[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52605-52606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21245]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[email protected], 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