Document ID: FDA-2008-N-0063-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements
Posted Date: 2008-01-28T05:00Z

[Federal Register: January 28, 2008 (Volume 73, Number 18)]
[Notices]               
[Page 4874-4875]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja08-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2008N-0017]

 
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 written or electronic comments on the collection of 
information by March 28, 2008.

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 the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 
801(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
381). In general, the notification identifies the product being

[[Page 4875]]

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), 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 available. 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     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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1.101 (d)-(e)                    400                  3               1200                 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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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours
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1.101 (b)-(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.

    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: January 18, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1356 Filed 1-25-08; 8:45 am]

BILLING CODE 4160-01-S