[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
[Notices]
[Pages 67655-67656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1093]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Additive Petitions and Investigational Food 
Additive Exemptions; Extension

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 a 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 food.

DATES: Submit electronic or written comments on the collection of 
information by January 14, 2013.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Drive, PI50-
400B, Rockville, MD 20850, 301-796-3794.

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 and Investigational Food Additive Exemptions, 
21 CFR 570.17 and 571 (OMB Control Number 0910-0546)--Extension

    Section 409(a) of the Federal Food, Drug and Cosmetic Act (FD&C 
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 FD&C Act specifies

[[Page 67656]]

the information that must be submitted by a petitioner in order to 
establish the safety of a food additive and to secure the issuance of a 
regulation permitting its use.
    To implement the provisions of section 409 of the FD&C Act, 
procedural regulations have been issued under 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 FD&C Act. The regulations add no substantive 
requirements to those indicated in the FD&C Act, but attempt to explain 
these requirements and provide a standard format for submission to 
speed processing of the petition. Labeling requirements for food 
additives intended for animal consumption are also set forth in various 
regulations contained in parts 501, 573, and 579. 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.
    With regard to the investigational use of food additives, section 
409(j) of the FD&C Act provides that any food additive or any food 
bearing or containing such an additive, may be exempted from the 
requirements of this section if intended solely for investigational use 
by qualified experts. Investigational use of a food additive is 
typically to address the safety and/or intended physical or technical 
effect of the additive.
    To implement the provisions of section 409(j), regulations have 
been issued under 21 CFR 570.17. These regulations are designed to 
specify more thoroughly the information that must be submitted to meet 
the requirement set down in broad terms by the FD&C Act. Labeling 
requirements for investigational food additives are also set forth in 
various regulations contained in part 501. The labeling regulations are 
considered by FDA to be cross referenced to Sec.  570.17, which is the 
subject of this same OMB clearance for investigational food additive 
files.
    FDA estimates the burden of this collection of information as 
follows:

                     Table 1--Estimated Annual Reporting Burden \1\ Food Additive Petitions
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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571.1(c) Moderate Category......               1               1               1           3,000           3,000
571.1(c) Complex Category.......               1               1               1          10,000          10,000
571.6 Amendment of Petition.....               2               2               4           1,300           5,200
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    Total Hours.................               4               4               6          14,300          18,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 1 petition of this type is received on an annual 
basis, resulting in a burden of 3,000 hours.
    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 1 petition of this type is received on an annual basis, 
resulting in a burden of 10,000 hours.
    Sec.  571.6: For a food additive petition amendment, the estimated 
time requirement per petition is approximately 1,300 hours. An average 
of 4 petitions of this type is received on an annual basis, resulting 
in a burden of 5,200 hours.

                Table 2--Estimated Annual Reporting Burden \1\ Investigation Food Additive Files
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                                                     Number of                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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570.17 Moderate Category........               9               1               9           1,500          13,500
570.17 Complex Category.........               4               1               4           5,000          20,000
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    Total Hours.................              13               2              13           6,500          33,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Sec.  570.17 Moderate Category: For an investigational food 
additive file without complex chemistry, manufacturing, efficacy, or 
safety issues, the estimated time requirement per file is approximately 
1,500 hours. An average of 9 files of this type are received on an 
annual basis, resulting in a burden of 13,500 hours.
    Sec.  570.17 Complex Category: For an investigational food additive 
file with complex chemistry, manufacturing, efficacy, and/or safety 
issues, the estimated time requirement per file is approximately 5,000 
hours. An average of 4 files of this type are received on an annual 
basis, resulting in a burden of 20,000 hours.

    Dated: November 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27485 Filed 11-9-12; 8:45 am]
BILLING CODE 4160-01-P