[Federal Register Volume 68, Number 218 (Wednesday, November 12, 2003)]
[Notices]
[Pages 64110-64111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0481]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Additive Petitions

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on food additive petitions.

DATES: Submit written or electronic comments on the collection of 
information by January 12, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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/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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Food Additive Petitions--21 CFR Part 571

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed 
to be unsafe unless its use is permitted by a regulation that 
prescribes the condition(s) under which it may safely be used, or 
unless it is exempted by regulation for investigational use. Section 
409(b) of the act specifies the information that must be submitted by a 
petition in order to establish the safety of a food additive and to 
secure the issuance of a regulation permitting its use.
    To implement the provision of section 409 of the act, procedural 
regulations have been issued under part 571 (21 CFR part 571). These 
procedural regulations are designed to specify more thoroughly the 
information that must be submitted to meet the requirement set down in 
broader terms by the law. The regulations add no substantive 
requirements to those indicated in the law, but attempt to explain the 
requirements and provide a standard format for submission to speed the 
processing of the petition. Labeling requirements for food additives 
intended for animal consumption are also set forth in various 
regulations contained in 21 CFR parts 572, 573, and 580. The labeling 
regulations are considered by FDA to be cross referenced to Sec.  
571.1, which is the subject of this same OMB clearance for food 
additive petitions.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                                              Annual
                        Number of            Frequency        Total Annual           Hours per
 21 CFR Section     [chyph]Respondents      [chyph]per      [chyph]Responses      [chyph]Response    Total Hours
                                             Response
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 571.1(c)        1                        1               1                     1,800                1,800
 moderate
 category
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571.1(c)         1                        1               1                     6,000                6,000
 complex
 category
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571.6            2                        2               4                     1,300                5,200
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[[Page 64111]]

 
TOTAL            4                        4               6                     9,100                13,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: November 4, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28252 Filed 11-10-03; 8:45 am]
BILLING CODE 4160-01-S