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 Com-
mittee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to address the 
shortage of influenza vaccine, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Emergency Flu Re-
sponse Act of 2004’’. 
SEC. 2. EMERGENCY FLU RESPONSE. 
Title XXI of the Public Health Service Act (42 
U.S.C. 300aa–1 et seq.) is amended by adding at the end 
the following:
‘‘Subtitle 3—Influenza Vaccine 
‘‘SEC. 2141. DEFINITION. 
‘‘In this subtitle, the term ‘priority group’ means a 
group described as a priority group for vaccination with 
influenza vaccine in recommendations entitled ‘Interim In-
fluenza Vaccination Recommendations - 2004–2005 Influ-
enza Season’, dated October 5, 2004, or any successor to 
such recommendations issued by the Secretary. 
‘‘SEC. 2142. EMERGENCY ACCESS TO INFLUENZA VACCINE. 
‘‘(a) DECLARATION OF EMERGENCY.— 
‘‘(1) IN GENERAL.—Under section 564(b)(1)(C) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3(b)(1)(C)), the Secretary shall im-
mediately declare the shortage of influenza vaccine 
in the United States for the 2004–2005 influenza 
season to be an emergency justifying an authoriza-
tion for a product under section 564 of such Act (21 
U.S.C. 360bbb). 
‘‘(2) DETERMINATION.—For the purpose of 
making determinations under section 564(b)(1)(C) 
of such Act to carry out paragraph (1), the Sec-
retary— 
‘‘(A) shall deem the shortage to be a public 
health emergency described in such section; and
‘‘(B) shall deem influenza virus to be a bi-
ological agent. 
‘‘(3) CONSTRUCTION.—Nothing in this sub-
section shall be considered to invoke the authorities 
described in section 319, or to limit the ability of the 
Secretary to invoke such authorities. 
‘‘(b) SEEKING INFLUENZA VACCINE.—The Secretary 
shall promptly consult with the health ministries of Can-
ada, countries that are members of the European Union 
as of January 1, 2003, Japan, and Switzerland to assess 
the availability of influenza vaccine for the 2004–2005 in-
fluenza season that— 
‘‘(1) has been approved, licensed, or otherwise 
cleared for marketing by the relevant regulatory 
agency in such a country; and 
‘‘(2) is in excess of the needs in such country 
for the vaccination of persons at high risk for com-
plications from influenza. 
‘‘(c) ISSUANCE OF AUTHORIZATION.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary 
shall 
promptly evaluate available influenza vaccine (as 
identified under subsection (b)) to determine wheth-
er the vaccine meets the criteria for issuance of an 
authorization under section 564(c) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–
3(c)). 
‘‘(2) CRITERIA.—For the purpose of making 
determinations under section 564(c) of such Act to 
carry out paragraph (1), the Secretary—
‘‘(A) shall deem influenza virus to be an 
agent that can cause a serious or life-threat-
ening disease or condition; and 
‘‘(B) shall deem the shortage described in 
subsection (a)(1) to be sufficient evidence that 
there is no alternative described in section 
564(c)(3). 
‘‘(d) VACCINE PURCHASE.—Not later than 30 days 
after the date of enactment of the Emergency Flu Re-
sponse Act of 2004, the Secretary shall purchase, at a rea-
sonable price, available influenza vaccine identified under 
subsection (b) for which the Secretary has issued an au-
thorization under section 564(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(c)). 
‘‘(e) VACCINE DISTRIBUTION.—Notwithstanding any 
other provision of law, the Secretary shall promptly import 
and distribute any influenza vaccine purchased under sub-
section (d), giving first priority to persons in priority 
groups.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for fiscal year 2005. 
‘‘SEC. 2143. EFFECTIVE RESPONSES TO VACCINE SHORT-
AGES. 
‘‘(a) IN GENERAL.—The Secretary shall award a 
grant to each State to allow such State to develop and 
implement a plan to respond to the shortage of influenza 
vaccine in the United States for the 2004–2005 influenza 
season. 
‘‘(b) USE OF FUNDS.—A State that receives a grant 
under this section shall use the funds made available 
through a grant under subsection (a) to develop— 
‘‘(1) a voluntary plan to ensure that the influ-
enza vaccine is, to the maximum extent possible, ad-
ministered to priority groups; 
‘‘(2) a system to notify health care providers 
about revisions in guidelines for administering influ-
enza vaccine; 
‘‘(3) an awareness campaign to inform the pub-
lic about recommendations concerning groups that 
are priority groups for vaccination with influenza 
vaccine; and 
‘‘(4) procedures to allow for the voluntary dona-
tion of vaccine as described in section 2145.
‘‘(c) AMOUNT.—The amount of a grant under sub-
section (a) shall be proportional to the population of the 
State and the severity of the shortage of influenza vaccine 
in such State, as determined by the Secretary. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for fiscal year 2005. 
‘‘SEC. 2144. EFFECTIVE MONITORING OF THE NATION’S IN-
FLUENZA VACCINE SUPPLY. 
‘‘(a) MANUFACTURERS.—Not later than 15 days 
after the date of enactment of the Emergency Flu Re-
sponse Act of 2004 and every 30 days thereafter, any per-
son who manufactures influenza vaccine for introduction 
into interstate commerce shall prepare and submit to the 
Secretary a summary report that lists— 
‘‘(1) each client, both public and private, who 
purchased influenza vaccine from the manufacturer 
during the period covered by the report; and 
‘‘(2) the number of doses of influenza vaccine 
sold to each client during the period. 
‘‘(b) STATE PUBLIC HEALTH AGENCIES.—To be eli-
gible to receive a grant under section 2143(a), a State 
through its public health agency shall, not later than 15 
days after the date of enactment of the Emergency Flu 
Response Act of 2004 and every 30 days thereafter, pre-
pare and submit to the Secretary a summary report de-
scribing— 
‘‘(1) the number of doses of influenza vaccine 
available in the State during the period covered by 
the report; 
‘‘(2) the number of such doses that were given 
to each priority group during that period; and 
‘‘(3) to the extent that such information is 
readily obtainable by the State, the manner in which 
such doses were distributed to consumers during 
such period, such as by distribution through public 
health agencies or private health care providers. 
‘‘SEC. 2145. CLEARINGHOUSES FOR VOLUNTARY DONATION 
OF INFLUENZA VACCINE. 
‘‘The Centers for Disease Control and Prevention, 
and each State public health agency described in section 
2144(b), shall establish a clearinghouse to— 
‘‘(1) enable persons to voluntarily donate influ-
enza vaccine doses; and 
‘‘(2) distribute the doses for administration to 
individuals in priority groups. 
‘‘SEC. 2146. PURCHASES OF INFLUENZA VACCINE. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
program through which the Secretary may—
‘‘(1) be administered only to employees of the 
legislative branch of the Federal Government who 
are in priority groups; and 
‘‘(2) provide to the Secretary any doses of the 
vaccine that are not needed for the vaccination of in-
dividuals in priority groups, so that the Secretary 
can distribute the doses for administration to indi-
viduals in the priority groups. 
‘‘SEC. 2148. ENHANCING EXISTING COUNTERMEASURES 
AGAINST INFLUENZA. 
‘‘(a) AUTHORIZATION TO PURCHASE.—The Secretary 
may, subject to amounts appropriated under subsection 
(d), purchase at a reasonable negotiated price, such addi-
tional amounts of any drug approved by the Commissioner 
of Food and Drugs to treat influenza as are determined 
necessary by the Secretary. 
‘‘(b) ADDITION TO STOCKPILE.—The Secretary shall 
include any drug purchased under subsection (a) in the 
stockpile established under section 121 of the Public 
Health Security and Bioterrorism Preparedness and Re-
sponse Act of 2002. 
‘‘(c) INCREASING THE EFFECTIVENESS OF EXISTING 
VACCINE SUPPLIES.—The Secretary, acting through the 
Director of the National Institutes of Health, shall con-
duct a clinical trial or trials to determine whether influ-
enza vaccine can be diluted and continue to retain its ef-
fectiveness in preventing influenza in individuals in pri-
ority groups. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for fiscal year 2005. 
‘‘SEC. 2149. NATIONAL QUARANTINE COMPENSATION PRO-
GRAM. 
‘‘(a) IN GENERAL.—There is established the National 
Quarantine Compensation Program to be administered by 
the Secretary under which compensation shall be paid to 
individuals who are subjected to an order of quarantine 
issued by a Federal or State health agency. 
‘‘(b) AMOUNT.—An individual’s compensation under 
the National Quarantine Compensation Program shall be 
equal to wages lost as a result of such individual being 
subjected to the quarantine. 
‘‘(c) APPROPRIATIONS.—There are authorized to be 
appropriated and there are hereby appropriated to carry 
out subsections (a) and (b) such sums as may be nec-
essary. 
‘‘SEC. 2150. EMPLOYMENT RIGHTS AND PROTECTIONS RE-
LATING TO FEDERALLY MANDATED HEALTH- 
RELATED QUARANTINE. 
‘‘(a) DEFINITIONS.—In this section:
‘‘(1) EMPLOYER.—The term ‘employer’— 
‘‘(A) means any person engaged in com-
merce or in any industry or activity affecting 
commerce; and 
‘‘(B) includes— 
‘‘(i)(I) any person who acts, directly 
or indirectly, in the interest of a person de-
scribed in subparagraph (A) to any of the 
employees of such person; or 
‘‘(II) any successor in interest of a 
person described in subparagraph (A); 
‘‘(ii) any public agency, as defined in 
section 3(x) of the Fair Labor Standards 
Act of 1938 (29 U.S.C. 203(x)); 
‘‘(iii) the Government Accountability 
Office, the Government Printing Office, 
and the Library of Congress; and 
‘‘(iv) all other legislative branch enti-
ties identified as employing offices in the 
Congressional Accountability Act of 1995 
(2 U.S.C. 1301 et seq.). 
‘‘(2) EMPLOYMENT BENEFITS.—The term ‘em-
ployment benefits’ means all benefits provided or 
made available to employees by an employer, includ-
ing group life insurance, health insurance, disability
insurance, sick leave, annual leave, educational bene-
fits, and pensions, regardless of whether such bene-
fits are provided by a practice or written policy of 
an employer or through an employee benefit plan, as 
defined in section 3 of the Employee Retirement In-
come Security Act of 1974 (29 U.S.C. 1002). 
‘‘(3) SECRETARY.— 
‘‘(A) IN GENERAL.—Except as otherwise 
provided in subparagraph (B), the term ‘Sec-
retary’ means the Secretary of Labor. 
‘‘(B) EXCEPTIONS.—In the case of actions 
brought regarding employees— 
‘‘(i) of the Government Accountability 
Office, the term ‘Secretary’ means the 
Comptroller General of the United States; 
‘‘(ii) of the Government Printing Of-
fice, the term ‘Secretary’ means the Public 
Printer; 
‘‘(iii) of the Library of Congress, the 
term ‘Secretary’ means the Librarian of 
Congress; and 
‘‘(iv) of any other legislative branch 
employer, the term ‘Secretary’ means the 
Office of Compliance.
‘‘(b) EMPLOYMENT RIGHTS, BENEFITS, AND PRO-
TECTION FROM DISCRIMINATION.— 
‘‘(1) RESTORATION
TO
POSITION.—Any indi-
vidual subjected to an order of quarantine issued by 
a Federal or State health agency shall be entitled, 
on return from such quarantine— 
‘‘(A) to be restored by the employer of 
such individual to the position of employment 
held by the individual when the quarantine of 
such individual commenced; or 
‘‘(B) to be restored to an equivalent posi-
tion with equivalent employment benefits, pay, 
and other terms and conditions of employment. 
‘‘(2) BENEFITS.—An individual restored to 
such individual’s position, or equivalent position, 
pursuant to paragraph (1) shall be entitled to the 
seniority and other rights and benefits that the indi-
vidual had on the date when the quarantine of such 
individual commenced, plus the additional seniority 
and rights and benefits that the individual would 
have attained had the individual not been subjected 
to a federally mandated health-related quarantine. 
‘‘(3) PROTECTION FROM DISCRIMINATION.—It 
shall be unlawful for an employer to discharge or in 
any other manner discriminate against any indi-
vidual on the basis of such individual’s being, or 
having been, subjected to a federally mandated 
health-related quarantine. 
‘‘(c) INVESTIGATIVE AUTHORITY; ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall ensure 
compliance with the provisions of subsection (b) and 
enforce violations of subsection (b). 
‘‘(2) SAME AUTHORITIES.—In order to carry 
out paragraph (1), the Secretary shall have the same 
authorities as provided to the Secretary under sec-
tions 106 and 107 of the Family and Medical Leave 
Act of 1993 (29 U.S.C. 209 and 210) to ensure 
compliance with and enforce violations of the Family 
and Medical Leave Act of 1993. 
‘‘(d) STATE AND LOCAL LAWS.—Nothing in this sec-
tion shall be construed to supersede any provision of any 
State or local law that provides greater rights than the 
rights established under this section.’’. 
‘‘SEC. 2151. ASSURING THAT INDIVIDUALS IN PRIORITY 
GROUPS RECEIVE VACCINES. 
‘‘(a) DETERMINATIONS.—Not later than 30 days 
after the date of enactment of the Emergency Flu Re-
sponse Act of 2004, and every 30 days thereafter, the Sec-
retary shall review the effectiveness of measures taken 
under sections 2142 through 2147 and determine whether