[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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