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.
Be it enacted by the Senate and House of Representa-
tives 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 VAC-
CINE.
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 fol-
lowing 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 vac-
cine, the Secretary has the authority, in lieu of such
purchaser, to take title to such quantities of the vac-
cine 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 au-
thority under paragraph (1) the purchaser does not
receive, or loses possession of, a quantity of influ-
enza vaccine for which the purchaser has made pay-
ment, 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 Sec-
retary 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 man-
ufacturer or distributor received or would have received
for the quantity of vaccine involved.
‘‘(c) AGENCY PROCEDURES.—With respect to the in-
fluenza season involved:
‘‘(1) If the Secretary makes an emergency dec-
laration 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 sub-
section, a determination that the extent of compli-
ance 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 author-
ity, order any manufacturer or distributor of influ-
enza 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 con-
tracts for sale of the vaccine.
‘‘(2) Any influenza vaccine to which the Sec-
retary 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 enti-
ties as the Secretary determines to be appro-
priate as a response to the emergency involved.
‘‘(e) RULES OF CONSTRUCTION.—
‘‘(1) EMERGENCY
DECLARATION.—The Sec-
retary shall be considered to have made an emer-
gency declaration under subsection (a)(1) if the Sec-
retary publishes in the Federal Register a declara-
tion 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 quan-
tity of influenza vaccine that has been or is
being manufactured for the influenza season in-
volved, the Secretary may make an emergency
declaration under subsection (a)(1) if the Sec-
retary 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 sec-
tion 317(j).
‘‘(B) DELIVERY WAITING TIME.—A deliv-
ery waiting time under subparagraph (A) for a
State or political subdivision of a State to re-
ceive influenza vaccine is the time elapsing be-
tween the date on which the State or subdivi-
sion enters into a contract to purchase such
vaccine and the date on which the State or sub-
division (or other entity designated under the
contract) takes custody of the vaccine, less any
period in which payment is due under the con-
tract and the State or subdivision has not made
payment, or in which the State or subdivision
otherwise is in significant violation of the con-
tract.
‘‘(f) DEFINITIONS.—For purposes of this subsection,
the terms ‘influenza season’ and ‘influenza vaccine’ have
the meanings given such terms by the Secretary.’’.
Æ