[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Page 64751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31051]
[[Page 64751]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0405]
Agency Information Collection Activities: Proposed Collection;
Reinstatement
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,
Federal agencies are required to publish notice in the Federal Register
concerning each proposed collection of information, including each
proposed reinstatement 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 comments on the collection of information by
February 4, 1997.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Peggy R. Wolff, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(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
reinstatement 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 listed below.
With respect to the following collection of information, FDA
invites comments on: (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--
Reinstatement)
Under the part 12 (21 CFR part 12) regulations issued under
sections 201-903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321-393), any interested person may participate in a formal evidentiary
hearing, either personally or through a representative by filing a
notice of participation under Sec. 12.45. Section 12.45 requires that
any person filing a notice of participation state the person's 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, in 21 CFR 13.25, concerning disclosure of data and information
by participants. A participant's appearance can be struck by the
presiding officer in accordance with Sec. 12.45(e).
The information obtained is used by the presiding officer and other
participants in a hearing to identify specific interests to be
presented. This preliminary information serves to expedite the
prehearing conference and commits participation.
The affected 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:
Estimated Annual Reporting Burden
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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12.45 92 1 92 3 276
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There are no capital costs or operating and maintenance costs associated with this collection of information.
The agency bases this estimate on fiscal year 1995 data in which
each notice of participation filed took an estimated 3 hours to
complete.
Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31051 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F
