H.R. 8205 – Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026

AI-Generated Summary

Updated October 9, 2026 at 3:41 AM UTC

The Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 extends the original ALS research and grant program through fiscal year 2031. It updates grant requirements, safety reporting, and the definition of clinical trial phases, and it directs the FDA to create and later report on a five‑year action plan for rare neurodegenerative diseases. The changes affect researchers, drug manufacturers, grant‑making institutions, and the FDA.

Key Provisions

Extends the expiration dates in the original ALS Act and its grant provisions from 2026 to 2031.
Requires the Secretary, when reviewing grant renewals for investigational drugs, to obtain and assess enrollment, safety, and any efficacy data from the drug’s sponsor.
Adds a requirement that grant recipients promptly report any new serious adverse events from phase 3 trials to the grant‑making institution, in addition to existing FDA safety reporting rules.
Expands the definition of a “phase 3” trial to include phase 2/3 combined trials that start enrollment within a timeframe set by the Secretary.
Renames the FDA action plan to focus on rare neurodegenerative diseases and mandates the FDA commissioner to publish a five‑year action plan within 18 months of enactment and a progress report after five years.

Legislative Activity

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19 earlier actions

SenateFloor Latest Action

Message on Senate action sent to the House.

October 14, 2026

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HouseIntro Referral

Introduced in House

April 6, 2026

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

April 6, 2026

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

April 6, 2026

HouseCommittee

Subcommittee Consideration and Mark-up Session Held

Health Subcommittee

May 13, 2026

HouseCommittee

Forwarded by Subcommittee to Full Committee by Voice Vote.

Health Subcommittee

May 13, 2026

HouseCommittee

Committee Consideration and Mark-up Session Held

Energy and Commerce Committee

May 21, 2026

HouseCommittee

Ordered to be Reported (Amended) by the Yeas and Nays: 46 - 0.

Energy and Commerce Committee

May 21, 2026

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 119-733.

Energy and Commerce Committee

July 9, 2026

HouseCalendars

Placed on the Union Calendar, Calendar No. 637.

July 9, 2026

HouseFloor

Mr. Guthrie moved to suspend the rules and pass the bill, as amended.

July 20, 2026 • 4:12 PM

HouseFloor

Considered under suspension of the rules. (consideration: CR H4652-4654; text: CR H4653)

July 20, 2026 • 4:12 PM

HouseFloor

DEBATE - The House proceeded with forty minutes of debate on H.R. 8205.

July 20, 2026 • 4:12 PM

HouseFloor

At the conclusion of debate, the chair put the question on the motion to suspend the rules. Mr. Guthrie objected to the vote on the grounds that a quorum was not present. Further proceedings on the motion were postponed. The point of no quorum was considered as withdrawn.

July 20, 2026 • 4:21 PM

HouseFloor

Considered as unfinished business. (consideration: CR H5159)

July 22, 2026 • 5:01 PM

HouseFloor

Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

July 22, 2026 • 5:01 PM

HouseFloor

On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

July 22, 2026 • 5:01 PM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

July 22, 2026 • 5:01 PM

SenateCalendars

Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 466.

July 23, 2026

SenateFloor

Passed Senate without amendment by Voice Vote. (consideration: CR S5120)

September 28, 2026

SenateFloor

Message on Senate action sent to the House.

October 14, 2026

Floor Debate

6 members

What members said about H.R. 8205 on the floor

+1

4 Republicans2 Democrats

Rep. Monica De La CruzR-TX-15 · Jul 9, 2026

Under clause 7 of rule XII, sponsors were added to public bills and resolutions, as follows: H.R. 7: Mr. Van Epps. H.R. 138: Ms. Norton, Ms. Hoyle of Oregon, and Mr. Calvert. H.R. 491: Ms. Wilson of…

Under clause 7 of rule XII, sponsors were added to public

bills and resolutions, as follows:

H.R. 7: Mr. Van Epps.

H.R. 138: Ms. Norton, Ms. Hoyle of Oregon, and Mr. Calvert.

H.R. 491: Ms. Wilson of Florida.

H.R. 516: Mr. Mullin.

H.R. 569: Ms. Fedorchak.

H.R. 614: Mr. Lawler.

H.R. 652: Ms. Moore of Wisconsin.

H.R. 1055: Mr. Costa and Mr. Keating.

H.R. 1065: Ms. Garcia of Texas.

H.R. 1105: Mr. Gallagher.

H.R. 1106: Mr. Riley of New York.

H.R. 1138: Ms. Salazar.

H.R. 1189: Ms. Clarke of New York.

H.R. 1227: Mr. Himes and Mr. Rulli.

H.R. 1229: Mr. Van Epps.

H.R. 1340: Mr. Obernolte.

H.R. 1589: Mr. Pappas.

H.R. 1685: Ms. DelBene.

H.R. 1700: Ms. McCollum.

H.R. 1782: Mr. Case.

H.R. 1787: Ms. Tlaib, Mr. Levin, Mr. Mrvan, Mr. Ivey, Mr.

Pocan, and Mr. Menefee.

H.R. 1946: Mr. Higgins of Louisiana.

H.R. 1970: Mr. Van Orden.

H.R. 2002: Mr. Fitzpatrick.

H.R. 2028: Mr. Torres of New York.

H.R. 2089: Mr. Timmons, Mr. Van Epps, Mrs. Fischbach, and

Ms. De La Cruz.

H.R. 2120: Ms. Perez.

H.R. 2245: Mr. Carson.

H.R. 2305: Mr. Thompson of Pennsylvania and Mr. Magaziner.

H.R. 2332: Mr. Carey.

H.R. 2350: Mr. Thompson of Pennsylvania.

H.R. 2414: Ms. McBride.

H.R. 2509: Mr. Langworthy.

H.R. 2531: Mr. Costa, Ms. Schrier, Mr. Norcross, and Mr.

Van Orden.

H.R. 2587: Mr. Figures.

H.R. 2678: Mr. Garcia of Illinois, Mrs. McIver, and Mr.

Conaway.

H.R. 2767: Mr. Lynch.

H.R. 2859: Ms. Ross.

H.R. 2936: Mrs. Foushee, Mr. Carbajal, and Mr. Amo.

H.R. 3045: Mr. Riley of New York and Mr. Whitesides.

H.R. 3057: Mr. Hunt.

H.R. 3105: Mr. Fitzgerald.

H.R. 3111: Mr. Pallone.

H.R. 3184: Mr. Crow and Mrs. Grijalva.

H.R. 3199: Mrs. Kim.

H.R. 3206: Mr. Cuellar.

H.R. 3223: Ms. Perez.

H.R. 3243: Mr. Cohen, Mr. Gomez, Mr. Espaillat, Mr. Casar,

Mrs. Foushee, Mr. Case, Ms. Clarke of New York, Ms.

Pettersen, Mr. Castro of Texas, Ms. Brown, and Ms. Meng.

H.R. 3295: Mrs. Kim.

H.R. 3307: Mr. Thanedar, Mr. Mackenzie, and Mr. Buchanan.

H.R. 3310: Mr. Moskowitz.

H.R. 3505: Mr. Amo.

H.R. 3644: Mr. Subramanyam.

H.R. 3821: Mr. Riley of New York.

H.R. 3906: Ms. Williams of Georgia.

H.R. 4092: Mr. Fulcher.

H.R. 4119: Mr. DesJarlais and Mr. Van Epps.

H.R. 4180: Mr. Beyer.

H.R. 4443: Mr. Larson of Connecticut.

H.R. 4487: Ms. Waters.

H.R. 4525: Mr. Deluzio.

H.R. 4620: Ms. De La Cruz.

H.R. 4696: Ms. Crockett and Mr. Torres of New York.

H.R. 4763: Mr. Raskin.

H.R. 4876: Ms. Scholten, Mr. Frost, and Mr. Crow.

H.R. 4881: Mr. Case.

H.R. 4958: Ms. Schrier.

H.R. 5106: Mr. Gallagher and Mr. Hamadeh of Arizona.

H.R. 5199: Mr. Nunn of Iowa.

H.R. 5203: Ms. Stansbury.

H.R. 5335: Mr. Gimenez.

H.R. 5448: Mr. McGovern.

H.R. 5463: Mr. Onder.

H.R. 5486: Mr. Pallone and Mrs. Fletcher.

H.R. 5521: Ms. Salinas.

H.R. 5543: Mr. Raskin.

H.R. 5549: Mrs. Spartz and Mr. Fulcher.

H.R. 5731: Mr. Figures.

H.R. 5791: Mr. Carbajal and Ms. Meng.

H.R. 6056: Mr. Correa, Mr. Meeks, and Ms. Williams of

Georgia.

H.R. 6130: Mr. Gray, Mr. Mrvan, Mr. Raskin, Mr. Larson of

Connecticut, Mrs. Ramirez, Mr. Schneider, Mr. Costa, Mr.

Garbarino, Mr. Rouzer, and Ms. McClellan.

H.R. 6181: Mr. Cisneros and Mr. Harder of California.

H.R. 6509: Mr. Mrvan.

H.R. 6520: Mr. Messmer.

H.R. 6529: Mr. Vindman.

H.R. 6574: Ms. Goodlander.

H.R. 6610: Mr. McCormick.

H.R. 6617: Ms. Hoyle of Oregon.

H.R. 6677: Ms. Hoyle of Oregon and Mr. Amo.

H.R. 6682: Mr. Riley of New York.

H.R. 6694: Ms. Velazquez and Ms. Ocasio-Cortez.

H.R. 6718: Mr. Carson.

H.R. 6766: Mr. Landsman and Mr. Obernolte.

H.R. 6806: Mr. Olszewski and Mr. Amo.

H.R. 6832: Mr. Feenstra.

H.R. 6849: Mr. Costa.

H.R. 7016: Mr. Beyer, Mr. Raskin, and Ms. Simon.

H.R. 7411: Mr. Carson.

H.R. 7539: Mr. Gallagher, Mr. Fine, Mrs. Miller of

Illinois, and Mr. Stauber.

H.R. 7601: Ms. Ocasio-Cortez.

H.R. 7622: Mr. Carson and Mr. Amo.

H.R. 7625: Mr. Garamendi.

H.R. 7651: Mr. Alford, Mr. Austin Scott of Georgia, and Ms.

Boebert.

H.R. 7905: Mr. Bacon.

H.R. 7945: Mr. Kustoff.

H.R. 7961: Ms. Houlahan and Mr. Amo.

H.R. 7977: Mr. Norcross.

H.R. 7986: Ms. Lofgren.

H.R. 7998: Ms. Norton.

H.R. 8016: Ms. Wasserman Schultz.

H.R. 8045: Mr. Scott of Virginia.

H.R. 8073: Mr. Figures.

H.R. 8162: Mr. Lawler.

H.R. 8200: Mr. Bost.

H.R. 8205: Mrs. Miller of West Virginia, Mrs. Hayes, Mr.

Latimer, Mr. Davis of North Carolina, Ms. McBride, Mr. Riley

of New York, Mr. Conaway, Ms. Stansbury, Ms. Ross, Ms.

Pingree, Mr. Himes, Mrs. Watson Coleman, Mr. Casten, Mr.

Landsman, Mrs. Grijalva, Ms. Mejia, Mr. Larson of

Connecticut, Mr. Sorensen, Mr. Peters, Mr. Jackson of

Illinois, Ms. Adams, Ms. Budzinski, Mrs. Beatty, Mr.

Magaziner, Ms. Kaptur, Mr. Carter of Louisiana, Mr. Suozzi,

and Ms. Scanlon.

H.R. 8271: Ms. Tenney.

H.R. 8330: Mr. Gallagher.

H.R. 8373: Mrs. Grijalva.

H.R. 8375: Mr. Carter of Louisiana, Ms. Budzinski, and Mr.

Ciscomani.

H.R. 8411: Mr. Johnson of Georgia.

H.R. 8465: Mr. Keating.

H.R. 8468: Mr. Hunt.

H.R. 8490: Mr. Carson.

H.R. 8501: Mr. Figures and Mr. Thompson of California.

H.R. 8600: Mr. Whitesides.

H.R. 8666: Mr. DeSaulnier, Ms. Friedman, and Mr. Tran.

H.R. 8691: Mr. Carson and Mr. Costa.

H.R. 8730: Mrs. Miller of West Virginia, Ms. Crockett, and

Mr. Mrvan.

H.R. 8839: Mr. Moskowitz.

H.R. 8887: Mr. Neguse.

H.R. 8892: Mr. Carey.

H.R. 8898: Ms. McBride and Mrs. Miller-Meeks.

H.R. 8909: Ms. Velazquez.

H.R. 8939: Ms. Waters.

H.R. 8955: Mr. Crow.

H.R. 8979: Mr. Figures.

H.R. 8982: Mr. Suozzi, Ms. Simon, and Mr. Subramanyam.

H.R. 8990: Mr. Moran.

H.R. 9021: Mr. Thanedar, Ms. Titus, and Mrs. McIver.

H.R. 9032: Ms. Waters and Ms. Crockett.

H.R. 9043: Mr. McDowell.

H.R. 9048: Mr. Riley of New York, Mrs. Kiggans of Virginia,

and Mr. Weber of Texas.

H.R. 9129: Ms. Salinas.

H.R. 9169: Mr. Van Drew.

H.R. 9183: Ms. Crockett.

H.R. 9189: Ms. Tlaib.

H.R. 9199: Mr. Norman.

H.R. 9204: Ms. Chu.

H.R. 9205: Ms. Chu.

H.R. 9211: Mr. Buchanan and Mr. Bell.

H.R. 9216: Mr. Cohen and Ms. Waters.

H.R. 9250: Mr. Garbarino, Ms. DelBene, Mr. Moore of West

Virginia, Mr. Garcia of California, Mr. Harrigan, Mr. Levin,

Mr. Flood, Ms. Chu, Mr. Meuser, and Ms. Crockett.

H.R. 9289: Mr. Vindman.

H.R. 9293: Mr. Evans of Colorado and Mr. Mackenzie.

H.R. 9332: Mr. Vindman.

H.R. 9339: Mr. Vindman.

H.R. 9361: Mr. Finstad and Mr. Jackson of Texas.

H.R. 9370: Ms. Brown and Ms. Scholten.

H.R. 9371: Mr. Frost.

H.R. 9382: Mr. Mannion and Ms. Tenney.

H.R. 9401: Mr. Lawler, Mr. Crow, and Ms. DelBene.

H.R. 9411: Mr. Fitzpatrick.

H.R. 9414: Mr. Vindman, Mr. Cisneros, Mr. Keating, and Ms.

McBride.

H.R. 9417: Mr. Moylan, Mr. Haridopolos, Mr. Rogers of

Kentucky, and Mr. McDowell.

H.R. 9421: Ms. Tenney and Mr. Steube.

H.R. 9441: Ms. Dexter and Mr. Tonko.

H.R. 9448: Ms. Ross, Mr. Lieu, and Mr. Nadler.

H.R. 9451: Mr. Fitzpatrick.

H.R. 9492: Mr. Fitzpatrick.

H.R. 9508: Mr. Fitzpatrick.

H.R. 9535: Mr. Van Drew.

H.R. 9580: Mr. Messmer.

H.R. 9591: Ms. Crockett, Mr. Evans of Pennsylvania, Ms.

Williams of Georgia, Ms. Underwood, Ms. Simon, Ms. Wilson of

Florida, and Ms. Chu.

H.J. Res. 12: Mr. Ciscomani.

H.J. Res. 135: Mr. Whitesides.

H.J. Res. 200: Mr. Menendez and Mr. Pallone.

H. Con. Res. 37: Mr. Tonko, Ms. Bonamici, and Mrs. Foushee.

H. Con. Res. 44: Ms. Pingree, Ms. Garcia of Texas, Mr.

Vargas, Ms. Wasserman Schultz, Mr. Krishnamoorthi, and Mr.

Pocan.

H. Res. 547: Ms. Waters.

H. Res. 1025: Ms. Waters.

H. Res. 1382: Mrs. Biggs of South Carolina.

H. Res. 1384: Mr. Bell, Ms. Brown, Mr. Garcia of Illinois,

Mrs. Beatty, Ms. Norton, Mrs. McIver, Mr. Goldman of New

York, Mr. Castro of Texas, Ms. Strickland, Mr. Davis of

Illinois, Ms. Barragan, Ms. Mejia, Mr. Conaway, Mr. Takano,

Mr. Menefee, Ms. Salinas, Mrs. Foushee, Ms. Chu, Mr. Cohen,

and Mr. Gomez.

H. Res. 1395: Mr. Fields.

H. Res. 1415: Mr. DeSaulnier and Ms. Jayapal.

H. Res. 1420: Ms. Underwood and Ms. Bynum.

Rep. Mike QuigleyD-IL-5 · Jul 20, 2026

Mr. Speaker, I thank the gentlewoman from Colorado for her kind remarks. Mr. Speaker, several years ago, a Chicagoan named Brian Wallach came to my office and shared the fact that he was just…

Mr. Speaker, I thank the gentlewoman from Colorado for her kind remarks.

Mr. Speaker, several years ago, a Chicagoan named Brian Wallach came to my office and shared the fact that he was just diagnosed with ALS, a devastating disease that steals a person's ability to move or speak.

The average life expectancy at the time with someone diagnosed with ALS was 2 to 5 years. When Brian came to visit us in Congress, that was the reality he was facing.

He cofounded an organization called I AM ALS with his wife, Sandra Abrevaya. Sandra's life changed overnight, too when she became an ALS caretaker. Since then, she cofounded a company to improve the care of people living with ALS.

This awe-inspiring couple came to my office with a big idea to advance ALS research and access to treatments. After meeting with Brian and Sandra, I was convinced that ALS was not incurable. The research was just underfunded. I was moved by their dedication to each other and the cause.

Like too many families across the country, my family has been touched by neurodegenerative disease. I lost my father to Parkinson's. However, since I started working on the first Accelerating Access to Critical Therapies for ALS Act, there hasn't been one Member of Congress whom I talked to who didn't have a personal story or know the impact of one of these diseases.

Our bipartisan work on the first Accelerating Access to Critical Therapies for ALS Act broke through the bitter politics that can divide this place. I believe we have the opportunity to do that again today.

In the last 5 years, ACT for ALS programs have helped people living with ALS to access promising therapies. They have created new methods for researchers to share their work and sustain critical natural history studies.

Since we passed the first bill 5 years ago, we have been able to secure over $350 million in Federal funding for these programs. Today, we are voting on a bill to extend these programs for 5 more years.

To everyone living with ALS who has advocated for this bill, I hope today's vote shows that Congress hears you and we are here for you and that, every once in a while, we break through. At those moments, I am proud to serve here.

To Brian who is still with us fighting the disease and Sandra: Thank you for your tireless advocacy and big dreams.

Finally, I thank Representative Ken Calvert for his work on this with me in the House, and Senators Chris Coons and Lisa Murkowski for their work in the Senate.

Mr. Speaker, I urge my colleagues to vote ``yes.''

Rep. Brett GuthrieR-KY-2 · Jul 20, 2026

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 8205) to amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year…

Mr. Speaker, I move to suspend the rules and pass the bill

(H.R. 8205) to amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks on the legislation and to include extraneous material on H.R. 8205.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in strong support of H.R. 8205 led by my colleagues, Representative Quigley and Representative Calvert.

H.R. 8205 reauthorizes the Accelerating Access to Critical Therapies for ALS Reauthorization Act, which has supported critical research and development for ALS therapies. The ACT for ALS program has worked to expand access to key therapies for both individuals with ALS and those with other rare neurodegenerative conditions. It is imperative that we pass this bill today to continue advancing research and therapeutic development in the fight against this disease.

To my fellow Americans living with ALS and their caregivers, Mr. Speaker, I want to take a moment to let them know that I recognize their resilience and their commitment to a better future for themselves and other patients with ALS. Mr. Speaker, I want them to know that I stand with them, and I ask that my colleagues do the same.

Mr. Speaker, I encourage my colleagues to support this bill, and I reserve the balance of my time.

Mr. Speaker, I yield myself the balance of my time to close.

Mr. Speaker, in closing, I will mention Brian and Sandra testified before our committee. When I was first elected to Congress, the Ensor family from Bullitt County, Kentucky, came to see me, and I got to know Mitch. I went to his funeral services, unfortunately. I was touched by his family, which is why this bill is important to me.

Mr. Speaker, I strongly encourage everybody to vote for this bill. There may be a procedural call on this bill. This bill will pass this week. I look forward to seeing it pass, being sent to the Senate, and hopefully signed into law very soon.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I object to the vote on the ground that a quorum is not present and make the point of order that a quorum is not present.

Rep. Diana DeGetteD-CO-1 · Jul 20, 2026

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, about 5,000 Americans are diagnosed with ALS every year. It is a disease that causes the nervous system to stop working and die,…

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, about 5,000 Americans are diagnosed with ALS every year. It is a disease that causes the nervous system to stop working and die, leading to muscle weakness and eventually paralysis. Essentially, when someone gets the diagnosis, it is a death sentence.

I am all too familiar with this disease and its rapid progression because in 1996, I lost my father-in-law to ALS.

The original Accelerating Access to Critical Therapies for ALS Act passed in 2021 and unleashed incredible Federal resources to improve our understanding of this relentless disease in search of a cure. It revolutionized the way FDA uses real-world evidence to foster the development of ALS therapeutics and gave patients a chance to try investigational drugs for rare neurodegenerative diseases.

We have the opportunity today to ensure ALS patients can continue to access promising new therapies, and our preeminent biomedical research institutions can continue to work towards a cure. This reauthorization will provide the continuing statutory basis for the great work that the Accelerating Access to Critical Therapies for ALS Act began, and it couldn't come at a better moment.

We have seen immense research progress in the 5 years since passage. Health Subcommittee members here today heard from Brian Wallach and Sandra Abrevaya in our hearing on this bill a few months ago when they told us with no uncertainty how important it is for people facing down this cruel disease that we keep this momentum going.

Brian and Sandra are an inspiration to all of us and to people everywhere who are seeking cures for these terrible diseases.

I want to tell Congressman Mike Quigley that his unwavering leadership on the original Accelerating Access to Critical Therapies for ALS Act and this reauthorization is saving and improving lives. I thank them for putting us on the path of finding a cure for ALS.

Mr. Speaker, I yield 3 minutes to the gentleman from Illinois (Mr. Quigley), who is the sponsor of this bill.

Rep. Ken CalvertR-CA-41 · Jul 20, 2026

Mr. Speaker, I rise today in support of the ACT for ALS Reauthorization Act, H.R. 8205, legislation that will reauthorize programs that support research and development of drugs and other therapies…

Show 1 more

Sen. Mike LeeR-UT · Sep 28, 2026

Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 466, H.R. 8205. Mr. President, I ask unanimous consent that the bill be considered read a…

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Enrolled BillPublication date not provided

One Hundred Nineteenth Congress of the United States of America

At the Second Session

Begun and held at the City of Washington on Saturday, the third day of January, two thousand and twenty-six

H. R. 8205

AN ACT

To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.

1.

Short title

This Act may be cited as the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026.

2.

Reauthorization of Accelerating Access to Critical Therapies for ALS Act

(a)

In general

Section 7 of the Accelerating Access to Critical Therapies for ALS Act (Public Law 117–79) is amended by striking 2026 and inserting 2031.

(b)

Grants for ALS research

Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by striking 2026 and inserting 2031.

3.

Improvements to program for grants for research on therapies for ALS

(a)

Renewal of grants for research on therapies for ALS review

Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:

(4)

Renewal of grants for research on therapies for ALS review

In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.

.

(b)

Reporting safety data

Section 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended—

(1)

in paragraph (2)(B), by striking and at the end;

(2)

in paragraph (3), by striking the period at the end and inserting ; and; and

(3)

by adding at the end the following:

(4)

the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations).

.

(c)

Clarifying participating clinical trial definition

Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following:

(4)

The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section.

.

4.

FDA rare neurodegenerative disease action plan

Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended—

(1)

in the section heading, by striking ALS and other rare neurodegenerative disease action plan and inserting FDA rare neurodegenerative disease action plan; and

(2)

by adding at the end the following:

(c)

FDA rare neurodegenerative disease action plan

(1)

In general

Not later than 18 months after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration an action plan that includes a description of the actions that the Food and Drug Administration intends to take during the 5-year period following publication of the action plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a).

(2)

Report

Not later than 5 years after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, the Commissioner of Food and Drugs shall publish on the website of the Food and Drug Administration a report that describes the actions taken by the Food and Drug Administration under the action plan published under paragraph (1) and the extent to which such action plan meets the requirements specified in paragraph (1).

.

Speaker of the House of Representatives.

Vice President of the United States and President of the Senate.