I 
109TH CONGRESS 
1ST SESSION H. R. 4358 
To amend the Public Health Service Act to provide for emergency 
distributions of influenza vaccine. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 17, 2005 
Mr. DEFAZIO (for himself, Mr. HINCHEY, Mrs. MALONEY, Mr. MCNULTY, 
Mr. KUCINICH, Mr. ALLEN, Mr. GUTIERREZ, Mr. CROWLEY, Ms. LEE, 
Mr. HOLDEN, Mr. KILDEE, and Mr. SANDERS) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to provide for 
emergency distributions of influenza vaccine. 
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 ‘‘Influenza Vaccine 
Emergency Act’’.
SEC. 2. EMERGENCY DISTRIBUTIONS OF INFLUENZA VAC-
CINE. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 319K the following section: 
‘‘SEC. 319L. EMERGENCY AUTHORITIES REGARDING SUP-
PLY OF INFLUENZA VACCINE. 
‘‘(a) CONTINGENCY
CLAUSES
IN
SALES
CON-
TRACTS.—In entering into a contract for the sale of influ-
enza vaccine in interstate commerce, a manufacturer or 
distributor of such vaccine shall include in the contract 
a provision in writing expressing the policy that the sale 
to the purchaser under the contract is subject to the fol-
lowing conditions: 
‘‘(1) If the Secretary publishes in the Federal 
Register a declaration that there is a public health 
emergency by reason of a shortage of influenza vac-
cine, the Secretary has the authority, in lieu of such 
purchaser, to take title to such quantities of the vac-
cine as the Secretary determines to be necessary for 
purposes of the public health, subject to subsection 
(c)(2). 
‘‘(2) If by reason of the Secretary using the au-
thority under paragraph (1) the purchaser does not 
receive, or loses possession of, a quantity of influ-
enza vaccine for which the purchaser has made pay-
ment, the manufacturer or distributor (as the case 
may be) will provide to the purchaser a refund for 
such quantity. 
‘‘(b) COMPENSATION.—In the case of a contract for 
the sale of influenza vaccine with respect to which the Sec-
retary uses the authority referred to in subsection (a)(1), 
the Secretary shall pay to the manufacturer or distributor 
involved the same amount as, under the contract, the man-
ufacturer or distributor received or would have received 
for the quantity of vaccine involved. 
‘‘(c) AGENCY PROCEDURES.—With respect to the in-
fluenza season involved: 
‘‘(1) If the Secretary makes an emergency dec-
laration under subsection (a)(1), the Secretary shall 
determine the extent of compliance with guidelines 
for the distribution of influenza vaccine that have 
been established by the Secretary. 
‘‘(2) The Secretary may not use the authority 
referred to in subsection (a)(1) with respect to any 
contract unless the Secretary has published in the 
Federal Register, not earlier than 30 days after 
making the emergency declaration under such sub-
section, a determination that the extent of compli-
ance with such guidelines has not been sufficient to 
constitute an adequate response to the emergency.
‘‘(d) DISTRIBUTION OF VACCINE.—If the Secretary 
meets the condition described in subsection (c)(2) for the 
use of the authority referred to in subsection (a)(1): 
‘‘(1) The Secretary may, in lieu of such author-
ity, order any manufacturer or distributor of influ-
enza vaccine to honor its contracts with States or 
political subdivisions of States for the sale of such 
vaccine, in any case in which the manufacturer or 
distributor has conflicting obligations under its con-
tracts for sale of the vaccine. 
‘‘(2) Any influenza vaccine to which the Sec-
retary takes title under subsection (a)(1) shall be 
provided— 
‘‘(A) to States and political subdivisions of 
States in accordance with the immunization 
program under section 317(j); and 
‘‘(B) to such other public or private enti-
ties as the Secretary determines to be appro-
priate as a response to the emergency involved. 
‘‘(e) RULES OF CONSTRUCTION.— 
‘‘(1) EMERGENCY
DECLARATION.—The Sec-
retary shall be considered to have made an emer-
gency declaration under subsection (a)(1) if the Sec-
retary publishes in the Federal Register a declara-
tion described in such subsection.
‘‘(2) EMERGENCY SHORTAGE.— 
‘‘(A) OVERALL
QUANTITY
VS. DELIVERY 
WAITING TIME.—Without regard to whether the 
Secretary considers as adequate the total quan-
tity of influenza vaccine that has been or is 
being manufactured for the influenza season in-
volved, the Secretary may make an emergency 
declaration under subsection (a)(1) if the Sec-
retary determines that the delivery waiting time 
for States or political subdivisions of States to 
receive the vaccine for the season is a period 
whose duration constitutes a significant threat 
to children, adolescents, or adults who are 
served by the immunization program under sec-
tion 317(j). 
‘‘(B) DELIVERY WAITING TIME.—A deliv-
ery waiting time under subparagraph (A) for a 
State or political subdivision of a State to re-
ceive influenza vaccine is the time elapsing be-
tween the date on which the State or subdivi-
sion enters into a contract to purchase such 
vaccine and the date on which the State or sub-
division (or other entity designated under the 
contract) takes custody of the vaccine, less any 
period in which payment is due under the con-
tract and the State or subdivision has not made 
payment, or in which the State or subdivision 
otherwise is in significant violation of the con-
tract. 
‘‘(f) DEFINITIONS.—For purposes of this subsection, 
the terms ‘influenza season’ and ‘influenza vaccine’ have 
the meanings given such terms by the Secretary.’’. 
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