
[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65173-65174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20451]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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: Submit written comments (including recommendations) on the 
collection of information by October 23, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0016. Also include the FDA docket 
number found in brackets in the heading of this document.

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: 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 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. 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 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). 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, 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.

[[Page 65174]]

    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.
    In the Federal Register of February 1, 2023 (88 FR 6757), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    We estimate 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 burden                   operating and
        Activity/21 CFR section; or FDA form No.            respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         costs
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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
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\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 FAPs or CAPs is based on our 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.
    CAPs 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: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20451 Filed 9-20-23; 8:45 am]
BILLING CODE 4164-01-P


