Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels, 18660-18662 [2025-07588]
Download as PDF
<![CDATA[
18660
Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
NW, Washington, DC 20551–0001, not
later than May 16, 2025.
A. Federal Reserve Bank of Atlanta
(Erien O. Terry, Assistant Vice
President) 1000 Peachtree Street NE,
Atlanta, Georgia 30309. Comments can
also be sent electronically to
Applications.Comments@atl.frb.org:
1. Community Bankshares, Inc.,
through its wholly-owned subsidiary,
Phoenix Lender Services, LLC, both of
LaGrange, Georgia; to engage de novo in
extending credit and servicing loans,
pursuant to section 225.28(b)(1) of the
Board’s Regulation Y.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennell,
Associate Secretary of the Board.
[FR Doc. 2025–07545 Filed 4–30–25; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–5581]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
The Food and Drug
Administration (FDA, Agency, 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 June 2,
2025.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0546. Also include
the FDA docket number found in
brackets in the heading of this
document.
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
17:24 Apr 30, 2025
Jkt 265001
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
(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
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), is available
for download from our website at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-262-pre-submissionconsultation-process-animal-foodadditive-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)’’
(January 2025), 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
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
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)
18661
regarding declarations for animal food
product labels.
In the Federal Register of December
19, 2024 (89 FR 103838), we published
a 60-day notice soliciting public
comment on the proposed collection of
information. One comment was received
offering general support for the utility of
the information collection.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Total
annual
responses
1
1
1
3
3
5
3,000 .........................
10,000 .......................
1,300 .........................
9,000
30,000
6,500
1
1
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
Number of
respondents
Regulatory authority; submission of information
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
Investigational Food Additive Files
21 CFR 570.17; Moderate Category .....................................
21 CFR 570.17; Complex Category ......................................
8
10
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 .....................................................................
lotter on DSK11XQN23PROD with NOTICES1
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.
§ 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.
§ 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.
§ 571.6 Amendment of Petition: For
a food additive petition amendment, the
VerDate Sep<11>2014
17:24 Apr 30, 2025
Jkt 265001
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,
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01MYN1.SGM
01MYN1
18662
Federal Register / Vol. 90, No. 83 / Thursday, May 1, 2025 / Notices
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 premarket
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: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2025–07588 Filed 4–30–25; 8:45 am]
The Food and Drug
Administration (FDA, Agency, 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 June 2,
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 0910–0659. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
SUMMARY:
BILLING CODE 4164–01–P
Antimicrobial Animal Drug Sales and
Distribution—21 CFR 514.87
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB Control Number 0910–0659—
Extension
This information collection helps
support implementation of Agency
statutory and regulatory requirements
regarding new animal drugs containing
an antimicrobial active ingredient.
Sponsors of approved or conditionally
approved applications for new animal
drugs containing an antimicrobial active
ingredient are required by section 512 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360b) to
submit to FDA an annual report on the
amount of each such ingredient in the
Food and Drug Administration
[Docket No. FDA–2024–N–4470]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Antimicrobial
Animal Drug Sales and Distribution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
drug that is sold or distributed for use
in food-producing animals. Sponsors are
also required to maintain distribution
records for their animal drug products,
including separate information for each
month of the calendar year, under
section 512(l)(3) of the FD&C Act. These
provisions were enacted to assist FDA
in our continuing analysis of the
interactions (including drug resistance),
efficacy, and safety of antimicrobials
approved for use in both humans and
food-producing animals for the purpose
of mitigating the public health risk
associated with antimicrobial resistance.
Section 514.87 of our regulations (21
CFR 514.87) codifies the reporting
requirements established in the FD&C
Act. Sponsors submit antimicrobial
animal drug sales and distribution
reports to us on Form FDA 3744. Each
report must specify: (1) the amount of
each antimicrobial active ingredient by
container size, strength, and dosage
form; (2) quantities distributed
domestically and quantities exported;
and (3) a listing of the target animals,
indications, and production classes that
are specified on the approved label of
the product. The report must cover the
period of the preceding calendar year
and include separate information for
each month of the calendar year. Each
report must also provide a speciesspecific estimate of the percentage of
each product that was sold or
distributed domestically in the reporting
year for use in cattle, swine, chickens,
or turkeys for such species that appear
on the approved label.
Description of Respondents: Animal
drug manufacturers (sponsors).
Respondents include individuals and
the private sector (for-profit businesses).
In the Federal Register of October 24,
2024 (89 FR 84887), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
lotter on DSK11XQN23PROD with NOTICES1
514.87(a)–(e)—Annual Reports for Sponsors With Active
Applications—Paper Submission .....................................
514.87(a)–(e)—Annual Reports for Sponsors With Active
Applications—Electronic Submission ...............................
514.87(a)–(e)—Annual Reports for Sponsors With Inactive
Applications—Paper Submission .....................................
VerDate Sep<11>2014
17:24 Apr 30, 2025
Jkt 265001
Number of
responses per
respondent
Number of
respondents
21 CFR Section
PO 00000
Frm 00024
Fmt 4703
Average
burden per
response
Total annual
responses
Total hours
1
1
1
62
62
15
10.1
152
52
7,904
2
3.5
7
2
14
Sfmt 4703
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18660-18662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07588]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-5581]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 June 2, 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 0910-0546. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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), is 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)'' (January 2025), 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
[[Page 18661]]
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.
In the Federal Register of December 19, 2024 (89 FR 103838), we
published a 60-day notice soliciting public comment on the proposed
collection of information. One comment was received offering general
support for the utility of the information collection.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total
Regulatory authority; Number of responses per annual Average burden per response Total
submission of information respondents respondent responses hours
----------------------------------------------------------------------------------------------------------------
Food Additive Petitions
----------------------------------------------------------------------------------------------------------------
21 CFR 571.1(c); Moderate 3 1 3 3,000...................... 9,000
Category.
21 CFR 571.1(c); Complex 3 1 3 10,000..................... 30,000
Category.
21 CFR 571.6; Amendment of 5 1 5 1,300...................... 6,500
Petition.
----------------------------------------------------------------------------------------------------------------
Investigational Food Additive Files
----------------------------------------------------------------------------------------------------------------
21 CFR 570.17; Moderate 8 1 8 1,500...................... 12,000
Category.
21 CFR 570.17; Complex 10 1 10 5,000...................... 50,000
Category.
----------------------------------------------------------------------------------------------------------------
Animal Food Ingredient Consultation
----------------------------------------------------------------------------------------------------------------
Consultation Category........ 12 1 12 3,000...................... 36,000
Amendment of Consultation.... 12 1 12 1,300...................... 15,600
----------------------------------------------------------------------------------------------------------------
Color Additives
----------------------------------------------------------------------------------------------------------------
21 CFR 501.22(k); labeling of 3,120 0.8292 2,587 0.25 (15 minutes).......... 647
color additive or lake of
color additive; labeling of
color additives not subject
to certification.
----------------------------------------------------------------------------------
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.
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
[[Page 18662]]
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 premarket 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: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07588 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P
