[Federal Register Volume 62, Number 241 (Tuesday, December 16, 1997)]
[Notices]
[Pages 65812-65813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32805]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0489]


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 proposed 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 parties 
filing a petition for administrative reconsideration of an action.

DATES: Submit written comments on the collection of information by 
February 17, 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, 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

[[Page 65813]]

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.

Petition For Administrative Reconsideration of Action--21 CFR Part 
10.33--(OMB Control Number 0910-0192)--Reinstatement

    Section 10.33 (21 CFR 10.33), issued under section 701(a) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets 
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's 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 not 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:

                                       Estimated Annual Reporting Burden1                                       
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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)                                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 
agency records and experience over the past 3 years. Agency personnel 
handling the petitions for administrative reconsideration of an action 
estimate approximately seven requests being received by the agency 
annually, each requiring an average of 100 hours preparation time.

    Dated: December 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32805 Filed 12-15-97; 8:45 am]
BILLING CODE 4160-01-F