[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Notices]               
[Page 18030-18031]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0541]

 
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 May 9, 
2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4659.

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
    In the Federal Register of December 27, 2004 (69 FR 77255), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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 were 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)

[[Page 18031]]

 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), 
would not result in a notification to FDA.
    The recordkeepers for 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.

                                 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          Respondent        Total Hours
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1.101(d) and (e)                 419                2.8              1,164                 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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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section     Recordkeepers        per Record          Records          Recordkeeper       Total Hours
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1.101(b) and (c)                 324                2.8                901                 26            23,426
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7023 Filed 4-7-05; 8:45 am]

BILLING CODE 4160-01-S