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.

(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 ( printed 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;

(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 § 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 § 246.10(e)(3); and

(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: