Document ID: FDA-2008-N-0397-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2008-11-18T05:00Z

[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]               
[Page 68430-68431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no08-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0397]

 
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 
December 19, 2008.

[[Page 68431]]

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: 202-395-6974, or e-mailed 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:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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--(OMB Control Number 0910-0275--
Extension)

    Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections 
of the 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 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 
act.
    In the Federal Register of July 18, 2008 (73 FR 41360), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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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                                                           No. of        Annual Frequency  per      Total Annual        Hours Per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
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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 act 
against a particular food located in the State.

    Dated: November 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-27258 Filed 11-18-08; 8:45 am]

BILLING CODE 4160-01-S