[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Page 1142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-261]



[[Page 1142]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1511]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Petition for Administrative Reconsideration of 
Action

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
February 5, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (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.

Petition for Administrative Reconsideration of Action--21 CFR 10.33 
(OMB Control Number 0910-0192)--Extension

    The regulations in 21 CFR 10.33, issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(a)), set forth the 
format and procedures by which an interested person may petition the 
Commissioner of Food and Drugs (the Commissioner) for reconsideration 
of an agency action. A petition for reconsideration must contain a full 
statement in a well-organized format of the factual and legal grounds 
upon which the petition relies. The grounds must demonstrate that 
relevant information and views contained in the administrative record 
were not previously or adequately considered by the Commissioner. Each 
petition must be submitted no later than 30 days after the decision 
involved. The Commissioner may, for good cause, permit a petition to be 
filed after 30 days. An interested person who wishes to rely on 
information or views not included in the administrative record shall 
submit them with a new petition to modify the decision. FDA uses the 
information provided to determine whether to grant the petition for 
reconsideration. Respondents to this collection of information are 
individuals of households, State or local governments, not-for-profit 
institutions, and businesses or other for-profit institutions.
    In the Federal Register of September 25, 2000 (65 FR 57615), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
    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              No. of        Frequency per    Total Annual      Hours per      Total Hours
                                  Respondents       Response         Responses       Response
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10.33(b)                             12                1               12              10            120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate for this collection of information is based on 
agency records and experience over the past 3 years. Agency personnel 
handling the petitions for administrative reconsideration of an action 
estimate approximately 12 requests being received by the agency 
annually, each requiring an average of 10 hours preparation time.

    Dated: December 27, 2000.
Margaret M. Dotzel,
Associate Commisioner for Policy.
[FR Doc. 01-261 Filed 1-4-01; 8:45 am]
BILLING CODE 4160-01-F