Notice2024-30227
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
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Published
December 19, 2024
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 additives intended for use in animal food, 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 89 Issue 244 (Thursday, December 19, 2024)</title>
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[Federal Register Volume 89, Number 244 (Thursday, December 19, 2024)]
[Notices]
[Pages 103838-103841]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30227]
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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.
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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 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 <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 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:
<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
[[Page 103839]]
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-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 <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: 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,
<a href="/cdn-cgi/l/email-protection#2a7a786b795e4b4c4c6a4c4e4b04424259044d455c"><span class="__cf_email__" data-cfemail="9fcfcddeccebfef9f9dff9fbfeb1f7f7ecb1f8f0e9">[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 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally</a>. 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic</a>, 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
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Food Additive Petitions
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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
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Animal Food Ingredient Consultation
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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
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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
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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.
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
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