
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24718-24720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11009]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2010-N-0258]


Agency Information Collection Activities; Proposed Collection; 
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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the 
information collection provisions of FDA's regulations for submission 
of petitions, including food and color additive petitions (FAPs and 
CAPs) (including labeling) submission of information to a master file 
in support of petitions, and electronic submission using FDA Form 3503.

DATES: Submit either electronic or written comments on the collection 
of information by July 31, 2017. Late, untimely filed comments will not 
be considered. Electronic comments must be submitted on or before July 
31, 2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of July 31, 
2017. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0258 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Submission of Petitions: Food 
Additive, Color Additive (Including Labeling); Submission of 
Information to a Master File in Support of Petitions; Electronic 
Submission Using Food and Drug Administration Form 3503.'' Received 
comments, those filed in a timely manner (see DATES), will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of

[[Page 24719]]

comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov, 301-796-
7726.

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.

Submission of Petitions: Food Additive, Color Additive (Including 
Labeling); Submission of Information to a Master File in Support of 
Petitions; Electronic Submission Using FDA Form 3503--21 CFR 70.25, 
71.1, 171.1, 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 Sec.  409 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 Sec.  409(h) is effective. FAPs are 
submitted by individuals or companies to obtain approval of a new food 
additive or to amend the conditions of use permitted 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 in order 
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 Sec.  721(f). 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, devices, or cosmetics be labeled with sufficient information to 
ensure their safe use.
    FDA scientific personnel reviews 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, cosmetics, or medical devices.
    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 FDA Form 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                 21 CFR section/FDA form                    respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Color Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 24720]]

 
                                                                 Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1...................................................               3               1               3           7,093          21,279               0
FDA Form 3503...........................................               6               1               6               1               6               0
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...............................................  ..............  ..............  ..............  ..............          23,959          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 the requested amendment. A complete 
schedule of fees is set forth in Sec.  70.19. An average of one 
Category A and one Category B color additive petition is expected per 
year. The maximum color additive petition fee for a Category A petition 
is $2,600 and the maximum color additive petition fee for a Category B 
petition is $3,000. Because an average of 2 CAPs are expected per 
calendar year, the estimated total annual cost burden to petitioners 
for this startup cost would be less than or equal to $5,600 ((1 x 
$2,600) + (1 x $3,000) listing fees = $5,600). There are no capital 
costs associated with CAPs. The labeling requirements for food and 
color additives were designed to specify the 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. Label 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. Label 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.  70.25 and Sec.  71.1, and the burden hours 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: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11009 Filed 5-26-17; 8:45 am]
 BILLING CODE 4164-01-P


