[Federal Register Volume 69, Number 247 (Monday, December 27, 2004)]
[Notices]
[Pages 77255-77256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0541]


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 February 25, 2005.

ADDRESSES: Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit written comments 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 Management 
Programs (HFA-250), Food and Drug

[[Page 77256]]

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 total burden estimate of 43,214 is based on the number of 
notifications received by the relevant FDA centers in fiscal year 2004, 
or the last year the figures available.
    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). 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), 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.
    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) through (e)               419                  2.8          1164              17          19,788
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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   Total Annual         Hours per
 21 CFR Section  No. of Recordkeepers   of Recordkeeping      Records         Recordkeeper         Total Hours
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1.101(b)                324                     2.8           901                 26               23,426
 through (c)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28137 Filed 12-23-04; 8:45 am]
BILLING CODE 4160-01-S