Influenza Vaccine Emergency Act - Amends the Public Health Service Act to require influenza vaccine manufacturers to include a provision in any contract for the sale of the vaccine in interstate commerce expressing the policy that the Secretary of Health and Human Services has the authority to take title to necessary quantities of the vaccine if the Secretary declares that there is a public health emergency by reason of an influenza vaccine shortage, and that the manufacturer will reimburse the purchaser for any such quantity not received.
Requires the Secretary to pay the manufacturer or distributor for any quantity taken at the price the manufacturer or distributor would have received for that quantity of vaccine.
Requires the Secretary to determine the extent of compliance with guidelines for the distribution of influenza vaccine and, before using the authority to take title to the vaccine, to publish notice that such compliance has not been sufficient to constitute an adequate response to the emergency. Allows the Secretary, in lieu of taking title to a vaccine, to order any vaccine manufacturer or distributor to honor its contracts with States or political subdivisions. Requires the Secretary to provide any influenza vaccine to States, political subdivisions, and such other public or private entities as appropriate as a response to the emergency involved. Allows the Secretary to make an emergency declaration if the delivery waiting time for States or political subdivisions to receive the vaccine constitutes a significant threat to children, adolescents, or adults served by the immunization program.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5243 Introduced in House (IH)]
108th CONGRESS
2d Session
H. R. 5243
To amend the Public Health Service Act to provide for emergency
distributions of influenza vaccine.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 7, 2004
Mr. DeFazio (for himself, Ms. Woolsey, Mr. George Miller of California,
Mr. Boswell, Mr. Costello, Mr. Abercrombie, Mr. Sanders, Mr. Scott of
Virginia, Mr. Crowley, Mr. Baird, Mr. Hinchey, Mr. Holden, Mr.
Gutierrez, Mrs. Christensen, Mrs. Maloney, Ms. Norton, Mr. Etheridge,
Ms. McCollum, Ms. DeLauro, Ms. McCarthy of Missouri, Mr. Conyers, Mr.
Moore, Mr. Pallone, Mr. Wexler, Mr. Filner, and Mr. Ford) 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 Representatives 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 VACCINE.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by section 102 of Public Law 106-505 (114 Stat.
2315), is amended--
(1) by redesignating sections 319A through 319G as sections
319B through 319H, respectively; and
(2) by inserting after section 319 the following section:
``emergency authorities regarding supply of influenza vaccine
``Sec. 319A. (a) Contingency Clauses in Sales Contracts.--In
entering into a contract for the sale of influenza 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 following 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 vaccine, the Secretary has the
authority, in lieu of such purchaser, to take title to such
quantities of the vaccine 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 authority
under paragraph (1) the purchaser does not receive, or loses
possession of, a quantity of influenza vaccine for which the
purchaser has made payment, 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 Secretary 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 manufacturer or distributor received or would have
received for the quantity of vaccine involved.
``(c) Agency Procedures.--With respect to the influenza season
involved:
``(1) If the Secretary makes an emergency declaration 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
subsection, a determination that the extent of compliance 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 authority, order
any manufacturer or distributor of influenza 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 contracts for sale of the vaccine.
``(2) Any influenza vaccine to which the Secretary 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 entities as
the Secretary determines to be appropriate as a
response to the emergency involved.
``(e) Rules of Construction.--
``(1) Emergency declaration.--The Secretary shall be
considered to have made an emergency declaration under
subsection (a)(1) if the Secretary publishes in the Federal
Register a declaration 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 quantity of influenza vaccine that
has been or is being manufactured for the influenza
season involved, the Secretary may make an emergency
declaration under subsection (a)(1) if the Secretary
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
section 317(j).
``(B) Delivery waiting time.--A delivery waiting
time under subparagraph (A) for a State or political
subdivision of a State to receive influenza vaccine is
the time elapsing between the date on which the State
or subdivision enters into a contract to purchase such
vaccine and the date on which the State or subdivision
(or other entity designated under the contract) takes
custody of the vaccine, less any period in which
payment is due under the contract and the State or
subdivision has not made payment, or in which the State
or subdivision otherwise is in significant violation of
the contract.
``(f) Definitions.--For purposes of this subsection, the terms
`influenza season' and `influenza vaccine' have the meanings given such
terms by the Secretary.''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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