
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2867-2868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-783]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 18, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0546. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food Additive Petitions (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 of the act. 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.
    In the Federal Register of October 6, 2009 (74 FR 51287), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 2868]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of        Annual Frequency of     Total Annual        Hours  per
                    21 CFR Section                         Respondents           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               1300              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.

    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 one petitions of this type is received on an annual 
basis, resulting in a burden of 3,000 hours.
    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 one petition of this type is received on an annual basis, 
resulting in a burden of 10,000 hours.
    571.6: For a food additive petition amendment, the estimated time 
requirement per petition is approximately 1,300 hours. An average of 
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: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-783 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S


