Federal Register, Volume 62 Issue 241 (Tuesday, December 16, 1997)

[Federal Register Volume 62, Number 241 (Tuesday, December 16, 1997)]
[Notices]
[Pages 65812-65813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32805]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0489]

Agency Information Collection Activities: Proposed Collection;
Comment Request

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
(the PRA), 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 requirements for parties
filing a petition for administrative reconsideration of an action.

DATES: Submit written comments on the collection of information by
February 17, 1998.

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: 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

[[Page 65813]]

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.

Petition For Administrative Reconsideration of Action--21 CFR Part
10.33--(OMB Control Number 0910-0192)--Reinstatement

Section 10.33 (21 CFR 10.33), issued under section 701(a) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(a)), sets
forth the format and procedures by which an interested person may
petition the Commissioner of Food and Drugs (the Commissioner) for
reconsideration of an agency's action. A petition for reconsideration
must contain a full statement in a well-organized format of the factual
and legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. Each petition must be submitted no later than 30
days after the decision involved. The Commissioner may, for good cause,
permit a petition to be filed after 30 days. An interested person who
wishes to rely on information or views not included in the
administrative record shall submit them with a new petition to modify
the decision. FDA uses the information provided to determine whether to
grant the petition for reconsideration. Respondents to this collection
of information are individuals of households, state or local
governments, not-for-profit institutions, and businesses or other for-
profit institutions.
FDA estimates the burden of this collection of information as
follows:

Estimated Annual Reporting Burden^{1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
10.33(b) 7 1 7 100 700
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The burden estimate for this collection of information is based on
agency records and experience over the past 3 years. Agency personnel
handling the petitions for administrative reconsideration of an action
estimate approximately seven requests being received by the agency
annually, each requiring an average of 100 hours preparation time.

Dated: December 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32805 Filed 12-15-97; 8:45 am]
BILLING CODE 4160-01-F}