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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-D-0814]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
 DATES: Submit written comments (including recommendations) on the collection of information by October 30, 2023.
 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 
                        *https://www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0256. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Infant Formula Requirements Under the Federal Food, Drug, and Cosmetic Act—21 CFR Parts 106 and 107 OMB Control Number 0910-0256—Revision This information collection supports FDA regulations, and associated Agency forms and guidance, pertaining to infant formula requirements. Statutory provisions for infant formula under the Federal Food, Drug, and Cosmetic Act (FD&C Act) were enacted to protect the health of infants and include specific current good manufacturing practice, labeling (disclosure), and a number of reporting and recordkeeping requirements. Section 412 of the FD&C Act (21 U.S.C. 350a) requires manufacturers of infant formula to establish and document the adherence to quality control procedures, notify FDA when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of infant formula distribution. Notification requirements are also included in the regulations regarding the quantitative formulation of the infant formula; a description of any reformulation or change in processing; assurances that the formula will not be marketed until regulatory requirements are met as demonstrated by specific testing; and assurances that manufacturing processes comply with the regulations. The regulations are found in 21 CFR part 106: Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications; and part 107 (21 CFR part 107): Infant Formula. In the 
                    **Federal Register**
                     of October 6, 2022 (87 FR 60689), we provided notice communicating updates to the information collection and invited public comment on the proposed 
                    ( print page 67304)
                    collections of information. No comments were received. On our own initiative, for efficiency of Agency operations, we are again revising the information collection to include related activities applicable to regulations in part 107, subpart E (21 CFR 107.200 through 107.280) pertaining to infant formula recalls. These information collections are currently approved in OMB control number 0910-0188. Specifically, 21 CFR 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, Agency regulations in 21 CFR 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 (21 CFR 107.250). 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 (21 CFR 107.260). 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 (§ 107.280 (21 CFR 107.280)). We estimate the burden of the collection of information as follows: Table 1—Estimated Annual Reporting Burden 1
21 CFR section; activity
Number of
                             respondents
Number of
                             responses per respondent
Total annual
                             responses
Average
                             burden per 
                             response
Total hours107.230; Elements of infant formula recall
2
1
2
4,450
8,900107.240; Notification requirements
2
1
2
1,482
2,964107.250; Termination of infant formula recall
2
1
2
120
240107.260; Revision of an infant formula recall
1
1
1
625
625Total




12,7291
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The reporting and third-party disclosure burden estimates are based on current available data showing eight manufacturers of infant formula and that there have been, on average, two infant formula recalls per year for the past 3 years. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. Accordingly, because we believe that associated records are maintained as a usual and customary part of normal business activities, we include no separate burden estimate for recordkeeping requirements found in § 107.280. Table 2—Estimated Annual Third-Party Disclosure Burden 1
21 CFR section; activity
Number of
                             respondents
Number of
                             disclosures 
                             per 
                             respondent
Total annual
                             disclosures
Average
                             burden per 
                             disclosure
Total hours107.230; Elements of infant formula recall
2
1
2
50
100107.260; Revision of an infant formula recall
1
1
1
25
25Total




1251
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Although we have increased the number of respondents to the information collection since our last request for OMB approval, we have made no adjustments to the burden we estimate for the time necessary to complete activities associated with infant formula recalls. Dated: September 26, 2023. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2023-21432 Filed 9-28-23; 8:45 am] BILLING CODE 4164-01-P