I
109th CONGRESS
1st Session
H. R. 3369
IN THE HOUSE OF REPRESENTATIVES
July 20, 2005
Mrs. Lowey (for herself, Mr. Frelinghuysen, Ms. DeLauro, Mr. Case, Ms. Schakowsky, Mr. McNulty, Mr. McDermott, Ms. Bordallo, Mr. Schiff, Mr. Farr, Ms. McCollum of Minnesota, and Mr. Davis of Illinois) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
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.
Short title
This Act may be cited as the Attacking Viral Influenza Across Nations Act of 2005
.
Findings
Congress makes the following findings:
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.
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 over 500,000 deaths in the United States and more than 20,000,000 deaths worldwide.
The Centers for Disease Control and Prevention has estimated conservatively that up to 207,000 Americans would die, and up to 734,000 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.
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.
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 and Vietnam (including a possible human-to-human infection in Thailand).
As of April 15, 2005, 88 confirmed human cases of avian influenza (H5N1) have been reported, 51 of which resulted in death. Of these cases, 68 were in Vietnam, 17 in Thailand, and 3 in Cambodia.
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.
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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.
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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.
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.
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
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).
Proposal for international Fund to support pandemic influenza control
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.
Content of proposal
The proposal submitted under subsection (a) shall describe, with respect to the Pandemic Fund—
funding sources;
administration;
application process by which a country may apply to receive assistance from such Fund;
factors used to make a determination regarding a submitted application, which may include—
the gross domestic product of the applicant country;
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
the willingness of the country to cooperate with other countries with respect to preventing and controlling the spread of the pandemic influenza; and
any other information the Secretary determines necessary.
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.
Policy coordinating Committee on pandemic influenza preparedness
In general
There is established the Pandemic Influenza Preparedness Policy Coordinating Committee (referred to in this section as the Committee
).
Membership
In general
The Committee shall be composed of—
the Secretary;
the Secretary of Agriculture;
the Secretary of State;
the Secretary of Defense;
the Secretary of Commerce;
the Administrator of the Environmental Protection Agency;
the Secretary of Transportation;
the Secretary of Homeland Security;
the Secretary of Veterans Affairs; and
other representatives as determined appropriate by the Co-Chairs of the Committee.
Co-Chairs
The Secretary and the Secretary of Agriculture shall serve as the Co-Chairs of the Committee.
Term
The members of the Committee shall serve for the life of the Committee.
Meetings
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.
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.
Duties of the Committee
Preparedness plans
Each member of the Committee shall submit to the Committee a pandemic influenza preparedness plan for the agency involved that describes—
initiatives and proposals by such member to address pandemic influenza (including avian influenza) preparedness; and
any activities and coordination with international entities related to such initiatives and proposals.
Interagency Plan and recommendations
In general
Preparedness Plan
Based on the preparedness plans described under paragraph (1), and not later than 90 days after the date of enactment of the Pandemic Influenza Preparedness Act of 2005, the Committee shall develop an Interagency Preparedness Plan that integrates and coordinates such preparedness plans.
Content of Plan
The Interagency Preparedness Plan under clause (i) shall include a description of—
departmental or agency responsibility and accountability for each component of such plan;
funding requirements and sources;
international collaboration and coordination efforts; and
recommendations and a timeline for implementation of such plan.
Report
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.
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—
progress made toward plan implementation, as described under clause (i); and
progress of the domestic preparedness programs under section 2144 and of the international assistance programs under section 2145.
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.
Domestic pandemic influenza preparedness activities
Pandemic preparedness activities
The Secretary shall strengthen, expand, and coordinate domestic pandemic influenza preparedness activities.
State Preparedness Plan
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—
designate an official or office as responsible for pandemic influenza preparedness;
submit to the Director of the Centers for Disease Control and Prevention a Pandemic Influenza Preparedness Plan described under paragraph (2); and
have such Preparedness Plan approved in accordance with this subsection.
Preparedness Plan
In general
The Pandemic Influenza Preparedness Plan required under paragraph (1) shall address—
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;
methods to ensure surge capacity in hospitals, laboratories, outpatient healthcare provider offices, medical suppliers, and communication networks;
assisting the recruitment and coordination of national and State volunteer banks of healthcare professionals;
distribution of vaccines, antivirals, and other treatments to priority groups, and monitor effectiveness and adverse events;
networks that provide alerts and other information for healthcare providers and organizations at the National, State, and regional level;
communication with the public with respect to prevention and obtaining care during pandemic influenza;
maintenance of core public functions, including public utilities, refuse disposal, mortuary services, transportation, police and firefighter services, and other critical services;
provision of security for—
first responders and other medical personnel and volunteers;
hospitals, treatment centers, and isolation and quarantine areas;
transport and delivery of resources, including vaccines, medications and other supplies; and
other persons or functions as determined appropriate by the Secretary;
the acquisition of necessary legal authority for pandemic activities;
integration with existing national, State, and regional bioterrorism preparedness activities or infrastructure;
coordination among public and private health sectors with respect to healthcare delivery, including mass vaccination and treatment systems, during pandemic influenza; and
coordination with Federal pandemic influenza preparedness activities.
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.
Approval of State Plan
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.
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.
Reporting of State Plan
All Pandemic Influenza Preparedness Plans submitted and approved under this section shall be made available to the public.
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.
Waiver
The Secretary may grant a temporary waiver of 1 or more of the requirements under this subsection.
Domestic surveillance
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.
Assistance to States
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).
Types of assistance
Assistance provided to States under subparagraph (A) may include—
the establishment or expansion of State surveillance and alert systems, including the Sentinel Physician Surveillance System and 122 Cities Mortalities Report System;
the provision of equipment and supplies;
support for epidemiological analysis and investigation of novel strains;
the sharing of biological specimens and epidemiological and clinical data within and across States; and
other activities determined appropriate by the Secretary.
Detail of officers
The Secretary may detail officers to States for technical assistance as needed to carry out this subsection.
Private sector involvement
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.
Grant program
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.
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; and
be a State with a collaborative relationship with a private health system organization or institution.
Use of funds
Funds under a grant under subparagraph (A) may be used to—
develop and implement surveillance protocols for patients in outpatient and hospital settings;
establish a communication alert plan for patients for reportable signs and symptoms that may suggest influenza;
purchase necessary equipment and supplies;
increase laboratory testing and networking capacity;
conduct epidemiological and other analyses; or
report and disseminate data.
Detail of officers
The Secretary may detail officers to grantees under subparagraph (A) for technical assistance.
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).
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.
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.
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.
International pandemic influenza assistance
In general
The Secretary shall assist other countries in preparation for, and response to, pandemic influenza, including possible pandemic avian influenza.
International surveillance
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.
Assistance
The Secretary and the Secretary of Agriculture shall assist other countries to meet the standards established in paragraph (1) through—
the detail of officers to foreign countries for the provision of technical assistance or training;
laboratory testing, including testing of specimens for viral isolation or subtype analysis;
epidemiological analysis and investigation of novel strains;
provision of equipment or supplies;
coordination of surveillance activities within and among countries;
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
other activities as determined necessary by the Secretary.
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.
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.
Public education and awareness campaign
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.
Details of campaign
The campaign established under subsection (a) shall—
be culturally and linguistically appropriate for domestic populations;
be adaptable for use in foreign countries;
target high-risk populations (those most likely to contract, transmit, and die from influenza);
promote personal influenza precautionary measures and knowledge, and the need for general vaccination, as appropriate; and
describe precautions at the State and local level that could be implemented during pandemic influenza, including quarantine and other measures.
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—
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;
to educate and train volunteer, non-medical personnel whose assistance may be required during a pandemic influenza outbreak; and
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.
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—
vaccine development and manufacture, including strategies to increase immunological response;
effectiveness of inducing heterosubtypic immunity;
antivirals, including minimal dose or course of treatment and timing to achieve prophylactic or therapeutic effect;
side effects and drug safety of vaccines and antivirals in subpopulations;
alternative routes of delivery;
more efficient methods for testing and determining virus subtype;
protective measures; and
other areas determined appropriate by the Director of NIH; and
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.
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—
communication strategies for the public during pandemic influenza, taking into consideration age, racial and ethnic background, health literacy, and risk status;
changing and influencing human behavior as it relates to vaccination; and
development and implementation of a public, non-commercial and non-competitive broadcast system and person-to-person networks.
Institute of Medicine study on the legal, ethical, and social implications of pandemic influenza
In general
The Secretary shall contract with the Institute of Medicine to—
study the legal, ethical, and social implications of, with respect to pandemic influenza—
animal/human interchange;
global surveillance;
case contact investigations;
vaccination and medical treatment;
community hygiene;
travel and border controls;
decreased social mixing and increased social distance;
civil confinement; and
other topics as determined appropriate by the Secretary.
not later than 1 year after the date of enactment of the Attacking Viral Influenza Across Nations Act of 2005, submit to the Secretary a report that describes recommendations based on the study conducted under paragraph (1).
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.
National Pandemic Influenza Economics Advisory Committee
In general
There is established the National Pandemic Influenza Economics Advisory Committee (referred to in this section as the Committee
).
Membership
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.
Chair
The Comptroller General of the United States shall select a Chair from among the members of the Committee.
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—
the development, storage and distribution of vaccines;
the storage and distribution of antiviral and other medications and supplies;
increased surveillance activities;
provision of preventive and medical care during pandemic;
reimbursement for health providers and other core public function employees;
reasonable compensation for farmers and other workers that bear direct or disproportionate loss of revenue; and
other issues determined appropriate by the Chair.
Compensation
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.
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.
Staff
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.
Detail of Federal Government employees
In general
An employee of the Federal Government may be detailed to the Committee without reimbursement.
Civil service status
The detail of the employee shall be without interruption or loss of civil service status or privilege.
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.
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Pandemic influenza and Animal Health
In general
The Secretary of Agriculture shall expand and intensify efforts to prevent pandemic influenza, including possible pandemic avian influenza.
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.
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—
support the eradication of infectious animal diseases and zoonosis;
increase transparency in animal disease states;
collect, analyze, and disseminate veterinary data;
strengthen international coordination and cooperation in the control of animal diseases; and
promote the safety of world trade in animals and animal products.
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.