[Federal Register: December 27, 2004 (Volume 69, Number 247)]
[Notices]
[Page 77255-77256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de04-77]

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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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]

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