H.R. 2821: FDA Modernization Act 3.0
Sponsor
Earl Carter
Republican · GA-1
FDA should stop treating animal tests as the default
Why it matters
More than 20 FDA drug rules would be rewritten, and the agency would have just 1 year to do it. H.R. 2821 pushes FDA to treat modern nonclinical testing methods as part of the mainstream rulebook, not an afterthought.
H.R. 2821 gives FDA 1 year to rewrite more than 20 regulations so animal testing is no longer treated as the default term in key drug rules.
This bill is less about inventing a new science policy and more about forcing FDA to catch up. Congress already changed federal law in 2022 to recognize nonclinical tests, but the bill says FDA's regulations still need to be updated to match.
Under H.R. 2821, FDA would publish an interim final rule that takes effect immediately. That rule would replace references to animal tests, data, studies, models, and research with broader nonclinical language across a long list of drug, biologics, and over-the-counter regulations.
For drugmakers, researchers, and companies building alternatives to animal testing, the practical change is clearer rules about what kinds of preclinical evidence FDA can recognize. Patients could also benefit indirectly if that reduces confusion in the early stages of drug development.
The bill also gives FDA a procedural shortcut so it can issue the rule without clearing one of the usual upfront hurdles in the rulemaking process. And it makes a small technical fix by renaming a duplicate subsection in existing law.
What this bill does not do is ban animal testing or guarantee faster drug approvals. It updates the language of FDA's rulebook and tells the agency to do it quickly.
Bill Progress
Latest Action · Jul 21, 2026
Passed the House, received in Senate
H.R. 2821 Bill Summary
What H.R. 2821 actually does.
FDA gets a 1-year deadline
H.R. 2821 requires FDA to publish an interim final rule within 1 year of enactment. That rule would take effect as soon as it is issued.
Nonclinical testing replaces older animal-testing language
The bill orders FDA to replace references to animal tests, data, studies, models, and research with nonclinical terms across key regulations. The goal is to align the agency's rules with a broader set of testing methods Congress already recognized in 2022.
Core FDA definitions get updated
FDA would have to add the definition of a nonclinical test to four foundational regulatory definitions sections. That matters because those definitions shape how drug and biologics submissions are read across the agency.
The changes reach drug, OTC, and biologics rules
The bill names more than 20 specific regulatory provisions for amendment, covering investigational drugs, full drug applications, generic drug applications, over-the-counter products, and biologics.
FDA can move without the usual upfront delay
Congress says FDA would not need to make the normal good-cause showing before issuing this interim final rule. That gives the agency a faster path to put the changes in place.
A drafting glitch in existing law gets fixed
The bill also renames a duplicate subsection in current law so two different provisions are no longer labeled the same way.
Who benefits from H.R. 2821?
Drug and biotech companies trying to bring treatments to market
They would get a rulebook that better matches current law, with less ambiguity about whether nonclinical evidence can be used in place of older animal-focused terminology.
Companies building alternatives to animal testing
Developers of lab-grown tissue models, computer modeling tools, and other nonclinical methods would benefit from clearer recognition in FDA regulations.
Patients waiting for new medicines
Patients could benefit indirectly if cleaner FDA rules reduce friction in early drug development. The bill does not promise faster approvals, but it is aimed at clearing one source of regulatory mismatch.
FDA staff who have to apply outdated language
Reviewers and agency lawyers would get a direct congressional instruction to modernize the regulations instead of continuing to work around older wording.
Who is affected by H.R. 2821?
FDA and HHS
The agencies would have to rewrite the regulations, publish the interim final rule within 1 year, and make sure the update is immediately effective.
Drug sponsors and compliance teams
Companies would need to update submission templates, internal guidance, and regulatory strategies to match the new terminology once the rule takes effect.
Organizations that rely heavily on animal-testing frameworks
They would still be able to use animal data where relevant, but the regulations would no longer frame animal testing as the default label across these provisions.
Senators deciding whether cleanup bills deserve floor time
Because H.R. 2821 has already been received in the Senate, the next practical question is whether leadership treats it as a bipartisan modernization measure or lets it stall.
What Congress Is Saying
H.R. 2821 has come up 25 times in the Congressional Record so far.
Mr. Speaker, I rise in support of H.R. 2821, the FDA Modernization Act 3.0, led by Representative Barragan and Representative Carter of Georgia. The FDA Modernization Act 3.0 would require the Food and Drug Administration to update regulations to replace references to animal tests, data, studies, models, and research in specified sections of Title 21 of the Code of Federal Regulations with references to nonclinical tests.
H.R. 2821 also appeared in 21 routine cosponsor filings.
HR2821 Legislative Journey
Sent to Senate
Jul 21, 2026
Received in the Senate.
House: Vote Held
Jul 20, 2026
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
House: Committee Action
Jun 18, 2026
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
House: Vote: 44-0
May 21, 2026
Ordered to be Reported by the Yeas and Nays: 44 - 0.
House: Vote Held
May 13, 2026
Forwarded by Subcommittee to Full Committee by Voice Vote.
House: Committee Action
Apr 10, 2026
Referred to the Subcommittee on Health.
House: Committee Action
Apr 10, 2025
Referred to the House Committee on Energy and Commerce.
About the Sponsor
Earl Carter
Republican, Georgia's 1st congressional district · 11 years in Congress
Committees: Energy and Commerce, the Budget
View full profile →
Cosponsors (41)
This bill has 41 cosponsors: 21 Democrats, 20 Republicans, reflecting bipartisan support. Cosponsors represent 16 states: California, Colorado, Connecticut, and 13 more.
Nanette Barragán
Democrat · CA
Vern Buchanan
Republican · FL
Rosa DeLauro
Democrat · CT
Diana Harshbarger
Republican · TN
Troy Carter
Democrat · LA
Lloyd Doggett
Democrat · TX
Jerrold Nadler
Democrat · NY
Mike Carey
Republican · OH
Brian Fitzpatrick
Republican · PA
Nicole Malliotakis
Republican · NY
Dan Crenshaw
Republican · TX
Judy Chu
Democrat · CA
Committee Sponsors
Energy and Commerce Committee
11 of 54 committee members cosponsored
22 Republicans across this committee haven't cosponsored yet. Mobilize their constituents
H.R. 2821 Quick Facts
- Committee
- Energy and Commerce
- Chamber
- House
- Policy
- Health
- Introduced
- Apr 10, 2025
Passed the House, received in Senate
Jul 21, 2026
Official Sources
Official bill page with status, text, actions, and related information for the FDA Modernization Act 3.0.
The bill repeatedly amends and references section 505 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 355.
H.R. 2821 orders updates across numerous sections of Title 21 of the Code of Federal Regulations.
H.R. 2821 Common Questions
What does H.R. 2821 actually do?
It tells FDA to update its regulations so they use broader nonclinical testing language instead of older animal-testing wording in more than 20 drug-related rules.
Would H.R. 2821 ban animal testing?
No. It updates FDA's regulatory language and recognizes nonclinical methods more clearly, but it does not ban animal testing or say animal data can never be used.
How fast would FDA have to act?
FDA would have 1 year after enactment to publish the rule, and the bill says that rule would take effect immediately once issued.
Why is Congress doing this now?
Because Congress already changed federal law in 2022 to recognize nonclinical tests more broadly, and H.R. 2821 says FDA's regulations still need to catch up.
Who would feel the biggest effect from H.R. 2821?
Drug developers, biotech firms, alternative-testing companies, and FDA reviewers would see the most direct change because they work with these regulations day to day.
Does the bill only affect experimental drug rules?
No. It also reaches full drug applications, generic drug applications, over-the-counter drug rules, and biologics regulations.
Could this make new drugs reach patients faster?
Possibly indirectly. The bill does not change approval deadlines, but clearer rules could reduce confusion about what kinds of preclinical evidence FDA can consider.
What is the technical fix in H.R. 2821?
It renames a duplicate subsection in existing law so two different provisions are no longer labeled with the same letter.
Based on H.R. 2821 bill text
H.R. 2821 Bill Text
“To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.”
Source: U.S. Government Publishing Office
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