[Federal Register Volume 85, Number 165 (Tuesday, August 25, 2020)]
[Notices]
[Pages 52353-52354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18602]


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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 September 24, 2020.

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: 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, 
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; Electronic Submission Using Form FDA 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 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) of the FD&C Act 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 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) of the FD&C Act. 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, 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

[[Page 52354]]

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). COSM provides a real-time user interface process we believe 
will assist respondents in preparing and making submissions to Offices 
in 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 seven days a 
week. Information submitted to COSM is the same information respondents 
would submit to FURLS. 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 March 17, 2020 (85 FR 15188), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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                      operating and
                  21 CFR section; form                      respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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                                                                           CAP
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70.25, 71.1.............................................               2               1               2           1,337           2,674          $5,600
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                                                                          FAPs
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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 FAPs or CAPs 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.
    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 Sec.  70.19. An average of one Category A and one 
Category B color additive petition is expected per year. The maximum 
CAP 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: August 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18602 Filed 8-24-20; 8:45 am]
BILLING CODE 4164-01-P


