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File name: SSJ Final redacted v1_Redacted.pdf

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a. Leading NIH’s Biosafety Modernization Initiative, an NIH Director priority involving a comprehensive effort to modernize and strengthen biosafety policies, practices, and oversight to keep pace with evolving risks posed by rapidly advancing science and technology. This includes development of a new, comprehensive biosafety policy framework to be issued by the end of the year. Adequate contractor support is essential to meeting this commitment.

b. Administration of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the primary Federal framework governing biosafety oversight of such research. Activities include: o Registering and maintaining Institutional Biosafety Committees (IBCs) in the NIH OSP Registration Management System, including review and approval of committee membership (more than 4,000 registered IBCs), which serve as the foundation of institutional biosafety oversight in the United States o Assessing and making determinations regarding appropriate biosafety levels and containment requirements to ensure protection of public health o Responding to approximately 1,000 biosafety inquiries annually o Reviewing and responding to approximately 250 biosafety incident reports annually
c. Administration of the National Science Advisory Board for Biosecurity (NSABB), a Congressionally mandated Federal advisory committee, including operational, logistical, and policy support on behalf of HHS. The purpose of the National Science Advisory Board for Biosecurity (NSABB) is to provide technical advice, guidance, or recommendations, to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research, including — (1) oversight of federally-conducted or federally-supported dual use biomedical research, such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research, taking into consideration national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration; and (2) pursuant to section 205 of the PAHPA, when requested by the Secretary of Health and Human Services (Secretary) (a) a core curriculum and training requirements for workers in maximum containment biological laboratories; and (b) periodic evaluations of maximum containment biological

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