
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39793-39795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0258]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Submission of 
Petitions: Food Additive, Color Additive (Including Labeling), 
Submission of Information to a Master File in Support of Petitions; and 
Electronic Submission Using Food and Drug Administration Form 3503

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 
September 21, 2017.

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 0910-0016 and 
title ``Submission of Petitions: Food Additive, Color Additive 
(Including Labeling), Submission of Information to a Master File in 
Support of Petitions; and Electronic Submission Using Food and Drug 
Administration Form 3503.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@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.
    Submission of Petitions: Food Additive, Color Additive (Including 
Labeling), Submission of Information to a Master File in Support of 
Petitions; and Electronic Submission Using Food and Drug Administration 
Form 3503--21 CFR 70.25, 71.1, and 171.1, and 21 CFR parts 172, 173, 
179, and 180; OMB Control Number 0910-0016--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: (1) The additive and its use, or intended 
use, are in conformity with a regulation issued under section 409 of 
the FD&C Act that describes the condition(s) under which the additive 
may be safely used; (2) the additive and its use, or intended use, 
conform to the terms of an exemption for investigational use; or (3) a 
food contact notification submitted under section 409(h) is effective. 
Food additive petitions (FAPs) are submitted by individuals or 
companies to obtain approval of a new food additive or to amend the 
conditions of use permitted

[[Page 39794]]

under an existing food additive regulation. Section 171.1 of FDA's 
regulations (21 CFR 171.1) specifies the information that a petitioner 
must submit to establish that the proposed use of a food additive is 
safe and to secure the publication of a food additive regulation 
describing the conditions under which the additive may be safely used. 
Parts 172, 173, 179, and 180 (21 CFR parts 172, 173, 179, and 180) 
contain labeling requirements for certain food additives to ensure 
their safe use.
    Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a 
color additive shall be deemed to be unsafe unless the additive and its 
use are in conformity with a regulation that describes the condition(s) 
under which the additive may safely be used, or the additive and its 
use conform to the terms of an exemption for investigational use issued 
under section 721(f). Color additive petitions (CAPs) are submitted by 
individuals or companies to obtain approval of a new color additive or 
a change in the conditions of use permitted for a color additive that 
is already approved. Section 71.1 of the Agency's regulations (21 CFR 
71.1) specifies the information that a petitioner must submit to 
establish the safety of a color additive and to secure the issuance of 
a regulation permitting its use. FDA's color additive labeling 
requirements in Sec.  70.25 (21 CFR 70.25) require that color additives 
that are to be used in food, drugs, medical devices, or cosmetics be 
labeled with sufficient information to ensure their safe use.
    FDA scientific personnel review FAPs to ensure the safety of the 
intended use of the additive in or on food, or that may be present in 
food as a result of its use in articles that contact food. Likewise, 
FDA personnel review CAPs to ensure the safety of the color additive 
prior to its use in food, drugs, medical devices, or cosmetics.
    Interested persons may transmit FAP or CAP regulatory submissions 
in electronic format or paper format to the Office of Food Additive 
Safety in the Center for Food Safety and Applied Nutrition using Form 
FDA 3503. Form FDA 3503 helps the respondent organize their submission 
to focus on the information needed for FDA's safety review. Form FDA 
3503 can also be used to organize information within a master file 
submitted in support of petitions according to the items listed on the 
form. Master files can be used as repositories for information that can 
be referenced in multiple submissions to the Agency, thus minimizing 
paperwork burden for food and color additive approvals. FDA estimates 
that the amount of time for respondents to complete Form FDA 3503 will 
continue to be 1 hour.
    Description of Respondents: Respondents are businesses engaged in 
the manufacture or sale of food, food ingredients, color additives, or 
substances used in materials that come into contact with food.
    In the Federal Register of May 30, 2017 (82 FR 24718), 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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                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
                 21 CFR section/FDA form                    respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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                                                                Color Additive Petitions
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70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
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                                                                 Food Additive Petitions
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171.1...................................................               3               1               3           7,093          21,279               0
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FDA Form 3503...........................................               6               1               6               1               6               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,959           5,600
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\1\ There are no capital costs associated with this collection of information.

    The estimate of burden for food additive or color additive 
petitions is based on FDA's experience with the petition process. The 
burden for this information collection has changed since the last OMB 
approval because the Generally Recognized as Safe affirmations have 
been removed pursuant to the implementation of ``Substances Generally 
Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR 
parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior 
estimate of the number of petitions received because the average number 
of petitions received annually has varied little over the past 10 
years. The figures for hours per response are based on estimates from 
experienced persons in the Agency and in industry. Although the 
estimated hour burden varies with the type of petition submitted, an 
average petition involves analytical work and appropriate toxicological 
studies, as well as the work of drafting the petition itself. The 
burden varies depending on the complexity of the petition, including 
the amount and types of data needed for scientific analysis.
    Color additives are subjected to payment of fees for the 
petitioning process. The listing fee for a color additive petition 
ranges from $1,600 to $3,000, depending on the intended use of the 
color additive and the scope of minimum information needed for labeling 
in order that food and color manufacturers may comply with all 
applicable provisions of the FD&C Act and other specific labeling acts 
administered by FDA. Labeling information does not require any 
additional information gathering beyond what is already required to 
assure conformance with all specifications and limitations in any given 
food or color additive regulation. Labeling information does not have 
any specific recordkeeping requirements unique to preparing the label. 
Therefore, because labeling requirements under Sec.  70.25 for a 
particular color additive involve information required as part of the 
CAP safety review process, the estimate for number of respondents is 
the same for Sec. Sec.  70.25 and 71.1, and the burden hours

[[Page 39795]]

for labeling are included in the estimate for Sec.  71.1. Also, because 
labeling requirements under parts 172, 173, 179, and 180 for particular 
food additives involve information required as part of the FAP safety 
review process under Sec.  171.1, the burden hours for labeling are 
included in the estimate for Sec.  171.1.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17703 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P


