Document ID: FDA-2008-N-0653-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-04-03T04:00Z

[Federal Register: April 3, 2009 (Volume 74, Number 63)]
[Notices]               
[Page 15295-15296]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap09-39]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0653]

 
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 May 4, 
2009.

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: 202-395-6974, or e-mailed 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:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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

    The regulations in 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)), 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.
    In the Federal Register of January 14, 2009 (74 FR 2080), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 15296]]

                                  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                           5                     1                  5                 20                100
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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 five requests are received 
by the agency annually, with each requiring approximately 20 hours of 
preparation time.

    Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7472 Filed 4-2-09; 8:45 am]

BILLING CODE 4160-01-S