4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2023-N-5656] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA, 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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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 0910-0275. 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. State Enforcement Notifications--21 CFR 100.2(d) OMB Control Number 0910-0275--Extension This information collection supports Agency regulations. Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain sections of the FD&C Act in their own name and within their own jurisdiction. However, before doing so, a State must provide notice to FDA according to § 100.2 (21 CFR 100.2). The information required in a letter of notification under § 100.2(d) enables us to identify the food against which a State intends to take action and to advise that State whether Federal enforcement action against the food has been taken or is in process. With certain narrow exceptions, Federal enforcement action precludes State action under the FD&C Act. In the Federal Register of January 23, 2024 (89 FR 4315), we published a 60-day notice soliciting comment on the proposed collection of information. No comments were received. We estimate the burden of this collection of information as follows: 21 CFR Section; Activity Table 1.--Estimated Annual Reporting Burden1 No. of No. of Responses per Total Annual Respondents Respondent Responses Average Burden Total Hours per Response 100.2(d); notification 1 1 1 10 10 are no capital costs or operating and maintenance costs associated with this collection of information. 1There Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. The estimated reporting burden for § 100.2(d) is minimal because enforcement notifications are seldom used by States. During the last 3 years, we have not received any new enforcement notifications; therefore, we estimate that one or fewer notifications will be submitted annually. Although we have not received any new enforcement notifications in the last 3 years, these information collection provisions should be extended to provide for the potential future need of a State government to submit enforcement notifications informing us when it intends to take enforcement action under the FD&C Act against a particular food located in the State. Dated: June 13, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-13388 Filed: 6/17/2024 8:45 am; Publication Date: 6/18/2024]