Implementation of Emergency Research Informed Consent Waiver Rule; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting on the implementation of a final rule that defined conditions for an exception to the normal requirements for obtaining informed consent from persons participating as subjects in research. FDA is holding the public meeting because some parties interested in research conducted under the final rule have expressed to FDA a need for additional information on acceptable implementation procedures. The purpose of this public meeting is to provide an open discussion of the issues involved in implementing the requirements of the rule. DATES: The public meeting will be held on September 29 and 30, 1997. On September 29, 1997, the meeting will be from 9:30 a.m. to approximately 5:30 p.m. On September 30, 1997, the meeting will be from 8 a.m. to approximately 11:45 a.m. Registration is recommended by September 19, 1997. Opportunity for public participation will be provided during both days of the meeting. Written comments will be accepted until October 31, 1997.