Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration of Color Additives on Animal Food Labels, 56277-56279 [2021-22045]
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1022]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Reporting
Associated With Food Additive
Petitions, Investigational Food
Additive Files Exemptions, and
Declaration of Color Additives on
Animal Food Labels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 associated with
food additive petitions, investigational
food additive files exemptions, and
declaration of color additives on animal
food labels.
DATES: Submit either electronic or
written comments on the collection of
information by December 7, 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 December 7,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 7, 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.
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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
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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–
2021–N–1022 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Reporting
Associated with Food Additive
Petitions, Investigational Food Additive
Files Exemptions, and Declaration of
Color Additives on Animal Food
Labels.’’ 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
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56277
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: 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.
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
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
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.
Reporting Associated With Food
Additive Petitions, Investigational Food
Additive Files Exemptions, and
Declaration of Color Additives on
Animal Food Labels—21 CFR 501.22(k),
570.17, 571.1, and 571.6
OMB Control Number 0910–0546—
Extension
This information collection supports
FDA regulations as discussed below. In
this notice, we are combining all
reporting burden associated with FDA’s
regulations §§ 501.22(k), 570.17, 571.1,
and 571.6 (21 CFR 501.22(k), 570.17,
571.1, and 571.6) into one collection
and are consolidating the burden for
OMB control numbers 0910–0546 and
OMB control number 0910–0721. Upon
approval of the consolidated collection
OMB control number 0910–0546, we
will ask OMB to discontinue OMB
control number 0910–0721. The
information collection provisions
approved under OMB control numbers
0910–0546, and 0910–0721 are similar
in that they support FDA’s regulations
§§ 501.22(k), 570.17, 571.1, and 571.6.
Thus, with this notice, FDA proposes to
consolidate these collections of
information into one OMB control
number for government efficiency and
to allow the public to look to one OMB
control number for all reporting
associated with FDA’s regulations
§§ 501.22(k), 570.17, 571.1, and 571.6.
Food Additive Petitions and
Investigational Food Additive Files
Exemptions
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 its use is permitted by a
regulation which prescribes the
condition(s) under which it may safely
be used, or unless it is exempted by
regulation for investigational use.
Section 409(b) of FD&C Act specifies the
information that must be submitted by
a petitioner in order to establish the
safety of a food additive and to secure
the issuance of a regulation permitting
its use.
To implement the provisions of
section 409 of the FD&C Act, we issued
procedural regulations under 21 CFR
part 571. These procedural regulations
are designed to specify more thoroughly
the information that must be submitted
to meet the requirement set down in
broader terms by the FD&C Act. The
regulations add no substantive
requirements to those indicated in the
FD&C Act but attempt to explain these
requirements and provide a standard
format for submission to speed
processing of the food additive petition.
Labeling requirements for food additives
intended for animal consumption are
also set forth in various regulations
contained in parts 501, 573, and 579 (21
CFR parts 501, 573, and 579). The
labeling regulations are considered by
FDA to be cross-referenced to § 571.1,
which is the subject of this same OMB
clearance for food additive petitions.
Regarding the investigational use of
food additives, section 409(j) of the
FD&C Act provides that any food
additive or any food bearing or
containing such an additive may be
exempted from the requirements of this
section if intended solely for
investigational use by qualified experts.
Investigational use of a food additive is
typically to address the safety and/or
intended physical or technical effect of
the additive. To implement the
provisions of section 409(j) of the FD&C
Act, we issued regulations under
§ 570.17. These regulations are designed
to specify more thoroughly the
information that must be submitted to
meet the requirement set down in broad
terms by the FD&C Act. Labeling
requirements for investigational food
additive files are also set forth in
various regulations contained in part
501. The labeling regulations are
considered by FDA to be crossreferenced to § 570.17, which is the
subject of this same OMB clearance for
investigational food additive files.
The information collected is
necessary to protect the public health.
We use the information submitted by
food manufacturers or food additive
manufacturers to ascertain whether the
data establish the identity of the
substance, justify its intended effect in/
on the food, and establish that its
intended use in/on food is safe.
Animal Food Labeling; Declaration of
Certified and Non-Certified Color
Additives
FDA has the authority under the
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 set forth the
requirements for animal food labeling.
Under § 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.
Description of Respondents:
Respondents to this collection of
information are manufacturers of animal
food products that contain color
additives or are manufacturers of food
additives.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
Food Additive Petitions
571.1(c) Moderate Category ..............................................
571.1(c) Complex Category ...............................................
571.6 Amendment of Petition ..........................................
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6
5
5
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1
1
1
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6
5
5
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3,000
10,000
1,300
18,000
50,000
6,500
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Total annual
responses
Average burden
per response
Total hours
Investigational Food Additive Files
570.17
570.17
Moderate Category ..............................................
Complex Category ...............................................
6
7
1
1
6
7
1,500
5,000
9,000
35,000
Color Additives
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
647
Total Hours .................................................................
........................
........................
........................
..........................
119,147
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
* (15 minutes).
For the purpose of this consolidation,
we base our estimate of the total annual
responses on submissions received
during fiscal years 2019 and 2020. We
base our estimate of the hours per
response on our experience with the
labeling, food additive petition, and
filing processes.
The information collection reflects a
net decrease of 70,453 hours (189,600
OMB approved hours—119,147
estimated hours). We also experienced a
net increase of 2,587 responses from 35
OMB approved annual responses to
2,616 estimated annual responses.
These changes were due to the
consolidating of the information
collection covered by OMB control
number 0910–0721 and due to
estimated changes of the number of
respondents for food additive petitions
and investigational food additive files.
Section 571.1(c) Moderate Category:
The estimated time requirement per
food additive petition remains at
approximately 3,000 hours; however,
we now estimate that the number of
annual respondents has decreased from
12 to 6 respondents for a total of 18,000
hours.
Section 571.1(c) Complex Category:
The estimated time requirement per
food additive petition remains at
approximately 10,000 hours; however,
we now estimate that the number of
annual respondents has decreased from
12 to 5 respondents for a total of 50,000
hours.
Section 571.6 Amendment of
Petition: We estimated that the number
of annual respondents that will submit
an amendment has increased from two
to five respondents who will each
submit one amendment for a total of
6,500 hours. This is an increase of three
respondents and 3,900 hours from the
burden approved by OMB.
Section 570.17 Moderate Category:
We estimated that the number of annual
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respondents for investigational food
additive files has increased from four to
six respondents who will each submit
one file for a total of 9,000 hours. This
is an increase of two respondents and
3,000 hours from the burden approved
by OMB.
Section 570.17 Complex Category:
We estimated that the number of annual
respondents for investigational food
additive files has increased from five to
seven respondents who will each
submit one such file, for a total of
35,000 hours. This is an increase of
10,000 hour from the burden approved
by OMB.
Section 501.22(k) Labeling of Color
Additive or Lake of Color Additive;
Labeling of Color Additives Not Subject
to Certification: The information
collection reflects an adjustment in
burden by 647 hours and 2,587
responses. We attribute this adjustment
due to the consolidation of OMB control
number 0910–0546 and OMB control
number 0910–0721.
Dated: October 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–22045 Filed 10–7–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: The Maternal, Infant, and
Early Childhood Home Visiting
Program Quarterly Performance
Report, OMB No. 0906–0016, Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than November 8,
2021.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
ADDRESSES:
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]]>Agencies
[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56277-56279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22045]
[[Page 56277]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1022]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Associated With Food Additive Petitions,
Investigational Food Additive Files Exemptions, and Declaration of
Color Additives on Animal Food Labels
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 associated with food additive petitions, investigational
food additive files exemptions, and declaration of color additives on
animal food labels.
DATES: Submit either electronic or written comments on the collection
of information by December 7, 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 December 7, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 7, 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 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-2021-N-1022 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Reporting Associated with Food
Additive Petitions, Investigational Food Additive Files Exemptions, and
Declaration of Color Additives on Animal Food Labels.'' 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: 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,
[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
[[Page 56278]]
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.
Reporting Associated With Food Additive Petitions, Investigational Food
Additive Files Exemptions, and Declaration of Color Additives on Animal
Food Labels--21 CFR 501.22(k), 570.17, 571.1, and 571.6
OMB Control Number 0910-0546--Extension
This information collection supports FDA regulations as discussed
below. In this notice, we are combining all reporting burden associated
with FDA's regulations Sec. Sec. 501.22(k), 570.17, 571.1, and 571.6
(21 CFR 501.22(k), 570.17, 571.1, and 571.6) into one collection and
are consolidating the burden for OMB control numbers 0910-0546 and OMB
control number 0910-0721. Upon approval of the consolidated collection
OMB control number 0910-0546, we will ask OMB to discontinue OMB
control number 0910-0721. The information collection provisions
approved under OMB control numbers 0910-0546, and 0910-0721 are similar
in that they support FDA's regulations Sec. Sec. 501.22(k), 570.17,
571.1, and 571.6. Thus, with this notice, FDA proposes to consolidate
these collections of information into one OMB control number for
government efficiency and to allow the public to look to one OMB
control number for all reporting associated with FDA's regulations
Sec. Sec. 501.22(k), 570.17, 571.1, and 571.6.
Food Additive Petitions and Investigational Food Additive Files
Exemptions
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 its use is permitted by a regulation which
prescribes the condition(s) under which it may safely be used, or
unless it is exempted by regulation for investigational use. Section
409(b) of FD&C Act specifies the information that must be submitted by
a petitioner in order to establish the safety of a food additive and to
secure the issuance of a regulation permitting its use.
To implement the provisions of section 409 of the FD&C Act, we
issued procedural regulations under 21 CFR part 571. These procedural
regulations are designed to specify more thoroughly the information
that must be submitted to meet the requirement set down in broader
terms by the FD&C Act. The regulations add no substantive requirements
to those indicated in the FD&C Act but attempt to explain these
requirements and provide a standard format for submission to speed
processing of the food additive petition. Labeling requirements for
food additives intended for animal consumption are also set forth in
various regulations contained in parts 501, 573, and 579 (21 CFR parts
501, 573, and 579). The labeling regulations are considered by FDA to
be cross-referenced to Sec. 571.1, which is the subject of this same
OMB clearance for food additive petitions.
Regarding the investigational use of food additives, section 409(j)
of the FD&C Act provides that any food additive or any food bearing or
containing such an additive may be exempted from the requirements of
this section if intended solely for investigational use by qualified
experts. Investigational use of a food additive is typically to address
the safety and/or intended physical or technical effect of the
additive. To implement the provisions of section 409(j) of the FD&C
Act, we issued regulations under Sec. 570.17. These regulations are
designed to specify more thoroughly the information that must be
submitted to meet the requirement set down in broad terms by the FD&C
Act. Labeling requirements for investigational food additive files are
also set forth in various regulations contained in part 501. The
labeling regulations are considered by FDA to be cross-referenced to
Sec. 570.17, which is the subject of this same OMB clearance for
investigational food additive files.
The information collected is necessary to protect the public
health. We use the information submitted by food manufacturers or food
additive manufacturers to ascertain whether the data establish the
identity of the substance, justify its intended effect in/on the food,
and establish that its intended use in/on food is safe.
Animal Food Labeling; Declaration of Certified and Non-Certified Color
Additives
FDA has the authority under the 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 set forth the requirements for animal food labeling. Under
Sec. 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.
Description of Respondents: Respondents to this collection of
information are manufacturers of animal food products that contain
color additives or are manufacturers of food additives.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Food Additive Petitions
----------------------------------------------------------------------------------------------------------------
571.1(c) Moderate Category..... 6 1 6 3,000 18,000
571.1(c) Complex Category...... 5 1 5 10,000 50,000
571.6 Amendment of Petition.... 5 1 5 1,300 6,500
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[[Page 56279]]
Investigational Food Additive Files
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570.17 Moderate Category....... 6 1 6 1,500 9,000
570.17 Complex Category........ 7 1 7 5,000 35,000
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Color Additives
----------------------------------------------------------------------------------------------------------------
501.22(k); labeling of color 3,120 0.8292 2,587 * 0.25 647
additive or lake of color
additive; labeling of color
additives not subject to
certification.................
--------------------------------------------------------------------------------
Total Hours................ .............. .............. .............. ............... 119,147
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (15 minutes).
For the purpose of this consolidation, we base our estimate of the
total annual responses on submissions received during fiscal years 2019
and 2020. We base our estimate of the hours per response on our
experience with the labeling, food additive petition, and filing
processes.
The information collection reflects a net decrease of 70,453 hours
(189,600 OMB approved hours--119,147 estimated hours). We also
experienced a net increase of 2,587 responses from 35 OMB approved
annual responses to 2,616 estimated annual responses. These changes
were due to the consolidating of the information collection covered by
OMB control number 0910-0721 and due to estimated changes of the number
of respondents for food additive petitions and investigational food
additive files.
Section 571.1(c) Moderate Category: The estimated time requirement
per food additive petition remains at approximately 3,000 hours;
however, we now estimate that the number of annual respondents has
decreased from 12 to 6 respondents for a total of 18,000 hours.
Section 571.1(c) Complex Category: The estimated time requirement
per food additive petition remains at approximately 10,000 hours;
however, we now estimate that the number of annual respondents has
decreased from 12 to 5 respondents for a total of 50,000 hours.
Section 571.6 Amendment of Petition: We estimated that the number
of annual respondents that will submit an amendment has increased from
two to five respondents who will each submit one amendment for a total
of 6,500 hours. This is an increase of three respondents and 3,900
hours from the burden approved by OMB.
Section 570.17 Moderate Category: We estimated that the number of
annual respondents for investigational food additive files has
increased from four to six respondents who will each submit one file
for a total of 9,000 hours. This is an increase of two respondents and
3,000 hours from the burden approved by OMB.
Section 570.17 Complex Category: We estimated that the number of
annual respondents for investigational food additive files has
increased from five to seven respondents who will each submit one such
file, for a total of 35,000 hours. This is an increase of 10,000 hour
from the burden approved by OMB.
Section 501.22(k) Labeling of Color Additive or Lake of Color
Additive; Labeling of Color Additives Not Subject to Certification: The
information collection reflects an adjustment in burden by 647 hours
and 2,587 responses. We attribute this adjustment due to the
consolidation of OMB control number 0910-0546 and OMB control number
0910-0721.
Dated: October 1, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22045 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P
