I 

108TH CONGRESS 

2D SESSION H. R. 3758

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 HOUSE OF REPRESENTATIVES 

FEBRUARY 3, 2004

Mr. EMANUEL (for himself, Mr. SHIMKUS, Ms. DEGETTE, and Mr. ENGEL) 

introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and 

Means, for a period to be subsequently determined by the Speaker, in 

each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL

To 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,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Flu Protection Act 

3 of 2004’’. 

4 TITLE I—FLU VACCINE 

5 AWARENESS CAMPAIGN 

6 SEC. 101. AWARENESS CAMPAIGN AND EDUCATION AND 

7 OUTREACH EFFORTS. 

8 Title XXI of the Public Health Service Act (42 

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

10 the following: 

11 ‘‘Subtitle 3—Influenza Vaccine 

12 ‘‘AWARENESS CAMPAIGN AND EDUCATION AND OUTREACH

13 EFFORTS

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

15 through the Director of the Centers for Disease Control 

16 and Prevention (in this subtitle referred to as the ‘Direc17 tor’), shall conduct a public awareness campaign and edu18 cation and outreach efforts each year during the time pe19 riod preceding the influenza season on each of the fol20 lowing: 

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

22 vaccine. 

23 ‘‘(2) Which populations the Director rec24 ommends to receive the influenza vaccine to prevent 

25 health complications associated with influenza, in26 cluding health care workers and household contacts. 
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1 ‘‘(3) Professional medical education of physi2 cians, nurses, pharmacists, and other health care 

3 providers and such providers’ associated organiza4 tions. 

5 ‘‘(4) Information that emphasizes the safety, ef6 ficacy, and benefit of recommended vaccines for the 

7 public good. 

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

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

10 Centers for Medicare & Medicaid Services shall, at 

11 the earliest possible time in the influenza vaccine 

12 planning and production process, reach out to pro13 viders of medicare services, including managed care 

14 providers, nursing homes, hospitals, and physician 

15 offices to urge early and full preordering of the in16 fluenza vaccine so that production levels can accom17 modate the needs for the influenza vaccine. 

18 ‘‘(2) RATES OF IMMUNIZATION AMONG MEDI19 CARE RECIPIENTS.—The Director shall work with 

20 the Administrator of the Centers for Medicare & 

21 Medicaid Services to publish the rates of influenza 

22 immunization among individuals receiving assistance 

23 under the medicare program under title XVIII of the 

24 Social Security Act (42 U.S.C. 1395 et seq.). 
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1 ‘‘(c) STATE AND PUBLIC HEALTH ADULT IMMUNIZA2 TION ACTIVITIES.—The Director shall support the devel3 opment of State adult immunization programs that place 

4 emphasis on improving influenza vaccine delivery to high5 risk populations and the general population, including the 

6 exploration of improving access to the influenza vaccine. 

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

8 work with appropriate agencies in conducting a study to 

9 assess the efficacy of the influenza vaccine. 

10 ‘‘(e) EXISTING MODES OF COMMUNICATION.—In car11 rying out the public awareness campaign and education 

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

13 Director may use existing websites or structures for com14 munication. 

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

16 are authorized to be appropriated to carry out this section 

17 $10,000,000 for each of fiscal years 2004 through 2008.’’. 

18 TITLE II—ENCOURAGING VAC19 CINE PRODUCTION CAPACITY 

20 SEC. 201. INCENTIVES FOR THE CONSTRUCTION OF VAC21 CINE MANUFACTURING FACILITIES. 

22 (a) VACCINE MANUFACTURING FACILITIES INVEST23 MENT TAX CREDIT.—

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

25 Internal Revenue Code of 1986 (relating to amount 
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1 of investment credit) is amended by striking ‘‘and’’ 

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

3 at the end of paragraph (3) and inserting ‘‘, and’’, 

4 and by adding at the end the following new para5 graph: 

6 ‘‘(4) the vaccine manufacturing facilities invest7 ment credit.’’. 

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

9 Code is amended by adding at the end the following 

10 new subsection: 

11 ‘‘(c) VACCINE MANUFACTURING FACILITIES INVEST12 MENT CREDIT.—

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

14 the vaccine manufacturing facilities investment cred15 it for any taxable year is an amount equal to 20 per16 cent of the qualified investment for such taxable 

17 year. 

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

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

20 taxable year is the basis of each vaccine manufac21 turing facilities property placed in service by the tax22 payer during such taxable year. 

23 ‘‘(3) VACCINE MANUFACTURING FACILITIES

24 PROPERTY.—For purposes of this subsection, the 
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1 term ‘vaccine manufacturing facilities property’ 

2 means real and tangible personal property—

3 ‘‘(A)(i) the original use of which com4 mences with the taxpayer, or 

5 ‘‘(ii) which is acquired through purchase 

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

7 ‘‘(B) which is depreciable under section 

8 167, 

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

10 distribution, or research and development of 

11 vaccines, and 

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

13 standards and regulations which are promul14 gated by the Food and Drug Administration, 

15 the Occupational Safety and Health Adminis16 tration, or the Environmental Protection Agen17 cy and which are applicable to such property. 

18 ‘‘(4) CERTAIN PROGRESS EXPENDITURE RULES

19 MADE APPLICABLE.—Rules similar to rules of sub20 sections (c)(4) and (d) of section 46 (as in effect on 

21 the day before the date of the enactment of the Rev22 enue Reconciliation Act of 1990) shall apply for pur23 poses of this subsection. 
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1 ‘‘(5) TERMINATION.—This subsection shall not 

2 apply to any property placed in service after Decem3 ber 31, 2008.’’. 

4 (b) TECHNICAL AMENDMENTS.—

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

6 such Code is amended by striking ‘‘and’’ at the end 

7 of clause (ii), by striking the period at the end of 

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

9 the end the following new clause: 

10 ‘‘(iv) the basis of any vaccine manu11 facturing facilities property.’’. 

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

13 such Code is amended by inserting ‘‘or 48(c)(4)’’ be14 fore the period. 

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

16 such Code is amended to read as follows: 

17 ‘‘SEC. 48. OTHER CREDITS.’’. 

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

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

20 amended by striking the item relating to section 48 

21 and inserting the following:

‘‘Sec. 48. Other credits.’’.

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

23 this section shall apply to property placed in service after 

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

25 section 48(m) of the Internal Revenue Code of 1986 (as 
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1 in effect on the day before the date of the enactment of 

2 the Revenue Reconciliation Act of 1990). 

3 TITLE III—ENSURING SUFFI4 CIENT FLU VACCINE SUPPLY 

5 SEC. 301. VACCINE SUPPLY. 

6 Subtitle 3 of title XXI of the Public Health Service 

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

8 the end the following: 

9 ‘‘VACCINE SUPPLY

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

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

12 each year, the Director shall enter into a contract 

13 with one or more manufacturers to produce such ad14 ditional doses of the influenza vaccine as determined 

15 necessary by the Director. 

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

17 additional doses shall provide that the manufacturer 

18 will be compensated by the Director at an equitable 

19 rate negotiated by the Director and the manufac20 turer for any doses that—

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

22 through routine market mechanisms at the end 

23 of the influenza season for that year; and 

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

25 produced by such manufacturer. 
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1 ‘‘(3) WHEN SUCH VACCINE PURCHASES

2 SHOULD TAKE PLACE.—The Director may purchase 

3 from a manufacturer the doses for which it has con4 tracted at any time after which it is determined by 

5 the Director, in consultation with the manufacturer, 

6 that the doses will likely not be absorbed by the pri7 vate market. 

8 ‘‘(b) CONTINGENCY PLAN.—The Director shall en9 courage States to develop a contingency plan, in coordina10 tion with the Department of Health and Human Services, 

11 for maximizing influenza immunization for high-risk popu12 lations in the event of a delay or shortage of the influenza 

13 vaccine. 

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

15 are authorized to be appropriated to carry out this section 

16 such sums as may be necessary.’’. 

17 TITLE IV—PREPARING FOR A 

18 PANDEMIC OR EPIDEMIC 

19 SEC. 401. PREPARATION FOR INFLUENZA PANDEMIC OR 

20 EPIDEMIC. 

21 Subtitle 3 of title XXI of the Public Health Service 

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

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

24 ‘‘PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC

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

26 The Secretary, acting through the Director, shall establish 
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1 a protocol to attempt to prevent, prepare for, and respond 

2 to an influenza pandemic or epidemic. Such protocol shall 

3 be updated as determined appropriate by the Director. 

4 ‘‘(b) CONTENTS OF PROTOCOL.—The protocol estab5 lished under subsection (a) shall—

6 ‘‘(1) address methods to coordinate dissemina7 tion of the influenza vaccine to key populations in 

8 the event of an influenza pandemic or epidemic; 

9 ‘‘(2) address expansion of influenza vaccine 

10 manufacturing capacity (including making advance 

11 arrangements for ensuring the availability of raw 

12 materials) to respond to the needs of the United 

13 States during an influenza pandemic or epidemic; 

14 ‘‘(3) improve upon the current influenza vac15 cines and production and dissemination methods; 

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

17 produce the influenza vaccine; 

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

19 vaccine should be produced on an annual basis and 

20 which strains of influenza should be covered by such 

21 vaccine in a particular year; 

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

23 and professional education on the need to receive an 

24 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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