of a covered countermeasure regardless of 
whether the covered countermeasure is on 
the commercial market, so long as the cov-
ered countermeasure is deployed in a dec-
laration described in paragraph (2) and 
the Secretary does not specifically prohibit 
such private donation or sale in such dec-
laration. 
‘‘(C) POTENTIAL LIABILITY UPON DETER-
MINATION.— 
‘‘(i) IN
GENERAL.—A manufacturer, 
distributor, or administrator of a covered 
countermeasure or a health care provider 
who administers a covered countermeasure 
shall not be immune under subsection (a) 
or exempted from a cause of action under 
subparagraph (A) if— 
‘‘(I) in the case of a manufac-
turer or distributor, the Secretary 
makes an affirmative determination 
under subparagraph (D)(ii) against 
such manufacturer or distributor; or 
‘‘(II) in the case of an adminis-
trator or health care provider, the ad-
ministrator or health care provider
acts with willful misconduct as that 
term is defined in regulations promul-
gated by the Secretary and the Attor-
ney General. 
‘‘(D) INVESTIGATION
AND
DETERMINA-
TION
BY
SECRETARY
CONCERNING
ACTIONS 
AGAINST
MANUFACTURERS, 
OR
DISTRIBU-
TORS.— 
‘‘(i) 
INVESTIGATION
BY
SEC-
RETARY.—A petitioner seeking a deter-
mination under clause (ii) may petition the 
Secretary to investigate allegations of will-
ful misconduct against a manufacturer or 
distributor for a loss arising out of, relat-
ing to, or resulting from a covered applica-
tion of a covered countermeasure as pro-
vided for in subparagraph (A). The peti-
tion shall demonstrate to the Secretary 
that such petitioner has suffered a loss as 
a direct result of the willful misconduct of 
a manufacturer or distributor. The deci-
sion whether or not to undertake the inves-
tigation shall be within the Secretary’s dis-
cretion and shall not be subject to judicial 
review.
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—To make an affirmative deter-
mination under this subparagraph, the 
Secretary shall find, by clear and con-
vincing evidence, that— 
‘‘(I) the manufacturer or dis-
tributor of a covered countermeasure 
violated a provision of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) or this Act, and 
such violation is material to the loss 
alleged; and 
‘‘(II) in violating either such Act, 
such 
manufacturer 
or 
distributor 
acted with willful misconduct and 
such misconduct— 
‘‘(aa) caused the covered 
countermeasure to present a sig-
nificant or unreasonable risk to 
human health; and 
‘‘(bb) 
proximately 
caused 
the injury alleged by the peti-
tioner. 
‘‘(iii) NOTICE AND HEARING.—If the 
Secretary finds that an affirmative deter-
mination will likely be made under clause 
(ii), the Secretary shall undertake an ac-
tion in accordance with section 556 of title 
5, United States Code. 
‘‘(iv) EFFECT OF DETERMINATION.— 
Subject to subsection (c) and subpara-
graph (C) of this paragraph, the only ex-
ception to the immunity from suit and li-
ability of manufacturers or distributors of 
a covered countermeasure provided for in 
subsection (a) and subparagraph (A) of 
this paragraph shall be for actions against 
a manufacturer or distributor as provided 
for in such subparagraph (A) that are sub-
ject to an affirmative determination under 
clause (ii). 
‘‘(v) JUDICIAL REVIEW.— 
‘‘(I) MANUFACTURERS
OR
DIS-
TRIBUTORS.—At any time prior to the 
90th day following an affirmative de-
termination by the Secretary under 
subparagraph (D)(ii), any manufac-
turer or distributor subject to such an 
affirmative determination may file a 
petition with the United States Court
of Appeals for the District of Colum-
bia, for a judicial review of such de-
termination. The court’s review under 
this subclause shall be limited in scope 
to a review of the record to determine 
whether the Secretary’s actions were 
unsupported by substantial evidence 
or unwarranted by the facts. A copy 
of the petition shall be transmitted by 
the clerk of the court to the Secretary 
or other officer designated by the Sec-
retary for that purpose. The Secretary 
thereupon shall file in the court the 
record of the findings on which the 
Secretary based his or her determina-
tion. The filing of a petition under 
this clause shall automatically stay 
the Secretary’s determination for the 
duration of the judicial proceeding. 
‘‘(II) PETITIONERS.—Any person 
who brought a petition to the Sec-
retary under subparagraph (D)(i) 
may, at any time prior to the 90th 
day following a determination by the 
Secretary under subparagraph (D)(ii),
file a petition with the United States 
Court of Appeals for the District of 
Columbia Circuit, for a judicial review 
of 
such 
determination. 
Notwith-
standing any other provision of law, 
the court’s review under this sub-
clause shall be limited in scope to a 
review of the record to determine 
whether the Secretary’s actions were 
arbitrary, capricious, or an abuse of 
discretion. 
‘‘(vi) TOLLING OF STATUTE OF LIMI-
TATIONS.—The computation of the statute 
of limitations for any action against a 
manufacturer or distributor described in 
this subparagraph shall not include any pe-
riod of time that occurs prior to the time 
at which an affirmative determination by 
the Secretary under this subparagraph be-
comes final, and upon— 
‘‘(I) the expiration of the 90-day 
period following such determination if 
the aggrieved party does not seek ju-
dicial review of such determination 
under clause (ii); or
‘‘(II) the conclusion of a judicial 
review proceeding under clause (ii), 
including any appeal. 
‘‘(vii) PROCEDURES
FOR
ACTIONS 
AGAINST MANUFACTURERS AND DISTRIBU-
TORS.—An action that is allowed under 
this paragraph shall be brought in the 
United States District Court. No jury trial 
shall be allowed. If the plaintiff prevails, 
the court may award only compensatory 
damages, and not punitive damages. 
‘‘(E) REGULATORY AUTHORITY.—Not later 
than 90 days after the date of enactment of 
this section, the Secretary, in consultation with 
the Attorney General, shall promulgate regula-
tions to define what actions by a manufacturer, 
distributor, administrator, or health care pro-
vider of a covered countermeasure shall be 
deemed to constitute ‘willful misconduct’ for 
purposes of clause (i). In promulgating such 
regulations, the Secretary shall consider the na-
ture of the actual or potential public health 
emergency, the timing and extent of any cov-
ered countermeasure program, and any other 
circumstances the Secretary determines to be
significant, so that any civil actions permitted 
under this subsection will not adversely affect 
public health. The Secretary may specify the 
period of time for which such regulations apply. 
‘‘(F) PROCEDURES FOR SUIT AGAINST AD-
MINISTRATORS
AND
HEALTH
CARE
PRO-
VIDERS.—An action that is permitted under 
this subsection shall be brought in United 
States District Court. A plaintiff in such action 
shall specify in his or her complaint each action 
or omission that allegedly constitutes willful 
misconduct. No jury trial shall be allowed. No 
discovery will be allowed before the court rules 
on any motion to dismiss or a motion for sum-
mary judgment. If a plaintiff prevails, the court 
may award only compensatory damages, and 
not punitive damages. 
‘‘(G) SCOPE.—Subparagraph (C) shall 
apply regardless of whether the action or liabil-
ity described in subsection (a) or the claim de-
scribed in subparagraph (A) of this paragraph 
arises from the covered application by the Fed-
eral Government or by any person. 
‘‘(2) DECLARATION BY THE SECRETARY.—
‘‘(A) IN
GENERAL.—The Secretary may 
issue a declaration, pursuant to this paragraph, 
that an actual or potential public health emer-
gency makes it advisable that a covered coun-
termeasure be manufactured, tested, or de-
ployed to a covered individual. 
‘‘(B) SECURITY
COUNTERMEASURE
OR 
QUALIFIED
PANDEMIC
OR
EPIDEMIC
PROD-
UCT.—The Secretary shall specify in a declara-
tion under subparagraph (A) the covered coun-
termeasure to be sold by, purchased from, or 
donated by a manufacturer or drawn from the 
Strategic National Stockpile. 
‘‘(C) EFFECTIVE PERIOD.—The Secretary 
shall specify in a declaration under subpara-
graph (A) the beginning and the ending dates 
of the effective period of the declaration. The 
Secretary may subsequently amend such dec-
laration to shorten or extend such effective pe-
riod if the new ending date is after the date on 
which the declaration is amended. 
‘‘(D) PUBLICATION.—The Secretary shall 
promptly publish each declaration under sub-
section (a) and any amendments in the Federal 
Register.
‘‘(c) ACTIONS
BY
AND
AGAINST
THE
UNITED 
STATES.— 
‘‘(1) ACTIONS BY THE UNITED STATES.—Noth-
ing in this section shall be construed to abrogate or 
limit any right, remedy, or authority that the United 
States or any agency thereof may possess under any 
other provision of law. 
‘‘(2) IMMUNITY.—The United States shall be 
immune from an action or liability caused by or aris-
ing out of the covered application of a covered coun-
termeasure, described in subsection (b)(1)(A), to the 
same extent as a health care provider, a manufac-
turer, a distributor, or an administrator of a covered 
countermeasure. 
‘‘(d) SEVERABILITY.—If any provision of this section, 
or the application of such provision, to any person or cir-
cumstance is held to be unconstitutional, the remainder 
of this section and the application of such provisions to 
any person or circumstance shall not be affected thereby. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) ADMINISTRATOR.—The term ‘adminis-
trator’ includes a State or local government, a per-
son employed by the State or local government, or 
other person, who supervised or administered a pro-
gram with respect to the administration, dispensing,
distribution, or provision of a security counter-
measure or a qualified pandemic or epidemic prod-
uct, including a person who has established require-
ments, provided policy guidance, or supplied tech-
nical or scientific advice assistance or provides a fa-
cility to administer or use a covered countermeasure 
in accordance with a designation under subsection 
(b)(2). 
‘‘(2) COVERED APPLICATION.—The term ‘cov-
ered application’ means design, development, clinical 
testing and investigation, manufacture, labeling, dis-
tribution, sale, purchase, donation, dispensing, pre-
scribing, administration, licensing, or use of a quali-
fied pandemic or epidemic product or a security 
countermeasure. 
‘‘(3) COVERED COUNTERMEASURE.—The term 
‘covered countermeasure’ means a qualified pan-
demic or epidemic product or a security counter-
measure. 
‘‘(4) COVERED
INDIVIDUAL.—The term ‘cov-
ered individual’ means one or more categories of in-
dividuals who the Secretary has identified in a dec-
laration under subsection (b)(2). 
‘‘(5) DEPLOYED.—The term ‘deployed’ means 
manufactured, tested, distributed, sold, purchased,
donated, dispensed, prescribed, administered, li-
censed, or used. 
‘‘(6) HEALTH
CARE
PROVIDER.—The term 
‘health care provider’ means a person, including a 
volunteer, who is licensed or authorized under State 
law to distribute, prescribe, administer, or dispense, 
a security countermeasure or a qualified pandemic 
or epidemic product. 
‘‘(7) LOSS.—The term ‘loss’ means death, in-
jury, illness, disability, condition, medical moni-
toring, or loss of or damage to property, including 
business interruption loss. 
‘‘(8) MANUFACTURER.—The term ‘manufac-
turer’ includes— 
‘‘(A) a contractor or subcontractor of a 
manufacturer; 
‘‘(B) a supplier or licensor of any product, 
intellectual property, service, research tool, or 
component of the qualified pandemic or epi-
demic product or security countermeasure; and 
‘‘(C) any or all of the parents, subsidiaries, 
affiliates, successors, and assigns of a manufac-
turer. 
‘‘(9) QUALIFIED PANDEMIC OR EPIDEMIC PROD-
UCT.—The term ‘qualified pandemic or epidemic
product’ means a drug (as such term is defined in 
section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1)), biological prod-
uct (as such term is defined by section 351(i) of this 
Act), device (as such term is defined by section 
201(h) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 321(h)), that is manufactured, used, de-
signed, developed, modified, licensed, or procured to 
diagnose, mitigate, prevent, treat, or cure a pan-
demic or epidemic or limit the harm such pandemic 
or epidemic might otherwise cause or a serious or 
life-threatening disease or condition caused by such 
a product, that— 
‘‘(A)(i) is approved or cleared under chap-
ter V of the Federal Food, Drug, and Cosmetic 
Act or licensed under section 351 of this Act; 
‘‘(ii) is authorized for emergency use in ac-
cordance with section 564 of the Federal Food, 
Drug, and Cosmetic Act;. or 
‘‘(iii) is the object of research for possible 
use to treat, identify, or prevent harm from 
pandemic flu; and 
‘‘(B) is specified in a declaration under 
subsection (b)(2).
‘‘(10) PERSON.—The term ‘person’ includes an 
individual, partnership, corporation, association, en-
tity, or public or private corporation, including a 
Federal, State, or local government agency or de-
partment. 
‘‘(11) 
SECURITY
COUNTERMEASURE.—The 
term ‘security countermeasure’ has the meaning 
given such term in section 319F–2(c)(1)(B).’’. 
SEC. 202. VACCINE BUYBACK PROGRAM. 
(a) IN GENERAL.—The Secretary shall establish an 
influenza vaccine buyback protocol under which the Sec-
retary may enter into buyback contracts with manufactur-
ers of influenza vaccine to purchase such manufacturers’ 
excess stocks of influenza vaccine so long as such vaccine 
has been manufactured in accordance with the rec-
ommendations of the Advisory Committee for the produc-
tion of seasonal influenza vaccine. 
(b) MANUFACTURERS.—The Secretary shall have the 
discretion to award buyback contracts under subsection 
(a) to several influenza vaccine manufacturers in a man-
ner consistent with the goal of providing stability in the 
influenza vaccine market, as long as the Federal Govern-
ment purchases not more than 50 percent of the excess 
influenza vaccine stock of any single manufacturer at mar-
ket price.
SEC. 203. APPROVAL OF VACCINES. 
(a) 
CRITERIA
FOR
FAST-TRACK
APPROVAL.— 
Promptly after the date of the enactment of this Act, the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall consult with 
potential manufacturers of vaccines against pandemic in-
fluenza to develop specific criteria for fast-track approval 
of such vaccines. 
(b) PROVISIONS RELATING TO INFLUENZA VACCINE 
MANUFACTURERS.—Chapter IX of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 909. PROVISIONS RELATING TO INFLUENZA VACCINE 
MANUFACTURERS. 
‘‘(a) 
ASSISTANCE
AND
TECHNICAL
TRAINING 
BRANCH.—The Secretary shall expand and strengthen the 
activities of the Manufacturer Assistance and Technical 
Training Branch at the Center for Biologics Evaluation 
and Research of the Food and Drug Administration to 
provide for the dissemination of information, and to pro-
vide technical guidance, to entities seeking to comply with 
regulations of the Secretary relating to the production of 
biologic materials, particularly influenza vaccine. 
‘‘(b) PROVISIONS RELATED TO THE EMERGENCY AC-
QUISITION OF VACCINES.—
‘‘(1) INCREASED COMMUNICATION.—The Food 
and Drug Administration shall carry out activities to 
increase communication between the agency and the 
scientific community regarding vaccine development 
and regulation, including participation in con-
ferences on the science related to infectious diseases, 
influenza, biologic manufacturing, and other issues 
as determined appropriate by the Director of the 
Center for Biologics Evaluation and Research. 
‘‘(2) REGULATORY
ROADMAP.—The Commis-
sioner, in consultation with the Director of the Cen-
ters for Disease Control and Prevention, the Sec-
retary, and other agencies or participants as deter-
mined appropriate by the Secretary, shall develop a 
regulatory roadmap to address the following issues 
surrounding emergency use authorization of influ-
enza vaccine, as determined by the Secretary during 
a public health emergency involving an actual or im-
minent outbreak of naturally occurring or engi-
neered seasonal influenza: 
‘‘(A) Policies for the emergency use au-
thorization of influenza vaccine that is produced 
and sold in other countries so that such vaccine 
may be imported into the United States by the
United States government during a vaccine 
shortage. 
‘‘(B) Policies for the facilitation of the dis-
tribution of any such vaccine imported into the 
United States during a vaccine shortage, in-
cluding the interstate transportation, allocation 
and equitable distribution of vaccine among 
high priority populations (as defined by the Ad-
visory Committee on Immunization Practices 
and the Centers for Disease Control and Pre-
vention) during an emergency use situation. 
‘‘(C) Policies for the communication and 
coordination of a response to an emergency use 
authorization with State and local health de-
partments, including guidelines for notification 
of such entities in such situations. 
‘‘(D) Policies for the emergency use au-
thorization of vaccines that are in clinical devel-
opment in both the United States and other 
countries, including clarification of IND proto-
cols for such vaccines, particularly those using 
new vaccine development technologies. 
‘‘(3) CONSULTATION.—In developing the road-
map under paragraph (2), the Commissioner shall 
solicit input from private and nonprofit stakeholders,
including State and local health officials, and such 
input shall include recommendations for developing 
emergency use authorization guidelines that main-
tain the scientific and regulatory standards of the 
Food and Drug Administration.’’. 
SEC. 204. ESTABLISHMENT OF OFFICE OF SAFETY EVALUA-
TION AND PANDEMIC PREPAREDNESS. 
Title XXI of the Public Health Service Act (42 
U.S.C. 300aa–1 et seq.) is amended by adding at the end 
the following: 
‘‘Subtitle 3—Office of Safety Eval-
uation and Pandemic Prepared-
ness 
‘‘SEC. 2141. ESTABLISHMENT; DEFINITIONS. 
‘‘(a) ESTABLISHMENT.—There is established in the 
Office of the Secretary the Office of Safety Evaluation and 
Pandemic Preparedness, to be headed by the Director of 
Safety Evaluation and Pandemic Preparedness. 
‘‘(b) DEFINITIONS.—In this subtitle: 
‘‘(1) The term ‘Director’ means the Director of 
Safety Evaluation and Pandemic Preparedness. 
‘‘(2) The term ‘Office’ means, unless otherwise 
specified, the Office of Safety Evaluation and Pan-
demic Preparedness.
‘‘(3) The term ‘qualified pandemic or epidemic 
product’ has the meaning given to that term in sec-
tion 4101 of title 28, United States Code. 
‘‘(4) The term ‘security countermeasure’ has 
the meaning given to that term in section 4101 of 
title 28, United States Code. 
‘‘SEC. 2142. AUTHORITIES. 
‘‘(a) IN GENERAL.—With respect to qualified pan-
demic or epidemic products and security countermeasures, 
the Director shall— 
‘‘(1) conduct or support safety research, includ-
ing research on— 
‘‘(A) acute and chronic adverse reactions, 
including with respect to subpopulations; 
‘‘(B) components of such products and 
countermeasures, including additives, adjuvants, 
and preservatives; and 
‘‘(C) delivery mechanisms; 
‘‘(2) conduct or support long- and short-term 
monitoring, including with respect to new and al-
tered products and countermeasures; 
‘‘(3) conduct or support research across a range 
of disciplines, including molecular genetics, toxi-
cology, pharmacokinetics, cell biology, neurology, im-
munology, and epidemiology;
‘‘(4) conduct or support research to address 
issues raised in claims of injury brought before the 
Secretary or the Attorney General of the United 
States; 
‘‘(5) develop and test hypotheses about poten-
tial adverse reactions; 
‘‘(6) evaluate, on a regular basis, the compli-
ance of health care providers and the manufacturers 
of such products and countermeasures with Federal 
requirements for reporting adverse reactions related 
to such products and countermeasures; 
‘‘(7) conduct or support research to evaluate re-
ports of injury following administration of such 
products and countermeasures for the purpose of de-
veloping tests to prescreen individuals and sub-
populations at greater risk of injury; and 
‘‘(8) conduct or support research to evaluate bi-
ological mechanisms of injury for the purpose of 
eliminating or reducing the risk of such injury 
through better prescreening tools or through modi-
fication of such products and countermeasures. 
‘‘(b) PERSONNEL.—In carrying out this subtitle, the 
Director— 
‘‘(1) may not employ at management positions 
any individual—
‘‘(A) who has been employed by the Cen-
ters for Disease Control and Prevention or the 
Food and Drug Administration to carry out any 
function relating to monitoring, or research on, 
adverse reactions related to a licensed vaccine; 
or 
‘‘(B) who has been employed by a vaccine 
manufacturer; and 
‘‘(2) shall ensure that all personnel assigned to 
carry out functions relating to monitoring, or re-
search on, adverse reactions related to qualified pan-
demic or epidemic products or security counter-
measures do not have any related professional, fa-
milial, or financial conflict of interest. 
‘‘(c) GRANT APPLICANTS.—In awarding any grant 
relating to research on adverse reactions related to quali-
fied pandemic or epidemic products or security counter-
measures, the Director— 
‘‘(1) shall ensure that the applicant for the 
grant does not have— 
‘‘(A) any financial conflict of interest that 
might compromise the research findings, such 
as holding a related patent or having a family 
member who holds a related patent; or
‘‘(B) any conflict of interest resulting from 
the applicant’s association with an entity with 
direct or indirect financial interest in the out-
comes of the research, such as receiving money 
or an in-kind contribution from a manufacturer 
of such products or countermeasures; and 
‘‘(2) shall disqualify any applicant having any 
contractual relationship with, or receiving any fund-
ing from, any person with a direct or indirect inter-
est in the outcomes of the research.’’. 
TITLE III—PANDEMIC 
PREPAREDNESS 
SEC. 301. PUBLIC EDUCATION ON PANDEMIC INFLUENZA 
AND PREPAREDNESS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall develop and 
implement a public education campaign about pandemic 
influenza and preparedness. 
(b) CERTAIN REQUIREMENTS.—The education and 
outreach activities under subsection (a) shall include— 
(1) efforts to distribute information concerning 
the potential need for general vaccination; education 
materials on personal precautionary measures;
(2) the development of a strategy with the busi-
ness community to provide information about the 
economic disruptions that may arise during a pan-
demic period; 
(3) consulting with State and local governments 
to inform the public on procedures that may be 
taken during a pandemic period, including with re-
spect to vaccine and antiviral distributions and quar-
antines. 
SEC. 302. EDUCATIONAL EFFORTS AND GRANTS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 319B the following: 
‘‘SEC. 319B–1. IMMUNIZATION EDUCATIONAL EFFORTS AND 
GRANTS. 
‘‘(a) IN GENERAL.—The Director of the Centers for 
Disease Control and Prevention, in conjunction with State 
and local health departments, shall revise and expand the 
influenza-related educational materials to the Centers for 
Disease Control and Prevention, and facilitate the use of 
such materials by health care providers and patients. The 
Director is authorized to coordinate such educational ef-
forts with nonprofit provider and patient advocacy groups. 
‘‘(b) INFLUENZA VACCINE EDUCATION AND OUT-
REACH.—
‘‘(1) IN GENERAL.—In order to achieve an opti-
mal balance in the influenza vaccine market, and to 
ensure that the recommendations of the Advisory 
Committee on Immunization Practices to the Cen-
ters for Disease Control and Prevention for vaccine 
administration are carried out to the maximum ex-
tent possible, the Director of the Centers for Disease 
Control and Prevention, in conjunction with State 
and local health departments, shall carry out influ-
enza immunization education and outreach activities 
that target physicians and other health care pro-
viders, health insurance providers, health care insti-
tutions and patients, particularly those in high pri-
ority populations (as defined by the Advisory Com-
mittee on Immunization Practices and the Centers 
for Disease Control and Prevention) (referred to in 
this section as ‘high priority populations’). 
‘‘(2) TYPES
OF
ACTIVITIES.—The education 
and outreach activities under paragraph (1) shall in-
clude— 
‘‘(A) activities to encourage voluntary par-
ticipation in influenza vaccination programs, 
with the goal of increasing overall influenza 
vaccination rates in the United States, achiev-
ing full influenza vaccination of all high priority
populations, and full use of each season’s influ-
enza vaccine supply; 
‘‘(B) the provision of information on influ-
enza prevention; 
‘‘(C) activities to increase the number of 
healthcare providers who receive influenza vac-
cines each year; and 
‘‘(D) other influenza educational efforts 
determined appropriate by the Director. 
‘‘(c) GRANTS.—The Director of the Centers for Dis-
ease Control and Prevention may award grants to State 
and local health departments to carry out activities to en-
courage individuals, particularly those from high priority 
populations, to seek out influenza vaccinations. 
‘‘(d) COLLABORATION.—State and local health de-
partments that receive grants under subsection (b) are en-
couraged to collaborate on projects with physicians and 
other health care providers, health insurance providers, 
health care institutions, and groups representing high pri-
ority populations.’’. 
SEC. 303. DOMESTIC SURVEILLANCE OF WILD BIRDS. 
(a) IN GENERAL.— The United State Geological Sur-
vey, working in coordination with the United States Fish 
and Wildlife Service, the National Park Service, and other
relevant agencies, shall carry out an interagency effort to 
detect avian influenza in wild birds. 
(b) TYPES OF ACTIVITIES.—The efforts under sub-
section (a) shall include— 
(1) preparing standard guidelines for routine 
and systematic monitoring of wild birds; 
(2) developing a uniform protocol for reporting 
mortality events; developing instructions for safe 
handling and shipping of specimens to diagnostic fa-
cilities; 
(3) training for field personnel in procedures; 
and 
(4) reporting on finding back to the field. 
SEC. 304. RESEARCH AT THE NATIONAL INSTITUTES OF 
HEALTH. 
The Director of the National Institutes of Health (re-
ferred to in this section as the ‘‘Director of NIH’’), in 
collaboration with the Director of the Centers for Disease 
Control and Prevention, and other relevant agencies, shall 
expand and intensify human and animal research, with re-
spect to influenza, on— 
(1) vaccine development and manufacture, in-
cluding strategies to increase immunological re-
sponse;
(2) effectiveness of inducing heterosubtypic im-
munity; 
(3) antigen-sparing studies; 
(4) antivirals, including minimal dose or course 
of treatment and timing to achieve prophylactic or 
therapeutic effect; 
(5) side effects and drug safety of vaccines and 
antivirals in subpopulations; 
(6) alternative routes of delivery of vaccines, 
antivirals, and other medications as appropriate; 
(7) more efficient methods for testing and de-
termining virus subtype; 
(8) protective measures; 
(9) modes of influenza transmission; 
(10) effectiveness of masks, hand-washing, and 
other non-pharmaceutical measures in preventing 
transmission; 
(11) improved diagnostic tools for influenza; 
and 
(12) other areas determined appropriate by the 
Director of NIH. 
SEC. 305. RESEARCH AT THE CENTERS FOR DISEASE CON-
TROL AND PREVENTION. 
The Director of the Centers for Disease Control and 
Prevention, in collaboration with other relevant agencies,
shall expand and intensify research, with respect to influ-
enza, on— 
(1) historical research on prior pandemics to 
better understand pandemic epidemiology, trans-
mission, protective measures, high-risk groups, and 
other lessons that may be applicable to future pan-
demic; 
(2) communication strategies for the public dur-
ing pandemic influenza, taking into consideration 
age, racial and ethnic background, health literacy, 
and risk status; 
(3) changing and influencing human behavior 
as it relates to vaccination; 
(4) population-based surveillance methods to es-
timate influenza infection rates and rates of out-
patient illness; 
(5) vaccine effectiveness; 
(6) systems to monitor vaccination coverage lev-
els and adverse events from vaccination; and 
(7) other areas determined appropriate by the 
Director of the Centers for Disease Control and Pre-
vention. 
SEC. 306. GLOBAL SURVEILLANCE. 
The Director of the Centers for Disease Control and 
Prevention, in collaboration with the Department of State
and other relevant agencies, shall expand and intensify the 
efforts of the Global Disease Detection Initiative. The Sec-
retary shall increase the number of international public 
health sites and staff abroad in countries impacted by pan-
demic influenza to conduct disease identification and 
intervention activities, provide critical public health exper-
tise to countries in need, train international collaborators 
to recognize and respond to influenza and other disease 
threats, and improve communication capabilities. The Di-
rector of the Centers for Disease Control and Prevention 
shall conduct a feasibility study and plan for the contain-
ment of a human pandemic flu outbreak abroad. 
SEC. 307. PROPOSAL FOR INTERNATIONAL FUND TO SUP-
PORT PANDEMIC INFLUENZA CONTROL. 
(a) IN GENERAL.—The Secretary should submit to 
the Director of the World Health Organization a proposal 
to study the feasibility of establishing a fund, (referred 
to in this section as the ‘‘Pandemic Fund’’) to support 
pandemic influenza control and relief activities conducted 
in countries affected by pandemic influenza, including 
pandemic avian influenza. 
(b) CONTENT
OF PROPOSAL.—The proposal sub-
mitted under subsection (a) shall describe, with respect 
to the Pandemic Fund— 
(1) funding sources;
(2) administration; 
(3) application process by which a country may 
apply to receive assistance from such Fund; 
(4) factors used to make a determination re-
garding a submitted application, which may in-
clude— 
(A) the gross domestic product of the ap-
plicant country; 
(B) the burden of need, as determined by 
human morbidity and mortality and economic 
impact related to pandemic influenza and the 
existing capacity and resources of the applicant 
country to control the spread of the disease; 
and 
(C) the willingness of the country to co-
operate with other countries with respect to 
preventing and controlling the spread of the 
pandemic influenza; and 
(5) any other information the Secretary deter-
mines necessary. 
(c) USE
OF FUNDS.—Funds from any Pandemic 
Fund established as provided for in this section shall be 
used to complement and augment ongoing bilateral pro-
grams and activities from the United States and other 
donor nations.
SEC. 308. PANDEMIC INFLUENZA AND ANIMAL HEALTH. 
(a) IN GENERAL.—The Secretary of Agriculture shall 
expand and intensify efforts to prevent pandemic influ-
enza, including possible pandemic avian influenza. 
(b) REPORT.—Not later than 180 days after the date 
of enactment this Act, the Secretary of Agriculture shall 
submit to Congress a report that describes the anticipated 
impact of pandemic influenza on the United States agri-
culture industry. 
(c) ASSISTANCE.—The Secretary of Agriculture, in 
consultation with the Secretary of Health and Human 
Services, the World Health Organization, and the World 
Organization for Animal Health, shall provide domestic 
and international assistance with respect to pandemic in-
fluenza preparedness to— 
(1) support the eradication of infectious animal 
diseases and zoonosis; 
(2) increase transparency in animal disease 
states; 
(3) collect, analyze, and disseminate veterinary 
data; 
(4) strengthen international coordination and 
cooperation in the control of animal diseases; and 
(5) promote the safety of world trade in ani-
mals and animal products.
TITLE IV—STATE AND LOCAL 
INFRASTRUCTURE 
SEC. 401. STATE PREPAREDNESS PLAN. 
(a) IN GENERAL.—As a condition of receiving funds 
from the Centers for Disease Control and Prevention or 
the Health Resources and Services Administration related 
to bioterrorism, a State shall— 
(1) designate an official or office as responsible 
for pandemic influenza preparedness; 
(2) submit to the Director of the Centers for 
Disease Control and Prevention (referred to in this 
section as the ‘‘Director’’) a Pandemic Influenza 
Preparedness Plan described under subsection (b); 
and 
(3) have such Preparedness Plan approved in 
accordance with this section. 
(b) PREPAREDNESS PLAN.— 
(1) IN
GENERAL.—The Pandemic Influenza 
Preparedness Plan required under subsection (a) 
shall address— 
(A) human and animal surveillance activi-
ties, including capacity for epidemiological anal-
ysis, isolation and subtyping of influenza vi-
ruses year-round, including for avian influenza
among domestic poultry, and reporting of infor-
mation across human and veterinary sectors; 
(B) methods to ensure surge capacity in 
hospitals, laboratories, outpatient healthcare 
provider offices, medical suppliers, and commu-
nication networks; 
(C) assisting the recruitment and coordina-
tion of national and State volunteer banks of 
healthcare professionals; 
(D) distribution of vaccines, antivirals, and 
other treatments to priority groups, and mon-
itor effectiveness and adverse events; 
(E) networks that provide alerts and other 
information for healthcare providers and orga-
nizations at the National, State, and regional 
level; 
(F) communication with the public with re-
spect to prevention and obtaining care during 
pandemic influenza; 
(G) maintenance of core public functions, 
including public utilities, refuse disposal, mor-
tuary services, transportation, police and fire-
fighter services, and other critical services; 
(H) provision of security for—
(i) first responders and other medical 
personnel and volunteers; 
(ii) hospitals, treatment centers, and 
isolation and quarantine areas; 
(iii) transport and delivery of re-
sources, including vaccines, medications 
and other supplies; and 
(iv) other persons or functions as de-
termined appropriate by the Secretary; 
(I) the acquisition of necessary legal au-
thority for pandemic activities; 
(J) integration with existing national, 
State, and regional bioterrorism preparedness 
activities or infrastructure; 
(K) coordination among public and private 
health sectors with respect to healthcare deliv-
ery, including mass vaccination and treatment 
systems, during pandemic influenza; and 
(L) coordination with Federal pandemic in-
fluenza preparedness activities. 
(2) UNDERSERVED
POPULATIONS.—The Pan-
demic Influenza Preparedness Plan required under 
subsection (a) shall include a specific focus on sur-
veillance, prevention, and medical care for tradition-
ally underserved populations, including low-income,
racial and ethnic minority, immigrant, and unin-
sured populations. 
(c) APPROVAL OF STATE PLAN.— 
(1) IN GENERAL.—The Director shall develop 
criteria to rate State Pandemic Influenza Prepared-
ness Plans required under subsection (a) and deter-
mine the minimum rating needed for approval. 
(2) TIMING OF APPROVAL.—Not later than 90 
days after a State submits a State Pandemic Influ-
enza Preparedness Plan as required under sub-
section (a), the Director shall make a determination 
regarding approval of such Plan. 
(d) REPORTING OF STATE PLAN.—All Pandemic In-
fluenza Preparedness Plans submitted and approved 
under this section shall be made available to Congress, 
State officials, and the public as determined appropriate 
by the Director. 
(e) ASSISTANCE TO STATES.—The Centers for Dis-
ease Control and Prevention and the Health Resources 
and Services Administration may provide assistance to 
States in carrying out this section, or implementing an 
approved State Pandemic Influenza Preparedness Plan, 
which may include the detail of an officer to approved do-
mestic pandemic sites or the purchase of equipment and 
supplies.
(f) WAIVER.—The Director may grant a temporary 
waiver of 1 or more of the requirements under this section. 
TITLE V—GENERAL PROVISIONS 
SEC. 501. AUTHORIZATION OF APPROPRIATIONS. 
For the purpose of carrying out this Act and the 
amendments made by this Act, there are authorized to be 
appropriated such sums as may be necessary for each of 
the fiscal years 2006 through 2010. 
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