Notice2023-26250
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 228 (Wednesday, November 29, 2023)</title>
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[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Page 83417]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#91c1c3d0c2e5f0f7f7d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b">[email protected]</span></a>.
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
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