Document ID: FDA-2010-N-0595-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exports; Notification and Recordkeeping Requirements
Posted Date: 2011-07-08T04:00Z

[Federal Register Volume 76, Number 131 (Friday, July 8, 2011)]
[Notices]
[Pages 40376-40377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17140]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0595]

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 August 
8, 2011.

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 e-mailed to oira_submission@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 Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794; Jonna.Capezzuto@fda.hhs.gov.

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--21 CFR Part 1 
(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 FD&C 
Act (21 U.S.C. 381)). 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 FD&C 
Act (21 U.S.C. 382) 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 and maintain 
records demonstrating their

[[Page 40377]]

compliance with the requirements in section 801(e)(1) of the FD&C Act.
    In the Federal Register of December 6, 2010 (75 FR 75677), 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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                                                                                           Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
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1.101 (d)..........................................................             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
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                                                                                           Annual
                           21 CFR section                               Number of       frequency of     Total annual      Hours per       Total hours
                                                                      record-keepers   recordkeeping       records        recordkeeper
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1.101(b), (c), (e).................................................             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: July 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17140 Filed 7-7-11; 8:45 am]
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