Table of Contents

To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, and for other purposes.

Section 1. Short title; table of contents

(a) Short title–

This Act may be cited as the “Pandemic and All-Hazards Preparedness Reauthorization Act of 2013”.

(b) Table of contents–

The table of contents of this Act is as follows:

• • Sec. 1. Short title; table of contents.
• Title I—Strengthening national preparedness and response for public health emergencies
  • Sec. 101. National Health Security Strategy.
  • Sec. 102. Assistant Secretary for Preparedness and Response.
  • Sec. 103. National Advisory Committee on Children and Disasters.
  • Sec. 104. Modernization of the National Disaster Medical System.
  • Sec. 105. Continuing the role of the Department of Veterans Affairs.
• Title II—Optimizing State and local all-hazards preparedness and response
  • Sec. 201. Temporary redeployment of federally funded personnel during a public health emergency.
  • Sec. 202. Improving State and local public health security.
  • Sec. 203. Hospital preparedness and medical surge capacity.
  • Sec. 204. Enhancing situational awareness and biosurveillance.
  • Sec. 205. Eliminating duplicative Project Bioshield reports.
• Title III—Enhancing Medical Countermeasure Review
  • Sec. 301. Special protocol assessment.
  • Sec. 302. Authorization for medical products for use in emergencies.
  • Sec. 303. Definitions.
  • Sec. 304. Enhancing medical countermeasure activities.
  • Sec. 305. Regulatory management plans.
  • Sec. 306. Report.
  • Sec. 307. Pediatric medical countermeasures.
• Title IV—Accelerating medical countermeasure advanced research and development
  • Sec. 401. BioShield.
  • Sec. 402. Biomedical Advanced Research and Development Authority.
  • Sec. 403. Strategic National Stockpile.
  • Sec. 404. National Biodefense Science Board.

Title I— Strengthening national preparedness and response for public health emergencies

Sec. 101. National Health Security Strategy

(a) In general– Section 2802 of the Public Health Service Act (42 U.S.C. 300hh–1)is amended—

(1) in subsection (a)(1), by striking “2009” and inserting “2014”; and

(2) in subsection (b)—

(A) in paragraph (1)(A), by inserting “, including drills and exercises to ensure medical surge capacity for events without notice” after “exercises”; and

(B) in paragraph (3)—

(i) in the matter preceding subparagraph (A)—

(I) by striking “facilities), and trauma care” and inserting “and ambulatory care facilities and which may include dental health facilities), and trauma care, critical care,”; and

(II) by inserting “(including related availability, accessibility, and coordination)” after “public health emergencies”;

(ii) in subparagraph (A), by inserting “and trauma” after “medical”;

(iii) in subparagraph (B), by striking “Medical evacuation and fatality management” and inserting “Fatality management”;

(iv) by redesignating subparagraphs (C), (D), and (E)as subparagraphs (D), (E), and (F), respectively;

(v) by inserting after subparagraph (B), the following the new subparagraph:

(C) Coordinated medical triage and evacuation to appropriate medical institutions based on patient medical need, taking into account regionalized systems of care.;

(vi) in subparagraph (E), as redesignated by clause (iv), by inserting “(which may include such dental health assets)” after “medical assets”; and

(vii) by adding at the end the following:

(G) Optimizing a coordinated and flexible approach to the medical surge capacity of hospitals, other health care facilities, critical care, and trauma care (which may include trauma centers) and emergency medical systems.;

(C) in paragraph (4)—

(i) in subparagraph (A), by inserting “, including the unique needs and considerations of individuals with disabilities,” after “medical needs of at-risk individuals”; and

(ii) in subparagraph (B), by inserting “the” before “purpose of this section”; and

(D) by adding at the end the following:

(7) Countermeasures–

(A) Promoting strategic initiatives to advance countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, chemical, radiological, or nuclear agent or agents, whether naturally occurring, unintentional, or deliberate.

(B) For purposes of this paragraph, the term countermeasures has the same meaning as the terms qualified countermeasures under section 319F–1, “qualified pandemic and epidemic products” under section 319F–3, and “security countermeasures” under section 319F–2.

(8) Medical and public health community resiliency– Strengthening the ability of States, local communities, and tribal communities to prepare for, respond to, and be resilient in the event of public health emergencies, whether naturally occurring, unintentional, or deliberate by—

(A) optimizing alignment and integration of medical and public health preparedness and response planning and capabilities with and into routine daily activities; and

(B) promoting familiarity with local medical and public health systems..

(b) At-Risk individuals– Section 2814 of the Public Health Service Act (42 U.S.C. 300hh–16)is amended—

(1) by striking paragraphs (5), (7), and (8);

(2) in paragraph (4), by striking “2811(b)(3)(B)” and inserting “2802(b)(4)(B)”;

(3) by redesignating paragraphs (1) through (4) as paragraphs (2) through (5), respectively;

(4) by inserting before paragraph (2)(as so redesignated), the following:

(1) monitor emerging issues and concerns as they relate to medical and public health preparedness and response for at-risk individuals in the event of a public health emergency declared by the Secretary under section 319;;

(5) by amending paragraph (2)(as so redesignated) to read as follows:

(2) oversee the implementation of the preparedness goals described in section 2802(b) with respect to the public health and medical needs of at-risk individuals in the event of a public health emergency, as described in section 2802(b)(4);; and

(6) by inserting after paragraph (6), the following:

(7) disseminate and, as appropriate, update novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies in as timely a manner as is practicable, including from the time a public health threat is identified; and

(8) ensure that public health and medical information distributed by the Department of Health and Human Services during a public health emergency is delivered in a manner that takes into account the range of communication needs of the intended recipients, including at-risk individuals..

Sec. 102. Assistant Secretary for Preparedness and Response

(a) In general– Section 2811 of the Public Health Service Act (42 U.S.C. 300hh–10)is amended—

(1) in subsection (b)—

(A) in paragraph (3), by inserting “, security countermeasures (as defined in section 319F–2),” after “qualified countermeasures (as defined in section 319F–1)”;

(B) in paragraph (4), by adding at the end the following: