109 HR 4603 IH: Pandemic and Seasonal Influenza Act of 2005
U.S. House of Representatives
2005-12-16
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the Pandemic and Seasonal Influenza Act of 2005
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents
Title I—Domestic programs regarding seasonal and pandemic influenza
Sec. 101. Emergency declaration; compensation program; liability protections
Sec. 102. Additional funding for various programs and activities relating to seasonal and pandemic influenza
Sec. 103. Accountability
Sec. 104. Grants to improve State, local, and hospital preparedness for and response to public health emergencies; State pandemic influenza preparedness plans
Sec. 105. Partnerships for community and hospital preparedness
Sec. 106. Purchase of unsold doses of seasonal vaccines
Sec. 107. Surveillance
Sec. 108. Global Network for Avian Influenza Surveillance
Sec. 109. Procurements for Strategic National Stockpile
Sec. 110. National tracking and distribution system for vaccines and anti-virals
Sec. 111. Public education and awareness campaign
Sec. 112. Health professional training
Sec. 113. Research at National Institutes of Health
Sec. 114. Research at Centers for Disease Control and Prevention
Sec. 115. Collaboration with National Science Foundation regarding effective communication strategies
Sec. 116. Funds for inspections of manufacturing facilities; postmarket safety
Sec. 117. Coordination with Department of Homeland Security
Sec. 118. Definition
Title II—Protecting health care workers and first responders from pandemic Influenza
Sec. 201. Preparedness and response
Sec. 202. Relation to States and political subdivisions receiving funds under title I
Title III—International assistance to combat the avian influenza virus
Sec. 301. Findings
Sec. 302. Bilateral assistance
Sec. 303. Multilateral assistance
Sec. 304. Establishment of multi-donor trust fund
Sec. 305. Coordinator of United States assistance to combat the avian influenza virus
Sec. 306. Designation of high risk foreign countries and development of country strategies
Sec. 307. United States avian influenza virus early warning system
Sec. 308. Report
Sec. 309. Definitions
Sec. 310. Authorization of appropriations
<enum>I</enum><header>Domestic programs regarding seasonal and pandemic influenza</header>
<section id="HA0EE01963EF74C0F8E03C9AB9788E14E"><enum>101.</enum><header>Emergency declaration; compensation program; liability protections</header><text display-inline="no-display-inline">Title XXI of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-1">42 U.S.C. 300aa–1 et seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="HC8EE999509714E26A494D98CEEB21478" display-inline="no-display-inline">
<subtitle id="H0607DC15BA904D7FA673D4A1E0F9BF78"><enum>3</enum><header>Pandemic influenza</header>
<part id="HA7A5743FA96C4AD0BA9ECF457B4DC57B"><enum>A</enum><header>Emergency declaration regarding covered countermeasure</header>
<section id="HA21BFF9D2B174184B2366423657028AA"><enum>2141.</enum><header>Emergency declaration</header>
<subsection id="H3E78C4776148466FB0946D8B88A92645"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">If the Secretary determines that a virus is causing pandemic influenza in humans, or that there is a credible risk that a particular virus may in the future cause such influenza, the Secretary may, through publication in the Federal Register, issue a declaration providing that parts B and C (relating to compensation for injuries, and to immunity from liability and to civil actions against the Federal Government for compensation, respectively) are in effect with respect to the countermeasure or countermeasures specified in the declaration.</text></subsection>
<subsection id="H2C75775D01D1409E87AF8CF58BF12DE2"><enum>(b)</enum><header>Certain requirements</header><text>A declaration under subsection (a) is effective with respect to a countermeasure for purposes of this subtitle only if the declaration—</text>
<paragraph id="H67039A31EB6447E4B2DDB6BDEA4D3979"><enum>(1)</enum><text>identifies a category or categories of individuals and recommends that the countermeasure be administered to individuals in such categories for the purpose of preventing the influenza involved; and</text></paragraph>
<paragraph id="H3EBDFA92600542239DD13C002768BE8D"><enum>(2)</enum><text>specifies the period during which the declaration will be in effect, including a beginning date and an ending date.</text></paragraph></subsection>
<subsection id="H60664FCA72434370BF2D16AAE7D80072"><enum>(c)</enum><header>Amendments</header><text>The Secretary may, through publication in the Federal Register, amend a declaration under subsection (a), including an amendment to shorten or extend the effective period of the declaration.</text></subsection>
<subsection id="HC08B8F5AE8E94E8684E8E7BF28F371B3"><enum>(d)</enum><header>Definitions</header><text>For purposes of this subtitle:</text>
<paragraph id="H210E2E34E54C46F50006753983001872"><enum>(1)</enum><text>The term <quote>countermeasure</quote> means a vaccine that—</text>
<subparagraph id="HA8CA0268B1AD449C92B06384251005AA"><enum>(A)</enum><text>is licensed under section 351 to prevent influenza (or a particular type of influenza); or</text></subparagraph>
<subparagraph id="H248B3C95D3874AE5A2B3CD1F34951787"><enum>(B)</enum><text display-inline="yes-display-inline">is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act to prevent influenza (or a particular type of influenza). </text></subparagraph> </paragraph>
<paragraph id="HB861EF3DA84C4D15BA1F810033F828D"><enum>(2)</enum><text>The term <quote>covered countermeasure</quote> means a countermeasure specified in a declaration under subsection (a).</text></paragraph>
<paragraph id="H53DB9BEBD569450C8DB400FC591390BE"><enum>(3)</enum><text>The term <quote>covered individual</quote>, with respect to a declaration under subsection (a), means an individual—</text>
<subparagraph id="HCAE637B2F0294FB4AB06015D23479C32"><enum>(A)</enum><text>who is within a category of individuals identified in the declaration pursuant to subsection (b)(1); and</text></subparagraph>
<subparagraph id="HD4FD34D767EF41C5AC496376CB4F6DCC"><enum>(B)</enum><text>to whom a countermeasure specified in the declaration has been administered.</text></subparagraph></paragraph></subsection></section></part>
<part id="HA01B27D46B774BA39F73A277CF9FE3BC"><enum>B</enum><header>Compensation program</header>
<section id="HAF2C16EF508A425EA6CC00C81DA3C2E"><enum>2151.</enum><header>Compensation for injuries for administration during effective period of declaration</header>
<subsection id="H01E4A3B805FC4A49B000ED5FA5D42678"><enum>(a)</enum><header>In general</header><text>The Secretary shall by regulation establish in accordance with this part a program under which compensation may be paid for a countermeasure-related injury or death that is associated with the administration of a covered countermeasure to a covered individual during the effective period of the applicable declaration under section 2141(a).</text></subsection>
<subsection id="H03BA3251BA984AEABEE796F7D600F875"><enum>(b)</enum><header>Relationship to national vaccine injury compensation program under subtitle <enum-in-header>2</enum-in-header></header>
<paragraph id="H49EBF24018794ECAB0C83260F05E9FB2"><enum>(1)</enum><header>In general</header><text>Except as otherwise provided in this part, the provisions of subtitle 2 (including provisions taking effect on or after the effective date of this section) apply with respect to a covered countermeasure to the same extent and in the same manner as such provisions apply with respect to a vaccine included on the vaccine injury table under section 2114.</text></paragraph>
<paragraph id="H039BA60A0E4D4E17A4FF823CE78416BC"><enum>(2)</enum><header>Limitation regarding subtitle 2 vaccines</header><text>Subsection (a) does not apply with respect to a covered countermeasure if the countermeasure is included on the vaccine injury table under section 2114.</text></paragraph>
<paragraph id="HC0741B0A32674AA6932115039D00B89D"><enum>(3)</enum><header>Separate program; separate judicial resources</header><text>This subtitle may not be construed as having any legal effect on the program under subtitle 2. The program under subsection (a) shall, consistent with applicable appropriations Acts, be administered in a manner that ensures that administrative resources of the United States Claims Courts used for the program under subtitle 2 are not, by reason of the program under this part, reduced below the level of such resources used for such program for fiscal year 2006, as adjusted to offset the effects of inflation occurring after the beginning of such fiscal year.</text></paragraph></subsection>
<subsection id="H6C6CDA082AED4EB782AFA6700B34E99"><enum>(c)</enum><header>Compensation secondary to other coverage</header>
<paragraph id="H10560CE74E924AEDBF1097D0CFADD15C"><enum>(1)</enum><header>In general</header><text>Except as provided in paragraph (2), compensation under subsection (a) shall be secondary to any obligation of the United States, or any third party (including any State or local governmental entity, private insurance carrier, or employer), under any other provision of law or contractual agreement to pay for or provide such compensation.</text></paragraph>
<paragraph id="HB580DA11943845588EBEA0B344A8E7B2"><enum>(2)</enum><header>Certain programs</header><text>Paragraph (1) does not apply with respect to the program under title XIX of the Social Security Act or the program under part C of this subtitle.</text></paragraph>
<paragraph id="H13B1E9EFB62348D090002FFD42A1E7AD"><enum>(3)</enum><header>Payments pursuant to subrogation</header><text>With respect to an obligation to which compensation under subsection (a) is secondary for purposes of paragraph (1), the Secretary may, notwithstanding such obligation, make a payment under subsection (a) in the amount of the obligation if such payment is requested by or on behalf of the covered individual involved. If the Secretary makes such a payment—</text>
<subparagraph id="H2217830DF97E4BC882C03DFFEBC7E18C"><enum>(A)</enum><text>the rights of such individual under the obligation are subrogated to the Federal Government;</text></subparagraph>
<subparagraph id="H0A4BDA596EB04ED983FAC662440637A7"><enum>(B)</enum><text>the Secretary, pursuant to such subrogation, shall collect the amount due the covered individual under the obligation; and</text></subparagraph>
<subparagraph id="H6983FB35CE33444CAA9112DC9C4C1CA2"><enum>(C)</enum><text>the Secretary shall deposit the amount collected under subparagraph (B) in the fund under section 2153.</text></subparagraph></paragraph></subsection> </section>
<section id="H7B48363212E54A17942CB336EAC65EDE"><enum>2152.</enum><header>Variations from subtitle 2 program</header>
<subsection id="H6365103089E84773B8779F001B56876C"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">For purposes of section 2151(b)(1), the applicability with respect to a covered countermeasure of the provisions of the program under subtitle 2 is subject to this section.</text> </subsection>
<subsection id="HA956540250424BC791FDF6CBD614ECC"><enum>(b)</enum><header>Source of funds for compensation</header><text>Amounts for providing compensation under section 2151(a) are available under section 2153, not from a tax imposed on the sale of such countermeasure under the Internal Revenue Code of 1986.</text></subsection>
<subsection id="HFEFF552894534F858B3965F542794D76"><enum>(c)</enum><header>Injury table</header><text display-inline="yes-display-inline">With respect to section 2114 as applied for purposes of section 2151(a), the Secretary shall include in the injury table provisions regarding a covered countermeasure as soon as is practicable after the Secretary issues the applicable declaration under section 2141(a).</text> </subsection>
<subsection id="H2E3EAC7A065A43B886180382808E8497" commented="no"><enum>(d)</enum><header>Compensation in event of death</header><text display-inline="yes-display-inline">With respect to section 2115(a)(2) as applied for purposes of section 2151(a), an award for the estate of the deceased shall be—</text>
<paragraph id="HF9359664942E4EC8A7885B8BA04E8721" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline"> if the deceased was under the age of 18, $250,000, as increased to the extent necessary to offset the effect of inflation occurring after the beginning of fiscal year 2006; or</text></paragraph>
<paragraph id="HC6F6CAEE8BAF4BA18765A0D7C404B97D" commented="no"><enum>(2)</enum><text> if the deceased was 18 years of age or older, the greater of—</text>
<subparagraph id="HAEF32C0D4BC6420082E944158989AE2C" commented="no"><enum>(A)</enum><text>$250,000, as so increased; or</text></subparagraph>
<subparagraph id="HF820A5B9BE97455AB3BB85054508C1BB" commented="no"><enum>(B)</enum><text>the projected loss of employment income, except that the amount under this item may not exceed an amount equal to 400 percent of the amount that applies under subparagraph (A).</text></subparagraph></paragraph></subsection>
<subsection id="H6678DB50C9274F52A90972F0FE29D678"><enum>(e)</enum><header>Election regarding civil action</header><text display-inline="yes-display-inline">With respect to the election under sections 2111(a)(2) and 2121 to file a civil action, such an election does not apply for purposes of section 2151(a). The authority to bring a civil action with respect to liability arising out of the administration of a covered countermeasure, and the relationship between such an action and compensation under section 2151(a), is regulated by part C. </text></subsection></section>
<section id="HBF917DA7EE8C472D8068C487A01E986F"><enum>2153.</enum><header>Injury compensation fund</header>
<subsection id="HC799271101A14BF1B8003259C3FE23E1"><enum>(a)</enum><header>In general</header><text>There is established within the Treasury of the United States a fund to be known as the Pandemic Influenza Countermeasure Injury Compensation Fund (referred to in this section as the <quote>Fund</quote>). The Fund shall consist of amounts appropriated in subsection (b). Amounts appropriated for the Fund are available until expended.</text></subsection>
<subsection id="HC7EC679E3ED44136A552A5DF1130F54E"><enum>(b)</enum><header>Funds</header><text>There is hereby appropriated, out of any amounts in the Treasury not otherwise appropriated, such sums as may be necessary for each fiscal year—</text>
<paragraph id="HAAB90AC689D34251A13029C5D5F47FEB"><enum>(1)</enum><text>to provide compensation under section 2115 as applied for purposes of section 2151(a); and</text></paragraph>
<paragraph id="HE1FC1FF6CA254C77813E3BB0BCD6CFD"><enum>(2)</enum><text>to provide for the administrative expenses of carrying out this part.</text></paragraph></subsection></section></part>
<part id="HCF6704A55667454180A283374D58A000"><enum>C</enum><header>Liability protections; civil actions for compensation</header>
<section id="H0603EB313B9C41E5B412D100D887E404"><enum>2161.</enum><header>Civil actions against Federal Government; individual immunity of manufacturers, distributors, and health care providers</header>
<subsection id="H8B4F68D4A5A34E49A97E0027B0A7126B"><enum>(a)</enum><header>Deemed status of covered persons as federal employees</header>
<paragraph id="H23900C79EB15455589FAAED900002F8F"><enum>(1)</enum><header>Deemed status; civil action against federal government</header><text>For purposes of section 224(a), and subject to the provisions of this section, a covered person shall be deemed to be an employee of the Public Health Service with respect to liability arising out of the administration of a covered countermeasure to a covered individual during the effective period of the applicable declaration by the Secretary under section 2141(a).</text></paragraph>
<paragraph id="HCE0B4AD365FF4BB1AA0831055114C83"><enum>(2)</enum><header>Covered person</header><text>For purposes of this part, the term <quote>covered person</quote>, when used with respect to the administration of a covered countermeasure, means a person who is—</text>
<subparagraph id="HE4E885337E04495200B009EE067BBDE5"><enum>(A)</enum><text>a manufacturer or distributor of such countermeasure;</text></subparagraph>
<subparagraph id="HCA5C4FBE5CE149CF9D452B9F3F86E6B5"><enum>(B)</enum><text>a health care entity under whose auspices—</text>
<clause id="H322E0B70520A44D994B63C981CA032EA"><enum>(i)</enum><text>the countermeasure was administered;</text></clause>
<clause id="H653119162E2148BB90F284200EDCE7F"><enum>(ii)</enum><text>a determination was made as to whether, or under what circumstances, an individual should receive the countermeasure;</text></clause>
<clause id="H4ABF787A765A496CB2B2334F48BE01B6"><enum>(iii)</enum><text>the immediate site of administration of the countermeasure on the body was monitored, managed, or cared for; or</text></clause>
<clause id="H373DAF8997244682B13C896FF0B50079"><enum>(iv)</enum><text>an evaluation was made of whether the administration of the countermeasure was effective;</text></clause></subparagraph>
<subparagraph id="HAEA760E30910426E9361CC4E3479BCDB"><enum>(C)</enum><text>a qualified person who administered the countermeasure;</text></subparagraph>
<subparagraph id="H2BAD44544E8B40588EA3BC1E828FDE3F"><enum>(D)</enum><text>a State, a political subdivision of a State, or an agency or official of a State or of such a political subdivision, if such State, subdivision, agency, or official has established requirements, provided policy guidance, supplied technical or scientific advice or assistance, or otherwise supervised or administered a program with respect to administration of such countermeasures;</text></subparagraph>
<subparagraph id="HC12D2D5B05FF4EE988E0C3399EA85F6"><enum>(E)</enum><text>an official, agent, or employee of a person described in subparagraph (A), (B), (C), or (D);</text></subparagraph>
<subparagraph id="H89CA83B8AC8D451F94BBCF6700246110"><enum>(F)</enum><text>a contractor of, or a volunteer working for, a person described in subparagraph (A), (B), or (D), if the contractor or volunteer performs a function for which a person described in such subparagraph is a covered person; or</text></subparagraph>
<subparagraph id="H7D1E67A81D5742328290CFC097BBDE"><enum>(G)</enum><text>an individual who has privileges or is otherwise authorized to provide health care under the auspices of an entity described in subparagraph (B).</text></subparagraph></paragraph>
<paragraph id="H17781650F4F44340A100872292503655"><enum>(3)</enum><header>Qualified person</header><text>For purposes of this part, the term <quote>qualified person</quote>, when used with respect to the administration of a covered countermeasure, means a licensed health professional or other individual who—</text>
<subparagraph id="H1E6A46E88F274379BEF6DB7F159BAFEB"><enum>(A)</enum><text>is authorized to administer such countermeasure under the law of the State in which the countermeasure was administered; or</text></subparagraph>
<subparagraph id="HB424785F3B4A48A3AE81D53A1CE9271"><enum>(B)</enum><text>is otherwise authorized by the Secretary to administer such countermeasure.</text></subparagraph></paragraph>
<paragraph id="H6118E34A8EA94FDF00DCA2E250A6F718"><enum>(4)</enum><header>Arising out of administration of a covered countermeasure</header><text>For purposes of this part, the term <quote>arising out of administration of a covered countermeasure</quote>, when used with respect to a claim or liability, includes a claim or liability arising out of—</text>
<subparagraph id="HBC293B6E40674776953830EE520012DF"><enum>(A)</enum><text>determining whether, or under what conditions, an individual should receive a covered countermeasure;</text></subparagraph>
<subparagraph id="H59FB80EF5DBB497C9382D42459D95AD"><enum>(B)</enum><text>obtaining informed consent of an individual to the administration of a covered countermeasure; or</text></subparagraph>
<subparagraph id="H24A64C27486C4F59B4A612B34F70078B"><enum>(C)</enum><text>monitoring, management, or care of an immediate site of administration on the body of a covered countermeasure, or evaluation of whether the administration of the countermeasure has been effective.</text></subparagraph></paragraph></subsection>
<subsection id="HA841038198F64691941B71EB5196ED31"><enum>(b)</enum><header>Liability of federal government only for administrations within scope of declaration</header><text>Except as provided in subsection (g)(2)(B), the United States shall be liable under this section with respect to a claim arising out of the administration of a covered countermeasure to an individual only if—</text>
<paragraph id="H8A6832C849ED45BF8B258646E693B804"><enum>(1)</enum><text>the countermeasure was administered to the individual by a qualified person for the purpose of preventing influenza (or a type of influenza);</text></paragraph>
<paragraph id="H105ACE680E0B45E4AC00167D1BFA31B"><enum>(2)</enum><text>such administration by the qualified person was during the effective period of such declaration; and</text></paragraph>
<paragraph id="H2C2E6A6ACEB24B379653C6FBA7E3D5FE"><enum>(3)</enum>
<subparagraph id="H2B940388639F48498245DB8E76D44C22" display-inline="yes-display-inline"><enum>(A)</enum><text>the individual was at the time of such administration a covered individual under the applicable declaration under section 2141(a); or</text></subparagraph>
<subparagraph id="H2BCE7318A1BF4DB1A80079A20780BD7E" indent="up1"><enum>(B)</enum><text>the qualified person had reasonable grounds to believe that the individual was within a category of individuals identified in the declaration.</text></subparagraph></paragraph> </subsection>
<subsection id="H1C019F8BC9064ADEA7F7B644244432B4"><enum>(c)</enum><header>Variations from title 28 remedy</header>
<paragraph id="H85A37F525AE543C5B17F59B6A634CDA2"><enum>(1)</enum><header>Inapplicability of certain exceptions from liability</header><text>Notwithstanding the provisions of law referred to in section 224(a) that provide a remedy pursuant to such section (relating to title 28, United States Code), the following exceptions from liability under such provisions do not apply for purposes of a civil action pursuant to subsection (a):</text>
<subparagraph id="H62BBBA677454437396FB2488124111DC"><enum>(A)</enum><text display-inline="yes-display-inline">The exception established in <external-xref legal-doc="usc" parsable-cite="usc/28/2680">section 2680(a)</external-xref> of title 28, United States Code (known as the discretionary function exception).</text></subparagraph>
<subparagraph id="HF8115E65F2524434B499A5CEAF8166CB"><enum>(B)</enum><text display-inline="yes-display-inline">The exception established in section 2680(h) of such title (relating to intentional torts).</text></subparagraph>
<subparagraph id="H6723E3E5FD29471BA73418CA82C3CCB1"><enum>(C)</enum><text>The exception for strict liability in tort pursuant to section 1346(b) of such title.</text></subparagraph>
<subparagraph id="H7C0905E622974AEB88876154EAD9226B"><enum>(D)</enum><text>The exception established in section 2680(k) of such title (relating to claims arising in a foreign country), except that such section is inapplicable only in the case of a covered individual who is a United States citizen, a member of the Armed Forces, or the spouse or child of a member of such Forces.</text></subparagraph>
<subparagraph id="HD7D4F5392EE4499FBEB637EE69CC66E1"><enum>(E)</enum><text>The exception established in Feres v. United States, 340 U.S. 135 (1950) (relating to injuries to military personnel sustained incident to service, and known as the Feres doctrine).</text></subparagraph> </paragraph>
<paragraph id="H241A575B01A040469D4F83235698E965"><enum>(2)</enum><header>Breach of warranty</header><text display-inline="yes-display-inline">Notwithstanding the provisions of law referred to in section 224(a) that provide a remedy pursuant to such section, the liability of the United States shall, for purposes of a civil action pursuant to subsection (a), include liability based on a claim of breach of warranty.</text></paragraph>
<paragraph id="H128D4D89E18D4CFFAE250053C044D115"><enum>(3)</enum><header>Unavailability of government contractor defense</header><text>In a civil action pursuant to subsection (a), the United States may not assert the defense established in Boyle v. United Technologies Corp, 487 U.S. 500 (1988) (relating to compliance with Federal contracts, and known as the government contractor defense).</text></paragraph>
<paragraph id="HF45931CFF5124D8494396C528D5FED84" commented="no"><enum>(4)</enum><header>Governing law</header><text>Notwithstanding the provisions of law referred to in section 224(a) that provide a remedy pursuant to such section, for purposes of a civil action pursuant to subsection (a):</text>
<subparagraph id="H0D66BE9507C541F3940088B4C8058FE9" commented="no"><enum>(A)</enum><text>References in section 1346(b) and <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/28/171">chapter 171</external-xref> of title 28, United States Code, to the place where the act or omission complained of occurred are deemed to be references to the place where the injury occurred, subject to subparagraph (B).</text></subparagraph>
<subparagraph id="HC46DB6E40DBF40389275A95100ADDC34" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">For purposes of subparagraph (A) as applied for purposes of paragraph (1)(D), the place of injury is deemed to be the domicile in the United States of the covered individual involved, or if such individual does not have a domicile in the United States, the place in the United States that was the most recent domicile in the United States of the individual.</text></subparagraph></paragraph>
<paragraph id="HE81A02DACFAD43089D9C25DD881C00BD"><enum>(5)</enum><header>Venue</header><text display-inline="yes-display-inline">For purposes of a civil action pursuant to subsection (a), the reference in <external-xref legal-doc="usc" parsable-cite="usc/28/1402">section 1402(b)</external-xref> of title 28, United States Code, to the place wherein the act or omission complained of occurred is deemed to be a reference to the place wherein the injury occurred.</text></paragraph> </subsection>
<subsection id="H572B4E441FE3452B92C3FD3C408F13B1"><enum>(d)</enum><header>Relation to part B program</header>
<paragraph id="H857C2FF806114882A551A250F2C8AB00"><enum>(1)</enum><header>In general</header><text>A person may not, pursuant to subsection (a), bring a claim under section 224(a) unless such person has exhausted such remedies as are available under part B, except that if the Secretary fails to make a final determination on a request for compensation filed in accordance with the requirements of such part within 240 days after such request was filed, the person may seek any remedy that may be available under this section.</text></paragraph>
<paragraph id="HC5D03D8333254C59ABAAF93744F8C6A0"><enum>(2)</enum><header>Rule of construction regarding civil actions against federal government</header><text>This section shall not be construed as superseding or otherwise affecting the application of a requirement, under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/28/171">chapter 171</external-xref> of title 28, United States Code, to exhaust administrative remedies.</text></paragraph>
<paragraph id="HDAF9EAB4E01C4525AB1883CB05D74148"><enum>(3)</enum><header>Tolling of statute of limitations</header><text>The time limit for filing a claim pursuant to this section, or for filing an action based on such claim, shall be tolled during the pendency of a petition for compensation under part B.</text></paragraph>
<paragraph id="HE528777A255041729679864B72149026"><enum>(4)</enum><header>Offset</header><text>The value of compensation provided under part B for an incident or series of incidents shall be offset against the amount of an award, compromise, or settlement of money damages in a claim or suit pursuant to subsection (a) based on the same incident or series of incidents.</text></paragraph></subsection>
<subsection id="HE1582A2A15084E2AA0EBE9ED4FF4149F"><enum>(e)</enum><header>Exclusivity</header><text>For purposes of subsection (a), the remedy provided by section 224(a) shall be exclusive of any other civil action or proceeding for any claim or suit this section encompasses, except for a proceeding under part B.</text></subsection>
<subsection id="HAFA55CF3CB854C938C8C66B00B418CD"><enum>(f)</enum><header>Removal of action to united states district court</header>
<paragraph id="H7DFEA6B8412E45BA9F601D84934F2E88"><enum>(1)</enum><header>In general</header><text>Any civil action brought in a State court against a covered person with respect to liability described in subsection (a) shall be removed without bond to the district court of the United States of the district and division embracing the place wherein the action is pending, subject to subsection (c)(5), and the proceeding deemed a civil action brought against the United States pursuant to subsection (a).</text></paragraph>
<paragraph id="HEE99B5B3AE6940D6BB814FF57DB3AD77"><enum>(2)</enum><header>Certain procedures</header><text>With respect to section 224(c) as applied for purposes of subsection (a), the following applies:</text>
<subparagraph id="HCBE9C9EA2DEE4F069F946B000043BCC"><enum>(A)</enum><text>Paragraph (1) of this subsection applies in lieu of the first sentence of such section.</text></subparagraph>
<subparagraph id="H1111BF3321494D808C9B00B2C5C9317"><enum>(B)</enum><text>A civil action in a State court shall be considered as having been brought against a covered person with respect to liability described in subsection (a) if, in the pleadings for the action—</text>
<clause id="H548BDD38E2B34FD49963C7527719D1C"><enum>(i)</enum><text>the plaintiff alleges that a vaccine caused the injury involved and seeks damages for the injury; and</text></clause>
<clause id="HFF4EE3B9B8D641F0B9802684FE0021E3"><enum>(ii)</enum><text>the plaintiff or the defendant alleges that a Federal declaration has been issued with respect to the vaccine (without regard to whether section 2141(a) is specified), or the defendant alleges that Federal law grants the defendant immunity from liability for the injury (without regard to whether the defendant states that the defendant is a covered person under this section), or both.</text> </clause></subparagraph></paragraph></subsection>
<subsection id="HBA00361254D840AD846CB3002466739C"><enum>(g)</enum><header>Cooperation of covered person with federal government</header>
<paragraph id="HAB72910EC1F940DE00D7516BAE1F1F83"><enum>(1)</enum><header>In general</header><text>This section applies with respect to a covered person only if the person cooperates with the United States in the processing and defense of the claim or action involved.</text></paragraph>
<paragraph id="HF9205745B8FE49D59D2DE92F88B16CB7"><enum>(2)</enum><header>Consequences of failure to cooperate</header><text>Upon the motion of the United States or any other party and upon finding that a covered person has failed to cooperate within the meaning of paragraph (1)—</text>
<subparagraph id="H7242FFCB14A846E98ECE95D1373F094"><enum>(A)</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></subparagraph>
<subparagraph id="H496F09BA89D549A8B333933D74DD2769"><enum>(B)</enum><text>the United States shall not be liable based on the acts or omissions of such person; and</text></subparagraph>
<subparagraph id="H4451599B25574655996D00C9C41F3B23"><enum>(C)</enum><text>the Attorney General shall not be obligated to defend such action.</text></subparagraph></paragraph></subsection>
<subsection id="HA511DD88663641198508DE899FA7587"><enum>(h)</enum><header>Recourse against covered person in case of gross misconduct or contract violation</header>
<paragraph id="HD3E0D0298B714382B6E7F68B8758C5A3"><enum>(1)</enum><header>In general</header><text>Should payment be made by the United States to any claimant bringing a claim pursuant to this section, 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 the failure of any covered person to carry out any obligation or responsibility assumed by such person under a contract with the United States or from any grossly negligent, reckless, or illegal conduct or willful misconduct on the part of such person.</text></paragraph>
<paragraph id="HA424A531CDCC4E1CBD426720CAF39543"><enum>(2)</enum><header>Venue</header><text>The United States may bring an action pursuant to paragraph (1) against such person in the judicial district of the United States in which such person resides or has its principal place of business.</text></paragraph></subsection></section></part> </subtitle><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H4D13EA8908D0458DADE20314309500EC"><enum>102.</enum><header>Additional funding for various programs and activities relating to seasonal and pandemic influenza</header>
<subsection id="H65ACAD8539574B3FA97D6482F21EAC0"><enum>(a)</enum><header>In general</header><text>With respect to influenza, there is authorized to be appropriated, as described in subsections (b) and (c), a total of $1,975,000,000 in addition to amounts otherwise authorized to be appropriated.</text></subsection>
<subsection id="H6D55A82164314BE9B7E701EDC16F9782"><enum>(b)</enum><header>Fiscal year 2006</header><text>In addition to amounts otherwise authorized to be appropriated for fiscal year 2006 for the following programs and activities, there are authorized to be appropriated for such fiscal year for such programs and activities the following amounts:</text>
<paragraph id="H3179434BA3FC416DA6EF87E193AC4603"><enum>(1)</enum><text display-inline="yes-display-inline">For seasonal influenza vaccine, $465,000,000, to remain available until expended, subject to providing for 15,000,000 doses in fiscal year 2006 and increasing to 35,000,000 doses in fiscal year 2008.</text></paragraph>
<paragraph id="HBA4DA215413F4D8BB571C2F3E8DC01C7"><enum>(2)</enum><text>For removing the unfunded mandate on States for purchasing anti-virals, $510,000,000, to remain available until expended.</text></paragraph>
<paragraph id="H35B29D3358234865969DD81D39B84B10"><enum>(3)</enum><text display-inline="yes-display-inline">For funding for States and local governments for pandemic influenza planning activities, $200,000,000, to remain available until expended.</text></paragraph>
<paragraph id="H7005BABADA4242428D8149BEE3367999"><enum>(4)</enum><text display-inline="yes-display-inline">For an international effort lead by the United States to detect and contain an influenza pandemic, $500,000,000, to remain available until expended.</text></paragraph></subsection>
<subsection id="H1602E38BBCB14EC887892DDA0705CE00"><enum>(c)</enum><header>Fiscal years <enum-in-header>2006</enum-in-header> through <enum-in-header>2010</enum-in-header></header><text display-inline="yes-display-inline">In addition to amounts otherwise authorized to be appropriated for fiscal years 2006 through 2010 for States and local governments to restore preparedness grants, to increase the capacity to provide immunizations against influenza, and to develop surge capacity in medical facilities, there is authorized to be appropriated for such purposes $300,000,000 for each of the fiscal years 2006 through 2010.</text></subsection>
<subsection id="HF579D75D674C44B6BD798F4700A07EC3"><enum>(d)</enum><header>Vaccine compensation program regarding pandemic influenza</header><text>For compensation under part B of subtitle 3 of title XXI of the Public Health Service (as added by section 101 of this Act), amounts are available as provided in section 2153 of such part.</text></subsection></section>
<section id="HEE78C39ACD68452DBC0020129C8D0069"><enum>103.</enum><header>Accountability</header>
<subsection id="H829F6D42C20D4169A5B267051488C8C3"><enum>(a)</enum><header>Annual reports to Congress</header><text display-inline="yes-display-inline">Subject to subsection (b), the Secretary shall annually submit to the Congress a report that provides information on the following with respect to pandemic influenza preparedness:</text>
<paragraph id="HF95CA4BDF2494F4B8594444400DFF1B6"><enum>(1)</enum><text display-inline="yes-display-inline">Progress on the implementation of the HHS Pandemic Influenza Plan (issued by the Secretary in November 2005).</text></paragraph>
<paragraph id="HD9D8431C0E144F82B321FC2BA7507B36"><enum>(2)</enum><text>Actions of the Secretary to coordinate the provision of technical assistance across Federal agencies and State and local governments.</text></paragraph>
<paragraph id="HC9EA3C27DA6444F9A1C1284BC33C41C6"><enum>(3)</enum><text>Outreach and education campaigns conducted by the Secretary for businesses, health care providers, and the public.</text></paragraph>
<paragraph id="HEA45C578D07B44A49B1C6844D487D194"><enum>(4)</enum><text display-inline="yes-display-inline">Actions of the Secretary to address supply-chain issues.</text></paragraph>
<paragraph id="HC3060D7C1DAB473CBE19B904FB4E907B"><enum>(5)</enum><text display-inline="yes-display-inline">The extent to which the HHS Pandemic Influenza Plan has been directed toward traditionally underserved populations, including low-income, racial and ethnic minorities, immigrants, and uninsured populations.</text></paragraph>
<paragraph id="H3494928290AD465BA08BC874DAE55823"><enum>(6)</enum><text display-inline="yes-display-inline">Any deficiencies in such Plan that have been identified by the Comptroller General of the United States under subsection (e).</text></paragraph></subsection>
<subsection id="H28261E9DAB6441A5BE663B4BC9D4E3D2"><enum>(b)</enum><header>Plan for education of health professionals regarding vaccine; postimmunization follow-up and surveillance</header><text>The first report under subsection (a) shall be submitted not later than 90 days after the date of the enactment of this Act. Such first report shall include the following plans with respect to a vaccine against pandemic influenza:</text>
<paragraph id="H39F73F4919A5435700A1ED468DEA21D0"><enum>(1)</enum><text display-inline="yes-display-inline">With respect to health professionals who will administer the vaccine, a plan to educate the professionals on the known or suspected complications of the vaccine, side effects of the vaccine, and precautions regarding the vaccine. Such plan shall include the following:</text>
<subparagraph id="HBA8DC88D20A44A6495AFBC31F13567FB"><enum>(A)</enum><text>Education on—</text>
<clause id="HC73C5AF9F458450984D715916D3B11D"><enum>(i)</enum><text>the locations at which individuals should seek postimmunization follow-up medical care for adverse health conditions that may be associated with the vaccine; and</text></clause>
<clause id="HB7FE35AE66BF4A6C9C8660344B3F3067"><enum>(ii)</enum><text>obtaining compensation for injuries from the vaccine through the National Vaccine Injury Compensation Program under subtitle 2 of title XXI of the Public Health Service Act, or through the compensation program under part B of subtitle 3 of such title (as added by section 101 of this Act), as the case may be.</text></clause></subparagraph>
<subparagraph id="H4756101193DD424794EFB426F0853315"><enum>(B)</enum><text>Provisions for updating the educational content of the plan pursuant to information from postimmunization surveillance described in paragraph (2).</text></subparagraph> </paragraph>
<paragraph id="H775F417C844D4E1B942DA98ED94BFA19"><enum>(2)</enum><text>A plan for postimmunization surveillance. Such plan shall include provisions for the surveillance and reporting of the health effects of the vaccine, and a statement of whether such activities will include personal interviews and follow-up health screenings.</text></paragraph>
<paragraph id="H84168A69337249CA95A16C9D6E63CA90"><enum>(3)</enum><text>A plan for determining the populations for which the vaccine is contraindicated and for determining prescreening recipients of the vaccine, and for disseminating such information, including a specification of the means of dissemination. Such plan shall include information on the implementation of confidential methods of prescreening to be used by health professionals to determine if a potential vaccine recipient is a member of such a population.</text></paragraph></subsection>
<subsection id="H7320D506664443AD847FD2C0AE05E245"><enum>(c)</enum><header>Poultry workers</header>
<paragraph id="H41AEDB07CAF245968E49E11EB979A1E"><enum>(1)</enum><header>In general</header><text>Not later than 30 days after the date of the enactment of this Act, the Secretary of Health and Human Services, in coordination with the Secretary of Agriculture, the Secretary of Interior, and the Secretary of Labor, shall convene a meeting of experts, representatives of the poultry industry, representatives of poultry workers and other appropriate parties to evaluate the risks to poultry workers posed by exposure to the H5N1 virus, the likelihood of transmission of the virus from birds to poultry workers and the necessary measures to protect poultry workers from exposure.</text></paragraph>
<paragraph id="H55453A35478A4442AB088233727398BE"><enum>(2)</enum><header>Revision of preparedness plan</header><text>Not later than 30 days after the meeting under paragraph (1), the Secretary shall revise the HHS Pandemic Influenza Plan to include the findings and recommendations of the participants in the meeting.</text></paragraph>
<paragraph id="HCC14B196AC8D487889F32846DDCDA301"><enum>(3)</enum><header>Implementation of recommendations</header><text>The Secretary of Health and Human Services, Secretary of Agriculture, the Secretary of Interior, and the Secretary of Labor shall take the recommended steps to implement the recommendations of the participants in the meeting under paragraph (1).</text> </paragraph></subsection>
<subsection id="H445B7FEC159844DF85EEE7BE8BDA3DC4"><enum>(d)</enum><header>Annual budget request</header><text display-inline="yes-display-inline">The Secretary shall annually submit to the Congress a budget request related to the National Pandemic Influenza Preparedness Plan.</text> </subsection>
<subsection id="HF6445ED9F02E42219CF8E205240087B0"><enum>(e)</enum><header>Biannual GAO reports</header>
<paragraph id="H8C79A0BEC4C049019B54BF8E1EBA82C3"><enum>(1)</enum><header>In general</header><text>The Comptroller General of the United States shall, on an biannual basis, submit to the Congress and the Secretary a report concerning the HHS Pandemic Influenza Plan.</text></paragraph>
<paragraph id="HF32A2CD166EA458FADE4212460A0C592"><enum>(2)</enum><header>Requirements</header><text>At a minimum, each report under paragraph (1) shall evaluate the ability of the HHS Pandemic Influenza Plan to—</text>
<subparagraph id="H2ABCB51BE87F4FCAB3337F7BA5AB847B"><enum>(A)</enum><text>address the organizational structure and chain of command, both in the Federal government and at the State level;</text></subparagraph>
<subparagraph id="H25C882B4A45E42B4BA1F8FD51D3CC1E3"><enum>(B)</enum><text>ensure adequate laboratory surveillance of influenza, including the ability to isolate and subtype influenza viruses year round;</text></subparagraph>
<subparagraph id="HC89D3FE3D51B4EEB8C5E95E0AFF60920"><enum>(C)</enum><text>improve vaccine research, development, and production;</text></subparagraph>
<subparagraph id="H190D9624AC284B859D81B64B46A84C05"><enum>(D)</enum><text>procure adequate doses of anti-virals for treatment;</text></subparagraph>
<subparagraph id="H4A02D6984D144A75A72C87445217B69"><enum>(E)</enum><text>develop systems for tracking and distributing anti-viral medication and vaccines;</text></subparagraph>
<subparagraph id="H531E64552E63429FB930499D482CD7B7"><enum>(F)</enum><text>prioritize who would receive anti-virals and vaccines based on limited supplies;</text></subparagraph>
<subparagraph id="H6099229B599F46BDBDBEFA92A359B321"><enum>(G)</enum><text>stockpile medical and safety equipment for health care workers and first responders;</text></subparagraph>
<subparagraph id="H6D896DC08DCF4C0DA9FC63706E47614F"><enum>(H)</enum><text>assure surge capacity capabilities for health care providers and institutions;</text></subparagraph>
<subparagraph id="H6F106732AE444E559DAFD64E5501BF9D"><enum>(I)</enum><text>secure a backup health care workforce in the event of a pandemic;</text></subparagraph>
<subparagraph id="H02917DDC60FA4B60A9F327B9EE39A48"><enum>(J)</enum><text>ensure the availability of food, water, and other essential items during a pandemic;</text></subparagraph>
<subparagraph id="H457481631B614DDC86229762FC9247F7"><enum>(K)</enum><text>provide guidance on needed State and local authority to implement public health measures such as isolation or quarantine;</text></subparagraph>
<subparagraph id="HE141B497F15F42859F8730491D856CE5"><enum>(L)</enum><text>maintain core public functions, including public utilities, refuse disposal, mortuary services, transportation, police and firefighter services, and other critical services;</text></subparagraph>
<subparagraph id="H093791AFF66F46E381635D3CDA2C4F71"><enum>(M)</enum><text>establish networks that provide alerts and other information for health care providers;</text></subparagraph>
<subparagraph id="H4DC47CCE32604510AD30A900F7B6A0C9"><enum>(N)</enum><text>communicate with the public with respect to prevention and obtaining care during a pandemic; and</text></subparagraph>
<subparagraph id="HF992435BDB9D4FEBA28FD089A6F25AC"><enum>(O)</enum><text>provide security for first responders and other medical personnel and volunteers, hospitals, treatment centers, isolation and quarantine areas, and transportation and delivery of resources.</text></subparagraph></paragraph></subsection></section>
<section id="H8A52580D18CA4C8292B675BCB13F00"><enum>104.</enum><header>Grants to improve State, local, and hospital preparedness for and response to public health emergencies; State pandemic influenza preparedness plans</header>
<subsection id="H31AE2BA8A709495E92CA290532DE0047"><enum>(a)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">Section 319C–1(j)(1)(B) of the Public Health Service Act (42 U.S.C. 247d–3a(j)(1)(B)) is amended by striking <quote>For the purpose of carrying out this section,</quote> and inserting the following: <quote>For the purpose of carrying out this section, including preparing for and responding to pandemic influenza,</quote>; and</text> </subsection>
<subsection id="HCFA194988ACE434984ED502DC7537CA2"><enum>(b)</enum><header>State pandemic Influenza preparedness plans</header><text display-inline="yes-display-inline">Section 319C–1 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-3a">42 U.S.C. 247d–3a</external-xref>), as amended by subsection (a) of this section, is amended—</text>
<paragraph id="H560C23AE5DA944AA89744D2D3FBC24D3"><enum>(1)</enum><text>by redesignating subsections (i) and (j) as subsections (j) and (k), respectively; and</text></paragraph>
<paragraph id="HA48CA3208C6148D8B42553954DC5B992"><enum>(2)</enum><text>by inserting after subsection (h) the following subsection:</text>
<quoted-block style="OLC" id="H5ACAFEBE8CA64337BE91CBB0004200E6" display-inline="no-display-inline">
<subsection id="H04783F763FBB4024BCC39984848E719E"><enum>(i)</enum><header>Pandemic influenza; state preparedness plan</header>
<paragraph id="H527B1F6B978B4E32BF013F9035C92C93"><enum>(1)</enum><header>In general</header><text>As a condition of receiving an award under subsection (a), the State involved shall—</text>
<subparagraph id="H40D66A230ED64BB0B4F96768E2D4741"><enum>(A)</enum><text>designate an official or office as responsible for pandemic influenza preparedness;</text></subparagraph>
<subparagraph id="H9EC72E9A87044B4FBC9486E11897DA1B"><enum>(B)</enum><text>submit to the Director of the Centers for Disease Control and Prevention a Pandemic Influenza Preparedness Plan described under paragraph (2); and</text></subparagraph>
<subparagraph id="HE0F0A67D166A41119FE1A404470091B3"><enum>(C)</enum><text>have such Preparedness Plan approved in accordance with this subsection.</text></subparagraph></paragraph>
<paragraph id="HC1A3F2B89140409DA6D82932CE2ADB"><enum>(2)</enum><header>Preparedness Plan</header>
<subparagraph id="H1E37DC7FCA4B4180B2E0F08B074E1203"><enum>(A)</enum><header>In general</header><text>The Pandemic Influenza Preparedness Plan required under paragraph (1) shall address—</text>
<clause id="HC1885655FBF644E2804910E45D13002B"><enum>(i)</enum><text>human and animal surveillance activities, including capacity for epidemiological analysis, isolation and subtyping of influenza viruses year-round, including for avian influenza among domestic poultry, and reporting of information across human and veterinary sectors;</text></clause>
<clause id="H454D397FAC394512A85DB60AD475E88"><enum>(ii)</enum><text>methods to ensure surge capacity in hospitals, laboratories, outpatient health care provider offices, medical suppliers, and communication networks;</text></clause>
<clause id="HBA9C3F8DDBF5438ABFCEAC2EAA4CE5B3"><enum>(iii)</enum><text>assisting the recruitment and coordination of national and State volunteer banks of health care professionals;</text></clause>
<clause id="H3FBD4F094DA140148D7476DFCC1B71E9"><enum>(iv)</enum><text>distribution of vaccines, anti-virals, and other treatments to priority groups, and monitor effectiveness and adverse events;</text></clause>
<clause id="HD6DC1CBF92C94694AF00ADEEBEC36F63"><enum>(v)</enum><text>networks that provide alerts and other information for health care providers and organizations at the National, State, and regional level;</text></clause>
<clause id="HD3485B46BB2644E8B72572C755BC1800"><enum>(vi)</enum><text>communication with the public with respect to prevention and obtaining care during pandemic influenza;</text></clause>
<clause id="HF7BED67283114D90B3BEE7538809FF00"><enum>(vii)</enum><text>maintenance of core public functions, including public utilities, refuse disposal, mortuary services, transportation, police and firefighter services, and other critical services;</text></clause>
<clause id="H701768A39F5B4671AA95090565DF46F0"><enum>(viii)</enum><text>provision of security for—</text>
<subclause id="H09347F0F396E4F8FA4FF715DF9433225"><enum>(I)</enum><text>first responders and other medical personnel and volunteers;</text></subclause>
<subclause id="H87D0D5F8DAB843B1BC38A9F82CEB4AF"><enum>(II)</enum><text>hospitals, treatment centers, and isolation and quarantine areas;</text></subclause>
<subclause id="H552B602F6E6B44CE929BED5331002ECD"><enum>(III)</enum><text>transport and delivery of resources, including vaccines, medications and other supplies; and</text></subclause>
<subclause id="H4BEE5CD28E6D4D9D8B1484745FC24E8C"><enum>(IV)</enum><text>other persons or functions as determined appropriate by the Secretary;</text></subclause></clause>
<clause id="H4741751543F948448F3E69797700BA5F"><enum>(ix)</enum><text>the acquisition of necessary legal authority for pandemic activities;</text></clause>
<clause id="H0036B40BBEA0413AA1EE46007F971C37"><enum>(x)</enum><text>integration with existing national, State, and regional bioterrorism preparedness activities or infrastructure;</text></clause>
<clause id="H890C1DC1E30940C78B99D7EE3D50EF3F"><enum>(xi)</enum><text>coordination among public and private health sectors with respect to health care delivery, including mass vaccination and treatment systems, during pandemic influenza; and</text></clause>
<clause id="HB194094A73894BB8A3CF617852F94289"><enum>(xii)</enum><text>coordination with Federal pandemic influenza preparedness activities.</text></clause></subparagraph>
<subparagraph id="HA45BF059120940B1A712C9D2DEE64CBB"><enum>(B)</enum><header>Underserved populations</header><text>The Pandemic Influenza Preparedness Plan required under paragraph (1) shall include a specific focus on surveillance, prevention, and medical care for traditionally underserved populations, including low-income, racial and ethnic minority, immigrant, and uninsured populations.</text></subparagraph></paragraph>
<paragraph id="HE3A5F403A0E24EE5A1149D5B417F995F"><enum>(3)</enum><header>Approval of State Plan</header>
<subparagraph id="HC39494276E2B4933AC7B07621077F19B"><enum>(A)</enum><header>In general</header><text>The Secretary shall develop criteria to rate State Pandemic Influenza Preparedness Plans required under paragraph (1) and determine the minimum rating needed for approval.</text></subparagraph>
<subparagraph id="H7AADE40B4548448EA5904EDA8F85E109"><enum>(B)</enum><header>Timing of approval</header><text>Not later than 90 days after a State submits a State Pandemic Influenza Preparedness Plan as required under paragraph (1), the Secretary shall make a determination regarding approval of such Plan.</text></subparagraph></paragraph>
<paragraph id="HC04183953A93485791BCF185FD27279D"><enum>(4)</enum><header>Reporting of State Plan</header><text>All Pandemic Influenza Preparedness Plans submitted and approved under this section shall be made available to Congress, State officials, and the public as determined appropriate by the Secretary.</text></paragraph>
<paragraph id="H0251E17E955A4971895155E6FAA2BF07"><enum>(5)</enum><header>Assistance to States</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Administrator of the Health Resources and Services Administration, may provide assistance to States in carrying out this subsection, or implementing an approved State Pandemic Influenza Preparedness Plan, which may include the detail of an officer to approved domestic pandemic sites or the purchase of equipment and supplies.</text></paragraph>
<paragraph id="H86BCCCC6AAB1436C004431CB690017B9"><enum>(6)</enum><header>Waiver</header><text>The Secretary may grant a temporary waiver of 1 or more of the requirements under this subsection.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section>
<section id="HBA396FDA90FE4942A86B0477607123D" commented="no"><enum>105.</enum><header>Partnerships for community and hospital preparedness</header><text display-inline="no-display-inline">Section 319C–2(i) of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/247d-4">42 U.S.C. 247d–4(i)</external-xref>) is amended by striking <quote>For the purpose of carrying out this section,</quote> and inserting the following: <quote>For the purpose of carrying out this section, including preparing for pandemic influenza,</quote>; and</text> </section>
<section id="H10EFD2A0EE2A4F9390DB8991ED598F5E"><enum>106.</enum><header>Purchase of unsold doses of seasonal vaccines</header>
<subsection id="H2D8A33F6152944DC00BB273B6C877522"><enum>(a)</enum><header>Producer-specific negotiation on supply for season</header><text>In the case of influenza vaccine and each other periodic-change vaccine, the Secretary shall, for each applicable vaccine season, negotiate with each producer of the vaccine to reach an agreement on the number of doses of the vaccine that the producer will manufacture for such season. The Secretary is not required under the preceding sentence to enter into such an agreement with any producer.</text></subsection>
<subsection id="HF1A2B61BF23C44F9BC5E5D8C2D63822E"><enum>(b)</enum><header>Purchase of percentage of unsold doses</header><text>With respect to the number of doses of a periodic-change vaccine manufactured for an applicable vaccine season by a producer in accordance with an agreement under subsection (a), the Secretary shall purchase from the producer 50 percent of such doses that are unsold for the season.</text></subsection>
<subsection id="H01214D6FC18842188EA3BE3B235BDCCB"><enum>(c)</enum><header>Price per dose</header>
<paragraph id="HE1E1E12E6A3247E1B73619DBAEB78FC1"><enum>(1)</enum><header>Average sales price</header><text>Subject to paragraph (2), the price per dose paid by the Secretary in a purchase of periodic-change vaccine under subsection (b) shall be the average sales price for the vaccine for the applicable vaccine season, as determined by the Secretary.</text></paragraph>
<paragraph id="HC10AD3F69A6F4085AD64A8B5DD760A8"><enum>(2)</enum><header>Audits; adjustments</header><text>The Secretary may enter into an agreement under subsection (a) with a producer regarding a periodic-change vaccine only if the agreement includes a provision that permits the Secretary to conduct audits of sales of such vaccine at wholesale by the producer. The average sales price determined under paragraph (1) for a dose of the vaccine for an applicable vaccine season shall be adjusted by the Secretary as determined necessary by the Secretary on the basis of such audits and on the basis of any other information available to the Secretary on sales of the vaccine at wholesale.</text></paragraph></subsection>
<subsection id="H9798AAC564454609AF9463ED2CE85FAF"><enum>(d)</enum><header>Definitions</header><text>For purposes of this section:</text>
<paragraph id="H69FE18FE0A2047B18283D431CAC68FF3"><enum>(1)</enum><text>The term <quote>approved vaccine</quote> means a vaccine for which a biologics license under section 351 is in effect.</text></paragraph>
<paragraph id="H17123353BF5A4DB69E971E2F2F30ECE5" commented="no" display-inline="no-display-inline"><enum>(2)</enum>
<subparagraph id="H7843DDC745DA43AFAC649832B8B47948" commented="no" display-inline="yes-display-inline"><enum>(A)</enum><text>The term <quote>federally recommended vaccine</quote>, with respect to an adult, means an approved vaccine recommended by the Advisory Committee on Immunization Practices (an advisory committee established by the Secretary, acting through the Director of the Centers for Disease Control and Prevention).</text></subparagraph>
<subparagraph id="HB17971D784C6419E8B27004695B23330" indent="up1" commented="no"><enum>(B)</enum><text display-inline="yes-display-inline">The term <quote>federally recommended vaccine</quote>, with respect to a child, means a vaccine on the list referred to in section 1928(e) of the Social Security Act.</text></subparagraph></paragraph>
<paragraph id="HAE0E1D3585CB4EE58CE300CE964B77DD"><enum>(3)</enum><text>The term <quote>periodic-change vaccine</quote> means a federally recommended vaccine that is designed only for a single applicable vaccine season due to characteristics of the etiologic agent or agents for the disease involved, or due to characteristics of the vaccine, that adversely affect the extent to which the vaccine is safe and effective after such season. Such term includes influenza vaccine.</text></paragraph>
<paragraph id="H361D727305034180A8CD8049D986E945"><enum>(4)</enum><text>The term <quote>producer</quote> means a person who—</text>
<subparagraph id="H336D41B7CA9F4C4D92EF88F27148F327"><enum>(A)</enum><text>manufactures an approved vaccine; or</text></subparagraph>
<subparagraph id="H332C8C6C0631477290C0AAF5B34F0065"><enum>(B)</enum><text>who intends to manufacture such a vaccine and is determined by the Secretary to have the capacity to meet legal requirements applicable to such manufacturing.</text></subparagraph></paragraph>
<paragraph id="HBCC3D6DCFF55402DB121F000AFF3F9A4"><enum>(5)</enum>
<subparagraph id="HCADB7F862FB84192B8BEAA029994B9AE" display-inline="yes-display-inline"><enum>(A)</enum><text>The term <quote>vaccine season</quote>, with respect to a periodic-change vaccine, means a consecutive number of months, not exceeding 24 months, during which the Secretary recommends that the public in general, or particular populations, as the case may be, receive immunizations against the disease involved.</text></subparagraph>
<subparagraph id="H6454DED2AEC54927AE8E8C477DDB86FC" indent="up1"><enum>(B)</enum><text>The term <quote>applicable vaccine season</quote>, with respect to a periodic-change vaccine, means the vaccine season that is applicable to such vaccine.</text></subparagraph></paragraph></subsection>
<subsection id="HDC47B476500146488062AD9578E2A806" commented="no"><enum>(e)</enum><header>Direct spending</header><text display-inline="yes-display-inline">The requirement under subsection (b) that the Secretary make purchases of doses of periodic-change vaccine constitutes budget authority in advance of appropriations Acts, and represents the obligation of the United States to make outlays for such purchases in accordance with this subsection.</text></subsection></section>
<section id="HAC848810C5404EEA8C6FBC74240022F5"><enum>107.</enum><header>Surveillance</header>
<subsection id="H696AF39BD3954DF595E55532CDC18969"><enum>(a)</enum><header>Domestic surveillance</header>
<paragraph id="H269BEAC199204567BA41A11316AF9FAD"><enum>(1)</enum><header>In general</header><text>The Secretary, in coordination with the Secretary of Agriculture, shall establish minimum thresholds for States with respect to adequate surveillance for pandemic influenza, including possible pandemic avian influenza.</text></paragraph>
<paragraph id="H32AF3FBFEA864D94005130DBFD7391DC"><enum>(2)</enum><header>Assistance to States</header>
<subparagraph id="H16B12357EE5E43C5BA7F1B1B4D69AF19"><enum>(A)</enum><header>In general</header><text>The Secretary, in coordination with the Secretary of Agriculture, shall provide assistance to States and regions to meet the minimum thresholds established under paragraph (1).</text></subparagraph>
<subparagraph id="H62C64490591842409F901C07B0B8A0F7"><enum>(B)</enum><header>Types of assistance</header><text>Assistance provided to States under subparagraph (A) may include—</text>
<clause id="H1AA1B6FE07AA4D0B9D948E627C8DED68"><enum>(i)</enum><text>the establishment or expansion of State surveillance and alert systems, including the Sentinel Physician Surveillance System and 122 Cities Mortalities Report System;</text></clause>
<clause id="H34E5EAE202C84450B9BCAD9BAAAE52B4"><enum>(ii)</enum><text>the provision of equipment and supplies;</text></clause>
<clause id="HB10BF6E50D384509939844FA7EA71704"><enum>(iii)</enum><text>support for epidemiological analysis and investigation of novel strains;</text></clause>
<clause id="HEE069AB9EB8541CCB45F6E7EFF7A8A"><enum>(iv)</enum><text>the sharing of biological specimens and epidemiological and clinical data within and across States; and</text></clause>
<clause id="H505DB47ACC6F414EA07FCE0A4CF00B5"><enum>(v)</enum><text>other activities determined appropriate by the Secretary.</text></clause></subparagraph></paragraph>
<paragraph id="H2B8604DB24ED4026B8DBF8BC44A7B8A3"><enum>(3)</enum><header>Detail of officers</header><text>The Secretary may detail officers to States for technical assistance as needed to carry out this subsection.</text></paragraph></subsection>
<subsection id="H122D8E590C5A41AB9FC125AFE7590095"><enum>(b)</enum><header>Private sector involvement</header>
<paragraph id="HF8F6037CE5914074ABB7CDE2C89740C8"><enum>(1)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention and the Administrator of the Health Resources and Services Administration, and in coordination with private sector entities, shall integrate and coordinate public and private influenza surveillance activities, as appropriate.</text></paragraph>
<paragraph id="HA46127B330624B958DB58C399C43DB58"><enum>(2)</enum><header>Grant program</header>
<subparagraph id="H32D3018861C44281A0797380A6E36ECF"><enum>(A)</enum><header>In general</header><text>In carrying out the activities under paragraph (1), the Secretary may establish a grant program, or expand existing grant programs, to provide funding to eligible entities to coordinate or integrate as appropriate, pandemic preparedness surveillance activities between States and private health sector entities, including hospitals, health plans, and other health systems.</text></subparagraph>
<subparagraph id="HB957766A2E484677BA18FC61799E0071"><enum>(B)</enum><header>Eligibility</header><text>To be eligible to receive a grant under subparagraph (A), an entity shall submit an application at such time, in such manner, and containing such information as the Secretary may require.</text></subparagraph>
<subparagraph id="H1A9BAB30B6B8463B8B4642C1FA990976"><enum>(C)</enum><header>Use of funds</header><text>Funds under a grant under subparagraph (A) may be used to—</text>
<clause id="HF8F18F6580BB4138A1250970952259B7"><enum>(i)</enum><text>develop and implement surveillance protocols for patients in outpatient and hospital settings;</text></clause>
<clause id="HDE4528800277482F9E00A091A93650A9"><enum>(ii)</enum><text>establish a communication alert plan for patients for reportable signs and symptoms that may suggest influenza;</text></clause>
<clause id="H7CEFA9F212DB4D1786AD04C8D7AACC9"><enum>(iii)</enum><text>plan for the vaccination of populations and, if appropriate, dissemination of anti-viral drugs;</text></clause>
<clause id="H763E727E61A646D39FFE3C06FF5CCD57"><enum>(iv)</enum><text>purchase necessary equipment and supplies;</text></clause>
<clause id="H51917A59A73F48EEA90003B6499DB63D"><enum>(v)</enum><text>increase laboratory testing and networking capacity;</text></clause>
<clause id="H622CAE44C6A445B794678700002099B0"><enum>(vi)</enum><text>conduct epidemiological and other analyses; or</text></clause>
<clause id="H9954022A40564F43849162EE8100FE43"><enum>(vii)</enum><text>report and disseminate data.</text></clause></subparagraph>
<subparagraph id="H2042576090AD45E6A7D14DFE5F004529"><enum>(D)</enum><header>Detail of officers</header><text>The Secretary may detail officers to grantees under subparagraph (A) for technical assistance.</text></subparagraph>
<subparagraph id="H66224890D80541E0BCDBF358D0F67E5F"><enum>(E)</enum><header>Requirement</header><text>As a condition of receiving a grant under subparagraph (A), a State shall have a plan to meet minimum thresholds for State influenza surveillance established by the Director of the Centers for Disease Control and Prevention in coordination with the Secretary of Agriculture under subsection (b).</text></subparagraph></paragraph></subsection></section>
<section id="H3988687E351E43DFA78EBC9F894BF7C" display-inline="no-display-inline" section-type="subsequent-section"><enum>108.</enum><header>Global Network for Avian Influenza Surveillance</header>
<subsection id="H9C1097D8B0D447FA83AD9021B61206E3"><enum>(a)</enum><header>Purpose</header><text display-inline="yes-display-inline">The purpose of this section is to establish a Global Network for Avian Influenza Surveillance—</text>
<paragraph id="HDF5BC6D777204031BA02C914F9744900"><enum>(1)</enum><text>to more rapidly and efficiently detect, verify, and report on the presence of infectious diseases, such as highly pathogenic avian influenza, in migratory birds and resident waterfowl around the world;</text></paragraph>
<paragraph id="HABDAF27014E643B3ADECF597BA748D46"><enum>(2)</enum><text>to use information on viral strains found during surveillance of wild birds to better delineate any mutations in the virus that may be detectable within wild bird populations;</text></paragraph>
<paragraph id="HCE00799C2A5E414EADF0361360929CC0"><enum>(3)</enum><text>to use information on when and where HPAI and other pathogens of concern are identified in migratory birds—</text>
<subparagraph id="H14442739652F4472B9FF16824FBC7600"><enum>(A)</enum><text>to better guide preparedness in the United States and around the world; and</text></subparagraph>
<subparagraph id="H724930512E844B5D98CC36D6D6DB95B"><enum>(B)</enum><text>to carry out a comprehensive migratory bird disease surveillance initiative that will provide regions, countries, and specific locations with early warning information that will help target resources toward enhancement of poultry biosecurity and surveillance, heightened public health vigilance, and related areas;</text></subparagraph></paragraph>
<paragraph id="H485EE085549D4A2686008FA32CE1395C"><enum>(4)</enum><text>to create an open access database within which information on HPAI and other pathogens of interest identified in migratory birds can be shared as close to real time as possible;</text></paragraph>
<paragraph id="H1AC62E46BBBD489AB8F51EA7F134CFEE"><enum>(5)</enum><text>to protect the health and safety of United States citizens and officials traveling or living abroad; and</text></paragraph>
<paragraph id="H4A637F13F0694992A1D9002C70C65E81"><enum>(6)</enum><text>to protect the economic interests of the United States and its partners from threats to health, agriculture, and natural resources.</text></paragraph></subsection>
<subsection id="HD1D927340B93483E85C9D1CC2852223B"><enum>(b)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H726D033295A74285AF2DD27CA2DA9904"><enum>(1)</enum><header>Eligible organization</header><text>The term <term>eligible organization</term> means a nongovernmental wildlife conservation organization chartered in the United States with—</text>
<subparagraph id="H5FB12794CF154883B4E1F89942509220"><enum>(A)</enum><text>extensive global wildlife health experience in tracking disease in wild birds, including free-ranging, captive, and wild bird species;</text></subparagraph>
<subparagraph id="H5AF33FC2C5F040B8994500A1F900F3F6"><enum>(B)</enum><text>proven ability in identifying avian influenza in wild birds; and</text></subparagraph>
<subparagraph id="HCE268C8A26BB4557B627EF06962C2F00"><enum>(C)</enum><text>accredited zoological facilities in the United States.</text></subparagraph></paragraph>
<paragraph id="H9D2571EB382149FBB4FFA58C7D204BB0"><enum>(2)</enum><header>GNAIS</header><text>The term <term>GNAIS</term> means the Global Network for Avian Influenza Surveillance established under subsection (c)(1).</text></paragraph>
<paragraph id="H8F1F2E448F1A4052AC94466FB4CD41DB"><enum>(3)</enum><header>GNAIS partners</header><text>The term <term>GNAIS partners</term> means the partners of the GNAIS described in subsection (c)(2).</text></paragraph>
<paragraph id="H2550C42C8E834CC78B5DAC140697D538"><enum>(4)</enum><header>HPAI</header><text>The term <term>HPAI</term> means highly pathogenic avian influenza.</text></paragraph>
<paragraph id="H4D598ABF205248C8B5F703808EC574A8"><enum>(5)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Health and Human Services, acting—</text>
<subparagraph id="H646AD25D8F644898822636EDCF14CA7D"><enum>(A)</enum><text>through the Influenza Branch of the Centers for Disease Control and Prevention; and</text></subparagraph>
<subparagraph id="HE03B2D18BFE14C12B4CB04A8AAF0029"><enum>(B)</enum><text>in partnership with an eligible organization.</text></subparagraph></paragraph></subsection>
<subsection id="H7398386DE13541189158F4CD2B003618"><enum>(c)</enum><header>Global Network for Avian Influenza Surveillance</header>
<paragraph id="HAB8DA563527A4E7E87009CB410084EF"><enum>(1)</enum><header>Establishment</header><text>Not later than 90 days after the date of enactment of this Act, the Secretary shall offer to enter into a contract with 1 or more eligible organizations to establish a Global Network for Avian Influenza Surveillance.</text></paragraph>
<paragraph id="HD659DA11C9594B2195F7119FB7AA80DB"><enum>(2)</enum><header>Partners</header><text>In administering the GNAIS, the Secretary and the eligible organization shall collaborate with appropriate—</text>
<subparagraph id="H9D59DCC362E543AC00426C49CB001654"><enum>(A)</enum><text>Federal and State agency partners, including—</text>
<clause id="H1EA42B7BC6254D198E55451FA05F6E65"><enum>(i)</enum><text>the Department of Agriculture, acting through—</text>
<subclause id="HC1B5160840FA40B2BB69AADF1EDC72A1"><enum>(I)</enum><text>the Agricultural Research Service; and</text></subclause>
<subclause id="HB4FC95359DDC483482F6B296AF9D43DE"><enum>(II)</enum><text>the Animal and Plant Health Inspection Service;</text></subclause></clause>
<clause id="H993A327379D14B0AB9C63C30BEA92D4D"><enum>(ii)</enum><text>the Department of the Interior, acting through—</text>
<subclause id="H9942AC81FA2F4DB1BD8B4C75F7330024"><enum>(I)</enum><text>the United States Geological Survey; and</text></subclause>
<subclause id="H8221721A003E496E8538004F53FD8C6F"><enum>(II)</enum><text>the United States Fish and Wildlife Service; and</text></subclause></clause>
<clause id="HF052D236277D4345A6F1D057CDC01CA8"><enum>(iii)</enum><text>various State wildlife agencies in the United States;</text></clause></subparagraph>
<subparagraph id="H2F95CDA18ED04C5ABD757B3BC5A96F23"><enum>(B)</enum><text>multilateral agency partners, including—</text>
<clause id="H94071A903E3A42D8BB5C33BFAE419DDF"><enum>(i)</enum><text>the Food and Agriculture Organization;</text></clause>
<clause id="H9381639592624E0EBD34290064485B92"><enum>(ii)</enum><text>the World Health Organization;</text></clause>
<clause id="HBF0B37670C8A4FA4903D4BFC8DE6C6E"><enum>(iii)</enum><text>the Office International des Epizooties, the world animal health organization; and</text></clause>
<clause id="HE1B151B911BD4BE7AB00B400C9C38FFE"><enum>(iv)</enum><text>the World Conservation Union;</text></clause></subparagraph>
<subparagraph id="H833DC2408107420296EF7CAA5418B232"><enum>(C)</enum><text>conservation organizations with expertise in international and domestic bird monitoring and surveillance;</text></subparagraph>
<subparagraph id="H8840E19F145642A08300708DDC43E854"><enum>(D)</enum><text>accredited colleges of veterinary medicine; and</text></subparagraph>
<subparagraph id="H5E855ED7430041C185D4172BF5AADC20"><enum>(E)</enum><text>other national and international partners, as necessary.</text></subparagraph></paragraph>
<paragraph id="H39E984E9B526486FAE8603E2B64BC5EB"><enum>(3)</enum><header>International surveillance</header><text>The eligible organization, in coordination with the Influenza Branch of the Centers for Disease Control and Prevention, shall manage an international surveillance program under which Federal GNAIS partners shall, and non-Federal GNAIS partners are encouraged to—</text>
<subparagraph id="H20373CA21CA643C0B6FEEE7223D756E4"><enum>(A)</enum><text>monitor and test for the presence or arrival of avian influenza and other significant avian pathogens at important bird areas around the world and in marketplaces with intense trade in wild birds;</text></subparagraph>
<subparagraph id="H2942D858FD0A4829A933ACACA2E19324"><enum>(B)</enum><text>use trained professionals to collect samples and other data and send samples to appropriate diagnostic centers;</text></subparagraph>
<subparagraph id="HF229495096C944B9A9AAEB8600CF2500"><enum>(C)</enum><text>use the GNAIS, in partnership with relevant agencies and organizations, for conducting—</text>
<clause id="H61D35299ED534CE3AFAC00FDCBBB02EF"><enum>(i)</enum><text>disease surveillance activities on migratory birds worldwide;</text></clause>
<clause id="H067265A0AA2541E487E992C911268D1F"><enum>(ii)</enum><text>domestic and international field investigations on migratory birds;</text></clause>
<clause id="H413184E7E77446CB948B4631B713E531"><enum>(iii)</enum><text>training and capacity-building activities related to the relationships between human health, domestic animal health, and wildlife health; and</text></clause>
<clause id="HF0C31268C4284DF9A0260564EC86B100"><enum>(iv)</enum><text>research on methods and approaches for detection and enhanced surveillance of HPAI and other pathogens in migratory birds; and</text></clause></subparagraph>
<subparagraph id="H7216B517B3B34460884C259CABFB4B78"><enum>(D)</enum><text>send samples for avian influenza testing to certified laboratories that—</text>
<clause id="H68D23595120D477A8C5C5C2FAB83D243"><enum>(i)</enum><text>meet internationally established methods standards;</text></clause>
<clause id="H0E856B6308984D778084831CB0CFE52D"><enum>(ii)</enum><text>are located at—</text>
<subclause id="HFA13F5C528BC4D28A6D5A96E1C9600AF"><enum>(I)</enum><text>the Influenza Branch of the Centers for Disease Control and Prevention;</text></subclause>
<subclause id="H892A631510CC455495AB223349080071"><enum>(II)</enum><text>the Office International des Epizooties, the world animal health organization;</text></subclause>
<subclause id="H5AB591F21B0846ED8B6ECD0452C6A89B"><enum>(III)</enum><text>the Food and Agriculture Organization;</text></subclause>
<subclause id="HA4EB80893BC44D60967F778C6E90C4DF"><enum>(IV)</enum><text>National Veterinary Services Laboratories of the Department of Agriculture; or</text></subclause>
<subclause id="HC2C4E273E1384AA48C10DBEA9F9324B3"><enum>(V)</enum><text>the Agricultural Research Service; and</text></subclause></clause>
<clause id="H44A28F8164164023A00972BF00097D6D"><enum>(iii)</enum><text>report the findings back to the eligible organization and GNAIS partners.</text></clause></subparagraph></paragraph>
<paragraph id="H0EE041D8DE954E1C9456898420826B4E"><enum>(4)</enum><header>Network</header>
<subparagraph id="HFDCC45A8331A444F9EC8FE00008886FB"><enum>(A)</enum><header>Partners</header><text>Federal GNAIS partners shall, and non-Federal GNAIS partners are encouraged to, transmit information related to global distribution and characteristics of avian influenza to the Secretary acting through the eligible organization.</text></subparagraph>
<subparagraph id="HBF819C269BC04B9B8113ACC11E9F4B50"><enum>(B)</enum><header>Administration</header><text>The Secretary, acting through the eligible organization, shall—</text>
<clause id="H254D0D3281274E13BE5D9E3E3FCEB4B0"><enum>(i)</enum><text>use surveillance reports and other formal and informal sources of information to identify and investigate local disease outbreaks of avian influenza, in coordination with GNAIS partners;</text></clause>
<clause id="HC7635A8AE98B4A109623E49EDD5D566"><enum>(ii)</enum><text>develop a long-term baseline of regional data related to HPAI and pathogens in migratory birds for analysis between and across sites to create a system to identify when and where outbreaks might occur and paths of dispersal;</text></clause>
<clause id="H31229A8A22F54C8BB2E1003DF6745CF9"><enum>(iii)</enum><text>provide technical assistance for disease prevention and control programs based on scientific understanding of the relationships between wildlife health, domestic animal health, and human health;</text></clause>
<clause id="H64FC1724051A4FC0ABD0242B22134500"><enum>(iv)</enum><text>provide analytical disease findings regularly to the Influenza Branch of the Centers for Disease Control and Prevention and other Federal GNAIS partners to prevent or combat human diseases;</text></clause>
<clause id="H71BFB84047D74D77B5E3003C8C62E35E"><enum>(v)</enum><text>conduct other activities as are necessary to support the GNAIS network and GNAIS partners; and</text></clause>
<clause id="HEC2785B357C648CD00603DD852844B53"><enum>(vi)</enum><text>coordinate GNAIS surveillance results at the headquarters of the eligible organization.</text></clause></subparagraph></paragraph>
<paragraph id="H8B4D7738274D45D8BD80D70A392F1C"><enum>(5)</enum><header>Database</header>
<subparagraph id="H3B7641435B65421FAA6B8B4B82635EA9"><enum>(A)</enum><header>In general</header><text>The Secretary, acting through the eligible organization, shall manage, map, and make available on a database on the Internet all results and information gathered under this section.</text></subparagraph>
<subparagraph id="HF4CADFF7E870466E968093BB33FA9300"><enum>(B)</enum><header>Requirements</header><text>The database shall—</text>
<clause id="HAB69C40A6AA9408FB456A2EB03B87220"><enum>(i)</enum><text>provide geographic data on wild bird populations and the movements of the populations and laboratory test results; and</text></clause>
<clause id="H3DF38D8121EF474E923F00209507B6B4"><enum>(ii)</enum><text>be available for viewing by any Federal agency, foreign country, multilateral institution, organization, or individual.</text></clause></subparagraph></paragraph>
<paragraph id="H9BE75FFA267B427F9DC066C61FBED28E"><enum>(6)</enum><header>Training</header><text>The Secretary shall request accredited colleges of veterinary medicine and other GNAIS partners to train members of the GNAIS network to—</text>
<subparagraph id="H4DED3FEF9B3D45B8B77362AAAA97983E"><enum>(A)</enum><text>monitor important bird areas around the world; and</text></subparagraph>
<subparagraph id="H993ECBD4AC3A475A8DDD86657EEF96A1"><enum>(B)</enum><text>test for the presence or arrival of avian influenza and other significant avian pathogens of zoonotic concern.</text></subparagraph></paragraph></subsection>
<subsection id="HA6EE08EBB22840899C33B4EA498EE37D"><enum>(d)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section $10,000,000 for each of the fiscal years 2006 through 2010.</text></subsection></section>
<section id="HB7B6202BB16043B59B326DCFBD414500" commented="no"><enum>109.</enum><header>Procurements for Strategic National Stockpile</header> <text display-inline="no-display-inline">For the purpose of preventing and treating pandemic influenza, the Secretary shall take immediate action to procure for the stockpile under section 319F–2 of the Public Health Service Act such quantities of anti-virals, vaccines, essential medications, and other supplies as the Secretary determines to be necessary.</text></section>
<section id="H40860683B39A462C84BCBC40C894BC5D" commented="no"><enum>110.</enum><header>National tracking and distribution system for vaccines and anti-virals</header>
<subsection id="H70781629189543BB958BC2BF00B0F667" commented="no"><enum>(a)</enum><header>In general</header><text>The Secretary shall develop and implement a national system for the tracking and distribution of anti-viral medications and vaccines in order to prepare and respond to pandemic influenza.</text></subsection>
<subsection id="H4F474224ED704CDF8050E2BDD1D84267" commented="no"><enum>(b)</enum><header>System</header><text>The system developed under paragraph (1) shall—</text>
<paragraph id="HBBDDC34856884ACD00A8E4286EBADF46" commented="no"><enum>(1)</enum><text>allow for the electronic tracking of all domestically available anti-viral medication and vaccines for pandemic influenza;</text></paragraph>
<paragraph id="H5D5AFAA22F934B72A2DFC7E1CE1DA77" commented="no"><enum>(2)</enum><text>anticipate shortages, and alert officials if shortages are expected in such medications and vaccines;</text></paragraph>
<paragraph id="HCDC30DBCE4434B7EA3002B84A287EB62" commented="no"><enum>(3)</enum><text>target distribution to high-risk groups, including health professionals and relief personnel and other individuals determined to be most susceptible to disease or death from pandemic flu;</text></paragraph>
<paragraph id="HEFC5AE9C35FF46188505DC7EBF5CB439" commented="no"><enum>(4)</enum><text>ensure equitable distribution, particularly across low-income and other underserved groups; and</text></paragraph>
<paragraph id="H15BEBB872B274B8880B923E5FE2F4889" commented="no"><enum>(5)</enum><text>integrate with existing State and local systems as appropriate.</text> </paragraph></subsection></section>
<section id="H69C9E884A7EE4F1A94ADC0BACB065D3E" display-inline="no-display-inline"><enum>111.</enum><header>Public education and awareness campaign</header>
<subsection id="HA3C70180A1CC40FBBA70479F52829BA6"><enum>(a)</enum><header>In general</header><text>The Director of the Centers for Disease Control and Prevention, in consultation with the United States Agency for International Development, the World Health Organization, the World Organization for Animal Health, and foreign countries, shall develop an outreach campaign with respect to public education and awareness of influenza and influenza preparedness.</text></subsection>
<subsection id="HBB585001926C4204B0AC56F5047D4CAA"><enum>(b)</enum><header>Details of campaign</header><text>The campaign established under subsection (a) shall—</text>
<paragraph id="H380D8F5E421041D494E77461DC57C8BE"><enum>(1)</enum><text>be culturally and linguistically appropriate for domestic populations;</text></paragraph>
<paragraph id="H5D8B2B8587284B1589A8DDBB73CCE6C6"><enum>(2)</enum><text>be adaptable for use in foreign countries;</text></paragraph>
<paragraph id="HA59FDEFA035E4BABBB49FC241FB4C5D7"><enum>(3)</enum><text>target high-risk populations (those most likely to contract, transmit, and die from influenza);</text></paragraph>
<paragraph id="HB836CBABCD4945E5008F72E961BA26FC"><enum>(4)</enum><text>promote personal influenza precautionary measures and knowledge, and the need for general vaccination, as appropriate; and</text></paragraph>
<paragraph id="HE37DAD13E6C54E5FB4581B124E9E9EDF"><enum>(5)</enum><text>describe precautions at the State and local level that could be implemented during pandemic influenza, including quarantine and other measures.</text></paragraph></subsection></section>
<section id="H1DC80EBDB3A543F09247C58840F5B85"><enum>112.</enum><header>Health professional training</header><text display-inline="no-display-inline">The Secretary, directly or through contract, and in consultation with professional health and medical societies, shall develop and disseminate pandemic influenza training curricula—</text>
<paragraph id="H8B29428DE5A540E291723F722C4B047F"><enum>(1)</enum><text>to educate and train health professionals, including physicians, nurses, public health practitioners, virologists and epidemiologists, veterinarians, mental health providers, allied health professionals, and paramedics and other first responders;</text></paragraph>
<paragraph id="HBD2EA763787D4CCCAD23E2404F80A3A4"><enum>(2)</enum><text>to educate and train volunteer, non-medical personnel whose assistance may be required during a pandemic influenza outbreak; and</text></paragraph>
<paragraph id="H560A721373F94054A87F51BE00A66487"><enum>(3)</enum><text>that address prevention, including use of quarantine and other isolation precautions, pandemic influenza diagnosis, medical guidelines for use of anti-virals and vaccines, and professional requirements and responsibilities, as appropriate.</text></paragraph></section>
<section id="H0B5D4EB2B79146A3A4E95816BDD90066"><enum>113.</enum><header>Research at National Institutes of Health</header>
<subsection id="H544DCE433B934090ADC8D744EDFC4441"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Director of the National Institutes of Health (referred to in this section as the <quote>Director of NIH</quote>), 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 respect to influenza, on—</text>
<paragraph id="H0675C89B56064B49AAE1D2ECE762BD7F"><enum>(1)</enum><text>vaccine development and manufacture, including strategies to increase immunological response;</text></paragraph>
<paragraph id="HB1FF84DACF1045D887CB18E52EC46D9E"><enum>(2)</enum><text>effectiveness of inducing heterosubtypic immunity;</text></paragraph>
<paragraph id="H338A4C4301AB4E98A8FDEC4D1365C3B"><enum>(3)</enum><text>antigen-sparing studies;</text></paragraph>
<paragraph id="H99A71B5703E245A49391034E2F5DDB15"><enum>(4)</enum><text>anti-virals, including minimal dose or course of treatment and timing to achieve prophylactic or therapeutic effect;</text></paragraph>
<paragraph id="HA503DEA93735470B801642E5AB7784A0"><enum>(5)</enum><text>side effects and drug safety of vaccines and anti-virals in subpopulations;</text></paragraph>
<paragraph id="HE4E1117A631643B8B924EFB9A09907A7"><enum>(6)</enum><text>alternative routes of delivery of vaccines, anti-virals, and other medications as appropriate;</text></paragraph>
<paragraph id="H9F63AAE38C304AB89E3C227700EA0861"><enum>(7)</enum><text>more efficient methods for testing and determining virus subtype;</text></paragraph>
<paragraph id="HA7D10D65280A4B488491A6AB17643A0"><enum>(8)</enum><text>protective measures;</text></paragraph>
<paragraph id="H7A800C81DB2A475DAB3400DDF8B434BA"><enum>(9)</enum><text>modes of influenza transmission;</text></paragraph>
<paragraph id="H96077067D9AB4A8CB1B2002D8547627D"><enum>(10)</enum><text>effectiveness of masks, hand-washing, and other non-pharmaceutical measures in preventing transmission;</text></paragraph>
<paragraph id="HAF9BE617D6CD475E879093A476953448"><enum>(11)</enum><text>improved diagnostic tools for influenza; and</text></paragraph>
<paragraph id="HA3BCC42F568A4D39B8962821B0A2F946"><enum>(12)</enum><text>other areas determined appropriate by the Director of NIH.</text></paragraph></subsection>
<subsection id="H453B7B779CEB433D9700BC622CF747C0" display-inline="no-display-inline"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">For the purposes of carrying out subsection (a), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.</text> </subsection></section>
<section id="HAC5E892ECF104EE5A130192259A3200"><enum>114.</enum><header>Research at Centers for Disease Control and Prevention</header>
<subsection id="H7C24A172A62244749DE3031ECFBA2917"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Director of the Centers for Disease Control and Prevention, in collaboration with other relevant agencies, shall expand and intensify research, with respect to influenza, on—</text>
<paragraph id="HA6BE7C107CE444BDB41E8CFB11589EC1"><enum>(1)</enum><text>historical research on prior pandemics to better understand pandemic epidemiology, transmission, protective measures, high-risk groups, and other lessons that may be applicable to future pandemic;</text></paragraph>
<paragraph id="H3A5139C9B8764E1B86046E0048EE81C"><enum>(2)</enum><text>communication strategies for the public during pandemic influenza, taking into consideration age, racial and ethnic background, health literacy, and risk status;</text></paragraph>
<paragraph id="H862E30AE58014153A50788780071CF85"><enum>(3)</enum><text>changing and influencing human behavior as it relates to vaccination;</text></paragraph>
<paragraph id="HEA017B52B1D14A63B5D1C0053000787"><enum>(4)</enum><text>development and implementation of a public, non-commercial and non-competitive broadcast system and person-to-person networks;</text></paragraph>
<paragraph id="H758A2986EE404CCA85B880995C7EC811"><enum>(5)</enum><text>population-based surveillance methods to estimate influenza infection rates and rates of outpatient illness;</text></paragraph>
<paragraph id="H29AFAC2F16414C468D28D4A3B000A5DC"><enum>(6)</enum><text>vaccine effectiveness;</text></paragraph>
<paragraph id="HEDFE3C22CB724D4F9503534D075900FE"><enum>(7)</enum><text>systems to monitor vaccination coverage levels and adverse events from vaccination; and</text></paragraph>
<paragraph id="H9E53C983CC454D3AAFB281F68BCD9733"><enum>(8)</enum><text>other areas determined appropriate by the Director of the Centers for Disease Control and Prevention.</text></paragraph></subsection>
<subsection id="H2A3551C8516D4A3FAFCDB963B687E657" display-inline="no-display-inline"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">For the purposes of carrying out subsection (a), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.</text></subsection></section>
<section id="H659ABE0BF51E474D98D661728279E97D"><enum>115.</enum><header>Collaboration with National Science Foundation regarding effective communication strategies</header>
<subsection id="HD0F2D7CCBC1145BDB9CFB2F761FAB1F6"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary and the National Science Foundation shall collaborate to develop best practices and fund social science research toward developing effective communication strategies with respect to preparedness for and response to pandemic influenza.</text> </subsection>
<subsection id="HD0483B2BA0E847A0B7DD36978020A556" display-inline="no-display-inline"><enum>(b)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">For the purposes of carrying out subsection (a), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.</text></subsection></section>
<section id="H4874788EF36A4E1EB862543386B4AF9B" display-inline="no-display-inline" section-type="subsequent-section"><enum>116.</enum><header>Funds for inspections of manufacturing facilities; postmarket safety</header>
<subsection id="HAD7BC01B3B4F48DFAA666BCFBF3139B7"><enum>(a)</enum><header>Inspections</header><text display-inline="yes-display-inline">With respect to facilities that manufacture influenza vaccine, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010 for the purpose of providing additional funds to the Food and Drug Administration to conduct inspections of such facilities to determine whether the facilities are in compliance with regulations under section 501 of the Federal Food, Drug, and Cosmetic Act (relating to adulteration). Such authorizations are in addition to other authorizations of appropriations that are available for such purpose.</text></subsection>
<subsection id="H20A026800635481A9741F26BFE00B4DA"><enum>(b)</enum><header>Postmarket safety</header><text display-inline="yes-display-inline">For the purpose of providing additional funds to the Food and Drug Administration to carry out postmarket safety activities with respect to vaccines approved under section 351 of the Public Health Service Act to prevent influenza, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010. Such authorizations are in addition to other authorizations of appropriations that are available for such purpose.</text></subsection></section>
<section id="HF1B1A1D5E94F4DE6805EB0AD7F25D1E1"><enum>117.</enum><header>Coordination with Department of Homeland Security</header><text display-inline="no-display-inline">Consistent with section 505(a) of the Homeland Security Act of 2002, the Secretary of Health and Human Services shall collaborate with the Secretary of Homeland Security in developing and implementing a coordinated strategy for preparing for and responding to pandemic influenza, including carrying out such relevant activities under the National Response Plan (developed under Homeland Security Presidential Directive 5) as are consistent with such section 505(a).</text></section>
<section id="HFDE4083B9F8245669D57867CDAB3C102"><enum>118.</enum><header>Definition</header><text display-inline="no-display-inline">For purposes of this title, the term <quote>Secretary</quote> means the Secretary of Health and Human Services, unless the context of usage indicates otherwise.</text></section>
<enum>II</enum><header>Protecting health care workers and first responders from pandemic Influenza</header>
<section id="H7E4A228FF8994F8BA5210384B2DDE6E5"><enum>201.</enum><header>Preparedness and response</header>
<subsection id="H448F6E6B23044A0DBC07FFBE2F484734"><enum>(a)</enum><header>In general</header><text>The Secretary of Labor and the Secretary of Health and Human Services shall develop and issue workplace standards, recommendations and plans to protect health care workers and first responders, including police, firefighters, and emergency medical personnel from workplace exposure to pandemic influenza. Such standards, recommendations and plans shall set forth appropriate measures to protect workers both in preparation for a potential pandemic influenza occurrence and in response to an actual occurrence of pandemic influenza.</text></subsection>
<subsection id="HE82682EA55A649EB8D08944825D392F0"><enum>(b)</enum><header>Workplace safety and health standards</header>
<paragraph id="HB7E273813C214206AC196CA65EDD60E8"><enum>(1)</enum><header>In general</header><text>Within 6 months after the date of the enactment of this Act, pursuant to section 6(c) of the Occupational Safety and Health Act, the Secretary of Labor, in consultation with the Director of the National Institute for Occupational Safety and Health, shall develop and issue an emergency temporary standard for the protection of health care workers and first responders against occupational exposure to pandemic influenza, including avian influenza caused by the H5N1 virus. Within 6 months after the issuance of an emergency standard, the Secretary of Labor shall issue a final permanent standard for occupational exposure to pandemic influenza under section 6(b) of the Occupational Safety and Health Act. The emergency temporary standard and final permanent standard shall provide, at a minimum, for the following:</text>
<subparagraph id="H80310FC28A5D4209BB9C9764EDA3F0BE"><enum>(A)</enum><text>The development and implementation of an exposure control plan to protect workers from airborne and contact hazards in conformance with the Guideline for Protecting Workers Against Avian Flu issued by the Occupational Safety and Health Administration March 2004, the Centers for Disease Control and Prevention Interim Recommendations for Infection Control in Health-Care Facilities Caring for Patients with Known or Suspected Avian Influenza issued May 21, 2004, and the World Health Organization (WHO) Global Influenza Preparedness Plan issued April 2005.</text></subparagraph>
<subparagraph id="HE3CD16FAFAB04433AFFF8BBFBFD09F92"><enum>(B)</enum><text>Personal protective equipment, in conformance with the requirements of 29 CFR 1910.134 and 29 CFR 1910.132.</text></subparagraph>
<subparagraph id="H79A117E4089B454D9D1FC6777BD14932"><enum>(C)</enum><text>Training and information in conformance with the OSHA Bloodborne Pathogens standard under 29 CFR 1910.1030(g).</text></subparagraph>
<subparagraph id="HD562FAC48A5643FB00359FB869C69827"><enum>(D)</enum><text>Appropriate medical surveillance for workers exposed to the pandemic influenza virus, including the H5N1 virus.</text></subparagraph>
<subparagraph id="HA3F60CE9CBF747ADA186D82EE13C1FBA"><enum>(E)</enum><text>Immunization against the pandemic influenza virus, if such a vaccine has been approved by the Food and Drug Administration and is available.</text></subparagraph></paragraph>
<paragraph id="H7692558F68A74F7D94C18861AAAD7839"><enum>(2)</enum><header>Effective date</header><text>The emergency standard issued under paragraph (1) shall take effect not later than 90 days after the promulgation of such standard, except that the effective date for any requirements for engineering controls shall go into effect not later than 90 days after the promulgation of the final permanent standard. The provisions of the emergency temporary standard shall remain in effect until the final permanent standard is in effect.</text></paragraph> </subsection>
<subsection id="HAEDB1931F684400B8FAB6A51400C2F2"><enum>(c)</enum><header>Pandemic influenza preparedness plan revisions</header>
<paragraph id="H1FAFE293F0B34A10B233D227C10094EA"><enum>(1)</enum><header>Minimal requirements</header><text>Within 30 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise the provisions of the pandemic influenza plan of the Department of Health and Human Services to conform with the minimal worker protection requirements set forth in subsection (b).</text></paragraph>
<paragraph id="H9D2669A0049E489EB2CE0029FD311CCA"><enum>(2)</enum><header>Final standard</header><text>Within 30 days of the promulgation of a final standard under subsection (b), the Secretary of Health and Human Services shall modify the pandemic influenza plan of the Department of Health and Human Services to conform with the provisions of the occupational safety and health standard issued by the Secretary of Labor.</text></paragraph></subsection></section>
<section id="HF1A8E6B90DA145FF9D58272FFC97E190"><enum>202.</enum><header>Relation to States and political subdivisions receiving funds under title I</header><text display-inline="no-display-inline">An award of a grant, cooperative agreement, or contract may not be made to any State or political subdivision of a State under any program receiving funds under title I or any program amended by such title unless the State or political subdivision agrees to comply with the standards issued under section 201 for protecting health care workers and first responders from pandemic influenza.</text></section>
<enum>III</enum><header>International assistance to combat the avian influenza virus</header>
<section id="H9319AE5739F24E00AB8730A55CD459DE" commented="no"><enum>301.</enum><header>Findings</header><text display-inline="no-display-inline">Congress makes the following findings:</text>
<paragraph id="H6C61CFECEDCC4B1F956DE2AE92B29E73" commented="no"><enum>(1)</enum><text display-inline="yes-display-inline">The H5N1 strain of the avian influenza virus is now endemic in parts of Southeast Asia, where Cambodia, Indonesia, Laos, and Thailand are the worst-affected countries. </text></paragraph>
<paragraph id="H91446192937C41DF9873AAD01193A5EB" commented="no"><enum>(2)</enum><text>More than 150 million birds, mostly chickens, have died or been culled as a result of the avian influenza virus and losses to the farmers are estimated to be in excess of $10,000,000,000. Sixty-three out of 124 humans who have been infected with the virus have died since December 2003. </text></paragraph>
<paragraph id="H1E68C12A578B45658039090059350039" commented="no"><enum>(3)</enum><text>Despite control measures, the avian influenza virus continues to spread and raise serious public health concerns at the global level.</text></paragraph>
<paragraph id="H8C4D741B659047F4A000CFEE585BD732" commented="no"><enum>(4)</enum><text>Farmers have faced economic hardships as a result of the avian influenza virus as they have had to sacrifice their infected flocks for slaughter, as well as dealing with consumer anxiety about the safety of eating chickens or eggs. </text></paragraph>
<paragraph id="H81B366ED7A3143E194BF18D65EF5318" commented="no"><enum>(5)</enum><text>The major world animal and human health organizations, such as the World Health Organization (WHO) and the Food and Agricultural Organization (FAO), have developed a global strategy and regional and country-specific plans to minimize the global threat of the avian influenza virus to humans and to domestic poultry and other animal populations through the control and gradual eradication of the virus.</text></paragraph>
<paragraph id="H5DEB0240E3E541E6A45411CD1DF795D" commented="no"><enum>(6)</enum><text>Experts are concerned about the spread of the avian influenza virus to countries with a high prevalence of HIV/AIDS, particularly countries of sub-Saharan Africa, as it will be difficult to single out the symptoms of the avian influenza virus in people living with HIV/AIDS. The avian influenza virus is already prevalent in Asia which is home to the second largest number of people living with HIV/AIDS in the world.</text></paragraph>
<paragraph id="H9DE393043BFF4832A08DAE5800A2548F" commented="no"><enum>(7)</enum><text>Scientists warn that the avian influenza virus could easily mutate into a more easily transferable form, which might trigger an international human pandemic influenza. </text></paragraph>
<paragraph id="HA69A881A7791466285A95D275563C54F" commented="no"><enum>(8)</enum><text>In the Emergency Supplemental Appropriations Act for Defense, the Global War on Terror, and Tsunami Relief, 2005 (<external-xref legal-doc="public-law" parsable-cite="pl/109/13">Public Law 109–13</external-xref>), Congress approved $25,000,000 in emergency funding for a coordinated international program to prevent and control the spread of the avian influenza virus.</text></paragraph>
<paragraph id="H4230B8E718D9435DADDF71167D5B7DB5" commented="no"><enum>(9)</enum><text>In September 2005, the Government of the United States announced the International Partnership on Avian and Pandemic Influenza, the aim of which is to combat the threat of the avian influenza virus and improve global readiness by elevating the issue on national agendas, coordinating efforts among donor and affected nations, mobilizing and leveraging resources, increasing transparency and the quality of surveillance, and building local capacity to identify, contain, and respond to the virus.</text></paragraph>
<paragraph id="H640EBCA781D640A891C19C4C6C053518" commented="no"><enum>(10)</enum><text>The World Bank, comprised of the International Bank for Reconstruction and Development (IBRD) and the International Development Association (IDA), determined that the financial needs of countries affected by the avian influenza virus will potentially reach $1,000,000,000 over the next three years. This figure does not include, however, financing for human or animal vaccine development, anti-viral medicines, or compensating farmers for loss of income due to animals that have been culled, all of which could potentially double the financial needs of the affected countries to combat the virus.</text></paragraph>
<paragraph id="HCC8D188B77C5467F88A49E02B018514F" commented="no"><enum>(11)</enum><text>On November 1, 2005, the Administration requested $251,000,000 to detect and contain outbreaks of avian influenza virus before the outbreaks spread around the world.</text></paragraph>
<paragraph id="H5CD60A3ECCAE4BF78567EF415C5245C" commented="no"><enum>(12)</enum><text>On November 7, 2005, the World Health Organization, the Food and Agricultural Organization, the World Organization for Animal Health, and the World Bank convened a meeting on the avian influenza virus and human pandemic influenza and set out key action steps to respond to the threat of the avian influenza virus. </text></paragraph>
<paragraph id="H9BBC3CE2111E48B194DF6F52D07F00E6" commented="no"><enum>(13)</enum><text>At this meeting, member states of these organizations agreed to improve surveillance of the avian influenza virus, support and train for rapid containment of the virus, assist countries in controlling the virus in animal populations, improve preparedness for human pandemic influenza, develop integrated national plans, and support factual and transparent communications, including risk communications. The participants also agreed on the urgent need for financing of these activities.</text></paragraph></section>
<section id="HA4DBC278628D4D038050B11C35A9A925"><enum>302.</enum><header>Bilateral assistance</header>
<subsection id="H8292345FFB8249D1AAF6EFF0483B60C4"><enum>(a)</enum><header>Authorization</header><text display-inline="yes-display-inline">The Secretary of State, in consultation and coordination with the Administrator of the United States Agency for International Development and the heads of other relevant departments and agencies of the Government of the United States, is authorized to provide assistance, on such terms and conditions as the Secretary may determine, to foreign countries to combat the avian influenza virus. The Secretary may provide assistance under this section notwithstanding any provision of law that restricts assistance to foreign countries.</text></subsection>
<subsection id="HC55C4D38160744ECA2C957F1300BFD5"><enum>(b)</enum><header>Activities supported</header><text display-inline="yes-display-inline">Assistance provided under subsection (a) shall, to the maximum extent practicable, be used to—</text>
<paragraph id="HBD2B98A8910D4685839499040056727C"><enum>(1)</enum><text display-inline="yes-display-inline">develop national and regional early warning systems for outbreaks and incidence of the avian influenza virus; </text></paragraph>
<paragraph id="H3758634055AC4AB7BC87C6F8907EFEE6"><enum>(2)</enum><text display-inline="yes-display-inline">improve institutional capacity in the health sector to respond to outbreaks of the avian influenza virus, including strengthening animal and human disease surveillance, monitoring, and laboratory diagnosis, training and equipping rapid response teams, and encouraging national and local governments to provide incentives for reporting of possible animal or human cases of the avian influenza virus;</text></paragraph>
<paragraph id="H6CD706751673413B9098FF2FF36F31E4"><enum>(3)</enum><text>strengthen veterinary systems and expand culling programs for animals;</text></paragraph>
<paragraph id="HD3AF25DF3D914A5C9E593100E0006DFA"><enum>(4)</enum><text>assist national and local governments in rapid containment of outbreaks of the avian influenza virus in animals in conjunction with international and regional organizations;</text></paragraph>
<paragraph id="H22D00CD0EEAF4F8EB204DB9BFA3E0717"><enum>(5)</enum><text>assist in the development of national and regional animal and human health preparedness plans;</text></paragraph>
<paragraph id="H53187D0073A344EEBF043DE1F997FB00"><enum>(6)</enum><text>implement public information and communication plans in animal husbandry and public recognition of human pandemic influenza;</text></paragraph>
<paragraph id="HB36C54745E484B969FC3100B868223D"><enum>(7)</enum><text>support the health component of United States embassies and missions; </text></paragraph>
<paragraph id="H304D57D758D246F8A79700097778A75E"><enum>(8)</enum><text>develop and support evacuation contingency plans in countries in which human pandemic influenza has been detected;</text></paragraph>
<paragraph id="H0AB275687B314E96BEEE86679BE91CA2"><enum>(9)</enum><text>assist national and local governments in providing compensation to farmers for culling of animals and incentives for reporting cases of the avian influenza virus; </text></paragraph>
<paragraph id="HCB49D4D2683047629F95ECD10006A6D4"><enum>(10)</enum><text>expand emergency anti-viral stockpiles for the avian influenza virus; </text></paragraph>
<paragraph id="HB3774B700BDC473A8FC509742365D0C7"><enum>(11)</enum><text>strengthen educational and cultural exchanges for doctors, nurses, health administrators, and other health officials to improve institutional knowledge for combating the avian influenza virus and other infectious diseases; </text></paragraph>
<paragraph id="H4861167E0BD24F398346003085332DD5"><enum>(12)</enum><text>leverage private sector resources to provide incentives to farmers to report outbreaks of the avian influenza virus and to national and local governments for control efforts; and</text></paragraph>
<paragraph id="HB77C145F016740859F110700DD20B23D"><enum>(13)</enum><text>support the role of civil society, nongovernmental organizations, and other community groups in the development of public information campaigns with respect to the avian influenza virus.</text></paragraph></subsection></section>
<section id="H2467FBDF7C774F97A84DEBF337EFE454"><enum>303.</enum><header>Multilateral assistance</header>
<subsection id="HFB7987D79C50496298FE61101CE64179"><enum>(a)</enum><header>Authorization</header>
<paragraph id="HF4AB201F05BD4ACC83D98DFF075647A1"><enum>(1)</enum><header>In general</header><text>The Secretary of State is authorized to provide assistance to combat the avian influenza virus by making voluntary contributions to the World Health Organization, the Food and Agricultural Organization, the World Organization for Animal Health, and other appropriate international and regional organizations. The Secretary may make voluntary contributions under this section notwithstanding any provision of law that restricts voluntary contributions to international organizations.</text></paragraph>
<paragraph id="H68D404E0825B4550ABD55CF11B9D293D"><enum>(2)</enum><header>Limitation</header><text>The amount of United States voluntary contributions under paragraph (1) to an organization specified in such paragraph for a calendar year may not exceed 33 percent of the total amount of voluntary contributions by all countries to the organization for the calendar year. </text></paragraph></subsection>
<subsection id="H9D04B5BCF8E542CEB3D7EEA44907859B"><enum>(b)</enum><header>Activities supported</header><text>Assistance provided under subsection (a) shall, to the maximum extent practicable, be used to—</text>
<paragraph id="HB86C6F537551459CBDD57852B085A18"><enum>(1)</enum><text>support the programs and activities of the Senior United Nations System Coordinator for Avian and Human Influenza; </text></paragraph>
<paragraph id="H3D27C6E14595485B97485805FF78E100"><enum>(2)</enum><text>support the programs and activities of the World Health Organization to—</text>
<subparagraph id="H63C9E8313C5C4891BB6D9E38C210D677"><enum>(A)</enum><text>provide direct support to foreign government health agencies to provide human surveillance, increase response capacity, and strengthen veterinary systems with respect to the avian influenza virus;</text></subparagraph>
<subparagraph id="H2613E4CB28804E008143B4CBBF378CE1"><enum>(B)</enum><text display-inline="yes-display-inline">improve country level and regional planning and coordination with respect to the avian influenza virus; and</text></subparagraph>
<subparagraph id="H7A85093EDC854A148EE700AF36148C63"><enum>(C)</enum><text>develop standard operating procedures for rapid deployment of anti-viral stockpiles to achieve early containment of the avian influenza virus; </text></subparagraph></paragraph>
<paragraph id="HDABC06DF9A704051AFA8023D24770014"><enum>(3)</enum><text>support the programs and activities of the Food and Agricultural Organization to—</text>
<subparagraph id="HE17B2D75670D480F9E6B1590ACC498DB"><enum>(A)</enum><text>improve diagnostics infrastructure and operations for animal health; and</text></subparagraph>
<subparagraph id="H9AD6327731504C0D9D782F5FCB3306D"><enum>(B)</enum><text>provide direct support to foreign government agriculture agencies for animal health planning and commodities; and </text></subparagraph></paragraph>
<paragraph id="HB10E541D581649AF8954DDC4D3D2DA89"><enum>(4)</enum><text display-inline="yes-display-inline">support the programs and activities of other appropriate international organizations with respect to the avian influenza virus.</text></paragraph></subsection></section>
<section id="H7BA572A6EE5C4CE28DF8A3C4900D4A" commented="no"><enum>304.</enum><header>Establishment of multi-donor trust fund</header>
<subsection id="H49EB588328D0449FB11E4BFBB0902F53" commented="no"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The Secretary of the Treasury shall instruct the United States Executive Director at the International Bank for Reconstruction and Development to use the voice and vote of the United States to promote the establishment of a multi-donor trust fund to be administered by the International Bank for Reconstruction and Development with the specific aim of supporting country-level activities to combat the avian influenza virus.</text></subsection>
<subsection id="HF62AFAE7DB4843278882CBC67492375D"><enum>(b)</enum><header>Contribution authority</header><text>The Secretary of the Treasury may make contributions on behalf of the United States to a fund established and administered as described in subsection (a).</text></subsection>
<subsection id="H37117F50C7B049E38CA436BD5563D63C" commented="no"><enum>(c)</enum><header>Funding</header><text display-inline="yes-display-inline">The amounts appropriated under section 310 shall be available for contributions under subsection (b).</text></subsection></section>
<section id="H3561B01703B24A46BEF41910701B8D00" display-inline="no-display-inline"><enum>305.</enum><header>Coordinator of United States assistance to combat the avian influenza virus</header>
<subsection id="HBCABEB7884F54B3D878B9CDC75274ECF"><enum>(a)</enum><header>Designation</header><text display-inline="yes-display-inline">The Secretary of State shall designate a coordinator of United States assistance to combat the avian influenza virus (hereafter in this section referred to as the <quote>coordinator</quote>).</text></subsection>
<subsection id="HB97094CB15A247078200DE5E71124830"><enum>(b)</enum><header>Duties</header><text>The coordinator shall—</text>
<paragraph id="H6C228FBC7AF94DAF808418638F6D38EA"><enum>(1)</enum><text display-inline="yes-display-inline">ensure policy and program coordination among the relevant departments and agencies of the Government of the United States of the provision of assistance to combat the avian influenza virus in foreign countries at both the department and agency level and the field operations level, including by resolving policy and program disputes among such departments and agencies with respect to the provision of such assistance; </text></paragraph>
<paragraph id="H75052E4C2FAD48CC8578E597428FEFBB"><enum>(2)</enum><text display-inline="yes-display-inline">ensure proper administration and oversight by the relevant departments and agencies of the Government of the United States of the provision of assistance to combat the avian influenza virus in foreign countries in accordance with the country strategies developed pursuant to section 306; </text></paragraph>
<paragraph id="H04544BD9A52947D7A700EACF7D11B9E8"><enum>(3)</enum><text display-inline="yes-display-inline">ensure the provision of United States assistance to combat the avian influenza virus in foreign countries is coordinated with the early warning system established under section 307;</text></paragraph>
<paragraph id="HD7EF547C1A7F4686BBBF24FD715FD1AF"><enum>(4)</enum><text display-inline="yes-display-inline">ensure the coordination of the provision of United States assistance to combat the avian influenza virus in foreign countries with the provision of related assistance of other countries and international and regional organizations, including the United Nations and international financial institutions; and</text></paragraph>
<paragraph id="H2E60C6EE7F0A4D9C81B70056465E0011"><enum>(5)</enum><text display-inline="yes-display-inline">liaise with United States ambassadors and country teams to ensure coordination and coherence at the field operations level in the provision of United States assistance to combat the avian influenza virus in foreign countries.</text></paragraph></subsection>
<subsection id="H8F028F0E4B354B3EA87035C192D0EA35"><enum>(c)</enum><header>Rank and status of coordinator</header><text display-inline="yes-display-inline">The coordinator designated under subsection (a) shall have the rank and status of ambassador.</text></subsection></section>
<section id="H49878335F251409E9093E29B6851B6EF" display-inline="no-display-inline"><enum>306.</enum><header>Designation of high risk foreign countries and development of country strategies</header>
<subsection id="HBF2E6173191C4FB1A900349F7E515EF"><enum>(a)</enum><header>Designation of countries and development of country strategies</header><text display-inline="yes-display-inline">The Secretary of State, acting through the coordinator, and in consultation with the Administrator of the United States Agency for International Development and the heads of other relevant departments and agencies of the Government of the United States, shall—</text>
<paragraph id="HB1A16C52576E4552AC27F23BF5008DF"><enum>(1)</enum><text display-inline="yes-display-inline">designate foreign countries that are at high risk for outbreaks of the avian influenza virus based on data from the relevant departments and agencies of the Government of the United States, the World Health Organization, the Food and Agricultural Organization, and other relevant international and regional organizations, and civil society organizations; and</text></paragraph>
<paragraph id="H997FA504EDF241CCB7D20A22780EE59"><enum>(2)</enum><text display-inline="yes-display-inline">develop country strategies to prevent, mitigate, and respond to outbreaks of the avian influenza virus in foreign countries designated pursuant to paragraph (1).</text></paragraph></subsection>
<subsection id="H434B0DBCBA74433FB31C6FB748189FB9"><enum>(b)</enum><header>Content of country strategies</header><text display-inline="yes-display-inline">Each country strategy developed pursuant to subsection (a)(2) shall include—</text>
<paragraph id="HE012F70EF65E4596904F996CE9DF9503"><enum>(1)</enum><text>an analysis of the types and amount of assistance that are needed by the country from—</text>
<subparagraph id="HCC5E4F13976F46C888CF00610055B968"><enum>(A)</enum><text>the Government of the United States; and </text></subparagraph>
<subparagraph id="HFDB0B489FBF84C64AAA0E31EA9796FDD"><enum>(B)</enum><text>international organizations, international financial institutions, and donor countries; and </text></subparagraph></paragraph>
<paragraph id="H062BAC45033F49D5B057DFA0FE483FFD"><enum>(2)</enum><text display-inline="yes-display-inline">a specific action plan, to be developed in consultation with the government of the country, international organizations, and other appropriate entities, to prevent, mitigate, and respond to outbreaks of the avian influenza virus in the country.</text></paragraph></subsection></section>
<section id="H528B082B421D4DBFA2AC5CC11D0418AA" display-inline="no-display-inline"><enum>307.</enum><header>United States avian influenza virus early warning system</header>
<subsection id="HD14B75A4CD38498080528BEA918D67BE"><enum>(a)</enum><header>Establishment</header><text display-inline="yes-display-inline">The Administrator of the United States Agency for International Development, in consultation with the Secretary of Health and Human Services and the heads of other relevant departments and agencies of the Government of the United States, shall establish an early warning system to prevent, mitigate, and respond to outbreaks of the avian influenza virus in foreign countries.</text></subsection>
<subsection id="H5B5D09CA7F62473983CDE57FA2E5FAB6"><enum>(b)</enum><header>Components</header><text>The early warning system established pursuant to subsection (a) shall consist of—</text>
<paragraph id="H4E86CC46A6E947FBAF6FD7A2007D6249"><enum>(1)</enum><text>a database of information relating to the occurrence of outbreaks of the avian influenza virus in foreign countries;</text></paragraph>
<paragraph id="H00884CD859F04F8891BA00737951981C"><enum>(2)</enum><text display-inline="yes-display-inline">a list, to be updated regularly, of foreign countries in which there is low to moderate risk of outbreaks of the avian influenza virus in order to enhance the preparedness of the Government of the United States to prevent, mitigate, and respond to such outbreaks; and </text></paragraph>
<paragraph id="H51E430FCDB3641C78007014989BEE516"><enum>(3)</enum><text>an analysis of the response capacity of the national government of countries with a low to moderate risk of outbreaks of the avian influenza virus and steps that are being taken by local, national, and international governmental and nongovernmental organizations to prevent, mitigate, and respond to such outbreaks.</text></paragraph></subsection>
<subsection id="H4FB195097B8F49E9957F2E00D7EFBEC8"><enum>(c)</enum><header>Report</header><text display-inline="yes-display-inline">The Administrator of the United States Agency for International Development shall submit to the relevant departments and agencies of the Government of the United States and to United States embassies and consular posts a monthly report that contains the list developed pursuant to subsection (b)(2).</text></subsection></section>
<section id="HC19E0F995DF04D29A72731F6AA297BD1"><enum>308.</enum><header>Report</header>
<subsection id="H39F1EEFCA94944C6B6DDD262ABC54BCA"><enum>(a)</enum><header>Report</header><text>Not later than 180 days after the date of the enactment of this Act, and annually thereafter until 2008, the Secretary of State shall transmit to the appropriate congressional committees a report on the implementation of this title. </text></subsection>
<subsection id="H19248AEB659D4367A6CEF450CE3E3595"><enum>(b)</enum><header>Contents</header><text>The report required by subsection (a) shall include—</text>
<paragraph id="HD8223888E6CC4B3695039BBD7035A300"><enum>(1)</enum><text display-inline="yes-display-inline">the name of each recipient of assistance under sections 302 and 303, the amount of assistance provided to the recipient, a description of the purpose for which the assistance was provided, and the results of the assistance, if available;</text></paragraph>
<paragraph id="HA18FC5E3711644AAB527F4A74B391B39" commented="no"><enum>(2)</enum><text>a description of the progress of establishing the multi-donor trust fund described in section 304(a) and the amount of assistance provided to the multi-donor trust fund since its establishment;</text></paragraph>
<paragraph id="H2D7635696B5F403FA500021E40FA36DE"><enum>(3)</enum><text display-inline="yes-display-inline">a description of the specific actions of the coordinator pursuant to section 305(b) to ensure policy and program coordination of the provision of assistance to combat the avian influenza virus, the obstacles in ensuring such coordination, and recommendations to improve such coordination;</text></paragraph>
<paragraph id="HD0CAA973D22C4E37B39F590074B73BB3"><enum>(4)</enum><text display-inline="yes-display-inline">a list of the foreign countries designated pursuant to section 306(a)(1) and summaries of the country strategies required by subsections (a)(2) and (b) of section 306; and </text></paragraph>
<paragraph id="H44979F31372C4C9CBDAF38B36FBB047B"><enum>(5)</enum><text display-inline="yes-display-inline">a description of the progress of establishing an early warning system required by section 307 and, once established, a summary of the list required by section 307(b)(2). </text></paragraph></subsection></section>
<section id="H420D783652934DB0BED867006E73ED00"><enum>309.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph id="HBD82073E67704EFA8512008BBCF3700"><enum>(1)</enum><header>Appropriate congressional committees</header><text>The term <quote>appropriate congressional committees</quote> means—</text>
<subparagraph id="HAA4499E945264D9285BC599BE2E735B"><enum>(A)</enum><text>the Committee on Appropriations, the Committee on Energy and Commerce, and the Committee on International Relations of the House of Representatives; and</text></subparagraph>
<subparagraph id="HA8EB394E6E874F4AAF239946214196A7"><enum>(B)</enum><text>the Committee on Appropriations, the Committee on Foreign Relations, and the Committee on Health, Education, Labor, and Pensions of the Senate.</text></subparagraph></paragraph>
<paragraph id="H24655E15516D41E1BBEED9BCFA8224C"><enum>(2)</enum><header>Avian influenza virus</header><text>The term <quote>avian influenza virus</quote> means an influenza A virus of subtype H5 or H7 that—</text>
<subparagraph id="HE9D78392FB9F4C759CF64B3F9CEABC37"><enum>(A)</enum><text>causes avian influenza; and</text></subparagraph>
<subparagraph id="HBD3CDCB16550477CAD59870097DADA05"><enum>(B)</enum><text>has been determined by the President to pose a threat to the public health.</text></subparagraph></paragraph>
<paragraph id="HD161BB59B24C4823B5B72595CB8421DB"><enum>(3)</enum><header>Coordinator</header><text>The term <quote>coordinator</quote> means the coordinator designated by the Secretary pursuant to section 305(a). </text></paragraph>
<paragraph id="H59F17EF206664E1BB711A4FD684E1D97"><enum>(4)</enum><header>Relevant departments and agencies of the government of the united states</header><text>The term <quote>relevant departments and agencies of the Government of the United States</quote> means—</text>
<subparagraph id="H082A1BA3E462451AAA04DCD9961F8CEB"><enum>(A)</enum><text>the Department of State;</text></subparagraph>
<subparagraph id="H80CAE1C55D784BC9ACD271F10447314"><enum>(B)</enum><text>the United States Agency for International Development;</text></subparagraph>
<subparagraph id="HDA5D9A3F1F364EC683BB1F47BA659E8D"><enum>(C)</enum><text>the Department of Health and Human Services (including its agencies and offices); and</text></subparagraph>
<subparagraph id="HCDC9239D9EC8466DB82D28318B379B28"><enum>(D)</enum><text>any other department or agency of the Government of the United States that participates in international avian influenza virus activities pursuant to the authorities of such department or agency or this Act.</text></subparagraph></paragraph>
<paragraph id="H3A3F47597CA84E4883276365258E8825"><enum>(5)</enum><header>Secretary</header><text>The term <quote>Secretary</quote> means the Secretary of State. </text></paragraph></section>
<section id="H69197368D8EA45DDB750FA31BDF1AF7C"><enum>310.</enum><header>Authorization of appropriations</header>
<subsection id="HC2D070D62A274E5F8329352EED2EB1DC"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">There is authorized to be appropriated to carry out this title $750,000,000 for fiscal year 2007.</text></subsection>
<subsection id="H7155A9B89DA243CC8E5D8671E3F8383C"><enum>(b)</enum><header>Availability</header><text display-inline="yes-display-inline">Amounts appropriated pursuant to the authorization of appropriations under subsection (a) are authorized to remain available until expended.</text></subsection></section>