[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Notices]
[Pages 22959-22960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10779]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0143]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 May
28, 1997.
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: Margaret 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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507) FDA has submitted the following proposed collection of
information to OMB for review and clearance.
Citizen Petition--21 CFR Part 10.30--(OMB Control Number 0910-
0183--Reinstatement)
The Administrative Procedure 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.
[[Page 22960]]
The information is used by the agency to determine the need for, 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 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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10.30 120 1 120 12 1,440
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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 of burden on fiscal year 1995 data
in which there were 120 petitions filed that each took an estimated 12
hours to complete.
Dated: April 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10779 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F
