From: Walsh, Maria R
Sent: Tuesday, October 19, 2004 9:03 AM
To: Butler, Jennie C
Cc: Kang, Kyong A
Subject: FW: Radioactive Drugs for Certain Research Uses -- Public
Meeting ( November 16) Docket No. 2004N-0432

Jennie,

Five requests to present for Docket No. 2004N-0432

Maria

-----Original Message-----
From: Cannon Hugh C. [mailto:HCannon@snm.org] 
Sent: Friday, October 15, 2004 4:24 PM
To: walsh@cder.fda.gov
Subject: Radioactive Drugs for Certain Research Uses -- Public Meeting ( November 16) Docket No. 2004N-0432


	As requested in the Federal Register Announcement the following individuals intend to testify at the meeting:

	Radiation Dose Limits for Adult Subjects:
		Henry D. Royal, MD - representing the University of St. Louis
		Mallinckrodt Institute of Radiology		
		Division of Nuclear Medicine
		510 South Kingshighway
		St. Louis, MO 63110
		Telephone Number:  (314) 362-2809	
		E-mail:  RoyalH@mir.wustl.edu
		Dr. Royal will discuss present dose limits and their appropriateness for different age groups in light
		of the scientific knowledge advancements since 1975.
		His presentation will take approximately 10 minutes.

	Assurance of Safety for Pediatric Subjects 
		Michael J. Gelfand. MD - representing Children's Hospital
		Children's Hospital
		519 Chisholm Trail
		Cincinnati, OH 45215
		Telephone: (513) 636-7650
		E-mail:  Michael.gelfand@cchmc.org
		Dr. Gelfand will address the safeguards for pediatric subjects provided by 361.1 and their
		adequacy ensuring no significant risks for pediatric subjects.
		His presentation will take approximately 10 minutes.

	Exclusion of Pregnant Women
		Henry D. Royal, MD - representing the University of St. Louis
		Mallinckrodt Institute of Radiology
		Division of Nuclear Medicine
		510 South Kingshighway
		St. Louis, MO 63110	
		Telephone: (314) 362-2809
		E-mail:  RoyalH@mir.wustl.edu
		Dr. Royal will discuss the assurances that should be provided to guarantee each female subject
		of childbearing age participating in research studies is not pregnant.
		His presentation will take approximately 10 minutes.

	RDRC Membership
		Terence Beven, FACNP - representing the American College of Nuclear Physicians
		Department of Nuclear Medicine
		Our Lady of The Lake Regional Medical Center
		5000 Hennessy Boulevard
		Baton Rouge, LA 70808
		Telephone:  (225) 765-8995
		E-mail:  tbeven1957@aol.com
		Dr. Beven will speak to the membership of the RDRC and the process of "vetting" new members.
		He will speak for approximately 10 minutes.		

		

		
	RDRC Membership
		Mathew L. Thakur - representing the Society of Nuclear Medicine
		Thomas Jefferson University			
		Department of Radiology
		1020 Locust Street, Rm.359 JAH
		Philadelphia, PA 19107
		Telephone:  (215) 503-7874
		E-mail:  Mathew.Thakur@ Jefferson.edu
		Dr. Thakur will discuss the value of diverse expertise in structuring the RDRC in its work.
		He will speak for approximately 10 minutes.