Document ID: FDA-2010-N-0001-0094
Agency: fda
Document Type: Notice
Title: Veterinary Medicine Advisory Committee; Notice of Meeting
Posted Date: 2010-08-26T04:00Z

[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Notices]               
[Page 52605-52606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au10-125]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
Veterinary Medicine Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    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: 240-276-9020, email: 
aleta.sindelar@fda.hhs.gov, 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

[[Page 52606]]

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.
[FR Doc. 2010-21245 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S