[Federal Register Volume 65, Number 186 (Monday, September 25, 2000)]
[Notices]
[Pages 57614-57615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24537]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0472]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Petition for Administrative Stay 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 filing a 
petition for administrative stay of 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. 3501093520), 
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: (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 Stay of Action--21 CFR 10.35 (OMB 
Control Number 0910-0194)--Reinstatement)--Extension

    The regulations in 21 CFR 10.35, issued under the authority of 
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 file a petition for an administrative stay of action.
    Respondents to this information collection are interested persons 
who choose to file a petition for an administrative stay of action. 
Such a petition must: (1) Identify the decision involved; (2) state the 
action requested, including the length of time for which a stay is 
requested; and (3) include a statement of the factual and legal grounds 
on which the interested person relies in seeking the stay. The 
information provided in the petition is used by the agency to determine 
whether the requested stay should be granted.
    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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10.35...........................              13               1              13              10            130
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 57615]]

    The burden estimate for this collection of information is based on 
FDA's experience with petitions for administrative stay of action over 
the past 3 years. Agency personnel responsible for processing the 
filing of petitions for administrative stays of action estimate that 13 
such petitions are received by the agency annually, with each requiring 
approximately 10 hours of preparation time.

    Dated: September 19, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24537 Filed 9-22-00; 8:45 am]
BILLING CODE 4160-01-F