Amendments to the Public Health Service Act

Title XXI of the Public Health Service Act (42 U.S.C. 300aa–1 et seq.) is amended by adding at the end the following:

Pandemic influenza preparedness

2141.

Definition

For purposes of this subtitle, the term State shall have the meaning given such term in section 2(f) and shall include Indian tribes and tribal organizations (as defined in section 4(b) and 4(c) of the Indian Self-Determination and Education Assistance Act).

2142.

Proposal for international Fund to support pandemic influenza control

(a)

In general

The Secretary should submit to the Director of the World Health Organization a proposal to study the feasibility of establishing a fund, (referred to in this section as the Pandemic Fund) to support pandemic influenza control and relief activities conducted in countries affected by pandemic influenza, including pandemic avian influenza. (b)

Content of proposal

The proposal submitted under subsection (a) shall describe, with respect to the Pandemic Fund— (1)funding sources; (2)administration; (3)application process by which a country may apply to receive assistance from such Fund; (4)factors used to make a determination regarding a submitted application, which may include— (A)the gross domestic product of the applicant country; (B)the burden of need, as determined by human morbidity and mortality and economic impact related to pandemic influenza and the existing capacity and resources of the applicant country to control the spread of the disease; and (C)the willingness of the country to cooperate with other countries with respect to preventing and controlling the spread of the pandemic influenza; and (5)any other information the Secretary determines necessary. (c)

Use of funds

Funds from any Pandemic Fund established as provided for in this section shall be used to complement and augment ongoing bilateral programs and activities from the United States and other donor nations.

2143.

Policy coordinating Committee on pandemic influenza preparedness

(a)

In general

There is established the Pandemic Influenza Preparedness Policy Coordinating Committee (referred to in this section as the Committee). (b)

Membership

(1)

In general

The Committee shall be composed of— (A)the Secretary; (B)the Secretary of Agriculture; (C)the Secretary of State; (D)the Secretary of Defense; (E)the Secretary of Commerce; (F)the Administrator of the Environmental Protection Agency; (G)the Secretary of Transportation; (H)the Secretary of Homeland Security; (I)the Secretary of Veterans Affairs; and (J)other representatives as determined appropriate by the Co-Chairs of the Committee. (2)

Co-Chairs

The Secretary and the Secretary of Agriculture shall serve as the Co-Chairs of the Committee. (3)

Term

The members of the Committee shall serve for the life of the Committee. (c)

Meetings

(1)

In general

The Committee shall meet not less often than 2 times per year at the call of the Co-Chairs or as determined necessary by the President. (2)

Representation

A member of the Committee under subsection (b) may designate a representative to participate in Committee meetings, but such representative shall hold the position of at least an assistant secretary or equivalent position. (d)

Duties of the Committee

(1)

Preparedness plans

Each member of the Committee shall submit to the Committee a pandemic influenza preparedness plan for the agency involved that describes— (A)initiatives and proposals by such member to address pandemic influenza (including avian influenza) preparedness; and (B)any activities and coordination with international entities related to such initiatives and proposals. (2)

Interagency Plan and recommendations

(A)

In general

(i)

Preparedness Plan

Based on the preparedness plans described under paragraph (1), and not later than 90 days after the date of enactment of the Attacking Viral Influenza Across Nations Act of 2008, the Committee shall develop an Interagency Preparedness Plan that integrates and coordinates such preparedness plans. (ii)

Content of Plan

The Interagency Preparedness Plan under clause (i) shall include a description of— (I)departmental or agency responsibility and accountability for each component of such plan; (II)funding requirements and sources; (III)international collaboration and coordination efforts; and (IV)recommendations and a timeline for implementation of such plan. (B)

Report

(i)

In general

The Committee shall submit to the President and Congress, and make available to the public, a report that includes the Interagency Preparedness Plan. (ii)

Updated report

The Committee shall submit to the President and Congress, and make available to the public, on a biannual basis, an update of the report that includes a description of— (I)progress made toward plan implementation, as described under clause (i); and (II)progress of the domestic preparedness programs under section 2144 and of the international assistance programs under section 2145. (C)

Consultation with international entities

In developing the preparedness plans described under subparagraph (A) and the report under subparagraph (B), the Committee may consult with representatives from the World Health Organization, the World Organization for Animal Health, and other international bodies, as appropriate.

2144.

Domestic pandemic influenza preparedness activities

(a)

Pandemic preparedness activities

The Secretary shall strengthen, expand, and coordinate domestic pandemic influenza preparedness activities. (b)

State Preparedness Plan

(1)

In general

As a condition of receiving funds from the Centers for Disease Control and Prevention or the Health Resources and Services Administration related to bioterrorism, a State shall— (A)designate an official or office as responsible for pandemic influenza preparedness; (B)submit to the Director of the Centers for Disease Control and Prevention a Pandemic Influenza Preparedness Plan described under paragraph (2); and (C)have such Preparedness Plan approved in accordance with this subsection. (2)

Preparedness Plan

(A)

In general

The Pandemic Influenza Preparedness Plan required under paragraph (1) shall address— (i)human and animal surveillance activities, including capacity for epidemiological analysis, isolation and subtyping of influenza viruses year-round, including for avian influenza among domestic poultry, and reporting of information across human and veterinary sectors; (ii)methods to ensure surge capacity in hospitals, laboratories, outpatient healthcare provider offices, medical suppliers, and communication networks; (iii)assisting the recruitment and coordination of national and State volunteer banks of healthcare professionals; (iv)distribution of vaccines, antivirals, and other treatments to priority groups, and monitor effectiveness and adverse events; (v)networks that provide alerts and other information for healthcare providers and organizations at the National, State, and regional level; (vi)communication with the public with respect to prevention and obtaining care during pandemic influenza; (vii)maintenance of core public functions, including public utilities, refuse disposal, mortuary services, transportation, police and firefighter services, and other critical services; (viii)provision of security for— (I)first responders and other medical personnel and volunteers; (II)hospitals, treatment centers, and isolation and quarantine areas; (III)transport and delivery of resources, including vaccines, medications and other supplies; and (IV)other persons or functions as determined appropriate by the Secretary; (ix)the acquisition of necessary legal authority for pandemic activities; (x)integration with existing national, State, and regional bioterrorism preparedness activities or infrastructure; (xi)coordination among public and private health sectors with respect to healthcare delivery, including mass vaccination and treatment systems, during pandemic influenza; and (xii)coordination with Federal pandemic influenza preparedness activities. (B)

Underserved populations

The Pandemic Influenza Preparedness Plan required under paragraph (1) shall include a specific focus on surveillance, prevention, and medical care for traditionally underserved populations, including low-income, racial and ethnic minority, immigrant, and uninsured populations. (3)

Approval of State Plan

(A)

In general

The Director of the Centers for Disease Control and Prevention, in collaboration with the Secretary of Agriculture and the Administrator of the Health Resources and Services Administration, shall develop criteria to rate State Pandemic Influenza Preparedness Plans required under paragraph (1) and determine the minimum rating needed for approval. (B)

Timing of approval

Not later than 180 days after a State submits a State Pandemic Influenza Preparedness Plan as required under paragraph (1), the Director of the Centers for Disease Control and Prevention shall make a determination regarding approval of such Plan. (4)

Reporting of State Plan

All Pandemic Influenza Preparedness Plans submitted and approved under this section shall be made available to the public. (5)

Assistance to States

The Centers for Disease Control and Prevention and the Health Resources and Services Administration may provide assistance to States in carrying out this subsection, or implementing an approved State Pandemic Influenza Preparedness Plan, which may include the detail of an officer to approved domestic pandemic sites or the purchase of equipment and supplies. (6)

Waiver

The Secretary may grant a temporary waiver of 1 or more of the requirements under this subsection. (c)

Domestic surveillance

(1)

In general

The Secretary, in coordination with the Secretary of Agriculture, shall establish minimum thresholds for States with respect to adequate surveillance for pandemic influenza, including possible pandemic avian influenza. (2)

Assistance to States

(A)

In general

The Secretary, in coordination with the Secretary of Agriculture, shall provide assistance to States and regions to meet the minimum thresholds established under paragraph (1). (B)

Types of assistance

Assistance provided to States under subparagraph (A) may include— (i)the establishment or expansion of State surveillance and alert systems, including the Sentinel Physician Surveillance System and 122 Cities Mortalities Report System; (ii)the provision of equipment and supplies; (iii)support for epidemiological analysis and investigation of novel strains; (iv)the sharing of biological specimens and epidemiological and clinical data within and across States; and (v)other activities determined appropriate by the Secretary. (3)

Detail of officers

The Secretary may detail officers to States for technical assistance as needed to carry out this subsection. (d)

Private sector involvement

(1)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Administrator of the Health Resources and Services Administration, and in coordination with private sector entities, shall integrate and coordinate public and private influenza surveillance activities, as appropriate. (2)

Grant program

(A)

In general

In carrying out the activities under paragraph (1), the Secretary may establish a grant program to provide grants to eligible entities to coordinate pandemic preparedness surveillance activities between States and private health sector entities, including health plans and other health systems. (B)

Eligibility

To be eligible to receive a grant under subparagraph (A), an entity shall— (i)submit an application at such time, in such manner, and containing such information as the Secretary may require; and (ii)be a State with a collaborative relationship with a private health system organization or institution. (C)

Use of funds

Funds under a grant under subparagraph (A) may be used to— (i)develop and implement surveillance protocols for patients in outpatient and hospital settings; (ii)establish a communication alert plan for patients for reportable signs and symptoms that may suggest influenza; (iii)purchase necessary equipment and supplies; (iv)increase laboratory testing and networking capacity; (v)conduct epidemiological and other analyses; or (vi)report and disseminate data. (D)

Detail of officers

The Secretary may detail officers to grantees under subparagraph (A) for technical assistance. (E)

Requirement

As a condition of receiving a grant under subparagraph (A), a State shall have a plan to meet minimum thresholds for State influenza surveillance established by the Director of the Centers for Disease Control and Prevention in coordination with the Secretary of Agriculture under subsection (b). (e)

Temporary facility

The Secretary may establish a temporary Federal facility or body to coordinate Federal support and assistance to States and localities, activities across Federal agencies or departments, or direct implementation of Federal authorities and responsibilities when appropriate under Federal law or when State and local actions to address the pandemic or threat of pandemic are deemed insufficient by the Secretary or Director of the Centers for Disease Control and Prevention. (f)

Procurement of antivirals for the Strategic National Stockpile

The Secretary shall determine the minimum number of doses of antivirals needed to prevent infection or treat infection during pandemic influenza, including possible pandemic avian influenza, for health professionals (including doctors, nurses, mental health professionals, pharmacists, veterinarians, laboratory personnel, epidemiologists, virologists and public health practitioners), core public utility employees, and those persons expected to be at high risk for serious morbidity and mortality from pandemic influenza, and take immediate steps to procure this minimum number of doses for the Strategic National Stockpile described under section 319F–2. (g)

Procurement of vaccines for the Strategic National Stockpile

Subject to development and testing of potential vaccines for pandemic influenza, including possible pandemic avian influenza, the Secretary shall determine the minimum number of doses of vaccines needed to prevent infection during at least the first wave of pandemic influenza for health professionals (including doctors, nurses, mental health professionals, pharmacists, veterinarians, laboratory personnel, epidemiologists, virologists, and public health practitioners), core public utility employees, and those persons expected to be at high risk for serious morbidity and mortality from pandemic influenza, and take immediate steps to procure this minimum number of doses for the Strategic National Stockpile described under section 319F–2.

2145.

International pandemic influenza assistance

(a)

In general

The Secretary shall assist other countries in preparation for, and response to, pandemic influenza, including possible pandemic avian influenza. (b)

International surveillance

(1)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and in collaboration with the Secretary of Agriculture, in consultation with the World Health Organization and the World Organization for Animal Health, shall establish minimum standards for surveillance capacity for all countries with respect to pandemic influenza, including possible pandemic avian influenza. (2)

Assistance

The Secretary and the Secretary of Agriculture shall assist other countries to meet the standards established in paragraph (1) through— (A)the detail of officers to foreign countries for the provision of technical assistance or training; (B)laboratory testing, including testing of specimens for viral isolation or subtype analysis; (C)epidemiological analysis and investigation of novel strains; (D)provision of equipment or supplies; (E)coordination of surveillance activities within and among countries; (F)the establishment and maintenance of an Internet database that is accessible to health officials domestically and internationally, for the purpose of reporting new cases or clusters of influenza and under information that may help avert the pandemic spread of influenza; and (G)other activities as determined necessary by the Secretary. (c)

Increased international medical capacity during pandemic influenza

The Secretary, in consultation with the Secretary of State, may provide vaccines, antiviral medications, and supplies to foreign countries from the Strategic National Stockpile described under section 319F–2. (d)

Assistance to foreign countries

The Centers for Disease Control and Prevention and the Health Resources and Services Administration may provide assistance to foreign countries in carrying out this section, which may include the detail of an officer to approved international pandemic sites or the purchase of equipment and supplies.

2146.

Public education and awareness campaign

(a)

In general

The Director of the Centers for Disease Control and Prevention, in consultation with the United States Agency for International Development, the World Health Organization, the World Organization for Animal Health, and foreign countries, shall develop an outreach campaign with respect to public education and awareness of influenza and influenza preparedness. (b)

Details of campaign

The campaign established under subsection (a) shall— (1)be culturally and linguistically appropriate for domestic populations; (2)be adaptable for use in foreign countries; (3)target high-risk populations (those most likely to contract, transmit, and die from influenza); (4)promote personal influenza precautionary measures and knowledge, and the need for general vaccination, as appropriate; and (5)describe precautions at the State and local level that could be implemented during pandemic influenza, including quarantine and other measures.

2147.

Health professional training

The Secretary, directly or through contract, and in consultation with professional health and medical societies, shall develop and disseminate pandemic influenza training curricula— (1)to educate and train health professionals, including physicians, nurses, public health practitioners, virologists and epidemiologists, veterinarians, mental health providers, allied health professionals, and paramedics and other first responders; (2)to educate and train volunteer, non-medical personnel whose assistance may be required during a pandemic influenza outbreak; and (3)that address prevention, including use of quarantine and other isolation precautions, pandemic influenza diagnosis, medical guidelines for use of antivirals and vaccines, and professional requirements and responsibilities, as appropriate.

2148.

Research at the national institutes of health

The Director of the National Institutes of Health (referred to in this section as the Director of NIH), in collaboration with the Director of the Centers for Disease Control and Prevention, and other relevant agencies, shall expand and intensify— (1)human and animal research, with respect to influenza, on— (A)vaccine development and manufacture, including strategies to increase immunological response; (B)effectiveness of inducing heterosubtypic immunity; (C)antivirals, including minimal dose or course of treatment and timing to achieve prophylactic or therapeutic effect; (D)side effects and drug safety of vaccines and antivirals in subpopulations; (E)alternative routes of delivery; (F)more efficient methods for testing and determining virus subtype; (G)protective measures; and (H)other areas determined appropriate by the Director of NIH; and (2)historical research on prior pandemics to better understand pandemic epidemiology, transmission, protective measures, high-risk groups, and other lessons that may be applicable to future pandemics.

2149.

Research at the Centers for Disease Control and Prevention

The Director of the Centers for Disease Control and Prevention, in collaboration with other relevant agencies, shall expand and intensify research, with respect to influenza, on— (1)communication strategies for the public during pandemic influenza, taking into consideration age, racial and ethnic background, health literacy, and risk status; (2)changing and influencing human behavior as it relates to vaccination; and (3)development and implementation of a public, non-commercial and non-competitive broadcast system and person-to-person networks.

2150.

Institute of Medicine study on the legal, ethical, and social implications of pandemic influenza

(a)

In general

The Secretary shall contract with the Institute of Medicine to— (1)study the legal, ethical, and social implications of, with respect to pandemic influenza— (A)animal/human interchange; (B)global surveillance; (C)case contact investigations; (D)vaccination and medical treatment; (E)community hygiene; (F)travel and border controls; (G)decreased social mixing and increased social distance; (H)civil confinement; and (I)other topics as determined appropriate by the Secretary. (2)not later than 1 year after the date of enactment of the Attacking Viral Influenza Across Nations Act of 2008, submit to the Secretary a report that describes recommendations based on the study conducted under paragraph (1). (b)

Implementation of recommendations

Not later than 180 days after the submission of the report of under subsection (a)(2), the Secretary shall address the recommendations of the Institute of Medicine regarding the domestic and international allocation and distribution of pandemic influenza vaccine and antivirals.

2151.

National Pandemic Influenza Economics Advisory Committee

(a)

In general

There is established the National Pandemic Influenza Economics Advisory Committee (referred to in this section as the Committee). (b)

Membership

(1)

In general

The members of the Committee shall be appointed by the Comptroller General of the United States and shall include domestic and international experts on pandemic influenza, public health, veterinary science, commerce, economics, finance, and international diplomacy. (2)

Chair

The Comptroller General of the United States shall select a Chair from among the members of the Committee. (c)

Duties

The Committee shall study and make recommendations to Congress and the Secretary on the financial and economic impact of pandemic influenza and possible financial structures for domestic and international pandemic response, relating to— (1)the development, storage and distribution of vaccines; (2)the storage and distribution of antiviral and other medications and supplies; (3)increased surveillance activities; (4)provision of preventive and medical care during pandemic; (5)reimbursement for health providers and other core public function employees; (6)reasonable compensation for farmers and other workers that bear direct or disproportionate loss of revenue; and (7)other issues determined appropriate by the Chair. (d)

Compensation

(1)

In general

Each member of the Committee who is not an officer or employee of the Federal Government shall be compensated at a rate equal to the daily equivalent of the annual rate of basic pay prescribed for level IV of the Executive Schedule under section 5315 of title 5, United States Code, for each day (including travel time) during which such member is engaged in the performance of the duties of the Committee. All members who are officers or employees of the United States shall serve without compensation in addition to that received for their services as officers or employees of the United States. (2)

Travel expenses

A member of the Committee shall be allowed travel expenses, including per diem in lieu of subsistence, at rates authorized for an employee of an agency under subchapter I of chapter 57 of title 5, United States Code, while away from the home or regular place of business of the member in the performance of the duties of the Committee. (e)

Staff

(1)

In general

The Chair of the Committee shall provide the Committee with such professional and clerical staff, such information, and the services of such consultants as may be necessary to assist the Committee in carrying out the functions under this section. (2)

Detail of Federal Government employees

(A)

In general

An employee of the Federal Government may be detailed to the Committee without reimbursement. (B)

Civil service status

The detail of the employee shall be without interruption or loss of civil service status or privilege. (3)

Procurement of temporary and intermittent services

The Chair of the Committee may procure temporary and intermittent services in accordance with section 3109(b) of title 5, United States Code, at rates for individuals that do not exceed the daily equivalent of the annual rate of basic pay prescribed for level V of the Executive Schedule under section 5316 of that title.