88 FR 228 pg. 83417 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Type: NOTICEVolume: 88Number: 228Page: 83417
Page: 83417Docket number: [Docket No. FDA-2023-N-2707]
FR document: [FR Doc. 2023-26250 Filed 11-28-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2707]
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, 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:
| 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.
[FR Doc. 2023-26250 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P