2023-26250. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption

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, [e-mail].

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 hours
100.1; petition for exemption from preemption	1	1	1	40	40
1  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.