
[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Page 83417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26250]


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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.

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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, 
[email protected].

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 Sec.  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\
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                                                                                         Number of
                      21 CFR section; activity                          Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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100.1; petition for exemption from preemption......................               1                1                1               40               40
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The reporting burden for Sec.  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


