Document ID: FDA-2010-N-0001-0006
Agency: fda
Document Type: Notice
Title: Veterinary Medicine Advisory Committee; Notice of Meeting
Posted Date: 2010-01-28T05:00Z

[Federal Register: January 28, 2010 (Volume 75, Number 18)]
[Notices]               
[Page 4576]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja10-72]                         

[[Page 4576]]

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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 March 24, 2010, from 
8:30 a.m. to 5 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, e-mail: 
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 March 24, 2010, the committee will discuss and make 
recommendations regarding modifications, if any, to the current risk 
minimization and restricted distribution program for Pfizer's PROHEART 
6 (NADA 141-189), the subsequent safety data collected under the Center 
for Veterinary Medicine's risk minimization and restricted distribution 
program, and the agency's role in continued product postmarketing 
surveillance.
    FDA intends to make background material available to the public 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. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    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 
March 17, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. 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 March 9, 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 March 10, 
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 public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-1626 Filed 1-27-10; 8:45 am]
BILLING CODE 4160-01-S