[Federal Register Volume 69, Number 119 (Tuesday, June 22, 2004)]
[Notices]
[Page 34683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


International Workshop on Minor Use and Minor Species: A Global 
Perspective; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``International Workshop on Minor Use and Minor 
Species (MUMS): A Global Perspective.'' The workshop is the result of a 
partnership between FDA's Center for Veterinary Medicine (CVM) and the 
U.S. Department of Agriculture's (USDA's) minor use animal drug 
program, the National Research Support Project 7 (NRSP-7). The 
purpose of the workshop is to assemble international expertise to 
discuss the global pursuit of drug approvals for MUMS. The workshop is 
planned to provide several ``forums'' for discussion of the global 
perspectives of drug needs and drug approvals for minor species and 
minor uses. Areas to be discussed include data requirements for MUMS 
drug approvals (effectiveness, target animal safety, human food safety, 
environmental safety, etc.), the classification of minor species, and 
husbandry practices in the various regions of the world. Anticipated 
outcomes of the workshop include methods and strategies to improve 
cooperation and coordination of national and regional programs to 
maximize MUMS drug approvals internationally.
    Date and Time: This 2-day public workshop will be held on October 
7, 2004, from 8:30 a.m. to 5:45 p.m., and on October 8, 2004, from 8:30 
a.m. to 12:15 p.m. Registration opens at 7:30 a.m. each day.
    Location: The public workshop will be held at the DoubleTree Hotel, 
Plaza Room III, 1750 Rockville Pike, Rockville, MD.
    The DoubleTree Hotel is accessible via the Washington, DC Metro 
Transit System, Red Line, and is located next to the Twinbrook Metro 
Station. The hotel is a short walk from the station.
    Contact: Margaret Oeller, Center for Veterinary Medicine (HFV-1), 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 
301-827-3067, FAX: 301-827-4572, or e-mail: [email protected].
    Registration: Registration forms for the workshop are available 
from the CVM/FDA's Web site and should be completed online. If a paper 
copy is needed, please contact Anna Roy, Center for Veterinary Medicine 
(HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 
20855, 301-827-2957, FAX: 301-827-4572, or e-mail: [email protected] by 
Wednesday, October 6, 2004. There is no registration fee for the public 
workshop. Because seating is limited, we recommend early registration.
    If you need special accommodations due to a disability, please 
contact Anna Roy at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: FDA's CVM, in partnership with the USDA's 
National Research Support Project 7 (NRSP-7), will convene a 
public workshop entitled ``International Workshop on Minor Use and 
Minor Species (MUMS): A Global Perspective.'' International 
representatives have been invited to speak on pertinent issues relating 
to product approvals for MUMS from their respective countries.
    There will be an opportunity to raise additional questions and 
issues for discussion during open public comment periods during each 
day of the workshop. Prior to the meeting, the draft agenda for this 
public workshop will be posted on CVM's Web site at http://www.fda.gov/cvm/default.html and on the NRSP-7 Web site at http://www.nrsp7.org 
(FDA has verified the Web site address, but FDA is not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register).
    Transcripts: Transcripts of the workshop will be posted on the CVM 
Web site at http://www.fda.gov/cvm/default.html. Written copies of the 
transcript may be requested in writing from the Freedom of Information 
Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 
12A-16, Rockville, MD 20857, after the public workshop, at a cost of 10 
cents per page.
    Questions about the workshop may be directed to Margaret Oeller, 
CVM, at 301-827-3067 or [email protected] by Tuesday, October 5, 
2004.

    Dated: June 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14015 Filed 6-21-04; 8:45 am]
BILLING CODE 4160-01-S