Document ID: FDA-2011-N-0797-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: State Enforcement Notifications
Posted Date: 2011-11-09T05:00Z

[Federal Register Volume 76, Number 217 (Wednesday, November 9, 2011)]
[Notices]
[Pages 69742-69743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29058]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements 
contained in existing FDA regulations governing State enforcement 
notifications.

DATES: Submit either electronic or written comments on the collection 
of information by January 9, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 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.
    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.

[[Page 69743]]

    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: November 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29058 Filed 11-8-11; 8:45 am]
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