[Federal Register Volume 81, Number 39 (Monday, February 29, 2016)]
[Notices]
[Pages 10250-10252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04228]


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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 March 
30, 2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 10251]]

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 (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 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.
    In the Federal Register of October 21, 2015 (80 FR 63795), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate 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
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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571.1(c) Moderate Category......              12               1              12           3,000          36,000
571.1(c) Complex Category.......              12               1              12          10,000         120,000
571.6 Amendment of Petition.....               2               1               2           1,300           2,600
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    Total Hours.................  ..............  ..............  ..............  ..............         158,600
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We base our estimate of the total annual responses on submissions 
received during fiscal years 2014 and 2015. We base our estimate of the 
hours per response upon our experience with the petition and filing 
processes.
    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. 
We estimate that, annually, 12 respondents will each submit 1 such 
petition, for a total of 36,000 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. 
We estimate that, annually, 12 respondents will each submit 1 such 
petition, for a total of 120,000 hours.
    571.6: For a food additive petition amendment, the estimated time 
requirement per petition is approximately 1,300 hours. We estimate 
that, annually, 2 respondents will each submit 1 such amendment, for a 
total of 2,600 hours.

               Table 2--Estimated Annual Reporting Burden \1\ Investigational Food Additive Files
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                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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570.17 Moderate Category........               4               1               4           1,500           6,000
570.17 Complex Category.........               5               1               5           5,000          25,000
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    Total Hours.................  ..............  ..............  ..............  ..............          31,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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. 
We estimate that, annually, 4 respondents will each submit 1 such file, 
for a total of 6,000 hours.
    570.17 complex category: For an investigational food additive file 
with

[[Page 10252]]

complex chemistry, manufacturing, efficacy, and/or safety issues, the 
estimated time requirement per file is approximately 5,000 hours. We 
estimate that, annually, 5 respondents will each submit 1 such file, 
for a total of 25,000 hours.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04228 Filed 2-26-16; 8:45 am]
BILLING CODE 4164-01-P