Description
This guidance describes the types of information the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends be included in:
Scope & Applicability
Product Classes
1Substances added to animal food requiring approval
Stakeholders
7Party submitting a citizen petition; party evaluating whether a food allergen is of public health importance; Party recommended to conduct systematic reviews and evidence scoring.
treatment blinding to study personnel
Entity that authorizes protocol deviations in writing.
Entity responsible for submitting applications under section 524B
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
The manufacturer or distributor submitting the notification; The person or firm submitting the NDIN
Required for GRAS status determinations
Regulatory Context
Attributes
6Data providing the primary basis for a safety conclusion
number of animals used in the study should be justified in terms of the power of the study
Information such as hypotheses tested, parameters estimated, assumptions made, level of significance
Requirements of study animals that must be met during the study.
Data requested by CVM to demonstrate the safety of the cat food
Time required before slaughter to ensure no residues; time animals must be held after drug treatment before slaughter
Identified Hazards
Hazards
3risk assessment for pharmaceuticals affecting the immune system
circumstances indicating potential for serious harm to the environment
Assessment of toxicity required in a 351(k) BLA
Related CFR Sections (10)
- 21CFR571.7§ 571.7 Withdrawal of petition without prejudice.
(a) In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In suchRead full regulation →
- 21CFR571.100§ 571.100 Regulation based on petition.
(a) The Commissioner will forward for publication in the Federal Register, within 90 days after filing of the petition (or within 180 days if the time is extended as provided for in section 409(c)(2) of the act), a regulation prescribing the conditions under which the food additive may be safely useRead full regulation →
- 21CFR570.275§ 570.275 Public disclosure of a GRAS notice.
(a) The data and information in a GRAS notice (including data and information submitted in any amendment or supplement to your GRAS notice, or incorporated into your GRAS notice) are:Read full regulation →
- 21CFR571.1§ 571.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions of section 409(b) of the act shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state petitiRead full regulation →
- 21CFR20.111§ 20.111 Data and information submitted voluntarily to the Food and Drug Administration.
(a) The provisions of this section shall apply only to data and information submitted voluntarily to the Food and Drug Administration, whether in the course of a factory inspection or at any other time, and not as a part of any petition, application, master file, or other required submission or requRead full regulation →
- 21CFR25.40§ 25.40 Environmental assessments.
(a) As defined by CEQ in 40 CFR 1508.9 , an EA is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the proposal, of alternatives as required by secRead full regulation →
- 21CFR25.32§ 25.32 Foods, food additives, and color additives.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR570.3§ 570.3 Definitions.
(a) Secretary means the Secretary of Health and Human Services.Read full regulation →
- 21CFR570.17§ 570.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.
A food additive or food containing a food additive intended for investigational use by qualified experts shall be exempt from the requirements of section 409 of the act under the following conditions:Read full regulation →
- 21CFR570.250§ 570.250 Part 6 of a GRAS notice: Narrative.
In Part 6 of your GRAS notice, you must include a narrative that provides the basis for your conclusion of GRAS status, in which:Read full regulation →
Related Warning Letters (9)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
See Also (8)
- Guidance for Industry: Pre-Petition Consultations for Food Additives and Color Additives (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities (Status: Final)
- Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Status: Final)
- Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use (Status: Final)
- French Translation of Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry (Questions et Réponses relatives au Registre des aliments à signaler) (Status: Final)
- Small Entity Compliance Guide: Prevention of Salmonella Enteritidis in Shell Eggs During Production, Transportation, and Storage (Status: Final)
- Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) (Status: Draft)