[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4245 Introduced in House (IH)]







109th CONGRESS
  1st Session
                                H. R. 4245

    To provide for programs and activities with respect to pandemic 
                   influenza, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            November 7, 2005

 Mr. Lewis of California (for himself, Mr. Regula, Mr. Frelinghuysen, 
  Mr. Dreier, Mrs. Bono, Mr. Issa, and Mr. Doolittle) introduced the 
   following bill; which was referred to the Committee on Energy and 
     Commerce, and in addition to the Committees on Resources and 
Agriculture, for a period to be subsequently determined by the Speaker, 
 in each case for consideration of such provisions as fall within the 
                jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
    To provide for programs and activities with respect to pandemic 
                   influenza, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Influenza 
Preparedness and Prevention Act of 2005''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
               TITLE I--VACCINE AND ANTIVIRAL PURCHASING

Sec. 101. Influenza antivirals supply.
Sec. 102. Procurement of vaccines for the Strategic National Stockpile.
Sec. 103. Procurement of essential supplies.
                 TITLE II--VACCINE PRODUCTION CAPACITY

Sec. 201. Liability protections for pandemics, epidemics, and 
                            biodefense countermeasures.
Sec. 202. Vaccine buyback program.
Sec. 203. Approval of vaccines.
Sec. 204. Establishment of Office of Safety Evaluation and Pandemic 
                            Preparedness.
                    TITLE III--PANDEMIC PREPAREDNESS

Sec. 301. Public education on pandemic influenza and preparedness.
Sec. 302. Educational efforts and grants.
Sec. 303. Domestic surveillance of wild birds.
Sec. 304. Research at the National Institutes of Health.
Sec. 305. Research at the Centers for Disease Control and Prevention.
Sec. 306. Global surveillance.
Sec. 307. Proposal for international fund to support pandemic influenza 
                            control.
Sec. 308. Pandemic influenza and animal health.
                TITLE IV--STATE AND LOCAL INFRASTRUCTURE

Sec. 401. State preparedness plan.
                      TITLE V--GENERAL PROVISIONS

Sec. 501. Authorization of appropriations.

               TITLE I--VACCINE AND ANTIVIRAL PURCHASING

SEC. 101. INFLUENZA ANTIVIRALS SUPPLY.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this Act as the ``Secretary'') shall establish a 
stockpile of anti-virals to use for rapid response to an influenza 
outbreak.
    (b) Amount.--The stockpile established under subsection (a) shall 
be of sufficient quantity to treat not less than 25 percent of the 
population of the United States.

SEC. 102. PROCUREMENT OF VACCINES FOR THE STRATEGIC NATIONAL STOCKPILE.

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

SEC. 103. PROCUREMENT OF ESSENTIAL SUPPLIES.

    The Secretary shall, as soon as is practicable, take action to 
procure for the Strategic National Stockpile essential supplies 
(including ventilators, syringes, respirators, surgical masks, and 
gloves) that may be needed in the event of a pandemic.

                 TITLE II--VACCINE PRODUCTION CAPACITY

SEC. 201. LIABILITY PROTECTIONS FOR PANDEMICS, EPIDEMICS, AND 
              BIODEFENSE COUNTERMEASURES.

     Part B of title III of the Public Health Service Act is amended by 
inserting after section 319F-2 (42 U.S.C. 247d-6b) the following:

``SEC. 319F-3. LIABILITY PROTECTIONS FOR PANDEMIC AND EPIDEMIC PRODUCTS 
              AND SECURITY COUNTERMEASURES.

    ``(a) Authority.--As provided for in subsection (b), and subject to 
paragraph (1)(C) of such subsection, a manufacturer, distributor, 
administrator, or health care provider shall be immune, under Federal 
and State law, from suit or liability caused by or arising out of the 
covered application of a covered countermeasure pursuant to a 
declaration by the Secretary described in subsection (b)(2).
    ``(b) Litigation Management.--
            ``(1) Limitation on cause of action.--
                    ``(A) No cause of action in certain cases.--
                            ``(i) In general.--No cause of action shall 
                        exist against a manufacturer, distributor, 
                        administrator, or a health care provider 
                        described in subsection (a) for claims of loss 
                        arising out of, relating to, or resulting from 
                        the covered application of a covered 
                        countermeasure that is deployed pursuant to a 
                        declaration by the Secretary described in 
                        paragraph (2).
                            ``(ii) Rule of construction.--For purposes 
                        of this section, the term `arising out of, 
                        relating to, or resulting from' shall not be 
                        construed to apply to a loss that has no causal 
                        relationship with the administration or use of 
                        a covered countermeasure.
                    ``(B) Rule.--
                            ``(i) Subsequent injury.--The protections 
                        provided for in subsection (a) and subparagraph 
                        (A) of this paragraph shall apply to a covered 
                        application of a covered countermeasure 
                        regardless of the date of alleged injury.
                            ``(ii) Private donation or sale.--The 
                        protections provided for in subsection (a) and 
                        subparagraph (A) of this paragraph shall apply 
                        to a covered application of a covered 
                        countermeasure regardless of whether the 
                        covered countermeasure is on the commercial 
                        market, so long as the covered countermeasure 
                        is deployed in a declaration described in 
                        paragraph (2) and the Secretary does not 
                        specifically prohibit such private donation or 
                        sale in such declaration.
                    ``(C) Potential liability upon determination.--
                            ``(i) In general.--A manufacturer, 
                        distributor, or administrator of a covered 
                        countermeasure or a health care provider who 
                        administers a covered countermeasure shall not 
                        be immune under subsection (a) or exempted from 
                        a cause of action under subparagraph (A) if--
                                    ``(I) in the case of a manufacturer 
                                or distributor, the Secretary makes an 
                                affirmative determination under 
                                subparagraph (D)(ii) against such 
                                manufacturer or distributor; or
                                    ``(II) in the case of an 
                                administrator or health care provider, 
                                the administrator or health care 
                                provider acts with willful misconduct 
                                as that term is defined in regulations 
                                promulgated by the Secretary and the 
                                Attorney General.
                    ``(D) Investigation and determination by secretary 
                concerning actions against manufacturers, or 
                distributors.--
                            ``(i) Investigation by secretary.--A 
                        petitioner seeking a determination under clause 
                        (ii) may petition the Secretary to investigate 
                        allegations of willful misconduct against a 
                        manufacturer or distributor for a loss arising 
                        out of, relating to, or resulting from a 
                        covered application of a covered countermeasure 
                        as provided for in subparagraph (A). The 
                        petition shall demonstrate to the Secretary 
                        that such petitioner has suffered a loss as a 
                        direct result of the willful misconduct of a 
                        manufacturer or distributor. The decision 
                        whether or not to undertake the investigation 
                        shall be within the Secretary's discretion and 
                        shall not be subject to judicial review.
                            ``(ii) Determination by secretary.--To make 
                        an affirmative determination under this 
                        subparagraph, the Secretary shall find, by 
                        clear and convincing evidence, that--
                                    ``(I) the manufacturer or 
                                distributor of a covered countermeasure 
                                violated a provision of the Federal 
                                Food, Drug, and Cosmetic Act (21 U.S.C. 
                                301 et seq.) or this Act, and such 
                                violation is material to the loss 
                                alleged; and
                                    ``(II) in violating either such 
                                Act, such manufacturer or distributor 
                                acted with willful misconduct and such 
                                misconduct--
                                            ``(aa) caused the covered 
                                        countermeasure to present a 
                                        significant or unreasonable 
                                        risk to human health; and
                                            ``(bb) proximately caused 
                                        the injury alleged by the 
                                        petitioner.
                            ``(iii) Notice and hearing.--If the 
                        Secretary finds that an affirmative 
                        determination will likely be made under clause 
                        (ii), the Secretary shall undertake an action 
                        in accordance with section 556 of title 5, 
                        United States Code.
                            ``(iv) Effect of determination.--Subject to 
                        subsection (c) and subparagraph (C) of this 
                        paragraph, the only exception to the immunity 
                        from suit and liability of manufacturers or 
                        distributors of a covered countermeasure 
                        provided for in subsection (a) and subparagraph 
                        (A) of this paragraph shall be for actions 
                        against a manufacturer or distributor as 
                        provided for in such subparagraph (A) that are 
                        subject to an affirmative determination under 
                        clause (ii).
                            ``(v) Judicial review.--
                                    ``(I) Manufacturers or 
                                distributors.--At any time prior to the 
                                90th day following an affirmative 
                                determination by the Secretary under 
                                subparagraph (D)(ii), any manufacturer 
                                or distributor subject to such an 
                                affirmative determination may file a 
                                petition with the United States Court 
                                of Appeals for the District of 
                                Columbia, for a judicial review of such 
                                determination. The court's review under 
                                this subclause shall be limited in 
                                scope to a review of the record to 
                                determine whether the Secretary's 
                                actions were unsupported by substantial 
                                evidence or unwarranted by the facts. A 
                                copy of the petition shall be 
                                transmitted by the clerk of the court 
                                to the Secretary or other officer 
                                designated by the Secretary for that 
                                purpose. The Secretary thereupon shall 
                                file in the court the record of the 
                                findings on which the Secretary based 
                                his or her determination. The filing of 
                                a petition under this clause shall 
                                automatically stay the Secretary's 
                                determination for the duration of the 
                                judicial proceeding.
                                    ``(II) Petitioners.--Any person who 
                                brought a petition to the Secretary 
                                under subparagraph (D)(i) may, at any 
                                time prior to the 90th day following a 
                                determination by the Secretary under 
                                subparagraph (D)(ii), file a petition 
                                with the United States Court of Appeals 
                                for the District of Columbia Circuit, 
                                for a judicial review of such 
                                determination. Notwithstanding any 
                                other provision of law, the court's 
                                review under this subclause shall be 
                                limited in scope to a review of the 
                                record to determine whether the 
                                Secretary's actions were arbitrary, 
                                capricious, or an abuse of discretion.
                            ``(vi) Tolling of statute of limitations.--
                        The computation of the statute of limitations 
                        for any action against a manufacturer or 
                        distributor described in this subparagraph 
                        shall not include any period of time that 
                        occurs prior to the time at which an 
                        affirmative determination by the Secretary 
                        under this subparagraph becomes final, and 
                        upon--
                                    ``(I) the expiration of the 90-day 
                                period following such determination if 
                                the aggrieved party does not seek 
                                judicial review of such determination 
                                under clause (ii); or
                                    ``(II) the conclusion of a judicial 
                                review proceeding under clause (ii), 
                                including any appeal.
                            ``(vii) Procedures for actions against 
                        manufacturers and distributors.--An action that 
                        is allowed under this paragraph shall be 
                        brought in the United States District Court. No 
                        jury trial shall be allowed. If the plaintiff 
                        prevails, the court may award only compensatory 
                        damages, and not punitive damages.
                    ``(E) Regulatory authority.--Not later than 90 days 
                after the date of enactment of this section, the 
                Secretary, in consultation with the Attorney General, 
                shall promulgate regulations to define what actions by 
                a manufacturer, distributor, administrator, or health 
                care provider of a covered countermeasure shall be 
                deemed to constitute `willful misconduct' for purposes 
                of clause (i). In promulgating such regulations, the 
                Secretary shall consider the nature of the actual or 
                potential public health emergency, the timing and 
                extent of any covered countermeasure program, and any 
                other circumstances the Secretary determines to be 
                significant, so that any civil actions permitted under 
                this subsection will not adversely affect public 
                health. The Secretary may specify the period of time 
                for which such regulations apply.
                    ``(F) Procedures for suit against administrators 
                and health care providers.--An action that is permitted 
                under this subsection shall be brought in United States 
                District Court. A plaintiff in such action shall 
                specify in his or her complaint each action or omission 
                that allegedly constitutes willful misconduct. No jury 
                trial shall be allowed. No discovery will be allowed 
                before the court rules on any motion to dismiss or a 
                motion for summary judgment. If a plaintiff prevails, 
                the court may award only compensatory damages, and not 
                punitive damages.
                    ``(G) Scope.--Subparagraph (C) shall apply 
                regardless of whether the action or liability described 
                in subsection (a) or the claim described in 
                subparagraph (A) of this paragraph arises from the 
                covered application by the Federal Government or by any 
                person.
            ``(2) Declaration by the secretary.--
                    ``(A) In general.--The Secretary may issue a 
                declaration, pursuant to this paragraph, that an actual 
                or potential public health emergency makes it advisable 
                that a covered countermeasure be manufactured, tested, 
                or deployed to a covered individual.
                    ``(B) Security countermeasure or qualified pandemic 
                or epidemic product.--The Secretary shall specify in a 
                declaration under subparagraph (A) the covered 
                countermeasure to be sold by, purchased from, or 
                donated by a manufacturer or drawn from the Strategic 
                National Stockpile.
                    ``(C) Effective period.--The Secretary shall 
                specify in a declaration under subparagraph (A) the 
                beginning and the ending dates of the effective period 
                of the declaration. The Secretary may subsequently 
                amend such declaration to shorten or extend such 
                effective period if the new ending date is after the 
                date on which the declaration is amended.
                    ``(D) Publication.--The Secretary shall promptly 
                publish each declaration under subsection (a) and any 
                amendments in the Federal Register.
    ``(c) Actions by and Against the United States.--
            ``(1) Actions by the united states.--Nothing in this 
        section shall be construed to abrogate or limit any right, 
        remedy, or authority that the United States or any agency 
        thereof may possess under any other provision of law.
            ``(2) Immunity.--The United States shall be immune from an 
        action or liability caused by or arising out of the covered 
        application of a covered countermeasure, described in 
        subsection (b)(1)(A), to the same extent as a health care 
        provider, a manufacturer, a distributor, or an administrator of 
        a covered countermeasure.
    ``(d) Severability.--If any provision of this section, or the 
application of such provision, to any person or circumstance is held to 
be unconstitutional, the remainder of this section and the application 
of such provisions to any person or circumstance shall not be affected 
thereby.
    ``(e) Definitions.--In this section:
            ``(1) Administrator.--The term `administrator' includes a 
        State or local government, a person employed by the State or 
        local government, or other person, who supervised or 
        administered a program with respect to the administration, 
        dispensing, distribution, or provision of a security 
        countermeasure or a qualified pandemic or epidemic product, 
        including a person who has established requirements, provided 
        policy guidance, or supplied technical or scientific advice 
        assistance or provides a facility to administer or use a 
        covered countermeasure in accordance with a designation under 
        subsection (b)(2).
            ``(2) Covered application.--The term `covered application' 
        means design, development, clinical testing and investigation, 
        manufacture, labeling, distribution, sale, purchase, donation, 
        dispensing, prescribing, administration, licensing, or use of a 
        qualified pandemic or epidemic product or a security 
        countermeasure.
            ``(3) Covered countermeasure.--The term `covered 
        countermeasure' means a qualified pandemic or epidemic product 
        or a security countermeasure.
            ``(4) Covered individual.--The term `covered individual' 
        means one or more categories of individuals who the Secretary 
        has identified in a declaration under subsection (b)(2).
            ``(5) Deployed.--The term `deployed' means manufactured, 
        tested, distributed, sold, purchased, donated, dispensed, 
        prescribed, administered, licensed, or used.
            ``(6) Health care provider.--The term `health care 
        provider' means a person, including a volunteer, who is 
        licensed or authorized under State law to distribute, 
        prescribe, administer, or dispense, a security countermeasure 
        or a qualified pandemic or epidemic product.
            ``(7) Loss.--The term `loss' means death, injury, illness, 
        disability, condition, medical monitoring, or loss of or damage 
        to property, including business interruption loss.
            ``(8) Manufacturer.--The term `manufacturer' includes--
                    ``(A) a contractor or subcontractor of a 
                manufacturer;
                    ``(B) a supplier or licensor of any product, 
                intellectual property, service, research tool, or 
                component of the qualified pandemic or epidemic product 
                or security countermeasure; and
                    ``(C) any or all of the parents, subsidiaries, 
                affiliates, successors, and assigns of a manufacturer.
            ``(9) Qualified pandemic or epidemic product.--The term 
        `qualified pandemic or epidemic product' means a drug (as such 
        term is defined in section 201(g)(1) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as 
        such term is defined by section 351(i) of this Act), device (as 
        such term is defined by section 201(h) of the Federal Food, 
        Drug and Cosmetic Act (21 U.S.C. 321(h)), that is manufactured, 
        used, designed, developed, modified, licensed, or procured to 
        diagnose, mitigate, prevent, treat, or cure a pandemic or 
        epidemic or limit the harm such pandemic or epidemic might 
        otherwise cause or a serious or life-threatening disease or 
        condition caused by such a product, that--
                    ``(A)(i) is approved or cleared under chapter V of 
                the Federal Food, Drug, and Cosmetic Act or licensed 
                under section 351 of this Act;
                    ``(ii) is authorized for emergency use in 
                accordance with section 564 of the Federal Food, Drug, 
                and Cosmetic Act;. or
                    ``(iii) is the object of research for possible use 
                to treat, identify, or prevent harm from pandemic flu; 
                and
                    ``(B) is specified in a declaration under 
                subsection (b)(2).
            ``(10) Person.--The term `person' includes an individual, 
        partnership, corporation, association, entity, or public or 
        private corporation, including a Federal, State, or local 
        government agency or department.
            ``(11) Security countermeasure.--The term `security 
        countermeasure' has the meaning given such term in section 
        319F-2(c)(1)(B).''.

SEC. 202. VACCINE BUYBACK PROGRAM.

    (a) In General.--The Secretary shall establish an influenza vaccine 
buyback protocol under which the Secretary may enter into buyback 
contracts with manufacturers of influenza vaccine to purchase such 
manufacturers' excess stocks of influenza vaccine so long as such 
vaccine has been manufactured in accordance with the recommendations of 
the Advisory Committee for the production of seasonal influenza 
vaccine.
    (b) Manufacturers.--The Secretary shall have the discretion to 
award buyback contracts under subsection (a) to several influenza 
vaccine manufacturers in a manner consistent with the goal of providing 
stability in the influenza vaccine market, as long as the Federal 
Government purchases not more than 50 percent of the excess influenza 
vaccine stock of any single manufacturer at market price.

SEC. 203. APPROVAL OF VACCINES.

    (a) Criteria for Fast-Track Approval.--Promptly after the date of 
the enactment of this Act, the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall consult with 
potential manufacturers of vaccines against pandemic influenza to 
develop specific criteria for fast-track approval of such vaccines.
    (b) Provisions Relating to Influenza Vaccine Manufacturers.--
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 
et seq.) is amended by adding at the end the following:

``SEC. 909. PROVISIONS RELATING TO INFLUENZA VACCINE MANUFACTURERS.

    ``(a) Assistance and Technical Training Branch.--The Secretary 
shall expand and strengthen the activities of the Manufacturer 
Assistance and Technical Training Branch at the Center for Biologics 
Evaluation and Research of the Food and Drug Administration to provide 
for the dissemination of information, and to provide technical 
guidance, to entities seeking to comply with regulations of the 
Secretary relating to the production of biologic materials, 
particularly influenza vaccine.
    ``(b) Provisions Related to the Emergency Acquisition of 
Vaccines.--
            ``(1) Increased communication.--The Food and Drug 
        Administration shall carry out activities to increase 
        communication between the agency and the scientific community 
        regarding vaccine development and regulation, including 
        participation in conferences on the science related to 
        infectious diseases, influenza, biologic manufacturing, and 
        other issues as determined appropriate by the Director of the 
        Center for Biologics Evaluation and Research.
            ``(2) Regulatory roadmap.--The Commissioner, in 
        consultation with the Director of the Centers for Disease 
        Control and Prevention, the Secretary, and other agencies or 
        participants as determined appropriate by the Secretary, shall 
        develop a regulatory roadmap to address the following issues 
        surrounding emergency use authorization of influenza vaccine, 
        as determined by the Secretary during a public health emergency 
        involving an actual or imminent outbreak of naturally occurring 
        or engineered seasonal influenza:
                    ``(A) Policies for the emergency use authorization 
                of influenza vaccine that is produced and sold in other 
                countries so that such vaccine may be imported into the 
                United States by the United States government during a 
                vaccine shortage.
                    ``(B) Policies for the facilitation of the 
                distribution of any such vaccine imported into the 
                United States during a vaccine shortage, including the 
                interstate transportation, allocation and equitable 
                distribution of vaccine among high priority populations 
                (as defined by the Advisory Committee on Immunization 
                Practices and the Centers for Disease Control and 
                Prevention) during an emergency use situation.
                    ``(C) Policies for the communication and 
                coordination of a response to an emergency use 
                authorization with State and local health departments, 
                including guidelines for notification of such entities 
                in such situations.
                    ``(D) Policies for the emergency use authorization 
                of vaccines that are in clinical development in both 
                the United States and other countries, including 
                clarification of IND protocols for such vaccines, 
                particularly those using new vaccine development 
                technologies.
            ``(3) Consultation.--In developing the roadmap under 
        paragraph (2), the Commissioner shall solicit input from 
        private and nonprofit stakeholders, including State and local 
        health officials, and such input shall include recommendations 
        for developing emergency use authorization guidelines that 
        maintain the scientific and regulatory standards of the Food 
        and Drug Administration.''.

SEC. 204. ESTABLISHMENT OF OFFICE OF SAFETY EVALUATION AND PANDEMIC 
              PREPAREDNESS.

    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--Office of Safety Evaluation and Pandemic Preparedness

``SEC. 2141. ESTABLISHMENT; DEFINITIONS.

    ``(a) Establishment.--There is established in the Office of the 
Secretary the Office of Safety Evaluation and Pandemic Preparedness, to 
be headed by the Director of Safety Evaluation and Pandemic 
Preparedness.
    ``(b) Definitions.--In this subtitle:
            ``(1) The term `Director' means the Director of Safety 
        Evaluation and Pandemic Preparedness.
            ``(2) The term `Office' means, unless otherwise specified, 
        the Office of Safety Evaluation and Pandemic Preparedness.
            ``(3) The term `qualified pandemic or epidemic product' has 
        the meaning given to that term in section 4101 of title 28, 
        United States Code.
            ``(4) The term `security countermeasure' has the meaning 
        given to that term in section 4101 of title 28, United States 
        Code.

``SEC. 2142. AUTHORITIES.

    ``(a) In General.--With respect to qualified pandemic or epidemic 
products and security countermeasures, the Director shall--
            ``(1) conduct or support safety research, including 
        research on--
                    ``(A) acute and chronic adverse reactions, 
                including with respect to subpopulations;
                    ``(B) components of such products and 
                countermeasures, including additives, adjuvants, and 
                preservatives; and
                    ``(C) delivery mechanisms;
            ``(2) conduct or support long- and short-term monitoring, 
        including with respect to new and altered products and 
        countermeasures;
            ``(3) conduct or support research across a range of 
        disciplines, including molecular genetics, toxicology, 
        pharmacokinetics, cell biology, neurology, immunology, and 
        epidemiology;
            ``(4) conduct or support research to address issues raised 
        in claims of injury brought before the Secretary or the 
        Attorney General of the United States;
            ``(5) develop and test hypotheses about potential adverse 
        reactions;
            ``(6) evaluate, on a regular basis, the compliance of 
        health care providers and the manufacturers of such products 
        and countermeasures with Federal requirements for reporting 
        adverse reactions related to such products and countermeasures;
            ``(7) conduct or support research to evaluate reports of 
        injury following administration of such products and 
        countermeasures for the purpose of developing tests to 
        prescreen individuals and subpopulations at greater risk of 
        injury; and
            ``(8) conduct or support research to evaluate biological 
        mechanisms of injury for the purpose of eliminating or reducing 
        the risk of such injury through better prescreening tools or 
        through modification of such products and countermeasures.
    ``(b) Personnel.--In carrying out this subtitle, the Director--
            ``(1) may not employ at management positions any 
        individual--
                    ``(A) who has been employed by the Centers for 
                Disease Control and Prevention or the Food and Drug 
                Administration to carry out any function relating to 
                monitoring, or research on, adverse reactions related 
                to a licensed vaccine; or
                    ``(B) who has been employed by a vaccine 
                manufacturer; and
            ``(2) shall ensure that all personnel assigned to carry out 
        functions relating to monitoring, or research on, adverse 
        reactions related to qualified pandemic or epidemic products or 
        security countermeasures do not have any related professional, 
        familial, or financial conflict of interest.
    ``(c) Grant Applicants.--In awarding any grant relating to research 
on adverse reactions related to qualified pandemic or epidemic products 
or security countermeasures, the Director--
            ``(1) shall ensure that the applicant for the grant does 
        not have--
                    ``(A) any financial conflict of interest that might 
                compromise the research findings, such as holding a 
                related patent or having a family member who holds a 
                related patent; or
                    ``(B) any conflict of interest resulting from the 
                applicant's association with an entity with direct or 
                indirect financial interest in the outcomes of the 
                research, such as receiving money or an in-kind 
                contribution from a manufacturer of such products or 
                countermeasures; and
            ``(2) shall disqualify any applicant having any contractual 
        relationship with, or receiving any funding from, any person 
        with a direct or indirect interest in the outcomes of the 
        research.''.

                    TITLE III--PANDEMIC PREPAREDNESS

SEC. 301. PUBLIC EDUCATION ON PANDEMIC INFLUENZA AND PREPAREDNESS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the Centers for Disease Control and Prevention, 
shall develop and implement a public education campaign about pandemic 
influenza and preparedness.
    (b) Certain Requirements.--The education and outreach activities 
under subsection (a) shall include--
            (1) efforts to distribute information concerning the 
        potential need for general vaccination; education materials on 
        personal precautionary measures;
            (2) the development of a strategy with the business 
        community to provide information about the economic disruptions 
        that may arise during a pandemic period;
            (3) consulting with State and local governments to inform 
        the public on procedures that may be taken during a pandemic 
        period, including with respect to vaccine and antiviral 
        distributions and quarantines.

SEC. 302. EDUCATIONAL EFFORTS AND GRANTS.

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

``SEC. 319B-1. IMMUNIZATION EDUCATIONAL EFFORTS AND GRANTS.

    ``(a) In General.--The Director of the Centers for Disease Control 
and Prevention, in conjunction with State and local health departments, 
shall revise and expand the influenza-related educational materials to 
the Centers for Disease Control and Prevention, and facilitate the use 
of such materials by health care providers and patients. The Director 
is authorized to coordinate such educational efforts with nonprofit 
provider and patient advocacy groups.
    ``(b) Influenza Vaccine Education and Outreach.--
            ``(1) In general.--In order to achieve an optimal balance 
        in the influenza vaccine market, and to ensure that the 
        recommendations of the Advisory Committee on Immunization 
        Practices to the Centers for Disease Control and Prevention for 
        vaccine administration are carried out to the maximum extent 
        possible, the Director of the Centers for Disease Control and 
        Prevention, in conjunction with State and local health 
        departments, shall carry out influenza immunization education 
        and outreach activities that target physicians and other health 
        care providers, health insurance providers, health care 
        institutions and patients, particularly those in high priority 
        populations (as defined by the Advisory Committee on 
        Immunization Practices and the Centers for Disease Control and 
        Prevention) (referred to in this section as `high priority 
        populations').
            ``(2) Types of activities.--The education and outreach 
        activities under paragraph (1) shall include--
                    ``(A) activities to encourage voluntary 
                participation in influenza vaccination programs, with 
                the goal of increasing overall influenza vaccination 
                rates in the United States, achieving full influenza 
                vaccination of all high priority populations, and full 
                use of each season's influenza vaccine supply;
                    ``(B) the provision of information on influenza 
                prevention;
                    ``(C) activities to increase the number of 
                healthcare providers who receive influenza vaccines 
                each year; and
                    ``(D) other influenza educational efforts 
                determined appropriate by the Director.
    ``(c) Grants.--The Director of the Centers for Disease Control and 
Prevention may award grants to State and local health departments to 
carry out activities to encourage individuals, particularly those from 
high priority populations, to seek out influenza vaccinations.
    ``(d) Collaboration.--State and local health departments that 
receive grants under subsection (b) are encouraged to collaborate on 
projects with physicians and other health care providers, health 
insurance providers, health care institutions, and groups representing 
high priority populations.''.

SEC. 303. DOMESTIC SURVEILLANCE OF WILD BIRDS.

    (a) In General.-- The United State Geological Survey, working in 
coordination with the United States Fish and Wildlife Service, the 
National Park Service, and other relevant agencies, shall carry out an 
interagency effort to detect avian influenza in wild birds.
    (b) Types of Activities.--The efforts under subsection (a) shall 
include--
            (1) preparing standard guidelines for routine and 
        systematic monitoring of wild birds;
            (2) developing a uniform protocol for reporting mortality 
        events; developing instructions for safe handling and shipping 
        of specimens to diagnostic facilities;
            (3) training for field personnel in procedures; and
            (4) reporting on finding back to the field.

SEC. 304. 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. 305. 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) population-based surveillance methods to estimate 
        influenza infection rates and rates of outpatient illness;
            (5) vaccine effectiveness;
            (6) systems to monitor vaccination coverage levels and 
        adverse events from vaccination; and
            (7) other areas determined appropriate by the Director of 
        the Centers for Disease Control and Prevention.

SEC. 306. GLOBAL SURVEILLANCE.

     The Director of the Centers for Disease Control and Prevention, in 
collaboration with the Department of State and other relevant agencies, 
shall expand and intensify the efforts of the Global Disease Detection 
Initiative. The Secretary shall increase the number of international 
public health sites and staff abroad in countries impacted by pandemic 
influenza to conduct disease identification and intervention 
activities, provide critical public health expertise to countries in 
need, train international collaborators to recognize and respond to 
influenza and other disease threats, and improve communication 
capabilities. The Director of the Centers for Disease Control and 
Prevention shall conduct a feasibility study and plan for the 
containment of a human pandemic flu outbreak abroad.

SEC. 307. PROPOSAL FOR INTERNATIONAL FUND TO SUPPORT PANDEMIC INFLUENZA 
              CONTROL.

    (a) In General.--The Secretary should submit to the Director of the 
World Health Organization a proposal to study the feasibility of 
establishing a fund, (referred to in this section as the ``Pandemic 
Fund'') to support pandemic influenza control and relief activities 
conducted in countries affected by pandemic influenza, including 
pandemic avian influenza.
    (b) Content of Proposal.--The proposal submitted under subsection 
(a) shall describe, with respect to the Pandemic Fund--
            (1) funding sources;
            (2) administration;
            (3) application process by which a country may apply to 
        receive assistance from such Fund;
            (4) factors used to make a determination regarding a 
        submitted application, which may include--
                    (A) the gross domestic product of the applicant 
                country;
                    (B) the burden of need, as determined by human 
                morbidity and mortality and economic impact related to 
                pandemic influenza and the existing capacity and 
                resources of the applicant country to control the 
                spread of the disease; and
                    (C) the willingness of the country to cooperate 
                with other countries with respect to preventing and 
                controlling the spread of the pandemic influenza; and
            (5) any other information the Secretary determines 
        necessary.
    (c) Use of Funds.--Funds from any Pandemic Fund established as 
provided for in this section shall be used to complement and augment 
ongoing bilateral programs and activities from the United States and 
other donor nations.

SEC. 308. 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 agriculture industry.
    (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.

                TITLE IV--STATE AND LOCAL INFRASTRUCTURE

SEC. 401. STATE PREPAREDNESS PLAN.

    (a) 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--
            (1) designate an official or office as responsible for 
        pandemic influenza preparedness;
            (2) submit to the Director of the Centers for Disease 
        Control and Prevention (referred to in this section as the 
        ``Director'') a Pandemic Influenza Preparedness Plan described 
        under subsection (b); and
            (3) have such Preparedness Plan approved in accordance with 
        this section.
    (b) Preparedness Plan.--
            (1) In general.--The Pandemic Influenza Preparedness Plan 
        required under subsection (a) shall address--
                    (A) 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;
                    (B) methods to ensure surge capacity in hospitals, 
                laboratories, outpatient healthcare provider offices, 
                medical suppliers, and communication networks;
                    (C) assisting the recruitment and coordination of 
                national and State volunteer banks of healthcare 
                professionals;
                    (D) distribution of vaccines, antivirals, and other 
                treatments to priority groups, and monitor 
                effectiveness and adverse events;
                    (E) networks that provide alerts and other 
                information for healthcare providers and organizations 
                at the National, State, and regional level;
                    (F) communication with the public with respect to 
                prevention and obtaining care during pandemic 
                influenza;
                    (G) maintenance of core public functions, including 
                public utilities, refuse disposal, mortuary services, 
                transportation, police and firefighter services, and 
                other critical services;
                    (H) 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;
                    (I) the acquisition of necessary legal authority 
                for pandemic activities;
                    (J) integration with existing national, State, and 
                regional bioterrorism preparedness activities or 
                infrastructure;
                    (K) coordination among public and private health 
                sectors with respect to healthcare delivery, including 
                mass vaccination and treatment systems, during pandemic 
                influenza; and
                    (L) coordination with Federal pandemic influenza 
                preparedness activities.
            (2) Underserved populations.--The Pandemic Influenza 
        Preparedness Plan required under subsection (a) 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.
    (c) Approval of State Plan.--
            (1) In general.--The Director shall develop criteria to 
        rate State Pandemic Influenza Preparedness Plans required under 
        subsection (a) and determine the minimum rating needed for 
        approval.
            (2) Timing of approval.--Not later than 90 days after a 
        State submits a State Pandemic Influenza Preparedness Plan as 
        required under subsection (a), the Director shall make a 
        determination regarding approval of such Plan.
    (d) 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.
    (e) 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 section, 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.
    (f) Waiver.--The Director may grant a temporary waiver of 1 or more 
of the requirements under this section.

                      TITLE V--GENERAL PROVISIONS

SEC. 501. AUTHORIZATION OF APPROPRIATIONS.

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