Notice2023-20451
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 182 (Thursday, September 21, 2023)</title>
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[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65173-65174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#f0a0a2b1a384919696b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="b3e3e1f2e0c7d2d5d5f3d5d7d29ddbdbc09dd4dcc5">[email protected]</span></a>.
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: <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm</a>.
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
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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
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