<enum>I</enum><header>Flu vaccine awareness campaign</header> <section id="H3C083E73F832417A89C62BEC999E4E7F"><enum>101.</enum><header>Awareness campaign and education and outreach efforts</header><text display-inline="no-display-inline">Title XXI of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<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 act-name="Public Health Service Act" id="HBCB7FC37DF5344B1857100440003A3AB" style="traditional"> <subtitle id="H85F0344F4CE84C87A214C985B9A6FCC3"><enum>3</enum><header>Influenza vaccine</header> <section id="H8910B0476BCE479CB2CEBB40AB4E774"><enum>2141.</enum><header>Awareness campaign and education and outreach efforts</header> <subsection commented="no" display-inline="yes-display-inline" id="H97DC4ACE2D754F7590B0293D65437B9B"><enum>(a)</enum><header>Campaign</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention (in this subtitle referred to as the <quote>Director</quote>), shall conduct a public awareness campaign and education and outreach efforts each year during the time period preceding the influenza season on each of the following:</text> <paragraph id="HB47CBC153509470085EE6B36B2FCC340"><enum>(1)</enum><text>The importance of receiving the influenza vaccine.</text></paragraph> <paragraph id="HFD2EC82F91D44E788DC5A7BBA1CB5796"><enum>(2)</enum><text>Which populations the Director recommends to receive the influenza vaccine to prevent health complications associated with influenza, including health care workers and household contacts.</text></paragraph> <paragraph id="H7DBED3F8DA4346298BD640C041C8F398"><enum>(3)</enum><text>Professional medical education of physicians, nurses, pharmacists, and other health care providers and such providers’ associated organizations.</text></paragraph> <paragraph id="HFBFA4CBAE44C445B8048F6E709E7CDE1"><enum>(4)</enum><text>Information that emphasizes the safety and benefit of recommended vaccines for the public good.</text></paragraph></subsection> <subsection id="H9B767A99D9744A7691DBE49DDB6967D8"><enum>(b)</enum><header>Outreach to Medicare recipients</header> <paragraph id="H5A2565C6A131467D95662539DCD2F029"><enum>(1)</enum><header>In general</header><text>The Administrator of the Centers for Medicare & Medicaid Services shall, at the earliest possible time in the influenza vaccine planning and production process, reach out to providers of medicare services, including managed care providers, nursing homes, hospitals, and physician offices to urge early and full preordering of the influenza vaccine so that production levels can accommodate the needs for the influenza vaccine.</text></paragraph> <paragraph id="H9C27BC1A77EC41F40066599B15E29494"><enum>(2)</enum><header>Rates of immunization among Medicare recipients</header><text>The Director shall work with the Administrator of the Centers for Medicare & Medicaid Services to publish the rates of influenza immunization among individuals receiving assistance under the medicare program under title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>).</text></paragraph></subsection> <subsection id="H0E9AAA3386A343FBA3402C0980F1C3B4"><enum>(c)</enum><header>State and public health adult immunization activities</header><text>The Director shall support the development of State adult immunization programs that place emphasis on improving influenza vaccine delivery to high-risk populations and the general population, including the exploration of improving access to the influenza vaccine.</text></subsection> <subsection id="HC204210578674005A05FE259BB00009D"><enum>(d)</enum><header>Efficacy of vaccine</header><text>The Director shall work with appropriate agencies in conducting a study to assess the efficacy of the influenza vaccine.</text></subsection> <subsection id="H6A4972207AAE40C8B9B57CC6C10730DE"><enum>(e)</enum><header>Existing modes of communication</header><text>In carrying out the public awareness campaign and education and outreach efforts under subsections (a) and (b), the Director may use existing websites or structures for communication.</text></subsection> <subsection id="HBE4C23C3308A4AFEAF7F52F5E7E9DC1"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2005 through 2009.</text></subsection></section></subtitle><after-quoted-block>.</after-quoted-block></quoted-block></section>

109 HR 628 IH: Flu Protection Act of 2005 U.S. House of Representatives 2005-02-08 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.

109th CONGRESS 1st Session

H. R. 628

IN THE HOUSE OF REPRESENTATIVES

February 8, 2005

Mr. Emanuel (for himself, Mr. Snyder, Mr. Reyes, Mr. Abercrombie, Mr. Gutierrez, Mr. Hinchey, Mrs. Maloney, Mr. Payne, Ms. Woolsey, Mr. Berry, Mr. Kennedy of Rhode Island, Mr. Engel, and Ms. DeLauro) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

To amend the Public Health Service Act to provide for an influenza vaccine awareness campaign, ensure a sufficient influenza vaccine supply, and prepare for an influenza pandemic or epidemic, to amend the Internal Revenue Code of 1986 to encourage vaccine production capacity, and for other purposes.

Short title

This Act may be cited as the

Flu Protection Act of 2005

<enum>I</enum><header>Flu vaccine awareness campaign</header> <section id="H3C083E73F832417A89C62BEC999E4E7F"><enum>101.</enum><header>Awareness campaign and education and outreach efforts</header><text display-inline="no-display-inline">Title XXI of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<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 act-name="Public Health Service Act" id="HBCB7FC37DF5344B1857100440003A3AB" style="traditional"> <subtitle id="H85F0344F4CE84C87A214C985B9A6FCC3"><enum>3</enum><header>Influenza vaccine</header> <section id="H8910B0476BCE479CB2CEBB40AB4E774"><enum>2141.</enum><header>Awareness campaign and education and outreach efforts</header> <subsection commented="no" display-inline="yes-display-inline" id="H97DC4ACE2D754F7590B0293D65437B9B"><enum>(a)</enum><header>Campaign</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention (in this subtitle referred to as the <quote>Director</quote>), shall conduct a public awareness campaign and education and outreach efforts each year during the time period preceding the influenza season on each of the following:</text> <paragraph id="HB47CBC153509470085EE6B36B2FCC340"><enum>(1)</enum><text>The importance of receiving the influenza vaccine.</text></paragraph> <paragraph id="HFD2EC82F91D44E788DC5A7BBA1CB5796"><enum>(2)</enum><text>Which populations the Director recommends to receive the influenza vaccine to prevent health complications associated with influenza, including health care workers and household contacts.</text></paragraph> <paragraph id="H7DBED3F8DA4346298BD640C041C8F398"><enum>(3)</enum><text>Professional medical education of physicians, nurses, pharmacists, and other health care providers and such providers’ associated organizations.</text></paragraph> <paragraph id="HFBFA4CBAE44C445B8048F6E709E7CDE1"><enum>(4)</enum><text>Information that emphasizes the safety and benefit of recommended vaccines for the public good.</text></paragraph></subsection> <subsection id="H9B767A99D9744A7691DBE49DDB6967D8"><enum>(b)</enum><header>Outreach to Medicare recipients</header> <paragraph id="H5A2565C6A131467D95662539DCD2F029"><enum>(1)</enum><header>In general</header><text>The Administrator of the Centers for Medicare & Medicaid Services shall, at the earliest possible time in the influenza vaccine planning and production process, reach out to providers of medicare services, including managed care providers, nursing homes, hospitals, and physician offices to urge early and full preordering of the influenza vaccine so that production levels can accommodate the needs for the influenza vaccine.</text></paragraph> <paragraph id="H9C27BC1A77EC41F40066599B15E29494"><enum>(2)</enum><header>Rates of immunization among Medicare recipients</header><text>The Director shall work with the Administrator of the Centers for Medicare & Medicaid Services to publish the rates of influenza immunization among individuals receiving assistance under the medicare program under title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>).</text></paragraph></subsection> <subsection id="H0E9AAA3386A343FBA3402C0980F1C3B4"><enum>(c)</enum><header>State and public health adult immunization activities</header><text>The Director shall support the development of State adult immunization programs that place emphasis on improving influenza vaccine delivery to high-risk populations and the general population, including the exploration of improving access to the influenza vaccine.</text></subsection> <subsection id="HC204210578674005A05FE259BB00009D"><enum>(d)</enum><header>Efficacy of vaccine</header><text>The Director shall work with appropriate agencies in conducting a study to assess the efficacy of the influenza vaccine.</text></subsection> <subsection id="H6A4972207AAE40C8B9B57CC6C10730DE"><enum>(e)</enum><header>Existing modes of communication</header><text>In carrying out the public awareness campaign and education and outreach efforts under subsections (a) and (b), the Director may use existing websites or structures for communication.</text></subsection> <subsection id="HBE4C23C3308A4AFEAF7F52F5E7E9DC1"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $10,000,000 for each of fiscal years 2005 through 2009.</text></subsection></section></subtitle><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>II</enum><header>Encouraging vaccine production capacity</header> <section id="HA46FE25C830D4F8D8D92E87300F10140"><enum>201.</enum><header>Incentives for the construction of vaccine manufacturing facilities</header> <subsection id="H061C22C2DE15457A8E5900137397314D"><enum>(a)</enum><header>Vaccine manufacturing facilities investment tax credit</header> <paragraph id="HD38040C8891B41C99ED120003C6B4375"><enum>(1)</enum><header>Allowance of credit</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/46">Section 46</external-xref> of the Internal Revenue Code of 1986 (relating to amount of investment credit) is amended by striking <quote>and</quote> at the end of paragraph (1), by striking the period at the end of paragraph (2) and inserting <quote>, and</quote>, and by adding at the end the following new paragraph:</text> <quoted-block id="H69C916F43B064CFF9E30986196F20095"> <paragraph id="HA28E797B8DD944D5867B95425F80F986"><enum>(3)</enum><text>the vaccine manufacturing facilities investment credit.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="H1E32B7911C6F40FC81C394445B4002E"><enum>(2)</enum><header>Amount of credit</header><text>Subpart E of part IV of subchapter A of chapter 1 of such Code (relating to rules for computing investment credit) is amended by inserting after section 48 the following new section:</text> <quoted-block id="H158C2BD2E9B94C99B62402D3D399D429"> <section id="H977785751EFF490AA8F5DFFA7301C375"><enum>48A.</enum><header>Vaccine manufacturing facilities credit</header> <subsection id="H330F1D7E9F114FEE8CAEA0CAE927D71C"><enum>(a)</enum><header>In general</header><text>For purposes of section 46, the vaccine manufacturing facilities investment credit for any taxable year is an amount equal to 20 percent of the qualified investment for such taxable year.</text></subsection> <subsection id="H3700D8A719CD44EAA1A2101E328075B"><enum>(b)</enum><header>Qualified investment</header> <paragraph id="H512A525849A84A938400D4E01EF64981"><enum>(1)</enum><header>In general</header><text>For purposes of subsection (a), the qualified investment for any taxable year is the basis of each vaccine manufacturing facilities property placed in service by the taxpayer during such taxable year.</text></paragraph> <paragraph id="H66B851637ED54EA4B1AA5695EFCA8094"><enum>(2)</enum><header>Vaccine manufacturing facilities property</header><text>For purposes of this section, the term <term>vaccine manufacturing facilities property</term> means real and tangible personal property—</text> <subparagraph id="H0A3D8470CCB143E386A0AB79F677A47B"><enum>(A)</enum> <clause commented="no" display-inline="yes-display-inline" id="HD7D25557C6CB4061A18DD8A26B950921"><enum>(i)</enum><text>the original use of which commences with the taxpayer, or</text></clause> <clause id="H10C39559D9764408BCD0943800E34054" indent="up1"><enum>(ii)</enum><text>which is acquired through purchase (as defined by section 179(d)(2)),</text></clause></subparagraph> <subparagraph id="H5ED4EF08C9474D33A11EC9543CA66527"><enum>(B)</enum><text>which is depreciable under section 167,</text></subparagraph> <subparagraph id="H18CD8BF1FC334E608897C4CB82813565"><enum>(C)</enum><text>which is used for the manufacture, distribution, or research and development of vaccines, and</text></subparagraph> <subparagraph id="H76AFAEB553EF4AB38D25F191A3085345"><enum>(D)</enum><text>which is in compliance with any standards and regulations which are promulgated by the Food and Drug Administration, the Occupational Safety and Health Administration, or the Environmental Protection Agency and which are applicable to such property.</text></subparagraph></paragraph></subsection> <subsection id="H4D22824948D64692ACF627D8FDBD1FE9"><enum>(c)</enum><header>Certain progress expenditure rules made applicable</header><text>Rules similar to rules of subsections (c)(4) and (d) of section 46 (as in effect on the day before the date of the enactment of the Revenue Reconciliation Act of 1990) shall apply for purposes of this subsection.</text></subsection> <subsection id="H879A99BC20314BF5AABF91C24E498852"><enum>(d)</enum><header>Termination</header><text>This subsection shall not apply to any property placed in service after December 31, 2009.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H50BFA24A4CF149E59467C9A6041B32B3"><enum>(b)</enum><header>Technical amendments</header> <paragraph id="HF0112246F5584511BF6FD3D220C631EB"><enum>(1)</enum><text>Clause (iii) of section 49(a)(1)(C) of such Code is amended to read as follows:</text> <quoted-block id="HA4A70B6E885840D1B59CF4382C11E1EE"> <clause id="H9CB172FDD8474AE98E005C5BD680533D"><enum>(iii)</enum><text>the basis of any vaccine manufacturing facilities property.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph> <paragraph id="HF21962D1232C49679B52CD55C5227E12"><enum>(2)</enum><text>Subparagraph (E) of section 50(a)(2) of such Code is amended by inserting <quote>or 48A(c)</quote> before the period.</text></paragraph> <paragraph id="H67D46C1883C64D5AB7B9F5D227EAE09B"><enum>(3)</enum><text display-inline="yes-display-inline">The table of sections for subpart E of part IV of subchapter A of chapter 1 of such Code is amended by inserting after the item relating to section 48 the following:</text> <quoted-block style="OLC" id="H8C6817DE2CB74ADAA183209088007E72" display-inline="no-display-inline"> <toc regeneration="no-regeneration"> <toc-entry level="section">Sec. 48A. Vaccine manufacturing facilities credit</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection> <subsection id="H6BE236FB9E4D446BA72282D2D364559B"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to property placed in service after December 31, 2004, under rules similar to the rules of <external-xref legal-doc="usc" parsable-cite="usc/26/48">section 48(m)</external-xref> of the Internal Revenue Code of 1986 (as in effect on the day before the date of enactment of the Revenue Reconciliation Act of 1990).</text></subsection></section> <enum>III</enum><header>Ensuring sufficient flu vaccine supply</header> <section id="H6604CCECA95F42F489C328C823FB5075"><enum>301.</enum><header>Vaccine supply</header><text display-inline="no-display-inline">Subtitle 3 of title XXI of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>, as added by section 101, is amended by adding at the end the following:</text> <quoted-block act-name="Public Health Service Act" id="H6008F3C474F84AE9B99D145B224DD168" style="traditional"> <section id="HB34FD52878DD455BA1E97069E5A22DF4"><enum>2142.</enum><header>Vaccine supply</header> <subsection commented="no" display-inline="yes-display-inline" id="HA41ABC349A4D4603849424906C541580"><enum>(a)</enum><header>Requests for more doses</header> <paragraph id="H53D0D4683567427CB65E9D7134140000"><enum>(1)</enum><header>In general</header><text>Not later than March 15 of each year, the Director shall enter into contracts with manufacturers to produce such additional doses of the influenza vaccine as determined necessary by the Director.</text></paragraph> <paragraph id="H5D9D80AB056C4D3985A861E0F4CEA73"><enum>(2)</enum><header>Content of contract</header><text>A contract for additional doses shall provide that the manufacturer will be compensated by the Director at an equitable rate negotiated by the Director and the manufacturer for any doses that—</text> <subparagraph id="HD7D5F13E746B4B50925205E608E661AB"><enum>(A)</enum><text>were not sold by the manufacturer through routine market mechanisms at the end of the influenza season for that year; and</text></subparagraph> <subparagraph id="HEE4FA3F503FE490CB900734EB5B20000"><enum>(B)</enum><text>were requested by the Director to be produced by such manufacturer.</text></subparagraph></paragraph> <paragraph id="H3BC34E53F3B7405892C91E00CF301DE6"><enum>(3)</enum><header>When such vaccine purchases should take place</header><text>The Director may purchase from the manufacturer the doses for which it has contracted at any time after which it is determined by the Director, in consultation with the manufacturer, that the doses will likely not be absorbed by the private market.</text></paragraph></subsection> <subsection id="H6A03E4662B9343E5A703BDA68CE46816"><enum>(b)</enum><header>Contingency plan</header><text>The Director shall encourage States to develop a contingency plan, in coordination with the Department of Health and Human Services, for maximizing influenza immunization for high-risk populations in the event of a delay or shortage of the influenza vaccine.</text></subsection> <subsection id="HD178942A16204EFE8BBE20B126C3DD7"><enum>(c)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section such sums as may be necessary.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>IV</enum><header>Preparing for a pandemic or epidemic</header> <section id="H476130188FB2424FAB9E336FDF50BCB1"><enum>401.</enum><header>Preparation for influenza pandemic or epidemic</header><text display-inline="no-display-inline">Subtitle 3 of title XXI of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>, as added by section 101 and amended by section 301, is further amended by adding at the end the following:</text> <quoted-block act-name="Public Health Service Act" id="H0022CA002C744D8DAB1CC94F26816700" style="traditional"> <section id="H535EA624F2AF495A85D36B83662F86B5"><enum>2143.</enum><header>Preparation for influenza pandemic or epidemic</header> <subsection commented="no" display-inline="yes-display-inline" id="HC5A989F71FE547ECBF3CD7AE796E6845"><enum>(a)</enum><header>Establishment of a protocol</header><text>The Secretary, acting through the Director, shall continue progress on the pandemic preparedness plan and establish a protocol to attempt to prevent, prepare for, and respond to an influenza pandemic or epidemic. Such protocol shall be updated as determined appropriate by the Director.</text></subsection> <subsection id="H32D38118886C4AA18CE32B84F9FED828"><enum>(b)</enum><header>Contents of protocol</header><text>The protocol established under subsection (a) shall—</text> <paragraph id="H159EB3CCE4434DCE8E889814E8194F85"><enum>(1)</enum><text>address methods to coordinate dissemination of the influenza vaccine to key populations in the event of an influenza pandemic or epidemic;</text></paragraph> <paragraph id="HD0406F5BC8484689A9ACCCDA814EA240"><enum>(2)</enum><text>address expansion of influenza vaccine manufacturing capacity (including making advance arrangements for ensuring the availability of raw materials) to respond to the needs of the United States during an influenza pandemic or epidemic;</text></paragraph> <paragraph id="HA4B2DA4F71A443149F911944628148B1"><enum>(3)</enum><text>improve upon the current influenza vaccines and production and dissemination methods;</text></paragraph> <paragraph id="H9A13C945DFB14224A535F6356BB28DDB"><enum>(4)</enum><text>address alternative ways to manufacture or produce the influenza vaccine;</text></paragraph> <paragraph id="HF91708B71F3A47B581A3C45C8762013D"><enum>(5)</enum><text>address alternative methods to prevent the spread of, and complications associated with, influenza, including antiviral medications;</text></paragraph> <paragraph id="H38792375521E4F5C8512CFFE22E207EC"><enum>(6)</enum><text>address a tracking method for publicly and privately sold doses of the influenza vaccine to enable the Director to determine, after consultation with manufacturers of the influenza vaccine, how much supply is in circulation in the case of an influenza pandemic or epidemic; and</text></paragraph> <paragraph id="HA0287E6CE1044837B3BD91B9B0069431"><enum>(7)</enum><text>address other issues determined by the Director to be appropriate.</text></paragraph></subsection> <subsection id="H99C5015CE9194AF08EB1D040E1EF3C41"><enum>(c)</enum><header>Coordination; preparation; prevention</header><text>In establishing the protocol under subsection (a), the Director shall—</text> <paragraph id="H31172A1E7F3345F58DB57EBA1C030157"><enum>(1)</enum><text>coordinate with health care providers, manufacturers, research institutions, health care organizations, and other expert stakeholders; and</text></paragraph> <paragraph id="H219E62E4FD4F47EC85497996FFF0CC50"><enum>(2)</enum><text>assist States with preparedness activities for a rapid State and local response to an influenza pandemic, including exploring methods of making the influenza vaccine more accessible to the general population.</text></paragraph></subsection> <subsection id="H7710AA8A84AE45078C3253E9391735F7"><enum>(d)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this section $100,000,000 for each of fiscal years 2005 through 2009.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section> <enum>V</enum><header>Notice of intent to withdraw from the market</header> <section id="HE07FADEA9DEF4C6EBB25FF3B91A300AA"><enum>501.</enum><header>Manufacturer withdrawal from the market</header><text display-inline="no-display-inline">Title XXI of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/300aa-1">42 U.S.C. 300aa–1 et seq.</external-xref>), as amended by this Act, is further amended by adding at the end the following:</text> <quoted-block act-name="Public Health Service Act" id="HC61B0FEAB69341AB98A14EA07651569D" style="traditional"> <subtitle id="HAA033181913A4EFDAED23B74DD9B03D8"><enum>4</enum><header>Notice of intent To withdraw from the market</header> <section id="HB456B750B7C34427A6A0B3881309E8E4"><enum>2151.</enum><header>Manufacturer withdrawal from the market</header><text>Any manufacturer of a vaccine that receives authority under Federal law to distribute such vaccine shall provide advance notification to the Department of Health and Human Services regarding such manufacturer’s intent to stop the distribution of such vaccine into the marketplace.</text></section></subtitle><after-quoted-block>.</after-quoted-block></quoted-block></section>