[Federal Register: November 1, 2005 (Volume 70, Number 210)]
[Notices]
[Page 65904-65905]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no05-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0426]
Agency Information Collection Activities; Proposed Collection;
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 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 reporting requirements for
filing a notice of participation with FDA.
DATES: Submit written or electronic comments on the collection of
information by January 3, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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 Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4659.
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 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.
Notice of Participation--21 CFR 12.45 (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), 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
[[Page 65905]]
businesses, or other for profit groups and institutions.
FDA estimates the burden of this collection of information as
follows:
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Annual Frequency
21 CFR Section No. of Respondents per Response Total Annual Responses Hours per 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: October 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21774 Filed 10-31-05; 8:45 am]
BILLING CODE 4160-01-S