Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 52605 

number of oral presentations, we may 

need to limit the time allotted for each 

oral presentation (e.g., 5 minutes each). 

Depending on the content of the 

presentations, the time allotted for oral 

presentations may vary. We request that 

interested persons and groups having 

similar interests consolidate their 

requests for oral presentation and 

present them through a single 

representative. If you need special 

accommodations due to a disability, 

please inform us (see Table 1 and FOR

FURTHER INFORMATION CONTACT). 

We will also accept registration 

onsite; however, space is limited. Onsite 

registration will be accepted on a firstcome, first-served basis and will be 

closed when the maximum seating 

capacity is reached. Requests for an 

opportunity to make a presentation from 

individuals or organizations that did not 

register in advance to make an oral 

presentation may be granted if time 

permits. 

Persons who registered in advance for 

the hearing should check in at the onsite 

registration desk between 8:30 and 9 

a.m. Persons who wish to register onsite 

on the day of the hearing should do so 

at the registration desk between 8:30 

and 9 a.m. We encourage all 

participants to attend the entire day. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

Table 1) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VII. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: August 23, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21243 Filed 8–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

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: 

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/Advisory

Committees/CommitteesMeeting

Materials/VeterinaryMedicine

AdvisoryCommittee/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/Veterinary

MedicineAdvisoryCommittee/ 

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/Veterinary

MedicineAdvisoryCommittee/ 

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/Development

ApprovalProcess/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 

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52606 Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices 

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/Advisory

Committees/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 

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