[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Pages 64751-64752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0406]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Reinstatement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 the filing of citizen
petitions with FDA.
DATES: Submit written comments on the collection of information by
February 4, 1997.
[[Page 64752]]
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.
Citizen Petition--21 CFR 10.30 (OMB Control Number 0910-0183--
Reinstatement)
The Administrative Procedures Act (5 U.S.C. 553(e)), provides that
every agency shall accord any interested person the right to petition
for issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR
10.30) provides that any person may submit to the agency a citizen
petition requesting the Commissioner of Food and Drugs to issue, amend,
or revoke a regulation or order, or to take or refrain from taking any
other form of administrative action.
The information is used by the agency to determine the need or
desirability of the requested action and also to determine if the
submitted information is sufficient to support the action. FDA
determines whether or not to grant the petition based on the
information submitted.
The affected respondents are individuals or households, state or
local governments, not-for-profit institutions and businesses or other
for-profit institutions or groups.
FDA estimates the burden resulting from the requirements of
Sec. 10.30 as follows:
Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.30 120 1 120 12 1,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
The agency bases this estimate of burden on fiscal year 1995 data
in which there were 120 petitions filed that each took an estimated 12
hours to complete.
Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31052 Filed 12-5-96; 8:45 am]
BILLING CODE 4160-01-F
