Drugs and Biological Products: Safety Evaluation and Marketing Authorizations. You may contact the Federal Register via the Internet at , or a paper copy can be shipped by fax to 1, Attention; Department of Health and Human Services, Federal Register, P.O. Box 25296, Atlanta, GA 30. The Federal Register's main entry point is .
The following information has been added to the FDA's “Current Contents” section, for informational purposes only, and is subject to change without further notice:
Hepatitis B vaccine, in remarketing trials. FDA has submitted a request for comments on the dosing schedule of hepatitis B vaccine in the remarketing trial. The dosing schedule is as follows:
Dose for healthy adults (25 to 63 years of age) and children 2 to 5 years of age:
0.5 mL/kg/day in divided doses to be administered 1 hour after a single hepatic microdialysis (MD) visit; 1.5 mL/kg/day in divided doses to be administered by 2-minute IV infusion for each dose between 9 and 10 days following initial 2-hour MD visit if herb surface antigen (Head) levels are high and not expected to decrease or change over time; or 2.0 mL/kg/day in divided doses to be administered each week for a total of 6 doses within a 12-week period if a decrease in Head levels is expected to occur within the 12-week period. The dose should be administered on a schedule that allows the minimum number of hours between each dose to vary according to the clinical and metabolic status of the patient. The last dose should be administered as soon as possible after the last MD visit (the minimum interval before the next dose).
Hepatitis B vaccine, in pre-marketing clinical trials. FDA has submitted a request for comments on the study design for a remarketing study of intramuscular (IM) Hepatitis B vaccine. The study was initiated in the United Kingdom in October 1997 and ended in June 2000. The study design was similar to the intramuscular (IM) study conducted by the National Research Council Scientific and Technical Advisory Committee (SNAP, R.P., and K.J.L., unpublished observations).
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Federal Register / Vol. 64, No. 72 / Thursday, April 15, 1999 / Rules and Regulations * * * * * FR Doc. 99 9427 Filed 4 14 99; 8:45 am BILLING CODE 4190 29 P DEPARTMENT OF HEALTH AND HUMAN SERVICES
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