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

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2024-N-5581]</DEPDOC> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit written comments (including recommendations) on the collection of information by June 2, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. <HD SOURCE="HD1">Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declarations on Animal Food Labels</HD> <HD SOURCE="HD2">OMB Control Number 0910-0546—Revision</HD> 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 <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-262-pre-submission-consultation-process-animal-food-additive-petitions-or-generally.</E> 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 <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic,</E> 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. <E T="03">Description of Respondents:</E> 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 <E T="04">Federal Register</E> 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. <GPOTABLE COLS="6" OPTS="L2,nj,i1" CDEF="s50,11,12,9,xs80,9"> <TTITLE> Table 1—Estimated Annual Reporting Burden  <SU>1</SU> </TTITLE> <CHED H="1">Regulatory authority; submission of information</CHED> <ENT I="01">21 CFR 571.1(c); Moderate Category</ENT> <ENT>3</ENT> <ENT>1</ENT> <ENT>3</ENT> <ENT>3,000</ENT> <ENT>9,000</ENT> <ENT I="01">21 CFR 571.1(c); Complex Category</ENT> <ENT>3</ENT> <ENT>1</ENT> <ENT>3</ENT> <ENT>10,000</ENT> <ENT>30,000</ENT> <ENT I="01">21 CFR 571.6; Amendment of Petition</ENT> <ENT>5</ENT> <ENT>1</ENT> <ENT>5</ENT> <ENT>1,300</ENT> <ENT>6,500</ENT> </ROW> <ROW EXPSTB="04" RUL="s"> <E T="02">Investigational Food Additive Files</E> </ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">21 CFR 570.17; Moderate Category</ENT> <ENT>8</ENT> <ENT>1</ENT> <ENT>8</ENT> <ENT>1,500</ENT> <ENT>12,000</ENT> <ENT I="01">21 CFR 570.17; Complex Category</ENT> <ENT>10</ENT> <ENT>1</ENT> <ENT>10</ENT> <ENT>5,000</ENT> <ENT>50,000</ENT> </ROW> <ROW EXPSTB="04" RUL="s"> <E T="02">Animal Food Ingredient Consultation</E> </ENT> </ROW> <ROW EXPSTB="00"> <ENT I="01">Consultation Category</ENT> <ENT I="01">Amendment of Consultation</ENT> <ENT>12</ENT> <ENT>1</ENT> <ENT>12</ENT> <ENT>1,300</ENT> <ENT>15,600</ENT> </ROW> <ROW EXPSTB="04" RUL="s"> <ENT I="01">21 CFR 501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification</ENT> <ENT>3,120</ENT> <ENT>0.8292</ENT> <ENT>2,587</ENT> <ENT>0.25 (15 minutes)</ENT> <ENT>647</ENT> </ROW> <ROW> <ENT I="03">Total Hours</ENT>  There are no capital costs or operating and maintenance costs associated with this collection of information. </TNOTE> </GPOTABLE> 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. <E T="03">§ 571.1(c) Moderate Category:</E> 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 wi ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━