DECEMBER 8, 2021 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on May 25, 2021] 
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. 
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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 
purposes of scientific research utilizing data from expanded 
access to investigational drugs for individuals who are not 
otherwise eligible for clinical trials for the prevention, diag-
nosis, mitigation, treatment, or cure of amyotrophic lateral 
sclerosis. In the case of a participating entity seeking such 
a grant, an expanded access request 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 Regula-
tions (or any successor regulations), before the application 
for such grant is submitted. 
(b) APPLICATION.— 
(1) IN GENERAL.—A participating entity seeking 
a grant under this section shall submit to the Sec-
retary an application at such time, in such manner, 
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and containing such information as the Secretary 
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 will be used to sup-
port research or development related to the preven-
tion, diagnosis, mitigation, treatment, or cure of 
amyotrophic lateral sclerosis. 
(3) 
NONINTERFERENCE
WITH
CLINICAL 
TRIALS.—An application submitted under paragraph 
(1) shall include a description of how the proposed ex-
panded access program will be designed so as not to 
interfere with patient enrollment in ongoing clinical 
trials for investigational therapies for the prevention, 
diagnosis, 
mitigation, 
treatment, 
or 
cure 
of 
amyotrophic lateral sclerosis. 
(c) SELECTION.—Consistent with sections 406 and 492 
of the Public Health Service Act (42 U.S.C. 284a, 289a), 
the Secretary shall, in determining whether to award a 
grant under this section, confirm that— 
(1) such grant will be used to support a sci-
entific research objective relating to the prevention, 
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diagnosis, 
mitigation, 
treatment, 
or 
cure 
of 
amyotrophic lateral sclerosis (as described in sub-
section (a)); 
(2) such grant shall not have the effect of dimin-
ishing eligibility for, or impeding enrollment of, ongo-
ing clinical trials for the prevention, diagnosis, miti-
gation, treatment, or cure of amyotrophic lateral scle-
rosis by determining that individuals who receive ex-
panded access to investigational drugs through such a 
grant are not eligible for enrollment in— 
(A) ongoing clinical trials that are reg-
istered 
on 
ClinicalTrials.gov 
(or 
successor 
website), with respect to a drug for the preven-
tion, diagnosis, mitigation, treatment, or cure of 
amyotrophic lateral sclerosis; or 
(B) clinical trials for the prevention, diag-
nosis, 
mitigation, 
treatment, 
or 
cure 
of 
amyotrophic lateral sclerosis for which an ex-
emption under section 505(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 
has been granted by the Food and Drug Admin-
istration and which are expected to begin enroll-
ment within one year; and 
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(3) the resulting project funded by such grant 
will allow for equitable access to investigational drugs 
by minority and underserved populations. 
(d) USE OF FUNDS.—A participating entity shall use 
funds received through the grant— 
(1) to pay the manufacturer or sponsor for the 
direct costs of the investigational drug, as authorized 
under section 312.8(d) of title 21, Code of Federal 
Regulations (or successor regulations), to prevent, di-
agnose, mitigate, treat, or cure amyotrophic lateral 
sclerosis that is the subject of an expanded access re-
quest described in subsection (a), if such costs are jus-
tified 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 mission 
of the grant; or 
(3) for the direct and indirect costs of the entity 
in conducting research with respect to such drug. 
(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 inves-
tigational new drug application under section 505(i) 
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