Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products. It provides investigational new drug application (IND) sponsors and applicants for a BLA, or a supplement to a BLA, with recommendations on considerations when assessing whether to submit an Environmental Assessment (EA) for gene therapies, vectored vaccines, and related recombinant viral or microbial products. It also recommends what information should be included in an EA and what sponsors and applicants can expect once an EA is filed. The guidance, when finalized, will supplement the Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications, dated 7/1998. To download this draft guidance, click here. To view this notice, click here.