Notice2021-22045
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
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Published
October 8, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 193 (Friday, October 8, 2021)</title>
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[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56277-56279]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22045]
[[Page 56277]]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#5d0d0f1c0e293c3b3b1d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="f9a9abb8aa8d989f9fb99f9d98d791918ad79e968f">[email protected]</span></a>.
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\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Food Additive Petitions
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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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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
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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.................
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Total Hours................ .............. .............. .............. ............... 119,147
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\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
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