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S.3678
Pandemic and All-Hazards Preparedness Act (Enrolled as Agreed to or Passed by Both House and Senate)

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SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

(a) Assistant Secretary for Preparedness and Response- Subtitle B of title XXVIII of the Public Health Service Act (42 U.S.C. 300hh-11 et seq.) is amended--

(1) in the subtitle heading, by inserting `All -Hazards' before `Emergency Preparedness' ;

(2) by redesignating section 2811 as section 2812;

(3) by inserting after the subtitle heading the following new section:

`SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL -HAZARDS PUBLIC HEALTH EMERGENCIES.

`(a) In General- There is established within the Department of Health and Human Services the position of the Assistant Secretary for Preparedness and Response. The President, with the advice and consent of the Senate, shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary.

`(b) Duties- Subject to the authority of the Secretary, the Assistant Secretary for Preparedness and Response shall carry out the following functions:

`(1) LEADERSHIP- Serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies.

`(2) PERSONNEL- Register, credential, organize, train, equip, and have the authority to deploy Federal public health and medical personnel under the authority of the Secretary, including the National Disaster Medical System, and coordinate such personnel with the Medical Reserve Corps and the Emergency System for Advance Registration of Volunteer Health Professionals.

`(3) COUNTERMEASURES- Oversee advanced research, development, and procurement of qualified countermeasures (as defined in section 319F-1) and qualified pandemic or epidemic products (as defined in section 319F-3).

`(4) COORDINATION-

`(A) FEDERAL INTEGRATION- Coordinate with relevant Federal officials to ensure integration of Federal preparedness and response activities for public health emergencies.

`(B) STATE, LOCAL, AND TRIBAL INTEGRATION- Coordinate with State, local, and tribal public health officials, the Emergency Management Assistance Compact, health care systems, and emergency medical service systems to ensure effective integration of Federal public health and medical assets during a public health emergency.

`(C) EMERGENCY MEDICAL SERVICES- Promote improved emergency medical services medical direction, system integration, research, and uniformity of data collection, treatment protocols, and policies with regard to public health emergencies.

`(5) LOGISTICS- In coordination with the Secretary of Veterans Affairs, the Secretary of Homeland Security, the General Services Administration, and other public and private entities, provide logistical support for medical and public health aspects of Federal responses to public health emergencies.

`(6) LEADERSHIP- Provide leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response.

`(c) Functions- The Assistant Secretary for Preparedness and Response shall--

`(1) have authority over and responsibility for--

`(A) the National Disaster Medical System (in accordance with section 301 of the Pandemic and All -Hazards Preparedness Act ); and

`(B) the Hospital Preparedness Cooperative Agreement Program pursuant to section 319C-2;

`(2) exercise the responsibilities and authorities of the Secretary with respect to the coordination of--

`(A) the Medical Reserve Corps pursuant to section 2813;

`(B) the Emergency System for Advance Registration of Volunteer Health Professionals pursuant to section 319I;

`(C) the Strategic National Stockpile; and

`(D) the Cities Readiness Initiative; and

`(3) assume other duties as determined appropriate by the Secretary.'; and

(4) by striking `Assistant Secretary for Public Health Emergency Preparedness' each place it appears and inserting `Assistant Secretary for Preparedness and Response'.

(b) Transfer of Functions; References-

(1) TRANSFER OF FUNCTIONS- There shall be transferred to the Office of the Assistant Secretary for Preparedness and Response the functions, personnel, assets, and liabilities of the Assistant Secretary for Public Health Emergency Preparedness as in effect on the day before the date of enactment of this Act .

(2) REFERENCES- Any reference in any Federal law, Executive order, rule, regulation, or delegation of authority, or any document of or pertaining to the Assistant Secretary for Public Health Emergency Preparedness as in effect the day before the date of enactment of this Act , shall be deemed to be a reference to the Assistant Secretary for Preparedness and Response.

(c) Stockpile- Section 319F-2(a)(1) of the Public Health Service Act (42 U.S.C. 247d-6b(a)(1)) is amended by--

(1) inserting `in collaboration with the Director of the Centers for Disease Control and Prevention, and' after `Secretary,'; and

(2) inserting at the end the following: `The Secretary shall conduct an annual review (taking into account at-risk individuals) of the contents of the stockpile, including non-pharmaceutical supplies, and make necessary additions or modifications to the contents based on such review.'.

(d) At-Risk Individuals- Title XXVIII of the Public Health Service Act (42 U.S.C. 300hh et seq.), as amended by section 303 of this Act , is amended by inserting after section 2813 the following:

`SEC. 2814. AT-RISK INDIVIDUALS.

`The Secretary, acting through such employee of the Department of Health and Human Services as determined by the Secretary and designated publicly (which may, at the discretion of the Secretary, involve the appointment or designation of an individual as the Director of At-Risk Individuals), shall--

`(1) oversee the implementation of the National Preparedness goal of taking into account 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);

`(2) assist other Federal agencies responsible for planning for, responding to, and recovering from public health emergencies in addressing the needs of at-risk individuals;

`(3) provide guidance to and ensure that recipients of State and local public health grants include preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency, as described in section 319C-1(b)(2)(A)(iii);

`(4) ensure that the contents of the strategic national stockpile take into account at-risk populations as described in section 2811(b)(3)(B);

`(5) oversee the progress of the Advisory Committee on At-Risk Individuals and Public Health Emergencies established under section 319F(b)(2) and make recommendations with a focus on opportunities for action based on the work of the Committee;

`(6) oversee curriculum development for the public health and medical response training program on medical management of casualties, as it concerns at-risk individuals as described in subparagraphs (A) through (C) of section 319F(a)(2);

`(7) disseminate novel and best practices of outreach to and care of at-risk individuals before, during, and following public health emergencies; and

`(8) not later than one year after the date of enactment of the Pandemic and All -Hazards Preparedness Act , prepare and submit to Congress a report describing the progress made on implementing the duties described in this section.'.

SEC. 103. NATIONAL HEALTH SECURITY STRATEGY.

Title XXVIII of the Public Health Service Act (300hh-11 et seq.), as amended by section 101, is amended by inserting after section 2801 the following:

`SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

`(a) In General-

`(1) PREPAREDNESS AND RESPONSE REGARDING PUBLIC HEALTH EMERGENCIES- Beginning in 2009 and every four years thereafter, the Secretary shall prepare and submit to the relevant committees of Congress a coordinated strategy (to be known as the National Health Security Strategy) and any revisions thereof, and an accompanying implementation plan for public health emergency preparedness and response. Such National Health Security Strategy shall identify the process for achieving the preparedness goals described in subsection (b) and shall be consistent with the National Preparedness Goal, the National Incident Management System, and the National Response Plan developed pursuant to section 502(6) of the Homeland Security Act of 2002, or any successor plan.

`(2) EVALUATION OF PROGRESS- The National Health Security Strategy shall include an evaluation of the progress made by Federal, State, local, and tribal entities, based on the evidence-based benchmarks and objective standards that measure levels of preparedness established pursuant to section 319C-1(g). Such evaluation shall include aggregate and State-specific breakdowns of obligated funding spent by major category (as defined by the Secretary) for activities funded through awards pursuant to sections 319C-1 and 319C-2.

`(3) PUBLIC HEALTH WORKFORCE- In 2009, the National Health Security Strategy shall include a national strategy for establishing an effective and prepared public health workforce, including defining the functions, capabilities, and gaps in such workforce, and identifying strategies to recruit, retain, and protect such workforce from workplace exposures during public health emergencies.

`(b) Preparedness Goals- The National Health Security Strategy shall include provisions in furtherance of the following:

`(1) INTEGRATION- Integrating public health and public and private medical capabilities with other first responder systems, including through--

`(A) the periodic evaluation of Federal, State, local, and tribal preparedness and response capabilities through drills and exercises; and

`(B) integrating public and private sector public health and medical donations and volunteers.

`(2) PUBLIC HEALTH- Developing and sustaining Federal, State, local, and tribal essential public health security capabilities, including the following:

`(A) Disease situational awareness domestically and abroad, including detection, identification, and investigation.

`(B) Disease containment including capabilities for isolation, quarantine, social distancing, and decontamination.

`(C) Risk communication and public preparedness .

`(D) Rapid distribution and administration of medical countermeasures.

`(3) MEDICAL- Increasing the preparedness , response capabilities, and surge capacity of hospitals, other health care facilities (including mental health facilities), and trauma care and emergency medical service systems, with respect to public health emergencies, which shall include developing plans for the following:

`(A) Strengthening public health emergency medical management and treatment capabilities.

`(B) Medical evacuation and fatality management.

`(C) Rapid distribution and administration of medical countermeasures.

`(D) Effective utilization of any available public and private mobile medical assets and integration of other Federal assets.

`(E) Protecting health care workers and health care first responders from workplace exposures during a public health emergency.

`(4) AT-RISK INDIVIDUALS-

`(A) Taking into account the public health and medical needs of at-risk individuals in the event of a public health emergency.

`(B) For purpose of this section and sections 319C-1, 319F, and 319L, the term `at-risk individuals' means children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency, as determined by the Secretary.

`(5) COORDINATION- Minimizing duplication of, and ensuring coordination between, Federal, State, local, and tribal planning, preparedness , and response activities (including the State Emergency Management Assistance Compact). Such planning shall be consistent with the National Response Plan, or any successor plan, and National Incident Management System and the National Preparedness Goal.

`(6) CONTINUITY OF OPERATIONS- Maintaining vital public health and medical services to allow for optimal Federal, State, local, and tribal operations in the event of a public health emergency.'.

TITLE II--PUBLIC HEALTH SECURITY PREPAREDNESS

SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

Section 319C-1 of the Public Health Service Act (42 U.S.C. 247d-3a) is amended--

(1) by amending the heading to read as follows: `improving state and local public health security.';

(2) by striking subsections (a) through (i) and inserting the following:

`(a) In General- To enhance the security of the United States with respect to public health emergencies, the Secretary shall award cooperative agreements to eligible entities to enable such entities to conduct the activities described in subsection (d).

`(b) Eligible Entities- To be eligible to receive an award under subsection (a), an entity shall--

`(1)(A) be a State;

`(B) be a political subdivision determined by the Secretary to be eligible for an award under this section (based on criteria described in subsection (i)(4)); or

`(C) be a consortium of entities described in subparagraph (A); and

`(2) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including--

`(A) an All -Hazards Public Health Emergency Preparedness and Response Plan which shall include--

`(i) a description of the activities such entity will carry out under the agreement to meet the goals identified under section 2802;

`(ii) a pandemic influenza plan consistent with the requirements of paragraphs (2) and (5) of subsection (g);

`(iii) preparedness and response strategies and capabilities that take into account the medical and public health needs of at-risk individuals in the event of a public health emergency;

`(iv) a description of the mechanism the entity will implement to utilize the Emergency Management Assistance Compact or other mutual aid agreements for medical and public health mutual aid; and

`(v) a description of how the entity will include the State Unit on Aging in public health emergency preparedness ;

`(B) an assurance that the entity will report to the Secretary on an annual basis (or more frequently as determined by the Secretary) on the evidence-based benchmarks and objective standards established by the Secretary to evaluate the preparedness and response capabilities of such entity under subsection (g);

`(C) an assurance that the entity will conduct, on at least an annual basis, an exercise or drill that meets any criteria established by the Secretary to test the preparedness and response capabilities of such entity, and that the entity will report back to the Secretary within the application of the following year on the strengths and weaknesses identified through such exercise or drill, and corrective actions taken to address material weaknesses;

`(D) an assurance that the entity will provide to the Secretary the data described under section 319D(d)(3) as determined feasible by the Secretary;

`(E) an assurance that the entity will conduct activities to inform and educate the hospitals within the jurisdiction of such entity on the role of such hospitals in the plan required under subparagraph (A);

`(F) an assurance that the entity, with respect to the plan described under subparagraph (A), has developed and will implement an accountability system to ensure that such entity make satisfactory annual improvement and describe such system in the plan under subparagraph (A);

`(G) a description of the means by which to obtain public comment and input on the plan described in subparagraph (A) and on the implementation of such plan, that shall include an advisory committee or other similar mechanism for obtaining comment from the public and from other State, local, and tribal stakeholders; and

`(H) as relevant, a description of the process used by the entity to consult with local departments of public health to reach consensus, approval, or concurrence on the relative distribution of amounts received under this section.

`(c) Limitation- Beginning in fiscal year 2009, the Secretary may not award a cooperative agreement to a State unless such State is a participant in the Emergency System for Advance Registration of Volunteer Health Professionals described in section 319I.

`(d) Use of Funds-

`(1) IN GENERAL- An award under subsection (a) shall be expended for activities to achieve the preparedness goals described under paragraphs (1), (2), (4), (5), and (6) of section 2802(b).

`(2) EFFECT OF SECTION- Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority.

`(e) Coordination With Local Response Capabilities- An entity shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities of relevant Metropolitan Medical Response Systems, local public health departments, the Cities Readiness Initiative, and local emergency plans.

`(f) Consultation With Homeland Security- In making awards under subsection (a), the Secretary shall consult with the Secretary of Homeland Security to--

`(1) ensure maximum coordination of public health and medical preparedness and response activities with the Metropolitan Medical Response System, and other relevant activities;

`(2) minimize duplicative funding of programs and activities;

`(3) analyze activities, including exercises and drills, conducted under this section to develop recommendations and guidance on best practices for such activities; and

`(4) disseminate such recommendations and guidance, including through expanding existing lessons learned information systems to create a single Internet-based point of access for sharing and distributing medical and public health best practices and lessons learned from drills, exercises, disasters, and other emergencies.

`(g) Achievement of Measurable Evidence-Based Benchmarks and Objective Standards-

`(1) IN GENERAL- Not later than 180 days after the date of enactment of the Pandemic and All -Hazards Preparedness Act , the Secretary shall develop or where appropriate adopt, and require the application of, measurable evidence-based benchmarks and objective standards that measure levels of preparedness with respect to the activities described in this section and with respect to activities described in section 319C-2.
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