[Federal Register: September 19, 2003 (Volume 68, Number 182)]
[Notices]
[Page 54908-54909]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se03-73]
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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 <bestpharmaceuticals@mail.nih.gov.
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
<bestpharmaceuticals@mail.nih.gov, 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]
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