Document ID: FDA-2008-N-0653-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-01-14T05:00Z

[Federal Register: January 14, 2009 (Volume 74, Number 9)]
[Notices]               
[Page 2080-2081]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ja09-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 March 16, 2009.

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 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: 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

[[Page 2081]]

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 (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) 
(21CFR 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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                      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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: January 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-574 Filed 1-13-09; 8:45 am]

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