II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Influenza Vaccine Se5 curity Act of 2005’’. 
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1 TITLE I—MARKET GUARANTEES 

2 SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

3 ACT. 

4 Title XXI of the Public Health Service Act (42 

5 U.S.C. 300aa–1 et seq.) is amended by adding at the end 

6 the following: 

7 ‘‘Subtitle 3—Influenza Vaccine 

8 Security 

9 ‘‘SEC. 2141. ESTABLISHMENT OF AN INFLUENZA VACCINE 

10 TARGET AND STOCKPILE. 

11 ‘‘(a) ANNUAL TARGET.—The Secretary, in consulta12 tion with the Advisory Committee on Immunization Prac13 tices to the Centers for Disease Control and Prevention 

14 (referred to in this subtitle as the ‘Advisory Committee’), 

15 shall determine an annual production target for influenza 

16 vaccine, based on the recommendations of the Advisory 

17 Committee. Based on such target, the Secretary, acting 

18 through the Centers for Disease Control and Prevention, 

19 shall coordinate with the private market to encourage the 

20 production of such vaccine in amounts that will meet the 

21 annual target. 

22 ‘‘(b) STOCKPILE.—Prior to the start of each annual 

23 influenza season (as determined by the Secretary), the 

24 Secretary is authorized to purchase and store from mul25 tiple manufacturers an amount equal to not to exceed 10 
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1 percent of the total amount of influenza vaccine, including 

2 one or more active vaccine antigen ingredients in bulk or 

3 filled form, that is designated for production by the Advi4 sory Committee for placement in the strategic national 

5 stockpile under section 121 of the Public Health Security 

6 and Bioterrorism Preparedness and Response Act of 

7 2002. Such vaccine shall be held in reserve to be used in 

8 the event of a vaccine shortage in a given influenza season. 

9 The Secretary shall coordinate with the manufacturers in10 volved to ensure that reserving amounts of vaccine for the 

11 stockpile does not interfere with the early season delivery 

12 or early season administration of vaccine to high priority 

13 populations (as defined by the Advisory Committee on Im14 munization Practices and the Centers for Disease Control 

15 and Prevention) (referred to in this subtitle as ‘high pri16 ority populations’). 

17 ‘‘SEC. 2142. VACCINE BUYBACK PROGRAM. 

18 ‘‘(a) IN GENERAL.—The Secretary shall establish an 

19 influenza vaccine buyback protocol under which the Sec20 retary may enter into buyback contracts with manufactur21 ers of influenza vaccine to purchase such manufacturers’ 

22 excess stocks of influenza vaccine so long as such vaccine 

23 has been manufactured in accordance with the rec24 ommendations of the Advisory Committee for the produc25 tion of seasonal influenza vaccine. 
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1 ‘‘(b) MANUFACTURERS.—The Secretary shall have 

2 the discretion to award buyback contracts under sub3 section (a) to several influenza vaccine manufacturers in 

4 a manner consistent with the goal of providing stability 

5 in the influenza vaccine market, as long as the Federal 

6 Government purchases not more than 50 percent of the 

7 excess influenza vaccine stock of any single manufacturer 

8 at market price. 

9 ‘‘(c) COOPERATION WITH MANUFACTURERS, DIS10 TRIBUTORS, AND WHOLESALERS.—As a condition of par11 ticipation in the buyback program under this section, the 

12 Director of the Centers for Disease Control and Preven13 tion shall work in cooperation with influenza vaccine man14 ufacturers and wholesalers and distributors within the 

15 chain of custody from factory to health care institution 

16 or health care providers to share pertinent information 

17 that will allow for the tracking of influenza vaccine, maxi18 mize the delivery and availability of influenza vaccines to 

19 high priority populations, and ensure that influenza vac20 cine is delivered on an equitable basis, particularly in 

21 times of vaccine shortages. 

22 ‘‘(d) CONFIDENTIALITY.—The information submitted 

23 to the Centers for Disease Control and Prevention or its 

24 contractors, if any, under subsections (c) and (d) shall re25 main confidential in accordance with the exception from 
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1 the public disclosure of trade secrets, commercial or finan2 cial information, and information obtained from an indi3 vidual that is privileged and confidential, as provided for 

4 in section 552(b)(4) of title 5, United States Code, and 

5 subject to the penalties and exceptions under sections 

6 1832 and 1833 of title 18, United States Code, relating 

7 to the protection and theft of trade secrets, and subject 

8 to privacy protections that are consistent with the regula9 tions promulgated under section 264(c) of the Health In10 surance Portability and Accountability Act of 1996. None 

11 of such information provided by a manufacturer, whole12 saler, or distributor shall be disclosed without its consent 

13 to another manufacturer, wholesaler, or distributor, or 

14 shall be used in any manner to give a manufacturer, 

15 wholesaler, or distributor a proprietary advantage over its 

16 competitors. 

17 ‘‘(e) ABILITY TO NEGOTIATE.—The Secretary shall 

18 have the ability to negotiate, on a case-by-case basis, the 

19 submission of information under subsection (c), as long 

20 as the information provided will achieve the goals of track21 ing of the influenza vaccine, maximizing the delivery and 

22 availability of influenza vaccines to high priority popu23 lations, and ensuring that influenza vaccine is delivered 

24 on an equitable geographical basis, particularly in times 

25 of vaccine shortages. 
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1 ‘‘(f) NOTICE.— 

2 ‘‘(1) IN GENERAL.—For purposes of maintain3 ing and administering the supply of vaccines de4 scribed under subsection (a), the Secretary shall by 

5 contract require that a manufacturer of a vaccine in6 cluded in such supply provide not less than 12 

7 months notice to the Secretary of a purposeful dis8 continuance of the manufacture of such vaccine by 

9 the manufacture of the vaccine. 

10 ‘‘(2) REDUCTION OF PERIOD OF NOTICE.—The 

11 notification period required under paragraph (1) 

12 shall not apply in a case in which vaccine production 

13 is interrupted because of unforeseen manufacturing 

14 concerns. 

15 ‘‘SEC. 2143. ANTIVIRAL PURCHASE PROGRAM. 

16 ‘‘(a) IN GENERAL.—The Secretary shall increase the 

17 amount of antiviral medications contained in the strategic 

18 national stockpile under section 121 of the Public Health 

19 Security and Bioterrorism Preparedness and Response 

20 Act of 2002, in such amounts as necessary, as determined 

21 appropriate in consultation with the Director of the Cen22 ters for Disease Control and Prevention, to provide ade23 quate protection to not less than those responding to an 

24 influenza epidemic. 
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1 ‘‘(b) PEDIATRIC ANTIVIRAL.—The Secretary is en2 couraged to work with all relevant Federal agencies and 

3 the private sector to develop and approve an antiviral for 

4 use in the pediatric population. 

5 ‘‘SEC. 2144. AUTHORIZATION OF APPROPRIATIONS. 

6 ‘‘There are authorized to be appropriated such sums 

7 as may be necessary to carry out this subtitle in each of 

8 fiscal years 2007 through 2011.’’. 

9 TITLE II—FOOD AND DRUG AD10 MINISTRATION ASSISTANCE 

11 TO MANUFACTURERS 

12 SEC. 201. AMENDMENT TO THE FOOD, DRUG, AND COS13 METIC ACT. 

14 Chapter IX of the Federal Food, Drug, and Cosmetic 

15 Act (21 U.S.C. 391 et seq.) is amended by adding at the 

16 end the following: 

17 ‘‘SEC. 909. PROVISIONS RELATING TO INFLUENZA VACCINE 

18 MANUFACTURERS. 

19 ‘‘(a) ASSISTANCE AND TECHNICAL TRAINING

20 BRANCH.—The Secretary shall expand and strengthen the 

21 activities of the Manufacturer Assistance and Technical 

22 Training Branch at the Center for Biologics Evaluation 

23 and Research of the Food and Drug Administration to 

24 provide for the dissemination of information, and to pro25 vide technical guidance, to entities seeking to comply with 
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1 regulations of the Secretary relating to the production of 

2 biologic materials, particularly influenza vaccine. 

3 ‘‘(b) TECHNICAL ASSISTANCE GRANTS.— 

4 ‘‘(1) IN GENERAL.—The Secretary, in consulta5 tion with the Commissioner, shall award technical 

6 assistance grants to entities seeking to— 

7 ‘‘(A) enter the United States influenza vac8 cine market; 

9 ‘‘(B) expand their vaccine production ca10 pacity for the United States influenza vaccine 

11 market; or 

12 ‘‘(C) improve their ability to remain within 

13 the United States influenza vaccine market. 

14 ‘‘(2) ACTIVITIES.—Amounts awarded under 

15 grants under paragraph (1) shall be used for one or 

16 more of the following activities: 

17 ‘‘(A) Establishing or making capital im18 provements in technology, machinery, or pro19 duction capacity to vaccine manufacturing fa20 cilities located within the United States to en21 able such facilities to comply with the regula22 tions of the Food and Drug Administration. 

23 ‘‘(B) The training of employees of United 

24 States-based vaccine manufacturing facilities in 

25 vaccine production methods. 
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1 ‘‘(C) Any other activities approved by the 

2 Commissioner as assisting with the goal of in3 creasing manufacturer participation in the vac4 cine market and improving domestically-based 

5 vaccine manufacturing capacity. 

6 ‘‘(c) PROVISIONS RELATED TO THE EMERGENCY AC7 QUISITION OF VACCINES.— 

8 ‘‘(1) INCREASED COMMUNICATION.—The Food 

9 and Drug Administration shall carry out activities to 

10 increase communication between the agency and the 

11 scientific community regarding vaccine development 

12 and regulation, including participation in con13 ferences on the science related to infectious diseases, 

14 influenza, biologic manufacturing, and other issues 

15 as determined appropriate by the Director of the 

16 Center for Biologics Evaluation and Research. 

17 ‘‘(2) REGULATORY ROADMAP.—The Commis18 sioner, in consultation with the Director of the Cen19 ters for Disease Control and Prevention, the Sec20 retary, and other agencies or participants as deter21 mined appropriate by the Secretary, shall develop a 

22 regulatory roadmap to address the following issues 

23 surrounding emergency use authorization of influ24 enza vaccine, as determined by the Secretary during 

25 a public health emergency involving an actual or im-
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1 minent outbreak of naturally occurring or engi2 neered seasonal influenza: 

3 ‘‘(A) Policies for the emergency use au4 thorization of influenza vaccine that is produced 

5 and sold in other countries so that such vaccine 

6 may be imported into the United States by the 

7 United States government during a vaccine 

8 shortage. 

9 ‘‘(B) Policies for the facilitation of the dis10 tribution of any such vaccine imported into the 

11 United States during a vaccine shortage, in12 cluding the interstate transportation, allocation 

13 and equitable distribution of vaccine among 

14 high priority populations (as defined by the Ad15 visory Committee on Immunization Practices 

16 and the Centers for Disease Control and Pre17 vention) during an emergency use situation. 

18 ‘‘(C) Policies for the communication and 

19 coordination of a response to an emergency use 

20 authorization with State and local health de21 partments, including guidelines for notification 

22 of such entities in such situations. 

23 ‘‘(D) Policies for the emergency use au24 thorization of vaccines that are in clinical devel25 opment in both the United States and other 
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1 countries, including clarification of IND proto2 cols for such vaccines, particularly those using 

3 new vaccine development technologies. 

4 ‘‘(3) CONSULTATION.—In developing the road5 map under paragraph (2), the Commissioner shall 

6 solicit input from private and nonprofit stakeholders, 

7 including State and local health officials, and such 

8 input shall include recommendations for developing 

9 emergency use authorization guidelines that main10 tain the scientific and regulatory standards of the 

11 Food and Drug Administration. 

12 ‘‘(4) STANDING ORDERS.— 

13 ‘‘(A) DEVELOPMENT.—The Secretary shall 

14 direct the Centers for Disease Control and Pre15 vention, in conjunction with State and local 

16 health departments and representatives of State 

17 medical boards and nursing examiners, to de18 velop and publish a model standing order that 

19 will, at a minimum, address the need for stand20 ing orders to administer influenza vaccine in 

21 hospitals, nursing homes, and by home health 

22 care providers. The Centers for Disease Control 

23 and Prevention is encouraged to expand such a 

24 model standing order to take into account— 
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1 ‘‘(i) the administration of other Medi2 care covered vaccines; and 

3 ‘‘(ii) the delivery of influenza vaccine 

4 to patients in children’s hospitals or other 

5 institutions serving the long-term care 

6 needs of a pediatric population. 

7 ‘‘(B) IMPLEMENTATION.—Not less than 1 

8 year after the publication of the standing order 

9 under paragraph (A), States shall be required 

10 to implement such standing order in order to be 

11 eligible to receive grants under this Act. 

12 ‘‘(C) RULE OF CONSTRUCTION.—Nothing 

13 in this paragraph shall be construed as pre14 cluding the application of State laws, so long as 

15 such laws don not restrict the implementation 

16 of this requirements of the Influenza Vaccine 

17 Security Act of 2005 (and the amendments 

18 made by such Act). 

19 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.— 

20 ‘‘(1) IN GENERAL.—There are authorized to be 

21 appropriated to carry out this section, $75,000,000 

22 for each of fiscal years 2007 through 2011. 

23 ‘‘(2) USE OF FUNDS.—The Secretary shall en24 sure that $5,000,000 of the amount appropriated 

25 under paragraph (1) for fiscal year 2007, and such 
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1 sums as may be necessary for each of fiscal years 

2 2008 through 2011, shall be made available for the 

3 purpose of increasing the ability of the Food and 

4 Drug Administration to provide the technical assist5 ance and take advantage of the training opportuni6 ties as designated in this section.’’. 

7 TITLE III—VACCINE DEVELOP8 MENT RESEARCH AND CO9 ORDINATION 

10 SEC. 301. INCREASED FUNDING FOR NEW AND EXISTING 

11 VACCINE DEVELOPMENT RESEARCH. 

12 Subpart 6 of part C of title IV of the Public Health 

13 Service Act (42 U.S.C. 285f et seq.) is amended by adding 

14 at the end the following: 

15 ‘‘SEC. 447C. INCREASED FUNDING FOR NEW AND EXISTING 

16 VACCINE DEVELOPMENT RESEARCH. 

17 ‘‘(a) NEW RESEARCH.— 

18 ‘‘(1) SOLICITATION OF PROPOSALS.—The Insti19 tute shall solicit proposals for research into improved 

20 technologies for influenza vaccine development, in21 cluding a permanent influenza vaccine. The Sec22 retary, acting through the Director of the Institute 

23 may award grants to fund such proposals. 

24 ‘‘(2) PRIORITY.—In funding proposals sub25 mitted under paragraph (1), the Institute shall give 
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1 priority to proposals for research that contributes to 

2 the goal of providing marketable influenza vaccine 

3 alternatives within the 10-year period after the date 

4 of enactment of this section. 

5 ‘‘(b) EXISTING RESEARCH.— 

6 ‘‘(1) IN GENERAL.—The Director of the Insti7 tute, acting jointly with the Director of Intramural 

8 Research at the Institute and the Scientific Director 

9 of the Vaccine Research Program at the Institute, 

10 and in consultation with any other officials deter11 mined appropriate by the Director, shall review vac12 cine development research that is being conducted 

13 under grants awarded by the Institute to identify re14 search that could provide the United States with im15 proved technologies for vaccine production that could 

16 be marketed within the United States within the 10- 

17 year period beginning on the date of enactment of 

18 this section. 

19 ‘‘(2) SUPPLEMENTARY FUNDING.—The Direc20 tor of the Institute shall provide supplementary 

21 grant funding to the research identified under para22 graph (1) that the Director determines could result 

23 in the production described in such paragraph. 

24 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

25 There is authorized to be appropriated to carry out 
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1 this section, $100,000,000 for each of fiscal years 

2 2007 through 2011.’’. 

3 SEC. 302. AUTHORITY OF THE NATIONAL IMMUNIZATION 

4 PROGRAM FOR COORDINATION OF, EDU5 CATION, OUTREACH, AND COMMUNICATION 

6 ACROSS HHS. 

7 Section 2102 of the Public Health Service Act (42 

8 U.S.C. 300aa–2) is amended— 

9 (1) in subsection (a), by adding at the end the 

10 following: 

11 ‘‘(10) COORDINATION OF SUPPORT.—The Di12 rector of the Program shall— 

13 ‘‘(A) coordinate education, outreach, and 

14 communication efforts in regard to all influenza 

15 vaccine research activities within the Depart16 ment in support of the goal of— 

17 ‘‘(i) increasing overall influenza vac18 cination rates in the United States, par19 ticularly those of high priority populations 

20 (as defined by the Advisory Committee on 

21 Immunization Practices and the Centers 

22 for Disease Control and Prevention) and 

23 health care providers, 

24 ‘‘(ii) ensuring that safe and effective 

25 marketable vaccines produced with im-
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1 proved technologies that supplement the 

2 current egg-based system of production 

3 shall be available within the 10-year period 

4 after the enactment of this paragraph; and 

5 ‘‘(iii) any other vaccine promotion ac6 tivities as directed by the Secretary; 

7 ‘‘(B) coordinate educational efforts under 

8 this paragraph with the National Vaccine Pro9 gram Office, State and local health depart10 ments, the National Institutes of Health, and 

11 all other relevant Federal and other entities as 

12 designated by the Director; and 

13 ‘‘(C) provide an annual report to Congress 

14 on the progress being made toward the goals 

15 described in subparagraph (A).’’; and 

16 (2) by adding at the end the following: 

17 ‘‘(c) APPROPRIATIONS FOR COORDINATION OF IN18 FLUENZA VACCINE OUTREACH ACTIVITIES.—There is au19 thorized to be appropriated to carry out activities under 

20 subsection (a)(10), $2,000,000 for each of fiscal years 

21 2007 through 2011.’’. 
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1 TITLE IV—INCREASED INFLU2 ENZA VACCINE AND OUT3 BREAK SURVEILLANCE AC4 TIVITIES 

5 SEC. 401. TRACKING NETWORK AND DEMONSTRATION 

6 GRANTS. 

7 Title III of the Public Health Service Act is amended 

8 by inserting after section 319B (42 U.S.C. 247d–2) the 

9 following: 

10 ‘‘SEC. 319B–1. TRACKING NETWORK AND DEMONSTRATION 

11 GRANTS. 

12 ‘‘(a) TRACKING SYSTEM.— 

13 ‘‘(1) ESTABLISHMENT.—Not later than 2 years 

14 after the date of enactment of this section, the Di15 rector of the Centers for Disease Control and Pre16 vention, in conjunction with State and local public 

17 health officials, shall establish an electronic tracking 

18 system through which the Director and such officials 

19 can determine the amount of influenza vaccine that 

20 is available for distribution to patients, as well as 

21 the need for such vaccine on a county-by-county 

22 basis, and the progress of vaccine delivery and dis23 tribution efforts at the State and local level. 

24 ‘‘(2) ESTIMATES.—The tracking system estab25 lished under paragraph (1) shall collect estimates of 
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1 the size of high priority populations (as defined by 

2 the Advisory Committee on Immunization Practices 

3 and the Centers for Disease Control and Prevention) 

4 (referred to in this section as ‘high priority popu5 lations’) in each county in the United States, so as 

6 to better determine where influenza vaccine re7 sources may need to be directed in the case of an 

8 emergency. 

9 ‘‘(3) PROVISION OF INFORMATION.—To be eli10 gible to participate in buyback programs the vaccine 

11 manufacturer shall provide information to the track12 ing system as the Director of the Centers for Dis13 ease Control and Prevention determines appropriate 

14 in accordance with subtitle 3 of title XXI. 

15 ‘‘(4) DATABASE.—In consultation with manu16 facturers, distributors, wholesalers, and State and 

17 local health departments, the Secretary shall develop 

18 guidelines for the development and use of a database 

19 in order to maintain confidentiality and ensure that 

20 none of the information provided under paragraph 

21 (3) and contained in the database can be used to 

22 provide a proprietary advantage within the vaccine 

23 market while allowing State and local health officials 

24 such information to maximize the delivery and avail25 ability of vaccines to high priority populations. 
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1 ‘‘(b) EXPANSION OF CURRENT SYSTEMS AND ACTIVI2 TIES.— 

3 ‘‘(1) SURVEILLANCE SYSTEM.—Not later than 

4 4 years after the date of enactment of this section, 

5 the Director of the Centers for Disease Control and 

6 Prevention shall upgrade the influenza surveillance 

7 system of the Centers for Disease Control and Pre8 vention to report influenza data from State and local 

9 health departments into the tracking system estab10 lished under subsection (a)(1). 

11 ‘‘(2) EDUCATIONAL MATERIALS.—The tracking 

12 system shall contain information to assist users in 

13 accessing influenza education, outreach, and commu14 nications tools, such as those developed and financed 

15 under the Influenza Vaccine Security Act of 2005 

16 (and the amendments made by such Act). 

17 ‘‘(3) EMERGENCY PROVIDER DATABASE.—The 

18 Director of the Centers for Disease Control and Pre19 vention shall coordinate access to, in conjunction 

20 with State and local health departments and State 

21 licensing boards for health professionals, a database 

22 registry of medical personnel who can provide serv23 ices in the event of a health emergency, including 

24 pandemic influenza or an influenza vaccine shortage. 
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1 Such information shall be made available through 

2 the tracking network. 

3 ‘‘(c) DEMONSTRATION GRANTS.— 

4 ‘‘(1) IN GENERAL.—The Director of the Cen5 ters for Disease Control and Prevention shall award 

6 demonstration grants to State and local health de7 partments to enable such departments to enter into 

8 contract with hospitals, community health centers, 

9 long-term care facilities, physicians’ offices, and 

10 health care facilities operated or funded by such de11 partments to assist such entities in upgrading their 

12 information technology, infrastructure, and work13 force in a manner that will allow such entities to im14 prove their ability to report and track influenza vac15 cine dissemination. 

16 ‘‘(2) PRIORITY.—In awarding grants under 

17 paragraph (1), priority shall be given to entities that 

18 serve high priority populations in medically under19 served areas. 

20 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

21 are authorized to be appropriated— 

22 ‘‘(1) to carry out subsection (a), $100,000,000 

23 for each of fiscal years 2007 through 2011, of which 

24 $500,000 for each fiscal year shall be made available 

25 to implement subsection (b)(3); and 
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1 ‘‘(2) to carry out subsection (c), $100,000,000 

2 for each of fiscal years 2007 through 2011.’’. 

3 TITLE V—FLU VACCINE 

4 OUTREACH AND EDUCATION 

5 SEC. 501. EDUCATIONAL EFFORTS AND GRANTS. 

6 Title III of the Public Health Service Act is amended 

7 by inserting after section 319B–1 (as added by section 

8 401) the following: 

9 ‘‘SEC. 319B–2. IMMUNIZATION EDUCATIONAL EFFORTS AND 

10 GRANTS. 

11 ‘‘(a) IN GENERAL.—The Director of the Centers for 

12 Disease Control and Prevention, in conjunction with State 

13 and local health departments, shall revise and expand the 

14 influenza-related educational materials to the Centers for 

15 Disease Control and Prevention, and facilitate the use of 

16 such materials by health care providers and patients. The 

17 Director is authorized to coordinate such educational ef18 forts with nonprofit provider and patient advocacy groups. 

19 ‘‘(b) INFLUENZA VACCINE EDUCATION AND OUT20 REACH.— 

21 ‘‘(1) IN GENERAL.—In order to achieve an opti22 mal balance in the influenza vaccine market, and to 

23 ensure that the recommendations of the Advisory 

24 Committee on Immunization Practices to the Cen25 ters for Disease Control and Prevention for vaccine 
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1 administration are carried out to the maximum ex2 tent possible, the Director of the Centers for Disease 

3 Control and Prevention, in conjunction with State 

4 and local health departments, shall carry out influ5 enza immunization education and outreach activities 

6 that target physicians and other health care pro7 viders, health insurance providers, health care insti8 tutions and patients, particularly those in high pri9 ority populations (as defined by the Advisory Com10 mittee on Immunization Practices and the Centers 

11 for Disease Control and Prevention) (referred to in 

12 this section as ‘high priority populations’). 

13 ‘‘(2) TYPES OF ACTIVITIES.—The education 

14 and outreach activities under paragraph (1) shall in15 clude— 

16 ‘‘(A) activities to encourage voluntary par17 ticipation in influenza vaccination programs, 

18 with the goal of increasing overall influenza 

19 vaccination rates in the United States, achiev20 ing full influenza vaccination of all high priority 

21 populations, and full use of each season’s influ22 enza vaccine supply; 

23 ‘‘(B) the provision of information on influ24 enza prevention; 
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1 ‘‘(C) activities to increase the number of 

2 healthcare providers who receive influenza vac3 cines each year; and 

4 ‘‘(D) other influenza educational efforts 

5 determined appropriate by the Director. 

6 ‘‘(c) GRANTS.—The Director of the Centers for Dis7 ease Control and Prevention may award grants to State 

8 and local health departments to carry out activities to en9 courage individuals, particularly those from high priority 

10 populations, to seek out influenza vaccinations. 

11 ‘‘(d) COLLABORATION.—State and local health de12 partments that receive grants under subsection (b) are en13 couraged to collaborate on projects with physicians and 

14 other health care providers, health insurance providers, 

15 health care institutions, and groups representing high pri16 ority populations. 

17 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—In ad18 dition to any amounts otherwise available through the Sec19 retary for influenza outreach and education, there is au20 thorized to be appropriated to carry out this section, 

21 $10,000,000 for each of fiscal years 2007 through 2011.’’. 
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1 TITLE VI—COMPENSATION 

2 SEC. 601. COMPENSATION. 

3 Section 224 of the Public Health Service Act (42 

4 U.S.C. 233) is amended by adding at the end the fol5 lowing: 

6 ‘‘(q) MANUFACTURE, ADMINISTRATION, AND USE OF

7 PANDEMIC INFLUENZA TECHNOLOGIES.— 

8 ‘‘(1) DEFINITIONS.—In this subsection: 

9 ‘‘(A) COVERED PERSON.—The term ‘cov10 ered person’ means— 

11 ‘‘(i) a manufacturer of a qualified 

12 pandemic influenza technology; 

13 ‘‘(ii) a distributor of a qualified pan14 demic influenza technology; 

15 ‘‘(iii) a hospital, clinic, and other 

16 healthcare entity under whose auspices a 

17 qualified pandemic influenza technology is 

18 administered; 

19 ‘‘(iv) a licensed health care profes20 sional or other individual authorized to ad21 minister a qualified pandemic influenza 

22 technology under State law; and 

23 ‘‘(v) any official, agent, or employee of 

24 any of the entities described in clauses (i) 

25 through (iv), or of a State or locally ad-
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1 ministered health plan, or a volunteer act2 ing under a publicly funded health pro3 gram, who is acting within the scope of his 

4 or her agency or employment. 

5 ‘‘(B) PANDEMIC INFLUENZA TECH6 NOLOGY.—The term ‘pandemic influenza tech7 nology’ means any vaccine product developed or 

8 procured for the specific purpose of preventing 

9 or treating pandemic influenza or any vaccine 

10 product limiting the harm such pandemic might 

11 otherwise cause. 

12 ‘‘(C) QUALIFIED PANDEMIC INFLUENZA

13 TECHNOLOGY.—The term ‘qualified pandemic 

14 influenza technology’ means a pandemic influ15 enza technology that has been designated by the 

16 Secretary in accordance with paragraph (2). 

17 ‘‘(2) DESIGNATION BY SECRETARY.— 

18 ‘‘(A) IN GENERAL.—The Secretary may 

19 designate a pandemic influenza technology as a 

20 qualified pandemic influenza technology if the 

21 Secretary determines that there is a public 

22 health emergency involving an actual or immi23 nent outbreak of naturally occurring or engi24 neered pandemic influenza and requiring the 
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1 manufacture, distribution, and administration 

2 of pandemic influenza technology. 

3 ‘‘(B) RECOMMENDED DESIGNATION.—A 

4 person may recommend to the Secretary at any 

5 time the designation of a technology under sub6 paragraph (A) and may provide data and infor7 mation to support such recommendation. 

8 ‘‘(C) EFFECTIVE PERIOD.—The Secretary 

9 shall specify in a designation under this para10 graph the beginning and ending dates of the ef11 fective period of such designation, and may sub12 sequently amend such designation to shorten or 

13 extend such effective period. 

14 ‘‘(D) PUBLICATION.—The Secretary shall 

15 provide for the publication of each designation 

16 under this paragraph, and each amendment 

17 thereto, in the Federal Register. Such designa18 tion or amendment shall take effect imme19 diately upon such publication and shall not be 

20 subject to the provisions of section 553 of title 

21 5, United States Code, concerning prior notice 

22 and opportunity for comment. 

23 ‘‘(E) VACCINE INJURY COMPENSATION

24 PROGRAM.—Nothing in this Act shall be con25 strued to supersede the authority of the Vaccine 
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1 Injury Compensation Program in regards to 

2 vaccine products on the table, such as trivalent 

3 influenza vaccine. 

4 ‘‘(3) LIABILITY OF UNITED STATES.— 

5 ‘‘(A) IN GENERAL.—For purposes of this 

6 section, a covered person shall be deemed to be 

7 an employee of the Public Health Service with 

8 respect to liability for personal injury or death 

9 arising out of the manufacture, administration, 

10 or use of a qualified pandemic influenza tech11 nology. The liability of the United States under 

12 this subsection shall be as set forth in section 

13 1346(b) and chapter 171 of title 28, United 

14 States Code, except— 

15 ‘‘(i) as otherwise provided in this sec16 tion; and 

17 ‘‘(ii) that the liability of the United 

18 States may be based on any cause of ac19 tion seeking compensation for harm alleg20 edly arising out of the manufacture, ad21 ministration, or use of a qualified pan22 demic influenza technology, regardless of 

23 whether such cause of action is alleged as 

24 negligence, strict liability in tort, breach of 

25 warranty, failure to warn, or other action. 
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1 ‘‘(B) SCOPE.—For purposes of this sec2 tion, any activity reasonably related to the man3 ufacture, distribution, or administration of a 

4 qualified pandemic influenza technology shall be 

5 considered to be a medical, surgical, dental, or 

6 related function within the scope of the covered 

7 person’s employment by the Public Health 

8 Service. 

9 ‘‘(C) GOVERNING LAW.—Notwithstanding 

10 the provisions of section 1346(b)(1) and chap11 ter 171 of title 28, United States Code, as they 

12 relate to governing law, the liability of the 

13 United States as provided in this subsection 

14 shall be in accordance with the law of the place 

15 of injury. 

16 ‘‘(D) MILITARY PERSONNEL AND UNITED

17 STATES CITIZENS OVERSEES.— 

18 ‘‘(i) MILITARY PERSONNEL.—The li19 ability of the United States as provided in 

20 this subsection shall extend to claims 

21 brought by United States military per22 sonnel. 

23 ‘‘(ii) CLAIMS ARISING IN A FOREIGN

24 COUNTRY.—Notwithstanding the provisions 

25 of section 2680(k) of title 28, United 
29 

•S 1828 IS

1 States Code, the liability of the United 

2 States as provided in this subsection shall 

3 extend to claims based on injuries arising 

4 in a foreign country where the injured 

5 party is a member of the United States 

6 military, is the spouse or child of a mem7 ber of the United States military, or is a 

8 United States citizen. 

9 ‘‘(iii) GOVERNING LAW.—With regard 

10 to all claims brought under clause (ii), and 

11 notwithstanding the provisions of section 

12 1346(b)(1) and chapter 171 of title 28, 

13 United States Code, and of subparagraph 

14 (C), as they relate to governing law, the li15 ability of the United States as provided in 

16 this subsection shall be in accordance with 

17 the law of the claimant’s domicile in the 

18 United States or most recent domicile 

19 within the United States. 

20 ‘‘(4) EXCLUSIVITY OF REMEDY.—The remedy 

21 provided for by this section shall be exclusive of any 

22 other civil action or proceeding against a covered 

23 person, for personal injury or death arising out of 

24 the manufacture, administration, or use of a quali-
30 

•S 1828 IS

1 fied pandemic influenza technology during the effec2 tive period of the designation under paragraph (2). 

3 ‘‘(5) COVERED PERSON TO COOPERATE WITH

4 UNITED STATES.— 

5 ‘‘(A) IN GENERAL.—A covered person shall 

6 cooperate with the United States in the proc7 essing and defense of a claim or action under 

8 this subsection based upon the acts or omis9 sions of such person. 

10 ‘‘(B) CONSEQUENCES OF FAILURE TO CO11 OPERATE.—Upon the motion of the United 

12 States or any other party and upon a finding 

13 that a covered person has failed to cooperate 

14 with the United States as provided for in sub15 paragraph (A)— 

16 ‘‘(i) the court shall substitute such 

17 person as the party defendant in place of 

18 the United States and, upon motion, shall 

19 remand any such suit to the court in which 

20 it was instituted if it appears that the 

21 court lacks subject matter jurisdiction; 

22 ‘‘(ii) the United States shall not be 

23 liable based on the acts or omissions of 

24 such person; and 
31 

•S 1828 IS

1 ‘‘(iii) the Attorney General shall not 

2 be obligated to defend such action. 

3 ‘‘(6) RECOURSE AGAINST COVERED PERSONS IN

4 CASE OF GROSS MISCONDUCT OR MATERIAL BREACH

5 OF CONTRACT.— 

6 ‘‘(A) IN GENERAL.—If payment is made by 

7 the United States to any claimant bringing a 

8 claim against a covered person under this sub9 section, either by way of administrative deter10 mination, settlement, or court judgment, the 

11 United States shall have, notwithstanding any 

12 provision of State law, the right to recover for 

13 that portion of the damages so awarded or paid, 

14 as well as interest and any costs of litigation, 

15 resulting from— 

16 ‘‘(i) such covered person’s intentional 

17 breach of a procurement contract, so long 

18 as such breach was materially related to 

19 the injury that is the subject of the claim, 

20 or 

21 ‘‘(ii) any grossly negligent or reckless 

22 conduct, or willful misconduct, on the part 

23 of such covered person, so long as such 

24 conduct or misconduct was materially re-
32 

•S 1828 IS

1 lated to the injury that is the subject to 

2 the claim. 

3 ‘‘(B) ACTION BY THE UNITED STATES.— 

4 The United States may maintain an action 

5 under this paragraph against a covered person 

6 described in subparagraph (A) in the district 

7 court of the United States in which such person 

8 resides or has its principal place of business.’’. 

Æ