H. R. 3537—4 
(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 Administration 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 funding. 
(c) GIFTS.— 
(1) IN GENERAL.—The Partnership may solicit and accept 
gifts, grants, and other donations, establish accounts, and invest 
and expend funds in support of basic research and research 
associated with phase 3 clinical trials conducted with respect 
to investigational drugs that are the subjects of expanded access 
requests under section 561 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb). 
(2) USE.—In addition to any amounts appropriated for pur-
poses of carrying out this section, the Partnership may use, 
without further appropriation, any funds derived from a gift, 
grant, or other donation accepted pursuant to paragraph (1). 
SEC. 4. ALS AND OTHER RARE NEURODEGENERATIVE DISEASE 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 people 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. 
(b) CONTENTS.—The initial action plan published under sub-
section (a) shall— 
(1) identify appropriate representation from within the 
Food 
and 
Drug 
Administration 
to 
be 
responsible 
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 including patients, sponsors, and 
the external biomedical research community; 
(B) consideration of cross-cutting clinical and regu-
latory policy issues, including consistency of regulatory 
advice and decisionmaking; 
(C) identification of key regulatory science and policy 
issues critical to advancing development of safe and effec-
tive drugs; and 
(D) enhancement of collaboration and engagement of 
the relevant centers and offices of the Food and Drug 
Administration with other operating divisions within the
H. R. 3537—5 
Department of Health and Human Services, the Partner-
ship, and the broader neurodegenerative disease commu-
nity; and 
(3) be subject to revision, as determined appropriate by 
the Secretary of Health and Human Services. 
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, including 
costs incurred with respect to the development and critical evalua-
tion of tools, methods, and processes— 
(1) to characterize such neurodegenerative diseases 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 existing clinical 
trial networks. 
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 Rep-
resentatives 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 sclerosis; and 
(B) data concerning such grants, including— 
(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 amyotrophic lateral sclerosis 
under each grant; 
(vi) whether the investigational drug that was the 
subject of such a grant was approved by the Food 
and Drug Administration; and 
(vii) the average number of days between when 
a grant application is submitted and when a grant 
is awarded; and 
(2) with respect to grants awarded under the program 
established under section 5—
H. R. 3537—6 
(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 sclerosis; 
(B) an analysis of what is known about how such 
grants increased efficiency and productivity 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, including— 
(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; and 
(v) whether the investigational drug that was the 
subject of such a grant received approval by the Food 
and Drug Administration. 
SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 
For purposes of carrying out this Act, there are authorized 
to be appropriated $100,000,000 for each of fiscal years 2022 
through 2026. 
Speaker of the House of Representatives. 
Vice President of the United States and
President of the Senate.