Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives, 12690-12692 [2021-04461]
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12690
Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
Center for Food Safety and Applied
Nutrition (CFSAN). Form FDA 3666 is
entitled ‘‘Early Food Safety Evaluation
of a New Non-Pesticidal Protein
Produced by a New Plant Variety (New
Protein Consultation)’’ and may be used
in lieu of a cover letter for a New
Protein Consultation (NPC). The form
may be accessed at FDA’s web page for
forms (https://www.fda.gov/about-fda/
reports-manuals-forms/forms) using the
search term ‘‘3666.’’ To enable fieldfillable functionality of FDA forms, they
must be downloaded. Form FDA 3666
prompts a submitter to include certain
elements of an NPC in a standard format
and helps the respondent organize their
submission to focus on the information
needed for our safety review. The form,
and elements prepared as attachments
to the form, may be prepared using the
CFSAN Online Submission Module
(https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/
cfsan-online-submission-module-cosm).
Once the submission is prepared, it may
be submitted in electronic format via the
Electronic Submissions Gateway
(https://www.fda.gov/industry/
electronic-submissions-gateway), paper
format, or as electronic files on physical
media with paper signature page. We
use this information to evaluate the food
safety of a specific new protein
produced by a new plant variety.
Description of Respondents: The
respondents to this collection of
information are developers of new plant
varieties intended for food use.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
GFI section VI: Format for submission
Average
burden per
response
Total annual
responses
Total hours
First four data components ......................
Two other data components ....................
3666
3666
6
6
1
1
6
6
4
16
24
96
Total ..................................................
........................
........................
........................
........................
........................
120
1 There
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Number of
responses per
respondent
Number of
responses
Form FDA No.
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
estimated number of annual responses
and average burden per response are
based on our experience with early food
safety evaluations. Completing an early
food safety evaluation for a new protein
from a new plant variety is a one-time
burden (one evaluation per new
protein). Many developers of novel
plants may choose not to submit an
evaluation because the field testing of a
plant containing a new protein is
conducted in such a way (e.g., on such
a small scale, or in such isolated
conditions, etc.) that cross-pollination
with traditional crops or commingling
of plant material is not likely to be an
issue. Also, other developers may have
previously communicated with us about
the food safety of a new plant protein,
for example, when the same protein was
expressed in a different crop.
We estimate the annual number of
NPCs submitted by developers will be
six or fewer. The early food safety
evaluation for new proteins includes six
main data components. Four of these
data components, having to do with the
identity and source of the protein, are
easily and quickly obtainable. We
estimate that completing these data
components will take about 4 hours per
NPC.
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis that can be performed using
publicly available databases. The other
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20:27 Mar 03, 2021
Jkt 253001
data component involves ‘‘wet’’ lab
work to assess the new protein’s
stability and the resistance of the
protein to enzymatic degradation using
appropriate in vitro assays (protein
digestibility study). The paperwork
burden of these two data components
consists of the time it takes the company
to assemble the information on these
two data components and include it in
an NPC. We estimate that completing
these data components will take about
16 hours per NPC.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04448 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Food
Labeling; Declaration of Certified and
Non-Certified Color Additives
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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 regulations
requiring the declaration of color
additives on animal food labels.
DATES: Submit either electronic or
written comments on the collection of
information by May 3, 2021.
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 3, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 3, 2021. 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
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–
2009–N–0025 for ‘‘Animal Food
Labeling; Declaration of Certified and
Non-Certified Color Additives.’’
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
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20:27 Mar 03, 2021
Jkt 253001
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-201509-18/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:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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12691
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.
Animal Food Labeling; Declaration of
Certified and Non-Certified Color
Additives—21 CFR 501.22(k)
OMB Control Number 0910–0721—
Extension
FDA has the authority under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to issue regulations
concerning animal food. Specifically,
section 403(i) of the FD&C Act (21
U.S.C. 343(i)) requires that certified
color additives used in or on a food
must be declared by their common or
usual names and not be designated by
the collective term ‘‘colorings.’’ Our
regulations in part 501 (21 CFR part
501) set forth the requirements for
animal food labeling. Under § 501.22(k)
(21 CFR 501.22(k)), animal food
manufacturers must declare on the
animal food label the presence of
certified and noncertified color
additives in their animal food products.
Our animal food labeling regulation at
§ 501.22(k) is consistent with the
regulations requiring the declaration of
color additives on human food labels.
The purpose of the labeling is to provide
animal owners with information on the
color additives used in animal food.
Animal owners use the information to
become knowledgeable about the foods
they purchase for their animals. Color
additive information enables a
consumer to comparison shop and to
avoid substances to which their animals
may be sensitive.
Description of Respondents:
Respondents to this collection of
information are manufacturers of pet
food products that contain color
additives.
FDA estimates the burden of this
collection of information as follows:
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12692
Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification.
3,120
0.8292
2,587
0.25 .............
(15 minutes).
1 There
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04461 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2019–N–3077]
[FR Doc. 2021–04470 Filed 3–3–21; 8:45 am]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Obtaining Information To Understand
and Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that a collection of
information entitled ‘‘Obtaining
Information to Understand and
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
On
December 18, 2020, the Agency
submitted a proposed collection of
information entitled ‘‘Obtaining
Information to Understand and
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities’’ to OMB for
review and clearance under 44 U.S.C.
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:27 Mar 03, 2021
Jkt 253001
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0883. The approval expires on
January 31, 2022. A copy of the
supporting statement for this
information collection is available on
the internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Food and Drug Administration
ACTION:
647
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Total hours
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1228]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Study of Multiple
Indications in Direct-to-Consumer
Television Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 April 5,
2021.
SUMMARY:
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
ADDRESSES:
PO 00000
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Sfmt 4703
by using the search function. The title
of this information collection is ‘‘Study
of Multiple Indications in Direct-toConsumer Television Advertisements.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Study of Multiple Indications in Directto-Consumer Television Advertisements
OMB Control Number 0910–NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act.
The Office of Prescription Drug
Promotion’s (OPDP) mission is to
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have
consistently conducted research to
evaluate the aspects of prescription drug
promotion that are most central to our
mission, focusing in particular on three
main topic areas: (1) Advertising
features, including content and format;
(2) target populations; and (3) research
quality. Through the evaluation of
advertising features, we assess how
elements such as graphics, format, and
disease and product characteristics
impact the communication and
E:\FR\FM\04MRN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12690-12692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0025]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Food Labeling; Declaration of Certified and
Non-Certified Color Additives
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 regulations requiring the declaration of color additives on animal
food labels.
DATES: Submit either electronic or written comments on the collection
of information by May 3, 2021.
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 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 3, 2021. 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
[[Page 12691]]
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-2009-N-0025 for ``Animal Food Labeling; Declaration of Certified
and Non-Certified Color Additives.'' 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: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Animal Food Labeling; Declaration of Certified and Non-Certified Color
Additives--21 CFR 501.22(k)
OMB Control Number 0910-0721--Extension
FDA has the authority under the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to issue regulations concerning animal food.
Specifically, section 403(i) of the FD&C Act (21 U.S.C. 343(i))
requires that certified color additives used in or on a food must be
declared by their common or usual names and not be designated by the
collective term ``colorings.'' Our regulations in part 501 (21 CFR part
501) set forth the requirements for animal food labeling. Under Sec.
501.22(k) (21 CFR 501.22(k)), animal food manufacturers must declare on
the animal food label the presence of certified and noncertified color
additives in their animal food products. Our animal food labeling
regulation at Sec. 501.22(k) is consistent with the regulations
requiring the declaration of color additives on human food labels. The
purpose of the labeling is to provide animal owners with information on
the color additives used in animal food. Animal owners use the
information to become knowledgeable about the foods they purchase for
their animals. Color additive information enables a consumer to
comparison shop and to avoid substances to which their animals may be
sensitive.
Description of Respondents: Respondents to this collection of
information are manufacturers of pet food products that contain color
additives.
FDA estimates the burden of this collection of information as
follows:
[[Page 12692]]
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
501.22(k); labeling of color additive or lake 3,120 0.8292 2,587 0.25.............................. 647
of color additive; labeling of color additives (15 minutes)......................
not subject to certification.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04461 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P
