[Federal Register Volume 67, Number 230 (Friday, November 29, 2002)]
[Notices]
[Pages 71178-71179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0280]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Filing Objections and Requests for a Hearing 
on a Regulation or Order

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 
December 29, 2002.

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: 
Stuart Shapiro, 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.

Filing Objections and Requests for a Hearing on a Regulation or Order 
(OMB Control Number 0910-0184)--Extension

    The provision in 21 CFR 12.22, issued under section 701(e)(2) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), sets 
forth the instructions for

[[Page 71179]]

filing objections and requests for a hearing on a regulation or order 
under Sec.  12.20(d) (21 CFR 12.20(d)). Objections and requests must be 
submitted within the time specified in Sec.  12.20(e). Each objection, 
for which a hearing has been requested, must be separately numbered and 
specify the provision of the regulation or the proposed order. In 
addition, each objection must include a detailed description and 
analysis of the factual information and any other document, with some 
exceptions, supporting the objection. Failure to include this 
information constitutes a waiver of the right to a hearing on that 
objection. FDA uses the description and analysis to determine whether a 
hearing request is justified. The description and analysis may be used 
only for the purpose of determining whether a hearing has been 
justified under 21 CFR 12.24 and do not limit the evidence that may be 
presented if a hearing is granted. Respondents to this information 
collection are those parties that may be adversely affected by an order 
or regulation.
    In the Federal Register of July 8, 2002 (67 FR 45125), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
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                                    Annual
                        No. of    Frequency    Total      Hours    Total
   21 CFR Section    Respondents     per       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
12.22                      10           1         10        20      200
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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 
past filings. Agency personnel responsible for processing the filing of 
objections and requests for a public hearing on a specific regulation 
or order, estimate approximately 10 requests are received by the agency 
annually, with each requiring approximately 20 hours of preparation 
time.

    Dated: November 21, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30157 Filed 11-27-02; 8:45 am]
BILLING CODE 4160-01-S