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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2023-N-2707]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) 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 December 29, 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 0910-0277. Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
                        *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. State Petitions for Exemption From Preemption OMB Control Number 0910-0277—Extension This information collection supports FDA regulations. Under section 403A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343-1(b)), States may petition FDA for exemption from Federal preemption of State food labeling and standard-of-identity requirements. Section 100.1(c) (21 CFR 100.1(c)) provides prerequisites a petition must satisfy for an exemption from preemption. Section 100.1(d) sets forth the information a State is required to submit in such a petition. The petition must be submitted to the Dockets Management Staff. The information required under § 100.1 enables FDA to determine whether the State food labeling or standard-of-identity requirement satisfies the criteria of section 403A(b) of the FD&C Act for granting exemption from Federal preemption. In the 
                    **Federal Register**
                     of July 31, 2023 (88 FR 49469), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four information collection topics solicited. *Description of Respondents:*
                     The respondents to this collection of information are State and local governments who regulate food labeling and standards-of-identity. We estimate the burden of this 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 hours100.1; petition for exemption from preemption
1
1
1
40
401
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The reporting burden for § 100.1 is minimal because petitions for exemption from preemption are seldom submitted by States. In the next 3 years, we estimate that one or fewer petitions will be submitted annually. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: November 24, 2023. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2023-26250 Filed 11-28-23; 8:45 am] BILLING CODE 4164-01-P