[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]
BILLING CODE 4160-01-S