Bill > S2700

This bill, the FDA and NIH Workforce Authorities Modernization Act, aims to update and enhance the workforce capabilities of the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). Key provisions include expanding the Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service to allow for up to 2,000 members, increasing its capacity to recruit and retain top scientific and technical experts in biomedical research and product assessment, and allowing for higher compensation for these critical roles, capped at the President's salary. The bill also grants the FDA new hiring authorities for scientific, technical, and professional personnel involved in medical product development and regulation, allowing for flexible compensation to attract and retain qualified individuals, and establishes Intercenter Institutes within the FDA to improve coordination and streamline the review of medical products for major disease areas. Furthermore, it exempts NIH research information collection from certain paperwork requirements, modifies provisions related to the Reagan-Udall Foundation for the FDA to allow for a larger and more diverse board, and clarifies rules around scientific meetings and travel for HHS personnel. The bill also introduces requirements for manufacturers to make their expanded access policies for investigational drugs publicly available and mandates the finalization of guidance on how the FDA uses adverse event data from such programs, alongside other technical amendments and clarifications to existing laws concerning drug and device regulation.