I 

108TH CONGRESS 

2D SESSION H. R. 5409 

To amend the Public Health Service Act to address the shortage of influenza 

vaccine, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 19, 2004 

Mrs. LOWEY (for herself, Mr. VAN HOLLEN, Mr. BISHOP of New York, and 

Mr. ISRAEL) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to address the 

shortage of influenza vaccine, 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 ‘‘Emergency Flu Re5 sponse Act of 2004’’. 

6 SEC. 2. EMERGENCY FLU RESPONSE. 

7 Title XXI of the Public Health Service Act (42 

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

9 the following: 
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1 ‘‘Subtitle 3—Influenza Vaccine 

2 ‘‘SEC. 2141. DEFINITION. 

3 ‘‘In this subtitle, the term ‘priority group’ means a 

4 group described as a priority group for vaccination with 

5 influenza vaccine in recommendations entitled ‘Interim In6 fluenza Vaccination Recommendations - 2004–2005 Influ7 enza Season’, dated October 5, 2004, or any successor to 

8 such recommendations issued by the Secretary. 

9 ‘‘SEC. 2142. EMERGENCY ACCESS TO INFLUENZA VACCINE. 

10 ‘‘(a) DECLARATION OF EMERGENCY.— 

11 ‘‘(1) IN GENERAL.—Under section 564(b)(1)(C) 

12 of the Federal Food, Drug, and Cosmetic Act (21 

13 U.S.C. 360bbb–3(b)(1)(C)), the Secretary shall im14 mediately declare the shortage of influenza vaccine 

15 in the United States for the 2004–2005 influenza 

16 season to be an emergency justifying an authoriza17 tion for a product under section 564 of such Act (21 

18 U.S.C. 360bbb). 

19 ‘‘(2) DETERMINATION.—For the purpose of 

20 making determinations under section 564(b)(1)(C) 

21 of such Act to carry out paragraph (1), the Sec22 retary— 

23 ‘‘(A) shall deem the shortage to be a public 

24 health emergency described in such section; and 
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1 ‘‘(B) shall deem influenza virus to be a bi2 ological agent. 

3 ‘‘(3) CONSTRUCTION.—Nothing in this sub4 section shall be considered to invoke the authorities 

5 described in section 319, or to limit the ability of the 

6 Secretary to invoke such authorities. 

7 ‘‘(b) SEEKING INFLUENZA VACCINE.—The Secretary 

8 shall promptly consult with the health ministries of Can9 ada, countries that are members of the European Union 

10 as of January 1, 2003, Japan, and Switzerland to assess 

11 the availability of influenza vaccine for the 2004–2005 in12 fluenza season that— 

13 ‘‘(1) has been approved, licensed, or otherwise 

14 cleared for marketing by the relevant regulatory 

15 agency in such a country; and 

16 ‘‘(2) is in excess of the needs in such country 

17 for the vaccination of persons at high risk for com18 plications from influenza. 

19 ‘‘(c) ISSUANCE OF AUTHORIZATION.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall 

21 promptly evaluate available influenza vaccine (as 

22 identified under subsection (b)) to determine wheth23 er the vaccine meets the criteria for issuance of an 

24 authorization under section 564(c) of the Federal 
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1 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–

2 3(c)). 

3 ‘‘(2) CRITERIA.—For the purpose of making 

4 determinations under section 564(c) of such Act to 

5 carry out paragraph (1), the Secretary—

6 ‘‘(A) shall deem influenza virus to be an 

7 agent that can cause a serious or life-threat8 ening disease or condition; and 

9 ‘‘(B) shall deem the shortage described in 

10 subsection (a)(1) to be sufficient evidence that 

11 there is no alternative described in section 

12 564(c)(3). 

13 ‘‘(d) VACCINE PURCHASE.—Not later than 30 days 

14 after the date of enactment of the Emergency Flu Re15 sponse Act of 2004, the Secretary shall purchase, at a rea16 sonable price, available influenza vaccine identified under 

17 subsection (b) for which the Secretary has issued an au18 thorization under section 564(c) of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(c)). 

20 ‘‘(e) VACCINE DISTRIBUTION.—Notwithstanding any 

21 other provision of law, the Secretary shall promptly import 

22 and distribute any influenza vaccine purchased under sub23 section (d), giving first priority to persons in priority 

24 groups. 
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1 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 such sums as may be necessary for fiscal year 2005. 

4 ‘‘SEC. 2143. EFFECTIVE RESPONSES TO VACCINE SHORT5 AGES. 

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

7 grant to each State to allow such State to develop and 

8 implement a plan to respond to the shortage of influenza 

9 vaccine in the United States for the 2004–2005 influenza 

10 season. 

11 ‘‘(b) USE OF FUNDS.—A State that receives a grant 

12 under this section shall use the funds made available 

13 through a grant under subsection (a) to develop— 

14 ‘‘(1) a voluntary plan to ensure that the influ15 enza vaccine is, to the maximum extent possible, ad16 ministered to priority groups; 

17 ‘‘(2) a system to notify health care providers 

18 about revisions in guidelines for administering influ19 enza vaccine; 

20 ‘‘(3) an awareness campaign to inform the pub21 lic about recommendations concerning groups that 

22 are priority groups for vaccination with influenza 

23 vaccine; and 

24 ‘‘(4) procedures to allow for the voluntary dona25 tion of vaccine as described in section 2145. 
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1 ‘‘(c) AMOUNT.—The amount of a grant under sub2 section (a) shall be proportional to the population of the 

3 State and the severity of the shortage of influenza vaccine 

4 in such State, as determined by the Secretary. 

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

6 are authorized to be appropriated to carry out this section 

7 such sums as may be necessary for fiscal year 2005. 

8 ‘‘SEC. 2144. EFFECTIVE MONITORING OF THE NATION’S IN9 FLUENZA VACCINE SUPPLY. 

10 ‘‘(a) MANUFACTURERS.—Not later than 15 days 

11 after the date of enactment of the Emergency Flu Re12 sponse Act of 2004 and every 30 days thereafter, any per13 son who manufactures influenza vaccine for introduction 

14 into interstate commerce shall prepare and submit to the 

15 Secretary a summary report that lists— 

16 ‘‘(1) each client, both public and private, who 

17 purchased influenza vaccine from the manufacturer 

18 during the period covered by the report; and 

19 ‘‘(2) the number of doses of influenza vaccine 

20 sold to each client during the period. 

21 ‘‘(b) STATE PUBLIC HEALTH AGENCIES.—To be eli22 gible to receive a grant under section 2143(a), a State 

23 through its public health agency shall, not later than 15 

24 days after the date of enactment of the Emergency Flu 

25 Response Act of 2004 and every 30 days thereafter, pre-
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1 pare and submit to the Secretary a summary report de2 scribing— 

3 ‘‘(1) the number of doses of influenza vaccine 

4 available in the State during the period covered by 

5 the report; 

6 ‘‘(2) the number of such doses that were given 

7 to each priority group during that period; and 

8 ‘‘(3) to the extent that such information is 

9 readily obtainable by the State, the manner in which 

10 such doses were distributed to consumers during 

11 such period, such as by distribution through public 

12 health agencies or private health care providers. 

13 ‘‘SEC. 2145. CLEARINGHOUSES FOR VOLUNTARY DONATION 

14 OF INFLUENZA VACCINE. 

15 ‘‘The Centers for Disease Control and Prevention, 

16 and each State public health agency described in section 

17 2144(b), shall establish a clearinghouse to— 

18 ‘‘(1) enable persons to voluntarily donate influ19 enza vaccine doses; and 

20 ‘‘(2) distribute the doses for administration to 

21 individuals in priority groups. 

22 ‘‘SEC. 2146. PURCHASES OF INFLUENZA VACCINE. 

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

24 program through which the Secretary may— 
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1 ‘‘(1) purchase from private employers, vaccine 

2 wholesalers, and other appropriate individuals and 

3 entities, doses of influenza vaccine that are not need4 ed for the vaccination of priority groups; and 

5 ‘‘(2) distribute the doses purchased under para6 graph (1) for administration to individuals in pri7 ority areas. 

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

9 are authorized to be appropriated to carry out this section 

10 such sums as may be necessary for fiscal year 2005. 

11 ‘‘SEC. 2147. USE OF INFLUENZA VACCINE. 

12 ‘‘(a) EXECUTIVE BRANCH.—The head of each Execu13 tive agency (as defined in section 105 of title 5, United 

14 States Code) shall ensure that any influenza vaccine in 

15 the possession of the head of the agency shall— 

16 ‘‘(1) be administered only to employees of the 

17 agency who are in priority groups; and 

18 ‘‘(2) provide to the Secretary any doses of the 

19 vaccine that are not needed for the vaccination of in20 dividuals in priority groups, so that the Secretary 

21 can distribute the doses for administration to indi22 viduals in the priority groups. 

23 ‘‘(b) LEGISLATIVE BRANCH.—The Attending Physi24 cian of the Capitol shall ensure that any influenza vaccine 

25 in the possession of the Attending Physician shall— 
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1 ‘‘(1) be administered only to employees of the 

2 legislative branch of the Federal Government who 

3 are in priority groups; and 

4 ‘‘(2) provide to the Secretary any doses of the 

5 vaccine that are not needed for the vaccination of in6 dividuals in priority groups, so that the Secretary 

7 can distribute the doses for administration to indi8 viduals in the priority groups. 

9 ‘‘SEC. 2148. ENHANCING EXISTING COUNTERMEASURES 

10 AGAINST INFLUENZA. 

11 ‘‘(a) AUTHORIZATION TO PURCHASE.—The Secretary 

12 may, subject to amounts appropriated under subsection 

13 (d), purchase at a reasonable negotiated price, such addi14 tional amounts of any drug approved by the Commissioner 

15 of Food and Drugs to treat influenza as are determined 

16 necessary by the Secretary. 

17 ‘‘(b) ADDITION TO STOCKPILE.—The Secretary shall 

18 include any drug purchased under subsection (a) in the 

19 stockpile established under section 121 of the Public 

20 Health Security and Bioterrorism Preparedness and Re21 sponse Act of 2002. 

22 ‘‘(c) INCREASING THE EFFECTIVENESS OF EXISTING

23 VACCINE SUPPLIES.—The Secretary, acting through the 

24 Director of the National Institutes of Health, shall con25 duct a clinical trial or trials to determine whether influ-
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1 enza vaccine can be diluted and continue to retain its ef2 fectiveness in preventing influenza in individuals in pri3 ority groups. 

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

5 are authorized to be appropriated to carry out this section 

6 such sums as may be necessary for fiscal year 2005. 

7 ‘‘SEC. 2149. NATIONAL QUARANTINE COMPENSATION PRO8 GRAM. 

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

10 Quarantine Compensation Program to be administered by 

11 the Secretary under which compensation shall be paid to 

12 individuals who are subjected to an order of quarantine 

13 issued by a Federal or State health agency. 

14 ‘‘(b) AMOUNT.—An individual’s compensation under 

15 the National Quarantine Compensation Program shall be 

16 equal to wages lost as a result of such individual being 

17 subjected to the quarantine. 

18 ‘‘(c) APPROPRIATIONS.—There are authorized to be 

19 appropriated and there are hereby appropriated to carry 

20 out subsections (a) and (b) such sums as may be nec21 essary. 

22 ‘‘SEC. 2150. EMPLOYMENT RIGHTS AND PROTECTIONS RE23 LATING TO FEDERALLY MANDATED HEALTH24 RELATED QUARANTINE. 

25 ‘‘(a) DEFINITIONS.—In this section: 
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1 ‘‘(1) EMPLOYER.—The term ‘employer’— 

2 ‘‘(A) means any person engaged in com3 merce or in any industry or activity affecting 

4 commerce; and 

5 ‘‘(B) includes— 

6 ‘‘(i)(I) any person who acts, directly 

7 or indirectly, in the interest of a person de8 scribed in subparagraph (A) to any of the 

9 employees of such person; or 

10 ‘‘(II) any successor in interest of a 

11 person described in subparagraph (A); 

12 ‘‘(ii) any public agency, as defined in 

13 section 3(x) of the Fair Labor Standards 

14 Act of 1938 (29 U.S.C. 203(x)); 

15 ‘‘(iii) the Government Accountability 

16 Office, the Government Printing Office, 

17 and the Library of Congress; and 

18 ‘‘(iv) all other legislative branch enti19 ties identified as employing offices in the 

20 Congressional Accountability Act of 1995 

21 (2 U.S.C. 1301 et seq.). 

22 ‘‘(2) EMPLOYMENT BENEFITS.—The term ‘em23 ployment benefits’ means all benefits provided or 

24 made available to employees by an employer, includ25 ing group life insurance, health insurance, disability 
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1 insurance, sick leave, annual leave, educational bene2 fits, and pensions, regardless of whether such bene3 fits are provided by a practice or written policy of 

4 an employer or through an employee benefit plan, as 

5 defined in section 3 of the Employee Retirement In6 come Security Act of 1974 (29 U.S.C. 1002). 

7 ‘‘(3) SECRETARY.— 

8 ‘‘(A) IN GENERAL.—Except as otherwise 

9 provided in subparagraph (B), the term ‘Sec10 retary’ means the Secretary of Labor. 

11 ‘‘(B) EXCEPTIONS.—In the case of actions 

12 brought regarding employees— 

13 ‘‘(i) of the Government Accountability 

14 Office, the term ‘Secretary’ means the 

15 Comptroller General of the United States; 

16 ‘‘(ii) of the Government Printing Of17 fice, the term ‘Secretary’ means the Public 

18 Printer; 

19 ‘‘(iii) of the Library of Congress, the 

20 term ‘Secretary’ means the Librarian of 

21 Congress; and 

22 ‘‘(iv) of any other legislative branch 

23 employer, the term ‘Secretary’ means the 

24 Office of Compliance. 
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1 ‘‘(b) EMPLOYMENT RIGHTS, BENEFITS, AND PRO2 TECTION FROM DISCRIMINATION.— 

3 ‘‘(1) RESTORATION TO POSITION.—Any indi4 vidual subjected to an order of quarantine issued by 

5 a Federal or State health agency shall be entitled, 

6 on return from such quarantine— 

7 ‘‘(A) to be restored by the employer of 

8 such individual to the position of employment 

9 held by the individual when the quarantine of 

10 such individual commenced; or 

11 ‘‘(B) to be restored to an equivalent posi12 tion with equivalent employment benefits, pay, 

13 and other terms and conditions of employment. 

14 ‘‘(2) BENEFITS.—An individual restored to 

15 such individual’s position, or equivalent position, 

16 pursuant to paragraph (1) shall be entitled to the 

17 seniority and other rights and benefits that the indi18 vidual had on the date when the quarantine of such 

19 individual commenced, plus the additional seniority 

20 and rights and benefits that the individual would 

21 have attained had the individual not been subjected 

22 to a federally mandated health-related quarantine. 

23 ‘‘(3) PROTECTION FROM DISCRIMINATION.—It 

24 shall be unlawful for an employer to discharge or in 

25 any other manner discriminate against any indi-
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1 vidual on the basis of such individual’s being, or 

2 having been, subjected to a federally mandated 

3 health-related quarantine. 

4 ‘‘(c) INVESTIGATIVE AUTHORITY; ENFORCEMENT.— 

5 ‘‘(1) IN GENERAL.—The Secretary shall ensure 

6 compliance with the provisions of subsection (b) and 

7 enforce violations of subsection (b). 

8 ‘‘(2) SAME AUTHORITIES.—In order to carry 

9 out paragraph (1), the Secretary shall have the same 

10 authorities as provided to the Secretary under sec11 tions 106 and 107 of the Family and Medical Leave 

12 Act of 1993 (29 U.S.C. 209 and 210) to ensure 

13 compliance with and enforce violations of the Family 

14 and Medical Leave Act of 1993. 

15 ‘‘(d) STATE AND LOCAL LAWS.—Nothing in this sec16 tion shall be construed to supersede any provision of any 

17 State or local law that provides greater rights than the 

18 rights established under this section.’’. 

19 ‘‘SEC. 2151. ASSURING THAT INDIVIDUALS IN PRIORITY 

20 GROUPS RECEIVE VACCINES. 

21 ‘‘(a) DETERMINATIONS.—Not later than 30 days 

22 after the date of enactment of the Emergency Flu Re23 sponse Act of 2004, and every 30 days thereafter, the Sec24 retary shall review the effectiveness of measures taken 

25 under sections 2142 through 2147 and determine whether 
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1 the measures have ensured the distribution of influenza 

2 vaccine for administration to individuals in priority 

3 groups. If the Secretary determines that the measures 

4 have not ensured that distribution, the Secretary— 

5 ‘‘(1) may take the actions described in sub6 section (b) if the Secretary determines that such ac7 tions are needed to protect the public health; and 

8 ‘‘(2) shall notify the appropriate committees of 

9 Congress of such determination. 

10 ‘‘(b) ASSURING THE INDIVIDUALS IN PRIORITY

11 GROUPS RECEIVE VACCINES.—On making the determina12 tion described in subsection (a), the Secretary may require 

13 that a person, not including a person that is a manufac14 turer of influenza vaccine, who possesses influenza vaccine 

15 sell such person’s supply of the influenza vaccine to the 

16 Federal Government, as an exercise of the Federal Gov17 ernment’s power to take private property for public use, 

18 for just compensation. 

19 ‘‘(c) PRIORITIZATION.—The Secretary shall dis20 tribute the doses of influenza vaccine obtained under sub21 section (b) in a manner determined appropriate by the 

22 Secretary to ensure that such vaccine is administered to 

23 individual in priority groups.’’. 

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