[Federal Register: March 16, 2006 (Volume 71, Number 51)]
[Notices]
[Page 13602-13603]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr06-49]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0426]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 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 April
17, 2006.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (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
Section 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. This section also requires that the notice
include a statement that the person will present testimony at the
hearing and will comply with specific requirements in Sec. 12.85, or,
in the case of a hearing before a Public Board of Inquiry (21 CFR
13.25). 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 pre-
hearing 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 November 1, 2005 (70 FR 65904), FDA
published a 60-day notice requesting public comment on the information
collection provisions to which one comment was received. However, it
was not related to the information collection.
[[Page 13603]]
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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12.45 264 1 264 3 792
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3819 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S