government is saying about the trials...
(October 31, 2002) The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are soliciting public review and comment on a proposed research protocol entitled "A Multicenter, Randomized Dose Response Study of the Safety, Clinical and Immune Responses of Dryvax Administered to Children 2 to 5 Years of Age" as announced in Federal Register Vol. 67, No. 211 Thursday October 31, 2002 Page 66403, available for review on the OHRP website at:
http://ohrp.osophs.dhhs.gov/dpanel/fr1031.pdf. This proposed research would include children as research subjects. Experts in relevant disciplines have reviewed the protocol, but prior to the Secretary, HHS, and Commissioner, FDA, making a final determination on whether this clinical investigation may proceed, public review and comment are hereby solicited pursuant to HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR 50.54. Materials are available for review on the OHRP website at:
http://ohrp.osophs.dhhs.gov/dpanel/dpindex.htm. Public comment on the proposed research protocol should be submitted to:
http://www.fda.gov/dockets/ecomments. Received comments may be viewed on the FDA website at:
http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm.
