Notice2024-13388
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
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
June 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 118 (Tuesday, June 18, 2024)</title>
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[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51533-51534]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13388]
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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.
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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 July 18, 2024.
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 0910-0275. 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,
<a href="/cdn-cgi/l/email-protection#e8b8baa9bb9c898e8ea88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="b6e6e4f7e5c2d7d0d0f6d0d2d798dedec598d1d9c0">[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 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 Sec. 100.2 (21 CFR 100.2). The information required
in a letter of notification under Sec. 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:
[[Page 51534]]
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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100.2(d); notification............................................. 1 1 1 10 10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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 Sec. 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 6-17-24; 8:45 am]
BILLING CODE 4164-01-P
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