[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Notices]
[Pages 14717-14718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7893]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0489]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
April 26, 1998.
[[Page 14718]]
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collections
of information to OMB for review and clearance.
Petition For Administrative Reconsideration of Action--21 CFR
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:
Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
10.33(b) 7 1 7 10 70
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Due to a typographical error, the total burden hours were reported
as 700 in FDA's December 16, 1997 (62 FR 65812), notice providing 60
days for public comment on this collection of information. The total
has been corrected to 70. 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 10
hours preparation time.
Dated: March 18, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-7893 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F
