[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