Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels, 103838-103841 [2024-30227]
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<![CDATA[
103838
2 Totals
Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
may not sum due to rounding.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 2
Number of
recordkeepers
21 CFR section; activity
§ 1.1113; recordkeeping associated with ISO/IEC
17011:2017.
§ 1.1124; ABs—additional recordkeeping requirements a recognized accreditation body must
maintain, for 5 years after the date of creation of
the records, records created while it is recognized
demonstrating its compliance with this subpart.
§ 1.1138; laboratories—becoming accredited to ISO/
IEC 17025:2017 (one-time); Laboratories adding
ISO 17025 to become LAAF-accredited.
§ 1.1138; laboratories—maintaining ISO/IEC 17025:
2017 accreditation.
§ 1.1154; laboratories—additional recordkeeping requirements; a LAAF-accredited laboratory must
maintain, for 5 years after the date of creation,
records created and received while it is LAAF-accredited that relate to compliance with this subpart.
Total ....................................................................
1 There
2 Totals
Total annual
records
Average burden per
recordkeeping
Total hours
8
2
8
22 ............................
176
9
1
9
91.06 (91 hours and
4 minutes).
820
160
2
320
450.765 (450 hours
and 46 minutes).
144,245
........................
........................
345
.................................
145,241
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
The burden we attribute to reporting
and recordkeeping activities is assumed
to be distributed among the individual
elements of the respective information
collection activities. Although we have
not received a notice of intent to
relinquish records since the last
approval of this information collection,
we include one response for the purpose
of estimating burden.
We calculate the number of food
testing laboratories seeking
accreditation based on the number of
applicants. As a result, the number of
respondents to the information
collection decreased (from 170
respondents in the currently approved
collection to 160 respondents).
Consequently, we have adjusted our
burden estimate, which results in a
decrease of 227 responses and 9,303
burden hours from the currently
approved information collection.
Dated: December 11, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–30230 Filed 12–18–24; 8:45 am]
BILLING CODE 4164–01–P
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Number of
records per
recordkeeper
VerDate Sep<11>2014
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Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Additives
Intended for Use in Animal Food, Food
Additive Petitions, Investigational
Food Additive Files Exemptions, and
Declaration on Animal Food Labels
Food and Drug Administration,
HHS.
ACTION:
Electronic Submissions
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 additives intended for use in
animal food, food additive petitions,
investigational food additive files
exemptions, and declaration of color
additives on animal food labels.
SUMMARY:
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You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 18, 2025. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ADDRESSES:
[Docket No. FDA–2024–N–5581]
AGENCY:
Either electronic or written
comments on the collection of
information must be submitted by
February 18, 2025.
DATES:
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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
E:\FR\FM\19DEN1.SGM
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Federal Register / Vol. 89, No. 244 / Thursday, December 19, 2024 / Notices
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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–
2024–N–5581 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Additives Intended For Use In Animal
Food, Food Additive Petitions,
Investigational Food Additive Files
Exemptions, and Declaration 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
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‘‘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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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
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103839
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Additives Intended For Use in
Animal Food, Food Additive Petitions,
Investigational Food Additive Files
Exemptions, and Declarations on
Animal Food Labels
OMB Control Number 0910–0546—
Revision
This information collection helps
support implementation of FDA’s
authority over food additives intended
for use in animal food. Misbranded
foods are prohibited under section 403
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 343); food
additives are covered in section 409 of
the FD&C Act (21 U.S.C. 348), which
provides, at section 409(a) of the FD&C
Act, that a food additive shall be
deemed to be unsafe unless its use is
permitted by a regulation that 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 the FD&C Act provides
for petitions to establish safety of food
additives and specifies information that
must be submitted to FDA before a
regulation permitting its use may be
issued. Agency regulation in 21 CFR
part 570 sets forth general provisions
applicable to food additives intended
for use in animal food; provides relevant
definitions; establishes principles for
determining safety; and explains
prescribed elements to be included in a
Generally Recognized as Safe (GRAS)
notice. The regulation also provides for
certain exemptions for investigational
use and discusses related procedures.
Agency regulation in 21 CFR part 571
establishes procedural requirements
applicable to the submission of petitions
filed under section 409(b) of the FD&C
Act, including content and format
elements to facilitate FDA processing of
a food additive petition. Finally, Agency
regulation in 21 CFR part 501
establishes disclosure requirements for
animal food labeling, including the
disclosure of the presence of certified
and noncertified color additives (21 CFR
501.22(k)). Additional disclosure
requirements are found in 21 CFR parts
573 (food additives permitted in feed
and drinking water of animals) and 579
(irradiation in the production,
processing, and handling of animal
food), and are included in the scope of
coverage for the information collection.
We are revising the information
collection to include related authority
established through enactment of the
Animal Drug and Animal Generic Drug
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User Fee Amendments of 2018 (2018
Amendments) (Pub. L. 115–234).
Intending to help ensure the safety of
pet food, section 306(c) of the 2018
Amendments provides for the issuance
of guidance on pre-petition
consultations for animal food additives.
We have issued the following guidance
documents to assist respondents in this
regard:
Guidance for Industry (GFI) #262,
‘‘Pre-Submission Consultation Process
for Animal Food Additive Petitions or
Generally Recognized as Safe (GRAS)
Notices’’ (December 2020), available for
download from our website at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/cvmgfi-262-pre-submission-consultationprocess-animal-food-additive-petitionsor-generally. The guidance document
describes the types of information our
Center for Veterinary Medicine
recommends be included in:
1. pre-petition consultations prior to
submission of food additive petitions
(FAP) for food additives intended for
use in animal food;
2. pre-submission consultations
regarding an animal food substance for
which an entity plans to provide notice
of its conclusion that the intended use
of the substance is GRAS under FDA’s
animal food GRAS Notification
program; or
3. a Food Use Authorization request
to permit the use, in human or animal
foods, of animal products derived from
animals that have been administered an
investigational substance intended for
use in animal food.
Additionally, GFI #294, ‘‘Animal
Food Ingredient Consultation (AFIC)’’
(August 2024), available for download at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-294-animal-foodingredient-consultation-afic, describes
the AFIC process, which provides for a
way, within the regulatory framework,
for firms that are developing animal
food ingredients to consult with FDA,
and for FDA to review information from
developers and the public regarding the
ingredients and any relevant safety
concerns. The AFIC process includes
opportunities for public awareness of,
and input on, the ingredients for which
FDA is providing consultation. The
guidance document also explains that
FDA generally would not intend to take
enforcement action against an
ingredient for being an unapproved
animal food additive if FDA has sent an
AFIC ‘‘consultation complete’’ letter,
provided the ingredient is used in
accordance with the terms described in
the letter and there continues to be no
questions or concerns about the safety of
the ingredient.
Description of Respondents:
Respondents to this collection of
information are animal food
manufacturers or animal food additive
manufactures. With regard to
submission activities, we assume 2,508
respondents based on the number of
registrants who identify as animal food
additive manufacturers. With regard to
labeling activities under 21 CFR
501.22(k), we assume 3,120 respondents
based on information found in previous
Agency rulemaking (RIN–0910AG02)
regarding declarations for animal food
product labels.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Regulatory authority; submission of information
Total annual
responses
Average burden per
response
Total hours
Food Additive Petitions
21 CFR 571.1(c) Moderate Category ..........................
21 CFR 571.1(c) Complex Category ...........................
21 CFR 571.6 Amendment of Petition ........................
3
3
5
1
1
1
3
3
5
3,000 ......................
10,000 ....................
1,300 ......................
9,000
30,000
6,500
8
10
1,500 ......................
5,000 ......................
12,000
50,000
1
1
12
12
3,000 ......................
1,300 ......................
36,000
15,600
3,120
0.8292
2,587
0.25 (15 minutes) ...
647
........................
........................
........................
................................
159,747
Investigational Food Additive Files
21 CFR 570.17 Moderate Category ............................
21 CFR 570.17 Complex Category .............................
8
10
1
1
Animal Food Ingredient Consultation
Consultation Category .................................................
Amendment of Consultation ........................................
12
12
Color Additives
21 CFR 501.22(k); labeling of color additive or lake
of color additive; labeling of color additives not
subject to certification.
Total Hours ...........................................................
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have determined that food
additive petitions and investigational
food additive files that are submitted,
fall into one of two categories of
complexity. Fluctuations in the number
and types of food and color additive
petitions received in any given year are
governed by market forces.
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§ 571.1(c) Moderate Category: For a
food additive petition without complex
chemistry, manufacturing, efficacy and/
or safety issues, the estimated time
requirement per petition is
approximately 3,000 hours. We estimate
that, annually, 3 respondents will
submit 1 such petition, for a total of
9,000 hours.
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§ 571.1(c) Complex Category: For a
food additive petition with complex
chemistry, manufacturing, efficacy and/
or safety issues, the estimated time
requirement per petition is
approximately 10,000 hours. We
estimate that, annually, 3 respondents
will each submit 1 such petition, for a
total of 30,000 hours.
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§ 571.6 Amendment of Petition: For a
food additive petition amendment, the
estimated time requirement per petition
is approximately 1,300 hours. We
estimate that, annually, 5 respondents
will each submit 1 such amendment, for
a total of 6,500 hours.
§ 570.17 Moderate Category: For an
investigational food additive file
without complex chemistry,
manufacturing, efficacy and/or safety
issues, the estimated time requirement
per file is approximately 1,500 hours.
We estimate that, annually, 8
respondents will each submit 1 such
file, for a total of 12,000 hours.
§ 570.17 Complex Category: For an
investigational food additive file with
complex chemistry, manufacturing,
efficacy and/or safety issues, the
estimated time requirement per file is
approximately 5,000 hours. We estimate
that, annually, 10 respondents will each
submit 1 such file, for a total of 50,000
hours.
Consultation Category: We estimate
developers of animal food ingredients
will spend 3,000 hours consulting with
FDA on an ingredient. We estimate that,
annually, 12 respondents will consult
with FDA, for a total of 36,000 hours.
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 for a particular
color additive or food additive involve
information required as part of the
safety review process, the burden hours
for labeling are included in the estimate
for 21 CFR 501.22(k) and 571.1.
We base our estimate of the total
annual responses on submissions
received over the last 3 years. We base
our estimate of the hours per response
on our experience with the labeling,
food additive petition, and filing
processes.
Based on review of the information
collection, there was a decrease of food
additive petition (FAP) responses and a
corresponding decrease in burden hours
for FAPs. We attribute this adjustment
to an increase in the number of GRAS
notices (21 CFR part 570, subpart E)
received, which tend to substitute for
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FAP submissions due to a similar
quantity and quality of data and
information requirement. These
numbers can fluctuate year to year. We
also note that investigational food
additive file responses have increased
due to more respondents providing
information during the pre-market
process prior to providing a more formal
regulatory response (e.g., FAP or GRAS
notice). We did not adjust the number
of responses received for the declaration
of color additives on animal food labels
from the previous collection.
Our estimated burden for the
information collection reflects an
overall increase of 40,600 total hours
and 24 responses. We attribute this to
accounting for the consultation process
for firms developing animal food
ingredients.
Dated: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–30227 Filed 12–18–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1055]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, us, or we) 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 January 21,
2025.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0847. Also include
SUMMARY:
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103841
the FDA docket number found in
brackets in the heading of this
document.
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.
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.
Data To Support Social and Behavioral
Research as Used by the Food and Drug
Administration
OMB Control Number 0910–0847—
Extension
This information collection is
intended to support FDA-conducted
research. Understanding patients,
consumers, and healthcare
professionals’ perceptions and
behaviors plays an important role in
improving FDA’s regulatory decisionmaking processes and communications
that affect various stakeholders. FDA
uses the following methodology to
achieve these goals: (1) creation and
validation of survey instruments; (2) use
of techniques to evaluate sampling and
recruitment methods; (3) evaluation of
the validity and reliability of survey
instruments; (4) individual in-depth
interviews, (5) general public focus
group interviews, (6) intercept
interviews, (7) self-administered
surveys, (8) gatekeeper surveys, and (9)
focus group interviews. These methods
serve the narrowly defined need for
direct and informal opinion on a
specific topic and serve as a qualitative
and quantitative research tool having
two major purposes:
• Obtaining useful, valid, and reliable
information for the development of
variables and measures for formulating
the basic objectives of social and
behavioral research and
• Successfully communicating and
addressing behavioral changes with
intended audiences to assess the
potential effectiveness of FDA
communications, behavioral
interventions, and other materials.
While FDA will use these methods to
test and refine its ideas and help
develop communication and behavioral
strategies research, the Agency will
generally conduct further research
before making important decisions
(such as adopting new policies and
allocating or redirecting significant
resources to support these policies).
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]]>Agencies
[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103838-103841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30227]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5581]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Additives Intended for Use in Animal Food, Food
Additive Petitions, Investigational Food Additive Files Exemptions, and
Declaration 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 additives intended for use in animal
food, food additive petitions, investigational food additive files
exemptions, and declaration of color additives on animal food labels.
DATES: Either electronic or written comments on the collection of
information must be submitted by February 18, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 18, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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
[[Page 103839]]
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-2024-N-5581 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Additives Intended For Use
In Animal Food, Food Additive Petitions, Investigational Food Additive
Files Exemptions, and Declaration 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Food Additives Intended For Use in Animal Food, Food Additive
Petitions, Investigational Food Additive Files Exemptions, and
Declarations on Animal Food Labels
OMB Control Number 0910-0546--Revision
This information collection helps support implementation of FDA's
authority over food additives intended for use in animal food.
Misbranded foods are prohibited under section 403 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343); food additives are
covered in section 409 of the FD&C Act (21 U.S.C. 348), which provides,
at section 409(a) of the FD&C Act, that a food additive shall be deemed
to be unsafe unless its use is permitted by a regulation that
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 the FD&C Act provides for petitions to establish safety of
food additives and specifies information that must be submitted to FDA
before a regulation permitting its use may be issued. Agency regulation
in 21 CFR part 570 sets forth general provisions applicable to food
additives intended for use in animal food; provides relevant
definitions; establishes principles for determining safety; and
explains prescribed elements to be included in a Generally Recognized
as Safe (GRAS) notice. The regulation also provides for certain
exemptions for investigational use and discusses related procedures.
Agency regulation in 21 CFR part 571 establishes procedural
requirements applicable to the submission of petitions filed under
section 409(b) of the FD&C Act, including content and format elements
to facilitate FDA processing of a food additive petition. Finally,
Agency regulation in 21 CFR part 501 establishes disclosure
requirements for animal food labeling, including the disclosure of the
presence of certified and noncertified color additives (21 CFR
501.22(k)). Additional disclosure requirements are found in 21 CFR
parts 573 (food additives permitted in feed and drinking water of
animals) and 579 (irradiation in the production, processing, and
handling of animal food), and are included in the scope of coverage for
the information collection.
We are revising the information collection to include related
authority established through enactment of the Animal Drug and Animal
Generic Drug
[[Page 103840]]
User Fee Amendments of 2018 (2018 Amendments) (Pub. L. 115-234).
Intending to help ensure the safety of pet food, section 306(c) of the
2018 Amendments provides for the issuance of guidance on pre-petition
consultations for animal food additives. We have issued the following
guidance documents to assist respondents in this regard:
Guidance for Industry (GFI) #262, ``Pre-Submission Consultation
Process for Animal Food Additive Petitions or Generally Recognized as
Safe (GRAS) Notices'' (December 2020), available for download from our
website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally. The guidance document
describes the types of information our Center for Veterinary Medicine
recommends be included in:
1. pre-petition consultations prior to submission of food additive
petitions (FAP) for food additives intended for use in animal food;
2. pre-submission consultations regarding an animal food substance
for which an entity plans to provide notice of its conclusion that the
intended use of the substance is GRAS under FDA's animal food GRAS
Notification program; or
3. a Food Use Authorization request to permit the use, in human or
animal foods, of animal products derived from animals that have been
administered an investigational substance intended for use in animal
food.
Additionally, GFI #294, ``Animal Food Ingredient Consultation
(AFIC)'' (August 2024), available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic, describes the AFIC process,
which provides for a way, within the regulatory framework, for firms
that are developing animal food ingredients to consult with FDA, and
for FDA to review information from developers and the public regarding
the ingredients and any relevant safety concerns. The AFIC process
includes opportunities for public awareness of, and input on, the
ingredients for which FDA is providing consultation. The guidance
document also explains that FDA generally would not intend to take
enforcement action against an ingredient for being an unapproved animal
food additive if FDA has sent an AFIC ``consultation complete'' letter,
provided the ingredient is used in accordance with the terms described
in the letter and there continues to be no questions or concerns about
the safety of the ingredient.
Description of Respondents: Respondents to this collection of
information are animal food manufacturers or animal food additive
manufactures. With regard to submission activities, we assume 2,508
respondents based on the number of registrants who identify as animal
food additive manufacturers. With regard to labeling activities under
21 CFR 501.22(k), we assume 3,120 respondents based on information
found in previous Agency rulemaking (RIN-0910AG02) regarding
declarations for animal food product labels.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Regulatory authority; submission of Number of responses per Total annual Average burden per response Total hours
information respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 571.1(c) Moderate Category............ 3 1 3 3,000.................................... 9,000
21 CFR 571.1(c) Complex Category............. 3 1 3 10,000................................... 30,000
21 CFR 571.6 Amendment of Petition........... 5 1 5 1,300.................................... 6,500
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Investigational Food Additive Files
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21 CFR 570.17 Moderate Category.............. 8 1 8 1,500.................................... 12,000
21 CFR 570.17 Complex Category............... 10 1 10 5,000.................................... 50,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Animal Food Ingredient Consultation
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation Category........................ 12 1 12 3,000.................................... 36,000
Amendment of Consultation.................... 12 1 12 1,300.................................... 15,600
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Color Additives
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR 501.22(k); labeling of color additive 3,120 0.8292 2,587 0.25 (15 minutes)........................ 647
or lake of color additive; labeling of color
additives not subject to certification.
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Total Hours.............................. .............. .............. .............. ......................................... 159,747
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have determined that food additive petitions and investigational
food additive files that are submitted, fall into one of two categories
of complexity. Fluctuations in the number and types of food and color
additive petitions received in any given year are governed by market
forces.
Sec. 571.1(c) Moderate Category: For a food additive petition
without complex chemistry, manufacturing, efficacy and/or safety
issues, the estimated time requirement per petition is approximately
3,000 hours. We estimate that, annually, 3 respondents will submit 1
such petition, for a total of 9,000 hours.
Sec. 571.1(c) Complex Category: For a food additive petition with
complex chemistry, manufacturing, efficacy and/or safety issues, the
estimated time requirement per petition is approximately 10,000 hours.
We estimate that, annually, 3 respondents will each submit 1 such
petition, for a total of 30,000 hours.
[[Page 103841]]
Sec. 571.6 Amendment of Petition: For a food additive petition
amendment, the estimated time requirement per petition is approximately
1,300 hours. We estimate that, annually, 5 respondents will each submit
1 such amendment, for a total of 6,500 hours.
Sec. 570.17 Moderate Category: For an investigational food
additive file without complex chemistry, manufacturing, efficacy and/or
safety issues, the estimated time requirement per file is approximately
1,500 hours. We estimate that, annually, 8 respondents will each submit
1 such file, for a total of 12,000 hours.
Sec. 570.17 Complex Category: For an investigational food additive
file with complex chemistry, manufacturing, efficacy and/or safety
issues, the estimated time requirement per file is approximately 5,000
hours. We estimate that, annually, 10 respondents will each submit 1
such file, for a total of 50,000 hours.
Consultation Category: We estimate developers of animal food
ingredients will spend 3,000 hours consulting with FDA on an
ingredient. We estimate that, annually, 12 respondents will consult
with FDA, for a total of 36,000 hours.
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 for a particular color
additive or food additive involve information required as part of the
safety review process, the burden hours for labeling are included in
the estimate for 21 CFR 501.22(k) and 571.1.
We base our estimate of the total annual responses on submissions
received over the last 3 years. We base our estimate of the hours per
response on our experience with the labeling, food additive petition,
and filing processes.
Based on review of the information collection, there was a decrease
of food additive petition (FAP) responses and a corresponding decrease
in burden hours for FAPs. We attribute this adjustment to an increase
in the number of GRAS notices (21 CFR part 570, subpart E) received,
which tend to substitute for FAP submissions due to a similar quantity
and quality of data and information requirement. These numbers can
fluctuate year to year. We also note that investigational food additive
file responses have increased due to more respondents providing
information during the pre-market process prior to providing a more
formal regulatory response (e.g., FAP or GRAS notice). We did not
adjust the number of responses received for the declaration of color
additives on animal food labels from the previous collection.
Our estimated burden for the information collection reflects an
overall increase of 40,600 total hours and 24 responses. We attribute
this to accounting for the consultation process for firms developing
animal food ingredients.
Dated: December 12, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30227 Filed 12-18-24; 8:45 am]
BILLING CODE 4164-01-P
