[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20661-20662]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07892]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Additive 
Petitions and Investigational Food Additive Exemptions

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 May 6, 
2013.

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 emailed 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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.capezzuto@fda.hhs.gov.

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 and Investigational Food Additive Exemptions--
(OMB Control Number 0910-0546)--Extension

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
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 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 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 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 (21 CFR 
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) of the FD&C Act, 
regulations have been issued under Sec.  570.17 (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. In the Federal 
Register of November 13, 2012, (75 FR 67655), 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 No. of       No. of  responses     Total annual     Average  burden
                      21 CFR Section                          respondents      per  respondent       responses        per  response       Total hours
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                                                                 Food Additive Petitions
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571.1(c) moderate category...............................                  1                  1                  1              3,000              3,000
517.1(c) complex category................................                  1                  1                  1             10,000             10,000
517.1(c) complex category................................                  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.

    Section 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.
    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 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 four 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\
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                                                                 No. of       No. of  responses     Total annual     Average  burden
                      21 CFR Section                          respondents      per  respondent       responses        per  response       Total hours
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                                                            Investigation Food Additive Files
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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
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             33,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Section 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 nine files of this type is received on an 
annual basis, resulting in a burden of 13,500 hours.
    Section 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 four files of this type is received on an 
annual basis, resulting in a burden of 20,000 hours.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07892 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P