[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15188-15190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05447]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0908]


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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 Form FDA 3503.

DATES: Submit either electronic or written comments on the collection 
of information by May 18, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 18, 2020. 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.

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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2020-N-0908 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; and Electronic 
Submission Using Food and Drug Administration Form 3503.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 Dockets Management Staff. 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 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/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

[[Page 15189]]

docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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--Revision

    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: (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.
    Respondents 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 (CFSAN) 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.
    We are revising the information collection to reflect ongoing 
modernization efforts. We have augmented our FDA Unified Registration 
and Listing System (FURLS) with the CFSAN Online Submission Module 
(``COSM''). The COSM provides a real-time user interface process we 
believe will assist respondents in preparing and making submissions to 
Offices in CFSAN. The COSM is a web-based tool that supports electronic 
submissions, thereby eliminating the need for printing and mailing of 
paper submissions. COSM is available 24 hours a day and seven days a 
week. Information submitted to COSM is the same information respondents 
would submit to the FURLS system. Information about COSM, including 
user instruction, is available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
    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.
    We estimate the burden of this collection of information as 
follows:

[[Page 15190]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
                   21 CFR section/form                      respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         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
Form FDA 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.

    Our estimate of burden attributable to food additive or color 
additive petitions is based on our experience with the information 
collection, which has not changed since our last review, and we 
therefore retain the currently approved burden. This estimate reflects 
the average number of petitions we have received annually over a period 
of 10 years. The attendant burden we estimate also reflects an industry 
average, although burden associated with individual petitions may vary 
depending on the complexity of the petition, and the amount and type of 
data needed for scientific analysis.
    Color additive petitions are subject to fees. 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. Sec.  70.25 and 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: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05447 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P