[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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