[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Notices]
[Pages 57615-57616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24538]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1511]


Agency Information Collection Activities; Proposed Collection; 
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 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 requirements for parties 
filing a petition for administrative reconsideration of an action.

DATES: Submit written or electronic comments on the collection of 
information by November 24, 2000.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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:  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:  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 a 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: (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.

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                       Number of       Annual frequency     Total annual        Hours per
  21 CFR section      respondents       per  response        responses           response         Total hours
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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.


[[Page 57616]]

    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: September 19, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24538 Filed 9-22-00; 8:45 am]
BILLING CODE 4160-01-F