating 
clinical trial receive an investigational drug through 
such trial. 
(f) SUNSET.—The Secretary may not award grants 
under this section on or after September 30, 2026. 
SEC. 3. HHS PUBLIC-PRIVATE PARTNERSHIP FOR RARE 
NEURODEGENERATIVE DISEASES. 
(a) ESTABLISHMENT.—Not later than one year after 
the date of enactment of this Act, the Secretary of Health 
and Human Services (referred to in this section as the ‘‘Sec-
retary’’) shall establish and implement a Public-Private 
Partnership for Neurodegenerative Diseases between the Na-
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tional Institutes of Health, the Food and Drug Administra-
tion, and one or more eligible entities (to be known and 
referred to in this section as the ‘‘Partnership’’) through 
cooperative agreements, contracts, or other appropriate 
mechanisms with such eligible entities, for the purpose of 
advancing the understanding of neurodegenerative diseases 
and fostering the development of treatments for amytrophic 
lateral sclerosis and other rare neurodegenerative diseases. 
The Partnership shall— 
(1) establish partnerships and consortia with 
other public and private entities and individuals with 
expertise in amyotrophic lateral sclerosis and other 
rare neurodegenerative diseases for the purposes de-
scribed in this subsection; 
(2) focus on advancing regulatory science and 
scientific research that will support and accelerate the 
development and review of drugs for patients with 
amyotrophic 
lateral 
sclerosis 
and 
other 
rare 
neurodegenerative diseases; and 
(3) foster the development of effective drugs that 
improve the lives of people that suffer from 
amyotrophic 
lateral 
sclerosis 
and 
other 
rare 
neurodegenerative diseases. 
(b) ELIGIBLE ENTITY.—In this section, the term ‘‘eli-
gible entity’’ means an entity that— 
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(1) is— 
(A) an institution of higher education (as 
such term is defined in section 1001 of the High-
er Education Act of 1965 (20 U.S.C. 1001)) or 
a consortium of such institutions; or 
(B) an organization described in section 
501(c)(3) of the Internal Revenue Code of 1986 
and exempt from tax under subsection (a) of 
such section; 
(2) has experienced personnel with clinical and 
other technical expertise in the field of biomedical 
sciences and demonstrated connection to the patient 
population; 
(3) demonstrates to the Secretary’s satisfaction 
that the entity is capable of identifying and estab-
lishing collaborations between public and private en-
tities 
and 
individuals 
with 
expertise 
in 
neurodegenerative diseases, including patients, in 
order to facilitate— 
(A) development and critical evaluation of 
tools, methods, and processes— 
(i) to characterize neurodegenerative 
diseases and their natural history; 
(ii) to identify molecular targets for 
neurodegenerative diseases; and 
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(iii) to increase efficiency, predict-
ability, and productivity of clinical develop-
ment of therapies, including advancement of 
rational therapeutic development and estab-
lishment of clinical trial networks; and 
(B) securing funding for the Partnership 
from Federal and non-Federal governmental 
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 support 
of basic research and research associated with phase 
3 clinical trials conducted with respect to investiga-
tional drugs that are the subjects of expanded access 
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requests 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). 
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 Commissioner of Food 
and Drugs shall publish on the website of the Food and 
Drug Administration an action plan describing actions the 
Food and Drug Administration intends to take during the 
5-year period following publication 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 peo-
ple living with amyotrophic lateral sclerosis and other 
rare neurodegenerative diseases; and 
(2) facilitate access to investigational drugs for 
amyotrophic 
lateral 
sclerosis 
and 
other 
rare 
neurodegenerative diseases. 
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