I

107TH CONGRESS

1ST SESSION H. R. 910

To amend the Public Health Service Act to provide for emergency

distributions of influenza vaccine.

IN THE HOUSE OF REPRESENTATIVES

MARCH 7, 2001

Mr. DEFAZIO (for himself 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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Influenza Vaccine

5 Emergency Act’’.

6 SEC. 2. EMERGENCY DISTRIBUTIONS OF INFLUENZA VAC7 CINE.

8 Part B of title III of the Public Health Service Act

9 (42 U.S.C. 243 et seq.), as amended by section 102 of

10 Public Law 106–505 (114 Stat. 2315), is amended—
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1 (1) by redesignating sections 319A through

2 319G as sections 319B through 319H, respectively;

3 and

4 (2) by inserting after section 319 the following

5 section:

6 ‘‘EMERGENCY AUTHORITIES REGARDING SUPPLY OF

7 INFLUENZA VACCINE

8 ‘‘SEC. 319A. (a) CONTINGENCY CLAUSES IN SALES

9 CONTRACTS.—In entering into a contract for the sale of

10 influenza vaccine in interstate commerce, a manufacturer

11 or distributor of such vaccine shall include in the contract

12 a provision in writing expressing the policy that the sale

13 to the purchaser under the contract is subject to the fol14 lowing conditions:

15 ‘‘(1) If the Secretary publishes in the Federal

16 Register a declaration that there is a public health

17 emergency by reason of a shortage of influenza vac18 cine, the Secretary has the authority, in lieu of such

19 purchaser, to take title to such quantities of the vac20 cine as the Secretary determines to be necessary for

21 purposes of the public health, subject to subsection

22 (c)(2).

23 ‘‘(2) If by reason of the Secretary using the au24 thority under paragraph (1) the purchaser does not

25 receive, or loses possession of, a quantity of influ26 enza vaccine for which the purchaser has made pay-
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1 ment, the manufacturer or distributor (as the case

2 may be) will provide to the purchaser a refund for

3 such quantity.

4 ‘‘(b) COMPENSATION.—In the case of a contract for

5 the sale of influenza vaccine with respect to which the Sec6 retary uses the authority referred to in subsection (a)(1),

7 the Secretary shall pay to the manufacturer or distributor

8 involved the same amount as, under the contract, the man9 ufacturer or distributor received or would have received

10 for the quantity of vaccine involved.

11 ‘‘(c) AGENCY PROCEDURES.—With respect to the in12 fluenza season involved:

13 ‘‘(1) If the Secretary makes an emergency dec14 laration under subsection (a)(1), the Secretary shall

15 determine the extent of compliance with guidelines

16 for the distribution of influenza vaccine that have

17 been established by the Secretary.

18 ‘‘(2) The Secretary may not use the authority

19 referred to in subsection (a)(1) with respect to any

20 contract unless the Secretary has published in the

21 Federal Register, not earlier than 30 days after

22 making the emergency declaration under such sub23 section, a determination that the extent of compli24 ance with such guidelines has not been sufficient to

25 constitute an adequate response to the emergency.
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1 ‘‘(d) DISTRIBUTION OF VACCINE.—If the Secretary

2 meets the condition described in subsection (c)(2) for the

3 use of the authority referred to in subsection (a)(1):

4 ‘‘(1) The Secretary may, in lieu of such author5 ity, order any manufacturer or distributor of influ6 enza vaccine to honor its contracts with States or

7 political subdivisions of States for the sale of such

8 vaccine, in any case in which the manufacturer or

9 distributor has conflicting obligations under its con10 tracts for sale of the vaccine.

11 ‘‘(2) Any influenza vaccine to which the Sec12 retary takes title under subsection (a)(1) shall be

13 provided—

14 ‘‘(A) to States and political subdivisions of

15 States in accordance with the immunization

16 program under section 317(j); and

17 ‘‘(B) to such other public or private enti18 ties as the Secretary determines to be appro19 priate as a response to the emergency involved.

20 ‘‘(e) RULES OF CONSTRUCTION.—

21 ‘‘(1) EMERGENCY DECLARATION.—The Sec22 retary shall be considered to have made an emer23 gency declaration under subsection (a)(1) if the Sec24 retary publishes in the Federal Register a declara25 tion described in such subsection.
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1 ‘‘(2) EMERGENCY SHORTAGE.—

2 ‘‘(A) OVERALL QUANTITY VS. DELIVERY

3 WAITING TIME.—Without regard to whether the

4 Secretary considers as adequate the total quan5 tity of influenza vaccine that has been or is

6 being manufactured for the influenza season in7 volved, the Secretary may make an emergency

8 declaration under subsection (a)(1) if the Sec9 retary determines that the delivery waiting time

10 for States or political subdivisions of States to

11 receive the vaccine for the season is a period

12 whose duration constitutes a significant threat

13 to children, adolescents, or adults who are

14 served by the immunization program under sec15 tion 317(j).

16 ‘‘(B) DELIVERY WAITING TIME.—A deliv17 ery waiting time under subparagraph (A) for a

18 State or political subdivision of a State to re19 ceive influenza vaccine is the time elapsing be20 tween the date on which the State or subdivi21 sion enters into a contract to purchase such

22 vaccine and the date on which the State or sub23 division (or other entity designated under the

24 contract) takes custody of the vaccine, less any

25 period in which payment is due under the con-
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1 tract and the State or subdivision has not made

2 payment, or in which the State or subdivision

3 otherwise is in significant violation of the con4 tract.

5 ‘‘(f) DEFINITIONS.—For purposes of this subsection,

6 the terms ‘influenza season’ and ‘influenza vaccine’ have

7 the meanings given such terms by the Secretary.’’.

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