[Federal Register Volume 83, Number 125 (Thursday, June 28, 2018)]
[Notices]
[Pages 30447-30448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13868]


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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) 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: Fax written comments on the collection of information by July 
30, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#5e31372c3f012d2b3c33372d2d3731301e31333c703b312e70393128"><span class="__cf_email__" data-cfemail="b6d9dfc4d7e9c5c3d4dbdfc5c5dfd9d8f6d9dbd498d3d9c698d1d9c0">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0275. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#247476657750454242644240450a4c4c570a434b52"><span class="__cf_email__" data-cfemail="08585a495b7c696e6e486e6c692660607b266f677e">[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.

[[Page 30448]]

State Enforcement Notifications

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 February 7, 2018 (83 FR 5438), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment in support of the 
information collection.
    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 part                                 Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents      respondents       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Section 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.

    The estimated burden for this information collection has not 
changed since the last OMB approval. 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, 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: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13868 Filed 6-27-18; 8:45 am]
BILLING CODE 4164-01-P


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