90 FR 83 pgs. 18660-18662 - 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
Type: NOTICEVolume: 90Number: 83Pages: 18660 - 18662
Pages: 18660, 18661, 18662Docket number: [Docket No. FDA-2024-N-5581]
FR document: [FR Doc. 2025-07588 Filed 4-30-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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, 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 (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.
[top] 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
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.
| Regulatory authority; submission of information | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 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 |
| Investigational Food Additive Files | |||||
| 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 |
| Color Additives | |||||
| 21 CFR 501.22(k); labeling of color additive or lake of color additive; labeling of color additives not subject to certification | 3,120 | 0.8292 | 2,587 | 0.25 (15 minutes) | 647 |
| 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.
§?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 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.
[top] We base our estimate of the total annual responses on submissions received over the last 3 years. We base
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