I 

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.

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’’. 
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1 SEC. 2. EMERGENCY DISTRIBUTIONS OF INFLUENZA VAC2 CINE. 

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

4 (42 U.S.C. 243 et seq.), as amended by section 102 of 

5 Public Law 106–505 (114 Stat. 2315), is amended—

6 (1) by redesignating sections 319A through 

7 319G as sections 319B through 319H, respectively; 

8 and 

9 (2) by inserting after section 319 the following 

10 section: 

11 ‘‘EMERGENCY AUTHORITIES REGARDING SUPPLY OF

12 INFLUENZA VACCINE

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

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

15 influenza vaccine in interstate commerce, a manufacturer 

16 or distributor of such vaccine shall include in the contract 

17 a provision in writing expressing the policy that the sale 

18 to the purchaser under the contract is subject to the fol19 lowing conditions: 

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

21 Register a declaration that there is a public health 

22 emergency by reason of a shortage of influenza vac23 cine, the Secretary has the authority, in lieu of such 

24 purchaser, to take title to such quantities of the vac25 cine as the Secretary determines to be necessary for 
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1 purposes of the public health, subject to subsection 

2 (c)(2). 

3 ‘‘(2) If by reason of the Secretary using the au4 thority under paragraph (1) the purchaser does not 

5 receive, or loses possession of, a quantity of influ6 enza vaccine for which the purchaser has made pay7 ment, the manufacturer or distributor (as the case 

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

9 such quantity. 

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

11 the sale of influenza vaccine with respect to which the Sec12 retary uses the authority referred to in subsection (a)(1), 

13 the Secretary shall pay to the manufacturer or distributor 

14 involved the same amount as, under the contract, the man15 ufacturer or distributor received or would have received 

16 for the quantity of vaccine involved. 

17 ‘‘(c) AGENCY PROCEDURES.—With respect to the in18 fluenza season involved: 

19 ‘‘(1) If the Secretary makes an emergency dec20 laration under subsection (a)(1), the Secretary shall 

21 determine the extent of compliance with guidelines 

22 for the distribution of influenza vaccine that have 

23 been established by the Secretary. 

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

25 referred to in subsection (a)(1) with respect to any 
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1 contract unless the Secretary has published in the 

2 Federal Register, not earlier than 30 days after 

3 making the emergency declaration under such sub4 section, a determination that the extent of compli5 ance with such guidelines has not been sufficient to 

6 constitute an adequate response to the emergency. 

7 ‘‘(d) DISTRIBUTION OF VACCINE.—If the Secretary 

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

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

10 ‘‘(1) The Secretary may, in lieu of such author11 ity, order any manufacturer or distributor of influ12 enza vaccine to honor its contracts with States or 

13 political subdivisions of States for the sale of such 

14 vaccine, in any case in which the manufacturer or 

15 distributor has conflicting obligations under its con16 tracts for sale of the vaccine. 

17 ‘‘(2) Any influenza vaccine to which the Sec18 retary takes title under subsection (a)(1) shall be 

19 provided—

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

21 States in accordance with the immunization 

22 program under section 317(j); and 

23 ‘‘(B) to such other public or private enti24 ties as the Secretary determines to be appro25 priate as a response to the emergency involved. 
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1 ‘‘(e) RULES OF CONSTRUCTION.—

2 ‘‘(1) EMERGENCY DECLARATION.—The Sec3 retary shall be considered to have made an emer4 gency declaration under subsection (a)(1) if the Sec5 retary publishes in the Federal Register a declara6 tion described in such subsection. 

7 ‘‘(2) EMERGENCY SHORTAGE.—

8 ‘‘(A) OVERALL QUANTITY VS. DELIVERY

9 WAITING TIME.—Without regard to whether the 

10 Secretary considers as adequate the total quan11 tity of influenza vaccine that has been or is 

12 being manufactured for the influenza season in13 volved, the Secretary may make an emergency 

14 declaration under subsection (a)(1) if the Sec15 retary determines that the delivery waiting time 

16 for States or political subdivisions of States to 

17 receive the vaccine for the season is a period 

18 whose duration constitutes a significant threat 

19 to children, adolescents, or adults who are 

20 served by the immunization program under sec21 tion 317(j). 

22 ‘‘(B) DELIVERY WAITING TIME.—A deliv23 ery waiting time under subparagraph (A) for a 

24 State or political subdivision of a State to re25 ceive influenza vaccine is the time elapsing be-
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1 tween the date on which the State or subdivi2 sion enters into a contract to purchase such 

3 vaccine and the date on which the State or sub4 division (or other entity designated under the 

5 contract) takes custody of the vaccine, less any 

6 period in which payment is due under the con7 tract and the State or subdivision has not made 

8 payment, or in which the State or subdivision 

9 otherwise is in significant violation of the con10 tract. 

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

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

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

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