[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55918-55919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0624]
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 either electronic or written comments on the collection
of information by November 8, 2011.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B,
Rockville, MD 20850, 301-796-7726, [email protected].
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
[[Page 55919]]
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 21 CFR 12.85, or,
in the case of a hearing before a Public Board of Inquiry, concerning
disclosure of data and information by participants (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
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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12.45........................... 4 1 4 3 12
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimates for this collection of information are based
on Agency records and experience over the past 3 years.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23105 Filed 9-8-11; 8:45 am]
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