[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4358 Introduced in House (IH)]







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 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.) is amended by inserting after section 319K the following 
section:

``SEC. 319L. EMERGENCY AUTHORITIES REGARDING SUPPLY OF INFLUENZA 
              VACCINE.

    ``(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.''.
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