[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1828 Introduced in Senate (IS)]








109th CONGRESS
  1st Session
                                S. 1828

    To amend the Public Health Service Act to improve and secure an 
                 adequate supply of influenza vaccine.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 6, 2005

  Mrs. Clinton (for herself and Mr. Roberts) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To amend the Public Health Service Act to improve and secure an 
                 adequate supply of influenza vaccine.

    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 ``Influenza Vaccine Security Act of 
2005''.

                       TITLE I--MARKET GUARANTEES

SEC. 101. AMENDMENT 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--Influenza Vaccine Security

``SEC. 2141. ESTABLISHMENT OF AN INFLUENZA VACCINE TARGET AND 
              STOCKPILE.

    ``(a) Annual Target.--The Secretary, in consultation with the 
Advisory Committee on Immunization Practices to the Centers for Disease 
Control and Prevention (referred to in this subtitle as the `Advisory 
Committee'), shall determine an annual production target for influenza 
vaccine, based on the recommendations of the Advisory Committee. Based 
on such target, the Secretary, acting through the Centers for Disease 
Control and Prevention, shall coordinate with the private market to 
encourage the production of such vaccine in amounts that will meet the 
annual target.
    ``(b) Stockpile.--Prior to the start of each annual influenza 
season (as determined by the Secretary), the Secretary is authorized to 
purchase and store from multiple manufacturers an amount equal to not 
to exceed 10 percent of the total amount of influenza vaccine, 
including one or more active vaccine antigen ingredients in bulk or 
filled form, that is designated for production by the Advisory 
Committee for placement in the strategic national stockpile under 
section 121 of the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002. Such vaccine shall be held in reserve to be 
used in the event of a vaccine shortage in a given influenza season. 
The Secretary shall coordinate with the manufacturers involved to 
ensure that reserving amounts of vaccine for the stockpile does not 
interfere with the early season delivery or early season administration 
of vaccine to high priority populations (as defined by the Advisory 
Committee on Immunization Practices and the Centers for Disease Control 
and Prevention) (referred to in this subtitle as `high priority 
populations').

``SEC. 2142. 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.
    ``(c) Cooperation With Manufacturers, Distributors, and 
Wholesalers.--As a condition of participation in the buyback program 
under this section, the Director of the Centers for Disease Control and 
Prevention shall work in cooperation with influenza vaccine 
manufacturers and wholesalers and distributors within the chain of 
custody from factory to health care institution or health care 
providers to share pertinent information that will allow for the 
tracking of influenza vaccine, maximize the delivery and availability 
of influenza vaccines to high priority populations, and ensure that 
influenza vaccine is delivered on an equitable basis, particularly in 
times of vaccine shortages.
    ``(d) Confidentiality.--The information submitted to the Centers 
for Disease Control and Prevention or its contractors, if any, under 
subsections (c) and (d) shall remain confidential in accordance with 
the exception from the public disclosure of trade secrets, commercial 
or financial information, and information obtained from an individual 
that is privileged and confidential, as provided for in section 
552(b)(4) of title 5, United States Code, and subject to the penalties 
and exceptions under sections 1832 and 1833 of title 18, United States 
Code, relating to the protection and theft of trade secrets, and 
subject to privacy protections that are consistent with the regulations 
promulgated under section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996. None of such information provided by a 
manufacturer, wholesaler, or distributor shall be disclosed without its 
consent to another manufacturer, wholesaler, or distributor, or shall 
be used in any manner to give a manufacturer, wholesaler, or 
distributor a proprietary advantage over its competitors.
    ``(e) Ability to Negotiate.--The Secretary shall have the ability 
to negotiate, on a case-by-case basis, the submission of information 
under subsection (c), as long as the information provided will achieve 
the goals of tracking of the influenza vaccine, maximizing the delivery 
and availability of influenza vaccines to high priority populations, 
and ensuring that influenza vaccine is delivered on an equitable 
geographical basis, particularly in times of vaccine shortages.
    ``(f) Notice.--
            ``(1) In general.--For purposes of maintaining and 
        administering the supply of vaccines described under subsection 
        (a), the Secretary shall by contract require that a 
        manufacturer of a vaccine included in such supply provide not 
        less than 12 months notice to the Secretary of a purposeful 
        discontinuance of the manufacture of such vaccine by the 
        manufacture of the vaccine.
            ``(2) Reduction of period of notice.--The notification 
        period required under paragraph (1) shall not apply in a case 
        in which vaccine production is interrupted because of 
        unforeseen manufacturing concerns.

``SEC. 2143. ANTIVIRAL PURCHASE PROGRAM.

    ``(a) In General.--The Secretary shall increase the amount of 
antiviral medications contained in the strategic national stockpile 
under section 121 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002, in such amounts as necessary, as 
determined appropriate in consultation with the Director of the Centers 
for Disease Control and Prevention, to provide adequate protection to 
not less than those responding to an influenza epidemic.
    ``(b) Pediatric Antiviral.--The Secretary is encouraged to work 
with all relevant Federal agencies and the private sector to develop 
and approve an antiviral for use in the pediatric population.

``SEC. 2144. AUTHORIZATION OF APPROPRIATIONS.

    ``There are authorized to be appropriated such sums as may be 
necessary to carry out this subtitle in each of fiscal years 2007 
through 2011.''.

   TITLE II--FOOD AND DRUG ADMINISTRATION ASSISTANCE TO MANUFACTURERS

SEC. 201. AMENDMENT TO THE FOOD, DRUG, AND COSMETIC ACT.

    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) Technical Assistance Grants.--
            ``(1) In general.--The Secretary, in consultation with the 
        Commissioner, shall award technical assistance grants to 
        entities seeking to--
                    ``(A) enter the United States influenza vaccine 
                market;
                    ``(B) expand their vaccine production capacity for 
                the United States influenza vaccine market; or
                    ``(C) improve their ability to remain within the 
                United States influenza vaccine market.
            ``(2) Activities.--Amounts awarded under grants under 
        paragraph (1) shall be used for one or more of the following 
        activities:
                    ``(A) Establishing or making capital improvements 
                in technology, machinery, or production capacity to 
                vaccine manufacturing facilities located within the 
                United States to enable such facilities to comply with 
                the regulations of the Food and Drug Administration.
                    ``(B) The training of employees of United States-
                based vaccine manufacturing facilities in vaccine 
                production methods.
                    ``(C) Any other activities approved by the 
                Commissioner as assisting with the goal of increasing 
                manufacturer participation in the vaccine market and 
                improving domestically-based vaccine manufacturing 
                capacity.
    ``(c) 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.
            ``(4) Standing orders.--
                    ``(A) Development.--The Secretary shall direct the 
                Centers for Disease Control and Prevention, in 
                conjunction with State and local health departments and 
                representatives of State medical boards and nursing 
                examiners, to develop and publish a model standing 
                order that will, at a minimum, address the need for 
                standing orders to administer influenza vaccine in 
                hospitals, nursing homes, and by home health care 
                providers. The Centers for Disease Control and 
                Prevention is encouraged to expand such a model 
                standing order to take into account--
                            ``(i) the administration of other Medicare 
                        covered vaccines; and
                            ``(ii) the delivery of influenza vaccine to 
                        patients in children's hospitals or other 
                        institutions serving the long-term care needs 
                        of a pediatric population.
                    ``(B) Implementation.--Not less than 1 year after 
                the publication of the standing order under paragraph 
                (A), States shall be required to implement such 
                standing order in order to be eligible to receive 
                grants under this Act.
                    ``(C) Rule of construction.--Nothing in this 
                paragraph shall be construed as precluding the 
                application of State laws, so long as such laws don not 
                restrict the implementation of this requirements of the 
                Influenza Vaccine Security Act of 2005 (and the 
                amendments made by such Act).
    ``(d) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section, $75,000,000 for each of fiscal years 
        2007 through 2011.
            ``(2) Use of funds.--The Secretary shall ensure that 
        $5,000,000 of the amount appropriated under paragraph (1) for 
        fiscal year 2007, and such sums as may be necessary for each of 
        fiscal years 2008 through 2011, shall be made available for the 
        purpose of increasing the ability of the Food and Drug 
        Administration to provide the technical assistance and take 
        advantage of the training opportunities as designated in this 
        section.''.

        TITLE III--VACCINE DEVELOPMENT RESEARCH AND COORDINATION

SEC. 301. INCREASED FUNDING FOR NEW AND EXISTING VACCINE DEVELOPMENT 
              RESEARCH.

    Subpart 6 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285f et seq.) is amended by adding at the end the following:

``SEC. 447C. INCREASED FUNDING FOR NEW AND EXISTING VACCINE DEVELOPMENT 
              RESEARCH.

    ``(a) New Research.--
            ``(1) Solicitation of proposals.--The Institute shall 
        solicit proposals for research into improved technologies for 
        influenza vaccine development, including a permanent influenza 
        vaccine. The Secretary, acting through the Director of the 
        Institute may award grants to fund such proposals.
            ``(2) Priority.--In funding proposals submitted under 
        paragraph (1), the Institute shall give priority to proposals 
        for research that contributes to the goal of providing 
        marketable influenza vaccine alternatives within the 10-year 
        period after the date of enactment of this section.
    ``(b) Existing Research.--
            ``(1) In general.--The Director of the Institute, acting 
        jointly with the Director of Intramural Research at the 
        Institute and the Scientific Director of the Vaccine Research 
        Program at the Institute, and in consultation with any other 
        officials determined appropriate by the Director, shall review 
        vaccine development research that is being conducted under 
        grants awarded by the Institute to identify research that could 
        provide the United States with improved technologies for 
        vaccine production that could be marketed within the United 
        States within the 10-year period beginning on the date of 
        enactment of this section.
            ``(2) Supplementary funding.--The Director of the Institute 
        shall provide supplementary grant funding to the research 
        identified under paragraph (1) that the Director determines 
        could result in the production described in such paragraph.
            ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this section, $100,000,000 for 
        each of fiscal years 2007 through 2011.''.

SEC. 302. AUTHORITY OF THE NATIONAL IMMUNIZATION PROGRAM FOR 
              COORDINATION OF, EDUCATION, OUTREACH, AND COMMUNICATION 
              ACROSS HHS.

    Section 2102 of the Public Health Service Act (42 U.S.C. 300aa-2) 
is amended--
            (1) in subsection (a), by adding at the end the following:
            ``(10) Coordination of support.--The Director of the 
        Program shall--
                    ``(A) coordinate education, outreach, and 
                communication efforts in regard to all influenza 
                vaccine research activities within the Department in 
                support of the goal of--
                            ``(i) increasing overall influenza 
                        vaccination rates in the United States, 
                        particularly those of high priority populations 
                        (as defined by the Advisory Committee on 
                        Immunization Practices and the Centers for 
                        Disease Control and Prevention) and health care 
                        providers,
                            ``(ii) ensuring that safe and effective 
                        marketable vaccines produced with improved 
                        technologies that supplement the current egg-
                        based system of production shall be available 
                        within the 10-year period after the enactment 
                        of this paragraph; and
                            ``(iii) any other vaccine promotion 
                        activities as directed by the Secretary;
                    ``(B) coordinate educational efforts under this 
                paragraph with the National Vaccine Program Office, 
                State and local health departments, the National 
                Institutes of Health, and all other relevant Federal 
                and other entities as designated by the Director; and
                    ``(C) provide an annual report to Congress on the 
                progress being made toward the goals described in 
                subparagraph (A).''; and
            (2) by adding at the end the following:
    ``(c) Appropriations for Coordination of Influenza Vaccine Outreach 
Activities.--There is authorized to be appropriated to carry out 
activities under subsection (a)(10), $2,000,000 for each of fiscal 
years 2007 through 2011.''.

    TITLE IV--INCREASED INFLUENZA VACCINE AND OUTBREAK SURVEILLANCE 
                               ACTIVITIES

SEC. 401. TRACKING NETWORK AND DEMONSTRATION GRANTS.

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

``SEC. 319B-1. TRACKING NETWORK AND DEMONSTRATION GRANTS.

    ``(a) Tracking System.--
            ``(1) Establishment.--Not later than 2 years after the date 
        of enactment of this section, the Director of the Centers for 
        Disease Control and Prevention, in conjunction with State and 
        local public health officials, shall establish an electronic 
        tracking system through which the Director and such officials 
        can determine the amount of influenza vaccine that is available 
        for distribution to patients, as well as the need for such 
        vaccine on a county-by-county basis, and the progress of 
        vaccine delivery and distribution efforts at the State and 
        local level.
            ``(2) Estimates.--The tracking system established under 
        paragraph (1) shall collect estimates of the size of 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') in each county in the United States, so as to 
        better determine where influenza vaccine resources may need to 
        be directed in the case of an emergency.
            ``(3) Provision of information.--To be eligible to 
        participate in buyback programs the vaccine manufacturer shall 
        provide information to the tracking system as the Director of 
        the Centers for Disease Control and Prevention determines 
        appropriate in accordance with subtitle 3 of title XXI.
            ``(4) Database.--In consultation with manufacturers, 
        distributors, wholesalers, and State and local health 
        departments, the Secretary shall develop guidelines for the 
        development and use of a database in order to maintain 
        confidentiality and ensure that none of the information 
        provided under paragraph (3) and contained in the database can 
        be used to provide a proprietary advantage within the vaccine 
        market while allowing State and local health officials such 
        information to maximize the delivery and availability of 
        vaccines to high priority populations.
    ``(b) Expansion of Current Systems and Activities.--
            ``(1) Surveillance system.--Not later than 4 years after 
        the date of enactment of this section, the Director of the 
        Centers for Disease Control and Prevention shall upgrade the 
        influenza surveillance system of the Centers for Disease 
        Control and Prevention to report influenza data from State and 
        local health departments into the tracking system established 
        under subsection (a)(1).
            ``(2) Educational materials.--The tracking system shall 
        contain information to assist users in accessing influenza 
        education, outreach, and communications tools, such as those 
        developed and financed under the Influenza Vaccine Security Act 
        of 2005 (and the amendments made by such Act).
            ``(3) Emergency provider database.--The Director of the 
        Centers for Disease Control and Prevention shall coordinate 
        access to, in conjunction with State and local health 
        departments and State licensing boards for health 
        professionals, a database registry of medical personnel who can 
        provide services in the event of a health emergency, including 
        pandemic influenza or an influenza vaccine shortage. Such 
        information shall be made available through the tracking 
        network.
    ``(c) Demonstration Grants.--
            ``(1) In general.--The Director of the Centers for Disease 
        Control and Prevention shall award demonstration grants to 
        State and local health departments to enable such departments 
        to enter into contract with hospitals, community health 
        centers, long-term care facilities, physicians' offices, and 
        health care facilities operated or funded by such departments 
        to assist such entities in upgrading their information 
        technology, infrastructure, and workforce in a manner that will 
        allow such entities to improve their ability to report and 
        track influenza vaccine dissemination.
            ``(2) Priority.--In awarding grants under paragraph (1), 
        priority shall be given to entities that serve high priority 
        populations in medically underserved areas.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) to carry out subsection (a), $100,000,000 for each of 
        fiscal years 2007 through 2011, of which $500,000 for each 
        fiscal year shall be made available to implement subsection 
        (b)(3); and
            ``(2) to carry out subsection (c), $100,000,000 for each of 
        fiscal years 2007 through 2011.''.

              TITLE V--FLU VACCINE OUTREACH AND EDUCATION

SEC. 501. EDUCATIONAL EFFORTS AND GRANTS.

    Title III of the Public Health Service Act is amended by inserting 
after section 319B-1 (as added by section 401) the following:

``SEC. 319B-2. 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.
    ``(e) Authorization of Appropriations.--In addition to any amounts 
otherwise available through the Secretary for influenza outreach and 
education, there is authorized to be appropriated to carry out this 
section, $10,000,000 for each of fiscal years 2007 through 2011.''.

                         TITLE VI--COMPENSATION

SEC. 601. COMPENSATION.

    Section 224 of the Public Health Service Act (42 U.S.C. 233) is 
amended by adding at the end the following:
    ``(q) Manufacture, Administration, and Use of Pandemic Influenza 
Technologies.--
            ``(1) Definitions.--In this subsection:
                    ``(A) Covered person.--The term `covered person' 
                means--
                            ``(i) a manufacturer of a qualified 
                        pandemic influenza technology;
                            ``(ii) a distributor of a qualified 
                        pandemic influenza technology;
                            ``(iii) a hospital, clinic, and other 
                        healthcare entity under whose auspices a 
                        qualified pandemic influenza technology is 
                        administered;
                            ``(iv) a licensed health care professional 
                        or other individual authorized to administer a 
                        qualified pandemic influenza technology under 
                        State law; and
                            ``(v) any official, agent, or employee of 
                        any of the entities described in clauses (i) 
                        through (iv), or of a State or locally 
                        administered health plan, or a volunteer acting 
                        under a publicly funded health program, who is 
                        acting within the scope of his or her agency or 
                        employment.
                    ``(B) Pandemic influenza technology.--The term 
                `pandemic influenza technology' means any vaccine 
                product developed or procured for the specific purpose 
                of preventing or treating pandemic influenza or any 
                vaccine product limiting the harm such pandemic might 
                otherwise cause.
                    ``(C) Qualified pandemic influenza technology.--The 
                term `qualified pandemic influenza technology' means a 
                pandemic influenza technology that has been designated 
                by the Secretary in accordance with paragraph (2).
            ``(2) Designation by secretary.--
                    ``(A) In general.--The Secretary may designate a 
                pandemic influenza technology as a qualified pandemic 
                influenza technology if the Secretary determines that 
                there is a public health emergency involving an actual 
                or imminent outbreak of naturally occurring or 
                engineered pandemic influenza and requiring the 
                manufacture, distribution, and administration of 
                pandemic influenza technology.
                    ``(B) Recommended designation.--A person may 
                recommend to the Secretary at any time the designation 
                of a technology under subparagraph (A) and may provide 
                data and information to support such recommendation.
                    ``(C) Effective period.--The Secretary shall 
                specify in a designation under this paragraph the 
                beginning and ending dates of the effective period of 
                such designation, and may subsequently amend such 
                designation to shorten or extend such effective period.
                    ``(D) Publication.--The Secretary shall provide for 
                the publication of each designation under this 
                paragraph, and each amendment thereto, in the Federal 
                Register. Such designation or amendment shall take 
                effect immediately upon such publication and shall not 
                be subject to the provisions of section 553 of title 5, 
                United States Code, concerning prior notice and 
                opportunity for comment.
                    ``(E) Vaccine injury compensation program.--Nothing 
                in this Act shall be construed to supersede the 
                authority of the Vaccine Injury Compensation Program in 
                regards to vaccine products on the table, such as 
                trivalent influenza vaccine.
            ``(3) Liability of united states.--
                    ``(A) In general.--For purposes of this section, a 
                covered person shall be deemed to be an employee of the 
                Public Health Service with respect to liability for 
                personal injury or death arising out of the 
                manufacture, administration, or use of a qualified 
                pandemic influenza technology. The liability of the 
                United States under this subsection shall be as set 
                forth in section 1346(b) and chapter 171 of title 28, 
                United States Code, except--
                            ``(i) as otherwise provided in this 
                        section; and
                            ``(ii) that the liability of the United 
                        States may be based on any cause of action 
                        seeking compensation for harm allegedly arising 
                        out of the manufacture, administration, or use 
                        of a qualified pandemic influenza technology, 
                        regardless of whether such cause of action is 
                        alleged as negligence, strict liability in 
                        tort, breach of warranty, failure to warn, or 
                        other action.
                    ``(B) Scope.--For purposes of this section, any 
                activity reasonably related to the manufacture, 
                distribution, or administration of a qualified pandemic 
                influenza technology shall be considered to be a 
                medical, surgical, dental, or related function within 
                the scope of the covered person's employment by the 
                Public Health Service.
                    ``(C) Governing law.--Notwithstanding the 
                provisions of section 1346(b)(1) and chapter 171 of 
                title 28, United States Code, as they relate to 
                governing law, the liability of the United States as 
                provided in this subsection shall be in accordance with 
                the law of the place of injury.
                    ``(D) Military personnel and united states citizens 
                oversees.--
                            ``(i) Military personnel.--The liability of 
                        the United States as provided in this 
                        subsection shall extend to claims brought by 
                        United States military personnel.
                            ``(ii) Claims arising in a foreign 
                        country.--Notwithstanding the provisions of 
                        section 2680(k) of title 28, United States 
                        Code, the liability of the United States as 
                        provided in this subsection shall extend to 
                        claims based on injuries arising in a foreign 
                        country where the injured party is a member of 
                        the United States military, is the spouse or 
                        child of a member of the United States 
                        military, or is a United States citizen.
                            ``(iii) Governing law.--With regard to all 
                        claims brought under clause (ii), and 
                        notwithstanding the provisions of section 
                        1346(b)(1) and chapter 171 of title 28, United 
                        States Code, and of subparagraph (C), as they 
                        relate to governing law, the liability of the 
                        United States as provided in this subsection 
                        shall be in accordance with the law of the 
                        claimant's domicile in the United States or 
                        most recent domicile within the United States.
            ``(4) Exclusivity of remedy.--The remedy provided for by 
        this section shall be exclusive of any other civil action or 
        proceeding against a covered person, for personal injury or 
        death arising out of the manufacture, administration, or use of 
        a qualified pandemic influenza technology during the effective 
        period of the designation under paragraph (2).
            ``(5) Covered person to cooperate with united states.--
                    ``(A) In general.--A covered person shall cooperate 
                with the United States in the processing and defense of 
                a claim or action under this subsection based upon the 
                acts or omissions of such person.
                    ``(B) Consequences of failure to cooperate.--Upon 
                the motion of the United States or any other party and 
                upon a finding that a covered person has failed to 
                cooperate with the United States as provided for in 
                subparagraph (A)--
                            ``(i) the court shall substitute such 
                        person as the party defendant in place of the 
                        United States and, upon motion, shall remand 
                        any such suit to the court in which it was 
                        instituted if it appears that the court lacks 
                        subject matter jurisdiction;
                            ``(ii) the United States shall not be 
                        liable based on the acts or omissions of such 
                        person; and
                            ``(iii) the Attorney General shall not be 
                        obligated to defend such action.
            ``(6) Recourse against covered persons in case of gross 
        misconduct or material breach of contract.--
                    ``(A) In general.--If payment is made by the United 
                States to any claimant bringing a claim against a 
                covered person under this subsection, either by way of 
                administrative determination, settlement, or court 
                judgment, the United States shall have, notwithstanding 
                any provision of State law, the right to recover for 
                that portion of the damages so awarded or paid, as well 
                as interest and any costs of litigation, resulting 
                from--
                            ``(i) such covered person's intentional 
                        breach of a procurement contract, so long as 
                        such breach was materially related to the 
                        injury that is the subject of the claim, or
                            ``(ii) any grossly negligent or reckless 
                        conduct, or willful misconduct, on the part of 
                        such covered person, so long as such conduct or 
                        misconduct was materially related to the injury 
                        that is the subject to the claim.
                    ``(B) Action by the united states.--The United 
                States may maintain an action under this paragraph 
                against a covered person described in subparagraph (A) 
                in the district court of the United States in which 
                such person resides or has its principal place of 
                business.''.
                                 <all>