Regulacje i polityka gospodarcza · 31.10.2002

Solicitation of Public Review and Comment on Research Protocol: A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Response of Dryvax® Administered to Children 2 to 5 Years of Age

The Office for Human Research Protections (OHRP), Office of Public Health and Science, Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), HHS are soliciting public review and comment on a proposed research protocol entitled "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Response of Dryvax[reg] Administered to Children 2 to 5 Years of Age." The proposed research would be supported by a contract awarded by the National Institutes of Health (NIH) and conducted under an Investigational New Drug Application (IND) filed with the FDA. Public review and comment is solicited regarding the proposed research protocol pursuant to the requirements of HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR 50.54.