Document ID: FDA-2018-N-0074-0006
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
Posted Date: 2021-05-12T04:00Z

[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26046-26047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09968]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0074]

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 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 June 11, 2021.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
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 its own name and within its 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 December 17, 2020 (85 FR 81932), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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100.2(d)...........................................................               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

[[Page 26047]]

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, we believe 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: May 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09968 Filed 5-11-21; 8:45 am]
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