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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 [www.gpo.gov]
[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 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
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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.
                                              ----------------------------------------------------------------------------------------------------------
    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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