‘‘(b) CONTINGENCY PLAN.—The Director 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 101 and amended by section 301, 
is further amended by adding at the end the following: 
‘‘PREPARATION FOR INFLUENZA PANDEMIC OR EPIDEMIC 
‘‘SEC. 2143. (a) ESTABLISHMENT OF A PROTOCOL.—
The Secretary, acting through the Director, shall continue 
progress on the pandemic preparedness plan and 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. 
‘‘(b) CONTENTS OF PROTOCOL.—The protocol estab-
lished under subsection (a) shall—
‘‘(1) address methods to coordinate dissemina-
tion of the influenza vaccine to key populations in 
the event of an influenza pandemic or epidemic; 
‘‘(2) address expansion of influenza vaccine 
manufacturing 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; 
‘‘(3) improve upon the current influenza vac-
cines and production and dissemination methods; 
‘‘(4) address alternative ways to manufacture or 
produce the influenza vaccine; 
‘‘(5) address alternative methods to prevent the 
spread of, and complications associated with, influ-
enza, including antiviral medications; 
‘‘(6) address a tracking method for publicly and 
privately sold doses of the influenza vaccine to en-
able the Director to determine, after consultation 
with manufacturers of the influenza vaccine, how 
much supply is in circulation in the case of an influ-
enza pandemic or epidemic; and 
‘‘(7) address other issues determined by the Di-
rector to be appropriate.
‘‘(c) COORDINATION; PREPARATION; PREVENTION.—
In establishing the protocol under subsection (a), the Di-
rector shall—
‘‘(1) coordinate with health care providers, 
manufacturers, research institutions, health care or-
ganizations, and other expert stakeholders; and 
‘‘(2) 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 
$100,000,000 for each of fiscal years 2005 through 
2009.’’. 
TITLE V—NOTICE OF INTENT TO 
WITHDRAW FROM THE MARKET 
SEC. 501. MANUFACTURER WITHDRAWAL FROM THE MAR-
KET. 
Title XXI of the Public Health Service Act (42 
U.S.C. 300aa–1 et seq.), as amended by this Act, is fur-
ther amended by adding at the end the following:
‘‘Subtitle 4—Notice of Intent to Withdraw From the 
Market 
‘‘MANUFACTURER WITHDRAWAL FROM THE MARKET 
‘‘SEC. 2151. 
Any manufacturer of a vaccine that receives authority 
under Federal law to distribute such vaccine shall provide 
advance notification to the Department of Health and 
Human Services regarding such manufacturer’s intent to 
stop the distribution of such vaccine into the market-
place.’’.
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