[Federal Register Volume 71, Number 170 (Friday, September 1, 2006)]
[Notices]
[Pages 52124-52125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14510]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0328]


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 October 31, 2006.

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 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 (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), FDA. 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 (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 anymore. 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 food additive petitions 
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.
    Under Sec.  571.1(c) complex category, for a food additive petition 
with

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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.

                                                     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                                                                   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.


    Dated: August 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14510 Filed 8-31-06; 8:45 am]
BILLING CODE 4160-01-S