Analyst Brief July 20, 2026

H.R. 2821 — FDA Modernization Act 3.0

Current Status

Reported by Committee

Executive Summary

H.R. 2821, the 'FDA Modernization Act 3.0,' mandates the FDA to update its regulations to reflect recent statutory changes that allow nonclinical testing methods (such as organ-on-a-chip or AI models) to replace animal testing in drug development. By requiring an interim final rule within one year that immediately takes effect, the bill forces the FDA to align the Code of Federal Regulations with the FDA Modernization Act 2.0 (passed in the 2023 omnibus). This removes lingering regulatory ambiguity that might otherwise deter pharmaceutical companies from utilizing innovative, non-animal testing alternatives.

Bill Data

Primary Sponsor

Mr. Carter (R-GA)

Bill Number

H.R. 2821

Session

119th

Co-Sponsors

Ms. BarragánMr. BuchananMs. DeLauroMrs. HarshbargerMr. Carter of Louisiana
View on Congress.gov ↗

Arguments For

  • Accelerates the adoption of modern, human-relevant testing methods (e.g., microphysiological systems, AI), potentially speeding up drug development and reducing R&D costs.
  • Delivers a major bipartisan win for animal welfare advocates by forcing bureaucratic compliance with previously passed legislation (FDA Modernization Act 2.0).
  • Provides regulatory certainty to biotech and pharmaceutical companies investing in non-animal testing alternatives by explicitly updating the Code of Federal Regulations.

Likely Supporters

Animal welfare organizations (e.g., Humane Society, PETA)Biotech companies developing alternative testing methodsPharmaceutical industry groups seeking faster R&D timelines

Arguments Against

  • Bypassing the standard APA notice-and-comment rulemaking process (via an immediately effective interim final rule) could lead to unintended regulatory gaps or poorly drafted regulations.
  • Some traditional toxicologists and researchers may argue that completely scrubbing 'animal' from regulations might cause confusion in areas where animal models are still scientifically necessary for certain safety profiles.

Likely Opponents

Traditional research institutions heavily reliant on animal models (muted opposition)

📋 Key Provisions

  • Requires the FDA to issue an interim final rule within one year of enactment.
  • Mandates replacing the word 'animal' with 'nonclinical' in over 20 specific sections of the Code of Federal Regulations (21 CFR) regarding tests, data, studies, models, and research.
  • Incorporates the statutory definition of 'nonclinical test' into relevant FDA regulatory definitions (sections 312.3, 314.3, 315.2, and 601.31 of title 21, CFR).
  • Exempts the interim final rule from standard Administrative Procedure Act (APA) notice-and-comment requirements, making it immediately effective without requiring a showing of 'good cause'.
  • Makes a technical correction to Section 505 of the FD&C Act to fix duplicate subsection lettering regarding clinical trial diversity action plans.
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Claim Analysis Page 3, Line 14

Requires an interim final rule within 1 year of enactment.

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"not later than 1 year"

Claim Analysis Page 3, Line 21

Replaces references to 'animal' tests with 'nonclinical' tests.

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"replace any references to ‘‘animal’’ tests"

Claim Analysis Page 5, Line 17

Makes the interim final rule immediately effective without demonstrating good cause.

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"come immediately effective as an interim final rule"