I 
109TH CONGRESS 
1ST SESSION H. R. 4245 
To provide for programs and activities with respect to pandemic influenza, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 7, 2005 
Mr. LEWIS of California (for himself, Mr. REGULA, Mr. FRELINGHUYSEN, Mr. 
DREIER, Mrs. BONO, Mr. ISSA, and Mr. DOOLITTLE) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committees on Resources and Agriculture, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To provide for programs and activities with respect to 
pandemic influenza, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Influenza Preparedness and Prevention Act of 2005’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents.
TITLE I—VACCINE AND ANTIVIRAL PURCHASING 
Sec. 101. Influenza antivirals supply. 
Sec. 102. Procurement of vaccines for the Strategic National Stockpile. 
Sec. 103. Procurement of essential supplies. 
TITLE II—VACCINE PRODUCTION CAPACITY 
Sec. 201. Liability protections for pandemics, epidemics, and biodefense coun-
termeasures. 
Sec. 202. Vaccine buyback program. 
Sec. 203. Approval of vaccines. 
Sec. 204. Establishment of Office of Safety Evaluation and Pandemic Pre-
paredness. 
TITLE III—PANDEMIC PREPAREDNESS 
Sec. 301. Public education on pandemic influenza and preparedness. 
Sec. 302. Educational efforts and grants. 
Sec. 303. Domestic surveillance of wild birds. 
Sec. 304. Research at the National Institutes of Health. 
Sec. 305. Research at the Centers for Disease Control and Prevention. 
Sec. 306. Global surveillance. 
Sec. 307. Proposal for international fund to support pandemic influenza con-
trol. 
Sec. 308. Pandemic influenza and animal health. 
TITLE IV—STATE AND LOCAL INFRASTRUCTURE 
Sec. 401. State preparedness plan. 
TITLE V—GENERAL PROVISIONS 
Sec. 501. Authorization of appropriations. 
TITLE I—VACCINE AND 
ANTIVIRAL PURCHASING 
SEC. 101. INFLUENZA ANTIVIRALS SUPPLY. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this Act as the ‘‘Sec-
retary’’) shall establish a stockpile of anti-virals to use for 
rapid response to an influenza outbreak. 
(b) AMOUNT.—The stockpile established under sub-
section (a) shall be of sufficient quantity to treat not less 
than 25 percent of the population of the United States.
SEC. 102. PROCUREMENT OF VACCINES FOR THE STRA-
TEGIC NATIONAL STOCKPILE. 
Subject to development and testing of potential vac-
cines for pandemic influenza, including possible pandemic 
avian influenza, the Secretary shall determine the min-
imum number of doses of vaccines needed to prevent infec-
tion during at least the first wave of pandemic influenza 
for health professionals (including doctors, nurses, mental 
health professionals, pharmacists, veterinarians, labora-
tory personnel, epidemiologists, virologists, and public 
health practitioners), core public utility employees, and 
those persons expected to be at high risk for serious mor-
bidity and mortality from pandemic influenza, and take 
immediate steps to procure this minimum number of doses 
for the Strategic National Stockpile. 
SEC. 103. PROCUREMENT OF ESSENTIAL SUPPLIES. 
The Secretary shall, as soon as is practicable, take 
action to procure for the Strategic National Stockpile es-
sential supplies (including ventilators, syringes, res-
pirators, surgical masks, and gloves) that may be needed 
in the event of a pandemic.
TITLE II—VACCINE 
PRODUCTION CAPACITY 
SEC. 
201. 
LIABILITY 
PROTECTIONS 
FOR 
PANDEMICS, 
EPIDEMICS, 
AND 
BIODEFENSE 
COUNTER-
MEASURES. 
Part B of title III of the Public Health Service Act 
is amended by inserting after section 319F–2 (42 U.S.C. 
247d–6b) the following: 
‘‘SEC. 319F–3. LIABILITY PROTECTIONS FOR PANDEMIC AND 
EPIDEMIC PRODUCTS AND SECURITY COUN-
TERMEASURES. 
‘‘(a) AUTHORITY.—As provided for in subsection (b), 
and subject to paragraph (1)(C) of such subsection, a 
manufacturer, distributor, administrator, or health care 
provider shall be immune, under Federal and State law, 
from suit or liability caused by or arising out of the cov-
ered application of a covered countermeasure pursuant to 
a declaration by the Secretary described in subsection 
(b)(2). 
‘‘(b) LITIGATION MANAGEMENT.— 
‘‘(1) LIMITATION ON CAUSE OF ACTION.— 
‘‘(A) NO CAUSE OF ACTION IN CERTAIN 
CASES.— 
‘‘(i) IN GENERAL.—No cause of action 
shall exist against a manufacturer, dis-
tributor, administrator, or a health care 
provider described in subsection (a) for 
claims of loss arising out of, relating to, or 
resulting from the covered application of a 
covered countermeasure that is deployed 
pursuant to a declaration by the Secretary 
described in paragraph (2). 
‘‘(ii) RULE OF CONSTRUCTION.—For 
purposes of this section, the term ‘arising 
out of, relating to, or resulting from’ shall 
not be construed to apply to a loss that 
has no causal relationship with the admin-
istration or use of a covered counter-
measure. 
‘‘(B) RULE.— 
‘‘(i) SUBSEQUENT INJURY.—The pro-
tections provided for in subsection (a) and 
subparagraph (A) of this paragraph shall 
apply to a covered application of a covered 
countermeasure regardless of the date of 
alleged injury. 
‘‘(ii) PRIVATE DONATION OR SALE.— 
The protections provided for in subsection 
(a) and subparagraph (A) of this para-
graph shall apply to a covered application