[Federal Register Volume 68, Number 182 (Friday, September 19, 2003)]
[Notices]
[Pages 54908-54909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23904]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Issues and Challenges in the Design and Conduct of Clinical 
Trials of Drugs in Pre-Term Infants and Neonates

    The National Institute of Child Health and Human Development 
(NICHD) of the National Institutes of Health (NIH), Department of 
Health and Human Services, will sponsor a working meeting to explore 
approaches for the design and conduct of clinical trials to foster safe 
and effective drug therapies in pre-term infants and neonates on March 
29-March 30, 2004, at the Baltimore and Washington International 
Airport Marriott Hotel.
    The NICHD is sponsoring the meeting in collaboration with the Food 
and Drug Administration, the Fogarty International Center, and other 
NIH institutes and centers, including the National Cancer Institute; 
National Heart, Lung, and Blood Institute; National Institute of Dental 
and Craniofacial Research; National Institute of Diabetes ands 
Digestive and Kidney Diseases; National Institute of Neurological 
Disorders and Stroke; National Institute of Allergy and Infectious 
Diseases; National Institute of General Medical Sciences; National Eye 
Institute; National Institute of Environmental Health Sciences; 
National Institute of Arthritis and Musculoskeletal and Skin Diseases; 
National Institute of Mental Health; National Institute on Drug Abuse; 
National Institute on Alcohol Abuse and Alcoholism; National Institute 
of Nursing Research; National Human

[[Page 54909]]

Genome Research Institute; National Center for Research Resources; and 
National Center for Complementary and Alternative Medicine.
    The purpose of the working meeting is to discuss the current status 
of drug research in neonates and pre-term infants. The meeting will 
focus on exploring gaps in existing knowledge in this field and in 
developing strategies to rectify the gaps that could be implemented by 
federal agencies and the scientific community.
    Participants at the meeting will develop recommendations for 
potential research approaches for current and future pharmaceutical 
agents for use in newborns. The focus will be on issues related to: 
Trial design, ethics, pharmacokinetics, pharmacodynamics, efficacy and 
toxicity, drug formulations, drug prioritization, and surveillance of 
adverse events. Additional discussion will consider the assessment of 
long term outcomes and issues related to research in small 
subpopulations.
    Attendance at the meeting will be limited. Persons interested in 
attending the meeting should submit a request containing the following 
information to <[email protected].

Name
Address
Telephone
Fax
E-mail

    Persons interested in obtaining more information about the meeting 
may contact Dr. Donald Mattison, NICHD, 6100 Executive Boulevard, Room 
4B-100, Rockville, MD 20892, e-mail 
<[email protected], telephone 301-496-5097 
(not a toll-free number).

    Dated: September 12, 2003.
Raynard Kington,
Deputy Director, National Institutes of Health.
[FR Doc. 03-23904 Filed 9-18-03; 8:45 am]
BILLING CODE 4140-01-P