The U.S. Food & Drug Administration issued on Nov. 30 a draft guidance for industry (GFI #233), "Veterinary Feed Directive Common Format Questions and Answers" to provide animal drug sponsors who are seeking approval for use of their drug in or on animal feed as a veterinary feed directive (VFD) drug with a recommended common format for a fillable form — called a VFD — that can later be used by veterinarians to authorize the use of the sponsor’s drug in feed.
The draft guidance describes the requirements for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal feed as a VFD drug, as well as the required and optional information to be included on the VFD. The draft guidance also provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by a sponsor.
By recommending a common format, the draft guidance is expected to help veterinarians, distributors (including feed mills) and animal producers quickly identify relevant information on a VFD order, FDA said. A common format is also expected to reduce the risk of a veterinarian making an error or leaving out required information when filling in the form.
FDA is accepting public comments beginning Dec. 1. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2010-N-0155 in the search box. Note that the docket will not be open to accept comments until this date. The comment period will close 60 days after it publishes in the Federal Register.