[Congressional Record Volume 151, Number 128 (Wednesday, October 5, 2005)]
[Senate]
[Pages S11132-S11139]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REID (for himself, Mr. Obama, Mr. Bayh, Mr. Kennedy, Mr. 
        Harkin, Mr. Durbin, Mr. Reed, Mr. Dodd, Mrs. Murray, Ms. 
        Mikulski, Mrs. Clinton, Mr. Kohl, and Mr. Dayton):
  S. 1821. 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; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. REID. Mr. President, four years after 9/11, the government was 
supposed to be prepared for a crisis like Hurricane Katrina. Yet as we 
all saw, the government was not. We owe it to the American people to do 
better in the future.
  Once again, the experts are warning us. This time, it's not about 
levees or terrorists. It's about another pandemic flu.
  According to the experts, another pandemic flu is not a matter of if 
but a question of when. As Dr. Julie Gerberding of the Centers for 
Disease Control put it: ``. . . many influenza experts, including those 
at CDC, consider the threat of a serious influenza pandemic to the 
United States to be high. Although the timing and impact of an 
influenza pandemic is unpredictable, the occurrence is inevitable and 
potentially devastating.''
  The devastation caused by Hurricane Katrina would pale in comparison 
to the potential consequences of a global pandemic. A respected U.S. 
health expert has concluded that 1.7 million Americans would die in the 
first year alone of an outbreak. A pandemic flu outbreak in the Untied 
States today could cost our economy hundreds of billions of dollars due 
to death, lost productivity and disruptions to commerce and society.
  Perhaps the only thing more troubling than contemplating the possible 
consequences of an avian flu pandemic is recognizing that neither this 
Nation nor the world are prepared to deal with it.
  Our National Pandemic Plan is still in draft stages. We lack the 
capacity to rapidly manufacture vaccines in mass

[[Page S11133]]

quantities. We barely have enough antiviral medication for 2 percent of 
our population. Our health care infrastructure is not prepared to 
handle a pandemic. And the medical community, businesses, and general 
public need to be better prepared.
  These are just a few ways we are not as prepared as we should be.
  America can do better. An avian flu pandemic may be inevitable, but 
the devastating consequences are not. We need to heed the warnings and 
take action immediately.
  Last week, the Senate unanimously approved an amendment offered by 
Senators Harkin, Obama, Kennedy, Durbin and me that will begin to 
provide the resources necessary to protect Americans against this 
looming threat.
  Today, I am proud to introduce, along with Senators Obama, Bayh, 
Kennedy, Harkin and Durbin, the Pandemic Preparedness and Response Act 
of 2005. This legislation builds on our commitment to protecting 
Americans by preparing for the possibility of a pandemic.
  Specifically, the Pandemic Preparedness and Response Act will ensure 
that we have a national plan to address a flu pandemic. Under our bill, 
a new Director of Pandemic Preparedness and Response within the 
Executive Office of the President will be responsible for finalizing 
and carrying out the National Pandemic Influenza Preparedness Plan. 
There should be no question about who is in charge of preparing our 
nation for this looming threat. This new position will also ensure 
that, in the event of a pandemic, we will have a single senior official 
whose primary responsibility is to coordinate the federal government's 
response and ensure coordination between local governments and the 
private sector. This is serious responsibility, and our bill will 
ensure that the new Director is held accountable for preparing and 
protecting Americans against the threat of a pandemic.
  Our bill will improve surveillance and international partnerships so 
we may detect the emergence of a flu strain with pandemic potential 
immediately. Specifically, our bill establishes and implements a 
comprehensive diplomatic strategy targeted at nations most at risk for 
an epidemic of avian influenza. It also provides assistance for 
international surveillance and medical care, and creates an 
International Fund to support pre-pandemic influenza control and relief 
activities in countries affected by avian influenza.
  Domestic surveillance efforts will also be bolstered by our 
legislation. Our bill improves state surveillance capacity, and expands 
efforts by the Department of Agriculture to prevent pandemic avian 
influenza.
  The Pandemic Preparedness and Response Act will improve our capacity 
to develop, produce and distribute a vaccine that will be effective 
against a pandemic flu. It will expand research at the National 
Institutes of Health so we may develop more efficient methods of 
producing vaccines. Our bill would enhance our vaccine production 
capacity by creating a guaranteed market for seasonal flu vaccine 
through a federal buyback program for a portion of unsold doses. And 
among other provisions, our bill will improve access to vaccinations 
during a pandemic by enhancing annual flu vaccination coverage for 
uninsured and underinsured adults and children.
  Our legislation will ensure that we have enough antivirals, vaccines 
and other essential medications and supplies in the Strategic National 
Stockpile. Specifically, our bill requires that we procure enough 
antiviral medication to cover a minimum of 50 percent of the population 
for the Strategic National Stockpile. This legislation will protect 
Americans from the price-gouging of medications during a pandemic, and 
establishes a mass tracking and distribution system for vaccines and 
antiviral medications so we can direct medications and vaccines to 
where they are needed the most.
  The Pandemic Preparedness and Response Act will also improve our 
surge capacity so that the American people can be assured there will be 
an adequate supply of health care providers and institutions to care 
for them in the event of a pandemic. Our bill will also ensure that 
public education and awareness campaigns targeted to businesses, health 
care providers and the American public related to pandemic preparedness 
are conducted.
  And finally, the Pandemic Preparedness and Response Act will ensure 
that adequate resources are available to address this looming threat.
  I hope that my colleagues will join me in supporting this legislation 
so we may ensure that we do everything possible to prepare and protect 
Americans from the threat of a global flu pandemic.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 1821

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

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

     SEC. 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 over 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 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.
       (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.

     SEC. 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:

             ``Subtitle 3--Pandemic Influenza Preparedness

     ``SEC. 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).

     ``SEC. 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;

[[Page S11134]]

       ``(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;
       ``(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

     ``SEC. 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.

     ``SEC. 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;

[[Page S11135]]

       ``(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).

     ``SEC. 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.

[[Page S11136]]

       ``(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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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

[[Page S11137]]

       ``(I) other topics as determined appropriate by the 
     Secretary.
       ``(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.

     ``SEC. 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.

     SEC. 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.

  ``Subtitle 4--Strengthening Public Health Immunization Capacity and 
                                 Supply

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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

[[Page S11138]]

       ``(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.

     ``SEC. 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.

     ``SEC. 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.

     ``SEC. 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.''.

     SEC. 4. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN COMMERCE 
                   RELATED TO TREATMENTS FOR PANDEMIC INFLUENZA.

       Section 319F-3 of the Public Health Service Act (as added 
     by section __ and amended by section __(a)) is further 
     amended by adding at the end the following:
       ``(i) Unfair or Deceptive Acts or Practices in Commerce 
     Related to Treatments for Pandemic Influenza.--
       ``(1) Sales to consumers at unconscionable price.--
       ``(A) 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--
       ``(i) is unconscionably excessive (as determined by the 
     Secretary); or
       ``(ii) indicates the seller is taking unfair advantage of 
     the circumstances to increase prices unreasonably.
       ``(B) Factors to be considered.--In determining whether a 
     violation of paragraph (1) has occurred, a court shall take 
     into account, among other factors, whether--
       ``(i) 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
       ``(ii) 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.
       ``(C) Mitigating factors.--In determining whether a 
     violation of subparagraph (A) 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.
       ``(2) 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--
       ``(A) that person knew, or reasonably should have known, 
     the information to be false or misleading;
       ``(B) the information was required by law to be reported; 
     and
       ``(C) 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.
       ``(3) 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.''.

     SEC. 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.

  Mr. OBAMA. Mr. President, I rise today to talk about a critical 
issue--the possibility of an avian influenza pandemic.
  When I started talking about this 7 months ago, not too many folks 
paid attention. Perhaps because the shorthand for this looming crisis 
is the ``bird flu,'' people assume it is just going to get birds and 
animals sick.
  In reality, however, what is at stake here is the potential of a 
pandemic that we have not seen in the United States since 1918. As has 
already been stated, our top scientists and medical personnel, 
including the heads of the NIH, CDC, and the Department of Health and 
Human Services, all agree that it is almost inevitable that an avian 
flu pandemic will strike.
  The key question is the extent of the damage, especially in terms of 
lives lost. The answer to this question will, in large measure, depend 
on our level of preparedness and the amount of resources we are willing 
to immediately commit to deal with this looming crisis.

[[Page S11139]]

  After Katrina, I hope we all learned a lesson about the critical 
value of preparedness.
  I rise today to introduce, along with Senators Reid, Bayh, and 
Kennedy, S. 1821, legislation that dramatically enhances the ability of 
the United States and international community to prevent and respond to 
an avian flu pandemic.
  The bill we are introducing today--the Pandemic Preparedness and 
Response Act or PPRA--incorporates much of my AVIAN Act, and has a 
number of new and important provisions, that will protect Americans 
from pandemic flu.
  The PPRA establishes leadership at the very top level by requiring 
the President to name a national director for Pandemic Preparedness and 
Response, who will sit in the executive office. This director will be 
in charge of all preparedness and response activities at the national 
level, including coordinating the activities and programs of each 
Federal agency.
  It is not enough for the Department of Health and Human Services and 
Department of Homeland Security to be ready; we must have a commerce 
plan, a transportation plan, a diplomatic plan aimed at our foreign 
partners, and a plan for our military personnel and veterans.
  We have asked this director to procure enough antivirals to cover 50 
percent of the populations, and sufficient vaccines and other supplies 
we need for the Strategic National Stockpile. The director will also 
create a national tracking and distribution system to ensure the fair 
and equitable allocation of drugs and vaccines when the pandemic 
strikes.
  On the State level, we have asked the Director of the CDC and HRSA to 
work with States and give them the help they need to make sure they are 
ready to respond as well. Our success at preventing or containing an 
outbreak of avian flu will depend on the preparedness of our State and 
local partners.
  Understanding that international collaboration and cooperation is key 
to surveillance and quick response, we have created an international 
pandemic fund, and requested the Secretary of State develop and 
implement a diplomatic policy aimed at the Southeast and East Asian 
countries. Senator Lugar and I have been hard at work on this last 
point for months.
  Finally, we recognize that this Nation will never have enough 
vaccines, or the ability to produce sufficient vaccines, if we don't 
create the incentives for more drug manufacturers to get into the 
vaccine business. We just have three domestic flu vaccine 
manufacturers, and that is unacceptable. This bill authorizes the 
Secretary to enhance vaccine production capacity by creating a 
guaranteed market for seasonal flu vaccine through a Federal buyback 
program for unsold doses of seasonal flu vaccine. It also increases 
public education and outreach activities for Americans, to stimulate 
demand for the seasonal flu vaccine.
  An outbreak of the avian flu could occur in a year, 5 years, 10 
years, or if we were incredibly lucky not happen at all. But the one 
good thing about investing in measures to deal with this looming crisis 
is--and I will end on this point--if we spend the money now, it will 
pay dividends, even if this particular strain of the avian flu outbreak 
does not occur.
  Why is this the case?
  This is not--no pun intended--a case of Chicken Little.
  The risk of some sort of pandemic, and the mutations of flus for 
which we have no immunity, is almost inevitable. The H5N1 strain may 
not be the strain that leads to a full blown pandemic. But, another 
strain could easily come along and cause serious damage in the future.
  My point is this: undertaking these measures is going to be a wise 
investment that will help protect the lives of millions of people here 
in the United States and across the globe. This legislation gets at the 
heart of this issue.
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