
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55922-55923]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23106]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0625]


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 either electronic or written comments on the collection 
of information by November 8, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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

[[Page 55923]]

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

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

    The regulations 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)), set 
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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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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12.22..............................................................               3                1                3               20               60
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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 three requests are received by the 
Agency annually, with each requiring approximately 20 hours of 
preparation time.

    Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23106 Filed 9-8-11; 8:45 am]
BILLING CODE 4160-01-P


