‘‘Subtitle 3—Influenza Vaccine 
‘‘VACCINE SUPPLY 
‘‘SEC. 2141. (a) REQUESTS FOR MORE DOSES.—
‘‘(1) IN GENERAL.—Not later than March 15 of 
each year, the Secretary shall enter into contracts 
with manufacturers to produce such additional doses 
of the influenza vaccine as determined necessary by 
the Secretary. 
‘‘(2) CONTENT OF CONTRACT.—A contract for 
additional doses shall provide that the manufacturer 
will be compensated by the Secretary at an equitable 
rate negotiated by the Secretary and the manufac-
turer for any doses that—
‘‘(A) were not sold by the manufacturer 
through routine market mechanisms at the end 
of the influenza season for that year; and 
‘‘(B) were requested by the Secretary to be 
produced by such manufacturer. 
‘‘(3) 
WHEN
SUCH
VACCINE
PURCHASES 
SHOULD TAKE PLACE.—The Secretary may purchase 
from the manufacturer the doses for which it has 
contracted at any time after which it is determined 
by the Secretary, in consultation with the manufac-
turer, that the doses will likely not be absorbed by 
the private market.
‘‘(b) CONTINGENCY PLAN.—The Secretary shall en-
courage States to develop a contingency plan, in coordina-
tion with the Department of Health and Human Services, 
for maximizing influenza immunization for high-risk popu-
lations in the event of a delay or shortage of the influenza 
vaccine. 
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary.’’. 
TITLE IV—PREPARING FOR A 
PANDEMIC OR EPIDEMIC 
SEC. 401. PREPARATION FOR INFLUENZA PANDEMIC OR 
EPIDEMIC. 
Subtitle 3 of title XXI of the Public Health Service 
Act, as added by section 301, is amended by adding at 
the end the following: 
‘‘PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC 
‘‘SEC. 2142. (a) ESTABLISHMENT OF A PROTOCOL.—
The Secretary, acting through the Director of the Na-
tional Vaccine Program (referred to in this section as the 
‘Director of the Program’), shall continue progress on the 
pandemic preparedness plan and, in consultation with the 
Director of the Centers for Disease Control and Preven-
tion, establish a protocol to attempt to prevent, prepare 
for, and respond to an influenza pandemic or epidemic.
Such protocol shall be updated as determined appropriate 
by the Director of the Program. 
‘‘(b) CONTENTS OF PROTOCOL.—The protocol estab-
lished under subsection (a) shall—
‘‘(1) improve upon the current influenza vac-
cines and production and dissemination methods; 
and 
‘‘(2) address—
‘‘(A) methods to coordinate dissemination 
of the influenza vaccine to key populations in 
the event of an influenza pandemic or epidemic; 
‘‘(B) expansion of influenza vaccine manu-
facturing capacity (including making advance 
arrangements for ensuring the availability of 
raw materials) to respond to the needs of the 
United States during an influenza pandemic or 
epidemic; 
‘‘(C) alternative ways to manufacture or 
produce the influenza vaccine; 
‘‘(D) alternative methods to prevent the 
spread of, and complications associated with, 
influenza, including antiviral medications; 
‘‘(E) vaccine manufacturing capacity, pro-
duction, and dissemination to improve pre-
paredness for immediate pandemic threats, 
which may include avian influenza; 
‘‘(F) a tracking method for publicly and 
privately sold doses of the influenza vaccine to 
enable the Director of the Program to deter-
mine, after consultation with manufacturers of 
the influenza vaccine, how much supply is in 
circulation in the case of an influenza pandemic 
or epidemic; and 
‘‘(G) other issues determined by the Direc-
tor of the Program to be appropriate. 
‘‘(c) COORDINATION; PREPARATION; PREVENTION.—
In establishing the protocol under subsection (a), the Di-
rector of the Program shall—
‘‘(1) coordinate with health care providers, 
manufacturers, research institutions, health care or-
ganizations, and other expert stakeholders; 
‘‘(2) continue building international and na-
tional surveillance capacity; 
‘‘(3) continue to engage in epidemiological stud-
ies and research on novel influenza viruses; and 
‘‘(4) assist States with preparedness activities 
for a rapid State and local response to an influenza 
pandemic, including exploring methods of making
the influenza vaccine more accessible to the general 
population. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$150,000,000 for each of fiscal years 2005 through 
2009.’’.
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