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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Issues Final Rules for NADA Presubmission Conferences

August 18, 2004

FDA has issued a final regulation that describes the procedures to be followed for requesting, conducting, and documenting presubmission conferences. Under the Animal Drug Availability Act (ADAA) amendments to the Federal Food, Drug, and Cosmetic Act, any person intending to file a new animal drug application (NADA), supplemental NADA, or to investigate a new animal drug is entitled to one or more conferences with FDA to reach an agreement establishing a submission or investigational requirement.

The general principle underlying the conduct of a presubmission conference is that there should be candid, full, and open communication.

A potential applicant's request for a presubmission conference must be submitted to FDA in a signed letter. The letter must include a proposed agenda that clearly outlines the scope, purpose, and objectives of the presubmission conference and must list the names and positions of the representatives who are expected to attend the conference on behalf of the applicant. A potential applicant may request one or more presubmission conferences any time prior to the filing of a NADA or an abbreviated new animal drug application (ANADA.) A request for a presubmission conference must be received by FDA at least 30 calendars days in advance of the requested conference date. In addition to a detailed agenda, the potential applicant must provide to FDA a copy of any materials to be presented at the conference, a list of proposed indications and, if available, a copy of the proposed labeling for the product under consideration, and copies of materials evaluated or referenced relative to issues listed in the agenda.

The final rule, which is effective November 1, 2004, is contained in the August 18. 2004, Federal Register. Single copies of the rule may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800. Please send one self-addressed adhesive label to assist in processing your request.

Additional information about this final rule is available from Gail L. Schmerfeld, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-1796, e-mail: gschmer1@cvm.fda.gov.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855