[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Notices]
[Pages 63181-63182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30982]


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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

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 reinstatement 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 comments on the collection of information by 
January 26, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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, rm. 16B-19, 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 reinstatement 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 listed below.
    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.

[[Page 63182]]

Petition For Administrative Stay of Action--21 CFR Part 10.35 (OMB 
Control Number 0910--0194)--Reinstatement

    Section 10.35 (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)), 
sets 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<SUP>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                                   7               1               7             100             700       
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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 
seven such petitions are received by the agency annually, with each 
requiring approximately 100 hours of preparation time.

    Dated: November 19, 1997
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-30982 Filed 11-25-97; 8:45 am]
BILLING CODE 4160-01-F