[Federal Register Volume 90, Number 240 (Wednesday, December 17, 2025)]
[Rules and Regulations]
[Pages 58507-58508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-23089]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
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Federal Register / Vol. 90, No. 240 / Wednesday, December 17, 2025 /
Rules and Regulations
[[Page 58507]]
DEPARTMENT OF AGRICULTURE
Food and Nutrition Service
7 CFR Part 246
[FNS-2023-0027]
RIN 0584-AE94
Special Supplemental Nutrition Program for Women, Infants, and
Children (WIC): Implementation of the Access to Baby Formula Act of
2022 and Related Provisions; Correcting Amendments
AGENCY: Food and Nutrition Service (FNS), USDA.
ACTION: Correcting amendments.
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SUMMARY: On December 14, 2023, the U.S. Department of Agriculture's
Food and Nutrition Service (FNS) published a final rule that went into
effect on February 12, 2024. The rule amended the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC) regulations to
implement the provisions of the Access to Baby Formula Act of 2022
(ABFA) and make related amendments. In reviewing the resulting changes
to the Code of Federal Regulations (CFR), FNS found that the final rule
inadvertently omitted provisions from the CFR and contained several
non-substantive errors. This document corrects those errors in the WIC
regulations.
DATES: Effective on December 17, 2025.
FOR FURTHER INFORMATION CONTACT: Allison Post, Chief, WIC
Administration, Benefits, and Certification Branch, Policy Division,
Supplemental Nutrition and Safety Programs, Food and Nutrition Service,
USDA, 1320 Braddock Place, Alexandria, Virginia, (703) 457-7708 or
[email protected].
SUPPLEMENTARY INFORMATION: FNS published a final rule with request for
comments in the Federal Register on December 14, 2023 (88 FR 86545),
titled Special Supplemental Nutrition Program for Women, Infants, and
Children (WIC): Implementation of the Access to Baby Formula Act of
2022 and Related Provisions. The rule, which went into effect on
February 12, 2024, revised the Special Supplemental Nutrition Program
for Women, Infants, and Children (WIC) regulations at 7 CFR part 246 to
incorporate Access to Baby Formula Act of 2022 (ABFA; Pub. L. 117-129)
provisions and to make related amendments. The rule included changes to
the introductory text of Sec. 246.16a(c)(5) to clarify terminology
describing bidders for infant formula cost containment contracts. In
making this change, subparagraphs (i) through (iii) of Sec.
246.16a(c)(5) were inadvertently removed, leaving only the introductory
text of Sec. 246.16a(c)(5). This action reintroduces the inadvertently
omitted provisions. Additionally, the rule introduced several non-
substantive errors into the WIC regulations. This action corrects those
errors by:
[ssquf] Editing definitions at Sec. 246.2 to spell out the acronym
``FDA'' in the definition of ``recall'' and to clarify phrasing in the
definition of ``supply chain disruption.''
[ssquf] Standardizing a repeated list of program disruptions used
throughout Sec. 246.4(a)(30) and adding missing semi-colons to Sec.
246.4(a)(30)(i)(B) and (C).
[ssquf] Adding the word ``transaction'' to Sec. 246.4(a)(30)(i)(F)
to correct terminology. The word ``redemption'' is currently used
incorrectly to refer to both participant transactions and vendor
redemptions.
[ssquf] Correcting capitalization in Sec. 246.16a(n)(2) and Sec.
246.29(a).
[ssquf] Replacing ``USDA'' with ``the Secretary'' in Sec. 246.29
to align with phrasing used throughout WIC regulations.
This action incorporates all the corrections listed above into the
final regulations. FNS does not expect these corrections to result in
any policy or process changes.
List of Subjects in 7 CFR Part 246
Administrative practice and procedure, Civil rights, Food
assistance programs, Grant programs--health, Grant programs--social
programs, Indians, Infants and children, Maternal and child health,
Nutrition, Penalties, Reporting and recordkeeping requirements, Women.
For the reasons discussed in the preamble, FNS corrects 7 CFR part
246 by making the following correcting amendments:
PART 246--SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS
AND CHILDREN
0
1. The authority citation for part 246 continues to read as follows:
Authority: 42 U.S.C. 1786.
0
2. In Sec. 246.2, revise the definitions of ``Recall'' and ``Supply
chain disruption'' to read as follows:
Sec. 246.2 Definitions.
* * * * *
Recall means recall as defined in 21 CFR 7.3(g) or any successor
regulation. Recalls may be conducted voluntarily by a manufacturer or
may be required by the U.S. Food and Drug Administration (FDA).
* * * * *
Supply chain disruption means a shortage of WIC supplemental foods
that limits WIC participants' ability to reasonably purchase
supplemental foods using WIC benefits within a State agency's
jurisdiction, as determined, and declared by the Secretary for the
purposes of WIC.
* * * * *
0
3. In Sec. 246.4:
0
a. Revise paragraphs (a)(30)(i)(B), (C), and (F), and paragraphs
(a)(30)(iii), (v), and (vii) to read as follows:
Sec. 246.4 State plan.
(a) * * *
(30) * * *
(i) * * *
(B) Alternate certification and benefit issuance;
(C) Verification of Certification (VOC) issuance;
* * * * *
(F) Benefit transaction and redemption; and
* * * * *
(iii) A designated emergency contact within the State agency for an
emergency period, supplemental food recall, and other supply chain
disruptions;
* * * * *
(v) A plan to establish relationships with relief agencies
responsible for disaster and public health emergency planning
applicable to the State agency's jurisdiction and participants to
support data-informed approaches when
[[Page 58508]]
responding to an emergency period, supplemental food recall, and other
supply chain disruptions;
* * * * *
(vii) A communications plan to keep FNS, State and local agency
staff, authorized WIC vendors, WIC participants, and the public
informed during an emergency period, supplemental food recall, and
other supply chain disruptions;
* * * * *
0
4. In Sec. 246.16a:
0
a. Add paragraphs (c)(5)(i) through (iii); and
0
b. Revise paragraph (n)(2).
The addition and revision read as follows:
Sec. 246.16a Infant formula and authorized foods cost containment.
* * * * *
(c) * * *
(5) * * *
(i) Calculating the standardized number of units of infant formula.
The State agency must specify a standardized number of units (e.g.,
cans) of infant formula by physical form (e.g., concentrated liquid,
powdered, and ready-to-feed) to be bid upon. The standardized number of
units must contain the equivalent of the total number of ounces by
physical form needed to give the maximum allowance to the average
monthly number of infants using each form. The number of infants does
not include infant participants who are exclusively breastfed and those
who are issued exempt infant formula. The average monthly number of
infants using each physical form must be based on at least 6 months of
the most recent participation and issuance data. In order to calculate
the standardized number of units of infant formula by form to be bid
upon, the average monthly number of infants using each physical form is
multiplied by the maximum monthly allowable number of ounces for each
form (as allowed under table 1 to Sec. 246.10(e)(9)), and divided by
the corresponding unit size (i.e., number of ounces per unit being
bid). In order to compare bids, total cost is calculated by multiplying
this standardized number of units by the net price for each physical
form. Alternative calculations that arrive at a mathematically
equivalent result are acceptable.
(ii) Determining the lowest total monthly net price or highest
rebate. To determine the lowest total monthly net price a State agency
must multiply the net price per unit by the established standardized
amount of infant formula to be bid upon as calculated in paragraph
(c)(4)(i) of this section. If the bid evaluation is based on highest
rebate offered, the State agency must multiply the rebate offered by
the established amount of infant formula to be bid upon as calculated
in paragraph (c)(4)(i) of this section.
(iii) Highest rebate limitation. Before issuing the bid
solicitation, a State agency that elects to evaluate bids by highest
rebate must demonstrate to FNS's satisfaction that the weighted average
retail prices for different brands of infant formula in the State vary
by 5 percent or less. The weighted average retail price must take into
account the prices charged for each type and physical form of infant
formula by authorized vendors or, if a State agency elects, it may
include stores that do not participate in the WIC program in the State.
The State agency must also base calculations on the proportion of each
type and physical form of infant formula the State agency issues based
on the data provided to bidders pursuant to paragraph (c)(5) of this
section.
* * * * *
(n) * * *
(2) Allow the issuance of non-contract brand infant formulas
without medical documentation, with the exception of participants
receiving Food Package III as defined in Sec. 246.10(e)(3); and
* * * * *
0
5. In Sec. 246.29:
0
a. Revise the last sentence of the introductory text of paragraph (a);
and
0
b. Revise the introductory text of paragraph (c).
The revisions read as follows:
Sec. 246.29 Waivers of program requirements.
(a) * * * To be considered, a waiver or modification issued under
this section must meet the following requirements:
* * * * *
(c) State agency waiver requests. State agencies shall submit
requests for a modification or waiver for the Secretary's approval.
Requests shall include but not necessarily be limited to:
* * * * *
Patrick A. Penn,
Deputy Under Secretary, Food, Nutrition and Consumer Services.
[FR Doc. 2025-23089 Filed 12-16-25; 8:45 am]
BILLING CODE 3410-30-P