2010-21245. Veterinary Medicine Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Veterinary Medicine Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on September 19, 2010, from 1 p.m. to 5:30 p.m. and on September 20, 2010, from 8 a.m. until 6 p.m.

Location: Rockville Hilton, 1750 Rockville Pike, Rockville, MD 20852, 301-468-1100.

Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9004, FAX: [phone], email: [e-mail], or 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.

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 a new animal drug application (NADA) 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 entitled “An overview of Atlantic salmon, its natural history, aquaculture, and genetic engineering” and “The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon” can be found at http://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​VeterinaryMedicineAdvisoryCommittee/​ucm201810.htm.

In a separate notice published elsewhere in this issue of the Federal Register, FDA is announcing 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” at http://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​VeterinaryMedicineAdvisoryCommittee/​ucm201810.htm.

FDA anticipates making the meeting materials available approximately 16 days before this meeting, but in any event no later than 2 business days before the meeting at http://www.fda.gov/​AdvisoryCommittees/​CommitteesMeetingMaterials/​VeterinaryMedicineAdvisoryCommittee/​ucm201810.htm. 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.

Additional information regarding the Center for Veterinary Medicine's (CVM's) regulatory oversight of genetically engineered animals can be found at http://www.fda.gov/​AnimalVeterinary/​DevelopmentApprovalProcess/​GeneticEngineering/​GeneticallyEngineeredAnimals/​default.htm.

Please be advised that as soon as a transcript is available, it can be obtained in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent 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.

Procedure: 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 p.m. on 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 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 http://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm111462.htm for procedures on publioc conduct during advisory committee meetings.

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

Dated: August 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.