[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1144-1145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-266]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0472]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 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.
    In the Federal Register of September 25, 2000 (65 FR 57614), 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:

[[Page 1145]]



                                Table 1. -- Estimated Annual Reporting Burden\1\
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   21 CFR                            Annual Frequency     Total Annual
   Section     No. of Respondents      per Response         Responses      Hours per Response      Total Hours
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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.

    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: December 27, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-266 Filed 1-4-01; 8:45 am]
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