Description
Intentional genomic alterations (IGAs) in animals are made using modern molecular technologies, which include rDNA technologies and genome editing technologies such as CRISPR. Some IGAs are in animals of food producing species (such as pigs and rabbits) that serve as models of human or animal disease for use in research and development of therapeutic products.
Scope & Applicability
Product Classes
3Evaluation of IGAs in animal models of disease for Category 2 determination
IGAs that meet this definition are regulated by APHIS
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
Stakeholders
3Requires approval and oversight of applicable animal research
Entity subject to user fees under the FD&C Act
Includes sponsors, researchers, or individuals interacting with CVM
Regulatory Context
Attributes
1Expected traits expressed by animals with IGAs
Identified Hazards
Hazards
3Risk of altered animals escaping physical facilities
Unique risks posed by altered animals to people
Potential for animals to escape and establish in the environment
Related CFR Sections (3)
- 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 →
- 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 →
See Also (8)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals (Status: Final)
- CVM GFI #187A Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach (Status: Final)
- CVM GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process (Status: Final)
- Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry (Status: Final)
- Submitting Debarment Certification Statements (Status: Draft)
- CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (Status: Final)