II 

109TH CONGRESS 

1ST SESSION S. 1821 

To amend the Public Health Service Act with respect to preparation for 

an influenza pandemic, including an avian influenza pandemic, and for 

other purposes. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 5, 2005 

Mr. REID (for himself, Mr. OBAMA, Mr. BAYH, Mr. KENNEDY, Mr. HARKIN, 

Mr. DURBIN, Mr. REED, Mr. DODD, Mrs. MURRAY, Ms. MIKULSKI, Mrs. 

CLINTON, Mr. KOHL, and Mr. DAYTON) 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 with respect to 

preparation for an influenza pandemic, including an 

avian influenza pandemic, and for other purposes. 

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 ‘‘Pandemic Prepared5 ness and Response Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 
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1 (1) The Department of Health and Human 

2 Services reports that an influenza pandemic has a 

3 greater potential to cause rapid increases in death 

4 and illness than virtually any other natural health 

5 threat. 

6 (2) Three pandemics occurred during the 20th 

7 century: the Spanish flu pandemic in 1918, the 

8 Asian flu pandemic in 1957, and the Hong Kong flu 

9 pandemic in 1968. The Spanish flu pandemic was 

10 the most severe, causing over 500,000 deaths in the 

11 United States and more than 20,000,000 deaths 

12 worldwide. 

13 (3) The Centers for Disease Control and Pre14 vention has estimated conservatively that up to 

15 207,000 Americans would die, and up to 734,000 

16 would be hospitalized, during the next pandemic. 

17 The costs of the pandemic, including the total direct 

18 costs associated with medical care and indirect costs 

19 of lost productivity and death, are estimated at be20 tween $71,000,000,000 and $166,500,000,000. 

21 These costs do not include the economic effects of 

22 pandemic on commerce and society. 

23 (4) Recent studies suggest that avian influenza 

24 strains, which are endemic in wild birds and poultry 

25 populations in some countries, are becoming increas-
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1 ingly capable of causing severe disease in humans 

2 and are likely to cause the next pandemic flu. 

3 (5) In 2004, 8 nations—Thailand, Vietnam, In4 donesia, Japan, Laos, China, Cambodia, and the Re5 public of Korea—experienced outbreaks of avian flu 

6 (H5N1) among poultry flocks. Cases of human in7 fections were confirmed in Thailand, Cambodia, In8 donesia, and Vietnam (including a possible human9 to-human infection in Thailand). 

10 (6) As of September 29, 2005, 116 confirmed 

11 human cases of avian influenza (H5N1) have been 

12 reported, 60 of which resulted in death. Of these 

13 cases, 91 were in Vietnam, 17 in Thailand, 4 in 

14 Cambodia, and 4 in Indonesia. 

15 (7) On February 21, 2005, Dr. Julie 

16 Gerberding, Director of the Centers for Disease 

17 Control and Prevention, stated that ‘‘this is a very 

18 ominous situation for the globe . . . the most impor19 tant threat we are facing right now.’’. 

20 (8) On February 23, 2005, Dr. Shigeru Omi, 

21 Asia regional director of the World Health Organiza22 tion (WHO), stated with respect to the avian flu, 

23 ‘‘We at WHO believe that the world is now in the 

24 gravest possible danger of a pandemic.’’. 
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1 (9) The best defense against influenza 

2 pandemics is a heightened global surveillance sys3 tem. In many of the nations where avian flu (H5N1) 

4 has become endemic the early detection capabilities 

5 are severely lacking, as is the transparency in the 

6 health systems. 

7 (10) In addition to surveillance, pandemic pre8 paredness requires domestic and international co9 ordination and cooperation to ensure an adequate 

10 medical response, including communication and in11 formation networks, public health measures to pre12 vent spread, use of vaccination and antivirals, provi13 sion of health outpatient and inpatient services, and 

14 maintenance of core public functions. 

15 SEC. 3. AMENDMENTS TO THE PUBLIC HEALTH SERVICE 

16 ACT. 

17 Title XXI of the Public Health Service Act (42 

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

19 the following: 

20 ‘‘Subtitle 3—Pandemic Influenza 

21 Preparedness 

22 ‘‘SEC. 2141. DEFINITION. 

23 ‘‘For purposes of this subtitle, the term ‘State’ shall 

24 have the meaning given such term in section 2(f) and shall 

25 include Indian tribes and tribal organizations (as defined 
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1 in section 4(b) and 4(c) of the Indian Self-Determination 

2 and Education Assistance Act). 

3 ‘‘SEC. 2142. NATIONAL DIRECTOR OF PANDEMIC PRE4 PAREDNESS AND RESPONSE. 

5 ‘‘(a) APPOINTMENT.—The President shall appoint an 

6 individual to serve as the National Director of Pandemic 

7 Preparedness and Response (referred to in this section as 

8 the ‘Director’) within the Executive Office of the Presi9 dent. 

10 ‘‘(b) RESPONSIBILITIES.—The Director shall— 

11 ‘‘(1) serve as the chairperson of the Pandemic 

12 Influenza Preparedness Policy Coordinating Com13 mittee (as described in section 2143); 

14 ‘‘(2) coordinate the Federal interagency prepa15 ration for a pandemic; 

16 ‘‘(3) coordinate the Federal interagency re17 sponse to a pandemic; 

18 ‘‘(4) oversee approval of State pandemic plans 

19 to ensure nationwide preparedness standards and re20 gional coordination as provided for under section 

21 2144(b)(3); 

22 ‘‘(5) ensure coordination between the govern23 mental and non-governmental economic and finance 

24 infrastructure as it relates to pandemic preparedness 

25 and response; 
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1 ‘‘(6) as soon as practicable, finalize a National 

2 Pandemic Influenza Preparedness Plan that de3 scribes programs and activities to decrease the bur4 den of disease, minimize social disruption, and re5 duce economic impact from an influenza pandemic; 

6 ‘‘(7) implement the National Pandemic Influ7 enza Preparedness Plan; 

8 ‘‘(8) make the National Pandemic Influenza 

9 Preparedness Plan available to Congress, and the 

10 public as appropriate; 

11 ‘‘(9) submit to Congress an annual budget re12 quest related to the National Pandemic Influenza 

13 Preparedness Plan; 

14 ‘‘(10) report to Congress on a biannual basis 

15 progress regarding the implementation of the Na16 tional Pandemic Influenza Preparedness Plan; 

17 ‘‘(11) address any deficiencies in the National 

18 Pandemic Influenza Preparedness Plan as deter19 mined by the Government Accountability Office re20 port under subsection (c); 

21 ‘‘(12) coordinate the provision of technical as22 sistance related to pandemic preparedness across 

23 Federal agencies, States, and local governments; 
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1 ‘‘(13) ensure outreach and education campaigns 

2 are conducted related to preparedness for busi3 nesses, health care providers, and the public; 

4 ‘‘(14) address supply chain issues related to a 

5 pandemic; 

6 ‘‘(15) ensure that the National Pandemic Influ7 enza Preparedness Plan includes a specific focus on 

8 traditionally underserved populations, including low9 income, racial and ethnic minorities, immigrants, 

10 and uninsured populations; and 

11 ‘‘(16) hire staff, request information, assist12 ance, or detailees from other Federal agencies, and 

13 carry out other activities related to staffing and ad14 ministration. 

15 ‘‘(c) GAO REPORT.— 

16 ‘‘(1) IN GENERAL.—Not later than 60 days 

17 after the Director has finalized the National Pan18 demic Influenza Preparedness Plan under subsection 

19 (b)(5), the Government Accountability Office shall 

20 submit to the Director and Congress a report con21 cerning the National Pandemic Influenza Prepared22 ness Plan. 

23 ‘‘(2) REQUIREMENTS.—At a minimum, the re24 port under paragraph (1) shall evaluate the ability 
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1 of the National Pandemic Influenza Preparedness 

2 Plan to— 

3 ‘‘(A) address the organizational structure 

4 and chain of command, both in the Federal 

5 government and at the State level; 

6 ‘‘(B) ensure adequate laboratory surveil7 lance of influenza, including the ability to iso8 late and subtype influenza viruses year round; 

9 ‘‘(C) improve vaccine research, develop10 ment, and production; 

11 ‘‘(D) procure adequate doses of antivirals 

12 for treatment. 

13 ‘‘(E) develop systems for tracking and dis14 tributing antiviral medication and vaccines; 

15 ‘‘(F) prioritize who would receive antivirals 

16 and vaccines based on limited supplies; 

17 ‘‘(G) stockpile medical and safety equip18 ment for health care workers and first respond19 ers; 

20 ‘‘(H) assure surge capacity capabilities for 

21 health care providers and institutions; 

22 ‘‘(I) secure a backup health care workforce 

23 in the event of a pandemic; 

24 ‘‘(J) ensure the availability of food, water, 

25 and other essential items during a pandemic; 
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1 ‘‘(K) provide guidance on needed State and 

2 local authority to implement public health 

3 measures such as isolation or quarantine; 

4 ‘‘(L) maintain core public functions, in5 cluding public utilities, refuse disposal, mor6 tuary services, transportation, police and fire7 fighter services, and other critical services; 

8 ‘‘(M) establish networks that provide alerts 

9 and other information for health care providers; 

10 ‘‘(N) communicate with the public with re11 spect to prevention and obtaining care during a 

12 pandemic; and 

13 ‘‘(O) provide security for first responders 

14 and other medical personnel and volunteers, 

15 hospitals, treatment centers, isolation and quar16 antine areas, and transportation and delivery of 

17 resources. 

18 ‘‘SEC. 2143. POLICY COORDINATING COMMITTEE ON PAN19 DEMIC INFLUENZA PREPAREDNESS. 

20 ‘‘(a) IN GENERAL.—There is established the Pan21 demic Influenza Preparedness Policy Coordinating Com22 mittee (referred to in this section as the ‘Committee’). 

23 ‘‘(b) MEMBERSHIP.— 

24 ‘‘(1) IN GENERAL.—The Committee shall be 

25 composed of— 
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1 ‘‘(1) IN GENERAL.—The Committee shall be 

2 composed of— 

3 ‘‘(A) the Secretary; 

4 ‘‘(B) the Secretary of Homeland Security; 

5 ‘‘(C) the Secretary of Agriculture; 

6 ‘‘(D) the Secretary of State; 

7 ‘‘(E) the Secretary of Defense; 

8 ‘‘(F) the Secretary of Commerce; 

9 ‘‘(G) the Administrator of the Environ10 mental Protection Agency; 

11 ‘‘(H) the Secretary of Transportation; 

12 ‘‘(I) the Secretary of Veterans Affairs; and 

13 ‘‘(J) other representatives as determined 

14 appropriate by the Chair of the Committee. 

15 ‘‘(2) CHAIR.—The Director of Pandemic Pre16 paredness and Response shall serve as the Chair of 

17 the Committee. 

18 ‘‘(3) TERM.—The members of the Committee 

19 shall serve for the life of the Committee. 

20 ‘‘(c) MEETINGS.— 

21 ‘‘(1) IN GENERAL.—The Committee shall meet 

22 not less often than 2 times per year at the call of 

23 the Chair or as determined necessary by the Presi24 dent. 
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1 ‘‘(2) REPRESENTATION.—A member of the 

2 Committee under subsection (b) may designate a 

3 representative to participate in Committee meetings, 

4 but such representative shall hold the position of at 

5 least an assistant secretary or equivalent position. 

6 ‘‘(d) DUTIES OF THE COMMITTEE.— 

7 ‘‘(1) PREPAREDNESS PLANS.—Each member of 

8 the Committee shall submit to the Committee a pan9 demic influenza preparedness plan for the agency in10 volved that describes— 

11 ‘‘(A) initiatives and proposals by such 

12 member to address pandemic influenza (includ13 ing avian influenza) preparedness; and 

14 ‘‘(B) any activities and coordination with 

15 international entities related to such initiatives 

16 and proposals. 

17 ‘‘(2) INTERAGENCY PLAN AND RECOMMENDA18 TIONS.— 

19 ‘‘(A) IN GENERAL.— 

20 ‘‘(i) PREPAREDNESS PLAN.—Based on 

21 the preparedness plans described under 

22 paragraph (1), and not later than 90 days 

23 after the date of enactment of this subtitle, 

24 the Committee shall develop an Inter-
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1 agency Preparedness Plan that integrates 

2 and coordinates such preparedness plans. 

3 ‘‘(ii) CONTENT OF PLAN.—The Inter4 agency Preparedness Plan under clause (i) 

5 shall include a description of— 

6 ‘‘(I) departmental or agency re7 sponsibility and accountability for 

8 each component of such plan; 

9 ‘‘(II) funding requirements and 

10 sources; 

11 ‘‘(III) international collaboration 

12 and coordination efforts; and 

13 ‘‘(IV) recommendations and a 

14 timeline for implementation of such 

15 plan. 

16 ‘‘(B) REPORT.— 

17 ‘‘(i) IN GENERAL.—The Committee 

18 shall submit to the President and Con19 gress, and make available to the public as 

20 appropriate, a report that includes the 

21 Interagency Preparedness Plan. 

22 ‘‘(ii) UPDATED REPORT.—The Com23 mittee shall submit to the President and 

24 Congress, and make available to the public 

25 as appropriate, on a biannual basis, an up-
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1 date of the report that includes a descrip2 tion of— 

3 ‘‘(I) progress made toward plan 

4 implementation, as described under 

5 clause (i); and 

6 ‘‘(II) progress of the domestic 

7 preparedness programs under section 

8 2144 and of the international assist9 ance programs under section 2145. 

10 ‘‘(C) CONSULTATION WITH INTER11 NATIONAL ENTITIES.—In developing the pre12 paredness plans described under subparagraph 

13 (A) and the report under subparagraph (B), the 

14 Committee should consult with representatives 

15 from the World Health Organization, the World 

16 Organization for Animal Health, and other 

17 international bodies, as appropriate. 

18 ‘‘(e) APPLICATION OF FACA.—Notwithstanding the 

19 Federal Advisory Committee Act, non-government individ20 uals and entities may participate in the activities of the 

21 Committee. 

22 ‘‘SEC. 2144. DOMESTIC PANDEMIC INFLUENZA PREPARED23 NESS ACTIVITIES. 

24 ‘‘(a) PANDEMIC PREPAREDNESS ACTIVITIES.—The 

25 Director of Pandemic Preparedness and Response shall 
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1 strengthen, expand, and coordinate domestic pandemic in2 fluenza preparedness activities. 

3 ‘‘(b) STATE PREPAREDNESS PLAN.— 

4 ‘‘(1) IN GENERAL.—As a condition of receiving 

5 funds from the Centers for Disease Control and Pre6 vention or the Health Resources and Services Ad7 ministration related to bioterrorism, a State shall— 

8 ‘‘(A) designate an official or office as re9 sponsible for pandemic influenza preparedness; 

10 ‘‘(B) submit to the Director of the Centers 

11 for Disease Control and Prevention a Pandemic 

12 Influenza Preparedness Plan described under 

13 paragraph (2); and 

14 ‘‘(C) have such Preparedness Plan ap15 proved in accordance with this subsection. 

16 ‘‘(2) PREPAREDNESS PLAN.— 

17 ‘‘(A) IN GENERAL.—The Pandemic Influ18 enza Preparedness Plan required under para19 graph (1) shall address— 

20 ‘‘(i) human and animal surveillance 

21 activities, including capacity for epidemio22 logical analysis, isolation and subtyping of 

23 influenza viruses year-round, including for 

24 avian influenza among domestic poultry, 
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1 and reporting of information across human 

2 and veterinary sectors; 

3 ‘‘(ii) methods to ensure surge capacity 

4 in hospitals, laboratories, outpatient 

5 healthcare provider offices, medical sup6 pliers, and communication networks; 

7 ‘‘(iii) assisting the recruitment and 

8 coordination of national and State volun9 teer banks of healthcare professionals; 

10 ‘‘(iv) distribution of vaccines, 

11 antivirals, and other treatments to priority 

12 groups, and monitor effectiveness and ad13 verse events; 

14 ‘‘(v) networks that provide alerts and 

15 other information for healthcare providers 

16 and organizations at the National, State, 

17 and regional level; 

18 ‘‘(vi) communication with the public 

19 with respect to prevention and obtaining 

20 care during pandemic influenza; 

21 ‘‘(vii) maintenance of core public 

22 functions, including public utilities, refuse 

23 disposal, mortuary services, transportation, 

24 police and firefighter services, and other 

25 critical services; 
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1 ‘‘(viii) provision of security for— 

2 ‘‘(I) first responders and other 

3 medical personnel and volunteers; 

4 ‘‘(II) hospitals, treatment cen5 ters, and isolation and quarantine 

6 areas; 

7 ‘‘(III) transport and delivery of 

8 resources, including vaccines, medica9 tions and other supplies; and 

10 ‘‘(IV) other persons or functions 

11 as determined appropriate by the Sec12 retary; 

13 ‘‘(ix) the acquisition of necessary legal 

14 authority for pandemic activities; 

15 ‘‘(x) integration with existing na16 tional, State, and regional bioterrorism 

17 preparedness activities or infrastructure; 

18 ‘‘(xi) coordination among public and 

19 private health sectors with respect to 

20 healthcare delivery, including mass vac21 cination and treatment systems, during 

22 pandemic influenza; and 

23 ‘‘(xii) coordination with Federal pan24 demic influenza preparedness activities. 
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1 ‘‘(B) UNDERSERVED POPULATIONS.—The 

2 Pandemic Influenza Preparedness Plan required 

3 under paragraph (1) shall include a specific 

4 focus on surveillance, prevention, and medical 

5 care for traditionally underserved populations, 

6 including low-income, racial and ethnic minor7 ity, immigrant, and uninsured populations. 

8 ‘‘(3) APPROVAL OF STATE PLAN.— 

9 ‘‘(A) IN GENERAL.—The Director of Pan10 demic Preparedness and Response, in collabora11 tion with the Pandemic Influenza Preparedness 

12 Policy Coordinating Committee, shall develop 

13 criteria to rate State Pandemic Influenza Pre14 paredness Plans required under paragraph (1) 

15 and determine the minimum rating needed for 

16 approval. 

17 ‘‘(B) TIMING OF APPROVAL.—Not later 

18 than 90 days after a State submits a State 

19 Pandemic Influenza Preparedness Plan as re20 quired under paragraph (1), the Director of 

21 Pandemic Preparedness and Response shall 

22 make a determination regarding approval of 

23 such Plan. 

24 ‘‘(4) REPORTING OF STATE PLAN.—All Pan25 demic Influenza Preparedness Plans submitted and 
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1 approved under this section shall be made available 

2 to Congress, State officials, and the public as deter3 mined appropriate by the Director. 

4 ‘‘(5) ASSISTANCE TO STATES.—The Centers for 

5 Disease Control and Prevention and the Health Re6 sources and Services Administration may provide as7 sistance to States in carrying out this subsection, or 

8 implementing an approved State Pandemic Influenza 

9 Preparedness Plan, which may include the detail of 

10 an officer to approved domestic pandemic sites or 

11 the purchase of equipment and supplies. 

12 ‘‘(6) WAIVER.—The Director of Pandemic Pre13 paredness and Response may grant a temporary 

14 waiver of 1 or more of the requirements under this 

15 subsection. 

16 ‘‘(c) DOMESTIC SURVEILLANCE.— 

17 ‘‘(1) IN GENERAL.—The Secretary, in coordina18 tion with the Secretary of Agriculture, shall establish 

19 minimum thresholds for States with respect to ade20 quate surveillance for pandemic influenza, including 

21 possible pandemic avian influenza. 

22 ‘‘(2) ASSISTANCE TO STATES.— 

23 ‘‘(A) IN GENERAL.—The Secretary, in co24 ordination with the Secretary of Agriculture, 

25 shall provide assistance to States and regions to 
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1 meet the minimum thresholds established under 

2 paragraph (1). 

3 ‘‘(B) TYPES OF ASSISTANCE.—Assistance 

4 provided to States under subparagraph (A) may 

5 include— 

6 ‘‘(i) the establishment or expansion of 

7 State surveillance and alert systems, in8 cluding the Sentinel Physician Surveillance 

9 System and 122 Cities Mortalities Report 

10 System; 

11 ‘‘(ii) the provision of equipment and 

12 supplies; 

13 ‘‘(iii) support for epidemiological anal14 ysis and investigation of novel strains; 

15 ‘‘(iv) the sharing of biological speci16 mens and epidemiological and clinical data 

17 within and across States; and 

18 ‘‘(v) other activities determined appro19 priate by the Secretary. 

20 ‘‘(3) DETAIL OF OFFICERS.—The Secretary 

21 may detail officers to States for technical assistance 

22 as needed to carry out this subsection. 

23 ‘‘(d) PRIVATE SECTOR INVOLVEMENT.— 

24 ‘‘(1) IN GENERAL.—The Secretary, acting 

25 through the Director of the Centers for Disease 
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1 Control and Prevention and the Administrator of the 

2 Health Resources and Services Administration, and 

3 in coordination with private sector entities, shall in4 tegrate and coordinate public and private influenza 

5 surveillance activities, as appropriate. 

6 ‘‘(2) GRANT PROGRAM.— 

7 ‘‘(A) IN GENERAL.—In carrying out the 

8 activities under paragraph (1), the Secretary 

9 may establish a grant program, or expand exist10 ing grant programs, to provide funding to eligi11 ble entities to coordinate or integrate as appro12 priate, pandemic preparedness surveillance ac13 tivities between States and private health sector 

14 entities, including hospitals, health plans, and 

15 other health systems. 

16 ‘‘(B) ELIGIBILITY.—To be eligible to re17 ceive a grant under subparagraph (A), an entity 

18 shall submit an application at such time, in 

19 such manner, and containing such information 

20 as the Secretary may require. 

21 ‘‘(C) USE OF FUNDS.—Funds under a 

22 grant under subparagraph (A) may be used 

23 to— 
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1 ‘‘(i) develop and implement surveil2 lance protocols for patients in outpatient 

3 and hospital settings; 

4 ‘‘(ii) establish a communication alert 

5 plan for patients for reportable signs and 

6 symptoms that may suggest influenza; 

7 ‘‘(iii) plan for the vaccination of popu8 lations and, if appropriate, dissemination 

9 of antiviral drugs; 

10 ‘‘(iv) purchase necessary equipment 

11 and supplies; 

12 ‘‘(v) increase laboratory testing and 

13 networking capacity; 

14 ‘‘(vi) conduct epidemiological and 

15 other analyses; or 

16 ‘‘(vii) report and disseminate data. 

17 ‘‘(D) DETAIL OF OFFICERS.—The Sec18 retary may detail officers to grantees under 

19 subparagraph (A) for technical assistance. 

20 ‘‘(E) REQUIREMENT.—As a condition of 

21 receiving a grant under subparagraph (A), a 

22 State shall have a plan to meet minimum 

23 thresholds for State influenza surveillance es24 tablished by the Director of the Centers for 

25 Disease Control and Prevention in coordination 
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1 with the Secretary of Agriculture under sub2 section (b). 

3 ‘‘(e) PROCUREMENT OF ANTIVIRALS FOR THE STRA4 TEGIC NATIONAL STOCKPILE.—The Secretary shall take 

5 immediate action to procure for the Strategic National 

6 Stockpile described under section 319F-2 antivirals need7 ed to prevent or treat infection during a pandemic influ8 enza, including possible pandemic avian influenza, for at 

9 least 50 percent of the population. 

10 ‘‘(f) PROCUREMENT OF VACCINES FOR THE STRA11 TEGIC NATIONAL STOCKPILE.—Subject to development 

12 and testing of potential vaccines for pandemic influenza, 

13 including possible pandemic avian influenza, the Secretary 

14 shall determine the minimum number of doses of vaccines 

15 needed to prevent infection during at least the first wave 

16 of pandemic influenza for health professionals (including 

17 doctors, nurses, mental health professionals, pharmacists, 

18 laboratory personnel, epidemiologists, virologists, and pub19 lic health practitioners), core public utility employees, and 

20 those persons expected to be at high risk for serious mor21 bidity and mortality from pandemic influenza, and take 

22 immediate steps to procure this minimum number of doses 

23 for the Strategic National Stockpile described under sec24 tion 319F–2. 
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1 ‘‘(g) PROCUREMENT OF ESSENTIAL MEDICATIONS.— 

2 The Secretary shall, as soon as is practicable, take action 

3 to procure for the Strategic National Stockpile essential 

4 medications and other supplies that may be needed in the 

5 event of a pandemic. 

6 ‘‘(h) NATIONAL TRACKING AND DISTRIBUTION SYS7 TEM FOR VACCINES AND ANTIVIRALS.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall develop 

9 and implement a national system for the tracking 

10 and distribution of antiviral medications and vac11 cines in order to prepare and respond to pandemic 

12 influenza. 

13 ‘‘(2) SYSTEM.—The system developed under 

14 paragraph (1) shall— 

15 ‘‘(A) allow for the electronic tracking of all 

16 domestically available antiviral medication and 

17 vaccines for pandemic influenza; 

18 ‘‘(B) anticipate shortages, and alert offi19 cials if shortages are expected in such medica20 tions and vaccines; 

21 ‘‘(C) target distribution to high-risk 

22 groups, including health professionals and relief 

23 personnel and other individuals determined to 

24 be most susceptible to disease or death from 

25 pandemic flu; 
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1 ‘‘(D) ensure equitable distribution, particu2 larly across low-income and other underserved 

3 groups; and 

4 ‘‘(E) integrate with existing State and 

5 local systems as appropriate. 

6 ‘‘(i) REIMBURSEMENTS.—The Secretary shall have 

7 the authority to reimburse State and local health depart8 ments for expenditures related to influenza vaccine pur9 chase and administration during a public health emer10 gency under section 319(a). 

11 ‘‘SEC. 2145. PROPOSAL FOR INTERNATIONAL FUND TO SUP12 PORT PANDEMIC INFLUENZA CONTROL. 

13 ‘‘(a) IN GENERAL.—The Director of Pandemic Pre14 paredness and Response should submit to the Director of 

15 the World Health Organization a proposal to study the 

16 feasibility of establishing a fund, (referred to in this sec17 tion as the ‘Pandemic Fund’) to support pre-pandemic in18 fluenza control, surveillance, and relief activities con19 ducted in countries affected by avian influenza or other 

20 viruses likely to cause pandemic influenza. 

21 ‘‘(b) CONTENT OF PROPOSAL.—The proposal sub22 mitted under subsection (a) shall describe, with respect 

23 to the Pandemic Fund— 

24 ‘‘(1) funding sources; 

25 ‘‘(2) administration; 
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1 ‘‘(3) application process by which a country 

2 may apply to receive assistance from such Fund; 

3 ‘‘(4) factors used to make a determination re4 garding a submitted application, which may in5 clude— 

6 ‘‘(A) the gross domestic product of the ap7 plicant country; 

8 ‘‘(B) the burden of need, as determined by 

9 estimated human morbidity and mortality and 

10 economic impact related to pandemic influenza 

11 and the existing capacity and resources of the 

12 applicant country to control the spread of the 

13 disease; and 

14 ‘‘(C) the willingness of the country to co15 operate with other countries with respect to 

16 preventing and controlling the spread of the 

17 pandemic influenza; and 

18 ‘‘(5) any other information the Secretary deter19 mines necessary. 

20 ‘‘(c) USE OF FUNDS.—Funds from any Pandemic 

21 Fund established as provided for in this section shall be 

22 used to complement and augment ongoing bilateral pro23 grams and activities from the United States and other 

24 donor nations, or establish new programs as needed. 
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1 ‘‘SEC. 2146. INTERNATIONAL DIPLOMATIC AND DEVELOP2 MENT STRATEGY. 

3 ‘‘(a) POLICY.—It is the policy of the United States 

4 to develop and implement a comprehensive diplomatic 

5 strategy targeted at (but not limited to) nations in South6 east and East Asia that are most at risk for an outbreak 

7 of the avian influenza, including Cambodia, China, Laos, 

8 Thailand, Indonesia, and Vietnam, in order to strengthen 

9 international public health structures to detect, prevent, 

10 and effectively respond to an outbreak of the avian flu. 

11 ‘‘(b) STRATEGY.—The strategy developed and imple12 mented under subsection (a) shall include— 

13 ‘‘(1) supporting information sharing and 

14 strengthening surveillance, and rapid response ca15 pacities in key nations, including the development of 

16 pandemic preparedness and response plans; 

17 ‘‘(2) issuing demarches to key nations in the re18 gion urging additional cooperation and coordination 

19 with the United States, regional governments, and 

20 international organizations; 

21 ‘‘(3) provide for regular visits by cabinet-level 

22 officials of the United States Government, including 

23 the Secretary of State, Secretary of Health and 

24 Human Services, Secretary of Agriculture, Secretary 

25 of Homeland Security, and Secretary of Defense, to 
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1 key nations in Southeast and East Asia in order to 

2 enhance cooperation; 

3 ‘‘(4) expanding ongoing technical assistance 

4 programs, including training of personnel, procuring 

5 laboratory equipment, logistics support, bio-safety 

6 procedures, quality control, and case detection inves7 tigation techniques; 

8 ‘‘(5) exchanges of scientists and medical per9 sonnel engaged in significant work on issues related 

10 to avian flu; 

11 ‘‘(6) encouraging regional governments to im12 plement viable compensation schemes to encourage 

13 reporting by poultry farmers of cases of avian influ14 enza in commercial flocks; 

15 ‘‘(7) forward deployment of additional United 

16 States Government science and medical personnel to 

17 embassies and consulates in the region; 

18 ‘‘(8) public awareness campaigns in the region, 

19 including increased involvement of the Broadcasting 

20 Board of Governors and Voice of America, to ensure 

21 timely and accurate dissemination of information; 

22 ‘‘(9) using the voice and vote of the United 

23 States at meeting of appropriate international orga24 nizations to support the aforementioned efforts; and 
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1 ‘‘(10) integrating the private sector, especially 

2 those entities with a strong presence in the region, 

3 into this effort. 

4 ‘‘SEC. 2147. INTERNATIONAL PANDEMIC INFLUENZA AS5 SISTANCE. 

6 ‘‘(a) IN GENERAL.—The Secretary shall assist other 

7 countries in preparation for, and response to, pandemic 

8 influenza, including possible pandemic avian influenza. 

9 ‘‘(b) INTERNATIONAL SURVEILLANCE.— 

10 ‘‘(1) IN GENERAL.—The Secretary, acting 

11 through the Director of the Centers for Disease 

12 Control and Prevention, and in collaboration with 

13 the Secretary of Agriculture, in consultation with the 

14 World Health Organization and the World Organiza15 tion for Animal Health, shall establish minimum 

16 standards for surveillance capacity for all countries 

17 with respect to viral strains with pandemic potential, 

18 including avian influenza. 

19 ‘‘(2) ASSISTANCE.—The Secretary and the Sec20 retary of Agriculture shall assist other countries to 

21 meet the standards established in paragraph (1) 

22 through— 

23 ‘‘(A) the detail of officers to foreign coun24 tries for the provision of technical assistance or 

25 training; 
29 

•S 1821 IS 

1 ‘‘(B) laboratory testing, including testing 

2 of specimens for viral isolation or subtype anal3 ysis; 

4 ‘‘(C) epidemiological analysis and inves5 tigation of novel strains; 

6 ‘‘(D) provision of equipment or supplies; 

7 ‘‘(E) coordination of surveillance activities 

8 within and among countries; 

9 ‘‘(F) the establishment and maintenance of 

10 an Internet database that is accessible to health 

11 officials domestically and internationally, for 

12 the purpose of reporting new cases or clusters 

13 of influenza and other information that may 

14 help avert the pandemic spread of influenza; 

15 and 

16 ‘‘(G) other activities as determined nec17 essary by the Secretary. 

18 ‘‘(c) INCREASED INTERNATIONAL MEDICAL CAPAC19 ITY DURING PANDEMIC INFLUENZA.—Notwithstanding 

20 any other provision of law, the Secretary, in consultation 

21 with the Secretary of State, may provide vaccines, 

22 antiviral medications, and supplies to foreign countries 

23 from the Strategic National Stockpile described under sec24 tion 319F–2. 
30 

•S 1821 IS 

1 ‘‘(d) ASSISTANCE TO FOREIGN COUNTRIES.—The 

2 Centers for Disease Control and Prevention and the 

3 Health Resources and Services Administration may pro4 vide assistance to foreign countries in carrying out this 

5 section, which may include the detail of an officer to ap6 proved international pandemic sites or the purchase of 

7 equipment and supplies. 

8 ‘‘SEC. 2148. PUBLIC EDUCATION AND AWARENESS CAM9 PAIGN. 

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

11 Disease Control and Prevention, in consultation with the 

12 United States Agency for International Development, the 

13 World Health Organization, the World Organization for 

14 Animal Health, and foreign countries, shall develop an 

15 outreach campaign with respect to public education and 

16 awareness of influenza and influenza preparedness. 

17 ‘‘(b) DETAILS OF CAMPAIGN.—The campaign estab18 lished under subsection (a) shall— 

19 ‘‘(1) be culturally and linguistically appropriate 

20 for domestic populations; 

21 ‘‘(2) be adaptable for use in foreign countries; 

22 ‘‘(3) target high-risk populations (those most 

23 likely to contract, transmit, and die from influenza); 
31 

•S 1821 IS 

1 ‘‘(4) promote personal influenza precautionary 

2 measures and knowledge, and the need for general 

3 vaccination, as appropriate; and 

4 ‘‘(5) describe precautions at the State and local 

5 level that could be implemented during pandemic in6 fluenza, including quarantine and other measures. 

7 ‘‘SEC. 2149. HEALTH PROFESSIONAL TRAINING. 

8 ‘‘The Secretary, directly or through contract, and in 

9 consultation with professional health and medical soci10 eties, shall develop and disseminate pandemic influenza 

11 training curricula— 

12 ‘‘(1) to educate and train health professionals, 

13 including physicians, nurses, public health practi14 tioners, virologists and epidemiologists, veterinar15 ians, mental health providers, allied health profes16 sionals, and paramedics and other first responders; 

17 ‘‘(2) to educate and train volunteer, non-med18 ical personnel whose assistance may be required dur19 ing a pandemic influenza outbreak; and 

20 ‘‘(3) that address prevention, including use of 

21 quarantine and other isolation precautions, pan22 demic influenza diagnosis, medical guidelines for use 

23 of antivirals and vaccines, and professional require24 ments and responsibilities, as appropriate. 
32 

•S 1821 IS 

1 ‘‘SEC. 2150. RESEARCH AT THE NATIONAL INSTITUTES OF 

2 HEALTH. 

3 ‘‘The Director of the National Institutes of Health 

4 (referred to in this section as the ‘Director of NIH’), in 

5 collaboration with the Director of the Centers for Disease 

6 Control and Prevention, and other relevant agencies, shall 

7 expand and intensify human and animal research, with re8 spect to influenza, on— 

9 ‘‘(1) vaccine development and manufacture, in10 cluding strategies to increase immunological re11 sponse; 

12 ‘‘(2) effectiveness of inducing heterosubtypic 

13 immunity; 

14 ‘‘(3) antigen-sparing studies; 

15 ‘‘(4) antivirals, including minimal dose or 

16 course of treatment and timing to achieve prophy17 lactic or therapeutic effect; 

18 ‘‘(5) side effects and drug safety of vaccines 

19 and antivirals in subpopulations; 

20 ‘‘(6) alternative routes of delivery of vaccines, 

21 antivirals, and other medications as appropriate; 

22 ‘‘(7) more efficient methods for testing and de23 termining virus subtype; 

24 ‘‘(8) protective measures; 

25 ‘‘(9) modes of influenza transmission; 
33 

•S 1821 IS 

1 ‘‘(10) effectiveness of masks, hand-washing, 

2 and other non-pharmaceutical measures in pre3 venting transmission; 

4 ‘‘(11) improved diagnostic tools for influenza; 

5 and 

6 ‘‘(12) other areas determined appropriate by 

7 the Director of NIH. 

8 ‘‘SEC. 2151. RESEARCH AT THE CENTERS FOR DISEASE CON9 TROL AND PREVENTION. 

10 ‘‘The Director of the Centers for Disease Control and 

11 Prevention, in collaboration with other relevant agencies, 

12 shall expand and intensify research, with respect to influ13 enza, on— 

14 ‘‘(1) historical research on prior pandemics to 

15 better understand pandemic epidemiology, trans16 mission, protective measures, high-risk groups, and 

17 other lessons that may be applicable to future pan18 demic; 

19 ‘‘(2) communication strategies for the public 

20 during pandemic influenza, taking into consideration 

21 age, racial and ethnic background, health literacy, 

22 and risk status; 

23 ‘‘(3) changing and influencing human behavior 

24 as it relates to vaccination; 
34 

•S 1821 IS 

1 ‘‘(4) development and implementation of a pub2 lic, non-commercial and non-competitive broadcast 

3 system and person-to-person networks; 

4 ‘‘(5) population-based surveillance methods to 

5 estimate influenza infection rates and rates of out6 patient illness; 

7 ‘‘(6) vaccine effectiveness; 

8 ‘‘(7) systems to monitor vaccination coverage 

9 levels and adverse events from vaccination; and 

10 ‘‘(8) other areas determined appropriate by the 

11 Director of the Centers for Disease Control and Pre12 vention. 

13 ‘‘SEC. 2152. INSTITUTE OF MEDICINE STUDY ON THE LEGAL, 

14 ETHICAL, AND SOCIAL IMPLICATIONS OF 

15 PANDEMIC INFLUENZA. 

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

17 with the Institute of Medicine to— 

18 ‘‘(1) study the legal, ethical, and social implica19 tions of, with respect to pandemic influenza— 

20 ‘‘(A) animal/human interchange; 

21 ‘‘(B) global surveillance; 

22 ‘‘(C) case contact investigations; 

23 ‘‘(D) vaccination and medical treatment; 

24 ‘‘(E) community hygiene; 

25 ‘‘(F) travel and border controls; 
35 

•S 1821 IS 

1 ‘‘(G) decreased social mixing and increased 

2 social distance; 

3 ‘‘(H) civil confinement; and 

4 ‘‘(I) other topics as determined appropriate 

5 by the Secretary; and 

6 ‘‘(2) not later than 1 year after the date of en7 actment of the Pandemic Preparedness and Re8 sponse Act, submit to the Secretary a report that 

9 describes recommendations based on the study con10 ducted under paragraph (1). 

11 ‘‘(b) IMPLEMENTATION OF RECOMMENDATIONS.— 

12 Not later than 90 days after the submission of the report 

13 of under subsection (a)(2), the Secretary shall address the 

14 recommendations of the Institute of Medicine regarding 

15 the domestic and international allocation and distribution 

16 of pandemic influenza vaccine and antivirals. 

17 ‘‘SEC. 2153. NATIONAL PANDEMIC INFLUENZA ECONOMICS 

18 ADVISORY COMMITTEE. 

19 ‘‘(a) IN GENERAL.—There is established the National 

20 Pandemic Influenza Economics Advisory Committee (re21 ferred to in this section as the ‘Committee’). 

22 ‘‘(b) MEMBERSHIP.— 

23 ‘‘(1) IN GENERAL.—The members of the Com24 mittee shall be appointed by the Comptroller General 

25 of the United States and shall include domestic and 
36 

•S 1821 IS 

1 international experts on pandemic influenza, public 

2 health, veterinary science, commerce, economics, fi3 nance, and international diplomacy. 

4 ‘‘(2) CHAIR.—The Comptroller General of the 

5 United States shall select a Chair from among the 

6 members of the Committee. 

7 ‘‘(c) DUTIES.—The Committee shall study and make 

8 recommendations to Congress and the Secretary on the 

9 financial and economic impact of pandemic influenza and 

10 possible financial structures for domestic and inter11 national pandemic response, relating to— 

12 ‘‘(1) the development, storage, and distribution 

13 of vaccines; 

14 ‘‘(2) the development, storage, and distribution 

15 of antiviral and other medications and supplies; 

16 ‘‘(3) increased surveillance activities; 

17 ‘‘(4) provision of preventive and medical care 

18 during pandemic; 

19 ‘‘(5) reimbursement for health providers and 

20 other core public function employees; 

21 ‘‘(6) reasonable compensation for farmers and 

22 other workers that bear direct or disproportionate 

23 loss of revenue; and 

24 ‘‘(7) other issues determined appropriate by the 

25 Chair. 
37 

•S 1821 IS 

1 ‘‘(d) COMPENSATION.— 

2 ‘‘(1) IN GENERAL.—Each member of the Com3 mittee who is not an officer or employee of the Fed4 eral Government shall be compensated at a rate 

5 equal to the daily equivalent of the annual rate of 

6 basic pay prescribed for level IV of the Executive 

7 Schedule under section 5315 of title 5, United 

8 States Code, for each day (including travel time) 

9 during which such member is engaged in the per10 formance of the duties of the Committee. All mem11 bers who are officers or employees of the United 

12 States shall serve without compensation in addition 

13 to that received for their services as officers or em14 ployees of the United States. 

15 ‘‘(2) TRAVEL EXPENSES.—A member of the 

16 Committee shall be allowed travel expenses, includ17 ing per diem in lieu of subsistence, at rates author18 ized for an employee of an agency under subchapter 

19 I of chapter 57 of title 5, United States Code, while 

20 away from the home or regular place of business of 

21 the member in the performance of the duties of the 

22 Committee. 

23 ‘‘(e) STAFF.— 

24 ‘‘(1) IN GENERAL.—The Chair of the Com25 mittee shall provide the Committee with such profes-
38 

•S 1821 IS 

1 sional and clerical staff, such information, and the 

2 services of such consultants as may be necessary to 

3 assist the Committee in carrying out the functions 

4 under this section. 

5 ‘‘(2) DETAIL OF FEDERAL GOVERNMENT EM6 PLOYEES.— 

7 ‘‘(A) IN GENERAL.—An employee of the 

8 Federal Government may be detailed to the 

9 Committee without reimbursement. 

10 ‘‘(B) CIVIL SERVICE STATUS.—The detail 

11 of the employee shall be without interruption or 

12 loss of civil service status or privilege. 

13 ‘‘(3) PROCUREMENT OF TEMPORARY AND

14 INTERMITTENT SERVICES.—The Chair of the Com15 mittee may procure temporary and intermittent serv16 ices in accordance with section 3109(b) of title 5, 

17 United States Code, at rates for individuals that do 

18 not exceed the daily equivalent of the annual rate of 

19 basic pay prescribed for level V of the Executive 

20 Schedule under section 5316 of that title. 

21 ‘‘SEC. 2154. PANDEMIC INFLUENZA AND ANIMAL HEALTH. 

22 ‘‘(a) IN GENERAL.—The Secretary of Agriculture 

23 shall expand and intensify efforts to prevent pandemic in24 fluenza, including possible pandemic avian influenza. 
39 

•S 1821 IS 

1 ‘‘(b) REPORT.—Not later than 180 days after the 

2 date of enactment this Act, the Secretary of Agriculture 

3 shall submit to Congress a report that describes the antici4 pated impact of pandemic influenza on the United States. 

5 ‘‘(c) ASSISTANCE.—The Secretary of Agriculture, in 

6 consultation with the Secretary of Health and Human 

7 Services, the World Health Organization, and the World 

8 Organization for Animal Health, shall provide domestic 

9 and international assistance with respect to pandemic in10 fluenza preparedness to— 

11 ‘‘(1) support the eradication of infectious ani12 mal diseases and zoonosis; 

13 ‘‘(2) increase transparency in animal disease 

14 states; 

15 ‘‘(3) collect, analyze, and disseminate veterinary 

16 data; 

17 ‘‘(4) strengthen international coordination and 

18 cooperation in the control of animal diseases; and 

19 ‘‘(5) promote the safety of world trade in ani20 mals and animal products. 

21 ‘‘(d) ELECTRONIC DATABASE.—The Secretary of Ag22 riculture, in conjunction with the Secretary of Health and 

23 Human Services, shall establish an electronic disease sur24 veillance database in order to trace the incidence of avian 
40 

•S 1821 IS 

1 influenza in both animals and humans in the United 

2 States. 

3 ‘‘(e) IMPROVEMENTS IN THE NATIONAL ANIMAL

4 HEALTH LABORATORY NETWORK.—The Secretary of Ag5 riculture shall evaluate the National Animal Health Lab6 oratory Network and make recommendations for improve7 ments to participating laboratories and other State animal 

8 health laboratories to rapidly diagnose and research avian 

9 influenza outbreaks. 

10 ‘‘(f) COMMUNICATIONS LIAISONS.— 

11 ‘‘(1) IN GENERAL.—The Secretary of Agri12 culture jointly with the Secretary of Homeland Secu13 rity shall designate a liaison in each State to facili14 tate and coordinate communications among and be15 tween States in the event of an agriculture emer16 gency. 

17 ‘‘(2) FUNCTIONS.—Each liaison designated 

18 under paragraph (1) shall— 

19 ‘‘(A) be the central point of contact for 

20 animal health in communications with the De21 partment of Agriculture and the Department of 

22 Homeland Security; 

23 ‘‘(B) communicate Federal preparedness 

24 and response plans to State and local agri25 culture officials and veterinarians; and 
41 

•S 1821 IS 

1 ‘‘(C) communicate concerns from State 

2 and local agriculture officials and veterinarians 

3 to the Department of Agriculture and Depart4 ment of Homeland Security and the Depart5 ment of Health and Human Services. 

6 ‘‘Subtitle 4—Strengthening Public 

7 Health Immunization Capacity 

8 and Supply 

9 ‘‘SEC. 2161. FINDINGS. 

10 ‘‘Congress finds that— 

11 ‘‘(1) effective pandemic influenza preparedness 

12 and response is dependent upon the existence of 

13 solid public health infrastructure to combat seasonal 

14 flu; 

15 ‘‘(2) the domestic surveillance and vaccine pro16 duction and distribution capabilities needed in a 

17 time of crisis should be well established and active 

18 in a non-crisis capacity to enable a more efficient re19 sponse to pandemic influenza; and 

20 ‘‘(3) each State receiving Federal funds should 

21 have a State Immunization Program Coordinator, 

22 who should be responsible for coordinating and im23 plementing activities related to influenza. 

24 ‘‘SEC. 2162. VACCINE SUPPLY. 

25 ‘‘(a) REQUESTS FOR MORE DOSES.— 
42 

•S 1821 IS 

1 ‘‘(1) IN GENERAL.—Not later than March 15 of 

2 each year, the Secretary shall enter into contracts 

3 with manufacturers to produce such additional doses 

4 of the influenza vaccine as determined necessary by 

5 the Secretary. 

6 ‘‘(2) CONTENT OF CONTRACT.—A contract for 

7 additional doses shall provide that the manufacturer 

8 will be compensated by the Secretary at an equitable 

9 rate negotiated by the Secretary and the manufac10 turer for any doses that— 

11 ‘‘(A) were not sold by the manufacturer 

12 through routine market mechanisms at the end 

13 of the influenza season for that year; and 

14 ‘‘(B) were requested by the Secretary to be 

15 produced by such manufacturer. 

16 ‘‘(3) WHEN SUCH VACCINE PURCHASES

17 SHOULD TAKE PLACE.—The Secretary may purchase 

18 from the manufacturer the doses for which it has 

19 contracted at any time after which it is determined 

20 by the Secretary, in consultation with the manufac21 turer, that the doses will likely not be absorbed by 

22 the private market. 

23 ‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated to carry out this section 

25 such sums as may be necessary. 
43 

•S 1821 IS 

1 ‘‘SEC. 2163. DISCONTINUANCE OF INFLUENZA VACCINE. 

2 ‘‘(a) IN GENERAL.— 

3 ‘‘(1) NOTICE TO SECRETARY.—A manufacturer 

4 of the influenza vaccine shall notify the Secretary of 

5 a discontinuance of the manufacture of the vaccine 

6 at least 12 months prior to the date of the dis7 continuance. 

8 ‘‘(2) DIRECTOR OF CENTERS FOR DISEASE

9 CONTROL AND PREVENTION.—Promptly after receiv10 ing a notice under paragraph (1), the Secretary shall 

11 inform the Director of the Centers for Disease Con12 trol and Prevention of the notice. Promptly after de13 termining that a reduction under subsection (b) ap14 plies with respect to such a notice, the Secretary 

15 shall inform such Director of the reduction. 

16 ‘‘(3) RELATIONSHIP TO SEPARATE NOTICE PRO17 GRAM.—In the case of influenza vaccine that is ap18 proved by the Secretary and is a drug described in 

19 section 506C(a), this section applies to the vaccine 

20 in lieu of section 506C. 

21 ‘‘(b) REDUCTION IN NOTIFICATION PERIOD.—The 

22 notification period required under subsection (a) for a 

23 manufacturer may be reduced if the manufacturer certifies 

24 to the Secretary that good cause exists for the reduction, 

25 such as a situation in which— 
44 

•S 1821 IS 

1 ‘‘(1) a public health problem may result from 

2 continuation of the manufacturing for the 12-month 

3 period; 

4 ‘‘(2) a biomaterials shortage prevents the con5 tinuation of the manufacturing for the 12-month pe6 riod; 

7 ‘‘(3) continuation of the manufacturing for the 

8 12-month period may cause substantial economic 

9 hardship for the manufacturer; 

10 ‘‘(4) the manufacturer has filed for bankruptcy 

11 under chapter 7 or 11 of title 11, United States 

12 Code; or 

13 ‘‘(5) the manufacturer can continue the dis14 tribution of the vaccine involved for 12 months. 

15 ‘‘(c) DISTRIBUTION.—To the maximum extent prac16 ticable, the Secretary shall distribute information on the 

17 discontinuation of the manufacture of influenza vaccines 

18 to appropriate physician and patient organizations. 

19 ‘‘SEC. 2164. SHORTAGE PREPAREDNESS AND RESPONSE. 

20 ‘‘(a) EMERGENCY RESPONSE PLANS REGARDING

21 SHORTAGES.— 

22 ‘‘(1) NATIONAL EMERGENCY RESPONSE

23 PLAN.—The Secretary shall develop and maintain a 

24 national plan for the response to potential shortages 

25 in supplies of influenza vaccines that would con-
45 

•S 1821 IS 

1 stitute public health emergencies. The plan shall in2 clude provisions with respect to communication 

3 among relevant entities, distribution of available 

4 supplies of the influenza vaccine involved, the des5 ignation of populations to be given priority for im6 munizations, interactions with State and local gov7 ernments, the use of the National Stockpile, and 

8 special considerations for specific vaccines. The ini9 tial plan shall be completed not later than 12 

10 months after the date of the enactment of this sec11 tion. 

12 ‘‘(2) STATE EMERGENCY RESPONSE PLAN.— 

13 Each State that receives funds under this Act shall, 

14 not later than 6 months after the date on which the 

15 National Plan is issued under paragraph (1), de16 velop, through the State Immunization Coordinator, 

17 a State Emergency Response Plan that is modeled 

18 on the National Plan. 

19 ‘‘SEC. 2165. PROVISIONS TO INCREASE VACCINE COVERAGE 

20 RATES. 

21 ‘‘(a) IN GENERAL.—The Secretary shall develop a 

22 plan for the distribution of seasonal flu vaccines to ensure 

23 that uninsured and underinsured adults and children have 

24 access to annual influenza vaccines and vaccines for condi25 tions potentially exacerbated by exposure to pandemic in-
46 

•S 1821 IS 

1 fluenza. Immunizations should be available to such popu2 lations as well as children in the VFC program through 

3 a wide variety of providers including both Federally quali4 fied health centers and State and local health depart5 ments. 

6 ‘‘(b) REQUIREMENT.—The Secretary shall— 

7 ‘‘(1) conduct an assessment to determine the 

8 number of adults in need of vaccinations and the 

9 barriers to vaccinating adults; and 

10 ‘‘(2) develop and implement strategies to in11 crease the rate of immunizations in populations in 

12 which a significant number of individuals have not 

13 received immunizations with the federally rec14 ommended vaccines (as defined in section 317A(g)) 

15 for the populations. 

16 ‘‘(c) DEFINITION.—For purposes of this section, the 

17 term ‘adult’ means an individual who is not a child as de18 fined in section 1928 of the Social Security Act. 

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

20 is authorized to be appropriated to carry out this section, 

21 such sums as may be necessary. 

22 ‘‘SEC. 2166. OUTREACH, COMMUNICATION, EDUCATION. 

23 ‘‘(a) EDUCATION PROGRAM REGARDING ADULT IM24 MUNIZATIONS.—The Secretary, acting through the Direc25 tor of the Centers for Disease Control and Prevention (in 
47 

•S 1821 IS 

1 this section referred to as the ‘Director’), shall conduct 

2 a public awareness campaign and education and outreach 

3 efforts each year during the time period preceding the in4 fluenza season on each of the following: 

5 ‘‘(1) The importance of receiving the influenza 

6 vaccine. 

7 ‘‘(2) Which populations the Director rec8 ommends to receive the influenza vaccine to prevent 

9 health complications associated with influenza, in10 cluding health care workers and their household con11 tacts. 

12 ‘‘(3) Professional medical education of physi13 cians, nurses, pharmacists, and other health care 

14 providers and such providers’ associated organiza15 tions. 

16 ‘‘(4) Information that emphasizes the safety 

17 and benefit of recommended vaccines for the public 

18 good. 

19 ‘‘(b) OUTREACH TO MEDICARE RECIPIENTS.— 

20 ‘‘(1) PROGRAM.— 

21 ‘‘(A) IN GENERAL.—The Director, in con22 sultation with the Administrator of the Centers 

23 for Medicare & Medicaid Services, shall, at the 

24 earliest possible time in the influenza vaccine 

25 planning and production process, reach out to 
48 

•S 1821 IS 

1 providers of medicare services, including man2 aged care providers, nursing homes, hospitals, 

3 and physician offices to urge early and full 

4 preordering of the influenza vaccine so that pro5 duction levels can accommodate the needs for 

6 the influenza vaccine. 

7 ‘‘(B) RATES OF IMMUNIZATION AMONG

8 MEDICARE RECIPIENTS.—The Director shall 

9 work with the Administrator of the Centers for 

10 Medicare & Medicaid Services to publish the 

11 rates of influenza immunization among individ12 uals receiving assistance under the medicare 

13 program under title XVIII of the Social Secu14 rity Act (42 U.S.C. 1395 et seq.). 

15 ‘‘(2) STATE AND PUBLIC HEALTH ADULT IMMU16 NIZATION ACTIVITIES.—The Director shall support 

17 the development of State adult immunization pro18 grams that place emphasis on improving influenza 

19 vaccine delivery to high-risk populations and the 

20 general population, including the exploration of im21 proving access to the influenza vaccine. 

22 ‘‘(3) EXISTING MODES OF COMMUNICATION.— 

23 In carrying out the public awareness campaign and 

24 education and outreach efforts under paragraph (1) 
49 

•S 1821 IS 

1 and (2), the Director may use existing websites or 

2 structures for communication. 

3 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.— 

4 There are authorized to be appropriated to carry out 

5 this subsection $10,000,000 for each of fiscal years 

6 2005 through 2009. 

7 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the 

8 purpose of carrying out this section, there are authorized 

9 to be appropriated such sums as may be necessary for 

10 each of the fiscal years 2006 through 2010.’’. 

11 SEC. 4. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN 

12 COMMERCE RELATED TO TREATMENTS FOR 

13 PANDEMIC INFLUENZA. 

14 Section 319F–3 of the Public Health Service Act (as 

15 added by section ll and amended by section ll(a)) 

16 is further amended by adding at the end the following: 

17 ‘‘(i) UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN

18 COMMERCE RELATED TO TREATMENTS FOR PANDEMIC

19 INFLUENZA.— 

20 ‘‘(1) SALES TO CONSUMERS AT UNCONSCION21 ABLE PRICE.— 

22 ‘‘(A) IN GENERAL.—During any public 

23 health emergency declared by the Secretary 

24 under section 319 related to pandemic influ25 enza, it shall be unlawful for any person to sell 
50 

•S 1821 IS 

1 any drug (including an anti-viral drug), device, 

2 or biologic for the prevention or treatment of 

3 influenza in, or for use in, the area to which 

4 that declaration applies at a price that— 

5 ‘‘(i) is unconscionably excessive (as 

6 determined by the Secretary); or 

7 ‘‘(ii) indicates the seller is taking un8 fair advantage of the circumstances to in9 crease prices unreasonably. 

10 ‘‘(B) FACTORS TO BE CONSIDERED.—In 

11 determining whether a violation of paragraph 

12 (1) has occurred, a court shall take into ac13 count, among other factors, whether— 

14 ‘‘(i) the amount charged represents a 

15 gross disparity between the price of a 

16 drug, device, or biologic for the prevention 

17 or treatment of influenza and the price at 

18 which the drug, device, or biologic was of19 fered for sale in the usual course of the 

20 seller’s business immediately prior to the 

21 public health emergency; or 

22 ‘‘(ii) the amount charged grossly ex23 ceeds the price at which the same or simi24 lar drug, device, or biologic for the preven25 tion or treatment of influenza was readily 
51 

•S 1821 IS 

1 obtainable by other purchasers in the area 

2 in which the declaration applies. 

3 ‘‘(C) MITIGATING FACTORS.—In deter4 mining whether a violation of subparagraph (A) 

5 has occurred, the court shall also take into ac6 count, among other factors, the price that 

7 would reasonably equate supply and demand in 

8 a competitive and freely functioning market and 

9 whether the price at which the drug, device, or 

10 biologic for the prevention or treatment of influ11 enza was sold reasonably reflects additional 

12 costs, not within the control of the seller, that 

13 were paid or incurred by the seller. 

14 ‘‘(2) FALSE PRICING INFORMATION.—It shall 

15 be unlawful for any person to report information re16 lated to the wholesale price of any drug, device, or 

17 biologic for the prevention or treatment of influenza 

18 to the Secretary if— 

19 ‘‘(A) that person knew, or reasonably 

20 should have known, the information to be false 

21 or misleading; 

22 ‘‘(B) the information was required by law 

23 to be reported; and 

24 ‘‘(C) the person intended the false or mis25 leading data to affect data compiled by the de-
52 

•S 1821 IS 

1 partment or agency involved for statistical or 

2 analytical purposes with respect to the market 

3 for drugs, devices, or biologics for the preven4 tion or treatment of influenza. 

5 ‘‘(3) MARKET MANIPULATION.—It shall be un6 lawful for any person, directly or indirectly, to use 

7 or employ, in connection with the purchase or sale 

8 of drugs, devices, or biologics for the prevention or 

9 treatment of influenza at wholesale, any manipula10 tive or deceptive device or contrivance, in contraven11 tion of such rules and regulations as the Secretary 

12 may prescribe as necessary or appropriate in the 

13 public interest or for the protection of United States 

14 citizens.’’. 

15 SEC. 5. AUTHORIZATION OF APPROPRIATIONS. 

16 There are authorized to be appropriated such sums 

17 as may be necessary to carry out this Act (and the amend18 ments made by this Act) for each of the fiscal years 2006 

19 through 2010. 

Æ