[Federal Register Volume 64, Number 155 (Thursday, August 12, 1999)]
[Notices]
[Pages 44018-44019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2553]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Citizen Petition

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 extension 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 
contained in existing FDA regulations relative to a participant's right 
to petition for issuance amendment or repeal of a rule.

DATES: Submit written comments on the collection of information by 
October 12, 1999.

ADDRESSES:  Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 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 extension 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 set forth in this document.
     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--
Extension)

    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 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, nonprofit institutions and

[[Page 44019]]

businesses or other for-profit institutions or groups.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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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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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 6, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-20794 Filed 8-11-99; 8:45 am]
BILLING CODE 4160-01-F