A suitability petition is a request by a drug sponsor (called the “petitioner”) to submit an abbreviated new animal drug application (ANADA) for a proposed generic new animal drug that differs from the reference listed new animal drug (RLNAD). Permissible changes provided under § 512(n)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C act) include:
- Route of administration;
- Dosage form;
- Strength (concentration);
- A change in one of the active ingredients in the reference listed combination new animal drug (same pharmaceutical class); or
- whose use with other animal drugs in animal feed differs from that of an approved new animal drug.
Suitability petitions are a type of Citizen Petition and are submitted through the Division of Dockets Management. Please refer to 21 CFR 10.30 for details on how to submit a suitability petition.
Below is a list of the type of information we need to make a determination about your suitability petition. We have received this information in table and other formats.
- Identification of the petitioner, including name, address, phone number, and email address, and a citation to § 512(n)(3) of the FD&C act as the basis for the suitability petition;
- Action requested: Identification of the proposed generic product and a description of the permissible change(s) being requested;
- Identification of the requested RLNAD, including dosage form; strength, & active ingredient(s);
- Comprehensive statement of grounds (justification) for the proposed change from the RLNAD being requested;
- Side-by-side comparison of suggested label changes for the proposed generic new animal drug and the currently approved labeling for the RLNAD;
- Request for a categorical exclusion under 21 CFR 25.30(h) from the requirement to prepare an environmental assessment or an environmental assessment under 21 CFR 25.40;
- If requested by the Commissioner following review of the petition, an economic impact statement. The petitioner must indicate that such an analysis will be provided upon request; and
- Certification that this petition includes, to the best knowledge and belief of the petitioner, all information and views on which the petition relies, and that it includes representative data and information known to the petitioner, which are unfavorable to the petition.
The Policy and Procedures 1243.3040 document entitled Processing Suitability Petitions is publicly available. This manual provides additional information about the suitability petition process.