Document ID: FDA-2008-N-0063-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements
Posted Date: 2008-05-08T04:00Z

[Federal Register: May 8, 2008 (Volume 73, Number 90)]
[Notices]               
[Page 26119]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my08-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0063] (formerly Docket No. 2008N-0016)

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Exports: Notification 
and Recordkeeping Requirements

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 June 9, 
2008.

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 baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0482. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Exports: Notification and Recordkeeping Requirements--(OMB Control 
Number 0910-0482)--Extension

    The respondents to this information collection are exporters who 
have notified FDA of their intent to export unapproved products that 
may not be sold or marketed in the United States as allowed under 
section 801(e) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 381(e)). In general, the notification identifies the product 
being exported (e.g. name, description, and in some cases, country of 
destination) and specifies where the notification should be sent. These 
notifications are sent only for an initial export; subsequent exports 
of the same product to the same destination (or, in the case of certain 
countries identified in section 802(b) of the act (21 U.S.C. 382(b)), 
to any of those countries would not result in a notification to FDA.
    The recordkeepers to this information collection are exporters who 
export human drugs, biologics, devices, animal drugs, foods and 
cosmetics that may not be sold in the United States to maintain records 
demonstrating their compliance with the requirements in section 
801(e)(1) of the act.
    The total burden estimate of 39,120 is based on the number of 
notifications received by the relevant FDA centers in fiscal year 2007, 
or the last year the figures were available.
    In the Federal Register of January 28, 2008 (73 FR 4874), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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1.101(d) and (e)                 400                  3              1,200                 15             18,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
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1.101(b) and (c)                 320                  3                960                 22             21,120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10204 Filed 5-7-08; 8:45 am]

BILLING CODE 4160-01-S