I 
116TH CONGRESS 
2D SESSION 
H. R. 7071 
To provide for the acceleration of access to clinical therapies for the treatment 
of amyotrophic lateral sclerosis, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 1, 2020 
Mr. FORTENBERRY (for himself and Mr. QUIGLEY) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To provide for the acceleration of access to clinical therapies 
for the treatment of 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 RAPID DEVELOPMENT OF THERAPIES 
FOR ALS AND OTHER RAPIDLY PROGRESSING 
NEURODEGENERATIVE DISEASES. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall award grants to eligible entities for 
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the provision of investigational drugs through an expanded 
access program pursuant to section 561 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) for 
individuals for the prevention, diagnosis, mitigation, treat-
ment, or cure of amyotrophic lateral sclerosis or another 
rapidly progressing neurodegenerative disease. 
(b) VESTED AUTHORITY.—For purposes of develop-
ment of an investigational drug pursuant to subsection 
(a), the Secretary may vest authority in the participating 
clinical trial site or sites to make the determination under 
subsection (b)(2), (c)(6), or (c)(7), as applicable, of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb). 
(c) TIMING.—Not later than 60 days after the date 
of submission of an application for a grant under this sec-
tion— 
(1) the Secretary, acting through the Director 
of the National Institutes of Health, shall determine 
whether to award the grant; and 
(2) the Secretary acting through the Commis-
sioner of Food and Drugs (or by vesting authority 
in the participating clinical trial site, as applicable) 
shall make the determinations required of the Sec-
retary under subsection (b) or (c), as applicable, of 
section 561 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360bbb) for the provision of 
the investigational drug to occur. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘Director’’ means the Director of 
the National Institutes of Health. 
(2) The term ‘‘eligible entity’’ means an entity 
that is— 
(A) 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 investigational new 
drug application under section 505(i) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(i)); or 
(B) a participating clinical trial site for 
such an applicant. 
(3) The term ‘‘participating clinical trial’’ 
means a phase 2 or 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 treat amyotrophic lateral scle-
rosis 
or 
another 
rapidly 
progressing 
neurodegenerative disease. 
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(4) The term ‘‘participating clinical trial site’’ 
means a health care facility at which patients par-
ticipating in a participating clinical trial receive 
treatment through such trial. 
(5) The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
(e) FUNDING.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this section— 
(A) $75,000,000 for each of fiscal years 
2021 and 2022; and 
(B) $150,000,000 for each of fiscal years 
2023 and 2024. 
(2) GIFTS, GRANTS, AND OTHER DONATIONS TO 
FOUNDATION.— 
(A) ACCEPTANCE.—Pursuant to section 
499(c) of the Public Health Service Act (42 
U.S.C. 290b(c)), the Foundation for the Na-
tional Institutes of Health may solicit and ac-
cept gifts, grants, and other donations, estab-
lish accounts, and invest and expend funds in 
support of carrying out this section. 
(B) USE.—In addition to the amounts 
made available pursuant to the authorizations 
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of appropriations in paragraph (1), the Director 
may use, without further appropriation, any 
funds derived from a gift, grant, or other dona-
tion accepted pursuant to subparagraph (A). 
(f) REVIEW AND EXPANSION.—Not later than 18 
months after the date of the enactment of this Act— 
(1) the Secretary of Health and Human Serv-
ices shall convene an independent review panel that 
includes representatives of patients, researchers, 
drug sponsors, and government agencies; and 
(2) the independent review panel shall submit 
to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report on the findings and conclusions of the 
panel with respect to the design and implementation 
of the program under this section for 2023 and 
2024. 
SEC. 
3. 
FDA 
CENTER 
OF 
EXCELLENCE 
FOR 
NEURODEGENERATIVE DISEASES. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
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‘‘SEC. 
1015. 
CENTER 
OF 
EXCELLENCE 
FOR 
NEURODEGENERATIVE DISEASES. 
‘‘(a) ESTABLISHMENT.—Not later than September 
2021, the Secretary shall establish within the Food and 
Drug Administration a center of excellence, to be known 
as the Center of Excellence for Neurodegenerative Dis-
eases (in this section referred to as the ‘Center of Excel-
lence’). 
‘‘(b) DUTIES AND AUTHORITIES.—The Center of Ex-
cellence shall have duties and authorities similar to those 
of the Center of Excellence for Oncology established under 
section 1014, including the duties and authorities of the 
Center of Excellence for Oncology with respect to Project 
Facilitate.’’. 
Æ 
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