Description
This guidance explains how FDA's approval process applies in the context of heritable intentional genomic alterations (IGA) in animals.
Scope & Applicability
Product Classes
4The subject of the approval process guidance.
Products requiring a VFD format in applications
The regulated article consisting of genomic alterations in animals.; IGAs in animals subject to the approval process; The primary subject of the approval process guidance; IGAs in animals subject to approval and recordkeeping
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
6Cybersecurity is part of device safety and effectiveness
Information to be collected and reported in annual reports
Establishing whether the IGA poses risks to humans or health
Demonstrating the stability of the IGA across generations
Consistency of the introduced trait over multiple generations.
Demonstration that the IGA is stably inherited.
Identified Hazards
Hazards
6FSIS tests for residues above tolerance concentrations
Potential for mutations elsewhere in the genome
Risk of unintended DNA integration or large deletions
Production of novel substances not ordinarily produced
Potential risk to receptor populations
Potential environmental impact examined in the EA.
Related CFR Sections (15)
- 21CFR510.206§ 510.206 Review of information supporting actions to establish or amend an import tolerance.
In establishing or amending an import tolerance, the Commissioner shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Commissioner to establish tolerances for applications for new animal drugs filed under section 512(b)(1) Read full regulation →
- 21CFR510.201§ 510.201 Scope.
This subpart applies to tolerances for residues of new animal drugs not approved or conditionally approved for use in the United States, but lawfully used in another country and present in imported, animal-derived food and food products.Read full regulation →
- 21CFR514.80§ 514.80 Records and reports concerning experience with approved new animal drugs.
The following table outlines the purpose for each paragraph of this section:Read full regulation →
- 21CFR514.8§ 514.8 Supplements and other changes to an approved application.
(a) Definitions.Read full regulation →
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead 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 →
- 21CFR558.6§ 558.6 Veterinary feed directive drugs.
(a) General requirements related to veterinary feed directive (VFD) drugs.Read full regulation →
- 21CFR510.4§ 510.4 Biologics; products subject to license control.
An animal drug produced and distributed in full conformance with the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq. ) and any regulations issued thereunder shall not be deemed to be subject to section 512 of the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR511.1§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal Food, Drug, and Cosmetic Act.
(a) New animal drugs for tests in vitro and in laboratory research animals.Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.33§ 25.33 Animal drugs.
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 →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR514.11§ 514.11 Confidentiality of data and information in a new animal drug application file.
(a) For purposes of this section the NADA file includes all data and information submitted with or incorporated by reference in the NADA, INAD's incorporated into the NADA, supplemental NADA's, reports under §§ 514.80 and 510.301 of this chapter , master files, and other related submissions. The avaRead full regulation →
- 21CFR25.51§ 25.51 Environmental assessments and findings of no significant impact.
(a) Data and information that are protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the portion of environmental documents that is made public. When such data and information are pertinent to the environmental review of a proposed action, an applicanRead full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-08-26
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CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Supergoop!
- 2025-08-12
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K & Care Organics
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Fallien Cosmeceuticals Ltd. dba Fallene Ltd.
- 2025-05-27
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Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
- 2025-04-29
Electronic Drug Registration and Listing System (eDRLS)/Violations
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
- 2025-02-18
CGMP/Finished Pharmaceutical/Adulterated
Jagsonpal Pharmaceuticals Limited
- 2024-10-22
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
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See Also (8)
- CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine (Status: Final)
- CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for Industry (Status: Final)
- CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use (Status: Final)
- CVM GFI #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209 (Status: Final)
- CVM GFI #218 Cell-Based Products for Animal Use (Status: Final)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)
- Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)