< Back to H.R. 4062 (109th Congress, 2005–2006)

Text of the Pandemic Preparedness and Response Act

This bill was introduced on October 17, 2005, in a previous session of Congress, but was not enacted. The text of the bill below is as of Oct 17, 2005 (Introduced).

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I

109th CONGRESS

1st Session

H. R. 4062

IN THE HOUSE OF REPRESENTATIVES

October 17, 2005

(for herself, Mr. Emanuel, Mr. Case, Mr. Conyers, Mrs. Maloney, Mr. Jackson of Illinois, Mrs. Christensen, Mr. Owens, Mr. Kildee, Mr. McNulty, Mr. Payne, Mr. Price of North Carolina, Mr. Reyes, Mr. Hoyer, Mr. Van Hollen, Mr. Pallone, Mr. DeFazio, Mr. Inslee, Mr. McGovern, Mr. Gutierrez, Ms. Bean, Ms. Jackson-Lee of Texas, Mr. Nadler, Mr. Schiff, Mr. Skelton, Mr. Sanders, Ms. Bordallo, Mr. Moran of Virginia, Mr. Markey, Mr. Wexler, Mr. Ackerman, and Mr. Allen) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend the Public Health Service Act with respect to preparation for an influenza pandemic, including an avian influenza pandemic, and for other purposes.

1.

Short title

This Act may be cited as the Pandemic Preparedness and Response Act.

2.

Findings

Congress makes the following findings:

(1)

The Department of Health and Human Services reports that an influenza pandemic has a greater potential to cause rapid increases in death and illness than virtually any other natural health threat.

(2)

Three pandemics occurred during the 20th century: the Spanish flu pandemic in 1918, the Asian flu pandemic in 1957, and the Hong Kong flu pandemic in 1968. The Spanish flu pandemic was the most severe, causing an estimated 500,000 deaths in the United States and more than 20,000,000 deaths worldwide.

(3)

The Centers for Disease Control and Prevention has estimated conservatively that up to 207,000 Americans would die, and up to 10 million would be hospitalized, during the next pandemic. The costs of the pandemic, including the total direct costs associated with medical care and indirect costs of lost productivity and death, are estimated at between $71,000,000,000 and $166,500,000,000. These costs do not include the economic effects of pandemic on commerce and society.

(4)

Recent studies suggest that avian influenza strains, which are endemic in wild birds and poultry populations in some countries, are becoming increasingly capable of causing severe disease in humans and are likely to cause the next pandemic flu.

(5)

In 2004, 8 nations—Thailand, Vietnam, Indonesia, Japan, Laos, China, Cambodia, and the Republic of Korea—experienced outbreaks of avian flu (H5N1) among poultry flocks. Cases of human infections were confirmed in Thailand, Cambodia, Indonesia, and Vietnam (including a possible human-to-human infection in Thailand).

(6)

As of September 29, 2005, 116 confirmed human cases of avian influenza (H5N1) have been reported, 60 of which resulted in death. Of these cases, 91 were in Vietnam, 17 in Thailand, 4 in Cambodia, and 4 in Indonesia.

(7)

On February 21, 2005, Dr. Julie Gerberding, Director of the Centers for Disease Control and Prevention, stated that this is a very ominous situation for the globe . . . the most important threat we are facing right now..

(8)

On February 23, 2005, Dr. Shigeru Omi, Asia regional director of the World Health Organization (WHO), stated with respect to the avian flu, We at WHO believe that the world is now in the gravest possible danger of a pandemic..

(9)

The best defense against influenza pandemics is a heightened global surveillance system. In many of the nations where avian flu (H5N1) has become endemic the early detection capabilities are severely lacking, as is the transparency in the health systems.

(10)

In addition to surveillance, pandemic preparedness requires domestic and international coordination and cooperation to ensure an adequate medical response, including communication and information networks, public health measures to prevent spread, use of vaccination and antivirals, provision of health outpatient and inpatient services, and maintenance of core public functions.

3.

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:

3

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.

National Director of Pandemic Preparedness and Response

(a)

Appointment

The President shall appoint an individual to serve as the National Director of Pandemic Preparedness and Response (referred to in this section as the Director) within the Executive Office of the President.

(b)

Responsibilities

The Director shall—

(1)

serve as the chairperson of the Pandemic Influenza Preparedness Policy Coordinating Committee (as described in section 2143);

(2)

coordinate the Federal interagency preparation for a pandemic;

(3)

coordinate the Federal interagency response to a pandemic;

(4)

oversee approval of State pandemic plans to ensure nationwide preparedness standards and regional coordination as provided for under section 2144(b)(3);

(5)

ensure coordination between the governmental and non-governmental economic and finance infrastructure as it relates to pandemic preparedness and response;

(6)

as soon as practicable, finalize a National Pandemic Influenza Preparedness Plan that describes programs and activities to decrease the burden of disease, minimize social disruption, and reduce economic impact from an influenza pandemic;

(7)

implement the National Pandemic Influenza Preparedness Plan;

(8)

make the National Pandemic Influenza Preparedness Plan available to Congress, and the public as appropriate;

(9)

submit to Congress an annual budget request related to the National Pandemic Influenza Preparedness Plan;

(10)

report to Congress on a biannual basis progress regarding the implementation of the National Pandemic Influenza Preparedness Plan;

(11)

address any deficiencies in the National Pandemic Influenza Preparedness Plan as determined by the Government Accountability Office report under subsection (c);

(12)

coordinate the provision of technical assistance related to pandemic preparedness across Federal agencies, States, and local governments;

(13)

ensure outreach and education campaigns are conducted related to preparedness for businesses, health care providers, and the public;

(14)

address supply chain issues related to a pandemic;

(15)

ensure that the National Pandemic Influenza Preparedness Plan includes a specific focus on traditionally underserved populations, including low-income, racial and ethnic minorities, immigrants, and uninsured populations; and

(16)

hire staff, request information, assistance, or detailees from other Federal agencies, and carry out other activities related to staffing and administration.

(c)

GAO report

(1)

In general

Not later than 60 days after the Director has finalized the National Pandemic Influenza Preparedness Plan under subsection (b)(5), the Government Accountability Office shall submit to the Director and Congress a report concerning the National Pandemic Influenza Preparedness Plan.

(2)

Requirements

At a minimum, the report under paragraph (1) shall evaluate the ability of the National Pandemic Influenza Preparedness Plan to—

(A)

address the organizational structure and chain of command, both in the Federal government and at the State level;

(B)

ensure adequate laboratory surveillance of influenza, including the ability to isolate and subtype influenza viruses year round;

(C)

improve vaccine research, development, and production;

(D)

procure adequate doses of antivirals for treatment.

(E)

develop systems for tracking and distributing antiviral medication and vaccines;

(F)

prioritize who would receive antivirals and vaccines based on limited supplies;

(G)

stockpile medical and safety equipment for health care workers and first responders;

(H)

assure surge capacity capabilities for health care providers and institutions;

(I)

secure a backup health care workforce in the event of a pandemic;

(J)

ensure the availability of food, water, and other essential items during a pandemic;

(K)

provide guidance on needed State and local authority to implement public health measures such as isolation or quarantine;

(L)

maintain core public functions, including public utilities, refuse disposal, mortuary services, transportation, police and firefighter services, and other critical services;

(M)

establish networks that provide alerts and other information for health care providers;

(N)

communicate with the public with respect to prevention and obtaining care during a pandemic; and

(O)

provide security for first responders and other medical personnel and volunteers, hospitals, treatment centers, isolation and quarantine areas, and transportation and delivery of resources.

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 Homeland Security;

(C)

the Secretary of Agriculture;

(D)

the Secretary of State;

(E)

the Secretary of Defense;

(F)

the Secretary of Commerce;

(G)

the Administrator of the Environmental Protection Agency;

(H)

the Secretary of Transportation;

(I)

the Secretary of Veterans Affairs; and

(J)

other representatives as determined appropriate by the Chair of the Committee.

(2)

Chair

The Director of Pandemic Preparedness and Response shall serve as the Chair 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 Chair 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 this subtitle, 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 as appropriate, 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 as appropriate, 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 should consult with representatives from the World Health Organization, the World Organization for Animal Health, and other international bodies, as appropriate.

(e)

Application of FACA

Notwithstanding the Federal Advisory Committee Act, non-government individuals and entities may participate in the activities of the Committee.

2144.

Domestic pandemic influenza preparedness activities

(a)

Pandemic preparedness activities

The Director of Pandemic Preparedness and Response 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 Pandemic Preparedness and Response, in collaboration with the Pandemic Influenza Preparedness Policy Coordinating Committee, 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 90 days after a State submits a State Pandemic Influenza Preparedness Plan as required under paragraph (1), the Director of Pandemic Preparedness and Response 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 Congress, State officials, and the public as determined appropriate by the Director.

(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 Director of Pandemic Preparedness and Response 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, or expand existing grant programs, to provide funding to eligible entities to coordinate or integrate as appropriate, pandemic preparedness surveillance activities between States and private health sector entities, including hospitals, health plans, and other health systems.

(B)

Eligibility

To be eligible to receive a grant under subparagraph (A), an entity shall submit an application at such time, in such manner, and containing such information as the Secretary may require.

(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)

plan for the vaccination of populations and, if appropriate, dissemination of antiviral drugs;

(iv)

purchase necessary equipment and supplies;

(v)

increase laboratory testing and networking capacity;

(vi)

conduct epidemiological and other analyses; or

(vii)

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)

Procurement of antivirals for the Strategic National Stockpile

The Secretary shall take immediate action to procure for the Strategic National Stockpile described under section 319F-2 antivirals needed to prevent or treat infection during a pandemic influenza, including possible pandemic avian influenza, for at least 50 percent of the population.

(f)

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, 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 essential medications

The Secretary shall, as soon as is practicable, take action to procure for the Strategic National Stockpile essential medications and other supplies that may be needed in the event of a pandemic.

(h)

National tracking and distribution system for vaccines and antivirals

(1)

In general

The Secretary shall develop and implement a national system for the tracking and distribution of antiviral medications and vaccines in order to prepare and respond to pandemic influenza.

(2)

System

The system developed under paragraph (1) shall—

(A)

allow for the electronic tracking of all domestically available antiviral medication and vaccines for pandemic influenza;

(B)

anticipate shortages, and alert officials if shortages are expected in such medications and vaccines;

(C)

target distribution to high-risk groups, including health professionals and relief personnel and other individuals determined to be most susceptible to disease or death from pandemic flu;

(D)

ensure equitable distribution, particularly across low-income and other underserved groups; and

(E)

integrate with existing State and local systems as appropriate.

(i)

Reimbursements

The Secretary shall have the authority to reimburse State and local health departments for expenditures related to influenza vaccine purchase and administration during a public health emergency under section 319(a).

2145.

Proposal for international Fund to support pandemic influenza control

(a)

In general

The Director of Pandemic Preparedness and Response 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 pre-pandemic influenza control, surveillance, and relief activities conducted in countries affected by avian influenza or other viruses likely to cause pandemic 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 estimated 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, or establish new programs as needed.

2146.

International diplomatic and development strategy

(a)

Policy

It is the policy of the United States to develop and implement a comprehensive diplomatic strategy targeted at (but not limited to) nations in Southeast and East Asia that are most at risk for an outbreak of the avian influenza, including Cambodia, China, Laos, Thailand, Indonesia, and Vietnam, in order to strengthen international public health structures to detect, prevent, and effectively respond to an outbreak of the avian flu.

(b)

Strategy

The strategy developed and implemented under subsection (a) shall include—

(1)

supporting information sharing and strengthening surveillance, and rapid response capacities in key nations, including the development of pandemic preparedness and response plans;

(2)

issuing demarches to key nations in the region urging additional cooperation and coordination with the United States, regional governments, and international organizations;

(3)

provide for regular visits by cabinet-level officials of the United States Government, including the Secretary of State, Secretary of Health and Human Services, Secretary of Agriculture, Secretary of Homeland Security, and Secretary of Defense, to key nations in Southeast and East Asia in order to enhance cooperation;

(4)

expanding ongoing technical assistance programs, including training of personnel, procuring laboratory equipment, logistics support, bio-safety procedures, quality control, and case detection investigation techniques;

(5)

exchanges of scientists and medical personnel engaged in significant work on issues related to avian flu;

(6)

encouraging regional governments to implement viable compensation schemes to encourage reporting by poultry farmers of cases of avian influenza in commercial flocks;

(7)

forward deployment of additional United States Government science and medical personnel to embassies and consulates in the region;

(8)

public awareness campaigns in the region, including increased involvement of the Broadcasting Board of Governors and Voice of America, to ensure timely and accurate dissemination of information;

(9)

using the voice and vote of the United States at meeting of appropriate international organizations to support the aforementioned efforts; and

(10)

integrating the private sector, especially those entities with a strong presence in the region, into this effort.

2147.

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 viral strains with pandemic potential, including 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 other 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

Notwithstanding any other provision of law, 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.

2148.

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.

2149.

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.

2150.

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 human and animal research, with respect to influenza, on—

(1)

vaccine development and manufacture, including strategies to increase immunological response;

(2)

effectiveness of inducing heterosubtypic immunity;

(3)

antigen-sparing studies;

(4)

antivirals, including minimal dose or course of treatment and timing to achieve prophylactic or therapeutic effect;

(5)

side effects and drug safety of vaccines and antivirals in subpopulations;

(6)

alternative routes of delivery of vaccines, antivirals, and other medications as appropriate;

(7)

more efficient methods for testing and determining virus subtype;

(8)

protective measures;

(9)

modes of influenza transmission;

(10)

effectiveness of masks, hand-washing, and other non-pharmaceutical measures in preventing transmission;

(11)

improved diagnostic tools for influenza; and

(12)

other areas determined appropriate by the Director of NIH.

2151.

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)

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 pandemic;

(2)

communication strategies for the public during pandemic influenza, taking into consideration age, racial and ethnic background, health literacy, and risk status;

(3)

changing and influencing human behavior as it relates to vaccination;

(4)

development and implementation of a public, non-commercial and non-competitive broadcast system and person-to-person networks;

(5)

population-based surveillance methods to estimate influenza infection rates and rates of outpatient illness;

(6)

vaccine effectiveness;

(7)

systems to monitor vaccination coverage levels and adverse events from vaccination; and

(8)

other areas determined appropriate by the Director of the Centers for Disease Control and Prevention.

2152.

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; and

(2)

not later than 1 year after the date of enactment of the Pandemic Preparedness and Response Act, submit to the Secretary a report that describes recommendations based on the study conducted under paragraph (1).

(b)

Implementation of recommendations

Not later than 90 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.

2153.

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 development, 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.

2154.

Pandemic influenza and Animal Health

(a)

In general

The Secretary of Agriculture shall expand and intensify efforts to prevent pandemic influenza, including possible pandemic avian influenza.

(b)

Report

Not later than 180 days after the date of enactment this Act, the Secretary of Agriculture shall submit to Congress a report that describes the anticipated impact of pandemic influenza on the United States.

(c)

Assistance

The Secretary of Agriculture, in consultation with the Secretary of Health and Human Services, the World Health Organization, and the World Organization for Animal Health, shall provide domestic and international assistance with respect to pandemic influenza preparedness to—

(1)

support the eradication of infectious animal diseases and zoonosis;

(2)

increase transparency in animal disease states;

(3)

collect, analyze, and disseminate veterinary data;

(4)

strengthen international coordination and cooperation in the control of animal diseases; and

(5)

promote the safety of world trade in animals and animal products.

(d)

Electronic database

The Secretary of Agriculture, in conjunction with the Secretary of Health and Human Services, shall establish an electronic disease surveillance database in order to trace the incidence of avian influenza in both animals and humans in the United States.

(e)

Improvements in the National Animal Health Laboratory Network

The Secretary of Agriculture shall evaluate the National Animal Health Laboratory Network and make recommendations for improvements to participating laboratories and other State animal health laboratories to rapidly diagnose and research avian influenza outbreaks.

(f)

Communications liaisons

(1)

In general

The Secretary of Agriculture jointly with the Secretary of Homeland Security shall designate a liaison in each State to facilitate and coordinate communications among and between States in the event of an agriculture emergency.

(2)

Functions

Each liaison designated under paragraph (1) shall—

(A)

be the central point of contact for animal health in communications with the Department of Agriculture and the Department of Homeland Security;

(B)

communicate Federal preparedness and response plans to State and local agriculture officials and veterinarians; and

(C)

communicate concerns from State and local agriculture officials and veterinarians to the Department of Agriculture and Department of Homeland Security and the Department of Health and Human Services.

4

Strengthening public health immunization capacity and supply

2161.

Findings

Congress finds that—

(1)

effective pandemic influenza preparedness and response is dependent upon the existence of solid public health infrastructure to combat seasonal flu;

(2)

the domestic surveillance and vaccine production and distribution capabilities needed in a time of crisis should be well established and active in a non-crisis capacity to enable a more efficient response to pandemic influenza; and

(3)

each State receiving Federal funds should have a State Immunization Program Coordinator, who should be responsible for coordinating and implementing activities related to influenza.

2162.

Vaccine supply

(a)

Requests for more doses

(1)

In general

Not later than March 15 of each year, the Secretary shall enter into contracts with manufacturers to produce such additional doses of the influenza vaccine as determined necessary by the Secretary.

(2)

Content of contract

A contract for additional doses shall provide that the manufacturer will be compensated by the Secretary at an equitable rate negotiated by the Secretary and the manufacturer for any doses that—

(A)

were not sold by the manufacturer through routine market mechanisms at the end of the influenza season for that year; and

(B)

were requested by the Secretary to be produced by such manufacturer.

(3)

When such vaccine purchases should take place

The Secretary may purchase from the manufacturer the doses for which it has contracted at any time after which it is determined by the Secretary, in consultation with the manufacturer, that the doses will likely not be absorbed by the private market.

(b)

Authorization of appropriations

There are authorized to be appropriated to carry out this section such sums as may be necessary.

2163.

Discontinuance of influenza vaccine

(a)

In general

(1)

Notice to Secretary

A manufacturer of the influenza vaccine shall notify the Secretary of a discontinuance of the manufacture of the vaccine at least 12 months prior to the date of the discontinuance.

(2)

Director of Centers for Disease Control and Prevention

Promptly after receiving a notice under paragraph (1), the Secretary shall inform the Director of the Centers for Disease Control and Prevention of the notice. Promptly after determining that a reduction under subsection (b) applies with respect to such a notice, the Secretary shall inform such Director of the reduction.

(3)

Relationship to separate notice program

In the case of influenza vaccine that is approved by the Secretary and is a drug described in section 506C(a), this section applies to the vaccine in lieu of section 506C.

(b)

Reduction in notification period

The notification period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause exists for the reduction, such as a situation in which—

(1)

a public health problem may result from continuation of the manufacturing for the 12-month period;

(2)

a biomaterials shortage prevents the continuation of the manufacturing for the 12-month period;

(3)

continuation of the manufacturing for the 12-month period may cause substantial economic hardship for the manufacturer;

(4)

the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code; or

(5)

the manufacturer can continue the distribution of the vaccine involved for 12 months.

(c)

Distribution

To the maximum extent practicable, the Secretary shall distribute information on the discontinuation of the manufacture of influenza vaccines to appropriate physician and patient organizations.

2164.

Shortage preparedness and response

(a)

Emergency response plans regarding shortages

(1)

National emergency response Plan

The Secretary shall develop and maintain a national plan for the response to potential shortages in supplies of influenza vaccines that would constitute public health emergencies. The plan shall include provisions with respect to communication among relevant entities, distribution of available supplies of the influenza vaccine involved, the designation of populations to be given priority for immunizations, interactions with State and local governments, the use of the National Stockpile, and special considerations for specific vaccines. The initial plan shall be completed not later than 12 months after the date of the enactment of this section.

(2)

State Emergency Response Plan

Each State that receives funds under this Act shall, not later than 6 months after the date on which the National Plan is issued under paragraph (1), develop, through the State Immunization Coordinator, a State Emergency Response Plan that is modeled on the National Plan.

2165.

Provisions to increase vaccine coverage rates

(a)

In general

The Secretary shall develop a plan for the distribution of seasonal flu vaccines to ensure that uninsured and underinsured adults and children have access to annual influenza vaccines and vaccines for conditions potentially exacerbated by exposure to pandemic influenza. Immunizations should be available to such populations as well as children in the VFC program through a wide variety of providers including both Federally qualified health centers and State and local health departments.

(b)

Requirement

The Secretary shall—

(1)

conduct an assessment to determine the number of adults in need of vaccinations and the barriers to vaccinating adults; and

(2)

develop and implement strategies to increase the rate of immunizations in populations in which a significant number of individuals have not received immunizations with the federally recommended vaccines (as defined in section 317A(g)) for the populations.

(c)

Definition

For purposes of this section, the term adult means an individual who is not a child as defined in section 1928 of the Social Security Act.

(d)

Authorization of appropriations

There is authorized to be appropriated to carry out this section, such sums as may be necessary.

2166.

Outreach, communication, education

(a)

Education program regarding adult immunizations

The Secretary, acting through the Director of the Centers for Disease Control and Prevention (in this section referred to as the Director), shall conduct a public awareness campaign and education and outreach efforts each year during the time period preceding the influenza season on each of the following:

(1)

The importance of receiving the influenza vaccine.

(2)

Which populations the Director recommends to receive the influenza vaccine to prevent health complications associated with influenza, including health care workers and their household contacts.

(3)

Professional medical education of physicians, nurses, pharmacists, and other health care providers and such providers’ associated organizations.

(4)

Information that emphasizes the safety and benefit of recommended vaccines for the public good.

(b)

Outreach to Medicare recipients

(1)

Program

(A)

In general

The Director, in consultation with the Administrator of the Centers for Medicare & Medicaid Services, shall, at the earliest possible time in the influenza vaccine planning and production process, reach out to providers of medicare services, including managed care providers, nursing homes, hospitals, and physician offices to urge early and full preordering of the influenza vaccine so that production levels can accommodate the needs for the influenza vaccine.

(B)

Rates of immunization among Medicare recipients

The Director shall work with the Administrator of the Centers for Medicare & Medicaid Services to publish the rates of influenza immunization among individuals receiving assistance under the medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).

(2)

State and public health adult immunization activities

The Director shall support the development of State adult immunization programs that place emphasis on improving influenza vaccine delivery to high-risk populations and the general population, including the exploration of improving access to the influenza vaccine.

(3)

Existing modes of communication

In carrying out the public awareness campaign and education and outreach efforts under paragraph (1) and (2), the Director may use existing websites or structures for communication.

(4)

Authorization of appropriations

There are authorized to be appropriated to carry out this subsection $10,000,000 for each of fiscal years 2005 through 2009.

(c)

Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.

.

4.

Unfair or deceptive acts or practices in commerce related to treatments for pandemic influenza

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319K the following section:

319L.

Unfair or deceptive acts or practices in commerce related to treatments for pandemic influenza

(a)

Sales to consumers at unconscionable price

(1)

In general

During any public health emergency declared by the Secretary under section 319 related to pandemic influenza, it shall be unlawful for any person to sell any drug (including an anti-viral drug), device, or biologic for the prevention or treatment of influenza in, or for use in, the area to which that declaration applies at a price that—

(A)

is unconscionably excessive (as determined by the Secretary); or

(B)

indicates the seller is taking unfair advantage of the circumstances to increase prices unreasonably.

(2)

Factors to be considered

In determining whether a violation of paragraph (1) has occurred, a court shall take into account, among other factors, whether—

(A)

the amount charged represents a gross disparity between the price of a drug, device, or biologic for the prevention or treatment of influenza and the price at which the drug, device, or biologic was offered for sale in the usual course of the seller’s business immediately prior to the public health emergency; or

(B)

the amount charged grossly exceeds the price at which the same or similar drug, device, or biologic for the prevention or treatment of influenza was readily obtainable by other purchasers in the area in which the declaration applies.

(3)

Mitigating factors

In determining whether a violation of paragraph (1) has occurred, the court shall also take into account, among other factors, the price that would reasonably equate supply and demand in a competitive and freely functioning market and whether the price at which the drug, device, or biologic for the prevention or treatment of influenza was sold reasonably reflects additional costs, not within the control of the seller, that were paid or incurred by the seller.

(b)

False pricing information

It shall be unlawful for any person to report information related to the wholesale price of any drug, device, or biologic for the prevention or treatment of influenza to the Secretary if—

(1)

that person knew, or reasonably should have known, the information to be false or misleading;

(2)

the information was required by law to be reported; and

(3)

the person intended the false or misleading data to affect data compiled by the department or agency involved for statistical or analytical purposes with respect to the market for drugs, devices, or biologics for the prevention or treatment of influenza.

(c)

Market manipulation

It shall be unlawful for any person, directly or indirectly, to use or employ, in connection with the purchase or sale of drugs, devices, or biologics for the prevention or treatment of influenza at wholesale, any manipulative or deceptive device or contrivance, in contravention of such rules and regulations as the Secretary may prescribe as necessary or appropriate in the public interest or for the protection of United States citizens.

.

5.

Authorization of appropriations

There are authorized to be appropriated such sums as may be necessary to carry out this Act (and the amendments made by this Act) for each of the fiscal years 2006 through 2010.