Document ID: FDA-2011-N-0625-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Filing Objections and Requests for Hearing on Regulation or Order
Posted Date: 2012-03-16T04:00Z

[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15763-15764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6393]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
16, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0184. 
Also include the FDA 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., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 15764]]

collection of information to OMB for review and clearance.

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 Sec.  12.24 (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 accordance with 5 CFR 1320.8(d), FDA published a 60-day notice 
for public comment in the Federal Register of September 9, 2011 (76 FR 
55922), to which the Agency received two comments. However, these 
comments did not address the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       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: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6393 Filed 3-15-12; 8:45 am]
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