Bill Summary
The FDA Modernization Act 3.0 is a legislative proposal that aims to update regulations concerning nonclinical testing methods in the approval process for drugs and biological products. The Act mandates the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to publish an interim final rule within one year of enactment. This rule will revise specific sections of the Code of Federal Regulations (CFR) to eliminate references to "animal" testing and replace them with "nonclinical" testing terminology, reflecting a shift towards alternative testing approaches. Additionally, the Act seeks to define "nonclinical test" more clearly within the relevant sections of the Federal Food, Drug, and Cosmetic Act. The interim final rule will take effect immediately upon publication, bypassing the usual requirement to demonstrate good cause for such immediate implementation. Furthermore, the Act includes a technical amendment to reorganize a subsection related to clinical trial diversity.
Possible Impacts
Here are three examples of how the FDA Modernization Act 3.0 could affect people:
1. **Reduction in Animal Testing**: The legislation aims to replace references to "animal" tests with "nonclinical tests" in regulatory frameworks. This could lead to a significant reduction in the number of animals used for testing pharmaceuticals and cosmetics, which may appeal to animal welfare advocates and the general public who are concerned about ethical treatment of animals. As a result, consumers may feel more comfortable with products developed under these new guidelines.
2. **Faster Drug Development and Approval**: By streamlining the regulatory process and allowing for nonclinical testing methods, the Act could expedite the development and approval of new drugs and treatments. This acceleration could lead to quicker access to innovative therapies for patients with serious health conditions, ultimately improving health outcomes and potentially saving lives.
3. **Increased Research Opportunities**: The emphasis on nonclinical testing methods may encourage pharmaceutical companies and researchers to explore alternative testing approaches, such as computer modeling or in vitro studies. This expansion of research methodologies could foster innovation in drug development and create new job opportunities in scientific and technical fields, benefiting the workforce and economy.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2821 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 2821
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 10, 2025
Mr. Carter of Georgia (for himself, Ms. Barragan, Mr. Buchanan, Ms.
DeLauro, Mrs. Harshbarger, and Mr. Carter of Louisiana) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Modernization Act 3.0''.
SEC. 2. REGULATIONS ON NONCLINICAL TESTING METHODS.
(a) Interim Final Rule.--
(1) In general.--In order to ensure implementation of the
amendments to section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the
Consolidated Appropriations Act, 2023 (Public Law 117-328; 136
Stat. 5821), not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall publish an
interim final rule--
(A) to amend the sections of title 21, Code of
Federal Regulations, described in paragraph (2) to
replace any references to ``animal'' tests, data,
studies, models, and research with a reference to
nonclinical tests, data, studies, models, and research;
and
(B) to add the definition of ``nonclinical test''
in section 505(z) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(z)) to sections 312.3,
314.3, 315.2, and 601.31 of title 21, Code of Federal
Regulations.
(2) CFR sections described.--The sections of title 21, Code
of Federal Regulations, described in this paragraph are the
following:
(A) Section 312.22(c).
(B) Section 312.23(a)(3)(iv).
(C) Section 312.23(a)(5)(ii).
(D) Section 312.23(a)(5)(iii).
(E) Section 312.23(a)(8).
(F) Section 312.23(a)(8)(i).
(G) Section 312.23(a)(8)(ii).
(H) Section 312.23(a)(10)(i).
(I) Section 312.23(a)(10)(ii).
(J) Section 312.33(b)(6).
(K) Section 312.82(a).
(L) Section 312.88.
(M) Section 314.50(d)(2).
(N) Section 314.50(d)(2)(iv).
(O) Section 314.50(d)(5)(i).
(P) Section 314.50(d)(5)(vi)(a).
(Q) Section 314.50(d)(5)(vi)(b).
(R) Section 314.93(e)(2).
(S) Section 315.6(d).
(T) Section 330.10(a)(2).
(U) Section 601.35(d).
(V) Any other section necessary to ensure
regulatory consistency with the amendments to section
505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)) made by section 3209(a) of the
Consolidated Appropriations Act, 2023 (Public Law 117-
328; 136 Stat. 5821).
(3) Effectiveness of interim final rule.--Notwithstanding
subparagraph (B) of section 553(b) of title 5, United States
Code, the interim final rule issued by the Secretary of Health
and Human Services under paragraph (1) shall become immediately
effective as an interim final rule without requiring the
Secretary of Health and Human Services to demonstrate good
cause therefor.
(b) Technical Amendment.--Section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) is amended by designating the second
subsection (z) (relating to clinical trial diversity action plans), as
added by section 3601(a) of the Health Extenders, Improving Access to
Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of
2022 (division FF of Public Law 117-328), as subsection (aa).
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