Document ID: FDA-2009-N-0465-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-10-06T04:00Z

[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]               
[Page 51287-51288]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0465]

 
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, 
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 food additive petitions 
regarding animal feed.

DATES: Submit written or electronic comments on the collection of 
information by December 7, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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 Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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 (OMB Control Number 0910-
0546)--Extension

    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 which 
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 seek to explain the 
requirements and provide a standard format for submission of petitions, 
that when implemented, will speed up the time for processing. Labeling 
requirements for food additives intended for animal consumption are 
also set forth in various regulations contained in 21 CFR parts 573, 
582, and 584. 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:

[[Page 51288]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                   No. of      Annual Frequency  Total Annual    Hours per
        21 CFR Section           Respondents     per Response      Responses     Response        Total Hours
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571.1(c) moderate category                 1                  1             1         3,000                3,000
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571.1(c) complex category                  1                  1             1        10,000               10,000
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571.6 amendment of petition                2                  2             4         1,300                5,200
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Total Hours                                                                                               18,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA derived the annual reporting burden estimate for the different 
categories as follows:
    Section 571.1(c)--moderate category: For food additive petition 
without complex chemistry, manufacturing, efficacy, or safety issues, 
the estimated time requirement per petition is approximately 3,000 
hours. An average of 1 (one) petitions of this type is received on an 
annual basis, resulting in a burden of 3,000 hours.
    Section 571.1(c)--complex category: For a food additive petition 
with complex chemistry, manufacturing, efficacy, and/or safety issues, 
the estimated time requirement per petition is approximately 10,000 
hours. An average of 1 (one) petition of this type is received on an 
annual basis, resulting in a burden of 10,000 hours.
    Section 571.6: For a food additive petition amendment, the 
estimated time requirement per petition is approximately 1,300 hours. 
An average of 4 (four) petitions of this type is received on an annual 
basis, resulting in a burden of 5,200 hours.
    Thus, the estimated total annual burden for this information 
collection is 18,200 hours.

    Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24047 Filed 10-05-09; 8:45 am]

BILLING CODE 4160-01-S