[Federal Register: November 29, 2002 (Volume 67, Number 230)]
[Notices]
[Page 71178-71179]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no02-91]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0280]
Agency Information Collection Activities; Submission for OMB
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 the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments on the collection of information by
December 29, 2002.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Stuart Shapiro, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (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
The provision 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)), sets
forth the instructions for
[[Page 71179]]
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 July 8, 2002 (67 FR 45125), 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:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
No. of Frequency Total Hours Total
21 CFR Section Respondents per Annual per Hours
Response Responses Response
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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.
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 10 requests are received by the agency
annually, with each requiring approximately 20 hours of preparation
time.
Dated: November 21, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-30157 Filed 11-27-02; 8:45 am]
BILLING CODE 4160-01-S