Veterinary Feed Directive

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Advance notice of proposed rulemaking.

SUMMARY:

The Food and Drug Administration (FDA or the agency) is announcing an advance notice of proposed rulemaking (ANPRM) to solicit comments from the public regarding potential changes to its current regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is undertaking a review of these requirements in an effort to identify possible changes to improve efficiency. Therefore, the agency is requesting public comment on all aspects of the VFD regulation, particularly suggestions relating to improving efficiency. This information may be used to help draft a proposed rule in the near future.

DATES:

Submit electronic or written comments by June 28, 2010.

ADDRESSES:

You may submit comments, identified by Docket No. FDA-2010-N-0155, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

• FAX: 301-827-6870.
• Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Neal Bataller, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9201, e-mail: Neal.Bataller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Before 1996, two options existed for regulating the distribution of animal drugs, including drugs in animal feed: (1) Over-the-counter (OTC) and (2) prescription. In 1996, Congress passed and the President signed into law the Animal Drug Availability Act (ADAA) (Public Law 104-250), to facilitate the approval and marketing of new animal drugs and medicated feeds. As part of the ADAA, Congress determined that certain new animal drugs should be approved for use in animal feed but only if these medicated feeds were administered under a veterinarian's order and professional supervision. Therefore, the ADAA created a new category of products called veterinary feed directive drugs (or VFD drugs). VFD drugs are new animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional practice.

In the Federal Register of December 8, 2000 (65 FR 76924), FDA issued a final rule amending the new animal drug regulations to implement the VFD-related provisions of the ADAA. FDA reaffirmed that certain new animal drugs should be approved for use in animal feed only if these medicated feeds are administered under a veterinarian's order and professional supervision. Veterinarian oversight is important for assuring the safe and appropriate use of certain new animal drugs. For example, safety concerns relating to the difficulty of disease diagnosis, drug toxicity, drug residues, antimicrobial resistance, or other reasons may dictate that the use of a medicated feed be limited to use by order and under the supervision of a licensed veterinarian.

It has been 9 years since FDA began implementing the final rule regulating VFDs. Although, currently there are few approved VFD animal drug products, FDA has received a number of informal general comments that characterize the current VFD process as being overly burdensome. In addition, there are concerns that the process in its current form will become particularly problematic to administer in the future as the number of approved VFD animal drugs increases. When veterinary oversight of a medicated feed is determined to be necessary, it is critically important that such oversight be facilitated through an efficient VFD process. In response to these concerns, the agency is undertaking a review of the VFD regulations to determine whether changes are warranted to improve the program's efficiency.

II. Agency Request for Comments

The purpose of this document is to solicit public comment on whether such efficiency improvements are needed and, if so, on possible revisions to the VFD regulations. Such comments are welcome on all aspects of the VFD regulation. To facilitate FDA's review of submitted comments, please organize your comments based on the major categories of requirements included in the current VFD regulation at 21 CFR 558.6. These categories of requirements are listed following this paragraph. (See A through F.) If your comment addresses an issue outside of one of these categories, please categorize your comment as G. “Other:”

A. Conditions that must be met by veterinarians issuing a VFD;

B. What veterinarians must do with a VFD (e.g., disposition of original VFD and copies);

C. Records that must be kept related to the VFDs;

D. Notification requirements for distributors of animal feeds containing a VFD drug;

E. Additional recordkeeping requirements that apply to distributors;

F. Cautionary statements required for VFD drugs and animal feeds containing VFD drugs; and

G. Other.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.