[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4257 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4257

To amend the Child Nutrition Act of 1966 to establish requirements for 
   infant formula cost containment contracts, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                 May 18 (legislative day, May 17), 2022

  Ms. Stabenow (for herself, Mr. Boozman, Mr. Leahy, Mr. Hoeven, Mr. 
   Brown, Mr. Marshall, Ms. Klobuchar, Mrs. Capito, Mr. Bennet, Mr. 
  Tillis, Mrs. Gillibrand, Ms. Collins, Ms. Smith, Mr. Grassley, Mr. 
 Booker, Mrs. Fischer, Mr. Warnock, Mr. Cornyn, Mr. Casey, Mr. Lujan, 
 Mr. Durbin, Ms. Hassan, Ms. Duckworth, and Mr. Kelly) introduced the 
 following bill; which was read twice and referred to the Committee on 
                  Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
To amend the Child Nutrition Act of 1966 to establish requirements for 
   infant formula cost containment contracts, 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 ``Access to Baby Formula Act of 
2022''.

SEC. 2. INFANT FORMULA REQUIREMENTS.

    Section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786) is 
amended--
            (1) in subsection (b), by adding at the end the following:
            ``(24) Supply chain disruption.--The term `supply chain 
        disruption' means a shortage of supplemental foods that impedes 
        the redemption of food instruments, as determined by the 
        Secretary.'';
            (2) in subsection (h)(8), by adding at the end the 
        following:
                    ``(L) Infant formula cost containment contract 
                requirements.--
                            ``(i) In general.--Not later than 120 days 
                        after the date of enactment of this 
                        subparagraph, the Secretary shall issue an 
                        interim final rule to require that each infant 
                        formula cost containment contract entered into 
                        between a State and an infant formula 
                        manufacturer on or after the effective date of 
                        the interim final rule includes remedies in the 
                        event of an infant formula recall, including 
                        how an infant formula manufacturer will protect 
                        against disruption to program participants in 
                        the State.
                            ``(ii) Rebates.--In the case of an infant 
                        formula recall, an infant formula manufacturer 
                        contracted to provide infant formula under this 
                        section shall comply with the contract 
                        requirements under clause (i).
                            ``(iii) Regulations.--The Secretary shall 
                        promulgate regulations to carry out this 
                        subparagraph--
                                    ``(I) pursuant to section 808(2) of 
                                title 5, United States Code; and
                                    ``(II) that shall be carried out 
                                without regard to chapter 35 of title 
                                44, United States Code (commonly known 
                                as the `Paperwork Reduction Act').
                    ``(M) Memorandum of understanding.--Not later than 
                30 days after the date of enactment of this 
                subparagraph, the Secretary shall ensure that there is 
                a memorandum of understanding that establishes 
                procedures to promote coordination and information 
                sharing between the Department of Agriculture and the 
                Department of Health and Human Services regarding any 
                supply chain disruption, including a supplemental food 
                recall.''; and
            (3) by adding at the end the following:
    ``(r) Emergencies and Disasters.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Emergency period.--The term `emergency 
                period' means a period during which there is--
                            ``(i) a public health emergency declared by 
                        the Secretary of Health and Human Services 
                        under section 319 of the Public Health Service 
                        Act (42 U.S.C. 247d);
                            ``(ii) a renewal of a public health 
                        emergency described in clause (i) pursuant to 
                        section 319 of that Act (42 U.S.C. 247d);
                            ``(iii) a major disaster declared by the 
                        President under section 401 of the Robert T. 
                        Stafford Disaster Relief and Emergency 
                        Assistance Act (42 U.S.C. 5170); or
                            ``(iv) an emergency declared by the 
                        President under section 501 of the Robert T. 
                        Stafford Disaster Relief and Emergency 
                        Assistance Act (42 U.S.C. 5191).
                    ``(B) Qualified administrative requirement.--The 
                term `qualified administrative requirement' means--
                            ``(i) a requirement under this section; and
                            ``(ii) any regulatory requirement 
                        promulgated pursuant to this section.
            ``(2) Modification or waiver of requirements.--
        Notwithstanding any other provision of law, during an emergency 
        period, the Secretary may modify or waive any qualified 
        administrative requirement for a State agency if--
                    ``(A) the qualified administrative requirement 
                cannot be met by the State agency during any portion of 
                the emergency period due to the conditions that 
                prompted the emergency period; and
                    ``(B) the modification or waiver of the qualified 
                administrative requirement--
                            ``(i) is necessary to provide assistance to 
                        participants of the program established by this 
                        section; and
                            ``(ii) does not substantially weaken the 
                        nutritional quality of supplemental foods 
                        provided under the program.
            ``(3) Duration.--A modification or waiver under paragraph 
        (2) shall be in effect for a period determined by the 
        Secretary, but not later than 60 days after the end of the 
        applicable emergency period.
    ``(s) Product Recalls and Supply Chain Disruptions.--
            ``(1) Definition of qualified administrative requirement.--
        In this subsection, the term `qualified administrative 
        requirement' has the meaning given the term in subsection 
        (r)(1).
            ``(2) Modification or waiver of requirements.--
        Notwithstanding any other provision of law, in order to address 
        a supplemental food product recall or supply chain disruption, 
        the Secretary may modify or waive a qualified administrative 
        requirement to allow 1 or more State agencies--
                    ``(A) to permit vendors authorized to participate 
                in the program under this section to exchange or 
                substitute authorized supplemental foods obtained with 
                food instruments with food items that are not identical 
                (including in brand and size);
                    ``(B) to modify or waive any requirement with 
                respect to medical documentation for the issuance of 
                noncontract brand infant formula, except the 
                requirements for participants receiving Food Package 
                III (as defined in section 246.10(e)(3) of title 7, 
                Code of Federal Regulations (as in effect on the date 
                of enactment of this subsection));
                    ``(C) to modify or waive the maximum monthly 
                allowance for infant formula;
                    ``(D) to modify or waive any additional requirement 
                with respect to supplemental food products provided 
                under the program under this section if the 
                modification or waiver--
                            ``(i) may facilitate increased access to 
                        those products;
                            ``(ii) does not substantially weaken the 
                        nutritional quality of those products; and
                            ``(iii) is in accordance with any 
                        applicable guidance or directive from the 
                        Administrator of Food and Drugs determined to 
                        be applicable by the Secretary.
            ``(3) Duration.--A modification or waiver under paragraph 
        (2)--
                    ``(A) may be--
                            ``(i) available for a period of not more 
                        than 45 days, to begin on a date determined by 
                        the Secretary; and
                            ``(ii) renewed, subject to the condition 
                        that the Secretary shall provide notice of the 
                        renewal not less than 15 days before the 
                        renewal shall take effect; and
                    ``(B) shall not be available after the date that is 
                60 days after the supplemental food product recall or 
                supply chain disruption for which the modification or 
                waiver is established ceases to exist.''.
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