Document ID: FDA-2020-N-0908-0005
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2023-02-01T05:00Z

[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6757-6759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02046]

[[Page 6757]]

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

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.

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

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 (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: Either electronic or written comments on the collection of 
information must be submitted by April 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 3, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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, 240-402-7500.
     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 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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

[[Page 6758]]

    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; and Electronic Submission Using Form

FDA 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 (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 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. 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 section 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, cosmetics, or medical devices 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, 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.
    We improved the information collection by using the CFSAN Online 
Submission Module (COSM). COSM provides a real-time user interface 
process that assists respondents in preparing and making submissions to 
CFSAN. 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 7 days a week. 
Further 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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                             Number of       Number of     Total annual   Average burden                   operating and
        Activity/21 CFR section; or FDA form No.            respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Petitions: Color Additive Including                      2               1               2           1,337           2,674          $5,600
 Labeling--70.25 and 71.1...............................
Submission of Petitions: Food Additive Including                       3               1               3           7,093          21,279               0
 Labeling--171.1........................................
Form FDA 3503 \2\.......................................               5               1               5               1               5               0
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............          23,958          $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
\2\ Form FDA 3503 is used for both CAPs and FAPs.

    We have adjusted our burden estimate, which has resulted in a 
decrease to the currently approved burden by 1 hour. Our estimate of 
burden attributable to food additive or color additive petitions is 
based on our

[[Page 6759]]

experience with the information collection, which has not changed since 
our last review, and 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 
CAP 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 21 CFR 70.19. An average of one 
Category A and one Category B CAP is expected per year. The maximum CAP 
fee for a Category A petition is $2,600, and the maximum CAP fee for a 
Category B petition is $3,000. Because an average of two 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). 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: January 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02046 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P