The U.S. Food and Drug Administration has issued draft guidance for industry (GFI #233) entitled, “Veterinary Feed Directive Common Format Questions and Answers” to provide animal drug sponsors who are seeking approval for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The draft guidance describes the requirements for sponsor submission of a VFD to FDA as part of the application process for approval of a new animal drug for use in or on animal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 The draft guidance also provides examples that illustrate how a common VFD format might appear and how some of the information on the VFD may be pre-populated by a sponsor. By recommending a common format, the draft guidance is expected to help veterinarians, distributors (including feed mills), and animal producers quickly identify relevant information on a VFD order. 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.

Guidance documents represent the FDA’s current thinking on particular topics, policies, and regulatory issues. While “guidance for industry” documents are prepared primarily for industry, they also are used by FDA staff and other stakeholders to understand the agency’s interpretation of laws and policies.

The FDA is accepting public comments beginning on December 1, 2015. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2010-N-0155 in the search box. Please 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. While comments are welcome at any time, you should submit them by the closing date for the FDA to consider your comments in drafting the final guidance.

To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2010-N-0155 on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852