Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Providing Submissions in Electronic Format —Postmarketing Safety Reports for Vaccines. It provides information and recommendations on the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved BLAs including individual case safety reports and attachments to ICSRs into the Vaccine Adverse Event Reporting System. The draft guidance, when finalized, also will supersede the document entitled for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1) dated 9/1998. To download this guidance, click here. To view this notice, click here.