H.R. 4165 — To amend the Public Health Service Act to provide for the inclusion of a biological attribution strategy, and an early warning strategy and implementation plan, in the National Health Security Strategy, and for other purposes.

This section directs the Secretary of Health and Human Services to develop a biological attribution strategy (i.e., to improve federal coordination in attributing the source, cause, or origin of biological hazards and pathogens of pandemic potential) as a new national public health preparedness goal under Section 2802(b) of the Public Health Service Act (42 U.S.C. 300hh-1(b)). The strategy must include (1) descriptions of biological attribution duties for relevant federal agencies (including routine activities, event triggers for determinations, and exercises of capabilities); (2) each agency's process for attribution determinations (addressing national security); (3) assignments, milestones, and timelines to build national attribution capacity; and (4) a plan for new technologies (e.g., diagnostics, sequencing, safe collection) via internal and public-private initiatives. In developing the strategy, the Secretary must coordinate with the Administration for Strategic Preparedness and Response, Office of Science and Technology Policy, and Office of the Director of National Intelligence.

This section amends Section 2802(b) of the Public Health Service Act by adding a new national public health preparedness goal (paragraph (12)) requiring the Secretary of Health and Human Services to develop and implement an early warning strategy and plan for biological, chemical, and radiological threats, in accordance with new subsection (d). (As background, Section 2802(b) enumerates 11 existing national preparedness goals that guide HHS public health and medical response capabilities, including leadership in emergencies under 42 U.S.C. 300hh.) New subsection (d)(1) specifies the strategy's objectives as (A) developing a robust early warning function incorporating new technologies, emphasizing diagnostics, sequencing, and safe collection capabilities; (B) identifying new biological threats at the earliest time to inform responses; (C) understanding the prevalence of current and recurring threats; (D) adapting technologies to emerging chemical and radiological threats, including synthetic drugs and fentanyl; (E) conducting ongoing detection from sources such as wastewater, airports, and transportation hubs; and (F) enabling rapid deployment of technologies at scale during public health events. Subsection (d)(2) requires the Secretary, in developing the strategy, to consult with state and local public health entities, private sector and academic partners, and appropriate federal officials—including the Assistant Secretary for Strategic Preparedness and Response and the Director of the Centers for Disease Control and Prevention—to coordinate activities, streamline programs, and eliminate duplication. It further directs the Secretary to periodically meet with the Director of National Intelligence regarding foreign and cross-border threats.