[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7248 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 7248
To amend the Federal Food, Drug, and Cosmetic Act to establish a
process for the qualification of nonclinical testing methods to reduce
and replace the use of animals in nonclinical research, improve the
predictivity of nonclinical testing methods, and reduce development
time for a biological product or other drug, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 6, 2024
Mr. Carter of Georgia (for himself, Ms. Barragan, Mrs. Harshbarger, Mr.
Buchanan, Mr. Carter of Louisiana, Mr. Waltz, Ms. DeLauro, Mr. Nehls,
Mr. Gooden of Texas, Mr. Crenshaw, and Mr. Fitzpatrick) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish a
process for the qualification of nonclinical testing methods to reduce
and replace the use of animals in nonclinical research, improve the
predictivity of nonclinical testing methods, and reduce development
time for a biological product or other drug, and for other purposes.
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. NONCLINICAL TESTING METHODS QUALIFICATION PROCESS AT THE FOOD
AND DRUG ADMINISTRATION.
(a) In General.--Subchapter A of chapter V of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 507 the following:
``SEC. 507A. NONCLINICAL TESTING METHODS QUALIFICATION PROCESS.
``(a) In General.--
``(1) Process description.--The Secretary shall establish a
process for the qualification of a nonclinical testing method,
with respect to drugs, under which--
``(A) persons may request qualification of a
nonclinical testing method for a particular context of
use; and
``(B) the Secretary shall grant or deny such
request in accordance with this section.
``(2) Initiation.--The Secretary shall initiate the process
under paragraph (1) not later than 1 year after the date of
enactment of this section.
``(b) Eligible Nonclinical Testing Methods.--To be eligible for
qualification under this section, a nonclinical testing method shall--
``(1) be intended to replace or reduce animal testing; and
``(2) either--
``(A) improve the predictivity of nonclinical
testing for safety and efficacy; or
``(B) reduce development time for a drug (including
any biological product).
``(c) Qualification of Nonclinical Testing Methods.--
``(1) Process.--The Secretary shall establish a process for
submission of a request under subsection (a).
``(2) Contents.--At a minimum, a request under subsection
(a) shall include preliminary information demonstrating that
the nonclinical testing method meets the criteria described in
subsection (b) in a particular context of use.
``(3) Advice regarding the method of nonclinical testing.--
The Secretary may facilitate the development and review of
preliminary information submitted pursuant to paragraph (2) in
a request under subsection (a) by--
``(A) providing timely advice to, and interaction
with, the person submitting the request regarding the
development of the method of nonclinical testing; and
``(B) involving senior managers and experienced
staff of the Food and Drug Administration, as
appropriate, in a collaborative, cross-disciplinary
review of the proposed method of nonclinical testing.
``(4) Engagement of external experts.--In reviewing a
request under subsection (a), the Secretary may--
``(A) through the use of cooperative agreements or
other appropriate mechanisms, consult with biomedical
research consortia and other expert stakeholders with
specific expertise in nonclinical testing methods; and
``(B) consider recommendations of biomedical
research consortia or other qualified experts in
deciding whether to grant or deny the request.
``(5) Review of requests.--
``(A) Timing.--Not later than 180 calendar days
after the receipt of a request under subsection (a),
the Secretary shall determine whether to grant or deny
the request.
``(B) Determination.--In reviewing a nonclinical
testing method pursuant to a request under subsection
(a), the Secretary shall determine whether to grant or
deny the request based on whether the method satisfies
the criteria listed in subsection (b) as demonstrated
by--
``(i) the information submitted in the
request or supplements thereto; and
``(ii) any additional information provided
by external experts.
``(C) Qualification decision.--If the Secretary
determines pursuant to subparagraph (B) that a
nonclinical testing method satisfies the criteria
listed in subsection (b), the Secretary shall grant the
request for qualification of the method in a particular
context of use.
``(d) Effects of Qualification.--If the Secretary qualifies a
nonclinical testing method pursuant to a request under this section--
``(1) the method shall be available for use by the holder
of the qualification or a person authorized by such holder for
drug development in the particular context of use for which the
method is qualified; and
``(2) the Secretary shall--
``(A) expedite the development and review of an
application submitted under section 505 of this Act or
section 351 of the Public Health Service Act, including
supplemental applications, for drugs that are developed
using the qualified nonclinical testing method; and
``(B) allow the holder of the qualification or a
person authorized by such holder to reference or rely
upon, in an application submitted under section 505 of
this Act or section 351 of the Public Health Service
Act, including a supplemental application, data and
information about the qualification of the nonclinical
testing method in the same context of use for which the
qualification was granted.
``(e) Review of Applications Utilizing Qualified Nonclinical
Testing Methods.--The Secretary shall expedite the development and
review of an application submitted under section 505 of this Act or
section 351 of the Public Health Service Act for drugs for which a
nonclinical testing method qualified under this section is used.
``(f) Transparency.--
``(1) Submission of report to congress.--Not later than 2
years after the date of enactment of this section and annually
thereafter, the Secretary shall publish on the website of the
Food and Drug Administration and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report containing an evaluation of the
process under this section.
``(2) Contents of report.--Each report under paragraph (1)
shall include--
``(A) for the period covered by the report--
``(i) the types of nonclinical testing
methods qualified under the process;
``(ii) the number of requests for
qualification under subsection (a), and the
number of such requests that have been granted;
``(iii) the average number of calendar days
for the review of requests under subsection (a)
before granting or denying such requests;
``(iv) an analysis of the factors that
result in determinations to qualify or not
qualify a nonclinical testing method under this
section; and
``(v) the number of applications received
under section 505 of this Act or section 351 of
the Public Health Service Act that rely on a
nonclinical testing method qualified under this
section, and the number of such applications
approved; and
``(B) for the period beginning on the date of
enactment of this section through the end of the period
covered by the report, the number of animals estimated
to have been saved as a result of the process under
this section.
``(g) Nonclinical Testing Method Defined.--In this section, the
term `nonclinical testing method' has the meaning given to such term in
section 505(z) except that such term excludes any animal test.''.
(b) Public Meeting.-- Not later than 180 days after the date of
enactment of this Act, the Secretary of Health and Human Services shall
publish in the Federal Register a notice to convene a public meeting to
discuss and obtain input and recommendations from relevant
stakeholders, including regulated industry, biomedical consortia,
contract research organizations, and patients, regarding--
(1) the goals and scope of the process under 507A of the
Federal Food, Drug, and Cosmetic Act, as added by subsection
(a);
(2) a framework, procedures, and requirements for such
process; and
(3) ways in which the Food and Drug Administration will
support the use of nonclinical testing methods to replace or
reduce the use of animals in nonclinical testing.
(c) FDA Guidance.--
(1) Nonclinical testing methods qualification process.--The
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall--
(A) not later than 1 year after the date of the
public meeting under subsection (b), propose guidance
on the goals and implementation of the process under
section 507A of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (a);
(B) provide a period for public comment on such
proposed guidance; and
(C) not later than 1 year after the end of such
public comment period, finalize such guidance.
(2) Contents.--The guidance under paragraph (1) shall
address--
(A) the process by which a person may request
qualification under section 507A of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a);
(B) the eligibility criteria under subsection (b)
of such section 507A;
(C) the information that a person requesting such
qualification is required to submit under subsection
(c) of such section 507A; and
(D) how the Secretary intends to evaluate requests
under such section 507A.
SEC. 3. REGULATIONS ON NONCLINICAL TESTING METHODS.
(a) In General.--Not later than 90 days after the date of enactment
of this Act, the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, shall initiate a rulemaking under
section 553 of title 5, United States Code, to implement section 505(z)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)).
(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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