4164-01-P
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.
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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
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 0910-0275. 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, 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 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 § 100.2 (21 CFR
100.2). The information required in a letter of notification under § 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:
21 CFR Section; Activity

Table 1.--Estimated Annual Reporting Burden1
No. of
No. of Responses per Total Annual
Respondents
Respondent
Responses

Average Burden Total Hours
per Response

100.2(d); notification
1
1
1
10
10
are no capital costs or operating and maintenance costs associated with this collection of information.

1There

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
§ 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: 6/17/2024 8:45 am; Publication Date: 6/18/2024]