[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Pages 64751-64752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31052]


[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--

    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]