The new report should contain comments on the significan ce of the new event in light of the previous, similar reports. Written IND safety reports with Analysis of Similar Events are to be submitted to the FDA within 15 calendar days of first learning of the event. 6.5.3.2 IND Annual Reports In accordance with the regulation 21 CFR § 312.33, the Sponsor shall within 60 days of the anniversary date that the IND went into effect submit a brief report of the adverse events and progress of the investigation. Please refer to Code of Federal Regulations, 21 CFR § 312.33 for a lis t of the elements required for the annual report. All IND annual reports will be submitted to the FDA by the Sponsor-Investigator. 6.5.4 Recombinant DNA Advisory Committee (RAC) Unexpected SAEs believed to be rela ted to GVAX will be reported to RAC by email if fatal or life-threatening within 7 calendar days or by written report if related and unexpected to GVAX within 15 calendar days. SAEs that are unrelated or related and expected with GVAX will be reported to RAC in the Annual Report. Follow-up information will be submitted to the RAC as soon as relevant information is available.