[Federal Register Volume 67, Number 130 (Monday, July 8, 2002)]
[Notices]
[Pages 45125-45126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0280]


Agency Information Collection Activities; Proposed Collection; 
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 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 
objections and requests for a hearing on a regulation or order.

DATES: Submit written or electronic comments on the collection of 
information by September 6, 2002.

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

[[Page 45126]]

(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 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.

Filing Objections and Requests for a Hearing on a Regulation or Order--
21 CFR Part 12 (OMB Control No. 0910-0184)--Extension

    Section 12.22 (21 CFR 12.22), issued under section 701(e)(2) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(2)), 
sets forth the instructions for 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                               Annual Frequency per                             Hours per
                   21 CFR Section                       No. of Respondents           Response         Total Annual Responses    Response     Total Hours
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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: June 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17075 Filed 7-5-02; 8:45 am]
BILLING CODE 4160-01-S