[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4062 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4062

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 17, 2005

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

_______________________________________________________________________

                                 A BILL


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

    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 an estimated 500,000 
        deaths in the United States and more than 20,000,000 deaths 
        worldwide.
            (3) The Centers for Disease Control and Prevention has 
        estimated conservatively that up to 207,000 Americans would 
        die, and up to 10 million would be hospitalized, during the 
        next pandemic. The costs of the pandemic, including the total 
        direct costs associated with medical care and indirect costs of 
        lost productivity and death, are estimated at between 
        $71,000,000,000 and $166,500,000,000. These costs do not 
        include the economic effects of pandemic on commerce and 
        society.
            (4) Recent studies suggest that avian influenza strains, 
        which are endemic in wild birds and poultry populations in some 
        countries, are becoming increasingly capable of causing severe 
        disease in humans and are likely to cause the next pandemic 
        flu.
            (5) In 2004, 8 nations--Thailand, Vietnam, Indonesia, 
        Japan, Laos, China, Cambodia, and the Republic of Korea--
        experienced outbreaks of avian flu (H5N1) among poultry flocks. 
        Cases of human infections were confirmed in Thailand, Cambodia, 
        Indonesia, and Vietnam (including a possible human-to-human 
        infection in Thailand).
            (6) As of September 29, 2005, 116 confirmed human cases of 
        avian influenza (H5N1) have been reported, 60 of which resulted 
        in death. Of these cases, 91 were in Vietnam, 17 in Thailand, 4 
        in Cambodia, and 4 in Indonesia.
            (7) On February 21, 2005, Dr. Julie Gerberding, Director of 
        the Centers for Disease Control and Prevention, stated that 
        ``this is a very ominous situation for the globe . . . the most 
        important threat we are facing right now.''.
            (8) On February 23, 2005, Dr. Shigeru Omi, Asia regional 
        director of the World Health Organization (WHO), stated with 
        respect to the avian flu, ``We at WHO believe that the world is 
        now in the gravest possible danger of a pandemic.''.
            (9) The best defense against influenza pandemics is a 
        heightened global surveillance system. In many of the nations 
        where avian flu (H5N1) has become endemic the early detection 
        capabilities are severely lacking, as is the transparency in 
        the health systems.
            (10) In addition to surveillance, pandemic preparedness 
        requires domestic and international coordination and 
        cooperation to ensure an adequate medical response, including 
        communication and information networks, public health measures 
        to prevent spread, use of vaccination and antivirals, provision 
        of health outpatient and inpatient services, and maintenance of 
        core public functions.

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;
            ``(4) oversee approval of State pandemic plans to ensure 
        nationwide preparedness standards and regional coordination as 
        provided for under section 2144(b)(3);
            ``(5) ensure coordination between the governmental and non-
        governmental economic and finance infrastructure as it relates 
        to pandemic preparedness and response;
            ``(6) as soon as practicable, finalize a National Pandemic 
        Influenza Preparedness Plan that describes programs and 
        activities to decrease the burden of disease, minimize social 
        disruption, and reduce economic impact from an influenza 
        pandemic;
            ``(7) implement the National Pandemic Influenza 
        Preparedness Plan;
            ``(8) make the National Pandemic Influenza Preparedness 
        Plan available to Congress, and the public as appropriate;
            ``(9) submit to Congress an annual budget request related 
        to the National Pandemic Influenza Preparedness Plan;
            ``(10) report to Congress on a biannual basis progress 
        regarding the implementation of the National Pandemic Influenza 
        Preparedness Plan;
            ``(11) address any deficiencies in the National Pandemic 
        Influenza Preparedness Plan as determined by the Government 
        Accountability Office report under subsection (c);
            ``(12) coordinate the provision of technical assistance 
        related to pandemic preparedness across Federal agencies, 
        States, and local governments;
            ``(13) ensure outreach and education campaigns are 
        conducted related to preparedness for businesses, health care 
        providers, and the public;
            ``(14) address supply chain issues related to a pandemic;
            ``(15) ensure that the National Pandemic Influenza 
        Preparedness Plan includes a specific focus on traditionally 
        underserved populations, including low-income, racial and 
        ethnic minorities, immigrants, and uninsured populations; and
            ``(16) hire staff, request information, assistance, or 
        detailees from other Federal agencies, and carry out other 
        activities related to staffing and administration.
    ``(c) GAO Report.--
            ``(1) In general.--Not later than 60 days after the 
        Director has finalized the National Pandemic Influenza 
        Preparedness Plan under subsection (b)(5), the Government 
        Accountability Office shall submit to the Director and Congress 
        a report concerning the National Pandemic Influenza 
        Preparedness Plan.
            ``(2) Requirements.--At a minimum, the report under 
        paragraph (1) shall evaluate the ability of the National 
        Pandemic Influenza Preparedness Plan to--
                    ``(A) address the organizational structure and 
                chain of command, both in the Federal government and at 
                the State level;
                    ``(B) ensure adequate laboratory surveillance of 
                influenza, including the ability to isolate and subtype 
                influenza viruses year round;
                    ``(C) improve vaccine research, development, and 
                production;
                    ``(D) procure adequate doses of antivirals for 
                treatment.
                    ``(E) develop systems for tracking and distributing 
                antiviral medication and vaccines;
                    ``(F) prioritize who would receive antivirals and 
                vaccines based on limited supplies;
                    ``(G) stockpile medical and safety equipment for 
                health care workers and first responders;
                    ``(H) assure surge capacity capabilities for health 
                care providers and institutions;
                    ``(I) secure a backup health care workforce in the 
                event of a pandemic;
                    ``(J) ensure the availability of food, water, and 
                other essential items during a pandemic;
                    ``(K) provide guidance on needed State and local 
                authority to implement public health measures such as 
                isolation or quarantine;
                    ``(L) maintain core public functions, including 
                public utilities, refuse disposal, mortuary services, 
                transportation, police and firefighter services, and 
                other critical services;
                    ``(M) establish networks that provide alerts and 
                other information for health care providers;
                    ``(N) communicate with the public with respect to 
                prevention and obtaining care during a pandemic; and
                    ``(O) provide security for first responders and 
                other medical personnel and volunteers, hospitals, 
                treatment centers, isolation and quarantine areas, and 
                transportation and delivery of resources.

``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;
                            ``(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.
    ``(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
                    ``(I) other topics as determined appropriate by the 
                Secretary; and
            ``(2) not later than 1 year after the date of enactment of 
        the Pandemic Preparedness and Response Act, submit to the 
        Secretary a report that describes recommendations based on the 
        study conducted under paragraph (1).
    ``(b) Implementation of Recommendations.--Not later than 90 days 
after the submission of the report of under subsection (a)(2), the 
Secretary shall address the recommendations of the Institute of 
Medicine regarding the domestic and international allocation and 
distribution of pandemic influenza vaccine and antivirals.

``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
            ``(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.

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

``SEC. 319L. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN COMMERCE RELATED 
              TO TREATMENTS FOR PANDEMIC INFLUENZA.

    ``(a) Sales to Consumers at Unconscionable Price.--
            ``(1) In general.--During any public health emergency 
        declared by the Secretary under section 319 related to pandemic 
        influenza, it shall be unlawful for any person to sell any drug 
        (including an anti-viral drug), device, or biologic for the 
        prevention or treatment of influenza in, or for use in, the 
        area to which that declaration applies at a price that--
                    ``(A) is unconscionably excessive (as determined by 
                the Secretary); or
                    ``(B) indicates the seller is taking unfair 
                advantage of the circumstances to increase prices 
                unreasonably.
            ``(2) Factors to be considered.--In determining whether a 
        violation of paragraph (1) has occurred, a court shall take 
        into account, among other factors, whether--
                    ``(A) the amount charged represents a gross 
                disparity between the price of a drug, device, or 
                biologic for the prevention or treatment of influenza 
                and the price at which the drug, device, or biologic 
                was offered for sale in the usual course of the 
                seller's business immediately prior to the public 
                health emergency; or
                    ``(B) the amount charged grossly exceeds the price 
                at which the same or similar drug, device, or biologic 
                for the prevention or treatment of influenza was 
                readily obtainable by other purchasers in the area in 
                which the declaration applies.
            ``(3) Mitigating factors.--In determining whether a 
        violation of paragraph (1) has occurred, the court shall also 
        take into account, among other factors, the price that would 
        reasonably equate supply and demand in a competitive and freely 
        functioning market and whether the price at which the drug, 
        device, or biologic for the prevention or treatment of 
        influenza was sold reasonably reflects additional costs, not 
        within the control of the seller, that were paid or incurred by 
        the seller.
    ``(b) False Pricing Information.--It shall be unlawful for any 
person to report information related to the wholesale price of any 
drug, device, or biologic for the prevention or treatment of influenza 
to the Secretary if--
            ``(1) that person knew, or reasonably should have known, 
        the information to be false or misleading;
            ``(2) the information was required by law to be reported; 
        and
            ``(3) the person intended the false or misleading data to 
        affect data compiled by the department or agency involved for 
        statistical or analytical purposes with respect to the market 
        for drugs, devices, or biologics for the prevention or 
        treatment of influenza.
    ``(c) Market Manipulation.--It shall be unlawful for any person, 
directly or indirectly, to use or employ, in connection with the 
purchase or sale of drugs, devices, or biologics for the prevention or 
treatment of influenza at wholesale, any manipulative or deceptive 
device or contrivance, in contravention of such rules and regulations 
as the Secretary may prescribe as necessary or appropriate in the 
public interest or for the protection of United States citizens.''.

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.
                                 <all>