[Federal Register Volume 71, Number 220 (Wednesday, November 15, 2006)]
[Notices]
[Pages 66541-66543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0328]


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 
December 15, 2006.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

[[Page 66542]]

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 (21 U.S.C. 348(b)) 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 (21 U.S.C. 
348), 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 573 and 
582. 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.
    On September 29, 2004, OMB approved a new information collection on 
food additive petitions submitted by the Center for Veterinary Medicine 
(CVM). The terms of clearance for this information collection stated 
that, given the interrelatedness of this collection to the information 
collected under OMB control number 0910-0016 by the Center for Food 
Safety and Applied Nutrition (CFSAN), FDA should consider merging the 
two collections. In consultation with CFSAN, CVM has decided not to 
merge these two collections, because what was once a food additive 
petitions approval (OMB control number 0910-0016), is now also the 
approval for affirmation of generally recognized as safe (GRAS) status 
(formerly OMB control number 0910-0132), labeling requirements for 
color additives (other than hair dyes) and petitions (formerly OMB 
control number 0910-0185), electronic submission of food and color 
additive petitions (formerly OMB control number 0910-0480), and 
substances approved for use in the preparation of meat and poultry 
products (formerly OMB control number 0910-0461). Thus, adding one CVM 
process to a collection now containing four dissimilar CFSAN processes 
is not justifiable any more. Finally, the CVM food additive petition 
process stems from a different section of the CFR and the two processes 
are handled separately. CVM's food additive petition process relates to 
part 571; CFSAN's process relates to 21 CFR part 171. There is no 
efficiency in discussing these separate processes in a single 
collection of information.
    Respondents are expected to be the veterinary feed industry.
    FDA estimates the burden of this collection of information as 
follows:
    The estimated annual burden for this information collection is 
18,000 hours.
    Food additive petitions submitted to CVM are estimated to fall into 
one of two categories of complexity that also can be used to represent 
estimates of the information collection burden for food additive 
petitions. These include only expected petitions for food additives not 
eligible for exemption under new section 409(h) of the act (21 U.S.C. 
348(h)).
    Under Sec.  571.1(c) moderate category, for a 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 petition of this type is received on an 
annual basis, resulting in a burden of 3,000 hours.
    Under Sec.  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.
    Under Sec.  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 are received on an annual 
basis, resulting in a burden of 5,200 hours.
    In the Federal Register of September 1, 2006 (71 FR 52124), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     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                                                                   2                     2                  4              1,300              5,200
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Total                                                                                                                                             18,200
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 66543]]

    Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19201 Filed 11-14-06; 8:45 am]
BILLING CODE 4160-01-S