1.This Act may be cited as
the Influenza Vaccine Security Act of
2005
.
<enum>I</enum><header>Market
Guarantees</header>
<section id="id57FBBF3EFBBC40A38BAF317097E037A8"><enum>101.</enum><header>Amendment to
the Public Health Service Act</header>
<subsection id="ID33e5049b07214beeb8a06bc9b6c966b7"><enum></enum><text>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:</text>
<quoted-block display-inline="no-display-inline" id="idF263A06D4E814444AF0BBE88C8206631" style="OLC">
<subtitle id="idA9D0459A4370490283AEE3D65D87CCBF"><enum>3</enum><header>Influenza vaccine
security</header>
<section commented="no" display-inline="no-display-inline" id="idCAF8F32A82464A2AB2B44EA26087C0B7" section-type="subsequent-section"><enum>2141.</enum><header>Establishment of an
influenza vaccine target and stockpile</header>
<subsection commented="no" display-inline="no-display-inline" id="idE87A4EA0DBE64DF697587568FC670753"><enum>(a)</enum><header>Annual
target</header><text display-inline="yes-display-inline">The Secretary, in
consultation with the Advisory Committee on Immunization Practices to the
Centers for Disease Control and Prevention (referred to in this subtitle as the
<quote>Advisory Committee</quote>), shall determine an annual production target
for influenza vaccine, based on the recommendations of the Advisory Committee.
Based on such target, the Secretary, acting through the Centers for Disease
Control and Prevention, shall coordinate with the private market to encourage
the production of such vaccine in amounts that will meet the annual
target.</text>
</subsection><subsection commented="no" display-inline="no-display-inline" id="id408926091E934DACB56AADB7C504D0F6"><enum>(b)</enum><header>Stockpile</header><text display-inline="yes-display-inline">Prior to the start of each annual influenza
season (as determined by the Secretary), the Secretary is authorized to
purchase and store from multiple manufacturers an amount equal to not to exceed
10 percent of the total amount of influenza vaccine, including one or more
active vaccine antigen ingredients in bulk or filled form, that is designated
for production by the Advisory Committee for placement in the strategic
national stockpile under section 121 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. Such vaccine shall be held
in reserve to be used in the event of a vaccine shortage in a given influenza
season. The Secretary shall coordinate with the manufacturers involved to
ensure that reserving amounts of vaccine for the stockpile does not interfere
with the early season delivery or early season administration of vaccine to
high priority populations (as defined by the Advisory Committee on Immunization
Practices and the Centers for Disease Control and Prevention) (referred to in
this subtitle as <quote>high priority populations</quote>).</text>
</subsection></section><section id="id6847234603214DE09ACAD145A3E5C6F5"><enum>2142.</enum><header>Vaccine
buyback program</header>
<subsection id="id18F07DE86E054FDCBAABED4FF532764C"><enum>(a)</enum><header>In
general</header><text>The Secretary shall establish an influenza vaccine
buyback protocol under which the Secretary may enter into buyback contracts
with manufacturers of influenza vaccine to purchase such manufacturers' excess
stocks of influenza vaccine so long as such vaccine has been manufactured in
accordance with the recommendations of the Advisory Committee for the
production of seasonal influenza vaccine.</text>
</subsection><subsection id="id546D824C91554CD191FB86B25C5E4CC5"><enum>(b)</enum><header>Manufacturers</header><text>The
Secretary shall have the discretion to award buyback contracts under subsection
(a) to several influenza vaccine manufacturers in a manner consistent with the
goal of providing stability in the influenza vaccine market, as long as the
Federal Government purchases not more than 50 percent of the excess influenza
vaccine stock of any single manufacturer at market price.</text>
</subsection><subsection id="id0AC90C4DE70946E7B735C4BFE40F9BD5"><enum>(c)</enum><header>Cooperation
with manufacturers, distributors, and wholesalers</header><text>As a condition
of participation in the buyback program under this section, the Director of the
Centers for Disease Control and Prevention shall work in cooperation with
influenza vaccine manufacturers and wholesalers and distributors within the
chain of custody from factory to health care institution or health care
providers to share pertinent information that will allow for the tracking of
influenza vaccine, maximize the delivery and availability of influenza vaccines
to high priority populations, and ensure that influenza vaccine is delivered on
an equitable basis, particularly in times of vaccine shortages.</text>
</subsection><subsection id="ID4fc6c280279e4a5993efbe877ecf5844"><enum>(d)</enum><header>Confidentiality</header><text>The
information submitted to the Centers for Disease Control and Prevention or its
contractors, if any, under subsections (c) and (d) shall remain confidential in
accordance with the exception from the public disclosure of trade secrets,
commercial or financial information, and information obtained from an
individual that is privileged and confidential, as provided for in section
552(b)(4) of title 5, United States Code, and subject to the penalties and
exceptions under sections 1832 and 1833 of title 18, United States Code,
relating to the protection and theft of trade secrets, and subject to privacy
protections that are consistent with the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability Act of 1996. None
of such information provided by a manufacturer, wholesaler, or distributor
shall be disclosed without its consent to another manufacturer, wholesaler, or
distributor, or shall be used in any manner to give a manufacturer, wholesaler,
or distributor a proprietary advantage over its competitors.</text>
</subsection><subsection id="id63A2BB63E23D492BBEA0BFF84FF5B111"><enum>(e)</enum><header>Ability to
negotiate</header><text>The Secretary shall have the ability to negotiate, on a
case-by-case basis, the submission of information under subsection (c), as long
as the information provided will achieve the goals of tracking of the influenza
vaccine, maximizing the delivery and availability of influenza vaccines to high
priority populations, and ensuring that influenza vaccine is delivered on an
equitable geographical basis, particularly in times of vaccine
shortages.</text>
</subsection><subsection id="idC431BD34172546788F078753CD3B17D4"><enum>(f)</enum><header>Notice</header>
<paragraph id="IDca5fdf9ec706403a8349747013d5aaa1"><enum>(1)</enum><header>In
general</header><text>For purposes of maintaining and administering the supply
of vaccines described under subsection (a), the Secretary shall by contract
require that a manufacturer of a vaccine included in such supply provide not
less than 12 months notice to the Secretary of a purposeful discontinuance of
the manufacture of such vaccine by the manufacture of the vaccine.</text>
</paragraph><paragraph id="ID319c7285706843979680975687160c66"><enum>(2)</enum><header>Reduction of
period of notice</header><text>The notification period required under paragraph
(1) shall not apply in a case in which vaccine production is interrupted
because of unforeseen manufacturing concerns.</text>
</paragraph></subsection></section><section id="idFB1644E0E0CE4A52A061558B1305E3AD"><enum>2143.</enum><header>Antiviral
purchase program</header>
<subsection id="id66095E48A7C7409C93F67AE619CAF700"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary shall
increase the amount of antiviral medications contained in the strategic
national stockpile under section 121 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002, in such amounts as
necessary, as determined appropriate in consultation with the Director of the
Centers for Disease Control and Prevention, to provide adequate protection to
not less than those responding to an influenza epidemic.</text>
</subsection><subsection id="id3B48EB158C3E426B8C725F6A2AAEE17F"><enum>(b)</enum><header>Pediatric
antiviral</header><text display-inline="yes-display-inline">The Secretary is
encouraged to work with all relevant Federal agencies and the private sector to
develop and approve an antiviral for use in the pediatric population.</text>
</subsection></section><section id="id34E3AAB313F8425FAADE803C57CDDFF4"><enum>2144.</enum><header>Authorization
of appropriations</header>
<subsection id="ID8fb97baf962a42b7aa8c02264c56a186"><enum></enum><text>There are
authorized to be appropriated such sums as may be necessary to carry out this
subtitle in each of fiscal years 2007 through
2011.</text>
</subsection></section></subtitle><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>II</enum><header>Food and Drug
Administration assistance to manufacturers</header>
<section id="id41F1731FDD2C40338F20AB423F9CC1D2"><enum>201.</enum><header>Amendment to
the Food, Drug, and Cosmetic Act</header>
<subsection id="IDf193dcdd0a8c40109bb5bf81f8503829"><enum></enum><text>Chapter IX of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE32A5A1CF8BE410FA166E185F8230A4B" style="OLC">
<section id="id0168B83C80AD4C23A5B781B252E13587"><enum>909.</enum><header>Provisions
relating to influenza vaccine manufacturers</header>
<subsection id="id1E38659F839C4B5B88B9B478D9E9D65D"><enum>(a)</enum><header>Assistance and
technical training branch</header><text display-inline="yes-display-inline">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 provide technical guidance, to entities
seeking to comply with regulations of the Secretary relating to the production
of biologic materials, particularly influenza vaccine.</text>
</subsection><subsection id="id57A47C656D324D9FA19AD2C0BA02889C"><enum>(b)</enum><header>Technical
assistance grants</header>
<paragraph id="id90E81D6077F644C39A40114871C9A439"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary, in
consultation with the Commissioner, shall award technical assistance grants to
entities seeking to—</text>
<subparagraph id="idF3DA8F3E094C4DE58CA949DFAA99B7B2"><enum>(A)</enum><text display-inline="yes-display-inline">enter the United States influenza vaccine
market;</text>
</subparagraph><subparagraph id="idF875433E7DB84957AF32AD6FA718266E"><enum>(B)</enum><text display-inline="yes-display-inline">expand their vaccine production capacity
for the United States influenza vaccine market; or</text>
</subparagraph><subparagraph id="id5A515B8DC8CA4069B2D99D6423927D18"><enum>(C)</enum><text display-inline="yes-display-inline">improve their ability to remain within the
United States influenza vaccine market.</text>
</subparagraph></paragraph><paragraph id="id3F6E266334BC4D3481D5F7965D1E0EB7"><enum>(2)</enum><header>Activities</header><text display-inline="yes-display-inline">Amounts awarded under grants under
paragraph (1) shall be used for one or more of the following activities:</text>
<subparagraph id="ID2e3c87bf6552476289db52d527355ee8"><enum>(A)</enum><text>Establishing or
making capital improvements in technology, machinery, or production capacity to
vaccine manufacturing facilities located within the United States to enable
such facilities to comply with the regulations of the Food and Drug
Administration.</text>
</subparagraph><subparagraph id="ID222352f2f3f248bcb64ffb0b742d85b8"><enum>(B)</enum><text>The training of
employees of United States-based vaccine manufacturing facilities in vaccine
production methods.</text>
</subparagraph><subparagraph id="ID3ebbaf47ba66469ebc8e38808b103e42"><enum>(C)</enum><text>Any other
activities approved by the Commissioner as assisting with the goal of
increasing manufacturer participation in the vaccine market and improving
domestically-based vaccine manufacturing capacity.</text>
</subparagraph></paragraph></subsection><subsection id="id26E06B0C8F894189B8E7B41124E13165"><enum>(c)</enum><header>Provisions
related to the emergency acquisition of vaccines</header>
<paragraph id="id812167A2F6D24217858020FFD5BBCE27"><enum>(1)</enum><header>Increased
communication</header><text>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 conferences 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.</text>
</paragraph><paragraph id="id26D716BF79474D3DB8426B175142376D"><enum>(2)</enum><header>Regulatory
roadmap</header><text>The Commissioner, in consultation with the Director of
the Centers for Disease Control and Prevention, the Secretary, and other
agencies or participants as determined appropriate by the Secretary, shall
develop a regulatory roadmap to address the following issues surrounding
emergency use authorization of influenza vaccine, as determined by the
Secretary during a public health emergency involving an actual or imminent
outbreak of naturally occurring or engineered seasonal influenza:</text>
<subparagraph id="id744F85BDA6AD41CA8A0F55BC2E9135F2"><enum>(A)</enum><text>Policies for the
emergency use authorization 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.</text>
</subparagraph><subparagraph id="idE903156B97EC4846B32270A89853CEFE"><enum>(B)</enum><text>Policies for the
facilitation of the distribution of any such vaccine imported into the United
States during a vaccine shortage, including the interstate transportation,
allocation and equitable distribution of vaccine among high priority
populations (as defined by the Advisory Committee on Immunization Practices and
the Centers for Disease Control and Prevention) during an emergency use
situation.</text>
</subparagraph><subparagraph id="ID9988992a1b08470090e09bfe1865d0f9"><enum>(C)</enum><text>Policies for the
communication and coordination of a response to an emergency use authorization
with State and local health departments, including guidelines for notification
of such entities in such situations.</text>
</subparagraph><subparagraph id="id611D643538304CBB8060C0026A599705"><enum>(D)</enum><text>Policies for the
emergency use authorization of vaccines that are in clinical development in
both the United States and other countries, including clarification of IND
protocols for such vaccines, particularly those using new vaccine development
technologies.</text>
</subparagraph></paragraph><paragraph id="id73500132DF55441FA1F7C244B5D10268"><enum>(3)</enum><header>Consultation</header><text>In
developing the roadmap 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 maintain the scientific and
regulatory standards of the Food and Drug Administration.</text>
</paragraph><paragraph id="id14F6438DF2F441CC9074996DD223AE6C"><enum>(4)</enum><header>Standing
orders</header>
<subparagraph id="idA63902F786BC48B6A4EBE27F1DEE2FC8"><enum>(A)</enum><header>Development</header><text>The
Secretary shall direct the Centers for Disease Control and Prevention, in
conjunction with State and local health departments and representatives of
State medical boards and nursing examiners, to develop and publish a model
standing order that will, at a minimum, address the need for standing orders to
administer influenza vaccine in hospitals, nursing homes, and by home health
care providers. The Centers for Disease Control and Prevention is encouraged to
expand such a model standing order to take into account—</text>
<clause id="id409E656C10E543E4ABBF1D85A2CEAB4B"><enum>(i)</enum><text>the
administration of other Medicare covered vaccines; and</text>
</clause><clause id="id4D8F3E2C41464D65BCD61309E54C5E3E"><enum>(ii)</enum><text>the delivery of
influenza vaccine to patients in children's hospitals or other institutions
serving the long-term care needs of a pediatric population.</text>
</clause></subparagraph><subparagraph id="IDddec9e3fe40e47e9935f3e0659bb289c"><enum>(B)</enum><header>Implementation</header><text>Not
less than 1 year after the publication of the standing order under paragraph
(A), States shall be required to implement such standing order in order to be
eligible to receive grants under this Act.</text>
</subparagraph><subparagraph id="IDee77555c9868459e941c9fcaf230af6b"><enum>(C)</enum><header>Rule of
construction</header><text>Nothing in this paragraph shall be construed as
precluding the application of State laws, so long as such laws don not restrict
the implementation of this requirements of the
<short-title>Influenza Vaccine Security Act of
2005</short-title> (and the amendments made by such Act).</text>
</subparagraph></paragraph></subsection><subsection id="id72E9F27145D94ADB860A2A99B6DFA033"><enum>(d)</enum><header>Authorization
of appropriations</header>
<paragraph id="idC585A207A603428CB7B03848B6DB48DA"><enum>(1)</enum><header>In
general</header><text>There are authorized to be appropriated to carry out this
section, $75,000,000 for each of fiscal years 2007 through 2011.</text>
</paragraph><paragraph id="ID934f5cb177714ca292d198c368485ac8"><enum>(2)</enum><header>Use of
funds</header><text>The Secretary shall ensure that $5,000,000 of the amount
appropriated under paragraph (1) for fiscal year 2007, and such sums as may be
necessary for each of fiscal years 2008 through 2011, shall be made available
for the purpose of increasing the ability of the Food and Drug Administration
to provide the technical assistance and take advantage of the training
opportunities as designated in this
section.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><enum>III</enum><header>Vaccine
development research and coordination</header>
<section id="idE09B20B560B442E79C17D1E0B07CD97B"><enum>301.</enum><header>Increased
funding for new and existing vaccine development research</header><text display-inline="no-display-inline">Subpart 6 of part C of title IV of the
Public Health Service Act (42 U.S.C. 285f et seq.) is amended by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id05B1DFB090DF44D88C4257F5A5C896BD" style="OLC">
<section id="id28E002C8F78B474DBE9EE6E9EFB2A8ED"><enum>447C.</enum><header>Increased
funding for new and existing vaccine development research</header>
<subsection id="id50EA6AD36EDE4FE4A3DC76A0769315B7"><enum>(a)</enum><header>New
research</header>
<paragraph id="id165E477124474BBD8697D733C005B12C"><enum>(1)</enum><header>Solicitation of
proposals</header><text display-inline="yes-display-inline">The Institute shall
solicit proposals for research into improved technologies for influenza vaccine
development, including a permanent influenza vaccine. The Secretary, acting
through the Director of the Institute may award grants to fund such
proposals.</text>
</paragraph><paragraph id="id5D6F4A785A9C4C11A8219888AD64E2E1"><enum>(2)</enum><header>Priority</header><text display-inline="yes-display-inline">In funding proposals submitted under
paragraph (1), the Institute shall give priority to proposals for research that
contributes to the goal of providing marketable influenza vaccine alternatives
within the 10-year period after the date of enactment of this section.</text>
</paragraph></subsection><subsection id="ID97cdb11282984a00b201d8e00e24d78e"><enum>(b)</enum><header>Existing
research</header>
<paragraph id="id6CE37D195A884B509345FAA0F0CEBEC8"><enum>(1)</enum><header>In
general</header><text>The Director of the Institute, acting jointly with the
Director of Intramural Research at the Institute and the Scientific Director of
the Vaccine Research Program at the Institute, and in consultation with any
other officials determined appropriate by the Director, shall review vaccine
development research that is being conducted under grants awarded by the
Institute to identify research that could provide the United States with
improved technologies for vaccine production that could be marketed within the
United States within the 10-year period beginning on the date of enactment of
this section.</text>
</paragraph><paragraph id="idAEE688C9246A44D7B9A16ADCD67D085D"><enum>(2)</enum><header>Supplementary
funding</header><text>The Director of the Institute shall provide supplementary
grant funding to the research identified under paragraph (1) that the Director
determines could result in the production described in such paragraph.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2F15372383094948A76DBA4E10547BC2"><enum>(3)</enum><header>Authorization
of appropriations</header><text display-inline="yes-display-inline">There is
authorized to be appropriated to carry out this section, $100,000,000 for each
of fiscal years 2007 through
2011.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idF442B8053BC440FB8FE8B64F54BF5F37"><enum>302.</enum><header>Authority of
the National Immunization Program for coordination of, education, outreach, and
communication across HHS</header><text display-inline="no-display-inline">Section 2102 of the Public Health Service
Act (42 U.S.C. 300aa–2) is amended—</text>
<paragraph id="idA40516C6C8A1477B8AE173D8B5125B7D"><enum>(1)</enum><text display-inline="yes-display-inline">in subsection (a), by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="idC726A4772088441689F1FC53E9859B67" style="OLC">
<paragraph id="IDc81102eb946540b4bcfc4248a0ed3d7b"><enum>(10)</enum><header>Coordination
of support</header><text>The Director of the Program shall—</text>
<subparagraph id="IDf54600eb1e054292b8190c5a59fb8179"><enum>(A)</enum><text>coordinate
education, outreach, and communication efforts in regard to all influenza
vaccine research activities within the Department in support of the goal
of—</text>
<clause id="ID3423481ea3f346d292fdab77e7e3ee66"><enum>(i)</enum><text>increasing
overall influenza vaccination rates in the United States, particularly those of
high priority populations (as defined by the Advisory Committee on Immunization
Practices and the Centers for Disease Control and Prevention) and health care
providers,</text>
</clause><clause id="IDe0a0a19b1d5d4f219b9d71ba841e290b"><enum>(ii)</enum><text>ensuring that
safe and effective marketable vaccines produced with improved technologies that
supplement the current egg-based system of production shall be available within
the 10-year period after the enactment of this paragraph; and</text>
</clause><clause id="ID87189ae2eb264ddb825d6736e5233ad9"><enum>(iii)</enum><text>any other
vaccine promotion activities as directed by the Secretary;</text>
</clause></subparagraph><subparagraph id="ID648808d6c6b842b798476dab9723108a"><enum>(B)</enum><text>coordinate
educational efforts under this paragraph with the National Vaccine Program
Office, State and local health departments, the National Institutes of Health,
and all other relevant Federal and other entities as designated by the
Director; and</text>
</subparagraph><subparagraph id="IDe644350c4c7e40b0857faefcfd24a70b"><enum>(C)</enum><text>provide an annual
report to Congress on the progress being made toward the goals described in
subparagraph (A).</text>
</subparagraph></paragraph><after-quoted-block>;
and</after-quoted-block></quoted-block>
</paragraph><paragraph id="id93F24442D9F6402ABD69CF322F2495F8"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block display-inline="no-display-inline" id="id6262D34F894C453DB8AFE5EDC7F08DFD" style="OLC">
<subsection id="ID5c41a24d3ecb4261821fcdc6c69bb3fa"><enum>(c)</enum><header>Appropriations
for coordination of influenza vaccine outreach activities</header><text>There
is authorized to be appropriated to carry out activities under subsection
(a)(10), $2,000,000 for each of fiscal years 2007 through
2011.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><enum>IV</enum><header>Increased
influenza vaccine and outbreak surveillance activities</header>
<section id="idA8015556D63F4B69BD38EEEBED7E955C"><enum>401.</enum><header>Tracking
network and demonstration grants</header><text display-inline="no-display-inline">Title III of the Public Health Service Act
is amended by inserting after section 319B (42 U.S.C. 247d–2) the
following:</text>
<quoted-block display-inline="no-display-inline" id="idB7DD6271B9154B17A93C784612025ABB" style="OLC">
<section id="id164E78CB48B74C768FA5AE814B78DCCF"><enum>319B–1.</enum><header>Tracking
network and demonstration grants</header>
<subsection id="idB65107F820C740B6803D0C5AC23C1C80"><enum>(a)</enum><header>Tracking
system</header>
<paragraph id="id9A171AB3AAD54599B021F37C147F3658"><enum>(1)</enum><header>Establishment</header><text display-inline="yes-display-inline">Not later than 2 years after the date of
enactment of this section, the Director of the Centers for Disease Control and
Prevention, in conjunction with State and local public health officials, shall
establish an electronic tracking system through which the Director and such
officials can determine the amount of influenza vaccine that is available for
distribution to patients, as well as the need for such vaccine on a
county-by-county basis, and the progress of vaccine delivery and distribution
efforts at the State and local level.</text>
</paragraph><paragraph id="id746BDA5E1BD74AB2B8818E05A497B3EE"><enum>(2)</enum><header>Estimates</header><text>The
tracking system established under paragraph (1) shall collect estimates of the
size of high priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and Prevention)
(referred to in this section as <quote>high priority populations</quote>) in
each county in the United States, so as to better determine where influenza
vaccine resources may need to be directed in the case of an emergency.</text>
</paragraph><paragraph id="IDc0e258dca1a64eb2b9ac4b54b057d4b3"><enum>(3)</enum><header>Provision of
information</header><text>To be eligible to participate in buyback programs the
vaccine manufacturer shall provide information to the tracking system as the
Director of the Centers for Disease Control and Prevention determines
appropriate in accordance with subtitle 3 of title XXI.</text>
</paragraph><paragraph id="ID4bbf744112f34dd78731e819c6b8b954"><enum>(4)</enum><header>Database</header><text>In
consultation with manufacturers, distributors, wholesalers, and State and local
health departments, the Secretary shall develop guidelines for the development
and use of a database in order to maintain confidentiality and ensure that none
of the information provided under paragraph (3) and contained in the database
can be used to provide a proprietary advantage within the vaccine market while
allowing State and local health officials such information to maximize the
delivery and availability of vaccines to high priority populations.</text>
</paragraph></subsection><subsection id="id8AF6A4F1CEC04B69B4098BEDE33BB2E3"><enum>(b)</enum><header>Expansion of
current systems and activities</header>
<paragraph id="id2C8D762E227C4FD5A97FDAD1A27F6FCB"><enum>(1)</enum><header>Surveillance
system</header><text>Not later than 4 years after the date of enactment of this
section, the Director of the Centers for Disease Control and Prevention shall
upgrade the influenza surveillance system of the Centers for Disease Control
and Prevention to report influenza data from State and local health departments
into the tracking system established under subsection (a)(1).</text>
</paragraph><paragraph id="idE33E9E1BF65D4FA086FBAAF22677EA1A"><enum>(2)</enum><header>Educational
materials</header><text>The tracking system shall contain information to assist
users in accessing influenza education, outreach, and communications tools,
such as those developed and financed under the
<short-title>Influenza Vaccine Security Act of
2005</short-title> (and the amendments made by such Act).</text>
</paragraph><paragraph id="ID81832815c21e4ceb9b1aaf6cfca03a34"><enum>(3)</enum><header>Emergency
provider database</header><text>The Director of the Centers for Disease Control
and Prevention shall coordinate access to, in conjunction with State and local
health departments and State licensing boards for health professionals, a
database registry of medical personnel who can provide services in the event of
a health emergency, including pandemic influenza or an influenza vaccine
shortage. Such information shall be made available through the tracking
network.</text>
</paragraph></subsection><subsection id="id6A0D13E1AD3A44DB9B28BE534459705B"><enum>(c)</enum><header>Demonstration
grants</header>
<paragraph id="id30FFD436FDCD46DCBC91FAEFE16A21B6"><enum>(1)</enum><header>In
general</header><text>The Director of the Centers for Disease Control and
Prevention shall award demonstration grants to State and local health
departments to enable such departments to enter into contract with hospitals,
community health centers, long-term care facilities, physicians’ offices, and
health care facilities operated or funded by such departments to assist such
entities in upgrading their information technology, infrastructure, and
workforce in a manner that will allow such entities to improve their ability to
report and track influenza vaccine dissemination.</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9C6AAB03E133453DA2CA77BED8C55F54"><enum>(2)</enum><header>Priority</header><text>In
awarding grants under paragraph (1), priority shall be given to entities that
serve high priority populations in medically underserved areas.</text>
</paragraph></subsection><subsection id="id9A579091C2E948C1A5A762D7099CF8B1"><enum>(d)</enum><header>Authorization
of appropriations</header><text>There are authorized to be appropriated—</text>
<paragraph id="idBF055F95AE184680870C4B3C7DD9EA92"><enum>(1)</enum><text>to carry out
subsection (a), $100,000,000 for each of fiscal years 2007 through 2011, of
which $500,000 for each fiscal year shall be made available to implement
subsection (b)(3); and</text>
</paragraph><paragraph id="id1B10CF0876964EF78F57A8F95FA6D717"><enum>(2)</enum><text>to carry out
subsection (c), $100,000,000 for each of fiscal years 2007 through
2011.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>V</enum><header>Flu
vaccine outreach and education</header>
<section id="id597B5D7C1B294FE09638649247EBEE76"><enum>501.</enum><header>Educational
efforts and grants</header><text display-inline="no-display-inline">Title III
of the Public Health Service Act is amended by inserting after section 319B–1
(as added by section 401) the following:</text>
<quoted-block display-inline="no-display-inline" id="id63E029E1E3524FE8AD1A19393E75B57B" style="OLC">
<section id="idD56D08E9024D4AD0AF2602862F3035A6"><enum>319B–2.</enum><header>Immunization
educational efforts and grants</header>
<subsection id="idF835E02828244B1799D021205B9CA6DB"><enum>(a)</enum><header>In
general</header><text>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 efforts with nonprofit provider and patient advocacy
groups.</text>
</subsection><subsection id="id50E7F520AE094DAEB1E2BE3B0CD96C5F"><enum>(b)</enum><header>Influenza
vaccine education and outreach</header>
<paragraph id="idEC4E929E7EF94F109AB9B9C0FC63ACD1"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">In order to achieve
an optimal balance in the influenza vaccine market, and to ensure that the
recommendations of the Advisory Committee on Immunization Practices to the
Centers for Disease Control and Prevention for vaccine administration are
carried out to the maximum extent possible, the Director of the Centers for
Disease Control and Prevention, in conjunction with State and local health
departments, shall carry out influenza immunization education and outreach
activities that target physicians and other health care providers, health
insurance providers, health care institutions and patients, particularly those
in high priority populations (as defined by the Advisory Committee on
Immunization Practices and the Centers for Disease Control and Prevention)
(referred to in this section as <quote>high priority
populations</quote>).</text>
</paragraph><paragraph id="idDD985BAC7A604B73B3F27888CE700AEF"><enum>(2)</enum><header>Types of
activities</header><text display-inline="yes-display-inline">The education and
outreach activities under paragraph (1) shall include—</text>
<subparagraph id="ID7ba609ac3f3c40f1984c0a5643bd117a"><enum>(A)</enum><text>activities to
encourage voluntary participation in influenza vaccination programs, with the
goal of increasing overall influenza vaccination rates in the United States,
achieving full influenza vaccination of all high priority populations, and full
use of each season’s influenza vaccine supply;</text>
</subparagraph><subparagraph id="IDe06b048573a74bab827d1828273afd99"><enum>(B)</enum><text>the provision of
information on influenza prevention;</text>
</subparagraph><subparagraph id="id270E11D6B3904944AEFB23F773A1380A"><enum>(C)</enum><text>activities to
increase the number of healthcare providers who receive influenza vaccines each
year; and</text>
</subparagraph><subparagraph id="ID9f40dc47f6ed4d3894fc652f542e3697"><enum>(D)</enum><text>other influenza
educational efforts determined appropriate by the Director.</text>
</subparagraph></paragraph></subsection><subsection id="id7F817508B3FB4CC883E2B2C0FBA12510"><enum>(c)</enum><header>Grants</header><text>The
Director of the Centers for Disease Control and Prevention may award grants to
State and local health departments to carry out activities to encourage
individuals, particularly those from high priority populations, to seek out
influenza vaccinations.</text>
</subsection><subsection id="IDe6eef2b6f0d64c0db2af8a245025bb64"><enum>(d)</enum><header>Collaboration</header><text>State
and local health departments that receive grants under subsection (b) are
encouraged to collaborate on projects with physicians and other health care
providers, health insurance providers, health care institutions, and groups
representing high priority populations.</text>
</subsection><subsection id="id4503D3954C0949718E733627AF7C8563"><enum>(e)</enum><header>Authorization
of appropriations</header><text>In addition to any amounts otherwise available
through the Secretary for influenza outreach and education, there is authorized
to be appropriated to carry out this section, $10,000,000 for each of fiscal
years 2007 through
2011.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>VI</enum><header>Compensation</header>
<section id="IDA26DB06119BD4F6DBB74A64B2717ED87"><enum>601.</enum><header>Compensation</header><text display-inline="no-display-inline">Section 224 of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name> (42 U.S.C.
233) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" display-inline="no-display-inline" id="ID7E50C72C6B4444EB8D2E714503D3D322" style="OLC">
<subsection id="IDAE55B556BAF247699E1F4C535910D07E"><enum>(q)</enum><header>Manufacture,
administration, and use of pandemic influenza technologies</header>
<paragraph id="ID70D776A15F784A89BB56D4AA6CEC8AA5"><enum>(1)</enum><header>Definitions</header><text>In
this subsection:</text>
<subparagraph id="ID538936FB3D4441DD954B794697A6DEAD"><enum>(A)</enum><header>Covered
person</header><text>The term <term>covered person</term> means—</text>
<clause id="ID31663DCCD98345A0B929539ED0E01B71"><enum>(i)</enum><text>a
manufacturer of a qualified pandemic influenza technology;</text>
</clause><clause id="ID2970C54D86044C4AA6C6DBFE6A0C929B"><enum>(ii)</enum><text>a distributor of
a qualified pandemic influenza technology;</text>
</clause><clause id="ID3BA01B31E5A2404C804915BD945A426D"><enum>(iii)</enum><text>a hospital,
clinic, and other healthcare entity under whose auspices a qualified pandemic
influenza technology is administered;</text>
</clause><clause id="IDFFD4B12224D1412290D7FED921E9F004"><enum>(iv)</enum><text>a licensed
health care professional or other individual authorized to administer a
qualified pandemic influenza technology under State law; and</text>
</clause><clause id="IDA1AD2C2C80C040D580FB5464F5A8CF71"><enum>(v)</enum><text>any official,
agent, or employee of any of the entities described in clauses (i) through
(iv), or of a State or locally administered health plan, or a volunteer acting
under a publicly funded health program, who is acting within the scope of his
or her agency or employment.</text>
</clause></subparagraph><subparagraph id="ID6C992EC10BBF4C519A049295C757ED54"><enum>(B)</enum><header>Pandemic
influenza technology</header><text>The term <term>pandemic influenza
technology</term> means any vaccine product developed or procured for the
specific purpose of preventing or treating pandemic influenza or any vaccine
product limiting the harm such pandemic might otherwise cause.</text>
</subparagraph><subparagraph id="ID8149FEA4E0404A28AF34CA4CE92FA552"><enum>(C)</enum><header>Qualified
pandemic influenza technology</header><text>The term <term>qualified pandemic
influenza technology</term> means a pandemic influenza technology that has been
designated by the Secretary in accordance with paragraph (2).</text>
</subparagraph></paragraph><paragraph id="ID2837262DD62B4FDF8D82CC6CF53E26F7"><enum>(2)</enum><header>Designation by
Secretary</header>
<subparagraph id="IDB9DC25776E8341048D35C21AB38A709E"><enum>(A)</enum><header>In
general</header><text>The Secretary may designate a pandemic influenza
technology as a qualified pandemic influenza technology if the Secretary
determines that there is a public health emergency involving an actual or
imminent outbreak of naturally occurring or engineered pandemic influenza and
requiring the manufacture, distribution, and administration of pandemic
influenza technology.</text>
</subparagraph><subparagraph id="IDC13C9510BB2D47A6B5F267BE4491B2E9"><enum>(B)</enum><header>Recommended
designation</header><text>A person may recommend to the Secretary at any time
the designation of a technology under subparagraph (A) and may provide data and
information to support such recommendation.</text>
</subparagraph><subparagraph id="ID54E0D887E3CA49F0A4E5A276DDB4AED9"><enum>(C)</enum><header>Effective
period</header><text>The Secretary shall specify in a designation under this
paragraph the beginning and ending dates of the effective period of such
designation, and may subsequently amend such designation to shorten or extend
such effective period.</text>
</subparagraph><subparagraph id="ID953501FF30BB4DA59A96B09A5BEFB5E9"><enum>(D)</enum><header>Publication</header><text>The
Secretary shall provide for the publication of each designation under this
paragraph, and each amendment thereto, in the Federal Register. Such
designation or amendment shall take effect immediately upon such publication
and shall not be subject to the provisions of section 553 of title 5, United
States Code, concerning prior notice and opportunity for comment.</text>
</subparagraph><subparagraph id="ID14ca826b537b43d4b098fd8d9b4cdbb5"><enum>(E)</enum><header>Vaccine injury
compensation program</header><text>Nothing in this Act shall be construed to
supersede the authority of the Vaccine Injury Compensation Program in regards
to vaccine products on the table, such as trivalent influenza vaccine.</text>
</subparagraph></paragraph><paragraph id="ID1B1E94D5C66545AEB26E8CD87F1007EA"><enum>(3)</enum><header>Liability of
United States</header>
<subparagraph id="ID12406F2A526B45DAAE510278CEF53423"><enum>(A)</enum><header>In
general</header><text>For purposes of this section, a covered person shall be
deemed to be an employee of the Public Health Service with respect to liability
for personal injury or death arising out of the manufacture, administration, or
use of a qualified pandemic influenza technology. The liability of the United
States under this subsection shall be as set forth in section 1346(b) and
chapter 171 of title 28, United States Code, except—</text>
<clause id="id34DD9EA942ED45428F6A916B89D8CDA5"><enum>(i)</enum><text>as otherwise
provided in this section; and</text>
</clause><clause id="id812A8A5B23EC4C9AA8B962654F67F6AC"><enum>(ii)</enum><text>that the
liability of the United States may be based on any cause of action seeking
compensation for harm allegedly arising out of the manufacture, administration,
or use of a qualified pandemic influenza technology, regardless of whether such
cause of action is alleged as negligence, strict liability in tort, breach of
warranty, failure to warn, or other action.</text>
</clause></subparagraph><subparagraph id="ID014689A9063D41BF9BE5764A4A28D41D"><enum>(B)</enum><header>Scope</header><text>For
purposes of this section, any activity reasonably related to the manufacture,
distribution, or administration of a qualified pandemic influenza technology
shall be considered to be a medical, surgical, dental, or related function
within the scope of the covered person’s employment by the Public Health
Service.</text>
</subparagraph><subparagraph id="id2A7551E6A70F4B8C82C393FA04760494"><enum>(C)</enum><header>Governing
law</header><text>Notwithstanding the provisions of section 1346(b)(1) and
chapter 171 of title 28, United States Code, as they relate to governing law,
the liability of the United States as provided in this subsection shall be in
accordance with the law of the place of injury.</text>
</subparagraph><subparagraph id="id5832D3AF641D49AEB4491287C9DC840A"><enum>(D)</enum><header>Military
personnel and united states citizens oversees</header>
<clause id="ID4068bde6d17b4c90bcfad278af5c8255"><enum>(i)</enum><header>Military
personnel</header><text>The liability of the United States as provided in this
subsection shall extend to claims brought by United States military
personnel.</text>
</clause><clause id="ID9ae6a6d4cae44163a2b910cf13f73dc6"><enum>(ii)</enum><header>Claims arising
in a foreign country</header><text>Notwithstanding the provisions of section
2680(k) of title 28, United States Code, the liability of the United States as
provided in this subsection shall extend to claims based on injuries arising in
a foreign country where the injured party is a member of the United States
military, is the spouse or child of a member of the United States military, or
is a United States citizen.</text>
</clause><clause id="ID66fbbeefc2c448ad97dfdafed29d0567"><enum>(iii)</enum><header>Governing
law</header><text>With regard to all claims brought under clause (ii), and
notwithstanding the provisions of section 1346(b)(1) and chapter 171 of title
28, United States Code, and of subparagraph (C), as they relate to governing
law, the liability of the United States as provided in this subsection shall be
in accordance with the law of the claimant's domicile in the United States or
most recent domicile within the United States.</text>
</clause></subparagraph></paragraph><paragraph id="IDC6E3277DE7744D429FDF4B110076D292"><enum>(4)</enum><header>Exclusivity of
remedy</header><text>The remedy provided for by this section shall be exclusive
of any other civil action or proceeding against a covered person, for personal
injury or death arising out of the manufacture, administration, or use of a
qualified pandemic influenza technology during the effective period of the
designation under paragraph (2).</text>
</paragraph><paragraph id="ID9940DAE6AD1C4196BADBFB2437E9C971"><enum>(5)</enum><header>Covered person
to cooperate with United States</header>
<subparagraph id="ID9061AE87BB3B47EA85E393231504D167"><enum>(A)</enum><header>In
general</header><text>A covered person shall cooperate with the United States
in the processing and defense of a claim or action under this subsection based
upon the acts or omissions of such person.</text>
</subparagraph><subparagraph id="ID8DE6606FDEDF4755946562218D1C02B9"><enum>(B)</enum><header>Consequences of
failure to cooperate</header><text>Upon the motion of the United States or any
other party and upon a finding that a covered person has failed to cooperate
with the United States as provided for in subparagraph (A)—</text>
<clause id="IDFB3E9CA9841045CD868A15EA40291B6A"><enum>(i)</enum><text>the court shall
substitute such person as the party defendant in place of the United States
and, upon motion, shall remand any such suit to the court in which it was
instituted if it appears that the court lacks subject matter
jurisdiction;</text>
</clause><clause id="IDBBC7C364F63A4A7690C98FC2AED231C0"><enum>(ii)</enum><text>the United
States shall not be liable based on the acts or omissions of such person;
and</text>
</clause><clause id="ID81607F1DBAB1420FB9062E1C5B7CBD27"><enum>(iii)</enum><text>the Attorney
General shall not be obligated to defend such action.</text>
</clause></subparagraph></paragraph><paragraph id="IDA41A6B2692AC4AAAB00AAC1993E0A9BC"><enum>(6)</enum><header>Recourse
against covered persons in case of gross misconduct or material breach of
contract</header>
<subparagraph id="ID9C3D84B112A946A7947457505B3C07A6"><enum>(A)</enum><header>In
general</header><text>If payment is made by the United States to any claimant
bringing a claim against a covered person under this subsection, either by way
of administrative determination, settlement, or court judgment, the United
States shall have, notwithstanding any provision of State law, the right to
recover for that portion of the damages so awarded or paid, as well as interest
and any costs of litigation, resulting from—</text>
<clause id="IDAD0E7626E8BC444DB16346DA65C9BC1F"><enum>(i)</enum><text>such covered
person’s intentional breach of a procurement contract, so long as such breach
was materially related to the injury that is the subject of the claim,
or</text>
</clause><clause id="ID8F1968281AC541C199F0EC8CB74AB86E"><enum>(ii)</enum><text>any grossly
negligent or reckless conduct, or willful misconduct, on the part of such
covered person, so long as such conduct or misconduct was materially related to
the injury that is the subject to the claim.</text>
</clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID61F7924469174A1DAF9340967FACE97F"><enum>(B)</enum><header>Action by the
United States</header><text>The United States may maintain an action under this
paragraph against a covered person described in subparagraph (A) in the
district court of the United States in which such person resides or has its
principal place of
business.</text>
</subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</section>