[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8010 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 8010

 To require the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, to act upon pending submissions for 
new infant formula, to increase regulatory flexibility in the event of 
          an infant formula shortage, and for other purposes.


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                    IN THE HOUSE OF REPRESENTATIVES

                              June 9, 2022

 Mr. Guthrie (for himself, Mr. Griffith, Mr. McKinley, Mr. Armstrong, 
    Mr. Joyce of Pennsylvania, Mr. Bucshon, Mr. Dunn, Mr. Carter of 
 Georgia, and Mr. Bilirakis) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

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                                 A BILL


 
 To require the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, to act upon pending submissions for 
new infant formula, to increase regulatory flexibility in the event of 
          an infant formula shortage, 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 ``More Options for Infants and Parents 
Act of 2022''.

SEC. 2. PENDING SUBMISSIONS FOR NEW INFANT FORMULA.

    Not later than 14 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 act upon any pending submissions from domestic 
manufacturers for new infant formula under section 412(c) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)).

SEC. 3. REGULATORY FLEXIBILITY IN THE EVENT OF AN INFANT FORMULA 
              SHORTAGE.

    Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a) is amended by adding at the end the following:
    ``(j) Regulatory Flexibility in the Event of a Shortage.--
            ``(1) List of products for substitution during a 
        shortage.--The Secretary shall publish and keep up-to-date a 
        list on the internet website of the Food and Drug 
        Administration detailing which infant formula products may be 
        appropriate substitutes for infant formula products--
                    ``(A) which the Secretary has determined to be in 
                shortage or at risk of being in shortage; and
                    ``(B) that are relied upon by infants and 
                individuals with amino-acid and metabolic conditions.
            ``(2) Flexibilities.--The Secretary--
                    ``(A) shall consider whether any infant formula 
                products may be substituted for those in shortage; and
                    ``(B) may waive any applicable requirements under 
                section 412 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 350a) regarding labeling and nutrient 
                content to facilitate such substitutions.''.
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