II 

109TH CONGRESS 

1ST SESSION S. 1074 

To improve the health of Americans and reduce health care costs by reorienting the Nation’s health care system toward prevention, wellness, and 

self care. 

IN THE SENATE OF THE UNITED STATES 

MAY 18, 2005 

Mr. HARKIN introduced the following bill; which was read twice and referred 

to the Committee on Finance 

A BILL 

To improve the health of Americans and reduce health care 

costs by reorienting the Nation’s health care system toward prevention, wellness, and self care. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Healthy Lifestyles and Prevention America Act’’ or the 

6 ‘‘HeLP America Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings. 
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TITLE I—HEALTHIER KIDS AND SCHOOLS 

Sec. 101. Fresh fruit and vegetable program. 

Sec. 102. Child nutrition promotion and school lunch protection. 

Sec. 103. School nutrition environment enhancement grants. 

Sec. 104. Grants for the integration of schools and mental health systems. 

Sec. 105. Baby friendly hospital-center for breastfeeding excellence. 

Sec. 106. Intervention to strengthen families and build children’s resilience. 

Sec. 107. Reservations for early head start programs. 

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. Living well with a disability and working well with a disability programs. 

Sec. 213. Enhanced standards for roads and intersection controls. 

Sec. 214. National assessment of mental health needs. 

Sec. 215. Preventive medicine and public health training grant program. 

Sec. 216. Task force for the promotion of breastfeeding in the workplace. 

Sec. 217. Lactation accomodation and breastfeeding promotion at work. 

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

CONSTITUENT 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
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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. Label and disclosure requirements for infant formulas. 

Sec. 304. Food advertising in schools. 

Sec. 305. Disallowance of deductions for advertising and marketing expenses 

relating to tobacco product use. 

Sec. 306. 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. Preventive mental health screenings. 

Sec. 403. Encouragement of cessation of tobacco use. 

Sec. 404. Recognition of school-based health centers as model for delivery of 

primary care for children under the medicaid and State children’s health insurance programs. 

Sec. 405. Preventive health care demonstration program. 

Sec. 406. 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. 

1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Health care costs in the United States are 

4 rising rapidly. Per capita health spending in the 

5 United States is 56 percent higher than the median 
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1 country that is a member of the Organization for 

2 Economic Cooperation and Development. 

3 (2) According to the Centers for Medicare and 

4 Medicaid Services, total health care spending in the 

5 United States in 2004 was $1,800,000,000,000 and 

6 is expected to rise to $3,600,000,000,000 by 2014. 

7 Furthermore, chronic disease accounts for approxi8 mately 75 percent of health care costs annually. 

9 (3) The United States spends less than 5 per10 cent of annual health care expenditures on preven11 tion 

12 (4) Reducing and preventing the incidence of 

13 chronic disease is one means by which to reduce 

14 health care costs in the United States. 

15 (5) More than 1,700,000 Americans die of a 

16 chronic disease each year, accounting for nearly 70 

17 percent of all deaths in the United States. 

18 (6) The economic impact of chronic disease can 

19 be seen in the annual costs associated with cardio20 vascular disease and stroke ($352,000,000,000), 

21 obesity ($117,000,000,000), cancer 

22 ($171,600,000,000), and diabetes 

23 ($132,000,000,000). 
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1 (7) Obesity related health conditions cost em2 ployers nearly $13,000,000,000 in health care and 

3 other indirect costs. 

4 (8) Health promotion investments by employers 

5 on average yield a return of $3 for every $1 invested 

6 in a program. 

7 (9) Being overweight or obese increase the risk 

8 of diabetes, heart disease, stroke, several types of 

9 cancer and other health problems. 

10 (10) An estimated 65 percent of adults and 15 

11 percent of children and adolescents in the United 

12 States are overweight or obese. 

13 (11) The rates of obesity have doubled in chil14 dren and tripled in teens since the 1980’s. 

15 (12) Almost 40 percent of Americans are sedentary. More than 1 16 ⁄3 of young people in grades 9 

17 through 12 do not regularly engage in vigorous-in18 tensity physical activity. 

19 (13) Only 1 in 5 young people eat the rec20 ommended 5 daily servings of fruits and vegetables. 

21 (14) Food and beverage advertisers collectively 

22 spend $10,000,000,000 to $12,000,000,000 a year 

23 to reach children and youth. 
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1 (15) Between 1977 and 1995, trips made by 

2 walking declined by 40 percent for adults while driv3 ing trips increased to almost 90 percent of the total. 

4 (16) Virtually all-new users of tobacco products 

5 are under the minimum legal age to purchase such 

6 products. Every day in America, more than 4,000 

7 kids try their first cigarette. Another 2,000 children 

8 become new daily smokers. 

9 (17) In 2002, nearly a quarter of American 

10 adults, 46,000,000 people, smoked cigarettes, includ11 ing almost 40 percent of college-aged students. 

12 (18) Research consistently shows that smoking 

13 cessation services offered as a combination of to14 bacco medication therapy and counseling can be one 

15 of the most cost-effective health interventions and 

16 can reduce smoking-related health care costs. 

17 (19) Physical and mental health are inter18 connected. Physical conditions often result in mental 

19 health complications and depression can manifest 

20 itself through physical symptoms. 

21 (20) The Surgeon General reported that mental 

22 disorders collectively account for over 15 percent of 

23 the overall burden of disease from all causes, slightly 

24 more than the burden associated with all forms of 

25 cancer. 
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1 (21) One of every 2 people who need mental 

2 health treatment in the United States does not re3 ceive it. Of children and adolescents 6 to 17 years 

4 old who need mental health services, nearly 80 per5 cent do not receive it. 

6 (22) Early screening and prevention programs 

7 in the schools can detect high risk children that are 

8 vulnerable to developing mental illness and assist in 

9 accessing appropriate services. 

10 (23) Children are at greater risk for mental 

11 health problems when they experience stressful fam12 ily circumstances such as social or economic dis13 advantage, severe marital discord, divorce, family vi14 olence, parental substance abuse or other mental dis15 order or physical illness, and parental absence due 

16 to military service, imprisonment, or death. 

17 (24) The 2003 President’s New Freedom Com18 mission on Mental Health urged a transformation of 

19 the approach to mental health in the United States, 

20 including improving the mental health of children 

21 and promoting resilience and prevention. 

22 (25) People with disabilities report substantial 

23 disparities in health compared with people without 

24 disabilities. These disparities are caused by a num25 ber of factors, including less access to health care 
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1 than individuals without disabilities. People with dis2 abilities report more days of pain, depression, and 

3 anxiety and they have higher rates of obesity. 

4 (26) Evidence shows that health promotion pro5 grams with exercise, nutrition, and wellness compo6 nents targeting people with disabilities can signifi7 cantly reduce the incidence of these conditions and 

8 lead to healthy outcomes for people with disabilities, 

9 as well as save money by reducing the frequency of 

10 medical visits. 

11 TITLE I—HEALTHIER KIDS AND 

12 SCHOOLS 

13 SEC. 101. FRESH FRUIT AND VEGETABLE PROGRAM. 

14 (a) ADDITIONAL FUNDING FOR FRESH FRUIT AND

15 VEGETABLE PROGRAM.—Section 18(g)(6)(B) of the Rich16 ard B. Russell National School Lunch Act (42 U.S.C. 

17 1769(g)(6)(B)) is amended— 

18 (1) by redesignating clause (ii) as clause (iv); 

19 and 

20 (2) by inserting after clause (i) the following: 

21 ‘‘(ii) ADDITIONAL MANDATORY FUND22 ING.—Out of any funds in the Treasury 

23 not otherwise appropriated, the Secretary 

24 of the Treasury shall transfer to the Sec25 retary of Agriculture to carry out and ex-
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1 pand the program under this subsection, to 

2 remain available until expended— 

3 ‘‘(I) on October 1, 2005, 

4 $1,000,000,000; and 

5 ‘‘(II) on October 1, 2006, and on 

6 each October 1 thereafter, the amount 

7 made available for the previous fiscal 

8 year, as adjusted under clause (iii). 

9 ‘‘(iii) ADJUSTMENT.—On October 1, 

10 2006, and on each October 1 thereafter of 

11 a fiscal year the amount made available 

12 under subclause (I) of clause (ii) shall be 

13 calculated by adjusting the amount made 

14 available for the previous fiscal year to re15 flect changes in the Consumer Price Index 

16 of the Bureau of Labor Statistics for fresh 

17 fruits and vegetables, with the adjust18 ment— 

19 ‘‘(I) rounded down to the nearest 

20 dollar increment; and 

21 ‘‘(II) based on the unrounded 

22 amounts for the preceding 12-month 

23 period.’’. 
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1 (b) HEALTHY COOKING PILOT PROGRAM.—Section 

2 18(g) of the Richard B. Russell National School Lunch 

3 Act (42 U.S.C. 1769(g)) is amended— 

4 (1) by redesignating paragraphs (4), (5), and 

5 (6) as paragraphs (5), (6), and (7), respectively; and 

6 (2) by inserting after paragraph (3) the fol7 lowing: 

8 ‘‘(4) HEALTHY COOKING PILOT PROGRAM.— 

9 ‘‘(A) IN GENERAL.—As part of the pro10 gram conducted under this subsection, the Sec11 retary shall carry out a pilot program under 

12 which the Secretary shall make competitive 

13 grants to selected elementary and secondary 

14 schools to teach children— 

15 ‘‘(i) how to eat a nutritious diet; 

16 ‘‘(ii) how to select foods to make a 

17 healthy meal; and 

18 ‘‘(iii) how to prepare healthy meals. 

19 ‘‘(B) SELECTION OF SCHOOLS.—In select20 ing schools to participate in the pilot program, 

21 the Secretary shall ensure that— 

22 ‘‘(i) only schools participating in the 

23 fruit and vegetable program under this 

24 subsection are eligible to receive funds 

25 under this paragraph; 
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1 ‘‘(ii) to the maximum extent prac2 ticable, at least 75 percent of schools se3 lected are schools in which at least 50 per4 cent of the students enrolled are eligible 

5 for free or reduced price meals under this 

6 Act; and 

7 ‘‘(iii) there is appropriate representa8 tion, as determined by the Secretary, of— 

9 ‘‘(I) rural, urban, and suburban 

10 schools; and 

11 ‘‘(II) elementary, middle, and 

12 secondary schools. 

13 ‘‘(C) PRIORITY CONSIDERATION.—In 

14 awarding competitive grants under this para15 graph, the Secretary shall give priority consid16 eration to schools that submit an application 

17 that includes the participation of the parents or 

18 families of the children enrolled in the school.’’. 

19 SEC. 102. CHILD NUTRITION PROMOTION AND SCHOOL 

20 LUNCH PROTECTION. 

21 Section 10 of the Child Nutrition Act of 1966 (42 

22 U.S.C. 1779) is amended— 

23 (1) by striking the section heading and all that 

24 follows through ‘‘(a) The Secretary’’ and inserting 

25 the following: 
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1 ‘‘SEC. 10. REGULATIONS. 

2 ‘‘(a) IN GENERAL.—The Secretary’’; and 

3 (2) by striking subsections (b) and (c) and in4 serting the following: 

5 ‘‘(b) FOOD OF MINIMAL NUTRITIONAL VALUE.— 

6 ‘‘(1) PROPOSED REGULATIONS.— 

7 ‘‘(A) IN GENERAL.—Not later than 180 

8 days after the date of enactment of this para9 graph, the Secretary shall promulgate proposed 

10 regulations— 

11 ‘‘(i) to revise the definition of ‘food of 

12 minimal nutritional value’ that is used to 

13 carry out this Act and the Richard B. Rus14 sell National School Lunch Act (42 U.S.C. 

15 1751 et seq.); and 

16 ‘‘(ii) to rename the term ‘food of poor 

17 nutritional value’. 

18 ‘‘(B) REQUIREMENTS.—In revising the 

19 definition, the Secretary shall— 

20 ‘‘(i) cover all foods made available— 

21 ‘‘(I) outside the school meal pro22 grams; 

23 ‘‘(II) on the school campus; and 

24 ‘‘(III) at any time during the 

25 school day; 
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1 ‘‘(ii) shall consider both the positive 

2 and negative contributions of nutrients, in3 gredients, and foods (including calories, 

4 portion size, saturated fat, trans fat, so5 dium, and added sugars) to the diets of 

6 children; 

7 ‘‘(iii) consider evidence concerning the 

8 relationship between consumption of cer9 tain nutrients, ingredients, and foods to 

10 both preventing and promoting the devel11 opment of overweight, obesity, and other 

12 chronic illnesses; and 

13 ‘‘(iv) consider recommendations made 

14 by authoritative scientific organizations 

15 concerning appropriate nutritional stand16 ards for foods sold outside of the reimburs17 able meal programs in schools. 

18 ‘‘(2) IMPLEMENTATION.— 

19 ‘‘(A) EFFECTIVE DATE.— 

20 ‘‘(i) IN GENERAL.—Except as pro21 vided in clause (ii), the proposed regula22 tions shall take effect at the beginning of 

23 the school year following the date on which 

24 the regulations are finalized. 
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1 ‘‘(ii) EXCEPTION.—If the regulations 

2 are finalized on a date that is not more 

3 than 60 days before the beginning of the 

4 school year, the proposed regulations shall 

5 take effect at the beginning of the fol6 lowing school year. 

7 ‘‘(B) FAILURE TO PROMULGATE.—If, on 

8 the date that is 1 year after the date of enact9 ment of this paragraph, the Secretary has not 

10 promulgated final regulations, the proposed reg11 ulations shall be considered to be final regula12 tions.’’. 

13 SEC. 103. SCHOOL NUTRITION ENVIRONMENT ENHANCE14 MENT GRANTS. 

15 Section 18 of the Richard B. Russell National School 

16 Lunch Act (42 U.S.C. 1769) is amended by adding at the 

17 end the following: 

18 ‘‘(l) HEALTHY SCHOOL NUTRITION ENVIRONMENT

19 INCENTIVE GRANTS.— 

20 ‘‘(1) IN GENERAL.—Following the publication 

21 of the recommendations of the Institute of Medicine 

22 study carried out using funds made available for 

23 public health improvement and leadership under the 

24 heading ‘CENTERS FOR DISEASE CONTROL AND

25 PREVENTION’ in the Department of Labor Appro-
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1 priations Act, 2005 (title I of division F of Public 

2 Law 108–447; 118 Stat. 3124) regarding appro3 priate nutritional standards for the availability, sale, 

4 content, and consumption of food at school, with 

5 particular attention given to foods offered in com6 petition with federally reimbursed meals and snacks, 

7 the Secretary may carry out a grant program to— 

8 ‘‘(A) provide schools with technical assist9 ance in implementing the recommendations of 

10 the Institute of Medicine regarding appropriate 

11 school nutrition standards; and 

12 ‘‘(B) assess the impact of implementing 

13 the recommendations on the health and well14 being of children enrolled in the schools. 

15 ‘‘(2) SELECTION OF SCHOOLS.—In selecting 

16 schools to receive incentive grants under this sub17 section, the Secretary shall— 

18 ‘‘(A) ensure that not less than 75 percent 

19 of schools selected to participate in the program 

20 established under this subsection are schools in 

21 which not less than 50 percent of the students 

22 enrolled in each school are eligible for free or 

23 reduced price meals under this Act; 

24 ‘‘(B) ensure that, of the schools selected to 

25 participate in the program, there is appropriate 
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1 representation of rural, urban, and suburban 

2 schools, as determined by the Secretary; 

3 ‘‘(C) ensure that, of the schools selected to 

4 participate in the program, there is appropriate 

5 representation of elementary, middle, and sec6 ondary schools, as determined by the Secretary; 

7 ‘‘(D) ensure that schools selected to receive 

8 a grant under this subsection meet the require9 ments of paragraph (3); 

10 ‘‘(E) give priority to schools that develop 

11 comprehensive plans that include the involve12 ment of a broad range of community stake13 holders in achieving healthy school nutrition en14 vironments; and 

15 ‘‘(F) give priority to schools that develop 

16 comprehensive plans that include a strategy for 

17 maintaining healthy school nutrition environ18 ments in the years following the fiscal years for 

19 which the schools receive grants under this sub20 section. 

21 ‘‘(3) REQUIREMENTS.— 

22 ‘‘(A) CRITERIA FOR HEALTHY SCHOOL EN23 VIRONMENTS.—The Secretary shall establish 

24 criteria, based upon the recommendations of the 

25 Institute of Medicine described in paragraph 
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1 (1), under which schools may receive grants 

2 under this section. 

3 ‘‘(B) PLAN.—To be eligible to receive a 

4 grant under this subsection, a school shall— 

5 ‘‘(i) submit to the Secretary a healthy 

6 school nutrition environment plan that de7 scribes the actions the school will take to 

8 meet the criteria established under sub9 paragraph (A); and 

10 ‘‘(ii) take the actions described in the 

11 plan. 

12 ‘‘(4) GRANTS.—For each of fiscal years 2007 

13 through 2011, the Secretary shall make a grant to 

14 each school selected under paragraph (2). 

15 ‘‘(5) EVALUATIONS.— 

16 ‘‘(A) IN GENERAL.—The Secretary, acting 

17 through the Administrator of the Food and Nu18 trition Service, shall conduct an evaluation of a 

19 representative sample of schools that receive 

20 grants under this subsection. 

21 ‘‘(B) CONTENT.—The evaluation shall 

22 measure, at a minimum, the effects of a healthy 

23 school nutrition environment on— 

24 ‘‘(i) overweight children and obesity; 

25 ‘‘(ii) dietary intake; 
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1 ‘‘(iii) nutrition education and behav2 ior; 

3 ‘‘(iv) parental and student attitudes 

4 and participation; and 

5 ‘‘(v) related funding issues, including 

6 the cost of maintaining a healthy school 

7 nutrition environment. 

8 ‘‘(C) REPORTS.—The Secretary shall sub9 mit to the Committee on Education and the 

10 Workforce of the House of Representatives and 

11 the Committee on Agriculture, Nutrition, and 

12 Forestry of the Senate— 

13 ‘‘(i) an interim report on the activities 

14 of schools evaluated under this subsection; 

15 and 

16 ‘‘(ii) a final report on the activities of 

17 schools evaluated under this subsection. 

18 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— 

19 ‘‘(A) IN GENERAL.—There are authorized 

20 to be appropriated such sums as are necessary 

21 to carry out this subsection for fiscal year 2007 

22 and each subsequent fiscal year, to remain 

23 available until expended. 

24 ‘‘(B) EVALUATIONS.—The Secretary may 

25 use not more than 10 percent of the total funds 
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1 made available for a fiscal year under subpara2 graph (A) to carry out paragraph (5).’’. 

3 SEC. 104. GRANTS FOR THE INTEGRATION OF SCHOOLS 

4 AND MENTAL HEALTH SYSTEMS. 

5 Section 5541 of the Elementary and Secondary Edu6 cation Act of 1965 (20 U.S.C. 7269) is amended— 

7 (1) in subsection (c), by adding at the end the 

8 following: 

9 ‘‘(7) To support schools that work with families 

10 and appropriate community partners to implement 

11 school-wide prevention strategies, based on mental 

12 health research, that will support early and intensive 

13 interventions. 

14 ‘‘(8) To provide necessary training and support 

15 to school personnel on how to recognize and seek 

16 needed support for children exhibiting early warning 

17 signs of behavioral and academic problems.’’; and 

18 (2) in subsection (d)— 

19 (A) in paragraph (4)— 

20 (i) in subparagraph (C), by striking 

21 ‘‘and’’ after the semicolon; 

22 (ii) in subparagraph (D), by striking 

23 the period and inserting ‘‘; and’’; and 

24 (iii) by adding at the end the fol25 lowing: 
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1 ‘‘(E) mental health services provided under 

2 this section by schools will be evidence-based or 

3 promising early interventions.’’; and 

4 (B) by adding at the end the following: 

5 ‘‘(7) An explanation of how the applicant will 

6 carry out public education programs in support of 

7 mental health promotion and prevention by collabo8 rating with— 

9 ‘‘(A) an institution of higher education (in10 cluding a graduate program in psychology, so11 cial work, or education at an institution of 

12 higher education); and 

13 ‘‘(B) private nonprofit community-based 

14 organizations that have experience in public 

15 education programs relating to mental health 

16 promotion and prevention.’’. 

17 SEC. 105. BABY FRIENDLY HOSPITAL-CENTER FOR 

18 BREASTFEEDING EXCELLENCE. 

19 (a) ESTABLISHMENT OF PROGRAM.—The Director of 

20 the Office on Women’s Health of the Department of 

21 Health and Human Services (referred to in this section 

22 as the ‘‘Director’’) shall establish a program to be known 

23 as the ‘‘Baby-Friendly Hospital Initiative’’ (referred to in 

24 this section and the ‘‘Initiative’’). 
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1 (b) CERTIFICATION PROCESS.—Under the Initiative, 

2 the Director shall establish a certification process under 

3 which a hospital can apply for a certification as a ‘‘baby 

4 friendly hospital/center for breastfeeding excellence’’. Such 

5 certification process shall be based upon the international 

6 guidelines of the Baby-Friendly Hospital Initiative estab7 lished by the World Health Organization and United Na8 tions Children’s Fund. 

9 (c) REQUIREMENTS.— 

10 (1) IN GENERAL.—To be certified as a baby 

11 friendly hospital/center for breastfeeding excellence, 

12 a hospital (as defined for purposes of this section by 

13 the Director, and which may include birth centers) 

14 shall carry out the following: 

15 (A) The hospital shall maintain a written 

16 breastfeeding policy that is routinely commu17 nicated to all of the healthcare staff of the hos18 pital. 

19 (B) The hospital shall provide training for 

20 all healthcare staff in the skills necessary to im21 plement the policy described in subparagraph 

22 (A). 

23 (C) The hospital shall ensure that all preg24 nant women who are patients at the hospital 
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1 are informed about the benefits and manage2 ment of breastfeeding. 

3 (D) The hospital shall help mothers ini4 tiate breastfeeding within one hour of birth. 

5 (E) The hospital shall demonstrate to 

6 mothers how to breastfeed and how to maintain 

7 lactation, even if the mother is separated from 

8 her infant. 

9 (F) The hospital shall give infants no food 

10 or drink other than breastmilk, unless medically 

11 indicated. 

12 (G) The hospital shall implement a ‘‘room13 ing in’’ policy by allowing mothers and infants 

14 to remain together 24 hours a day in the same 

15 hospital room. 

16 (H) The hospital shall encourage unre17 stricted breastfeeding. 

18 (I) The hospital shall provide no pacifiers 

19 or artificial nipples to breastfeeding infants. 

20 (J) The hospital shall foster the establish21 ment of breastfeeding support groups and refer 

22 mothers to such groups on discharge from the 

23 hospital. 

24 (2) INSPECTION.—A hospital shall be certified 

25 as a baby friendly hospital/center for breastfeeding 
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1 excellence only upon the completion of an on-site as2 sessment by the Director through which the Director 

3 has determined that the hospital is in compliance 

4 with the guidelines used for certification under sub5 section (b). 

6 (3) VERIFICATION.—Upon being certified as a 

7 baby friendly hospital/center for breastfeeding excel8 lence, a hospital shall agree to permit the Director 

9 to conduct on-site assessments to verify the contin10 ued compliance of the hospital with the requirements 

11 of paragraph (1). 

12 (d) AUTHORITY FOR AUTOMATIC CERTIFICATION.— 

13 The Director may automatically certify a hospital as a 

14 baby friendly hospital/center of breastfeeding excellence if 

15 such hospital has been designated as a baby-friendly hos16 pital under the Baby-Friendly USA program. 

17 (e) LIMITATION.—A hospital shall not make any 

18 claim that such hospital is a baby friendly hospital/center 

19 of breastfeeding excellence unless such hospital has been 

20 certified by the Director in accordance with this section. 

21 (f) TECHNICAL ASSISTANCE.—The Director shall 

22 provide, at the request of a hospital seeking a certification 

23 as a baby friendly hospital/center of breastfeeding excel24 lence, such technical assistance as appropriate to assist 

25 the requesting hospital to achieve such certification. 
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1 (g) CERTIFICATION COSTS.—Subject to the avail2 ability of appropriations, the Director may provide to a 

3 hospital that has successfully been certified as a baby 

4 friendly hospital/center of breastfeeding excellence under 

5 this Act, a one time award of up to $20,000 to offset the 

6 cost to such hospital of being certified as a baby friendly 

7 hospital/center of breastfeeding excellence. 

8 (h) RECOMMENDATIONS FOR ACCREDITING ENTI9 TIES.—Not later than 12 months after certifying the first 

10 baby friendly hospital/center for breastfeeding excellence 

11 under this section, the Director shall provide to the appro12 priate organizations or entities that are engaged in the 

13 accreditation of healthcare organizations, recommenda14 tions concerning steps that such accrediting entities may 

15 take to integrate the baby friendly hospital requirements 

16 used in the Baby Friendly Hospital Initiative into 

17 healthcare organization accreditation procedures and re18 quirements. 

19 (i) AUTHORIZATION OF APPROPRIATIONS.—There 

20 are authorized to be appropriated such sums as may be 

21 necessary to carry out this section. 
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1 SEC. 106. INTERVENTION TO STRENGTHEN FAMILIES AND 

2 BUILD CHILDREN’S RESILIENCE. 

3 Part B of title V of the Public Health Service Act 

4 (42 3 U.S.C. 290bb et seq.) is amended by adding at the 

5 end the following: 

6 ‘‘SEC. 520K. INTERVENTIONS TO STRENGTHEN FAMILIES 

7 AND BUILD CHILDREN’S RESILIENCE. 

8 ‘‘(a) IN GENERAL.—The Secretary shall award 

9 grants to eligible entities for the purpose of implementing 

10 programs that strengthen families of children at risk for 

11 emotional or behavioral problems due to family distress. 

12 ‘‘(b) ELIGIBLE ENTITY.—Entities eligible to receive 

13 funds under this section may include— 

14 ‘‘(1) a local public entity, including a health de15 partment or local education agency; 

16 ‘‘(2) an Indian tribal organization or agency; 

17 ‘‘(3) a federally qualified health center; 

18 ‘‘(4) a community-based organization; or 

19 ‘‘(5) any other entity determined appropriate by 

20 the Secretary, including a consortia or partnership 

21 of entities eligible to receive funds under this sec22 tion. 

23 ‘‘(c) USE OF FUNDS.— 

24 ‘‘(1) IN GENERAL.—An eligible entity that re25 ceives a grant under this section shall use the funds 

26 made available through the grant to carry out home- 
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1 based, school-based, and community-based activities 

2 that— 

3 ‘‘(A) promote strong, supportive families 

4 and child resilience through parenting skills 

5 training and supports, or skill-building services 

6 with children, as well as provide other consult7 ative services and support for family and other 

8 caregivers, such as child care providers, edu9 cators, and after-school program staff; 

10 ‘‘(B) enhance mental health promotion ac11 tivities in domains where children live, play, and 

12 learn; and 

13 ‘‘(C) enhance community wellness, and re14 duce the incidence of preventable mental health 

15 problems among children. 

16 ‘‘(2) INTERVENTION ACTIVITIES.—Intervention 

17 activities funded under this section shall— 

18 ‘‘(A) be consumer and family driven, and 

19 use strengths-based approaches; 

20 ‘‘(B) be designed to promote social and 

21 emotional competencies and increase children’s 

22 ability to successfully cope with stressful life 

23 circumstances; 

24 ‘‘(C) be designed to strengthen children 

25 and their families by enhancing the knowledge, 
27 

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1 social, emotional, and other life or work skills, 

2 and support of, parents or other significant 

3 caregivers; 

4 ‘‘(D) emphasize and model a positive, sup5 portive approach to working with children; 

6 ‘‘(E) be evidence-based and provide in7 depth and ongoing training and consultation in 

8 the adoption and use of evidence-based inter9 ventions by schools, communities, and families; 

10 ‘‘(F) include a rigorous evaluation compo11 nent, including outcome measures suited to the 

12 intervention and the overall goals of the grant, 

13 as well as use of comparison groups and moder14 ating and meditating process variables when15 ever possible; 

16 ‘‘(G) involve partnerships between commu17 nities or schools and universities where possible 

18 to support effective implementation and evalua19 tion of the intervention activities; 

20 ‘‘(H) provide facilitated referrals for par21 ents and other family members who need men22 tal health, substance abuse, or social work serv23 ices, and coordinate a referral network of pro24 fessionals with affordable fees; and 
28 

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1 ‘‘(I) emphasize local capacity-building to 

2 use evidence-based intervention, promote link3 ages among individuals and groups that serve 

4 children and families, and develop community 

5 outreach to support coalition-building. 

6 ‘‘(3) TARGET POPULATIONS.—Families targeted 

7 by these activities shall include those with children 

8 at risk for increased mental health problems due to 

9 stressful family circumstances, including— 

10 ‘‘(A) social or economic disadvantage; 

11 ‘‘(B) severe marital discord; 

12 ‘‘(C) divorce; 

13 ‘‘(D) family violence; 

14 ‘‘(E) parental substance abuse or other 

15 mental disorder or physical illness; 

16 ‘‘(F) parental death; 

17 ‘‘(G) parental absence due to military serv18 ice; 

19 ‘‘(H) parental absence due to imprison20 ment; and 

21 ‘‘(I) other family disruption determined ap22 propriate by the Secretary. 

23 ‘‘(d) PRIORITY FUNDING.—In awarding grants under 

24 subsection (a), the Secretary shall give priority to the fol25 lowing: 
29 

•S 1074 IS 

1 ‘‘(1) Entities that provide non-Federal contribu2 tions, either in cash or in kind. 

3 ‘‘(2) Entities with demonstrated experience with 

4 community-based partnerships. 

5 ‘‘(3) Entities with demonstrated experience and 

6 success with such interventions. 

7 ‘‘(4) Entities with demonstrated experience 

8 working with families. 

9 ‘‘(5) Entities that develop comprehensive plans 

10 that include a strategy for extending program activi11 ties developed under this section in the years fol12 lowing the fiscal years for which they receive grants 

13 under this section. 

14 ‘‘(6) Entities that submit plans that exhibit co15 operative plans that include the involvement of a 

16 broad range of stakeholders, including the following: 

17 ‘‘(A) Community-based organizations. 

18 ‘‘(B) Local governments. 

19 ‘‘(C) Local educational agencies. 

20 ‘‘(D) Local business and community asso21 ciations. 

22 ‘‘(E) Accredited colleges, universities, and 

23 community colleges. 

24 ‘‘(F) Other entities determined appropriate 

25 by the Secretary. 
30 

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1 ‘‘(e) EVALUATION.—Of the funds appropriated to 

2 carry out this section, the Secretary may reserve up to 

3 5 percent for each fiscal year for the purpose of carrying 

4 out evaluations of the activities carried out under this sec5 tion, including a national cross-site evaluation. Within 90 

6 days of the completion of any evaluations, they shall be 

7 provided to the relevant authorizing committees and to the 

8 Committees on Appropriations of the Senate and the 

9 House of Representatives. 

10 ‘‘(f) DURATION.—The Secretary shall award grants 

11 under this section for a period of not more than 5 years. 

12 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

13 is authorized to be appropriated to carry out this section, 

14 $25,000,000 for fiscal year 2006, and such sums as may 

15 be necessary for each of fiscal years 2007 to 2010.’’. 

16 SEC. 107. RESERVATIONS FOR EARLY HEAD START PRO17 GRAMS. 

18 Section 640(a)(6)(A) of the Head Start Act (42 

19 U.S.C. 9835(a)(6)(A)) is amended by striking ‘‘7.5 per20 cent’’ and all that follows and inserting ‘‘12 percent for 

21 fiscal year 2006, 14 percent for fiscal year 2007, 16 per22 cent for fiscal year 2008, 18 percent for fiscal year 2009, 

23 and 20 percent for fiscal year 2010, of the amount appro24 priated pursuant to section 639(a).’’. 
31 

•S 1074 IS 

1 TITLE II—HEALTHIER COMMU2 NITIES AND WORKPLACES 

3 Subtitle A—Incentives for a 

4 Healthy Workforce 

5 SEC. 201. SHORT TITLE. 

6 This subtitle may be cited as the ‘‘Healthy Workforce 

7 Act of 2005’’. 

8 SEC. 202. TAX CREDIT TO EMPLOYERS FOR COSTS OF IM9 PLEMENTING WELLNESS PROGRAMS. 

10 (a) IN GENERAL.—Subpart D of part IV of sub11 chapter A of chapter 1 of the Internal Revenue Code of 

12 1986 (relating to business related credits) is amended by 

13 adding at the end the following: 

14 ‘‘SEC. 45J. WELLNESS PROGRAM CREDIT. 

15 ‘‘(a) ALLOWANCE OF CREDIT.— 

16 ‘‘(1) IN GENERAL.—For purposes of section 38, 

17 the wellness program credit determined under this 

18 section for any taxable year is— 

19 ‘‘(A) in the case of a small business em20 ployer, an amount equal to 50 percent of the 

21 costs paid or incurred by the small business em22 ployer in connection with a qualified small busi23 ness wellness program during the taxable year, 

24 and 
32 

•S 1074 IS 

1 ‘‘(B) in the case of any other employer, an 

2 amount equal to 50 percent of the costs paid or 

3 incurred by the employer in connection with a 

4 qualified wellness program during the taxable 

5 year. 

6 ‘‘(2) LIMITATION.—The amount of credit al7 lowed under paragraph (1) for any taxable year shall 

8 not exceed the product of $200 and the number of 

9 employees of the employer or small business em10 ployer, as the case may be. 

11 ‘‘(b) QUALIFIED WELLNESS PROGRAM; QUALIFIED

12 SMALL BUSINESS WELLNESS PROGRAM.—For purposes 

13 of this section— 

14 ‘‘(1) QUALIFIED WELLNESS PROGRAM.—The 

15 term ‘qualified wellness program’ means a program 

16 which consists of all of the wellness program compo17 nents described in subsection (c) and which is cer18 tified by the Secretary of Health and Human Serv19 ices, in consultation with persons who have expertise 

20 in employer health promotion and wellness pro21 grams, as a qualified wellness program under this 

22 section. 

23 ‘‘(2) QUALIFIED SMALL BUSINESS WELLNESS

24 PROGRAM.—The term ‘qualified small business 

25 wellness program’ means a program which consists 
33 

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1 of any 2 of the components described in subsection 

2 (c) and which is certified by the Secretary of Health 

3 and Human Services, in consultation with persons 

4 who have expertise in employer health promotion 

5 and wellness programs, as a qualified small business 

6 wellness program under this section. 

7 ‘‘(c) WELLNESS PROGRAM COMPONENTS.—For pur8 poses of this section, the wellness program components de9 scribed in this subsection are the following: 

10 ‘‘(1) HEALTH AWARENESS COMPONENT.—A 

11 health awareness component which provides for the 

12 following: 

13 ‘‘(A) HEALTH EDUCATION.—The dissemi14 nation of health information which addresses 

15 the specific needs and health risks of employees. 

16 ‘‘(B) HEALTH SCREENINGS.—The oppor17 tunity for periodic screenings for health prob18 lems and referrals for appropriate follow up 

19 measures. 

20 ‘‘(2) BEHAVIORAL CHANGE COMPONENT.—A 

21 behavioral change component which provides for al22 tering employee lifestyles to encourage healthy living 

23 through counseling, seminars, on-line programs, or 

24 self-help materials. Such component shall include 

25 programs relating to— 
34 

•S 1074 IS 

1 ‘‘(A) smoking, 

2 ‘‘(B) obesity, 

3 ‘‘(C) stress management, 

4 ‘‘(D) physical fitness, 

5 ‘‘(E) nutrition, 

6 ‘‘(F) substance abuse, 

7 ‘‘(G) depression, 

8 ‘‘(H) mental health promotion (including 

9 anxiety), and 

10 ‘‘(I) sleep (including sleep disorders and 

11 the consequences of sleep deprivation). 

12 ‘‘(3) SUPPORTIVE ENVIRONMENT COMPO13 NENT.—A supportive environment component which 

14 includes the following: 

15 ‘‘(A) ON-SITE POLICIES.—Policies and 

16 services at the worksite which promote a 

17 healthy lifestyle, including policies relating to— 

18 ‘‘(i) smoking at the worksite, 

19 ‘‘(ii) the nutrition of food available at 

20 the worksite through cafeterias and vend21 ing options, 

22 ‘‘(iii) minimizing stress in the work23 place, 

24 ‘‘(iv) where applicable, accessible and 

25 attractive stairs, 
35 

•S 1074 IS 

1 ‘‘(v) the encouragement of physical 

2 activity during work hours, 

3 ‘‘(vi) the promotion of fatigue coun4 termeasures. 

5 ‘‘(B) PARTICIPATION INCENTIVES.— 

6 ‘‘(i) IN GENERAL.—Qualified incentive 

7 benefits for each employee who participates 

8 in the health screenings described in para9 graph (1)(B) or the behavioral change pro10 grams described in paragraph (2). 

11 ‘‘(ii) QUALIFIED INCENTIVE BEN12 EFIT.—For purposes of clause (i), the 

13 term ‘qualified incentive benefit’ means 

14 any benefit which is approved by the Sec15 retary of Health and Human Services. 

16 Such benefit may include an adjustment in 

17 health insurance premiums or co-pays. 

18 ‘‘(C) EMPLOYEE INPUT.—The opportunity 

19 for employees to participate in the management 

20 of any qualified wellness program or qualified 

21 small business wellness program to which this 

22 section applies. 

23 ‘‘(d) PARTICIPATION REQUIREMENT.— 

24 ‘‘(1) IN GENERAL.—No credit shall be allowed 

25 under subsection (a) unless the Secretary of Health 
36 

•S 1074 IS 

1 and Human Services certifies, as a part of any cer2 tification described in subsection (b), that each 

3 wellness program component of the qualified 

4 wellness program or qualified small business 

5 wellness program applies to all qualified employees 

6 of the employer. 

7 ‘‘(2) QUALIFIED EMPLOYEE.—For purposes of 

8 paragraph (1), the term ‘qualified employee’ means 

9 an employee who works an average of not less than 

10 25 hours per week during the taxable year. 

11 ‘‘(e) OTHER DEFINITIONS AND SPECIAL RULES.— 

12 For purposes of this section— 

13 ‘‘(1) EMPLOYEE AND EMPLOYER.— 

14 ‘‘(A) PARTNERS AND PARTNERSHIPS.— 

15 The term ‘employee’ includes a partner and the 

16 term ‘employer’ includes a partnership. 

17 ‘‘(B) CERTAIN RULES TO APPLY.—Rules 

18 similar to the rules of section 52 shall apply. 

19 ‘‘(2) SMALL BUSINESS EMPLOYER.— 

20 ‘‘(A) IN GENERAL.—The term ‘small busi21 ness employer’ means, with respect to any tax22 able year, an employer who employed an aver23 age of 200 or fewer employees on business days 

24 during such taxable year. 
37 

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1 ‘‘(B) CONTROLLED GROUPS.—For pur2 poses of subparagraph (A), all persons treated 

3 as a single employer under subsection (b), (c), 

4 (m), or (o) of section 414 shall be treated as a 

5 single employer. 

6 ‘‘(3) CERTAIN COSTS NOT INCLUDED.—Costs 

7 paid or incurred by an employer or small business 

8 employer for food or health insurance shall not be 

9 taken into account under subsection (a). 

10 ‘‘(4) NO CREDIT WHERE GRANT AWARDED.— 

11 No credit shall be allowable under subsection (a) to 

12 any person who receives a grant under section 201 

13 of the Health Workforce Act of 2005. 

14 ‘‘(f) PORTION OF CREDIT MADE REFUNDABLE.— 

15 ‘‘(1) IN GENERAL.—In the case of an eligible 

16 employer of an employee, the aggregate credits al17 lowed to a taxpayer under subpart C shall be in18 creased by the lesser of— 

19 ‘‘(A) the credit which would be allowed 

20 under this section without regard to this sub21 section and the limitation under section 38(c), 

22 or 

23 ‘‘(B) the amount by which the aggregate 

24 amount of credits allowed by this subpart (de25 termined without regard to this subsection) 
38 

•S 1074 IS 

1 would increase if the limitation imposed by sec2 tion 38(c) for any taxable year were increased 

3 by the amount of employer payroll taxes im4 posed on the taxpayer during the calendar year 

5 in which the taxable year begins. 

6 The amount of the credit allowed under this sub7 section shall not be treated as a credit allowed under 

8 this subpart and shall reduce the amount of the 

9 credit otherwise allowable under subsection (a) with10 out regard to section 38(c). 

11 ‘‘(2) ELIGIBLE EMPLOYER.—For purposes of 

12 this subsection, the term ‘eligible employer’ means 

13 an employer or small business employer which is— 

14 ‘‘(A) a State or political subdivision there15 of, the District of Columbia, a possession of the 

16 United States, or an agency or instrumentality 

17 of any of the foregoing, or 

18 ‘‘(B) any organization described in section 

19 501(c) of the Internal Revenue Code of 1986 

20 which is exempt from taxation under section 

21 501(a) of such Code. 

22 ‘‘(3) EMPLOYER PAYROLL TAXES.—For pur23 poses of this subsection— 

24 ‘‘(A) IN GENERAL.—The term ‘employer 

25 payroll taxes’ means the taxes imposed by— 
39 

•S 1074 IS 

1 ‘‘(i) section 3111(b), and 

2 ‘‘(ii) sections 3211(a) and 3221(a) 

3 (determined at a rate equal to the rate 

4 under section 3111(b)). 

5 ‘‘(B) SPECIAL RULE.—A rule similar to 

6 the rule of section 24(d)(2)(C) shall apply for 

7 purposes of subparagraph (A). 

8 ‘‘(g) TERMINATION.—This section shall not apply to 

9 any amount paid or incurred after December 31, 2015.’’. 

10 (b) TREATMENT AS GENERAL BUSINESS CREDIT.— 

11 Subsection (b) of section 38 of the Internal Revenue Code 

12 of 1986 (relating to general business credit) is amended 

13 by striking ‘‘plus’’ at the end of paragraph (18), by strik14 ing the period at the end of paragraph (19) and inserting 

15 ‘‘, plus’’, and by adding at the end the following: 

16 ‘‘(20) the wellness program credit determined 

17 under section 45J.’’. 

18 (c) DENIAL OF DOUBLE BENEFIT.—Section 280C of 

19 the Internal Revenue Code of 1986 (relating to certain 

20 expenses for which credits are allowable) is amended by 

21 adding at the end the following new subsection: 

22 ‘‘(e) WELLNESS PROGRAM CREDIT.— 

23 ‘‘(1) IN GENERAL.—No deduction shall be al24 lowed for that portion of the costs paid or incurred 

25 for a qualified wellness program (within the meaning 
40 

•S 1074 IS 

1 of section 45J) or a qualified small business wellness 

2 program (within the meaning of such section) allow3 able as a deduction for the taxable year which is 

4 equal to the amount of the credit allowable for the 

5 taxable year under section 45J. 

6 ‘‘(2) SIMILAR RULE WHERE TAXPAYER CAP7 ITALIZES RATHER THAN DEDUCTS EXPENSES.—If— 

8 ‘‘(A) the amount of the credit determined 

9 for the taxable year under section 45J, exceeds 

10 ‘‘(B) the amount allowable as a deduction 

11 for such taxable year for a qualified wellness 

12 program or a qualified small business wellness 

13 program, 

14 the amount chargeable to capital account for the 

15 taxable year for such expenses shall be reduced by 

16 the amount of such excess. 

17 ‘‘(3) CONTROLLED GROUPS.—In the case of a 

18 corporation which is a member of a controlled group 

19 of corporations (within the meaning of section 

20 41(f)(5)) or a trade or business which is treated as 

21 being under common control with other trades or 

22 business (within the meaning of section 

23 41(f)(1)(B)), this subsection shall be applied under 

24 rules prescribed by the Secretary similar to the rules 
41 

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1 applicable under subparagraphs (A) and (B) of sec2 tion 41(f)(1).’’. 

3 (d) CLERICAL AMENDMENT.—The table of sections 

4 for subpart D of part IV of subchapter A of chapter 1 

5 of the Internal Revenue Code of 1986 is amended by add6 ing at the end the following: 

‘‘Sec. 45J. Wellness program credit.’’. 

7 (e) EFFECTIVE DATE.—The amendments made by 

8 this section shall apply to taxable years beginning after 

9 December 31, 2005. 

10 (f) OUTREACH.— 

11 (1) IN GENERAL.—The Secretary of the Treas12 ury, in conjunction with the Director of the Centers 

13 for Disease Control and members of the business 

14 community, shall institute an outreach program to 

15 inform businesses about the availability of the 

16 wellness program credit under section 45J of the In17 ternal Revenue Code of 1986. 

18 (2) AUTHORIZATION OF APPROPRIATIONS.— 

19 There are authorized to be appropriated such sums 

20 as are necessary to carry out the outreach program 

21 described in paragraph (1). 

22 (g) RESTORATION OF HIGHEST INCOME TAX RATE

23 TO PRE-2001 LEVEL.—Section 1(i)(2) of the Internal 

24 Revenue Code of 1986 (relating to reductions in rates 
42 

•S 1074 IS 

1 after June 30, 2001) is amended by adding at the end 

2 the following new flush sentence: 

3 ‘‘In the case of taxable years beginning after 2005, 

4 the last item in the fourth column in the preceding 

5 table shall be applied by substituting ‘39.6%’ for 

6 ‘35.0%’.’’. 

7 (b) EFFECTIVE DATE.—The amendment made by 

8 this section shall apply to taxable years beginning after 

9 December 31, 2004. 

10 SEC. 203. INCOME EXCLUSION FOR EMPLOYER-PROVIDED 

11 OFF-PREMISES HEALTH CLUB SERVICES. 

12 (a) TREATMENT AS FRINGE BENEFIT.—Subpara13 graph (A) of section 132(j)(4) of the Internal Revenue 

14 Code of 1986 (relating to on-premises gyms and other ath15 letic facilities) is amended to read as follows: 

16 ‘‘(A) IN GENERAL.—Gross income shall 

17 not include— 

18 ‘‘(i) the value of any on-premises ath19 letic facility provided by an employer to its 

20 employees, and 

21 ‘‘(ii) fees or membership expenses 

22 paid by an employer to an athletic or fit23 ness facility described in subparagraph (C) 

24 on behalf of its employees, but only to the 
43 

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1 extent that such fees or expenses do not 

2 exceed $900. 

3 The preceding sentence shall apply with respect 

4 to any highly compensated employee only if ac5 cess to the facility is available on substantially 

6 the same terms to each member of a group of 

7 employees which is defined under a reasonable 

8 classification set up by the employer which does 

9 not discriminate in favor of highly compensated 

10 employees.’’. 

11 (b) ATHLETIC FACILITIES DESCRIBED.—Paragraph 

12 (4) of section 132(j) of such Code is amended by adding 

13 at the end the following new subparagraph: 

14 ‘‘(C) CERTAIN ATHLETIC OR FITNESS FA15 CILITIES DESCRIBED.—For purposes of sub16 paragraph (A)(ii), an athletic or fitness facility 

17 described in this subparagraph is a facility— 

18 ‘‘(i) providing instruction in a pro19 gram of physical exercise or offering facili20 ties for the preservation, maintenance, en21 couragement, or development of physical 

22 fitness, 

23 ‘‘(ii) which is not a private club owned 

24 and operated by its members, 
44 

•S 1074 IS 

1 ‘‘(iii) which does not offer golf, hunt2 ing, sailing, or riding facilities, 

3 ‘‘(iv) whose health or fitness facility is 

4 not incidental to its overall function and 

5 purpose, and 

6 ‘‘(v) which is fully compliant with the 

7 State of jurisdiction and Federal anti-dis8 criminations laws.’’. 

9 (c) EMPLOYER DEDUCTION FOR DUES TO CERTAIN

10 ATHLETIC FACILITIES.— 

11 (1) IN GENERAL.—Paragraph (3) of section 

12 274(a) of such Code (relating to denial of deduction 

13 for club dues) is amended— 

14 (A) by striking ‘‘Notwithstanding’’ and in15 serting the following: 

16 ‘‘(A) IN GENERAL.—Notwithstanding’’, 

17 and 

18 (B) by adding at the end the following new 

19 subparagraph: 

20 ‘‘(B) EXCEPTION FOR ATHLETIC FACILI21 TIES.—This paragraph shall not apply to fees 

22 or dues paid to athletic or fitness facilities 

23 (within the meaning of section 132(j)(4)(C)) to 

24 the extent that such fees or dues do not exceed 

25 $900 for any membership.’’. 
45 

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1 (2) CONFORMING AMENDMENT.—Section 

2 274(e)(4) of such Code is amended by striking ‘‘sub3 section (a)(3)’’ and by inserting ‘‘subsection 

4 (a)(3)(A)’’. 

5 (d) EFFECTIVE DATE.—The amendments made by 

6 this section shall apply to taxable years beginning after 

7 the date of the enactment of this Act. 

8 SEC. 204. CDC AND EMPLOYER-BASED WELLNESS PRO9 GRAMS. 

10 Title III of the Public Health Service Act (42 U.S.C. 

11 241 et seq.) is amended by adding at the end the fol12 lowing: 

13 ‘‘PART R—CDC AND EMPLOYER-BASED 

14 WELLNESS PROGRAMS 

15 ‘‘SEC. 399Z–1. EMPLOYER-BASED WELLNESS BEST PRAC16 TICES. 

17 ‘‘(a) IN GENERAL.—The Director of the Centers for 

18 Disease Control and Prevention shall conduct a study that 

19 analyzes employer-based wellness programs and deter20 mines— 

21 ‘‘(1) best practices of such programs that im22 pact and sustain behavior change in employees; 

23 ‘‘(2) the impact that such programs have on re24 ducing health risk prevalence and improving absen25 teeism of employees; and 
46 

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1 ‘‘(3) the return to employers on the investment 

2 made by such employers in such programs. 

3 ‘‘(b) REPORT.—After completing the study under 

4 subsection (a), the Director of the Centers for Disease 

5 Control and Prevention shall submit to Congress not later 

6 than 1 year after the date of enactment of this part— 

7 ‘‘(1) a report that includes recommendations of 

8 effective employer-based wellness programs; and 

9 ‘‘(2) an Employer Wellness Model that is sup10 ported by the Centers for Disease Control and Pre11 vention. 

12 ‘‘SEC. 399Z–2. WORKPLACE WELLNESS EDUCATION CAM13 PAIGN FOR EMPLOYERS. 

14 ‘‘The Director of the Centers for Disease Control and 

15 Prevention, in coordination with relevant worksite health 

16 promotion organizations, shall conduct an educational 

17 campaign to make employers, employer groups, and other 

18 interested parties aware of the benefits of employer-based 

19 wellness programs. Such campaign shall include informa20 tion about the Employer Wellness Model described in sec21 tion 399Z–1(b)(2) and information on developing, imple22 menting, and maintaining a program based on such model. 
47 

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1 ‘‘SEC. 399Z–3. EVALUATION OF EMPLOYER-BASED 

2 WELLNESS PROGRAMS. 

3 ‘‘The Director of the Centers for Disease Control and 

4 Prevention shall enter into contracts with entities to— 

5 ‘‘(1) provide employers with technical assistance 

6 in evaluating such employers’ employer-based 

7 wellness programs; and 

8 ‘‘(2) train employers on how to evaluate such 

9 employers’ employer-based wellness programs. 

10 ‘‘SEC. 399Z–4. REQUIREMENTS BASED ON APPROPRIATED 

11 FUNDS. 

12 ‘‘The Director of the Centers for Disease Control and 

13 Prevention shall be required to carry out the activities in 

14 sections 399Z–1, 399Z–2, and 399Z–3 only if funds are 

15 appropriated to carry out such sections.’’. 

16 Subtitle B—Healthy Communities 

17 SEC. 211. HEALTHY COMMUNITY GRANTS. 

18 Part P of title III of the Public Health Service Act 

19 (42 U.S.C. 280g et seq.) is amended by adding at the end 

20 the following: 

21 ‘‘SEC. 399P. HEALTHY COMMUNITY GRANTS. 

22 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

23 through the Director of the Centers for Disease Control 

24 and Prevention and in coordination with the Directors of 

25 other appropriate Federal agencies, shall award competi26 tive grants to eligible entities for the purpose of planning 
48 

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1 and implementing programs that seek to promote indi2 vidual and community health and to prevent the incidence 

3 of chronic disease. 

4 ‘‘(b) ELIGIBILITY.— 

5 ‘‘(1) IN GENERAL.—To be eligible to receive a 

6 grant under this section an entity shall— 

7 ‘‘(A) be— 

8 ‘‘(i) a city, county, or Indian tribe; 

9 ‘‘(ii) a local or tribal educational 

10 agency; 

11 ‘‘(iii) an accredited university, college, 

12 or community college; 

13 ‘‘(iv) a federally qualified health cen14 ter; 

15 ‘‘(v) a local health department; 

16 ‘‘(vi) a health care provider; 

17 ‘‘(vii) a community-based organiza18 tion; or 

19 ‘‘(viii) any other entity determined ap20 propriate by the Secretary, including a 

21 consortia or partnership of entities de22 scribed in any of clauses (i) through (vii); 

23 ‘‘(B) prepare and submit an application in 

24 accordance with paragraph (2); and 
49 

•S 1074 IS 

1 ‘‘(C) provide assurances that the entity will 

2 contribute the non-Federal share as required 

3 under paragraph (3) to the cost of the activities 

4 carried out under the grant. 

5 ‘‘(2) APPLICATION.— 

6 ‘‘(A) IN GENERAL.—An entity desiring a 

7 grant under this section shall submit an appli8 cation to the Secretary at such time, in such 

9 manner, and containing such information as the 

10 Secretary may require, including a plan that 

11 meets the requirements of subparagraph (B). 

12 ‘‘(B) PLAN.—A plan meets the require13 ments of this subparagraph if such plan, at a 

14 minimum, includes information regarding— 

15 ‘‘(i)(I) programs or community-based 

16 activities that the applicant proposes to 

17 carry out with funds received under this 

18 section and which seek to prevent and re19 duce the incidence of— 

20 ‘‘(aa) overweight and obesity, or 

21 chronic diseases associated with over22 weight and obesity; 

23 ‘‘(bb) tobacco use; or 

24 ‘‘(cc) mental illness; or 
50 

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1 ‘‘(II) other such activities, as deter2 mined appropriate by the Secretary, that 

3 are consistent with the goals of promoting 

4 individual and community health and pre5 venting chronic disease; and 

6 ‘‘(ii) the manner in which the appli7 cant will evaluate the effectiveness of the 

8 program or activities carried out under this 

9 section. 

10 ‘‘(3) NON-FEDERAL SHARE.—To be eligible to 

11 receive a grant under this section, an entity shall 

12 provide a non-Federal contribution, in cash or in 

13 kind, to the costs of activities under the grant in an 

14 amount that is equal to not less than 25 percent of 

15 the costs of such activities. 

16 ‘‘(c) USE OF FUNDS.—An entity that receives a grant 

17 under this section shall use the amount made available 

18 under the grant to carry out community-based activities, 

19 including— 

20 ‘‘(1) activities that seek to promote individual 

21 health and community wellness and to prevent and 

22 reduce the incidence of health problems and chronic 

23 diseases associated with— 

24 ‘‘(A) being overweight or obese; 

25 ‘‘(B) tobacco use; or 
51 

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1 ‘‘(C) mental illness; or 

2 ‘‘(2) other activities undertaken with the goals 

3 of health promotion and chronic disease prevention, 

4 as determined appropriate by the Secretary. 

5 ‘‘(d) PRIORITY.—In awarding grants under sub6 section (a), the Secretary shall give priority to— 

7 ‘‘(1) entities that demonstrate that they have 

8 previously applied successfully for funds to carry out 

9 activities that seek to promote individual and com10 munity health and to prevent the incidence of chron11 ic disease and that can cite published and peer-re12 viewed research demonstrating that the activities 

13 that the entity proposes to carry out under this sub14 section are effective; 

15 ‘‘(2) entities that will carry out programs or ac16 tivities that seek to accomplish a goal or goals set 

17 by the State in the Healthy People 2010 plan of the 

18 State; 

19 ‘‘(3) entities that provide non-Federal contribu20 tions, either in cash or in kind, to the costs of fund21 ing activities under the grant; 

22 ‘‘(4) entities that develop comprehensive plans 

23 that include a strategy for extending program activi24 ties developed under this section in the years fol-
52 

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1 lowing the fiscal years for which they receive grants 

2 under this section; 

3 ‘‘(5) entities located in communities that are 

4 medically underserved, as determined by the Sec5 retary; 

6 ‘‘(6) entities located in areas where the average 

7 poverty rate is 150 or higher than the average pov8 erty rate in the State involved, as determined by the 

9 Secretary; and 

10 ‘‘(7) entities that submit plans that exhibit 

11 multisectoral, cooperative conduct that includes the 

12 involvement of a broad range of stakeholders, includ13 ing— 

14 ‘‘(A) community-based organizations; 

15 ‘‘(B) local governments; 

16 ‘‘(C) local educational agencies; 

17 ‘‘(D) the private sector; 

18 ‘‘(E) State or local departments of health; 

19 ‘‘(F) accredited colleges, universities, and 

20 community colleges; 

21 ‘‘(G) health care providers; 

22 ‘‘(H) State and local departments of trans23 portation and city planning; and 

24 ‘‘(I) other entities determined appropriate 

25 by the Secretary. 
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1 ‘‘(e) TECHNICAL ASSISTANCE.—From amounts ap2 propriated to carry out this section, the Secretary may re3 serve not more than 10 percent for each fiscal year to pro4 vide entities receiving grants under this section with tech5 nical assistance in the implementation of the plans re6 quired under subsection (b)(2)(B). 

7 ‘‘(f) EVALUATION.—From amounts appropriated to 

8 carry out this section, the Secretary may reserve not to 

9 exceed 5 percent for each fiscal year for the purpose of 

10 carrying out evaluations of the activities carried out under 

11 this section. Not later than 90 days after the completion 

12 of any such evaluation, the results of such evaluation shall 

13 be submitted to the relevant authorizing committees of 

14 Congress and to the Committee on Appropriations of the 

15 Senate and the Committee on Appropriations of the House 

16 of Representatives. 

17 ‘‘(g) LIMITATION ON ADMINISTRATIVE COSTS.—An 

18 entity may not use more than 10 percent of amounts re19 ceived under a grant under this section for administrative 

20 expenses. 

21 ‘‘(h) SUPPLEMENT NOT SUPPLANT.—Amounts pro22 vided under a grant under this section shall be used to 

23 supplement, and not supplant, other amounts provided for 

24 activities of the type to be carried out under this section. 
54 

•S 1074 IS 

1 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There is 

2 authorized to be appropriated such sums as may be nec3 essary to carry out this section.’’. 

4 SEC. 212. LIVING WELL WITH A DISABILITY AND WORKING 

5 WELL WITH A DISABILITY PROGRAMS. 

6 Part P of title III of the Public Health Service Act 

7 (42 U.S.C. 280g et seq.), as amended by section 211, is 

8 further amended by adding at the end the following: 

9 ‘‘SEC. 399Q. LIVING WELL WITH A DISABILITY PROGRAMS. 

10 ‘‘(a) DEFINITIONS.—In this section: 

11 ‘‘(1) CENTER FOR INDEPENDENT LIVING.—The 

12 term ‘center for independent living’ means a center 

13 described in part C of title VII of the Rehabilitation 

14 Act of 1973 (29 U.S.C. 796f et seq.). 

15 ‘‘(2) DISABILITY.—The term ‘disability’ has the 

16 meaning given the term in section 3 of the Ameri17 cans with Disabilities Act of 1990 (42 U.S.C. 

18 12102). 

19 ‘‘(3) INDEPENDENT LIVING SERVICES.—The 

20 term ‘independent living services’ has the meaning 

21 given the term in section 7 of the Rehabilitation Act 

22 of 1973 (29 U.S.C. 705). 

23 ‘‘(b) GRANTS.—The Secretary, acting through the 

24 Director of the Centers for Disease Control and Preven25 tion, may make grants to eligible entities on a competitive 
55 

•S 1074 IS 

1 basis, to assist the entities in implementing Living Well 

2 With a Disability Programs, designed— 

3 ‘‘(1) to increase health-promoting behavior, 

4 such as engaging in exercise, eating nutritious food, 

5 and using stress management techniques, among in6 dividuals with disabilities; and 

7 ‘‘(2) to reduce the limitations of secondary con8 ditions for such individuals. 

9 ‘‘(c) ELIGIBILITY.—To be eligible to receive a grant 

10 under this section, an entity— 

11 ‘‘(1) shall be a nonprofit organization that 

12 serves individuals with disabilities; 

13 ‘‘(2) shall be a community-based organization 

14 that has experience in providing consumer-directed 

15 independent living services; and 

16 ‘‘(3) may be a center for independent living. 

17 ‘‘(d) APPLICATION.—To be eligible to receive a grant 

18 under this section for a program, an entity shall submit 

19 an application to the Secretary at such time, in such man20 ner, and containing such information as the Secretary may 

21 require, including information on— 

22 ‘‘(1) the number of individuals with disabilities 

23 who will be trained in the program; 

24 ‘‘(2) the entity’s capacity to collect data and in25 formation on outcomes of the program; and 
56 

•S 1074 IS 

1 ‘‘(3) the entity’s experience implementing simi2 lar training programs. 

3 ‘‘(e) PREFERENCE AND DISTRIBUTION.— 

4 ‘‘(1) PREFERENCE.—In making grants under 

5 this section, the Secretary shall give preference to el6 igible entities who— 

7 ‘‘(A) are currently (as of the date of sub8 mission of the application) serving individuals 

9 with disabilities and implementing training and 

10 peer support programs; 

11 ‘‘(B) indicate a commitment and ability to 

12 continue to train participants over several 

13 years; and 

14 ‘‘(C) have not previously provided training 

15 through a Living Well With a Disability Pro16 gram. 

17 ‘‘(2) DISTRIBUTION.—In making grants under 

18 this section, the Secretary shall, to the extent prac19 ticable, ensure an equitable geographic distribution 

20 of the grants. 

21 ‘‘(f) CURRICULUM, TRAINING, AND TECHNICAL AS22 SISTANCE.—An entity that receives a grant under this sec23 tion may use funds made available through the grant to 

24 acquire a curriculum, training, or technical assistance for 

25 the program carried out through the grant from an entity 
57 

•S 1074 IS 

1 qualified to implement, and train participants in, a Living 

2 Well With a Disability program. 

3 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section 

5 $2,000,000 for each of fiscal years 2005 through 2009. 

6 ‘‘SEC. 399R. WORKING WELL WITH A DISABILITY PRO7 GRAMS. 

8 ‘‘(a) DEFINITIONS.—In this section, the terms ‘cen9 ter for independent living’, ‘disability’, and ‘independent 

10 living services’ have the meanings given the terms in sec11 tion 399Q. 

12 ‘‘(b) AUTHORIZATION.—The Secretary, acting 

13 through the Director of the Centers for Disease Control 

14 and Prevention, may establish a demonstration program 

15 promoting the health and wellness of individuals with dis16 abilities in the workplace. 

17 ‘‘(c) GRANTS.—In carrying out the program, the Sec18 retary shall make grants to an eligible entity, to assist the 

19 entity in preparing for the implementation of, or imple20 menting, Working Well With a Disability Programs, which 

21 may include— 

22 ‘‘(1) gathering data on the positive effects of 

23 healthy behaviors on retention and productivity of 

24 individuals with disabilities who are employees or po25 tential employees; 
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•S 1074 IS 

1 ‘‘(2) building relationships between vocational 

2 rehabilitation programs and health promotion pro3 grams; 

4 ‘‘(3) adapting a Living Well With a Disability 

5 program to meet the needs of individuals seeking or 

6 entering employment; 

7 ‘‘(4) training individuals in methods of imple8 menting the program; 

9 ‘‘(5) implementing the program; and 

10 ‘‘(6) measuring the impact of the program on 

11 health and employment outcomes. 

12 ‘‘(d) ELIGIBILITY.—To be eligible to receive a grant 

13 under this section, an entity shall— 

14 ‘‘(1) have experience in implementing a Living 

15 Well With a Disability Program; and 

16 ‘‘(2) demonstrate that the entity is qualified 

17 and able to adapt the program to establish a Work18 ing Well With a Disability Program, and implement 

19 the program. 

20 ‘‘(e) PARTNERSHIP.—An entity that receives a grant 

21 under this section shall carry out the activities funded 

22 through the grant through a partnership with 1 or more 

23 entities that— 

24 ‘‘(1) shall be nonprofit organizations that serve 

25 individuals with disabilities; 
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•S 1074 IS 

1 ‘‘(2) shall be community-based organizations 

2 that have experience in providing consumer-directed 

3 independent living services; and 

4 ‘‘(3) may be centers for independent living. 

5 ‘‘(f) APPLICATION.—To be eligible to receive a grant 

6 under this section for a program, an entity shall submit 

7 an application to the Secretary at such time, in such man8 ner, and containing such information as the Secretary may 

9 require. 

10 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 

11 are authorized to be appropriated to carry out this section 

12 $1,000,000 for the period of fiscal years 2005 through 

13 2007.’’. 

14 SEC. 213. ENHANCED STANDARDS FOR ROADS AND INTER15 SECTION CONTROLS. 

16 (a) ENHANCED STANDARDS FOR ROADS AND INTER17 SECTION CONTROLS.—Section 133 of title 23, United 

18 States Code, is amended by adding at the end the fol19 lowing: 

20 ‘‘(g) ENHANCED STANDARDS FOR ROADS AND

21 INTERSECTION CONTROLS.— 

22 ‘‘(1) IN GENERAL.—Not later than 18 months 

23 after the date of enactment of this subsection, the 

24 Secretary, in coordination with the American Asso25 ciation of State Highway and Transportation Offi-
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1 cials and the Institute of Transportation Engineers, 

2 shall develop recommended enhanced standards for 

3 the design of roads and intersection controls (includ4 ing associated bicycle paths, bicycle lanes, and walk5 ways) to improve pedestrian and bicycle safety. 

6 ‘‘(2) ACCOMMODATION OF BICYCLES AND PE7 DESTRIANS.—The standards under paragraph (1) 

8 shall— 

9 ‘‘(A) cover all common types of facilities 

10 where pedestrians or bicycles are allowed on a 

11 road or on associated walkways and bicycle 

12 paths or lanes; and 

13 ‘‘(B) specify that generally, when the in14 creased cost is not excessive, as an element of 

15 good highway design for new construction or re16 construction facilities on which bicycles or pe17 destrians are permitted, the design shall include 

18 appropriate provisions to accommodate bicycles 

19 or pedestrians. 

20 ‘‘(3) INCREASED APPORTIONMENT.— 

21 ‘‘(A) IN GENERAL.—Beginning with the 

22 first fiscal year that begins after the date that 

23 is 2 years after the date of enactment of this 

24 subsection, if a State accepts the recommended 

25 enhanced standards for the State and local 
61 

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1 units of government to meet, the State shall re2 ceive a 4 percent increase in the amount of 

3 funds made available to the State under this 

4 section for each fiscal year, if, at least 10 days 

5 before the beginning of the fiscal year, the 

6 State— 

7 ‘‘(i) agrees to follow the enhanced 

8 standards; or 

9 ‘‘(ii) establishes an alternative en10 hanced standard that the Secretary ap11 proves. 

12 ‘‘(B) SIGNIFICANT COMMITMENT.—In de13 termining the significance of the required com14 mitment of funds under subparagraph (A), the 

15 Secretary shall take into consideration the ef16 fectiveness of the criteria required and an esti17 mation of increased costs. 

18 ‘‘(4) CONSTRUCTION REQUIREMENTS.—The 

19 Secretary and a State may establish differing re20 quirements for the construction of new facilities, for 

21 the rehabilitation of facilities, and for modifications 

22 specifically to improve safety and for facilities based 

23 on the level of expected pedestrian and bicycle traf24 fic.’’. 
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1 (b) NONMOTORIZED TRANSPORTATION SAFETY.— 

2 Section 120(c) of title 23, United States Code, is amend3 ed— 

4 (1) in the first sentence, by striking ‘‘The Fed5 eral’’ and inserting the following: 

6 ‘‘(2) FEDERAL SHARE.—The Federal’’; 

7 (2) in the second sentence, by striking ‘‘In this 

8 subsection, the term’’ and inserting the following: 

9 ‘‘(1) DEFINITIONS.—In this subsection: 

10 ‘‘(A) BICYCLE AND PEDESTRIAN SAFE11 TY.—The term ‘bicycle and pedestrian safety’ 

12 means any improvement that— 

13 ‘‘(i) promotes the safety of bicyclists 

14 and pedestrians (including people with dis15 abilities); and 

16 ‘‘(ii) is consistent with sections 134 

17 and 135. 

18 ‘‘(B) SAFETY REST AREA.—The term’’; 

19 (3) by moving paragraph (1) (as added by para20 graph (2)) so as to appear before paragraph (2) (as 

21 added by paragraph (1)); and 

22 (4) by adding at the end the following: 

23 ‘‘(3) STATEMENT OF POLICY BY STATE TRANS24 PORTATION DEPARTMENTS.— 
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1 ‘‘(A) IN GENERAL.—Each State transpor2 tation department shall adopt a statement of 

3 policy ensuring that the needs and safety of all 

4 road users (including the need for pedestrian 

5 and bicycle safety) are fully integrated into the 

6 planning, design, operation and maintenance of 

7 the transportation system of the State transpor8 tation department. 

9 ‘‘(B) BASIS.—In the case of bicycle and 

10 pedestrian safety, the statement of policy shall 

11 be based on the design guidance on accommo12 dating bicyclists and pedestrians of the Federal 

13 Highway Administration adopted in February 

14 2000. 

15 ‘‘(C) REPORTS.—Not later 1 year after the 

16 date of enactment of this paragraph, and each 

17 year thereafter, the Secretary shall submit to 

18 Congress a report on the statements of policy 

19 adopted under this paragraph. 

20 ‘‘(4) NONMOTORIZED TRANSPORTATION

21 GOAL.— 

22 ‘‘(A) IN GENERAL.—The Secretary shall 

23 take such actions as are necessary to, to the 

24 maximum extent practicable, double the per25 centage of trips made by foot or bicycle while 
64 

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1 simultaneously reducing crashes involving 

2 bicyclists and pedestrians by 10 percent, in a 

3 manner consistent with the goals of the na4 tional bicycling and walking study conducted 

5 during 1994. 

6 ‘‘(B) ADMINISTRATION.—Not later than 1 

7 year after the date of enactment of this para8 graph, the Secretary shall establish such base9 line and completion dates as are necessary to 

10 carry out subparagraph (A). 

11 ‘‘(5) RESEARCH FOR NONMOTORIZED USERS.— 

12 ‘‘(A) FINDINGS.—Congress finds that— 

13 ‘‘(i) it is in the national interest to 

14 meet the goals of the national bicycling 

15 and walking study by the completion date 

16 established under paragraph (4)(B); 

17 ‘‘(ii) research into the safety and op18 eration of the transportation system for 

19 nonmotorized users is inadequate, given 

20 that almost 1 in 10 trips are made by foot 

21 or bicycle and 1 in 8 traffic fatalities in22 volves a bicyclist or pedestrian; and 

23 ‘‘(iii) inadequate data collection, espe24 cially on exposure rates and infrastructure 

25 needs, are hampering efforts to improve bi-
65 

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1 cycle and pedestrian safety and use to 

2 meet local transportation needs. 

3 ‘‘(B) ALLOCATION OF RESEARCH FUNDS

4 FOR NONMOTORIZED USERS.— 

5 ‘‘(i) IN GENERAL.—The Secretary 

6 shall submit to Congress an annual report 

7 on the percentage of research funds that 

8 are allocated (for the most recent fiscal 

9 year for which data are available) to re10 search that directly benefits the planning, 

11 design, operation, and maintenance of the 

12 transportation system for nonmotorized 

13 users— 

14 ‘‘(I) by the Department of Trans15 portation; and 

16 ‘‘(II) by State transportation de17 partments. 

18 ‘‘(ii) NATIONAL COOPERATIVE HIGH19 WAY RESEARCH PROGRAM.—The Transpor20 tation Research Board of the National 

21 Academy of Sciences shall submit to Con22 gress an annual report on the percentage 

23 of research funds under the National Co24 operative Highway Research Program that 

25 are allocated (for the most recent fiscal 
66 

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1 year for which data are available) to re2 search that directly benefits the planning, 

3 design, operation, and maintenance of the 

4 transportation system for nonmotorized 

5 users. 

6 ‘‘(iii) DEPARTMENT OF TRANSPOR7 TATION ALLOCATION.—Effective beginning 

8 with the third full fiscal year that begins 

9 after the date of enactment of this para10 graph, the Secretary shall allocate at least 

11 10 percent of the research funds that are 

12 allocated by the Department of Transpor13 tation for each fiscal year to research that 

14 directly benefits the planning, design, oper15 ation, and maintenance of the transpor16 tation system for nonmotorized users. 

17 ‘‘(6) METROPOLITAN PLANNING ORGANIZA18 TIONS.— 

19 ‘‘(A) BICYCLE/PEDESTRIAN COORDINA20 TORS.—A metropolitan planning organization 

21 shall a designate a bicycle/pedestrian coordi22 nator to coordinate bicycle and pedestrian pro23 grams and activities carried out in the area 

24 served by the organization. 
67 

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1 ‘‘(B) CERTIFICATION.—A metropolitan 

2 planning organization shall certify to the Sec3 retary, as part of the certification review, 

4 that— 

5 ‘‘(i) the needs of bicyclists and pedes6 trians (including people who use wheel7 chairs and people with vision impairment) 

8 have been adequately addressed by the 

9 long-range transportation plan of the orga10 nization; and 

11 ‘‘(ii) the bicycle and pedestrian 

12 projects to implement the plan in a timely 

13 manner are included in the transportation 

14 improvement program of the organization. 

15 ‘‘(C) LONG-RANGE TRANSPORTATION

16 PLANS.— 

17 ‘‘(i) IN GENERAL.—Except as pro18 vided in clause (ii), a metropolitan plan19 ning organization shall develop and adopt 

20 a long-range transportation plan that— 

21 ‘‘(I) includes the most recent 

22 data available on the percentage of 

23 trips made by foot and by bicycle in 

24 each jurisdiction; 
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•S 1074 IS 

1 ‘‘(II) includes a target level for 

2 bicycle and pedestrian trips that is 

3 commensurate with the national goal 

4 of doubling the percentage of trips 

5 made by foot and bicycle established 

6 under paragraph (4); and 

7 ‘‘(III) identify the contribution 

8 made by each project under the trans9 portation improvement program of the 

10 organization toward meeting the goal 

11 of doubling the percentage of trips 

12 made by foot and bicycle. 

13 ‘‘(ii) APPLICATION.—Clause (i) does 

14 not apply to a metropolitan planning orga15 nization that adopts the design guidance 

16 described in paragraph (3)(B) for all 

17 transportation projects carried out by the 

18 organization. 

19 ‘‘(D) LOCAL JURISDICTIONS.—A metro20 politan planning organization shall strongly en21 courage local jurisdictions that are served by 

22 the organization to maximize the efforts of the 

23 local jurisdictions to include sidewalks, 

24 bikepaths, and road intersections that maximize 
69 

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1 bicycle and pedestrian safety in the local trans2 portation systems of the local jurisdictions.’’. 

3 (c) SAFE ROUTES TO SCHOOLS PROGRAM.— 

4 (1) IN GENERAL.—Subchapter I of chapter I of 

5 title 23, United States Code, is amended by insert6 ing after section 149 the following: 

7 ‘‘§ 150. Safe routes to schools program 

8 ‘‘(a) DEFINITIONS.—In this section: 

9 ‘‘(1) IN THE VICINITY OF SCHOOLS.—The term 

10 ‘in the vicinity of schools’ means, with respect to pri11 mary and middle schools, the area within bicycling 

12 and walking distance of the primary and middle 

13 schools (approximately 2 miles). 

14 ‘‘(2) PRIMARY AND MIDDLE SCHOOLS.—The 

15 term ‘primary and middle schools’ means schools 

16 providing education from kindergarten through 

17 eighth grade. 

18 ‘‘(b) ESTABLISHMENT.—The Secretary shall estab19 lish and carry out a safe routes to schools program for 

20 the benefit of children in primary and middle schools. 

21 ‘‘(c) PURPOSES.—The purposes of the program are— 

22 ‘‘(1) to enable and encourage children, includ23 ing children with disabilities, to walk and bicycle to 

24 primary and middle schools; 
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•S 1074 IS 

1 ‘‘(2) to make bicycling and walking to primary 

2 and middle schools a safer and more appealing 

3 transportation alternative, thereby encouraging a 

4 healthy and active lifestyle from an early age; and 

5 ‘‘(3) to facilitate the planning, development, 

6 and implementation of projects and activities that 

7 will improve safety and reduce traffic, fuel consump8 tion, and air pollution in the vicinity of primary and 

9 middle schools. 

10 ‘‘(d) APPORTIONMENT OF FUNDS.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraphs (2) 

12 and (3), amounts made available to carry out this 

13 subsection for a fiscal year shall be apportioned 

14 among the States in the ratio that— 

15 ‘‘(A) the total student enrollment in pri16 mary and middle schools in each State; bears to 

17 ‘‘(B) the total student enrollment in pri18 mary and middle schools in all the States. 

19 ‘‘(2) MINIMUM APPORTIONMENT.—No State 

20 shall receive an apportionment under this section for 

21 a fiscal year of less than $2,000,000. 

22 ‘‘(3) SET-ASIDE.—Before apportioning amounts 

23 made available to carry out this section under this 

24 subsection for a fiscal year, the Secretary shall set 

25 aside not more than 2 percent of those amounts to 
71 

•S 1074 IS 

1 pay the administrative expenses incurred by the Sec2 retary in carrying out this section. 

3 ‘‘(4) DETERMINATION OF STUDENT ENROLL4 MENTS.—Determinations under this subsection con5 cerning student enrollments shall be made by the 

6 Secretary. 

7 ‘‘(e) ADMINISTRATION OF AMOUNTS.—Amounts ap8 portioned to a State under this section shall be adminis9 tered by the applicable State transportation department. 

10 ‘‘(f) ELIGIBLE RECIPIENTS.—Amounts apportioned 

11 to a State under this section shall be used by the State 

12 to provide financial assistance to State, local, and regional 

13 agencies, including nonprofit organizations, that dem14 onstrate an ability to meet the requirements of this sec15 tion. 

16 ‘‘(g) ELIGIBLE PROJECTS AND ACTIVITIES.— 

17 ‘‘(1) INFRASTRUCTURE-RELATED PROJECTS.— 

18 ‘‘(A) IN GENERAL.—Amounts apportioned 

19 to a State under this section may be used for 

20 the planning, design, and construction of infra21 structure-related projects that will substantially 

22 improve the ability of students to walk and bi23 cycle to primary and middle schools in the vi24 cinity of primary and middle schools, includ25 ing— 
72 

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1 ‘‘(i) sidewalk improvements; 

2 ‘‘(ii) traffic calming and speed reduc3 tion improvements; 

4 ‘‘(iii) pedestrian and bicycle crossing 

5 improvements; 

6 ‘‘(iv) on-street bicycle facilities; 

7 ‘‘(v) off-street bicycle and pedestrian 

8 facilities; 

9 ‘‘(vi) secure bicycle parking facilities; 

10 and 

11 ‘‘(vii) traffic diversion improvements. 

12 ‘‘(B) LOCATION OF PROJECTS.—An infra13 structure-related project under subparagraph 

14 (A) may be carried out on any public road or 

15 any bicycle or pedestrian pathway or trail in the 

16 vicinity of a primary or middle school. 

17 ‘‘(2) NONINFRASTRUCTURE-RELATED ACTIVI18 TIES.— 

19 ‘‘(A) IN GENERAL.—In addition to projects 

20 described in paragraph (1), amounts appor21 tioned to a State under this section may be 

22 used for noninfrastructure-related activities to 

23 encourage walking and bicycling to primary and 

24 middle schools, including— 
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•S 1074 IS 

1 ‘‘(i) public awareness campaigns and 

2 outreach to press and community leaders; 

3 ‘‘(ii) traffic education and enforce4 ment in the vicinity of primary and middle 

5 schools; 

6 ‘‘(iii) student sessions on bicycle and 

7 pedestrian safety, health, and environment; 

8 and 

9 ‘‘(iv) funding for training, volunteers, 

10 and managers of safe routes to schools 

11 programs. 

12 ‘‘(B) ALLOCATION.—Not less than 10 per13 cent and not more than 30 percent of the 

14 amount apportioned to a State under this sub15 section for a fiscal year shall be used for non16 infrastructure-related activities under this para17 graph. 

18 ‘‘(3) SAFE ROUTES TO SCHOOL COORDI19 NATOR.—Each State receiving an apportionment 

20 under this section for a fiscal year shall use a suffi21 cient amount of the apportionment to fund a full22 time position of coordinator of the safe routes to 

23 schools program of the State. 

24 ‘‘(h) CLEARINGHOUSE.— 
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•S 1074 IS 

1 ‘‘(1) IN GENERAL.—The Secretary shall make 

2 grants to a national nonprofit organization engaged 

3 in promoting safe routes to schools to— 

4 ‘‘(A) operate a national safe routes to 

5 school clearinghouse; 

6 ‘‘(B) develop information and educational 

7 programs on safe routes to schools; and 

8 ‘‘(C) provide technical assistance and dis9 seminate techniques and strategies used for 

10 successful safe routes to schools programs. 

11 ‘‘(2) FUNDING.—The Secretary shall carry out 

12 this subsection using amounts set aside for adminis13 trative expenses under subsection (d)(3). 

14 ‘‘(i) TASK FORCE.— 

15 ‘‘(1) IN GENERAL.—The Secretary shall estab16 lish a national safe routes to schools task force com17 posed of leaders in health, transportation, and edu18 cation, including representatives of appropriate Fed19 eral agencies, to study and develop a strategy for ad20 vancing safe routes to schools programs nationwide. 

21 ‘‘(2) REPORT.—Not later than March 31, 2006, 

22 the Secretary shall submit to Congress a report con23 taining— 
75 

•S 1074 IS 

1 ‘‘(A) the results of the study conducted, 

2 and a description of the strategy developed, 

3 under paragraph (1); and 

4 ‘‘(B) information regarding the use of 

5 funds for infrastructure-related and noninfra6 structure-related activities under paragraphs 

7 (1) and (2) of subsection (g). 

8 ‘‘(3) FUNDING.—The Secretary shall carry out 

9 this subsection using amounts set aside for adminis10 trative expenses under subsection (d)(3). 

11 ‘‘(j) APPLICABILITY.— 

12 ‘‘(1) IN GENERAL.—Except as otherwise pro13 vided in this subsection, funds made available to 

14 carry out this section shall be available for obligation 

15 in the same manner as funds apportioned under this 

16 chapter. 

17 ‘‘(2) AVAILABILITY.—Funds made available to 

18 carry out this section shall not be transferable and 

19 shall remain available until expended. 

20 ‘‘(3) FEDERAL SHARE.—The Federal share of 

21 the cost of a project or activity under this section 

22 shall be 100 percent. 

23 ‘‘(4) FEDERAL-AID SYSTEM.—Notwithstanding 

24 any other provision of law, a project assisted under 
76 

•S 1074 IS 

1 this section shall be treated as a project on a Fed2 eral-aid system under this chapter.’’. 

3 (2) AUTHORIZATIONS OF APPROPRIATIONS.— 

4 There are authorized to be appropriated from the 

5 Highway Trust Fund (other than the Mass Transit 

6 Account) for the safe routes to schools programs 

7 under section 150 of title 23, United States Code 

8 (as added by paragraph (1))— 

9 (A) $175,000,000 for fiscal year 2006; 

10 (B) $200,000,000 for fiscal year 2007; 

11 (C) $200,000,000 for fiscal year 2008; 

12 (D) $200,000,000 for fiscal year 2009; 

13 and 

14 (E) $225,000,000 for fiscal year 2010. 

15 (3) CONFORMING AMENDMENTS.—The analysis 

16 for subchapter I of chapter 1 of title 23, United 

17 States Code is amended by inserting after the item 

18 relating to section 149 the following: 

‘‘150. Safe routes to schools program.’’. 

19 (d) NONMOTORIZED TRANSPORTATION PILOT PRO20 GRAM.— 

21 (1) ESTABLISHMENT.—The Secretary of Trans22 portation shall establish and carry out a non23 motorized transportation pilot program to construct, 

24 in 4 communities selected by the Secretary, a net25 work of nonmotorized transportation infrastructure 
77 

•S 1074 IS 

1 facilities (including sidewalks, bicycle lanes, and pe2 destrian and bicycle trails) that connect directly with 

3 transit stations, schools, residences, businesses, 

4 recreation areas, and other community activity cen5 ters. 

6 (2) PURPOSE.—The purpose of the program 

7 shall be to demonstrate the extent to which bicycling 

8 and walking can ease the burden on transportation 

9 systems, and represent a major portion of the trans10 portation needs that are met, within selected com11 munities. 

12 (3) GRANTS.— 

13 (A) IN GENERAL.—In carrying out the 

14 program, the Secretary may make grants to 

15 State, local, and regional agencies that the Sec16 retary determines are suitably equipped and or17 ganized to carry out the objectives and require18 ments of this subsection. 

19 (B) SUBALLOCATION.—An agency that re20 ceives a grant under this section may suballo21 cate grant funds to a nonprofit organization to 

22 carry out the program under this subsection. 

23 (4) APPLICABILITY OF TITLE 23.— 

24 (A) IN GENERAL.—Except as otherwise 

25 provided in this paragraph, funds made avail-
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1 able to carry out this subsection shall be avail2 able for obligation in the same manner as if the 

3 funds were apportioned under chapter 1 of title 

4 23, United States Code. 

5 (B) AVAILABILITY.—Funds made available 

6 to carry out this subsection shall not be trans7 ferable and shall remain available until ex8 pended. 

9 (C) FEDERAL SHARE.—The Federal share 

10 of the cost of a project carried out under this 

11 subsection shall be 80 percent. 

12 (5) STATISTICAL INFORMATION.—In carrying 

13 out the program, the Secretary shall— 

14 (A) develop statistical information on 

15 changes in motor vehicle, nonmotorized trans16 portation, and public transportation usage in 

17 communities participating in the program; and 

18 (B) assess how the changes— 

19 (i) decrease congestion and energy 

20 usage; 

21 (ii) increase the frequency of biking 

22 and walking; and 

23 (iii) promote better health and a 

24 cleaner environment. 
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•S 1074 IS 

1 (6) REPORTS.—The Secretary shall submit to 

2 Congress an interim report not later than September 

3 30, 2007, and a final report not later than Sep4 tember 30, 2010, on the results of the program. 

5 (7) AUTHORIZATIONS OF APPROPRIATIONS.— 

6 There is authorized to be appropriated from the 

7 Highway Trust Fund (other than the Mass Transit 

8 Account) to carry out the nonmotorized pilot pro9 gram under this subsection $25,000,000 for each of 

10 fiscal years 2006 through 2010. 

11 SEC. 214. NATIONAL ASSESSMENT OF MENTAL HEALTH 

12 NEEDS. 

13 Title V of the Public Health Service Act (42 U.S.C. 

14 290aa et seq.) is amended by inserting after section 506B 

15 (42 U.S.C. 290aa–5b) the following: 

16 ‘‘SEC. 506C. NATIONAL ASSESSMENT OF MENTAL HEALTH 

17 NEEDS. 

18 ‘‘(a) IN GENERAL.—The Secretary, acting through 

19 the Administrator, and in consultation with the Centers 

20 for Disease Control and Prevention and the Director of 

21 the National Institutes of Health, shall establish and im22 plement public health monitoring measures to address the 

23 mental and behavioral health needs of the population of 

24 the United States and other populations served by the Ad25 ministration, that include— 
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1 ‘‘(1) monitoring the mental health status of the 

2 population, including incidence and prevalence rates 

3 of mental and behavioral health problems through4 out the lifespan; 

5 ‘‘(2) monitoring mental and behavioral health 

6 risks; 

7 ‘‘(3) enhancing existing public health moni8 toring systems to include data on mental and behav9 ioral health status and risks; and 

10 ‘‘(4) monitoring the immediate and long-term 

11 impact of environmental factors to collect data on 

12 the prevalence of mental and behavioral health prob13 lems throughout the lifespan with the aim of encour14 aging early intervention and treatment. 

15 ‘‘(b) DISTINGUISHING AMONG AGE GROUPS.—In de16 signing and implementing the measures described in sub17 section (a) the Secretary shall ensure that methods of 

18 monitoring and reporting data distinguish among different 

19 age groups, including when identifying groups of children, 

20 and very young children under age 3, together with their 

21 parents. 

22 ‘‘(c) REPORT.—Not later than 1 year after the date 

23 of enactment of this section, the Secretary shall submit 

24 a report to Congress that describes the progress on the 
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1 implementation of the monitoring measures described in 

2 subsection (a). 

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

4 is authorized to be appropriated to carry out this section 

5 $5,000,000 for fiscal year 2006 and such sums as may 

6 be necessary for each of the following fiscal years.’’. 

7 SEC. 215. PREVENTIVE MEDICINE AND PUBLIC HEALTH 

8 TRAINING GRANT PROGRAM. 

9 Part C of title VII of the Public Health Service Act 

10 is amended by inserting after section 747 (42 U.S.C. 

11 293k) the following: 

12 ‘‘SEC. 747A. PREVENTIVE MEDICINE AND PUBLIC HEALTH 

13 TRAINING GRANT PROGRAM. 

14 ‘‘(a) GRANTS.—The Secretary may award grants to, 

15 or enter into contracts with, eligible entities to provide 

16 training to graduate medical residents in preventive medi17 cine and public health. 

18 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

19 or contract under subsection (a), an entity shall— 

20 ‘‘(1) be a school of public health, public health 

21 department, school of medicine or osteopathic medi22 cine, public or private hospital, or public or private 

23 non-profit entity; and 
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1 ‘‘(2) submit to the Secretary an application at 

2 such time, in such manner, and containing such in3 formation as the Secretary may require. 

4 ‘‘(c) PREFERENCE AND SPECIAL CONSIDERATION.— 

5 ‘‘(1) PREFERENCE.—In awarding grants or 

6 contracts under this section, the Secretary shall give 

7 preference to one or more eligible entities that have 

8 a record of training providers who practice preven9 tive medicine or public health as compared to other 

10 eligible entities. 

11 ‘‘(2) SPECIAL CONSIDERATION.—In awarding 

12 grants or contracts under this section, the Secretary 

13 shall give special consideration to eligible entities 

14 that will carry out projects under the grant or con15 tract that train physicians in community-based ap16 proaches to combating the incidence rates of obesity, 

17 diabetes, heart disease, cancer, and other chronic 

18 diseases, and institutions that have a record of 

19 training qualified individuals from disadvantaged 

20 backgrounds. 

21 ‘‘(d) USE OF FUNDS.—Amounts received under a 

22 grant or contract under this section shall be used to— 

23 ‘‘(1) to plan, develop, and operate residency 

24 programs for preventive medicine or public health; 
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1 ‘‘(2) provide financial assistance, including tui2 tion and stipends, to resident physicians (MD or 

3 DO) who plan to specialize in preventive medicine or 

4 public health; 

5 ‘‘(3) defray the costs associated with the plan6 ning, development, and operation of preventive medi7 cine or public health programs, including the devel8 opment of curriculum to be used in such program; 

9 and 

10 ‘‘(4) provide for the improvement of academic 

11 administrative units. 

12 ‘‘(e) DURATION OF AWARD.—A grant or contract 

13 under this section shall be for a term not to exceed 5 

14 years. 

15 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

16 is authorized to be appropriated to carry out this section, 

17 $43,000,000 for fiscal year 2006, and such sums as may 

18 be necessary for each succeeding fiscal year.’’. 

19 SEC. 216. TASK FORCE FOR THE PROMOTION OF 

20 BREASTFEEDING IN THE WORKPLACE. 

21 (a) ESTABLISHMENT.—The Secretary of Health and 

22 Human Services and the Secretary of Labor, or their des23 ignees, shall convene a task force for the purpose of pro24 moting breastfeeding among working mothers (referred to 

25 in this section as the ‘‘Task Force’’). 
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1 (b) MEMBERSHIP.—The Task Force shall be com2 posed of members who are— 

3 (1) expert staff from the Department of Labor 

4 with expertise in workforce issues; 

5 (2) expert staff from the Department of Health 

6 and Human Services with expertise in the areas of 

7 breastfeeding and breastfeeding promotion; 

8 (3) members of the United States Breastfeeding 

9 Committee; 

10 (4) expert staff from the Department of Agri11 culture; and 

12 (5) appointed by the Secretary of Health and 

13 Human Services and the Secretary of Labor, includ14 ing— 

15 (A) working mothers who have experience 

16 in working and breastfeeding; and 

17 (B) representatives of the human resource 

18 departments of both large and small employers 

19 that have successfully promoted breastfeeding 

20 and breastmilk pumping support at work. 

21 (c) PERIOD OF APPOINTMENT; VACANCIES.—Mem22 bers shall be appointed for the life of the Task Force. Any 

23 vacancy in the Task Force shall not affects its powers, 

24 but shall be filled in the same manner as the original ap25 pointment. 
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1 (d) CHAIR.—The Task Force shall be chaired jointly 

2 by the Secretary of Health and Human Services and the 

3 Secretary of Labor, or their designees. 

4 (e) DUTIES OF THE TASK FORCE.— 

5 (1) EXAMINATION.—Consistent with the De6 partment of Health and Human Services Blueprint 

7 for Action on Breastfeeding (2000), the Task Force 

8 shall examine the following issues: 

9 (A) The challenges that mothers face with 

10 continuing breastfeeding when the mothers re11 turn to work after giving birth. 

12 (B) The challenges that employers face in 

13 accommodating mothers who seek to continue 

14 to breastfeed or to express milk when the moth15 ers re-enter the workforce, including different 

16 challenges that mothers of varying socio-eco17 nomic status and in different professions may 

18 face. 

19 (C) The benefits that accrue to mothers, 

20 babies, and to employers when mothers are able 

21 to continue to breastfeed or to express 

22 breastmilk at work after the mothers have re23 entered the workforce. 

24 (D) Federal and State statutes that may 

25 have the effect of reducing breastfeeding and 
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•S 1074 IS 

1 breastfeeding retention rates among working 

2 mothers. 

3 (2) REPORTS.— 

4 (A) IN GENERAL.—Not later than 1 year 

5 after the date of enactment of this section, the 

6 Task Force shall issue a public report with rec7 ommendations on the following: 

8 (i) Steps that can be taken to promote 

9 breastfeeding among working mothers and 

10 to remove barriers to breastfeeding among 

11 working mothers. 

12 (ii) Potential ways in which the Fed13 eral Government can work with employers 

14 to promote breastfeeding among working 

15 mothers. 

16 (iii) Areas in which changes to exist17 ing Federal, State, or local laws would 

18 likely have the effect of making it easier 

19 for working mothers to breastfeed or would 

20 remove impediments to breastfeeding that 

21 currently exist in such laws. 

22 (iv) Whether or not increased rates of 

23 breastfeeding among working mothers 

24 would likely have the result of reducing 

25 health care costs among such mothers and 
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1 their children, and, in particular, whether 

2 increased rates of breastfeeding would be 

3 likely to result in lower Federal expendi4 tures on health care for such mothers and 

5 their children. 

6 (v) Areas in which the Federal Gov7 ernment, through additional appropria8 tions, increased efforts by Federal agen9 cies, or changes to existing Federal law, 

10 can and should increase the Federal Gov11 ernment’s efforts to promote breastfeeding 

12 among working mothers. 

13 (B) COPY TO CONGRESS.—Upon comple14 tion of the report described in subparagraph 

15 (A), the Task Force shall submit a copy of the 

16 report to the Committee on Health, Education, 

17 Labor, and Pensions of the Senate, the Com18 mittee on Appropriations of the Senate, the 

19 Committee on Education and the Workforce of 

20 the House of Representatives, and the Com21 mittee on Appropriations of the House of Rep22 resentatives. 

23 (f) POWERS OF THE TASK FORCE.— 

24 (1) HEARINGS.—The Task Force may hold 

25 such hearings, sit and act at such times and places, 
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1 take such testimony, and receive such evidence as 

2 the Task Force considers advisable to carry out this 

3 section. 

4 (2) INFORMATION FROM FEDERAL AGENCIES.— 

5 The Task Force may secure directly from any Fed6 eral department or agency such information as the 

7 Task Force considers necessary to carry out this 

8 section. Upon request of the Chair of the Task 

9 Force, the head of such department or agency shall 

10 furnish such information to the task Force. 

11 (3) POSTAL SERVICES.—The Task Force may 

12 use the United States mails in the same manner and 

13 under the same conditions as other departments and 

14 agencies of the Federal Government. 

15 (4) GIFTS.—The Task Force may accept, use, 

16 and dispose of gifts or donations of services or prop17 erty. 

18 (g) OPERATING EXPENSES.—The operating expenses 

19 of the Task Force, including travel expenses for members 

20 of the Task Force, shall be paid for from the general oper21 ating expenses funds of the Secretary of Health and 

22 Human Services and the Secretary of Labor. 
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1 SEC. 217. LACTATION ACCOMMODATION AND BREASTFEED2 ING PROMOTION AT WORK. 

3 (a) BREASTFEEDING AT WORK GENERAL REQUIRE4 MENTS.—The Family and Medical Leave Act of 1993 (29 

5 U.S.C. 2611 et seq.) is amended by inserting after title 

6 IV the following: 

7 ‘‘TITLE V—LACTATION PERIODS 

8 AND FACILITIES 

9 ‘‘SEC. 501. DEFINITIONS. 

10 ‘‘In this title: 

11 ‘‘(1) ELIGIBLE CHILD.—The term ‘eligible 

12 child’, used with respect to an eligible employee, 

13 means a son or daughter (as defined in section 101) 

14 who is a child of the employee. 

15 ‘‘(2) ELIGIBLE EMPLOYEE.—The term ‘eligible 

16 employee’ has the meaning given the term in section 

17 101, except that the limitations established in 

18 clauses (i) and (ii) of section 101(2)(A) shall not 

19 apply. The term ‘eligible employee’ does not include 

20 any Federal officer or employee covered under sub21 chapter VII of chapter 63 of title 5, United States 

22 Code, but does include a State employee described in 

23 section 304(a) of the Government Employee Rights 

24 Act of 1991 (42 U.S.C. 2000e–16c(a)). 

25 ‘‘(3) EMPLOYER.—The term ‘employer’ has the 

26 meaning given the term in section 101, and includes 
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1 an entity employing a State employee described in 

2 section 304(a) of the Government Employee Rights 

3 Act of 1991. 

4 ‘‘(4) UNDUE HARDSHIP.—The term ‘undue 

5 hardship’ means an action requiring significant dif6 ficulty or expense. 

7 ‘‘SEC. 502. LACTATION PERIODS. 

8 ‘‘(a) IN GENERAL.—An employer shall provide an ap9 propriate number of lactation periods, of reasonable 

10 length, for an eligible employee during each workday, to 

11 permit the employee to express milk for, or breastfeed, an 

12 eligible child. 

13 ‘‘(b) BREAK TIME.— 

14 ‘‘(1) UNPAID BREAK PERIODS.—Except as pro15 vided in paragraph (2), the lactation periods may 

16 consist of unpaid break periods. 

17 ‘‘(2) COMBINED BREAK PERIODS.—To the ex18 tent practicable, an employer shall combine break 

19 periods by providing the lactation periods for an eli20 gible employee at the same time as the employer 

21 provides other break periods for the employee. If the 

22 employer combines the break periods, the employee 

23 shall receive the same compensation for a combined 

24 break period as the employee would have received for 

25 an original break period. 
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1 ‘‘(c) LIMITATION.— 

2 ‘‘(1) UNDUE HARDSHIP.—An employer shall 

3 not be required to provide a lactation period under 

4 this section if the employer demonstrates that pro5 viding the period would impose an undue hardship 

6 on the employer, subject to paragraph (2). 

7 ‘‘(2) REASONABLE EFFORTS.—An employer 

8 who maintains that an undue hardship would result 

9 from providing a lactation period to an eligible em10 ployee shall demonstrate that the employer made 

11 reasonable efforts to comply with subsections (a) 

12 and (b). 

13 ‘‘SEC. 503. LACTATION FACILITIES. 

14 ‘‘(a) IN GENERAL.—An employer shall provide an ap15 propriate lactation facility for an eligible employee, within 

16 a reasonable distance from the employee’s usual work loca17 tion, to permit the employee to express milk for, or 

18 breastfeed, an eligible child. 

19 ‘‘(b) LIMITATION.— 

20 ‘‘(1) UNDUE HARDSHIP.—An employer shall 

21 not be required to provide a lactation facility under 

22 this section if the employer demonstrates that pro23 viding the facility would impose an undue hardship 

24 on the employer, subject to paragraph (2). 
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1 ‘‘(2) REASONABLE EFFORTS.—An employer 

2 who maintains that an undue hardship would result 

3 from providing a lactation facility to an eligible em4 ployee shall demonstrate that the employer made 

5 reasonable efforts to comply with subsection (a). 

6 ‘‘SEC. 504. ENFORCEMENT AND REMEDIES. 

7 ‘‘(a) ENFORCEMENT PROCESS.—The Secretary of 

8 Labor shall establish or designate a process through 

9 which— 

10 ‘‘(1) an individual may file a complaint regard11 ing a violation of this title; and 

12 ‘‘(2) an office designated by the Secretary in 

13 the Department of Labor shall receive, investigate, 

14 make determinations regarding, and administer rem15 edies with respect to such complaints. 

16 ‘‘(b) REMEDIES.—The Secretary of Labor shall es17 tablish remedies for violations of this title. 

18 ‘‘(c) GOVERNMENT ACCOUNTABILITY OFFICE AND

19 LIBRARY OF CONGRESS.—In the case of the Government 

20 Accountability Office and the Library of Congress, the au21 thority of the Secretary of Labor under this title shall be 

22 exercised respectively by the Comptroller General of the 

23 United States and the Librarian of Congress. 
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1 ‘‘SEC. 505. REGULATIONS. 

2 ‘‘The Secretary of Labor shall issue regulations to 

3 carry out this title, including provisions prescribing— 

4 ‘‘(1) an appropriate number and reasonable 

5 length of lactation periods, for purposes of section 

6 502; 

7 ‘‘(2) an appropriate lactation facility (which 

8 shall not be a restroom or a portion of a restroom) 

9 and a reasonable distance from a usual work loca10 tion, for purposes of section 503; and 

11 ‘‘(3) the process and remedies described in sec12 tion 504.’’. 

13 (b) BREASTFEEDING AT WORK FOR CIVIL SERVICE

14 EMPLOYEES.—Chapter 63 of title 5, United States Code, 

15 is amended by adding at the end: 

16 ‘‘SUBCHAPTER VII—LACTATION PERIODS AND 

17 FACILITIES 

18 ‘‘§ 6392. Definitions 

19 ‘‘For the purpose of this subchapter— 

20 ‘‘(1) the term ‘eligible child’, used with respect 

21 to an employee, means a son or daughter (as defined 

22 in section 6381) who is a child of the employee; 

23 ‘‘(2) the term ‘employee’ means any individual 

24 who is an ‘employee’, as defined by section 6301(2), 

25 including any individual employed in a position re26 ferred to in clause (v) or (ix) of section 6301(2), but 
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1 excluding any individual employed by the govern2 ment of the District of Columbia, any individual em3 ployed on a temporary or intermittent basis, and any 

4 employee of the General Accounting Office or the Li5 brary of Congress; and 

6 ‘‘(3) the term ‘undue hardship’ means an action 

7 requiring significant difficulty or expense. 

8 ‘‘§ 6392A. Lactation periods 

9 ‘‘(a) An employing agency shall provide an appro10 priate number of lactation periods, of reasonable length, 

11 for an employee during each workday, to permit the em12 ployee to express milk for, or breastfeed, an eligible child. 

13 ‘‘(b)(1) Except as provided in paragraph (2), the lac14 tation periods may consist of unpaid break periods. 

15 ‘‘(2) To the extent practicable, an employing agency 

16 shall combine break periods by providing the lactation pe17 riods for an employee at the same time as the employing 

18 agency provides other break periods for the employee. If 

19 the employing agency combines the break periods, the em20 ployee shall receive the same compensation for a combined 

21 break period as the employee would have received for an 

22 original break period. 

23 ‘‘(c)(1) An employing agency shall not be required to 

24 provide a lactation period under this section if the employ25 ing agency demonstrates that providing the period would 
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1 impose an undue hardship on the employing agency, sub2 ject to paragraph (2). 

3 ‘‘(2) An employing agency who maintains that an 

4 undue hardship would result from providing a lactation 

5 period to an employee shall demonstrate that the employ6 ing agency made reasonable efforts to comply with sub7 sections (a) and (b). 

8 ‘‘§ 6392B. Lactation facilities 

9 ‘‘(a) An employing agency shall provide an appro10 priate lactation facility for an employee, within a reason11 able distance from the employee’s usual work location, to 

12 permit the employee to express milk for, or breastfeed, an 

13 eligible child. 

14 ‘‘(b)(1) An employing agency shall not be required 

15 to provide a lactation facility under this section if the em16 ploying agency demonstrates that providing the facility 

17 would impose an undue hardship on the employing agency, 

18 subject to paragraph (2). 

19 ‘‘(2) An employing agency who maintains that an 

20 undue hardship would result from providing a lactation 

21 facility to an employee shall demonstrate that the employ22 ing agency made reasonable efforts to comply with sub23 section (a). 
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1 ‘‘§ 6392C. Remedies 

2 ‘‘(a) The Office of Personnel Management shall es3 tablish or designate a process through which— 

4 ‘‘(1) an individual may file a complaint regard5 ing a violation of this subchapter; and 

6 ‘‘(2) an office designated by the Director of the 

7 Office of Personnel Management shall receive, inves8 tigate, make determinations regarding, and admin9 ister remedies with respect to such complaints. 

10 ‘‘(b) The Office of Personnel Management shall es11 tablish remedies for violations of this subchapter. 

12 ‘‘§ 6392D. Regulations 

13 ‘‘(a) The Office of Personnel Management shall issue 

14 regulations to carry out this subchapter, including provi15 sions prescribing— 

16 ‘‘(1) an appropriate number and reasonable 

17 length of lactation periods, for purposes of section 

18 6392A; 

19 ‘‘(2) an appropriate lactation facility (which 

20 shall not be a restroom or a portion of a restroom) 

21 and a reasonable distance from a usual work loca22 tion, for purposes of section 6392B; and 

23 ‘‘(3) the process and remedies described in sec24 tion 6392C. 

25 ‘‘(b) The regulations prescribed under this sub26 chapter shall, to the extent appropriate, be consistent with 
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1 the regulations prescribed by the Secretary of Labor to 

2 carry out title V of the Family and Medical Leave Act 

3 of 1993.’’. 

4 (c) BREASTFEEDING AT WORK FOR CONGRESSIONAL

5 EMPLOYEES.— 

6 (1) APPLICATION OF LAWS.—Section 102(a) of 

7 the Congressional Accountability Act of 1995 (2 

8 U.S.C. 1302(a)) is amended— 

9 (A) in paragraph (5), by striking ‘‘The’’ 

10 and inserting ‘‘Title I of the’’; and 

11 (B) by adding at the end the following: 

12 ‘‘(12) Title V of the Family and Medical Leave 

13 Act of 1993.’’. 

14 (2) EXTENSION OF RIGHTS AND PROTEC15 TIONS.—Part A of title II of the Congressional Ac16 countability Act of 1995 (2 U.S.C. 1311 et seq.) is 

17 amended— 

18 (A) in section 202 (2 U.S.C. 1312), by 

19 striking the title and inserting the following: 

20 ‘‘SEC. 202. RIGHTS AND PROTECTIONS UNDER TITLE I OF 

21 THE FAMILY AND MEDICAL LEAVE ACT OF 

22 1993.’’; 

23 (B) by redesignating section 207 as section 

24 208; and 
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1 (C) by inserting after section 206 the fol2 lowing: 

3 ‘‘SEC. 207. RIGHTS AND PROTECTIONS UNDER TITLE V OF 

4 THE FAMILY AND MEDICAL LEAVE ACT OF 

5 1993. 

6 ‘‘(a) BREASTFEEDING RIGHTS AND PROTECTIONS

7 PROVIDED.— 

8 ‘‘(1) IN GENERAL.—The rights and protections 

9 established by sections 501 through 503 of the Fam10 ily and Medical Leave Act of 1993 shall apply to 

11 covered employees. 

12 ‘‘(2) DEFINITION.—For purposes of the appli13 cation described in paragraph (1)— 

14 ‘‘(A) the term ‘employer’ as used in the 

15 Family and Medical Leave Act of 1993 means 

16 any employing office; and 

17 ‘‘(B) the term ‘eligible employee’ as used 

18 in the Family and Medical Leave Act of 1993 

19 means a covered employee who has been em20 ployed in any employing office. 

21 ‘‘(b) REMEDY.—The remedy for a violation of sub22 section (a) shall be such remedy as would be appropriate 

23 if awarded under section 504 of the Family and Medical 

24 Leave Act of 1993. 

25 ‘‘(c) REGULATIONS.— 
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1 ‘‘(1) IN GENERAL.—The Board shall, pursuant 

2 to section 304, issue regulations to implement the 

3 rights and protections under this section. 

4 ‘‘(2) AGENCY REGULATIONS.—The regulations 

5 issued under paragraph (1) shall be the same as 

6 substantive regulations promulgated by the Sec7 retary of Labor to implement the statutory provi8 sions referred to in subsections (a) and (b), except 

9 insofar as the Board may determine, for good cause 

10 shown and stated together with the issued regula11 tions, that a modification of such promulgated regu12 lations would be more effective for the implementa13 tion of the rights and protections under this sec14 tion.’’. 

15 (3) TABLE OF CONTENTS.—The table of con16 tents for the Congressional Accountability Act of 

17 1995 is amended by striking the item relating to 

18 section 207 and inserting the following: 

‘‘Sec. 207. Rights and protections under title V of the Family and Medical 

Leave Act of 1993. 

‘‘Sec. 208. Prohibition of intimidation or reprisal.’’. 

19 (d) BREASTFEEDING AT WORK FOR EMPLOYEES IN

20 PRESIDENTIAL OFFICES.— 

21 (1) APPLICATION OF LAWS.—Section 402 of 

22 title 3, United States Code, is amended— 

23 (A) in paragraph (5), by striking ‘‘The’’ 

24 and inserting ‘‘Title I of the’’; and 
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1 (B) by adding at the end the following: 

2 ‘‘(12) Title V of the Family and Medical Leave 

3 Act of 1993.’’. 

4 (2) EXTENSION OF RIGHTS AND PROTEC5 TIONS.—Subchapter II of chapter 5 of title 3, 

6 United States Code, is amended— 

7 (A) in section 412, by striking the title and 

8 inserting the following: 

9 ‘‘SEC. 412. RIGHTS AND PROTECTIONS UNDER TITLE I OF 

10 THE FAMILY AND MEDICAL LEAVE ACT OF 

11 1993.’’; 

12 (B) by redesignating section 417 as section 

13 418; and 

14 (C) by inserting after section 416 the fol15 lowing: 

16 ‘‘SEC. 417. RIGHTS AND PROTECTIONS UNDER TITLE V OF 

17 THE FAMILY AND MEDICAL LEAVE ACT OF 

18 1993. 

19 ‘‘(a) BREASTFEEDING RIGHTS AND PROTECTIONS

20 PROVIDED.— 

21 ‘‘(1) IN GENERAL.—The rights and protections 

22 established by sections 501 through 503 of the Fam23 ily and Medical Leave Act of 1993 shall apply to 

24 covered employees. 
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1 ‘‘(2) DEFINITION.—For purposes of the appli2 cation described in paragraph (1)— 

3 ‘‘(A) the term ‘employer’ as used in the 

4 Family and Medical Leave Act of 1993 means 

5 any employing office; and 

6 ‘‘(B) the term ‘eligible employee’ as used 

7 in the Family and Medical Leave Act of 1993 

8 means a covered employee. 

9 ‘‘(b) REMEDY.—The remedy for a violation of sub10 section (a) shall be such remedy as would be appropriate 

11 if awarded under section 504 of the Family and Medical 

12 Leave Act of 1993. 

13 ‘‘(c) REGULATIONS.— 

14 ‘‘(1) IN GENERAL.—The President, or the des15 ignee of the President, shall issue regulations to im16 plement this section. 

17 ‘‘(2) AGENCY REGULATIONS.—The regulations 

18 issued under paragraph (1) shall be the same as 

19 substantive regulations promulgated by the Sec20 retary of Labor to implement the statutory provi21 sions referred to in subsections (a) and (b)— 

22 ‘‘(A) except to the extent that the Presi23 dent or designee may determine, for good cause 

24 shown and stated together with the issued regu25 lations, that a modification of such promulgated 
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1 regulations would be more effective for the im2 plementation of the rights and protections 

3 under this section; and 

4 ‘‘(B) except that the President or designee 

5 may, at the discretion of the President or des6 ignee, issue regulations to implement a provi7 sion of subchapter VII of chapter 63 of title 5, 

8 United States Code, that applies to employees 

9 in the executive branch of the Federal Govern10 ment in lieu of an analogous statutory provision 

11 referred to in subsection (a) or (b), if the 

12 issuance of such regulations— 

13 ‘‘(i) would be equally effective for the 

14 implementation of the rights and protec15 tions under this section; and 

16 ‘‘(ii) would promote uniformity in the 

17 application of Federal law to employees in 

18 the executive branch of the Federal Gov19 ernment.’’. 

20 (3) CONFORMING AMENDMENT.—Section 

21 411(e) of title 3, United States Code, is amended by 

22 striking ‘‘417’’ and inserting ‘‘418’’. 

23 (4) TABLE OF CONTENTS.—The table of con24 tents for chapter 5 of title 3, United States Code, 
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1 is amended by striking the item relating to section 

2 417 and inserting the following: 

‘‘417. Rights and protections under title V of the Family and Medical Leave 

Act of 1993. 

‘‘418. Prohibition of intimidation or reprisal.’’. 

3 (e) EFFECTIVE DATES.— 

4 (1) IN GENERAL.—Except as provided in para5 graph (2), this section and the amendments made by 

6 this section take effect 18 months after the date of 

7 enactment of this Act. 

8 (2) REGULATIONS.—Section 505 of the Family 

9 and Medical Leave Act of 1993 (as added by sub10 section (a)), section 6392D of title 5, United States 

11 Code (as added by subsection (b)), section 207(c) of 

12 the Congressional Accountability Act of 1995 (as 

13 added by subsection (c)), and section 417(c) of title 

14 3, United States Code (as added by subsection (d)) 

15 take effect on the date of enactment of this Act. 

16 Subtitle C—Family Smoking 

17 Prevention and Control 

18 SEC. 221. SHORT TITLE. 

19 This subtitle may be cited as the ‘‘Family Smoking 

20 Prevention and Tobacco Control Act’’. 

21 SEC. 222. FINDINGS. 

22 The Congress finds the following: 

23 (1) The use of tobacco products by the Nation’s 

24 children is a pediatric disease of considerable pro-
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1 portions that results in new generations of tobacco2 dependent children and adults. 

3 (2) A consensus exists within the scientific and 

4 medical communities that tobacco products are in5 herently dangerous and cause cancer, heart disease, 

6 and other serious adverse health effects. 

7 (3) Nicotine is an addictive drug. 

8 (4) Virtually all new users of tobacco products 

9 are under the minimum legal age to purchase such 

10 products. 

11 (5) Tobacco advertising and marketing con12 tribute significantly to the use of nicotine-containing 

13 tobacco products by adolescents. 

14 (6) Because past efforts to restrict advertising 

15 and marketing of tobacco products have failed ade16 quately to curb tobacco use by adolescents, com17 prehensive restrictions on the sale, promotion, and 

18 distribution of such products are needed. 

19 (7) Federal and State governments have lacked 

20 the legal and regulatory authority and resources 

21 they need to address comprehensively the public 

22 health and societal problems caused by the use of to23 bacco products. 

24 (8) Federal and State public health officials, 

25 the public health community, and the public at large 
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1 recognize that the tobacco industry should be subject 

2 to ongoing oversight. 

3 (9) Under article I, section 8 of the Constitu4 tion, the Congress is vested with the responsibility 

5 for regulating interstate commerce and commerce 

6 with Indian tribes. 

7 (10) The sale, distribution, marketing, adver8 tising, and use of tobacco products are activities in 

9 and substantially affecting interstate commerce be10 cause they are sold, marketed, advertised, and dis11 tributed in interstate commerce on a nationwide 

12 basis, and have a substantial effect on the Nation’s 

13 economy. 

14 (11) The sale, distribution, marketing, adver15 tising, and use of such products substantially affect 

16 interstate commerce through the health care and 

17 other costs attributable to the use of tobacco prod18 ucts. 

19 (12) It is in the public interest for Congress to 

20 enact legislation that provides the Food and Drug 

21 Administration with the authority to regulate to22 bacco products and the advertising and promotion of 

23 such products. The benefits to the American people 

24 from enacting such legislation would be significant 

25 in human and economic terms. 
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1 (13) Tobacco use is the foremost preventable 

2 cause of premature death in America. It causes over 

3 400,000 deaths in the United States each year and 

4 approximately 8,600,000 Americans have chronic ill5 nesses related to smoking. 

6 (14) Reducing the use of tobacco by minors by 

7 50 percent would prevent well over 10,000,000 of to8 day’s children from becoming regular, daily smokers, 

9 saving over 3,000,000 of them from premature 

10 death due to tobacco induced disease. Such a reduc11 tion in youth smoking would also result in approxi12 mately $75,000,000,000 in savings attributable to 

13 reduced health care costs. 

14 (15) Advertising, marketing, and promotion of 

15 tobacco products have been especially directed to at16 tract young persons to use tobacco products and 

17 these efforts have resulted in increased use of such 

18 products by youth. Past efforts to oversee these ac19 tivities have not been successful in adequately pre20 venting such increased use. 

21 (16) In 2002, the tobacco industry spent more 

22 than $12,466,000,000 to attract new users, retain 

23 current users, increase current consumption, and 

24 generate favorable long-term attitudes toward smok25 ing and tobacco use. 
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1 (17) Tobacco product advertising often 

2 misleadingly portrays the use of tobacco as socially 

3 acceptable and healthful to minors. 

4 (18) Tobacco product advertising is regularly 

5 seen by persons under the age of 18, and persons 

6 under the age of 18 are regularly exposed to tobacco 

7 product promotional efforts. 

8 (19) Through advertisements during and spon9 sorship of sporting events, tobacco has become 

10 strongly associated with sports and has become por11 trayed as an integral part of sports and the healthy 

12 lifestyle associated with rigorous sporting activity. 

13 (20) Children are exposed to substantial and 

14 unavoidable tobacco advertising that leads to favor15 able beliefs about tobacco use, plays a role in leading 

16 young people to overestimate the prevalence of to17 bacco use, and increases the number of young people 

18 who begin to use tobacco. 

19 (21) The use of tobacco products in motion pic20 tures and other mass media glamorizes its use for 

21 young people and encourages them to use tobacco 

22 products. 

23 (22) Tobacco advertising expands the size of 

24 the tobacco market by increasing consumption of to-
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1 bacco products including tobacco use by young peo2 ple. 

3 (23) Children are more influenced by tobacco 

4 advertising than adults, they smoke the most adver5 tised brands. 

6 (24) Tobacco company documents indicate that 

7 young people are an important and often crucial seg8 ment of the tobacco market. Children, who tend to 

9 be more price-sensitive than adults, are influenced 

10 by advertising and promotion practices that result in 

11 drastically reduced cigarette prices. 

12 (25) Comprehensive advertising restrictions will 

13 have a positive effect on the smoking rates of young 

14 people. 

15 (26) Restrictions on advertising are necessary 

16 to prevent unrestricted tobacco advertising from un17 dermining legislation prohibiting access to young 

18 people and providing for education about tobacco 

19 use. 

20 (27) International experience shows that adver21 tising regulations that are stringent and comprehen22 sive have a greater impact on overall tobacco use 

23 and young people’s use than weaker or less com24 prehensive ones. 
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1 (28) Text only requirements, although not as 

2 stringent as a ban, will help reduce underage use of 

3 tobacco products while preserving the informational 

4 function of advertising. 

5 (29) It is in the public interest for Congress to 

6 adopt legislation to address the public health crisis 

7 created by actions of the tobacco industry. 

8 (30) The final regulations promulgated by the 

9 Secretary of Health and Human Services in the Au10 gust 28, 1996, issue of the Federal Register (61 

11 Fed. Reg. 44615–44618) for inclusion as part 897 

12 of title 21, Code of Federal Regulations, are con13 sistent with the First Amendment to the United 

14 States Constitution and with the standards set forth 

15 in the amendments made by this subtitle for the reg16 ulation of tobacco products by the Food and Drug 

17 Administration and the restriction on the sale and 

18 distribution, including access to and the advertising 

19 and promotion of, tobacco products contained in 

20 such regulations are substantially related to accom21 plishing the public health goals of this Act. 

22 (31) The regulations described in paragraph 

23 (30) will directly and materially advance the Federal 

24 Government’s substantial interest in reducing the 

25 number of children and adolescents who use ciga-
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1 rettes and smokeless tobacco and in preventing the 

2 life-threatening health consequences associated with 

3 tobacco use. An overwhelming majority of Americans 

4 who use tobacco products begin using such products 

5 while they are minors and become addicted to the 

6 nicotine in those products before reaching the age of 

7 18. Tobacco advertising and promotion plays a cru8 cial role in the decision of these minors to begin 

9 using tobacco products. Less restrictive and less 

10 comprehensive approaches have not and will not be 

11 effective in reducing the problems addressed by such 

12 regulations. The reasonable restrictions on the ad13 vertising and promotion of tobacco products con14 tained in such regulations will lead to a significant 

15 decrease in the number of minors using and becom16 ing addicted to those products. 

17 (32) The regulations described in paragraph 

18 (30) impose no more extensive restrictions on com19 munication by tobacco manufacturers and sellers 

20 than are necessary to reduce the number of children 

21 and adolescents who use cigarettes and smokeless to22 bacco and to prevent the life-threatening health con23 sequences associated with tobacco use. Such regula24 tions are narrowly tailored to restrict those adver25 tising and promotional practices which are most like-
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1 ly to be seen or heard by youth and most likely to 

2 entice them into tobacco use, while affording tobacco 

3 manufacturers and sellers ample opportunity to con4 vey information about their products to adult con5 sumers. 

6 (33) Tobacco dependence is a chronic disease, 

7 one that typically requires repeated interventions to 

8 achieve long-term or permanent abstinence. 

9 (34) Because the only known safe alternative to 

10 smoking is cessation, interventions should target all 

11 smokers to help them quit completely. 

12 (35) Tobacco products have been used to facili13 tate and finance criminal activities both domestically 

14 and internationally. Illicit trade of tobacco products 

15 has been linked to organized crime and terrorist 

16 groups. 

17 (36) It is essential that the Food and Drug Ad18 ministration review products sold or distributed for 

19 use to reduce risks or exposures associated with to20 bacco products and that it be empowered to review 

21 any advertising and labeling for such products. It is 

22 also essential that manufacturers, prior to marketing 

23 such products, be required to demonstrate that such 

24 products will meet a series of rigorous criteria, and 

25 will benefit the health of the population as a whole, 
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1 taking into account both users of tobacco products 

2 and persons who do not currently use tobacco prod3 ucts. 

4 (37) Unless tobacco products that purport to 

5 reduce the risks to the public of tobacco use actually 

6 reduce such risks, those products can cause substan7 tial harm to the public health to the extent that the 

8 individuals, who would otherwise not consume to9 bacco products or would consume such products less, 

10 use tobacco products purporting to reduce risk. 

11 Those who use products sold or distributed as modi12 fied risk products that do not in fact reduce risk, 

13 rather than quitting or reducing their use of tobacco 

14 products, have a substantially increased likelihood of 

15 suffering disability and premature death. The costs 

16 to society of the widespread use of products sold or 

17 distributed as modified risk products that do not in 

18 fact reduce risk or that increase risk include thou19 sands of unnecessary deaths and injuries and huge 

20 costs to our health care system. 

21 (38) As the National Cancer Institute has 

22 found, many smokers mistakenly believe that ‘‘low 

23 tar’’ and ‘‘light’’ cigarettes cause fewer health prob24 lems than other cigarettes. As the National Cancer 

25 Institute has also found, mistaken beliefs about the 
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1 health consequences of smoking ‘‘low tar’’ and 

2 ‘‘light’’ cigarettes can reduce the motivation to quit 

3 smoking entirely and thereby lead to disease and 

4 death. 

5 (39) Recent studies have demonstrated that 

6 there has been no reduction in risk on a population7 wide basis from ‘‘low tar’’ and ‘‘light’’ cigarettes and 

8 such products may actually increase the risk of to9 bacco use. 

10 (40) The dangers of products sold or distrib11 uted as modified risk tobacco products that do not 

12 in fact reduce risk are so high that there is a com13 pelling governmental interest in insuring that state14 ments about modified risk tobacco products are com15 plete, accurate, and relate to the overall disease risk 

16 of the product. 

17 (41) As the Federal Trade Commission has 

18 found, consumers have misinterpreted advertise19 ments in which one product is claimed to be less 

20 harmful than a comparable product, even in the 

21 presence of disclosures and advisories intended to 

22 provide clarification. 

23 (42) Permitting manufacturers to make unsub24 stantiated statements concerning modified risk to25 bacco products, whether express or implied, even if 
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1 accompanied by disclaimers would be detrimental to 

2 the public health. 

3 (43) The only way to effectively protect the 

4 public health from the dangers of unsubstantiated 

5 modified risk tobacco products is to empower the 

6 Food and Drug Administration to require that prod7 ucts that tobacco manufacturers sold or distributed 

8 for risk reduction be approved in advance of mar9 keting, and to require that the evidence relied on to 

10 support approval of these products is rigorous. 

11 SEC. 223. PURPOSE. 

12 The purposes of this Act are— 

13 (1) to provide authority to the Food and Drug 

14 Administration to regulate tobacco products under 

15 the Federal Food, Drug, and Cosmetic Act (21 

16 U.S.C. 301 et seq.), by recognizing it as the primary 

17 Federal regulatory authority with respect to the 

18 manufacture, marketing, and distribution of tobacco 

19 products; 

20 (2) to ensure that the Food and Drug Adminis21 tration has the authority to address issues of par22 ticular concern to public health officials, especially 

23 the use of tobacco by young people and dependence 

24 on tobacco; 
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1 (3) to authorize the Food and Drug Adminis2 tration to set national standards controlling the 

3 manufacture of tobacco products and the identity, 

4 public disclosure, and amount of ingredients used in 

5 such products; 

6 (4) to provide new and flexible enforcement au7 thority to ensure that there is effective oversight of 

8 the tobacco industry’s efforts to develop, introduce, 

9 and promote less harmful tobacco products; 

10 (5) to vest the Food and Drug Administration 

11 with the authority to regulate the levels of tar, nico12 tine, and other harmful components of tobacco prod13 ucts; 

14 (6) in order to ensure that consumers are better 

15 informed, to require tobacco product manufacturers 

16 to disclose research which has not previously been 

17 made available, as well as research generated in the 

18 future, relating to the health and dependency effects 

19 or safety of tobacco products; 

20 (7) to continue to permit the sale of tobacco 

21 products to adults in conjunction with measures to 

22 ensure that they are not sold or accessible to under23 age purchasers; 

24 (8) to impose appropriate regulatory controls on 

25 the tobacco industry; 
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1 (9) to promote cessation to reduce disease risk 

2 and the social costs associated with tobacco related 

3 diseases; and 

4 (10) to strengthen legislation against illicit 

5 trade in tobacco products. 

6 SEC. 224. SCOPE AND EFFECT. 

7 (a) INTENDED EFFECT.—Nothing in this Act (or an 

8 amendment made by this Act) shall be construed to— 

9 (1) establish a precedent with regard to any 

10 other industry, situation, circumstance, or legal ac11 tion; or 

12 (2) affect any action pending in Federal, State, 

13 or Tribal court, or any agreement, consent decree, or 

14 contract of any kind. 

15 (b) AGRICULTURAL ACTIVITIES.—The provisions of 

16 this Act (or an amendment made by this Act) which au17 thorize the Secretary to take certain actions with regard 

18 to tobacco and tobacco products shall not be construed to 

19 affect any authority of the Secretary of Agriculture under 

20 existing law regarding the growing, cultivation, or curing 

21 of raw tobacco. 

22 SEC. 225. SEVERABILITY. 

23 If any provision of this Act, the amendments made 

24 by this Act, or the application of any provision of this Act 

25 to any person or circumstance is held to be invalid, the 
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1 remainder of this Act, the amendments made by this Act, 

2 and the application of the provisions of this Act to any 

3 other person or circumstance shall not be affected and 

4 shall continue to be enforced to the fullest extent possible. 

5 PART I—AUTHORITY OF THE FOOD AND DRUG 

6 ADMINISTRATION 

7 SEC. 231. AMENDMENT OF FEDERAL FOOD, DRUG, AND 

8 COSMETIC ACT. 

9 (a) DEFINITION OF TOBACCO PRODUCTS.—Section 

10 201 of the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 321) is amended by adding at the end the fol12 lowing: 

13 ‘‘(nn)(1) The term ‘tobacco product’ means any prod14 uct made or derived from tobacco that is intended for 

15 human consumption, including any component, part, or 

16 accessory of a tobacco product (except for raw materials 

17 other than tobacco used in manufacturing a component, 

18 part, or accessory of a tobacco product). 

19 ‘‘(2) The term ‘tobacco product’ does not mean— 

20 ‘‘(A) a product in the form of conventional food 

21 (including water and chewing gum), a product rep22 resented for use as or for use in a conventional food, 

23 or a product that is intended for ingestion in cap24 sule, tablet, softgel, or liquid form; or 
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1 ‘‘(B) an article that is approved or is regulated 

2 as a drug by the Food and Drug Administration. 

3 ‘‘(3) The products described in paragraph (2)(A) 

4 shall be subject to chapter IV or chapter V of this Act 

5 and the articles described in paragraph (2)(B) shall be 

6 subject to chapter V of this Act. 

7 ‘‘(4) A tobacco product may not be marketed in com8 bination with any other article or product regulated under 

9 this Act (including a drug, biologic, food, cosmetics, med10 ical device, or a dietary supplement).’’. 

11 (b) FDA AUTHORITY OVER TOBACCO PRODUCTS.— 

12 The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 301 et seq.) is amended— 

14 (1) by redesignating chapter IX as chapter X; 

15 (2) by redesignating sections 901 through 907 

16 as sections 1001 through 1007; and 

17 (3) by inserting after section 803 the following: 

18 ‘‘CHAPTER IX—TOBACCO PRODUCTS 

19 ‘‘SEC. 900. DEFINITIONS. 

20 ‘‘In this chapter: 

21 ‘‘(1) ADDITIVE.—The term ‘additive’ means 

22 any substance the intended use of which results or 

23 may reasonably be expected to result, directly or in24 directly, in its becoming a component or otherwise 

25 affecting the characteristic of any tobacco product 
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1 (including any substances intended for use as a fla2 voring, coloring or in producing, manufacturing, 

3 packing, processing, preparing, treating, packaging, 

4 transporting, or holding), except that such term does 

5 not include tobacco or a pesticide chemical residue 

6 in or on raw tobacco or a pesticide chemical. 

7 ‘‘(2) BRAND.—The term ‘brand’ means a vari8 ety of tobacco product distinguished by the tobacco 

9 used, tar content, nicotine content, flavoring used, 

10 size, filtration, or packaging, logo, registered trade11 mark or brand name, identifiable pattern of colors, 

12 or any combination of such attributes. 

13 ‘‘(3) CIGARETTE.—The term ‘cigarette’ has the 

14 meaning given that term by section 3(1) of the Fed15 eral Cigarette Labeling and Advertising Act (15 

16 U.S.C. 1332(1)), but also includes tobacco, in any 

17 form, that is functional in the product, which, be18 cause of its appearance, the type of tobacco used in 

19 the filler, or its packaging and labeling, is likely to 

20 be offered to, or purchased by, consumers as a ciga21 rette or as roll-your-own tobacco. 

22 ‘‘(4) CIGARETTE TOBACCO.—The term ‘ciga23 rette tobacco’ means any product that consists of 

24 loose tobacco that is intended for use by consumers 

25 in a cigarette. Unless otherwise stated, the require-
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1 ments for cigarettes shall also apply to cigarette to2 bacco. 

3 ‘‘(5) COMMERCE.—The term ‘commerce’ has 

4 the meaning given that term by section 3(2) of the 

5 Federal Cigarette Labeling and Advertising Act (15 

6 U.S.C. 1332(2)). 

7 ‘‘(6) COUNTERFEIT TOBACCO PRODUCT.—The 

8 term ‘counterfeit tobacco product’ means a tobacco 

9 product (or the container or labeling of such a prod10 uct) that, without authorization, bears the trade11 mark, trade name, or other identifying mark, im12 print or device, or any likeness thereof, of a tobacco 

13 product listed in a registration under section 

14 905(i)(1). 

15 ‘‘(7) DISTRIBUTOR.—The term ‘distributor’ as 

16 regards a tobacco product means any person who 

17 furthers the distribution of a tobacco product, 

18 whether domestic or imported, at any point from the 

19 original place of manufacture to the person who sells 

20 or distributes the product to individuals for personal 

21 consumption. Common carriers are not considered 

22 distributors for purposes of this chapter. 

23 ‘‘(8) ILLICIT TRADE.—The term ‘illicit trade’ 

24 means any practice or conduct prohibited by law 

25 which relates to production, shipment, receipt, pos-
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1 session, distribution, sale, or purchase of tobacco 

2 products including any practice or conduct intended 

3 to facilitate such activity. 

4 ‘‘(9) INDIAN TRIBE.—The term ‘Indian tribe’ 

5 has the meaning given such term in section 4(e) of 

6 the Indian Self Determination and Education Assist7 ance Act (25 U.S.C. 450b(e)). 

8 ‘‘(10) LITTLE CIGAR.—The term ‘little cigar’ 

9 has the meaning given that term by section 3(7) of 

10 the Federal Cigarette Labeling and Advertising Act 

11 (15 U.S.C. 1332(7)). 

12 ‘‘(11) NICOTINE.—The term ‘nicotine’ means 

13 the chemical substance named 3-(1-Methyl-2- 

14 pyrrolidinyl) pyridine or C[10]H[14]N[2], including 

15 any salt or complex of nicotine. 

16 ‘‘(12) PACKAGE.—The term ‘package’ means a 

17 pack, box, carton, or container of any kind or, if no 

18 other container, any wrapping (including cello19 phane), in which a tobacco product is offered for 

20 sale, sold, or otherwise distributed to consumers. 

21 ‘‘(13) RETAILER.—The term ‘retailer’ means 

22 any person who sells tobacco products to individuals 

23 for personal consumption, or who operates a facility 

24 where self-service displays of tobacco products are 

25 permitted. 
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1 ‘‘(14) ROLL-YOUR-OWN TOBACCO.—The term 

2 ‘roll-your-own tobacco’ means any tobacco which, be3 cause of its appearance, type, packaging, or labeling, 

4 is suitable for use and likely to be offered to, or pur5 chased by, consumers as tobacco for making ciga6 rettes. 

7 ‘‘(15) SMOKE CONSTITUENT.—The term ‘smoke 

8 constituent’ means any chemical or chemical com9 pound in mainstream or sidestream tobacco smoke 

10 that either transfers from any component of the cig11 arette to the smoke or that is formed by the combus12 tion or heating of tobacco, additives, or other compo13 nent of the tobacco product. 

14 ‘‘(16) SMOKELESS TOBACCO.—The term 

15 ‘smokeless tobacco’ means any tobacco product that 

16 consists of cut, ground, powdered, or leaf tobacco 

17 and that is intended to be placed in the oral or nasal 

18 cavity. 

19 ‘‘(17) STATE.—The term ‘State’ means any 

20 State of the United States and, for purposes of this 

21 chapter, includes the District of Columbia, the Com22 monwealth of Puerto Rico, Guam, the Virgin Is23 lands, American Samoa, Wake Island, Midway Is24 lands, Kingman Reef, Johnston Atoll, the Northern 
123 

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1 Mariana Islands, and any other trust territory or 

2 possession of the United States. 

3 ‘‘(18) TOBACCO PRODUCT MANUFACTURER.— 

4 Term ‘tobacco product manufacturer’ means any 

5 person, including any repacker or relabeler, who— 

6 ‘‘(A) manufactures, fabricates, assembles, 

7 processes, or labels a tobacco product; or 

8 ‘‘(B) imports a finished cigarette or 

9 smokeless tobacco product for sale or distribu10 tion in the United States. 

11 ‘‘(19) UNITED STATES.—The term ‘United 

12 States’ means the 50 States of the United States of 

13 America and the District of Columbia, the Common14 wealth of Puerto Rico, Guam, the Virgin Islands, 

15 American Samoa, Wake Island, Midway Islands, 

16 Kingman Reef, Johnston Atoll, the Northern Mar17 iana Islands, and any other trust territory or posses18 sion of the United States. 

19 ‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS. 

20 ‘‘(a) IN GENERAL.—Tobacco products shall be regu21 lated by the Secretary under this chapter and shall not 

22 be subject to the provisions of chapter V, unless— 

23 ‘‘(1) such products are intended for use in the 

24 diagnosis, cure, mitigation, treatment, or prevention 
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1 of disease (within the meaning of section 

2 201(g)(1)(B) or section 201(h)(2)); or 

3 ‘‘(2) a claim is made for such products under 

4 section 201(g)(1)(C) or 201(h)(3); 

5 other than modified risk tobacco products approved 

6 in accordance with section 911. 

7 ‘‘(b) APPLICABILITY.—This chapter shall apply to all 

8 tobacco products subject to the regulations referred to in 

9 section 232 of the Family Smoking Prevention and To10 bacco Control Act, and to any other tobacco products that 

11 the Secretary by regulation deems to be subject to this 

12 chapter. 

13 ‘‘(c) SCOPE.— 

14 ‘‘(1) IN GENERAL.—Nothing in this chapter, or 

15 any policy issued or regulation promulgated there16 under, or the Family Smoking Prevention and To17 bacco Control Act, shall be construed to affect the 

18 Secretary’s authority over, or the regulation of, 

19 products under this Act that are not tobacco prod20 ucts under chapter V or any other chapter. 

21 ‘‘(2) LIMITATION OF AUTHORITY.— 

22 ‘‘(A) IN GENERAL.—The provisions of this 

23 chapter shall not apply to tobacco leaf that is 

24 not in the possession of a manufacturer of to25 bacco products, or to the producers of tobacco 
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1 leaf, including tobacco growers, tobacco ware2 houses, and tobacco grower cooperatives, nor 

3 shall any employee of the Food and Drug Ad4 ministration have any authority to enter onto a 

5 farm owned by a producer of tobacco leaf with6 out the written consent of such producer. 

7 ‘‘(B) EXCEPTION.—Notwithstanding any 

8 other provision of this subparagraph, if a pro9 ducer of tobacco leaf is also a tobacco product 

10 manufacturer or controlled by a tobacco prod11 uct manufacturer, the producer shall be subject 

12 to this chapter in the producer’s capacity as a 

13 manufacturer. 

14 ‘‘(C) RULE OF CONSTRUCTION.—Nothing 

15 in this chapter shall be construed to grant the 

16 Secretary authority to promulgate regulations 

17 on any matter that involves the production of 

18 tobacco leaf or a producer thereof, other than 

19 activities by a manufacturer affecting produc20 tion. 

21 ‘‘SEC. 902. ADULTERATED TOBACCO PRODUCTS. 

22 ‘‘A tobacco product shall be deemed to be adulterated 

23 if— 

24 ‘‘(1) it consists in whole or in part of any filthy, 

25 putrid, or decomposed substance, or is otherwise 
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•S 1074 IS 

1 contaminated by any added poisonous or added dele2 terious substance that may render the product inju3 rious to health; 

4 ‘‘(2) it has been prepared, packed, or held 

5 under insanitary conditions whereby it may have 

6 been contaminated with filth, or whereby it may 

7 have been rendered injurious to health; 

8 ‘‘(3) its package is composed, in whole or in 

9 part, of any poisonous or deleterious substance 

10 which may render the contents injurious to health; 

11 ‘‘(4) it is, or purports to be or is represented 

12 as, a tobacco product which is subject to a tobacco 

13 product standard established under section 907 un14 less such tobacco product is in all respects in con15 formity with such standard; 

16 ‘‘(5)(A) it is required by section 910(a) to have 

17 premarket approval and does not have an approved 

18 application in effect; or 

19 ‘‘(B) it is in violation of the order approving 

20 such an application; 

21 ‘‘(6) the methods used in, or the facilities or 

22 controls used for, its manufacture, packing or stor23 age are not in conformity with applicable require24 ments under section 906(e)(1) or an applicable con-
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1 dition prescribed by an order under section 

2 906(e)(2); or 

3 ‘‘(7) it is in violation of section 911. 

4 ‘‘SEC. 903. MISBRANDED TOBACCO PRODUCTS. 

5 ‘‘(a) IN GENERAL.—A tobacco product shall be 

6 deemed to be misbranded— 

7 ‘‘(1) if its labeling is false or misleading in any 

8 particular; 

9 ‘‘(2) if in package form unless it bears a label 

10 containing— 

11 ‘‘(A) the name and place of business of the 

12 tobacco product manufacturer, packer, or dis13 tributor; 

14 ‘‘(B) an accurate statement of the quantity 

15 of the contents in terms of weight, measure, or 

16 numerical count; 

17 ‘‘(C) an accurate statement of the percent18 age of the tobacco used in the product that is 

19 domestically grown tobacco and the percentage 

20 that is foreign grown tobacco; and 

21 ‘‘(D) the statement required under section 

22 921(a), except that under subparagraph (B) 

23 reasonable variations shall be permitted, and 

24 exemptions as to small packages shall be estab-
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1 lished, by regulations prescribed by the Sec2 retary; 

3 ‘‘(3) if any word, statement, or other informa4 tion required by or under authority of this chapter 

5 to appear on the label or labeling is not prominently 

6 placed thereon with such conspicuousness (as com7 pared with other words, statements or designs in the 

8 labeling) and in such terms as to render it likely to 

9 be read and understood by the ordinary individual 

10 under customary conditions of purchase and use; 

11 ‘‘(4) if it has an established name, unless its 

12 label bears, to the exclusion of any other nonpropri13 etary name, its established name prominently print14 ed in type as required by the Secretary by regula15 tion; 

16 ‘‘(5) if the Secretary has issued regulations re17 quiring that its labeling bear adequate directions for 

18 use, or adequate warnings against use by children, 

19 that are necessary for the protection of users unless 

20 its labeling conforms in all respects to such regula21 tions; 

22 ‘‘(6) if it was manufactured, prepared, propa23 gated, compounded, or processed in any State in an 

24 establishment not duly registered under section 

25 905(b), 905(c), 905(d), or 905(h), if it was not in-
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•S 1074 IS 

1 cluded in a list required by section 905(i), if a notice 

2 or other information respecting it was not provided 

3 as required by such section or section 905(j), or if 

4 it does not bear such symbols from the uniform sys5 tem for identification of tobacco products prescribed 

6 under section 905(e) as the Secretary by regulation 

7 requires; 

8 ‘‘(7) if, in the case of any tobacco product dis9 tributed or offered for sale in any State— 

10 ‘‘(A) its advertising is false or misleading 

11 in any particular; or 

12 ‘‘(B) it is sold or distributed in violation of 

13 regulations prescribed under section 906(d); 

14 ‘‘(8) unless, in the case of any tobacco product 

15 distributed or offered for sale in any State, the man16 ufacturer, packer, or distributor thereof includes in 

17 all advertisements and other descriptive printed mat18 ter issued or caused to be issued by the manufac19 turer, packer, or distributor with respect to that to20 bacco product— 

21 ‘‘(A) a true statement of the tobacco prod22 uct’s established name as described in para23 graph (4), printed prominently; and 

24 ‘‘(B) a brief statement of— 
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1 ‘‘(i) the uses of the tobacco product 

2 and relevant warnings, precautions, side 

3 effects, and contraindications; and 

4 ‘‘(ii) in the case of specific tobacco 

5 products made subject to a finding by the 

6 Secretary after notice and opportunity for 

7 comment that such action is appropriate to 

8 protect the public health, a full description 

9 of the components of such tobacco product 

10 or the formula showing quantitatively each 

11 ingredient of such tobacco product to the 

12 extent required in regulations which shall 

13 be issued by the Secretary after an oppor14 tunity for a hearing; 

15 ‘‘(9) if it is a tobacco product subject to a to16 bacco product standard established under section 

17 907, unless it bears such labeling as may be pre18 scribed in such tobacco product standard; or 

19 ‘‘(10) if there was a failure or refusal— 

20 ‘‘(A) to comply with any requirement pre21 scribed under section 904 or 908; or 

22 ‘‘(B) to furnish any material or informa23 tion required under section 909. 

24 ‘‘(b) PRIOR APPROVAL OF LABEL STATEMENTS.— 

25 The Secretary may, by regulation, require prior approval 
131 

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1 of statements made on the label of a tobacco product. No 

2 regulation issued under this subsection may require prior 

3 approval by the Secretary of the content of any advertise4 ment, except for modified risk tobacco products as pro5 vided in section 911. No advertisement of a tobacco prod6 uct published after the date of enactment of the Family 

7 Smoking Prevention and Tobacco Control Act shall, with 

8 respect to the language of label statements as prescribed 

9 under section 4 of the Cigarette Labeling and Advertising 

10 Act and section 3 of the Comprehensive Smokeless To11 bacco Health Education Act of 1986 or the regulations 

12 issued under such sections, be subject to the provisions 

13 of sections 12 through 15 of the Federal Trade Commis14 sion Act (15 U.S.C. 52 through 55). 

15 ‘‘SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE 

16 SECRETARY. 

17 ‘‘(a) REQUIREMENT.—Not later than 6 months after 

18 the date of enactment of the Family Smoking Prevention 

19 and Tobacco Control Act, each tobacco product manufac20 turer or importer, or agents thereof, shall submit to the 

21 Secretary the following information: 

22 ‘‘(1) A listing of all ingredients, including to23 bacco, substances, compounds, and additives that 

24 are, as of such date, added by the manufacturer to 

25 the tobacco, paper, filter, or other part of each to-
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1 bacco product by brand and by quantity in each 

2 brand and subbrand. 

3 ‘‘(2) A description of the content, delivery, and 

4 form of nicotine in each tobacco product measured 

5 in milligrams of nicotine in accordance with regula6 tions promulgated by the Secretary in accordance 

7 with section 4(a)(4) of the Federal Cigarette Label8 ing and Advertising Act. 

9 ‘‘(3) A listing of all constituents, including 

10 smoke constituents as applicable, identified by the 

11 Secretary as harmful or potentially harmful to 

12 health in each tobacco product, and as applicable in 

13 the smoke of each tobacco product, by brand and by 

14 quantity in each brand and subbrand. Effective be15 ginning 2 years after the date of enactment of this 

16 chapter, the manufacturer, importer, or agent shall 

17 comply with regulations promulgated under section 

18 916 in reporting information under this paragraph, 

19 where applicable. 

20 ‘‘(4) All documents developed after the date of 

21 enactment of the Family Smoking Prevention and 

22 Tobacco Control Act that relate to health, toxi23 cological, behavioral, or physiologic effects of current 

24 or future tobacco products, their constituents (in-
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•S 1074 IS 

1 cluding smoke constituents), ingredients, compo2 nents, and additives. 

3 ‘‘(b) DATA SUBMISSION.—At the request of the Sec4 retary, each tobacco product manufacturer or importer of 

5 tobacco products, or agents thereof, shall submit the fol6 lowing: 

7 ‘‘(1) Any or all documents (including under8 lying scientific information) relating to research ac9 tivities, and research findings, conducted, supported, 

10 or possessed by the manufacturer (or agents thereof) 

11 on the health, toxicological, behavioral, or physio12 logic effects of tobacco products and their constitu13 ents (including smoke constituents), ingredients, 

14 components, and additives. 

15 ‘‘(2) Any or all documents (including under16 lying scientific information) relating to research ac17 tivities, and research findings, conducted, supported, 

18 or possessed by the manufacturer (or agents thereof) 

19 that relate to the issue of whether a reduction in 

20 risk to health from tobacco products can occur upon 

21 the employment of technology available or known to 

22 the manufacturer. 

23 ‘‘(3) Any or all documents (including under24 lying scientific or financial information) relating to 

25 marketing research involving the use of tobacco 
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1 products or marketing practices and the effective2 ness of such practices used by tobacco manufactur3 ers and distributors. 

4 An importer of a tobacco product not manufactured in the 

5 United States shall supply the information required of a 

6 tobacco product manufacturer under this subsection. 

7 ‘‘(c) TIME FOR SUBMISSION.— 

8 ‘‘(1) IN GENERAL.—At least 90 days prior to 

9 the delivery for introduction into interstate com10 merce of a tobacco product not on the market on the 

11 date of enactment of the Family Smoking Preven12 tion and Tobacco Control Act, the manufacturer of 

13 such product shall provide the information required 

14 under subsection (a). 

15 ‘‘(2) DISCLOSURE OF ADDITIVE.—If at any 

16 time a tobacco product manufacturer adds to its to17 bacco products a new tobacco additive or increases 

18 the quantity of an existing tobacco additive, the 

19 manufacturer shall, except as provided in paragraph 

20 (3), at least 90 days prior to such action so advise 

21 the Secretary in writing. 

22 ‘‘(3) DISCLOSURE OF OTHER ACTIONS.—If at 

23 any time a tobacco product manufacturer eliminates 

24 or decreases an existing additive, or adds or in25 creases an additive that has by regulation been des-
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•S 1074 IS 

1 ignated by the Secretary as an additive that is not 

2 a human or animal carcinogen, or otherwise harmful 

3 to health under intended conditions of use, the man4 ufacturer shall within 60 days of such action so ad5 vise the Secretary in writing. 

6 ‘‘(d) DATA LIST.— 

7 ‘‘(1) IN GENERAL.—Not later than 3 years 

8 after the date of enactment of the Family Smoking 

9 Prevention and Tobacco Control Act, and annually 

10 thereafter, the Secretary shall publish in a format 

11 that is understandable and not misleading to a lay 

12 person, and place on public display (in a manner de13 termined by the Secretary) the list established under 

14 subsection (e). 

15 ‘‘(2) CONSUMER RESEARCH.—The Secretary 

16 shall conduct periodic consumer research to ensure 

17 that the list published under paragraph (1) is not 

18 misleading to lay persons. Not later than 5 years 

19 after the date of enactment of the Family Smoking 

20 Prevention and Tobacco Control Act, the Secretary 

21 shall submit to the appropriate committees of Con22 gress a report on the results of such research, to23 gether with recommendations on whether such publi24 cation should be continued or modified. 
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•S 1074 IS 

1 ‘‘(e) DATA COLLECTION.—Not later than 12 months 

2 after the date of enactment of the Family Smoking Pre3 vention and Tobacco Control Act, the Secretary shall es4 tablish a list of harmful and potentially harmful constitu5 ents, including smoke constituents, to health in each to6 bacco product by brand and by quantity in each brand 

7 and subbrand. The Secretary shall publish a public notice 

8 requesting the submission by interested persons of sci9 entific and other information concerning the harmful and 

10 potentially harmful constituents in tobacco products and 

11 tobacco smoke. 

12 ‘‘SEC. 905. ANNUAL REGISTRATION. 

13 ‘‘(a) DEFINITIONS.—In this section: 

14 ‘‘(1) MANUFACTURE, PREPARATION, 

15 COMPOUNDING, OR PROCESSING.—The term ‘manu16 facture, preparation, compounding, or processing’ 

17 shall include repackaging or otherwise changing the 

18 container, wrapper, or labeling of any tobacco prod19 uct package in furtherance of the distribution of the 

20 tobacco product from the original place of manufac21 ture to the person who makes final delivery or sale 

22 to the ultimate consumer or user. 

23 ‘‘(2) NAME.—The term ‘name’ shall include in 

24 the case of a partnership the name of each partner 

25 and, in the case of a corporation, the name of each 
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1 corporate officer and director, and the State of in2 corporation. 

3 ‘‘(b) REGISTRATION BY OWNERS AND OPERATORS.— 

4 On or before December 31 of each year every person who 

5 owns or operates any establishment in any State engaged 

6 in the manufacture, preparation, compounding, or proc7 essing of a tobacco product or tobacco products shall reg8 ister with the Secretary the name, places of business, and 

9 all such establishments of that person. 

10 ‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA11 TORS.—Every person upon first engaging in the manufac12 ture, preparation, compounding, or processing of a tobacco 

13 product or tobacco products in any establishment owned 

14 or operated in any State by that person shall immediately 

15 register with the Secretary that person’s name, place of 

16 business, and such establishment. 

17 ‘‘(d) REGISTRATION OF ADDED ESTABLISHMENTS.— 

18 Every person required to register under subsection (b) or 

19 (c) shall immediately register with the Secretary any addi20 tional establishment which that person owns or operates 

21 in any State and in which that person begins the manufac22 ture, preparation, compounding, or processing of a tobacco 

23 product or tobacco products. 

24 ‘‘(e) UNIFORM PRODUCT IDENTIFICATION SYS25 TEM.—The Secretary may by regulation prescribe a uni-
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•S 1074 IS 

1 form system for the identification of tobacco products and 

2 may require that persons who are required to list such 

3 tobacco products under subsection (i) shall list such to4 bacco products in accordance with such system. 

5 ‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA6 TION.—The Secretary shall make available for inspection, 

7 to any person so requesting, any registration filed under 

8 this section. 

9 ‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB10 LISHMENTS.—Every establishment in any State registered 

11 with the Secretary under this section shall be subject to 

12 inspection under section 704, and every such establish13 ment engaged in the manufacture, compounding, or proc14 essing of a tobacco product or tobacco products shall be 

15 so inspected by 1 or more officers or employees duly des16 ignated by the Secretary at least once in the 2-year period 

17 beginning with the date of registration of such establish18 ment under this section and at least once in every succes19 sive 2-year period thereafter. 

20 ‘‘(h) FOREIGN ESTABLISHMENTS SHALL REG21 ISTER.—Any establishment within any foreign country en22 gaged in the manufacture, preparation, compounding, or 

23 processing of a tobacco product or tobacco products, shall 

24 register under this section under regulations promulgated 

25 by the Secretary. Such regulations shall require such es-
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•S 1074 IS 

1 tablishment to provide the information required by sub2 section (i) of this section and shall include provisions for 

3 registration of any such establishment upon condition that 

4 adequate and effective means are available, by arrange5 ment with the government of such foreign country or oth6 erwise, to enable the Secretary to determine from time to 

7 time whether tobacco products manufactured, prepared, 

8 compounded, or processed in such establishment, if im9 ported or offered for import into the United States, shall 

10 be refused admission on any of the grounds set forth in 

11 section 801(a). 

12 ‘‘(i) REGISTRATION INFORMATION.— 

13 ‘‘(1) PRODUCT LIST.—Every person who reg14 isters with the Secretary under subsection (b), (c), 

15 (d), or (h) shall, at the time of registration under 

16 any such subsection, file with the Secretary a list of 

17 all tobacco products which are being manufactured, 

18 prepared, compounded, or processed by that person 

19 for commercial distribution and which has not been 

20 included in any list of tobacco products filed by that 

21 person with the Secretary under this paragraph or 

22 paragraph (2) before such time of registration. Such 

23 list shall be prepared in such form and manner as 

24 the Secretary may prescribe and shall be accom25 panied by— 
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1 ‘‘(A) in the case of a tobacco product con2 tained in the applicable list with respect to 

3 which a tobacco product standard has been es4 tablished under section 907 or which is subject 

5 to section 910, a reference to the authority for 

6 the marketing of such tobacco product and a 

7 copy of all labeling for such tobacco product; 

8 ‘‘(B) in the case of any other tobacco prod9 uct contained in an applicable list, a copy of all 

10 consumer information and other labeling for 

11 such tobacco product, a representative sampling 

12 of advertisements for such tobacco product, 

13 and, upon request made by the Secretary for 

14 good cause, a copy of all advertisements for a 

15 particular tobacco product; and 

16 ‘‘(C) if the registrant filing a list has de17 termined that a tobacco product contained in 

18 such list is not subject to a tobacco product 

19 standard established under section 907, a brief 

20 statement of the basis upon which the reg21 istrant made such determination if the Sec22 retary requests such a statement with respect 

23 to that particular tobacco product. 

24 ‘‘(2) BIANNUAL REPORT OF ANY CHANGE IN

25 PRODUCT LIST.—Each person who registers with the 
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•S 1074 IS 

1 Secretary under this section shall report to the Sec2 retary once during the month of June of each year 

3 and once during the month of December of each 

4 year the following: 

5 ‘‘(A) A list of each tobacco product intro6 duced by the registrant for commercial distribu7 tion which has not been included in any list 

8 previously filed by that person with the Sec9 retary under this subparagraph or paragraph 

10 (1). A list under this subparagraph shall list a 

11 tobacco product by its established name and 

12 shall be accompanied by the other information 

13 required by paragraph (1). 

14 ‘‘(B) If since the date the registrant last 

15 made a report under this paragraph that person 

16 has discontinued the manufacture, preparation, 

17 compounding, or processing for commercial dis18 tribution of a tobacco product included in a list 

19 filed under subparagraph (A) or paragraph (1), 

20 notice of such discontinuance, the date of such 

21 discontinuance, and the identity of its estab22 lished name. 

23 ‘‘(C) If since the date the registrant re24 ported under subparagraph (B) a notice of dis25 continuance that person has resumed the manu-
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1 facture, preparation, compounding, or proc2 essing for commercial distribution of the to3 bacco product with respect to which such notice 

4 of discontinuance was reported, notice of such 

5 resumption, the date of such resumption, the 

6 identity of such tobacco product by established 

7 name, and other information required by para8 graph (1), unless the registrant has previously 

9 reported such resumption to the Secretary 

10 under this subparagraph. 

11 ‘‘(D) Any material change in any informa12 tion previously submitted under this paragraph 

13 or paragraph (1). 

14 ‘‘(j) REPORT PRECEDING INTRODUCTION OF CER15 TAIN SUBSTANTIALLY-EQUIVALENT PRODUCTS INTO

16 INTERSTATE COMMERCE.— 

17 ‘‘(1) IN GENERAL.—Each person who is re18 quired to register under this section and who pro19 poses to begin the introduction or delivery for intro20 duction into interstate commerce for commercial dis21 tribution of a tobacco product intended for human 

22 use that was not commercially marketed (other than 

23 for test marketing) in the United States as of June 

24 1, 2003, shall, at least 90 days prior to making such 

25 introduction or delivery, report to the Secretary (in 
143 

•S 1074 IS 

1 such form and manner as the Secretary shall pre2 scribe)— 

3 ‘‘(A) the basis for such person’s determina4 tion that the tobacco product is substantially 

5 equivalent, within the meaning of section 910, 

6 to a tobacco product commercially marketed 

7 (other than for test marketing) in the United 

8 States as of June 1, 2003, that is in compliance 

9 with the requirements of this Act; and 

10 ‘‘(B) action taken by such person to com11 ply with the requirements under section 907 

12 that are applicable to the tobacco product. 

13 ‘‘(2) APPLICATION TO CERTAIN POST JUNE 1, 

14 2003 PRODUCTS.—A report under this subsection for 

15 a tobacco product that was first introduced or deliv16 ered for introduction into interstate commerce for 

17 commercial distribution in the United States after 

18 June 1, 2003, and prior to the date that is 15 

19 months after the date of enactment of the Family 

20 Smoking Prevention and Tobacco Control Act shall 

21 be submitted to the Secretary not later than 15 

22 months after such date of enactment. 

23 ‘‘(3) EXEMPTIONS.— 

24 ‘‘(A) IN GENERAL.—The Secretary may by 

25 regulation, exempt from the requirements of 
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•S 1074 IS 

1 this subsection tobacco products that are modi2 fied by adding or deleting a tobacco additive, or 

3 increasing or decreasing the quantity of an ex4 isting tobacco additive, if the Secretary deter5 mines that— 

6 ‘‘(i) such modification would be a 

7 minor modification of a tobacco product 

8 authorized for sale under this Act; 

9 ‘‘(ii) a report under this subsection is 

10 not necessary to ensure that permitting the 

11 tobacco product to be marketed would be 

12 appropriate for protection of the public 

13 health; and 

14 ‘‘(iii) an exemption is otherwise appro15 priate. 

16 ‘‘(B) REGULATIONS.—Not later than 9 

17 months after the date of enactment of the Fam18 ily Smoking Prevention and Tobacco Control 

19 Act, the Secretary shall issue regulations to im20 plement this paragraph. 

21 ‘‘SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL 

22 OF TOBACCO PRODUCTS. 

23 ‘‘(a) IN GENERAL.—Any requirement established by 

24 or under section 902, 903, 905, or 909 applicable to a 

25 tobacco product shall apply to such tobacco product until 
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•S 1074 IS 

1 the applicability of the requirement to the tobacco product 

2 has been changed by action taken under section 907, sec3 tion 910, section 911, or subsection (d) of this section, 

4 and any requirement established by or under section 902, 

5 903, 905, or 909 which is inconsistent with a requirement 

6 imposed on such tobacco product under section 907, sec7 tion 910, section 911, or subsection (d) of this section 

8 shall not apply to such tobacco product. 

9 ‘‘(b) INFORMATION ON PUBLIC ACCESS AND COM10 MENT.—Each notice of proposed rulemaking under section 

11 907, 908, 909, 910, or 911 or under this section, any 

12 other notice which is published in the Federal Register 

13 with respect to any other action taken under any such sec14 tion and which states the reasons for such action, and 

15 each publication of findings required to be made in con16 nection with rulemaking under any such section shall set 

17 forth— 

18 ‘‘(1) the manner in which interested persons 

19 may examine data and other information on which 

20 the notice or findings is based; and 

21 ‘‘(2) the period within which interested persons 

22 may present their comments on the notice or find23 ings (including the need therefore) orally or in writ24 ing, which period shall be at least 60 days but may 

25 not exceed 90 days unless the time is extended by 
146 

•S 1074 IS 

1 the Secretary by a notice published in the Federal 

2 Register stating good cause therefore. 

3 ‘‘(c) LIMITED CONFIDENTIALITY OF INFORMA4 TION.—Any information reported to or otherwise obtained 

5 by the Secretary or the Secretary’s representative under 

6 section 903, 904, 907, 908, 909, 910, 911, or 704, or 

7 under subsection (e) or (f) of this section, which is exempt 

8 from disclosure under subsection (a) of section 552 of title 

9 5, United States Code, by reason of subsection (b)(4) of 

10 that section shall be considered confidential and shall not 

11 be disclosed, except that the information may be disclosed 

12 to other officers or employees concerned with carrying out 

13 this chapter, or when relevant in any proceeding under 

14 this chapter. 

15 ‘‘(d) RESTRICTIONS.— 

16 ‘‘(1) IN GENERAL.—The Secretary may by reg17 ulation require restrictions on the sale and distribu18 tion of a tobacco product, including restrictions on 

19 the access to, and the advertising and promotion of, 

20 the tobacco product, if the Secretary determines that 

21 such regulation would be appropriate for the protec22 tion of the public health. The Secretary may by reg23 ulation impose restrictions on the advertising and 

24 promotion of a tobacco product consistent with and 

25 to full extent permitted by the first amendment to 
147 

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1 the Constitution. The finding as to whether such 

2 regulation would be appropriate for the protection of 

3 the public health shall be determined with respect to 

4 the risks and benefits to the population as a whole, 

5 including users and non-users of the tobacco prod6 uct, and taking into account— 

7 ‘‘(A) the increased or decreased likelihood 

8 that existing users of tobacco products will stop 

9 using such products; and 

10 ‘‘(B) the increased or decreased likelihood 

11 that those who do not use tobacco products will 

12 start using such products. 

13 No such regulation may require that the sale or dis14 tribution of a tobacco product be limited to the writ15 ten or oral authorization of a practitioner licensed 

16 by law to prescribe medical products. 

17 ‘‘(2) LABEL STATEMENTS.—The label of a to18 bacco product shall bear such appropriate state19 ments of the restrictions required by a regulation 

20 under subsection (a) as the Secretary may in such 

21 regulation prescribe. 

22 ‘‘(3) LIMITATIONS.— 

23 ‘‘(A) IN GENERAL.—No restrictions under 

24 paragraph (1) may— 
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•S 1074 IS 

1 ‘‘(i) prohibit the sale of any tobacco 

2 product in face-to-face transactions by a 

3 specific category of retail outlets; or 

4 ‘‘(ii) establish a minimum age of sale 

5 of tobacco products to any person older 

6 than 18 years of age. 

7 ‘‘(B) MATCHBOOKS.—For purposes of any 

8 regulations issued by the Secretary, matchbooks 

9 of conventional size containing not more than 

10 20 paper matches, and which are customarily 

11 given away for free with the purchase of to12 bacco products shall be considered as adult 

13 written publications which shall be permitted to 

14 contain advertising. Notwithstanding the pre15 ceding sentence, if the Secretary finds that such 

16 treatment of matchbooks is not appropriate for 

17 the protection of the public health, the Sec18 retary may determine by regulation that match19 books shall not be considered adult written pub20 lications. 

21 ‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE22 MENTS.— 

23 ‘‘(1) METHODS, FACILITIES, AND CONTROLS TO

24 CONFORM.— 
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•S 1074 IS 

1 ‘‘(A) IN GENERAL.—The Secretary may, in 

2 accordance with subparagraph (B), prescribe 

3 regulations (which may differ based on the type 

4 of tobacco product involved) requiring that the 

5 methods used in, and the facilities and controls 

6 used for, the manufacture, pre-production de7 sign validation (including a process to assess 

8 the performance of a tobacco product), packing 

9 and storage of a tobacco product, conform to 

10 current good manufacturing practice, as pre11 scribed in such regulations, to assure that the 

12 public health is protected and that the tobacco 

13 product is in compliance with this chapter. 

14 Good manufacturing practices may include the 

15 testing of raw tobacco for pesticide chemical 

16 residues regardless of whether a tolerance for 

17 such chemical residues has been established. 

18 ‘‘(B) REQUIREMENTS.—The Secretary 

19 shall— 

20 ‘‘(i) before promulgating any regula21 tion under subparagraph (A), afford the 

22 Tobacco Products Scientific Advisory Com23 mittee an opportunity to submit rec24 ommendations with respect to the regula25 tion proposed to be promulgated; 
150 

•S 1074 IS 

1 ‘‘(ii) before promulgating any regula2 tion under subparagraph (A), afford oppor3 tunity for an oral hearing; 

4 ‘‘(iii) provide the advisory committee a 

5 reasonable time to make its recommenda6 tion with respect to proposed regulations 

7 under subparagraph (A); and 

8 ‘‘(iv) in establishing the effective date 

9 of a regulation promulgated under this 

10 subsection, take into account the dif11 ferences in the manner in which the dif12 ferent types of tobacco products have his13 torically been produced, the financial re14 sources of the different tobacco product 

15 manufacturers, and the state of their exist16 ing manufacturing facilities, and shall pro17 vide for a reasonable period of time for 

18 such manufacturers to conform to good 

19 manufacturing practices. 

20 ‘‘(2) EXEMPTIONS; VARIANCES.— 

21 ‘‘(A) PETITION.—Any person subject to 

22 any requirement prescribed under paragraph 

23 (1) may petition the Secretary for a permanent 

24 or temporary exemption or variance from such 

25 requirement. Such a petition shall be submitted 
151 

•S 1074 IS 

1 to the Secretary in such form and manner as 

2 the Secretary shall prescribe and shall— 

3 ‘‘(i) in the case of a petition for an ex4 emption from a requirement, set forth the 

5 basis for the petitioner’s determination 

6 that compliance with the requirement is 

7 not required to assure that the tobacco 

8 product will be in compliance with this 

9 chapter; 

10 ‘‘(ii) in the case of a petition for a 

11 variance from a requirement, set forth the 

12 methods proposed to be used in, and the 

13 facilities and controls proposed to be used 

14 for, the manufacture, packing, and storage 

15 of the tobacco product in lieu of the meth16 ods, facilities, and controls prescribed by 

17 the requirement; and 

18 ‘‘(iii) contain such other information 

19 as the Secretary shall prescribe. 

20 ‘‘(B) REFERRAL TO THE TOBACCO PROD21 UCTS SCIENTIFIC ADVISORY COMMITTEE.—The 

22 Secretary may refer to the Tobacco Products 

23 Scientific Advisory Committee any petition sub24 mitted under subparagraph (A). The Tobacco 

25 Products Scientific Advisory Committee shall 
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•S 1074 IS 

1 report its recommendations to the Secretary 

2 with respect to a petition referred to it within 

3 60 days after the date of the petition’s referral. 

4 Within 60 days after— 

5 ‘‘(i) the date the petition was sub6 mitted to the Secretary under subpara7 graph (A); or 

8 ‘‘(ii) the day after the petition was re9 ferred to the Tobacco Products Scientific 

10 Advisory Committee, whichever occurs 

11 later, the Secretary shall by order either 

12 deny the petition or approve it. 

13 ‘‘(C) APPROVAL.—The Secretary may ap14 prove— 

15 ‘‘(i) a petition for an exemption for a 

16 tobacco product from a requirement if the 

17 Secretary determines that compliance with 

18 such requirement is not required to assure 

19 that the tobacco product will be in compli20 ance with this chapter; and 

21 ‘‘(ii) a petition for a variance for a to22 bacco product from a requirement if the 

23 Secretary determines that the methods to 

24 be used in, and the facilities and controls 

25 to be used for, the manufacture, packing, 
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•S 1074 IS 

1 and storage of the tobacco product in lieu 

2 of the methods, controls, and facilities pre3 scribed by the requirement are sufficient to 

4 assure that the tobacco product will be in 

5 compliance with this chapter. 

6 ‘‘(D) CONDITIONS.—An order of the Sec7 retary approving a petition for a variance shall 

8 prescribe such conditions respecting the meth9 ods used in, and the facilities and controls used 

10 for, the manufacture, packing, and storage of 

11 the tobacco product to be granted the variance 

12 under the petition as may be necessary to as13 sure that the tobacco product will be in compli14 ance with this chapter. 

15 ‘‘(E) HEARING.—After the issuance of an 

16 order under subparagraph (B) respecting a pe17 tition, the petitioner shall have an opportunity 

18 for an informal hearing on such order. 

19 ‘‘(3) COMPLIANCE.—Compliance with require20 ments under this subsection shall not be required be21 fore the period ending 3 years after the date of en22 actment of the Family Smoking Prevention and To23 bacco Control Act. 

24 ‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 

25 may enter into contracts for research, testing, and dem-
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•S 1074 IS 

1 onstrations respecting tobacco products and may obtain 

2 tobacco products for research, testing, and demonstration 

3 purposes without regard to section 3324(a) and (b) of title 

4 31, United States Code, and section 5 of title 41, United 

5 States Code. 

6 ‘‘SEC. 907. TOBACCO PRODUCT STANDARDS. 

7 ‘‘(a) IN GENERAL.— 

8 ‘‘(1) SPECIAL RULE FOR CIGARETTES.—A ciga9 rette or any of its component parts (including the 

10 tobacco, filter, or paper) shall not contain, as a con11 stituent (including a smoke constituent) or additive, 

12 an artificial or natural flavor (other than tobacco or 

13 menthol) or an herb or spice, including strawberry, 

14 grape, orange, clove, cinnamon, pineapple, vanilla, 

15 coconut, licorice, cocoa, chocolate, cherry, or coffee, 

16 that is a characterizing flavor of the tobacco product 

17 or tobacco smoke. Nothing in this subparagraph 

18 shall be construed to limit the Secretary’s authority 

19 to take action under this section or other sections of 

20 this Act applicable to menthol or any artificial or 

21 natural flavor, herb, or spice not specified in this 

22 paragraph. 

23 ‘‘(2) REVISION OF TOBACCO PRODUCT STAND24 ARDS.—The Secretary may revise the tobacco prod-
155 

•S 1074 IS 

1 uct standards in paragraph (1) in accordance with 

2 subsection (b). 

3 ‘‘(3) TOBACCO PRODUCT STANDARDS.—The 

4 Secretary may adopt tobacco product standards in 

5 addition to those in paragraph (1) if the Secretary 

6 finds that a tobacco product standard is appropriate 

7 for the protection of the public health. This finding 

8 shall be determined with respect to the risks and 

9 benefits to the population as a whole, including 

10 users and non-users of the tobacco product, and tak11 ing into account— 

12 ‘‘(A) the increased or decreased likelihood 

13 that existing users of tobacco products will stop 

14 using such products; and 

15 ‘‘(B) the increased or decreased likelihood 

16 that those who do not use tobacco products will 

17 start using such products. 

18 ‘‘(4) CONTENT OF TOBACCO PRODUCT STAND19 ARDS.—A tobacco product standard established 

20 under this section for a tobacco product— 

21 ‘‘(A) shall include provisions that are ap22 propriate for the protection of the public health, 

23 including provisions, where appropriate— 

24 ‘‘(i) for the reduction of nicotine 

25 yields of the product; 
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•S 1074 IS 

1 ‘‘(ii) for the reduction or elimination 

2 of other constituents, including smoke con3 stituents, or harmful components of the 

4 product; or 

5 ‘‘(iii) relating to any other require6 ment under (B); 

7 ‘‘(B) shall, where appropriate for the pro8 tection of the public health, include— 

9 ‘‘(i) provisions respecting the con10 struction, components, ingredients, addi11 tives, constituents, including smoke con12 stituents, and properties of the tobacco 

13 product; 

14 ‘‘(ii) provisions for the testing (on a 

15 sample basis or, if necessary, on an indi16 vidual basis) of the tobacco product; 

17 ‘‘(iii) provisions for the measurement 

18 of the tobacco product characteristics of 

19 the tobacco product; 

20 ‘‘(iv) provisions requiring that the re21 sults of each or of certain of the tests of 

22 the tobacco product required to be made 

23 under clause (ii) show that the tobacco 

24 product is in conformity with the portions 
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•S 1074 IS 

1 of the standard for which the test or tests 

2 were required; and 

3 ‘‘(v) a provision requiring that the 

4 sale and distribution of the tobacco prod5 uct be restricted but only to the extent 

6 that the sale and distribution of a tobacco 

7 product may be restricted under a regula8 tion under section 906(d); and 

9 ‘‘(C) shall, where appropriate, require the 

10 use and prescribe the form and content of label11 ing for the proper use of the tobacco product. 

12 ‘‘(5) PERIODIC RE-EVALUATION OF TOBACCO

13 PRODUCT STANDARDS.—The Secretary shall provide 

14 for periodic evaluation of tobacco product standards 

15 established under this section to determine whether 

16 such standards should be changed to reflect new 

17 medical, scientific, or other technological data. The 

18 Secretary may provide for testing under paragraph 

19 (4)(B) by any person. 

20 ‘‘(6) INVOLVEMENT OF OTHER AGENCIES; IN21 FORMED PERSONS.—In carrying out duties under 

22 this section, the Secretary shall endeavor to— 

23 ‘‘(A) use personnel, facilities, and other 

24 technical support available in other Federal 

25 agencies; 
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•S 1074 IS 

1 ‘‘(B) consult with other Federal agencies 

2 concerned with standard-setting and other na3 tionally or internationally recognized standard4 setting entities; and 

5 ‘‘(C) invite appropriate participation, 

6 through joint or other conferences, workshops, 

7 or other means, by informed persons represent8 ative of scientific, professional, industry, agri9 cultural, or consumer organizations who in the 

10 Secretary’s judgment can make a significant 

11 contribution. 

12 ‘‘(b) ESTABLISHMENT OF STANDARDS.— 

13 ‘‘(1) NOTICE.— 

14 ‘‘(A) IN GENERAL.—The Secretary shall 

15 publish in the Federal Register a notice of pro16 posed rulemaking for the establishment, amend17 ment, or revocation of any tobacco product 

18 standard. 

19 ‘‘(B) REQUIREMENTS OF NOTICE.—A no20 tice of proposed rulemaking for the establish21 ment or amendment of a tobacco product stand22 ard for a tobacco product shall— 

23 ‘‘(i) set forth a finding with sup24 porting justification that the tobacco prod-
159 

•S 1074 IS 

1 uct standard is appropriate for the protec2 tion of the public health; 

3 ‘‘(ii) set forth proposed findings with 

4 respect to the risk of illness or injury that 

5 the tobacco product standard is intended 

6 to reduce or eliminate; and 

7 ‘‘(iii) invite interested persons to sub8 mit an existing tobacco product standard 

9 for the tobacco product, including a draft 

10 or proposed tobacco product standard, for 

11 consideration by the Secretary. 

12 ‘‘(C) STANDARD.—Upon a determination 

13 by the Secretary that an additive, constituent 

14 (including smoke constituent), or other compo15 nent of the product that is the subject of the 

16 proposed tobacco product standard is harmful, 

17 it shall be the burden of any party challenging 

18 the proposed standard to prove that the pro19 posed standard will not reduce or eliminate the 

20 risk of illness or injury. 

21 ‘‘(D) FINDING.—A notice of proposed rule22 making for the revocation of a tobacco product 

23 standard shall set forth a finding with sup24 porting justification that the tobacco product 
160 

•S 1074 IS 

1 standard is no longer appropriate for the pro2 tection of the public health. 

3 ‘‘(E) CONSIDERATION BY SECRETARY.— 

4 The Secretary shall consider all information 

5 submitted in connection with a proposed stand6 ard, including information concerning the coun7 tervailing effects of the tobacco product stand8 ard on the health of adolescent tobacco users, 

9 adult tobacco users, or non-tobacco users, such 

10 as the creation of a significant demand for con11 traband or other tobacco products that do not 

12 meet the requirements of this chapter and the 

13 significance of such demand, and shall issue the 

14 standard if the Secretary determines that the 

15 standard would be appropriate for the protec16 tion of the public health. 

17 ‘‘(F) COMMENT.—The Secretary shall pro18 vide for a comment period of not less than 60 

19 days. 

20 ‘‘(2) PROMULGATION.— 

21 ‘‘(A) IN GENERAL.—After the expiration of 

22 the period for comment on a notice of proposed 

23 rulemaking published under paragraph (1) re24 specting a tobacco product standard and after 

25 consideration of such comments and any report 
161 

•S 1074 IS 

1 from the Tobacco Products Scientific Advisory 

2 Committee, the Secretary shall— 

3 ‘‘(i) promulgate a regulation estab4 lishing a tobacco product standard and 

5 publish in the Federal Register findings on 

6 the matters referred to in paragraph (1); 

7 or 

8 ‘‘(ii) publish a notice terminating the 

9 proceeding for the development of the 

10 standard together with the reasons for 

11 such termination. 

12 ‘‘(B) EFFECTIVE DATE.—A regulation es13 tablishing a tobacco product standard shall set 

14 forth the date or dates upon which the standard 

15 shall take effect, but no such regulation may 

16 take effect before 1 year after the date of its 

17 publication unless the Secretary determines 

18 that an earlier effective date is necessary for 

19 the protection of the public health. Such date or 

20 dates shall be established so as to minimize, 

21 consistent with the public health, economic loss 

22 to, and disruption or dislocation of, domestic 

23 and international trade. 

24 ‘‘(3) POWER RESERVED TO CONGRESS.—Be25 cause of the importance of a decision of the Sec-
162 

•S 1074 IS 

1 retary to issue a regulation establishing a tobacco 

2 product standard— 

3 ‘‘(A) banning all cigarettes, all smokeless 

4 tobacco products, all little cigars, all cigars 

5 other than little cigars, all pipe tobacco, or all 

6 roll your own tobacco products; or 

7 ‘‘(B) requiring the reduction of nicotine 

8 yields of a tobacco product to zero, 

9 Congress expressly reserves to itself such power. 

10 ‘‘(4) AMENDMENT; REVOCATION.— 

11 ‘‘(A) AUTHORITY.—The Secretary, upon 

12 the Secretary’s own initiative or upon petition 

13 of an interested person may by a regulation, 

14 promulgated in accordance with the require15 ments of paragraphs (1) and (2)(B), amend or 

16 revoke a tobacco product standard. 

17 ‘‘(B) EFFECTIVE DATE.—The Secretary 

18 may declare a proposed amendment of a to19 bacco product standard to be effective on and 

20 after its publication in the Federal Register and 

21 until the effective date of any final action taken 

22 on such amendment if the Secretary determines 

23 that making it so effective is in the public inter24 est. 
163 

•S 1074 IS 

1 ‘‘(5) REFERENCE TO ADVISORY COMMITTEE.— 

2 The Secretary may— 

3 ‘‘(A) on the Secretary’s own initiative, 

4 refer a proposed regulation for the establish5 ment, amendment, or revocation of a tobacco 

6 product standard; or 

7 ‘‘(B) upon the request of an interested per8 son which demonstrates good cause for referral 

9 and which is made before the expiration of the 

10 period for submission of comments on such pro11 posed regulation, refer such proposed regulation 

12 to the Tobacco Products Scientific Advisory 

13 Committee, for a report and recommendation 

14 with respect to any matter involved in the pro15 posed regulation which requires the exercise of 

16 scientific judgment. If a proposed regulation is 

17 referred under this paragraph to the Tobacco 

18 Products Scientific Advisory Committee, the 

19 Secretary shall provide the advisory committee 

20 with the data and information on which such 

21 proposed regulation is based. The Tobacco 

22 Products Scientific Advisory Committee shall, 

23 within 60 days after the referral of a proposed 

24 regulation and after independent study of the 

25 data and information furnished to it by the Sec-
164 

•S 1074 IS 

1 retary and other data and information before it, 

2 submit to the Secretary a report and rec3 ommendation respecting such regulation, to4 gether with all underlying data and information 

5 and a statement of the reason or basis for the 

6 recommendation. A copy of such report and rec7 ommendation shall be made public by the Sec8 retary. 

9 ‘‘SEC. 908. NOTIFICATION AND OTHER REMEDIES. 

10 ‘‘(a) NOTIFICATION.—If the Secretary determines 

11 that— 

12 ‘‘(1) a tobacco product which is introduced or 

13 delivered for introduction into interstate commerce 

14 for commercial distribution presents an unreasonable 

15 risk of substantial harm to the public health; and 

16 ‘‘(2) notification under this subsection is nec17 essary to eliminate the unreasonable risk of such 

18 harm and no more practicable means is available 

19 under the provisions of this chapter (other than this 

20 section) to eliminate such risk, the Secretary may 

21 issue such order as may be necessary to assure that 

22 adequate notification is provided in an appropriate 

23 form, by the persons and means best suited under 

24 the circumstances involved, to all persons who 

25 should properly receive such notification in order to 
165 

•S 1074 IS 

1 eliminate such risk. The Secretary may order notifi2 cation by any appropriate means, including public 

3 service announcements. Before issuing an order 

4 under this subsection, the Secretary shall consult 

5 with the persons who are to give notice under the 

6 order. 

7 ‘‘(b) NO EXEMPTION FROM OTHER LIABILITY.— 

8 Compliance with an order issued under this section shall 

9 not relieve any person from liability under Federal or 

10 State law. In awarding damages for economic loss in an 

11 action brought for the enforcement of any such liability, 

12 the value to the plaintiff in such action of any remedy 

13 provided under such order shall be taken into account. 

14 ‘‘(c) RECALL AUTHORITY.— 

15 ‘‘(1) IN GENERAL.—If the Secretary finds that 

16 there is a reasonable probability that a tobacco prod17 uct contains a manufacturing or other defect not or18 dinarily contained in tobacco products on the market 

19 that would cause serious, adverse health con20 sequences or death, the Secretary shall issue an 

21 order requiring the appropriate person (including 

22 the manufacturers, importers, distributors, or retail23 ers of the tobacco product) to immediately cease dis24 tribution of such tobacco product. The order shall 

25 provide the person subject to the order with an op-
166 

•S 1074 IS 

1 portunity for an informal hearing, to be held not 

2 later than 10 days after the date of the issuance of 

3 the order, on the actions required by the order and 

4 on whether the order should be amended to require 

5 a recall of such tobacco product. If, after providing 

6 an opportunity for such a hearing, the Secretary de7 termines that inadequate grounds exist to support 

8 the actions required by the order, the Secretary shall 

9 vacate the order. 

10 ‘‘(2) AMENDMENT OF ORDER TO REQUIRE RE11 CALL.— 

12 ‘‘(A) IN GENERAL.—If, after providing an 

13 opportunity for an informal hearing under 

14 paragraph (1), the Secretary determines that 

15 the order should be amended to include a recall 

16 of the tobacco product with respect to which the 

17 order was issued, the Secretary shall, except as 

18 provided in subparagraph (B), amend the order 

19 to require a recall. The Secretary shall specify 

20 a timetable in which the tobacco product recall 

21 will occur and shall require periodic reports to 

22 the Secretary describing the progress of the re23 call. 

24 ‘‘(B) NOTICE.—An amended order under 

25 subparagraph (A)— 
167 

•S 1074 IS 

1 ‘‘(i) shall not include recall of a to2 bacco product from individuals; and 

3 ‘‘(ii) shall provide for notice to per4 sons subject to the risks associated with 

5 the use of such tobacco product. 

6 In providing the notice required by clause (ii), 

7 the Secretary may use the assistance of retail8 ers and other persons who distributed such to9 bacco product. If a significant number of such 

10 persons cannot be identified, the Secretary shall 

11 notify such persons under section 705(b). 

12 ‘‘(3) REMEDY NOT EXCLUSIVE.—The remedy 

13 provided by this subsection shall be in addition to 

14 remedies provided by subsection (a) of this section. 

15 ‘‘SEC. 909. RECORDS AND REPORTS ON TOBACCO PROD16 UCTS. 

17 ‘‘(a) IN GENERAL.—Every person who is a tobacco 

18 product manufacturer or importer of a tobacco product 

19 shall establish and maintain such records, make such re20 ports, and provide such information, as the Secretary may 

21 by regulation reasonably require to assure that such to22 bacco product is not adulterated or misbranded and to 

23 otherwise protect public health. Regulations prescribed 

24 under the preceding sentence— 
168 

•S 1074 IS 

1 ‘‘(1) may require a tobacco product manufac2 turer or importer to report to the Secretary when3 ever the manufacturer or importer receives or other4 wise becomes aware of information that reasonably 

5 suggests that one of its marketed tobacco products 

6 may have caused or contributed to a serious unex7 pected adverse experience associated with the use of 

8 the product or any significant increase in the fre9 quency of a serious, expected adverse product experi10 ence; 

11 ‘‘(2) shall require reporting of other significant 

12 adverse tobacco product experiences as determined 

13 by the Secretary to be necessary to be reported; 

14 ‘‘(3) shall not impose requirements unduly bur15 densome to a tobacco product manufacturer or im16 porter, taking into account the cost of complying 

17 with such requirements and the need for the protec18 tion of the public health and the implementation of 

19 this chapter; 

20 ‘‘(4) when prescribing the procedure for making 

21 requests for reports or information, shall require 

22 that each request made under such regulations for 

23 submission of a report or information to the Sec24 retary state the reason or purpose for such request 
169 

•S 1074 IS 

1 and identify to the fullest extent practicable such re2 port or information; 

3 ‘‘(5) when requiring submission of a report or 

4 information to the Secretary, shall state the reason 

5 or purpose for the submission of such report or in6 formation and identify to the fullest extent prac7 ticable such report or information; and 

8 ‘‘(6) may not require that the identity of any 

9 patient or user be disclosed in records, reports, or 

10 information required under this subsection unless re11 quired for the medical welfare of an individual, to 

12 determine risks to public health of a tobacco prod13 uct, or to verify a record, report, or information sub14 mitted under this chapter. 

15 In prescribing regulations under this subsection, the Sec16 retary shall have due regard for the professional ethics of 

17 the medical profession and the interests of patients. The 

18 prohibitions of paragraph (6) continue to apply to records, 

19 reports, and information concerning any individual who 

20 has been a patient, irrespective of whether or when he 

21 ceases to be a patient. 

22 ‘‘(b) REPORTS OF REMOVALS AND CORRECTIONS.— 

23 ‘‘(1) IN GENERAL.—Except as provided in para24 graph (2), the Secretary shall by regulation require 

25 a tobacco product manufacturer or importer of a to-
170 

•S 1074 IS 

1 bacco product to report promptly to the Secretary 

2 any corrective action taken or removal from the 

3 market of a tobacco product undertaken by such 

4 manufacturer or importer if the removal or correc5 tion was undertaken— 

6 ‘‘(A) to reduce a risk to health posed by 

7 the tobacco product; or 

8 ‘‘(B) to remedy a violation of this chapter 

9 caused by the tobacco product which may 

10 present a risk to health. 

11 A tobacco product manufacturer or importer of a to12 bacco product who undertakes a corrective action or 

13 removal from the market of a tobacco product which 

14 is not required to be reported under this subsection 

15 shall keep a record of such correction or removal. 

16 ‘‘(2) EXCEPTION.—No report of the corrective 

17 action or removal of a tobacco product may be re18 quired under paragraph (1) if a report of the correc19 tive action or removal is required and has been sub20 mitted under subsection (a). 

21 ‘‘SEC. 910. APPLICATION FOR REVIEW OF CERTAIN TO22 BACCO PRODUCTS. 

23 ‘‘(a) IN GENERAL.— 
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•S 1074 IS 

1 ‘‘(1) NEW TOBACCO PRODUCT DEFINED.—For 

2 purposes of this section the term ‘new tobacco prod3 uct’ means— 

4 ‘‘(A) any tobacco product (including those 

5 products in test markets) that was not commer6 cially marketed in the United States as of June 

7 1, 2003; or 

8 ‘‘(B) any modification (including a change 

9 in design, any component, any part, or any con10 stituent, including a smoke constituent, or in 

11 the content, delivery or form of nicotine, or any 

12 other additive or ingredient) of a tobacco prod13 uct where the modified product was commer14 cially marketed in the United States after June 

15 1, 2003. 

16 ‘‘(2) PREMARKET APPROVAL REQUIRED.— 

17 ‘‘(A) NEW PRODUCTS.—Approval under 

18 this section of an application for premarket ap19 proval for any new tobacco product is required 

20 unless— 

21 ‘‘(i) the manufacturer has submitted a 

22 report under section 905(j); and 

23 ‘‘(ii) the Secretary has issued an order 

24 that the tobacco product— 
172 

•S 1074 IS 

1 ‘‘(I) is substantially equivalent to 

2 a tobacco product commercially mar3 keted (other than for test marketing) 

4 in the United States as of June 1, 

5 2003; and 

6 ‘‘(II)(aa) is in compliance with 

7 the requirements of this Act; or 

8 ‘‘(bb) is exempt from the require9 ments of section 905(j) pursuant to a 

10 regulation issued under section 

11 905(j)(3). 

12 ‘‘(B) APPLICATION TO CERTAIN POST

13 JUNE 1, 2003 PRODUCTS.—Subparagraph (A) 

14 shall not apply to a tobacco product— 

15 ‘‘(i) that was first introduced or deliv16 ered for introduction into interstate com17 merce for commercial distribution in the 

18 United States after June 1, 2003, and 

19 prior to the date that is 15 months after 

20 the date of enactment of the Family Smok21 ing Prevention and Tobacco Control Act; 

22 and 

23 ‘‘(ii) for which a report was submitted 

24 under section 905(j) within such 15-month 

25 period, until the Secretary issues an order 
173 

•S 1074 IS 

1 that the tobacco product is not substan2 tially equivalent. 

3 ‘‘(3) SUBSTANTIALLY EQUIVALENT DEFINED.— 

4 ‘‘(A) IN GENERAL.—In this section and 

5 section 905(j), the terms ‘substantially equiva6 lent’ or ‘substantial equivalence’ mean, with re7 spect to the tobacco product being compared to 

8 the predicate tobacco product, that the Sec9 retary by order has found that the tobacco 

10 product— 

11 ‘‘(i) has the same characteristics as 

12 the predicate tobacco product; or 

13 ‘‘(ii) has different characteristics and 

14 the information submitted contains infor15 mation, including clinical data if deemed 

16 necessary by the Secretary, that dem17 onstrates that it is not appropriate to reg18 ulate the product under this section be19 cause the product does not raise different 

20 questions of public health. 

21 ‘‘(B) CHARACTERISTICS.—In subpara22 graph (A), the term ‘characteristics’ means the 

23 materials, ingredients, design, composition, 

24 heating source, or other features of a tobacco 

25 product. 
174 

•S 1074 IS 

1 ‘‘(C) LIMITATION.—A tobacco product may 

2 not be found to be substantially equivalent to a 

3 predicate tobacco product that has been re4 moved from the market at the initiative of the 

5 Secretary or that has been determined by a ju6 dicial order to be misbranded or adulterated. 

7 ‘‘(4) HEALTH INFORMATION.— 

8 ‘‘(A) SUMMARY.—As part of a submission 

9 under section 905(j) respecting a tobacco prod10 uct, the person required to file a premarket no11 tification under such section shall provide an 

12 adequate summary of any health information 

13 related to the tobacco product or state that 

14 such information will be made available upon 

15 request by any person. 

16 ‘‘(B) REQUIRED INFORMATION.—Any sum17 mary under subparagraph (A) respecting a to18 bacco product shall contain detailed information 

19 regarding data concerning adverse health ef20 fects and shall be made available to the public 

21 by the Secretary within 30 days of the issuance 

22 of a determination that such tobacco product is 

23 substantially equivalent to another tobacco 

24 product. 

25 ‘‘(b) APPLICATION.— 
175 

•S 1074 IS 

1 ‘‘(1) CONTENTS.—An application for premarket 

2 approval shall contain— 

3 ‘‘(A) full reports of all information, pub4 lished or known to, or which should reasonably 

5 be known to, the applicant, concerning inves6 tigations which have been made to show the 

7 health risks of such tobacco product and wheth8 er such tobacco product presents less risk than 

9 other tobacco products; 

10 ‘‘(B) a full statement of the components, 

11 ingredients, additives, and properties, and of 

12 the principle or principles of operation, of such 

13 tobacco product; 

14 ‘‘(C) a full description of the methods used 

15 in, and the facilities and controls used for, the 

16 manufacture, processing, and, when relevant, 

17 packing and installation of, such tobacco prod18 uct; 

19 ‘‘(D) an identifying reference to any to20 bacco product standard under section 907 

21 which would be applicable to any aspect of such 

22 tobacco product, and either adequate informa23 tion to show that such aspect of such tobacco 

24 product fully meets such tobacco product stand-
176 

•S 1074 IS 

1 ard or adequate information to justify any devi2 ation from such standard; 

3 ‘‘(E) such samples of such tobacco product 

4 and of components thereof as the Secretary 

5 may reasonably require; 

6 ‘‘(F) specimens of the labeling proposed to 

7 be used for such tobacco product; and 

8 ‘‘(G) such other information relevant to 

9 the subject matter of the application as the Sec10 retary may require. 

11 ‘‘(2) REFERENCE TO TOBACCO PRODUCTS SCI12 ENTIFIC ADVISORY COMMITTEE.—Upon receipt of an 

13 application meeting the requirements set forth in 

14 paragraph (1), the Secretary— 

15 ‘‘(A) may, on the Secretary’s own initia16 tive; or 

17 ‘‘(B) may, upon the request of an appli18 cant, refer such application to the Tobacco 

19 Products Scientific Advisory Committee for ref20 erence and for submission (within such period 

21 as the Secretary may establish) of a report and 

22 recommendation respecting approval of the ap23 plication, together with all underlying data and 

24 the reasons or basis for the recommendation. 

25 ‘‘(c) ACTION ON APPLICATION.— 
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•S 1074 IS 

1 ‘‘(1) DEADLINE.— 

2 ‘‘(A) IN GENERAL.—As promptly as pos3 sible, but in no event later than 180 days after 

4 the receipt of an application under subsection 

5 (b), the Secretary, after considering the report 

6 and recommendation submitted under para7 graph (2) of such subsection, shall— 

8 ‘‘(i) issue an order approving the ap9 plication if the Secretary finds that none of 

10 the grounds for denying approval specified 

11 in paragraph (2) of this subsection applies; 

12 or 

13 ‘‘(ii) deny approval of the application 

14 if the Secretary finds (and sets forth the 

15 basis for such finding as part of or accom16 panying such denial) that 1 or more 

17 grounds for denial specified in paragraph 

18 (2) of this subsection apply. 

19 ‘‘(B) RESTRICTIONS ON SALE AND DIS20 TRIBUTION.—An order approving an application 

21 for a tobacco product may require as a condi22 tion to such approval that the sale and distribu23 tion of the tobacco product be restricted but 

24 only to the extent that the sale and distribution 
178 

•S 1074 IS 

1 of a tobacco product may be restricted under a 

2 regulation under section 906(d). 

3 ‘‘(2) DENIAL OF APPROVAL.—The Secretary 

4 shall deny approval of an application for a tobacco 

5 product if, upon the basis of the information sub6 mitted to the Secretary as part of the application 

7 and any other information before the Secretary with 

8 respect to such tobacco product, the Secretary finds 

9 that— 

10 ‘‘(A) there is a lack of a showing that per11 mitting such tobacco product to be marketed 

12 would be appropriate for the protection of the 

13 public health; 

14 ‘‘(B) the methods used in, or the facilities 

15 or controls used for, the manufacture, proc16 essing, or packing of such tobacco product do 

17 not conform to the requirements of section 

18 906(e); 

19 ‘‘(C) based on a fair evaluation of all mate20 rial facts, the proposed labeling is false or mis21 leading in any particular; or 

22 ‘‘(D) such tobacco product is not shown to 

23 conform in all respects to a tobacco product 

24 standard in effect under section 907, compli25 ance with which is a condition to approval of 
179 

•S 1074 IS 

1 the application, and there is a lack of adequate 

2 information to justify the deviation from such 

3 standard. 

4 ‘‘(3) DENIAL INFORMATION.—Any denial of an 

5 application shall, insofar as the Secretary determines 

6 to be practicable, be accompanied by a statement in7 forming the applicant of the measures required to 

8 place such application in approvable form (which 

9 measures may include further research by the appli10 cant in accordance with 1 or more protocols pre11 scribed by the Secretary). 

12 ‘‘(4) BASIS FOR FINDING.—For purposes of 

13 this section, the finding as to whether approval of a 

14 tobacco product is appropriate for the protection of 

15 the public health shall be determined with respect to 

16 the risks and benefits to the population as a whole, 

17 including users and nonusers of the tobacco product, 

18 and taking into account— 

19 ‘‘(A) the increased or decreased likelihood 

20 that existing users of tobacco products will stop 

21 using such products; and 

22 ‘‘(B) the increased or decreased likelihood 

23 that those who do not use tobacco products will 

24 start using such products. 

25 ‘‘(5) BASIS FOR ACTION.— 
180 

•S 1074 IS 

1 ‘‘(A) INVESTIGATIONS.—For purposes of 

2 paragraph (2)(A), whether permitting a tobacco 

3 product to be marketed would be appropriate 

4 for the protection of the public health shall, 

5 when appropriate, be determined on the basis of 

6 well-controlled investigations, which may in7 clude 1 or more clinical investigations by ex8 perts qualified by training and experience to 

9 evaluate the tobacco product. 

10 ‘‘(B) OTHER EVIDENCE.—If the Secretary 

11 determines that there exists valid scientific evi12 dence (other than evidence derived from inves13 tigations described in subparagraph (A)) which 

14 is sufficient to evaluate the tobacco product the 

15 Secretary may authorize that the determination 

16 for purposes of paragraph (2)(A) be made on 

17 the basis of such evidence. 

18 ‘‘(d) WITHDRAWAL AND TEMPORARY SUSPENSION.— 

19 ‘‘(1) IN GENERAL.—The Secretary shall, upon 

20 obtaining, where appropriate, advice on scientific 

21 matters from an advisory committee, and after due 

22 notice and opportunity for informal hearing to the 

23 holder of an approved application for a tobacco 

24 product, issue an order withdrawing approval of the 

25 application if the Secretary finds— 
181 

•S 1074 IS 

1 ‘‘(A) that the continued marketing of such 

2 tobacco product no longer is appropriate for the 

3 protection of the public health; 

4 ‘‘(B) that the application contained or was 

5 accompanied by an untrue statement of a mate6 rial fact; 

7 ‘‘(C) that the applicant— 

8 ‘‘(i) has failed to establish a system 

9 for maintaining records, or has repeatedly 

10 or deliberately failed to maintain records 

11 or to make reports, required by an applica12 ble regulation under section 909; 

13 ‘‘(ii) has refused to permit access to, 

14 or copying or verification of, such records 

15 as required by section 704; or 

16 ‘‘(iii) has not complied with the re17 quirements of section 905; 

18 ‘‘(D) on the basis of new information be19 fore the Secretary with respect to such tobacco 

20 product, evaluated together with the evidence 

21 before the Secretary when the application was 

22 approved, that the methods used in, or the fa23 cilities and controls used for, the manufacture, 

24 processing, packing, or installation of such to25 bacco product do not conform with the require-
182 

•S 1074 IS 

1 ments of section 906(e) and were not brought 

2 into conformity with such requirements within a 

3 reasonable time after receipt of written notice 

4 from the Secretary of nonconformity; 

5 ‘‘(E) on the basis of new information be6 fore the Secretary, evaluated together with the 

7 evidence before the Secretary when the applica8 tion was approved, that the labeling of such to9 bacco product, based on a fair evaluation of all 

10 material facts, is false or misleading in any par11 ticular and was not corrected within a reason12 able time after receipt of written notice from 

13 the Secretary of such fact; or 

14 ‘‘(F) on the basis of new information be15 fore the Secretary, evaluated together with the 

16 evidence before the Secretary when the applica17 tion was approved, that such tobacco product is 

18 not shown to conform in all respects to a to19 bacco product standard which is in effect under 

20 section 907, compliance with which was a con21 dition to approval of the application, and that 

22 there is a lack of adequate information to jus23 tify the deviation from such standard. 

24 ‘‘(2) APPEAL.—The holder of an application 

25 subject to an order issued under paragraph (1) with-
183 

•S 1074 IS 

1 drawing approval of the application may, by petition 

2 filed on or before the 30th day after the date upon 

3 which such holder receives notice of such with4 drawal, obtain review thereof in accordance with 

5 subsection (e). 

6 ‘‘(3) TEMPORARY SUSPENSION.—If, after pro7 viding an opportunity for an informal hearing, the 

8 Secretary determines there is reasonable probability 

9 that the continuation of distribution of a tobacco 

10 product under an approved application would cause 

11 serious, adverse health consequences or death, that 

12 is greater than ordinarily caused by tobacco prod13 ucts on the market, the Secretary shall by order 

14 temporarily suspend the approval of the application 

15 approved under this section. If the Secretary issues 

16 such an order, the Secretary shall proceed expedi17 tiously under paragraph (1) to withdraw such appli18 cation. 

19 ‘‘(e) SERVICE OF ORDER.—An order issued by the 

20 Secretary under this section shall be served— 

21 ‘‘(1) in person by any officer or employee of the 

22 department designated by the Secretary; or 

23 ‘‘(2) by mailing the order by registered mail or 

24 certified mail addressed to the applicant at the ap-
184 

•S 1074 IS 

1 plicant’s last known address in the records of the 

2 Secretary. 

3 ‘‘(f) RECORDS.— 

4 ‘‘(1) ADDITIONAL INFORMATION.—In the case 

5 of any tobacco product for which an approval of an 

6 application filed under subsection (b) is in effect, the 

7 applicant shall establish and maintain such records, 

8 and make such reports to the Secretary, as the Sec9 retary may by regulation, or by order with respect 

10 to such application, prescribe on the basis of a find11 ing that such records and reports are necessary in 

12 order to enable the Secretary to determine, or facili13 tate a determination of, whether there is or may be 

14 grounds for withdrawing or temporarily suspending 

15 such approval. 

16 ‘‘(2) ACCESS TO RECORDS.—Each person re17 quired under this section to maintain records, and 

18 each person in charge or custody thereof, shall, upon 

19 request of an officer or employee designated by the 

20 Secretary, permit such officer or employee at all rea21 sonable times to have access to and copy and verify 

22 such records. 

23 ‘‘(g) INVESTIGATIONAL TOBACCO PRODUCT EXEMP24 TION FOR INVESTIGATIONAL USE.—The Secretary may 

25 exempt tobacco products intended for investigational use 
185 

•S 1074 IS 

1 from the provisions of this chapter under such conditions 

2 as the Secretary may by regulation prescribe. 

3 ‘‘SEC. 911. MODIFIED RISK TOBACCO PRODUCTS. 

4 ‘‘(a) IN GENERAL.—No person may introduce or de5 liver for introduction into interstate commerce any modi6 fied risk tobacco product unless approval of an application 

7 filed pursuant to subsection (d) is effective with respect 

8 to such product. 

9 ‘‘(b) DEFINITIONS.—In this section: 

10 ‘‘(1) MODIFIED RISK TOBACCO PRODUCT.—The 

11 term ‘modified risk tobacco product’ means any to12 bacco product that is sold or distributed for use to 

13 reduce harm or the risk of tobacco-related disease 

14 associated with commercially marketed tobacco prod15 ucts. 

16 ‘‘(2) SOLD OR DISTRIBUTED.— 

17 ‘‘(A) IN GENERAL.—With respect to a to18 bacco product, the term ‘sold or distributed for 

19 use to reduce harm or the risk of tobacco-re20 lated disease associated with commercially mar21 keted tobacco products’ means a tobacco prod22 uct— 

23 ‘‘(i) the label, labeling, or advertising 

24 of which represents explicitly or implicitly 

25 that— 
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1 ‘‘(I) the tobacco product presents 

2 a lower risk of tobacco-related disease 

3 or is less harmful than one or more 

4 other commercially marketed tobacco 

5 products; 

6 ‘‘(II) the tobacco product or its 

7 smoke contains a reduced level of a 

8 substance or presents a reduced expo9 sure to a substance; or 

10 ‘‘(III) the tobacco product or its 

11 smoke does not contain or is free of a 

12 substance; 

13 ‘‘(ii) the label, labeling, or advertising 

14 of which uses the descriptors ‘light’, ‘mild’, 

15 or ‘low’ or similar descriptors; or 

16 ‘‘(iii) the tobacco product manufac17 turer of which has taken any action di18 rected to consumers through the media or 

19 otherwise, other than by means of the to20 bacco product’s label, labeling or adver21 tising, after the date of enactment of the 

22 Family Smoking Prevention and Tobacco 

23 Control Act, respecting the product that 

24 would be reasonably expected to result in 

25 consumers believing that the tobacco prod-
187 

•S 1074 IS 

1 uct or its smoke may present a lower risk 

2 of disease or is less harmful than one or 

3 more commercially marketed tobacco prod4 ucts, or presents a reduced exposure to, or 

5 does not contain or is free of, a substance 

6 or substances. 

7 ‘‘(B) LIMITATION.—No tobacco product 

8 shall be considered to be ‘sold or distributed for 

9 use to reduce harm or the risk of tobacco-re10 lated disease associated with commercially mar11 keted tobacco products’, except as described in 

12 subparagraph (A). 

13 ‘‘(c) TOBACCO DEPENDENCE PRODUCTS.—A product 

14 that is intended to be used for the treatment of tobacco 

15 dependence, including smoking cessation, is not a modified 

16 risk tobacco product under this section and is subject to 

17 the requirements of chapter V. 

18 ‘‘(d) FILING.—Any person may file with the Sec19 retary an application for a modified risk tobacco product. 

20 Such application shall include— 

21 ‘‘(1) a description of the proposed product and 

22 any proposed advertising and labeling; 

23 ‘‘(2) the conditions for using the product; 

24 ‘‘(3) the formulation of the product; 

25 ‘‘(4) sample product labels and labeling; 
188 

•S 1074 IS 

1 ‘‘(5) all documents (including underlying sci2 entific information) relating to research findings 

3 conducted, supported, or possessed by the tobacco 

4 product manufacturer relating to the effect of the 

5 product on tobacco-related diseases and health-re6 lated conditions, including information both favor7 able and unfavorable to the ability of the product to 

8 reduce risk or exposure and relating to human 

9 health; 

10 ‘‘(6) data and information on how consumers 

11 actually use the tobacco product; and 

12 ‘‘(7) such other information as the Secretary 

13 may require. 

14 ‘‘(e) PUBLIC AVAILABILITY.—The Secretary shall 

15 make the application described in subsection (d) publicly 

16 available (except matters in the application which are 

17 trade secrets or otherwise confidential, commercial infor18 mation) and shall request comments by interested persons 

19 on the information contained in the application and on the 

20 label, labeling, and advertising accompanying such appli21 cation. 

22 ‘‘(f) ADVISORY COMMITTEE.— 

23 ‘‘(1) IN GENERAL.—The Secretary shall refer to 

24 an advisory committee any application submitted 

25 under this subsection. 
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1 ‘‘(2) RECOMMENDATIONS.—Not later than 60 

2 days after the date an application is referred to an 

3 advisory committee under paragraph (1), the advi4 sory committee shall report its recommendations on 

5 the application to the Secretary. 

6 ‘‘(g) APPROVAL.— 

7 ‘‘(1) MODIFIED RISK PRODUCTS.—Except as 

8 provided in paragraph (2), the Secretary shall ap9 prove an application for a modified risk tobacco 

10 product filed under this section only if the Secretary 

11 determines that the applicant has demonstrated that 

12 such product, as it is actually used by consumers, 

13 will— 

14 ‘‘(A) significantly reduce harm and the 

15 risk of tobacco-related disease to individual to16 bacco users; and 

17 ‘‘(B) benefit the health of the population 

18 as a whole taking into account both users of to19 bacco products and persons who do not cur20 rently use tobacco products. 

21 ‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— 

22 ‘‘(A) IN GENERAL.—The Secretary may 

23 approve an application for a tobacco product 

24 that has not been approved as a modified risk 

25 tobacco product pursuant to paragraph (1) if 
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•S 1074 IS 

1 the Secretary makes the findings required 

2 under this paragraph and determines that the 

3 applicant has demonstrated that— 

4 ‘‘(i) the approval of the application 

5 would be appropriate to promote the public 

6 health; 

7 ‘‘(ii) any aspect of the label, labeling, 

8 and advertising for such product that 

9 would cause the tobacco product to be a 

10 modified risk tobacco product under sub11 section (b)(2) is limited to an explicit or 

12 implicit representation that such tobacco 

13 product or its smoke contains or is free of 

14 a substance or contains a reduced level of 

15 a substance, or presents a reduced expo16 sure to a substance in tobacco smoke; 

17 ‘‘(iii) scientific evidence is not avail18 able and, using the best available scientific 

19 methods, cannot be made available without 

20 conducting long-term epidemiological stud21 ies for an application to meet the stand22 ards set forth in paragraph (1); and 

23 ‘‘(iv) the scientific evidence that is 

24 available without conducting long-term epi25 demiological studies demonstrates that a 
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•S 1074 IS 

1 measurable and substantial reduction in 

2 morbidity or mortality among individual 

3 tobacco users is anticipated in subsequent 

4 studies. 

5 ‘‘(B) ADDITIONAL FINDINGS REQUIRED.— 

6 In order to approve an application under sub7 paragraph (A) the Secretary must also find 

8 that the applicant has demonstrated that— 

9 ‘‘(i) the magnitude of the overall re10 ductions in exposure to the substance or 

11 substances which are the subject of the ap12 plication is substantial, such substance or 

13 substances are harmful, and the product as 

14 actually used exposes consumers to the 

15 specified reduced level of the substance or 

16 substances; 

17 ‘‘(ii) the product as actually used by 

18 consumers will not expose them to higher 

19 levels of other harmful substances com20 pared to the similar types of tobacco prod21 ucts then on the market unless such in22 creases are minimal and the anticipated 

23 overall impact of use of the product re24 mains a substantial and measurable reduc-
192 

•S 1074 IS 

1 tion in overall morbidity and mortality 

2 among individual tobacco users; 

3 ‘‘(iii) testing of actual consumer per4 ception shows that, as the applicant pro5 poses to label and market the product, con6 sumers will not be misled into believing 

7 that the product— 

8 ‘‘(I) is or has been demonstrated 

9 to be less harmful; or 

10 ‘‘(II) presents or has been dem11 onstrated to present less of a risk of 

12 disease than 1 or more other commer13 cially marketed tobacco products; and 

14 ‘‘(iv) approval of the application is ex15 pected to benefit the health of the popu16 lation as a whole taking into account both 

17 users of tobacco products and persons who 

18 do not currently use tobacco products. 

19 ‘‘(C) CONDITIONS OF APPROVAL.— 

20 ‘‘(i) IN GENERAL.—Applications ap21 proved under this paragraph shall be lim22 ited to a term of not more than 5 years, 

23 but may be renewed upon a finding by the 

24 Secretary that the requirements of this 
193 

•S 1074 IS 

1 paragraph continue to be satisfied based 

2 on the filing of a new application. 

3 ‘‘(ii) AGREEMENTS BY APPLICANT.— 

4 Applications approved under this para5 graph shall be conditioned on the appli6 cant’s agreement to conduct post-market 

7 surveillance and studies and to submit to 

8 the Secretary the results of such surveil9 lance and studies to determine the impact 

10 of the application approval on consumer 

11 perception, behavior, and health and to en12 able the Secretary to review the accuracy 

13 of the determinations upon which the ap14 proval was based in accordance with a pro15 tocol approved by the Secretary. 

16 ‘‘(iii) ANNUAL SUBMISSION.—The re17 sults of such post-market surveillance and 

18 studies described in clause (ii) shall be 

19 submitted annually. 

20 ‘‘(3) BASIS.—The determinations under para21 graphs (1) and (2) shall be based on— 

22 ‘‘(A) the scientific evidence submitted by 

23 the applicant; and 

24 ‘‘(B) scientific evidence and other informa25 tion that is available to the Secretary. 
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1 ‘‘(4) BENEFIT TO HEALTH OF INDIVIDUALS

2 AND OF POPULATION AS A WHOLE.—In making the 

3 determinations under paragraphs (1) and (2), the 

4 Secretary shall take into account— 

5 ‘‘(A) the relative health risks to individuals 

6 of the tobacco product that is the subject of the 

7 application; 

8 ‘‘(B) the increased or decreased likelihood 

9 that existing users of tobacco products who 

10 would otherwise stop using such products will 

11 switch to the tobacco product that is the subject 

12 of the application; 

13 ‘‘(C) the increased or decreased likelihood 

14 that persons who do not use tobacco products 

15 will start using the tobacco product that is the 

16 subject of the application; 

17 ‘‘(D) the risks and benefits to persons 

18 from the use of the tobacco product that is the 

19 subject of the application as compared to the 

20 use of products for smoking cessation approved 

21 under chapter V to treat nicotine dependence; 

22 and 

23 ‘‘(E) comments, data, and information 

24 submitted by interested persons. 

25 ‘‘(h) ADDITIONAL CONDITIONS FOR APPROVAL.— 
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•S 1074 IS 

1 ‘‘(1) MODIFIED RISK PRODUCTS.—The Sec2 retary shall require for the approval of an applica3 tion under this section that any advertising or label4 ing concerning modified risk products enable the 

5 public to comprehend the information concerning 

6 modified risk and to understand the relative signifi7 cance of such information in the context of total 

8 health and in relation to all of the diseases and 

9 health-related conditions associated with the use of 

10 tobacco products. 

11 ‘‘(2) COMPARATIVE CLAIMS.— 

12 ‘‘(A) IN GENERAL.—The Secretary may re13 quire for the approval of an application under 

14 this subsection that a claim comparing a to15 bacco product to 1 or more other commercially 

16 marketed tobacco products shall compare the 

17 tobacco product to a commercially marketed to18 bacco product that is representative of that type 

19 of tobacco product on the market (for example 

20 the average value of the top 3 brands of an es21 tablished regular tobacco product). 

22 ‘‘(B) QUANTITATIVE COMPARISONS.—The 

23 Secretary may also require, for purposes of sub24 paragraph (A), that the percent (or fraction) of 

25 change and identity of the reference tobacco 
196 

•S 1074 IS 

1 product and a quantitative comparison of the 

2 amount of the substance claimed to be reduced 

3 shall be stated in immediate proximity to the 

4 most prominent claim. 

5 ‘‘(3) LABEL DISCLOSURE.— 

6 ‘‘(A) IN GENERAL.—The Secretary may re7 quire the disclosure on the label of other sub8 stances in the tobacco product, or substances 

9 that may be produced by the consumption of 

10 that tobacco product, that may affect a disease 

11 or health-related condition or may increase the 

12 risk of other diseases or health-related condi13 tions associated with the use of tobacco prod14 ucts. 

15 ‘‘(B) CONDITIONS OF USE.—If the condi16 tions of use of the tobacco product may affect 

17 the risk of the product to human health, the 

18 Secretary may require the labeling of conditions 

19 of use. 

20 ‘‘(4) TIME.—The Secretary shall limit an ap21 proval under subsection (g)(1) for a specified period 

22 of time. 

23 ‘‘(5) ADVERTISING.—The Secretary may re24 quire that an applicant, whose application has been 

25 approved under this subsection, comply with require-
197 

•S 1074 IS 

1 ments relating to advertising and promotion of the 

2 tobacco product. 

3 ‘‘(i) POSTMARKET SURVEILLANCE AND STUDIES.— 

4 ‘‘(1) IN GENERAL.—The Secretary shall require 

5 that an applicant under subsection (g)(1) conduct 

6 post market surveillance and studies for a tobacco 

7 product for which an application has been approved 

8 to determine the impact of the application approval 

9 on consumer perception, behavior, and health, to en10 able the Secretary to review the accuracy of the de11 terminations upon which the approval was based, 

12 and to provide information that the Secretary deter13 mines is otherwise necessary regarding the use or 

14 health risks involving the tobacco product. The re15 sults of post-market surveillance and studies shall be 

16 submitted to the Secretary on an annual basis. 

17 ‘‘(2) SURVEILLANCE PROTOCOL.—Each appli18 cant required to conduct a surveillance of a tobacco 

19 product under paragraph (1) shall, within 30 days 

20 after receiving notice that the applicant is required 

21 to conduct such surveillance, submit, for the ap22 proval of the Secretary, a protocol for the required 

23 surveillance. The Secretary, within 60 days of the 

24 receipt of such protocol, shall determine if the prin25 cipal investigator proposed to be used in the surveil-
198 

•S 1074 IS 

1 lance has sufficient qualifications and experience to 

2 conduct such surveillance and if such protocol will 

3 result in collection of the data or other information 

4 designated by the Secretary as necessary to protect 

5 the public health. 

6 ‘‘(j) WITHDRAWAL OF APPROVAL.—The Secretary, 

7 after an opportunity for an informal hearing, shall with8 draw the approval of an application under this section if 

9 the Secretary determines that— 

10 ‘‘(1) the applicant, based on new information, 

11 can no longer make the demonstrations required 

12 under subsection (g), or the Secretary can no longer 

13 make the determinations required under subsection 

14 (g); 

15 ‘‘(2) the application failed to include material 

16 information or included any untrue statement of ma17 terial fact; 

18 ‘‘(3) any explicit or implicit representation that 

19 the product reduces risk or exposure is no longer 

20 valid, including if— 

21 ‘‘(A) a tobacco product standard is estab22 lished pursuant to section 907; 

23 ‘‘(B) an action is taken that affects the 

24 risks presented by other commercially marketed 
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•S 1074 IS 

1 tobacco products that were compared to the 

2 product that is the subject of the application; or 

3 ‘‘(C) any postmarket surveillance or stud4 ies reveal that the approval of the application is 

5 no longer consistent with the protection of the 

6 public health; 

7 ‘‘(4) the applicant failed to conduct or submit 

8 the postmarket surveillance and studies required 

9 under subsection (g)(2)(C)(ii) or (i); or 

10 ‘‘(5) the applicant failed to meet a condition 

11 imposed under subsection (h). 

12 ‘‘(k) CHAPTER IV OR V.—A product approved in ac13 cordance with this section shall not be subject to chapter 

14 IV or V. 

15 ‘‘(l) IMPLEMENTING REGULATIONS OR GUIDANCE.— 

16 ‘‘(1) SCIENTIFIC EVIDENCE.—Not later than 2 

17 years after the date of enactment of the Family 

18 Smoking Prevention and Tobacco Control Act, the 

19 Secretary shall issue regulations or guidance (or any 

20 combination thereof) on the scientific evidence re21 quired for assessment and ongoing review of modi22 fied risk tobacco products. Such regulations or guid23 ance shall— 

24 ‘‘(A) establish minimum standards for sci25 entific studies needed prior to approval to show 
200 

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1 that a substantial reduction in morbidity or 

2 mortality among individual tobacco users is 

3 likely; 

4 ‘‘(B) include validated biomarkers, inter5 mediate clinical endpoints, and other feasible 

6 outcome measures, as appropriate; 

7 ‘‘(C) establish minimum standards for post 

8 market studies, that shall include regular and 

9 long-term assessments of health outcomes and 

10 mortality, intermediate clinical endpoints, con11 sumer perception of harm reduction, and the 

12 impact on quitting behavior and new use of to13 bacco products, as appropriate; 

14 ‘‘(D) establish minimum standards for re15 quired postmarket surveillance, including ongo16 ing assessments of consumer perception; and 

17 ‘‘(E) require that data from the required 

18 studies and surveillance be made available to 

19 the Secretary prior to the decision on renewal 

20 of a modified risk tobacco product. 

21 ‘‘(2) CONSULTATION.—The regulations or guid22 ance issued under paragraph (1) shall be developed 

23 in consultation with the Institute of Medicine, and 

24 with the input of other appropriate scientific and 
201 

•S 1074 IS 

1 medical experts, on the design and conduct of such 

2 studies and surveillance. 

3 ‘‘(3) REVISION.—The regulations or guidance 

4 under paragraph (1) shall be revised on a regular 

5 basis as new scientific information becomes avail6 able. 

7 ‘‘(4) NEW TOBACCO PRODUCTS.—Not later 

8 than 2 years after the date of enactment of the 

9 Family Smoking Prevention and Tobacco Control 

10 Act, the Secretary shall issue a regulation or guid11 ance that permits the filing of a single application 

12 for any tobacco product that is a new tobacco prod13 uct under section 910 and for which the applicant 

14 seeks approval as a modified risk tobacco product 

15 under this section. 

16 ‘‘(m) DISTRIBUTORS.—No distributor may take any 

17 action, after the date of enactment of the Family Smoking 

18 Prevention and Tobacco Control Act, with respect to a to19 bacco product that would reasonably be expected to result 

20 in consumers believing that the tobacco product or its 

21 smoke may present a lower risk of disease or is less harm22 ful than one or more commercially marketed tobacco prod23 ucts, or presents a reduced exposure to, or does not con24 tain or is free of, a substance or substances. 
202 

•S 1074 IS 

1 ‘‘SEC. 912. JUDICIAL REVIEW. 

2 ‘‘(a) RIGHT TO REVIEW.— 

3 ‘‘(1) IN GENERAL.—Not later than 30 days 

4 after— 

5 ‘‘(A) the promulgation of a regulation 

6 under section 907 establishing, amending, or 

7 revoking a tobacco product standard; or 

8 ‘‘(B) a denial of an application for ap9 proval under section 910(c), any person ad10 versely affected by such regulation or denial 

11 may file a petition for judicial review of such 

12 regulation or denial with the United States 

13 Court of Appeals for the District of Columbia 

14 or for the circuit in which such person resides 

15 or has their principal place of business. 

16 ‘‘(2) REQUIREMENTS.— 

17 ‘‘(A) COPY OF PETITION.—A copy of the 

18 petition filed under paragraph (1) shall be 

19 transmitted by the clerk of the court involved to 

20 the Secretary. 

21 ‘‘(B) RECORD OF PROCEEDINGS.—On re22 ceipt of a petition under subparagraph (A), the 

23 Secretary shall file in the court in which such 

24 petition was filed— 
203 

•S 1074 IS 

1 ‘‘(i) the record of the proceedings on 

2 which the regulation or order was based; 

3 and 

4 ‘‘(ii) a statement of the reasons for 

5 the issuance of such a regulation or order. 

6 ‘‘(C) DEFINITION OF RECORD.—In this 

7 section, the term ‘record’ means— 

8 ‘‘(i) all notices and other matter pub9 lished in the Federal Register with respect 

10 to the regulation or order reviewed; 

11 ‘‘(ii) all information submitted to the 

12 Secretary with respect to such regulation 

13 or order; 

14 ‘‘(iii) proceedings of any panel or ad15 visory committee with respect to such reg16 ulation or order; 

17 ‘‘(iv) any hearing held with respect to 

18 such regulation or order; and 

19 ‘‘(v) any other information identified 

20 by the Secretary, in the administrative pro21 ceeding held with respect to such regula22 tion or order, as being relevant to such 

23 regulation or order. 

24 ‘‘(b) STANDARD OF REVIEW.—Upon the filing of the 

25 petition under subsection (a) for judicial review of a regu-
204 

•S 1074 IS 

1 lation or order, the court shall have jurisdiction to review 

2 the regulation or order in accordance with chapter 7 of 

3 title 5, United States Code, and to grant appropriate re4 lief, including interim relief, as provided for in such chap5 ter. A regulation or denial described in subsection (a) shall 

6 be reviewed in accordance with section 706(2)(A) of title 

7 5, United States Code. 

8 ‘‘(c) FINALITY OF JUDGMENT.—The judgment of the 

9 court affirming or setting aside, in whole or in part, any 

10 regulation or order shall be final, subject to review by the 

11 Supreme Court of the United States upon certiorari or 

12 certification, as provided in section 1254 of title 28, 

13 United States Code. 

14 ‘‘(d) OTHER REMEDIES.—The remedies provided for 

15 in this section shall be in addition to, and not in lieu of, 

16 any other remedies provided by law. 

17 ‘‘(e) REGULATIONS AND ORDERS MUST RECITE

18 BASIS IN RECORD.—To facilitate judicial review, a regula19 tion or order issued under section 906, 907, 908, 909, 

20 910, or 916 shall contain a statement of the reasons for 

21 the issuance of such regulation or order in the record of 

22 the proceedings held in connection with its issuance. 

23 ‘‘SEC. 913. EQUAL TREATMENT OF RETAIL OUTLETS. 

24 ‘‘The Secretary shall issue regulations to require that 

25 retail establishments for which the predominant business 
205 

•S 1074 IS 

1 is the sale of tobacco products comply with any advertising 

2 restrictions applicable to retail establishments accessible 

3 to individuals under the age of 18. 

4 ‘‘SEC. 914. JURISDICTION OF AND COORDINATION WITH 

5 THE FEDERAL TRADE COMMISSION. 

6 ‘‘(a) JURISDICTION.— 

7 ‘‘(1) IN GENERAL.—Except where expressly 

8 provided in this chapter, nothing in this chapter 

9 shall be construed as limiting or diminishing the au10 thority of the Federal Trade Commission to enforce 

11 the laws under its jurisdiction with respect to the 

12 advertising, sale, or distribution of tobacco products. 

13 ‘‘(2) ENFORCEMENT.—Any advertising that vio14 lates this chapter or a provision of the regulations 

15 referred to in section 232 of the Family Smoking 

16 Prevention and Tobacco Control Act, is an unfair or 

17 deceptive act or practice under section 5(a) of the 

18 Federal Trade Commission Act (15 U.S.C. 45(a)) 

19 and shall be considered a violation of a rule promul20 gated under section 18 of that Act (15 U.S.C. 57a). 

21 ‘‘(b) COORDINATION.—With respect to the require22 ments of section 4 of the Federal Cigarette Labeling and 

23 Advertising Act (15 U.S.C. 1333) and section 3 of the 

24 Comprehensive Smokeless Tobacco Health Education Act 

25 of 1986 (15 U.S.C. 4402)— 
206 

•S 1074 IS 

1 ‘‘(1) the Chairman of the Federal Trade Com2 mission shall coordinate with the Secretary con3 cerning the enforcement of such Act as such enforce4 ment relates to unfair or deceptive acts or practices 

5 in the advertising of cigarettes or smokeless tobacco; 

6 and 

7 ‘‘(2) the Secretary shall consult with the Chair8 man of such Commission in revising the label state9 ments and requirements under such sections. 

10 ‘‘SEC. 915. CONGRESSIONAL REVIEW PROVISIONS. 

11 ‘‘In accordance with section 801 of title 5, United 

12 States Code, Congress shall review, and may disapprove, 

13 any rule under this chapter that is subject to section 801. 

14 This section and section 801 do not apply to the regula15 tions referred to in section 232 of the Family Smoking 

16 Prevention and Tobacco Control Act. 

17 ‘‘SEC. 916. REGULATION REQUIREMENT. 

18 ‘‘(a) TESTING, REPORTING, AND DISCLOSURE.—Not 

19 later than 24 months after the date of enactment of the 

20 Family Smoking Prevention and Tobacco Control Act, the 

21 Secretary, acting through the Commissioner of the Food 

22 and Drug Administration, shall promulgate regulations 

23 under this Act that meet the requirements of subsection 

24 (b). 
207 

•S 1074 IS 

1 ‘‘(b) CONTENTS OF RULES.—The regulations pro2 mulgated under subsection (a) shall require testing and 

3 reporting of tobacco product constituents, ingredients, and 

4 additives, including smoke constituents, by brand and sub5 brand that the Secretary determines should be tested to 

6 protect the public health. The regulations may require 

7 that tobacco product manufacturers, packagers, or import8 ers make disclosures relating to the results of the testing 

9 of tar and nicotine through labels or advertising or other 

10 appropriate means, and make disclosures regarding the re11 sults of the testing of other constituents, including smoke 

12 constituents, ingredients, or additives, that the Secretary 

13 determines should be disclosed to the public to protect the 

14 public health and will not mislead consumers about the 

15 risk of tobacco related disease. 

16 ‘‘(c) AUTHORITY.—The Food and Drug Administra17 tion shall have the authority under this chapter to conduct 

18 or to require the testing, reporting, or disclosure of to19 bacco product constituents, including smoke constituents. 

20 ‘‘SEC. 917. PRESERVATION OF STATE AND LOCAL AUTHOR21 ITY. 

22 ‘‘(a) IN GENERAL.— 

23 ‘‘(1) PRESERVATION.—Nothing in this chapter, 

24 or rules promulgated under this chapter, shall be 

25 construed to limit the authority of a Federal agency 
208 

•S 1074 IS 

1 (including the Armed Forces), a State or political 

2 subdivision of a State, or the government of an In3 dian tribe to enact, adopt, promulgate, and enforce 

4 any law, rule, regulation, or other measure with re5 spect to tobacco products that is in addition to, or 

6 more stringent than, requirements established under 

7 this chapter, including a law, rule, regulation, or 

8 other measure relating to or prohibiting the sale, 

9 distribution, possession, exposure to, access to, ad10 vertising and promotion of, or use of tobacco prod11 ucts by individuals of any age, information reporting 

12 to the State, or measures relating to fire safety 

13 standards for tobacco products. No provision of this 

14 chapter shall limit or otherwise affect any State, 

15 Tribal, or local taxation of tobacco products. 

16 ‘‘(2) PREEMPTION OF CERTAIN STATE AND

17 LOCAL REQUIREMENTS.— 

18 ‘‘(A) IN GENERAL.—Except as provided in 

19 paragraph (1) and subparagraph (B), no State 

20 or political subdivision of a State may establish 

21 or continue in effect with respect to a tobacco 

22 product any requirement which is different 

23 from, or in addition to, any requirement under 

24 the provisions of this chapter relating to to25 bacco product standards, premarket approval, 
209 

•S 1074 IS 

1 adulteration, misbranding, labeling, registra2 tion, good manufacturing standards, or modi3 fied risk tobacco products. 

4 ‘‘(B) EXCEPTION.—Subparagraph (A) 

5 does not apply to requirements relating to the 

6 sale, distribution, possession, information re7 porting to the State, exposure to, access to, the 

8 advertising and promotion of, or use of, tobacco 

9 products by individuals of any age, or relating 

10 to fire safety standards for tobacco products. 

11 Information disclosed to a State under subpara12 graph (A) that is exempt from disclosure under 

13 section 554(b)(4) of title 5, United States Code, 

14 shall be treated as trade secret and confidential 

15 information by the State. 

16 ‘‘(b) RULE OF CONSTRUCTION REGARDING PRODUCT

17 LIABILITY.—No provision of this chapter relating to a to18 bacco product shall be construed to modify or otherwise 

19 affect any action or the liability of any person under the 

20 product liability law of any State. 

21 ‘‘SEC. 918. TOBACCO PRODUCTS SCIENTIFIC ADVISORY 

22 COMMITTEE. 

23 ‘‘(a) ESTABLISHMENT.—Not later than 1 year after 

24 the date of enactment of the Family Smoking Prevention 

25 and Tobacco Control Act, the Secretary shall establish an 
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•S 1074 IS 

1 11-member advisory committee, to be known as the ‘To2 bacco Products Scientific Advisory Committee’. 

3 ‘‘(b) MEMBERSHIP.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) MEMBERS.—The Secretary shall ap6 point as members of the Tobacco Products Sci7 entific Advisory Committee individuals who are 

8 technically qualified by training and experience 

9 in the medicine, medical ethics, science, or tech10 nology involving the manufacture, evaluation, or 

11 use of tobacco products, who are of appro12 priately diversified professional backgrounds. 

13 The committee shall be composed of— 

14 ‘‘(i) 7 individuals who are physicians, 

15 dentists, scientists, or health care profes16 sionals practicing in the area of oncology, 

17 pulmonology, cardiology, toxicology, phar18 macology, addiction, or any other relevant 

19 specialty; 

20 ‘‘(ii) 1 individual who is an officer or 

21 employee of a State or local government or 

22 of the Federal Government; 

23 ‘‘(iii) 1 individual as a representative 

24 of the general public; 
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•S 1074 IS 

1 ‘‘(iv) 1 individual as a representative 

2 of the interests in the tobacco manufac3 turing industry; and 

4 ‘‘(v) 1 individual as a representative 

5 of the interests of the tobacco growers. 

6 ‘‘(B) NONVOTING MEMBERS.—The mem7 bers of the committee appointed under clauses 

8 (iv) and (v) of subparagraph (A) shall serve as 

9 consultants to those described in clauses (i) 

10 through (iii) of subparagraph (A) and shall be 

11 nonvoting representatives. 

12 ‘‘(2) LIMITATION.—The Secretary may not ap13 point to the Advisory Committee any individual who 

14 is in the regular full-time employ of the Food and 

15 Drug Administration or any agency responsible for 

16 the enforcement of this Act. The Secretary may ap17 point Federal officials as ex officio members. 

18 ‘‘(3) CHAIRPERSON.—The Secretary shall des19 ignate 1 of the members of the Advisory Committee 

20 to serve as chairperson. 

21 ‘‘(c) DUTIES.—The Tobacco Products Scientific Ad22 visory Committee shall provide advice, information, and 

23 recommendations to the Secretary— 

24 ‘‘(1) as provided in this chapter; 
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1 ‘‘(2) on the effects of the alteration of the nico2 tine yields from tobacco products; 

3 ‘‘(3) on whether there is a threshold level below 

4 which nicotine yields do not produce dependence on 

5 the tobacco product involved; and 

6 ‘‘(4) on its review of other safety, dependence, 

7 or health issues relating to tobacco products as re8 quested by the Secretary. 

9 ‘‘(d) COMPENSATION; SUPPORT; FACA.— 

10 ‘‘(1) COMPENSATION AND TRAVEL.—Members 

11 of the Advisory Committee who are not officers or 

12 employees of the United States, while attending con13 ferences or meetings of the committee or otherwise 

14 engaged in its business, shall be entitled to receive 

15 compensation at rates to be fixed by the Secretary, 

16 which may not exceed the daily equivalent of the 

17 rate in effect for level 4 of the Senior Executive 

18 Schedule under section 5382 of title 5, United 

19 States Code, for each day (including travel time) 

20 they are so engaged; and while so serving away from 

21 their homes or regular places of business each mem22 ber may be allowed travel expenses, including per 

23 diem in lieu of subsistence, as authorized by section 

24 5703 of title 5, United States Code, for persons in 

25 the Government service employed intermittently. 
213 

•S 1074 IS 

1 ‘‘(2) ADMINISTRATIVE SUPPORT.—The Sec2 retary shall furnish the Advisory Committee clerical 

3 and other assistance. 

4 ‘‘(3) NONAPPLICATION OF FACA.—Section 14 of 

5 the Federal Advisory Committee Act (5 U.S.C. 

6 App.) does not apply to the Advisory Committee. 

7 ‘‘(e) PROCEEDINGS OF ADVISORY PANELS AND COM8 MITTEES.—The Advisory Committee shall make and 

9 maintain a transcript of any proceeding of the panel or 

10 committee. Each such panel and committee shall delete 

11 from any transcript made under this subsection informa12 tion which is exempt from disclosure under section 552(b) 

13 of title 5, United States Code. 

14 ‘‘SEC. 919. DRUG PRODUCTS USED TO TREAT TOBACCO DE15 PENDENCE. 

16 ‘‘The Secretary shall— 

17 ‘‘(1) at the request of the applicant, consider 

18 designating nicotine replacement products as fast 

19 track research and approval products within the 

20 meaning of section 506; 

21 ‘‘(2) consider approving the extended use of nic22 otine replacement products (such as nicotine patch23 es, nicotine gum, and nicotine lozenges) for the 

24 treatment of tobacco dependence; and 
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•S 1074 IS 

1 ‘‘(3) review and consider the evidence for addi2 tional indications for nicotine replacement products, 

3 such as for craving relief or relapse prevention. 

4 ‘‘SEC. 920. USER FEE. 

5 ‘‘(a) ESTABLISHMENT OF QUARTERLY USER FEE.— 

6 The Secretary shall assess a quarterly user fee with re7 spect to every quarter of each fiscal year commencing fis8 cal year 2005, calculated in accordance with this section, 

9 upon each manufacturer and importer of tobacco products 

10 subject to this chapter. 

11 ‘‘(b) FUNDING OF FDA REGULATION OF TOBACCO

12 PRODUCTS.—The Secretary shall make user fees collected 

13 pursuant to this section available to pay, in each fiscal 

14 year, for the costs of the activities of the Food and Drug 

15 Administration related to the regulation of tobacco prod16 ucts under this chapter. 

17 ‘‘(c) ASSESSMENT OF USER FEE.— 

18 ‘‘(1) AMOUNT OF ASSESSMENT.—Except as 

19 provided in paragraph (4), the total user fees as20 sessed each year pursuant to this section shall be 

21 sufficient, and shall not exceed what is necessary, to 

22 pay for the costs of the activities described in sub23 section (b) for each fiscal year. 

24 ‘‘(2) ALLOCATION OF ASSESSMENT BY CLASS

25 OF TOBACCO PRODUCTS.— 
215 

•S 1074 IS 

1 ‘‘(A) IN GENERAL.—Subject to paragraph 

2 (3), the total user fees assessed each fiscal year 

3 with respect to each class of importers and 

4 manufacturers shall be equal to an amount that 

5 is the applicable percentage of the total costs of 

6 activities of the Food and Drug Administration 

7 described in subsection (b). 

8 ‘‘(B) APPLICABLE PERCENTAGE.—For 

9 purposes of subparagraph (A) the applicable 

10 percentage for a fiscal year shall be the fol11 lowing: 

12 ‘‘(i) 92.07 percent shall be assessed 

13 on manufacturers and importers of ciga14 rettes; 

15 ‘‘(ii) 0.05 percent shall be assessed on 

16 manufacturers and importers of little ci17 gars; 

18 ‘‘(iii) 7.15 percent shall be assessed 

19 on manufacturers and importers of cigars 

20 other than little cigars; 

21 ‘‘(iv) 0.43 percent shall be assessed on 

22 manufacturers and importers of snuff; 

23 ‘‘(v) 0.10 percent shall be assessed on 

24 manufacturers and importers of chewing 

25 tobacco; 
216 

•S 1074 IS 

1 ‘‘(vi) 0.06 percent shall be assessed on 

2 manufacturers and importers of pipe to3 bacco; and 

4 ‘‘(vii) 0.14 percent shall be assessed 

5 on manufacturers and importers of roll6 your-own tobacco. 

7 ‘‘(3) DISTRIBUTION OF FEE SHARES OF MANU8 FACTURERS AND IMPORTERS EXEMPT FROM USER

9 FEE.—Where a class of tobacco products is not sub10 ject to a user fee under this section, the portion of 

11 the user fee assigned to such class under subsection 

12 (d)(2) shall be allocated by the Secretary on a pro 

13 rata basis among the classes of tobacco products 

14 that are subject to a user fee under this section. 

15 Such pro rata allocation for each class of tobacco 

16 products that are subject to a user fee under this 

17 section shall be the quotient of— 

18 ‘‘(A) the sum of the percentages assigned 

19 to all classes of tobacco products subject to this 

20 section; divided by 

21 ‘‘(B) the percentage assigned to such class 

22 under paragraph (2). 

23 ‘‘(4) ANNUAL LIMIT ON ASSESSMENT.—The 

24 total assessment under this section— 
217 

•S 1074 IS 

1 ‘‘(A) for fiscal year 2005 shall be 

2 $85,000,000; 

3 ‘‘(B) for fiscal year 2006 shall be 

4 $175,000,000; 

5 ‘‘(C) for fiscal year 2007 shall be 

6 $300,000,000; and 

7 ‘‘(D) for each subsequent fiscal year, shall 

8 not exceed the limit on the assessment imposed 

9 during the previous fiscal year, as adjusted by 

10 the Secretary (after notice, published in the 

11 Federal Register) to reflect the greater of— 

12 ‘‘(i) the total percentage change that 

13 occurred in the Consumer Price Index for 

14 all urban consumers (all items; United 

15 States city average) for the 12-month pe16 riod ending on June 30 of the preceding 

17 fiscal year for which fees are being estab18 lished; or 

19 ‘‘(ii) the total percentage change for 

20 the previous fiscal year in basic pay under 

21 the General Schedule in accordance with 

22 section 5332 of title 5, United States 

23 Code, as adjusted by any locality-based 

24 comparability payment pursuant to section 
218 

•S 1074 IS 

1 5304 of such title for Federal employees 

2 stationed in the District of Columbia. 

3 ‘‘(5) TIMING OF USER FEE ASSESSMENT.—The 

4 Secretary shall notify each manufacturer and im5 porter of tobacco products subject to this section of 

6 the amount of the quarterly assessment imposed on 

7 such manufacturer or importer under subsection (f) 

8 during each quarter of each fiscal year. Such notifi9 cations shall occur not earlier than 3 months prior 

10 to the end of the quarter for which such assessment 

11 is made, and payments of all assessments shall be 

12 made not later than 60 days after each such notifi13 cation. 

14 ‘‘(d) DETERMINATION OF USER FEE BY COMPANY

15 MARKET SHARE.— 

16 ‘‘(1) IN GENERAL.—The user fee to be paid by 

17 each manufacturer or importer of a given class of to18 bacco products shall be determined in each quarter 

19 by multiplying— 

20 ‘‘(A) such manufacturer’s or importer’s 

21 market share of such class of tobacco products; 

22 by 

23 ‘‘(B) the portion of the user fee amount 

24 for the current quarter to be assessed on manu-
219 

•S 1074 IS 

1 facturers and importers of such class of tobacco 

2 products as determined under subsection (e). 

3 ‘‘(2) NO FEE IN EXCESS OF MARKET SHARE.— 

4 No manufacturer or importer of tobacco products 

5 shall be required to pay a user fee in excess of the 

6 market share of such manufacturer or importer. 

7 ‘‘(e) DETERMINATION OF VOLUME OF DOMESTIC

8 SALES.— 

9 ‘‘(1) IN GENERAL.—The calculation of gross 

10 domestic volume of a class of tobacco product by a 

11 manufacturer or importer, and by all manufacturers 

12 and importers as a group, shall be made by the Sec13 retary using information provided by manufacturers 

14 and importers pursuant to subsection (f), as well as 

15 any other relevant information provided to or ob16 tained by the Secretary. 

17 ‘‘(2) MEASUREMENT.—For purposes of the cal18 culations under this subsection and the information 

19 provided under subsection (f) by the Secretary, gross 

20 domestic volume shall be measured by— 

21 ‘‘(A) in the case of cigarettes, the number 

22 of cigarettes sold; 

23 ‘‘(B) in the case of little cigars, the num24 ber of little cigars sold; 
220 

•S 1074 IS 

1 ‘‘(C) in the case of large cigars, the num2 ber of cigars weighing more than 3 pounds per 

3 thousand sold; and 

4 ‘‘(D) in the case of other classes of tobacco 

5 products, in terms of number of pounds, or 

6 fraction thereof, of these products sold. 

7 ‘‘(f) MEASUREMENT OF GROSS DOMESTIC VOL8 UME.— 

9 ‘‘(1) IN GENERAL.—Each manufacturer and 

10 importer of tobacco products shall submit to the 

11 Secretary a certified copy of each of the returns or 

12 forms described by this paragraph that are required 

13 to be filed with a Government agency on the same 

14 date that those returns or forms are filed, or re15 quired to be filed, with such agency. The returns 

16 and forms described by this paragraph are those re17 turns and forms related to the release of tobacco 

18 products into domestic commerce, as defined by sec19 tion 5702(k) of the Internal Revenue Code of 1986, 

20 and the repayment of the taxes imposed under chap21 ter 52 of such Code (ATF Form 500.24 and United 

22 States Customs Form 7501 under currently applica23 ble regulations). 

24 ‘‘(2) PENALTIES.—Any person that knowingly 

25 fails to provide information required under this sub-
221 

•S 1074 IS 

1 section or that provides false information under this 

2 subsection shall be subject to the penalties described 

3 in section 1003 of title 18, United States Code. In 

4 addition, such person may be subject to a civil pen5 alty in an amount not to exceed 2 percent of the 

6 value of the kind of tobacco products manufactured 

7 or imported by such person during the applicable 

8 quarter, as determined by the Secretary. 

9 ‘‘(g) EFFECTIVE DATE.—The user fees prescribed by 

10 this section shall be assessed in fiscal year 2005, based 

11 on domestic sales of tobacco products during fiscal year 

12 2004 and shall be assessed in each fiscal year thereafter.’’. 

13 SEC. 232. INTERIM FINAL RULE. 

14 (a) CIGARETTES AND SMOKELESS TOBACCO.— 

15 (1) IN GENERAL.—Not later than 30 days after 

16 the date of enactment of this Act, the Secretary of 

17 Health and Human Services shall publish in the 

18 Federal Register an interim final rule regarding 

19 cigarettes and smokeless tobacco, which is hereby 

20 deemed to be in compliance with the Administrative 

21 Procedures Act and other applicable law. 

22 (2) CONTENTS OF RULE.—Except as provided 

23 in this subsection, the interim final rule published 

24 under paragraph (1), shall be identical in its provi25 sions to part 897 of the regulations promulgated by 
222 

•S 1074 IS 

1 the Secretary of Health and Human Services in the 

2 August 28, 1996, issue of the Federal Register (61 

3 Fed. Reg., 44615–44618). Such rule shall— 

4 (A) provide for the designation of jurisdic5 tional authority that is in accordance with this 

6 subsection; 

7 (B) strike Subpart C—Labeling and sec8 tion 897.32(c); and 

9 (C) become effective not later than 1 year 

10 after the date of enactment of this Act. 

11 (3) AMENDMENTS TO RULE.—Prior to making 

12 amendments to the rule published under paragraph 

13 (1), the Secretary shall promulgate a proposed rule 

14 in accordance with the Administrative Procedures 

15 Act. 

16 (4) RULE OF CONSTRUCTION.—Except as pro17 vided in paragraph (3), nothing in this section shall 

18 be construed to limit the authority of the Secretary 

19 to amend, in accordance with the Administrative 

20 Procedures Act, the regulation promulgated pursu21 ant to this section. 

22 (b) LIMITATION ON ADVISORY OPINIONS.—As of the 

23 date of enactment of this Act, the following documents 

24 issued by the Food and Drug Administration shall not 

25 constitute advisory opinions under section 10.85(d)(1) of 
223 

•S 1074 IS 

1 title 21, Code of Federal Regulations, except as they apply 

2 to tobacco products, and shall not be cited by the Sec3 retary of Health and Human Services or the Food and 

4 Drug Administration as binding precedent: 

5 (1) The preamble to the proposed rule in the 

6 document entitled ‘‘Regulations Restricting the Sale 

7 and Distribution of Cigarettes and Smokeless To8 bacco Products to Protect Children and Adoles9 cents’’ (60 Fed. Reg. 41314–41372 (August 11, 

10 1995)). 

11 (2) The document entitled ‘‘Nicotine in Ciga12 rettes and Smokeless Tobacco Products is a Drug 

13 and These Products Are Nicotine Delivery Devices 

14 Under the Federal Food, Drug, and Cosmetic Act’’ 

15 (60 Fed. Reg. 41453–41787 (August 11, 1995)). 

16 (3) The preamble to the final rule in the docu17 ment entitled ‘‘Regulations Restricting the Sale and 

18 Distribution of Cigarettes and Smokeless Tobacco to 

19 Protect Children and Adolescents’’ (61 Fed. Reg. 

20 44396–44615 (August 28, 1996)). 

21 (4) The document entitled ‘‘Nicotine in Ciga22 rettes and Smokeless Tobacco is a Drug and These 

23 Products are Nicotine Delivery Devices Under the 

24 Federal Food, Drug, and Cosmetic Act; Jurisdic-
224 

•S 1074 IS 

1 tional Determination’’ (61 Fed. Reg. 44619–45318 

2 (August 28, 1996)). 

3 SEC. 233. CONFORMING AND OTHER AMENDMENTS TO GEN4 ERAL PROVISIONS. 

5 (a) AMENDMENT OF FEDERAL FOOD, DRUG, AND

6 COSMETIC ACT.—Except as otherwise expressly provided, 

7 whenever in this section an amendment is expressed in 

8 terms of an amendment to, or repeal of, a section or other 

9 provision, the reference is to a section or other provision 

10 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 301 et seq.). 

12 (b) SECTION 301.—Section 301 (21 U.S.C. 331) is 

13 amended— 

14 (1) in subsection (a), by inserting ‘‘tobacco 

15 product,’’ after ‘‘device,’’; 

16 (2) in subsection (b), by inserting ‘‘tobacco 

17 product,’’ after ‘‘device,’’; 

18 (3) in subsection (c), by inserting ‘‘tobacco 

19 product,’’ after ‘‘device,’’; 

20 (4) in subsection (e), by striking ‘‘515(f), or 

21 519’’ and inserting ‘‘515(f), 519, or 909’’; 

22 (5) in subsection (g), by inserting ‘‘tobacco 

23 product,’’ after ‘‘device,’’; 

24 (6) in subsection (h), by inserting ‘‘tobacco 

25 product,’’ after ‘‘device,’’; 
225 

•S 1074 IS 

1 (7) in subsection (j), by striking ‘‘708, or 721’’ 

2 and inserting ‘‘708, 721, 904, 905, 906, 907, 908, 

3 909, or section 921(b)’’; 

4 (8) in subsection (k), by inserting ‘‘tobacco 

5 product,’’ after ‘‘device,’’; 

6 (9) by striking subsection (p) and inserting the 

7 following: 

8 ‘‘(p) The failure to register in accordance with section 

9 510 or 905, the failure to provide any information re10 quired by section 510(j), 510(k), 905(i), or 905(j), or the 

11 failure to provide a notice required by section 510(j)(2) 

12 or 905(i)(2).’’; 

13 (10) by striking subsection (q)(1) and inserting 

14 the following: 

15 ‘‘(q)(1) The failure or refusal— 

16 ‘‘(A) to comply with any requirement prescribed 

17 under section 518, 520(g), 903(b)(8), or 908, or 

18 condition prescribed under section 

19 903(b)(6)(B)(ii)(II); 

20 ‘‘(B) to furnish any notification or other mate21 rial or information required by or under section 519, 

22 520(g), 904, 909, or section 921; or 

23 ‘‘(C) to comply with a requirement under sec24 tion 522 or 913.’’; 
226 

•S 1074 IS 

1 (11) in subsection (q)(2), by striking ‘‘device,’’ 

2 and inserting ‘‘device or tobacco product,’’; 

3 (12) in subsection (r), by inserting ‘‘or tobacco 

4 product’’ after ‘‘device’’ each time that it appears; 

5 and 

6 (13) by adding at the end the following: 

7 ‘‘(aa) The sale of tobacco products in violation 

8 of a no-tobacco-sale order issued under section 

9 303(f). 

10 ‘‘(bb) The introduction or delivery for introduc11 tion into interstate commerce of a tobacco product 

12 in violation of section 911. 

13 ‘‘(cc)(1) Forging, counterfeiting, simulating, or 

14 falsely representing, or without proper authority 

15 using any mark, stamp (including tax stamp), tag, 

16 label, or other identification device upon any tobacco 

17 product or container or labeling thereof so as to 

18 render such tobacco product a counterfeit tobacco 

19 product. 

20 ‘‘(2) Making, selling, disposing of, or keeping in 

21 possession, control, or custody, or concealing any 

22 punch, die, plate, stone, or other item that is de23 signed to print, imprint, or reproduce the trade24 mark, trade name, or other identifying mark, im25 print, or device of another or any likeness of any of 
227 

•S 1074 IS 

1 the foregoing upon any tobacco product or container 

2 or labeling thereof so as to render such tobacco 

3 product a counterfeit tobacco product. 

4 ‘‘(3) The doing of any act that causes a tobacco 

5 product to be a counterfeit tobacco product, or the 

6 sale or dispensing, or the holding for sale or dis7 pensing, of a counterfeit tobacco product. 

8 ‘‘(dd) The charitable distribution of tobacco 

9 products. 

10 ‘‘(ee) The failure of a manufacturer or dis11 tributor to notify the Attorney General of their 

12 knowledge of tobacco products used in illicit trade.’’. 

13 (c) SECTION 303.—Section 303 (21 U.S.C. 333(f)) 

14 is amended in subsection (f)— 

15 (1) by striking the subsection heading and in16 serting the following: 

17 ‘‘(f) CIVIL PENALTIES; NO-TOBACCO-SALE OR18 DERS.—’’; 

19 (2) in paragraph (1)(A), by inserting ‘‘or to20 bacco products’’ after ‘‘devices’’; 

21 (3) in paragraph (2)(C), by striking ‘‘paragraph 

22 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

23 (4) by redesignating paragraphs (3), (4), and 

24 (5) as paragraphs (4), (5), and (6), and inserting 

25 after paragraph (2) the following: 
228 

•S 1074 IS 

1 ‘‘(3) If the Secretary finds that a person has 

2 committed repeated violations of restrictions promul3 gated under section 906(d) at a particular retail out4 let then the Secretary may impose a no-tobacco-sale 

5 order on that person prohibiting the sale of tobacco 

6 products in that outlet. A no-tobacco-sale order may 

7 be imposed with a civil penalty under paragraph 

8 (1).’’; 

9 (5) in paragraph (4) as so redesignated— 

10 (A) in subparagraph (A)— 

11 (i) by striking ‘‘assessed’’ the first 

12 time it appears and inserting ‘‘assessed, or 

13 a no-tobacco-sale order may be imposed,’’; 

14 and 

15 (ii) by striking ‘‘penalty’’ and insert16 ing ‘‘penalty, or upon whom a no-tobacco17 order is to be imposed,’’; 

18 (B) in subparagraph (B)— 

19 (i) by inserting after ‘‘penalty,’’ the 

20 following: ‘‘or the period to be covered by 

21 a no-tobacco-sale order,’’; and 

22 (ii) by adding at the end the fol23 lowing: ‘‘A no-tobacco-sale order perma24 nently prohibiting an individual retail out25 let from selling tobacco products shall in-
229 

•S 1074 IS 

1 clude provisions that allow the outlet, after 

2 a specified period of time, to request that 

3 the Secretary compromise, modify, or ter4 minate the order.’’; and 

5 (C) by adding at the end, the following: 

6 ‘‘(D) The Secretary may compromise, mod7 ify, or terminate, with or without conditions, 

8 any no-tobacco-sale order.’’; 

9 (6) in paragraph (5) as so redesignated— 

10 (A) by striking ‘‘(3)(A)’’ as redesignated, 

11 and inserting ‘‘(4)(A)’’; 

12 (B) by inserting ‘‘or the imposition of a 

13 no-tobacco-sale order’’ after ‘‘penalty’’ the first 

14 2 places it appears; and 

15 (C) by striking ‘‘issued.’’ and inserting 

16 ‘‘issued, or on which the no-tobacco-sale order 

17 was imposed, as the case may be.’’; and 

18 (7) in paragraph (6), as so redesignated, by 

19 striking ‘‘paragraph (4)’’ each place it appears and 

20 inserting ‘‘paragraph (5)’’. 

21 (d) SECTION 304.—Section 304 (21 U.S.C. 334) is 

22 amended— 

23 (1) in subsection (a)(2)— 

24 (A) by striking ‘‘and’’ before ‘‘(D)’’; and 
230 

•S 1074 IS 

1 (B) by striking ‘‘device.’’ and inserting the 

2 following: ‘‘, (E) Any adulterated or misbranded 

3 tobacco product.’’; 

4 (2) in subsection (d)(1), by inserting ‘‘tobacco 

5 product,’’ after ‘‘device,’’; 

6 (3) in subsection (g)(1), by inserting ‘‘or to7 bacco product’’ after ‘‘device’’ each place it appears; 

8 and 

9 (4) in subsection (g)(2)(A), by inserting ‘‘or to10 bacco product’’ after ‘‘device’’ each place it appears. 

11 (e) SECTION 702.—Section 702(a) (21 U.S.C. 

12 372(a)) is amended— 

13 (1) by inserting ‘‘(1)’’ after ‘‘(a)’’; and 

14 (2) by adding at the end thereof the following: 

15 ‘‘(2) For a tobacco product, to the extent feasible, 

16 the Secretary shall contract with the States in accordance 

17 with paragraph (1) to carry out inspections of retailers 

18 within that State in connection with the enforcement of 

19 this Act.’’. 

20 (f) SECTION 703.—Section 703 (21 U.S.C. 373) is 

21 amended— 

22 (1) by inserting ‘‘tobacco product,’’ after ‘‘de23 vice,’’ each place it appears; and 

24 (2) by inserting ‘‘tobacco products,’’ after ‘‘de25 vices,’’ each place it appears. 
231 

•S 1074 IS 

1 (g) SECTION 704.—Section 704 (21 U.S.C. 374) is 

2 amended— 

3 (1) in subsection (a)(1)(A), by inserting ‘‘to4 bacco products,’’ after ‘‘devices,’’ each place it ap5 pears; 

6 (2) in subsection (a)(1)(B), by inserting ‘‘or to7 bacco product’’ after ‘‘restricted devices’’ each place 

8 it appears; and 

9 (3) in subsection (b), by inserting ‘‘tobacco 

10 product,’’ after ‘‘device,’’. 

11 (h) SECTION 705.—Section 705(b) (21 U.S.C. 

12 375(b)) is amended by inserting ‘‘tobacco products,’’ after 

13 ‘‘devices,’’. 

14 (i) SECTION 709.—Section 709 (21 U.S.C. 379) is 

15 amended by inserting ‘‘or tobacco product’’ after ‘‘device’’. 

16 (j) SECTION 801.—Section 801 (21 U.S.C. 381) is 

17 amended— 

18 (1) in subsection (a)— 

19 (A) by inserting ‘‘tobacco products,’’ after 

20 ‘‘devices,’’ the first time it appears; 

21 (B) by inserting ‘‘or section 905(j)’’ after 

22 ‘‘section 510’’; and 

23 (C) by striking ‘‘drugs or devices’’ each 

24 time it appears and inserting ‘‘drugs, devices, 

25 or tobacco products’’; 
232 

•S 1074 IS 

1 (2) in subsection (e)(1), by inserting ‘‘tobacco 

2 product,’’ after ‘‘device,’’; and 

3 (3) by adding at the end the following: 

4 ‘‘(p)(1) Not later than 2 years after the date of enact5 ment of the Family Smoking Prevention and Tobacco 

6 Control Act, and annually thereafter, the Secretary shall 

7 submit to the Committee on Health, Education, Labor, 

8 and Pensions of the Senate and the Committee on Energy 

9 and Commerce of the House of Representatives, a report 

10 regarding— 

11 ‘‘(A) the nature, extent, and destination of 

12 United States tobacco product exports that do not 

13 conform to tobacco product standards established 

14 pursuant to this Act; 

15 ‘‘(B) the public health implications of such ex16 ports, including any evidence of a negative public 

17 health impact; and 

18 ‘‘(C) recommendations or assessments of policy 

19 alternatives available to Congress and the Executive 

20 Branch to reduce any negative public health impact 

21 caused by such exports. 

22 ‘‘(2) The Secretary is authorized to establish appro23 priate information disclosure requirements to carry out 

24 this subsection.’’. 
233 

•S 1074 IS 

1 (k) SECTION 1003.—Section 1003(d)(2)(C) (as re2 designated by section 231(a)) is amended— 

3 (1) by striking ‘‘and’’ after ‘‘cosmetics,’’; and 

4 (2) inserting a comma and ‘‘and tobacco prod5 ucts’’ after ‘‘devices’’. 

6 (l) GUIDANCE AND EFFECTIVE DATES.— 

7 (1) IN GENERAL.—The Secretary of Health and 

8 Human Services shall issue guidance— 

9 (A) defining the term ‘‘repeated violation’’, 

10 as used in section 303(f) of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 333(f)) as 

12 amended by subsection (c), by identifying the 

13 number of violations of particular requirements 

14 over a specified period of time at a particular 

15 retail outlet that constitute a repeated violation; 

16 (B) providing for timely and effective no17 tice to the retailer of each alleged violation at 

18 a particular retail outlet; 

19 (C) providing for an expedited procedure 

20 for the administrative appeal of an alleged vio21 lation; 

22 (D) providing that a person may not be 

23 charged with a violation at a particular retail 

24 outlet unless the Secretary has provided notice 
234 

•S 1074 IS 

1 to the retailer of all previous violations at that 

2 outlet; 

3 (E) establishing a period of time during 

4 which, if there are no violations by a particular 

5 retail outlet, that outlet will not be considered 

6 to have been the site of repeated violations 

7 when the next violation occurs; and 

8 (F) providing that good faith reliance on 

9 the presentation of a false government issued 

10 photographic identification that contains a date 

11 of birth does not constitute a violation of any 

12 minimum age requirement for the sale of to13 bacco products if the retailer has taken effective 

14 steps to prevent such violations, including— 

15 (i) adopting and enforcing a written 

16 policy against sales to minors; 

17 (ii) informing its employees of all ap18 plicable laws; 

19 (iii) establishing disciplinary sanctions 

20 for employee noncompliance; and 

21 (iv) requiring its employees to verify 

22 age by way of photographic identification 

23 or electronic scanning device. 

24 (2) GENERAL EFFECTIVE DATE.—The amend25 ments made by subsection (c), other than the 
235 

•S 1074 IS 

1 amendment made by paragraph (2) of such sub2 section, shall take effect upon the issuance of guid3 ance described in paragraph (1). 

4 (3) SPECIAL EFFECTIVE DATE.—The amend5 ments made by paragraph (2) of subsection (c) shall 

6 take effect on the date of enactment of this Act. 

7 PART II—TOBACCO PRODUCT WARNINGS; CON8 STITUENT AND SMOKE CONSTITUENT DIS9 CLOSURE 

10 SEC. 235. CIGARETTE LABEL AND ADVERTISING WARNINGS. 

11 Section 4 of the Federal Cigarette Labeling and Ad12 vertising Act (15 U.S.C. 1333) is amended to read as fol13 lows: 

14 ‘‘SEC. 4. LABELING. 

15 ‘‘(a) LABEL REQUIREMENTS.— 

16 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

17 person to manufacture, package, sell, offer to sell, 

18 distribute, or import for sale or distribution within 

19 the United States any cigarettes the package of 

20 which fails to bear, in accordance with the require21 ments of this section, one of the following labels: 

22 ‘‘ ‘WARNING: Cigarettes are addictive’. 

23 ‘‘ ‘WARNING: Tobacco smoke can harm your 

24 children’. 
236 

•S 1074 IS 

1 ‘‘ ‘WARNING: Cigarettes cause fatal lung dis2 ease’. 

3 ‘‘ ‘WARNING: Cigarettes cause cancer’. 

4 ‘‘ ‘WARNING: Cigarettes cause strokes and 

5 heart disease’. 

6 ‘‘ ‘WARNING: Smoking during pregnancy can 

7 harm your baby’. 

8 ‘‘ ‘WARNING: Smoking can kill you’. 

9 ‘‘ ‘WARNING: Tobacco smoke causes fatal lung 

10 disease in non-smokers’. 

11 ‘‘ ‘WARNING: Quitting smoking now greatly 

12 reduces serious risks to your health’. 

13 ‘‘(2) PLACEMENT; TYPOGRAPHY; ETC.— 

14 ‘‘(A) IN GENERAL.—Each label statement 

15 required by paragraph (1) shall be located in 

16 the upper portion of the front and rear panels 

17 of the package, directly on the package under18 neath the cellophane or other clear wrapping. 

19 Except as provided in subparagraph (B), each 

20 label statement shall comprise at least the top 

21 30 percent of the front and rear panels of the 

22 package. The word ‘WARNING’ shall appear in 

23 capital letters and all text shall be in con24 spicuous and legible 17-point type, unless the 

25 text of the label statement would occupy more 
237 

•S 1074 IS 

1 than 70 percent of such area, in which case the 

2 text may be in a smaller conspicuous and leg3 ible type size, provided that at least 60 percent 

4 of such area is occupied by required text. The 

5 text shall be black on a white background, or 

6 white on a black background, in a manner that 

7 contrasts, by typography, layout, or color, with 

8 all other printed material on the package, in an 

9 alternating fashion under the plan submitted 

10 under subsection (b)(4). 

11 ‘‘(B) HINGED LID BOXES.—For any ciga12 rette brand package manufactured or distrib13 uted before January 1, 2000, which employs a 

14 hinged lid style (if such packaging was used for 

15 that brand in commerce prior to June 21, 

16 1997), the label statement required by para17 graph (1) shall be located on the hinged lid 

18 area of the package, even if such area is less 

19 than 25 percent of the area of the front panel. 

20 Except as provided in this paragraph, the provi21 sions of this subsection shall apply to such 

22 packages. 

23 ‘‘(3) DOES NOT APPLY TO FOREIGN DISTRIBU24 TION.—The provisions of this subsection do not 

25 apply to a tobacco product manufacturer or dis-
238 

•S 1074 IS 

1 tributor of cigarettes which does not manufacture, 

2 package, or import cigarettes for sale or distribution 

3 within the United States. 

4 ‘‘(4) APPLICABILITY TO RETAILERS.—A retailer 

5 of cigarettes shall not be in violation of this sub6 section for packaging that is supplied to the retailer 

7 by a tobacco product manufacturer, importer, or dis8 tributor and is not altered by the retailer in a way 

9 that is material to the requirements of this sub10 section except that this paragraph shall not relieve 

11 a retailer of liability if the retailer sells or distributes 

12 tobacco products that are not labeled in accordance 

13 with this subsection. 

14 ‘‘(b) ADVERTISING REQUIREMENTS.— 

15 ‘‘(1) IN GENERAL.—It shall be unlawful for any 

16 tobacco product manufacturer, importer, distributor, 

17 or retailer of cigarettes to advertise or cause to be 

18 advertised within the United States any cigarette 

19 unless its advertising bears, in accordance with the 

20 requirements of this section, one of the labels speci21 fied in subsection (a) of this section. 

22 ‘‘(2) TYPOGRAPHY, ETC.—Each label statement 

23 required by subsection (a) of this section in cigarette 

24 advertising shall comply with the standards set forth 

25 in this paragraph. For press and poster advertise-
239 

•S 1074 IS 

1 ments, each such statement and (where applicable) 

2 any required statement relating to tar, nicotine, or 

3 other constituent (including a smoke constituent) 

4 yield shall comprise at least 20 percent of the area 

5 of the advertisement and shall appear in a con6 spicuous and prominent format and location at the 

7 top of each advertisement within the trim area. The 

8 Secretary may revise the required type sizes in such 

9 area in such manner as the Secretary determines ap10 propriate. The word ‘WARNING’ shall appear in 

11 capital letters, and each label statement shall appear 

12 in conspicuous and legible type. The text of the label 

13 statement shall be black if the background is white 

14 and white if the background is black, under the plan 

15 submitted under paragraph (4) of this subsection. 

16 The label statements shall be enclosed by a rectan17 gular border that is the same color as the letters of 

18 the statements and that is the width of the first 

19 downstroke of the capital ‘W’ of the word ‘WARN20 ING’ in the label statements. The text of such label 

21 statements shall be in a typeface pro rata to the fol22 lowing requirements: 45-point type for a whole-page 

23 broadsheet newspaper advertisement; 39-point type 

24 for a half-page broadsheet newspaper advertisement; 

25 39-point type for a whole-page tabloid newspaper ad-
240 

•S 1074 IS 

1 vertisement; 27-point type for a half-page tabloid 

2 newspaper advertisement; 31.5-point type for a dou3 ble page spread magazine or whole-page magazine 

4 advertisement; 22.5-point type for a 28 centimeter 

5 by 3 column advertisement; and 15-point type for a 

6 20 centimeter by 2 column advertisement. The label 

7 statements shall be in English, except that in the 

8 case of— 

9 ‘‘(A) an advertisement that appears in a 

10 newspaper, magazine, periodical, or other publi11 cation that is not in English, the statements 

12 shall appear in the predominant language of the 

13 publication; and 

14 ‘‘(B) in the case of any other advertise15 ment that is not in English, the statements 

16 shall appear in the same language as that prin17 cipally used in the advertisement. 

18 ‘‘(3) MATCHBOOKS.—Notwithstanding para19 graph (2), for matchbooks (defined as containing not 

20 more than 20 matches) customarily given away with 

21 the purchase of tobacco products, each label state22 ment required by subsection (a) may be printed on 

23 the inside cover of the matchbook. 

24 ‘‘(4) ADJUSTMENT BY SECRETARY.—The Sec25 retary may, through a rulemaking under section 553 
241 

•S 1074 IS 

1 of title 5, United States Code, adjust the format and 

2 type sizes for the label statements required by this 

3 section or the text, format, and type sizes of any re4 quired tar, nicotine yield, or other constituent (in5 cluding smoke constituent) disclosures, or to estab6 lish the text, format, and type sizes for any other 

7 disclosures required under the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 301 et. seq.). The text 

9 of any such label statements or disclosures shall be 

10 required to appear only within the 20 percent area 

11 of cigarette advertisements provided by paragraph 

12 (2) of this subsection. The Secretary shall promul13 gate regulations which provide for adjustments in 

14 the format and type sizes of any text required to ap15 pear in such area to ensure that the total text re16 quired to appear by law will fit within such area. 

17 ‘‘(c) MARKETING REQUIREMENTS.— 

18 ‘‘(1) RANDOM DISPLAY.—The label statements 

19 specified in subsection (a)(1) shall be randomly dis20 played in each 12-month period, in as equal a num21 ber of times as is possible on each brand of the 

22 product and be randomly distributed in all areas of 

23 the United States in which the product is marketed 

24 in accordance with a plan submitted by the tobacco 
242 

•S 1074 IS 

1 product manufacturer, importer, distributor, or re2 tailer and approved by the Secretary. 

3 ‘‘(2) ROTATION.—The label statements speci4 fied in subsection (a)(1) shall be rotated quarterly in 

5 alternating sequence in advertisements for each 

6 brand of cigarettes in accordance with a plan sub7 mitted by the tobacco product manufacturer, im8 porter, distributor, or retailer to, and approved by, 

9 the Secretary. 

10 ‘‘(3) REVIEW.—The Secretary shall review each 

11 plan submitted under paragraph (2) and approve it 

12 if the plan— 

13 ‘‘(A) will provide for the equal distribution 

14 and display on packaging and the rotation re15 quired in advertising under this subsection; and 

16 ‘‘(B) assures that all of the labels required 

17 under this section will be displayed by the to18 bacco product manufacturer, importer, dis19 tributor, or retailer at the same time. 

20 ‘‘(4) APPLICABILITY TO RETAILERS.—This sub21 section and subsection (b) apply to a retailer only if 

22 that retailer is responsible for or directs the label 

23 statements required under this section except that 

24 this paragraph shall not relieve a retailer of liability 

25 if the retailer displays, in a location open to the pub-
243 

•S 1074 IS 

1 lic, an advertisement that is not labeled in accord2 ance with the requirements of this subsection and 

3 subsection (b).’’. 

4 SEC. 236. AUTHORITY TO REVISE CIGARETTE WARNING 

5 LABEL STATEMENTS. 

6 Section 4 of the Federal Cigarette Labeling and Ad7 vertising Act (15 U.S.C. 1333), as amended by section 

8 235, is further amended by adding at the end the fol9 lowing: 

10 ‘‘(d) CHANGE IN REQUIRED STATEMENTS.—The 

11 Secretary may, by a rulemaking conducted under section 

12 553 of title 5, United States Code, adjust the format, type 

13 size, and text of any of the label requirements, require 

14 color graphics to accompany the text, increase the re15 quired label area from 30 percent up to 50 percent of the 

16 front and rear panels of the package, or establish the for17 mat, type size, and text of any other disclosures required 

18 under the Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 301 et seq.), if the Secretary finds that such a 

20 change would promote greater public understanding of the 

21 risks associated with the use of tobacco products.’’. 
244 

•S 1074 IS 

1 SEC. 237. STATE REGULATION OF CIGARETTE ADVER2 TISING AND PROMOTION. 

3 Section 5 of the Federal Cigarette Labeling and Ad4 vertising Act (15 U.S.C. 1334) is amended by adding at 

5 the end the following: 

6 ‘‘(c) EXCEPTION.—Notwithstanding subsection (b), a 

7 State or locality may enact statutes and promulgate regu8 lations, based on smoking and health, that take effect 

9 after the effective date of the Family Smoking Prevention 

10 and Tobacco Control Act, imposing specific bans or re11 strictions on the time, place, and manner, but not content, 

12 of the advertising or promotion of any cigarettes.’’. 

13 SEC. 238. SMOKELESS TOBACCO LABELS AND ADVERTISING 

14 WARNINGS. 

15 Section 3 of the Comprehensive Smokeless Tobacco 

16 Health Education Act of 1986 (15 U.S.C. 4402) is amend17 ed to read as follows: 

18 ‘‘SEC. 3. SMOKELESS TOBACCO WARNING. 

19 ‘‘(a) GENERAL RULE.— 

20 ‘‘(1) It shall be unlawful for any person to man21 ufacture, package, sell, offer to sell, distribute, or 

22 import for sale or distribution within the United 

23 States any smokeless tobacco product unless the 

24 product package bears, in accordance with the re25 quirements of this Act, one of the following labels: 
245 

•S 1074 IS 

1 ‘‘ ‘WARNING: This product can cause mouth 

2 cancer’. 

3 ‘‘ ‘WARNING: This product can cause gum dis4 ease and tooth loss’. 

5 ‘‘ ‘WARNING: This product is not a safe alter6 native to cigarettes’. 

7 ‘‘ ‘WARNING: Smokeless tobacco is addictive’. 

8 ‘‘(2) Each label statement required by para9 graph (1) shall be— 

10 ‘‘(A) located on the 2 principal display 

11 panels of the package, and each label statement 

12 shall comprise at least 30 percent of each such 

13 display panel; and 

14 ‘‘(B) in 17-point conspicuous and legible 

15 type and in black text on a white background, 

16 or white text on a black background, in a man17 ner that contrasts by typography, layout, or 

18 color, with all other printed material on the 

19 package, in an alternating fashion under the 

20 plan submitted under subsection (b)(3), except 

21 that if the text of a label statement would oc22 cupy more than 70 percent of the area specified 

23 by subparagraph (A), such text may appear in 

24 a smaller type size, so long as at least 60 per-
246 

•S 1074 IS 

1 cent of such warning area is occupied by the 

2 label statement. 

3 ‘‘(3) The label statements required by para4 graph (1) shall be introduced by each tobacco prod5 uct manufacturer, packager, importer, distributor, or 

6 retailer of smokeless tobacco products concurrently 

7 into the distribution chain of such products. 

8 ‘‘(4) The provisions of this subsection do not 

9 apply to a tobacco product manufacturer or dis10 tributor of any smokeless tobacco product that does 

11 not manufacture, package, or import smokeless to12 bacco products for sale or distribution within the 

13 United States. 

14 ‘‘(5) A retailer of smokeless tobacco products 

15 shall not be in violation of this subsection for pack16 aging that is supplied to the retailer by a tobacco 

17 products manufacturer, importer, or distributor and 

18 that is not altered by the retailer unless the retailer 

19 offers for sale, sells, or distributes a smokeless to20 bacco product that is not labeled in accordance with 

21 this subsection. 

22 ‘‘(b) REQUIRED LABELS.— 

23 ‘‘(1) It shall be unlawful for any tobacco prod24 uct manufacturer, packager, importer, distributor, or 

25 retailer of smokeless tobacco products to advertise or 
247 

•S 1074 IS 

1 cause to be advertised within the United States any 

2 smokeless tobacco product unless its advertising 

3 bears, in accordance with the requirements of this 

4 section, one of the labels specified in subsection (a). 

5 ‘‘(2) Each label statement required by sub6 section (a) in smokeless tobacco advertising shall 

7 comply with the standards set forth in this para8 graph. For press and poster advertisements, each 

9 such statement and (where applicable) any required 

10 statement relating to tar, nicotine, or other con11 stituent yield shall— 

12 ‘‘(A) comprise at least 20 percent of the 

13 area of the advertisement, and the warning area 

14 shall be delineated by a dividing line of con15 trasting color from the advertisement; and 

16 ‘‘(B) the word ‘WARNING’ shall appear in 

17 capital letters and each label statement shall 

18 appear in conspicuous and legible type. The text 

19 of the label statement shall be black on a white 

20 background, or white on a black background, in 

21 an alternating fashion under the plan submitted 

22 under paragraph (3). 

23 ‘‘(3)(A) The label statements specified in sub24 section (a)(1) shall be randomly displayed in each 

25 12-month period, in as equal a number of times as 
248 

•S 1074 IS 

1 is possible on each brand of the product and be ran2 domly distributed in all areas of the United States 

3 in which the product is marketed in accordance with 

4 a plan submitted by the tobacco product manufac5 turer, importer, distributor, or retailer and approved 

6 by the Secretary. 

7 ‘‘(B) The label statements specified in sub8 section (a)(1) shall be rotated quarterly in alter9 nating sequence in advertisements for each brand of 

10 smokeless tobacco product in accordance with a plan 

11 submitted by the tobacco product manufacturer, im12 porter, distributor, or retailer to, and approved by, 

13 the Secretary. 

14 ‘‘(C) The Secretary shall review each plan sub15 mitted under subparagraph (B) and approve it if the 

16 plan— 

17 ‘‘(i) will provide for the equal distribution 

18 and display on packaging and the rotation re19 quired in advertising under this subsection; and 

20 ‘‘(ii) assures that all of the labels required 

21 under this section will be displayed by the to22 bacco product manufacturer, importer, dis23 tributor, or retailer at the same time. 

24 ‘‘(D) This paragraph applies to a retailer only 

25 if that retailer is responsible for or directs the label 
249 

•S 1074 IS 

1 statements under this section, unless the retailer dis2 plays in a location open to the public, an advertise3 ment that is not labeled in accordance with the re4 quirements of this subsection. 

5 ‘‘(c) TELEVISION AND RADIO ADVERTISING.—It is 

6 unlawful to advertise smokeless tobacco on any medium 

7 of electronic communications subject to the jurisdiction of 

8 the Federal Communications Commission.’’. 

9 SEC. 239. AUTHORITY TO REVISE SMOKELESS TOBACCO 

10 PRODUCT WARNING LABEL STATEMENTS. 

11 Section 3 of the Comprehensive Smokeless Tobacco 

12 Health Education Act of 1986 (15 U.S.C. 4402), as 

13 amended by section 237, is further amended by adding 

14 at the end the following: 

15 ‘‘(d) AUTHORITY TO REVISE WARNING LABEL

16 STATEMENTS.—The Secretary may, by a rulemaking con17 ducted under section 553 of title 5, United States Code, 

18 adjust the format, type size, and text of any of the label 

19 requirements, require color graphics to accompany the 

20 text, increase the required label area from 30 percent up 

21 to 50 percent of the front and rear panels of the package, 

22 or establish the format, type size, and text of any other 

23 disclosures required under the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 301 et seq.), if the Secretary 

25 finds that such a change would promote greater public un-
250 

•S 1074 IS 

1 derstanding of the risks associated with the use of smoke2 less tobacco products.’’. 

3 SEC. 240. TAR, NICOTINE, AND OTHER SMOKE CON4 STITUENT DISCLOSURE TO THE PUBLIC. 

5 Section 4(a) of the Federal Cigarette Labeling and 

6 Advertising Act (15 U.S.C. 1333 (a)), as amended by sec7 tion 235, is further amended by adding at the end the 

8 following: 

9 ‘‘(4)(A) The Secretary shall, by a rulemaking 

10 conducted under section 553 of title 5, United 

11 States Code, determine (in the Secretary’s sole dis12 cretion) whether cigarette and other tobacco product 

13 manufacturers shall be required to include in the 

14 area of each cigarette advertisement specified by 

15 subsection (b) of this section, or on the package 

16 label, or both, the tar and nicotine yields of the ad17 vertised or packaged brand. Any such disclosure 

18 shall be in accordance with the methodology estab19 lished under such regulations, shall conform to the 

20 type size requirements of subsection (b) of this sec21 tion, and shall appear within the area specified in 

22 subsection (b) of this section. 

23 ‘‘(B) Any differences between the requirements 

24 established by the Secretary under subparagraph (A) 

25 and tar and nicotine yield reporting requirements es-
251 

•S 1074 IS 

1 tablished by the Federal Trade Commission shall be 

2 resolved by a memorandum of understanding be3 tween the Secretary and the Federal Trade Commis4 sion. 

5 ‘‘(C) In addition to the disclosures required by 

6 subparagraph (A) of this paragraph, the Secretary 

7 may, under a rulemaking conducted under section 

8 553 of title 5, United States Code, prescribe disclo9 sure requirements regarding the level of any ciga10 rette or other tobacco product constituent including 

11 any smoke constituent. Any such disclosure may be 

12 required if the Secretary determines that disclosure 

13 would be of benefit to the public health, or otherwise 

14 would increase consumer awareness of the health 

15 consequences of the use of tobacco products, except 

16 that no such prescribed disclosure shall be required 

17 on the face of any cigarette package or advertise18 ment. Nothing in this section shall prohibit the Sec19 retary from requiring such prescribed disclosure 

20 through a cigarette or other tobacco product pack21 age or advertisement insert, or by any other means 

22 under the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 301 et seq.). 

24 ‘‘(D) This paragraph applies to a retailer only 

25 if that retailer is responsible for or directs the label 
252 

•S 1074 IS 

1 statements required under this section, except that 

2 this paragraph shall not relieve a retailer of liability 

3 if the retailer sells or distributes tobacco products 

4 that are not labeled in accordance with the require5 ments of this subsection.’’. 

6 PART III—PREVENTION OF ILLICIT TRADE IN 

7 TOBACCO PRODUCTS 

8 SEC. 241. LABELING, RECORDKEEPING, RECORDS INSPEC9 TION. 

10 Chapter IX of the Federal Food, Drug, and Cosmetic 

11 Act, as added by section 231, is further amended by add12 ing at the end the following: 

13 ‘‘SEC. 921. LABELING, RECORDKEEPING, RECORDS INSPEC14 TION. 

15 ‘‘(a) ORIGIN LABELING.—The label, packaging, and 

16 shipping containers of tobacco products for introduction 

17 or delivery for introduction into interstate commerce in the 

18 United States shall bear the statement ‘sale only allowed 

19 in the United States.’ 

20 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING

21 FOR TRACKING AND TRACING.— 

22 ‘‘(1) IN GENERAL.—Not later than 9 months 

23 after the date of enactment of the Family Smoking 

24 Prevention and Tobacco Control Act, the Secretary 

25 shall promulgate regulations regarding the establish-
253 

•S 1074 IS 

1 ment and maintenance of records by any person who 

2 manufactures, processes, transports, distributes, re3 ceives, packages, holds, exports, or imports tobacco 

4 products. 

5 ‘‘(2) INSPECTION.—In promulgating the regula6 tions described in paragraph (1), the Secretary shall 

7 consider which records are needed for inspection to 

8 monitor the movement of tobacco products from the 

9 point of manufacture through distribution to retail 

10 outlets to assist in investigating potential illicit 

11 trade, smuggling or counterfeiting of tobacco prod12 ucts. 

13 ‘‘(3) CODES.—The Secretary may require codes 

14 on the labels of tobacco products or other designs or 

15 devices for the purpose of tracking or tracing the to16 bacco product through the distribution system. 

17 ‘‘(4) SIZE OF BUSINESS.—The Secretary shall 

18 take into account the size of a business in promul19 gating regulations under this section. 

20 ‘‘(5) RECORDKEEPING BY RETAILERS.—The 

21 Secretary shall not require any retailer to maintain 

22 records relating to individual purchasers of tobacco 

23 products for personal consumption. 

24 ‘‘(c) RECORDS INSPECTION.—If the Secretary has a 

25 reasonable belief that a tobacco product is part of an illicit 
254 

•S 1074 IS 

1 trade or smuggling or is a counterfeit product, each person 

2 who manufactures, processes, transports, distributes, re3 ceives, holds, packages, exports, or imports tobacco prod4 ucts shall, at the request of an officer or employee duly 

5 designated by the Secretary, permit such officer or em6 ployee, at reasonable times and within reasonable limits 

7 and in a reasonable manner, upon the presentation of ap8 propriate credentials and a written notice to such person, 

9 to have access to and copy all records (including financial 

10 records) relating to such article that are needed to assist 

11 the Secretary in investigating potential illicit trade, smug12 gling or counterfeiting of tobacco products. 

13 ‘‘(d) KNOWLEDGE OF ILLEGAL TRANSACTION.— 

14 ‘‘(1) IN GENERAL.—If the manufacturer or dis15 tributor of a tobacco product has knowledge which 

16 reasonably supports the conclusion that a tobacco 

17 product manufactured or distributed by such manu18 facturer or distributor that has left the control of 

19 such person may be or has been— 

20 ‘‘(A) imported, exported, distributed or of21 fered for sale in interstate commerce by a per22 son without paying duties or taxes required by 

23 law; or 

24 ‘‘(B) imported, exported, distributed or di25 verted for possible illicit marketing, the manu-
255 

•S 1074 IS 

1 facturer or distributor shall promptly notify the 

2 Attorney General of such knowledge. 

3 ‘‘(2) KNOWLEDGE DEFINED.—For purposes of 

4 this subsection, the term ‘knowledge’ as applied to 

5 a manufacturer or distributor means— 

6 ‘‘(A) the actual knowledge that the manu7 facturer or distributor had; or 

8 ‘‘(B) the knowledge which a reasonable 

9 person would have had under like circumstances 

10 or which would have been obtained upon the ex11 ercise of due care.’’. 

12 SEC. 242. STUDY AND REPORT. 

13 (a) STUDY.—The Comptroller General of the United 

14 States shall conduct a study of cross-border trade in to15 bacco products to— 

16 (1) collect data on cross-border trade in tobacco 

17 products, including illicit trade and trade of counter18 feit tobacco products and make recommendations on 

19 the monitoring of such trade; 

20 (2) collect data on cross-border advertising (any 

21 advertising intended to be broadcast, transmitted, or 

22 distributed from the United States to another coun23 try) of tobacco products and make recommendations 

24 on how to prevent or eliminate, and what tech-
256 

•S 1074 IS 

1 nologies could help facilitate the elimination of, 

2 cross-border advertising. 

3 (b) REPORT.—Not later than 18 months after the 

4 date of enactment of this Act, the Comptroller General 

5 of the United States shall submit to the Committee on 

6 Health, Education, Labor, and Pensions of the Senate and 

7 the Committee on Energy and Commerce of the House 

8 of Representatives a report on the study described in sub9 section (a). 

10 TITLE III—RESPONSIBLE MAR11 KETING AND CONSUMER 

12 AWARENESS 

13 Subtitle A—General Provisions 

14 SEC. 301. NUTRITION LABELING OF RESTAURANT FOODS. 

15 Section 403(q)(5) of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 343(q)(5)(A)(i)) is amended— 

17 (1) in clause (A)— 

18 (A) in subclause (i), by inserting ‘‘except 

19 as provided in clauses (H) and (I),’’ before 

20 ‘‘which’’ the first place it appears; and 

21 (B) in subclause (ii), by inserting ‘‘except 

22 as provided in clauses (H) and (I),’’ before 

23 ‘‘which’’ the first place it appears; and 

24 (2) by adding at the end the following: 
257 

•S 1074 IS 

1 ‘‘(H) RESTAURANTS AND RETAIL FOOD ESTABLISH2 MENTS.— 

3 ‘‘(i) IN GENERAL.—Except for food described in 

4 subclause (iii), in the case of food that is served, 

5 processed, or prepared in a restaurant or similar re6 tail food establishment that is part of a chain with 

7 20 or more locations doing business under the same 

8 trade name (regardless of the type of ownership of 

9 the locations), the restaurant or establishment shall 

10 disclose the information described in subclause (ii). 

11 ‘‘(ii) INFORMATION REQUIRED TO BE DIS12 CLOSED.—Except as provided in subclause (iii), the 

13 establishment shall disclose— 

14 ‘‘(I)(aa) in a statement adjacent to the 

15 name of the food on any menu listing the food 

16 for sale, or by any other means deemed equiva17 lent by the Secretary, the number of calories, 

18 grams of saturated fat plus trans fat, and milli19 grams of sodium contained in a standard serv20 ing of the food, as usually offered for sale, in 

21 a clear and conspicuous manner; and 

22 ‘‘(bb) information, specified by the Sec23 retary by regulation, designed to enable the 

24 public to understand, in the context of a total 
258 

•S 1074 IS 

1 daily diet, the significance of the nutrition in2 formation that is provided; and 

3 ‘‘(II) in a statement adjacent to the name 

4 of the food on any menu board or other sign 

5 listing the food for sale, or by any other means 

6 deemed equivalent by the Secretary— 

7 ‘‘(aa) the number of calories con8 tained in a serving of the food, as usually 

9 offered for sale, in a clear and conspicuous 

10 manner; and 

11 ‘‘(bb) notification that the information 

12 required by subitems (aa) and (bb) of item 

13 (I) shall be provided in writing at the re14 quest of a prospective purchaser. 

15 ‘‘(iii) NONAPPLICABILITY TO CERTAIN FOOD.— 

16 This clause does not apply to— 

17 ‘‘(I) items that are not listed on a menu or 

18 menu board (such as condiments and other 

19 items placed on the table or counter for general 

20 use); or 

21 ‘‘(II) daily specials, temporary menu items, 

22 or other irregular menu items, as specified by 

23 the Secretary by regulation. 

24 ‘‘(iv) SELF-SERVICE FACILITIES.—In the case 

25 of food sold at a salad bar, buffet line, cafeteria line, 
259 

•S 1074 IS 

1 or similar self-service facility, a restaurant or other 

2 establishment shall place a sign that lists calories 

3 per standard serving adjacent to each food offered. 

4 ‘‘(v) VOLUNTARY PROVISION OF NUTRITION IN5 FORMATION; STATE REGULATION OF NUTRITION IN6 FORMATION FOR RESTAURANT FOOD.— 

7 ‘‘(I) RETAIL FOOD ESTABLISHMENTS.— 

8 Nothing in this clause precludes a restaurant or 

9 similar retail food establishment from providing 

10 additional nutrition information, voluntarily, if 

11 the information complies with the nutrition la12 beling requirements contained in this subpara13 graph. 

14 ‘‘(II) STATE OR LOCAL REQUIREMENTS.— 

15 Nothing in this clause precludes a State or po16 litical subdivision of a State from requiring that 

17 a restaurant or similar food establishment pro18 vide nutrition information in addition to that 

19 required under this clause. 

20 ‘‘(vi) REGULATIONS.— 

21 ‘‘(I) PROPOSED REGULATION.—Not later 

22 than 1 year after the date of enactment of this 

23 clause, the Secretary shall promulgate proposed 

24 regulations to carry out this clause. 
260 

•S 1074 IS 

1 ‘‘(II) CONTENTS.—The regulations shall 

2 allow for the variations in serving sizes and in 

3 food preparation that can reasonably be ex4 pected to result from inadvertent human error, 

5 training of food service workers, and other fac6 tors. 

7 ‘‘(III) FINAL REGULATIONS.—Not later 

8 than 2 years after the date of enactment of this 

9 clause, the Secretary shall promulgate final reg10 ulations to implement this clause. 

11 ‘‘(IV) FAILURE TO PROMULGATE FINAL

12 REGULATIONS BY REQUIRED DATE.—If the Sec13 retary does not promulgate final regulations 

14 under item (III) by the date that is 2 years 

15 after the date of enactment of this clause— 

16 ‘‘(aa) the proposed regulations issued 

17 in accordance with item (I) shall become 

18 effective as the final regulations on the day 

19 after that date; and 

20 ‘‘(bb) the Secretary shall publish in 

21 the Federal Register notice of the final 

22 regulations. 

23 ‘‘(I) VENDING MACHINES.— 

24 ‘‘(i) IN GENERAL.—In the case of an article of 

25 food sold from a vending machine that— 
261 

•S 1074 IS 

1 ‘‘(I) does not permit a prospective pur2 chaser to examine the article so as to be able 

3 to read a statement affixed to the article before 

4 purchasing the article; and 

5 ‘‘(II) is operated by a person that is en6 gaged in the business of owning and operating 

7 20 or more vending machines; 

8 the vending machine operator shall provide a con9 spicuous sign in close proximity to the article that 

10 includes a statement disclosing the number of cal11 ories contained in the article. 

12 ‘‘(ii) VOLUNTARY PROVISION OF NUTRITION IN13 FORMATION; STATE REGULATION OF NUTRITION IN14 FORMATION FOR VENDING MACHINES.— 

15 ‘‘(I) VENDING MACHINE OPERATORS.— 

16 Nothing in this clause precludes a vending ma17 chine operator from providing additional nutri18 tion information, voluntarily, if the information 

19 complies with the nutrition labeling require20 ments contained in this subparagraph. 

21 ‘‘(II) STATE OR LOCAL REQUIREMENTS.— 

22 Nothing in this title precludes a State or polit23 ical subdivision of a State from requiring that 

24 a vending machine operator provide nutrition 
262 

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1 information in addition to that required under 

2 this clause. 

3 ‘‘(iii) REGULATIONS.— 

4 ‘‘(I) PROPOSED REGULATIONS.—Not later 

5 than 1 year after the date of enactment of this 

6 clause, the Secretary shall promulgate proposed 

7 regulations to carry out this clause. 

8 ‘‘(II) FINAL REGULATIONS.—Not later 

9 than 2 years after the date of enactment of this 

10 clause, the Secretary shall promulgate final reg11 ulations to implement this clause. 

12 ‘‘(III) FAILURE TO PROMULGATE FINAL

13 REGULATIONS BY REQUIRED DATE.—If the Sec14 retary does not promulgate final regulations 

15 under item (II) by the date that is 2 years after 

16 the date of enactment of this clause— 

17 ‘‘(aa) the proposed regulations issued 

18 in accordance with item (I) shall become 

19 effective as the final regulations on the day 

20 after that date; and 

21 ‘‘(bb) the Secretary shall publish in 

22 the Federal Register notice of the final 

23 regulations.’’. 
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1 SEC. 302. RULEMAKING AUTHORITY FOR ADVERTISING TO 

2 CHILDREN. 

3 (a) PURPOSE.—The purpose of this section is to re4 store the authority of the Federal Trade Commission to 

5 issue regulations that restrict the marketing or advertising 

6 of foods and beverages to children under the age of 18 

7 years if the Federal Trade Commission determines that 

8 there is evidence that consumption of certain foods and 

9 beverages is detrimental to the health of children. 

10 (b) AUTHORITY.—Section 18 of the Federal Trade 

11 Commission Act (15 U.S.C. 57a) is amended by striking 

12 subsection (h). 

13 SEC. 303. LABEL AND DISCLOSURE REQUIREMENTS FOR IN14 FANT FORMULAS. 

15 Section 412 of the Federal Food, Drug, and Cosmetic 

16 Act (21 U.S.C. 350a) is amended by adding at the end 

17 the following: 

18 ‘‘(j) LABEL AND DISCLOSURE REQUIREMENTS.— 

19 ‘‘(1) PACKAGING LABEL REQUIREMENTS.— 

20 ‘‘(A) IN GENERAL.—An infant formula 

21 shall be deemed misbranded unless the label of 

22 such infant formula contains the following 

23 statement: ‘The United States Department of 

24 Health and Human Services has determined 

25 that: (1) breast-feeding is the ideal method of 

26 feeding and nurturing infants; (2) breast milk 
264 

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1 is the most complete form of nutrition for in2 fants; and (3) breast milk is more beneficial to 

3 infants than infant formula.’. 

4 ‘‘(B) SPECIFICATIONS OF LABEL.—The 

5 label statement required under subparagraph 

6 (A) shall be— 

7 ‘‘(i) in conspicuous and legible type 

8 that is not smaller than 12-point font; 

9 ‘‘(ii) in black font on a white back10 ground, or white font on a black back11 ground; 

12 ‘‘(iii) with respect to typography and 

13 layout, in contrast with the other printed 

14 material on the package; and 

15 ‘‘(iv) enclosed by a border that is the 

16 same color as the letters of the statement. 

17 ‘‘(2) ADVERTISING REGULATIONS.— 

18 ‘‘(A) IN GENERAL.—The Secretary shall 

19 promulgate regulations establishing labeling 

20 and disclosure requirements for advertisements 

21 of infant formula. 

22 ‘‘(B) SPECIFICATIONS OF ADVERTISE23 MENTS.—The regulations promulgated under 

24 subparagraph (A) shall— 
265 

•S 1074 IS 

1 ‘‘(i) establish labeling and disclosure 

2 requirements for all forms of media by 

3 which infant formula is advertised, includ4 ing print, television, radio, and Internet 

5 marketing; and 

6 ‘‘(ii) be at least as stringent as the 

7 packaging label requirements under para8 graph (1).’’. 

9 SEC. 304. FOOD ADVERTISING IN SCHOOLS. 

10 Section 10 of the Child Nutrition Act of 1966 (42 

11 U.S.C. 1779) is amended by adding at the end the fol12 lowing: 

13 ‘‘(d) FOOD ADVERTISING.—The Secretary may pro14 hibit the advertising of food in participating schools if the 

15 Secretary determines that consumption of the advertised 

16 food has a detrimental effect on the diets or health of chil17 dren.’’. 

18 SEC. 305. DISALLOWANCE OF DEDUCTIONS FOR ADVER19 TISING AND MARKETING EXPENSES RELAT20 ING TO TOBACCO PRODUCT USE. 

21 (a) IN GENERAL.—Part IX of subchapter B of chap22 ter 1 of subtitle A of the Internal Revenue Code of 1986 

23 (relating to items not deductible) is amended by adding 

24 at the end the following new section: 
266 

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1 ‘‘SEC. 280I. DISALLOWANCE OF DEDUCTION FOR TOBACCO 

2 ADVERTISING AND MARKETING EXPENSES. 

3 ‘‘No deduction shall be allowed under this chapter for 

4 expenses relating to advertising or marketing cigars, ciga5 rettes, smokeless tobacco, pipe tobacco, or any similar to6 bacco product. For purposes of this section, any term used 

7 in this section which is also used in section 5702 shall 

8 have the same meaning given such term by section 5702.’’. 

9 (b) CONFORMING AMENDMENT.—The table of sec10 tions for such part IX is amended by adding after the 

11 item relating to section 280H the following new item: 

‘‘Sec. 280I. Disallowance of deduction for tobacco advertising 

and marketing expenses.’’. 

12 (c) EFFECTIVE DATE.—The amendments made by 

13 this section shall apply to taxable years beginning after 

14 the date of the enactment of this Act. 

15 SEC. 306. FEDERAL-STATE TOBACCO COUNTER-ADVER16 TISING PROGRAMS. 

17 Part P of title III of the Public Health Service Act 

18 (42 U.S.C. 280g et seq.), as amended in section 212, is 

19 further amended by adding at the end the following: 

20 ‘‘SEC. 399S. FEDERAL-STATE TOBACCO COUNTER-ADVER21 TISING PROGRAMS. 

22 ‘‘(a) IN GENERAL.—The Secretary, acting through 

23 the Director of the Centers for Disease Control and Pre24 vention, shall award grants to and enter into contracts 
267 

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1 with eligible entities for the implementation of national 

2 and local media (such as counter-advertising) and non3 media campaigns designed to reduce the use of tobacco 

4 products. 

5 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

6 under subsection (a), an entity shall be— 

7 ‘‘(1) a public entity, including a State public 

8 health department; or 

9 ‘‘(2) a private, nonprofit entity that— 

10 ‘‘(A) is not affiliated with a manufacturer 

11 or importer of a tobacco product; 

12 ‘‘(B) has demonstrated a record of con13 ducting a national antitobacco public education 

14 campaign to effectively reduce the use of to15 bacco products; 

16 ‘‘(C) has expertise in conducting a multi17 media communications campaign; and 

18 ‘‘(D) has expertise in developing strategies 

19 that affect behavior changes in children and 

20 other targeted populations. 

21 ‘‘(c) APPLICATION.—An eligible entity shall submit 

22 an application to the Secretary for a grant under this sec23 tion at such time, in such manner, and accompanied by 

24 such information as the Secretary may require. 
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1 ‘‘(d) USE OF FUNDS.—An eligible entity shall use 

2 amounts received under a grant under this section to— 

3 ‘‘(1) design and implement multimedia public 

4 education and social marketing campaigns that— 

5 ‘‘(A) discourage the use of tobacco prod6 ucts; 

7 ‘‘(B) encourage the use of products de8 signed to enable tobacco use cessation; and 

9 ‘‘(C) educate the public about the hazards 

10 of environmental tobacco smoke exposure; or 

11 ‘‘(2) conduct research related to the effective12 ness of the campaigns described in paragraph (1). 

13 ‘‘(e) ALLOCATION OF GRANTS.—Of the amounts 

14 awarded under this section, the Secretary shall award— 

15 ‘‘(1) 50 percent of such amounts to eligible 

16 public entities; and 

17 ‘‘(2) 50 percent of such amounts to eligible pri18 vate, nonprofit entities. 

19 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 

20 are authorized to be appropriated $200,000,000 to carry 

21 out this section.’’. 

22 Subtitle B—Penalties for Failure to 

23 Reduce Teen Smoking 

24 SEC. 311. CHILD CIGARETTE USE SURVEYS. 

25 (a) ANNUAL PERFORMANCE SURVEY.— 
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1 (1) IN GENERAL.—Not later than August 31, 

2 2006, and annually thereafter, the Secretary of 

3 Health and Human Services (referred to in this sec4 tion as the ‘‘Secretary’’) shall publish the results of 

5 an annual cigarette survey, to be carried out after 

6 the date of enactment of this Act and completed 

7 prior to August 21, 2006, and prior to August 21 

8 of each year thereafter, to determine— 

9 (A) the percentage of all young individuals 

10 who used a type of cigarette within the 30-day 

11 period prior to the conduct of the survey in12 volved; and 

13 (B) the percentage of young individuals 

14 who identify each brand of each type of ciga15 rette as the usual brand smoked within such 

16 30-day period. 

17 (2) YOUNG INDIVIDUALS.—For the purposes of 

18 this subtitle, the term ‘‘young individuals’’ means in19 dividuals who are under 18 years of age. 

20 (b) SIZE AND METHODOLOGY.— 

21 (1) IN GENERAL.—The survey referred to in 

22 subsection (a) shall be comparable in size and meth23 odology to the Monitoring the Future survey that 

24 was completed in 1999 to measure the use of ciga25 rettes (by brand) by youths under 18 years of age 
270 

•S 1074 IS 

1 within the 30-day period prior to the conduct of the 

2 study. 

3 (2) CONCLUSIVE ACCURATENESS.—A survey 

4 using the methodology described in paragraph (1) 

5 shall be deemed conclusively proper, correct, and ac6 curate for purposes of this section. 

7 (3) DEFINITION.—In this subtitle, the term 

8 ‘‘Monitoring the Future survey’’ means the com9 bined survey of 8th, 10th, and 12th grade students 

10 that was conducted at the Institute for Social Re11 search at the University of Michigan. 

12 (c) REDUCTION.—The Secretary, based on a com13 parison of the results of the first annual cigarette survey 

14 referred to in subsection (a) and the Monitoring the Fu15 ture survey referred to in subsection (b)(1), shall deter16 mine the percentage reduction (if any) in youth cigarette 

17 use for each manufacturer of cigarettes. 

18 (d) PARTICIPATION IN SURVEY.—Notwithstanding 

19 any other provision of law, the Secretary may conduct a 

20 survey under this section involving minors if the results 

21 of such survey with respect to such minors are kept con22 fidential and not disclosed. 

23 (e) NONAPPLICABILITY.—Chapter 35 of title 44, 

24 United States Code, shall not apply to information re25 quired for the purposes of carrying out this section. 
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1 (f) DEFINITION.—In this subtitle the term ‘‘ciga2 rette’’ has the meaning given such term in section 3(1) 

3 of the Federal Cigarette Labeling and Advertising Act (15 

4 U.S.C. 1332(1)). 

5 SEC. 312. CIGARETTE USE REDUCTION GOAL AND NON6 COMPLIANCE. 

7 (a) GOAL.—It shall be the cigarette use reduction 

8 goal that each manufacturer reduce youth cigarette use 

9 by at least 15 percent during the period between the Moni10 toring the Future survey referred to in section 311(b)(1) 

11 and the completion of the first annual cigarette survey 

12 (and such subsequent surveys as compared to the previous 

13 year’s survey) referred to in section 311(a). 

14 (b) NONCOMPLIANCE.— 

15 (1) INDUSTRY-WIDE PENALTY.—If the Sec16 retary determines that the cigarette use reduction 

17 goal under subsection (a) has not been achieved, the 

18 Secretary shall, not later than September 10, 2006, 

19 and September 10 of each year thereafter, impose 

20 an industry-wide penalty on the manufacturers of 

21 cigarettes in an amount that is in the aggregate 

22 equal to— 

23 (A) if youth cigarette use has been reduced 

24 by 5 percent or less, $6,000,000,000; 
272 

•S 1074 IS 

1 (B) if youth cigarette use has been reduced 

2 by at least 6 percent but less than 10 percent, 

3 $4,000,000,000; and 

4 (C) if youth cigarette use has been reduced 

5 by at least 11 percent but less than 15 percent, 

6 $2,000,000,000. 

7 (2) PAYMENT.—The industry-wide penalty im8 posed under this subsection shall be paid by each 

9 manufacturer based on the percentage of cigarettes 

10 of each such manufacturer that are used by youth 

11 (as determined under the Monitoring the Future 

12 survey and compared to the cigarettes manufactured 

13 by all manufacturers) as such percentage relates to 

14 the total amount to be paid by all manufacturers. 

15 (3) FINAL DETERMINATION.—The determina16 tion of the Secretary as to the amount and allocation 

17 of a surcharge under this subtitle shall be final and 

18 the manufacturer shall pay such surcharge within 10 

19 days of the date on which the manufacturer is as20 sessed. Such payment shall be retained by the Sec21 retary pending final judicial review of what, if any, 

22 change in the surcharge is appropriate. 

23 (4) COMPLIANCE BY CERTAIN MANUFACTUR24 ERS.—A manufacturer that individually complies 

25 with the goal under subsection (a) shall not be liable 
273 

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1 for the payment of any portion of the penalty under 

2 this subsection. 

3 (5) LIMITATION.—With respect to cigarettes, a 

4 manufacturer with a market share of 1 percent or 

5 less of youth cigarette use shall not be liable for the 

6 payment of a surcharge under this section. 

7 (c) PENALTIES NONDEDUCTIBLE.—The payment of 

8 penalties under this subtitle shall not be considered to be 

9 an ordinary and necessary expense in carrying on a trade 

10 or business for purposes of the Internal Revenue Code of 

11 1986 and shall not be deductible. 

12 (d) JUDICIAL REVIEW.— 

13 (1) AFTER PAYMENT.—A manufacturer of ciga14 rettes may seek judicial review of any action under 

15 this subtitle only after the assessment involved has 

16 been paid by the manufacturer to the Department of 

17 the Treasury and only in the United States District 

18 Court for the District of Columbia. 

19 (2) REVIEW BY ATTORNEY GENERAL.—Prior to 

20 the filing of an action by a manufacturer seeking ju21 dicial review of an action under this subtitle, the 

22 manufacturer shall notify the Attorney General of 

23 such intent to file and the Attorney General shall 

24 have 30 days in which to respond to the action. 
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•S 1074 IS 

1 (3) REVIEW.—The amount of any surcharge 

2 paid under this subtitle shall be subject to judicial 

3 review by the United States Court of Appeals for the 

4 District of Columbia Circuit, based on the arbitrary 

5 and capricious standard of section 706 of title 5, 

6 United States Code. Notwithstanding any other pro7 vision of law, no court shall have the authority to 

8 stay any surcharge payment due to the Secretary 

9 under this subtitle pending judicial review until the 

10 Secretary has made or failed to make a compliance 

11 determination, as described under this subtitle, that 

12 has adversely affected the person seeking the review. 

13 SEC. 313. ENFORCEMENT. 

14 (a) INITIAL PENALTY.—There is hereby imposed an 

15 initial penalty on the failure of any manufacturer to make 

16 any payment required under this subtitle within 10 days 

17 after the date on which such payment is due. 

18 (b) AMOUNT OF PENALTY.—The amount of the pen19 alty imposed by subsection (a) on any failure with respect 

20 to a manufacturer shall be an amount equal to 2 percent 

21 of the penalty owed under section 312 for each day during 

22 the noncompliance period. 

23 (c) NONCOMPLIANCE PERIOD.—For purposes of this 

24 section, the term ‘‘noncompliance period’’ means, with re-
275 

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1 spect to any failure to make the surcharge payment re2 quired under this subtitle, the period— 

3 (1) beginning on the due date for such pay4 ment; and 

5 (2) ending on the date on which such payment 

6 is paid in fall. 

7 (d) LIMITATIONS.—No penalty shall be imposed by 

8 subsection (a) on— 

9 (1) any failure to make a surcharge payment 

10 under this subtitle during any period for which it is 

11 established to the satisfaction of the Secretary that 

12 none of the persons responsible for such failure 

13 knew or, exercising reasonable diligence, would have 

14 known, that such failure existed; or 

15 (2) any manufacturer that produces less than 1 

16 percent of cigarettes used by youth in that year (as 

17 determined by the annual survey). 

18 TITLE IV—REIMBURSEMENT 

19 AND COVERAGE OF PREVEN20 TIVE SERVICES 

21 SEC. 401. COVERAGE OF SUBSTANCE USE (OTHER THAN TO22 BACCO), DIET, EXERCISE, INJURY PREVEN23 TION, AND DENTAL HEALTH COUNSELING. 

24 (a) COVERAGE.— 
276 

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1 (1) IN GENERAL.—Section 1861(s)(2) of the 

2 Social Security Act (42 U.S.C. 1395x(s)(2)), as 

3 amended by section 642(a) of the Medicare Prescrip4 tion Drug, Improvement, and Modernization Act of 

5 2003 (Public Law 108–173; 117 Stat. 2322), is 

6 amended— 

7 (A) in subparagraph (Y), by striking 

8 ‘‘and’’ after the semicolon at the end; 

9 (B) in subparagraph (Z), by adding ‘‘and’’ 

10 after the semicolon at the end; and 

11 (C) by adding at the end the following new 

12 subparagraph: 

13 ‘‘(AA) substance use (other than tobacco), diet, 

14 exercise, injury prevention, and dental health coun15 seling (as defined in subsection (bbb)(1));’’. 

16 (2) CONFORMING AMENDMENTS.—(A) Section 

17 1862(a)(12) of the Social Security Act (42 U.S.C. 

18 1395y(a)(12)) is amended by inserting ‘‘(except as 

19 otherwise allowed under subsection 

20 1861(s)(2)(AA))’’ after ‘‘directly supporting teeth’’. 

21 (B) Clauses (i) and (ii) of section 

22 1861(s)(2)(K) of the Social Security Act (42 U.S.C. 

23 1395x(s)(2)(K)), as amended by section 611(d)(2) of 

24 the Medicare Prescription Drug, Improvement, and 

25 Modernization Act of 2003 (Public Law 108–173; 
277 

•S 1074 IS 

1 117 Stat. 2304), are each amended by striking 

2 ‘‘subsection (ww)(1)’’ and inserting ‘‘subsections 

3 (ww)(1) and (bbb)’’. 

4 (b) SERVICES DESCRIBED.—Section 1861 of the So5 cial Security Act (42 U.S.C. 1395x), as amended by sec6 tion 706(b) of the Medicare Prescription Drug, Improve7 ment, and Modernization Act of 2003 (Public Law 108– 

8 173; 117 Stat. 2339), is amended by adding at the end 

9 the following new subsection: 

10 ‘‘Substance Use (Other Than Tobacco), Diet, Exercise, 

11 Injury Prevention, and Dental Health Counseling 

12 ‘‘(bbb) The term ‘substance use (other than tobacco), 

13 diet, exercise, injury prevention, and dental health coun14 seling’ means therapy and counseling relating to substance 

15 use (other than tobacco), diet, exercise, injury prevention, 

16 and dental health counseling that is furnished— 

17 ‘‘(1) by or under the supervision of a physician; 

18 or 

19 ‘‘(2) by any other health care professional 

20 who— 

21 ‘‘(A) is legally authorized to furnish such 

22 services under State law (or the State regu23 latory mechanism provided by State law) of the 

24 State in which the services are furnished; and 
278 

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1 ‘‘(B) is authorized to receive payment for 

2 other services under this title or is designated 

3 by the Secretary for this purpose.’’. 

4 (c) PAYMENT AND ELIMINATION OF COST-SHAR5 ING.— 

6 (1) PAYMENT AND ELIMINATION OF COINSUR7 ANCE.—Section 1833(a)(1) of the Social Security 

8 Act (42 U.S.C. 1395l(a)(1)), as amended by section 

9 302(b)(2) of the Medicare Prescription Drug, Im10 provement, and Modernization Act of 2003 (Public 

11 Law 108–173; 117 Stat. 2229), is amended— 

12 (A) in subparagraph (N), by inserting ‘‘or 

13 substance use (other than tobacco), diet, exer14 cise, injury prevention, and dental health coun15 seling (as defined in section 1861(bbb))’’ after 

16 ‘‘(as defined in section 1848(j)(3))’’; 

17 (B) by striking ‘‘and’’ before ‘‘(V)’’; and 

18 (C) by inserting before the semicolon at 

19 the end the following: ‘‘and (W) with respect to 

20 substance use (other than tobacco), diet, exer21 cise, injury prevention, and dental health coun22 seling (as defined in section 1861(bbb) the 

23 amount paid shall be the lesser of the actual 

24 charge for the services or the amount deter-
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1 mined under the payment basis determined 

2 under section 1848’’. 

3 (2) PAYMENT UNDER PHYSICIAN FEE SCHED4 ULE.—Section 1848(j)(3) of the Social Security Act 

5 (42 U.S.C. 1395w–4(j)(3)), as amended by section 

6 611(c) of the Medicare Prescription Drug, Improve7 ment, and Modernization Act of 2003 (Public Law 

8 108–173; 117 Stat. 2304), is amended by inserting 

9 ‘‘(2)(AA),’’ after ‘‘(2)(W),’’. 

10 (3) ELIMINATION OF COINSURANCE IN OUT11 PATIENT HOSPITAL SETTINGS.— 

12 (A) EXCLUSION FROM OPD FEE SCHED13 ULE.—Section 1833(t)(1)(B)(iv) of the Social 

14 Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)), as 

15 amended by section 614(a) of the Medicare 

16 Prescription Drug, Improvement, and Mod17 ernization Act of 2003 (Public Law 108–173; 

18 117 Stat. 2306), is amended by striking ‘‘and 

19 diagnostic mammography’’ and inserting ‘‘, di20 agnostic mammography, or substance use 

21 (other than tobacco), diet, exercise, injury pre22 vention, and dental health counseling (as de23 fined in section 1861(bbb))’’. 
280 

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1 (B) CONFORMING AMENDMENTS.—Section 

2 1833(a)(2) of the Social Security Act (42 

3 U.S.C. 1395l(a)(2)) is amended— 

4 (i) in subparagraph (F), by striking 

5 ‘‘and’’ after the semicolon at the end; 

6 (ii) in subparagraph (G)(ii), by strik7 ing the comma at the end and inserting 

8 ‘‘; and’’; and 

9 (iii) by inserting after subparagraph 

10 (G)(ii) the following new subparagraph: 

11 ‘‘(H) with respect to substance use (other 

12 than tobacco), diet, exercise, injury prevention, 

13 and dental health counseling (as defined in sec14 tion 1861(bbb)) furnished by an outpatient de15 partment of a hospital, the amount determined 

16 under paragraph (1)(W),’’. 

17 (4) ELIMINATION OF DEDUCTIBLE.—The first 

18 sentence of section 1833(b) of the Social Security 

19 Act (42 U.S.C. 1395l(b)) is amended— 

20 (A) by striking ‘‘and’’ before ‘‘(6)’’; and 

21 (B) by inserting before the period at the 

22 end the following: ‘‘, and (7) such deductible 

23 shall not apply with respect to substance use 

24 (other than tobacco), diet, exercise, injury pre-
281 

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1 vention, and dental health counseling (as de2 fined in section 1861(bbb))’’. 

3 (d) APPLICATION OF LIMITS ON BILLING.—Section 

4 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 

5 1395u(b)(18)(C)) is amended by adding at the end the 

6 following new clause: 

7 ‘‘(vii) Any health care professional designated 

8 under section 1861(bbb)(2)(B) to perform substance 

9 use (other than tobacco), diet, exercise, injury pre10 vention, and dental health counseling that is not oth11 erwise described in this subparagraph.’’. 

12 (e) EFFECTIVE DATE.—The amendments made by 

13 this section shall take effect as if included in the enact14 ment of the Medicare Prescription Drug, Improvement, 

15 and Modernization Act of 2003 (Public Law 108–173; 117 

16 Stat. 2066) and shall apply to services furnished on and 

17 after January 1, 2006. 

18 SEC. 402. PREVENTIVE MENTAL HEALTH SCREENINGS. 

19 (a) COVERAGE.— 

20 (1) IN GENERAL.—Section 1861(s)(2) of the 

21 Social Security Act (42 U.S.C. 1395x(s)(2)), as 

22 amended by section 401(a)(1), is amended— 

23 (A) in subparagraph (Z), by striking 

24 ‘‘and’’ after the semicolon at the end; 
282 

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1 (B) in subparagraph (AA), by adding 

2 ‘‘and’’ after the semicolon at the end; and 

3 (C) by adding at the end the following new 

4 subparagraph: 

5 ‘‘(BB) screenings for clinical depression, anx6 iety, and impaired cognitive functioning (as defined 

7 in subsection (ccc)(1));’’. 

8 (2) CONFORMING AMENDMENTS.—Clauses (i) 

9 and (ii) of section 1861(s)(2)(K) of the Social Secu10 rity Act (42 U.S.C. 1395x(s)(2)(K)), as amended by 

11 section 401(a)(2)(B), are each amended by striking 

12 ‘‘and (bbb)’’ and inserting ‘‘(bbb), and (ccc)’’. 

13 (b) SERVICES DESCRIBED.—Section 1861 of the So14 cial Security Act (42 U.S.C. 1395x), as amended by sec15 tion 401(b), is amended by adding at the end the following 

16 new subsection: 

17 ‘‘Screenings for Clinical Depression, Anxiety, and 

18 Impaired Cognitive Functioning 

19 ‘‘(ccc)(1) The term ‘screening for clinical depression, 

20 anxiety, and impaired cognitive functioning’ means a con21 sultation for the purpose of detecting clinical depression, 

22 anxiety, and impaired cognitive functioning during which 

23 a qualified health professional (as defined in paragraph 

24 (2))— 
283 

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1 ‘‘(A) uses a screening on the list established or 

2 identified under paragraph (3); 

3 ‘‘(B) assesses the individual’s risk of clinical de4 pression, anxiety, and impaired cognitive func5 tioning; and 

6 ‘‘(C) if the qualified health professional deter7 mines that the individual is at high risk for clinical 

8 depression, anxiety, or impaired cognitive func9 tioning, refers the individual for a full diagnostic 

10 evaluation and such additional treatment as may be 

11 required. 

12 Nothing in subparagraph (C) shall be construed as prohib13 iting a qualified health professional performing the screen14 ing for clinical depression, anxiety, and impaired cognitive 

15 functioning with respect to an individual from directly pro16 viding the diagnostic evaluation and additional treatment 

17 described in such clause to such individual if such profes18 sional is legally authorized to provide such an evaluation 

19 and additional treatment under State law (or the State 

20 regulatory mechanism provided by State law) of the State 

21 in which the screening is performed. 

22 ‘‘(2) For purposes of this subsection, the term ‘quali23 fied health professional’ means an individual who— 

24 ‘‘(A) is— 
284 

•S 1074 IS 

1 ‘‘(i) a physician (as defined in subsection 

2 (r)(1)); 

3 ‘‘(ii) a nurse practitioner (as defined in 

4 subsection (aa)(5)); or 

5 ‘‘(iii) a mental health care professional (in6 cluding clinical psychologists (as defined by the 

7 Secretary for purposes of section 1861(ii)) and 

8 clinical social workers (as defined in subsection 

9 1861(hh))) that is licensed or certified to per10 form mental health services by the State in 

11 which the screenings are performed; and 

12 ‘‘(B) has an agreement in effect with the Sec13 retary to accept— 

14 ‘‘(i) the amount determined under section 

15 1833(a)(1)(W) as full payment for screenings 

16 for clinical depression, anxiety, and impaired 

17 cognitive functioning; and 

18 ‘‘(ii) an assignment described in section 

19 1842(b)(3)(B)(ii) with respect to payment for 

20 each screening furnished by the professional to 

21 an individual enrolled under part B. 

22 ‘‘(3) The Secretary shall, in consultation with mental 

23 health professionals and other stakeholders with experi24 ence in screening for clinical depression, anxiety, and im25 paired cognitive functioning, shall establish or identify a 
285 

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1 list of approved screenings to be used under this para2 graph. The Secretary, in consultation with such profes3 sionals and stakeholders, shall review and update such list 

4 not less frequently than once every 5 years.’’. 

5 (c) PAYMENT AND ELIMINATION OF COST-SHAR6 ING.— 

7 (1) PAYMENT AND ELIMINATION OF COINSUR8 ANCE.—Section 1833(a)(1) of the Social Security 

9 Act (42 U.S.C. 1395l(a)(1)), as amended by section 

10 401(c)(1), is amended— 

11 (A) in subparagraph (N), by striking ‘‘or 

12 substance use (other than tobacco), diet, exer13 cise, injury prevention, and dental health coun14 seling (as defined in section 1861(bbb))’’ and 

15 inserting ‘‘substance use (other than tobacco), 

16 diet, exercise, injury prevention, and dental 

17 health counseling (as defined in section 

18 1861(bbb)), or screenings for clinical depres19 sion, anxiety, and impaired cognitive func20 tioning (as defined in section 1861(ccc))’’; and 

21 (B) in subparagraph (W), by inserting 

22 ‘‘and screenings for clinical depression, anxiety, 

23 and impaired cognitive functioning (as defined 

24 in section 1861(ccc))’’ after ‘‘(as defined in sec25 tion 1861(bbb))’’. 
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1 (2) PAYMENT UNDER PHYSICIAN FEE SCHED2 ULE.—Section 1848(j)(3) of the Social Security Act 

3 (42 U.S.C. 1395w–4(j)(3)), as amended by section 

4 401(c)(2), is amended by inserting ‘‘(2)(BB),’’ after 

5 ‘‘(2)(AA),’’. 

6 (3) ELIMINATION OF COINSURANCE IN OUT7 PATIENT HOSPITAL SETTINGS.— 

8 (A) EXCLUSION FROM OPD FEE SCHED9 ULE.—Section 1833(t)(1)(B)(iv) of the Social 

10 Security Act (42 U.S.C. 1395l(t)(1)(B)(iv)), as 

11 amended by section 401(c)(3)(A), is amended 

12 by striking ‘‘or substance use (other than to13 bacco), diet, exercise, injury prevention, and 

14 dental health counseling (as defined in section 

15 1861(bbb))’’ and inserting ‘‘substance use 

16 (other than tobacco), diet, exercise, injury pre17 vention, and dental health counseling (as de18 fined in section 1861(bbb)), or screenings for 

19 clinical depression, anxiety, and impaired cog20 nitive functioning (as defined in section 

21 1861(ccc))’’. 

22 (B) CONFORMING AMENDMENT.—Section 

23 1833(a)(2)(H) of the Social Security Act (42 

24 U.S.C. 1395l(a)(2)(H)), as added by section 

25 401(c)(3)(B)(iii), is amended by inserting ‘‘and 
287 

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1 screenings for clinical depression, anxiety, and 

2 impaired cognitive functioning (as defined in 

3 section 1861(ccc))’’ after ‘‘(as defined in section 

4 1861(bbb))’’. 

5 (4) ELIMINATION OF DEDUCTIBLE.—Section 

6 1833(b)(7) of the Social Security Act (42 U.S.C. 

7 1395l(b)(7)), as amended by section 401(c)(4), is 

8 amended by inserting ‘‘or screenings for clinical de9 pression, anxiety, and impaired cognitive functioning 

10 (as defined in section 1861(ccc))’’ before the period 

11 at the end. 

12 (d) APPLICATION OF LIMITS ON BILLING.—Section 

13 1842(b)(18)(C) of the Social Security Act (42 U.S.C. 

14 1395u(b)(18)(C)), as amended by section 401(d), is 

15 amended by adding at the end the following new clause: 

16 ‘‘(viii) A mental health care professional de17 scribed in section 1861(ccc)(2) that is authorized to 

18 perform screenings for clinical depression, anxiety, 

19 and impaired cognitive functioning (as defined in 

20 section 1861(ccc)(1)) that is not otherwise described 

21 in this subparagraph.’’. 

22 (e) FREQUENCY.—Section 1862(a)(1) of the Social 

23 Security Act (42 U.S.C. 1395y(a)(1)), as amended by sec24 tion 613(c) of the Medicare Prescription Drug, Improve-
288 

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1 ment, and Modernization Act of 2003 (Public Law 108– 

2 173; 117 Stat. 2306), is amended— 

3 (1) in subparagraph (L), by striking ‘‘and’’ 

4 after the comma at the end; 

5 (2) in subparagraph (M), by striking the semi6 colon at the end and inserting ‘‘, and’’; and 

7 (3) by adding at the end the following new sub8 paragraph: 

9 ‘‘(N) in the case of screenings for clinical de10 pression, anxiety, and impaired cognitive functioning 

11 (as defined in section 1861(ccc)(1)), which is per12 formed more frequently than is covered under such 

13 section;’’. 

14 (f) EFFECTIVE DATE.—The amendments made by 

15 this section shall take effect as if included in the enact16 ment of the Medicare Prescription Drug, Improvement, 

17 and Modernization Act of 2003 (Public Law 108–173; 117 

18 Stat. 2066) and shall apply to services furnished on and 

19 after January 1, 2006. 

20 SEC. 403. ENCOURAGEMENT OF CESSATION OF TOBACCO 

21 USE. 

22 (a) MEDICARE COVERAGE OF COUNSELING AND

23 PHARMACOTHERAPY FOR CESSATION OF TOBACCO

24 USE.— 

25 (1) COVERAGE.— 
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1 (A) IN GENERAL.—Section 1861(s)(2) of 

2 the Social Security Act (42 U.S.C. 

3 1395x(s)(2)), as amended by section 402(a)(1), 

4 is amended— 

5 (i) in subparagraph (AA), by striking 

6 ‘‘and’’ after the semicolon at the end; 

7 (ii) in subparagraph (BB), by adding 

8 ‘‘and’’ after the semicolon at the end; and 

9 (iii) by adding at the end the fol10 lowing new subparagraph: 

11 ‘‘(CC) counseling and pharmacotherapy for ces12 sation of tobacco use (as defined in subsection 

13 (ddd)(1));’’. 

14 (B) CONFORMING AMENDMENTS.—Clauses 

15 (i) and (ii) of section 1861(s)(2)(K) of the So16 cial Security Act (42 U.S.C. 1395x(s)(2)(K)), 

17 as amended by section 402(a)(2), are each 

18 amended by striking ‘‘and (ccc)’’ and inserting 

19 ‘‘(ccc), and (ddd)’’. 

20 (2) SERVICES DESCRIBED.—Section 1861 of 

21 the Social Security Act (42 U.S.C. 1395x), as 

22 amended by section 402(b), is amended by adding at 

23 the end the following new subsection: 
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1 ‘‘Counseling and Pharmacotherapy for Cessation of 

2 Tobacco Use 

3 ‘‘(ddd)(1) Subject to paragraphs (2) and (3), the 

4 term ‘counseling and pharmacotherapy for cessation of to5 bacco use’ means diagnostic, therapy, and counseling serv6 ices and pharmacotherapy (including the coverage of pre7 scription and nonprescription tobacco cessation agents ap8 proved by the Food and Drug Administration) for ces9 sation of tobacco use for individuals who use tobacco prod10 ucts or who are being treated for tobacco use which are 

11 furnished— 

12 ‘‘(A) by or under the supervision of a physician; 

13 or 

14 ‘‘(B) by any other health care professional 

15 who— 

16 ‘‘(i) is legally authorized to furnish such 

17 services under State law (or the State regu18 latory mechanism provided by State law) of the 

19 State in which the services are furnished; and 

20 ‘‘(ii) is authorized to receive payment for 

21 other services under this title or is designated 

22 by the Secretary for this purpose. 

23 ‘‘(2) Such term is limited to— 

24 ‘‘(A) services recommended in ‘Treating To25 bacco Use and Dependence: A Clinical Practice 
291 

•S 1074 IS 

1 Guideline’, published by the Public Health Service in 

2 June 2000, or any subsequent modification of such 

3 Guideline; and 

4 ‘‘(B) such other services that the Secretary rec5 ognizes to be effective. 

6 ‘‘(3) Each individual who is described in paragraph 

7 (1) and enrolled under part B shall be eligible for the serv8 ices described in this subsection for up to 3 attempts to 

9 cease the use of tobacco.’’. 

10 (3) PAYMENT AND ELIMINATION OF COST11 SHARING.— 

12 (A) PAYMENT AND ELIMINATION OF COIN13 SURANCE.—Section 1833(a)(1) of the Social 

14 Security Act (42 U.S.C. 1395l(a)(1)), as 

15 amended by section 402(c)(1), is amended— 

16 (i) in subparagraph (N) by striking 

17 ‘‘or screenings for clinical depression, anx18 iety, and impaired cognitive functioning (as 

19 defined in section 1861(ccc))’’ and insert20 ing ‘‘, screenings for clinical depression, 

21 anxiety, and impaired cognitive functioning 

22 (as defined in section 1861(ccc)), or coun23 seling and pharmacotherapy for cessation 

24 of tobacco use (as defined in section 

25 1861(ddd))’’; and 
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1 (ii) in subparagraph (W), by striking 

2 ‘‘and screenings for clinical depression, 

3 anxiety, and impaired cognitive functioning 

4 (as defined in section 1861(ccc))’’ and in5 serting ‘‘screenings for clinical depression, 

6 anxiety, and impaired cognitive functioning 

7 (as defined in section 1861(ccc)), and 

8 counseling and pharmacotherapy for ces9 sation of tobacco use (as defined in section 

10 1861(ddd))’’. 

11 (B) PAYMENT UNDER PHYSICIAN FEE

12 SCHEDULE.—Section 1848(j)(3) of the Social 

13 Security Act (42 U.S.C. 1395w–4(j)(3)), as 

14 amended by section 402(c)(2), is amended by 

15 inserting ‘‘(2)(CC) (with separate payment 

16 amounts for pharmacotherapy, including pre17 scription and nonprescription tobacco cessation 

18 agents approved by the Food and Drug Admin19 istration),’’ after ‘‘(2)(BB),’’. 

20 (C) ELIMINATION OF COINSURANCE IN

21 OUTPATIENT HOSPITAL SETTINGS.— 

22 (i) EXCLUSION FROM OPD FEE

23 SCHEDULE.—Section 1833(t)(1)(B)(iv) of 

24 the Social Security Act (42 U.S.C. 

25 1395l(t)(1)(B)(iv)), as amended by section 
293 

•S 1074 IS 

1 402(c)(3)(A), is amended by striking ‘‘or 

2 screenings for clinical depression, anxiety, 

3 and impaired cognitive functioning (as de4 fined in section 1861(ccc))’’ and inserting 

5 ‘‘screenings for clinical depression, anxiety, 

6 and impaired cognitive functioning (as de7 fined in section 1861(ccc)), or counseling 

8 and pharmacotherapy for cessation of to9 bacco use (as defined in section 

10 1861(ddd))’’. 

11 (ii) CONFORMING AMENDMENT.—Sec12 tion 1833(a)(2)(H) of the Social Security 

13 Act (42 U.S.C. 1395l(a)(2)(H)), as added 

14 by section 402(c)(3)(B), is amended by 

15 striking ‘‘and screenings for clinical de16 pression, anxiety, and impaired cognitive 

17 functioning (as defined in section 

18 1861(ccc))’’ and inserting ‘‘screenings for 

19 clinical depression, anxiety, and impaired 

20 cognitive functioning (as defined in section 

21 1861(ccc)), and counseling and 

22 pharmacotherapy for cessation of tobacco 

23 use (as defined in section 1861(ddd))’’. 

24 (D) ELIMINATION OF DEDUCTIBLE.—Sec25 tion 1833(b)(7) of the Social Security Act (42 
294 

•S 1074 IS 

1 U.S.C. 1395l(b)(7)), as added by section 

2 402(c)(4), is amended by striking ‘‘or 

3 screenings for clinical depression, anxiety, and 

4 impaired cognitive functioning (as defined in 

5 section 1861(ccc))’’ and inserting ‘‘screenings 

6 for clinical depression, anxiety, and impaired 

7 cognitive functioning (as defined in section 

8 1861(ccc)), or counseling and pharmacotherapy 

9 for cessation of tobacco use (as defined in sec10 tion 1861(ddd))’’. 

11 (4) APPLICATION OF LIMITS ON BILLING.—Sec12 tion 1842(b)(18)(C) of the Social Security Act (42 

13 U.S.C. 1395u(b)(18)(C)), as amended by section 

14 402(d), is amended by adding at the end the fol15 lowing new clause: 

16 ‘‘(ix) Any individual designated by the Sec17 retary under section 1861(ddd)(1)(B)(ii).’’. 

18 (5) FREQUENCY.—Section 1862(a)(1) of the 

19 Social Security Act (42 U.S.C. 1395y(a)(1)), as 

20 amended by section 402(e), is amended— 

21 (A) in subparagraph (M), by striking 

22 ‘‘and’’ after the comma at the end; 

23 (B) in subparagraph (N), by striking the 

24 semicolon at the end and inserting ‘‘, and’’; and 
295 

•S 1074 IS 

1 (C) by adding at the end the following new 

2 subparagraph: 

3 ‘‘(O) in the case of counseling and 

4 pharmacotherapy for cessation of tobacco use (as de5 fined in section 1861(ddd)), which is performed with 

6 respect to more attempts to cease tobacco use than 

7 is covered under such section;’’. 

8 (b) PROMOTING CESSATION OF TOBACCO USE

9 UNDER THE MEDICAID PROGRAM.— 

10 (1) DROPPING EXCEPTION FROM MEDICAID

11 PRESCRIPTION DRUG COVERAGE FOR TOBACCO CES12 SATION MEDICATIONS.—Section 1927(d)(2) of the 

13 Social Security Act (42 U.S.C. 1396r–8(d)(2)) is 

14 amended— 

15 (A) by striking subparagraph (E); 

16 (B) by redesignating subparagraphs (F) 

17 through (J) as subparagraphs (E) through (I), 

18 respectively; and 

19 (C) in subparagraph (F) (as redesignated 

20 by paragraph (2)), by inserting before the pe21 riod at the end the following: ‘‘, except agents 

22 approved by the Food and Drug Administration 

23 for purposes of promoting, and when used to 

24 promote, tobacco cessation’’. 
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•S 1074 IS 

1 (2) REQUIRING COVERAGE OF TOBACCO CES2 SATION COUNSELING AND PHARMACOTHERAPY

3 SERVICES FOR PREGNANT WOMEN.—Section 

4 1905(a)(4) of the Social Security Act (42 U.S.C. 

5 1396d(a)(4)) is amended— 

6 (A) by striking ‘‘and’’ before ‘‘(C)’’; and 

7 (B) by inserting before the semicolon at 

8 the end the following: ‘‘; and (D) counseling 

9 and pharmacotherapy for cessation of tobacco 

10 use (as defined in section 1861(ddd)) for preg11 nant women’’. 

12 (3) REMOVAL OF COST-SHARING FOR TOBACCO

13 CESSATION COUNSELING AND PHARMACOTHERAPY

14 SERVICES FOR PREGNANT WOMEN.—Section 1916 of 

15 the Social Security Act (42 U.S.C. 1396o) is amend16 ed in each of subsections (a)(2)(B) and (b)(2)(B), 

17 by inserting ‘‘, and counseling for cessation of to18 bacco use (as defined in section 1861(ddd))’’ after 

19 ‘‘complicate the pregnancy’’. 

20 (c) COVERAGE UNDER FEHBP.—The last sentence 

21 of section 8904(a) of title 5, United States Code, is 

22 amended by striking ‘‘both for costs associated with care 

23 in a general hospital and for other health services of a 

24 catastrophic nature’’ and inserting ‘‘for costs associated 

25 with care in a general hospital, for other health services 
297 

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1 of a catastrophic nature, and for counseling and 

2 pharmacotherapy for cessation of tobacco use (as defined 

3 in section 1861(ddd)(1) of the Social Security Act)’’. 

4 (d) EFFECTIVE DATE.—The amendments made by 

5 this section shall take effect as if included in the enact6 ment of the Medicare Prescription Drug, Improvement, 

7 and Modernization Act of 2003 (Public Law 108–173; 117 

8 Stat. 2066) and shall apply to services furnished on and 

9 after January 1, 2006. 

10 SEC. 404. RECOGNITION OF SCHOOL-BASED HEALTH CEN11 TERS AS MODEL FOR DELIVERY OF PRIMARY 

12 CARE FOR CHILDREN UNDER THE MEDICAID 

13 AND STATE CHILDREN’S HEALTH INSURANCE 

14 PROGRAMS. 

15 (a) IN GENERAL.—Title XIX of the Social Security 

16 Act (42 U.S.C. 1396 et seq.) is amended by inserting after 

17 section 1911 the following: 

18 ‘‘SCHOOL-BASED HEALTH CENTERS

19 ‘‘SEC. 1911A. Not later than 12 months after the 

20 date of enactment of this section, the Secretary shall es21 tablish procedures to encourage a State program estab22 lished under this title, title XXI, or both, to recognize 

23 school-based health centers as a model of delivery for pri24 mary care for children who are eligible for medical assist25 ance under this title or child health assistance under title 

26 XXI. Such procedures shall include the following: 
298 

•S 1074 IS 

1 ‘‘(1) RECOGNITION OF, AND REIMBURSEMENT

2 FOR, SERVICES PROVIDED THROUGH SCHOOL-BASED

3 HEALTH CENTERS.—Procedures that encourage a 

4 State to recognize as primary care providers under 

5 this title and title XXI, providers who furnish phys6 ical or mental health services that are available as 

7 medical assistance under this title or child health as8 sistance under title XXI to children who are eligible 

9 for such assistance through school-based health cen10 ters, and to reimburse such providers or centers (as 

11 appropriate) for furnishing such services to such 

12 children. 

13 ‘‘(2) EXCEPTIONS TO THE ‘FREE CARE’ 

14 RULE.—Procedures that allow a State the option to 

15 permit school-based health centers to bill the State 

16 for physical or mental health services that are avail17 able as medical assistance under this title or child 

18 health assistance under title XXI and that are fur19 nished to children who are eligible for such assist20 ance through such centers without billing all chil21 dren who are provided such services. 

22 ‘‘(3) EXCEPTIONS TO THE ‘THIRD PARTY LI23 ABILITY’ COST AVOIDANCE POLICY.—Procedures 

24 that encourage a State to include physical or mental 

25 health services that are available as medical assist-
299 

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1 ance under this title and that are provided through 

2 school-based health centers in the list of diagnosis 

3 billing codes for preventive pediatric care services 

4 that the State will pay for under this title and then 

5 seek reimbursement from any liable third party in 

6 accordance with the requirements of section 

7 1902(a)(25). 

8 ‘‘(4) ASSURANCE OF PAYMENT FOR SERVICES

9 COVERED BY A CONTRACT WITH A MANAGED CARE

10 ENTITY.—Procedures that encourage a State to in11 clude in any contract entered into with a managed 

12 care entity (as defined in section 1932(a)(1)(B)) 

13 under this title or title XXI provisions which ensure 

14 that the entity will make prompt payment to a 

15 school-based health center for furnishing physical or 

16 mental health services to a child who is eligible for 

17 medical assistance under this title or child health as18 sistance under title XXI that are within the scope of 

19 items and services for which benefits are available 

20 with respect to the child under the contract between 

21 the entity and the State (or to a provider who fur22 nishes such services to such a child through a 

23 school-based health center), regardless of whether 

24 the center (or provider) is a participating provider 

25 with respect to such entity, at a rate established by 
300 

•S 1074 IS 

1 the entity for such services that is not less than the 

2 level and amount of payment which the entity would 

3 make for the services if the services were furnished 

4 by a participating provider.’’. 

5 (b) REPORT TO CONGRESS.—Not later than 36 

6 months after the date of enactment of this section, the 

7 Secretary of Health and Human Services shall submit a 

8 report to Congress on the effectiveness of the procedures 

9 established in accordance with section 1911A of the Social 

10 Security Act (as added by subsection (a)) in encouraging 

11 the use of school-based health centers for the delivery of 

12 primary care physical and mental health services to chil13 dren who are eligible for medical assistance under title 

14 XIX of the Social Security Act (42 U.S.C. 1396 et seq.) 

15 or child health assistance under title XXI of such Act (42 

16 U.S.C. 1397aa et seq.), together with such recommenda17 tions for administrative or legislative action as the Sec18 retary determines to be appropriate. 

19 SEC. 405. PREVENTIVE HEALTH CARE DEMONSTRATION 

20 PROGRAM. 

21 (a) ESTABLISHMENT.— 

22 (1) IN GENERAL.—Not later than 18 months 

23 after the date of enactment of this Act, the Sec24 retary of Health and Human Services (in this sec25 tion referred to as the ‘‘Secretary’’) shall conduct a 
301 

•S 1074 IS 

1 5-year demonstration program under part B of title 

2 XVIII of the Social Security Act under which the 

3 Secretary establishes demonstration projects to con4 tract with appropriate entities to provide preventive 

5 health care to eligible beneficiaries through the de6 velopment and implementation of a disease preven7 tion plan (as described in subsection (b)). 

8 (2) SITES.—The Secretary shall designate at 

9 least 2 sites at which to conduct the demonstration 

10 program under this section, of which— 

11 (A) 1 shall be in an urban area; and 

12 (B) 1 shall be in a rural area. 

13 (3) NUMBER OF ELIGIBLE BENEFICIARIES.— 

14 Each demonstration project site under this section 

15 shall consist of at least 1,000 eligible beneficiaries 

16 representative of the population of individuals enti17 tled to benefits under part A of title XVIII of the 

18 Social Security Act, and enrolled under part B of 

19 such title. The Secretary may expand the population 

20 as needed to measure statistical significance. 

21 (4) IDENTIFYING ELIGIBLE BENEFICIARIES.— 

22 The Secretary shall develop a method for identifying 

23 eligible beneficiaries who may benefit from the dem24 onstration program and communicate with them re25 garding their eligibility. 
302 

•S 1074 IS 

1 (5) VOLUNTARY PARTICIPATION.—Participation 

2 of health care providers, and individual beneficiaries, 

3 in the demonstration program shall be voluntary. 

4 (b) DISEASE PREVENTION PLAN.— 

5 (1) IN GENERAL.—The disease prevention plan 

6 described in this subsection is a plan, developed in 

7 consultation with an eligible beneficiary participating 

8 in the demonstration program, to mitigate the risk 

9 factors associated with a particular disease. 

10 (2) PLAN CONTENTS.—The disease prevention 

11 plan should include the following: 

12 (A) POINT OF CONTACT.—The disease pre13 vention plan shall provide for a point of contact 

14 responsible for communicating with the partici15 pating beneficiary and with other health care 

16 providers on behalf of such beneficiary. 

17 (B) PERSONAL HEALTH CARE.—The dis18 ease prevention plan shall provide for instruc19 tion on personal health care. 

20 (C) PHYSICIAN AND HEALTH CARE PRO21 VIDER TRAINING.—The disease prevention plan 

22 shall provide for the training of physicians or 

23 other health care providers in the communica24 tion of relevant clinical information. 
303 

•S 1074 IS 

1 (D) MONITORING TECHNOLOGY.—The dis2 ease prevention plan may provide for necessary 

3 monitoring technology to facilitate the exchange 

4 of information, including information such as 

5 vital signs, symptoms, and health self assess6 ments. 

7 (c) PROGRAM STANDARDS AND CRITERIA.—The Sec8 retary shall establish performance standards for the dem9 onstration program under this section, including best 

10 practices for the prevention of chronic diseases. Such prac11 tices shall be standardized to the greatest extent possible. 

12 The eligibility of entities or individuals to enter into a con13 tract to provide preventive health care under the dem14 onstration program shall be conditioned, at a minimum, 

15 on performance that meets or exceeds such standards. 

16 (d) PAYMENT.—The Secretary shall develop a meth17 od and level of payment for entities that participate in 

18 the program under this section based on best practices, 

19 as determined by the Secretary. 

20 (e) WAIVER AUTHORITY.—The Secretary may waive 

21 such requirements of titles XI and XVIII of the Social 

22 Security Act as may be necessary to carry out the pur23 poses of the demonstration program under this section. 

24 (f) EVALUATION AND REPORT.— 
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•S 1074 IS 

1 (1) EVALUATION.—The Secretary shall conduct 

2 evaluations of— 

3 (A) the benefits due to a reduction, if any, 

4 in disease incidence for participants in the dem5 onstration projects compared to the medicare 

6 population as a whole, as determined by the use 

7 of appropriate statistical techniques; 

8 (B) the long term cost effectiveness of the 

9 demonstration projects to the medicare program 

10 in terms of acute care costs avoided due to dis11 ease prevention; and 

12 (C) patient satisfaction under the dem13 onstration projects. 

14 (2) REPORT.—Not later than 6 months after 

15 the date on which the demonstration program under 

16 this section ends, the Secretary shall prepare and 

17 submit to Congress a report on the demonstration 

18 program together with— 

19 (A) recommendations on whether the dem20 onstration program should be expanded in 

21 terms of its success in disease prevention and 

22 the cost effectiveness of the demonstration pro23 gram; and 
305 

•S 1074 IS 

1 (B) such recommendations for legislation 

2 or administrative action as the Secretary deter3 mines appropriate. 

4 (g) FUNDING.—The Secretary shall provide for the 

5 transfer from the Federal Supplementary Medical Insur6 ance Trust Fund under section 1841 of the Social Secu7 rity Act (42 U.S.C. 1395t) of such funds, not to exceed 

8 $50,000,000, as are necessary for the costs of carrying 

9 out the demonstration program under this Act. 

10 (h) DEFINITIONS.—In this section: 

11 (1) APPROPRIATE ENTITY.—The term ‘‘appro12 priate entity’’ means— 

13 (A) a chronic care improvement program; 

14 (B) a hospital; and 

15 (C) any other entity that the Secretary de16 termines appropriate based on clinical, finan17 cial, or other requirements appropriate to carry 

18 out the purposes of the demonstration program 

19 under this section. 

20 (2) ELIGIBLE BENEFICIARY.—The term ‘‘eligi21 ble beneficiary’’ means an individual who— 

22 (A) is entitled to benefits under part A of 

23 title XVIII of the Social Security Act or en24 rolled under part B of such title; and 
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•S 1074 IS 

1 (B) has 2 or more risk factors associated 

2 with— 

3 (i) chronic obstructive pulmonary dis4 ease; 

5 (ii) diabetes; or 

6 (iii) any other chronic condition that 

7 the Secretary determines would be appro8 priate for the purpose of providing signifi9 cant potential cost benefits to the medicare 

10 program through the prevention of such 

11 condition. 

12 SEC. 406. PREVENTIVE HEALTH SERVICES FOR WOMEN. 

13 Section 1509 of the Public Health Service Act (42 

14 U.S.C. 300n–4a) is amended to read as follows: 

15 ‘‘SEC. 1509. ESTABLISHMENT OF PROGRAM FOR ADDI16 TIONAL PREVENTIVE HEALTH SERVICES. 

17 ‘‘(a) IN GENERAL.—The Secretary, acting through 

18 the Director of the Centers for Disease Control and Pre19 vention, may, through a competitive review process, award 

20 grants to States that have received grants under section 

21 1501 for a fiscal year, to enable such State to carry out 

22 programs— 

23 ‘‘(1) to provide preventive health services, in ad24 dition to the services authorized in such section 
307 

•S 1074 IS 

1 1501, for diseases such as cardiovascular diseases, 

2 osteoporosis, and obesity; 

3 ‘‘(2) to provide screenings, such as screening 

4 for blood pressure, cholesterol, and osteoporosis, and 

5 other services that the Secretary, acting through the 

6 Director of the Centers for Disease Control and Pre7 vention, determines to be appropriate and feasible; 

8 ‘‘(3) for health education, counseling, and inter9 ventions for behavioral risk factors, such as physical 

10 inactivity and poor nutrition, and diseases referred 

11 to in paragraph (1); 

12 ‘‘(4) to provide appropriate referrals for medical 

13 treatment of women receiving services pursuant to 

14 paragraph (1) through (3), and ensuring, to the ex15 tent practicable, the provision of appropriate follow16 up services; and 

17 ‘‘(5) to evaluate the activities conducted under 

18 paragraphs (1) through (4) through appropriate sur19 veillance, research, or program monitoring activities. 

20 ‘‘(b) STATUS AS PARTICIPANT IN PROGRAM REGARD21 ING BREAST AND CERVICAL CANCER.—The Secretary 

22 may not make a grant to a State under subsection (a) 

23 unless the State involved agrees that services under the 

24 grant will be provided in conjunction with entities that are 
308 

•S 1074 IS 

1 screening women for breast or cervical cancer pursuant 

2 to a grant under section 1501. 

3 ‘‘(c) APPLICABILITY OF PROVISIONS.—The provi4 sions of this title shall apply to a grant under subsection 

5 (a) to the same extent and in the same manner as such 

6 provisions apply to a grant under section 1501. 

7 ‘‘(d) FUNDING.— 

8 ‘‘(1) IN GENERAL.—There is authorized to be 

9 appropriated such sums as may be necessary to 

10 carry out this section for fiscal year 2005 and for 

11 each subsequent fiscal year. 

12 ‘‘(2) LIMITATION REGARDING FUNDING WITH

13 RESPECT TO BREAST AND CERVICAL CANCER.—No 

14 additional resources shall be appropriated for a fis15 cal year under paragraph (1) unless the amount ap16 propriated under section 1510(a) for such fiscal year 

17 is at least $173,920,000.’’. 

18 TITLE V—HELP (HEALTHY LIFE19 STYLES AND PREVENTION) 

20 AMERICA TRUST FUND 

21 SEC. 501. HELP (HEALTHY LIFESTYLES AND PREVENTION) 

22 AMERICA TRUST FUND. 

23 (a) CREATION OF TRUST FUND.—There is estab24 lished in the Treasury of the United States a trust fund 

25 to be known as the ‘HeLP (Healthy Lifestyles and Preven-
309 

•S 1074 IS 

1 tion) America Trust Fund’ (referred to in this section as 

2 the ‘Trust Fund’), consisting of such amounts as may be 

3 appropriated or credited to the Trust Fund as provided 

4 in this section. 

5 (b) TRANSFERS TO TRUST FUND.—There is hereby 

6 appropriated to the Trust Fund an amount equivalent 

7 to— 

8 (1) the increase in revenues received in the 

9 Treasury as the result of the amendment made by 

10 section 305 of this Act, 

11 (2) the increase in revenues received in the 

12 Treasury as the result of the amendments made by 

13 title II of this Act, and 

14 (3) the receipts paid by tobacco companies 

15 under subtitle B of title III of this Act. 

16 (c) DISTRIBUTION OF AMOUNTS IN TRUST FUND.— 

17 (1) MANDATORY EXPENDITURES.—On a fiscal 

18 year basis (beginning with fiscal year 2006) and 

19 without further appropriation the Secretary of the 

20 Treasury shall distribute from amounts in the Trust 

21 Fund such amounts as are necessary to provide for 

22 the Federal expenditures attributable to the fol23 lowing: 
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1 (A) The amendments made to the Fruit 

2 and Vegetable Program by section 101 of this 

3 Act. 

4 (B) Smoking cessation drugs under title 

5 XIX of the Social Security Act as identified by 

6 the Secretary of Health and Human Services. 

7 (C) Coverage of smoking cessation under 

8 the Federal Employee Health Benefits Program 

9 under chapter 89 of title 5, United States Code 

10 (as amended by section 403). 

11 (D) The amendments made to the medi12 care program under title XVIII of the Social 

13 Security Act by sections 401 and 402 of this 

14 Act. 

15 (E) The preventive health care demonstra16 tion program carried out under section 405 of 

17 this Act. 

18 Such amounts shall be in addition to any other 

19 amounts appropriated for such purposes. 

20 (2) DISCRETIONARY EXPENDITURES.—Amounts 

21 in the Trust Fund not to exceed $2,050,000,000 

22 shall be available, as provided in appropriation Acts, 

23 for each fiscal year (beginning with fiscal year 2006) 

24 only for purposes of making expenditures to carry 

25 out the following: 
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1 (A) School nutrition environment enhance2 ment grants under section 18(l) of the Richard 

3 B. Russell National School Lunch Act (as 

4 added by section 103). 

5 (B) Mental health services in schools under 

6 paragraphs (7) and (8) of section 5541(c) of 

7 the Elementary and Secondary Education Act 

8 of 1965 (as added by section 104). 

9 (C) The Baby-Friendly Hospital Initiative 

10 carried out under section 105 of this Act. 

11 (D) The grant program to strengthen fam12 ilies and build children’s resilience carried out 

13 under section 520K of the Public Health Serv14 ice Act (as added by section 106). 

15 (E) The reservation for early Head Start 

16 programs under section 640(a)(6)(A) of the 

17 Head Start Act (as amended by section 107). 

18 (F) Community grants to prevent and re19 duce the incidence of chronic disease under sec20 tion 399P of the Public Health Service Act (as 

21 added by section 213). 

22 (G) Living well with a disability and work23 ing well with a disability programs under sec24 tions 399Q and 399R of the Public Health 

25 Service Act (as added by section 212). 
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1 (H) The amendments made to title 23, 

2 United States Code, by section 213 of this Act 

3 and the nonmotorized transportation pilot pro4 gram carried out under section 213(d). 

5 (I) The national assessment of mental 

6 health needs program carried out under section 

7 506C of the Public Health Service Act (as 

8 added by section 214). 

9 (J) The preventive medicine and public 

10 health training grant program carried out 

11 under section 747A of the Public Health Serv12 ice Act (as added by section 215). 

13 (K) Federal-State tobacco counter-adver14 tising programs under section 399S of the Pub15 lic Health Service Act (as added by section 

16 306). 

17 (L) Preventive health services for women, 

18 including well-integrated screening and evalua19 tion for women across the Nation, under section 

20 1509 of the Public Health Service Act (as 

21 added by section 406). 

22 (M) Carol M. White Physical Education 

23 Program under subpart 10 of part D of title V 

24 of the Elementary and Secondary Education 

25 Act of 1965. 
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1 (N) Research regarding obesity under sec2 tion 601 of this Act. 

3 (O) Expanded Food and Nutrition Edu4 cation Program under section 3175 of title 23, 

5 United States Code. 

6 (P) The following programs under the au7 thority of the Secretary of Health and Human 

8 Services through the Centers for Disease Con9 trol and Prevention: 

10 (i) Nutrition and physical activity 

11 grants. 

12 (ii) Division of Adolescent and School 

13 Health. 

14 (iii) Verb Campaign. 

15 (iv) Prevention research centers. 

16 (v) 5-a-day programs. 

17 (vi) Steps to a healthier United 

18 States. 

19 (Q) Access to local foods and school gar20 dens, as authorized by section 122 of the Child 

21 Nutrition and WIC Reauthorization Act of 

22 2004 (Public Law 108–265). 

23 (d) APPLICATION OF CERTAIN RULES.—For pur24 poses of this section, rules similar to the rules of sections 
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1 9601 and 9602 of the Internal Revenue Code of 1986 shall 

2 apply. 

3 TITLE VI—RESEARCH 

4 SEC. 601. EXPANSION OF RESEARCH REGARDING OBESITY. 

5 The Secretary of Health and Human Services shall, 

6 based on the conclusions of the United States Preventive 

7 Services Task Force on Obesity, conduct research on obe8 sity prevention, treatment, and control with regard to the 

9 following: 

10 (1) The effectiveness of physical activity and di11 etary counseling with children and adolescents in the 

12 primary care setting to prevent, treat, and control 

13 obesity. 

14 (2) The cost-effectiveness of intensive dietary 

15 and physical activity counseling to prevent, treat, 

16 and control obesity in a variety of populations. 

17 (3) The effectiveness of dietary and physical ac18 tivity counseling among children and adolescents, 

19 low income populations, and minority groups in the 

20 primary care setting to prevent, treat, and control 

21 obesity. 

22 (4) The effectiveness of the assessment of obe23 sity by a primary care physician and subsequent re-
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1 ferral for obesity counseling to a nonaffiliated obe2 sity expert or specialist. 

Æ