FDA Extends Comment Period on the Advanced Notice of Proposed Rulemaking for the Veterinary Feed Directive Regulation
The Food and Drug Administration has agreed to extend the comment period on the Advanced Notice of Proposed Rulemaking (ANPRM) for the veterinary feed directive program (VFD) for an additional 60 days. The agency is taking this action after receiving comments that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the ANPRM.
The public now has until August 27, 2010, to comment on the ANPRM and whether changes are warranted to improve the efficiency of the VFD program. The agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking.
The ANPRM was originally announced in the Federal Register on March 29, 2010, with a 90-day comment period.
The Agency is requesting public comment on all aspects of the VFD regulation, particularly suggestions related to improving efficiency. This information may be used to help draft a proposed rule in the near future.
The 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 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. While 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.
The agency invites comments on all aspects of the VFD regulation, available online at: http://edocket.access.gpo.gov/2010/pdf/2010-6872.pdf.