Document ID: FDA-2010-N-0595-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Exports; Notification and Recordkeeping Requirements
Posted Date: 2010-12-06T05:00Z

[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75677-75678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30433]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 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 the notification and 
recordkeeping requirements for persons exporting human drugs, 
biological products, devices, animal drugs, food, and cosmetics that 
may not be marketed or sold in the United States.

DATES: Submit either electronic or written comments on the collection 
of information by February 4, 2011.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug

[[Page 75678]]

Administration, 1350 Piccard Dr., PI50-410B, Rockville, MD 20850, 301-
796-3794, E-mail: Jonnalynn.Capezzuto@fda.hhs.gov.

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.

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 for this information collection export human 
drugs, biologics, devices, animal drugs, foods, and cosmetics that may 
not be sold in the United States and maintain records demonstrating 
their compliance with the requirements in section 801(e)(1) of 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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                                                                                           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) to (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
                        21 CFR Section                              Number of       frequency per     Total annual    Hours per record     Total hours
                                                                  recordkeepers     recordkeeping        records
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1.101 (b) to (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: November 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30433 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P