IB 

Union Calendar No. 148 

117TH CONGRESS 

1ST SESSION H. R. 3537 

[Report No. 117–207] 

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. CALVERT, 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. KILMER, 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 Commerce 


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DECEMBER 8, 2021 

Additional sponsors: Ms. SEWELL, Ms. SHERRILL, Mr. POSEY, Mr. COLE, Mr. 

CURTIS, Mr. CARSON, Mr. GONZALEZ of Ohio, Ms. CLARK of Massachusetts, Ms. HOULAHAN, Ms. NEWMAN, Mr. SMITH of New Jersey, Mr. 

LAHOOD, Mr. COSTA, Mr. SHERMAN, Mr. CHABOT, Mr. AGUILAR, Mrs. 

BEATTY, Ms. WASSERMAN SCHULTZ, Ms. DAVIDS of Kansas, Mr. HILL, 

Mrs. CAROLYN B. MALONEY of New York, Mr. VICENTE GONZALEZ of 

Texas, Ms. WEXTON, Mr. HUFFMAN, Mr. TONKO, Mrs. LURIA, Mr. 

BISHOP of Georgia, Mr. CORREA, Mr. KATKO, Mr. FOSTER, Ms. WILD, 

Mr. WOMACK, Ms. ROSS, Ms. LOIS FRANKEL of Florida, Mr. KELLER, 

Mr. STEWART, Mr. BROOKS, Mr. AUCHINCLOSS, Mr. WELCH, Mr. WILSON of South Carolina, Ms. SALAZAR, Mrs. TRAHAN, Ms. STEFANIK, Ms. 

MATSUI, Mr. CARTWRIGHT, Mr. YARMUTH, Mr. SCHNEIDER, Mr. 

DELGADO, Mr. WESTERMAN, Mr. GARCI ́A of Illinois, Ms. MANNING, Ms. 

PORTER, Mr. CRAWFORD, Mr. DEFAZIO, Mr. LANGEVIN, Miss RICE of 

New York, Mr. GOLDEN, Mr. SESSIONS, Mr. HARDER of California, Mr. 

LOWENTHAL, Mr. SOTO, Mr. RASKIN, Mr. JOYCE of Ohio, Mr. LAMBORN, 

Mr. JOHNSON of Georgia, Ms. BARRAGA ́N, Mr. DUNN, Mr. COURTNEY, 

Mr. CARTER of Louisiana, Mr. LUCAS, Mr. EMMER, Mr. GRAVES of Missouri, Ms. OMAR, Mr. PETERS, Ms. CRAIG, Mr. DANNY K. DAVIS of Illinois, Mr. BERA, Mr. BILIRAKIS, Ms. STRICKLAND, Mr. GIBBS, Mr. 

MEUSER, Mr. HIGGINS of New York, Mr. GALLAGHER, Mr. LAWSON of 

Florida, Mr. OWENS, Mrs. MILLER-MEEKS, Mr. CA ́RDENAS, Mr. 

WENSTRUP, Ms. JACOBS of California, Mr. PERLMUTTER, Mrs. 

HARTZLER, Mr. STAUBER, Mr. KRISHNAMOORTHI, Mr. KILDEE, Ms. 

SLOTKIN, Mr. SARBANES, Mr. GRIFFITH, Ms. SPANBERGER, Mr. MCGOVERN, Mr. KHANNA, Mr. MANN, Mr. BIGGS, Mr. SEAN PATRICK MALONEY

of New York, Mr. THOMPSON of Pennsylvania, Ms. DELBENE, Mr. NADLER, Ms. SA ́NCHEZ, Mr. MCNERNEY, Mrs. WATSON COLEMAN, Mrs. 

FLETCHER, Mr. MAST, Mr. STANTON, Mr. SMITH of Washington, Mr. 

WEBER of Texas, Ms. KELLY of Illinois, Mr. JONES, Mr. NEGUSE, Mr. 

KAHELE, Mr. HIMES, Mr. HUIZENGA, Mr. HIGGINS of Louisiana, Mr. 

BERGMAN, Mr. BALDERSON, Mr. DAVID SCOTT of Georgia, Mr. ADERHOLT, Mr. ARMSTRONG, Mr. DESJARLAIS, Mr. MOORE of Alabama, Mr. 

SCHIFF, Mr. THOMPSON of Mississippi, Mrs. KIM of California, Mr. 

FEENSTRA, Ms. ADAMS, Mr. KELLY of Mississippi, Mr. ALLRED, Mr. 

COHEN, Mr. BROWN of Maryland, Mr. JOHNSON of Ohio, Mrs. MURPHY

of Florida, Mr. LUETKEMEYER, Ms. WILLIAMS of Georgia, Mr. GOSAR, 

Mr. TIFFANY, Mr. CASTEN, Ms. CHENEY, Mrs. HAYES, Mr. JEFFRIES, 

Mr. SMUCKER, Ms. LOFGREN, Mr. HERN, Ms. TENNEY, Ms. BONAMICI, 

Mrs. STEEL, Mr. GARBARINO, Mr. NORCROSS, Ms. ESCOBAR, Mrs. 

CAMMACK, Mr. GOMEZ, Mr. TORRES of New York, Mr. BOWMAN, Ms. 

TLAIB, Ms. BASS, Ms. WILSON of Florida, Ms. CLARKE of New York, 

Mr. LEVIN of Michigan, Ms. STEVENS, Ms. LEGER FERNANDEZ, Ms. 

WATERS, Mr. KIND, Mr. CUELLAR, Mr. PHILLIPS, Mr. HAGEDORN, Mr. 

PALAZZO, Ms. BLUNT ROCHESTER, Mr. MOORE of Utah, Mr. BLUMENAUER, Ms. GRANGER, Ms. JAYAPAL, Mr. HORSFORD, Mr. CLINE, Ms. 

SPEIER, Mr. CARL, Mr. CAWTHORN, Mr. MURPHY of North Carolina, Mr. 

OBERNOLTE, Mr. KELLY of Pennsylvania, Mr. SCALISE, Ms. 

MALLIOTAKIS, Mr. EVANS, Mr. ZELDIN, Mr. SIMPSON, Mr. STEUBE, Mr. 


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JOHNSON of Louisiana, Mr. LOUDERMILK, Mrs. HINSON, Mr. 

LATURNER, Ms. BOURDEAUX, Ms. JOHNSON of Texas, Mr. CASE, Mr. 

JACOBS of New York, Mrs. BICE of Oklahoma, Mrs. WAGNER, Mr. 

GOODEN of Texas, Mr. HARRIS, Mr. JACKSON, Mr. MOONEY, Mr. BURGESS, Ms. LETLOW, Mr. UPTON, Ms. SCHRIER, Mr. BUTTERFIELD, Mr. 

BENTZ, Mrs. FISCHBACH, Mr. GRAVES of Louisiana, Mr. WALBERG, Mr. 

GOOD of Virginia, Mrs. TORRES of California, Mr. PAPPAS, Mrs. 

MCCLAIN, Mr. GUEST, Mr. C. SCOTT FRANKLIN of Florida, Mr. GOHMERT, Mr. ROUZER, Mr. BOST, Mr. WILLIAMS of Texas, Mr. BANKS, 

Mrs. LAWRENCE, Mr. CRIST, Ms. CASTOR of Florida, Ms. ESHOO, Mr. 

CRENSHAW, and Mr. NEWHOUSE


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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, investigational drugs for amyotrophic lateral sclerosis, and for 

other purposes. 


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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 to 

5 Critical Therapies for ALS Act’’. 

6 SEC. 2. GRANTS FOR RESEARCH ON THERAPIES FOR ALS. 

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

8 Human Services (referred to in this section as the ‘‘Sec9 retary’’) shall award grants to participating entities for 

10 purposes of scientific research utilizing data from expanded 

11 access to investigational drugs for individuals who are not 

12 otherwise eligible for clinical trials for the prevention, diag13 nosis, mitigation, treatment, or cure of amyotrophic lateral 

14 sclerosis. In the case of a participating entity seeking such 

15 a grant, an expanded access request must be submitted, and 

16 allowed to proceed by the Secretary, under section 561 of 

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

18 360bbb) and part 312 of title 21, Code of Federal Regula19 tions (or any successor regulations), before the application 

20 for such grant is submitted. 

21 (b) APPLICATION.— 

22 (1) IN GENERAL.—A participating entity seeking 

23 a grant under this section shall submit to the Sec24 retary an application at such time, in such manner, 


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1 and containing such information as the Secretary 

2 shall specify. 

3 (2) USE OF DATA.—An application submitted 

4 under paragraph (1) shall include a description of 

5 how data generated through an expanded access re6 quest under section 561 of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 360bbb) with respect to 

8 the investigational drug involved will be used to sup9 port research or development related to the preven10 tion, diagnosis, mitigation, treatment, or cure of 

11 amyotrophic lateral sclerosis. 

12 (3) NONINTERFERENCE WITH CLINICAL

13 TRIALS.—An application submitted under paragraph 

14 (1) shall include a description of how the proposed ex15 panded access program will be designed so as not to 

16 interfere with patient enrollment in ongoing clinical 

17 trials for investigational therapies for the prevention, 

18 diagnosis, mitigation, treatment, or cure of 

19 amyotrophic lateral sclerosis. 

20 (c) SELECTION.—Consistent with sections 406 and 492 

21 of the Public Health Service Act (42 U.S.C. 284a, 289a), 

22 the Secretary shall, in determining whether to award a 

23 grant under this section, confirm that— 

24 (1) such grant will be used to support a sci25 entific research objective relating to the prevention, 


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1 diagnosis, mitigation, treatment, or cure of 

2 amyotrophic lateral sclerosis (as described in sub3 section (a)); 

4 (2) such grant shall not have the effect of dimin5 ishing eligibility for, or impeding enrollment of, ongo6 ing clinical trials for the prevention, diagnosis, miti7 gation, treatment, or cure of amyotrophic lateral scle8 rosis by determining that individuals who receive ex9 panded access to investigational drugs through such a 

10 grant are not eligible for enrollment in— 

11 (A) ongoing clinical trials that are reg12 istered on ClinicalTrials.gov (or successor 

13 website), with respect to a drug for the preven14 tion, diagnosis, mitigation, treatment, or cure of 

15 amyotrophic lateral sclerosis; or 

16 (B) clinical trials for the prevention, diag17 nosis, mitigation, treatment, or cure of 

18 amyotrophic lateral sclerosis for which an ex19 emption under section 505(i) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) 

21 has been granted by the Food and Drug Admin22 istration and which are expected to begin enroll23 ment within one year; and 


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1 (3) the resulting project funded by such grant 

2 will allow for equitable access to investigational drugs 

3 by minority and underserved populations. 

4 (d) USE OF FUNDS.—A participating entity shall use 

5 funds received through the grant— 

6 (1) to pay the manufacturer or sponsor for the 

7 direct costs of the investigational drug, as authorized 

8 under section 312.8(d) of title 21, Code of Federal 

9 Regulations (or successor regulations), to prevent, di10 agnose, mitigate, treat, or cure amyotrophic lateral 

11 sclerosis that is the subject of an expanded access re12 quest described in subsection (a), if such costs are jus13 tified as part of peer review of the grant; 

14 (2) for the entity’s direct costs incurred in pro15 viding such drug consistent with the research mission 

16 of the grant; or 

17 (3) for the direct and indirect costs of the entity 

18 in conducting research with respect to such drug. 

19 (e) DEFINITIONS.—In this section: 

20 (1) The term ‘‘participating entity’’ means a 

21 participating clinical trial site or sites sponsored by 

22 a small business concern (as defined in section 3(a) 

23 of the Small Business Act (15 U.S.C. 632(a))) that is 

24 the sponsor of a drug that is the subject of an inves25 tigational new drug application under section 505(i) 


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1 of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 355(i)) to prevent, diagnose, mitigate, treat, or 

3 cure amyotrophic lateral sclerosis. 

4 (2) The term ‘‘participating clinical trial’’ 

5 means a phase 3 clinical trial conducted pursuant to 

6 an exemption under section 505(i) of the Federal 

7 Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or 

8 section 351(a) of the Public Health Service Act (42 

9 U.S.C. 262(a)) to investigate a drug intended to pre10 vent, diagnose, mitigate, treat, or cure amyotrophic 

11 lateral sclerosis. 

12 (3) The term ‘‘participating clinical trial site’’ 

13 means a health care facility, or network of facilities, 

14 at which patients participating in a participating 

15 clinical trial receive an investigational drug through 

16 such trial. 

17 (f) SUNSET.—The Secretary may not award grants 

18 under this section on or after September 30, 2026. 

19 SEC. 3. HHS PUBLIC-PRIVATE PARTNERSHIP FOR RARE 

20 NEURODEGENERATIVE DISEASES. 

21 (a) ESTABLISHMENT.—Not later than one year after 

22 the date of enactment of this Act, the Secretary of Health 

23 and Human Services (referred to in this section as the ‘‘Sec24 retary’’) shall establish and implement a Public-Private 

25 Partnership for Neurodegenerative Diseases between the NaVerDate Sep 11 2014 02:09 Dec 09, 2021 Jkt 029200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H3537.RH H3537

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1 tional Institutes of Health, the Food and Drug Administra2 tion, and one or more eligible entities (to be known and 

3 referred to in this section as the ‘‘Partnership’’) through 

4 cooperative agreements, contracts, or other appropriate 

5 mechanisms with such eligible entities, for the purpose of 

6 advancing the understanding of neurodegenerative diseases 

7 and fostering the development of treatments for amytrophic 

8 lateral sclerosis and other rare neurodegenerative diseases. 

9 The Partnership shall— 

10 (1) establish partnerships and consortia with 

11 other public and private entities and individuals with 

12 expertise in amyotrophic lateral sclerosis and other 

13 rare neurodegenerative diseases for the purposes de14 scribed in this subsection; 

15 (2) focus on advancing regulatory science and 

16 scientific research that will support and accelerate the 

17 development and review of drugs for patients with 

18 amyotrophic lateral sclerosis and other rare 

19 neurodegenerative diseases; and 

20 (3) foster the development of effective drugs that 

21 improve the lives of people that suffer from 

22 amyotrophic lateral sclerosis and other rare 

23 neurodegenerative diseases. 

24 (b) ELIGIBLE ENTITY.—In this section, the term ‘‘eli25 gible entity’’ means an entity that— 


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1 (1) is— 

2 (A) an institution of higher education (as 

3 such term is defined in section 1001 of the High4 er Education Act of 1965 (20 U.S.C. 1001)) or 

5 a consortium of such institutions; or 

6 (B) an organization described in section 

7 501(c)(3) of the Internal Revenue Code of 1986 

8 and exempt from tax under subsection (a) of 

9 such section; 

10 (2) has experienced personnel with clinical and 

11 other technical expertise in the field of biomedical 

12 sciences and demonstrated connection to the patient 

13 population; 

14 (3) demonstrates to the Secretary’s satisfaction 

15 that the entity is capable of identifying and estab16 lishing collaborations between public and private en17 tities and individuals with expertise in 

18 neurodegenerative diseases, including patients, in 

19 order to facilitate— 

20 (A) development and critical evaluation of 

21 tools, methods, and processes— 

22 (i) to characterize neurodegenerative 

23 diseases and their natural history; 

24 (ii) to identify molecular targets for 

25 neurodegenerative diseases; and 


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1 (iii) to increase efficiency, predict2 ability, and productivity of clinical develop3 ment of therapies, including advancement of 

4 rational therapeutic development and estab5 lishment of clinical trial networks; and 

6 (B) securing funding for the Partnership 

7 from Federal and non-Federal governmental 

8 sources, foundations, and private individuals; 

9 and 

10 (4) provides an assurance that the entity will 

11 not accept funding for a Partnership project from 

12 any organization that manufactures or distributes 

13 products regulated by the Food and Drug Adminis14 tration unless the entity provides assurances in its 

15 agreement with the Secretary that the results of the 

16 project will not be influenced by any source of fund17 ing. 

18 (c) GIFTS.— 

19 (1) IN GENERAL.—The Partnership may solicit 

20 and accept gifts, grants, and other donations, estab21 lish accounts, and invest and expend funds in support 

22 of basic research and research associated with phase 

23 3 clinical trials conducted with respect to investiga24 tional drugs that are the subjects of expanded access 


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1 requests under section 561 of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 360bbb). 

3 (2) USE.—In addition to any amounts appro4 priated for purposes of carrying out this section, the 

5 Partnership may use, without further appropriation, 

6 any funds derived from a gift, grant, or other dona7 tion accepted pursuant to paragraph (1). 

8 SEC. 4. ALS AND OTHER RARE NEURODEGENERATIVE DIS9 EASE ACTION PLAN. 

10 (a) IN GENERAL.—Not later than 6 months after the 

11 date of enactment of this Act, the Commissioner of Food 

12 and Drugs shall publish on the website of the Food and 

13 Drug Administration an action plan describing actions the 

14 Food and Drug Administration intends to take during the 

15 5-year period following publication of the plan with respect 

16 to program enhancements, policy development, regulatory 

17 science initiatives, and other appropriate initiatives to— 

18 (1) foster the development of safe and effective 

19 drugs that improve or extend, or both, the lives of peo20 ple living with amyotrophic lateral sclerosis and other 

21 rare neurodegenerative diseases; and 

22 (2) facilitate access to investigational drugs for 

23 amyotrophic lateral sclerosis and other rare 

24 neurodegenerative diseases. 


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1 (b) CONTENTS.—The initial action plan published 

2 under subsection (a) shall— 

3 (1) identify appropriate representation from 

4 within the Food and Drug Administration to be re5 sponsible for implementation of such action plan; 

6 (2) include elements to facilitate— 

7 (A) interactions and collaboration between 

8 the Food and Drug Administration, including 

9 the review centers thereof, and stakeholders in10 cluding patients, sponsors, and the external bio11 medical research community; 

12 (B) consideration of cross-cutting clinical 

13 and regulatory policy issues, including consist14 ency of regulatory advice and decisionmaking; 

15 (C) identification of key regulatory science 

16 and policy issues critical to advancing develop17 ment of safe and effective drugs; and 

18 (D) enhancement of collaboration and en19 gagement of the relevant centers and offices of the 

20 Food and Drug Administration with other oper21 ating divisions within the Department of Health 

22 and Human Services, the Partnership, and the 

23 broader neurodegenerative disease community; 

24 and 


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1 (3) be subject to revision, as determined appro2 priate by the Secretary of Health and Human Serv3 ices. 

4 SEC. 5. FDA RARE NEURODEGENERATIVE DISEASE GRANT 

5 PROGRAM. 

6 The Secretary of Health and Human Services, acting 

7 through the Commissioner of Food and Drugs, shall award 

8 grants and contracts to public and private entities to cover 

9 the costs of research on, and development of interventions 

10 intended to prevent, diagnose, mitigate, treat, or cure, 

11 amyotrophic lateral sclerosis and other rare 

12 neurodegenerative diseases in adults and children, includ13 ing costs incurred with respect to the development and crit14 ical evaluation of tools, methods, and processes— 

15 (1) to characterize such neurodegenerative dis16 eases and their natural history; 

17 (2) to identify molecular targets for such 

18 neurodegenerative diseases; and 

19 (3) to increase efficiency and productivity of 

20 clinical development of therapies, including through— 

21 (A) the use of master protocols and adaptive 

22 and add-on clinical trial designs; and 

23 (B) efforts to establish new or leverage exist24 ing clinical trial networks. 


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1 SEC. 6. GAO REPORT. 

2 Not later than 4 years after the date of the enactment 

3 of this Act, the Comptroller General of the United States 

4 shall submit to the Committee on Energy and Commerce 

5 of the House of Representatives and the Committee on 

6 Health, Education, Labor, and Pensions of the Senate a 

7 report containing— 

8 (1) with respect to grants awarded under the 

9 program established under section 2— 

10 (A) an analysis of what is known about the 

11 impact of such grants on research or development 

12 related to the prevention, diagnosis, mitigation, 

13 treatment, or cure of amyotrophic lateral scle14 rosis; and 

15 (B) data concerning such grants, includ16 ing— 

17 (i) the number of grants awarded; 

18 (ii) the participating entities to whom 

19 grants were awarded; 

20 (iii) the value of each such grant; 

21 (iv) a description of the research each 

22 such grant was used to further; 

23 (v) the number of patients who received 

24 expanded access to an investigational drug 

25 to prevent, diagnose, mitigate, treat, or cure 


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1 amyotrophic lateral sclerosis under each 

2 grant; 

3 (vi) whether the investigational drug 

4 that was the subject of such a grant was ap5 proved by the Food and Drug Administra6 tion; and 

7 (vii) the average number of days be8 tween when a grant application is sub9 mitted and when a grant is awarded; and 

10 (2) with respect to grants awarded under the 

11 program established under section 5— 

12 (A) an analysis of what is known about the 

13 impact of such grants on research or development 

14 related to the prevention, diagnosis, mitigation, 

15 treatment, or cure of amyotrophic lateral scle16 rosis; 

17 (B) an analysis of what is known about 

18 how such grants increased efficiency and produc19 tivity of the clinical development of therapies, 

20 including through the use of clinical trials that 

21 operated with common master protocols, or had 

22 adaptive or add-on clinical trial designs; and 

23 (C) data concerning such grants, includ24 ing— 

25 (i) the number of grants awarded; 


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1 (ii) the participating entities to whom 

2 grants were awarded; 

3 (iii) the value of each such grant; 

4 (iv) a description of the research each 

5 such grant was used to further; and 

6 (v) whether the investigational drug 

7 that was the subject of such a grant received 

8 approval by the Food and Drug Adminis9 tration. 

10 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

11 For purposes of carrying out this Act, there are author12 ized to be appropriated $100,000,000 for each of fiscal years 

13 2022 through 2026. 


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Union Calendar No. 148 

117TH CONGRESS 

1ST SESSION H. R. 3537 

[Report No. 117–207] 

A BILL 

To direct the Secretary of Health and Human 

lateral sclerosis, and for other purposes. access to, investigational drugs for amyotrophic Services to support research on, and expanded 

DECEMBER 8, 2021 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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