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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerating Access 

5 to Critical Therapies for ALS Act’’. 

6 SEC. 2. GRANTS FOR RAPID DEVELOPMENT OF THERAPIES 

7 FOR ALS AND OTHER RAPIDLY PROGRESSING 

8 NEURODEGENERATIVE DISEASES. 

9 (a) IN GENERAL.—The Secretary of Health and 

10 Human Services shall award grants to eligible entities for 


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1 the provision of investigational drugs through an expanded 

2 access program pursuant to section 561 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) for 

4 individuals for the prevention, diagnosis, mitigation, treat5 ment, or cure of amyotrophic lateral sclerosis or another 

6 rapidly progressing neurodegenerative disease. 

7 (b) VESTED AUTHORITY.—For purposes of develop8 ment of an investigational drug pursuant to subsection 

9 (a), the Secretary may vest authority in the participating 

10 clinical trial site or sites to make the determination under 

11 subsection (b)(2), (c)(6), or (c)(7), as applicable, of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 360bbb). 

14 (c) TIMING.—Not later than 60 days after the date 

15 of submission of an application for a grant under this sec16 tion— 

17 (1) the Secretary, acting through the Director 

18 of the National Institutes of Health, shall determine 

19 whether to award the grant; and 

20 (2) the Secretary acting through the Commis21 sioner of Food and Drugs (or by vesting authority 

22 in the participating clinical trial site, as applicable) 

23 shall make the determinations required of the Sec24 retary under subsection (b) or (c), as applicable, of 

25 section 561 of the Federal Food, Drug, and CosVerDate Sep 11 2014 20:05 Jun 20, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7071.IH H7071

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1 metic Act (21 U.S.C. 360bbb) for the provision of 

2 the investigational drug to occur. 

3 (d) DEFINITIONS.—In this section: 

4 (1) The term ‘‘Director’’ means the Director of 

5 the National Institutes of Health. 

6 (2) The term ‘‘eligible entity’’ means an entity 

7 that is— 

8 (A) a small business concern (as defined in 

9 section 3(a) of the Small Business Act (15 

10 U.S.C. 632(a))) that is the sponsor of a drug 

11 that is the subject of an investigational new 

12 drug application under section 505(i) of the 

13 Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 355(i)); or 

15 (B) a participating clinical trial site for 

16 such an applicant. 

17 (3) The term ‘‘participating clinical trial’’ 

18 means a phase 2 or phase 3 clinical trial conducted 

19 pursuant to an exemption under section 505(i) of 

20 the Federal Food, Drug, and Cosmetic Act (21 

21 U.S.C. 355(i)) or section 351(a) of the Public 

22 Health Service Act (42 U.S.C. 262(a)) to investigate 

23 a drug intended to treat amyotrophic lateral scle24 rosis or another rapidly progressing 

25 neurodegenerative disease. 


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1 (4) The term ‘‘participating clinical trial site’’ 

2 means a health care facility at which patients par3 ticipating in a participating clinical trial receive 

4 treatment through such trial. 

5 (5) The term ‘‘Secretary’’ means the Secretary 

6 of Health and Human Services. 

7 (e) FUNDING.— 

8 (1) AUTHORIZATION OF APPROPRIATIONS.— 

9 There are authorized to be appropriated to carry out 

10 this section— 

11 (A) $75,000,000 for each of fiscal years 

12 2021 and 2022; and 

13 (B) $150,000,000 for each of fiscal years 

14 2023 and 2024. 

15 (2) GIFTS, GRANTS, AND OTHER DONATIONS TO

16 FOUNDATION.— 

17 (A) ACCEPTANCE.—Pursuant to section 

18 499(c) of the Public Health Service Act (42 

19 U.S.C. 290b(c)), the Foundation for the Na20 tional Institutes of Health may solicit and ac21 cept gifts, grants, and other donations, estab22 lish accounts, and invest and expend funds in 

23 support of carrying out this section. 

24 (B) USE.—In addition to the amounts 

25 made available pursuant to the authorizations 


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1 of appropriations in paragraph (1), the Director 

2 may use, without further appropriation, any 

3 funds derived from a gift, grant, or other dona4 tion accepted pursuant to subparagraph (A). 

5 (f) REVIEW AND EXPANSION.—Not later than 18 

6 months after the date of the enactment of this Act— 

7 (1) the Secretary of Health and Human Serv8 ices shall convene an independent review panel that 

9 includes representatives of patients, researchers, 

10 drug sponsors, and government agencies; and 

11 (2) the independent review panel shall submit 

12 to the Committee on Energy and Commerce of the 

13 House of Representatives and the Committee on 

14 Health, Education, Labor, and Pensions of the Sen15 ate a report on the findings and conclusions of the 

16 panel with respect to the design and implementation 

17 of the program under this section for 2023 and 

18 2024. 

19 SEC. 3. FDA CENTER OF EXCELLENCE FOR 

20 NEURODEGENERATIVE DISEASES. 

21 Chapter X of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

23 end the following: 


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1 ‘‘SEC. 1015. CENTER OF EXCELLENCE FOR 

2 NEURODEGENERATIVE DISEASES. 

3 ‘‘(a) ESTABLISHMENT.—Not later than September 

4 2021, the Secretary shall establish within the Food and 

5 Drug Administration a center of excellence, to be known 

6 as the Center of Excellence for Neurodegenerative Dis7 eases (in this section referred to as the ‘Center of Excel8 lence’). 

9 ‘‘(b) DUTIES AND AUTHORITIES.—The Center of Ex10 cellence shall have duties and authorities similar to those 

11 of the Center of Excellence for Oncology established under 

12 section 1014, including the duties and authorities of the 

13 Center of Excellence for Oncology with respect to Project 

14 Facilitate.’’. 

Æ 


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