September 19-20, 2010: Veterinary Medicine Advisory Committee Meeting Announcement

Agenda

On September 19, 2010, the committee will receive an orientation on both general scientific issues surrounding genetically engineered animals and the statutory and regulatory constraints under which the agency must operate. On September 20, 2010, the Committee will consider issues regarding the safety and effectiveness of the new animal drug that is the subject of new animal drug application concerning AquAdvantage salmon produced by AquaBounty Technologies, Inc. These genetically engineered Atlantic salmon are intended to grow faster than conventionally bred Atlantic salmon. Two background documents, “An overview of Atlantic salmon, its natural history, aquaculture, and genetic engineering” and “The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon” are posted at 2010 VMAC Meeting Materials.

In a separate notice published elsewhere in this issue of the Federal Register, FDA has announced that it will hold a public hearing on the labeling of food, including naming of the food, from the AquAdvantage salmon on September 21, 2010. This public hearing will allow the public to comment on the application of food labeling principles to food from the AquAdvantage salmon, if the NADA is approved. An overview of the labeling issues to be addressed is described in “Background Document: Public Hearing before the Commissioner on the Labeling of Food Made from the AquAdvantage Salmon”.

Meeting Materials

Links to meeting materials will be added as they become available. FDA anticipates making the meeting materials available approximately 16 days before the meeting, but in any event no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

• 2010 VMAC Meeting Materials

Additional information regarding CVM’s regulatory oversight of genetically engineered animals can be found at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ GeneticEngineering/GeneticallyEngineeredAnimals/default.htm

The transcript of the meeting will be posted on FDA’s website as soon as it becomes available. Written requests for either a hardcopy or CD-ROM should be directed to the Division of Freedom of Information (HFI-35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, Rockville, MD 20857.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

• Written submissions may be made to the contact person on or before September 16, 2010
• Oral presentations from the public will be scheduled between approximately 2:45 p.m. and 4:00 p.m., September 20, 2010. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 7, 2010. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 9, 2010.
• Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
• FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Aleta Sindelar at 240-276-9004 at least 7 days in advance of the meeting.
• FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Contact Information

• Aleta Sindelar
  Center for Veterinary Medicine (HFV-3)
  Food and Drug Administration
  7519 Standish Place
  Rockville, MD 20855
  Telephone: 240-276-9004
  FAX: 240-276-9020
  E-mail: aleta.sindelar@fda.hhs.gov
• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)
  Code: 3014512548

Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).