Links to Regulatory Agencies and Documents
Centers for Disease Control and Prevention (CDC): Biosafety in Microbiological and Biomedical Laboratories (BMBL): This edition (5th) includes information on occupational medicine and immunization, decontamination and sterilization, biosecurity and risk assessment, agent summaries for some agricultural pathogens, and biological toxins.
National Institutes of Health (NIH) Office of Science Policy: NIH Guidelines, revised April 2019, in html format
7 CFR Part 331 and 9 CFR Part 121: Agricultural Bioterrorism Protection Act of 2002; Posession, Use and Transfer of Biological Agents and Toxins; Final Rule: Established regulations governing the possession, use, and transfer of biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products.
Human Gene Therapy Resources
Amendments to Streamline Review of Gene Therapy Trials and Transform the RAC to NExTRAC – April 2019: On August 16, 2018, the NIH director proposed streamlining the federal framework for oversight of gene therapy. This would eliminate duplicative review and reporting requirements for human gene transfer protocols. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC (NIH Recombinant DNA Advisory Committee) has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).
Template for Reporting Adverse Events in Human Gene Transfer Trials: The NIH Guidelines require that “any significant problems, violations, or any significant research-related accidents and illnesses” be reported to Office of Science Policy (OSP) within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. Specifically, Appendix G-II-B-2-k requires that spills and accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to the OSP (as well as the IBC). In addition, Appendices G-II-C-2-q and G-II-D-2-k require that spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to OSP (as well as the IBC and BSO).
Genetic Modification Clinical Research Information System: The Genetic Modification Clinical Research Information System (GeMCRIS) is a web-based information system for human gene transfer trials that was developed in collaboration with the Food and Drug Administration (FDA). This database will not be accessible after September 30, 2019; however, information may be accessed downloaded until that time.