[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Notices]
[Pages 52330-52331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-4069]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Notice of Participation; Extension
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 comments on the collection of information by
November 29, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (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: 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: 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 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.
[[Page 52331]]
Notice of Participation--21 CFR 12.45 (OMB Control Number 0910-
0191--Extension)
Under 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:
Table 1.--Estimated Annual Reporting Burden1
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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 30 1 30 3 90
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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 an average for the period 1996
through 1998 in which each notice of participation filed took an
estimated 3 hours to complete.
Dated: September 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-25101 Filed 9-27-99; 8:45 am]
BILLING CODE 4160-01-F
