Document ID: FDA-2011-N-0797-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; State Enforcement Notifications
Posted Date: 2012-02-29T05:00Z

[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12308-12309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4776]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0797]

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 March 
30, 2012.

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 oira_submission@omb.eop.gov. 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: Denver Presley, II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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

    Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 337(b)) authorizes States to

[[Page 12309]]

enforce certain sections of the FD&C Act in their own names, but 
provides that States must notify FDA before doing so. Section 100.2(d) 
(21 CFR 100.2(d)) sets forth the information that a State must provide 
to FDA in a letter of notification when it intends to take enforcement 
action under the FD&C Act against a particular food located in the 
State. The information required under Sec.  100.2(d) will enable FDA to 
identify the food against which the State intends to take action and 
advise the State whether Federal action has been taken against it. With 
certain narrow exceptions, Federal enforcement action precludes State 
action under the FD&C Act.
    In the Federal Register of November 9, 2011 (76 FR 69742), 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.

    The estimated reporting burden for Sec.  100.2(d) is minimal 
because enforcement notifications are seldom used by States. During the 
last 3 years, FDA has not received any new enforcement notifications; 
therefore, the Agency estimates that one or fewer notifications will be 
submitted annually. Although FDA has not received any new enforcement 
notifications in the last 3 years, it believes these information 
collection provisions should be extended to provide for the potential 
future need of a State government to submit enforcement notifications 
informing FDA when it intends to take enforcement action under the FD&C 
Act against a particular food located in the State.

    Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4776 Filed 2-28-12; 8:45 am]
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