119th Congress · introduced in the House · Apr 10, 2025
FDA Modernization Act 3.0
Official title from Congress.gov
Latest action (Jul 21, 2026): Received in the Senate.
View on Congress.govPolicy area: Health
Congressional Research Service summary, version: Introduced in House (Apr 10, 2025)
FDA Modernization Act 3.0
This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.
The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
Includes amendment, cloture, and procedural votes. Each is labeled with its exact question; only a passage question is a vote to pass the bill.
No recorded roll calls on this bill in coverage.
Received in the Senate.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
Considered under suspension of the rules. (consideration: CR H4639-4640)
Mr. Guthrie moved to suspend the rules and pass the bill.
Placed on the Union Calendar, Calendar No. 614.
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Ordered to be Reported by the Yeas and Nays: 44 - 0.
Committee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee by Voice Vote.
Subcommittee Consideration and Mark-up Session Held
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Administrative law and regulatory procedures · Department of Health and Human Services · Drug safety, medical device, and laboratory regulation · Medical research · Research administration and funding
LD-2 reports whose issue descriptions explicitly cite this bill (bill type and number validated against Congress.gov records). A citation does not establish the client's position or any contact with a member.
Loading lobbying reportsIntroduced in House
Actions from Congress.gov, newest first.
Coverage: reports for 2025 onward, posted Jan 1, 2025 through Oct 23, 2026.
31 citations; showing the 25 most recently posted.
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 20, 2026 · issue area: Animals
$120,000
Spent on own lobbying
HR 1657, Humane Cosmetics Act; H.R. 2821/S. 355, FDA Modernization Act 3.0 (issues related to animal-based testing for OTC products); Adoption of non-animal test methods/New Approach Methodologies (NA…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PUBLIC ACCESS TO SUNSCREENS (PASS) COALITION · lobbying firm or registrant: HOLLAND & KNIGHT LLP
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 17, 2026 · issue area: Medical/Disease Research/Clinical Labs
$80,000
Paid to lobbying firm
…scal Year 2027 appropriations for the Food and Drug Administration; FDA policy on animal testing for over-the-counter drugs; FDA Modernization Act 3.0 (S. 355; H.R. 2821).
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Oct 13, 2026 · issue area: Health Issues
$146,407
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act,…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Sep 30, 2026 · issue area: Agriculture
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q3 report (Jul 1, 2026 – Sep 30, 2026) · posted Sep 30, 2026 · issue area: Animals
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Agriculture
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Animals
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Animals
$140,000
Spent on own lobbying
HR 1657, Humane Cosmetics Act; H.R. 2821/S. 355, FDA Modernization Act 3.0 (issues related to animal-based testing for OTC products)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PUBLIC ACCESS TO SUNSCREENS (PASS) COALITION · lobbying firm or registrant: HOLLAND & KNIGHT LLP
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · amended · posted Jul 20, 2026 · issue area: Medical/Disease Research/Clinical Labs
$100,000
Paid to lobbying firm
…ation; use of sunscreen in schools to prevent sunburns in children; FDA policy on animal testing for over-the-counter drugs; FDA Modernization Act 3.0 (S. 355; H.R. 2821).
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PUBLIC ACCESS TO SUNSCREENS (PASS) COALITION · lobbying firm or registrant: HOLLAND & KNIGHT LLP
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 20, 2026 · issue area: Medical/Disease Research/Clinical Labs
$110,000
Paid to lobbying firm
…ation; use of sunscreen in schools to prevent sunburns in children; FDA policy on animal testing for over-the-counter drugs; FDA Modernization Act 3.0 (S. 355; H.R. 2821).
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q2 report (Apr 1, 2026 – Jun 30, 2026) · posted Jul 14, 2026 · issue area: Health Issues
$199,750
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act,…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 16, 2026 · issue area: Agriculture
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 16, 2026 · issue area: Animals
Amount not reported
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. View filing
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 15, 2026 · issue area: Animals
$130,000
Spent on own lobbying
HR 1657, Humane Cosmetics Act; H.R. 2821/S. 355, FDA Modernization Act 3.0 (issues related to animal-based testing for OTC products)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2026 Q1 report (Jan 1, 2026 – Mar 31, 2026) · posted Apr 14, 2026 · issue area: Health Issues
$159,409
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act,…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PERSONAL CARE PRODUCTS COUNCIL · lobbying firm or registrant: THE PERSONAL CARE PRODUCTS COUNCIL
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Animals
$120,000
Spent on own lobbying
HR 1657, Humane Cosmetics Act; H.R. 2821/S. 355, FDA Modernization Act 3.0 (issues related to animal-based testing for OTC products)
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Agriculture
$150,000
Spent on own lobbying
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Animals
$150,000
Spent on own lobbying
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Health Issues
$170,000
Paid to lobbying firm
FDA Modernization Act 3.0 (S. 355 / H.R. 2821); Expedited Access to Biosimilars Act (S. 1414); Orphan-drug exclusivity; draft Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) A…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PUBLIC ACCESS TO SUNSCREENS (PASS) COALITION · lobbying firm or registrant: HOLLAND & KNIGHT LLP
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 20, 2026 · issue area: Medical/Disease Research/Clinical Labs
$70,000
Paid to lobbying firm
…sunburns in children; the SAFE Sunscreen Standards Act (H.R. 3686); FDA policy on animal testing for over-the-counter drugs; FDA Modernization Act 3.0 (S. 355; H.R. 2821).
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
CONSUMER HEALTHCARE PRODUCTS ASSOCIATION · lobbying firm or registrant: CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2025 Q4 report (Oct 1, 2025 – Dec 31, 2025) · posted Jan 14, 2026 · issue area: Health Issues
$245,484
Paid to lobbying firm
S.2292 - Over-the-Counter Monograph Drug User Fee Amendments H.R.4273 - Over-the-Counter Monograph Drug User Fee Amendments S.355 - FDA Modernization Act 3.0 H.R.2821 - FDA Modernization Act 3.0 H.R.3686 - SAFE Sunscreen Standards Act H.R.1 - One Big Beautiful Bill Act H.R.5371 - Continuing Appropriations and Extensions Act,…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Agriculture
$150,000
Spent on own lobbying
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
ANIMAL WELLNESS ACTION · lobbying firm or registrant: ANIMAL WELLNESS ACTION
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Animals
$150,000
Spent on own lobbying
…R.3946 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting S.1454 - FIGHT Act of 2025 Increase enforcement tools to combat animal fighting H.R.2821 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 S.355 - FDA Modernization Act 3.0 Forcing implementation of FDA Mod 2.0 H.R.1992 - Kangaroo P…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA · lobbying firm or registrant: PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Health Issues
$9,030,000
Spent on own lobbying
…ial Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program H.R. 2214: DRUG Act H.R. 2821: FDA Modernization Act 3.0 H.R. 4317: PBM Reform Act of 2025 H.R. 5256: 340B ACCESS Act Supporting Underserved and Strengthening Transparency, Accountability,…
Congress inferred from the report year; bill number and the title cited with it match Congress.gov records, and the bill predates the report. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing
PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA INC · lobbying firm or registrant: COVINGTON & BURLING LLP
2025 Q3 report (Jul 1, 2025 – Sep 30, 2025) · posted Oct 20, 2025 · issue area: Health Issues
$130,000
Paid to lobbying firm
…he Inflation Reduction Act (P.L. 117-169); Biosimilars Access and Affordability Act (no bill number); REMEDY Act (S. 2620); FDA Modernization Act 3.0 (S. 355 / H.R. 2821); issues related to reauthorization of the Prescription Drug User Fee Act (no bill); proposed amendment to the National Defense Authorization Act for Fiscal Ye…
Congress inferred from the report year; bill number matches Congress.gov records and the bill predates the report; no title was cited with it. The amount is lobbying spending for every issue on this report, not this bill alone, and none of it is paid to any member of Congress. View filing