[Federal Register: November 16, 2005 (Volume 70, Number 220)]
[Notices]               
[Page 69577-69578]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16no05-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0427]

 
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 January 17, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(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: Jonna Capezzuto, Office of Management 
Programs (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 these topics: (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 Number 0910-0184)--Extension

    Under part 12 (21 CFR part 12), Sec.  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). 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 Sec.  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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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          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.


[[Page 69578]]

    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 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22753 Filed 11-15-05; 8:45 am]

BILLING CODE 4160-01-S