109 HR 4358 IH: Influenza Vaccine Emergency Act U.S. House of Representatives 2005-11-17 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 109th CONGRESS 1st Session H. R. 4358 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.

1.

Short title

This Act may be cited as the Influenza Vaccine Emergency Act.

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:

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.

.