[Federal Register: December 30, 2002 (Volume 67, Number 250)]
[Notices]
[Page 79639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de02-102]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0282]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Notice of Participation
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
January 29, 2003.
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.
Notice of Participation (OMB Control Number 0910-0191)--Extension
The regulations in Sec. 12.45 (21 CFR 12.45), issued under section
701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371), sets
forth the format and procedures for any interested person to file a
petition to participate in a formal evidentiary hearing, either
personally or through a representative. Section 12.45 requires that any
person filing a notice of participation state their specific interest
in the proceedings, including the specific issues of fact about which
the person desires to be heard. Section 12.45 also requires that the
notice include a statement that the person will present testimony at
the hearing and will comply with specific requirements in 21 CFR 12.85,
or in the case of a hearing before a Public Board of Inquiry (21 CFR
13.25), concerning disclosure of data and information by participants.
In accordance with Sec. 12.45(e), the presiding officer may omit a
participant's appearance. The presiding officer and other participants
will use the collected information in a hearing to identify specific
interests to be presented. This preliminary information serves to
expedite the prehearing conference and commits participation. The
respondents are individuals or households, State or local governments,
not-for-profit institutions, and businesses or other for-profit groups
and institutions.
In the Federal Register of July 18, 2002 (67 FR 47387), 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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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12.45 340 1 340 3 1,020
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The agency bases this estimate on past notices filed in which each
notice of participation took an estimated 3 hours to complete.
Dated: December 20, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32849 Filed 12-27-02; 8:45 am]
BILLING CODE 4160-01-S