SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Infant Formula Requirements—21 CFR Parts 106 and 107

OMB Control Number 0910-0256—Revision

Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the FD&C Act (21 U.S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures, notify us when infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of infant formula distribution. We have issued regulations to implement the FD&C Act's requirements for infant formula in parts 106 and 107 (21 CFR parts 106 and 107). We also regulate the labeling of infant formula under the authority of section 403 of the FD&C Act (21 U.S.C. 343). Under our labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. ( printed page 44861) Failure to comply with any of the applicable labeling regulations will render an infant formula misbranded under section 403 of the FD&C Act. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately.

While the infant formula regulations help ensure the consistent production of safe and nutritionally adequate infant formulas for healthy term infants, they apply with one narrow exception. Section 412(h)(1) of the FD&C Act exempts an infant formula represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of subsections 412(a), (b), and (c) of the FD&C Act. These formulas are customarily referred to as “exempt infant formulas.” Section 412(h)(2) of the FD&C Act authorizes us to establish terms and conditions for the exemption of an infant formula from the requirements of subsections 412(a), (b), and (c) of the FD&C Act.

In support of exempt infant formulas, we have issued the Agency guidance document titled “Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports” (April 2016). The guidance document includes our recommendation that manufacturers of exempt infant formulas follow, to the extent practicable, subparts A, B, C, D, and F of 21 CFR part 106, and is available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​guidance-industry-exempt-infant-formula-production.

We have also developed electronic Form FDA 3978 (Infant Formula Tracking System (IFTRACK)) so that infant formula manufacturers may electronically submit reports and notifications in a standardized format to FDA. However, manufacturers that prefer to submit paper submissions in a format of their own choosing will still have the option to do so. Form FDA 3978 prompts a respondent to include reports and notifications in a standard electronic format and helps the respondent organize their submission to include only the information needed for our review. Screenshots of Form FDA 3978 and instructions are available at https://www.fda.gov/​Food/​GuidanceRegulation/​FoodFacilityRegistration/​InfantFormula/​default.htm.

FDA has requested voluntary notifications pertaining to product samples found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed. Associated recordkeeping requirements are found in 21 CFR 106.55(e). FDA has requested this information to help prevent future Cronobacter spp. illnesses associated with powdered infant formula. As part of a constituent update, available at https://www.fda.gov/​food/​cfsan-constituent-updates/​fda-calls-enhanced-safety-measures-letter-powdered-infant-formula-industry, we issued a letter on March 8, 2023, to share current information to assist industry in improving the microbiological safety of powdered infant formula. As communicated in the letter, we shared the information with the expectation that infant formula manufacturers, packers, distributors, exporters, importers, and retailers will act to mitigate potential food safety risks in powdered infant formula in accordance with FDA regulations while further striving to improve operations, especially given the critical nature of these products.

Regulations in 21 CFR part 107, subpart E—Recalls (21 CFR 107.200 through 107.280) pertain to infant formula recalls. Specifically, § 107.230 requires manufacturing firms conducting infant formula recalls to:

(1) evaluate the hazard to human health;

(2) devise a written recall strategy;

(3) promptly notify each affected direct-account (customer) about the recall; and

(4) furnish the appropriate FDA district office with copies of these documents.

If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice.

Similarly, regulations in § 107.240 require recalling firms to:

(1) notify the appropriate FDA district office of the recall by telephone within 24 hours;

(2) submit a written report to that office within 14 days; and

(3) submit a written status report at least every 14 days until the recall is terminated.

Before terminating a recall, recalling firms are required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence. Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications. Finally, to facilitate identifying the location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula.

We use the information collection to determine industry compliance with Agency regulations which implement public health protection provisions of the FD&C Act applicable to infants and all infant formula. Respondent disclosures are used by consumers when purchasing, storing, and preparing infant formula to help ensure its safe use.

Section 424(a)(1) of the FD&C Act (21 U.S.C. 350m) requires a manufacturer of a critical food to notify FDA of a permanent discontinuance or an interruption of the manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of the food in the United States. Section 201(ss) of the FD&C Act (21 U.S.C. 321(ss)) defines a “critical food” as a food that is (1) an infant formula or (2) a medical food as defined in section 5(b)(3) of the Orphan Drug Act. A manufacturer of a critical food is required to notify FDA of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption. To help facilitate the process, FDA accepts notifications via email ( CriticalFoodShortage@fda.hhs.gov).

The draft guidance titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula” (December 2024), when finalized, will provide FDA's interpretation regarding the circumstances under which infant formula manufacturers should notify FDA. The draft guidance, available at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​draft-guidance-industry-notifying-fda-permanent-discontinuance-manufacture-or-interruption, provides recommendations for notifications to include certain information and how respondents should notify FDA of a permanent discontinuance or interruption of supply of infant formula.

Section 424(b) of the FD&C Act requires a manufacturer of a critical food to develop, maintain, and implement a redundancy risk management plan that identifies and evaluates risks to the supply of the food ( printed page 44862) for each establishment in which a critical food is manufactured. A risk management plan may identify and evaluate risks to the supply of more than one critical food manufactured at the same establishment. A risk management plan may also identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means. Records of a risk management plan are subject to FDA inspection and copying.

Description of Respondents: Respondents to this information collection are manufacturers of infant formula and include manufacturers of critical foods in the limited instance of a meaningful disruption in the supply of the food in the United States.

We estimate the burden of this collection of information as follows:

The estimates in table 1 are based on our experience with similar notification programs. Regarding activities found in the draft guidance, we estimate that each year 5 manufacturers of infant formula will submit notifications in compliance with section 424(a)(1) of the FD&C Act and following recommendations found in the draft guidance. We also estimate that each year 3 manufacturers of medical foods will submit notifications in compliance with section 424(a)(1) of the FD&C Act, for a total of 8 manufacturers of a critical food. We estimate that each manufacturer will submit 1 notification for 8 total annual notifications (8 manufacturers × 1 notification). Each submission will take an estimated 2 hours to complete for an annual reporting burden of 16 hours (8 notifications × 2 hours).

( printed page 44863)

Regarding recordkeeping found in the draft guidance, we estimate that each year 11 manufacturers of critical foods will create and maintain a risk management plan in compliance with section 424(b) of the FD&C Act. We estimate that each risk management plan will take an estimated 60 hours to create and maintain for an annual recordkeeping burden of 660 hours (11 records × 60 hours).

Based on a review of the information collection since our last request for OMB approval, we are revising the information collection to include activities recommended in the draft guidance titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula.” We are also removing burden associated with the guidance titled “Infant Formula Transition Plan for Exercise of Enforcement Discretion” (September 2022) as we are no longer experiencing disruptions in the supply of infant formula in the United States and therefore did not extend the guidance's in-effect end date. Lastly, we are correcting an inadvertent omission of 22 responses from the previous approval.

The draft guidance added 676 hours and 19 responses to the information collection. We also are adding 22 responses to correct an inadvertent omission. However, removal of the enforcement discretion guidance will reduce the burden estimate by 3,805 hours and 137 responses. Calculating hours and responses for the addition of the draft guidance and the correction along with the subtraction of the enforcement discretion guidance results in a net reduction of 3,129 hours (3,805 hours reduced for enforcement discretion guidance—676 hours added for draft guidance) and 96 responses (137 responses reduced for enforcement discretion guidance—19 responses added for draft guidance—22 responses added for the correction).

91 FR 44859