II 

108TH CONGRESS 

2D SESSION S. 2038

To amend the Public Health Service Act to provide for an influenza vaccine 

awareness campaign, ensure a sufficient influenza vaccine supply, and 

prepare for an influenza pandemic or epidemic, to amend the Internal 

Revenue Code of 1986 to encourage vaccine production capacity, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 28, 2004

Mr. BAYH (for himself, Mr. CRAIG, Ms. LANDRIEU, and Mr. DURBIN) introduced the following bill; which was read twice and referred to the Committee on Finance 

A BILL

To amend the Public Health Service Act to provide for 

an influenza vaccine awareness campaign, ensure a sufficient influenza vaccine supply, and prepare for an influenza pandemic or epidemic, to amend the Internal Revenue Code of 1986 to encourage vaccine production capacity, 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 ‘‘Flu Protection Act 

5 of 2004’’. 
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1 TITLE I—FLU VACCINE 

2 AWARENESS CAMPAIGN 

3 SEC. 101. AWARENESS CAMPAIGN AND EDUCATION AND 

4 OUTREACH EFFORTS. 

5 Title XXI of the Public Health Service Act (42 

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

7 the following: 

8 ‘‘Subtitle 3—Influenza Vaccine 

9 ‘‘AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH

10 EFFORTS

11 ‘‘SEC. 2141. (a) CAMPAIGN.—The Secretary, acting 

12 through the Director of the Centers for Disease Control 

13 and Prevention (in this subtitle referred to as the ‘Direc14 tor’), shall conduct a public awareness campaign and edu15 cation and outreach efforts each year during the time pe16 riod preceding the influenza season on each of the fol17 lowing: 

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

19 vaccine. 

20 ‘‘(2) Which populations the Director rec21 ommends to receive the influenza vaccine to prevent 

22 health complications associated with influenza, in23 cluding health care workers and household contacts. 

24 ‘‘(3) Professional medical education of physi25 cians, nurses, pharmacists, and other health care 
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1 providers and such providers’ associated organiza2 tions. 

3 ‘‘(4) Information that emphasizes the safety, ef4 ficacy, and benefit of recommended vaccines for the 

5 public good. 

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

7 ‘‘(1) IN GENERAL.—The Administrator of the 

8 Centers for Medicare & Medicaid Services shall, at 

9 the earliest possible time in the influenza vaccine 

10 planning and production process, reach out to pro11 viders of medicare services, including managed care 

12 providers, nursing homes, hospitals, and physician 

13 offices to urge early and full preordering of the in14 fluenza vaccine so that production levels can accom15 modate the needs for the influenza vaccine. 

16 ‘‘(2) RATES OF IMMUNIZATION AMONG MEDI17 CARE RECIPIENTS.—The Director shall work with 

18 the Administrator of the Centers for Medicare & 

19 Medicaid Services to publish the rates of influenza 

20 immunization among individuals receiving assistance 

21 under the medicare program under title XVIII of the 

22 Social Security Act (42 U.S.C. 1395 et seq.). 

23 ‘‘(c) STATE AND PUBLIC HEALTH ADULT IMMUNIZA24 TION ACTIVITIES.—The Director shall support the devel25 opment of State adult immunization programs that place 
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1 emphasis on improving influenza vaccine delivery to high2 risk populations and the general population, including the 

3 exploration of improving access to the influenza vaccine. 

4 ‘‘(d) EFFICACY OF VACCINE.—The Director shall 

5 work with appropriate agencies in conducting a study to 

6 assess the efficacy of the influenza vaccine. 

7 ‘‘(e) EXISTING MODES OF COMMUNICATION.—In car8 rying out the public awareness campaign and education 

9 and outreach efforts under subsections (a) and (b), the 

10 Director may use existing websites or structures for com11 munication. 

12 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 $10,000,000 for each of fiscal years 2004 through 2008.’’. 

15 TITLE II—ENCOURAGING VAC16 CINE PRODUCTION CAPACITY 

17 SEC. 201. INCENTIVES FOR THE CONSTRUCTION OF VAC18 CINE MANUFACTURING FACILITIES. 

19 (a) VACCINE MANUFACTURING FACILITIES INVEST20 MENT TAX CREDIT.—

21 (1) ALLOWANCE OF CREDIT.—Section 46 of the 

22 Internal Revenue Code of 1986 (relating to amount 

23 of investment credit) is amended by striking ‘‘and’’ 

24 at the end of paragraph (2), by striking the period 

25 at the end of paragraph (3) and inserting ‘‘, and’’,
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1 and by adding at the end the following new para2 graph: 

3 ‘‘(4) the vaccine manufacturing facilities invest4 ment credit.’’. 

5 (2) AMOUNT OF CREDIT.—Section 48 of such 

6 Code is amended by adding at the end the following 

7 new subsection: 

8 ‘‘(c) VACCINE MANUFACTURING FACILITIES INVEST9 MENT CREDIT.—

10 ‘‘(1) IN GENERAL.—For purposes of section 46, 

11 the vaccine manufacturing facilities investment cred12 it for any taxable year is an amount equal to 20 per13 cent of the qualified investment for such taxable 

14 year. 

15 ‘‘(2) QUALIFIED INVESTMENT.—For purposes 

16 of paragraph (1), the qualified investment for any 

17 taxable year is the basis of each vaccine manufac18 turing facilities property placed in service by the tax19 payer during such taxable year. 

20 ‘‘(3) VACCINE MANUFACTURING FACILITIES

21 PROPERTY.—For purposes of this subsection, the 

22 term ‘vaccine manufacturing facilities property’ 

23 means real and tangible personal property—

24 ‘‘(A)(i) the original use of which com25 mences with the taxpayer, or 
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1 ‘‘(ii) which is acquired through purchase 

2 (as defined by section 179(d)(2)), 

3 ‘‘(B) which is depreciable under section 

4 167, 

5 ‘‘(C) which is used for the manufacture, 

6 distribution, or research and development of 

7 vaccines, and 

8 ‘‘(D) which is in compliance with any 

9 standards and regulations which are promul10 gated by the Food and Drug Administration, 

11 the Occupational Safety and Health Adminis12 tration, or the Environmental Protection Agen13 cy and which are applicable to such property. 

14 ‘‘(4) CERTAIN PROGRESS EXPENDITURE RULES

15 MADE APPLICABLE.—Rules similar to rules of sub16 sections (c)(4) and (d) of section 46 (as in effect on 

17 the day before the date of the enactment of the Rev18 enue Reconciliation Act of 1990) shall apply for pur19 poses of this subsection. 

20 ‘‘(5) TERMINATION.—This subsection shall not 

21 apply to any property placed in service after Decem22 ber 31, 2008.’’. 

23 (b) TECHNICAL AMENDMENTS.—

24 (1) Subparagraph (C) of section 49(a)(1) of 

25 such Code is amended by striking ‘‘and’’ at the end 
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1 of clause (ii), by striking the period at the end of 

2 clause (iii) and inserting ‘‘, and’’, and by adding at 

3 the end the following new clause: 

4 ‘‘(iv) the basis of any vaccine manu5 facturing facilities property.’’. 

6 (2) Subparagraph (E) of section 50(a)(2) of 

7 such Code is amended by inserting ‘‘or 48(c)(4)’’ be8 fore the period. 

9 (3)(A) The section heading for section 48 of 

10 such Code is amended to read as follows: 

11 ‘‘SEC. 48. OTHER CREDITS.’’. 

12 (B) The table of sections for subpart E of part 

13 IV of subchapter A of chapter 1 of such Code is 

14 amended by striking the item relating to section 48 

15 and inserting the following:

‘‘Sec. 48. Other credits.’’.

16 (c) EFFECTIVE DATE.—The amendments made by 

17 this section shall apply to property placed in service after 

18 December 31, 2003, under rules similar to the rules of 

19 section 48(m) of the Internal Revenue Code of 1986 (as 

20 in effect on the day before the date of enactment of the 

21 Revenue Reconciliation Act of 1990). 
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1 TITLE III—ENSURING SUFFI2 CIENT FLU VACCINE SUPPLY 

3 SEC. 301. VACCINE SUPPLY. 

4 Subtitle 3 of title XXI of the Public Health Service 

5 Act, as added by section 101, is amended by adding at 

6 the end the following: 

7 ‘‘VACCINE SUPPLY

8 ‘‘SEC. 2142. (a) REQUESTS FOR MORE DOSES.—

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

10 each year, the Director shall enter into a contract 

11 with manufacturer(s) to produce such additional 

12 doses of the influenza vaccine as determined nec13 essary by the Director. 

14 ‘‘(2) CONTENT OF CONTRACT.—The contract 

15 for additional doses shall provide that the manufac16 turer(s) will be compensated by the Director at an 

17 equitable rate negotiated by the Director and the 

18 manufacturer for any doses that—

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

20 through routine market mechanisms at the end 

21 of the influenza season for that year; and 

22 ‘‘(B) were requested by the Director to be 

23 produced by such manufacturer(s). 

24 ‘‘(3) WHEN SUCH VACCINE PURCHASES

25 SHOULD TAKE PLACE.—The Director may purchase
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1 from the manufacturer(s) the doses for which it has 

2 contracted at any time after which it is determined 

3 by the Director, in consultation with the manufac4 turer(s), that the doses will likely not be absorbed 

5 by the private market. 

6 ‘‘(b) CONTINGENCY PLAN.—The Director shall en7 courage States to develop a contingency plan, in coordina8 tion with the Department of Health and Human Services, 

9 for maximizing influenza immunization for high-risk popu10 lations in the event of a delay or shortage of the influenza 

11 vaccine. 

12 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

13 are authorized to be appropriated to carry out this section 

14 such sums as may be necessary.’’. 

15 TITLE IV—PREPARING FOR A 

16 PANDEMIC OR EPIDEMIC 

17 SEC. 401. PREPARATION FOR INFLUENZA PANDEMIC OR 

18 EPIDEMIC. 

19 Subtitle 3 of title XXI of the Public Health Service 

20 Act, as added by section 101 and amended by section 301, 

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

22 ‘‘PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC

23 ‘‘SEC. 2143. (a) ESTABLISHMENT OF A PROTOCOL.—

24 The Secretary, acting through the Director, shall establish 

25 a protocol to attempt to prevent, prepare for, and respond 
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1 to an influenza pandemic or epidemic. Such protocol shall 

2 be updated as determined appropriate by the Director. 

3 ‘‘(b) CONTENTS OF PROTOCOL.—The protocol estab4 lished under subsection (a) shall—

5 ‘‘(1) address methods to coordinate dissemina6 tion of the influenza vaccine to key populations in 

7 the event of an influenza pandemic or epidemic; 

8 ‘‘(2) address expansion of influenza vaccine 

9 manufacturing capacity (including making advance 

10 arrangements for ensuring the availability of raw 

11 materials) to respond to the needs of the United 

12 States during an influenza pandemic or epidemic; 

13 ‘‘(3) improve upon the current influenza vac14 cines and production and dissemination methods; 

15 ‘‘(4) address alternative ways to manufacture or 

16 produce the influenza vaccine; 

17 ‘‘(5) address how many doses of the influenza 

18 vaccine should be produced on an annual basis and 

19 which strains of influenza should be covered by such 

20 vaccine in a particular year; 

21 ‘‘(6) address public awareness and education, 

22 and professional education on the need to receive an 

23 influenza vaccine; 
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1 ‘‘(7) address alternative methods to prevent the 

2 spread of, and complications associated with, influ3 enza, including antiviral medications; 

4 ‘‘(8) address a tracking method for publicly and 

5 privately sold doses of the influenza vaccine to en6 able the Director to determine, after consultation 

7 with manufacturers of the influenza vaccine, how 

8 much supply is in circulation in the case of an influ9 enza pandemic or epidemic; and 

10 ‘‘(9) address other issues determined by the Di11 rector to be appropriate. 

12 ‘‘(c) COORDINATION; PREPARATION; PREVENTION.—

13 In establishing the protocol under subsection (a), the Di14 rector shall—

15 ‘‘(1) coordinate with health care providers, 

16 manufacturers, research institutions, health care or17 ganizations, and other expert stakeholders; 

18 ‘‘(2)(A) conduct international and national sur19 veillance; 

20 ‘‘(B) build State surveillance capacity; 

21 ‘‘(C) collect influenza vaccine safety and effi22 cacy data; and 

23 ‘‘(D) engage in epidemiological studies and re24 search on novel influenza viruses; 
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1 ‘‘(3) assist States with preparedness activities 

2 for a rapid State and local response to an influenza 

3 pandemic, including exploring methods of making 

4 the influenza vaccine more accessible to the general 

5 population; and 

6 ‘‘(4) develop systems to routinely measure the 

7 impact of influenza on pediatric and high-risk popu8 lations. 

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

10 are authorized to be appropriated to carry out this section 

11 $100,000,000 for each of fiscal years 2004 through 

12 2008.’’. 

13 TITLE V—NOTICE OF INTENT TO 

14 WITHDRAW FROM THE MARKET 

15 SEC. 501. MANUFACTURER WITHDRAWAL FROM THE MAR16 KET. 

17 Title XXI of the Public Health Service Act (42 

18 U.S.C. 300aa–1 et seq.), as amended by this Act, is fur19 ther amended by adding at the end the following: 

20 ‘‘Subtitle 4—Notice of Intent To Withdraw From the 

21 Market 

22 ‘‘MANUFACTURER WITHDRAWAL FROM THE MARKET

23 ‘‘SEC. 2151. Any manufacturer of a vaccine that re24 ceives authority under Federal law to distribute such vac25 cine shall provide advance notification to the Department 
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1 of Health and Human Services regarding such manufac2 turer’s intent to stop the distribution of such vaccine into 

3 the marketplace.’’.

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