[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Notices]
[Page 10977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0427]


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 
3, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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

    Under part 12 (21 CFR part 12), Sec.  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 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.
    In the Federal Register of November 16, 2005 (70 FR 69577), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                           No. of        Annual Frequency  per      Total Annual        Hours per
                   21 CFR Section                       Respondents             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.


    Dated: February 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3020 Filed 3-2-06; 8:45 am]
BILLING CODE 4160-01-S