I 
117TH CONGRESS 
1ST SESSION H. R. 3537 
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. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 25, 2021 
Mr. QUIGLEY (for himself, Mr. FORTENBERRY, Mr. BRENDAN F. BOYLE of 
Pennsylvania, Mr. MOULTON, Mr. GARCIA of California, Mr. CARBAJAL, 
Mr. LARSON of Connecticut, Ms. JACKSON LEE, Ms. DEAN, Mr. SUOZZI, 
Ms. VELA´ZQUEZ, Mr. LEVIN of California, Mr. DEUTCH, Ms. NORTON, 
Mr. TIMMONS, Mr. BRADY, Mr. MCKINLEY, Mr. VAN DREW, Mr. CAL-
VERT, Mr. KEATING, Mr. DIAZ-BALART, Mr. CARTER of Georgia, Mrs. 
MCBATH, Mr. SMITH of Missouri, Mr. TURNER, Mr. DUNCAN, Mr. HICE 
of Georgia, Mr. YOUNG, Mr. SMITH of Nebraska, Mr. GROTHMAN, Mr. 
RUPPERSBERGER, Mr. RUTHERFORD, Mr. SCHWEIKERT, Mr. RYAN, Mr. 
CROW, Mr. GUTHRIE, Mr. FITZPATRICK, Ms. MCCOLLUM, Mr. AUSTIN 
SCOTT of Georgia, Mr. BAIRD, Mr. RODNEY DAVIS of Illinois, Mr. 
VALADAO, Mr. MOOLENAAR, Mr. MALINOWSKI, Ms. ROYBAL-ALLARD, 
Mr. PAYNE, Mr. LYNCH, Ms. HERRERA BEUTLER, Mr. BUCK, Mr. 
MULLIN, Mr. GRIJALVA, Mr. COOPER, Mr. PANETTA, Mr. KIM of New 
Jersey, Mr. SIRES, Ms. LEE of California, Ms. MOORE of Wisconsin, Ms. 
SCHAKOWSKY, Mr. THOMPSON of California, Mr. GALLEGO, Mrs. AXNE, 
Mrs. NAPOLITANO, Mr. ESPAILLAT, Ms. PRESSLEY, Mr. FLEISCHMANN, 
Mr. RESCHENTHALER, Mr. CICILLINE, Ms. DEGETTE, Mr. BURCHETT, 
Mr. LAMALFA, Ms. MENG, Ms. BROWNLEY, Mr. TRONE, Ms. KUSTER, 
Mr. CONNOLLY, Mr. MEEKS, Mrs. KIRKPATRICK, Mrs. DEMINGS, Mr. 
O’HALLERAN, Mr. LIEU, Mr. DESAULNIER, Mr. GARAMENDI, Mr. KIL-
MER, Mr. RUSH, Mr. MCCAUL, Mr. MCCLINTOCK, Mr. MFUME, Mr. 
LAMB, Mr. GREEN of Texas, Mr. SWALWELL, Mr. GOTTHEIMER, Ms. 
PINGREE, Ms. KAPTUR, Mr. FERGUSON, Ms. SCANLON, Mr. BACON, Mr. 
WITTMAN, Mr. MORELLE, Mr. AMODEI, and Mr. WALTZ) introduced the 
following bill; which was referred to the Committee on Energy and Com-
merce 
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A BILL 
To direct the Secretary of Health and Human Services to 
support research on, and expanded access to, investiga-
tional drugs for amyotrophic lateral sclerosis, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Accelerating Access 
to Critical Therapies for ALS Act’’. 
SEC. 2. GRANTS FOR RESEARCH ON THERAPIES FOR ALS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the Sec-
retary) shall award grants to participating entities for pur-
poses of expanded access for individuals to investigational 
drugs for the prevention, diagnosis, mitigation, treatment, 
or cure of amyotrophic lateral sclerosis. In the case of an 
applicant seeking such a grant, an expanded access re-
quest must be submitted, and allowed to proceed by the 
Secretary, under section 561 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb) and part 312 of 
title 21, Code of Federal Regulations (or any successor 
regulations), before the application for such grant is sub-
mitted. 
(b) APPLICATION.— 
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(1) IN GENERAL.—A participating entity seek-
ing a grant under this section shall submit to the 
Secretary an application at such time, in such man-
ner, and containing such information as the Sec-
retary shall specify. 
(2) USE OF DATA.—An application submitted 
under paragraph (1) shall include a description of 
how data generated through an expanded access re-
quest under section 561 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb) with respect 
to the investigational drug involved may be used by 
the Secretary to support research or development re-
lated to the prevention, diagnosis, mitigation, treat-
ment, or cure of amyotrophic lateral sclerosis or 
other rare neurodegenerative diseases. 
(c) SELECTION.—Not later than 120 days after the 
date of submission of an application for a grant under this 
section, the Secretary shall determine whether to award 
the grant, taking into consideration— 
(1) whether awarding such grant will support a 
research objective relating to expanding access to in-
vestigational drugs (as described in subsection (a)); 
and 
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(2) whether awarding such a grant may have 
the effect of diminishing eligibility for, or impeding 
enrollment of, ongoing clinical investigations. 
(d) USE OF FUNDS.—A participating entity may use 
funds received through the grant— 
(1) to pay the manufacturer or sponsor for the 
direct costs of such drug (as authorized under sec-
tion 312.8(d) of title 21, Code of Federal Regula-
tions (or successor regulations)), if such costs are 
justified as part of peer review of the grant; 
(2) for the entity’s direct costs incurred in pro-
viding such drug consistent with the research mis-
sion of the grant; or 
(3) for the direct and indirect costs of the enti-
ty in conducting research with respect to the drug 
involved. 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘participating entity’’ means a 
participating clinical trial site or sites sponsored by 
a small business concern (as defined in section 3(a) 
of the Small Business Act (15 U.S.C. 632(a)) that 
is the sponsor of a drug that is the subject of an in-
vestigational new drug application under section 
505(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(i)). 
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(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 nonprofit or public health care facility, or 
network of facilities, at which patients participating 
in a participating clinical trial receive an investiga-
tional drug through such trial. 
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 
‘‘Secretary’’) shall establish and implement a Public-Pri-
vate Partnership for Neurodegenerative Diseases between 
the National Institutes of Health, the Food and Drug Ad-
ministration, and one or more eligible entities (to be 
known and referred to in this section as the ‘‘Partner-
ship’’) through cooperative agreements, contracts, or other 
appropriate instruments with such eligible entities, for the 
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purpose of developing treatments for amytrophic lateral 
sclerosis and other rare neurodegenerative diseases. The 
Partnership shall— 
(1) establish partnerships, consortia, and col-
laborations with other public and private entities 
and individuals with expertise in amyotrophic lateral 
sclerosis and other rare neurodegenerative diseases 
for the purposes described 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 ‘‘el-
igible entity’’ means an entity that— 
(1) is— 
(A) an institution of higher education (as 
such term is defined in section 1001 of the 
Higher Education Act of 1965 (20 U.S.C. 
1001)) or a consortium of such institutions; or 
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(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 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 drug targets for 
neurodegenerative diseases; and 
(iii) to increase efficiency, predict-
ability, and productivity of clinical develop-
ment of therapies, including advancement 
of rational therapeutic development and es-
tablishment of clinical trial networks; and 
(B) securing funding for the Partnership 
from Federal and non-Federal governmental 
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