109 HR 5951 IH: Family Smoking Prevention and Tobacco Control Act
U.S. House of Representatives
2006-07-27
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 Healthy Lifestyles and Prevention America Act
or the HeLP America Act
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Title I—Healthier Kids and Schools
Sec. 101. Fresh Fruit and Vegetable Program.
Sec. 102. Food of minimal nutritional value.
Sec. 103. School nutrition environment enhancement grants.
Title II—Healthier Communities and Workplaces
Subtitle A—Incentives for a Healthy Workforce
Sec. 201. Short title.
Sec. 202. Tax credit to employers for costs of implementing wellness programs.
Sec. 203. Income exclusion for employer-provided off-premises health club services.
Sec. 204. CDC and employer-based wellness programs.
Subtitle B—Healthy Communities
Sec. 211. Healthy community grants.
Sec. 212. Preventive medicine and public health training grant program.
Subtitle C—Family Smoking Prevention and Control
Sec. 221. Short title.
Sec. 222. Findings.
Sec. 223. Purpose.
Sec. 224. Scope and effect.
Sec. 225. Severability.
Part I—Authority of the Food and Drug Administration
Sec. 231. Amendment of Federal Food, Drug, and Cosmetic Act.
Sec. 232. Interim final rule.
Sec. 233. Conforming and other amendments to general provisions.
Part II—Tobacco Product Warnings; Constituent and Smoke Cconstituent Disclosure
Sec. 235. Cigarette label and advertising warnings.
Sec. 236. Authority to revise cigarette WARNING label statements.
Sec. 237. State regulation of cigarette advertising and promotion.
Sec. 238. Smokeless tobacco labels and advertising warnings.
Sec. 239. Authority to revise smokeless tobacco product WARNING label statements.
Sec. 240. Tar, nicotine, and other smoke constituent disclosure to the public.
Part III—Prevention of Illicit Trade in Tobacco Products
Sec. 241. Labeling, recordkeeping, records inspection.
Sec. 242. Study and report.
Title III—Responsible Marketing and Consumer Awareness
Subtitle A—General Provisions
Sec. 301. Nutrition labeling of restaurant foods.
Sec. 302. Rulemaking authority for advertising to children.
Sec. 303. Food advertising in schools.
Sec. 304. Disallowance of deductions for advertising and marketing expenses relating to Tobacco product use.
Sec. 305. Federal-State Tobacco counter-advertising programs.
Subtitle B—Penalties for failure to reduce teen Smoking
Sec. 311. Child cigarette use surveys.
Sec. 312. Cigarette use reduction goal and noncompliance.
Sec. 313. Enforcement.
Title IV—Reimbursement and Coverage of Preventive Services
Sec. 401. Coverage of substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling.
Sec. 402. Encouragement of cessation of tobacco use.
Sec. 403. Recognition of school-based health centers as model for delivery of primary care for children under Medicaid and the State Children’s Health Insurance Program.
Sec. 404. Preventive health care demonstration program.
Sec. 405. Preventive health services for women.
Title V—HeLP (Healthy Lifestyles and Prevention) America Trust Fund
Sec. 501. HeLP (Healthy Lifestyles and Prevention) America Trust Fund.
Title VI—Research
Sec. 601. Expansion of research regarding obesity.
2.Congress makes the following findings:
(1)Health care costs in the United States are rising rapidly. Per capita health spending in the United States is 56 percent higher than the median country that is a member of the Organization for Economic Cooperation and Development.
(2)According to the Centers for Medicare and Medicaid Services, total health care spending in the United States in 2004 was $1,800,000,000,000 and is expected to rise to $3,600,000,000,000 by 2014. Furthermore, chronic disease accounts for approximately 75 percent of health care costs annually.
(3)The United States spends less than 5 percent of annual health care expenditures on prevention
(4)Reducing and preventing the incidence of chronic disease is one means by which to reduce health care costs in the United States.
(5)More than 1,700,000 Americans die of a chronic disease each year, accounting for nearly 70 percent of all deaths in the United States.
(6)The economic impact of chronic disease can be seen in the annual costs associated with cardiovascular disease and stroke ($352,000,000,000), obesity ($117,000,000,000), cancer ($171,600,000,000), and diabetes ($132,000,000,000).
(7)Obesity related health conditions cost employers nearly $13,000,000,000 in health care and other indirect costs.
(8)Health promotion investments by employers on average yield a return of $3 for every $1 invested in a program.
(9)Being overweight or obese increase the risk of diabetes, heart disease, stroke, several types of cancer and other health problems.
(10)An estimated 65 percent of adults and 15 percent of children and adolescents in the United States are overweight or obese.
(11)The rates of obesity have doubled in children and tripled in teens since the 1980’s.
(12)Almost 40 percent of Americans are sedentary. More than 1/3 of young people in grades 9 through 12 do not regularly engage in vigorous-intensity physical activity.
(13)Only 1 in 5 young people eat the recommended 5 daily servings of fruits and vegetables.
(14)Food and beverage advertisers collectively spend $10,000,000,000 to $12,000,000,000 a year to reach children and youth.
(15)Between 1977 and 1995, trips made by walking declined by 40 percent for adults while driving trips increased to almost 90 percent of the total.
(16)Virtually all-new users of tobacco products are under the minimum legal age to purchase such products. Every day in America, more than 4,000 kids try their first cigarette. Another 2,000 children become new daily smokers.
(17)In 2002, nearly a quarter of American adults, 46,000,000 people, smoked cigarettes, including almost 40 percent of college-aged students.
(18)Research consistently shows that smoking cessation services offered as a combination of tobacco medication therapy and counseling can be one of the most cost-effective health interventions and can reduce smoking-related health care costs.
<enum>I</enum><header>Healthier Kids and Schools</header>
<section id="HF0B060E9A87F4EA5B429CF841F915820"><enum>101.</enum><header>Fresh Fruit and Vegetable Program</header>
<subsection id="HBBABBEE153E64043BA294CC1F6549795"><enum>(a)</enum><header>Additional funding for fresh Fruit and Vegetable Program</header><text>Section 18(g)(6)(B) of the Richard B. Russell <act-name parsable-cite="NSLA">National School Lunch Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1769">42 U.S.C. 1769(g)(6)(B)</external-xref>) is amended—</text>
<paragraph id="H6B232570E4964F218EC144E103176BFC"><enum>(1)</enum><text>by redesignating clause (ii) as clause (iv); and</text></paragraph>
<paragraph id="HB7842EB0FF2747B4B2E5BDFB00C3B23B"><enum>(2)</enum><text>by inserting after clause (i) the following:</text>
<quoted-block id="H7284C99ED86749D88FC0E68FBCFB2BF0">
<clause id="H9B6434BDCC084605BD00E977702C8BDB"><enum>(ii)</enum><header>Additional mandatory funding</header><text>Out of any funds in the Treasury not otherwise appropriated, the Secretary of the Treasury shall transfer to the Secretary of Agriculture to carry out and expand the program under this subsection, to remain available until expended—</text>
<subclause id="HBE5D03E5B0A349498E6FC38601BCBE54"><enum>(I)</enum><text>on October 1, 2006, $1,000,000,000; and</text></subclause>
<subclause id="H643F69ACD4294097AC2F1B1C63BAB2E8"><enum>(II)</enum><text>on October 1, 2007, and on each October 1 thereafter, the amount made available for the previous fiscal year, as adjusted under clause (iii).</text></subclause></clause>
<clause id="H7196211389324A9B00B477AB2CD5E99B"><enum>(iii)</enum><header>Adjustment</header><text>On October 1, 2007, and on each October 1 thereafter of a fiscal year the amount made available under subclause (II) of clause (ii) shall be calculated by adjusting the amount made available for the previous fiscal year to reflect changes in the Consumer Price Index of the Bureau of Labor Statistics for fresh fruits and vegetables, with the adjustment—</text>
<subclause id="HD0413482D0F44A2BB541E6ABEA00D6B8"><enum>(I)</enum><text>rounded down to the nearest dollar increment; and</text></subclause>
<subclause id="HC10F63CED0004F80B6A8FFB0F3EEB00"><enum>(II)</enum><text>based on the unrounded amounts for the preceding 12-month period.</text></subclause></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H76671D9B6907487BA86636AA481F3F1"><enum>(b)</enum><header>Healthy cooking pilot program</header><text>Section 18(g) of the Richard B. Russell <act-name parsable-cite="NSLA">National School Lunch Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1769">42 U.S.C. 1769(g)</external-xref>) is amended—</text>
<paragraph id="H614C20EF1D114C58BBFCDE9368783E78"><enum>(1)</enum><text>by redesignating paragraphs (4), (5), and (6) as paragraphs (5), (6), and (7), respectively; and</text></paragraph>
<paragraph id="H02CB5D2583164BC2B099284F713D29E9"><enum>(2)</enum><text>by inserting after paragraph (3) the following:</text>
<quoted-block id="H35CE318289BB4D9995E200092CC2E11">
<paragraph id="H35C2E0D29E3946058BB7089D3752619B"><enum>(4)</enum><header>Healthy cooking pilot program</header>
<subparagraph id="HDBA051A68FB44388BECD40F841657287"><enum>(A)</enum><header>In general</header><text>As part of the program conducted under this subsection, the Secretary shall carry out a pilot program under which the Secretary shall make competitive grants to selected elementary and secondary schools to teach children—</text>
<clause id="HB8EFF31F495D4CE99D5F00F2B15CD7C0"><enum>(i)</enum><text>how to eat a nutritious diet;</text></clause>
<clause id="H788E313B184D42D0AB1CF268F112B58F"><enum>(ii)</enum><text>how to select foods to make a healthy meal; and</text></clause>
<clause id="H171920586F40459AA63F9BF393ABA2CC"><enum>(iii)</enum><text>how to prepare healthy meals.</text></clause></subparagraph>
<subparagraph id="H65A82C36929A44EAA5843D04BC82FB0"><enum>(B)</enum><header>Selection of schools</header><text>In selecting schools to participate in the pilot program, the Secretary shall ensure that—</text>
<clause id="HD8A8084BF28740C9AF90B09B42CC00FE"><enum>(i)</enum><text>only schools participating in the fruit and vegetable program under this subsection are eligible to receive funds under this paragraph;</text></clause>
<clause id="H4C1A0D16180A4372B973201029001884"><enum>(ii)</enum><text>to the maximum extent practicable, at least 75 percent of schools selected are schools in which at least 50 percent of the students enrolled are eligible for free or reduced price meals under this Act; and</text></clause>
<clause id="HF9595700ED58454E918FCF05F56F53F4"><enum>(iii)</enum><text>there is appropriate representation, as determined by the Secretary, of—</text>
<subclause id="H488ECB13B6294ABD91BD7E729FB4D8B"><enum>(I)</enum><text>rural, urban, and suburban schools; and</text></subclause>
<subclause id="H29718A8DB8F1481DA5B095CD1600BD66"><enum>(II)</enum><text>elementary, middle, and secondary schools.</text></subclause></clause></subparagraph>
<subparagraph indent="subparagraph" id="HA082D9B1518B4205A2BC9147CBB74E5D"><enum>(C)</enum><header>Priority consideration</header><text>In awarding competitive grants under this paragraph, the Secretary shall give priority consideration to schools that submit an application that includes the participation of the parents or families of the children enrolled in the school.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section>
<section id="HDFDFF21C2038433CB7319051511CAD40" display-inline="no-display-inline" section-type="subsequent-section"><enum>102.</enum><header>Food of minimal nutritional value</header><text display-inline="no-display-inline">Section 10 of the Child Nutrition Act of 1966 (<external-xref legal-doc="usc" parsable-cite="usc/42/1779">42 U.S.C. 1779</external-xref>) is amended—</text>
<paragraph id="H93C02F3F10E24A59AAD7184B88AAF6D0"><enum>(1)</enum><text display-inline="yes-display-inline">by striking the section heading and all that follows through <quote>(a) The Secretary</quote> and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H12526FA84162434282B80944B5409B7">
<section id="H4EA5BF34E0E145AAADEBE3DC0012A564"><enum>10.</enum><header>Regulations</header>
<subsection id="HCDE7385FB331464080EC1B11D1922F26"><enum>(a)</enum><header>In general</header><text>The Secretary</text></subsection></section><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="H6A58601FB6A9426F8DE6C6F9294D000"><enum>(2)</enum><text>by striking subsections (b) and (c) and inserting the following:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H5A8D9D5343A0457C843DF651BAD02738">
<subsection id="H79432ADB26D144B8BDDB938869F6E647"><enum>(b)</enum><header>Food of minimal nutritional value</header>
<paragraph id="HB21C115C368241EAB66793006FE1C62D"><enum>(1)</enum><header>Proposed regulations</header>
<subparagraph id="H9BD8200F809E442CA6D408B12DEEC987"><enum>(A)</enum><header>In general</header><text>Not later than 180 days after the date of enactment of this paragraph, the Secretary shall promulgate proposed regulations to revise the definition of <quote>food of minimal nutritional value</quote> that is used to carry out this Act and the Richard B. Russell National School Lunch Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1751">42 U.S.C. 1751 et seq.</external-xref>).</text></subparagraph>
<subparagraph id="H0B6858C81BF34727B5E25FAC6E43FC1F"><enum>(B)</enum><header>Application</header><text>The revised definition of <quote>food of minimal nutritional value</quote> shall apply to all foods sold—</text>
<clause id="H9E018D4461D0446F9035E5BC05F7A173"><enum>(i)</enum><text>outside the school meal programs;</text></clause>
<clause id="H8203A577C59F4AA79F9D7991EFC6FE23"><enum>(ii)</enum><text>on the school campus; and</text></clause>
<clause id="HAE1B17EBE73C4E50A03FB066D0424107"><enum>(iii)</enum><text>at any time during the school day.</text></clause></subparagraph>
<subparagraph id="H929F3F66723B47F2A62F902709ECEB57"><enum>(C)</enum><header>Requirements</header><text>In revising the definition, the Secretary shall consider—</text>
<clause id="H5291288CBE9B458EBFB6E7D95175F686"><enum>(i)</enum><text>both the positive and negative contributions of nutrients, ingredients, and foods (including calories, portion size, saturated fat, trans fat, sodium, and added sugars) to the diets of children;</text></clause>
<clause id="H4E862531F9194612B5694F697F4D73E1"><enum>(ii)</enum><text>evidence concerning the relationship between consumption of certain nutrients, ingredients, and foods to both preventing and promoting the development of overweight, obesity, and other chronic illnesses;</text></clause>
<clause id="HD66301EC53624A7F9F613531AA968BBD"><enum>(iii)</enum><text>recommendations made by authoritative scientific organizations concerning appropriate nutritional standards for foods sold outside of the reimbursable meal programs in schools; and</text></clause>
<clause id="H90F815862119483887B985C199EB73DF"><enum>(iv)</enum><text>special exemptions for school-sponsored fundraisers (other than fundraising through vending machines, school stores, snack bars, a la carte sales, and any other exclusions determined by the Secretary), if the fundraisers are approved by the school and are infrequent within the school.</text></clause></subparagraph></paragraph>
<paragraph id="HED20F5E0EF78496EA8DD024C729BD500"><enum>(2)</enum><header>Implementation</header>
<subparagraph id="HB0567AF740A944C3A300F202E2D36DE"><enum>(A)</enum><header>Effective date</header>
<clause id="HD1C45A6587214333828D9D9990D9C11"><enum>(i)</enum><header>In general</header><text>Except as provided in clause (ii), the proposed regulations shall take effect at the beginning of the school year following the date on which the regulations are finalized.</text></clause>
<clause id="H88574146510D425A856DD9D6970065BE"><enum>(ii)</enum><header>Exception</header><text>If the regulations are finalized on a date that is not more than 60 days before the beginning of the school year, the proposed regulations shall take effect at the beginning of the following school year.</text></clause></subparagraph>
<subparagraph id="H3DE7B59489FA47B09FC4A2F24677B2ED"><enum>(B)</enum><header>Failure to promulgate</header><text>If, on the date that is 1 year after the date of enactment of this paragraph, the Secretary has not promulgated final regulations, the proposed regulations shall be considered to be final regulations.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H04ED90B29328403E9B7B1114009D95DA"><enum>103.</enum><header>School nutrition environment enhancement grants</header><text display-inline="no-display-inline">Section 18 of the Richard B. Russell <act-name parsable-cite="NSLA">National School Lunch Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1769">42 U.S.C. 1769</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="National School Lunch Act" id="HC9BE37A3E196441FA200B58ECF6F014">
<subsection id="H318EC6FF07CF4481BF4EE1A3BB973DE4"><enum>(l)</enum><header>Healthy school nutrition environment incentive grants</header>
<paragraph id="H570AF45AE9F94F5100B1BF9F5FA65738"><enum>(1)</enum><header>In general</header><text>Following the publication of the recommendations of the Institute of Medicine study carried out using funds made available for public health improvement and leadership under the heading <quote>Centers for Disease Control and Prevention</quote> in the Department of Labor Appropriations Act, 2005 (title I of division F of <external-xref legal-doc="public-law" parsable-cite="pl/108/447">Public Law 108–447</external-xref>; 118 Stat. 3124) regarding appropriate nutritional standards for the availability, sale, content, and consumption of food at school, with particular attention given to foods offered in competition with federally reimbursed meals and snacks, the Secretary may carry out a grant program to—</text>
<subparagraph id="H1B9BD2D9A1D5425DA2B7199C84961BF8"><enum>(A)</enum><text>provide schools with technical assistance in implementing the recommendations of the Institute of Medicine regarding appropriate school nutrition standards; and</text></subparagraph>
<subparagraph id="HA2D15EF01D4B43809682FB24E18C54FD"><enum>(B)</enum><text>assess the impact of implementing the recommendations on the health and well-being of children enrolled in the schools.</text></subparagraph></paragraph>
<paragraph id="H794D80C5BA924D91B7CAA1BB8F53A243"><enum>(2)</enum><header>Selection of schools</header><text>In selecting schools to receive incentive grants under this subsection, the Secretary shall—</text>
<subparagraph id="HB114C266ED044D05B3BAF0A62D507B00"><enum>(A)</enum><text>ensure that not less than 75 percent of schools selected to participate in the program established under this subsection are schools in which not less than 50 percent of the students enrolled in each school are eligible for free or reduced price meals under this Act;</text></subparagraph>
<subparagraph id="HED44D407A0C44218B19699D77E51ABD3"><enum>(B)</enum><text>ensure that, of the schools selected to participate in the program, there is appropriate representation of rural, urban, and suburban schools, as determined by the Secretary;</text></subparagraph>
<subparagraph id="H8CAFB88984F8498BA5D72168A1E6E0D9"><enum>(C)</enum><text>ensure that, of the schools selected to participate in the program, there is appropriate representation of elementary, middle, and secondary schools, as determined by the Secretary;</text></subparagraph>
<subparagraph id="HE4938AEB0713452EA959BC9B8B169775"><enum>(D)</enum><text>ensure that schools selected to receive a grant under this subsection meet the requirements of paragraph (3);</text></subparagraph>
<subparagraph id="H74E87D07D7644992A53526820647CBCD"><enum>(E)</enum><text>give priority to schools that develop comprehensive plans that include the involvement of a broad range of community stakeholders in achieving healthy school nutrition environments; and</text></subparagraph>
<subparagraph id="H658E5957C36F464793748F2C88716869"><enum>(F)</enum><text>give priority to schools that develop comprehensive plans that include a strategy for maintaining healthy school nutrition environments in the years following the fiscal years for which the schools receive grants under this subsection.</text></subparagraph></paragraph>
<paragraph id="H83803E5C15A2404C9BFADDFF13AEA303"><enum>(3)</enum><header>Requirements</header>
<subparagraph id="H3ECB4BE1058549568140B803F1CBF1E1"><enum>(A)</enum><header>Criteria for healthy school environments</header><text>The Secretary shall establish criteria, based upon the recommendations of the Institute of Medicine described in paragraph (1), under which schools may receive grants under this section.</text></subparagraph>
<subparagraph id="HDC85929BA0C1424AA670E2F703E3D9F8"><enum>(B)</enum><header>Plan</header><text>To be eligible to receive a grant under this subsection, a school shall—</text>
<clause id="H08A0FA16C10D4B00AEDAFE009C5C8313"><enum>(i)</enum><text>submit to the Secretary a healthy school nutrition environment plan that describes the actions the school will take to meet the criteria established under subparagraph (A); and</text></clause>
<clause id="H852F67CD542545EABD004CF949F1E53F"><enum>(ii)</enum><text>take the actions described in the plan.</text></clause></subparagraph></paragraph>
<paragraph id="H564A159152874DD9B9B8C2BA3665D7B"><enum>(4)</enum><header>Grants</header><text>For each of fiscal years 2007 through 2011, the Secretary shall make a grant to each school selected under paragraph (2).</text></paragraph>
<paragraph id="H25DE9343ACA94595AC4CA236CAD4A202"><enum>(5)</enum><header>Evaluations</header>
<subparagraph id="H72665589A27C4179AF65271EDCF2EF8F"><enum>(A)</enum><header>In general</header><text>The Secretary, acting through the Administrator of the Food and Nutrition Service, shall conduct an evaluation of a representative sample of schools that receive grants under this subsection.</text></subparagraph>
<subparagraph id="HCAB7CAFBCD0D40918D1193524C42E2CD"><enum>(B)</enum><header>Content</header><text>The evaluation shall measure, at a minimum, the effects of a healthy school nutrition environment on—</text>
<clause id="HF2C0B49B21B64507AB64387480C2A409"><enum>(i)</enum><text>overweight children and obesity;</text></clause>
<clause id="H317B171637AE4F1A93F059821D811E5C"><enum>(ii)</enum><text>dietary intake;</text></clause>
<clause id="H4AF8FE3E1F314F2900A776EFC9AE6B44"><enum>(iii)</enum><text>nutrition education and behavior;</text></clause>
<clause id="HE234983BA7DE457A9ED903CDFB069550"><enum>(iv)</enum><text>parental and student attitudes and participation; and</text></clause>
<clause id="HF72CE345C8CA4CE6B500C8BDFBCD8D1"><enum>(v)</enum><text>related funding issues, including the cost of maintaining a healthy school nutrition environment.</text></clause></subparagraph>
<subparagraph id="H74F04332C0D84A3FA26BD4D91DFCBEE"><enum>(C)</enum><header>Reports</header><text>The Secretary shall submit to the Committee on Education and the Workforce of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate—</text>
<clause id="H4A845F0EDBCB4104B6E4DE73CDAE3C06"><enum>(i)</enum><text>an interim report on the activities of schools evaluated under this subsection; and</text></clause>
<clause id="HB9CEAFB3FEB94C4F93234E5E3CF1A63C"><enum>(ii)</enum><text>a final report on the activities of schools evaluated under this subsection.</text></clause></subparagraph></paragraph>
<paragraph id="H23DB3BCCC7A34BDFA7D3F2B639682955"><enum>(6)</enum><header>Authorization of appropriations</header>
<subparagraph id="H1B41EF3A33874F0186004C31163F747F"><enum>(A)</enum><header>In general</header><text>There are authorized to be appropriated such sums as are necessary to carry out this subsection for fiscal year 2007 and each subsequent fiscal year, to remain available until expended.</text></subparagraph>
<subparagraph id="H2C4B978250E545EBB5C80055CB8C384B"><enum>(B)</enum><header>Evaluations</header><text>The Secretary may use not more than 10 percent of the total funds made available for a fiscal year under subparagraph (A) to carry out paragraph (5).</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<enum>II</enum><header>Healthier Communities and Workplaces</header>
<subtitle id="H32CC27B7061145F788BAD6C786003CEE"><enum>A</enum><header>Incentives for a Healthy Workforce</header>
<section id="HDB4DDBA2CF594690B6EB986E2D4082E0"><enum>201.</enum><header>Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the <quote><short-title>Healthy Workforce Act of 2006</short-title></quote>.</text></section>
<section id="HDB6D162F007A4F42BD1EF26147425DA2"><enum>202.</enum><header>Tax credit to employers for costs of implementing wellness programs</header>
<subsection id="H278792EC2AED49AEAFC10B6FFF7587E"><enum>(a)</enum><header>In general</header><text>Subpart D of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 (relating to business related credits) is amended by adding at the end the following:</text>
<quoted-block id="HF7188AAD935E45DFB3C57856C92D898E">
<section id="HCE55CE743363415292C78E93B9A30898"><enum>45N.</enum><header>Wellness program credit</header>
<subsection id="H16656F9F783C482E0033A99E68E07592"><enum>(a)</enum><header>Allowance of credit</header>
<paragraph id="HA8A92B0D374C4F9AB67C891189711C19"><enum>(1)</enum><header>In general</header><text>For purposes of section 38, the wellness program credit determined under this section for any taxable year is—</text>
<subparagraph id="H2BEE360CB0904CCAB0F74D5E6C48008C"><enum>(A)</enum><text>in the case of a small business employer, an amount equal to 50 percent of the costs paid or incurred by the small business employer in connection with a qualified small business wellness program during the taxable year, and</text></subparagraph>
<subparagraph id="HE50777AF820E4229ABFAD418B6EF95D6"><enum>(B)</enum><text>in the case of any other employer, an amount equal to 50 percent of the costs paid or incurred by the employer in connection with a qualified wellness program during the taxable year.</text></subparagraph></paragraph>
<paragraph id="H858150E244FA44A000353C78AE26006F"><enum>(2)</enum><header>Limitation</header><text>The amount of credit allowed under paragraph (1) for any taxable year shall not exceed the product of $200 and the number of employees of the employer or small business employer, as the case may be.</text></paragraph></subsection>
<subsection id="HE9176B885407451182C8E89A3F8677C"><enum>(b)</enum><header>Qualified wellness program; qualified small business wellness program</header><text>For purposes of this section—</text>
<paragraph id="H2FF302CE4B314A1E84E54882009481AF"><enum>(1)</enum><header>Qualified wellness program</header><text>The term <term>qualified wellness program</term> means a program which consists of all of the wellness program components described in subsection (c) and which is certified by the Secretary of Health and Human Services, in consultation with persons who have expertise in employer health promotion and wellness programs, as a qualified wellness program under this section.</text></paragraph>
<paragraph id="HD2097434BA7B476E91A5C66BE0EA3533"><enum>(2)</enum><header>Qualified small business wellness program</header><text>The term <term>qualified small business wellness program</term> means a program which consists of any 2 of the components described in subsection (c) and which is certified by the Secretary of Health and Human Services, in consultation with persons who have expertise in employer health promotion and wellness programs, as a qualified small business wellness program under this section.</text></paragraph></subsection>
<subsection id="HA9FC891D2CD44F1783610158F35579E5"><enum>(c)</enum><header>Wellness program components</header><text>For purposes of this section, the wellness program components described in this subsection are the following:</text>
<paragraph id="HD7DCE0E07ABD48C5AC7E97277DAAD94B"><enum>(1)</enum><header>Health awareness component</header><text>A health awareness component which provides for the following:</text>
<subparagraph id="H893C0C2B531A4D9CBADBB338F2EE39DE"><enum>(A)</enum><header>Health education</header><text>The dissemination of health information which addresses the specific needs and health risks of employees.</text></subparagraph>
<subparagraph id="H4CB93272D78F453CB2BA8E2C00CD54F2"><enum>(B)</enum><header>Health screenings</header><text>The opportunity for periodic screenings for health problems and referrals for appropriate follow up measures.</text></subparagraph></paragraph>
<paragraph id="H236E9DE91AA34B92AAE1BDD927578BDA"><enum>(2)</enum><header>Behavioral change component</header><text>A behavioral change component which provides for altering employee lifestyles to encourage healthy living through counseling, seminars, on-line programs, or self-help materials. Such component shall include programs relating to—</text>
<subparagraph id="HBB2987C9083846EAA55E175825E95F83"><enum>(A)</enum><text>smoking,</text></subparagraph>
<subparagraph id="H4F1A9FCEFCD344789924C8A8E71DC633"><enum>(B)</enum><text>obesity,</text></subparagraph>
<subparagraph id="HB76AF8560CCC45728E1CF0DF4F7725A7"><enum>(C)</enum><text>stress management,</text></subparagraph>
<subparagraph id="H586E7DCD766A44CCBAF0AE13A4A75688"><enum>(D)</enum><text>physical fitness,</text></subparagraph>
<subparagraph id="H8742F504C6814FDBAE80ACCEAF900052"><enum>(E)</enum><text>nutrition,</text></subparagraph>
<subparagraph id="H3F596A6ABAB54BC8A4ABF9765DFC9E3B"><enum>(F)</enum><text>substance abuse,</text></subparagraph>
<subparagraph id="H83398DD73C6A4AF49C987380146D6EE6"><enum>(G)</enum><text>depression,</text></subparagraph>
<subparagraph id="HEF71B48604504ED200E900133BC53658"><enum>(H)</enum><text>mental health promotion (including anxiety), and</text></subparagraph>
<subparagraph id="HF88A9943DB6B4AF18866BD8FB8943BF"><enum>(I)</enum><text>sleep (including sleep disorders and the consequences of sleep deprivation).</text></subparagraph></paragraph>
<paragraph id="H6D33098B894F44D38CB82731CDF89BEE"><enum>(3)</enum><header>Supportive environment component</header><text>A supportive environment component which includes the following:</text>
<subparagraph id="H60F8DFF5D2E44893BE1C95FC3C7B759C"><enum>(A)</enum><header>On-site policies</header><text>Policies and services at the worksite which promote a healthy lifestyle, including policies relating to—</text>
<clause id="H4F6312CABE7641768FB67F07B97E80A7"><enum>(i)</enum><text>smoking at the worksite,</text></clause>
<clause id="H35541E617A64471C9CA9C24DA3CDA541"><enum>(ii)</enum><text>the nutrition of food available at the worksite through cafeterias and vending options,</text></clause>
<clause id="H6475FC9387AC4A2A9B7D9C779B27AD97"><enum>(iii)</enum><text>minimizing stress in the workplace,</text></clause>
<clause id="HACA80943E0A540979E00CA599B5EDD37"><enum>(iv)</enum><text>where applicable, accessible and attractive stairs,</text></clause>
<clause id="H81B733A422B745C6AEFB25673EF74CDD"><enum>(v)</enum><text>the encouragement of physical activity during work hours, and</text></clause>
<clause id="H31D407C4026C433DB021ACA12071B8A4"><enum>(vi)</enum><text>the promotion of fatigue countermeasures.</text></clause></subparagraph>
<subparagraph id="H035979E619B9464B8D81E8884CA6838"><enum>(B)</enum><header>Participation incentives</header>
<clause id="HB791D4CDF80745B0B03BB46FAFF1C368"><enum>(i)</enum><header>In general</header><text>Qualified incentive benefits for each employee who participates in the health screenings described in paragraph (1)(B) or the behavioral change programs described in paragraph (2).</text></clause>
<clause id="H5CCE67A638A2475EB99C8F675C62FCCB"><enum>(ii)</enum><header>Qualified incentive benefit</header><text>For purposes of clause (i), the term <term>qualified incentive benefit</term> means any benefit which is approved by the Secretary of Health and Human Services. Such benefit may include an adjustment in health insurance premiums or co-pays.</text></clause></subparagraph>
<subparagraph id="HA8AD53C7452F4D928C14B0391547888B"><enum>(C)</enum><header>Employee input</header><text>The opportunity for employees to participate in the management of any qualified wellness program or qualified small business wellness program to which this section applies.</text></subparagraph></paragraph></subsection>
<subsection id="HD1EF802B57F34C298C5987D8D3292B58"><enum>(d)</enum><header>Participation requirement</header>
<paragraph id="H6D0E969473DE43CC82B00009E100C11B"><enum>(1)</enum><header>In general</header><text>No credit shall be allowed under subsection (a) unless the Secretary of Health and Human Services certifies, as a part of any certification described in subsection (b), that each wellness program component of the qualified wellness program or qualified small business wellness program applies to all qualified employees of the employer.</text></paragraph>
<paragraph id="H2D883A1ECC564D9EAFE076003F6790B4"><enum>(2)</enum><header>Qualified employee</header><text>For purposes of paragraph (1), the term <term>qualified employee</term> means an employee who works an average of not less than 25 hours per week during the taxable year.</text></paragraph></subsection>
<subsection id="H22D516BC66AB4EDCB75D4D44C8B2938D"><enum>(e)</enum><header>Other definitions and special rules</header><text>For purposes of this section—</text>
<paragraph id="HEE8012441C22450386C8004D517EC000"><enum>(1)</enum><header>Employee and employer</header>
<subparagraph id="H1E27AF0C784B41CBB1F5B8DFE156FD43"><enum>(A)</enum><header>Partners and partnerships</header><text>The term <term>employee</term> includes a partner and the term <term>employer</term> includes a partnership.</text></subparagraph>
<subparagraph id="H4FC0B4BF321F447B89D3BC328C3D735C"><enum>(B)</enum><header>Certain rules to apply</header><text>Rules similar to the rules of section 52 shall apply.</text></subparagraph></paragraph>
<paragraph id="H3FD4D1A25C7E4CB1005FDCE78500F8B2"><enum>(2)</enum><header>Small business employer</header>
<subparagraph id="H5B28433A96664F06A6CEB28393C08560"><enum>(A)</enum><header>In general</header><text>The term <term>small business employer</term> means, with respect to any taxable year, an employer who employed an average of 200 or fewer employees on business days during such taxable year.</text></subparagraph>
<subparagraph id="HCA4096E60532465D8C65C3C366521785"><enum>(B)</enum><header>Controlled groups</header><text>For purposes of subparagraph (A), all persons treated as a single employer under subsection (b), (c), (m), or (o) of section 414 shall be treated as a single employer.</text></subparagraph></paragraph>
<paragraph id="H1907BDF707734628B5EED800D1014714"><enum>(3)</enum><header>Certain costs not included</header><text>Costs paid or incurred by an employer or small business employer for food or health insurance shall not be taken into account under subsection (a).</text></paragraph> </subsection>
<subsection id="H4A50E60C5C494A508CB2C40392B1C40"><enum>(f)</enum><header>Portion of credit made refundable</header>
<paragraph id="H70203C8E3CF04926A663D22FC9E19DF"><enum>(1)</enum><header>In general</header><text>In the case of an eligible employer of an employee, the aggregate credits allowed to a taxpayer under subpart C shall be increased by the lesser of—</text>
<subparagraph id="H4E811448D2294BB8872C8B4562F6FF00"><enum>(A)</enum><text>the credit which would be allowed under this section without regard to this subsection and the limitation under section 38(c), or</text></subparagraph>
<subparagraph id="H7DDB52E41B7F46F39E36B4298D00ACF1"><enum>(B)</enum><text>the amount by which the aggregate amount of credits allowed by this subpart (determined without regard to this subsection) would increase if the limitation imposed by section 38(c) for any taxable year were increased by the amount of employer payroll taxes imposed on the taxpayer during the calendar year in which the taxable year begins.</text></subparagraph><continuation-text continuation-text-level="paragraph">The amount of the credit allowed under this subsection shall not be treated as a credit allowed under this subpart and shall reduce the amount of the credit otherwise allowable under subsection (a) without regard to section 38(c).</continuation-text></paragraph>
<paragraph id="H12CC6BD449B74C248DB6B4CCFD708465"><enum>(2)</enum><header>Eligible employer</header><text>For purposes of this subsection, the term <term>eligible employer</term> means an employer or small business employer which is—</text>
<subparagraph id="H34B0356D1DB34798A5DE1311A1D566E9"><enum>(A)</enum><text>a State or political subdivision thereof, the District of Columbia, a possession of the United States, or an agency or instrumentality of any of the foregoing, or</text></subparagraph>
<subparagraph id="HE2A205DE1D014F66AFEA9404D63B18D"><enum>(B)</enum><text>any organization described in <external-xref legal-doc="usc" parsable-cite="usc/26/501">section 501(c)</external-xref> of the Internal Revenue Code of 1986 which is exempt from taxation under section 501(a) of such Code.</text></subparagraph></paragraph>
<paragraph id="H24A81B1A1DCE4BDD9B6CA40A4BCD00"><enum>(3)</enum><header>Employer payroll taxes</header><text>For purposes of this subsection—</text>
<subparagraph id="H4FF5683676084967A0A6AFFB00CD16B"><enum>(A)</enum><header>In general</header><text>The term <term>employer payroll taxes</term> means the taxes imposed by—</text>
<clause id="HFD408B4F8F0945AE00C85B06E918B2B0"><enum>(i)</enum><text>section 3111(b), and</text></clause>
<clause id="HBD9A43BB01EF411BA1261E459FD66F2E"><enum>(ii)</enum><text>sections 3211(a) and 3221(a) (determined at a rate equal to the rate under section 3111(b)).</text></clause></subparagraph>
<subparagraph id="H68B85219F1534FBE8200821E130930E5"><enum>(B)</enum><header>Special rule</header><text>A rule similar to the rule of section 24(d)(2)(C) shall apply for purposes of subparagraph (A).</text></subparagraph></paragraph></subsection>
<subsection id="HCEF883B7EBE445699B63C04033831126"><enum>(g)</enum><header>Termination</header><text>This section shall not apply to any amount paid or incurred after December 31, 2016.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HFA63A6C58E3C49D781D017DC1D9461BB"><enum>(b)</enum><header>Treatment as general business credit</header><text>Subsection (b) of <external-xref legal-doc="usc" parsable-cite="usc/26/38">section 38</external-xref> of the Internal Revenue Code of 1986 (relating to general business credit) is amended by striking <quote>and</quote> at the end of paragraph (29), by striking the period at the end of paragraph (30) and inserting <quote>, and</quote>, and by adding at the end the following:</text>
<quoted-block id="HB645D546B5744042AE64EBAE19F6C7C">
<paragraph id="H016F84F3AAF846659B6E076800EE327E"><enum>(31)</enum><text>the wellness program credit determined under section 45N.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HAE7DCEE2B1A141B5816612CA69D81C8B"><enum>(c)</enum><header>Denial of double benefit</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/280C">Section 280C</external-xref> of the Internal Revenue Code of 1986 (relating to certain expenses for which credits are allowable) is amended by adding at the end the following new subsection:</text>
<quoted-block id="H65DA541E831740B8B263CB51B69146FE">
<subsection id="H7F05C3BF0A524E799B342B00CB1425AD"><enum>(e)</enum><header>Wellness program credit</header>
<paragraph id="H3BCE6DD82B6243DA00D13F14D32006D"><enum>(1)</enum><header>In general</header><text>No deduction shall be allowed for that portion of the costs paid or incurred for a qualified wellness program (within the meaning of section 45N) or a qualified small business wellness program (within the meaning of such section) allowable as a deduction for the taxable year which is equal to the amount of the credit allowable for the taxable year under section 45N.</text></paragraph>
<paragraph id="HF4422371E5FF49C686ED69D77B940044"><enum>(2)</enum><header>Similar rule where taxpayer capitalizes rather than deducts expenses</header><text>If—</text>
<subparagraph id="H5583BFA8556E47A9AD4BF14D6F56C98"><enum>(A)</enum><text>the amount of the credit determined for the taxable year under section 45N, exceeds</text></subparagraph>
<subparagraph id="H51A08AFB9D3844FFAC55FC3D00BDFE70"><enum>(B)</enum><text>the amount allowable as a deduction for such taxable year for a qualified wellness program or a qualified small business wellness program, the amount chargeable to capital account for the taxable year for such expenses shall be reduced by the amount of such excess.</text></subparagraph></paragraph>
<paragraph id="HE9C967E201614DE9AFD0063C6793B325"><enum>(3)</enum><header>Controlled groups</header><text>In the case of a corporation which is a member of a controlled group of corporations (within the meaning of section 41(f)(5)) or a trade or business which is treated as being under common control with other trades or business (within the meaning of section 41(f)(1)(B)), this subsection shall be applied under rules prescribed by the Secretary similar to the rules applicable under subparagraphs (A) and (B) of section 41(f)(1).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HDF0340C63EEA4B2AABB9211EC5F79CCA"><enum>(d)</enum><header>Clerical amendment</header><text>The table of sections for subpart D of part IV of subchapter A of <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/26/1">chapter 1</external-xref> of the Internal Revenue Code of 1986 is amended by adding at the end the following:</text>
<quoted-block style="USC" id="H345EDBAA27654220AED1A78B88909674">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 45N. Wellness program credit.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HC26F34EA06BE4628A93C6048BAE9AEF4"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after December 31, 2006.</text></subsection>
<subsection id="H9E5059F2A1AA4084B2E074A88C75E14E"><enum>(f)</enum><header>Outreach</header>
<paragraph id="H4161DD53B1DF4B9388A7AFB6F4093019"><enum>(1)</enum><header>In general</header><text>The Secretary of the Treasury, in conjunction with the Director of the Centers for Disease Control and members of the business community, shall institute an outreach program to inform businesses about the availability of the wellness program credit under <external-xref legal-doc="usc" parsable-cite="usc/26/45N">section 45N</external-xref> of the Internal Revenue Code of 1986.</text></paragraph>
<paragraph id="HDC888D5E191248D8ACD271AD28DC88A6"><enum>(2)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated such sums as are necessary to carry out the outreach program described in paragraph (1).</text></paragraph></subsection>
<subsection id="H681A9483490A45A09838DC3E7815E283"><enum>(g)</enum><header>Restoration of highest income tax rate to pre-2001 level</header><text><external-xref legal-doc="usc" parsable-cite="usc/26/1">Section 1(i)(2)</external-xref> of the Internal Revenue Code of 1986 (relating to reductions in rates after June 30, 2001) is amended by adding at the end the following new flush sentence:</text>
<quoted-block style="OLC" id="H8DD2AAB87CD0447196098DBD83BC5D7F" display-inline="no-display-inline">
<quoted-block-continuation-text quoted-block-continuation-text-level="paragraph">In the case of taxable years beginning after 2006, the last item in the fourth column in the preceding table shall be applied by substituting <quote>39.6%</quote> for <quote>35.0%</quote></quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block> </subsection>
<subsection id="H5F24CC37F34448FFB8BD447CB24E86DE"><enum>(h)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after December 31, 2006.</text></subsection></section>
<section id="HAD86950285C545FA8491A92BA2621386"><enum>203.</enum><header>Income exclusion for employer-provided off-premises health club services</header>
<subsection id="H4F03F21581FE44D3871808EFA5A894E5"><enum>(a)</enum><header>Treatment as fringe benefit</header><text>Subparagraph (A) of <external-xref legal-doc="usc" parsable-cite="usc/26/132">section 132(j)(4)</external-xref> of the Internal Revenue Code of 1986 (relating to on-premises gyms and other athletic facilities) is amended to read as follows:</text>
<quoted-block id="H8EC32B371F114D4D8B3407BFC9564EEE">
<subparagraph id="HB73B88A4409B4931AFDD8C12006CB54B"><enum>(A)</enum><header>In general</header><text>Gross income shall not include—</text>
<clause id="H2F8BC7394CF24989A575E6E8FF522CDD"><enum>(i)</enum><text>the value of any on-premises athletic facility provided by an employer to its employees, and</text></clause>
<clause id="HE91A26A3CA7B4BBDBBF42652C3E8BD42"><enum>(ii)</enum><text>fees or membership expenses paid by an employer to an athletic or fitness facility described in subparagraph (C) on behalf of its employees, but only to the extent that such fees or expenses do not exceed $900.</text></clause><continuation-text continuation-text-level="subparagraph">The preceding sentence shall apply with respect to any highly compensated employee only if access to the facility is available on substantially the same terms to each member of a group of employees which is defined under a reasonable classification set up by the employer which does not discriminate in favor of highly compensated employees.</continuation-text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HB6A76C1E0CFD4E38BB29A26C8BB62100"><enum>(b)</enum><header>Athletic facilities described</header><text>Paragraph (4) of section 132(j) of such Code is amended by adding at the end the following new subparagraph:</text>
<quoted-block id="H9501E466B9FE4A9D8DE2758F0534BC74">
<subparagraph id="H66D8643A6E2D4A7695136371FCCE2CC3"><enum>(C)</enum><header>Certain athletic or fitness facilities described</header><text>For purposes of subparagraph (A)(ii), an athletic or fitness facility described in this subparagraph is a facility—</text>
<clause id="HA0CA2118BFED40E79398ECA3DCAE54D"><enum>(i)</enum><text>providing instruction in a program of physical exercise or offering facilities for the preservation, maintenance, encouragement, or development of physical fitness,</text></clause>
<clause id="H326EB12E39CC4D319DE611A74E998B64"><enum>(ii)</enum><text>which is not a private club owned and operated by its members,</text></clause>
<clause id="H75D254FE09254C049DB276DF505DC822"><enum>(iii)</enum><text>which does not offer golf, hunting, sailing, or riding facilities,</text></clause>
<clause id="H2E1EBA6184AD49ECB4D4CCBF7235477E"><enum>(iv)</enum><text>whose health or fitness facility is not incidental to its overall function and purpose, and</text></clause>
<clause id="HA08B462F15844F3D83F9B936006BDA21"><enum>(v)</enum><text>which is fully compliant with the State of jurisdiction and Federal anti-discriminations laws.</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H98179B9FCC5445A092E3E555A1A3DE2F"><enum>(c)</enum><header>Employer deduction for dues to certain athletic facilities</header>
<paragraph id="H041A120E75D04492AA498C9F08DCD977"><enum>(1)</enum><header>In general</header><text>Paragraph (3) of section 274(a) of such Code (relating to denial of deduction for club dues) is amended—</text>
<subparagraph id="HBFE88E01CBE4414BAC5DCA18A252479C"><enum>(A)</enum><text>by striking <quote>Notwithstanding</quote> and inserting the following:</text>
<quoted-block id="HC0DFE1DCF3CA4C949806F5B47254C1FF">
<subparagraph id="H3AA694EAB6AC4FDAA6E3DB0936B563AC"><enum>(A)</enum><header>In general</header><text>Notwithstanding</text></subparagraph><after-quoted-block>, and</after-quoted-block></quoted-block></subparagraph>
<subparagraph id="H1EBC5AF8A0B84650B607B1DC08B7824"><enum>(B)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="HF8A6C7463A99474491B4C60773EBC3C">
<subparagraph id="HDE8BCDF3F90843F88D5D36D0F039D24C"><enum>(B)</enum><header>Exception for athletic facilities</header><text>This paragraph shall not apply to fees or dues paid to athletic or fitness facilities (within the meaning of section 132(j)(4)(C)) to the extent that such fees or dues do not exceed $900 for any membership.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H4395B1B0584E4FCDA8D913C113EF104"><enum>(2)</enum><header>Conforming amendment</header><text>Section 274(e)(4) of such Code is amended by striking <quote>subsection (a)(3)</quote> and by inserting <quote>subsection (a)(3)(A)</quote>.</text></paragraph></subsection>
<subsection id="H7810EB859E17447EA713AF1C60C370A3"><enum>(d)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section id="H20744842C92E4FA2AD33C54F76C62836"><enum>204.</enum><header>CDC and employer-based wellness programs</header><text display-inline="no-display-inline">Title III of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/241">42 U.S.C. 241 et seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="HB3A558B3C87948589DFA527267CB758">
<part id="HD2C7BA58A51C4B838573C5B34082AF1C"><enum>R</enum><header>CDC and employer-based wellness programs</header>
<section id="H97A5BB95871C4950B2E1582E5D5BCC9C"><enum>399Z–1.</enum><header>Employer-based wellness best practices</header>
<subsection id="H6A54AD122ACF43BD966379E0000A834"><enum>(a)</enum><header>In general</header><text>The Director of the Centers for Disease Control and Prevention shall conduct a study that analyzes employer-based wellness programs and determines—</text>
<paragraph id="HA04DAF040C104A3783213D34DB019F87"><enum>(1)</enum><text>best practices of such programs that impact and sustain behavior change in employees;</text></paragraph>
<paragraph id="H7245FC0E7D66471FA1D28552F812BEEB"><enum>(2)</enum><text>the impact that such programs have on reducing health risk prevalence and improving absenteeism of employees; and</text></paragraph>
<paragraph id="H3EFFCF97B83348EAA1DC00421D5DF333"><enum>(3)</enum><text>the return to employers on the investment made by such employers in such programs.</text></paragraph></subsection>
<subsection id="HF1BECF8D72074E7AA77D689288CC7303"><enum>(b)</enum><header>Report</header><text>After completing the study under subsection (a), the Director of the Centers for Disease Control and Prevention shall submit to Congress not later than 1 year after the date of enactment of this part—</text>
<paragraph id="H3E015C2741194866A07EB11E99AD76E4"><enum>(1)</enum><text>a report that includes recommendations of effective employer-based wellness programs; and</text></paragraph>
<paragraph id="H59885FADA0934BC0A7D6978E6F47A604"><enum>(2)</enum><text>an Employer Wellness Model that is supported by the Centers for Disease Control and Prevention.</text></paragraph></subsection></section>
<section id="HAE1C95C997FD4373BCA920E5FAC47E2D"><enum>399Z–2.</enum><header>Workplace wellness education campaign for employers</header><text display-inline="no-display-inline">The Director of the Centers for Disease Control and Prevention, in coordination with relevant worksite health promotion organizations, shall conduct an educational campaign to make employers, employer groups, and other interested parties aware of the benefits of employer-based wellness programs. Such campaign shall include information about the Employer Wellness Model described in section 399Z–1(b)(2) and information on developing, implementing, and maintaining a program based on such model.</text></section>
<section id="H730699B908974DA2AE22832EB32CAB77"><enum>399Z–3.</enum><header>Evaluation of employer-based wellness programs</header><text display-inline="no-display-inline">The Director of the Centers for Disease Control and Prevention shall enter into contracts with entities to—</text>
<paragraph id="HCC85C751DF714F97B0F8C35740BB84D8"><enum>(1)</enum><text>provide employers with technical assistance in evaluating such employers’ employer-based wellness programs; and</text></paragraph>
<paragraph id="H48F07D7D5C804518A13187A994740038"><enum>(2)</enum><text>train employers on how to evaluate such employers’ employer-based wellness programs.</text></paragraph></section>
<section id="H4D43173577C346CA9CE56782B58D46B6"><enum>399Z–4.</enum><header>Requirements based on appropriated funds</header><text display-inline="no-display-inline">The Director of the Centers for Disease Control and Prevention shall be required to carry out the activities in sections 399Z–1, 399Z–2, and 399Z–3 only if funds are appropriated to carry out such sections.</text></section></part><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle>
<subtitle id="HF5A728E4D54F4A2DA1B57D104ED742B"><enum>B</enum><header>Healthy Communities</header>
<section id="H11101FBAA79640B4A0ABA7665633E16C"><enum>211.</enum><header>Healthy community grants</header><text display-inline="no-display-inline">Part P of title III of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g et seq.</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H550C3527AF5340E692BBC0F67D68EA6B">
<section id="H2170BED38F1042BEAAE57C77C65FA6D"><enum>399P.</enum><header>Healthy community grants</header>
<subsection id="HC6166FD12EEA44729687F477E2B769E5"><enum>(a)</enum><header>Establishment</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with the Directors of other appropriate Federal agencies, shall award competitive grants to eligible entities for the purpose of planning and implementing programs that seek to promote individual and community health and to prevent the incidence of chronic disease.</text></subsection>
<subsection id="H00EB0810B5934425A63C8F037131788B"><enum>(b)</enum><header>Eligibility</header>
<paragraph id="H3C0DA14C37444C158D7456EAA0DA5E4"><enum>(1)</enum><header>In general</header><text>To be eligible to receive a grant under this section an entity shall—</text>
<subparagraph id="H4762CFA57BC5486ABBE67C8B02F7818B"><enum>(A)</enum><text>be—</text>
<clause id="HA9F1F64950D249AFB14442F490ECE2D5"><enum>(i)</enum><text>a city, county, or Indian tribe;</text></clause>
<clause id="H831E1B63DA334362B46D91F6CEC1B4D1"><enum>(ii)</enum><text>a local or tribal educational agency;</text></clause>
<clause id="H1DF9AFB4AE3D4E0E9CB14B66C1256DD9"><enum>(iii)</enum><text>an accredited university, college, or community college;</text></clause>
<clause id="H71DD4F902EEE49028D6782C45DCF38B4"><enum>(iv)</enum><text>a federally qualified health center;</text></clause>
<clause id="HD2C059C8C73B4374ACE5602AD2F4532"><enum>(v)</enum><text>a local health department;</text></clause>
<clause id="H57507D35CCAC40DDBD97B81931FB7E4C"><enum>(vi)</enum><text>a health care provider;</text></clause>
<clause id="H8324DB4D3CC6466689DAB5A29534E58D"><enum>(vii)</enum><text>a community-based organization; or</text></clause>
<clause id="H7F94BD7B2CB24D1B8184FEC85B9FC658"><enum>(viii)</enum><text>any other entity determined appropriate by the Secretary, including a consortia or partnership of entities described in any of clauses (i) through (vii);</text></clause></subparagraph>
<subparagraph id="H266CCB95F43A41399700E17F69111E6B"><enum>(B)</enum><text>prepare and submit an application in accordance with paragraph (2); and</text></subparagraph>
<subparagraph id="HED04B4B23189407AA11B7E78B1009BAD"><enum>(C)</enum><text>provide assurances that the entity will contribute the non-Federal share as required under paragraph (3) to the cost of the activities carried out under the grant.</text></subparagraph></paragraph>
<paragraph id="HC2ABC725A9D2439A9B64046E22E888EC"><enum>(2)</enum><header>Application</header>
<subparagraph id="HFCFEA275F311474196B142C16086F537"><enum>(A)</enum><header>In general</header><text>An entity desiring a grant under this section shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require, including a plan that meets the requirements of subparagraph (B).</text></subparagraph>
<subparagraph id="HD43A9735CF7F4DFEAD43271629DE5C46"><enum>(B)</enum><header>Plan</header><text>A plan meets the requirements of this subparagraph if such plan, at a minimum, includes information regarding—</text>
<clause id="H6FA650CEC7E544799FA92FDDBE23D00"><enum>(i)</enum>
<subclause display-inline="yes-display-inline" id="HD2D8EEB7331D4602BCE8E4D11CFC265"><enum>(I)</enum><text>programs or community-based activities that the applicant proposes to carry out with funds received under this section and which seek to prevent and reduce the incidence of—</text>
<item indent="subclause" id="HCE6096BA951D478D8E18EF7841B60190"><enum>(aa)</enum><text>overweight and obesity, or chronic diseases associated with overweight and obesity;</text></item>
<item indent="subclause" id="H80269F6371E1450990EEEF3BAB1963DD"><enum>(bb)</enum><text>tobacco use; or</text></item>
<item indent="subclause" id="H4A1A1384FA134ECEAD7EE690FEAB8706"><enum>(cc)</enum><text>mental illness; or</text></item></subclause>
<subclause indent="clause" id="H073C3C4CC6824C45A6698472F893E781"><enum>(II)</enum><text>other such activities, as determined appropriate by the Secretary, that are consistent with the goals of promoting individual and community health and preventing chronic disease; and</text></subclause></clause>
<clause id="H7FEA31EF9B3346E08D478EF47EB8F8C"><enum>(ii)</enum><text>the manner in which the applicant will evaluate the effectiveness of the program or activities carried out under this section.</text></clause></subparagraph></paragraph>
<paragraph id="H2837E5380B4343988BD6F486856921AF"><enum>(3)</enum><header>Non-federal share</header><text>To be eligible to receive a grant under this section, an entity shall provide a non-Federal contribution, in cash or in kind, to the costs of activities under the grant in an amount that is equal to not less than 25 percent of the costs of such activities.</text></paragraph></subsection>
<subsection id="H480BE04E2FB24D2DAC963669C4F37EA0"><enum>(c)</enum><header>Use of funds</header><text>An entity that receives a grant under this section shall use the amount made available under the grant to carry out community-based activities, including—</text>
<paragraph id="HFB83399F17FE4290A1F7917C2976FC00"><enum>(1)</enum><text>activities that seek to promote individual health and community wellness and to prevent and reduce the incidence of health problems and chronic diseases associated with—</text>
<subparagraph id="HE9261525DFC144139799A878EC62DFC3"><enum>(A)</enum><text>being overweight or obese;</text></subparagraph>
<subparagraph id="HF3165FC63C9B4E0C825BA67CD15787B"><enum>(B)</enum><text>tobacco use; or</text></subparagraph>
<subparagraph id="HFB78EBDCE9AB44E300DC8D67842C3DEA"><enum>(C)</enum><text>mental illness; or</text></subparagraph></paragraph>
<paragraph id="H9A83F5C8439B4981AE5E6C7F40005978"><enum>(2)</enum><text>other activities undertaken with the goals of health promotion and chronic disease prevention, as determined appropriate by the Secretary.</text></paragraph></subsection>
<subsection id="HDCF36BEB45DA464FB169FA1010FEAD70"><enum>(d)</enum><header>Priority</header><text>In awarding grants under subsection (a), the Secretary shall give priority to—</text>
<paragraph id="H97F48424F50F48B58DB789F9811DB95F"><enum>(1)</enum><text>entities that demonstrate that they have previously applied successfully for funds to carry out activities that seek to promote individual and community health and to prevent the incidence of chronic disease and that can cite published and peer-reviewed research demonstrating that the activities that the entity proposes to carry out under this subsection are effective;</text></paragraph>
<paragraph id="HED215E024B514FD68D01B807B0F76D9D"><enum>(2)</enum><text>entities that will carry out programs or activities that seek to accomplish a goal or goals set by the State in the Healthy People 2010 plan of the State;</text></paragraph>
<paragraph id="H99E109EDB534484083B9CF4B2BF7E00"><enum>(3)</enum><text>entities that provide non-Federal contributions, either in cash or in kind, to the costs of funding activities under the grant;</text></paragraph>
<paragraph id="H2EA330C3150C4A23901521F75F379751"><enum>(4)</enum><text>entities that develop comprehensive plans that include a strategy for extending program activities developed under this section in the years following the fiscal years for which they receive grants under this section;</text></paragraph>
<paragraph id="HE5F6AC57D0D540DCAB4CC19E95E8D91"><enum>(5)</enum><text>entities located in communities that are medically underserved, as determined by the Secretary;</text></paragraph>
<paragraph id="H8DB2FE4EBAE14B910074236D5E46246F"><enum>(6)</enum><text>entities located in areas where the average poverty rate is 150 or higher than the average poverty rate in the State involved, as determined by the Secretary; and</text></paragraph>
<paragraph id="H94346B7AD895454CB2A2B8D96B1366C3"><enum>(7)</enum><text>entities that submit plans that exhibit multisectoral, cooperative conduct that includes the involvement of a broad range of stakeholders, including—</text>
<subparagraph id="H1730046049C74929B100DBB122D17218"><enum>(A)</enum><text>community-based organizations;</text></subparagraph>
<subparagraph id="HD8EF5B3E06914C2B8216193100753430"><enum>(B)</enum><text>local governments;</text></subparagraph>
<subparagraph id="H434D9198E553493AA8C1B3729F126000"><enum>(C)</enum><text>local educational agencies;</text></subparagraph>
<subparagraph id="HC7CD5B0D5C264AC0BB16CD98801F979E"><enum>(D)</enum><text>the private sector;</text></subparagraph>
<subparagraph id="H0DC411C964C448DA8340CDF738935E3C"><enum>(E)</enum><text>State or local departments of health;</text></subparagraph>
<subparagraph id="H33D53B0DC8784508ABFD5D001BA415A8"><enum>(F)</enum><text>accredited colleges, universities, and community colleges;</text></subparagraph>
<subparagraph id="HD4048A8C14D543408685C0A305EF9B4"><enum>(G)</enum><text>health care providers;</text></subparagraph>
<subparagraph id="HA9E7BF7CFD1242FBBC07E6FA4F3C40BD"><enum>(H)</enum><text>State and local departments of transportation and city planning; and</text></subparagraph>
<subparagraph id="HD8C1601347AF4E2D9DCB41F85933B855"><enum>(I)</enum><text>other entities determined appropriate by the Secretary.</text></subparagraph></paragraph></subsection>
<subsection id="H1BD3A885F65645C6BECC7C73288160BC"><enum>(e)</enum><header>Technical assistance</header><text>From amounts appropriated to carry out this section, the Secretary may reserve not more than 10 percent for each fiscal year to provide entities receiving grants under this section with technical assistance in the implementation of the plans required under subsection (b)(2)(B).</text></subsection>
<subsection id="HFB796AECC25E44F28635631F236E0241"><enum>(f)</enum><header>Evaluation</header><text>From amounts appropriated to carry out this section, the Secretary may reserve not to exceed 5 percent for each fiscal year for the purpose of carrying out evaluations of the activities carried out under this section. Not later than 90 days after the completion of any such evaluation, the results of such evaluation shall be submitted to the relevant authorizing committees of Congress and to the Committee on Appropriations of the Senate and the Committee on Appropriations of the House of Representatives.</text></subsection>
<subsection id="H7D4295264910471680E4D72F2C9F8F26"><enum>(g)</enum><header>Limitation on administrative costs</header><text>An entity may not use more than 10 percent of amounts received under a grant under this section for administrative expenses.</text></subsection>
<subsection id="HEE18808A948D4EC1A05039F1044E7E33"><enum>(h)</enum><header>Supplement not supplant</header><text>Amounts provided under a grant under this section shall be used to supplement, and not supplant, other amounts provided for activities of the type to be carried out under this section.</text></subsection>
<subsection id="HEF518C208F094DCAB702D70080007581"><enum>(i)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated such sums as may be necessary to carry out this section.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="HDE20C40BB8164778AB3F689FA83547C9"><enum>212.</enum><header>Preventive medicine and public health training grant program</header><text display-inline="no-display-inline">Part C of title VII of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> is amended by inserting after section 747 (<external-xref legal-doc="usc" parsable-cite="usc/42/293k">42 U.S.C. 293k</external-xref>) the following:</text>
<quoted-block act-name="Public Health Service Act" id="H1AA7AA5B1ED24D12B75715DB96AAE0A1">
<section id="HFBD1DE0E427A4114B65858AFA3A3A6B1"><enum>747A.</enum><header>Preventive medicine and public health training grant program</header>
<subsection id="HB72A109815014326AD024F69857977C5"><enum>(a)</enum><header>Grants</header><text>The Secretary may award grants to, or enter into contracts with, eligible entities to provide training to graduate medical residents in preventive medicine and public health.</text></subsection>
<subsection id="H36D16FDB407C4EF889B1637F18D7AAB4"><enum>(b)</enum><header>Eligibility</header><text>To be eligible to receive a grant or contract under subsection (a), an entity shall—</text>
<paragraph id="HD0A28F0CA6E0419C88182CF834F0391B"><enum>(1)</enum><text>be a school of public health, public health department, school of medicine or osteopathic medicine, public or private hospital, or public or private non-profit entity; and</text></paragraph>
<paragraph id="H09F533A50B334459B7E25ED2172C5B2E"><enum>(2)</enum><text>submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require.</text></paragraph></subsection>
<subsection id="HD1A6536533554AFBB1DF2110E03CBF71"><enum>(c)</enum><header>Preference and special consideration</header>
<paragraph id="HAFC740AB9A4645EBAA4DA4F18C1BC0E3"><enum>(1)</enum><header>Preference</header><text>In awarding grants or contracts under this section, the Secretary shall give preference to one or more eligible entities that have a record of training providers who practice preventive medicine or public health as compared to other eligible entities.</text></paragraph>
<paragraph id="H17DD2E422E8A4E34AD6CEDEEBEC6DB21"><enum>(2)</enum><header>Special consideration</header><text>In awarding grants or contracts under this section, the Secretary shall give special consideration to eligible entities that will carry out projects under the grant or contract that train physicians in community-based approaches to combating the incidence rates of obesity, diabetes, heart disease, cancer, and other chronic diseases, and institutions that have a record of training qualified individuals from disadvantaged backgrounds.</text></paragraph></subsection>
<subsection id="H6172727ABF3847EDBA706BAAFB1B1BA5"><enum>(d)</enum><header>Use of funds</header><text>Amounts received under a grant or contract under this section shall be used to—</text>
<paragraph id="H00D9C70D924A4EB395ACEF0022FAE11"><enum>(1)</enum><text>plan, develop, and operate residency programs for preventive medicine or public health;</text></paragraph>
<paragraph id="HE9718D235BB04A4392F888807251F88F"><enum>(2)</enum><text>provide financial assistance, including tuition and stipends, to resident physicians (MD or DO) who plan to specialize in preventive medicine or public health;</text></paragraph>
<paragraph id="H8D313B9BFF804E26A59289E3E347CFA"><enum>(3)</enum><text>defray the costs associated with the planning, development, and operation of preventive medicine or public health programs, including the development of curriculum to be used in such program; and</text></paragraph>
<paragraph id="HC98D681D6DFF42BDAA08D1080000F049"><enum>(4)</enum><text>provide for the improvement of academic administrative units.</text></paragraph></subsection>
<subsection id="HEDDDF055C3E948D4B91B6485E204ACB0"><enum>(e)</enum><header>Duration of award</header><text>A grant or contract under this section shall be for a term not to exceed 5 years.</text></subsection>
<subsection id="HBDE7F8BCFD394AA1B5D7D5CA4576A25E"><enum>(f)</enum><header>Authorization of appropriations</header><text>There is authorized to be appropriated to carry out this section, $43,000,000 for fiscal year 2007, and such sums as may be necessary for each succeeding fiscal year.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle>
<subtitle id="HBB7B3C256D4C4950B930F1462CD254D0"><enum>C</enum><header>Family Smoking Prevention and Control</header>
<section id="H787D5CC422F544B4ADBE2B1C12C022B5"><enum>221.</enum><header>Short title</header><text display-inline="no-display-inline">This subtitle may be cited as the <quote><short-title>Family Smoking Prevention and Tobacco Control Act</short-title></quote>.</text></section>
<section id="H65C10E1C508E47FA9458AC4910001D56"><enum>222.</enum><header>Findings</header><text display-inline="no-display-inline">The Congress finds the following:</text>
<paragraph id="H3ABA07BCBC2D47368153832E35298DD2"><enum>(1)</enum><text>The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.</text></paragraph>
<paragraph id="H0D43D7742DD54446BA0796D7BBEE172"><enum>(2)</enum><text>A consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects.</text></paragraph>
<paragraph id="H61E238F3BE0D4C21A3C2B7175E890768"><enum>(3)</enum><text>Nicotine is an addictive drug.</text></paragraph>
<paragraph id="H2D467678D92A400CABFC250811B2CED"><enum>(4)</enum><text>Virtually all new users of tobacco products are under the minimum legal age to purchase such products.</text></paragraph>
<paragraph id="H488F460B601C4B209300A4ECD09BBFA"><enum>(5)</enum><text>Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products by adolescents.</text></paragraph>
<paragraph id="H38A4C70F88FB44E2ABC3A3FF8B5BB84C"><enum>(6)</enum><text>Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed.</text></paragraph>
<paragraph id="H6089E2C7973049F792469B129D24E876"><enum>(7)</enum><text>Federal and State governments have lacked the legal and regulatory authority and resources they need to address comprehensively the public health and societal problems caused by the use of tobacco products.</text></paragraph>
<paragraph id="HF75E74D956E6439383CC16BE151FF022"><enum>(8)</enum><text>Federal and State public health officials, the public health community, and the public at large recognize that the tobacco industry should be subject to ongoing oversight.</text></paragraph>
<paragraph id="HFB46C1F9144B48E0A18E65FFB43E7FD"><enum>(9)</enum><text>Under article I, section 8 of the Constitution, the Congress is vested with the responsibility for regulating interstate commerce and commerce with Indian tribes.</text></paragraph>
<paragraph id="H568C981FA01841FDACC8CEE249FCCDE3"><enum>(10)</enum><text>The sale, distribution, marketing, advertising, and use of tobacco products are activities in and substantially affecting interstate commerce because they are sold, marketed, advertised, and distributed in interstate commerce on a nationwide basis, and have a substantial effect on the Nation’s economy.</text></paragraph>
<paragraph id="H33BBE2D2966544BBA53050F2E004E37"><enum>(11)</enum><text>The sale, distribution, marketing, advertising, and use of such products substantially affect interstate commerce through the health care and other costs attributable to the use of tobacco products.</text></paragraph>
<paragraph id="H9B6F8D2A16A04FFC9816AAD6D563FDFF"><enum>(12)</enum><text>It is in the public interest for Congress to enact legislation that provides the Food and Drug Administration with the authority to regulate tobacco products and the advertising and promotion of such products. The benefits to the American people from enacting such legislation would be significant in human and economic terms.</text></paragraph>
<paragraph id="HF62363FB88B4428D90F2D287CEBDE94B"><enum>(13)</enum><text>Tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year and approximately 8,600,000 Americans have chronic illnesses related to smoking.</text></paragraph>
<paragraph id="H0B294DA53BC6424CBA69BB50F6D90089"><enum>(14)</enum><text>Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs.</text></paragraph>
<paragraph id="HB96B6A0BBD934DDCBA7116BFF8A79806"><enum>(15)</enum><text>Advertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products and these efforts have resulted in increased use of such products by youth. Past efforts to oversee these activities have not been successful in adequately preventing such increased use.</text></paragraph>
<paragraph id="HB50C301AD9CC4274A6A574378372A5ED"><enum>(16)</enum><text>In 2002, the tobacco industry spent more than $12,466,000,000 to attract new users, retain current users, increase current consumption, and generate favorable long-term attitudes toward smoking and tobacco use.</text></paragraph>
<paragraph id="H6BBD5F1AD9374AAC98EC0932DC2C5203"><enum>(17)</enum><text>Tobacco product advertising often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors.</text></paragraph>
<paragraph id="H5D752AD981F64C83846538344C3463E4"><enum>(18)</enum><text>Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of 18 are regularly exposed to tobacco product promotional efforts.</text></paragraph>
<paragraph id="H6580CC9F66F14DBEB0DB7700724E5C40"><enum>(19)</enum><text>Through advertisements during and sponsorship of sporting events, tobacco has become strongly associated with sports and has become portrayed as an integral part of sports and the healthy lifestyle associated with rigorous sporting activity.</text></paragraph>
<paragraph id="H9A98EBF14770408A90C8000056E02DBF"><enum>(20)</enum><text>Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the number of young people who begin to use tobacco.</text></paragraph>
<paragraph id="H39320CC909AB4C4580A9C354AB28239C"><enum>(21)</enum><text>The use of tobacco products in motion pictures and other mass media glamorizes its use for young people and encourages them to use tobacco products.</text></paragraph>
<paragraph id="HB782AECF13FF40AA8F471CE8F4FC17EA"><enum>(22)</enum><text>Tobacco advertising expands the size of the tobacco market by increasing consumption of tobacco products including tobacco use by young people.</text></paragraph>
<paragraph id="H4C08492F533E4F2B957D11309531D5C6"><enum>(23)</enum><text>Children are more influenced by tobacco advertising than adults, they smoke the most advertised brands.</text></paragraph>
<paragraph id="HBBBC2F56A0D147D8BF9718DEA81286D7"><enum>(24)</enum><text>Tobacco company documents indicate that young people are an important and often crucial segment of the tobacco market. Children, who tend to be more price-sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices.</text></paragraph>
<paragraph id="H32B3591F565A4650891944ADE5556262"><enum>(25)</enum><text>Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people.</text></paragraph>
<paragraph id="HE4193131B344414F00E441FF569400C7"><enum>(26)</enum><text>Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from undermining legislation prohibiting access to young people and providing for education about tobacco use.</text></paragraph>
<paragraph id="HCA288E50896D47009F375E2C4B64B815"><enum>(27)</enum><text>International experience shows that advertising regulations that are stringent and comprehensive have a greater impact on overall tobacco use and young people’s use than weaker or less comprehensive ones.</text></paragraph>
<paragraph id="H74E0CD7B09A14B928EFB6D42769F2F06"><enum>(28)</enum><text>Text only requirements, although not as stringent as a ban, will help reduce underage use of tobacco products while preserving the informational function of advertising.</text></paragraph>
<paragraph id="H2039EB5C22134D43A761B911B48141F0"><enum>(29)</enum><text>It is in the public interest for Congress to adopt legislation to address the public health crisis created by actions of the tobacco industry.</text></paragraph>
<paragraph id="H41C4475247294063A721F6C978FBE633"><enum>(30)</enum><text>The final regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg. 44615–44618) for inclusion as part 897 of title 21, Code of Federal Regulations, are consistent with the First Amendment to the United States Constitution and with the standards set forth in the amendments made by this subtitle for the regulation of tobacco products by the Food and Drug Administration and the restriction on the sale and distribution, including access to and the advertising and promotion of, tobacco products contained in such regulations are substantially related to accomplishing the public health goals of this Act.</text></paragraph>
<paragraph id="H23B9DF958FD242178808B1D4D0CA8EAB"><enum>(31)</enum><text>The regulations described in paragraph (30) will directly and materially advance the Federal Government’s substantial interest in reducing the number of children and adolescents who use cigarettes and smokeless tobacco and in preventing the life-threatening health consequences associated with tobacco use. An overwhelming majority of Americans who use tobacco products begin using such products while they are minors and become addicted to the nicotine in those products before reaching the age of 18. Tobacco advertising and promotion plays a crucial role in the decision of these minors to begin using tobacco products. Less restrictive and less comprehensive approaches have not and will not be effective in reducing the problems addressed by such regulations. The reasonable restrictions on the advertising and promotion of tobacco products contained in such regulations will lead to a significant decrease in the number of minors using and becoming addicted to those products.</text></paragraph>
<paragraph id="H0592E527477B43E288ECFE282C8037E5"><enum>(32)</enum><text>The regulations described in paragraph (30) impose no more extensive restrictions on communication by tobacco manufacturers and sellers than are necessary to reduce the number of children and adolescents who use cigarettes and smokeless tobacco and to prevent the life-threatening health consequences associated with tobacco use. Such regulations are narrowly tailored to restrict those advertising and promotional practices which are most likely to be seen or heard by youth and most likely to entice them into tobacco use, while affording tobacco manufacturers and sellers ample opportunity to convey information about their products to adult consumers.</text></paragraph>
<paragraph id="H4A9AB4382A774CC1A100F77B02AE7B1E"><enum>(33)</enum><text>Tobacco dependence is a chronic disease, one that typically requires repeated interventions to achieve long-term or permanent abstinence.</text></paragraph>
<paragraph id="H5E50EF758302422D95C6CC2169B089B"><enum>(34)</enum><text>Because the only known safe alternative to smoking is cessation, interventions should target all smokers to help them quit completely.</text></paragraph>
<paragraph id="HEFD2D53C57814E288B369631BB66332F"><enum>(35)</enum><text>Tobacco products have been used to facilitate and finance criminal activities both domestically and internationally. Illicit trade of tobacco products has been linked to organized crime and terrorist groups.</text></paragraph>
<paragraph id="H0FE934FF5607409A907099EE77264571"><enum>(36)</enum><text>It is essential that the Food and Drug Administration review products sold or distributed for use to reduce risks or exposures associated with tobacco products and that it be empowered to review any advertising and labeling for such products. It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.</text></paragraph>
<paragraph id="HBA7ED429B71049FEB300F741D385A67E"><enum>(37)</enum><text>Unless tobacco products that purport to reduce the risks to the public of tobacco use actually reduce such risks, those products can cause substantial harm to the public health to the extent that the individuals, who would otherwise not consume tobacco products or would consume such products less, use tobacco products purporting to reduce risk. Those who use products sold or distributed as modified risk products that do not in fact reduce risk, rather than quitting or reducing their use of tobacco products, have a substantially increased likelihood of suffering disability and premature death. The costs to society of the widespread use of products sold or distributed as modified risk products that do not in fact reduce risk or that increase risk include thousands of unnecessary deaths and injuries and huge costs to our health care system.</text></paragraph>
<paragraph id="H3ECCE7B516274E67A4E87C4F9959FBB9"><enum>(38)</enum><text>As the National Cancer Institute has found, many smokers mistakenly believe that <quote>low tar</quote> and <quote>light</quote> cigarettes cause fewer health problems than other cigarettes. As the National Cancer Institute has also found, mistaken beliefs about the health consequences of smoking <quote>low tar</quote> and <quote>light</quote> cigarettes can reduce the motivation to quit smoking entirely and thereby lead to disease and death.</text></paragraph>
<paragraph id="HBE71818BE48749B18BD4E449A7E1DBB"><enum>(39)</enum><text>Recent studies have demonstrated that there has been no reduction in risk on a population-wide basis from <quote>low tar</quote> and <quote>light</quote> cigarettes and such products may actually increase the risk of tobacco use.</text></paragraph>
<paragraph id="HD3525FC8FB15406391699B0049925968"><enum>(40)</enum><text>The dangers of products sold or distributed as modified risk tobacco products that do not in fact reduce risk are so high that there is a compelling governmental interest in insuring that statements about modified risk tobacco products are complete, accurate, and relate to the overall disease risk of the product.</text></paragraph>
<paragraph id="H99376747AE244AA5006F2E2F1B4D11CD"><enum>(41)</enum><text>As the Federal Trade Commission has found, consumers have misinterpreted advertisements in which one product is claimed to be less harmful than a comparable product, even in the presence of disclosures and advisories intended to provide clarification.</text></paragraph>
<paragraph id="H20BDFF34D0AC4B77B342CF4B09F2FD95"><enum>(42)</enum><text>Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or implied, even if accompanied by disclaimers would be detrimental to the public health.</text></paragraph>
<paragraph id="H9A145FAF75BD43B58876C2CF759E058C"><enum>(43)</enum><text>The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for risk reduction be approved in advance of marketing, and to require that the evidence relied on to support approval of these products is rigorous.</text></paragraph></section>
<section id="H10CB1C59768743E9986991FA9FE99293"><enum>223.</enum><header>Purpose</header><text display-inline="no-display-inline">The purposes of this Act are—</text>
<paragraph id="H2C450A9DA7624CD1A4E9C4ACF63B3723"><enum>(1)</enum><text>to provide authority to the Food and Drug Administration to regulate tobacco products under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products;</text></paragraph>
<paragraph id="H8617A255F0EE4A8E977373FB3F22F39F"><enum>(2)</enum><text>to ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco;</text></paragraph>
<paragraph id="HA8FA6F0488EF48A5BC7900EFA4F2C46E"><enum>(3)</enum><text>to authorize the Food and Drug Administration to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products;</text></paragraph>
<paragraph id="HE04C14EEFE7A4574A10400ADDD34D2D6"><enum>(4)</enum><text>to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce, and promote less harmful tobacco products;</text></paragraph>
<paragraph id="HFB0316D4DA2B494B8785E07E72A596CF"><enum>(5)</enum><text>to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products;</text></paragraph>
<paragraph id="H099F894AC5F246D094DF3748BA8C242D"><enum>(6)</enum><text>in order to ensure that consumers are better informed, to require tobacco product manufacturers to disclose research which has not previously been made available, as well as research generated in the future, relating to the health and dependency effects or safety of tobacco products;</text></paragraph>
<paragraph id="H332BAC64E96B458E806D00F34725AC11"><enum>(7)</enum><text>to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers;</text></paragraph>
<paragraph id="HD673F431F8D743E2BA9B4C096EAA9500"><enum>(8)</enum><text>to impose appropriate regulatory controls on the tobacco industry;</text></paragraph>
<paragraph id="HBBCE318ED55344199FFF0297ECCAC998"><enum>(9)</enum><text>to promote cessation to reduce disease risk and the social costs associated with tobacco related diseases; and</text></paragraph>
<paragraph id="HFAE6B16C8E42481EADD8A24949AFA2FF"><enum>(10)</enum><text>to strengthen legislation against illicit trade in tobacco products.</text></paragraph></section>
<section id="H5EF057622DC14068AC42159388D9B224"><enum>224.</enum><header>Scope and effect</header>
<subsection id="H3DF113B594FF4A0FB6929E65BFF3D4B6"><enum>(a)</enum><header>Intended effect</header><text>Nothing in this Act (or an amendment made by this Act) shall be construed to—</text>
<paragraph id="H242C97F39CC041C0ACD07F1224DEBF57"><enum>(1)</enum><text>establish a precedent with regard to any other industry, situation, circumstance, or legal action; or</text></paragraph>
<paragraph id="HAAFB1C30ED324454945E56B342B4C1EB"><enum>(2)</enum><text>affect any action pending in Federal, State, or Tribal court, or any agreement, consent decree, or contract of any kind.</text></paragraph></subsection>
<subsection id="H99A2CD6376FA4CB49FA509EA98C0BC6E"><enum>(b)</enum><header>Agricultural activities</header><text>The provisions of this Act (or an amendment made by this Act) which authorize the Secretary to take certain actions with regard to tobacco and tobacco products shall not be construed to affect any authority of the Secretary of Agriculture under existing law regarding the growing, cultivation, or curing of raw tobacco.</text></subsection></section>
<section id="H457880C8EA2D4C12BD9245F1112EA8CD"><enum>225.</enum><header>Severability</header><text display-inline="no-display-inline">If any provision of this Act, the amendments made by this Act, or the application of any provision of this Act to any person or circumstance is held to be invalid, the remainder of this Act, the amendments made by this Act, and the application of the provisions of this Act to any other person or circumstance shall not be affected and shall continue to be enforced to the fullest extent possible.</text></section>
<part id="H617FB80EB2C2497C890093F000137C00"><enum>I</enum><header>Authority of the Food and Drug Administration</header>
<section id="H0992E396D2E648ADA2723D2E1303EE69"><enum>231.</enum><header>Amendment of Federal Food, Drug, and Cosmetic Act</header>
<subsection id="HECB91FA1B4084E90B4E3A86793E7B174"><enum>(a)</enum><header>Definition of Tobacco products</header><text>Section 201 of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/321">21 U.S.C. 321</external-xref>) is amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H1D0C900F02764B5EB547258EE1593662">
<subsection id="H301D78CBE63749C59B91B1BF47A34BFD"><enum>(nn)</enum>
<paragraph id="H08483176C05542A9A6B24007E51E462" display-inline="yes-display-inline"><enum>(1)</enum><text>The term <term>tobacco product</term> means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).</text></paragraph></subsection>
<paragraph indent="subsection" id="HDC07DAAE7EA548CB9BB0F12656807D8E"><enum>(2)</enum><text>The term <term>tobacco product</term> does not mean—</text>
<subparagraph indent="paragraph" id="HD24D2BD2D1F9400A9DA6BB4295EC8674"><enum>(A)</enum><text>a product in the form of conventional food (including water and chewing gum), a product represented for use as or for use in a conventional food, or a product that is intended for ingestion in capsule, tablet, softgel, or liquid form; or</text></subparagraph>
<subparagraph indent="paragraph" id="H932EBEC006C24421BEAE67DFB5F867D"><enum>(B)</enum><text>an article that is approved or is regulated as a drug by the Food and Drug Administration.</text></subparagraph></paragraph>
<paragraph indent="subsection" id="HF2C023227E9E4418ADA52500E25E00D3"><enum>(3)</enum><text>The products described in paragraph (2)(A) shall be subject to chapter IV or chapter V of this Act and the articles described in paragraph (2)(B) shall be subject to chapter V of this Act.</text></paragraph>
<paragraph indent="subsection" id="H288DE3B6C74C4B488F50089E9000007B"><enum>(4)</enum><text>A tobacco product may not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetics, medical device, or a dietary supplement).</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H00A4585128694512A87B2206AFAF19AE"><enum>(b)</enum><header>FDA authority over Tobacco products</header><text>The <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended—</text>
<paragraph id="H15373429F0CE4D8BA623D7D6CFA3FCD8"><enum>(1)</enum><text>by redesignating chapter IX as chapter X;</text></paragraph>
<paragraph id="H1596293D4882429B9BD0FCA92D8E528F"><enum>(2)</enum><text>by redesignating sections 901 through 907 as sections 1001 through 1007; and</text></paragraph>
<paragraph id="HA035A0E5565D4FC3A63420722D5021DE"><enum>(3)</enum><text>by inserting after section 803 the following:</text>
<quoted-block id="H17B7D25F643845F8848C31E9E719CABE">
<chapter id="HB11A549FCD83477F826CFCE0EE9DC6A6"><enum>IX</enum><header>Tobacco products</header>
<section id="HDB01C9E6222B4801AF01D1F800856DA"><enum>900.</enum><header>Definitions</header><text display-inline="no-display-inline">In this chapter:</text>
<paragraph id="H35684CABD6F04A12ABEF97C52BBE21DC"><enum>(1)</enum><header>Additive</header><text>The term <term>additive</term> means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring, coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.</text></paragraph>
<paragraph id="HD78DAC4C9E0B4BF38087C2EF5E1F86FC"><enum>(2)</enum><header>Brand</header><text>The term <term>brand</term> means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, or packaging, logo, registered trademark or brand name, identifiable pattern of colors, or any combination of such attributes.</text></paragraph>
<paragraph id="HDF7EB642DE644413ADDB92FF00FE2F1B"><enum>(3)</enum><header>Cigarette</header><text>The term <term>cigarette</term> has the meaning given that term by section 3(1) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1332">15 U.S.C. 1332(1)</external-xref>), but also includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.</text></paragraph>
<paragraph id="H139B78544E9444E193C47F8FF68D9562"><enum>(4)</enum><header>Cigarette Tobacco</header><text>The term <term>cigarette tobacco</term> means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements for cigarettes shall also apply to cigarette tobacco.</text></paragraph>
<paragraph id="H71396FC401C5459CA875F53BB7C80523"><enum>(5)</enum><header>Commerce</header><text>The term <term>commerce</term> has the meaning given that term by section 3(2) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1332">15 U.S.C. 1332(2)</external-xref>).</text></paragraph>
<paragraph id="HC94833EA7063466E89C7D8CDBD8CDB9E"><enum>(6)</enum><header>Counterfeit Tobacco product</header><text>The term <term>counterfeit tobacco product</term> means a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint or device, or any likeness thereof, of a tobacco product listed in a registration under section 905(i)(1).</text></paragraph>
<paragraph id="H3F08080F5A36463BB7D784B71814FFD6"><enum>(7)</enum><header>Distributor</header><text>The term <term>distributor</term> as regards a tobacco product means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for purposes of this chapter.</text></paragraph>
<paragraph id="H35B9C0A275284154A071C75386DE19F"><enum>(8)</enum><header>Illicit trade</header><text>The term <term>illicit trade</term> means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity.</text></paragraph>
<paragraph id="HCDF849629DFC4388BDF900AA7C79E719"><enum>(9)</enum><header>Indian tribe</header><text>The term <term>Indian tribe</term> has the meaning given such term in section 4(e) of the Indian Self Determination and Education Assistance Act (<external-xref legal-doc="usc" parsable-cite="usc/25/450b">25 U.S.C. 450b(e)</external-xref>).</text></paragraph>
<paragraph id="H68BC3311262F4E2398EED7F76C50004"><enum>(10)</enum><header>Little cigar</header><text>The term <term>little cigar</term> has the meaning given that term by section 3(7) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1332">15 U.S.C. 1332(7)</external-xref>).</text></paragraph>
<paragraph id="HA60C364F987443FAADB991E64D7C00"><enum>(11)</enum><header>Nicotine</header><text>The term <term>nicotine</term> means the chemical substance named 3-(1–Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine.</text></paragraph>
<paragraph id="H26072392136A4E10A5A357FAD988931B"><enum>(12)</enum><header>Package</header><text>The term <term>package</term> means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.</text></paragraph>
<paragraph id="H44AA00E061474F8BABAE842D3C84FA00"><enum>(13)</enum><header>Retailer</header><text>The term <term>retailer</term> means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted.</text></paragraph>
<paragraph id="HEB4B6A1000C44B418345C1BE921FBF81"><enum>(14)</enum><header>Roll-your-own Tobacco</header><text>The term <term>roll-your-own tobacco</term> means any tobacco which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.</text></paragraph>
<paragraph id="H44D142E48A04406FA92DEBCA6816C6"><enum>(15)</enum><header>Smoke constituent</header><text>The term <term>smoke constituent</term> means any chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product.</text></paragraph>
<paragraph id="H1CB4EA19A1334317A50601FB5D852D64"><enum>(16)</enum><header>Smokeless Tobacco</header><text>The term <term>smokeless tobacco</term> means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.</text></paragraph>
<paragraph id="HE539DB283F0D4ABB93891563007BB62C"><enum>(17)</enum><header>State</header><text>The term <term>State</term> means any State of the United States and, for purposes of this chapter, includes the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.</text></paragraph>
<paragraph id="H4A257FF1AC074E18B89EB52F98B4C222"><enum>(18)</enum><header>Tobacco product manufacturer</header><text>Term <term>tobacco product manufacturer</term> means any person, including any repacker or relabeler, who—</text>
<subparagraph id="HC096D6F3FB2040198C4381DFFBF81BE"><enum>(A)</enum><text>manufactures, fabricates, assembles, processes, or labels a tobacco product; or</text></subparagraph>
<subparagraph id="H3B84B31C19AC48ECB21FADA71D76E000"><enum>(B)</enum><text>imports a finished cigarette or smokeless tobacco product for sale or distribution in the United States.</text></subparagraph></paragraph>
<paragraph id="H68FE6FADD39444D89D00005321CE2800"><enum>(19)</enum><header>United States</header><text>The term <term>United States</term> means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.</text></paragraph></section>
<section id="H2C26F9285F5548B0B5718B57D1AC0025"><enum>901.</enum><header>FDA authority over Tobacco products</header>
<subsection id="HBB0C66A87B7D4255983EFF82DC26549"><enum>(a)</enum><header>In general</header><text>Tobacco products shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V, unless—</text>
<paragraph id="H77AB905E4CE14019B868313DA3D0FFF8"><enum>(1)</enum><text>such products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (within the meaning of section 201(g)(1)(B) or section 201(h)(2)); or</text></paragraph>
<paragraph id="H6D87789A1E634C83A200F253F3E04659"><enum>(2)</enum><text>a claim is made for such products under section 201(g)(1)(C) or 201(h)(3);</text><continuation-text continuation-text-level="paragraph">other than modified risk tobacco products approved in accordance with section 911.</continuation-text></paragraph></subsection>
<subsection id="H2F72AB123B194028BAB4F6DC6696FAAC"><enum>(b)</enum><header>Applicability</header><text>This chapter shall apply to all tobacco products subject to the regulations referred to in section 232 of the Family Smoking Prevention and Tobacco Control Act, and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.</text></subsection>
<subsection id="H6E6D2FB39B104FDEBB884C8441BCC660"><enum>(c)</enum><header>Scope</header>
<paragraph id="H00922138AD4E4C0BB8E9E3DC97386408"><enum>(1)</enum><header>In general</header><text>Nothing in this chapter, or any policy issued or regulation promulgated thereunder, or the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect the Secretary’s authority over, or the regulation of, products under this Act that are not tobacco products under chapter V or any other chapter.</text></paragraph>
<paragraph id="HF0617E28163442E78F50A4C432E70017"><enum>(2)</enum><header>Limitation of authority</header>
<subparagraph id="HB92A81DE977643AFB205DCB39D604E42"><enum>(A)</enum><header>In general</header><text>The provisions of this chapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer.</text></subparagraph>
<subparagraph id="HEB884DEE6CCB44DE9FFCAE47DFC61701"><enum>(B)</enum><header>Exception</header><text>Notwithstanding any other provision of this subparagraph, if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco product manufacturer, the producer shall be subject to this chapter in the producer’s capacity as a manufacturer.</text></subparagraph>
<subparagraph id="H1287E4A4A993411F809C09519EBC9B6E"><enum>(C)</enum><header>Rule of construction</header><text>Nothing in this chapter shall be construed to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.</text></subparagraph></paragraph></subsection></section>
<section id="H7C2322F9D2614376B7E8CA8BB0C13764"><enum>902.</enum><header>Adulterated Tobacco products</header><text display-inline="no-display-inline">A tobacco product shall be deemed to be adulterated if—</text>
<paragraph id="H2CBDD7CACE62425C982032E3007F7FC3"><enum>(1)</enum><text>it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health;</text></paragraph>
<paragraph id="HC0A7D62B2D664EBAAD12CF5EC2DAFEA8"><enum>(2)</enum><text>it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health;</text></paragraph>
<paragraph id="HED57C38E14A948A89DDBF4500AAF5A9"><enum>(3)</enum><text>its package is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;</text></paragraph>
<paragraph id="H95EE8DD892A2476290602CA15B2C522C"><enum>(4)</enum><text>it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard established under section 907 unless such tobacco product is in all respects in conformity with such standard;</text></paragraph>
<paragraph id="HDFE0E76C64314F178BAB3F9F011AF16"><enum>(5)</enum>
<subparagraph display-inline="yes-display-inline" id="H3310EAD390714A9682DC2EA77C797D9E"><enum>(A)</enum><text>it is required by section 910(a) to have premarket approval and does not have an approved application in effect; or</text></subparagraph>
<subparagraph indent="paragraph" id="HB03AB2C51A3242DA97B919E2B59F0E3"><enum>(B)</enum><text>it is in violation of the order approving such an application;</text></subparagraph></paragraph>
<paragraph id="H04364B04E67347598366662C41D6E24F"><enum>(6)</enum><text>the methods used in, or the facilities or controls used for, its manufacture, packing or storage are not in conformity with applicable requirements under section 906(e)(1) or an applicable condition prescribed by an order under section 906(e)(2); or</text></paragraph>
<paragraph id="H341E034C90F248C38B735B9C0561FCEF"><enum>(7)</enum><text>it is in violation of section 911.</text></paragraph></section>
<section id="HB85A2930D95B47E99D9171B1063B9F17"><enum>903.</enum><header>Misbranded Tobacco products</header>
<subsection id="HF3414D7C00D2481500193200F577C565"><enum>(a)</enum><header>In general</header><text>A tobacco product shall be deemed to be misbranded—</text>
<paragraph id="HD1F2ED3C7DBC4F4983321F50934249FE"><enum>(1)</enum><text>if its labeling is false or misleading in any particular;</text></paragraph>
<paragraph id="H7AE0F9EC61384C36BAC3ED5FD897800"><enum>(2)</enum><text>if in package form unless it bears a label containing—</text>
<subparagraph id="HA0FE3D4B8F324EE58006A0077E491E"><enum>(A)</enum><text>the name and place of business of the tobacco product manufacturer, packer, or distributor;</text></subparagraph>
<subparagraph id="H0A34FA31B8E14C089D7930084EA83B21"><enum>(B)</enum><text>an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;</text></subparagraph>
<subparagraph id="HB993625DB301444E9DB3877944C7FC0"><enum>(C)</enum><text>an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and</text></subparagraph>
<subparagraph id="H69688FF12DBE475E8BA2AA221C5C2636"><enum>(D)</enum><text>the statement required under section 921(a), except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;</text></subparagraph></paragraph>
<paragraph id="HFD8B8F27E0084A1F8C34F9102BC31FB"><enum>(3)</enum><text>if any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;</text></paragraph>
<paragraph id="HD1C2C388A3FD45CAA12283881FE74B41"><enum>(4)</enum><text>if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;</text></paragraph>
<paragraph id="H9B68AECF24B94F40B8B0956C454D7412"><enum>(5)</enum><text>if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;</text></paragraph>
<paragraph id="HD4A8ABA3356D43DD832494EABFECE3B7"><enum>(6)</enum><text>if it was manufactured, prepared, propagated, compounded, or processed in any State in an establishment not duly registered under section 905(b), 905(c), 905(d), or 905(h), if it was not included in a list required by section 905(i), if a notice or other information respecting it was not provided as required by such section or section 905(j), or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 905(e) as the Secretary by regulation requires;</text></paragraph>
<paragraph id="HF8E65F5FF9764B7A00546235654E1765"><enum>(7)</enum><text>if, in the case of any tobacco product distributed or offered for sale in any State—</text>
<subparagraph id="H11F332D8E4F443BE96B98940DCFD4CD5"><enum>(A)</enum><text>its advertising is false or misleading in any particular; or</text></subparagraph>
<subparagraph id="H7B387F5BD2A84614885CFC11DEE5D339"><enum>(B)</enum><text>it is sold or distributed in violation of regulations prescribed under section 906(d);</text></subparagraph></paragraph>
<paragraph id="HB814468B8AC04D2E9882A01DDDD3675E"><enum>(8)</enum><text>unless, in the case of any tobacco product distributed or offered for sale in any State, the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—</text>
<subparagraph id="HEA5A675DC15C4A9CABA88B313E6D2A5"><enum>(A)</enum><text>a true statement of the tobacco product’s established name as described in paragraph (4), printed prominently; and</text></subparagraph>
<subparagraph id="H0698254C20714C32B782B05F00EC03FB"><enum>(B)</enum><text>a brief statement of—</text>
<clause id="HBE61832D85AE4FA0A770112BF9A4ABB0"><enum>(i)</enum><text>the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications; and</text></clause>
<clause id="H1A41C3DD9DDB490CBF1BE0FDE3444792"><enum>(ii)</enum><text>in the case of specific tobacco products made subject to a finding by the Secretary after notice and opportunity for comment that such action is appropriate to protect the public health, a full description of the components of such tobacco product or the formula showing quantitatively each ingredient of such tobacco product to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing;</text></clause></subparagraph></paragraph>
<paragraph id="H13781EEDFC9E4144AC3975C4A3B18F06"><enum>(9)</enum><text>if it is a tobacco product subject to a tobacco product standard established under section 907, unless it bears such labeling as may be prescribed in such tobacco product standard; or</text></paragraph>
<paragraph id="HEE7BC11B9C934F94A700131B50D53BFD"><enum>(10)</enum><text>if there was a failure or refusal—</text>
<subparagraph id="H84F463233FEC4519BAEDF8B0533B1EE4"><enum>(A)</enum><text>to comply with any requirement prescribed under section 904 or 908; or</text></subparagraph>
<subparagraph id="H48C8B397D0E840778DA59F00CF757608"><enum>(B)</enum><text>to furnish any material or information required under section 909.</text></subparagraph></paragraph></subsection>
<subsection id="HCCDC8E7ABA3B45A7BED09E35BAD6231B"><enum>(b)</enum><header>Prior approval of label statements</header><text>The Secretary may, by regulation, require prior approval of statements made on the label of a tobacco product. No regulation issued under this subsection may require prior approval by the Secretary of the content of any advertisement, except for modified risk tobacco products as provided in section 911. No advertisement of a tobacco product published after the date of enactment of the Family Smoking Prevention and Tobacco Control Act shall, with respect to the language of label statements as prescribed under section 4 of the Cigarette Labeling and Advertising Act and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 or the regulations issued under such sections, be subject to the provisions of sections 12 through 15 of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (15 U.S.C. 52 through 55).</text></subsection></section>
<section id="H2091AECC0A3148DFA2E3CB09E67961EC"><enum>904.</enum><header>Submission of health information to the Secretary</header>
<subsection id="H0663FF4B99284D42A4B07B842BB61C00"><enum>(a)</enum><header>Requirement</header><text>Not later than 6 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:</text>
<paragraph id="H57E43D5B6DEB435D981079893D14D8B0"><enum>(1)</enum><text>A listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.</text></paragraph>
<paragraph id="H7E8E8E1B9FC7497BA6B194D8973B2EB9"><enum>(2)</enum><text>A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with section 4(a)(4) of the Federal Cigarette Labeling and Advertising Act.</text></paragraph>
<paragraph id="HB456A9EECE2B48EB8D7D00751CDC29E3"><enum>(3)</enum><text>A listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 2 years after the date of enactment of this chapter, the manufacturer, importer, or agent shall comply with regulations promulgated under section 916 in reporting information under this paragraph, where applicable.</text></paragraph>
<paragraph id="H42451AB73C944FC180DA98E98193659"><enum>(4)</enum><text>All documents developed after the date of enactment of the Family Smoking Prevention and Tobacco Control Act that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.</text></paragraph></subsection>
<subsection id="H2115C1233BBE4FD9A8F8A0F68B1F7B00"><enum>(b)</enum><header>Data submission</header><text>At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the following:</text>
<paragraph id="H5C0EEAB03252477D9FEFA0C12770D6E"><enum>(1)</enum><text>Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents (including smoke constituents), ingredients, components, and additives.</text></paragraph>
<paragraph id="H086759F93F0A4DEF99F7FA872D8562A"><enum>(2)</enum><text>Any or all documents (including underlying scientific information) relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) that relate to the issue of whether a reduction in risk to health from tobacco products can occur upon the employment of technology available or known to the manufacturer.</text></paragraph>
<paragraph id="H71F329250644418CBEE135E75E33EB1"><enum>(3)</enum><text>Any or all documents (including underlying scientific or financial information) relating to marketing research involving the use of tobacco products or marketing practices and the effectiveness of such practices used by tobacco manufacturers and distributors.</text></paragraph><continuation-text continuation-text-level="subsection">An importer of a tobacco product not manufactured in the United States shall supply the information required of a tobacco product manufacturer under this subsection.</continuation-text></subsection>
<subsection id="H9A72A54B9A574B5B89F9094C998764FA"><enum>(c)</enum><header>Time for submission</header>
<paragraph id="H52F6B4FD9D10463092B8F1CA3BC8B831"><enum>(1)</enum><header>In general</header><text>At least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the manufacturer of such product shall provide the information required under subsection (a).</text></paragraph>
<paragraph id="HC0DBA3912E694E6D88F3822438273747"><enum>(2)</enum><header>Disclosure of additive</header><text>If at any time a tobacco product manufacturer adds to its tobacco products a new tobacco additive or increases the quantity of an existing tobacco additive, the manufacturer shall, except as provided in paragraph (3), at least 90 days prior to such action so advise the Secretary in writing.</text></paragraph>
<paragraph id="H37B339879AB043BCBA70B6DA61391BA"><enum>(3)</enum><header>Disclosure of other actions</header><text>If at any time a tobacco product manufacturer eliminates or decreases an existing additive, or adds or increases an additive that has by regulation been designated by the Secretary as an additive that is not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use, the manufacturer shall within 60 days of such action so advise the Secretary in writing.</text></paragraph></subsection>
<subsection id="H425EED28DD374308BBE801606250D0A7"><enum>(d)</enum><header>Data list</header>
<paragraph id="HD457F7608557474CADA47BCAF4B015AC"><enum>(1)</enum><header>In general</header><text>Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall publish in a format that is understandable and not misleading to a lay person, and place on public display (in a manner determined by the Secretary) the list established under subsection (e).</text></paragraph>
<paragraph id="H96D7E221A5C445F193A44482B606B345"><enum>(2)</enum><header>Consumer research</header><text>The Secretary shall conduct periodic consumer research to ensure that the list published under paragraph (1) is not misleading to lay persons. Not later than 5 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall submit to the appropriate committees of Congress a report on the results of such research, together with recommendations on whether such publication should be continued or modified.</text></paragraph></subsection>
<subsection id="H5F9C402752674F579774B3854FEFD083"><enum>(e)</enum><header>Data collection</header><text>Not later than 12 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall establish a list of harmful and potentially harmful constituents, including smoke constituents, to health in each tobacco product by brand and by quantity in each brand and subbrand. The Secretary shall publish a public notice requesting the submission by interested persons of scientific and other information concerning the harmful and potentially harmful constituents in tobacco products and tobacco smoke.</text></subsection></section>
<section id="HD190527EDB3E449FA787BD506EF7C087"><enum>905.</enum><header>Annual registration</header>
<subsection id="H72CA2698C966458A8200A6B8F6602CA"><enum>(a)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H0FF79FAEE23B431E87AB4D1C42BD29FF"><enum>(1)</enum><header>Manufacture, preparation, compounding, or processing</header><text>The term <term>manufacture, preparation, compounding, or processing</term> shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user.</text></paragraph>
<paragraph id="HCF59A76DAEEA4B15B0503C3106D00F2"><enum>(2)</enum><header>Name</header><text>The term <term>name</term> shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation.</text></paragraph></subsection>
<subsection id="H74153D9AFB0D4C86B0316800C1FA29AA"><enum>(b)</enum><header>Registration by owners and operators</header><text>On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person.</text></subsection>
<subsection id="H68A9E0602C4D4411A9A5C62C3E3FA208"><enum>(c)</enum><header>Registration of new owners and operators</header><text>Every person upon first engaging in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products in any establishment owned or operated in any State by that person shall immediately register with the Secretary that person’s name, place of business, and such establishment.</text></subsection>
<subsection id="HA9CCA75A7A6643899E81BC38EB6D889"><enum>(d)</enum><header>Registration of added establishments</header><text>Every person required to register under subsection (b) or (c) shall immediately register with the Secretary any additional establishment which that person owns or operates in any State and in which that person begins the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products.</text></subsection>
<subsection id="HF4EA59D2BE114DF29D851D70F184DAD6"><enum>(e)</enum><header>Uniform product identification system</header><text>The Secretary may by regulation prescribe a uniform system for the identification of tobacco products and may require that persons who are required to list such tobacco products under subsection (i) shall list such tobacco products in accordance with such system.</text></subsection>
<subsection id="H2450E1E07E8C4960A9BE9F98B423F038"><enum>(f)</enum><header>Public access to registration information</header><text>The Secretary shall make available for inspection, to any person so requesting, any registration filed under this section.</text></subsection>
<subsection id="H4BA5579FECA442D882CF6500AA6E2118"><enum>(g)</enum><header>Biennial inspection of registered establishments</header><text>Every establishment in any State registered with the Secretary under this section shall be subject to inspection under section 704, and every such establishment engaged in the manufacture, compounding, or processing of a tobacco product or tobacco products shall be so inspected by 1 or more officers or employees duly designated by the Secretary at least once in the 2-year period beginning with the date of registration of such establishment under this section and at least once in every successive 2-year period thereafter.</text></subsection>
<subsection id="H94BF822C9E01414E942363F79817809B"><enum>(h)</enum><header>Foreign establishments shall register</header><text>Any establishment within any foreign country engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products, shall register under this section under regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (i) of this section and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether tobacco products manufactured, prepared, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 801(a).</text></subsection>
<subsection id="HA83FAAD3A3C44198B2D061A8149B0097"><enum>(i)</enum><header>Registration information</header>
<paragraph id="H1B6DC4629C614E16B5B938518E499EC1"><enum>(1)</enum><header>Product list</header><text>Every person who registers with the Secretary under subsection (b), (c), (d), or (h) shall, at the time of registration under any such subsection, file with the Secretary a list of all tobacco products which are being manufactured, prepared, compounded, or processed by that person for commercial distribution and which has not been included in any list of tobacco products filed by that person with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by—</text>
<subparagraph id="HEA67B275EBC04C1F81A51E3EF6EEA081"><enum>(A)</enum><text>in the case of a tobacco product contained in the applicable list with respect to which a tobacco product standard has been established under section 907 or which is subject to section 910, a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco product;</text></subparagraph>
<subparagraph id="H8C75CC41F47F4513A46CA3194300F47C"><enum>(B)</enum><text>in the case of any other tobacco product contained in an applicable list, a copy of all consumer information and other labeling for such tobacco product, a representative sampling of advertisements for such tobacco product, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular tobacco product; and</text></subparagraph>
<subparagraph id="HEC5D673A0A8A4F649E49B32248CCF259"><enum>(C)</enum><text>if the registrant filing a list has determined that a tobacco product contained in such list is not subject to a tobacco product standard established under section 907, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular tobacco product.</text></subparagraph></paragraph>
<paragraph id="H4DD8B5C6D66648A0A7C321277B8B3BFB"><enum>(2)</enum><header>Biannual report of any change in product list</header><text>Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following:</text>
<subparagraph id="H0E3D680EDB2A4EA7805D89E9DCABCB95"><enum>(A)</enum><text>A list of each tobacco product introduced by the registrant for commercial distribution which has not been included in any list previously filed by that person with the Secretary under this subparagraph or paragraph (1). A list under this subparagraph shall list a tobacco product by its established name and shall be accompanied by the other information required by paragraph (1).</text></subparagraph>
<subparagraph id="H8C8E3D6654B740FB9871EA17D3EE55A"><enum>(B)</enum><text>If since the date the registrant last made a report under this paragraph that person has discontinued the manufacture, preparation, compounding, or processing for commercial distribution of a tobacco product included in a list filed under subparagraph (A) or paragraph (1), notice of such discontinuance, the date of such discontinuance, and the identity of its established name.</text></subparagraph>
<subparagraph id="H44B1B79AFF3E4D668C9129C8EC91D728"><enum>(C)</enum><text>If since the date the registrant reported under subparagraph (B) a notice of discontinuance that person has resumed the manufacture, preparation, compounding, or processing for commercial distribution of the tobacco product with respect to which such notice of discontinuance was reported, notice of such resumption, the date of such resumption, the identity of such tobacco product by established name, and other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary under this subparagraph.</text></subparagraph>
<subparagraph id="H3055CEF521AA4CCE93A9685E7F2EF4A3"><enum>(D)</enum><text>Any material change in any information previously submitted under this paragraph or paragraph (1).</text></subparagraph></paragraph></subsection>
<subsection id="H928CF3A7EABF410EA52E8E9B0507F11E"><enum>(j)</enum><header>Report preceding introduction of certain Substantially-Equivalent products into interstate commerce</header>
<paragraph id="H40350611F21C45B687E3346523B6D300"><enum>(1)</enum><header>In general</header><text>Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product intended for human use that was not commercially marketed (other than for test marketing) in the United States as of June 1, 2003, shall, at least 90 days prior to making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall prescribe)—</text>
<subparagraph id="HD4A9313B885E471184B581D6E4E1BE2"><enum>(A)</enum><text>the basis for such person’s determination that the tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of June 1, 2003, that is in compliance with the requirements of this Act; and</text></subparagraph>
<subparagraph id="H133C9CB5AC664CB69F5CE61876CC668D"><enum>(B)</enum><text>action taken by such person to comply with the requirements under section 907 that are applicable to the tobacco product.</text></subparagraph></paragraph>
<paragraph id="H03333FE056E643A5B09E5C13F8EB19AF"><enum>(2)</enum><header>Application to certain post June 1, 2003 products</header><text>A report under this subsection for a tobacco product that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after June 1, 2003, and prior to the date that is 15 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act shall be submitted to the Secretary not later than 15 months after such date of enactment.</text></paragraph>
<paragraph id="HFCFB4B52FB3B441EA7BE657F1EB43D45"><enum>(3)</enum><header>Exemptions</header>
<subparagraph id="H14621AB79AB640B6BB22A10513D699E8"><enum>(A)</enum><header>In general</header><text>The Secretary may by regulation, exempt from the requirements of this subsection tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, if the Secretary determines that—</text>
<clause id="H39BD740BF01747938471FA6C6C287315"><enum>(i)</enum><text>such modification would be a minor modification of a tobacco product authorized for sale under this Act;</text></clause>
<clause id="HF5A6A55619774592AF5E9B5E35023721"><enum>(ii)</enum><text>a report under this subsection is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and</text></clause>
<clause id="H6A372CBF8F68471CB98711383B2E823B"><enum>(iii)</enum><text>an exemption is otherwise appropriate.</text></clause></subparagraph>
<subparagraph id="H5D1D7BB0AACD429BBD16A0FA4FA9C04"><enum>(B)</enum><header>Regulations</header><text>Not later than 9 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regulations to implement this paragraph.</text></subparagraph></paragraph></subsection></section>
<section id="H90AEFD41EEA049F287BB3F6496E8FA48"><enum>906.</enum><header>General provisions respecting control of Tobacco products</header>
<subsection id="H74BF4ACF5DF44E9F9D5186CAB7AB8EE0"><enum>(a)</enum><header>In general</header><text>Any requirement established by or under section 902, 903, 905, or 909 applicable to a tobacco product shall apply to such tobacco product until the applicability of the requirement to the tobacco product has been changed by action taken under section 907, section 910, section 911, or subsection (d) of this section, and any requirement established by or under section 902, 903, 905, or 909 which is inconsistent with a requirement imposed on such tobacco product under section 907, section 910, section 911, or subsection (d) of this section shall not apply to such tobacco product.</text></subsection>
<subsection id="H809F7D76B75F4CE78E7000CF5BEC8642"><enum>(b)</enum><header>Information on public access and comment</header><text>Each notice of proposed rulemaking under section 907, 908, 909, 910, or 911 or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth—</text>
<paragraph id="H4341D2FB4DE04285AF13FDF9A0867E50"><enum>(1)</enum><text>the manner in which interested persons may examine data and other information on which the notice or findings is based; and</text></paragraph>
<paragraph id="H358ADFE01A04455100FDD509E296BCB"><enum>(2)</enum><text>the period within which interested persons may present their comments on the notice or findings (including the need therefore) orally or in writing, which period shall be at least 60 days but may not exceed 90 days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefore.</text></paragraph></subsection>
<subsection id="H8854A2436259446CA8F63CA2E5F05300"><enum>(c)</enum><header>Limited confidentiality of information</header><text>Any information reported to or otherwise obtained by the Secretary or the Secretary’s representative under section 903, 904, 907, 908, 909, 910, 911, or 704, or under subsection (e) or (f) of this section, which is exempt from disclosure under subsection (a) of <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code, by reason of subsection (b)(4) of that section shall be considered confidential and shall not be disclosed, except that the information may be disclosed to other officers or employees concerned with carrying out this chapter, or when relevant in any proceeding under this chapter.</text></subsection>
<subsection id="HDA5AB6FB2DC14E9C944B53EA2F00416F"><enum>(d)</enum><header>Restrictions</header>
<paragraph id="HFB96762939244B7FA97FB8CE78451810"><enum>(1)</enum><header>In general</header><text>The Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. The Secretary may by regulation impose restrictions on the advertising and promotion of a tobacco product consistent with and to full extent permitted by the first amendment to the Constitution. The finding as to whether such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account—</text>
<subparagraph id="HF298EC84309F4AB09D01032E7FE1E53B"><enum>(A)</enum><text>the increased or decreased likelihood that existing users of tobacco products will stop using such products; and</text></subparagraph>
<subparagraph id="H7A78C43C6DE6434C853F8D7D64BC96B1"><enum>(B)</enum><text>the increased or decreased likelihood that those who do not use tobacco products will start using such products.</text></subparagraph><continuation-text continuation-text-level="paragraph">No such regulation may require that the sale or distribution of a tobacco product be limited to the written or oral authorization of a practitioner licensed by law to prescribe medical products.</continuation-text></paragraph>
<paragraph id="H95665DE414E5446CB2919F2DEBC48476"><enum>(2)</enum><header>Label statements</header><text>The label of a tobacco product shall bear such appropriate statements of the restrictions required by a regulation under subsection (a) as the Secretary may in such regulation prescribe.</text></paragraph>
<paragraph id="HBE81EF2F38FB4371A36EACA68C92A027"><enum>(3)</enum><header>Limitations</header>
<subparagraph id="HB968C53F515A4DF0B8D71485A5BB006D"><enum>(A)</enum><header>In general</header><text>No restrictions under paragraph (1) may—</text>
<clause id="H4CEB1D9C376B4B898C324054A1F6B104"><enum>(i)</enum><text>prohibit the sale of any tobacco product in face-to-face transactions by a specific category of retail outlets; or</text></clause>
<clause id="H1CE7466F0681459B9BDD65F17FD0B4AD"><enum>(ii)</enum><text>establish a minimum age of sale of tobacco products to any person older than 18 years of age.</text></clause></subparagraph>
<subparagraph id="H5C38860E45AB41EB985C0408FF01FFFB"><enum>(B)</enum><header>Matchbooks</header><text>For purposes of any regulations issued by the Secretary, matchbooks of conventional size containing not more than 20 paper matches, and which are customarily given away for free with the purchase of tobacco products shall be considered as adult written publications which shall be permitted to contain advertising. Notwithstanding the preceding sentence, if the Secretary finds that such treatment of matchbooks is not appropriate for the protection of the public health, the Secretary may determine by regulation that matchbooks shall not be considered adult written publications.</text></subparagraph></paragraph></subsection>
<subsection id="HB8D872DA351D43AEA0FD524EC468C785"><enum>(e)</enum><header>Good manufacturing practice requirements</header>
<paragraph id="H27EEEDCB2CD94054B0B0AE499DC95751"><enum>(1)</enum><header>Methods, facilities, and controls to conform</header>
<subparagraph id="H13579032584449AE8C73B471F5B1D500"><enum>(A)</enum><header>In general</header><text>The Secretary may, in accordance with subparagraph (B), prescribe regulations (which may differ based on the type of tobacco product involved) requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a tobacco product), packing and storage of a tobacco product, conform to current good manufacturing practice, as prescribed in such regulations, to assure that the public health is protected and that the tobacco product is in compliance with this chapter. Good manufacturing practices may include the testing of raw tobacco for pesticide chemical residues regardless of whether a tolerance for such chemical residues has been established.</text></subparagraph>
<subparagraph id="H6554F8F570AE49DE89FBD1A5002E7100"><enum>(B)</enum><header>Requirements</header><text>The Secretary shall—</text>
<clause id="H3255B444CEB441898009A5AEADFC9B74"><enum>(i)</enum><text>before promulgating any regulation under subparagraph (A), afford the Tobacco Products Scientific Advisory Committee an opportunity to submit recommendations with respect to the regulation proposed to be promulgated;</text></clause>
<clause id="H2E32A0F8C38F47728272FC9FC0CB0028"><enum>(ii)</enum><text>before promulgating any regulation under subparagraph (A), afford opportunity for an oral hearing;</text></clause>
<clause id="H995F6F2EC79942E5001511E809AAFF4F"><enum>(iii)</enum><text>provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A); and</text></clause>
<clause id="H1E887B53DA9B4EC3BE09BFBD893BCCD1"><enum>(iv)</enum><text>in establishing the effective date of a regulation promulgated under this subsection, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their existing manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices.</text></clause></subparagraph></paragraph>
<paragraph id="HB31E2A8F1E514ABC928484B63000D2FA"><enum>(2)</enum><header>Exemptions; variances</header>
<subparagraph id="HE734D63C88DC4D868CADCF84A1001CF6"><enum>(A)</enum><header>Petition</header><text>Any person subject to any requirement prescribed under paragraph (1) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as the Secretary shall prescribe and shall—</text>
<clause id="H4011B39AE3B34428B1BD76ACBEBBECC7"><enum>(i)</enum><text>in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner’s determination that compliance with the requirement is not required to assure that the tobacco product will be in compliance with this chapter;</text></clause>
<clause id="HB4013A86AA314DB2933B4C5273A11B52"><enum>(ii)</enum><text>in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, facilities, and controls prescribed by the requirement; and</text></clause>
<clause id="H1E6DBBD216B74A36A8891F70EE1800F6"><enum>(iii)</enum><text>contain such other information as the Secretary shall prescribe.</text></clause></subparagraph>
<subparagraph id="HE557C0480FF049E1A2DBC28697B663D0"><enum>(B)</enum><header>Referral to the Tobacco Products Scientific Advisory Committee</header><text>The Secretary may refer to the Tobacco Products Scientific Advisory Committee any petition submitted under subparagraph (A). The Tobacco Products Scientific Advisory Committee shall report its recommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition’s referral. Within 60 days after—</text>
<clause id="H6854F9C77E80437F0078226EA9223BE3"><enum>(i)</enum><text>the date the petition was submitted to the Secretary under subparagraph (A); or</text></clause>
<clause id="HFD1B9318B50B48239FDEFDBC5C86772B"><enum>(ii)</enum><text>the day after the petition was referred to the Tobacco Products Scientific Advisory Committee, whichever occurs later, the Secretary shall by order either deny the petition or approve it.</text></clause></subparagraph>
<subparagraph id="H2E2C8C7A4EEC46B9B63DEA665E02F33"><enum>(C)</enum><header>Approval</header><text>The Secretary may approve—</text>
<clause id="H5B21FA7CDDBC48AFBF3C548BAFB7F3E1"><enum>(i)</enum><text>a petition for an exemption for a tobacco product from a requirement if the Secretary determines that compliance with such requirement is not required to assure that the tobacco product will be in compliance with this chapter; and</text></clause>
<clause id="H1FA781E8DA264CC887B28789CEE106EE"><enum>(ii)</enum><text>a petition for a variance for a tobacco product from a requirement if the Secretary determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, and storage of the tobacco product in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the tobacco product will be in compliance with this chapter.</text></clause></subparagraph>
<subparagraph id="H4C5B8D78A77D4C2DB9B33F3DA224C918"><enum>(D)</enum><header>Conditions</header><text>An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, and storage of the tobacco product to be granted the variance under the petition as may be necessary to assure that the tobacco product will be in compliance with this chapter.</text></subparagraph>
<subparagraph id="HDF7887FE083A4178A689ED21A7430275"><enum>(E)</enum><header>Hearing</header><text>After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order.</text></subparagraph></paragraph>
<paragraph id="HA75FB50E6A384E9F886255253D79829B"><enum>(3)</enum><header>Compliance</header><text>Compliance with requirements under this subsection shall not be required before the period ending 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act.</text></paragraph></subsection>
<subsection id="H50DE42667DDF457987001405ADC5A5E9"><enum>(f)</enum><header>Research and development</header><text>The Secretary may enter into contracts for research, testing, and demonstrations respecting tobacco products and may obtain tobacco products for research, testing, and demonstration purposes without regard to section 3324(a) and (b) of title 31, United States Code, and <external-xref legal-doc="usc" parsable-cite="usc/41/5">section 5</external-xref> of title 41, United States Code.</text></subsection></section>
<section id="HB4F2A537CEA5440CADC0BF9943580700"><enum>907.</enum><header>Tobacco product standards</header>
<subsection id="H06341293DD06416B964C4399C2896F00"><enum>(a)</enum><header>In general</header>
<paragraph id="H36D44590E2364A31964B8794EDFC8B00"><enum>(1)</enum><header>Special rule for Cigarettes</header><text>A cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. Nothing in this subparagraph shall be construed to limit the Secretary’s authority to take action under this section or other sections of this Act applicable to menthol or any artificial or natural flavor, herb, or spice not specified in this paragraph.</text></paragraph>
<paragraph id="H3A8C9F3A75A04E7FADCB290099453B25"><enum>(2)</enum><header>Revision of Tobacco product standards</header><text>The Secretary may revise the tobacco product standards in paragraph (1) in accordance with subsection (b).</text></paragraph>
<paragraph id="H60166D749348403796D39F8DD423A535"><enum>(3)</enum><header>Tobacco product standards</header><text>The Secretary may adopt tobacco product standards in addition to those in paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This finding shall be determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product, and taking into account—</text>
<subparagraph id="HAB32A7A0649E46DB9ECB846642149382"><enum>(A)</enum><text>the increased or decreased likelihood that existing users of tobacco products will stop using such products; and</text></subparagraph>
<subparagraph id="HD6F13665F85C477B86BF9CC71A137DB"><enum>(B)</enum><text>the increased or decreased likelihood that those who do not use tobacco products will start using such products.</text></subparagraph></paragraph>
<paragraph id="H5DC9FA7845204542BBC9B988488A0AB"><enum>(4)</enum><header>Content of Tobacco product standards</header><text>A tobacco product standard established under this section for a tobacco product—</text>
<subparagraph id="H1C730881A25644DB8610D87EDC6DB608"><enum>(A)</enum><text>shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate—</text>
<clause id="HA3C8EE301DF640CEB83622F4E761F5D9"><enum>(i)</enum><text>for the reduction of nicotine yields of the product;</text></clause>
<clause id="H9438A012CEE74A53861FAAE007A47660"><enum>(ii)</enum><text>for the reduction or elimination of other constituents, including smoke constituents, or harmful components of the product; or</text></clause>
<clause id="HA56F29604E8A450C8FA5095519BE4FAE"><enum>(iii)</enum><text>relating to any other requirement under (B);</text></clause></subparagraph>
<subparagraph id="H0E45A8B004274FAAA98E87370027DBC"><enum>(B)</enum><text>shall, where appropriate for the protection of the public health, include—</text>
<clause id="HFDBBCB9A42E745FB94BC71BBCCEBC09C"><enum>(i)</enum><text>provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product;</text></clause>
<clause id="H126B7A19EAE842C6AAB9D200FF403719"><enum>(ii)</enum><text>provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the tobacco product;</text></clause>
<clause id="H62D099F3ECDA4B6AB21CB9A92C9094BB"><enum>(iii)</enum><text>provisions for the measurement of the tobacco product characteristics of the tobacco product;</text></clause>
<clause id="H17BCE80B5CAC40ACBD4504009DD384C9"><enum>(iv)</enum><text>provisions requiring that the results of each or of certain of the tests of the tobacco product required to be made under clause (ii) show that the tobacco product is in conformity with the portions of the standard for which the test or tests were required; and</text></clause>
<clause id="H7633F9F267654C628867ECAF9792F547"><enum>(v)</enum><text>a provision requiring that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d); and</text></clause></subparagraph>
<subparagraph id="H2EAFFB717A9442A1AB03AA784EBAFB8C"><enum>(C)</enum><text>shall, where appropriate, require the use and prescribe the form and content of labeling for the proper use of the tobacco product.</text></subparagraph></paragraph>
<paragraph id="H3586E2AA40F04E9DA7A11362B8309FD6"><enum>(5)</enum><header>Periodic re-evaluation of Tobacco product standards</header><text>The Secretary shall provide for periodic evaluation of tobacco product standards established under this section to determine whether such standards should be changed to reflect new medical, scientific, or other technological data. The Secretary may provide for testing under paragraph (4)(B) by any person.</text></paragraph>
<paragraph id="H13FF53B65AE74BFBB548FFFFBC4EEDD3"><enum>(6)</enum><header>Involvement of other agencies; informed persons</header><text>In carrying out duties under this section, the Secretary shall endeavor to—</text>
<subparagraph id="H205B63F2722C4451807F15BCD4CB426E"><enum>(A)</enum><text>use personnel, facilities, and other technical support available in other Federal agencies;</text></subparagraph>
<subparagraph id="HD4CDE4821C8D491BA9D71845C9255E3F"><enum>(B)</enum><text>consult with other Federal agencies concerned with standard-setting and other nationally or internationally recognized standard-setting entities; and</text></subparagraph>
<subparagraph id="H7FEEBDD2099D4FED898D8906004F9E59"><enum>(C)</enum><text>invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural, or consumer organizations who in the Secretary’s judgment can make a significant contribution.</text></subparagraph></paragraph></subsection>
<subsection id="H5ACCFAA928984BF594FBABB8D6C7FB65"><enum>(b)</enum><header>Establishment of standards</header>
<paragraph id="H5AEA281781A4467DAF3F31E8106CDB62"><enum>(1)</enum><header>Notice</header>
<subparagraph id="H2700B90E9D9646E4842C0019FAA70365"><enum>(A)</enum><header>In general</header><text>The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any tobacco product standard.</text></subparagraph>
<subparagraph id="H5D9738A65A3244AAA710AE3EE2CB057B"><enum>(B)</enum><header>Requirements of notice</header><text>A notice of proposed rulemaking for the establishment or amendment of a tobacco product standard for a tobacco product shall—</text>
<clause id="H4094EC48FF2244C88453229644A6F9B5"><enum>(i)</enum><text>set forth a finding with supporting justification that the tobacco product standard is appropriate for the protection of the public health;</text></clause>
<clause id="H3ABD89D48B3E41DFBE4314F93FE4D535"><enum>(ii)</enum><text>set forth proposed findings with respect to the risk of illness or injury that the tobacco product standard is intended to reduce or eliminate; and</text></clause>
<clause id="H1F434B450AAC4DEE81AC0073BE59D788"><enum>(iii)</enum><text>invite interested persons to submit an existing tobacco product standard for the tobacco product, including a draft or proposed tobacco product standard, for consideration by the Secretary.</text></clause></subparagraph>
<subparagraph id="HC900571FC3704B6AB329D01739793CAE"><enum>(C)</enum><header>Standard</header><text>Upon a determination by the Secretary that an additive, constituent (including smoke constituent), or other component of the product that is the subject of the proposed tobacco product standard is harmful, it shall be the burden of any party challenging the proposed standard to prove that the proposed standard will not reduce or eliminate the risk of illness or injury.</text></subparagraph>
<subparagraph id="HD414BD86B63A4D9E84E64D5806FAD968"><enum>(D)</enum><header>Finding</header><text>A notice of proposed rulemaking for the revocation of a tobacco product standard shall set forth a finding with supporting justification that the tobacco product standard is no longer appropriate for the protection of the public health.</text></subparagraph>
<subparagraph id="HC0CA6DBE85744BB6B6D6D8D52DE26000"><enum>(E)</enum><header>Consideration by Secretary</header><text>The Secretary shall consider all information submitted in connection with a proposed standard, including information concerning the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or non-tobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of this chapter and the significance of such demand, and shall issue the standard if the Secretary determines that the standard would be appropriate for the protection of the public health.</text></subparagraph>
<subparagraph id="H018F4C0EA3914F2EA5D23581BCD47052"><enum>(F)</enum><header>Comment</header><text>The Secretary shall provide for a comment period of not less than 60 days.</text></subparagraph></paragraph>
<paragraph id="HEAD2079F179F4ABABA58FFC0F4941424"><enum>(2)</enum><header>Promulgation</header>
<subparagraph id="H250D935F0FAD40DFA92C6B88AB28DD25"><enum>(A)</enum><header>In general</header><text>After the expiration of the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a tobacco product standard and after consideration of such comments and any report from the Tobacco Products Scientific Advisory Committee, the Secretary shall—</text>
<clause id="H0870BADDB8C647A384B51688FFBC7338"><enum>(i)</enum><text>promulgate a regulation establishing a tobacco product standard and publish in the Federal Register findings on the matters referred to in paragraph (1); or</text></clause>
<clause id="H8F1C8530FDB74786001E7DCFB9E85BC"><enum>(ii)</enum><text>publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination.</text></clause></subparagraph>
<subparagraph id="H757936EE672B487BBFB0C500749808A2"><enum>(B)</enum><header>Effective date</header><text>A regulation establishing a tobacco product standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before 1 year after the date of its publication unless the Secretary determines that an earlier effective date is necessary for the protection of the public health. Such date or dates shall be established so as to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade.</text></subparagraph></paragraph>
<paragraph id="HCBAE63F4A56A4096B0395D18AC81B098"><enum>(3)</enum><header>Power reserved to Congress</header><text>Because of the importance of a decision of the Secretary to issue a regulation establishing a tobacco product standard—</text>
<subparagraph id="H364D3931BBD3446293E6DEAA1D002FEC"><enum>(A)</enum><text>banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll your own tobacco products; or</text></subparagraph>
<subparagraph id="H21520A869BA34B45A7F4B8D51600FDC3"><enum>(B)</enum><text>requiring the reduction of nicotine yields of a tobacco product to zero,</text></subparagraph><continuation-text continuation-text-level="paragraph">Congress expressly reserves to itself such power.</continuation-text></paragraph>
<paragraph id="H3A6D0B8F849C4D7783E1E54F03A4B175"><enum>(4)</enum><header>Amendment; revocation</header>
<subparagraph id="H3F9900AD29834CF385389B31DDA4C21B"><enum>(A)</enum><header>Authority</header><text>The Secretary, upon the Secretary’s own initiative or upon petition of an interested person may by a regulation, promulgated in accordance with the requirements of paragraphs (1) and (2)(B), amend or revoke a tobacco product standard.</text></subparagraph>
<subparagraph id="H930D9D7A797E446691BA7D8CD9392C5F"><enum>(B)</enum><header>Effective date</header><text>The Secretary may declare a proposed amendment of a tobacco product standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if the Secretary determines that making it so effective is in the public interest.</text></subparagraph></paragraph>
<paragraph id="HAC725A6B6BA7434090A081567FA8C108"><enum>(5)</enum><header>Reference to Advisory Committee</header><text>The Secretary may—</text>
<subparagraph id="H7BADFB537CC341E9A11447C0D1E338B6"><enum>(A)</enum><text>on the Secretary’s own initiative, refer a proposed regulation for the establishment, amendment, or revocation of a tobacco product standard; or</text></subparagraph>
<subparagraph id="H481E56249CCD4503A2F5AF9C408B7FF"><enum>(B)</enum><text>upon the request of an interested person which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation, refer such proposed regulation to the Tobacco Products Scientific Advisory Committee, for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this paragraph to the Tobacco Products Scientific Advisory Committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regulation is based. The Tobacco Products Scientific Advisory Committee shall, within 60 days after the referral of a proposed regulation and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary.</text></subparagraph></paragraph></subsection></section>
<section id="H507031A37C5C495F851587AB5BE447CF"><enum>908.</enum><header>Notification and other remedies</header>
<subsection id="H17E143DDF1E9441BA7998F08DB22BE09"><enum>(a)</enum><header>Notification</header><text>If the Secretary determines that—</text>
<paragraph id="H1886FEF9D23844B191904C8F20119526"><enum>(1)</enum><text>a tobacco product which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and</text></paragraph>
<paragraph id="HE312FECCF4B24E1400C14C81A2E5D325"><enum>(2)</enum><text>notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this chapter (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly receive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.</text></paragraph></subsection>
<subsection id="H51AB45B2F0AD4942904BBD6D661F3425"><enum>(b)</enum><header>No exemption from other liability</header><text>Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided under such order shall be taken into account.</text></subsection>
<subsection id="H10AEF57ED40647CF87A530491B1C923C"><enum>(c)</enum><header>Recall authority</header>
<paragraph id="H2487EF46D1D041CF8C2897C6474E9800"><enum>(1)</enum><header>In general</header><text>If the Secretary finds that there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.</text></paragraph>
<paragraph id="HFD41895BF21343F9BF7E767E386FBFE1"><enum>(2)</enum><header>Amendment of order to require recall</header>
<subparagraph id="H1E2D822C583E47CEB7FE6586349F5561"><enum>(A)</enum><header>In general</header><text>If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.</text></subparagraph>
<subparagraph id="H9B247AF6DAB34576A2C2D27EE793239"><enum>(B)</enum><header>Notice</header><text>An amended order under subparagraph (A)—</text>
<clause id="H8388B0701D9C4F769FF2777488943CEE"><enum>(i)</enum><text>shall not include recall of a tobacco product from individuals; and</text></clause>
<clause id="H51BAC445CCC84B0DBEEBA709BA87016F"><enum>(ii)</enum><text>shall provide for notice to persons subject to the risks associated with the use of such tobacco product.</text></clause><continuation-text continuation-text-level="subparagraph">In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 705(b).</continuation-text></subparagraph></paragraph>
<paragraph id="H6B2E71662BD341E0B27073524B881412"><enum>(3)</enum><header>Remedy not exclusive</header><text>The remedy provided by this subsection shall be in addition to remedies provided by subsection (a) of this section.</text></paragraph></subsection></section>
<section id="H4A1E83001C764624BD13111351572E00"><enum>909.</enum><header>Records and reports on Tobacco products</header>
<subsection id="HF206C1EC8F3740B884BF7D7323B52774"><enum>(a)</enum><header>In general</header><text>Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence—</text>
<paragraph id="H94ABB2AA57994A339C3863324C8F2328"><enum>(1)</enum><text>may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience;</text></paragraph>
<paragraph id="H28A06AEF0A364DD2A4A431ADC8184B0"><enum>(2)</enum><text>shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported;</text></paragraph>
<paragraph id="HD2EB389D19EE4760879E979700063960"><enum>(3)</enum><text>shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this chapter;</text></paragraph>
<paragraph id="H756DB6C295B94D4C8414D687EF97983"><enum>(4)</enum><text>when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information;</text></paragraph>
<paragraph id="H83CAC92987DE4A03BA51B3E40093E2F"><enum>(5)</enum><text>when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; and</text></paragraph>
<paragraph id="H17BD576A9F694E92B0AB9E88C4D0D6F5"><enum>(6)</enum><text>may not require that the identity of any patient or user be disclosed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine risks to public health of a tobacco product, or to verify a record, report, or information submitted under this chapter.</text></paragraph><continuation-text continuation-text-level="subsection">In prescribing regulations under this subsection, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (6) continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient.</continuation-text></subsection>
<subsection id="H976BCC6C20F8493F989B1830FC6F07B0"><enum>(b)</enum><header>Reports of removals and corrections</header>
<paragraph id="HF57C9B745D5946F49B02A59DB7B3CC73"><enum>(1)</enum><header>In general</header><text>Except as provided in paragraph (2), the Secretary shall by regulation require a tobacco product manufacturer or importer of a tobacco product to report promptly to the Secretary any corrective action taken or removal from the market of a tobacco product undertaken by such manufacturer or importer if the removal or correction was undertaken—</text>
<subparagraph id="H2692C99FF2484873BB42061828B3ECBD"><enum>(A)</enum><text>to reduce a risk to health posed by the tobacco product; or</text></subparagraph>
<subparagraph id="HDB4F5DC2D6D04F4EAB6B75274E26B81E"><enum>(B)</enum><text>to remedy a violation of this chapter caused by the tobacco product which may present a risk to health.</text></subparagraph><continuation-text continuation-text-level="paragraph">A tobacco product manufacturer or importer of a tobacco product who undertakes a corrective action or removal from the market of a tobacco product which is not required to be reported under this subsection shall keep a record of such correction or removal.</continuation-text></paragraph>
<paragraph id="H034D0B9CF1B140F800D152CAD9C546B"><enum>(2)</enum><header>Exception</header><text>No report of the corrective action or removal of a tobacco product may be required under paragraph (1) if a report of the corrective action or removal is required and has been submitted under subsection (a).</text></paragraph></subsection></section>
<section id="H8B109B50CFB0473889D9EA480615E8F9"><enum>910.</enum><header>Application for review of certain Tobacco products</header>
<subsection id="HE63F366D4CB74422ADE5351D7BC201BA"><enum>(a)</enum><header>In general</header>
<paragraph id="HD8F406143FDD4A829700CA0085EDA433"><enum>(1)</enum><header>New Tobacco product defined</header><text>For purposes of this section the term <term>new tobacco product</term> means—</text>
<subparagraph id="H627C55F2FC954BEB97C00348F9370DD"><enum>(A)</enum><text>any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of June 1, 2003; or</text></subparagraph>
<subparagraph id="H86AE8F566FDF45FEADAA5061E47D66C"><enum>(B)</enum><text>any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after June 1, 2003.</text></subparagraph></paragraph>
<paragraph id="H09347C66A29447DCBD2C6E46413FDC63"><enum>(2)</enum><header>Premarket approval required</header>
<subparagraph id="H115B32E7C7354C9A8199D83124225E82"><enum>(A)</enum><header>New products</header><text>Approval under this section of an application for premarket approval for any new tobacco product is required unless—</text>
<clause id="HB9EB657FA5604B789459EF00D0CBE174"><enum>(i)</enum><text>the manufacturer has submitted a report under section 905(j); and</text></clause>
<clause id="H8B6E11EC379C4596BAFB305525F90FB"><enum>(ii)</enum><text>the Secretary has issued an order that the tobacco product—</text>
<subclause id="H9F7C476B235D44D7A85C09BF8C481134"><enum>(I)</enum><text>is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of June 1, 2003; and</text></subclause>
<subclause id="H7904D98A4C77484AAB5F786CEFF5B5E4"><enum>(II)</enum>
<item display-inline="yes-display-inline" id="HD7620A2071AB466085CD96370932DC9F"><enum>(aa)</enum><text>is in compliance with the requirements of this Act; or</text></item>
<item indent="subclause" id="H85C36AFE72B7403383E89DBF95F87FE"><enum>(bb)</enum><text>is exempt from the requirements of section 905(j) pursuant to a regulation issued under section 905(j)(3).</text></item></subclause></clause></subparagraph>
<subparagraph id="H534E04FB4C634C6D0035726F4E007100"><enum>(B)</enum><header>Application to certain post June 1, 2003 products</header><text>Subparagraph (A) shall not apply to a tobacco product—</text>
<clause id="H4E47FC8EBBE2422B93EC1BC5582013D0"><enum>(i)</enum><text>that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after June 1, 2003, and prior to the date that is 15 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act; and</text></clause>
<clause id="H54DB227B6C6A4FF89BB678A600C86979"><enum>(ii)</enum><text>for which a report was submitted under section 905(j) within such 15-month period, until the Secretary issues an order that the tobacco product is not substantially equivalent.</text></clause></subparagraph></paragraph>
<paragraph id="H1EF490FC58FE4C3F86DDD2E1DD76168"><enum>(3)</enum><header>Substantially equivalent defined</header>
<subparagraph id="HA0B89F1B88EC4151AA30F4AE85A0B628"><enum>(A)</enum><header>In general</header><text>In this section and section 905(j), the terms <term>substantially equivalent</term> or <term>substantial equivalence</term> mean, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product—</text>
<clause id="HF9AE02AF303143278000F239E7483B00"><enum>(i)</enum><text>has the same characteristics as the predicate tobacco product; or</text></clause>
<clause id="HF9391CDB8CCD4222B934EC1E54A98C00"><enum>(ii)</enum><text>has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.</text></clause></subparagraph>
<subparagraph id="H937A7CF4C96446289E8E00638BC3707C"><enum>(B)</enum><header>Characteristics</header><text>In subparagraph (A), the term <term>characteristics</term> means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.</text></subparagraph>
<subparagraph id="H6C8AD1F6EDA24935A101A448C980AABD"><enum>(C)</enum><header>Limitation</header><text>A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.</text></subparagraph></paragraph>
<paragraph id="HCD85F077AD424148AE9F65D707CA6EFC"><enum>(4)</enum><header>Health information</header>
<subparagraph id="HB49BB2E975254E3594A644BF563BF2FE"><enum>(A)</enum><header>Summary</header><text>As part of a submission under section 905(j) respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such information will be made available upon request by any person.</text></subparagraph>
<subparagraph id="HAE465AAFF2C94CB5AAE65BE3EEFAB2A8"><enum>(B)</enum><header>Required information</header><text>Any summary under subparagraph (A) respecting a tobacco product shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 30 days of the issuance of a determination that such tobacco product is substantially equivalent to another tobacco product.</text></subparagraph></paragraph></subsection>
<subsection id="HB7DD0C44ACF84A52A9DF30F712BAB4D"><enum>(b)</enum><header>Application</header>
<paragraph id="H568151EF008F4287894600007E95E4A8"><enum>(1)</enum><header>Contents</header><text>An application for premarket approval shall contain—</text>
<subparagraph id="HFAFFFC2297A3406C815C25E384BF2239"><enum>(A)</enum><text>full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;</text></subparagraph>
<subparagraph id="HD61924D3CBA84F40B258DC11E43A6EF"><enum>(B)</enum><text>a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product;</text></subparagraph>
<subparagraph id="H4C48B68FAB2A415C95C71E4FFA853900"><enum>(C)</enum><text>a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such tobacco product;</text></subparagraph>
<subparagraph id="HE911A5D3ADA5411EA6FB84DB27D78B9C"><enum>(D)</enum><text>an identifying reference to any tobacco product standard under section 907 which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;</text></subparagraph>
<subparagraph id="H8C64367FFF074B56A1374CBFD700F200"><enum>(E)</enum><text>such samples of such tobacco product and of components thereof as the Secretary may reasonably require;</text></subparagraph>
<subparagraph id="HC7C6E52982904384A8587427FBBE7967"><enum>(F)</enum><text>specimens of the labeling proposed to be used for such tobacco product; and</text></subparagraph>
<subparagraph id="HE327B396FCA2485F8B19C882E314E787"><enum>(G)</enum><text>such other information relevant to the subject matter of the application as the Secretary may require.</text></subparagraph></paragraph>
<paragraph id="H1757199C1DEA4BC8BE383772DE5B361D"><enum>(2)</enum><header>Reference to Tobacco Products Scientific Advisory Committee</header><text>Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary—</text>
<subparagraph id="HB439F51227EB4AE5B3018B6C4CF0C16C"><enum>(A)</enum><text>may, on the Secretary’s own initiative; or</text></subparagraph>
<subparagraph id="HC15FCC486DB349E1B0C12E9BA489C735"><enum>(B)</enum><text>may, upon the request of an applicant, refer such application to the Tobacco Products Scientific Advisory Committee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting approval of the application, together with all underlying data and the reasons or basis for the recommendation.</text></subparagraph></paragraph></subsection>
<subsection id="H73B28CF4EF0748B1B868420035B7F6D"><enum>(c)</enum><header>Action on application</header>
<paragraph id="HA925463B1E104FEABEA3EFB460A09EB"><enum>(1)</enum><header>Deadline</header>
<subparagraph id="H7C8250D23F67476999CFBA57A8EF65F4"><enum>(A)</enum><header>In general</header><text>As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under paragraph (2) of such subsection, shall—</text>
<clause id="HFB2F2FD9D9B245FFABA7BCE47E971571"><enum>(i)</enum><text>issue an order approving the application if the Secretary finds that none of the grounds for denying approval specified in paragraph (2) of this subsection applies; or</text></clause>
<clause id="HA3E6E5C43B8C41B9B1C22DAF26B36EBB"><enum>(ii)</enum><text>deny approval of the application if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.</text></clause></subparagraph>
<subparagraph id="H207424D2A8FF4DBCA1ACDD2422D24164"><enum>(B)</enum><header>Restrictions on sale and distribution</header><text>An order approving an application for a tobacco product may require as a condition to such approval that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 906(d).</text></subparagraph></paragraph>
<paragraph id="HB74F8160441D48599D2E5F23C66F4E84"><enum>(2)</enum><header>Denial of approval</header><text>The Secretary shall deny approval of an application for a tobacco product if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that—</text>
<subparagraph id="H5A1FFF7537124B57AB421C2D2F4893A4"><enum>(A)</enum><text>there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;</text></subparagraph>
<subparagraph id="HC800AEB9DB994D3FA7BE11FD03002358"><enum>(B)</enum><text>the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 906(e);</text></subparagraph>
<subparagraph id="H9441B8002F5A408B898E40439C4EECB0"><enum>(C)</enum><text>based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or</text></subparagraph>
<subparagraph id="H83ED1F791B8C4058A299877F5092D34E"><enum>(D)</enum><text>such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 907, compliance with which is a condition to approval of the application, and there is a lack of adequate information to justify the deviation from such standard.</text></subparagraph></paragraph>
<paragraph id="H8DA22926765F490893F95161805C013"><enum>(3)</enum><header>Denial information</header><text>Any denial of an application shall, insofar as the Secretary determines to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary).</text></paragraph>
<paragraph id="H7C9A2F511B784AE5A716AAA6F8D3E625"><enum>(4)</enum><header>Basis for finding</header><text>For purposes of this section, the finding as to whether approval of a tobacco product is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—</text>
<subparagraph id="H98DC63B029094D88947F2C7855B42276"><enum>(A)</enum><text>the increased or decreased likelihood that existing users of tobacco products will stop using such products; and</text></subparagraph>
<subparagraph id="H605B9F43D03A4CD9BBC202639C1D271"><enum>(B)</enum><text>the increased or decreased likelihood that those who do not use tobacco products will start using such products.</text></subparagraph></paragraph>
<paragraph id="H5C89EA296D84413FA1954E67F5329FDE"><enum>(5)</enum><header>Basis for action</header>
<subparagraph id="H5A3C198847AF4339BB87F01E7436E4E5"><enum>(A)</enum><header>Investigations</header><text>For purposes of paragraph (2)(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well-controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product.</text></subparagraph>
<subparagraph id="H466F784DCB87409996E8DC04228F5D28"><enum>(B)</enum><header>Other evidence</header><text>If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A)) which is sufficient to evaluate the tobacco product the Secretary may authorize that the determination for purposes of paragraph (2)(A) be made on the basis of such evidence.</text></subparagraph></paragraph></subsection>
<subsection id="H5314301474AA4ADEBEF1ADB6856A9A0"><enum>(d)</enum><header>Withdrawal and temporary suspension</header>
<paragraph id="H0934367EA1454EC00077D470011ACCD"><enum>(1)</enum><header>In general</header><text>The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from an advisory committee, and after due notice and opportunity for informal hearing to the holder of an approved application for a tobacco product, issue an order withdrawing approval of the application if the Secretary finds—</text>
<subparagraph id="HDE1897F78DE443069256DCD904017D55"><enum>(A)</enum><text>that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health;</text></subparagraph>
<subparagraph id="HB8F339E4BF9F4BEFB4D8BBAF75A79D00"><enum>(B)</enum><text>that the application contained or was accompanied by an untrue statement of a material fact;</text></subparagraph>
<subparagraph id="H9E12085FA4634234AC2C006175C36800"><enum>(C)</enum><text>that the applicant—</text>
<clause id="HCE51D97A0F9647E20084B7E1D2158373"><enum>(i)</enum><text>has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 909;</text></clause>
<clause id="H39C1F4430B7646C3A33D1FB604FDE5D8"><enum>(ii)</enum><text>has refused to permit access to, or copying or verification of, such records as required by section 704; or</text></clause>
<clause id="HC9F72A2309084FF7951245000049A98F"><enum>(iii)</enum><text>has not complied with the requirements of section 905;</text></clause></subparagraph>
<subparagraph id="HFA5D4180B2D84AF8B773E4CEFEE921CF"><enum>(D)</enum><text>on the basis of new information before the Secretary with respect to such tobacco product, evaluated together with the evidence before the Secretary when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such tobacco product do not conform with the requirements of section 906(e) and were not brought into conformity with such requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity;</text></subparagraph>
<subparagraph id="H1C20A843C85C41659900719E9F94C9B"><enum>(E)</enum><text>on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was approved, that the labeling of such tobacco product, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or</text></subparagraph>
<subparagraph id="H9D3CF9EC330E4ED69980AD37EC345089"><enum>(F)</enum><text>on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when the application was approved, that such tobacco product is not shown to conform in all respects to a tobacco product standard which is in effect under section 907, compliance with which was a condition to approval of the application, and that there is a lack of adequate information to justify the deviation from such standard.</text></subparagraph></paragraph>
<paragraph id="H9AB04E97F9824E19A5BE608BEB77E1C5"><enum>(2)</enum><header>Appeal</header><text>The holder of an application subject to an order issued under paragraph (1) withdrawing approval of the application may, by petition filed on or before the 30th day after the date upon which such holder receives notice of such withdrawal, obtain review thereof in accordance with subsection (e).</text></paragraph>
<paragraph id="H0F2576DCF2A64A158BFED53C7BAC74C"><enum>(3)</enum><header>Temporary suspension</header><text>If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable probability that the continuation of distribution of a tobacco product under an approved application would cause serious, adverse health consequences or death, that is greater than ordinarily caused by tobacco products on the market, the Secretary shall by order temporarily suspend the approval of the application approved under this section. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw such application.</text></paragraph></subsection>
<subsection id="H85C69AB8D07545038C93F818A8C77C10"><enum>(e)</enum><header>Service of order</header><text>An order issued by the Secretary under this section shall be served—</text>
<paragraph id="H933218939D574B46B2C2A9064ED56100"><enum>(1)</enum><text>in person by any officer or employee of the department designated by the Secretary; or</text></paragraph>
<paragraph id="H830F97B75834438F80C30008C7F267D5"><enum>(2)</enum><text>by mailing the order by registered mail or certified mail addressed to the applicant at the applicant’s last known address in the records of the Secretary.</text></paragraph></subsection>
<subsection id="H8B24716C399A4340A8D3D7F769135D33"><enum>(f)</enum><header>Records</header>
<paragraph id="HB0249CE85C0B4218A2A68BB8E46C8057"><enum>(1)</enum><header>Additional information</header><text>In the case of any tobacco product for which an approval of an application filed under subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, as the Secretary may by regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such approval.</text></paragraph>
<paragraph id="HD3205D2DC97D445B8E71C722318152F0"><enum>(2)</enum><header>Access to records</header><text>Each person required under this section to maintain records, and each person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records.</text></paragraph></subsection>
<subsection id="H6767158BCAA54D4A964466CDED386D17"><enum>(g)</enum><header>Investigational Tobacco product exemption for investigational use</header><text>The Secretary may exempt tobacco products intended for investigational use from the provisions of this chapter under such conditions as the Secretary may by regulation prescribe.</text></subsection></section>
<section id="HCC921EEFE05D41B99F71D8D7E9AA93AB"><enum>911.</enum><header>Modified risk Tobacco products</header>
<subsection id="H20D2E6D2FA1C4A44871FDE7C8059C486"><enum>(a)</enum><header>In general</header><text>No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless approval of an application filed pursuant to subsection (d) is effective with respect to such product.</text></subsection>
<subsection id="HEE6A1AED30BF48F68928F1F0E002B13"><enum>(b)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H05CE1181B186450992CBE3ECBDF8865F"><enum>(1)</enum><header>Modified risk Tobacco product</header><text>The term <term>modified risk tobacco product</term> means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.</text></paragraph>
<paragraph id="H2DCA82869E554A51981B75F685CB609E"><enum>(2)</enum><header>Sold or distributed</header>
<subparagraph id="H8E20D304A6FC42739FEEF06DCDED74F5"><enum>(A)</enum><header>In general</header><text>With respect to a tobacco product, the term <term>sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products</term> means a tobacco product—</text>
<clause id="H506E6CAA8DE44C25A9A2C1E5901FCD8B"><enum>(i)</enum><text>the label, labeling, or advertising of which represents explicitly or implicitly that—</text>
<subclause id="H1FF813BFCF054098A72D9029009147DC"><enum>(I)</enum><text>the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;</text></subclause>
<subclause id="H324371EA457740DFBA65B470AB3605C5"><enum>(II)</enum><text>the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or</text></subclause>
<subclause id="H7B3D7713FE78428BB021865EC86B4D61"><enum>(III)</enum><text>the tobacco product or its smoke does not contain or is free of a substance;</text></subclause></clause>
<clause id="H03B79314A4854B94A8B89BDAA6556907"><enum>(ii)</enum><text>the label, labeling, or advertising of which uses the descriptors <quote>light</quote>, <quote>mild</quote>, or <quote>low</quote> or similar descriptors; or</text></clause>
<clause id="H9E5E95F1BE4547DA8FE4CD27AA2345FF"><enum>(iii)</enum><text>the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling or advertising, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.</text></clause></subparagraph>
<subparagraph id="H3E3D420E2A744D09B6BD3D093398FC"><enum>(B)</enum><header>Limitation</header><text>No tobacco product shall be considered to be <quote>sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products</quote>, except as described in subparagraph (A).</text></subparagraph></paragraph></subsection>
<subsection id="HD2BB60E696B5499BA2596502E32D2787"><enum>(c)</enum><header>Tobacco dependence products</header><text>A product that is intended to be used for the treatment of tobacco dependence, including smoking cessation, is not a modified risk tobacco product under this section and is subject to the requirements of chapter V.</text></subsection>
<subsection id="H397F23217AC44E0B8FE7566352BD968B"><enum>(d)</enum><header>Filing</header><text>Any person may file with the Secretary an application for a modified risk tobacco product. Such application shall include—</text>
<paragraph id="H4971DFA088D4486D8DAB0065CA17B52D"><enum>(1)</enum><text>a description of the proposed product and any proposed advertising and labeling;</text></paragraph>
<paragraph id="HFD8E91C515F143C9859BC32B06D0D1AC"><enum>(2)</enum><text>the conditions for using the product;</text></paragraph>
<paragraph id="HA08D25539A2143F6BBAE5D838E9426FB"><enum>(3)</enum><text>the formulation of the product;</text></paragraph>
<paragraph id="H6C454DFFF4534F84A9C479A4218CDF88"><enum>(4)</enum><text>sample product labels and labeling;</text></paragraph>
<paragraph id="H5D38E4AEC93C4E3B945914CAE3A7CB30"><enum>(5)</enum><text>all documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or exposure and relating to human health;</text></paragraph>
<paragraph id="H8D7455677F054E1EB7003F45463C8370"><enum>(6)</enum><text>data and information on how consumers actually use the tobacco product; and</text></paragraph>
<paragraph id="H8DE0238640DD403F84DDCD1F28453000"><enum>(7)</enum><text>such other information as the Secretary may require.</text></paragraph></subsection>
<subsection id="H1C882D5A7E5C436F9827C21869E155C6"><enum>(e)</enum><header>Public availability</header><text>The Secretary shall make the application described in subsection (d) publicly available (except matters in the application which are trade secrets or otherwise confidential, commercial information) and shall request comments by interested persons on the information contained in the application and on the label, labeling, and advertising accompanying such application.</text></subsection>
<subsection id="HC91AEACB76DB4308B443C931F2071E21"><enum>(f)</enum><header>Advisory Committee</header>
<paragraph id="H04C86DA6D9C34D0B92C92CC656F65D9"><enum>(1)</enum><header>In general</header><text>The Secretary shall refer to an advisory committee any application submitted under this subsection.</text></paragraph>
<paragraph id="HE9084FF0E2C04A8F97B86E1100715969"><enum>(2)</enum><header>Recommendations</header><text>Not later than 60 days after the date an application is referred to an advisory committee under paragraph (1), the advisory committee shall report its recommendations on the application to the Secretary.</text></paragraph></subsection>
<subsection id="H6EE40F70722645D29E9834379F1CBB99"><enum>(g)</enum><header>Approval</header>
<paragraph id="H05D1D515A79E49D4008F7337BC9BC66"><enum>(1)</enum><header>Modified risk products</header><text>Except as provided in paragraph (2), the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will—</text>
<subparagraph id="HA1E62F3A08FE42C3A208F9D37DFA79E"><enum>(A)</enum><text>significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and</text></subparagraph>
<subparagraph id="H8465DBAC46984B578FDD7740A2E6B78F"><enum>(B)</enum><text>benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.</text></subparagraph></paragraph>
<paragraph id="H5ADC5010C071453D8EF996095B00A73E"><enum>(2)</enum><header>Special rule for certain products</header>
<subparagraph id="H37119E545EA743BE8680214292A6A2D0"><enum>(A)</enum><header>In general</header><text>The Secretary may approve an application for a tobacco product that has not been approved as a modified risk tobacco product pursuant to paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that—</text>
<clause id="HB08573B93063462F82CF1E33DB2E40C6"><enum>(i)</enum><text>the approval of the application would be appropriate to promote the public health;</text></clause>
<clause id="H48D61CC102E54398A1E01883A210C0B1"><enum>(ii)</enum><text>any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b)(2) is limited to an explicit or implicit representation that such tobacco product or its smoke contains or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke;</text></clause>
<clause id="H5C186C69A07948979EC29EF4B8E80991"><enum>(iii)</enum><text>scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and</text></clause>
<clause id="H62C40EF68DD94249A397287EDE71C54F"><enum>(iv)</enum><text>the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is anticipated in subsequent studies.</text></clause></subparagraph>
<subparagraph id="H0B6A426EAB9F4D2A83131FF15D71505"><enum>(B)</enum><header>Additional findings required</header><text>In order to approve an application under subparagraph (A) the Secretary must also find that the applicant has demonstrated that—</text>
<clause id="HD75CB07B1CFD4948963067B570412799"><enum>(i)</enum><text>the magnitude of the overall reductions in exposure to the substance or substances which are the subject of the application is substantial, such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances;</text></clause>
<clause id="H2876FEEBBE2942689968F2C00292C3D"><enum>(ii)</enum><text>the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the market unless such increases are minimal and the anticipated overall impact of use of the product remains a substantial and measurable reduction in overall morbidity and mortality among individual tobacco users;</text></clause>
<clause id="HB0A79D4C9BC04C4C9B635212A02B092F"><enum>(iii)</enum><text>testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product—</text>
<subclause id="H8A50609FA323477CBB50DC5CBC693337"><enum>(I)</enum><text>is or has been demonstrated to be less harmful; or</text></subclause>
<subclause id="H475AF74CE4E14592B01194FC74ECACF4"><enum>(II)</enum><text>presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and</text></subclause></clause>
<clause id="H82052FA00FF2470EB51FAD8CFD007960"><enum>(iv)</enum><text>approval of the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.</text></clause></subparagraph>
<subparagraph id="H2E834CA389D24D749167A17FFD45A358"><enum>(C)</enum><header>Conditions of approval</header>
<clause id="HDA800822C633451DB37E6E8C4B020036"><enum>(i)</enum><header>In general</header><text>Applications approved under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the requirements of this paragraph continue to be satisfied based on the filing of a new application.</text></clause>
<clause id="H633ECB35DFA442A700311EBA2CE9D131"><enum>(ii)</enum><header>Agreements by applicant</header><text>Applications approved under this paragraph shall be conditioned on the applicant’s agreement to conduct post-market surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the application approval on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the approval was based in accordance with a protocol approved by the Secretary.</text></clause>
<clause id="H7C2079C4E39E4E72BFB782798B0011E9"><enum>(iii)</enum><header>Annual submission</header><text>The results of such post-market surveillance and studies described in clause (ii) shall be submitted annually.</text></clause></subparagraph></paragraph>
<paragraph id="HED734468B5424F34875FF5749EC529A0"><enum>(3)</enum><header>Basis</header><text>The determinations under paragraphs (1) and (2) shall be based on—</text>
<subparagraph id="HAE92611B98494F99B4BDFB9E06FB0059"><enum>(A)</enum><text>the scientific evidence submitted by the applicant; and</text></subparagraph>
<subparagraph id="H968D27FED89A472EB3EC393EE26179D7"><enum>(B)</enum><text>scientific evidence and other information that is available to the Secretary.</text></subparagraph></paragraph>
<paragraph id="H9C5D64CC728C42CABA55C3A5D77BC863"><enum>(4)</enum><header>Benefit to health of individuals and of population as a whole</header><text>In making the determinations under paragraphs (1) and (2), the Secretary shall take into account—</text>
<subparagraph id="H173DFE15D662445D914900381574AF94"><enum>(A)</enum><text>the relative health risks to individuals of the tobacco product that is the subject of the application;</text></subparagraph>
<subparagraph id="H1CF467308B2D407BAD05130766A93CB8"><enum>(B)</enum><text>the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;</text></subparagraph>
<subparagraph id="HCB4C37EA86A749CFAAB8AB1361363252"><enum>(C)</enum><text>the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;</text></subparagraph>
<subparagraph id="H1354C7185E3C45E89D07D086BEAD22B4"><enum>(D)</enum><text>the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under chapter V to treat nicotine dependence; and</text></subparagraph>
<subparagraph id="HDD1339B0EE264A5C986EBEEDE98DF939"><enum>(E)</enum><text>comments, data, and information submitted by interested persons.</text></subparagraph></paragraph></subsection>
<subsection id="H1A3898A271C94B2AA07201182CE6562D"><enum>(h)</enum><header>Additional conditions for approval</header>
<paragraph id="H380F42CF0A344D3F91A300B013F768A2"><enum>(1)</enum><header>Modified risk products</header><text>The Secretary shall require for the approval of an application under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such information in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.</text></paragraph>
<paragraph id="HC4AC20609B6A40789B5717BDEEC4CBFC"><enum>(2)</enum><header>Comparative claims</header>
<subparagraph id="H1761DA3B8FE042D896B5B1F9A69E0072"><enum>(A)</enum><header>In general</header><text>The Secretary may require for the approval of an application under this subsection that a claim comparing a tobacco product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product).</text></subparagraph>
<subparagraph id="HDE6A19F615DB4C8E91AF655F3E43E2FA"><enum>(B)</enum><header>Quantitative comparisons</header><text>The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim.</text></subparagraph></paragraph>
<paragraph id="HA330D9E461E64991B2E46FCDCC41D722"><enum>(3)</enum><header>Label disclosure</header>
<subparagraph id="H3FF3D2ACC51A486FAF06CB5F2007203"><enum>(A)</enum><header>In general</header><text>The Secretary may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associated with the use of tobacco products.</text></subparagraph>
<subparagraph id="HEA724FE2829349CEABBDBD6C630F882"><enum>(B)</enum><header>Conditions of use</header><text>If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.</text></subparagraph></paragraph>
<paragraph id="HD2B011077EC54CA0A800EF85F61E2854"><enum>(4)</enum><header>Time</header><text>The Secretary shall limit an approval under subsection (g)(1) for a specified period of time.</text></paragraph>
<paragraph id="H23C28816DB36469D9B8F9B39C200008E"><enum>(5)</enum><header>Advertising</header><text>The Secretary may require that an applicant, whose application has been approved under this subsection, comply with requirements relating to advertising and promotion of the tobacco product.</text></paragraph></subsection>
<subsection id="HCF921809115247198E75F2E39679168C"><enum>(i)</enum><header>Postmarket surveillance and studies</header>
<paragraph id="H65186384778D4DF691B5DDC5C8BECFA0"><enum>(1)</enum><header>In general</header><text>The Secretary shall require that an applicant under subsection (g)(1) conduct post market surveillance and studies for a tobacco product for which an application has been approved to determine the impact of the application approval on consumer perception, behavior, and health, to enable the Secretary to review the accuracy of the determinations upon which the approval was based, and to provide information that the Secretary determines is otherwise necessary regarding the use or health risks involving the tobacco product. The results of post-market surveillance and studies shall be submitted to the Secretary on an annual basis.</text></paragraph>
<paragraph id="HB097338A9A134D449C3101599876D399"><enum>(2)</enum><header>Surveillance protocol</header><text>Each applicant required to conduct a surveillance of a tobacco product under paragraph (1) shall, within 30 days after receiving notice that the applicant is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of the data or other information designated by the Secretary as necessary to protect the public health.</text></paragraph></subsection>
<subsection id="HD4640761075B4C5F9E641C8422A1AB0"><enum>(j)</enum><header>Withdrawal of approval</header><text>The Secretary, after an opportunity for an informal hearing, shall withdraw the approval of an application under this section if the Secretary determines that—</text>
<paragraph id="H4215528268BE4E48B9EBF461062227C5"><enum>(1)</enum><text>the applicant, based on new information, can no longer make the demonstrations required under subsection (g), or the Secretary can no longer make the determinations required under subsection (g);</text></paragraph>
<paragraph id="H695D81EBC4E0411DAF3065DAF2F253ED"><enum>(2)</enum><text>the application failed to include material information or included any untrue statement of material fact;</text></paragraph>
<paragraph id="HE0171378A8824F1A001999529EB7C860"><enum>(3)</enum><text>any explicit or implicit representation that the product reduces risk or exposure is no longer valid, including if—</text>
<subparagraph id="HD59927BBA1AE4F98003C11BD9EB38100"><enum>(A)</enum><text>a tobacco product standard is established pursuant to section 907;</text></subparagraph>
<subparagraph id="H603A68D7D85D4C3AA187A7BFDF7F3F8B"><enum>(B)</enum><text>an action is taken that affects the risks presented by other commercially marketed tobacco products that were compared to the product that is the subject of the application; or</text></subparagraph>
<subparagraph id="H7AD0C30E095F4FDAB758C6B3C9B5836C"><enum>(C)</enum><text>any postmarket surveillance or studies reveal that the approval of the application is no longer consistent with the protection of the public health;</text></subparagraph></paragraph>
<paragraph id="HAA6D0AD952A24BA69D94EDAABEF3EF83"><enum>(4)</enum><text>the applicant failed to conduct or submit the postmarket surveillance and studies required under subsection (g)(2)(C)(ii) or (i); or</text></paragraph>
<paragraph id="HBA1C043E913146A59503989F298C9021"><enum>(5)</enum><text>the applicant failed to meet a condition imposed under subsection (h).</text></paragraph></subsection>
<subsection id="H3D34B8343B944A5A8496AA617409C8BA"><enum>(k)</enum><header>Chapter <enum-in-header>IV</enum-in-header> or v</header><text>A product approved in accordance with this section shall not be subject to chapter IV or V.</text></subsection>
<subsection id="H98C4727E6B5D4CF7B3C500AEB6003DCF"><enum>(l)</enum><header>Implementing regulations or guidance</header>
<paragraph id="H6640425A4836475C9963A2E535987BE2"><enum>(1)</enum><header>Scientific evidence</header><text>Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall—</text>
<subparagraph id="HF19532955BBE46B989048D4E34574024"><enum>(A)</enum><text>establish minimum standards for scientific studies needed prior to approval to show that a substantial reduction in morbidity or mortality among individual tobacco users is likely;</text></subparagraph>
<subparagraph id="H6A00AC8988C64CAFAB68E55C73718954"><enum>(B)</enum><text>include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate;</text></subparagraph>
<subparagraph id="H97D00410C143425F87B572E7F745AD65"><enum>(C)</enum><text>establish minimum standards for post market studies, that shall include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate;</text></subparagraph>
<subparagraph id="HFCA9B4F52342499EAED45E3933A976FB"><enum>(D)</enum><text>establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception; and</text></subparagraph>
<subparagraph id="H1E1025B1ABA943F2A9AAB5FB5699027"><enum>(E)</enum><text>require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product.</text></subparagraph></paragraph>
<paragraph id="H6FA8CE4D12EC471BA812ABFF63BFDDB0"><enum>(2)</enum><header>Consultation</header><text>The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies and surveillance.</text></paragraph>
<paragraph id="HB5A0E75B03C847419B00BCF2309C4BC0"><enum>(3)</enum><header>Revision</header><text>The regulations or guidance under paragraph (1) shall be revised on a regular basis as new scientific information becomes available.</text></paragraph>
<paragraph id="HEF17CF2C1CCB488EBFE5698FBA926DC0"><enum>(4)</enum><header>New Tobacco products</header><text>Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 910 and for which the applicant seeks approval as a modified risk tobacco product under this section.</text></paragraph></subsection>
<subsection id="H5BD0E83103384BBA9FD46D616B13A1D5"><enum>(m)</enum><header>Distributors</header><text>No distributor may take any action, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, with respect to a tobacco product that would reasonably be expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful than one or more commercially marketed tobacco products, or presents a reduced exposure to, or does not contain or is free of, a substance or substances.</text></subsection></section>
<section id="H7403AF0CE2B14F1A8E2B144FDFB9EA3"><enum>912.</enum><header>Judicial review</header>
<subsection id="H44ABCFD2FE504DF2AC287FBEC4806276"><enum>(a)</enum><header>Right to review</header>
<paragraph id="HB9A603AA74864B97A8AD34DB137E77A5"><enum>(1)</enum><header>In general</header><text>Not later than 30 days after—</text>
<subparagraph id="HE751AF9D3AD94F0A8F98D8849987E78B"><enum>(A)</enum><text>the promulgation of a regulation under section 907 establishing, amending, or revoking a tobacco product standard; or</text></subparagraph>
<subparagraph id="H19DA005844B642CC99080054823624E0"><enum>(B)</enum><text>a denial of an application for approval under section 910(c), any person adversely affected by such regulation or denial may file a petition for judicial review of such regulation or denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business.</text></subparagraph></paragraph>
<paragraph id="H89FCC43609AC4382B995DD15EC5CD313"><enum>(2)</enum><header>Requirements</header>
<subparagraph id="H03D151C665E845FF90001D00F04882EA"><enum>(A)</enum><header>Copy of petition</header><text>A copy of the petition filed under paragraph (1) shall be transmitted by the clerk of the court involved to the Secretary.</text></subparagraph>
<subparagraph id="HFF92E13803ED4C4687F88DF65641CDF1"><enum>(B)</enum><header>Record of proceedings</header><text>On receipt of a petition under subparagraph (A), the Secretary shall file in the court in which such petition was filed—</text>
<clause id="H2980318EBF9D4C20A03E7324F0A61000"><enum>(i)</enum><text>the record of the proceedings on which the regulation or order was based; and</text></clause>
<clause id="HA12E0A2AE65D446FA164C230026E8DB0"><enum>(ii)</enum><text>a statement of the reasons for the issuance of such a regulation or order.</text></clause></subparagraph>
<subparagraph id="HACCDE98ED21E4EA99BC1B4E718ECC21"><enum>(C)</enum><header>Definition of record</header><text>In this section, the term <term>record</term> means—</text>
<clause id="H686F34839D2E478797D81E487F454393"><enum>(i)</enum><text>all notices and other matter published in the Federal Register with respect to the regulation or order reviewed;</text></clause>
<clause id="H3667CFFDF1FA47ABAA6F5EF7805B7CA3"><enum>(ii)</enum><text>all information submitted to the Secretary with respect to such regulation or order;</text></clause>
<clause id="H3736473E9E9C4363A600B77FFFAFEA"><enum>(iii)</enum><text>proceedings of any panel or advisory committee with respect to such regulation or order;</text></clause>
<clause id="H551D7FB3A79B455F8B6E9100BE844EEE"><enum>(iv)</enum><text>any hearing held with respect to such regulation or order; and</text></clause>
<clause id="H4026F175F920426FBA00BC38A98B2031"><enum>(v)</enum><text>any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.</text></clause></subparagraph></paragraph></subsection>
<subsection id="HF6764F5994FF4F10A504DB12241E4E61"><enum>(b)</enum><header>Standard of review</header><text>Upon the filing of the petition under subsection (a) for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/7">chapter 7</external-xref> of title 5, United States Code, and to grant appropriate relief, including interim relief, as provided for in such chapter. A regulation or denial described in subsection (a) shall be reviewed in accordance with <external-xref legal-doc="usc" parsable-cite="usc/5/706">section 706(2)(A)</external-xref> of title 5, United States Code.</text></subsection>
<subsection id="H860B67AAB3814C04A5D847E2FE929D9"><enum>(c)</enum><header>Finality of judgment</header><text>The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in <external-xref legal-doc="usc" parsable-cite="usc/28/1254">section 1254</external-xref> of title 28, United States Code.</text></subsection>
<subsection id="HABEA5DAF8A0C4952B43F9306A1BC33A9"><enum>(d)</enum><header>Other remedies</header><text>The remedies provided for in this section shall be in addition to, and not in lieu of, any other remedies provided by law.</text></subsection>
<subsection id="H330BC147ECDB4ADA9882E700B01F6917"><enum>(e)</enum><header>Regulations and orders must recite basis in record</header><text>To facilitate judicial review, a regulation or order issued under section 906, 907, 908, 909, 910, or 916 shall contain a statement of the reasons for the issuance of such regulation or order in the record of the proceedings held in connection with its issuance.</text></subsection></section>
<section id="H7507266009704C5BA98674D69B00B06E"><enum>913.</enum><header>Equal treatment of retail outlets</header><text display-inline="no-display-inline">The Secretary shall issue regulations to require that retail establishments for which the predominant business is the sale of tobacco products comply with any advertising restrictions applicable to retail establishments accessible to individuals under the age of 18.</text></section>
<section id="HF55B392E52AB4AD2A47E788EF01F1CDA"><enum>914.</enum><header>Jurisdiction of and coordination with the Federal Trade Commission</header>
<subsection id="HBD480E2B17174B36AFD221F1FBE111FA"><enum>(a)</enum><header>Jurisdiction</header>
<paragraph id="HEA979142DEF94832984FF4D7A29F96AA"><enum>(1)</enum><header>In general</header><text>Except where expressly provided in this chapter, nothing in this chapter shall be construed as limiting or diminishing the authority of the Federal Trade Commission to enforce the laws under its jurisdiction with respect to the advertising, sale, or distribution of tobacco products.</text></paragraph>
<paragraph id="H182F64D4A0F148A7A7E72BC9A755F31F"><enum>(2)</enum><header>Enforcement</header><text>Any advertising that violates this chapter or a provision of the regulations referred to in section 232 of the Family Smoking Prevention and Tobacco Control Act, is an unfair or deceptive act or practice under section 5(a) of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/15/45">15 U.S.C. 45(a)</external-xref>) and shall be considered a violation of a rule promulgated under section 18 of that Act (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a</external-xref>).</text></paragraph></subsection>
<subsection id="H47146122083144118FE7EBDAC7DECC5"><enum>(b)</enum><header>Coordination</header><text>With respect to the requirements of section 4 of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>) and section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>)—</text>
<paragraph id="HA6E0F49DA6C54FA0AD117F05CAA4C23B"><enum>(1)</enum><text>the Chairman of the Federal Trade Commission shall coordinate with the Secretary concerning the enforcement of such Act as such enforcement relates to unfair or deceptive acts or practices in the advertising of cigarettes or smokeless tobacco; and</text></paragraph>
<paragraph id="H51D2DFE5E1064718B88FE155EAB8052D"><enum>(2)</enum><text>the Secretary shall consult with the Chairman of such Commission in revising the label statements and requirements under such sections.</text></paragraph></subsection></section>
<section id="HBFA859F4E7EF45FABE1F971998740029"><enum>915.</enum><header>Congressional review provisions</header><text display-inline="no-display-inline">In accordance with <external-xref legal-doc="usc" parsable-cite="usc/5/801">section 801</external-xref> of title 5, United States Code, Congress shall review, and may disapprove, any rule under this chapter that is subject to section 801. This section and section 801 do not apply to the regulations referred to in section 232 of the Family Smoking Prevention and Tobacco Control Act.</text></section>
<section id="HCA634FB1D2B54C07B2236C1BB90091E2"><enum>916.</enum><header>Regulation requirement</header>
<subsection id="H87EED04C8A83462100A9CBAD1418D39"><enum>(a)</enum><header>Testing, reporting, and disclosure</header><text>Not later than 24 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, acting through the Commissioner of the Food and Drug Administration, shall promulgate regulations under this Act that meet the requirements of subsection (b).</text></subsection>
<subsection id="H66CCC310F4E642F094F96BBAE05FEE10"><enum>(b)</enum><header>Contents of rules</header><text>The regulations promulgated under subsection (a) shall require testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, by brand and sub-brand that the Secretary determines should be tested to protect the public health. The regulations may require that tobacco product manufacturers, packagers, or importers make disclosures relating to the results of the testing of tar and nicotine through labels or advertising or other appropriate means, and make disclosures regarding the results of the testing of other constituents, including smoke constituents, ingredients, or additives, that the Secretary determines should be disclosed to the public to protect the public health and will not mislead consumers about the risk of tobacco related disease.</text></subsection>
<subsection id="H97E1C318F3104D7784644DA5A1DBBFEB"><enum>(c)</enum><header>Authority</header><text>The Food and Drug Administration shall have the authority under this chapter to conduct or to require the testing, reporting, or disclosure of tobacco product constituents, including smoke constituents.</text></subsection></section>
<section id="H97226A339ECB420C8CEAA5F00722D2D1"><enum>917.</enum><header>Preservation of State and local authority</header>
<subsection id="H96BABEC801CD4A9D00CE72E409B66DD2"><enum>(a)</enum><header>In general</header>
<paragraph id="HD53F9730F59143EDB68FF42FFC32F307"><enum>(1)</enum><header>Preservation</header><text>Nothing in this chapter, or rules promulgated under this chapter, shall be construed to limit the authority of a Federal agency (including the Armed Forces), a State or political subdivision of a State, or the government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule, regulation, or other measure with respect to tobacco products that is in addition to, or more stringent than, requirements established under this chapter, including a law, rule, regulation, or other measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this chapter shall limit or otherwise affect any State, Tribal, or local taxation of tobacco products.</text></paragraph>
<paragraph id="H279ACD5BE6BE4069AAB74B27ECDDE589"><enum>(2)</enum><header>Preemption of certain State and local requirements</header>
<subparagraph id="HC3F98055A32149BEB0588378245874C6"><enum>(A)</enum><header>In general</header><text>Except as provided in paragraph (1) and subparagraph (B), no State or political subdivision of a State may establish or continue in effect with respect to a tobacco product any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.</text></subparagraph>
<subparagraph id="H191C2664E3564594BADA9C871414C7A2"><enum>(B)</enum><header>Exception</header><text>Subparagraph (A) does not apply to requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to fire safety standards for tobacco products. Information disclosed to a State under subparagraph (A) that is exempt from disclosure under <external-xref legal-doc="usc" parsable-cite="usc/5/554">section 554(b)(4)</external-xref> of title 5, United States Code, shall be treated as trade secret and confidential information by the State.</text></subparagraph></paragraph></subsection>
<subsection id="H56CBB27D07A145D08B6400F5A4015819"><enum>(b)</enum><header>Rule of construction regarding product liability</header><text>No provision of this chapter relating to a tobacco product shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.</text></subsection></section>
<section id="H7DB770CCB84A45BABBD9D618E2E8E539"><enum>918.</enum><header>Tobacco Products Scientific Advisory Committee</header>
<subsection id="H5A67E59631EF48A09C250000F248F8B"><enum>(a)</enum><header>Establishment</header><text>Not later than 1 year after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall establish an 11-member advisory committee, to be known as the <quote>Tobacco Products Scientific Advisory Committee</quote>.</text></subsection>
<subsection id="HBD12E62B2D3945CBB047DAB0AD40EE4F"><enum>(b)</enum><header>Membership</header>
<paragraph id="H8BCBB1F535DB4B8E84202ED8CCE0D3B7"><enum>(1)</enum><header>In general</header>
<subparagraph id="HDD23CF6885AA415880CA57BEFC589651"><enum>(A)</enum><header>Members</header><text>The Secretary shall appoint as members of the Tobacco Products Scientific Advisory Committee individuals who are technically qualified by training and experience in the medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, who are of appropriately diversified professional backgrounds. The committee shall be composed of—</text>
<clause id="HFEF9866303C648AAAE14DBBCC5FC74"><enum>(i)</enum><text>7 individuals who are physicians, dentists, scientists, or health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or any other relevant specialty;</text></clause>
<clause id="HEB8CD3C3E3F14F70B4241751924D76D8"><enum>(ii)</enum><text>1 individual who is an officer or employee of a State or local government or of the Federal Government;</text></clause>
<clause id="H62C4FED8999B40B995F9B3BD6CD12229"><enum>(iii)</enum><text>1 individual as a representative of the general public;</text></clause>
<clause id="H7C0452DAE13646A5B8CCB60900D969A"><enum>(iv)</enum><text>1 individual as a representative of the interests in the tobacco manufacturing industry; and</text></clause>
<clause id="HAE71FF6DA22546249C8DAFDCEF7BAD90"><enum>(v)</enum><text>1 individual as a representative of the interests of the tobacco growers.</text></clause></subparagraph>
<subparagraph id="H51A82D0D8444478DB48B91AB867F7B75"><enum>(B)</enum><header>Nonvoting members</header><text>The members of the committee appointed under clauses (iv) and (v) of subparagraph (A) shall serve as consultants to those described in clauses (i) through (iii) of subparagraph (A) and shall be nonvoting representatives.</text></subparagraph></paragraph>
<paragraph id="H4BC161C2A27F4B518C8718C6F9056C9F"><enum>(2)</enum><header>Limitation</header><text>The Secretary may not appoint to the Advisory Committee any individual who is in the regular full-time employ of the Food and Drug Administration or any agency responsible for the enforcement of this Act. The Secretary may appoint Federal officials as ex officio members.</text></paragraph>
<paragraph id="H085AE92004364C01BC0422AB93926F66"><enum>(3)</enum><header>Chairperson</header><text>The Secretary shall designate 1 of the members of the Advisory Committee to serve as chairperson.</text></paragraph></subsection>
<subsection id="H22FC7E836E6D47D9BD1D3C766B1B8BB2"><enum>(c)</enum><header>Duties</header><text>The Tobacco Products Scientific Advisory Committee shall provide advice, information, and recommendations to the Secretary—</text>
<paragraph id="HB518E934C4754914BFB600CEC147A9BC"><enum>(1)</enum><text>as provided in this chapter;</text></paragraph>
<paragraph id="H7A724028EB9E440CAFC6535BC3C1BDB0"><enum>(2)</enum><text>on the effects of the alteration of the nicotine yields from tobacco products;</text></paragraph>
<paragraph id="H1338C68F2C7149469938C8EF75C00EC"><enum>(3)</enum><text>on whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and</text></paragraph>
<paragraph id="H266C3CF885FA4D0189E3ED47ABE45A5"><enum>(4)</enum><text>on its review of other safety, dependence, or health issues relating to tobacco products as requested by the Secretary.</text></paragraph></subsection>
<subsection id="HE91988EFBB4848378F25C846879DA295"><enum>(d)</enum><header>Compensation; support; FACA</header>
<paragraph id="HB22CBF00063547E1974CEDBE7340D400"><enum>(1)</enum><header>Compensation and travel</header><text>Members of the Advisory Committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which may not exceed the daily equivalent of the rate in effect for level 4 of the Senior Executive Schedule under <external-xref legal-doc="usc" parsable-cite="usc/5/5382">section 5382</external-xref> of title 5, United States Code, for each day (including travel time) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by <external-xref legal-doc="usc" parsable-cite="usc/5/5703">section 5703</external-xref> of title 5, United States Code, for persons in the Government service employed intermittently.</text></paragraph>
<paragraph id="H9B82335C865B41B6B500D0091D184445"><enum>(2)</enum><header>Administrative support</header><text>The Secretary shall furnish the Advisory Committee clerical and other assistance.</text></paragraph>
<paragraph id="HF8A164AECBE04BF791BF005213C413DA"><enum>(3)</enum><header>Nonapplication of FACA</header><text>Section 14 of the <act-name parsable-cite="FACA">Federal Advisory Committee Act</act-name> (5 U.S.C. App.) does not apply to the Advisory Committee.</text></paragraph></subsection>
<subsection id="HD7B1F46BB97C4EEB8DC65BEA50939D8F"><enum>(e)</enum><header>Proceedings of advisory panels and committees</header><text>The Advisory Committee shall make and maintain a transcript of any proceeding of the panel or committee. Each such panel and committee shall delete from any transcript made under this subsection information which is exempt from disclosure under <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552(b)</external-xref> of title 5, United States Code.</text></subsection></section>
<section id="H4B167144C7D1455F82F01B8119E42578"><enum>919.</enum><header>Drug products used to treat Tobacco dependence</header><text display-inline="no-display-inline">The Secretary shall—</text>
<paragraph id="HA55BE57F844F4C4A93A595EB00AEB4F"><enum>(1)</enum><text>at the request of the applicant, consider designating nicotine replacement products as fast track research and approval products within the meaning of section 506;</text></paragraph>
<paragraph id="HA7E300A02143447EB9D036AE5D64A1F9"><enum>(2)</enum><text>consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and</text></paragraph>
<paragraph id="H5A97D64C34CE4A958DD9D1EBB90B228"><enum>(3)</enum><text>review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.</text></paragraph></section>
<section id="H545B36B1FFD94811BB17B0F5F72453AB"><enum>920.</enum><header>User fee</header>
<subsection id="HF765F76EDF1440D1B8E30883C17D46E"><enum>(a)</enum><header>Establishment of quarterly user fee</header><text>The Secretary shall assess a quarterly user fee with respect to every quarter of each fiscal year commencing fiscal year 2007, calculated in accordance with this section, upon each manufacturer and importer of tobacco products subject to this chapter.</text></subsection>
<subsection id="H33B392B6BAE547DB8677DBAF282354A9"><enum>(b)</enum><header>Funding of FDA regulation of Tobacco products</header><text>The Secretary shall make user fees collected pursuant to this section available to pay, in each fiscal year, for the costs of the activities of the Food and Drug Administration related to the regulation of tobacco products under this chapter.</text></subsection>
<subsection id="H772E16DC7B494526A92C7C259CC5A6F8"><enum>(c)</enum><header>Assessment of user fee</header>
<paragraph id="HB7B65E74EBCF403E00332C5EDFF0EDCE"><enum>(1)</enum><header>Amount of assessment</header><text>Except as provided in paragraph (4), the total user fees assessed each year pursuant to this section shall be sufficient, and shall not exceed what is necessary, to pay for the costs of the activities described in subsection (b) for each fiscal year.</text></paragraph>
<paragraph id="HE1D04AB7B0A443D4AA9900612DC93914"><enum>(2)</enum><header>Allocation of assessment by class of Tobacco products</header>
<subparagraph id="H2BE9C6F3A5F94980B16228603350C023"><enum>(A)</enum><header>In general</header><text>Subject to paragraph (3), the total user fees assessed each fiscal year with respect to each class of importers and manufacturers shall be equal to an amount that is the applicable percentage of the total costs of activities of the Food and Drug Administration described in subsection (b).</text></subparagraph>
<subparagraph id="H0B3D9FC96E5B4054B43BB2CF005BFA12"><enum>(B)</enum><header>Applicable percentage</header><text>For purposes of subparagraph (A) the applicable percentage for a fiscal year shall be the following:</text>
<clause id="H173C2114C192439586D5CAE1DD9BCA75"><enum>(i)</enum><text>92.07 percent shall be assessed on manufacturers and importers of cigarettes;</text></clause>
<clause id="H1AFB084177424249A6C2DE2BAC007905"><enum>(ii)</enum><text>0.05 percent shall be assessed on manufacturers and importers of little cigars;</text></clause>
<clause id="HD15E375E58F04DF4B3E700E2B6F3961F"><enum>(iii)</enum><text>7.15 percent shall be assessed on manufacturers and importers of cigars other than little cigars;</text></clause>
<clause id="H9AB632FC33064DB48DDD8E007CED5FAF"><enum>(iv)</enum><text>0.43 percent shall be assessed on manufacturers and importers of snuff;</text></clause>
<clause id="HF109B9966FE74E9095FD58D542F4BC00"><enum>(v)</enum><text>0.10 percent shall be assessed on manufacturers and importers of chewing tobacco;</text></clause>
<clause id="H93A0CB177C174788B9B31F0003C2202C"><enum>(vi)</enum><text>0.06 percent shall be assessed on manufacturers and importers of pipe tobacco; and</text></clause>
<clause id="HD284FD777FF34451BBB110AB3DEE16A4"><enum>(vii)</enum><text>0.14 percent shall be assessed on manufacturers and importers of roll-your-own tobacco.</text></clause></subparagraph></paragraph>
<paragraph id="HB5F1E94560844F5DB0FEABECEF953900"><enum>(3)</enum><header>Distribution of fee shares of manufacturers and importers exempt from user fee</header><text>Where a class of tobacco products is not subject to a user fee under this section, the portion of the user fee assigned to such class under subsection (d)(2) shall be allocated by the Secretary on a pro rata basis among the classes of tobacco products that are subject to a user fee under this section. Such pro rata allocation for each class of tobacco products that are subject to a user fee under this section shall be the quotient of—</text>
<subparagraph id="H91C868A0B94B4BCE9FA3F67BA7EE5784"><enum>(A)</enum><text>the sum of the percentages assigned to all classes of tobacco products subject to this section; divided by</text></subparagraph>
<subparagraph id="H955C3AD9210B48148B110050D4BA71A1"><enum>(B)</enum><text>the percentage assigned to such class under paragraph (2).</text></subparagraph></paragraph>
<paragraph id="H413F4B48B1234353A02DAB9CEB81775E"><enum>(4)</enum><header>Annual limit on assessment</header><text>The total assessment under this section—</text>
<subparagraph id="HEFFF62A48D4E4ED39114A9E28300E649"><enum>(A)</enum><text>for fiscal year 2007 shall be $85,000,000;</text></subparagraph>
<subparagraph id="HADF1A4010B824109857E9DB574314853"><enum>(B)</enum><text>for fiscal year 2008 shall be $175,000,000;</text></subparagraph>
<subparagraph id="HF4DC5035AD5C44E1B4C291FBA20A84D"><enum>(C)</enum><text>for fiscal year 2009 shall be $300,000,000; and</text></subparagraph>
<subparagraph id="H56D44A4446EE423880A7D74061CC50D3"><enum>(D)</enum><text>for each subsequent fiscal year, shall not exceed the limit on the assessment imposed during the previous fiscal year, as adjusted by the Secretary (after notice, published in the Federal Register) to reflect the greater of—</text>
<clause id="HA705B06903D144E8BA2FDD66E203F114"><enum>(i)</enum><text>the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending on June 30 of the preceding fiscal year for which fees are being established; or</text></clause>
<clause id="H81711396F44C49C2997B07EEC940475D"><enum>(ii)</enum><text>the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with <external-xref legal-doc="usc" parsable-cite="usc/5/5332">section 5332</external-xref> of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to <external-xref legal-doc="usc" parsable-cite="usc/26/5304">section 5304</external-xref> of such title for Federal employees stationed in the District of Columbia.</text></clause></subparagraph></paragraph>
<paragraph id="HA06846C55F734FF4AA8DB6CD7E04E87F"><enum>(5)</enum><header>Timing of user fee assessment</header><text>The Secretary shall notify each manufacturer and importer of tobacco products subject to this section of the amount of the quarterly assessment imposed on such manufacturer or importer under subsection (f) during each quarter of each fiscal year. Such notifications shall occur not earlier than 3 months prior to the end of the quarter for which such assessment is made, and payments of all assessments shall be made not later than 60 days after each such notification.</text></paragraph></subsection>
<subsection id="HAF38E6C260834ACBBF9181B020CBF294"><enum>(d)</enum><header>Determination of user fee by company market share</header>
<paragraph id="H00A440D14553460386D9D64826E90074"><enum>(1)</enum><header>In general</header><text>The user fee to be paid by each manufacturer or importer of a given class of tobacco products shall be determined in each quarter by multiplying—</text>
<subparagraph id="H23ED32249FD440ED863F0055F1C0069"><enum>(A)</enum><text>such manufacturer’s or importer’s market share of such class of tobacco products; by</text></subparagraph>
<subparagraph id="H8F0F35EFFB53405BA8D3D01271C9D80"><enum>(B)</enum><text>the portion of the user fee amount for the current quarter to be assessed on manufacturers and importers of such class of tobacco products as determined under subsection (e).</text></subparagraph></paragraph>
<paragraph id="HDAA982810853427BA7B3ADD94ECEBCDF"><enum>(2)</enum><header>No fee in excess of market share</header><text>No manufacturer or importer of tobacco products shall be required to pay a user fee in excess of the market share of such manufacturer or importer.</text></paragraph></subsection>
<subsection id="H3ADD520C9E6949E2007BB2DD9BE04B38"><enum>(e)</enum><header>Determination of volume of domestic sales</header>
<paragraph id="HF60C3BEE2FE8429F9F007F07A73CDBB"><enum>(1)</enum><header>In general</header><text>The calculation of gross domestic volume of a class of tobacco product by a manufacturer or importer, and by all manufacturers and importers as a group, shall be made by the Secretary using information provided by manufacturers and importers pursuant to subsection (f), as well as any other relevant information provided to or obtained by the Secretary.</text></paragraph>
<paragraph id="H73CFBCB473504DEDB1AC00ED18BD0094"><enum>(2)</enum><header>Measurement</header><text>For purposes of the calculations under this subsection and the information provided under subsection (f) by the Secretary, gross domestic volume shall be measured by—</text>
<subparagraph id="H50AF4832FB0B46889D1BA296B43E02C8"><enum>(A)</enum><text>in the case of cigarettes, the number of cigarettes sold;</text></subparagraph>
<subparagraph id="H097A8D73B0774757A2D4EE75E9D9EF4C"><enum>(B)</enum><text>in the case of little cigars, the number of little cigars sold;</text></subparagraph>
<subparagraph id="H0366D419EFC74F999294B4D0E8534979"><enum>(C)</enum><text>in the case of large cigars, the number of cigars weighing more than 3 pounds per thousand sold; and</text></subparagraph>
<subparagraph id="H6E1A2285C4D94BCE9485E1F4F7DB2DAD"><enum>(D)</enum><text>in the case of other classes of tobacco products, in terms of number of pounds, or fraction thereof, of these products sold.</text></subparagraph></paragraph></subsection>
<subsection id="H3B5F559101D848AF9549FA5BD4A10755"><enum>(f)</enum><header>Measurement of gross domestic volume</header>
<paragraph id="HC745D895F68247BDA1325438F1CA1B54"><enum>(1)</enum><header>In general</header><text>Each manufacturer and importer of tobacco products shall submit to the Secretary a certified copy of each of the returns or forms described by this paragraph that are required to be filed with a Government agency on the same date that those returns or forms are filed, or required to be filed, with such agency. The returns and forms described by this paragraph are those returns and forms related to the release of tobacco products into domestic commerce, as defined by <external-xref legal-doc="usc" parsable-cite="usc/26/5702">section 5702(k)</external-xref> of the Internal Revenue Code of 1986, and the repayment of the taxes imposed under chapter 52 of such Code (ATF Form 500.24 and United States Customs Form 7501 under currently applicable regulations).</text></paragraph>
<paragraph id="H3BF69C22C9964FF2898979FFDC0F35F"><enum>(2)</enum><header>Penalties</header><text>Any person that knowingly fails to provide information required under this subsection or that provides false information under this subsection shall be subject to the penalties described in <external-xref legal-doc="usc" parsable-cite="usc/18/1003">section 1003</external-xref> of title 18, United States Code. In addition, such person may be subject to a civil penalty in an amount not to exceed 2 percent of the value of the kind of tobacco products manufactured or imported by such person during the applicable quarter, as determined by the Secretary.</text></paragraph></subsection>
<subsection id="H0A18BE79855A490FA78EEDFE3C4FC6D3"><enum>(g)</enum><header>Effective date</header><text>The user fees prescribed by this section shall be assessed in fiscal year 2007, based on domestic sales of tobacco products during fiscal year 2006 and shall be assessed in each fiscal year thereafter.</text></subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection></section>
<section id="H9739A0BFD08243BDA88858F118F85ED6"><enum>232.</enum><header>Interim final rule</header>
<subsection id="HC38FE170CD3040DD907EA887F4CB9881"><enum>(a)</enum><header>Cigarettes and Smokeless Tobacco</header>
<paragraph id="HDE6E037811334CFFA88B00B4A733B0BB"><enum>(1)</enum><header>In general</header><text>Not later than 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register an interim final rule regarding cigarettes and smokeless tobacco, which is hereby deemed to be in compliance with the Administrative Procedures Act and other applicable law.</text></paragraph>
<paragraph id="H3A193CF4BF35475A835CCFAC047C618"><enum>(2)</enum><header>Contents of rule</header><text>Except as provided in this subsection, the interim final rule published under paragraph (1), shall be identical in its provisions to part 897 of the regulations promulgated by the Secretary of Health and Human Services in the August 28, 1996, issue of the Federal Register (61 Fed. Reg., 44615–44618). Such rule shall—</text>
<subparagraph id="HC6690B52EFC14F1CAAC759006DB73985"><enum>(A)</enum><text>provide for the designation of jurisdictional authority that is in accordance with this subsection;</text></subparagraph>
<subparagraph id="H221334DE4EF44E3186ECD3B374DF00EB"><enum>(B)</enum><text>strike Subpart C—Labeling and section 897.32(c); and</text></subparagraph>
<subparagraph id="HD9DDB865344E4DC18E5CE4A42F256200"><enum>(C)</enum><text>become effective not later than 1 year after the date of enactment of this Act.</text></subparagraph></paragraph>
<paragraph id="H724A87882FBA402D83EE8DD76EA28BF9"><enum>(3)</enum><header>Amendments to rule</header><text>Prior to making amendments to the rule published under paragraph (1), the Secretary shall promulgate a proposed rule in accordance with the Administrative Procedures Act.</text></paragraph>
<paragraph id="H129B1A7223BC4412BFC0AF00B3136900"><enum>(4)</enum><header>Rule of construction</header><text>Except as provided in paragraph (3), nothing in this section shall be construed to limit the authority of the Secretary to amend, in accordance with the Administrative Procedures Act, the regulation promulgated pursuant to this section.</text></paragraph></subsection>
<subsection id="HFA3ECC5347704F02A800B05EF9C81F00"><enum>(b)</enum><header>Limitation on advisory opinions</header><text>As of the date of enactment of this Act, the following documents issued by the Food and Drug Administration shall not constitute advisory opinions under <external-xref legal-doc="regulation" parsable-cite="cfr/21/10.85">section 10.85(d)(1)</external-xref> of title 21, Code of Federal Regulations, except as they apply to tobacco products, and shall not be cited by the Secretary of Health and Human Services or the Food and Drug Administration as binding precedent:</text>
<paragraph id="HFF1100F804C940CBB5FA71A35300CC84"><enum>(1)</enum><text>The preamble to the proposed rule in the document entitled <quote>Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents</quote> (60 Fed. Reg. 41314–41372 (August 11, 1995)).</text></paragraph>
<paragraph id="H094EDD2D0B0E495D97A9A4B1011E00D7"><enum>(2)</enum><text>The document entitled <quote>Nicotine in Cigarettes and Smokeless Tobacco Products is a Drug and These Products Are Nicotine Delivery Devices Under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name></quote> (60 Fed. Reg. 41453–41787 (August 11, 1995)).</text></paragraph>
<paragraph id="H8D7BA7D4196A46419E56D5919BA54275"><enum>(3)</enum><text>The preamble to the final rule in the document entitled <quote>Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents</quote> (61 Fed. Reg. 44396–44615 (August 28, 1996)).</text></paragraph>
<paragraph id="HDAA7888DA24D4548B3DD0058EDA6F166"><enum>(4)</enum><text>The document entitled <quote>Nicotine in Cigarettes and Smokeless Tobacco is a Drug and These Products are Nicotine Delivery Devices Under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>; Jurisdictional Determination</quote> (61 Fed. Reg. 44619–45318 (August 28, 1996)).</text></paragraph></subsection></section>
<section id="HFA455E29B55C4A63B6CD2BA05C0001D4"><enum>233.</enum><header>Conforming and other amendments to general provisions</header>
<subsection id="H9BF6EF3F66354E6D8556B900CCD7ECCB"><enum>(a)</enum><header>Amendment of Federal food, drug, and Cosmetic Act</header><text>Except as otherwise expressly provided, whenever in this section an amendment is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference is to a section or other provision of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text></subsection>
<subsection id="HCC7213AA60504422A82E3997AA7B3AE"><enum>(b)</enum><header>Section <enum-in-header>301</enum-in-header></header><text>Section 301 (<external-xref legal-doc="usc" parsable-cite="usc/21/331">21 U.S.C. 331</external-xref>) is amended—</text>
<paragraph id="HB58AA1A6D58145E7B9901231ADB54C19"><enum>(1)</enum><text>in subsection (a), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="HA2D15AF2DEA8413E90B863CE725ECF3B"><enum>(2)</enum><text>in subsection (b), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="H2C07F75384B14FBCAC22D0A49CF46F82"><enum>(3)</enum><text>in subsection (c), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="H566DF11761104CA99CB6B192175FD5F6"><enum>(4)</enum><text>in subsection (e), by striking <quote>515(f), or 519</quote> and inserting <quote>515(f), 519, or 909</quote>;</text></paragraph>
<paragraph id="H395806CD4C0F47EEB8FFD47BE3FC9C8F"><enum>(5)</enum><text>in subsection (g), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="HA489D636C5B249938F105743346CA900"><enum>(6)</enum><text>in subsection (h), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="HA1C91BDD2E6C46A097253D8BF300B5C4"><enum>(7)</enum><text>in subsection (j), by striking <quote>708, or 721</quote> and inserting <quote>708, 721, 904, 905, 906, 907, 908, 909, or section 921(b)</quote>;</text></paragraph>
<paragraph id="H140A61FAC09647610012BA495B0662B3"><enum>(8)</enum><text>in subsection (k), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="H9CAA3F7E80064D509F8BC2561540BBAD"><enum>(9)</enum><text>by striking subsection (p) and inserting the following:</text>
<quoted-block id="H1A092CDEC6244BA693023C90AB82E06F">
<subsection id="HDAC2C3A4B0AA4F7482167CD7B0021B9F"><enum>(p)</enum><text>The failure to register in accordance with section 510 or 905, the failure to provide any information required by section 510(j), 510(k), 905(i), or 905(j), or the failure to provide a notice required by section 510(j)(2) or 905(i)(2).</text></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="H6FAB339FD62A41528F007CAA3C504300"><enum>(10)</enum><text>by striking subsection (q)(1) and inserting the following:</text>
<quoted-block id="H110F1FE53D8C45FFBFEA2769EB5715C9">
<subsection id="H9FC3CFE47F1C4A2D82F1B9B40396D73"><enum>(q)</enum>
<paragraph display-inline="yes-display-inline" id="HD7D1D1B45BCD4718BA105D4EAF38C040"><enum>(1)</enum><text>The failure or refusal—</text>
<subparagraph indent="paragraph" id="HAF1A80ED854C404ABBC7392E3B6882A3"><enum>(A)</enum><text>to comply with any requirement prescribed under section 518, 520(g), 903(b)(8), or 908, or condition prescribed under section 903(b)(6)(B)(ii)(II);</text></subparagraph>
<subparagraph indent="paragraph" id="H046A14C0E79740309FA9CE9631DD1B6"><enum>(B)</enum><text>to furnish any notification or other material or information required by or under section 519, 520(g), 904, 909, or section 921; or</text></subparagraph>
<subparagraph indent="paragraph" id="H6A879823FF12449FB7687B2F00CF58DC"><enum>(C)</enum><text>to comply with a requirement under section 522 or 913.</text></subparagraph></paragraph></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="H8F18CA15D72A4502A6314C8FE8C4D6D7"><enum>(11)</enum><text>in subsection (q)(2), by striking <quote>device,</quote> and inserting <quote>device or tobacco product,</quote>;</text></paragraph>
<paragraph id="H432465DC671043229853D1DFF899F88"><enum>(12)</enum><text>in subsection (r), by inserting <quote>or tobacco product</quote> after <quote>device</quote> each time that it appears; and</text></paragraph>
<paragraph id="H38F8370775434ACB86D2843592002022"><enum>(13)</enum><text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H02491858E02D4127B7609C05CB003DEC" display-inline="no-display-inline">
<subsection id="HE9000636669C4C0697AFF415C800033D"><enum>(aa)</enum><text>The sale of tobacco products in violation of a no-tobacco-sale order issued under section 303(f).</text></subsection>
<subsection id="H0C1F6A72B40B4832B9FECA3EB27E30"><enum>(bb)</enum><text>The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of section 911.</text></subsection>
<subsection id="H22F7DEBD36CA4DEBA0BF702734C33E65"><enum>(cc)</enum>
<paragraph id="H16F1D26BC29C478381470031674DF0D5" display-inline="yes-display-inline"><enum>(1)</enum><text>Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.</text></paragraph>
<paragraph id="H74EC23E5DDF241B9AA001BAFE9A9319D" indent="up1"><enum>(2)</enum><text>Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco product.</text></paragraph>
<paragraph id="H733CB9B027634815A1E336883F004FD6" indent="up1"><enum>(3)</enum><text>The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product.</text></paragraph></subsection>
<subsection id="H785C35BC55A745F9A6006D23EB96FB07"><enum>(dd)</enum><text>The charitable distribution of tobacco products.</text></subsection>
<subsection id="H3D0152CBC17F4E53BD55381500CDA74F"><enum>(ee)</enum><text>The failure of a manufacturer or distributor to notify the Attorney General of their knowledge of tobacco products used in illicit trade.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H8BBD0E6D031B44B58BF7E74708069C42"><enum>(c)</enum><header>Section <enum-in-header>303</enum-in-header></header><text>Section 303 (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>) is amended in subsection (f)—</text>
<paragraph id="H94A191CC7A1F493294FE024BAF1573"><enum>(1)</enum><text>by striking the subsection heading and inserting the following:</text>
<quoted-block id="HF99F2B2A2BFB434B8019DE30127CF500">
<subsection id="H8EBF0459C26743BB853C4F0099C22640"><enum>(f)</enum><header>Civil penalties; No-Tobacco-Sale orders</header></subsection><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HA32187EBDCD847BA956D74AC9B35FD3"><enum>(2)</enum><text>in paragraph (1)(A), by inserting <quote>or tobacco products</quote> after <quote>devices</quote>;</text></paragraph>
<paragraph id="H67731E4AE76B4F6CA890028D45ED7C25"><enum>(3)</enum><text>in paragraph (2)(C), by striking <quote>paragraph (3)(A)</quote> and inserting <quote>paragraph (4)(A)</quote>;</text></paragraph>
<paragraph id="H0F005E1BCACF4B829FAA9DB933CF266F"><enum>(4)</enum><text>by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), and inserting after paragraph (2) the following:</text>
<quoted-block id="H25CDB768BBF048C9A8720081B5BB3B1C">
<paragraph id="HD6295639C0DB4FA9BF22F005531CA06"><enum>(3)</enum><text>If the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1).</text></paragraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph>
<paragraph id="HA8D69EFCA78C47BCB0DB558732646E67"><enum>(5)</enum><text>in paragraph (4) as so redesignated—</text>
<subparagraph id="H798FE46D70294F219955BE896F066528"><enum>(A)</enum><text>in subparagraph (A)—</text>
<clause id="HFBA188AD681F46448048F6FA00EF7380"><enum>(i)</enum><text>by striking <quote>assessed</quote> the first time it appears and inserting <quote>assessed, or a no-tobacco-sale order may be imposed,</quote>; and</text></clause>
<clause id="H9A8168F611A84CDE9796F3B681FDF244"><enum>(ii)</enum><text>by striking <quote>penalty</quote> and inserting <quote>penalty, or upon whom a no-tobacco-order is to be imposed,</quote>;</text></clause></subparagraph>
<subparagraph id="H4404373151124EACAFDE8465A2BC6794"><enum>(B)</enum><text>in subparagraph (B)—</text>
<clause id="H82C58AA789CC42F4BC8572FC186B7B9"><enum>(i)</enum><text>by inserting after <quote>penalty,</quote> the following: <quote>or the period to be covered by a no-tobacco-sale order,</quote>; and</text></clause>
<clause id="HF8C4EEBAB1BE49B6B827351DE1D82B29"><enum>(ii)</enum><text>by adding at the end the following: <quote>A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, modify, or terminate the order.</quote>; and</text></clause></subparagraph>
<subparagraph id="H87C278FF84EB4EDD8EA97230E2A49B01"><enum>(C)</enum><text>by adding at the end, the following:</text>
<quoted-block id="H957CD825CA35482EB83C002800B4A4C0">
<subparagraph id="H9D2F0F560A804FCC96EDF800C580C3E"><enum>(D)</enum><text>The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HD5AF67AA32EF4220992755355EFA21A4"><enum>(6)</enum><text>in paragraph (5) as so redesignated—</text>
<subparagraph id="HDFE1E12D96364D408784E082AA440091"><enum>(A)</enum><text>by striking <quote>(3)(A)</quote> as redesignated, and inserting <quote>(4)(A)</quote>;</text></subparagraph>
<subparagraph id="H55C9FEC3196348C093027100D0B139DA"><enum>(B)</enum><text>by inserting <quote>or the imposition of a no-tobacco-sale order</quote> after <quote>penalty</quote> the first 2 places it appears; and</text></subparagraph>
<subparagraph id="H179CAABC82EB455EB2D3D0A04E1900A"><enum>(C)</enum><text>by striking <quote>issued.</quote> and inserting <quote>issued, or on which the no-tobacco-sale order was imposed, as the case may be.</quote>; and</text></subparagraph></paragraph>
<paragraph id="HC485A168034C4CB296326000000534E5"><enum>(7)</enum><text>in paragraph (6), as so redesignated, by striking <quote>paragraph (4)</quote> each place it appears and inserting <quote>paragraph (5)</quote>.</text></paragraph></subsection>
<subsection id="H7B0B05F7463940559E225134FD5E7C58"><enum>(d)</enum><header>Section <enum-in-header>304</enum-in-header></header><text>Section 304 (<external-xref legal-doc="usc" parsable-cite="usc/21/334">21 U.S.C. 334</external-xref>) is amended—</text>
<paragraph id="H1F2AE89B0B2B4139ADC46CF758FAC2B5"><enum>(1)</enum><text>in subsection (a)(2)—</text>
<subparagraph id="H9B1BDDCD22434D848D8DC4E0C629F0D3"><enum>(A)</enum><text>by striking <quote>and</quote> before <quote>(D)</quote>; and</text></subparagraph>
<subparagraph id="H9A661102783444528FA5E900004ECC70"><enum>(B)</enum><text>by striking <quote>device.</quote> and inserting the following: <quote>, (E) Any adulterated or misbranded tobacco product.</quote>;</text></subparagraph></paragraph>
<paragraph id="HE4B3205BC51E470C96D1631FBB64F7B1"><enum>(2)</enum><text>in subsection (d)(1), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>;</text></paragraph>
<paragraph id="H2698646F6D6D4822BBCBBD72CF6375FB"><enum>(3)</enum><text>in subsection (g)(1), by inserting <quote>or tobacco product</quote> after <quote>device</quote> each place it appears; and</text></paragraph>
<paragraph id="HEB4C6BB173874732982439428F1730DC"><enum>(4)</enum><text>in subsection (g)(2)(A), by inserting <quote>or tobacco product</quote> after <quote>device</quote> each place it appears.</text></paragraph></subsection>
<subsection id="HCC62A607C53B4BEAB36095D4686F53AF"><enum>(e)</enum><header>Section <enum-in-header>702</enum-in-header></header><text>Section 702(a) (<external-xref legal-doc="usc" parsable-cite="usc/21/372">21 U.S.C. 372(a)</external-xref>) is amended—</text>
<paragraph id="HBB42A94BF5094AD3AA10AE89AD49308E"><enum>(1)</enum><text>by inserting <quote>(1)</quote> after <quote>(a)</quote>; and</text></paragraph>
<paragraph id="HF7A4C48F8BC54B9FBDAAF7DD81CD72E"><enum>(2)</enum><text>by adding at the end thereof the following:</text>
<quoted-block id="HD043E07340504C6493D4F7A6C8FEEBCA">
<paragraph indent="subsection" id="H7491D477C6954AA2AE76DFE19EF0C62B"><enum>(2)</enum><text>For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with paragraph (1) to carry out inspections of retailers within that State in connection with the enforcement of this Act.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H09D0686F78E3497500D626B973ADEF4F"><enum>(f)</enum><header>Section <enum-in-header>703</enum-in-header></header><text>Section 703 (<external-xref legal-doc="usc" parsable-cite="usc/21/373">21 U.S.C. 373</external-xref>) is amended—</text>
<paragraph id="H411A77A163054DA8B58EF871382BFCA0"><enum>(1)</enum><text>by inserting <quote>tobacco product,</quote> after <quote>device,</quote> each place it appears; and</text></paragraph>
<paragraph id="HA0D8C104674849FEBD7D7B728FAEE89"><enum>(2)</enum><text>by inserting <quote>tobacco products,</quote> after <quote>devices,</quote> each place it appears.</text></paragraph></subsection>
<subsection id="H97C0BB7B31934893A300B327E41355D9"><enum>(g)</enum><header>Section <enum-in-header>704</enum-in-header></header><text>Section 704 (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>) is amended—</text>
<paragraph id="H0B54E387AEB44CD0945D2FC7F4C91BB3"><enum>(1)</enum><text>in subsection (a)(1)(A), by inserting <quote>tobacco products,</quote> after <quote>devices,</quote> each place it appears;</text></paragraph>
<paragraph id="H04918FF1A2B44C22A958DBDE03FD3BBE"><enum>(2)</enum><text>in subsection (a)(1)(B), by inserting <quote>or tobacco product</quote> after <quote>restricted devices</quote> each place it appears; and</text></paragraph>
<paragraph id="H0561E551B7E841C4AAF67748F8026FE9"><enum>(3)</enum><text>in subsection (b), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>.</text></paragraph></subsection>
<subsection id="H1D54A897E6BB4F719F78A00247BB0461"><enum>(h)</enum><header>Section <enum-in-header>705</enum-in-header></header><text>Section 705(b) (<external-xref legal-doc="usc" parsable-cite="usc/21/375">21 U.S.C. 375(b)</external-xref>) is amended by inserting <quote>tobacco products,</quote> after <quote>devices,</quote>.</text></subsection>
<subsection id="HC91E8561C33E47689900F00856549B87"><enum>(i)</enum><header>Section <enum-in-header>709</enum-in-header></header><text>Section 709 (<external-xref legal-doc="usc" parsable-cite="usc/21/379">21 U.S.C. 379</external-xref>) is amended by inserting <quote>or tobacco product</quote> after <quote>device</quote>.</text></subsection>
<subsection id="HB7A1E225B4C54C57A5D9720050E483A5"><enum>(j)</enum><header>Section <enum-in-header>801</enum-in-header></header><text>Section 801 (<external-xref legal-doc="usc" parsable-cite="usc/21/381">21 U.S.C. 381</external-xref>) is amended—</text>
<paragraph id="HE5A5CFA114EF4B689561E78C2CEA2C4"><enum>(1)</enum><text>in subsection (a)—</text>
<subparagraph id="H0C16B5C4D81B4573A1EE54E04F1B25"><enum>(A)</enum><text>by inserting <quote>tobacco products,</quote> after <quote>devices,</quote> the first time it appears;</text></subparagraph>
<subparagraph id="HF6B16866715E42EF8DE8C4A40953622B"><enum>(B)</enum><text>by inserting <quote>or section 905(j)</quote> after <quote>section 510</quote>; and</text></subparagraph>
<subparagraph id="H2199F0850230449A80E8549EE974134B"><enum>(C)</enum><text>by striking <quote>drugs or devices</quote> each time it appears and inserting <quote>drugs, devices, or tobacco products</quote>;</text></subparagraph></paragraph>
<paragraph id="HF4537DC6A0994164BCAC81CE3D96FE54"><enum>(2)</enum><text>in subsection (e)(1), by inserting <quote>tobacco product,</quote> after <quote>device,</quote>; and</text></paragraph>
<paragraph id="H65BF88A4F0B44E0BB209E30015865DA8"><enum>(3)</enum><text>by adding at the end the following:</text>
<quoted-block id="HCFA79A0833B74C33B7D59CBA5F3F9751">
<subsection id="HDE7A68B7AEC54546B5FF4149EEB9E86"><enum>(p)</enum>
<paragraph display-inline="yes-display-inline" id="H483004C1F8B24748963EC741001864A9"><enum>(1)</enum><text>Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report regarding—</text>
<subparagraph indent="paragraph" id="H355921C7F81C4DBD8476BB827F83DBDD"><enum>(A)</enum><text>the nature, extent, and destination of United States tobacco product exports that do not conform to tobacco product standards established pursuant to this Act;</text></subparagraph>
<subparagraph indent="paragraph" id="HD7513F9D30184CA695E4B480691FAA49"><enum>(B)</enum><text>the public health implications of such exports, including any evidence of a negative public health impact; and</text></subparagraph>
<subparagraph indent="paragraph" id="H71AE9238813D43A10046BFB22BFFE72"><enum>(C)</enum><text>recommendations or assessments of policy alternatives available to Congress and the Executive Branch to reduce any negative public health impact caused by such exports.</text></subparagraph></paragraph>
<paragraph indent="subsection" id="H3EA821E40A9F4FE085F532B5C4EB9D7D"><enum>(2)</enum><text>The Secretary is authorized to establish appropriate information disclosure requirements to carry out this subsection.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="H0C90F726B47544A3AE96E46F701272D2"><enum>(k)</enum><header>Section <enum-in-header>1003</enum-in-header></header><text>Section 1003(d)(2)(C) (as redesignated by <external-xref legal-doc="usc" parsable-cite="usc/26/231">section 231(a))</external-xref> is amended—</text>
<paragraph id="H3D448BA7EEBE4A74AED60010FAB17351"><enum>(1)</enum><text>by striking <quote>and</quote> after <quote>cosmetics,</quote>; and</text></paragraph>
<paragraph id="HD12B05E8F081486FB49FF1D6ACCA5B2C"><enum>(2)</enum><text>inserting a comma and <quote>and tobacco products</quote> after <quote>devices</quote>.</text></paragraph></subsection>
<subsection id="H5CB6BF26D537406DBA763EBC382319D5"><enum>(l)</enum><header>Guidance and effective dates</header>
<paragraph id="H2D9A575F6D804B11BC92DA6F3DBB2580"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services shall issue guidance—</text>
<subparagraph id="H838BE3802D05479C975631A16238692F"><enum>(A)</enum><text>defining the term <term>repeated violation</term>, as used in section 303(f) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/333">21 U.S.C. 333(f)</external-xref>) as amended by subsection (c), by identifying the number of violations of particular requirements over a specified period of time at a particular retail outlet that constitute a repeated violation;</text></subparagraph>
<subparagraph id="H8731F8E803D94355B07265DB00AD1E03"><enum>(B)</enum><text>providing for timely and effective notice to the retailer of each alleged violation at a particular retail outlet;</text></subparagraph>
<subparagraph id="H430737B18E4F436A8086839F10F34D72"><enum>(C)</enum><text>providing for an expedited procedure for the administrative appeal of an alleged violation;</text></subparagraph>
<subparagraph id="H3F24B9CCA5A04231BFBCA67E62F3900"><enum>(D)</enum><text>providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet;</text></subparagraph>
<subparagraph id="H17200DE567894386A0CABB5400FE497F"><enum>(E)</enum><text>establishing a period of time during which, if there are no violations by a particular retail outlet, that outlet will not be considered to have been the site of repeated violations when the next violation occurs; and</text></subparagraph>
<subparagraph id="HC9D3C48B1C46410CBFD34C0058126BA0"><enum>(F)</enum><text>providing that good faith reliance on the presentation of a false government issued photographic identification that contains a date of birth does not constitute a violation of any minimum age requirement for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including—</text>
<clause id="H4D6179F1BC2B4D50BDF23F4F019D616F"><enum>(i)</enum><text>adopting and enforcing a written policy against sales to minors;</text></clause>
<clause id="H4E36F8C619AD4274AAF6A4049300C488"><enum>(ii)</enum><text>informing its employees of all applicable laws;</text></clause>
<clause id="H2CE9E79FA6C7436EA579E9673CE8C12D"><enum>(iii)</enum><text>establishing disciplinary sanctions for employee noncompliance; and</text></clause>
<clause id="H8944964A689A4A61AA0012004B9FE49D"><enum>(iv)</enum><text>requiring its employees to verify age by way of photographic identification or electronic scanning device.</text></clause></subparagraph></paragraph>
<paragraph id="H4DE9A292FC5649099BAFD1A16E129E54"><enum>(2)</enum><header>General effective date</header><text>The amendments made by subsection (c), other than the amendment made by paragraph (2) of such subsection, shall take effect upon the issuance of guidance described in paragraph (1).</text></paragraph>
<paragraph id="H75EE5D93AF324CAB82B500009CF6B434"><enum>(3)</enum><header>Special effective date</header><text>The amendments made by paragraph (2) of subsection (c) shall take effect on the date of enactment of this Act.</text></paragraph></subsection></section></part>
<part id="HF3FBA77C8723418EA0C757BDC5C0992C"><enum>II</enum><header>Tobacco Product Warnings; Constituent and Smoke Cconstituent Disclosure</header>
<section id="H23AEBC71C0D34124B2BF8F15D0E6D9B7"><enum>235.</enum><header>Cigarette label and advertising warnings</header><text display-inline="no-display-inline">Section 4 of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>) is amended to read as follows:</text>
<quoted-block id="HABA738A860964ED9B7F314AAF22E2F08">
<section id="HCC01329387DB48D8AC498F68783B3EEA"><enum>4.</enum><header>Labeling</header>
<subsection id="HE89AA45860DC4BA8B315DA3777E0856"><enum>(a)</enum><header>Label requirements</header>
<paragraph id="HBE70675409204537A32E4B8999F6C23E"><enum>(1)</enum><header>In general</header><text>It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any cigarettes the package of which fails to bear, in accordance with the requirements of this section, one of the following labels:</text>
<quoted-block id="H3CB3BCEF207347CE9ED362A74EE6F8D8">
<paragraph id="H48C518308FC04864A4FF74B000B900DD"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Cigarettes are addictive</text></paragraph>
<paragraph id="HA091AE043CE1409FBD94D3D188A79C72"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Tobacco smoke can harm your children</text></paragraph>
<paragraph id="HA4AB170F2E06483EBCBBC79B1B78C497"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Cigarettes cause fatal lung disease</text></paragraph>
<paragraph id="H9E6972E9179E4AEE0029969243324E30"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Cigarettes cause cancer</text></paragraph>
<paragraph id="H471AB48BBE01415DA02D1681CFA56C7C"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Cigarettes cause strokes and heart disease</text></paragraph>
<paragraph id="H3A6B9FF3AB8740A8A66990048F086E50"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Smoking during pregnancy can harm your baby</text></paragraph>
<paragraph id="H972846BF326242B7A8750188F2290168"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Smoking can kill you</text></paragraph>
<paragraph id="HEEA7C94AF8E2426DA68167A622D98E34"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Tobacco smoke causes fatal lung disease in non-smokers</text></paragraph>
<paragraph id="HCCC0E833F21A41F09CD85FDB09D1E9F4"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Quitting smoking now greatly reduces serious risks to your health</text></paragraph> <after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HA77B35B04E904D83AAD90032C23000C"><enum>(2)</enum><header>Placement; typography; etc</header>
<subparagraph id="H03AE641262FA4CD285FFEA4F7418805B"><enum>(A)</enum><header>In general</header><text>Each label statement required by paragraph (1) shall be located in the upper portion of the front and rear panels of the package, directly on the package underneath the cellophane or other clear wrapping. Except as provided in subparagraph (B), each label statement shall comprise at least the top 30 percent of the front and rear panels of the package. The word <quote>WARNING</quote> shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label statement would occupy more than 70 percent of such area, in which case the text may be in a smaller conspicuous and legible type size, provided that at least 60 percent of such area is occupied by required text. The text shall be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the plan submitted under subsection (b)(4).</text></subparagraph>
<subparagraph id="HBFA218FB191F4101BB8D57777943A4DA"><enum>(B)</enum><header>Hinged lid boxes</header><text>For any cigarette brand package manufactured or distributed before January 1, 2000, which employs a hinged lid style (if such packaging was used for that brand in commerce prior to June 21, 1997), the label statement required by paragraph (1) shall be located on the hinged lid area of the package, even if such area is less than 25 percent of the area of the front panel. Except as provided in this paragraph, the provisions of this subsection shall apply to such packages.</text></subparagraph></paragraph>
<paragraph id="H746F13B6DF464CAA8DD2502137F504EC"><enum>(3)</enum><header>Does not apply to foreign distribution</header><text>The provisions of this subsection do not apply to a tobacco product manufacturer or distributor of cigarettes which does not manufacture, package, or import cigarettes for sale or distribution within the United States.</text></paragraph>
<paragraph id="H0173CA120F47404F8E05E1B3CC75FE82"><enum>(4)</enum><header>Applicability to retailers</header><text>A retailer of cigarettes shall not be in violation of this subsection for packaging that is supplied to the retailer by a tobacco product manufacturer, importer, or distributor and is not altered by the retailer in a way that is material to the requirements of this subsection except that this paragraph shall not relieve a retailer of liability if the retailer sells or distributes tobacco products that are not labeled in accordance with this subsection.</text></paragraph></subsection>
<subsection id="H56D0E8131C004AA0B48400CDFC66895"><enum>(b)</enum><header>Advertising requirements</header>
<paragraph id="HA22A68DE38024B2294C91100735B76C0"><enum>(1)</enum><header>In general</header><text>It shall be unlawful for any tobacco product manufacturer, importer, distributor, or retailer of cigarettes to advertise or cause to be advertised within the United States any cigarette unless its advertising bears, in accordance with the requirements of this section, one of the labels specified in subsection (a) of this section.</text></paragraph>
<paragraph id="H003A6AFFC73A47AA908DABD1C94D9000"><enum>(2)</enum><header>Typography, etc</header><text>Each label statement required by subsection (a) of this section in cigarette advertising shall comply with the standards set forth in this paragraph. For press and poster advertisements, each such statement and (where applicable) any required statement relating to tar, nicotine, or other constituent (including a smoke constituent) yield shall comprise at least 20 percent of the area of the advertisement and shall appear in a conspicuous and prominent format and location at the top of each advertisement within the trim area. The Secretary may revise the required type sizes in such area in such manner as the Secretary determines appropriate. The word <quote>WARNING</quote> shall appear in capital letters, and each label statement shall appear in conspicuous and legible type. The text of the label statement shall be black if the background is white and white if the background is black, under the plan submitted under paragraph (4) of this subsection. The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital <quote>W</quote> of the word <quote>WARNING</quote> in the label statements. The text of such label statements shall be in a typeface pro rata to the following requirements: 45-point type for a whole-page broadsheet newspaper advertisement; 39-point type for a half-page broadsheet newspaper advertisement; 39-point type for a whole-page tabloid newspaper advertisement; 27-point type for a half-page tabloid newspaper advertisement; 31.5-point type for a double page spread magazine or whole-page magazine advertisement; 22.5-point type for a 28 centimeter by 3 column advertisement; and 15-point type for a 20 centimeter by 2 column advertisement. The label statements shall be in English, except that in the case of—</text>
<subparagraph id="H95AD528AA2454FC6B2DBBB134CB4DAD"><enum>(A)</enum><text>an advertisement that appears in a newspaper, magazine, periodical, or other publication that is not in English, the statements shall appear in the predominant language of the publication; and</text></subparagraph>
<subparagraph id="H8E56AE1F565A4FD0BB2E02006153C300"><enum>(B)</enum><text>in the case of any other advertisement that is not in English, the statements shall appear in the same language as that principally used in the advertisement.</text></subparagraph></paragraph>
<paragraph id="H2CA66EF89DF84FDCAD08B3B1FA37115E"><enum>(3)</enum><header>Matchbooks</header><text>Notwithstanding paragraph (2), for matchbooks (defined as containing not more than 20 matches) customarily given away with the purchase of tobacco products, each label statement required by subsection (a) may be printed on the inside cover of the matchbook.</text></paragraph>
<paragraph id="H9AF3FAC471E542319C79C7B0FD3D9FB"><enum>(4)</enum><header>Adjustment by Secretary</header><text>The Secretary may, through a rulemaking under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code, adjust the format and type sizes for the label statements required by this section or the text, format, and type sizes of any required tar, nicotine yield, or other constituent (including smoke constituent) disclosures, or to establish the text, format, and type sizes for any other disclosures required under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (21 U.S.C. 301 et. seq.). The text of any such label statements or disclosures shall be required to appear only within the 20 percent area of cigarette advertisements provided by paragraph (2) of this subsection. The Secretary shall promulgate regulations which provide for adjustments in the format and type sizes of any text required to appear in such area to ensure that the total text required to appear by law will fit within such area.</text></paragraph></subsection>
<subsection id="HB4A480154B034CF296425938A8EE181C"><enum>(c)</enum><header>Marketing requirements</header>
<paragraph id="HF57D73D45D1242ECB96E987CDFBCE2B8"><enum>(1)</enum><header>Random display</header><text>The label statements specified in subsection (a)(1) shall be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the Secretary.</text></paragraph>
<paragraph id="HF37C30B234A54DE99896003CCF21F8F5"><enum>(2)</enum><header>Rotation</header><text>The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer to, and approved by, the Secretary.</text></paragraph>
<paragraph id="HE391214CD9BE4037A826F8510712AD56"><enum>(3)</enum><header>Review</header><text>The Secretary shall review each plan submitted under paragraph (2) and approve it if the plan—</text>
<subparagraph id="HD6B492C092EE463E9C830412274C0525"><enum>(A)</enum><text>will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and</text></subparagraph>
<subparagraph id="H8DA82C6CC06E4EF1BE6C98273C8D9CE0"><enum>(B)</enum><text>assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time.</text></subparagraph></paragraph>
<paragraph id="H139F54FFC77D48E9B28707FC0012ABDA"><enum>(4)</enum><header>Applicability to retailers</header><text>This subsection and subsection (b) apply to a retailer only if that retailer is responsible for or directs the label statements required under this section except that this paragraph shall not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that is not labeled in accordance with the requirements of this subsection and subsection (b).</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H3B8753CE95524F49BCA9966D1FE818AC"><enum>236.</enum><header>Authority to revise cigarette WARNING label statements</header><text display-inline="no-display-inline">Section 4 of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1333">15 U.S.C. 1333</external-xref>), as amended by section 235, is further amended by adding at the end the following:</text>
<quoted-block id="H34534CFFB6B8477782A75DB7FC83D94F">
<subsection id="HC53C7D6C32C9417BBE6F7CCC2BEFAFDB"><enum>(d)</enum><header>Change in required statements</header><text>The Secretary may, by a rulemaking conducted under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code, adjust the format, type size, and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30 percent up to 50 percent of the front and rear panels of the package, or establish the format, type size, and text of any other disclosures required under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H2B94BC7752E847BC992551F32D695569"><enum>237.</enum><header>State regulation of cigarette advertising and promotion</header><text display-inline="no-display-inline">Section 5 of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1334">15 U.S.C. 1334</external-xref>) is amended by adding at the end the following:</text>
<quoted-block id="H105AF3F562794AC183E1264097F099B">
<subsection id="HF492A6B02FBB49F2A107B346D71F919C"><enum>(c)</enum><header>Exception</header><text>Notwithstanding subsection (b), a State or locality may enact statutes and promulgate regulations, based on smoking and health, that take effect after the effective date of the Family Smoking Prevention and Tobacco Control Act, imposing specific bans or restrictions on the time, place, and manner, but not content, of the advertising or promotion of any cigarettes.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H3628336ECF01452ABDFF00DC00F08400"><enum>238.</enum><header>Smokeless tobacco labels and advertising warnings</header><text display-inline="no-display-inline">Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>) is amended to read as follows:</text>
<quoted-block id="HCA99FE1B0B654741BCF57EB232E7AC10">
<section id="H40AF17C06D214233AA7985BC8F91CDFE"><enum>3.</enum><header>Smokeless Tobacco WARNING</header>
<subsection id="H248A711B6E044458BEE7B698C2BDEE00"><enum>(a)</enum><header>General rule</header>
<paragraph id="HCC8FB6AF34464B149955B77C2EE093C8"><enum>(1)</enum><text>It shall be unlawful for any person to manufacture, package, sell, offer to sell, distribute, or import for sale or distribution within the United States any smokeless tobacco product unless the product package bears, in accordance with the requirements of this Act, one of the following labels:</text>
<quoted-block id="HBC9E7DF845934F16A96FEC0297A1D24F">
<paragraph id="H19434E7F060C4957B74CE9F1CBA034E9"><enum></enum><text>WARNING: This product can cause mouth cancer</text></paragraph>
<paragraph id="H946A45BE5EDA47DDB4CB94447CA519CD"><enum><?xm-replace_text {enum}?></enum><text>WARNING: This product can cause gum disease and tooth loss</text></paragraph>
<paragraph id="H9587DAD32779417200A5FEB4B940024"><enum><?xm-replace_text {enum}?></enum><text>WARNING: This product is not a safe alternative to cigarettes</text></paragraph>
<paragraph id="H8EB4065A0F0244F2B7503D0711E32F3E"><enum><?xm-replace_text {enum}?></enum><text>WARNING: Smokeless tobacco is addictive</text></paragraph> <after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H270784F5437D4A3AA6F4C7505F3012CA"><enum>(2)</enum><text>Each label statement required by paragraph (1) shall be—</text>
<subparagraph id="HDD40E52A5A6E4A8EB78906006947152F"><enum>(A)</enum><text>located on the 2 principal display panels of the package, and each label statement shall comprise at least 30 percent of each such display panel; and</text></subparagraph>
<subparagraph id="HB828CF5D272940D8BF7735C69532C34C"><enum>(B)</enum><text>in 17-point conspicuous and legible type and in black text on a white background, or white text on a black background, in a manner that contrasts by typography, layout, or color, with all other printed material on the package, in an alternating fashion under the plan submitted under subsection (b)(3), except that if the text of a label statement would occupy more than 70 percent of the area specified by subparagraph (A), such text may appear in a smaller type size, so long as at least 60 percent of such warning area is occupied by the label statement.</text></subparagraph></paragraph>
<paragraph id="H8900894BAE8D4DEA86DF3FC20493690"><enum>(3)</enum><text>The label statements required by paragraph (1) shall be introduced by each tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products concurrently into the distribution chain of such products.</text></paragraph>
<paragraph id="HFF99581B5A5B45FC83D85D4613253B00"><enum>(4)</enum><text>The provisions of this subsection do not apply to a tobacco product manufacturer or distributor of any smokeless tobacco product that does not manufacture, package, or import smokeless tobacco products for sale or distribution within the United States.</text></paragraph>
<paragraph id="HF6D55C59EF0D40ED8EFF03F6FF22385D"><enum>(5)</enum><text>A retailer of smokeless tobacco products shall not be in violation of this subsection for packaging that is supplied to the retailer by a tobacco products manufacturer, importer, or distributor and that is not altered by the retailer unless the retailer offers for sale, sells, or distributes a smokeless tobacco product that is not labeled in accordance with this subsection.</text></paragraph></subsection>
<subsection id="H0BB44CC1DFF04D049BA4BE0A7EAC44D"><enum>(b)</enum><header>Required labels</header>
<paragraph id="H6AE9704859964FE99C53F4948593BB87"><enum>(1)</enum><text>It shall be unlawful for any tobacco product manufacturer, packager, importer, distributor, or retailer of smokeless tobacco products to advertise or cause to be advertised within the United States any smokeless tobacco product unless its advertising bears, in accordance with the requirements of this section, one of the labels specified in subsection (a).</text></paragraph>
<paragraph id="H70DC55D1A9D34063894416D511AC667D"><enum>(2)</enum><text>Each label statement required by subsection (a) in smokeless tobacco advertising shall comply with the standards set forth in this paragraph. For press and poster advertisements, each such statement and (where applicable) any required statement relating to tar, nicotine, or other constituent yield shall—</text>
<subparagraph id="HD4905D4C251D4EB68D1CA2B2B9746F31"><enum>(A)</enum><text>comprise at least 20 percent of the area of the advertisement, and the warning area shall be delineated by a dividing line of contrasting color from the advertisement; and</text></subparagraph>
<subparagraph id="HACF3538382F14854A6D7D84209550037"><enum>(B)</enum><text>the word <quote>WARNING</quote> shall appear in capital letters and each label statement shall appear in conspicuous and legible type. The text of the label statement shall be black on a white background, or white on a black background, in an alternating fashion under the plan submitted under paragraph (3).</text></subparagraph></paragraph>
<paragraph id="HCA40EA8BD5564656882355F5276BC1B7"><enum>(3)</enum>
<subparagraph display-inline="yes-display-inline" id="H136EF3186C144D6AB2DE356DFDBED4F9"><enum>(A)</enum><text>The label statements specified in subsection (a)(1) shall be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product and be randomly distributed in all areas of the United States in which the product is marketed in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer and approved by the Secretary.</text></subparagraph>
<subparagraph indent="paragraph" id="H27EB2058E4A649A2A470E5E4E08AFD4"><enum>(B)</enum><text>The label statements specified in subsection (a)(1) shall be rotated quarterly in alternating sequence in advertisements for each brand of smokeless tobacco product in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer to, and approved by, the Secretary.</text></subparagraph>
<subparagraph indent="paragraph" id="H3EC4E1D0688A4760B901A4D66CB2B54B"><enum>(C)</enum><text>The Secretary shall review each plan submitted under subparagraph (B) and approve it if the plan—</text>
<clause indent="subparagraph" id="H04BACD5AA9964F86BADB87BA4DBFFAFE"><enum>(i)</enum><text>will provide for the equal distribution and display on packaging and the rotation required in advertising under this subsection; and</text></clause>
<clause indent="subparagraph" id="H6BCAAA3810AD454D98D22BE650FFD89B"><enum>(ii)</enum><text>assures that all of the labels required under this section will be displayed by the tobacco product manufacturer, importer, distributor, or retailer at the same time.</text></clause></subparagraph>
<subparagraph indent="paragraph" id="HC738357483FD4563A8EA4D4F33890043"><enum>(D)</enum><text>This paragraph applies to a retailer only if that retailer is responsible for or directs the label statements under this section, unless the retailer displays in a location open to the public, an advertisement that is not labeled in accordance with the requirements of this subsection.</text></subparagraph></paragraph></subsection>
<subsection id="H6D3919A27564433888C9080871B9CF14"><enum>(c)</enum><header>Television and radio advertising</header><text>It is unlawful to advertise smokeless tobacco on any medium of electronic communications subject to the jurisdiction of the Federal Communications Commission.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H43CFF14E146D4AAD9F00705864B30081"><enum>239.</enum><header>Authority to revise smokeless tobacco product WARNING label statements</header><text display-inline="no-display-inline">Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (<external-xref legal-doc="usc" parsable-cite="usc/15/4402">15 U.S.C. 4402</external-xref>), as amended by section 237, is further amended by adding at the end the following:</text>
<quoted-block id="HD26AFB631DCF45B487A2306C1B6B6E00">
<subsection id="H536089F01AF84AEDA8DB1ED305951B15"><enum>(d)</enum><header>Authority to revise WARNING label statements</header><text>The Secretary may, by a rulemaking conducted under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code, adjust the format, type size, and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30 percent up to 50 percent of the front and rear panels of the package, or establish the format, type size, and text of any other disclosures required under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of smokeless tobacco products.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H131BBE2389AA4DC7A60006992DFB0683"><enum>240.</enum><header>Tar, nicotine, and other smoke constituent disclosure to the public</header><text display-inline="no-display-inline">Section 4(a) of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333 (a)), as amended by section 235, is further amended by adding at the end the following:</text>
<quoted-block id="HC2856BE3DBD74CB2A4005DA2012D65A5">
<paragraph id="H9781F1B1551B4DFBB81DED62D30075FB"><enum>(4)</enum>
<subparagraph display-inline="yes-display-inline" id="H569E9B9493FA422D9D4E6969D2547F14"><enum>(A)</enum><text>The Secretary shall, by a rulemaking conducted under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code, determine (in the Secretary’s sole discretion) whether cigarette and other tobacco product manufacturers shall be required to include in the area of each cigarette advertisement specified by subsection (b) of this section, or on the package label, or both, the tar and nicotine yields of the advertised or packaged brand. Any such disclosure shall be in accordance with the methodology established under such regulations, shall conform to the type size requirements of subsection (b) of this section, and shall appear within the area specified in subsection (b) of this section.</text></subparagraph>
<subparagraph indent="paragraph" id="H333AEC6BD32B442985BE41FB32038183"><enum>(B)</enum><text>Any differences between the requirements established by the Secretary under subparagraph (A) and tar and nicotine yield reporting requirements established by the Federal Trade Commission shall be resolved by a memorandum of understanding between the Secretary and the Federal Trade Commission.</text></subparagraph>
<subparagraph indent="paragraph" id="HD331051BE0244FDFBAE8E99CF0E6487E"><enum>(C)</enum><text>In addition to the disclosures required by subparagraph (A) of this paragraph, the Secretary may, under a rulemaking conducted under <external-xref legal-doc="usc" parsable-cite="usc/5/553">section 553</external-xref> of title 5, United States Code, prescribe disclosure requirements regarding the level of any cigarette or other tobacco product constituent including any smoke constituent. Any such disclosure may be required if the Secretary determines that disclosure would be of benefit to the public health, or otherwise would increase consumer awareness of the health consequences of the use of tobacco products, except that no such prescribed disclosure shall be required on the face of any cigarette package or advertisement. Nothing in this section shall prohibit the Secretary from requiring such prescribed disclosure through a cigarette or other tobacco product package or advertisement insert, or by any other means under the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>).</text></subparagraph>
<subparagraph indent="paragraph" id="H0EC362C01C1242129F5765056136B2F2"><enum>(D)</enum><text>This paragraph applies to a retailer only if that retailer is responsible for or directs the label statements required under this section, except that this paragraph shall not relieve a retailer of liability if the retailer sells or distributes tobacco products that are not labeled in accordance with the requirements of this subsection.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section></part>
<part id="HE882F076FAEA48EEB47C3346EE910192"><enum>III</enum><header>Prevention of Illicit Trade in Tobacco Products</header>
<section id="H111378B4F2ED45AF8C29CEAF7BE8AEA1"><enum>241.</enum><header>Labeling, recordkeeping, records inspection</header><text display-inline="no-display-inline">Chapter IX of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name>, as added by section 231, is further amended by adding at the end the following:</text>
<quoted-block act-name="Federal Food, Drug, and Cosmetic Act" id="H5E9524659D8B48C89C65DE0FF696DE4">
<section id="H56C97D677C23484D843F29853CFB0510"><enum>921.</enum><header>Labeling, recordkeeping, records inspection</header>
<subsection id="H9C23C8121E66419AA98F001D74927EF8"><enum>(a)</enum><header>Origin labeling</header><text>The label, packaging, and shipping containers of tobacco products for introduction or delivery for introduction into interstate commerce in the United States shall bear the statement <quote>sale only allowed in the United States.</quote></text></subsection>
<subsection id="HD4BF7704920346F7A34156FFC639BA66"><enum>(b)</enum><header>Regulations concerning recordkeeping for tracking and tracing</header>
<paragraph id="HDFF5384F00D24F3EBD52AE2C8035F77F"><enum>(1)</enum><header>In general</header><text>Not later than 9 months after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall promulgate regulations regarding the establishment and maintenance of records by any person who manufactures, processes, transports, distributes, receives, packages, holds, exports, or imports tobacco products.</text></paragraph>
<paragraph id="HBB3CB4453C4A45ADB2ADD88B9BA6BEF"><enum>(2)</enum><header>Inspection</header><text>In promulgating the regulations described in paragraph (1), the Secretary shall consider which records are needed for inspection to monitor the movement of tobacco products from the point of manufacture through distribution to retail outlets to assist in investigating potential illicit trade, smuggling or counterfeiting of tobacco products.</text></paragraph>
<paragraph id="HEB7E006A53544297A1FDC1D7FA748100"><enum>(3)</enum><header>Codes</header><text>The Secretary may require codes on the labels of tobacco products or other designs or devices for the purpose of tracking or tracing the tobacco product through the distribution system.</text></paragraph>
<paragraph id="H4E3CD44D4F2A4D0CA4BEBB57E278CD71"><enum>(4)</enum><header>Size of business</header><text>The Secretary shall take into account the size of a business in promulgating regulations under this section.</text></paragraph>
<paragraph id="H3C4484BE46F040FF841D20C6A85FCA77"><enum>(5)</enum><header>Recordkeeping by retailers</header><text>The Secretary shall not require any retailer to maintain records relating to individual purchasers of tobacco products for personal consumption.</text></paragraph></subsection>
<subsection id="H18B5D287ACF3447600E427748C6E9D7E"><enum>(c)</enum><header>Records inspection</header><text>If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or smuggling or is a counterfeit product, each person who manufactures, processes, transports, distributes, receives, holds, packages, exports, or imports tobacco products shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, upon the presentation of appropriate credentials and a written notice to such person, to have access to and copy all records (including financial records) relating to such article that are needed to assist the Secretary in investigating potential illicit trade, smuggling or counterfeiting of tobacco products.</text></subsection>
<subsection id="H6C51D6087EE54D0AA736835D9CEE76E7"><enum>(d)</enum><header>Knowledge of illegal transaction</header>
<paragraph id="H74EC2C45C9EC4504B98639FEE193CE62"><enum>(1)</enum><header>In general</header><text>If the manufacturer or distributor of a tobacco product has knowledge which reasonably supports the conclusion that a tobacco product manufactured or distributed by such manufacturer or distributor that has left the control of such person may be or has been—</text>
<subparagraph id="H4F7C444C6A9147FFBFBE52685BF62D8E"><enum>(A)</enum><text>imported, exported, distributed or offered for sale in interstate commerce by a person without paying duties or taxes required by law; or</text></subparagraph>
<subparagraph id="HA308A72A246140F2ADC51FB81B20806B"><enum>(B)</enum><text>imported, exported, distributed or diverted for possible illicit marketing, the manufacturer or distributor shall promptly notify the Attorney General of such knowledge.</text></subparagraph></paragraph>
<paragraph id="HD994437372F54B9CA575CD1F03322D2"><enum>(2)</enum><header>Knowledge defined</header><text>For purposes of this subsection, the term <term>knowledge</term> as applied to a manufacturer or distributor means—</text>
<subparagraph id="HD253C6E4073541E686BCA496DC2881D4"><enum>(A)</enum><text>the actual knowledge that the manufacturer or distributor had; or</text></subparagraph>
<subparagraph id="H7E3517E3C41C4464B0436546E6C3EEC"><enum>(B)</enum><text>the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care.</text></subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H163E19D4E3044AAE99252FEDDC10FB19"><enum>242.</enum><header>Study and report</header>
<subsection id="HFDA30C83828D48AEBC41A7430276C76"><enum>(a)</enum><header>Study</header><text>The Comptroller General of the United States shall conduct a study of cross-border trade in tobacco products to—</text>
<paragraph id="H31D598163D8B4B258EF6F4F91E1577D"><enum>(1)</enum><text>collect data on cross-border trade in tobacco products, including illicit trade and trade of counterfeit tobacco products and make recommendations on the monitoring of such trade;</text></paragraph>
<paragraph id="H2D136BBE38534600AADE24688377E2FA"><enum>(2)</enum><text>collect data on cross-border advertising (any advertising intended to be broadcast, transmitted, or distributed from the United States to another country) of tobacco products and make recommendations on how to prevent or eliminate, and what technologies could help facilitate the elimination of, cross-border advertising.</text></paragraph></subsection>
<subsection id="H499C8341BF1F4F489710DC0020EFDD46"><enum>(b)</enum><header>Report</header><text>Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the study described in subsection (a).</text></subsection></section></part></subtitle>
<enum>III</enum><header>Responsible Marketing and Consumer Awareness</header>
<subtitle id="H92DA05FBD786475E9C47FC004E0061E6"><enum>A</enum><header>General Provisions</header>
<section id="H088F1CFF3F3E401EA311E1106061F8A0"><enum>301.</enum><header>Nutrition labeling of restaurant foods</header><text display-inline="no-display-inline">Section 403(q)(5) of the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/343">21 U.S.C. 343(q)(5)(A)(i)</external-xref>) is amended—</text>
<paragraph id="H7F36F6861B0E44D18F6C82D69C95A500"><enum>(1)</enum><text>in clause (A)—</text>
<subparagraph id="H6A7FCA1636624DC0BCFBAEE14D759643"><enum>(A)</enum><text>in subclause (i), by inserting <quote>except as provided in clauses (H) and (I),</quote> before <quote>which</quote> the first place it appears; and</text></subparagraph>
<subparagraph id="HAD3FF65AC6B940AB97AD56AB77FEECC9"><enum>(B)</enum><text>in subclause (ii), by inserting <quote>except as provided in clauses (H) and (I),</quote> before <quote>which</quote> the first place it appears; and</text></subparagraph></paragraph>
<paragraph id="H8B448B97AD534B9291D327984F89D8A7"><enum>(2)</enum><text>by adding at the end the following:</text>
<quoted-block id="HC21B95D5B7CF49B598EFF51C4D0BDAD">
<subparagraph indent="paragraph" id="H4E553578F1C54494A69407D08D9DBA6"><enum>(H)</enum><header>Restaurants and retail food establishments</header>
<clause indent="subparagraph" id="H79F8E73C1E6D4020BEC42D43D100B2CE"><enum>(i)</enum><header>In general</header><text>Except for food described in subclause (iii), in the case of food that is served, processed, or prepared in a restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same trade name (regardless of the type of ownership of the locations), the restaurant or establishment shall disclose the information described in subclause (ii).</text></clause>
<clause indent="subparagraph" id="HA22853E138AF41CB97F008842C95E7E9"><enum>(ii)</enum><header>Information required to be disclosed</header><text>Except as provided in subclause (iii), the establishment shall disclose—</text>
<subclause indent="clause" id="HC42B9EDCE5624301A210D578E46228A6"><enum>(I)</enum>
<item display-inline="yes-display-inline" id="H3F8713E5F7F04DC5B1B1F82438F15443"><enum>(aa)</enum><text>in a statement adjacent to the name of the food on any menu listing the food for sale, or by any other means deemed equivalent by the Secretary, the number of calories, grams of saturated fat plus trans fat, and milligrams of sodium contained in a standard serving of the food, as usually offered for sale, in a clear and conspicuous manner; and</text></item>
<item indent="clause" id="HAA5F05BFB4D841DBB39385B865CFF3A5"><enum>(bb)</enum><text>information, specified by the Secretary by regulation, designed to enable the public to understand, in the context of a total daily diet, the significance of the nutrition information that is provided; and</text></item></subclause>
<subclause indent="clause" id="H34620EBFF5DE41718F745C7DA09F5C71"><enum>(II)</enum><text>in a statement adjacent to the name of the food on any menu board or other sign listing the food for sale, or by any other means deemed equivalent by the Secretary—</text>
<item indent="subclause" id="H1296CB3B178C4BDF8489438E19E648FA"><enum>(aa)</enum><text>the number of calories contained in a serving of the food, as usually offered for sale, in a clear and conspicuous manner; and</text></item>
<item indent="subclause" id="H3D063A207443493CBDB808124E44D800"><enum>(bb)</enum><text>notification that the information required by subitems (aa) and (bb) of item (I) shall be provided in writing at the request of a prospective purchaser.</text></item></subclause></clause>
<clause indent="subparagraph" id="H0496A2A77D8A4254AB3286B2EF881EEA"><enum>(iii)</enum><header>Nonapplicability to certain food</header><text>This clause does not apply to—</text>
<subclause indent="clause" id="H05D5ABD6342248E4BC021FAD3105FD88"><enum>(I)</enum><text>items that are not listed on a menu or menu board (such as condiments and other items placed on the table or counter for general use); or</text></subclause>
<subclause indent="clause" id="H13C1F71E8C6649389C00E32B502D9BD9"><enum>(II)</enum><text>daily specials, temporary menu items, or other irregular menu items, as specified by the Secretary by regulation.</text></subclause></clause>
<clause indent="subparagraph" id="H677BB6D1B7E844C28C3DEE43814EC264"><enum>(iv)</enum><header>Self-service facilities</header><text>In the case of food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, a restaurant or other establishment shall place a sign that lists calories per standard serving adjacent to each food offered.</text></clause>
<clause indent="subparagraph" id="H66F8332C6F8B40358557155D96DF2052"><enum>(v)</enum><header>Voluntary provision of nutrition information; State regulation of nutrition information for restaurant food</header>
<subclause indent="clause" id="H838596E3F1FE42169CC2A6F7302B17D1"><enum>(I)</enum><header>Retail food establishments</header><text>Nothing in this clause precludes a restaurant or similar retail food establishment from providing additional nutrition information, voluntarily, if the information complies with the nutrition labeling requirements contained in this subparagraph.</text></subclause>
<subclause indent="clause" id="HB0E7BD3CC3614B67AE81A4C888C5449F"><enum>(II)</enum><header>State or local requirements</header><text>Nothing in this clause precludes a State or political subdivision of a State from requiring that a restaurant or similar food establishment provide nutrition information in addition to that required under this clause.</text></subclause></clause>
<clause indent="subparagraph" id="HD89399ED2E404313974F2200D8565556"><enum>(vi)</enum><header>Regulations</header>
<subclause indent="clause" id="HEC7F7DC7B79C4ED2B3C940F338D5EB26"><enum>(I)</enum><header>Proposed regulation</header><text>Not later than 1 year after the date of enactment of this clause, the Secretary shall promulgate proposed regulations to carry out this clause.</text></subclause>
<subclause indent="clause" id="H0719648C4B444D4AB69F038CB7EFA2A2"><enum>(II)</enum><header>Contents</header><text>The regulations shall allow for the variations in serving sizes and in food preparation that can reasonably be expected to result from inadvertent human error, training of food service workers, and other factors.</text></subclause>
<subclause indent="clause" id="HC27BEBF1B47942CFA2677000B60086E9"><enum>(III)</enum><header>Final regulations</header><text>Not later than 2 years after the date of enactment of this clause, the Secretary shall promulgate final regulations to implement this clause.</text></subclause>
<subclause indent="clause" id="H72A249AF272446BCA4CDD063B2F51EC0"><enum>(IV)</enum><header>Failure to promulgate final regulations by required date</header><text>If the Secretary does not promulgate final regulations under item (III) by the date that is 2 years after the date of enactment of this clause—</text>
<item indent="subclause" id="HC36EC823DF6145489C39652E2479A9BD"><enum>(aa)</enum><text>the proposed regulations issued in accordance with item (I) shall become effective as the final regulations on the day after that date; and</text></item>
<item indent="subclause" id="H5CAD206469084CBF9FDBDEE0DCA237F2"><enum>(bb)</enum><text>the Secretary shall publish in the Federal Register notice of the final regulations.</text></item> </subclause></clause> </subparagraph>
<subparagraph id="HC72137D3AD114D8FBE89A6DE4DB00FA" indent="paragraph"><enum>(I)</enum><header>Vending machines</header>
<clause indent="subparagraph" id="H1BB151E5E874456E979EC344CDDC5B8D"><enum>(i)</enum><header>In general</header><text>In the case of an article of food sold from a vending machine that—</text>
<subclause indent="clause" id="H31966A638D5342919658E8CE1B9C2E90"><enum>(I)</enum><text>does not permit a prospective purchaser to examine the article so as to be able to read a statement affixed to the article before purchasing the article; and</text></subclause>
<subclause indent="clause" id="H01CC670114EF4551B4765175D66701AD"><enum>(II)</enum><text>is operated by a person that is engaged in the business of owning and operating 20 or more vending machines;</text><continuation-text continuation-text-level="paragraph">the vending machine operator shall provide a conspicuous sign in close proximity to the article that includes a statement disclosing the number of calories contained in the article.</continuation-text></subclause></clause>
<clause indent="subparagraph" id="H267D0BF909334CC799437778D56C9261"><enum>(ii)</enum><header>Voluntary provision of nutrition information; State regulation of nutrition information for vending machines</header>
<subclause indent="clause" id="H1250BBCB431B4D5594FF7728CD10BAE5"><enum>(I)</enum><header>Vending machine operators</header><text>Nothing in this clause precludes a vending machine operator from providing additional nutrition information, voluntarily, if the information complies with the nutrition labeling requirements contained in this subparagraph.</text></subclause>
<subclause indent="clause" id="H8ED1D9728FE840428800B572F33C4CC8"><enum>(II)</enum><header>State or local requirements</header><text>Nothing in this title precludes a State or political subdivision of a State from requiring that a vending machine operator provide nutrition information in addition to that required under this clause.</text></subclause></clause>
<clause indent="subparagraph" id="H659ED8E158EA42A69C84DA1B3D6813F9"><enum>(iii)</enum><header>Regulations</header>
<subclause indent="clause" id="H0BE7FB3C2F3F48C08B35BE8EDA45A3"><enum>(I)</enum><header>Proposed regulations</header><text>Not later than 1 year after the date of enactment of this clause, the Secretary shall promulgate proposed regulations to carry out this clause.</text></subclause>
<subclause indent="clause" id="H455649B1CF8B4135AE3EE80100CC281E"><enum>(II)</enum><header>Final regulations</header><text>Not later than 2 years after the date of enactment of this clause, the Secretary shall promulgate final regulations to implement this clause.</text></subclause>
<subclause indent="clause" id="H177D23439F1F40C7AD006DB06180686B"><enum>(III)</enum><header>Failure to promulgate final regulations by required date</header><text>If the Secretary does not promulgate final regulations under item (II) by the date that is 2 years after the date of enactment of this clause—</text>
<item indent="subclause" id="HC8D3D87A8966442C9B2DDD261305B92"><enum>(aa)</enum><text>the proposed regulations issued in accordance with item (I) shall become effective as the final regulations on the day after that date; and</text></item>
<item indent="subclause" id="H53385AD7A59642B0B40741BAEC2F2933"><enum>(bb)</enum><text>the Secretary shall publish in the Federal Register notice of the final regulations.</text></item></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H66267E32EB704E818F045775A9388B9"><enum>302.</enum><header>Rulemaking authority for advertising to children</header>
<subsection id="H0719FB27A3F24919B53F8649F67CC327"><enum>(a)</enum><header>Purpose</header><text>The purpose of this section is to restore the authority of the Federal Trade Commission to issue regulations that restrict the marketing or advertising of foods and beverages to children under the age of 18 years if the Federal Trade Commission determines that there is evidence that consumption of certain foods and beverages is detrimental to the health of children.</text></subsection>
<subsection id="H3DB8A15D0E604C48865C75518900871C"><enum>(b)</enum><header>Authority</header><text>Section 18 of the <act-name parsable-cite="FTCA">Federal Trade Commission Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/15/57a">15 U.S.C. 57a</external-xref>) is amended by striking subsection (h).</text></subsection></section>
<section id="H2DAF70DAC6634BCF819FBF84A41B86C"><enum>303.</enum><header>Food advertising in schools</header><text display-inline="no-display-inline">Section 10 of the <act-name parsable-cite="CNA66">Child Nutrition Act of 1966</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1779">42 U.S.C. 1779</external-xref>), as amended by section 102 of this Act, is further amended by adding at the end the following:</text>
<quoted-block act-name="Child Nutrition Act of 1966" id="HA4912FDFBC114C20A853418D79B79D72">
<subsection id="H029AFF3A57BF4520B8D2E10CC4768C5"><enum>(c)</enum><header>Food advertising</header><text>The Secretary may prohibit the advertising of food in participating schools if the Secretary determines that consumption of the advertised food has a detrimental effect on the diets or health of children.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></section>
<section id="H9114FA1378004BD089E7104E186C08E4"><enum>304.</enum><header>Disallowance of deductions for advertising and marketing expenses relating to Tobacco product use</header>
<subsection id="H3D5DCEDEC08944F9B423D8512D00068D"><enum>(a)</enum><header>In general</header><text>Part IX of subchapter B of chapter 1 of subtitle A of the Internal Revenue Code of 1986 (relating to items not deductible) is amended by adding at the end the following new section:</text>
<quoted-block id="HECCA62E1C7B54D739C6CEF569BE3C5B0">
<section id="H00B91BBD2EFE4BE8883EEDBBB7FB9D0"><enum>280I.</enum><header>Disallowance of deduction for Tobacco advertising and marketing expenses</header><text display-inline="no-display-inline">No deduction shall be allowed under this chapter for expenses relating to advertising or marketing cigars, cigarettes, smokeless tobacco, pipe tobacco, or any similar tobacco product. For purposes of this section, any term used in this section which is also used in section 5702 shall have the same meaning given such term by section 5702.</text></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HF89873A968744A77B08165BDE117D94"><enum>(b)</enum><header>Conforming amendment</header><text>The table of sections for such part IX is amended by adding after the item relating to section 280H the following new item:</text>
<quoted-block style="USC" id="H8C434C8663174DD4A5C39D8B6AE08E0">
<toc regeneration="no-regeneration">
<toc-entry level="section">Sec. 280I. Disallowance of deduction for tobacco advertising and marketing expenses.</toc-entry></toc><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H8124CBD69161427D974BB6F0DB008B68"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.</text></subsection></section>
<section id="HE25FB479FF9645E29D23E7F0FE9C95B1"><enum>305.</enum><header>Federal-State Tobacco counter-advertising programs</header><text display-inline="no-display-inline">Part P of title III of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/280g">42 U.S.C. 280g et seq.</external-xref>), as amended in section 211, is further amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H91FB68735B16451C8659FF5B9D51EB9B">
<section id="H69CFAE94EDF7477387608C8EB5D08ED4"><enum>399Q.</enum><header>Federal-State Tobacco counter-advertising programs</header>
<subsection id="HD631C56592E647F1810735F3C8FA84BB"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to and enter into contracts with eligible entities for the implementation of national and local media (such as counter-advertising) and non-media campaigns designed to reduce the use of tobacco products.</text></subsection>
<subsection id="H393EA6A9CC404EFA82F25650FAB0D9E9"><enum>(b)</enum><header>Eligibility</header><text>To be eligible to receive a grant under subsection (a), an entity shall be—</text>
<paragraph id="H62B110F53417401DBF9E95003707F130"><enum>(1)</enum><text>a public entity, including a State public health department; or</text></paragraph>
<paragraph id="H44C479567F7D4D16A47E7104D8E72E55"><enum>(2)</enum><text>a private, nonprofit entity that—</text>
<subparagraph id="HEA5991A85461459F9EA367A1AD8CFB3"><enum>(A)</enum><text>is not affiliated with a manufacturer or importer of a tobacco product;</text></subparagraph>
<subparagraph id="H5E85C590BC044203A9614DC287874B41"><enum>(B)</enum><text>has demonstrated a record of conducting a national antitobacco public education campaign to effectively reduce the use of tobacco products;</text></subparagraph>
<subparagraph id="H9AE945A61C3E4627BA007B7CF5B5CE90"><enum>(C)</enum><text>has expertise in conducting a multi-media communications campaign; and</text></subparagraph>
<subparagraph id="HEA173B84262044FE8376E25885612F00"><enum>(D)</enum><text>has expertise in developing strategies that affect behavior changes in children and other targeted populations.</text></subparagraph></paragraph></subsection>
<subsection id="H940088154989443699376899D8FBDC6E"><enum>(c)</enum><header>Application</header><text>An eligible entity shall submit an application to the Secretary for a grant under this section at such time, in such manner, and accompanied by such information as the Secretary may require.</text></subsection>
<subsection id="H47817E8F1AEC426BBA2B2CA3FAD01109"><enum>(d)</enum><header>Use of funds</header><text>An eligible entity shall use amounts received under a grant under this section to—</text>
<paragraph id="HD81B2EBF16D747389426CF692E472CAA"><enum>(1)</enum><text>design and implement multimedia public education and social marketing campaigns that—</text>
<subparagraph id="H0CA37F2482ED408A941104723F745507"><enum>(A)</enum><text>discourage the use of tobacco products;</text></subparagraph>
<subparagraph id="HF06D8971C492407DB71E21EE405D1DA8"><enum>(B)</enum><text>encourage the use of products designed to enable tobacco use cessation; and</text></subparagraph>
<subparagraph id="HACB0AF6E2F334E938F42E8D3D674F34"><enum>(C)</enum><text>educate the public about the hazards of environmental tobacco smoke exposure; or</text></subparagraph></paragraph>
<paragraph id="HA81192FEC95B4174A1C4191779D6CA9F"><enum>(2)</enum><text>conduct research related to the effectiveness of the campaigns described in paragraph (1).</text></paragraph></subsection>
<subsection id="HB4EAF8FEF65D4A8084038D014D00B3F7"><enum>(e)</enum><header>Allocation of grants</header><text>Of the amounts awarded under this section, the Secretary shall award—</text>
<paragraph id="H2EB3CEB0EA6B48ABA47D708D58007FDE"><enum>(1)</enum><text>50 percent of such amounts to eligible public entities; and</text></paragraph>
<paragraph id="H8DBB2939C8054B63817F5D5F000089F9"><enum>(2)</enum><text>50 percent of such amounts to eligible private, nonprofit entities.</text></paragraph></subsection>
<subsection id="H3A20F08632754820B48F6984CBD4A818"><enum>(f)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated $200,000,000 to carry out this section.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section></subtitle>
<subtitle id="H7240EA7E63064227B11FC54BFC14D45C"><enum>B</enum><header>Penalties for failure to reduce teen Smoking</header>
<section id="H5BD444C9AE044E4F821EC38E84B92478"><enum>311.</enum><header>Child cigarette use surveys</header>
<subsection id="H324A2665309642D9002400D505839FE"><enum>(a)</enum><header>Annual performance survey</header>
<paragraph id="HEA80C372A13345F79BD4A09B9B89C00"><enum>(1)</enum><header>In general</header><text>Not later than August 31, 2007, and annually thereafter, the Secretary of Health and Human Services (referred to in this section as the <quote>Secretary</quote>) shall publish the results of an annual cigarette survey, to be carried out after the date of enactment of this Act and completed prior to August 21, 2007, and prior to August 21 of each year thereafter, to determine—</text>
<subparagraph id="H441DE273779A444D001194E69600D761"><enum>(A)</enum><text>the percentage of all young individuals who used a type of cigarette within the 30-day period prior to the conduct of the survey involved; and</text></subparagraph>
<subparagraph id="H9DE32BDC34AD4A65816E5F91D664A195"><enum>(B)</enum><text>the percentage of young individuals who identify each brand of each type of cigarette as the usual brand smoked within such 30-day period.</text></subparagraph></paragraph>
<paragraph id="HFFE0D957AEA04DDEB5C817B65BAE1CE6"><enum>(2)</enum><header>Young individuals</header><text>For the purposes of this subtitle, the term <term>young individuals</term> means individuals who are under 18 years of age.</text></paragraph></subsection>
<subsection id="HF9678008417A46CF916C5BCC8E2867BE"><enum>(b)</enum><header>Size and methodology</header>
<paragraph id="H968822520A014EB4B01C44CCFC833CDC"><enum>(1)</enum><header>In general</header><text>The survey referred to in subsection (a) shall be comparable in size and methodology to the Monitoring the Future survey that was completed in 1999 to measure the use of cigarettes (by brand) by youths under 18 years of age within the 30-day period prior to the conduct of the study.</text></paragraph>
<paragraph id="HE9E267C845CC4EA3841C2C75EBCB2EE1"><enum>(2)</enum><header>Conclusive accurateness</header><text>A survey using the methodology described in paragraph (1) shall be deemed conclusively proper, correct, and accurate for purposes of this section.</text></paragraph>
<paragraph id="H6C8B26EB485D4D9E863EEF0055F5F22D"><enum>(3)</enum><header>Definition</header><text>In this subtitle, the term <term>Monitoring the Future survey</term> means the combined survey of 8th, 10th, and 12th grade students that was conducted at the Institute for Social Research at the University of Michigan.</text></paragraph></subsection>
<subsection id="HEC314D57D54A40BDB8ECB807B2DDE5DC"><enum>(c)</enum><header>Reduction</header><text>The Secretary, based on a comparison of the results of the first annual cigarette survey referred to in subsection (a) and the Monitoring the Future survey referred to in subsection (b)(1), shall determine the percentage reduction (if any) in youth cigarette use for each manufacturer of cigarettes.</text></subsection>
<subsection id="H41197107C70F4301848D21DEF0007D90"><enum>(d)</enum><header>Participation in survey</header><text>Notwithstanding any other provision of law, the Secretary may conduct a survey under this section involving minors if the results of such survey with respect to such minors are kept confidential and not disclosed.</text></subsection>
<subsection id="H095FDCF1586940A09C95D54D8FC95835"><enum>(e)</enum><header>Nonapplicability</header><text><external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/44/35">Chapter 35</external-xref> of title 44, United States Code, shall not apply to information required for the purposes of carrying out this section.</text></subsection>
<subsection id="H93815327A4A343B6A4B013B7A5C8F06E"><enum>(f)</enum><header>Definition</header><text>In this subtitle the term <term>cigarette</term> has the meaning given such term in section 3(1) of the Federal Cigarette Labeling and Advertising Act (<external-xref legal-doc="usc" parsable-cite="usc/15/1332">15 U.S.C. 1332(1)</external-xref>).</text></subsection></section>
<section id="H388233E846DF4EE3BA4049FE5F9DEFC1"><enum>312.</enum><header>Cigarette use reduction goal and noncompliance</header>
<subsection id="H4D7B1A4B658D4ACA88B84CD100C9A8B9"><enum>(a)</enum><header>Goal</header><text>It shall be the cigarette use reduction goal that each manufacturer reduce youth cigarette use by at least 15 percent during the period between the Monitoring the Future survey referred to in section 311(b)(1) and the completion of the first annual cigarette survey (and such subsequent surveys as compared to the previous year’s survey) referred to in section 311(a).</text></subsection>
<subsection id="H9064A465D8F14B10B6F62527DF7EC68C"><enum>(b)</enum><header>Noncompliance</header>
<paragraph id="HBA815711398C474CB2D82E0032703C23"><enum>(1)</enum><header>Industry-wide penalty</header><text>If the Secretary determines that the cigarette use reduction goal under subsection (a) has not been achieved, the Secretary shall, not later than September 10, 2007, and September 10 of each year thereafter, impose an industry-wide penalty on the manufacturers of cigarettes in an amount that is in the aggregate equal to—</text>
<subparagraph id="H9B51663291AC424B8BFF225EDBDC3396"><enum>(A)</enum><text>if youth cigarette use has been reduced by 5 percent or less, $6,000,000,000;</text></subparagraph>
<subparagraph id="H13D3B6F322DF478B9D9B303C1B8FF128"><enum>(B)</enum><text>if youth cigarette use has been reduced by at least 6 percent but less than 10 percent, $4,000,000,000; and</text></subparagraph>
<subparagraph id="H7000FD6FFBBE4830833046E1FF06C2D7"><enum>(C)</enum><text>if youth cigarette use has been reduced by at least 11 percent but less than 15 percent, $2,000,000,000.</text></subparagraph></paragraph>
<paragraph id="H4957403EB8A543EF95A9B49097B436D"><enum>(2)</enum><header>Payment</header><text>The industry-wide penalty imposed under this subsection shall be paid by each manufacturer based on the percentage of cigarettes of each such manufacturer that are used by youth (as determined under the Monitoring the Future survey and compared to the cigarettes manufactured by all manufacturers) as such percentage relates to the total amount to be paid by all manufacturers.</text></paragraph>
<paragraph id="H91BB8C6F46EF46F7A2F4FC88224924FD"><enum>(3)</enum><header>Final determination</header><text>The determination of the Secretary as to the amount and allocation of a surcharge under this subtitle shall be final and the manufacturer shall pay such surcharge within 10 days of the date on which the manufacturer is assessed. Such payment shall be retained by the Secretary pending final judicial review of what, if any, change in the surcharge is appropriate.</text></paragraph>
<paragraph id="H70FFB9F0F9864DEAB7E0007110F3E783"><enum>(4)</enum><header>Compliance by certain manufacturers</header><text>A manufacturer that individually complies with the goal under subsection (a) shall not be liable for the payment of any portion of the penalty under this subsection.</text></paragraph>
<paragraph id="H07348163719C4496A0539F9C5C42A6E5"><enum>(5)</enum><header>Limitation</header><text>With respect to cigarettes, a manufacturer with a market share of 1 percent or less of youth cigarette use shall not be liable for the payment of a surcharge under this section.</text></paragraph></subsection>
<subsection id="H68372A5DC342425382A7048900422962"><enum>(c)</enum><header>Penalties nondeductible</header><text>The payment of penalties under this subtitle shall not be considered to be an ordinary and necessary expense in carrying on a trade or business for purposes of the Internal Revenue Code of 1986 and shall not be deductible.</text></subsection>
<subsection id="H421AABC6FFB24A1B007C7B96EA3421FF"><enum>(d)</enum><header>Judicial review</header>
<paragraph id="HC80CDFF8DDF74A288EAE26E0119C1100"><enum>(1)</enum><header>After payment</header><text>A manufacturer of cigarettes may seek judicial review of any action under this subtitle only after the assessment involved has been paid by the manufacturer to the Department of the Treasury and only in the United States District Court for the District of Columbia.</text></paragraph>
<paragraph id="HDAF8C0970DDF452D96FA3C911128F82"><enum>(2)</enum><header>Review by Attorney General</header><text>Prior to the filing of an action by a manufacturer seeking judicial review of an action under this subtitle, the manufacturer shall notify the Attorney General of such intent to file and the Attorney General shall have 30 days in which to respond to the action.</text></paragraph>
<paragraph id="H1E1F20255D984AA9AC09B8CC5890041"><enum>(3)</enum><header>Review</header><text>The amount of any surcharge paid under this subtitle shall be subject to judicial review by the United States Court of Appeals for the District of Columbia Circuit, based on the arbitrary and capricious standard of <external-xref legal-doc="usc" parsable-cite="usc/5/706">section 706</external-xref> of title 5, United States Code. Notwithstanding any other provision of law, no court shall have the authority to stay any surcharge payment due to the Secretary under this subtitle pending judicial review until the Secretary has made or failed to make a compliance determination, as described under this subtitle, that has adversely affected the person seeking the review.</text></paragraph></subsection></section>
<section id="HD1C882630F0149B38CCD170AF31F450"><enum>313.</enum><header>Enforcement</header>
<subsection id="H274D9ECA0AC848379013A76747552D63"><enum>(a)</enum><header>Initial penalty</header><text>There is hereby imposed an initial penalty on the failure of any manufacturer to make any payment required under this subtitle within 10 days after the date on which such payment is due.</text></subsection>
<subsection id="HF26196CB0CF44FC4ADAAA06FC309B8A0"><enum>(b)</enum><header>Amount of penalty</header><text>The amount of the penalty imposed by subsection (a) on any failure with respect to a manufacturer shall be an amount equal to 2 percent of the penalty owed under section 312 for each day during the noncompliance period.</text></subsection>
<subsection id="HD95AA31194E0489C00ABE62206399668"><enum>(c)</enum><header>Noncompliance period</header><text>For purposes of this section, the term <term>noncompliance period</term> means, with respect to any failure to make the surcharge payment required under this subtitle, the period—</text>
<paragraph id="HD02B803CE76E40E192F9BCD77BACC"><enum>(1)</enum><text>beginning on the due date for such payment; and</text></paragraph>
<paragraph id="H2694708433EB4B5AA9E643B2852CBE8D"><enum>(2)</enum><text>ending on the date on which such payment is paid in fall.</text></paragraph></subsection>
<subsection id="H84F92E3924204799BD2CBD48B30075A3"><enum>(d)</enum><header>Limitations</header><text>No penalty shall be imposed by subsection (a) on—</text>
<paragraph id="HE91B30E3D66544BE9E51947E6061EAFF"><enum>(1)</enum><text>any failure to make a surcharge payment under this subtitle during any period for which it is established to the satisfaction of the Secretary that none of the persons responsible for such failure knew or, exercising reasonable diligence, would have known, that such failure existed; or</text></paragraph>
<paragraph id="HD488C001989F446C93E7E147A1211C19"><enum>(2)</enum><text>any manufacturer that produces less than 1 percent of cigarettes used by youth in that year (as determined by the annual survey).</text></paragraph></subsection></section></subtitle>
<enum>IV</enum><header>Reimbursement and Coverage of Preventive Services</header>
<section id="H2184DBA52EE6401FB75524EE9124CF90"><enum>401.</enum><header>Coverage of substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling</header>
<subsection id="H3B882E435F0443F5934DF8AC199B4570"><enum>(a)</enum><header>Coverage</header>
<paragraph id="HE50314DF0D194A34ADC79FAB00083FC"><enum>(1)</enum><header>In general</header><text>Section 1861(s)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(s)(2)</external-xref>), as amended by section 5112(a) of the Deficit Reduction Act of 2005, is amended—</text>
<subparagraph id="HA3185EACCBF34FCDA079A04225D1F688"><enum>(A)</enum><text>in subparagraph (Z), by striking <quote>and</quote> after the semicolon at the end;</text></subparagraph>
<subparagraph id="H86BE653920EF40219FFFED8CB35B3CD"><enum>(B)</enum><text>in subparagraph (AA), by adding <quote>and</quote> after the semicolon at the end; and</text></subparagraph>
<subparagraph id="H99605C5D26414885A0772400EF6597D0"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="HEA5557B488B9412B9EA62CA54F319174">
<subitem indent="paragraph" id="H7F9BE28E473746F783898F83A81D8667"><enum>(BB)</enum><text>substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in subsection (ccc)(1));</text></subitem><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H7F633064B9FF43BCBB85ED1368AC6814"><enum>(2)</enum><header>Conforming amendments</header>
<subparagraph display-inline="yes-display-inline" id="HE4ACD7F039444EC3922D121BD3FCEFAF"><enum>(A)</enum><text>Section 1862(a)(12) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(a)(12)</external-xref>) is amended by inserting <quote>(except as otherwise allowed under subsection 1861(s)(2)(BB))</quote> after <quote>directly supporting teeth</quote>.</text></subparagraph>
<subparagraph indent="paragraph" id="H3B10907CC92245168B3F229177E370E4"><enum>(B)</enum><text>Clauses (i) and (ii) of section 1861(s)(2)(K) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(s)(2)(K)</external-xref>) are each amended by striking <quote>subsection (ww)(1)</quote> and inserting <quote>subsections (ww)(1) and (ccc)</quote>.</text></subparagraph></paragraph></subsection>
<subsection id="H542B6B35BA2F47818D6C39D7A6BF4E"><enum>(b)</enum><header>Services described</header><text>Section 1861 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>), as amended by section 5112(a) of the Deficit Reduction Act of 2005, is amended by adding at the end the following new subsection:</text>
<quoted-block act-name="Social Security Act" style="other" other-style="archaic" id="H0DBAEDB08CAC4B4BBC38372ED8D9C900">
<subsection id="H1B6024EB1DB146399742119E54369BC9"><enum>(ccc)</enum><header>Substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling</header><text>The term <term>substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling</term> means therapy and counseling relating to substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling that is furnished—</text>
<paragraph id="HB7D3A2E37AF04E5E8693D79255ECB794"><enum>(1)</enum><text>by or under the supervision of a physician; or</text></paragraph>
<paragraph id="HC36F6512001B4EC79893BA71C71500C1"><enum>(2)</enum><text>by any other health care professional who—</text>
<subparagraph id="H31CD03BE9B8C499886D100391770F5E"><enum>(A)</enum><text>is legally authorized to furnish such services under State law (or the State regulatory mechanism provided by State law) of the State in which the services are furnished; and</text></subparagraph>
<subparagraph id="H3D3C4F3FDB7B463F9B4F8D4FCBE650D"><enum>(B)</enum><text>is authorized to receive payment for other services under this title or is designated by the Secretary for this purpose.</text></subparagraph></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HB24F5F5F77F24811A2EE7CB50000CE37"><enum>(c)</enum><header>Payment and elimination of Cost-Sharing</header>
<paragraph id="HA9A486D675D948E2888395FE4587C3D1"><enum>(1)</enum><header>Payment and elimination of coinsurance</header><text>Section 1833(a)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(1)</external-xref>) is amended—</text>
<subparagraph id="H377DC84F0F16411189AE9934252548D8"><enum>(A)</enum><text>in subparagraph (N), by inserting <quote>or substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in section 1861(ccc))</quote> after <quote>(as defined in section 1848(j)(3))</quote>;</text></subparagraph>
<subparagraph id="H90A5B08AF68745A0844B13F98BCED307"><enum>(B)</enum><text>by striking <quote>and</quote> before <quote>(V)</quote>; and</text></subparagraph>
<subparagraph id="H69004F794AF94F5C9CEC05D6049F3148"><enum>(C)</enum><text>by inserting before the semicolon at the end the following: <quote>and (W) with respect to substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in section 1861(ccc) the amount paid shall be the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848</quote>.</text></subparagraph></paragraph>
<paragraph id="H37EBB16051334413A42D095E3939C107"><enum>(2)</enum><header>Payment under physician fee schedule</header><text>Section 1848(j)(3) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(j)(3)</external-xref>), as amended by section 5112(c) of the Deficit Reduction Act of 2005, is amended by inserting <quote>(2)(BB),</quote> after <quote>(2)(AA),</quote>.</text></paragraph>
<paragraph id="H0088BDA6F02245E8A9C8B61C87362C4F"><enum>(3)</enum><header>Elimination of coinsurance in outpatient hospital settings</header>
<subparagraph id="H211C3F85CE9B4D67A127CE9500514ECE"><enum>(A)</enum><header>Exclusion from opd fee schedule</header><text>Section 1833(t)(1)(B)(iv) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(1)(B)(iv)</external-xref>) is amended by striking <quote>and diagnostic mammography</quote> and inserting <quote>, diagnostic mammography, or substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in section 1861(bbb))</quote>.</text></subparagraph>
<subparagraph id="HF33565E902294BBF962F20C94B192D1C"><enum>(B)</enum><header>Conforming amendments</header><text>Section 1833(a)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(2)</external-xref>) is amended—</text>
<clause id="H04836C11D17743B1AA38A2BE22A848F"><enum>(i)</enum><text>in subparagraph (F), by striking <quote>and</quote> after the semicolon at the end;</text></clause>
<clause id="H5CFC670D385F4B9C9218C97E3EFD4D5"><enum>(ii)</enum><text>in subparagraph (G)(ii), by striking the comma at the end and inserting <quote>; and</quote>; and</text></clause>
<clause id="HB468DB2F651946769568DC1C73C4F11"><enum>(iii)</enum><text>by inserting after subparagraph (G)(ii) the following new subparagraph:</text>
<quoted-block id="H1B9DA0D965834FF79764BCB1513D35D3">
<subparagraph id="HE861EA39666D4EDB862976F13DEBEFA9"><enum>(H)</enum><text>with respect to substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in section 1861(ccc)) furnished by an outpatient department of a hospital, the amount determined under paragraph (1)(W),</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph>
<paragraph id="H22CA7C1455D542F3A72C3650F85674B"><enum>(4)</enum><header>Elimination of deductible</header><text>The first sentence of section 1833(b) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(b)</external-xref>), as amended by section 5112(e) of the Deficit Reduction Act of 2005, is amended—</text>
<subparagraph id="HD653537C2DEE4F73BFD3665005D00379"><enum>(A)</enum><text>by striking <quote>and</quote> before <quote>(7)</quote>; and</text></subparagraph>
<subparagraph id="H92AD844A54C5410D898E718ECCCFEF6"><enum>(B)</enum><text>by inserting before the period at the end the following: <quote>, and (8) such deductible shall not apply with respect to substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling (as defined in section 1861(ccc))</quote>.</text></subparagraph></paragraph></subsection>
<subsection id="HD9EBB0E98D0F4173AE60E1D14C200686"><enum>(d)</enum><header>Application of limits on billing</header><text>Section 1842(b)(18)(C) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395u">42 U.S.C. 1395u(b)(18)(C)</external-xref>) is amended by adding at the end the following new clause:</text>
<quoted-block act-name="Social Security Act" id="HE7E499ECEDFD48D5A06D121D0378BF2B">
<clause indent="paragraph" id="H824ACA2A4EF8411C9793BFBE5BDC417"><enum>(vii)</enum><text>Any health care professional designated under section 1861(ccc)(2)(B) to perform substance use (other than tobacco), diet, exercise, injury prevention, and dental health counseling that is not otherwise described in this subparagraph.</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="HA04FC44EA3F84EFC9BDB12D61271223"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to services furnished on and after January 1, 2007.</text></subsection></section>
<section id="HA943CA1D84A242879622A72F944BF495"><enum>402.</enum><header>Encouragement of cessation of tobacco use</header>
<subsection id="HBEB077C6AA954652A85C48E9103E06B8"><enum>(a)</enum><header>Medicare coverage of counseling and pharmacotherapy for cessation of tobacco use</header>
<paragraph id="HD13DD86B9BD34A9EBE0381DF17B0C555"><enum>(1)</enum><header>Coverage</header>
<subparagraph id="HA9F7958A4D4E432BB837AE1C422475A3"><enum>(A)</enum><header>In general</header><text>Section 1861(s)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(s)(2)</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(a)(1),</external-xref> is amended—</text>
<clause id="H9917EED0416448719C29CB90008B4703"><enum>(i)</enum><text>in subparagraph (AA), by striking <quote>and</quote> after the semicolon at the end;</text></clause>
<clause id="H9C857C75E3254CFAB3C24F00FDBF7901"><enum>(ii)</enum><text>in subparagraph (BB), by adding <quote>and</quote> after the semicolon at the end; and</text></clause>
<clause id="HD3F92981772E4D9297E209401519976"><enum>(iii)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="H99B27C09258F409FBEE4CC931926796E">
<subclause indent="paragraph" id="HD2D8D1D796AC4814A83796FBA4006646"><enum>(CC)</enum><text>counseling and pharmacotherapy for cessation of tobacco use (as defined in subsection (ddd)(1));</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph>
<subparagraph id="HCD65C38A52AA4C74BA0065A957AC7E09"><enum>(B)</enum><header>Conforming amendments</header><text>Clauses (i) and (ii) of section 1861(s)(2)(K) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(s)(2)(K)</external-xref>), as amended by section 401(a)(2)(B), are each amended by striking <quote>and (ccc)</quote> and inserting <quote>(ccc), and (ddd)</quote>.</text></subparagraph></paragraph>
<paragraph id="HA12179AE99014C59A6E0C3D34F0037E2"><enum>(2)</enum><header>Services described</header><text>Section 1861 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(b),</external-xref> is amended by adding at the end the following new subsection:</text>
<quoted-block act-name="Social Security Act" style="other" other-style="archaic" id="HB4DD6CE61F414CE39C27BA17C2CAC73">
<subsection id="H5108B35C95954612BFE228E9367F6C7B"><enum>(ddd)</enum><header>Counseling and pharmacotherapy for cessation of Tobacco use</header>
<paragraph display-inline="yes-display-inline" id="HCEA8B0D41ADC43A59EBDE4C6CEF85C3C"><enum>(1)</enum><text>Subject to paragraphs (2) and (3), the term <term>counseling and pharmacotherapy for cessation of tobacco use</term> means diagnostic, therapy, and counseling services and pharmacotherapy (including the coverage of prescription and nonprescription tobacco cessation agents approved by the Food and Drug Administration) for cessation of tobacco use for individuals who use tobacco products or who are being treated for tobacco use which are furnished—</text>
<subparagraph indent="paragraph" id="HED6FF0304F7A4173BFF77654A8623383"><enum>(A)</enum><text>by or under the supervision of a physician; or</text></subparagraph>
<subparagraph indent="paragraph" id="HF7143E26EF75478397809651E8009151"><enum>(B)</enum><text>by any other health care professional who—</text>
<clause id="H5406BBE2C6DB472880F9F4CCC6F9178E"><enum>(i)</enum><text>is legally authorized to furnish such services under State law (or the State regulatory mechanism provided by State law) of the State in which the services are furnished; and</text></clause>
<clause id="H7E59FE0B8E9D4A40944CAFA1C679B09B"><enum>(ii)</enum><text>is authorized to receive payment for other services under this title or is designated by the Secretary for this purpose.</text> </clause> </subparagraph></paragraph>
<paragraph indent="subsection" id="H6D2B096A3BDB4A5D9279DBE0A3971D68"><enum>(2)</enum><text>Such term is limited to—</text>
<subparagraph id="H55ED5A807B1444D9A780AD0AE535F00" indent="paragraph"><enum>(A)</enum><text>services recommended in <quote>Treating Tobacco Use and Dependence: A Clinical Practice Guideline</quote>, published by the Public Health Service in June 2000, or any subsequent modification of such Guideline; and</text></subparagraph>
<subparagraph id="H67EE16778F9344CE913901FC6317D824" indent="paragraph"><enum>(B)</enum><text>such other services that the Secretary recognizes to be effective.</text> </subparagraph> </paragraph>
<paragraph indent="subsection" id="H890C61F2D00B4340841F33AE6864235E"><enum>(3)</enum><text>Each individual who is described in paragraph (1) and enrolled under part B shall be eligible for the services described in this subsection for up to 3 attempts to cease the use of tobacco.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H16EC449433EC4904AC00E4B520447621"><enum>(3)</enum><header>Payment and elimination of cost-sharing</header>
<subparagraph id="H61F71A60612F45A08DE41ED3856CDC7F"><enum>(A)</enum><header>Payment and elimination of coinsurance</header><text>Section 1833(a)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(1)</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(c)(1),</external-xref> is amended—</text>
<clause id="HB4A1430A31F44A4D9962C1506E004E24"><enum>(i)</enum><text>in subparagraph (N), by striking <quote>or</quote> before <quote>substance abuse</quote> and by inserting after <quote>(ccc))</quote> the following: <quote>or counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd))</quote>; and</text></clause>
<clause id="H27F191A0F1FF4064809432A99961E17"><enum>(ii)</enum><text>in subparagraph (W), by inserting <quote>and counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd))</quote> after <quote>1861(ccc))</quote>.</text></clause></subparagraph>
<subparagraph id="HDD286908AD754758A7B64F45E8785613"><enum>(B)</enum><header>Payment under physician fee schedule</header><text>Section 1848(j)(3) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(j)(3)</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(c)(2),</external-xref> is amended by inserting <quote>(2)(CC) (with separate payment amounts for pharmacotherapy, including prescription and nonprescription tobacco cessation agents approved by the Food and Drug Administration),</quote> after <quote>(2)(BB),</quote>.</text></subparagraph>
<subparagraph id="HCCB6483A2EBD439981143456E987A89C"><enum>(C)</enum><header>Elimination of coinsurance in outpatient hospital settings</header>
<clause id="HF9BDB8D4549C4FAA921C6554A7A0A956"><enum>(i)</enum><header>Exclusion from opd fee schedule</header><text>Section 1833(t)(1)(B)(iv) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(t)(1)(B)(iv)</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(c)(3)(A),</external-xref> is amended by striking <quote>or</quote> before <quote>screenings</quote> and inserting after <quote>1861(ccc))</quote> the following: <quote>or counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd))</quote>.</text></clause>
<clause id="H2037ED1297F44847B1D200EAE2709EE"><enum>(ii)</enum><header>Conforming amendment</header><text>Section 1833(a)(2)(H) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(a)(2)(H)</external-xref>), as added by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(c)(4),</external-xref> is amended by inserting <quote>and counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd))</quote> after <quote>1861(ccc))</quote>.</text></clause></subparagraph>
<subparagraph id="HFAE4F42E14FF4F1682A3B7BF61A6B330"><enum>(D)</enum><header>Elimination of deductible</header><text display-inline="yes-display-inline">Section 1833(b)(8) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(b)(7)</external-xref>), as added by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(c)(4),</external-xref> is amended by inserting <quote>or counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd))</quote> before the period at the end.</text></subparagraph></paragraph>
<paragraph id="H1DDD1E3BD85E447BA3E63CC5001CD1DD"><enum>(4)</enum><header>Application of limits on billing</header><text>Section 1842(b)(18)(C) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395u">42 U.S.C. 1395u(b)(18)(C)</external-xref>), as amended by <external-xref legal-doc="usc" parsable-cite="usc/26/401">section 401(d),</external-xref> is amended by adding at the end the following new clause:</text>
<quoted-block act-name="Social Security Act" id="HCC9260A38B494606AE8949089BDBF9A4">
<clause indent="paragraph" id="HED1D05F48B6A4E8CAB1F321D00436221"><enum>(viii)</enum><text>Any individual designated by the Secretary under section 1861(ddd)(1)(B)(ii).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="HCC35FB3BAC0E422AACFC5DFF00CFC7CD"><enum>(5)</enum><header>Frequency</header><text>Section 1862(a)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(a)(1)</external-xref>), as amended by section 5112(d) of the Deficit Reduction Act of 2005, is amended—</text>
<subparagraph id="H7993535F138B4476827732CF1D008B00"><enum>(A)</enum><text>in subparagraph (M), by striking <quote>and</quote> after the comma at the end;</text></subparagraph>
<subparagraph id="HFCAF43612D2D479A9BB3ECB3402E916"><enum>(B)</enum><text>in subparagraph (N), by striking the semicolon at the end and inserting <quote>, and</quote>; and</text></subparagraph>
<subparagraph id="H3256B2F9046141CF00A642ED8F16BD1E"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="H9151D7E681DF4D69A7157135277CBC74">
<subparagraph indent="paragraph" id="H282F96F86BCC477A8836BEEA55399854"><enum>(O)</enum><text>in the case of counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd)), which is performed with respect to more attempts to cease tobacco use than is covered under such section;</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph></subsection>
<subsection id="H5409D811C04E46B0A34B1500B017B3B5"><enum>(b)</enum><header>Promoting cessation of tobacco use under the medicaid program</header>
<paragraph id="H4397CF2D53C7414CAC006B7023390015"><enum>(1)</enum><header>Dropping exception from medicaid prescription drug coverage for Tobacco cessation medications</header><text>Section 1927(d)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396r-8">42 U.S.C. 1396r–8(d)(2)</external-xref>) is amended—</text>
<subparagraph id="HCE396C448EB045C70074EEB03FD7BE4"><enum>(A)</enum><text>by striking subparagraph (E);</text></subparagraph>
<subparagraph id="H7C618512D9C646E49EF256FD97143F83"><enum>(B)</enum><text>by redesignating subparagraphs (F) through (J) as subparagraphs (E) through (I), respectively; and</text></subparagraph>
<subparagraph id="H549B368004C0436CAD28FF76E38D6188"><enum>(C)</enum><text>in subparagraph (F) (as redesignated by paragraph (2)), by inserting before the period at the end the following: <quote>, except agents approved by the Food and Drug Administration for purposes of promoting, and when used to promote, tobacco cessation</quote>.</text></subparagraph></paragraph>
<paragraph id="HB58EBDDE54414E4F84C4D15E1877F0E2"><enum>(2)</enum><header>Requiring coverage of Tobacco cessation counseling and pharmacotherapy services for pregnant women</header><text>Section 1905(a)(4) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396d">42 U.S.C. 1396d(a)(4)</external-xref>) is amended—</text>
<subparagraph id="H57B7E9C2E7434CF088955BC2FE73D11F"><enum>(A)</enum><text>by striking <quote>and</quote> before <quote>(C)</quote>; and</text></subparagraph>
<subparagraph id="H95E5E71B1ACE4988BF3242C9E00E194"><enum>(B)</enum><text>by inserting before the semicolon at the end the following: <quote>; and (D) counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd)) for pregnant women</quote>.</text></subparagraph></paragraph>
<paragraph id="HD77F56CB5A7448DE80C7B3AA51CF19FE"><enum>(3)</enum><header>Removal of Cost-Sharing for Tobacco cessation counseling and pharmacotherapy services for pregnant women</header><text>Section 1916 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396o">42 U.S.C. 1396o</external-xref>) is amended in each of subsections (a)(2)(B) and (b)(2)(B), by inserting <quote>, and counseling for cessation of tobacco use (as defined in section 1861(ddd))</quote> after <quote>complicate the pregnancy</quote>.</text></paragraph></subsection>
<subsection id="H1B9E532623CF4C9A8FF62070AE25D34C"><enum>(c)</enum><header>Coverage under FEHBP</header><text>The last sentence of <external-xref legal-doc="usc" parsable-cite="usc/5/8904">section 8904(a)</external-xref> of title 5, United States Code, is amended by striking <quote>both for costs associated with care in a general hospital and for other health services of a catastrophic nature</quote> and inserting <quote>for costs associated with care in a general hospital, for other health services of a catastrophic nature, and for counseling and pharmacotherapy for cessation of tobacco use (as defined in section 1861(ddd)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name>)</quote>.</text></subsection>
<subsection id="H245AC33642094155950647B4B82CFD65"><enum>(d)</enum><header>Effective date</header><text>The amendments made by this section shall apply to services furnished on and after January 1, 2007.</text></subsection></section>
<section id="HDE5ADAB75ED94052BFBFCC1D5E2A81D"><enum>403.</enum><header>Recognition of school-based health centers as model for delivery of primary care for children under Medicaid and the State Children’s Health Insurance Program</header>
<subsection id="H5CF818364AD74657ADC4263C83C3AFE1"><enum>(a)</enum><header>In general</header><text>Title XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396 et seq.</external-xref>) is amended by inserting after section 1911 the following:</text>
<quoted-block act-name="Social Security Act" style="traditional" other-style="archaic" id="HA2FBDE670BE941D1BAEFFC3CAB22F0B8">
<section id="H9C322C1726854D379EEC80C048A746EE"><enum>1911A.</enum><header>School-based health centers</header><text>Not later than 12 months after the date of enactment of this section, the Secretary shall establish procedures to encourage a State program established under this title, title XXI, or both, to recognize school-based health centers as a model of delivery for primary care for children who are eligible for medical assistance under this title or child health assistance under title XXI. Such procedures shall include the following:</text>
<paragraph id="H5412465D78D343C68316A15E5FBF83C"><enum>(1)</enum><header>Recognition of, and reimbursement for, services provided through school-based health Centers</header><text>Procedures that encourage a State to recognize as primary care providers under this title and title XXI, providers who furnish physical or mental health services that are available as medical assistance under this title or child health assistance under title XXI to children who are eligible for such assistance through school-based health centers, and to reimburse such providers or centers (as appropriate) for furnishing such services to such children.</text></paragraph>
<paragraph id="H9946F24A41EC4D0DADCA9DD234A26529"><enum>(2)</enum><header>Exceptions to the <quote>free care</quote> rule</header><text>Procedures that allow a State the option to permit school-based health centers to bill the State for physical or mental health services that are available as medical assistance under this title or child health assistance under title XXI and that are furnished to children who are eligible for such assistance through such centers without billing all children who are provided such services.</text></paragraph>
<paragraph id="H01719CD117E14B7CBE9DE98CC2CF258B"><enum>(3)</enum><header>Exceptions to the <quote>third party liability</quote> cost avoidance policy</header><text>Procedures that encourage a State to include physical or mental health services that are available as medical assistance under this title and that are provided through school-based health centers in the list of diagnosis billing codes for preventive pediatric care services that the State will pay for under this title and then seek reimbursement from any liable third party in accordance with the requirements of section 1902(a)(25).</text></paragraph>
<paragraph id="H83DE0E208F20414E92CD83837BF3EAA"><enum>(4)</enum><header>Assurance of payment for services covered by a contract with a managed care entity</header><text>Procedures that encourage a State to include in any contract entered into with a managed care entity (as defined in section 1932(a)(1)(B)) under this title or title XXI provisions which ensure that the entity will make prompt payment to a school-based health center for furnishing physical or mental health services to a child who is eligible for medical assistance under this title or child health assistance under title XXI that are within the scope of items and services for which benefits are available with respect to the child under the contract between the entity and the State (or to a provider who furnishes such services to such a child through a school-based health center), regardless of whether the center (or provider) is a participating provider with respect to such entity, at a rate established by the entity for such services that is not less than the level and amount of payment which the entity would make for the services if the services were furnished by a participating provider.</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H3BC901CC278446C4AF991F47731D7EBE"><enum>(b)</enum><header>Report to Congress</header><text>Not later than 36 months after the date of enactment of this section, the Secretary of Health and Human Services shall submit a report to Congress on the effectiveness of the procedures established in accordance with section 1911A of the <act-name parsable-cite="SSA">Social Security Act</act-name> (as added by subsection (a)) in encouraging the use of school-based health centers for the delivery of primary care physical and mental health services to children who are eligible for medical assistance under title XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1396">42 U.S.C. 1396 et seq.</external-xref>) or child health assistance under title XXI of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1397aa">42 U.S.C. 1397aa et seq.</external-xref>), together with such recommendations for administrative or legislative action as the Secretary determines to be appropriate.</text></subsection></section>
<section id="H532B7BF5ABEE4F949EABA890D4104E3C"><enum>404.</enum><header>Preventive health care demonstration program</header>
<subsection id="HD383335D184844D3B8408F00839C393F"><enum>(a)</enum><header>Establishment</header>
<paragraph id="HCF6E1AB41EB94770B785DB446564C283"><enum>(1)</enum><header>In general</header><text>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall conduct a 5-year demonstration program under part B of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> under which the Secretary establishes demonstration projects to contract with appropriate entities to provide preventive health care to eligible beneficiaries through the development and implementation of a disease prevention plan (as described in subsection (b)).</text></paragraph>
<paragraph id="H7C750A5BA4AA44E995636D4234B25200"><enum>(2)</enum><header>Sites</header><text>The Secretary shall designate at least 2 sites at which to conduct the demonstration program under this section, of which—</text>
<subparagraph id="HAAD4A01B33E3491DA3B731AF996FDA91"><enum>(A)</enum><text>1 shall be in an urban area; and</text></subparagraph>
<subparagraph id="HD56D4C04F9D2492299FD6869644D5C99"><enum>(B)</enum><text>1 shall be in a rural area.</text></subparagraph></paragraph>
<paragraph id="H8152C8EBCD204C598D578226AD9824A9"><enum>(3)</enum><header>Number of eligible beneficiaries</header><text>Each demonstration project site under this section shall consist of at least 1,000 eligible beneficiaries representative of the population of individuals entitled to benefits under part A of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name>, and enrolled under part B of such title. The Secretary may expand the population as needed to measure statistical significance.</text></paragraph>
<paragraph id="HFBE6A52AFBE84E72A5F32E5193BDD54D"><enum>(4)</enum><header>Identifying eligible beneficiaries</header><text>The Secretary shall develop a method for identifying eligible beneficiaries who may benefit from the demonstration program and communicate with them regarding their eligibility.</text></paragraph>
<paragraph id="H60F05B97EEFC46AF843384A62CC0A764"><enum>(5)</enum><header>Voluntary participation</header><text>Participation of health care providers, and individual beneficiaries, in the demonstration program shall be voluntary.</text></paragraph></subsection>
<subsection id="H04ED6CC26BA14BA78C4F2C9EC2AF9998"><enum>(b)</enum><header>Disease prevention plan</header>
<paragraph id="H3F4DE322544D4DE5BF75C41375BD577"><enum>(1)</enum><header>In general</header><text>The disease prevention plan described in this subsection is a plan, developed in consultation with an eligible beneficiary participating in the demonstration program, to mitigate the risk factors associated with a particular disease.</text></paragraph>
<paragraph id="H330E9A7B64F7461B98DBFFE3AFE557CC"><enum>(2)</enum><header>Plan contents</header><text>The disease prevention plan should include the following:</text>
<subparagraph id="H402886FEFC3A4763A12E2B0613FF9EA5"><enum>(A)</enum><header>Point of contact</header><text>The disease prevention plan shall provide for a point of contact responsible for communicating with the participating beneficiary and with other health care providers on behalf of such beneficiary.</text></subparagraph>
<subparagraph id="HF8FE70CA856B4781A3BC63F832D909B1"><enum>(B)</enum><header>Personal health care</header><text>The disease prevention plan shall provide for instruction on personal health care.</text></subparagraph>
<subparagraph id="H056338966F7E4A87AFBEDA04154063E3"><enum>(C)</enum><header>Physician and health care provider training</header><text>The disease prevention plan shall provide for the training of physicians or other health care providers in the communication of relevant clinical information.</text></subparagraph>
<subparagraph id="H8DC16FC8F48D463B8869B662C1837DF5"><enum>(D)</enum><header>Monitoring technology</header><text>The disease prevention plan may provide for necessary monitoring technology to facilitate the exchange of information, including information such as vital signs, symptoms, and health self assessments.</text></subparagraph></paragraph></subsection>
<subsection id="H0470AA1D22914B75B5E6BED21F45F902"><enum>(c)</enum><header>Program standards and criteria</header><text>The Secretary shall establish performance standards for the demonstration program under this section, including best practices for the prevention of chronic diseases. Such practices shall be standardized to the greatest extent possible. The eligibility of entities or individuals to enter into a contract to provide preventive health care under the demonstration program shall be conditioned, at a minimum, on performance that meets or exceeds such standards.</text></subsection>
<subsection id="HE999211685EC4784A800904CF584F4B2"><enum>(d)</enum><header>Payment</header><text>The Secretary shall develop a method and level of payment for entities that participate in the program under this section based on best practices, as determined by the Secretary.</text></subsection>
<subsection id="HE9E9A40D36B74543AA8B9C9B00B6FA4"><enum>(e)</enum><header>Waiver authority</header><text>The Secretary may waive such requirements of titles XI and XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> as may be necessary to carry out the purposes of the demonstration program under this section.</text></subsection>
<subsection id="H7F58886E50414843BB921DC528597744"><enum>(f)</enum><header>Evaluation and report</header>
<paragraph id="H5F223D97620344EA9F7BF0B52FF70872"><enum>(1)</enum><header>Evaluation</header><text>The Secretary shall conduct evaluations of—</text>
<subparagraph id="HD0D004FAB4E24FC6A7FEF0117789BF46"><enum>(A)</enum><text>the benefits due to a reduction, if any, in disease incidence for participants in the demonstration projects compared to the medicare population as a whole, as determined by the use of appropriate statistical techniques;</text></subparagraph>
<subparagraph id="H9E3D6DDF97FE4719B5AF49535E00006E"><enum>(B)</enum><text>the long term cost effectiveness of the demonstration projects to the medicare program in terms of acute care costs avoided due to disease prevention; and</text></subparagraph>
<subparagraph id="H9B620D54F3F147BCB1C0DC00BB000867"><enum>(C)</enum><text>patient satisfaction under the demonstration projects.</text></subparagraph></paragraph>
<paragraph id="HA37CD572A72A408E9E17DF378F35FF06"><enum>(2)</enum><header>Report</header><text>Not later than 6 months after the date on which the demonstration program under this section ends, the Secretary shall prepare and submit to Congress a report on the demonstration program together with—</text>
<subparagraph id="H3918F7160F404A4B9FFBA1B287EFC541"><enum>(A)</enum><text>recommendations on whether the demonstration program should be expanded in terms of its success in disease prevention and the cost effectiveness of the demonstration program; and</text></subparagraph>
<subparagraph id="HE933982D62F344DAB6B0D7613AC7DCE"><enum>(B)</enum><text>such recommendations for legislation or administrative action as the Secretary determines appropriate.</text></subparagraph></paragraph></subsection>
<subsection id="HFE3BCB2705E549F5BEDC002EDA62C430"><enum>(g)</enum><header>Funding</header><text>The Secretary shall provide for the transfer from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395t">42 U.S.C. 1395t</external-xref>) of such funds, not to exceed $50,000,000, as are necessary for the costs of carrying out the demonstration program under this Act.</text></subsection>
<subsection id="H45F874E817954AFFB117A12084C9B088"><enum>(h)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="H97070BE2634C4676A43EC979C45B8FCF"><enum>(1)</enum><header>Appropriate entity</header><text>The term <term>appropriate entity</term> means—</text>
<subparagraph id="H919478073A7A4EF7A202008BC8DCDAB6"><enum>(A)</enum><text>a chronic care improvement program;</text></subparagraph>
<subparagraph id="H587BA2114C5247A8A4F6A6AC6208D699"><enum>(B)</enum><text>a hospital; and</text></subparagraph>
<subparagraph id="HF0B81213B1314290B3879BA19DBA6E66"><enum>(C)</enum><text>any other entity that the Secretary determines appropriate based on clinical, financial, or other requirements appropriate to carry out the purposes of the demonstration program under this section.</text></subparagraph></paragraph>
<paragraph id="H7BD8021E91774BDD84E1EB92FC3BF20"><enum>(2)</enum><header>Eligible beneficiary</header><text>The term <term>eligible beneficiary</term> means an individual who—</text>
<subparagraph id="H8C9FCBD8B75142F39B806273F1268567"><enum>(A)</enum><text>is entitled to benefits under part A of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> or enrolled under part B of such title; and</text></subparagraph>
<subparagraph id="H72F785A022FA43ADAF7D2662DDB49B51"><enum>(B)</enum><text>has 2 or more risk factors associated with—</text>
<clause id="HF21DBFBD6A734272B36384D8CCD294A9"><enum>(i)</enum><text>chronic obstructive pulmonary disease;</text></clause>
<clause id="HCEFCE5885B684023A2094462145110F9"><enum>(ii)</enum><text>diabetes; or</text></clause>
<clause id="HDE219C862AE14D3C9413789EA964A0E2"><enum>(iii)</enum><text>any other chronic condition that the Secretary determines would be appropriate for the purpose of providing significant potential cost benefits to the medicare program through the prevention of such condition.</text></clause></subparagraph></paragraph></subsection></section>
<section id="HAA13A0784AD5425DBC427E5DFAA49846"><enum>405.</enum><header>Preventive health services for women</header><text display-inline="no-display-inline">Section 1509 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/300n-4a">42 U.S.C. 300n–4a</external-xref>) is amended to read as follows:</text>
<quoted-block act-name="Public Health Service Act" id="H1BE5EA760DA544488F7EB488918B1957">
<section id="H8F156B53A9EE4E758BD6B4BAC1CBFDA7"><enum>1509.</enum><header>Establishment of program for additional preventive health services</header>
<subsection id="H9018F40DA27A46AFAC716F6B4C00A76B"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may, through a competitive review process, award grants to States that have received grants under section 1501 for a fiscal year, to enable such State to carry out programs—</text>
<paragraph id="H8014B5A538EF408CB6650780C89EC592"><enum>(1)</enum><text>to provide preventive health services, in addition to the services authorized in such section 1501, for diseases such as cardiovascular diseases, osteoporosis, and obesity;</text></paragraph>
<paragraph id="H8DF8AED3EC1E480BAF8C2F2C7C9227BE"><enum>(2)</enum><text>to provide screenings, such as screening for blood pressure, cholesterol, and osteoporosis, and other services that the Secretary, acting through the Director of the Centers for Disease Control and Prevention, determines to be appropriate and feasible;</text></paragraph>
<paragraph id="H7C46BF590B5B45308100225BAB2B85BD"><enum>(3)</enum><text>for health education, counseling, and interventions for behavioral risk factors, such as physical inactivity and poor nutrition, and diseases referred to in paragraph (1);</text></paragraph>
<paragraph id="H93A597E0E56B4FD58CFDDC4DADD68230"><enum>(4)</enum><text>to provide appropriate referrals for medical treatment of women receiving services pursuant to paragraph (1) through (3), and ensuring, to the extent practicable, the provision of appropriate follow-up services; and</text></paragraph>
<paragraph id="H6FCDEDEF9D2E4156886426612719C985"><enum>(5)</enum><text>to evaluate the activities conducted under paragraphs (1) through (4) through appropriate surveillance, research, or program monitoring activities.</text></paragraph></subsection>
<subsection id="HAE939E5D83F147368BD4104197676408"><enum>(b)</enum><header>Status as participant in program regarding breast and cervical cancer</header><text>The Secretary may not make a grant to a State under subsection (a) unless the State involved agrees that services under the grant will be provided in conjunction with entities that are screening women for breast or cervical cancer pursuant to a grant under section 1501.</text></subsection>
<subsection id="H42760CD89C3A41488311F1E539EE8BAA"><enum>(c)</enum><header>Applicability of provisions</header><text>The provisions of this title shall apply to a grant under subsection (a) to the same extent and in the same manner as such provisions apply to a grant under section 1501.</text></subsection>
<subsection id="HA81C166D6E844FCCB89F4B682878C7E6"><enum>(d)</enum><header>Funding</header>
<paragraph id="H7914230036D84BC39EAF1EB6A6FBB614"><enum>(1)</enum><header>In general</header><text>There is authorized to be appropriated such sums as may be necessary to carry out this section for fiscal year 2007 and for each subsequent fiscal year.</text></paragraph>
<paragraph id="H7AAA7242034F4DF5A1FAAF83FA878200"><enum>(2)</enum><header>Limitation regarding funding with respect to breast and cervical cancer</header><text>No additional resources shall be appropriated for a fiscal year under paragraph (1) unless the amount appropriated under section 1510(a) for such fiscal year is at least $173,920,000.</text></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>
<enum>V</enum><header>HeLP (Healthy Lifestyles and Prevention) America Trust Fund</header>
<section id="HD0B50D6CA9994101A07BC96AD5103D"><enum>501.</enum><header>HeLP (Healthy Lifestyles and Prevention) America Trust Fund</header>
<subsection id="H05FB435CD0944CDD877D40BAC16903FE"><enum>(a)</enum><header>Creation of Trust Fund</header><text>There is established in the Treasury of the United States a trust fund to be known as the <quote>HeLP (Healthy Lifestyles and Prevention) America Trust Fund</quote> (referred to in this section as the <quote>Trust Fund</quote>), consisting of such amounts as may be appropriated or credited to the Trust Fund as provided in this section.</text></subsection>
<subsection id="HB5737D72332E4544AF2D77098978A27B"><enum>(b)</enum><header>Transfers to Trust Fund</header><text>There is hereby appropriated to the Trust Fund an amount equivalent to—</text>
<paragraph id="H7072CDA3E5CF4B61BCB10198D6917DF4"><enum>(1)</enum><text>the increase in revenues received in the Treasury as the result of the amendment made by section 304 of this Act,</text></paragraph>
<paragraph id="HE894B265D2AC42418FC7ADC42D455875"><enum>(2)</enum><text>the increase in revenues received in the Treasury as the result of the amendments made by title II of this Act, and</text></paragraph>
<paragraph id="H89F9D3967A2344529CF32285D8E0E01"><enum>(3)</enum><text>the receipts paid by tobacco companies under subtitle B of title III of this Act.</text></paragraph></subsection>
<subsection id="H88C0A8492F894212B28234155292C8AF"><enum>(c)</enum><header>Distribution of amounts in Trust Fund</header>
<paragraph id="HF6CEEC5920234D9F9492FABF046861B1"><enum>(1)</enum><header>Mandatory expenditures</header><text>On a fiscal year basis (beginning with fiscal year 2007) and without further appropriation the Secretary of the Treasury shall distribute from amounts in the Trust Fund such amounts as are necessary to provide for the Federal expenditures attributable to the following:</text>
<subparagraph id="H2F70E13919FF4800921B5D00045620C7"><enum>(A)</enum><text>The amendments made to the Fruit and Vegetable Program by section 101 of this Act.</text></subparagraph>
<subparagraph id="HCA7EC019E9114BD79D0100D25D3E9862"><enum>(B)</enum><text>Smoking cessation drugs under title XIX of the <act-name parsable-cite="SSA">Social Security Act</act-name> as identified by the Secretary of Health and Human Services.</text></subparagraph>
<subparagraph id="H3693EFB2925C4EC09EFEB184D96C39E"><enum>(C)</enum><text>Coverage of smoking cessation under the Federal Employee Health Benefits Program under <external-xref legal-doc="usc-chapter" parsable-cite="usc-chapter/5/89">chapter 89</external-xref> of title 5, United States Code (as amended by section 402(c)).</text></subparagraph>
<subparagraph id="HACEF687D57E54D89993132DF8D5D77F7"><enum>(D)</enum><text>The amendments made to the medicare program under title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> by sections 401 and 402 of this Act.</text></subparagraph>
<subparagraph id="H2189505F102E4CA6A100E04C30007884"><enum>(E)</enum><text>The preventive health care demonstration program carried out under section 404 of this Act.</text></subparagraph><continuation-text continuation-text-level="paragraph">Such amounts shall be in addition to any other amounts appropriated for such purposes.</continuation-text></paragraph>
<paragraph id="HF6FCD96F7F3D4DBDB0E03F016E63FF4C"><enum>(2)</enum><header>Discretionary expenditures</header><text>Amounts in the Trust Fund not to exceed $2,050,000,000 shall be available, as provided in appropriation Acts, for each fiscal year (beginning with fiscal year 2007) only for purposes of making expenditures to carry out the following:</text>
<subparagraph id="H58DA52BBA2024EA990D9B8B3CF6B1F4"><enum>(A)</enum><text>School nutrition environment enhancement grants under section 18(l) of the Richard B. Russell <act-name parsable-cite="NSLA">National School Lunch Act</act-name> (as added by section 103).</text></subparagraph>
<subparagraph id="HCC68AAD5FB3E44CBA42CD158C1973CCE"><enum>(B)</enum><text>Community grants to prevent and reduce the incidence of chronic disease under section 399P of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added by section 211).</text></subparagraph>
<subparagraph id="H356C90CCE256467FAFF7BAB6077802"><enum>(C)</enum><text>The preventive medicine and public health training grant program carried out under section 747A of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added by section 212).</text></subparagraph>
<subparagraph id="HF4001127E55E4D16B971006D00C6D215"><enum>(D)</enum><text>Federal-State tobacco counter-advertising programs under section 399Q of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added by section 305).</text></subparagraph>
<subparagraph id="HEF88E2D65FC54E8886483ED5ED34C4E3"><enum>(E)</enum><text>Preventive health services for women, including well-integrated screening and evaluation for women across the Nation, under section 1509 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as added by section 405).</text></subparagraph>
<subparagraph id="HBB1B13248C9542438E4300A768B39FF9"><enum>(F)</enum><text>Carol M. White Physical Education Program under subpart 10 of part D of title V of the <act-name parsable-cite="ESEA">Elementary and Secondary Education Act of 1965</act-name>.</text></subparagraph>
<subparagraph id="HA8A60BCD6F7F46E4891178E983AFC309"><enum>(G)</enum><text>Research regarding obesity under section 601 of this Act.</text></subparagraph>
<subparagraph id="HFF990518FE48487095B8825FDF92577E"><enum>(H)</enum><text>Expanded Food and Nutrition Education Program under <external-xref legal-doc="usc" parsable-cite="usc/23/3175">section 3175</external-xref> of title 23, United States Code.</text></subparagraph>
<subparagraph id="HFA95E9A8D6D54335A65DD7372EC8B6D9"><enum>(I)</enum><text>The following programs under the authority of the Secretary of Health and Human Services through the Centers for Disease Control and Prevention:</text>
<clause id="H3D7A276EB5D44527B5F20022D588A7A"><enum>(i)</enum><text>Nutrition and physical activity grants.</text></clause>
<clause id="HCCDA64AF5D8848C282E57D45E131A5E7"><enum>(ii)</enum><text>Division of Adolescent and School Health.</text></clause>
<clause id="H282C7B0681254FDEAA9E28D4808D59D"><enum>(iii)</enum><text>Verb Campaign.</text></clause>
<clause id="H3DF4A9ED1932406BB560891C37730982"><enum>(iv)</enum><text>Prevention research centers.</text></clause>
<clause id="HD9139EC858484E20B489CF2691632C17"><enum>(v)</enum><text>5-a-day programs.</text></clause>
<clause id="H1FDBB979D64B4AE0A741F71B0088AAC9"><enum>(vi)</enum><text>Steps to a healthier United States.</text></clause></subparagraph>
<subparagraph id="H9DDFCEA9D00D403DB8AF4DDAD008C63"><enum>(J)</enum><text>Access to local foods and school gardens, as authorized by section 122 of the Child Nutrition and WIC Reauthorization Act of 2004 (<external-xref legal-doc="public-law" parsable-cite="pl/108/265">Public Law 108–265</external-xref>).</text></subparagraph></paragraph></subsection>
<subsection id="H2724D60A206348C6BD9430E4DD1B9DAA"><enum>(d)</enum><header>Application of certain rules</header><text>For purposes of this section, rules similar to the rules of sections 9601 and 9602 of the Internal Revenue Code of 1986 shall apply.</text></subsection></section>
<enum>VI</enum><header>Research</header>
<section id="H85B089C6DFF54A2CB0886425575C1E39"><enum>601.</enum><header>Expansion of research regarding obesity</header><text display-inline="no-display-inline">The Secretary of Health and Human Services shall, based on the conclusions of the United States Preventive Services Task Force on Obesity, conduct research on obesity prevention, treatment, and control with regard to the following:</text>
<paragraph id="H72E6CF3BFD964985A600CA7EC07F5EA0"><enum>(1)</enum><text>The effectiveness of physical activity and dietary counseling with children and adolescents in the primary care setting to prevent, treat, and control obesity.</text></paragraph>
<paragraph id="H344FEA208FAA4D60AAFFCBC65F64A800"><enum>(2)</enum><text>The cost-effectiveness of intensive dietary and physical activity counseling to prevent, treat, and control obesity in a variety of populations.</text></paragraph>
<paragraph id="H34BB6BD5907D48F6932CEC65B2281DEB"><enum>(3)</enum><text>The effectiveness of dietary and physical activity counseling among children and adolescents, low income populations, and minority groups in the primary care setting to prevent, treat, and control obesity.</text></paragraph>
<paragraph id="HA16DB6D53A854271BBA6ECF558BC6BA2"><enum>(4)</enum><text>The effectiveness of the assessment of obesity by a primary care physician and subsequent referral for obesity counseling to a nonaffiliated obesity expert or specialist.</text></paragraph></section>