[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4596 Introduced in House (IH)]

  2d Session
                                H. R. 4596

 To provide for a comprehensive Federal effort relating to treatments 
       for, and the prevention of cancer, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 25, 2002

Mrs. Capps (for herself, Mrs. Roukema, Mr. Dingell, Mr. Jefferson, Mrs. 
  Maloney of New York, Mr. Kennedy of Rhode Island, Mr. McNulty, Mr. 
 Towns, Ms. Brown of Florida, Mr. Filner, Mr. Serrano, and Mr. Lynch) 
 introduced the following bill; which was referred to the Committee on 
Energy and Commerce, and in addition to the Committees on Education and 
  the Workforce, and Ways and Means, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To provide for a comprehensive Federal effort relating to treatments 
       for, and the prevention of cancer, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``National Cancer 
Act of 2002''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
    TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, AND 
                           TREATMENT PROGRAMS

Sec. 101. Expansion of cancer-related research, prevention, and 
                            treatment programs.
Sec. 102. National Institute for Environmental Health Sciences.
Sec. 103. Amendment to Public Health Service Act.
           TITLE II--CANCER-RELATED HEALTH INSURANCE COVERAGE

                  Subtitle A--Clinical Trials Coverage

Sec. 201. Coverage for clinical trials under the Public Health Service 
                            Act.
Sec. 202. Coverage for clinical trials under the Employee Retirement 
                            Income Security Act of 1974.
Sec. 203. Coverage for clinical trials under other public health 
                            insurance.
            Subtitle B--Cancer Screening and Other Coverage

Sec. 211. Cancer screening coverage.
               Subtitle C--Physicians and Quality of Care

Sec. 221. Managing physicians and quality of care for cancer patients 
                            under the Public Health Service Act.
Sec. 222. Managing physicians and quality of care for cancer patients 
                            under the Employee Retirement Income 
                            Security Act of 1974.
Sec. 223. Managing physicians and quality of care for cancer patients 
                            under Medicare.
Sec. 224. Managing physicians and quality of care for cancer patients 
                            under Medicaid and SCHIP.
                     Subtitle D--General Provisions

Sec. 231. Coverage under other public health insurance.
                     TITLE III--TOBACCO REGULATION

Sec. 301. Findings.
Sec. 302. Purpose.
Sec. 303. Scope and effect.
Sec. 304. Relationship to other, related Federal, State, local, and 
                            tribal laws.
Sec. 305. Definitions.
Sec. 306. FTC jurisdiction not affected.
Sec. 307. Congressional review provisions.
              TITLE IV--REGULATION OF THE TOBACCO INDUSTRY

Sec. 401. Amendment of Federal Food, Drug, and Cosmetic Act of 1938.
Sec. 402. Conforming and other amendments to general provisions.
Sec. 403. FDA rule in effect.
   TITLE V--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

         Subtitle A--Product Warnings, Labeling, and Packaging

Sec. 501. Cigarette label and advertising warnings.
Sec. 502. Authority to revise cigarette warning label statements.
Sec. 503. Smokeless tobacco labels and advertising warnings.
Sec. 504. Authority to revise smokeless tobacco product warning label 
                            statements.
Sec. 505. Tar, nicotine, and other smoke constituent disclosure to the 
                            public.
Subtitle B--Testing and Reporting of Tobacco Product Smoke Constituents

Sec. 511. Regulation requirement.
Sec. 512. FDA amendment.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Each year 1,300,000 Americans are diagnosed with 
        cancer. Each year 560,000 Americans die from cancer. 
        Approximately 40 percent of all Americans in the United States 
        will be diagnosed with cancer at some point in their lives.
            (2) Since 1971, when the National Cancer Act was enacted, 
        and the ``War on Cancer'' was declared, the science of cancer 
        has advanced dramatically. The revolution in molecular and 
        cellular biology has created unprecedented opportunities for 
        understanding cancer and the role of genetics, environmental 
        risk factors, and prevention lifestyle factors in relation to 
        cancer.
            (3) Since 1971, mortality rates for some cancers have 
        decreased, while such rates for other cancers have not.
            (4) Since 1971, the Nation's population has become 
        increasingly diverse and cancer affects various minority, 
        socioeconomic, and ethnic groups disproportionately.
            (5) Cancer screening can reduce cancer mortality, in some 
        cases by 30 percent or more. While effective screening tools 
        have yet to be developed for the majority of cancers, there are 
        some cancers for which screening tools and procedures do exist. 
        Screening for some cancers, such as breast and cervical 
        cancers, has improved dramatically; however, screening rates 
        are still lower than optimal. Cancer screening rates vary by 
        cancer site, population group, and health insurance coverage.
            (6) Public and private health insurance coverage offered in 
        the United States has dramatically changed since 1971. Today, 
        managed care coverage is more typical than the fee-for-service 
        coverage that was more common in the past. This change in the 
        form of coverage has introduced more economic considerations 
        into medical decisionmaking, which can affect the quality of 
        all health care provided, including cancer care.
            (7) Fewer than 5 percent of cancer patients participate in 
        cancer trials. Only 3 to 4 percent of the elderly, the 
        population most likely to develop cancer, participate in such 
        trials.
            (8) New translational cancer research centers are needed to 
        provide the preclinical and early clinical trials support 
        required to advance scientific discoveries into new drugs and 
        technologies to prevent, treat, and diagnose cancer.
            (9) The quality of cancer care is uneven and often based on 
        pure coincidence of where one lives. Many cancer patients do 
        not receive optimal care.
            (10) Cancer is a disease of aging and as the American 
        population ages, cancer incidence will grow. It is estimated 
        that the number of cancer diagnoses in 2010 will increase by 20 
        percent. The number of cancer deaths is anticipated to increase 
        by 20 percent, at an annual cost of over $200,000,000,000. With 
        such increases in the incidence of cancer, there will be a 
        serious shortage of individuals in the workforce to provide 
        cancer care, particularly in long-term care settings.
            (11) The number of medical researchers entering medical 
        research is declining, a decrease which will negatively affect 
        the prevention and treatment of cancer.
            (12) Since 1971, more cancer care, such as the 
        administration of chemotherapy, has moved from inpatient to 
        outpatient settings.
            (13) Since 1971, the conduct of research has involved more 
        collaboration between the public and private sectors and more 
        multidisciplinary approaches. The biotechnology industry has 
        grown and provided a broad array of new treatment options and 
        scientific opportunities for cancer patients, providers, and 
        researchers.
            (14) Since 1971, technology and communications have 
        expanded and increased in complexity, transforming research 
        methodologies and making the accessing and transmitting of 
        information more widespread and more readily available.

    TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, AND 
                           TREATMENT PROGRAMS

SEC. 101. EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, AND 
              TREATMENT PROGRAMS.

    Subpart 1 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285) is amended--
            (1) by inserting after the subpart heading the following:

 ``CHAPTER I--PURPOSE OF INSTITUTE AND NATIONAL CANCER PROGRAMS''; and

            (2) by adding at the end the following:

           ``CHAPTER II--PROGRAMS TO PREVENT AND TREAT CANCER

``SEC. 417D. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated to the National Cancer 
Institute to carry out this chapter, $4,800,000,000 for fiscal year 
2003, $5,300,000,000 for fiscal year 2004, $5,800,000,000 for fiscal 
year 2005, $6,400,000,000 for fiscal year 2006, and $7,100,000,000 for 
fiscal year 2007.

``SEC. 417D-1. STUDY AND STRATEGIC PLANS.

    ``(a) In General.--Not later than July 1, 2004, the Institute shall 
prepare 1 or more strategic plans to identify unmet needs and the level 
of funding in the areas of prevention, treatment, early detection, and 
quality of life, and to expand and intensify cancer research and 
cancer-related research by July 1, 2005 for--
            ``(1) behavioral research associated with causing and 
        preventing cancer;
            ``(2) research regarding prevention of cancer other than 
        behavioral interventions;
            ``(3) research to reduce disparities among racial and 
        ethnic minorities and other disparity populations;
            ``(4) research regarding palliative care, pain management;
            ``(5) research regarding preserving and restoring quality-
        of-life for cancer patients;
            ``(6) research regarding environmental risk factors for 
        cancer and gene-environment interactions;
            ``(7) research regarding management of symptoms;
            ``(8) research regarding tools for early detection, 
        especially for which there currently is no adequate screening 
        technologies; and
            ``(9) cancer survivorship.
    ``(b) Priorities.--The National Cancer Institute shall determine 
priorities based on scientific opportunities, in consultation with 
medical, scientific, patient, and provider representatives, and prepare 
1 or more strategic plans by July 1, 2004.

``SEC. 417D-2. GRANTS FOR TRANSLATIONAL CANCER RESEARCH.

    ``(a) In General.--The Director of the Institute shall carry out a 
program to establish translational cancer research centers.
    ``(b) Duties of Director.--In carrying out the program, the 
Director shall--
            ``(1) award grants to public or nonprofit private entities 
        to plan and operate a national network of at least 20 existing 
        or new translational cancer research centers to conduct 
        translational, multidisciplinary cancer research;
            ``(2) establish networks and partnerships linking the 
        translational cancer research centers described in paragraph 
        (1) to community cancer providers (hospitals, clinics, 
        providers' practices, particularly in underserved areas) and 
        expand opportunities for all cancer patients to participate in 
        clinical trials of new agents developed by these centers;
            ``(3) facilitate the process to award grants, contracts, 
        and cooperative agreements to private entities to conduct 
        translational cancer research in the following areas--
                    ``(A) cancer drugs, biologics, and devices; and
                    ``(B) cancer diagnostic tests, techniques and 
                technology; and
            ``(4) develop and implement a strategic plan by July 1, 
        2004, in collaboration with translational centers as authorized 
        in paragraph (7) for intensifying, expanding, and disseminating 
        results of translational research to providers of cancer care.
    ``(c) Grants.--
            ``(1) In general.--The Director shall award grants to 
        public or nonprofit private entities to establish translational 
        cancer research centers to conduct translational, 
        multidisciplinary cancer research. Funds shall not be used for 
        construction of new facilities.
            ``(2) Equity.--The Director shall award grants under 
        subsection (b)(1) to provide, to the greatest extent 
        practicable, a broad distribution of such grants among 
        geographic regions of the United States.
            ``(3) Duties.--A public or nonprofit entity that receives a 
        grant under subsection (b)(1) shall use funds received through 
        such grant to establish and operate a translational cancer 
        research center.
            ``(4) Application.--A public or nonprofit entity desiring a 
        grant under this subsection shall submit an application to the 
        Director at such time, in such manner, and containing such 
        information as the Director may reasonably require.
    ``(d) Duties of Translational Research Centers.--The translational 
research centers shall--
            ``(1) perform research for discovery and preclinical 
        evaluation of drugs, biologics, devices, technologies, and 
        strategies with potential to improve the prevention, diagnosis, 
        and treatment of cancer and to improve pain and symptom 
management and quality of life of cancer patients;
            ``(2) perform clinical research studies on promising cancer 
        treatments or strategies, in appropriate human populations;
            ``(3) evaluate promising cancer diagnostic tests, 
        techniques, or technologies in individuals being evaluated for 
        the presence of cancer;
            ``(4) perform all phases of clinical trials of new drugs, 
        devices, biologics, or other strategies for treating patients 
        with cancer, in collaboration with the existing NCI Cooperative 
        Groups;
            ``(5) develop and implement a plan to ensure the 
        availability of adequate sources of patients for each type of 
        clinical research study;
            ``(6) create systems and external relationships, which do 
        not duplicate capabilities available in the private sector, to 
        accelerate the findings from translational research to a stage 
        that private companies can assume development and 
        commercialization; and
            ``(7) develop and implement a plan expanding and 
        disseminating the efficacious products of translational 
        research to providers of cancer care, including products 
        approved by the Food and Drug Administration.
    ``(e) Definitions.--In this section:
            ``(1) Clinical trial.--The term `clinical trial' means a 
        scientifically-designed clinical investigation in which a 
        patient participates in examining the effects of a drug, 
        biologic medical treatment, or medical device for the 
        prevention, diagnosis, or treatment of cancer or the potential 
        side effects of treatment.
            ``(2) Translational cancer research.--The term 
        `translational cancer research' means scientific laboratory and 
        clinical research and testing needed to transform scientific 
        discoveries into new approaches and products that can prevent, 
        control, diagnose, and treat cancer, optimize quality of life, 
        and ultimately, cure cancer.
    ``(f) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $100,000,000 in fiscal year 
2003, and $100,000,000 for each of the fiscal years 2004, 2005, 2006, 
and 2007.

``SEC. 417D-3. CLINICAL TRIALS.

    ``(a) In General.--The Director of the Institute shall carry out a 
program to increase patient and provider participation in clinical 
trials.
    ``(b) Program.--The program described in subsection (a) shall 
include--
            ``(1) an outreach program;
            ``(2) a diversity assurance program;
            ``(3) an assistance program, including recommending sources 
        of funding for patients support costs; and
            ``(4) culturally appropriate materials.
    ``(c) Outreach Program.--In carrying out the outreach program 
described in subsection (a), the Director shall regularly provide 
information to cancer care providers, professional and patient 
organizations, including community-based organizations, and patients to 
increase provider participation and patient enrollment in clinical 
trials.
    ``(d) Diversity Assurance Program.--In carrying out the diversity 
assurance program described in subsection (a), the Director shall 
require that all research grant applications include assurances that 
the applicant will actively recruit a diverse patient population, 
including disparity populations, to participate in trials, when such 
recruitment is medically appropriate.

``SEC. 417D-4. CANCER CARE WORKFORCE.

    ``(a) In General.--The Secretary shall establish a program to 
address current and future cancer care workforce needs.
    ``(b) Program.--The program described in subsection (a) shall--
            ``(1) set annual and long-term training goals to assure an 
        adequate cancer care workforce;
            ``(2) prepare and implement a plan to provide assistance to 
        individuals based on cancer health professions with the most 
        severe shortages;
            ``(3) award grants, scholarships, fellowships, and loans to 
        eligible individuals to increase the cancer care workforce;
            ``(4) make awards to eligible individuals to increase 
        cancer care workforce training for all individuals to become 
        cancer care providers, especially but not limited to, such 
        individuals who make a commitment to serve in underserved 
        communities or areas with disproportionately high cancer 
        incidence or mortality and for health professions for which 
        there are anticipated shortages, including providers, 
        pharmacists, nurses for all settings, allied health 
        professionals, physicians, specialists, and public health 
        professionals; and
            ``(5) be coordinated with existing programs to prevent 
        duplication.
    ``(c) Eligibility.--To be eligible to receive a scholarship, loan, 
or fellowship under this section, an individual shall submit an 
application to the Secretary at such time, in such manner, and 
containing such information as the Secretary reasonably requires. In 
such application, such individual shall demonstrate the intent to seek 
training to get a certificate, license, or postsecondary degree in 
health care, or in the case of licensed health care professionals, the 
intent to seek professional development to upgrade skills and knowledge 
or to obtain specialized knowledge according to criteria developed by 
the Secretary.
    ``(d) Use of Funds.--A recipient of a grant, scholarship, loan, or 
fellowship under this section may use funds from such grant, 
scholarship, loan, or fellowship to pay the costs of tuition and fees 
for training in--
            ``(1) care and treatment of cancer patients and survivors;
            ``(2) quality of life and symptom management;
            ``(3) cancer screening and early detection;
            ``(4) cancer prevention;
            ``(5) genetic testing and counseling;
            ``(6) language and cultural competency in cancer care; and
            ``(7) palliative and end-of-life care.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $100,000,000 in fiscal year 
2003 and such sums as may be necessary in each year for fiscal years 
2004, 2005, 2006, and 2007.

``SEC. 417D-5. INSTITUTE OF MEDICINE STUDY ON CANCER.

    ``(a) Institute of Medicine Study.--The Secretary shall request the 
Institute of Medicine of the National Academies of Sciences to initiate 
a study by January 1, 2003, of the feasibility and costs of providing 
medicare coverage under title XVIII of the Social Security Act to 
individuals who are diagnosed with cancer and cancer survivors through 
5 years of remission of cancer at any age and who have no other means 
of purchasing health care or health insurance, as determined under 
criteria established by the Secretary.
    ``(b) Content.--
            ``(1) In general.--The study under subsection (a) shall be 
        conducted in 2 parts.
            ``(2) First part.--The first part shall--
                    ``(A) examine options for providing medicare 
                coverage to such individuals;
                    ``(B) estimate the cost to the medicare program and 
                to current and future beneficiaries; and
                    ``(C) identify advantages associated with medicare 
                coverage in terms of access to cancer care, improved 
                quality of care and patient outcomes and assess the 
                feasibility of providing medicare coverage to uninsured 
                cancer patients through 5 years of remission and make a 
                recommendation to Congress about whether Medicare 
                should be expanded to this population group.
            ``(3) Second part.--The second part shall--
                    ``(A) identify changes in medicare benefits to 
                facilitate the provision of care consistent with 
                quality cancer care standards, including prescription 
                drug benefits and benefits to improve home care, 
                symptom management, psychosocial services, and 
                palliative and hospice care;
                    ``(B) estimate the cost to the medicare program and 
                to beneficiaries; and
                    ``(C) assess the medical advantages and 
                disadvantages associated with expanding benefits.
            ``(4) Deadlines.--The first part shall be completed by June 
        30, 2004, and the second part shall be completed by December 
        31, 2004.
    ``(c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $1,000,000 in fiscal year 2003 
and $1,200,000 in fiscal year 2004.

``SEC. 417D-6. CANCER CARE GUIDELINES.

    ``The Agency for Healthcare Research and Quality shall regularly 
convene cancer experts, providers, patients, representatives of 
disparity populations, and other relevant experts, including 
representatives of the National Cancer Institute, the Health Resources 
Administration, and the Centers for Disease Control and Prevention, to 
coordinate the development and regularly update--
            ``(1) consensus protocols and practice guidelines for 
        optimal cancer treatments, including prevention, palliation, 
        symptom management, and end-of-life care;
            ``(2) quality of care measures to assist providers and 
        patients in making and evaluating treatment decisions; and
            ``(3) guidelines for providing patients with multi-
        disciplinary consultation before treatment is initiated and 
        with one physician, preferably a specialist when feasible, to 
        provide overall coordination and management of cancer care 
        among all providers of the patient's treatment and services.

``SEC. 417D-7. RESEARCH AND OTHER ACTIVITIES OF THE AGENCY FOR 
              HEALTHCARE RESEARCH AND QUALITY TO IMPROVE THE QUALITY 
              AND OUTCOMES OF CANCER CARE.

    ``(a) In General.--
            ``(1) Research.--The Director for Healthcare Research and 
        Quality shall conduct and support research and other activities 
        to build an evidence base regarding effective clinical and 
        organizational intervention strategies to improve the quality 
        and outcomes of cancer care, and access to such care, at all 
        stages of the health care continuum and to facilitate the 
        prompt use of that information to improve practice.
            ``(2) Factors.--In carrying out paragraph (1), the Director 
        shall take into account the breadth of the continuum of cancer 
        care, from prevention and early detection, through diagnosis 
        and treatment, to rehabilitation, long term survivorship and 
        remission, through psychosocial, palliative, and end-of-life 
        care.
    ``(b) Specific Requirements.--The Agency for Healthcare Research 
and Quality shall--
            ``(1) conduct and support research to develop new 
        scientific knowledge regarding the effectiveness and cost 
        effectiveness of interventions that improve the quality and 
        outcomes of cancer care, and access to such care;
            ``(2) regularly assess and synthesize existing scientific 
        evidence on the effectiveness of such interventions;
            ``(3) ensure the targeted dissemination of the most current 
        scientific evidence in appropriate formats for use by 
        professional societies and organizations representing 
        clinicians and other caregivers, organizations through which 
        health care and support services are delivered, and 
        organizations representing cancer patients and their families;
            ``(4) facilitate, as appropriate, the prompt use of 
        existing scientific information by the professional societies 
        and organization listed in paragraph (3) to develop guidance, 
        best practices, quality improvement strategies or other 
        initiatives to improve practice;
            ``(5) develop quality of care measures to assist clinicians 
        and other caregivers, providers and health plans, patients and 
        their families, and purchasers;
            ``(6) collect information, as appropriate, and conduct and 
        support research on trends in medical care practice patterns 
        and the relationship of such trends to the quality and outcomes 
        of cancer care; and
            ``(7) assess effective strategies by which an individual 
        physician can provide overall coordination and management of 
        cancer care.
    ``(c) Coordination of Federal Quality Improvement Activities and 
Reporting of Data.--In carrying out subsection (b)--
            ``(1) the Director for Healthcare Research and Quality, 
        working through the Quality Interagency Coordination (QUIC) 
        Task Force, and in collaboration with the Director, National 
        Cancer Institute, shall facilitate coordination of Federal 
        research and implementation initiatives to improve the quality 
        and outcomes of cancer care;
            ``(2) the Agency for Healthcare Research and Quality shall 
        serve as a resource for other Federal agencies in the 
        measurement of the quality of cancer care;
            ``(3) the Director for Healthcare Research and Quality and 
        the Director, National Cancer Institute shall work 
        cooperatively to develop data in order to set benchmarks for, 
        and subsequently measure changes in the quality of cancer care 
        for inclusion, as soon as practicable, in the annual report 
        required by section 913(b)(2); and
            ``(4) the Director for Healthcare Research and Quality 
        shall ensure coordination of these activities, as appropriate, 
        with his responsibilities for research on health disparities 
        under section 903.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $8,000,000 for each of the 
fiscal years 2003 through 2007.

``SEC. 417D-8. CENTERS FOR DISEASE CONTROL AND PREVENTION.

    ``(a) Program.--The Director of the Centers for Disease Control and 
Prevention shall--
            ``(1) expand and update the National Program of 
        Comprehensive Cancer Control Plans;
            ``(2) prepare a model State cancer control and prevention 
        program, including partnerships between nonprofit, private, and 
        public entities;
            ``(3) assist States, territories, tribal organizations, and 
        the District of Columbia in developing and implementing a 
        cancer prevention and control program so that every State will 
        have an active plan in place and so that States, territories, 
        tribal organizations, and the District of Columbia will use 
        treatments to prevent and control cancer and so that 
        disparities in specific populations will be addressed;
            ``(4) coordinate with the National Cancer Institute;
            ``(5) prepare model programs to prevent and control cancer 
        and improve access to and the quality of cancer care among 
        racial and ethnic minority and medically underserved 
        populations with disproportionate incidence of or death from 
        cancer;
            ``(6) promote cancer education, prevention, and early 
        detection of cancer; and
            ``(7) award grants to public and nonprofit organizations 
        for cancer control and prevention.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $65,000,000 for fiscal year 
2003 and such sums as may be necessary for fiscal years 2004, 2005, 
2006, and 2007.

``SEC. 417D-9. CANCER CARE RESEARCHERS.

    ``(a) Supply of Cancer Researchers.--In order to ensure a 
sufficient number of researchers trained in the prevention, diagnosis, 
cure, and treatment of cancer in future fiscal years, the Director of 
the National Cancer Institute, in coordination with the Secretary of 
Veterans Affairs, shall carry out activities to--
            ``(1) increase the number and amount of institutional 
        training grants to institutions supporting cancer research; and
            ``(2) increase the number of career development awards for 
        health professionals, particularly minorities, who intend to 
        have, or who expand, careers in basic, clinical, and 
        translational cancer research, including cancer prevention, 
        cancer information technology, bioinformatics, behavioral 
        research, and research on palliative, psychosocial, and end-of-
        life care.
    ``(b) Loan Repayment.--
            ``(1) Establishment.--The Director, in consultation with 
        the Director of the National Institutes of Health, shall 
        establish a cancer research loan repayment program.
            ``(2) Contracts.--Under the program established under 
        paragraph (1), the Director shall enter into contracts with 
        qualified health professionals under which such professionals 
        will agree to conduct cancer research, in consideration of the 
        Federal Government agreeing to repay, for each year of such 
        services, not more than $35,000 of the principal and interest 
        of the educational loans of such professionals obtained to 
        support training for degrees or licenses, as determined 
        appropriate by the Director.
    ``(c) Postdoctoral Stipends.--
            ``(1) In general.--The Director of the National Cancer 
        Institute, shall develop and implement, for postdoctoral 
        trainees and fellows, a stipend schedule that by October 1, 
        2003, begins for entry-level positions and individuals with no 
        or limited experience comparable to grade 11 of the Federal 
        general schedule under title 5, United States Code (civil 
        service salary schedule) and that adequately reflects training, 
        education, experience, and comparable salaries or stipends for 
        comparable work in non-Federal settings, and provides for 
        annual cost-of-living adjustments.
            ``(2) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection, $79,000,000 
        for fiscal year 2003, and $86,000,000 for fiscal year 2004, 
        $95,000,000 for fiscal year 2005, $105,000,000 for fiscal year 
        2006, and $115,000,000 for fiscal year 2007.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section,  $10,500,000 for fiscal year 
2003, and $10,500,000 for each of fiscal years 2004 through 2007.''.

SEC. 102. NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES.

    (a) In General.--Not later than October 1, 2002, the Director of 
the National Institute for Environmental Health Sciences shall, in 
coordination with the National Cancer Institute, prepare and submit to 
the Secretary of Health and Human Services a strategic plan that 
identifies the unmet needs regarding research on environmental risk 
factors for cancer and gene-environment interactions and describes how 
to increase the amount of such research and resources for such 
research.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary.

SEC. 103. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    (a) Programs.--Title XV of the Public Health Service Act (42 U.S.C. 
300k et seq.) is amended by adding at the end the following:

``SEC. 1511. DEMONSTRATION PROGRAM FOR COLORECTAL CANCER SCREENING.

    ``(a) In General.--The Director of the Centers for Disease Control 
and Prevention may award grants to States to screen for colorectal 
cancer.
    ``(b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $50,000,000 for fiscal year 
2003, and such sums as may be necessary for fiscal years 2004 through 
2007.''.
    (b) Supplemental Grants.--Section 1509(d)(1) of title XV of the 
Public Health Service Act (42 U.S.C. 300n-4a(d)(1)) is amended by 
striking ``$3,000,000'' and all that follows through the period, and 
inserting ``$250,000,000 for fiscal year 2003, and such sums as may be 
necessary for fiscal years 2004 through 2007.''.
    (c) Funding.--Section 1510(a) of title XV of the Public Health 
Service Act (42 U.S.C. 300n-5(a)) is amended by striking 
``$50,000,000'' and all that follows through the period, and inserting 
``such sums for each of the fiscal years 2003 through 2007.''.

           TITLE II--CANCER-RELATED HEALTH INSURANCE COVERAGE

                  Subtitle A--Clinical Trials Coverage

SEC. 201. COVERAGE FOR CLINICAL TRIALS UNDER THE PUBLIC HEALTH SERVICE 
              ACT.

    (a) Group.--Subpart 2 of part A of title XXVII of the Public Health 
Service Act (42 U.S.C. 300gg-4 et seq.) is amended by adding at the end 
the following:

``SEC. 2707. COVERAGE FOR INDIVIDUALS PARTICIPATING IN CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or health 
        insurance issuer that is providing health insurance coverage, 
        provides coverage to a qualified individual (as defined in 
        subsection (b)), the plan or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsection (c), may not deny (or 
                limit or impose additional conditions on) the coverage 
                of routine patient costs for items and services 
                furnished in connection with participation in the 
                trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the enrollee's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(3) Use of in-network providers.--If one or more 
        participating providers is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that a qualified individual 
        participate in the trial through such a participating provider 
        if the provider will accept the individual as a participant in 
        the trial. Nothing in this section should prevent a qualified 
        individual from participating in a trial even if the plan or 
        issuer does not have an in-network provider participating.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan, or who is an 
enrollee under health insurance coverage, and who is referred by the 
treating physician and meets the following conditions:
            ``(1) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) The treatment for the individual is being provided 
        with therapeutic or palliative intent.
            ``(3) The individual has been diagnosed by a qualified 
        provider to have cancer.
            ``(4) Either the referring physician is a participating 
        health care professional and has concluded that the 
        individual's participation in such trial would be appropriate 
        based upon the individual meeting the conditions described 
        above in paragraphs (1) through (3), or the participant, 
        beneficiary, or enrollee provides medical and scientific 
        information establishing that the individual's participation in 
        such trial would be appropriate based upon the individual 
        meeting the criteria described above in such paragraphs.
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan 
        or health insurance issuer shall provide for payment for 
        routine patient costs described in subsection (a)(2) but is not 
        required to pay for costs of items and services (as determined 
        by the appropriate Secretary) to be paid for by the sponsors of 
        an approved clinical trial.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate; or
                    ``(B) a nonparticipating provider, the payment rate 
                shall be at the rate the plan or issuer would normally 
                pay for comparable services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--In this section, the term 
`approved clinical trial' means a clinical research study or clinical 
investigation--
            ``(1) approved and funded (which may include funding 
        through in-kind contributions) by--
                    ``(A) the National Institutes of Health;
                    ``(B) a cooperative group or center of the National 
                Institutes of Health;
                    ``(C) the Department of Veterans Affairs;
                    ``(D) the Department of Defense;
                    ``(E) the Centers for Disease Control and 
                Prevention; or
                    ``(F) the Agency for Healthcare Research and 
                Quality;
            ``(2) approved by the Food and Drug Administration; or
            ``(3) a qualified non-governmental research entity that 
        specifies compliance with the guidelines set forth in section 
        46 of title 45, Code of Federal Regulations and whose research 
        is reviewed and approved through an institutional review board 
        that--
                    ``(A) has been registered with the Department of 
                Health and Human Services; and
                    ``(B) is an institutional review board of an 
                institution that has received an appropriate Federal 
                assurance from the Department of Health and Human 
                Services assuring compliance with such section of such 
                Code.
    ``(e) Conditions for Departments.--The conditions described in the 
paragraph for a study or investigation conducted by a department, are 
that the study or investigation has been reviewed and approved through 
a system of peer review that the appropriate Secretary determines--
            ``(1) to be comparable to the system of peer review of 
        studies and investigations used by the National Institutes of 
        Health; and
            ``(2) assures unbiased review of the highest ethical 
        standards by qualified individuals who have no interest in the 
        outcome of the review.
    ``(f) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials. 
Nothing in this section shall be construed to result in a reduction, 
diminishment, or change in coverage resulting in less coverage.''.
    (b) Individual.--Part B of title XXVII of the Public Health Service 
Act is amended by inserting after section 2752 (42 U.S.C. 300gg-52) the 
following:

``SEC. 2753. PATIENT PROTECTION STANDARDS.

    ``The provisions of section 2707 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as such provisions apply to health insurance 
coverage offered by a health insurance issuer in connection with a 
group health plan.''.

SEC. 202. COVERAGE FOR CLINICAL TRIALS UNDER THE EMPLOYEE RETIREMENT 
              INCOME SECURITY ACT OF 1974.

    (a) In General.--Subpart B of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et 
seq.) is amended by adding at the end the following:

``SEC. 714. COVERAGE FOR INDIVIDUALS PARTICIPATING IN CLINICAL TRIALS.

    ``(a) Coverage.--
            ``(1) In general.--If a group health plan, or health 
        insurance issuer offering group health insurance coverage, 
        provides coverage to a qualified individual (as defined in 
        subsection (b)), the plan or issuer--
                    ``(A) may not deny the individual participation in 
                the clinical trial referred to in subsection (b)(2);
                    ``(B) subject to subsection (c), may not deny (or 
                limit or impose additional conditions on) the coverage 
                of routine patient costs for items and services 
                furnished in connection with participation in the 
                trial; and
                    ``(C) may not discriminate against the individual 
                on the basis of the enrollee's participation in such 
                trial.
            ``(2) Exclusion of certain costs.--For purposes of 
        paragraph (1)(B), routine patient costs do not include the cost 
        of the tests or measurements conducted primarily for the 
        purpose of the clinical trial involved.
            ``(3) Use of in-network providers.--If one or more 
        participating providers is participating in a clinical trial, 
        nothing in paragraph (1) shall be construed as preventing a 
        plan or issuer from requiring that a qualified individual 
        participate in the trial through such a participating provider 
        if the provider will accept the individual as a participant in 
        the trial. Nothing in this section should prevent a qualified 
        individual from participating in a trial even if the plan or 
        issuer does not have an in-network provider participating.
    ``(b) Qualified Individual Defined.--For purposes of subsection 
(a), the term `qualified individual' means an individual who is a 
participant or beneficiary in a group health plan, or who is an 
enrollee under health insurance coverage, and who is referred by the 
treating physician and meets the following conditions:
            ``(1) The individual is eligible to participate in an 
        approved clinical trial according to the trial protocol with 
        respect to treatment of such illness.
            ``(2) The treatment for the individual is being provided 
        with therapeutic or palliative intent.
            ``(3) The individual has been diagnosed by a qualified 
        provider to have cancer.
            ``(4) Either the referring physician is a participating 
        health care professional and has concluded that the 
        individual's participation in such trial would be appropriate 
        based upon the individual meeting the conditions described 
        above in paragraphs (1) through (3) or the participant, 
        beneficiary, or enrollee provides medical and scientific 
        information establishing that the individual's participation in 
        such trial would be appropriate based upon the individual 
        meeting the criteria described above in such paragraphs.
    ``(c) Payment.--
            ``(1) In general.--Under this section a group health plan 
        or health insurance issuer shall provide for payment for 
        routine patient costs described in subsection (a)(2) but is not 
        required to pay for costs of items and services (as determined 
        by the appropriate Secretary) to be paid for by the sponsors of 
        an approved clinical trial.
            ``(2) Payment rate.--In the case of covered items and 
        services provided by--
                    ``(A) a participating provider, the payment rate 
                shall be at the agreed upon rate; or
                    ``(B) a nonparticipating provider, the payment rate 
                shall be at the rate the plan or issuer would normally 
                pay for comparable services under subparagraph (A).
    ``(d) Approved Clinical Trial Defined.--In this section, the term 
`approved clinical trial' means a clinical research study or clinical 
investigation--
            ``(1) approved and funded (which may include funding 
        through in-kind contributions) by--
                    ``(A) the National Institutes of Health;
                    ``(B) a cooperative group or center of the National 
                Institutes of Health;
                    ``(C) the Department of Veterans Affairs;
                    ``(D) the Department of Defense;
                    ``(E) the Centers for Disease Control and 
                Prevention; or
                    ``(F) the Agency for Healthcare Research and 
                Quality;
            ``(2) approved by the Food and Drug Administration; or
            ``(3) a qualified non-governmental research entity that 
        specifies compliance with the guidelines set forth in section 
        46 of title 45, Code of Federal Regulations, and whose research 
        is reviewed and approved through an institutional review board 
        that--
                    ``(A) has been registered with the Department of 
                Health and Human Services; and
                    ``(B) is an institutional review board of an 
                institution that has received an appropriate federal 
                assurance from the Department of Health and Human 
                Services assuring compliance with such section of such 
                Code.
    ``(e) Conditions for Departments.--The conditions described in the 
paragraph for a study or investigation conducted by a department, are 
that the study or investigation has been reviewed and approved through 
a system of peer review that the appropriate Secretary determines--
            ``(1) to be comparable to the system of peer review of 
        studies and investigations used by the National Institutes of 
        Health; and
            ``(2) assures unbiased review of the highest ethical 
        standards by qualified individuals who have no interest in the 
        outcome of the review.
    ``(f) Construction.--Nothing in this section shall be construed to 
limit a plan's or issuer's coverage with respect to clinical trials. 
Nothing in this section shall be construed to result in a reduction, 
diminishment, or change in coverage resulting in less coverage.''.
    (b) Conforming Amendment.--The table of contents in section 1 of 
the Employee Retirement Income Security Act of 1974 is amended by 
inserting after the item relating to section 713 the following new 
item:

``Sec. 714. Coverage for individuals participating in clinical 
                            trials.''.

SEC. 203. COVERAGE FOR CLINICAL TRIALS UNDER OTHER PUBLIC HEALTH 
              INSURANCE.

    Coverage for individuals participating in clinical trials, as 
described in section 2707 and 2753 of the Public Health Service Act (as 
added under section 201), shall be provided for any individual, 
participant, or beneficiary who has coverage under--
            (1) the medicaid program under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.);
            (2) the medicare program under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.);
            (3) the State Children's Health Insurance Program under 
        title XXI of the Social Security Act (42 U.S.C. 1398 et seq.);
            (4) a health plan offered under chapter 89 of title 5, 
        United States Code;
            (5) programs offered by the Department of Defense;
            (6) a medical care program of the Indian Health Service or 
        of a tribal organization; and
            (7) a health benefit plan under section 5(e) of the Peace 
        Corps Act (22 U.S.C. 2504(e)).

            Subtitle B--Cancer Screening and Other Coverage

SEC. 211. CANCER SCREENING COVERAGE.

    (a) Group Health Plans.--
            (1) Public health service act amendments.--
                    (A) In general.--Subpart 2 of part A of title XXVII 
                of the Public Health Service Act (42 U.S.C. 300gg-4 et 
                seq.), as amended by section 201(a), is further amended 
                by adding at the end the following:

``SEC. 2708. COVERAGE OF CANCER SCREENING.

    ``(a) Requirement.--A group health plan, and a health insurance 
issuer offering group health insurance coverage, shall provide coverage 
and payment under the plan or coverage for the following items and 
services under terms and conditions that are no less favorable than the 
terms and conditions applicable to other screening benefits otherwise 
provided under the plan or coverage:
            ``(1) Mammograms.--In the case of a female participant or 
        beneficiary who is 40 years of age or older, or is under 40 
        years of age but is at high risk (as defined in subsection (e)) 
        of developing breast cancer, an annual mammography (as defined 
        in section 1861(jj) of the Social Security Act) conducted by a 
        facility that has a certificate (or provisional certificate) 
        issued under section 354.
            ``(2) Clinical breast examinations.--In the case of a 
        female participant or beneficiary who--
                    ``(A)(i) is 40 years of age or older or (ii) is at 
                least 20 (but less than 40) years of age and is at high 
                risk of developing breast cancer, an annual clinical 
                breast examination; or
                    ``(B) is at least 20, but less than 40, years of 
                age and who is not at high risk of developing breast 
                cancer, a clinical breast examination every 3 years.
            ``(3) Pap tests and pelvic examinations.--In the case of a 
        female participant or beneficiary who is 18 years of age or 
        older, or who is under 18 years of age and is or has been 
        sexually active--
                    ``(A) an annual diagnostic laboratory test 
                (popularly known as a `pap smear') consisting of a 
                routine exfoliative cytology test (Papanicolaou test) 
                provided to a woman for the purpose of early detection 
                of cervical or vaginal cancer and including an 
                interpretation by a qualified health professional of 
                the results of the test; and
                    ``(B) an annual pelvic examination.
            ``(4) Colorectal cancer screening procedures.--In the case 
        of a participant or beneficiary who is 50 years of age or 
        older, or who is under 50 years of age and is at risk of 
        developing colorectal  cancer, the procedures described in 
section 1861(pp)(1) of the Social Security Act (42 U.S.C. 1395x(pp)(1)) 
or section 4104(a)(2) of the Balanced Budget Act of 1997 (111 Stat. 
362), shall be furnished to the individual for the purpose of early 
detection of colorectal cancer. The group health plan or health 
insurance issuer shall provide coverage for the method and frequency of 
colorectal cancer screening determined to be appropriate by a health 
care provider treating such participant or beneficiary, in consultation 
with the participant or beneficiary.
            ``(5) Prostate cancer screening.--In the case of a male 
        participant or beneficiary who is 50 years of age or older, or 
        who is younger than 50 years of age and is at high risk for 
        prostate cancer (including African American men or a male who 
        has a history of prostate cancer in a first degree family 
        member), the procedures described in section 1861(oo)(2) of the 
        Social Security Act (42 U.S.C. 1395x(oo)(2)) shall be furnished 
        to the individual for the early detection of prostate cancer. 
        The group health plan or health insurance issuer shall provide 
        coverage for the method and frequency of prostate cancer 
        screening determined to be appropriate by a health care 
        provider treating such participant or beneficiary, in 
        consultation with the participant or beneficiary.
            ``(6) Tobacco therapy and counseling.--
                    ``(A) In general.--Therapy and counseling for 
                cessation of tobacco use for individuals who use 
                tobacco products or who are being treated for tobacco 
                use that is furnished--
                            ``(i) by or under the supervision of a 
                        physician; or
                            ``(ii) by any other health care 
                        professional--
                                    ``(I) who is legally authorized to 
                                furnish such services under State law 
                                (or the State regulatory mechanism 
                                provided by State law) of the State in 
                                which the services are furnished; and
                                    ``(II) who, for medicare 
                                beneficiaries, is authorized to receive 
                                payment for other services under this 
                                title or is designated by the Secretary 
                                for this purpose.
                    ``(B) Limitation.--Subject to subparagraph (C), 
                such therapy and counseling are limited to--
                            ``(i) therapy and counseling services 
                        recommended in `Treating Tobacco Use and 
                        Dependence: A Clinical Practice Guideline', 
                        published by the Public Health Service in June 
                        2000, or any subsequent modification of such 
                        Guideline; and
                            ``(ii) such other therapy and counseling 
                        services that the Secretary recognizes to be 
                        effective.
                    ``(C) Exclusion.--Such therapy and counseling shall 
                not include coverage for drugs or biologicals that are 
                not otherwise covered under the plan or coverage.
            ``(7) Medical nutrition therapy services.--Medical 
        nutrition therapy services, as defined in section 1861(vv) of 
        the Social Security Act (42 U.S.C. 1395x(vv)) for the purpose 
        of improving the health of cancer patients and preventing 
        cancer in other beneficiaries.
            ``(8) Genetic tests and genetic services.--
                    ``(A) In general.--Genetic tests and genetic 
                services provided by a licensed health care 
                professional to obtain predictive genetic information 
                about an individual at risk of cancer for purposes of a 
health assessment, cancer management, cancer prevention, other 
diagnostic or therapeutic purposes, or genetic education and 
counseling.
                    ``(B) Definitions.--In this paragraph:
                            ``(i) Family member.--The term `family 
                        member' means with respect to an individual--
                                    ``(I) the spouse of the individual;
                                    ``(II) a dependent child of the 
                                individual, including a child who is 
                                born to or placed for adoption with the 
                                individual; and
                                    ``(III) all other individuals 
                                related by blood to the individual or 
                                the spouse or child described in 
                                subclause (I) or (II).
                            ``(ii) Genetic information.--The term 
                        `genetic information' means information about 
                        genes, gene products, or inherited 
                        characteristics that may derive from an 
                        individual or a family member of such 
                        individual (including information about a 
                        request for or the receipt of genetic services 
                        by such individual or family member of such 
                        individual).
                            ``(iii) Genetic services.--The term 
                        `genetic services' means health services, 
                        including genetic tests, provided to obtain, 
                        assess, or interpret genetic information for 
                        diagnostic and therapeutic purposes, and for 
                        genetic education and counseling.
                            ``(iv) Genetic test.--The term `genetic 
                        test' means the analysis of human DNA, RNA, 
                        chromosomes, proteins, and certain metabolites 
                        in order to detect genotypes, mutations, or 
                        chromosomal changes.
                            ``(v) Predictive genetic information.--
                                    ``(I) In general.--The term 
                                `predictive genetic information' 
                                means--
                                            ``(aa) information about an 
                                        individual's genetic tests;
                                            ``(bb) information about 
                                        genetic tests of family members 
                                        of the individual; or
                                            ``(cc) information about 
                                        the occurrence of a disease or 
                                        disorder in family members.
                                    ``(II) Limitations.--The term 
                                `predictive genetic information' shall 
                                not include--
                                            ``(aa) information about 
                                        the sex or age of the 
                                        individual;
                                            ``(bb) information about 
                                        chemical, blood, or urine 
                                        analyses of the individual, 
                                        unless these analyses are 
                                        genetic tests; or
                                            ``(cc) information about 
                                        physical exams of the 
                                        individual, and other 
                                        information relevant to 
                                        determining the current health 
                                        status of the individual.
            ``(9) Other tests and procedures.--Such other tests or 
        procedures for the detection of cancer, and modifications to 
        the tests and procedures, with such frequency, as the Secretary 
        determines to be appropriate, in consultation with appropriate 
        organizations and agencies, for the diagnosis or detection of 
        cancer.
    ``(b) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to require 
        an individual who is a participant or beneficiary to undergo a 
        procedure, examination, or test described in subsection (a).
            ``(2) Nothing in this section shall be construed as 
        preventing a group health plan or issuer from imposing 
        deductibles, coinsurance, or other cost-sharing in relation to 
        benefits described in subsection (a) consistent with such 
        subsection, except that such coinsurance or other cost-sharing 
        shall not discriminate on any basis related to the coverage 
        required under this section.
            ``(3) Nothing in this section shall be construed to result 
        in a reduction, diminishment, or change in coverage resulting 
        in less coverage.
    ``(d) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.
    ``(e) Risk Defined.--For purposes of this section, an individual is 
considered to be at `risk' of developing a particular type of cancer 
if, under guidelines developed or recognized by the Secretary based 
upon scientific evidence, the individual--
            ``(1) has 1 or more first degree family members who have 
        developed that type of cancer;
            ``(2) has previously had that type of cancer;
            ``(3) has the presence of an appropriate recognized gene 
        marker that is identified as putting the individual at a higher 
        risk of developing that type of cancer; or
            ``(4) has other predisposing or environmental risk factors 
        that significantly increases the risk of the individual 
        contracting that type of cancer.
For purposes of this subsection, the term `type of cancer' includes 
other types of cancer that the Secretary recognizes as closely related 
for purposes of establishing risk.

``SEC. 2709. PATIENT ACCESS TO INFORMATION.

    ``(a) Disclosure Requirement.--A group health plan, and health 
insurance issuer offering group health insurance coverage shall--
            ``(1) provide to participants and beneficiaries at the time 
        of initial coverage under the plan (or the effective date of 
        this section, in the case of individuals who are participants 
        or beneficiaries as of such date), and at least annually 
        thereafter, the information described in subsection (b) in 
        printed form;
            ``(2) provide to participants and beneficiaries, within a 
        reasonable period (as specified by the appropriate Secretary) 
        before or after the date of significant changes in the 
        information described in subsection (b), information in printed 
        form regarding such significant changes; and
            ``(3) upon request, make available to participants and 
        beneficiaries, the applicable authority, and prospective 
        participants and beneficiaries, the information described in 
        subsection (b) in printed form.
    ``(b) Information Provided.--The information described in 
subsection (a) that shall be disclosed includes the following, as such 
relates to cancer screening required under section 2708(a):
            ``(1) Benefits.--Benefits offered under the plan or 
        coverage, including--
                    ``(A) covered benefits, including benefit limits 
                and coverage exclusions;
                    ``(B) cost sharing, such as deductibles, 
                coinsurance, and copayment amounts, including any 
                liability for balance billing, any maximum limitations 
                on out of pocket expenses, and the maximum out of 
                pocket costs for services that are provided by 
                nonparticipating providers or that are furnished 
                without meeting the applicable utilization review 
                requirements;
                    ``(C) the extent to which benefits may be obtained 
                from nonparticipating providers; and
                    ``(D) the extent to which a participant, 
                beneficiary, or enrollee may select from among 
                participating providers and the types of providers 
                participating in the plan or issuer network.
            ``(2) Access.--A description of the following:
                    ``(A) The number, mix, and distribution of 
                providers under the plan or coverage.
                    ``(B) Out-of-network coverage (if any) provided by 
                the plan or coverage.
                    ``(C) Any point-of-service option (including any 
                supplemental premium or cost-sharing for such option).
                    ``(D) The procedures for participants, 
                beneficiaries, and enrollees to select, access, and 
                change participating primary and specialty providers.
                    ``(E) The rights and procedures for obtaining 
                referrals (including standing referrals) to 
                participating and nonparticipating providers.
                    ``(F) The name, address, and telephone number of 
                participating health care providers and an indication 
                of whether each such provider is available to accept 
                new patients.
                    ``(G) How the plan or issuer addresses the needs of 
                participants, beneficiaries, and enrollees and others 
                who do not speak English or who have other special 
                communications needs in accessing providers under the 
                plan or coverage, including the provision of 
                information under this subsection.''.
                    (B) Technical amendment.--Section 2723(c) of the 
                Public Health Service Act (42 U.S.C. 300gg-23(c)) is 
                amended by striking ``section 2704'' and inserting 
                ``sections 2704 and 2708''.
            (2) ERISA amendments.--
                    (A) In general.--Subpart B of part 7 of subtitle B 
                of title I of the Employee Retirement Income Security 
                Act of 1974 (29 U.S.C. 1185 et seq.), as amended by 
                section 202, is further amended by adding at the end 
                the following new section:

``SEC. 715. COVERAGE OF CANCER SCREENING.

    ``(a) Requirement.--A group health plan, and a health insurance 
issuer offering group health insurance coverage, shall provide coverage 
and payment under the plan or coverage for the following items and 
services under terms and conditions that are no less favorable than 
the  terms and conditions applicable to other screening benefits 
otherwise provided under the plan or coverage:
            ``(1) Mammograms.--In the case of a female participant or 
        beneficiary who is 40 years of age or older, or is under 40 
        years of age but is at high risk (as defined in subsection (e)) 
        of developing breast cancer, an annual mammography (as defined 
        in section 1861(jj) of the Social Security Act) conducted by a 
        facility that has a certificate (or provisional certificate) 
        issued under section 354 of the Public Health Service Act.
            ``(2) Clinical breast examinations.--In the case of a 
        female participant or beneficiary who--
                    ``(A)(i) is 40 years of age or older or (ii) is at 
                least 20 (but less than 40) years of age and is at high 
                risk of developing breast cancer, an annual clinical 
                breast examination; or
                    ``(B) is at least 20, but less than 40, years of 
                age and who is not at high risk of developing breast 
                cancer, a clinical breast examination each 3 years.
            ``(3) Pap tests and pelvic examinations.--In the case of a 
        female participant or beneficiary who is 18 years of age or 
        older, or who is under 18 years of age and is or has been 
        sexually active--
                    ``(A) an annual diagnostic laboratory test 
                (popularly known as a `pap smear') consisting of a 
                routine exfoliative cytology test (Papanicolaou test) 
                provided to a woman for the purpose of early detection 
                of cervical or vaginal cancer and including an 
                interpretation by a qualified health professional of 
                the results of the test; and
                    ``(B) an annual pelvic examination.
            ``(4) Colorectal cancer screening procedures.--In the case 
        of a participant or beneficiary who is 50 years of age or 
        older, or who is under 50 years of age and is at risk of 
        developing colorectal cancer, the procedures described in 
        section 1861(pp)(1) of the Social Security Act (42 U.S.C. 
        1395x(pp)(1)) or section 4104(a)(2) of the Balanced Budget Act 
        of 1997 (111 Stat. 362), shall be furnished to the individual 
        for the purpose of early detection of colorectal cancer. The 
        group health plan or health insurance issuer shall provided 
        coverage for the method and frequency of colorectal cancer 
        screening determined to be appropriate by a health care 
        provider treating such participant or beneficiary, in 
        consultation with the participant or beneficiary.
            ``(5) Prostate cancer screening.--In the case of a male 
        participant or beneficiary who is 50 years of age or older, or 
        who is younger than 50 years of age and is at high risk for 
        prostate cancer (including African American men or a male who 
        has a history of prostate cancer in a first degree family 
        member), the procedures described in section 1861(oo)(2) of the 
        Social Security Act (42 U.S.C. 1395x(oo)(2)) shall be furnished 
        to the individual for the early detection of prostate cancer. 
        The group health plan or health insurance issuer shall provide 
        coverage for the method and frequency of prostate cancer 
        screening determined to be appropriate by a health care 
        provider treating such participant or beneficiary, in 
        consultation with the participant or beneficiary.
            ``(6) Tobacco therapy and counseling.--
                    ``(A) In general.--Therapy and counseling for 
                cessation of tobacco use for individuals who use 
                tobacco products or who are being treated for tobacco 
                use that is furnished--
                            ``(i) by or under the supervision of a 
                        physician; or
                            ``(ii) by any other health care 
                        professional who--
                                    ``(I) is legally authorized to 
                                furnish such services under State law 
                                (or the State regulatory mechanism 
                                provided by State law) of the State in 
                                which the services are furnished; and
                                    ``(II) for medicare beneficiaries, 
                                is authorized to receive payment for 
                                other services under this title or is 
                                designated by the Secretary for this 
                                purpose.
                    ``(B) Limitation.--Subject to subparagraph (C), 
                such therapy and counseling are limited to--
                            ``(i) therapy and counseling services 
                        recommended in `Treating Tobacco Use and 
                        Dependence: A Clinical Practice Guideline', 
                        published by the Public Health Service in June 
                        2000, or any subsequent modification of such 
                        Guideline; and
                            ``(ii) such other therapy and counseling 
                        services that the Secretary recognizes to be 
                        effective.
                    ``(C) Exclusion.--Such therapy and counseling shall 
                not include coverage for drugs or biologicals that are 
                not otherwise covered under the plan or coverage.
            ``(7) Medical nutrition therapy services.--Medical 
        nutrition therapy services, as defined in section 1861(vv) of 
        the Social Security Act (42 U.S.C. 1395x(vv)) for the purpose 
        of improving the health of cancer patients and preventing 
        cancer in other beneficiaries.
            ``(8) Genetic tests and genetic services.--
                    ``(A) In general.--Genetic tests and genetic 
                services provided by a licensed health care 
                professional to obtain predictive genetic information 
                about an individual at risk of cancer for purposes of a 
                health assessment, cancer management, cancer 
                prevention, other diagnostic or therapeutic purposes, 
                or genetic education and counseling.
                    ``(B) Definitions.--In this paragraph:
                            ``(i) Family member.--The term `family 
                        member' means with respect to an individual--
                                    ``(I) the spouse of the individual;
                                    ``(II) a dependent child of the 
                                individual, including a child who is 
                                born to or placed for adoption with the 
                                individual; and
                                    ``(III) all other individuals 
                                related by blood to the individual or 
                                the spouse or child described in 
                                subclause (I) or (II).
                            ``(ii) Genetic information.--The term 
                        `genetic information' means information about 
                        genes, gene products, or inherited 
                        characteristics that may derive from an 
                        individual or a family member of such 
                        individual (including information about a 
                        request for or the receipt of genetic services 
                        by such individual or family member of such 
                        individual).
                            ``(iii) Genetic services.--The term 
                        `genetic services' means health services, 
                        including genetic tests, provided to obtain, 
                        assess, or interpret genetic information for 
                        diagnostic and therapeutic purposes, and for 
                        genetic education and counseling.
                            ``(iv) Genetic test.--The term `genetic 
                        test' means the analysis of human DNA, RNA, 
                        chromosomes, proteins, and certain metabolites 
                        in order to detect  genotypes, mutations, or 
chromosomal changes.
                            ``(v) Predictive genetic information.--
                                    ``(I) In general.--The term 
                                `predictive genetic information' 
                                means--
                                            ``(aa) information about an 
                                        individual's genetic tests;
                                            ``(bb) information about 
                                        genetic tests of family members 
                                        of the individual; or
                                            ``(cc) information about 
                                        the occurrence of a disease or 
                                        disorder in family members.
                                    ``(II) Limitations.--The term 
                                `predictive genetic information' shall 
                                not include--
                                            ``(aa) information about 
                                        the sex or age of the 
                                        individual;
                                            ``(bb) information about 
                                        chemical, blood, or urine 
                                        analyses of the individual, 
                                        unless these analyses are 
                                        genetic tests; or
                                            ``(cc) information about 
                                        physical exams of the 
                                        individual, and other 
                                        information relevant to 
                                        determining the current health 
                                        status of the individual.
            ``(9) Other tests and procedures.--Such other tests or 
        procedures for the detection of cancer, and modifications to 
        the tests and procedures, with such frequency, as the Secretary 
        determines to be appropriate, in consultation with appropriate 
        organizations and agencies, for the diagnosis or detection of 
        cancer.
    ``(b) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, may not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(c) Rules of Construction.--
            ``(1) Nothing in this section shall be construed to require 
        an individual who is a participant or beneficiary to undergo a 
        procedure, examination, or test described in subsection (a).
            ``(2) Nothing in this section shall be construed as 
        preventing a group health plan or issuer from imposing 
        deductibles, coinsurance, or other cost-sharing in relation to 
        benefits described in subsection (a) consistent with such 
        subsection, except that such coinsurance or other cost-sharing 
        shall not discriminate on any basis related to the coverage 
        required under this section.
            ``(3) Nothing in this section shall be construed to result 
        in a reduction, diminishment, or change in coverage resulting 
        in less coverage.
    ``(d) Notice Under Group Health Plan.--The imposition of the 
requirement of this section shall be treated as a material modification 
in the terms of the plan described in section 102(a), for purposes of 
assuring notice of such requirements under the plan; except that the 
summary description required to be provided under the last sentence of 
section 104(b)(1) with respect to such modification shall be provided 
by not later than 60 days after the first day of the first plan year in 
which such requirement apply.
    ``(e) Risk Defined.--For purposes of this section, an individual is 
considered to be at `risk' of developing a particular type of cancer 
if, under guidelines developed or recognized by the Secretary based 
upon scientific evidence, the individual--
            ``(1) has 1 or more first degree family members who have 
        developed that type of cancer;
            ``(2) has previously had that type of cancer;
            ``(3) has the presence of an appropriate recognized gene 
        marker that is identified as putting the individual at a higher 
        risk of developing that type of cancer; or
            ``(4) has other predisposing or environmental risk factors 
        that significantly increases the risk of the individual 
        contracting that type of cancer.
For purposes of this subsection, the term `type of cancer' includes 
other types of cancer that the Secretary recognizes as closely related 
for purposes of establishing risk.

``SEC. 716. PATIENT ACCESS TO INFORMATION.

    ``(a) Disclosure Requirement.--A group health plan, and health 
insurance issuer offering group health insurance coverage shall--
            ``(1) provide to participants and beneficiaries at the time 
        of initial coverage under the plan (or the effective date of 
        this section, in the case of individuals who are participants 
        or beneficiaries as of such date), and at least annually 
        thereafter, the information described in subsection (b) in 
        printed form;
            ``(2) provide to participants and beneficiaries, within a 
        reasonable period (as specified by the appropriate Secretary) 
        before or after the date of significant changes in the 
        information described in subsection (b), information in printed 
        form regarding such significant changes; and
            ``(3) upon request, make available to participants and 
        beneficiaries, the applicable authority, and prospective 
        participants and beneficiaries, the information described in 
        subsection (b) in printed form.
    ``(b) Information Provided.--The information described in 
subsection (a) that shall be disclosed includes the following, as such 
relates to cancer screening required under section 715(a):
            ``(1) Benefits.--Benefits offered under the plan or 
        coverage, including--
                    ``(A) covered benefits, including benefit limits 
                and coverage exclusions;
                    ``(B) cost sharing, such as deductibles, 
                coinsurance, and copayment amounts, including any 
                liability for balance billing, any maximum limitations 
                on out of pocket expenses, and the maximum out of 
                pocket costs for services that are provided by 
                nonparticipating providers or that are furnished 
                without meeting the applicable utilization review 
                requirements;
                    ``(C) the extent to which benefits may be obtained 
                from nonparticipating providers; and
                    ``(D) the extent to which a participant, 
                beneficiary, or enrollee may select from among 
                participating providers and the types of providers 
                participating in the plan or issuer network.
            ``(2) Access.--A description of the following:
                    ``(A) The number, mix, and distribution of 
                providers under the plan or coverage.
                    ``(B) Out-of-network coverage (if any) provided by 
                the plan or coverage.
                    ``(C) Any point-of-service option (including any 
                supplemental premium or cost-sharing for such option).
                    ``(D) The procedures for participants, 
                beneficiaries, and enrollees to select, access, and 
                change participating primary and specialty providers.
                    ``(E) The rights and procedures for obtaining 
                referrals (including standing referrals) to 
                participating and nonparticipating providers.
                    ``(F) The name, address, and telephone number of 
                participating health care providers and an indication 
                of whether each such provider is available to accept 
                new patients.
                    ``(G) How the plan or issuer addresses the needs of 
                participants, beneficiaries, and enrollees and others 
                who do not speak English or who have other special 
                communications needs in accessing providers under the 
                plan or coverage, including the provision of 
                information under this subsection.''.
                    (B) Technical amendments.--
                            (i) Section 731(c) of the Employee 
                        Retirement Income Security Act of 1974 (29 
                        U.S.C. 1191(c)) is amended by striking 
                        ``section 711'' and inserting ``sections 711 
                        and 715''.
                            (ii) Section 732(a) of the Employee 
                        Retirement Income Security Act of 1974 (29 
                        U.S.C. 1191a(a)) is amended by striking 
                        ``section 711'' and inserting ``sections 711 
                        and 715''.
                            (iii) The table of contents in section 1 of 
                        the Employee Retirement Income Security Act of 
                        1974, as amended by section 202, is further 
                        amended by inserting after the item relating to 
                        section 714 the following new items:

``Sec. 715. Coverage of cancer screening.
``Sec. 716. Patient access to information.''.
    (b) Individual Health Insurance.--
            (1) In general.--Part B of title XXVII of the Public Health 
        Service Act is amended by inserting after section 2753, as 
        added by section 201(b), the following new section:

``SEC. 2754. STANDARD RELATING PATIENT FREEDOM OF CHOICE.

    ``(a) In General.--The provisions of section 2708 (other than 
subsection (d)) shall apply to health insurance coverage offered by a 
health insurance issuer in the individual market with respect to an 
enrollee under such coverage in the same manner as they apply to health 
insurance coverage offered by a health insurance issuer in connection 
with a group health plan in the small or large group market to a 
participant or beneficiary in such plan.
    ``(b) Notice.--A health insurance issuer under this part shall 
comply with the notice requirement under section 715(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
referred to in subsection (a) as if such section applied to such issuer 
and such issuer were a group health plan.

``SEC. 2755. PATIENT ACCESS TO INFORMATION.

    ``The provisions of section 2709 shall apply health insurance 
coverage offered by a health insurance issuer in the individual market 
with respect to an enrollee under such coverage in the same manner as 
they apply to health insurance coverage offered by a health insurance 
issuer in connection with a group health plan in the small or large 
group market to a participant or beneficiary in such plan.''.
            (2) Technical amendment.--Section 2762(b)(2) of such Act 
        (42 U.S.C. 300gg-62(b)(2)) is amended by striking ``section 
        2751'' and inserting ``sections 2751 and 2754''.
    (c) Effective Dates.--
            (1) Group health plans.--Subject to paragraph (3), the 
        amendments made by subsection (a) shall apply with respect to 
        group health plans for plan years beginning on or after January 
        1, 2002.
            (2) Individual plans.--The amendment made by subsection (b) 
        shall apply with respect to health insurance coverage offered, 
        sold, issued, renewed, in effect, or operated in the individual 
        market on or after such date.
            (3) Collective bargaining agreement.--In the case of a 
        group health plan maintained pursuant to 1 or more collective 
        bargaining agreements between employee representatives and 1 or 
        more employers ratified before the date of enactment of this 
        Act, the amendments made to subsection (a) shall not apply to 
        plan years beginning before the later of--
                    (A) the date on which the last collective 
                bargaining agreements relating to the plan terminates 
                (determined without regard to any extension thereof 
                agreed to after the date of enactment of this Act), or
                    (B) January 1, 2002.
        For purposes of subparagraph (A), any plan amendment made 
        pursuant to a collective bargaining agreement relating to the 
        plan which amends the plan solely to conform to any requirement 
        added by subsection (a) shall not be treated as a termination 
        of such collective bargaining agreement.
    (d) Coordinated Regulations.--Section 104(1) of Health Insurance 
Portability and Accountability Act of 1996 (Public Law 104-191) is 
amended by striking ``this subtitle (and the amendments made by this 
subtitle and section 401)'' and inserting ``the provisions of part 7 of 
subtitle B of title I of the Employee Retirement Income Security Act of 
1974, the provisions of parts A and C of title XXVII of the Public 
Health Service Act, and chapter 100 of the Internal Revenue Code of 
1986''.
    (e) Modification of Coverage.--
            (1) In general.--The Secretary of Health and Human Services 
        may modify the coverage requirements for the amendments under 
        this subtitle to allow such requirements to incorporate and 
        reflect new scientific and technological advances regarding 
        cancer screening, practice pattern changes in such screening, 
        or other updated medical practices regarding such screening, 
        such as the use of new tests or other emerging technologies. 
        Such modifications shall not in any way diminish the coverage 
        requirements listed under this subtitle. Such modifications may 
        be made on the Secretary's own initiative or upon petition to 
        the Secretary by an individual or organization.
            (2) Consultation.--In modifying coverage requirements under 
        paragraph (1), the Secretary of Health and Human Services shall 
        consult with appropriate organizations, experts, and agencies.
            (3) Petitions.--The Secretary of Health and Human Services 
        may issue requirements for the petitioning process under 
        paragraph (1), including requirements that the petition be in 
        writing and include scientific or medical bases for the 
        modification sought. Upon receipt of such a petition, the 
        Secretary shall respond to the petitioner and decide whether to 
        propose a regulation proposing a change within 90 days of such 
        receipt. If a regulation is required, the Secretary shall 
        propose such regulation within 6 months of such determination. 
        The Secretary shall provide the petitioner the reasons for the 
        decision of the Secretary. The Secretary may  make changes 
requested by a petitioner in whole or in part.

               Subtitle C--Physicians and Quality of Care

SEC. 221. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER THE PUBLIC HEALTH SERVICE ACT.

    (a) Group.--Subpart 2 of part A of title XXVII of the Public Health 
Service Act (42 U.S.C. 300gg-4 et seq.), as amended by sections 201 and 
211, is further amended by adding at the end the following:

``SEC. 2710. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``(a) Managing Physician.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall ensure that 
with respect to items or services provided under the plan or coverage 
relating to the treatment of cancer, a lead managing physician be 
designated at the time of diagnosis by the provider and paid a bonus by 
the plan, in consultation with the participant or beneficiary, and 
other providers involved to provide for the overall coordination and 
management of the cancer care of the participant or beneficiary among 
all providers who provide items or services to the participant or 
beneficiary and paid for overall coordination of services.
    ``(b) Quality of Care.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall require that 
all participating health care professionals who provide primary care 
cancer services follow the most current quality-of-care cancer care 
guidelines, as developed by medical professionals with expertise in the 
field of medicine for which the guidelines are designed and widely 
recognized as medically necessary and appropriate.
    ``(c) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(d) Rules of Construction.--Nothing in this section shall be 
construed as preventing a group health plan or issuer from imposing 
deductibles, coinsurance, or other cost-sharing in relation to benefits 
described in subsections (a) or (b) consistent with such subsections, 
except that such coinsurance or other cost-sharing shall not 
discriminate on any basis related to the coverage required under this 
section.
    ``(e) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.''.
    (b) Individual.--Part B of title XXVII of the Public Health Service 
Act is amended by inserting after section 2755, as added by section 
211, the following:

``SEC. 2756. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``The provisions of section 2710 shall apply to health insurance 
coverage offered by a health insurance issuer in the individual market 
in the same manner as such provisions apply to health insurance 
coverage offered by a health insurance issuer in connection with a 
group health plan.''.

SEC. 222. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 
              1974.

    (a) In General.--Subpart B of part 7 of subtitle B of title I of 
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et 
seq.), as amended by sections 202 and 211, is further amended by adding 
at the end the following:

``SEC. 717. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER 
              PATIENTS.

    ``(a) Managing Physician.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall ensure that 
with respect to items or services provided under the plan or coverage 
relating to the treatment of cancer, a lead managing physician be 
designated at the time of diagnosis by the participant or beneficiary 
involved to provide for the overall coordination and management of the 
cancer care of the participant or beneficiary among all providers who 
provide items or services to the participant or beneficiary and paid 
for overall coordination of services.
    ``(b) Quality of Care.--A group health plan, or health insurance 
issuer that is providing health insurance coverage, shall require that 
all participating health care professionals who provide primary care 
cancer services follow the most current quality-of-care cancer care 
guidelines, as developed by medical professionals with expertise in the 
field of medicine for which the guidelines are designed and widely 
recognized as medically necessary and appropriate.
    ``(c) Prohibitions.--A group health plan, and a health insurance 
issuer offering group health insurance coverage in connection with a 
group health plan, shall not--
            ``(1) deny to an individual eligibility, or continued 
        eligibility, to enroll or to renew coverage under the terms of 
        the plan, solely for the purpose of avoiding the requirements 
        of this section;
            ``(2) provide monetary payments or rebates to individuals 
        to encourage such individuals to accept less than the minimum 
        protections available under this section;
            ``(3) penalize or otherwise reduce or limit the 
        reimbursement of a provider because such provider provided care 
        to an individual participant or beneficiary in accordance with 
        this section; or
            ``(4) provide incentives (monetary or otherwise) to a 
        provider to induce such provider to provide care to an 
        individual participant or beneficiary in a manner inconsistent 
        with this section.
    ``(d) Rules of Construction.--Nothing in this section shall be 
construed as preventing a group health plan or issuer from imposing 
deductibles, coinsurance, or other cost-sharing in relation to benefits 
described in subsections (a) or (b) consistent with such subsections, 
except that such coinsurance or other cost-sharing shall not 
discriminate on any basis related to the coverage required under this 
section.
    ``(e) Notice.--A group health plan under this part shall comply 
with the notice requirement under section 714(d) of the Employee 
Retirement Income Security Act of 1974 with respect to the requirements 
of this section as if such section applied to such plan.''.
    (b) Conforming Amendment.--The table of contents in section 1 of 
the Employee Retirement Income Security Act of 1974, as amended by 
sections 202 and 211, is further amended by inserting after the item 
relating to section 716 the following new item:

``Sec. 717. Managing physicians and quality of care for cancer 
                            patients.''.

SEC. 223. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER MEDICARE.

    (a) Application of Cancer Coverage Requirements.--Part B of title 
XVIII of the Social Security Act (42 U.S.C. 1395j et seq.) is amended 
by adding at the end the following:

             ``application of cancer coverage requirements

    ``Sec. 1849. The provisions of sections 2707, 2708, and 2710 of the 
Public Health Service Act shall apply to an individual who has been 
diagnosed with cancer and who is covered under the insurance program 
established under this part.''.
    (b) Additional Payment.--Section 1833(m) of the Social Security Act 
(42 U.S.C. 1395l(m)) is amended--
            (1) by inserting ``(1)'' after ``(m)''; and
            (2) by adding at the end the following new paragraph:
    ``(2) In the case of physicians' services furnished to an 
individual who has been diagnosed with cancer, who is covered under the 
insurance program established under this part who receives care for 
such cancer from a team of physicians, and who incurs expenses for 
physicians' services that are related to that diagnosis, there shall be 
paid to the physician designated by such team of physicians at the time 
of diagnosis of the individual as the physician responsible for the 
overall coordination and management of the medical and other health 
services provided to that individual during the period in which that 
individual is undergoing treatment for such cancer (or to an employer 
or facility in the cases described in clause (A) of section 1842(b)(6)) 
(on a monthly or quarterly basis) from the Federal Supplementary 
Medical Insurance Trust Fund a separate and additional payment amount 
for the services under this part in addition to any amount otherwise 
paid under this part.''.

SEC. 224. MANAGING PHYSICIANS AND QUALITY OF CARE FOR CANCER PATIENTS 
              UNDER MEDICAID AND SCHIP.

    (a) Medicaid.--Section 1902(a) of the Social Security Act (42 
U.S.C. 1396a(a)) is amended--
            (1) in paragraph (64), by striking ``and'' at the end;
            (2) in paragraph (65), by striking the period and inserting 
        ``; and''; and
            (3) by inserting after paragraph (65) the following:
            ``(66) provide--
                    ``(A) that the provisions of sections 2707, 2708, 
                and 2710 of the Public Health Service Act shall apply 
                to individuals eligible for medical assistance under 
                the State plan who have been diagnosed with cancer; and
                    ``(B) that, in the case of an individual who has 
                been diagnosed with cancer, who is eligible for medical 
                assistance under this title, and who receives care for 
                such cancer from a team of physicians, and who incurs 
                expenses for physicians' services that are related to 
                that diagnosis, that there shall be paid to the 
                physician designated by such team of physicians at the 
                time of diagnosis of the individual as the physician 
                responsible for the overall coordination and management 
                of the medical and other health services provided to 
                that individual during the period in which that 
                individual is undergoing treatment for such cancer, a 
                separate and additional payment amount for the services 
                provided in addition to any amount otherwise paid under 
                the State plan.''.
    (b) SCHIP.--Section 2103(f) of the Social Security Act (42 U.S.C. 
1397cc(f)) is amended by adding at the end the following:
            ``(3) Application of cancer coverage provisions.--
                    ``(A) In general.--The provisions of sections 2707, 
                2708, and 2710 of the Public Health Service Act shall 
                apply to the coverage offered under the State child 
                health plan.
                    ``(B) Additional payment.--The State child health 
                plan shall provide in the case of an individual who has 
                been diagnosed with cancer, who is eligible for child 
                health assistance under this title, and who receives 
                care for such cancer from a team of physicians, and who 
                incurs expenses for physicians' services that are 
                related to that diagnosis, that there shall be paid to 
                the physician designated by such team of physicians at 
                the time of diagnosis of the individual as the 
                physician responsible for the overall coordination and 
                management of the medical and other health services 
                provided to that individual during the period in which 
                that individual is undergoing treatment for such 
                cancer, a separate and additional payment amount for 
                the services provided in addition to any amount 
                otherwise paid under the State child health plan.''.

                     Subtitle D--General Provisions

SEC. 231. COVERAGE UNDER OTHER PUBLIC HEALTH INSURANCE.

    (a) In General.--The coverage described in subsection (b) shall be 
provided for any individual, participant, or beneficiary who has 
coverage under--
            (1) the medicaid program under title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.);
            (2) the medicare program under title XVIII of the Social 
        Security Act (42 U.S.C. 1395 et seq.);
            (3) the State Children's Health Insurance Program under 
        title XXI of the Social Security Act (42 U.S.C. 1398 et seq.);
            (4) a health plan offered under chapter 89 of title 5, 
        United States Code;
            (5) programs offered by the Department of Defense;
            (6) a medical care program of the Indian Health Service or 
        of a tribal organization; and
            (7) a health benefit plan under section 5(e) of the Peace 
        Corps Act (22 U.S.C. 2504(e)).
    (b) Coverage Described.--The coverage described in this subsection 
is--
            (1) the coverage described in section 2708 of the Public 
        Health Service Act (as added by section  211) for individuals 
participating in cancer screening activities; and
            (2) the coverage described in section 2710 of the Public 
        Health Service Act (as added by section 201) for individuals 
        receiving cancer-related items or services.
    (c) Application to Other Health Care Coverage.--Chapter 89 of title 
5, United States Code, is amended by adding at the end the following:
``Sec. 8915. Standards relating to coverage of cancer-related 
              activities
    ``(a) The provisions of sections 2707, 2708, 2709, and 2710 of the 
Public Health Service Act shall apply to the provision of items and 
services under this chapter.
    ``(b) Nothing in this section or section 2707, 2708, 2709, or 2710 
of the Public Health Service Act shall be construed as authorizing a 
health insurance issuer or entity to impose cost sharing with respect 
to the coverage or benefits required to be provided under such sections 
that is inconsistent with the cost sharing that is otherwise permitted 
under this chapter.''.

                     TITLE III--TOBACCO REGULATION

SEC. 301. FINDINGS.

    Congress finds the following:
            (1) The use of tobacco products by the Nation's children is 
        a pediatric disease of epic and worsening proportions that 
        results in new generations of tobacco-dependent children and 
        adults.
            (2) A consensus exists within the scientific and medical 
        communities that tobacco products are inherently dangerous and 
        cause cancer, heart disease, and other serious adverse health 
        effects.
            (3) Nicotine is an addictive drug.
            (4) Virtually all new users of tobacco products are under 
        the minimum legal age to purchase such products.
            (5) Tobacco advertising and marketing contribute 
        significantly to the use of nicotine-containing tobacco 
        products by adolescents.
            (6) Because past efforts to restrict advertising and 
        marketing of tobacco products have failed adequately to curb 
        tobacco use by adolescents, comprehensive restrictions on the 
        sale, promotion, and distribution of such products are needed.
            (7) Federal and State Governments have lacked the legal and 
        regulatory authority and resources they need to address 
        comprehensively the public health and societal problems caused 
        by the use of tobacco products.
            (8) Federal and State public health officials, the public 
        health community, and the public at large recognize that the 
        tobacco industry should be subject to ongoing oversight.
            (9) Under article I, section 8 of the Constitution, the 
        Congress is vested with the responsibility for regulating 
        interstate commerce and commerce with Indian tribes.
            (10) The sale, distribution, marketing, advertising, and 
        use of tobacco products are activities in and substantially 
        affecting interstate commerce because they are sold, marketed, 
        advertised, and distributed in interstate commerce on a 
        nationwide basis, and have a substantial effect on the Nation's 
        economy.
            (11) The sale, distribution, marketing, advertising, and 
        use of such products substantially affect interstate commerce 
        through the health care and other costs attributable to the use 
        of tobacco products.
            (12) It is in the public interest to restrict throughout 
        the Nation the sale, distribution, marketing, and advertising 
        of tobacco products only to persons of legal age to purchase 
        such products.
            (13) Public health authorities estimate that the benefits 
        to the Nation of enacting Federal legislation to accomplish 
        these goals would be significant in human and economic terms.
            (14) Reducing the use of tobacco by minors by 50 percent 
        would prevent well over 60,000 early deaths each year and save 
        up to $43 billion each year in reduced medical costs, improved 
        productivity, and the avoidance of premature deaths.
            (15) Advertising, marketing, and promotion of tobacco 
        products have been especially directed to attract young persons 
        to use tobacco products and these efforts have resulted in 
        increased use of such products by youth. Past efforts to 
        oversee these activities have not been successful in adequately 
        preventing such increased use.
            (16) In 1995, the tobacco industry spent close to 
        $8,400,000,000, more than $23,000,000 per day, to attract new 
        users, retain current users, increase current consumption, and 
        generate favorable long-term attitudes toward smoking and 
        tobacco use.
            (17) Tobacco product advertising often misleadingly 
        portrays the use of tobacco as socially acceptable and 
        healthful to minors.
            (18) Tobacco product advertising is regularly seen by 
        persons under the age of 18, and persons under the age of 18 
        are regularly exposed to tobacco product promotional efforts.
            (19) Through advertisements during and sponsorship of 
        sporting events, tobacco has become strongly associated with 
        sports and has become portrayed as an integral part of sports 
        and the healthy lifestyle associated with rigorous sporting 
        activity.
            (20) Children are exposed to substantial and unavoidable 
        tobacco advertising that leads to favorable beliefs about 
        tobacco use, plays a role in leading young people to 
        overestimate the prevalence of tobacco use, and increases the 
        number of young people who begin to use tobacco.
            (21) Tobacco advertising increases the size of the tobacco 
        market by increasing consumption of tobacco products including 
        increasing tobacco use by young people.
            (22) Children are more influenced by tobacco advertising 
        than adults, they smoke the most advertised brands.
            (23) Tobacco company documents indicate that young people 
        are an important and often crucial segment of the tobacco 
        market.
            (24) Comprehensive advertising restrictions will have a 
        positive effect on the smoking rates of young people.
            (25) Restrictions on advertising are necessary to prevent 
        unrestricted tobacco advertising from undermining legislation 
        prohibiting access to young people and providing for education 
        about tobacco use.
            (26) International experience shows that advertising 
        regulations that are stringent and comprehensive have a greater 
        impact on overall tobacco use and young people's use than 
        weaker or less comprehensive ones. Text-only requirements, 
        while not as stringent as a ban, will help reduce underage use 
        of tobacco products while preserving the informational function 
        of advertising.
            (27) It is in the public interest for Congress to adopt 
        legislation to address the public health crisis created by 
        actions of the tobacco industry.
            (28) The use of tobacco products in motion pictures and 
        other mass media glamorizes its use for young people and 
        encourages them to use tobacco products.

SEC. 302. PURPOSE.

    The purposes of this title are--
            (1) to clarify the authority of the Food and Drug 
        Administration to regulate tobacco products under the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by 
        recognizing it as the primary Federal regulatory authority with 
        respect to the manufacture, marketing, and distribution of 
        tobacco products;
            (2) to ensure that the Food and Drug Administration and the 
        States may continue to address issues of particular concern to 
        public health officials, especially the use of tobacco by young 
        people and dependence on tobacco;
            (3) to impose financial surcharges on tobacco product 
        manufacturers if tobacco use by young people does not 
        substantially decline;
            (4) to authorize appropriate agencies of the Federal 
        government to set national standards controlling the 
        manufacture of tobacco products and the identity, public 
        disclosure, and amount of ingredients used in such products;
            (5) to provide new and flexible enforcement authority to 
        ensure that the tobacco industry makes efforts to develop and 
        introduce less harmful tobacco products;
            (6) to confirm the Food and Drug Administration's authority 
        to regulate the levels of tar, nicotine, and other harmful 
        components of tobacco products;
            (7) in order to ensure that adults are better informed, to 
        require tobacco product manufacturers to disclose research 
        which has not previously been made available, as well as 
        research generated in the future, relating to the health and 
        dependency effects or safety of tobacco products;
            (8) to continue to permit the sale of tobacco products to 
        adults in conjunction with measures to ensure that they are not 
        sold or accessible to underage purchasers; and
            (9) to impose appropriate regulatory controls on the 
        tobacco industry.

SEC. 303. SCOPE AND EFFECT.

    (a) Intended Effect.--This title is not intended to--
            (1) establish a precedent with regard to any other 
        industry, situation, circumstance, or legal action; or
            (2) except as provided in this title, affect any action 
        pending in State, Tribal, or Federal court, or any agreement, 
        consent decree, or contract of any kind.
    (b) Taxation.--Notwithstanding any other provision of law, this 
title and the amendments made by this title shall not affect any 
authority of the Secretary of the Treasury (including any authority 
assigned to the Bureau of Alcohol, Tobacco and Firearms) or of State or 
local governments with regard to taxation for tobacco or tobacco 
products.
    (c) Agricultural Activities.--The provisions of this title which 
authorize the Secretary to take certain actions with regard to tobacco 
and tobacco products shall not be construed to affect any authority of 
the Secretary of Agriculture under existing law regarding the growing, 
cultivation, or curing of raw tobacco.

SEC. 304. RELATIONSHIP TO OTHER, RELATED FEDERAL, STATE, LOCAL, AND 
              TRIBAL LAWS.

    (a) Age Restrictions.--Nothing in this title or the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), as amended by this 
title, shall prevent a Federal agency (including the Armed Forces), a 
State or its political subdivisions, or the government of an Indian 
tribe from adopting and enforcing additional measures that further 
restrict or prohibit tobacco product sale to, use by, and accessibility 
to persons under the legal age of purchase established by such agency, 
State, subdivision, or government of an Indian tribe.
    (b) Additional Measures.--Except as otherwise expressly provided in 
this title, nothing in this title, the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.), or rules promulgated under such title or 
Act, shall limit the authority of a Federal agency (including the Armed 
Forces), a State or its political subdivisions, or the government of an 
Indian tribe to enact, adopt, promulgate, and enforce any law, rule, 
regulation, or other measure with respect to tobacco products, 
including laws, rules, regulations, or other measures relating to or 
prohibiting the sale, distribution, possession, exposure to, or use of 
tobacco products by persons of any age that are in addition to the 
provisions of this title and the amendments made by this title. No 
provision of this title or amendment made by this title shall limit or 
otherwise affect any State, Tribal, or local taxation of tobacco 
products.
    (c) No Less Stringent.--Nothing in this title or the amendments 
made by this title is intended to supersede any State, local, or Tribal 
law that is not less stringent than this title, or other Acts as 
amended by this title.
    (d) State Law Not Affected.--Except as otherwise expressly provided 
in this title, nothing in this title, the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), or rules promulgated under such 
title or Act, shall supersede the authority of the States, pursuant to 
State law, to expend funds provided by this title.

SEC. 305. DEFINITIONS.

    In this title:
            (1) Brand.--The term ``brand'' means a variety of tobacco 
        product distinguished by the tobacco used, tar content, 
        nicotine content, flavoring used, size, filtration, or 
        packaging, logo, registered trademark or brand name, 
        identifiable pattern of colors, or any combination of such 
        attributes.
            (2) Cigarette.--The term ``cigarette'' has the meaning 
        given that term by section 3(1) of the Federal Cigarette 
        Labeling and Advertising Act (15 U.S.C. 1332(1)), but also 
        includes tobacco, in any form, that is functional in the 
        product, which, because of its appearance, the type of tobacco 
        used in the filler, or its packaging and labeling, is likely to 
        be offered to, or purchased by, consumers as a cigarette or as 
        roll-your-own tobacco.
            (3) Cigarette tobacco.--The term ``cigarette tobacco'' 
        means any product that consists of loose tobacco that is 
        intended for use by consumers in a cigarette. Unless otherwise 
        stated, the requirements for cigarettes shall also apply to 
        cigarette tobacco.
            (4) Commerce.--The term ``commerce'' has the meaning given 
        that term by section 3(2) of the Federal Cigarette Labeling and 
        Advertising Act (15 U.S.C. 1332(2)).
            (5) Distributor.--The term ``distributor'' as regards a 
        tobacco product means any person who furthers the distribution 
        of cigarette or smokeless tobacco, whether domestic or 
        imported, at any point from the original place of manufacture 
        to the person who sells or distributes the product to 
        individuals for personal consumption. Common carriers are not 
        considered distributors for purposes of this title.
            (6) Indian country; indian lands.--The terms ``Indian 
        country'' and ``Indian lands'' have the meaning given the term 
        ``Indian country'' by section 1151 of title 18, United States 
        Code, and includes lands owned by an Indian tribe or a member 
        thereof over which the United States exercises jurisdiction on 
        behalf of the tribe or tribal member.
            (7) Indian tribe.--The term ``Indian tribe'' has the 
        meaning given such term in section 4(e) of the Indian Self 
        Determination and Education Assistance Act (25 U.S.C. 450b(e)).
            (8) Little cigar.--The term ``little cigar'' has the 
        meaning given that term by section 3(7) of the Federal 
        Cigarette Labeling and Advertising Act (15 U.S.C. 1332(7)).
            (9) Nicotine.--The term ``nicotine'' means the chemical 
        substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or 
        C[10]H[14]N[2], including any salt or complex of nicotine.
            (10) Package.--The term ``package'' means a pack, box, 
        carton, or container of any kind or, if no other container, any 
        wrapping (including cellophane), in which cigarettes or 
        smokeless tobacco are offered for sale, sold, or otherwise 
        distributed to consumers.
            (11) Point-of-sale.--The term ``point-of-sale'' means any 
        location at which a consumer can purchase or otherwise obtain 
        cigarettes or smokeless tobacco for personal consumption.
            (12) Retailer.--The term ``retailer'' means any person who 
        sells cigarettes or smokeless tobacco to individuals for 
        personal consumption, or who operates a facility where self-
        service displays of tobacco products are permitted.
            (13) Roll-your-own tobacco.--The term ``roll-your-own 
        tobacco'' means any tobacco which, because of its appearance, 
        type, packaging, or labeling, is suitable for use and likely to 
        be offered to, or purchased by, consumers as tobacco for making 
        cigarettes.
            (14) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (15) Smokeless tobacco.--The term ``smokeless tobacco'' 
        means any product that consists of cut, ground, powdered, or 
        leaf tobacco and that is intended to be placed in the oral or 
        nasal cavity.
            (16) State.--The term ``State'' means any State of the 
        United States and, for purposes of this Act, includes the 
        District of Columbia, the Commonwealth of Puerto Rico, Guam, 
        the Virgin Islands, American Samoa, Wake Island, Midway 
        Islands, Kingman Reef, Johnston Atoll, the Northern Mariana 
        Islands, and any other trust territory or possession of the 
        United States.
            (17) Tobacco product.--The term ``tobacco product'' means 
        cigarettes, cigarette tobacco, smokeless tobacco, little 
        cigars, roll-your-own tobacco, and fine cut products.
            (18) Tobacco product manufacturer.--The term ``tobacco 
        product manufacturer'' means any person, including any repacker 
        or relabeler, who--
                    (A) manufactures, fabricates, assembles, processes, 
                or labels a finished cigarette or smokeless tobacco 
                product; or
                    (B) imports a finished cigarette or smokeless 
                tobacco product for sale or distribution in the United 
                States.
            (19) United states.--The term ``United States'' means the 
        50 States of the United States of America and the District of 
        Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin 
        Islands, American Samoa, Wake Island, Midway Islands, Kingman 
        Reef, Johnston Atoll, the Northern Mariana Islands, and any 
        other trust territory or possession of the United States.

SEC. 306. FTC JURISDICTION NOT AFFECTED.

    (a) In General.--Except where expressly provided in this title, 
nothing in this title shall be construed as limiting or diminishing the 
authority of the Federal Trade Commission to enforce the laws under its 
jurisdiction with respect to the advertising, sale, or distribution of 
tobacco products.
    (b) Enforcement by FTC.--Any advertising that violates this title 
or part 897 of title 21, Code of Federal Regulations, is an unfair or 
deceptive act or practice under section 5(a) of the Federal Trade 
Commission Act (15 U.S.C. 45(a)) and shall be considered a violation of 
a rule promulgated under section 18 of that Act (15 U.S.C. 57a).

SEC. 307. CONGRESSIONAL REVIEW PROVISIONS.

    In accordance with section 801 of title 5, United States Code, the 
Congress shall review, and may disapprove, any rule under this title 
that is subject to section 801. This section does not apply to the rule 
set forth in part 897 of title 21, Code of Federal Regulations.

              TITLE IV--REGULATION OF THE TOBACCO INDUSTRY

SEC. 401. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT OF 1938.

    (a) Definition of Tobacco Products.--Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at 
the end the following:
            ``(kk) The term `tobacco product' means any product made or 
        derived from tobacco that is intended for human consumption, 
        including any component, part, or accessory of a tobacco 
        product (except for raw materials other than tobacco used in 
        manufacturing a component, part, or accessory of a tobacco 
        product).''.
    (b) FDA Authority Over Tobacco Products.--The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
            (1) by redesignating chapter IX as chapter X;
            (2) by redesignating sections 901 through 907 as sections 
        1001 through 1007; and
            (3) by inserting after section 803 the following:

                     ``CHAPTER IX--TOBACCO PRODUCTS

``SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

     ``(a) In General.--Tobacco products shall be regulated by the 
Secretary under this chapter and shall not be subject to the provisions 
of chapter V, unless--
            ``(1) such products are intended for use in the diagnosis, 
        cure, mitigation, treatment, or prevention of disease (within 
        the meaning of section 201(g)(1)(B) or section 201(h)(2)); or
            ``(2) a health claim is made for such products under 
        section 201(g)(1)(C) or 201(h)(3).
    ``(b) Applicability.--This chapter shall apply to all tobacco 
products subject to the provisions of part 897 of title 21, Code of 
Federal Regulations, and to any other tobacco products that the 
Secretary by regulation deems to be subject to this chapter.
    ``(c) Scope.--
            ``(1) Nothing in this chapter, any policy issued or 
        regulation promulgated thereunder, or the National Tobacco 
        Policy and Youth Smoking Reduction Act, shall be construed to 
        affect the Secretary's authority over, or the regulation of, 
        products under this Act that are not tobacco products under 
        chapter V of the Federal Food, Drug and Cosmetic Act or any 
        other chapter of that Act.
            ``(2) The provisions of this chapter shall not apply to 
        tobacco leaf that is not in the possession of the manufacturer, 
        or to the producers of tobacco leaf, including tobacco growers, 
        tobacco warehouses, and tobacco grower cooperatives, nor shall 
        any employee of the Food and Drug Administration have any 
        authority whatsoever to enter onto a farm owned by a producer 
        of tobacco leaf without the written consent of such producer. 
        Notwithstanding any other provision of this subparagraph, if a 
        producer of tobacco leaf is also a tobacco product manufacturer 
        or controlled by a tobacco product manufacturer, the producer 
        shall be subject to this chapter in the producer's capacity as 
        a manufacturer. Nothing in this chapter shall be construed to 
        grant the Secretary authority to promulgate regulations on any 
        matter that involves the production of tobacco leaf or a 
        producer thereof, other than activities by a manufacturer 
        affecting production. For purposes of the preceding sentence, 
        the term `controlled by' means a member of the same controlled 
        group of corporations as that term is used in section 52(a) of 
        the Internal Revenue Code of 1986, or under common control 
        within the meaning of the regulations promulgated under section 
        52(b) of such Code.

``SEC. 902. ADULTERATED TOBACCO PRODUCTS.

    ``A tobacco product shall be deemed to be adulterated if--
            ``(1) it consists in whole or in part of any filthy, 
        putrid, or decomposed substance, or is otherwise contaminated 
        by any poisonous or deleterious substance that may render the 
        product injurious to health;
            ``(2) it has been prepared, packed, or held under 
        insanitary conditions whereby it may have been contaminated 
        with filth, or whereby it may have been rendered injurious to 
        health;
            ``(3) its container is composed, in whole or in part, of 
        any poisonous or deleterious substance which may render the 
        contents injurious to health;
            ``(4) it is, or purports to be or is represented as, a 
        tobacco product which is subject to a performance standard 
        established under section 907 unless such tobacco product is in 
        all respects in conformity with such standard;
            ``(5) it is required by section 910(a) to have premarket 
        approval, is not exempt under section 906(f), and does not have 
        an approved application in effect;
            ``(6) the methods used in, or the facilities or controls 
        used for, its manufacture, packing or storage are not in 
        conformity with applicable requirements under section 906(e)(1) 
        or an applicable condition prescribed by an order under section 
        906(e)(2); or
            ``(7) it is a tobacco product for which an exemption has 
        been granted under section 906(f) for investigational use and 
        the person who was granted such exemption or any investigator 
        who uses such tobacco product under such exemption fails to 
        comply with a requirement prescribed by or under such section.

``SEC. 903. MISBRANDED TOBACCO PRODUCTS.

    ``(a) In General.--A tobacco product shall be deemed to be 
misbranded--
            ``(1) if its labeling is false or misleading in any 
        particular;
            ``(2) if in package form unless it bears a label 
        containing--
                    ``(A) the name and place of business of the tobacco 
                product manufacturer, packer, or distributor; and
                    ``(B) an accurate statement of the quantity of the 
                contents in terms of weight, measure, or numerical 
                count,
        except that under subparagraph (B) of this paragraph reasonable 
        variations shall be permitted, and exemptions as to small 
        packages shall be established, by regulations prescribed by the 
        Secretary;
            ``(3) if any word, statement, or other information required 
        by or under authority of this chapter to appear on the label or 
        labeling is not prominently placed thereon with such 
        conspicuousness (as compared with other words, statements or 
        designs in the labeling) and in such terms as to render it 
        likely to be read and understood by the ordinary individual 
        under customary conditions of purchase and use;
            ``(4) if it has an established name, unless its label 
        bears, to the exclusion of any other nonproprietary name, its 
        established name prominently printed in type as required by the 
        Secretary by regulation;
            ``(5) if the Secretary has issued regulations requiring 
        that its labeling bear adequate directions for use, or adequate 
        warnings against use by children, that are necessary for the 
        protection of users unless its labeling conforms in all 
        respects to such regulations;
            ``(6) if it was manufactured, prepared, propagated, 
        compounded, or processed in any State in an establishment not 
        duly registered under section 905(b), if it was not included in 
        a list required by section 905(i), if a notice or other 
        information respecting it was not provided as required by such 
        section or section 905(j), or if it does not bear such symbols 
        from the uniform system for identification of tobacco products 
        prescribed under section 905(e) as the Secretary by regulation 
        requires;
            ``(7) if, in the case of any tobacco product distributed or 
        offered for sale in any State--
                    ``(A) its advertising is false or misleading in any 
                particular; or
                    ``(B) it is sold, distributed, or used in violation 
                of regulations prescribed under section 906(d);
            ``(8) unless, in the case of any tobacco product 
        distributed or offered for sale in any State, the manufacturer, 
        packer, or distributor thereof includes in all advertisements 
        and other descriptive printed matter issued or caused to be 
        issued by the manufacturer, packer, or distributor with respect 
        to that tobacco product--
                    ``(A) a true statement of the tobacco product's 
                established name as defined in paragraph (4) of this 
                subsection, printed prominently; and
                    ``(B) a brief statement of--
                            ``(i) the uses of the tobacco product and 
                        relevant warnings, precautions, side effects, 
                        and contraindications; and
                            ``(ii) in the case of specific tobacco 
                        products made subject to a finding by the 
                        Secretary after notice and opportunity for 
                        comment that such action is necessary to 
                        protect the public health, a full description 
                        of the components of such tobacco product or 
                        the formula showing quantitatively each 
                        ingredient of such tobacco product to the 
                        extent required in regulations which shall be 
                        issued by the Secretary after an opportunity 
                        for a hearing;
            ``(9) if it is a tobacco product subject to a performance 
        standard established under section 907, unless it bears such 
        labeling as may be prescribed in such performance standard; or
            ``(10) if there was a failure or refusal--
                    ``(A) to comply with any requirement prescribed 
                under section 904 or 908;
                    ``(B) to furnish any material or information 
                required by or under section 909; or
                    ``(C) to comply with a requirement under section 
                912.
    ``(b) Prior Approval of Statements on Label.--The Secretary may, by 
regulation, require prior approval of statements made on the label of a 
tobacco product. No regulation issued under this subsection may require 
prior approval by the Secretary of the content of any advertisement and 
no advertisement of a tobacco product, published after the date of 
enactment of the National Tobacco Policy and Youth Smoking Reduction 
Act shall, with respect to the matters specified in this section or 
covered by regulations issued hereunder, be subject to the provisions 
of sections 12 through 15 of the Federal Trade Commission Act (15 
U.S.C. 52 through 55). This subsection does not apply to any printed 
matter which the Secretary determines to be labeling as defined in 
section 201(m).

``SEC. 904. SUBMISSION OF HEALTH INFORMATION TO THE SECRETARY.

    ``(a) Requirement.--Not later than 6 months after the date of 
enactment of the National Tobacco Policy and Youth Smoking Reduction 
Act, each tobacco product manufacturer or importer of tobacco products, 
or agents thereof, shall submit to the Secretary the following 
information:
            ``(1) A listing of all tobacco ingredients, substances and 
        compounds that are, on such date, added by the manufacturer to 
        the tobacco, paper, filter, or other component of each tobacco 
        product by brand and by quantity in each brand and subbrand.
            ``(2) A description of the content, delivery, and form of 
        nicotine in each tobacco product measured in milligrams of 
        nicotine.
            ``(3) All documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) on the health, behavioral, or 
        physiologic effects of tobacco products, their constituents, 
        ingredients, and components, and tobacco additives, described 
        in paragraph (1).
            ``(4) All documents (including underlying scientific 
        information) relating to research activities, and research 
        findings, conducted, supported, or possessed by the 
        manufacturer (or agents thereof) that relate to the issue of 
        whether a reduction in risk to health from tobacco products can 
        occur upon the employment of technology available or known to 
        the manufacturer.
            ``(5) All documents (including underlying scientific 
        information) relating to marketing research involving the use 
        of tobacco products.
An importer of a tobacco product not manufactured in the United States 
shall supply the information required of a tobacco product manufacturer 
under this subsection.
    ``(b) Annual Submission.--A tobacco product manufacturer or 
importer that is required to submit information under subsection (a) 
shall update such information on an annual basis under a schedule 
determined by the Secretary.
    ``(c) Time for Submission.--
            ``(1) New products.--At least 90 days prior to the delivery 
        for introduction into interstate commerce of a tobacco product 
        not on the market on the date of enactment of this chapter, the 
        manufacturer of such product shall provide the information 
        required under subsection (a) and such product shall be subject 
        to the annual submission under subsection (b).
            ``(2) Modification of existing products.--If at any time a 
        tobacco product manufacturer adds to its tobacco products a new 
        tobacco additive, increases or decreases the quantity of an 
        existing tobacco additive or the nicotine content, delivery, or 
        form, or eliminates a tobacco additive from any tobacco 
        product, the manufacturer shall within 60 days of such action 
        so advise the Secretary in writing and reference such 
        modification in submissions made under subsection (b).

``SEC. 905. ANNUAL REGISTRATION.

    ``(a) Definitions.--As used in this section--
            ``(1) the term `manufacture, preparation, compounding, or 
        processing' shall include repackaging or otherwise changing the 
        container, wrapper, or labeling of any tobacco product package 
        in furtherance of the distribution of the tobacco product from 
        the original place of manufacture to the person who makes final 
        delivery or sale to the ultimate consumer or user; and
            ``(2) the term `name' shall include in the case of a 
        partnership the name of each partner and, in the case of a 
        corporation, the name of each corporate officer and director, 
        and the State of incorporation.
    ``(b) Registration by Owners and Operators.--On or before December 
31 of each year every person who owns or operates any establishment in 
any State engaged in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products shall register with 
the Secretary the name, places of business, and all such establishments 
of that person.
    ``(c) Registration of New Owners and Operators.--Every person upon 
first engaging in the manufacture, preparation, compounding, or 
processing of a tobacco product or tobacco products in any 
establishment owned or operated in any State by that person shall 
immediately register with the Secretary that person's name, place of 
business, and such establishment.
    ``(d) Registration of Added Establishments.--Every person required 
to register under subsection (b) or (c) shall immediately register with 
the Secretary any additional establishment which that person owns or 
operates in any State and in which that person begins the manufacture, 
preparation, compounding, or processing of a tobacco product or tobacco 
products.
    ``(e) Uniform Product Identification System.--The Secretary may by 
regulation prescribe a uniform system for the identification of tobacco 
products and may require that persons who are required to list such 
tobacco products under subsection (i) of this section shall list such 
tobacco products in accordance with such system.
    ``(f) Public Access to Registration Information.--The Secretary 
shall make available for inspection, to any person so requesting, any 
registration filed under this section.
    ``(g) Biennial Inspection of Registered Establishments.--Every 
establishment in any State registered with the Secretary under this 
section shall be subject to inspection under section 704, and every 
such establishment engaged in the manufacture, compounding, or 
processing of a tobacco product or tobacco products shall be so 
inspected by one or more officers or employees duly designated by the 
Secretary at least once in the 2-year period beginning with the date of 
registration of such establishment under this section and at least once 
in every successive 2-year period thereafter.
    ``(h) Foreign Establishments May Register.--Any establishment 
within any foreign country engaged in the manufacture, preparation, 
compounding, or processing of a tobacco product or tobacco products, 
may register under this section under regulations promulgated by the 
Secretary. Such regulations shall require such establishment to provide 
the information required by subsection (i) of this section and shall 
include provisions for registration of any such establishment upon 
condition that adequate and effective means are available, by 
arrangement with the government of such foreign country or otherwise, 
to enable the Secretary to determine from time to time whether tobacco 
products manufactured, prepared, compounded, or processed in such 
establishment, if imported or offered for import into the United 
States, shall be refused admission on any of the grounds set forth in 
section 801(a).
    ``(i) Registration Information.--
            ``(1) Product list.--Every person who registers with the 
        Secretary under subsection (b), (c), or (d) of this section 
        shall, at the time of registration under any such subsection, 
        file with the Secretary a list of all tobacco products which 
        are being manufactured, prepared, compounded, or processed by 
        that person for commercial distribution and which has not been 
        included in any list of tobacco products filed by that person 
        with the Secretary under this paragraph or paragraph (2) before 
        such time of registration. Such list shall be prepared in such 
        form and manner as the Secretary may prescribe and shall be 
        accompanied by--
                    ``(A) in the case of a tobacco product contained in 
                the applicable list with respect to which a performance 
                standard has been established under section 907 or 
                which is subject to section 910, a reference to the 
                authority for the marketing of such tobacco product and 
                a copy of all labeling for such tobacco product;
                    ``(B) in the case of any other tobacco product 
                contained in an applicable list, a copy of all consumer 
                information and other labeling for such tobacco 
                product, a representative sampling of advertisements 
                for such tobacco product, and, upon request made by the 
                Secretary for good cause, a copy of all advertisements 
                for a particular tobacco product; and
                    ``(C) if the registrant filing a list has 
                determined that a tobacco product contained in such 
                list is not subject to a performance standard 
                established under section 907, a brief statement of the 
                basis upon which the registrant made such determination 
                if the Secretary requests such a statement with respect 
                to that particular tobacco product.
            ``(2) Biannual report of any change in product list.--Each 
        person who registers with the Secretary under this section 
        shall report to the Secretary once during the month of June of 
        each year and once during the month of December of each year 
the following:
                    ``(A) A list of each tobacco product introduced by 
                the registrant for commercial distribution which has 
                not been included in any list previously filed by that 
                person with the Secretary under this subparagraph or 
                paragraph (1) of this subsection. A list under this 
                subparagraph shall list a tobacco product by its 
                established name and shall be accompanied by the other 
                information required by paragraph (1).
                    ``(B) If since the date the registrant last made a 
                report under this paragraph that person has 
                discontinued the manufacture, preparation, compounding, 
                or processing for commercial distribution of a tobacco 
                product included in a list filed under subparagraph (A) 
                or paragraph (1), notice of such discontinuance, the 
                date of such discontinuance, and the identity of its 
                established name.
                    ``(C) If since the date the registrant reported 
                under subparagraph (B) a notice of discontinuance that 
                person has resumed the manufacture, preparation, 
                compounding, or processing for commercial distribution 
                of the tobacco product with respect to which such 
                notice of discontinuance was reported, notice of such 
                resumption, the date of such resumption, the identity 
                of such tobacco product by established name, and other 
                information required by paragraph (1), unless the 
                registrant has previously reported such resumption to 
                the Secretary under this subparagraph.
                    ``(D) Any material change in any information 
                previously submitted under this paragraph or paragraph 
                (1).
    ``(j) Report Preceding Introduction of Certain Substantially-
Equivalent Products Into Interstate Commerce.--
            ``(1) In general.--Each person who is required to register 
        under this section and who proposes to begin the introduction 
        or delivery for introduction into interstate commerce for 
        commercial distribution of a tobacco product intended for human 
        use that was not commercially marketed (other than for test 
        marketing) in the United States as of August 11, 1995, as 
        defined by the Secretary by regulation shall, at least 90 days 
        before making such introduction or delivery, report to the 
        Secretary (in such form and manner as the Secretary shall by 
        regulation prescribe)--
                    ``(A) the basis for such person's determination 
                that the tobacco product is substantially equivalent, 
                within the meaning of section 910, to a tobacco product 
                commercially marketed (other than for test marketing) 
                in the United States as of August 11, 1995, that is in 
                compliance with the requirements of this Act; and
                    ``(B) action taken by such person to comply with 
                the requirements under section 907 that are applicable 
                to the tobacco product.
            ``(2) Application to certain post-august 11th products.--A 
        report under this subsection for a tobacco product that was 
        first introduced or delivered for introduction into interstate 
        commerce for commercial distribution in the United States after 
        August 11, 1995, and before the date of enactment of the 
        National Tobacco Policy and Youth Smoking Reduction Act shall 
        be submitted to the Secretary within 6 months after the date of 
        enactment of that Act.

``SEC. 906. GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS.

    ``(a) In General.--Any requirement established by or under section 
902, 903, 905, or 909 applicable to a tobacco product shall apply to 
such tobacco product until the applicability of the requirement to the 
tobacco product has been changed by action taken under section 907, 
section 910, or subsection (d) of this section, and any requirement 
established by or under section 902, 903, 905, or 909 which is 
inconsistent with a requirement imposed on such tobacco product under 
section 907, section 910, or subsection (d) of this section shall not 
apply to such tobacco product.
    ``(b) Information on Public Access and Comment.--Each notice of 
proposed rulemaking under section 907, 908, 909, or 910, or under this 
section, any other notice which is published in the Federal Register 
with respect to any other action taken under any such section and which 
states the reasons for such action, and each publication of findings 
required to be made in connection with rulemaking under any such 
section shall set forth--
            ``(1) the manner in which interested persons may examine 
        data and other information on which the notice or findings is 
        based; and
            ``(2) the period within which interested persons may 
        present their comments on the notice or findings (including the 
        need therefor) orally or in writing, which period shall be at 
        least 60 days but may not exceed 90 days unless the time is 
        extended by the Secretary by a notice published in the Federal 
        Register stating good cause therefor.
    ``(c) Limited Confidentiality of Information.--Any information 
reported to or otherwise obtained by the Secretary or the Secretary's 
representative under section 904, 907, 908, 909, or 910 or 704, or 
under subsection (e) or (f) of this section, which is exempt from 
disclosure under subsection (a) of section 552 of title 5, United 
States Code, by reason of subsection (b)(4) of that section shall be 
considered confidential and shall not be disclosed, except that the 
information may be disclosed to other officers or employees concerned 
with carrying out this chapter, or when relevant in any proceeding 
under this chapter.
    ``(d) Restrictions.--
            ``(1) The Secretary may by regulation require that a 
        tobacco product be restricted to sale, distribution, or use 
        upon such conditions, including restrictions on the access to, 
        and the advertising and promotion of, the tobacco product, as 
        the Secretary may prescribe in such regulation if, because of 
        its potentiality for harmful effect or the collateral 
measures necessary to its use, the Secretary determines that such 
regulation would be appropriate for the protection of the public 
health. The finding as to whether such regulation would be appropriate 
for the protection of the public health shall be determined with 
respect to the risks and benefits to the population as a whole, 
including users and non-users of the tobacco product, and taking into 
account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
        No such condition may require that the sale or distribution of 
        a tobacco product be limited to the written or oral 
        authorization of a practitioner licensed by law to prescribe 
        medical products.
            ``(2) The label of a tobacco product shall bear such 
        appropriate statements of the restrictions required by a 
        regulation under subsection (a) as the Secretary may in such 
        regulation prescribe.
            ``(3) No restriction under paragraph (1) may prohibit the 
        sale of any tobacco product in face-to-face transactions by a 
        specific category of retail outlets.
    ``(e) Good Manufacturing Practice Requirements.--
            ``(1) Methods, facilities, and controls to conform.--
                    ``(A) The Secretary may, in accordance with 
                subparagraph (B), prescribe regulations requiring that 
                the methods used in, and the facilities and controls 
                used for, the manufacture, pre-production design 
                validation (including a process to assess the 
                performance of a tobacco product), packing and storage 
                of a tobacco product, conform to current good 
                manufacturing practice, as prescribed in such 
                regulations, to assure that the public health is 
                protected and that the tobacco product is in compliance 
                with this chapter.
                    ``(B) The Secretary shall--
                            ``(i) before promulgating any regulation 
                        under subparagraph (A), afford an advisory 
                        committee an opportunity to submit 
                        recommendations with respect to the regulation 
                        proposed to be promulgated;
                            ``(ii) before promulgating any regulation 
                        under subparagraph (A), afford opportunity for 
                        an oral hearing;
                            ``(iii) provide the advisory committee a 
                        reasonable time to make its recommendation with 
                        respect to proposed regulations under 
                        subparagraph (A); and
                            ``(iv) in establishing the effective date 
                        of a regulation promulgated under this 
                        subsection, take into account the differences 
                        in the manner in which the different types of 
                        tobacco products have historically been 
                        produced, the financial resources of the 
                        different tobacco product manufacturers, and 
                        the state of their existing manufacturing 
                        facilities; and shall provide for a reasonable 
                        period of time for such manufacturers to 
                        conform to good manufacturing practices.
            ``(2) Exemptions; variances.--
                    ``(A) Any person subject to any requirement 
                prescribed under paragraph (1) may petition the 
                Secretary for a permanent or temporary exemption or 
                variance from such requirement. Such a petition shall 
                be submitted to the Secretary in such form and manner 
                as the Secretary shall prescribe and shall--
                            ``(i) in the case of a petition for an 
                        exemption from a requirement, set forth the 
                        basis for the petitioner's determination that 
                        compliance with the requirement is not required 
                        to assure that the tobacco product will be in 
                        compliance with this chapter;
                            ``(ii) in the case of a petition for a 
                        variance from a requirement, set forth the 
                        methods proposed to be used in, and the 
                        facilities and controls proposed to be used 
                        for, the manufacture, packing, and storage of 
                        the tobacco product in lieu of the methods, 
                        facilities, and controls prescribed by the 
                        requirement; and
                            ``(iii) contain such other information as 
                        the Secretary shall prescribe.
                    ``(B) The Secretary may refer to an advisory 
                committee any petition submitted under subparagraph 
                (A). The advisory committee shall report its 
                recommendations to the Secretary with respect to a 
                petition referred to it within 60 days after the date 
                of the petition's referral. Within 60 days after--
                            ``(i) the date the petition was submitted 
                        to the Secretary under subparagraph (A); or
                            ``(ii) the day after the petition was 
                        referred to an advisory committee,
                whichever occurs later, the Secretary shall by order 
                either deny the petition or approve it.
                    ``(C) The Secretary may approve--
                            ``(i) a petition for an exemption for a 
                        tobacco product from a requirement if the 
                        Secretary determines that compliance with such 
                        requirement is not required to assure that the 
                        tobacco product will be in compliance with this 
                        chapter; and
                            ``(ii) a petition for a variance for a 
                        tobacco product from a requirement if the 
                        Secretary determines that the methods to be 
                        used in, and the facilities and controls to be 
                        used for, the manufacture, packing, and storage 
                        of the tobacco product in lieu of the methods, 
                        controls, and facilities prescribed by the 
                        requirement are sufficient to assure that the 
                        tobacco product will be in compliance with this 
                        chapter.
                    ``(D) An order of the Secretary approving a 
                petition for a variance shall prescribe such conditions 
                respecting the methods used in, and the facilities and 
                controls used for, the manufacture, packing, and 
                storage of the tobacco product to be granted the 
                variance under the petition as may be necessary to 
                assure that the tobacco product will be in compliance 
                with this chapter.
                    ``(E) After the issuance of an order under 
                subparagraph (B) respecting a petition, the petitioner 
                shall have an opportunity for an informal hearing on 
                such order.
            ``(3) Compliance with requirements under this subsection 
        shall not be required before the period ending 3 years after 
        the date of enactment of the National Tobacco Policy and Youth 
        Smoking Reduction Act.
    ``(f) Exemption for Investigational Use.--The Secretary may exempt 
tobacco products intended for investigational use from this chapter 
under such conditions as the Secretary may prescribe by regulation.
    ``(g) Research and Development.--The Secretary may enter into 
contracts for research, testing, and demonstrations respecting tobacco 
products and may obtain tobacco products for research, testing, and 
demonstration purposes without regard to section 3324(a) and (b) of 
title 31, United States Code, and section 5 of title 41, United States 
Code.

``SEC. 907. PERFORMANCE STANDARDS.

    ``(a) In General.--
            ``(1) Finding required.--The Secretary may adopt 
        performance standards for a tobacco product if the Secretary 
        finds that a performance standard is appropriate for the 
        protection of the public health. This finding shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and non-users of the 
        tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(2) Content of performance standards.--A performance 
        standard established under this section for a tobacco product--
                    ``(A) shall include provisions to provide 
                performance that is appropriate for the protection of 
                the public health, including provisions, where 
                appropriate--
                            ``(i) for the reduction or elimination of 
                        nicotine yields of the product;
                            ``(ii) for the reduction or elimination of 
                        other constituents or harmful components of the 
                        product; or
                            ``(iii) relating to any other requirement 
                        under (B);
                    ``(B) shall, where necessary to be appropriate for 
                the protection of the public health, include--
                            ``(i) provisions respecting the 
                        construction, components, ingredients, and 
                        properties of the tobacco product;
                            ``(ii) provisions for the testing (on a 
                        sample basis or, if necessary, on an individual 
                        basis) of the tobacco product;
                            ``(iii) provisions for the measurement of 
                        the performance characteristics of the tobacco 
                        product;
                            ``(iv) provisions requiring that the 
                        results of each or of certain of the tests of 
                        the tobacco product required to be made under 
                        clause (ii) show that the tobacco product is in 
                        conformity with the portions of the standard 
                        for which the test or tests were required; and
                            ``(v) a provision requiring that the sale 
                        and distribution of the tobacco product be 
                        restricted but only to the extent that the sale 
                        and distribution of a tobacco product may be 
                        restricted under a regulation under section 
                        906(d); and
                    ``(C) shall, where appropriate, require the use and 
                prescribe the form and content of labeling for the 
                proper use of the tobacco product.
            ``(3) Periodic re-evaluation of performance standards.--The 
        Secretary shall provide for periodic evaluation of performance 
        standards established under this section to determine whether 
        such standards should be changed to reflect new medical, 
        scientific, or other technological data. The Secretary may 
        provide for testing under paragraph (2) by any person.
            ``(4) Involvement of other agencies; informed persons.--In 
        carrying out duties under this section, the Secretary shall, to 
        the maximum extent practicable--
                    ``(A) use personnel, facilities, and other 
                technical support available in other Federal agencies;
                    ``(B) consult with other Federal agencies concerned 
                with standard-setting and other nationally or 
                internationally recognized standard-setting entities; 
                and
                    ``(C) invite appropriate participation, through 
                joint or other conferences, workshops, or other means, 
                by informed persons representative of scientific, 
                professional, industry, or consumer organizations who 
                in the Secretary's judgment can make a significant 
                contribution.
    ``(b) Establishment of Standards.--
            ``(1) Notice.--
                    ``(A) The Secretary shall publish in the Federal 
                Register a notice of proposed rulemaking for the 
                establishment, amendment, or revocation of any 
                performance standard for a tobacco product.
                    ``(B) A notice of proposed rulemaking for the 
                establishment or amendment of a performance standard 
                for a tobacco product shall--
                            ``(i) set forth a finding with supporting 
                        justification that the performance standard is 
                        appropriate for the protection of the public 
                        health;
                            ``(ii) set forth proposed findings with 
                        respect to the risk of illness or injury that 
                        the performance standard is intended to reduce 
                        or eliminate; and
                            ``(iii) invite interested persons to submit 
                        an existing performance standard for the 
                        tobacco product, including a draft or proposed 
                        performance standard, for consideration by the 
                        Secretary.
                    ``(C) A notice of proposed rulemaking for the 
                revocation of a performance standard shall set forth a 
                finding with supporting justification that the 
                performance standard is no longer necessary to be 
                appropriate for the protection of the public health.
                    ``(D) The Secretary shall consider all information 
                submitted in connection with a proposed standard, 
                including information concerning the countervailing 
                effects of the performance standard on the health of 
                adolescent tobacco users, adult tobacco users, or non-
                tobacco users, such as the creation of a significant 
                demand for contraband or other tobacco products that do 
                not meet the requirements of this chapter and the 
                significance of such demand, and shall issue the 
                standard if the Secretary determines that the standard 
                would be appropriate for the protection of the public 
                health.
                    ``(E) The Secretary shall provide for a comment 
                period of not less than 60 days.
            ``(2) Promulgation.--
                    ``(A) After the expiration of the period for 
                comment on a notice of proposed rulemaking published 
                under paragraph (1) respecting a performance standard 
                and after consideration of such comments and any report 
                from an advisory committee, the Secretary shall--
                            ``(i) promulgate a regulation establishing 
                        a performance standard and publish in the 
                        Federal Register findings on the matters 
                        referred to in paragraph (1); or
                            ``(ii) publish a notice terminating the 
                        proceeding for the development of the standard 
                        together with the reasons for such termination.
                    ``(B) A regulation establishing a performance 
                standard shall set forth the date or dates upon which 
                the standard shall take effect, but no such regulation 
                may take effect before one year after the date of its 
                publication unless the Secretary determines that an 
                earlier effective date is necessary for the protection 
                of the public health. Such date or dates shall be 
                established so as to minimize, consistent with the 
                public health, economic loss to, and disruption or 
                dislocation of, domestic and international trade.
            ``(3) Special rule for standard banning class of product or 
        eliminating nicotine content.--Because of the importance of a 
        decision of the Secretary to issue a regulation establishing a 
        performance standard--
                    ``(A) eliminating all cigarettes, all smokeless 
                tobacco products, or any similar class of tobacco 
                products, or
                    ``(B) requiring the reduction of nicotine yields of 
                a tobacco product to zero,
        it is appropriate for the Congress to have the opportunity to 
        review such a decision. Therefore, any such standard may not 
        take effect before a date that is 2 years after the President 
        notifies the Congress that a final regulation imposing the 
        restriction has been issued.
            ``(4) Amendment; revocation.--
                    ``(A) The Secretary, upon the Secretary's own 
                initiative or upon petition of an interested person may 
                by a regulation, promulgated in accordance with the 
                requirements of paragraphs (1) and (2)(B) of this 
                subsection, amend or revoke a performance standard.
                    ``(B) The Secretary may declare a proposed 
                amendment of a performance standard to be effective on 
                and after its publication in the Federal Register and 
                until the effective date of any final action taken on 
                such amendment if the Secretary determines that making 
                it so effective is in the public interest.
            ``(5) Reference to advisory committee.--The Secretary--
                    ``(A) may, on the Secretary's own initiative, refer 
                a proposed regulation for the establishment, amendment, 
                or revocation of a performance standard; or
                    ``(B) shall, upon the request of an interested 
                person which demonstrates good cause for referral and 
                which is made before the expiration of the period for 
                submission of comments on such proposed regulation,
refer such proposed regulation to an advisory committee, for a report 
and recommendation with respect to any matter involved in the proposed 
regulation which requires the exercise of scientific judgment. If a 
proposed regulation is referred under this subparagraph to the advisory 
committee, the Secretary shall provide the advisory committee with the 
data and information on which such proposed regulation is based. The 
advisory committee shall, within 60 days after the referral of a 
proposed regulation and after independent study of the data and 
information furnished to it by the Secretary and other data and 
information before it, submit to the Secretary a report and 
recommendation respecting such regulation, together with all underlying 
data and information and a statement of the reason or basis for the 
recommendation. A copy of such report and recommendation shall be made 
public by the Secretary.

``SEC. 908. NOTIFICATION AND OTHER REMEDIES.

    ``(a) Notification.--If the Secretary determines that--
            ``(1) a tobacco product which is introduced or delivered 
        for introduction into interstate commerce for commercial 
        distribution presents an unreasonable risk of substantial harm 
        to the public health; and
            ``(2) notification under this subsection is necessary to 
        eliminate the unreasonable risk of such harm and no more 
        practicable means is available under the provisions of this 
        chapter (other than this section) to eliminate such risk,
the Secretary may issue such order as may be necessary to assure that 
adequate notification is provided in an appropriate form, by the 
persons and means best suited under the circumstances involved, to all 
persons who should properly receive such notification in order to 
eliminate such risk. The Secretary may order notification by any 
appropriate means, including public service announcements. Before 
issuing an order under this subsection, the Secretary shall consult 
with the persons who are to give notice under the order.
    ``(b) No Exemption From Other Liability.--Compliance with an order 
issued under this section shall not relieve any person from liability 
under Federal or State law. In awarding damages for economic loss in an 
action brought for the enforcement of any such liability, the value to 
the plaintiff in such action of any remedy provided under such order 
shall be taken into account.
    ``(c) Recall Authority.--
            ``(1) In general.--If the Secretary finds that there is a 
        reasonable probability that a tobacco product contains a 
        manufacturing or other defect not ordinarily contained in 
        tobacco products on the market that would cause serious, 
        adverse health consequences or death, the Secretary shall issue 
        an order requiring the appropriate person (including the 
        manufacturers, importers, distributors, or retailers of the 
        tobacco product) to immediately cease distribution of such 
        tobacco product. The order shall provide the person subject to 
        the order with an opportunity for an informal hearing, to be 
        held not later than 10 days after the date of the issuance of 
        the order, on the actions required by the order and on whether 
        the order should be amended to require a recall of such tobacco 
        product. If, after providing an opportunity for such a hearing, 
        the Secretary determines that inadequate grounds exist to 
        support the actions required by the order, the Secretary shall 
        vacate the order.
            ``(2) Amendment of order to require recall.--
                    ``(A) If, after providing an opportunity for an 
                informal hearing under paragraph (1), the Secretary 
                determines that the order should be amended to include 
                a recall of the tobacco product with respect to which 
                the order was issued, the Secretary shall, except as 
                provided in subparagraph (B), amend the order to 
                require a recall. The Secretary shall specify a 
                timetable in which the tobacco product recall will 
                occur and shall require periodic reports to the 
                Secretary describing the progress of the recall.
                    ``(B) An amended order under subparagraph (A)--
                            ``(i) shall not include recall of a tobacco 
                        product from individuals; and
                            ``(ii) shall provide for notice to persons 
                        subject to the risks associated with the use of 
                        such tobacco product.
                In providing the notice required by clause (ii), the 
                Secretary may use the assistance of retailers and other 
                persons who distributed such tobacco product. If a 
                significant number of such persons cannot be 
                identified, the Secretary shall notify such persons 
                under section 705(b).
            ``(3) Remedy not exclusive.--The remedy provided by this 
        subsection shall be in addition to remedies provided by 
        subsection (a) of this section.

``SEC. 909. RECORDS AND REPORTS ON TOBACCO PRODUCTS.

    ``(a) In General.--Every person who is a tobacco product 
manufacturer or importer of a tobacco product shall establish and 
maintain such records, make such reports, and provide such information, 
as the Secretary may by regulation reasonably require to assure that 
such tobacco product is not adulterated or misbranded and to otherwise 
protect public health. Regulations prescribed under the preceding 
sentence--
            ``(1) may require a tobacco product manufacturer or 
        importer to report to the Secretary whenever the manufacturer 
        or importer receives or otherwise becomes aware of information 
        that reasonably suggests that one of its marketed tobacco 
        products may have caused or contributed to a serious unexpected 
        adverse experience associated with the use of the product or 
        any significant increase in the frequency of a serious, 
        expected adverse product experience;
            ``(2) shall require reporting of other significant adverse 
        tobacco product experiences as determined by the Secretary to 
        be necessary to be reported;
            ``(3) shall not impose requirements unduly burdensome to a 
        tobacco product manufacturer or importer, taking into account 
        the cost of complying with such requirements and the need for 
        the protection of the public health and the implementation of 
        this chapter;
            ``(4) when prescribing the procedure for making requests 
        for reports or information, shall require that each request 
        made under such regulations for submission of a report or 
        information to the Secretary state the reason or purpose for 
        such request and identify to the fullest extent practicable 
        such report or information;
            ``(5) when requiring submission of a report or information 
        to the Secretary, shall state the reason or purpose for the 
        submission of such report or information and identify to the 
        fullest extent practicable such report or information; and
            ``(6) may not require that the identity of any patient or 
        user be disclosed in records, reports, or information required 
        under this subsection unless required for the medical welfare 
        of an individual, to determine risks to public health of a 
        tobacco product, or to verify a record, report, or information 
        submitted under this chapter.
In prescribing regulations under this subsection, the Secretary shall 
have due regard for the professional ethics of the medical profession 
and the interests of patients. The prohibitions of paragraph (6) of 
this subsection continue to apply to records, reports, and information 
concerning any individual who has been a patient, irrespective of 
whether or when he ceases to be a patient.
    ``(b) Reports of Removals and Corrections.--
            ``(1) Except as provided in paragraph (3), the Secretary 
        shall by regulation require a tobacco product manufacturer or 
        importer of a tobacco product to report promptly to the 
        Secretary any corrective action taken or removal from the 
        market of a tobacco product undertaken by such manufacturer or 
        importer if the removal or correction was undertaken--
                    ``(A) to reduce a risk to health posed by the 
                tobacco product; or
                    ``(B) to remedy a violation of this chapter caused 
                by the tobacco product which may present a risk to 
                health.
        A tobacco product manufacturer or importer of a tobacco product 
        who undertakes a corrective action or removal from the market 
        of a tobacco product which is not required to be reported under 
        this subsection shall keep a record of such correction or 
        removal.
            ``(2) No report of the corrective action or removal of a 
        tobacco product may be required under paragraph (1) if a report 
        of the corrective action or removal is required and has been 
        submitted under subsection (a) of this section.

``SEC. 910. PREMARKET REVIEW OF CERTAIN TOBACCO PRODUCTS.

    ``(a) In General.--
            ``(1) Premarket approval required.--Approval under this 
        section of an application for premarket approval for any 
        tobacco product that is not commercially marketed (other than 
        for test marketing) in the United States as of the date of 
        introduction of the National Cancer Act of 2002, such approval, 
        is required unless the manufacturer has submitted a report 
        under section 905(j), and the Secretary has issued an order 
        that the tobacco product is substantially equivalent to a 
        tobacco product commercially marketed (other than for test 
        marketing) in the United States as of the date of introduction 
        of the National Cancer Act of 2002, that is in compliance with 
        the requirements of this Act.
            ``(2) Substantially equivalent defined.--
                    ``(A) For purposes of this section and section 
                905(j), the term `substantially equivalent' or 
                `substantial equivalence' mean, with respect to the 
                tobacco product being compared to the predicate tobacco 
                product, that the Secretary by order has found that the 
                tobacco product--
                            ``(i) has the same characteristics as the 
                        predicate tobacco product; or
                            ``(ii) has different characteristics and 
                        the information submitted contains information, 
                        including clinical data if deemed necessary by 
                        the Secretary, that demonstrates that it is not 
                        appropriate to regulate the product under this 
                        section because the product does not raise 
                        different questions of public health.
                    ``(B) For purposes of subparagraph (A), the term 
                `characteristics' means the materials, ingredients, 
                design, composition, heating source, or other features 
                of a tobacco product.
                    ``(C) A tobacco product may not be found to be 
                substantially equivalent to a predicate tobacco product 
                that has been removed from the market at the initiative 
                of the Secretary or that has been determined by a 
                judicial order to be misbranded or adulterated.
            ``(3) Health information.--
                    ``(A) As part of a submission under section 905(j) 
                respecting a tobacco product, the person required to 
                file a premarket notification under such section shall 
                provide an adequate summary of any health information 
                related to the tobacco product or state that such 
                information will be made available upon request by any 
                person.
                    ``(B) Any summary under subparagraph (A) respecting 
                a tobacco product shall contain detailed information 
                regarding data concerning adverse health effects and 
                shall be made available to the public by the Secretary 
                within 30 days of the issuance of a determination that 
                such tobacco product is substantially equivalent to 
                another tobacco product.
    ``(b) Application.--
            ``(1) Contents.--An application for premarket approval 
        shall contain--
                    ``(A) full reports of all information, published or 
                known to or which should reasonably be known to the 
                applicant, concerning investigations which have been 
                made to show the health risks of such tobacco product 
                and whether such tobacco product presents less risk 
                than other tobacco products;
                    ``(B) a full statement of the components, 
                ingredients, and properties, and of the principle or 
                principles of operation, of such tobacco product;
                    ``(C) a full description of the methods used in, 
                and the facilities and controls used for, the 
                manufacture, processing, and, when relevant, packing 
                and installation of, such tobacco product;
                    ``(D) an identifying reference to any performance 
                standard under section 907 which would be applicable to 
                any aspect of such tobacco product, and either adequate 
                information to show that such aspect of such tobacco 
                product fully meets such performance standard or 
                adequate information to justify any deviation from such 
                standard;
                    ``(E) such samples of such tobacco product and of 
                components thereof as the Secretary may reasonably 
                require;
                    ``(F) specimens of the labeling proposed to be used 
                for such tobacco product; and
                    ``(G) such other information relevant to the 
                subject matter of the application as the Secretary may 
                require.
            ``(2) Reference to advisory committee.--Upon receipt of an 
        application meeting the requirements set forth in paragraph 
        (1), the Secretary--
                    ``(A) may, on the Secretary's own initiative; or
                    ``(B) shall, upon the request of an applicant,
        refer such application to an advisory committee and for 
        submission (within such period as the Secretary may establish) 
        of a report and recommendation respecting approval of the 
        application, together with all underlying data and the reasons 
        or basis for the recommendation.
    ``(c) Action on Application.--
            ``(1) Deadline.--
                    ``(A) As promptly as possible, but in no event 
                later than 180 days after the receipt of an application 
                under subsection (b) of this section, the Secretary, 
                after considering the report and recommendation 
                submitted under paragraph (2) of such subsection, 
                shall--
                            ``(i) issue an order approving the 
                        application if the Secretary finds that none of 
                        the grounds for denying approval specified in 
                        paragraph (2) of this subsection applies; or
                            ``(ii) deny approval of the application if 
                        the Secretary finds (and sets forth the basis 
                        for such finding as part of or accompanying 
                        such denial) that one or more grounds for 
                        denial specified in paragraph (2) of this 
                        subsection apply.
                    ``(B) An order approving an application for a 
                tobacco product may require as a condition to such 
                approval that the sale and distribution of the tobacco 
                product be restricted but only to the extent that the 
                sale and distribution of a tobacco product may be 
                restricted under a regulation under section 906(d).
            ``(2) Denial of approval.--The Secretary shall deny 
        approval of an application for a tobacco product if, upon the 
        basis of the information submitted to the Secretary as part of 
        the application and any other information before the Secretary 
        with respect to such tobacco product, the Secretary finds 
        that--
                    ``(A) there is a lack of a showing that permitting 
                such tobacco product to be marketed would be 
                appropriate for the protection of the public health;
                    ``(B) the methods used in, or the facilities or 
                controls used for, the manufacture, processing, or 
                packing of such tobacco product do not conform to the 
                requirements of section 906(e);
                    ``(C) based on a fair evaluation of all material 
                facts, the proposed labeling is false or misleading in 
                any particular; or
                    ``(D) such tobacco product is not shown to conform 
                in all respects to a performance standard in effect 
                under section 907, compliance with which is a condition 
                to approval of the application, and there is a lack of 
                adequate information to justify the deviation from such 
                standard.
            ``(3) Denial information.--Any denial of an application 
        shall, insofar as the Secretary determines to be practicable, 
        be accompanied by a statement informing the applicant of the 
        measures required to place such application in approvable form 
        (which measures may include further research by the applicant 
        in accordance with one or more protocols prescribed by the 
        Secretary).
            ``(4) Basis for finding.--For purposes of this section, the 
        finding as to whether approval of a tobacco product is 
        appropriate for the protection of the public health shall be 
        determined with respect to the risks and benefits to the 
        population as a whole, including users and non-users of the 
        tobacco product, and taking into account--
                    ``(A) the increased or decreased likelihood that 
                existing users of tobacco products will stop using such 
                products; and
                    ``(B) the increased or decreased likelihood that 
                those who do not use tobacco products will start using 
                such products.
            ``(5) Basis for action.--
                    ``(A) For purposes of paragraph (2)(A), whether 
                permitting a tobacco product to be marketed would be 
                appropriate for the protection of the public health 
                shall, when appropriate, be determined on the basis of 
                well-controlled investigations, which may include one 
                or more clinical investigations by experts qualified by 
                training and experience to evaluate the tobacco 
                product.
                    ``(B) If the Secretary determines that there exists 
                valid scientific evidence (other than evidence derived 
                from investigations described in subparagraph (A)) 
                which is sufficient to evaluate the tobacco product the 
                Secretary may authorize that the determination for 
                purposes of paragraph (2)(A) be made on the basis of 
                such evidence.
    ``(d) Withdrawal and Temporary Suspension.--
            ``(1) In general.--The Secretary shall, upon obtaining, 
        where appropriate, advice on scientific matters from an 
        advisory committee, and after due notice and opportunity for 
        informal hearing to the holder of an approved application for a 
        tobacco product, issue an order withdrawing approval of the 
        application if the Secretary finds--
                    ``(A) that the continued marketing of such tobacco 
                product no longer is appropriate for the protection of 
                the public health;
                    ``(B) that the application contained or was 
                accompanied by an untrue statement of a material fact;
                    ``(C) that the applicant--
                            ``(i) has failed to establish a system for 
                        maintaining records, or has repeatedly or 
                        deliberately failed to maintain records or to 
                        make reports, required by an applicable 
                        regulation under section 909;
                            ``(ii) has refused to permit access to, or 
                        copying or verification of, such records as 
                        required by section 704; or
                            ``(iii) has not complied with the 
                        requirements of section 905;
                    ``(D) on the basis of new information before the 
                Secretary with respect to such tobacco product, 
                evaluated together with the evidence before the 
                Secretary when the application was approved, that the 
                methods used in, or the facilities and controls used 
                for, the manufacture, processing, packing, or 
                installation of such tobacco product do not conform 
                with the requirements of section 906(e) and were not 
                brought into conformity with such requirements within a 
                reasonable time after receipt of written notice from 
                the Secretary of nonconformity;
                    ``(E) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                the labeling of such tobacco product, based on a fair 
                evaluation of all material facts, is false or 
                misleading in any particular and was not corrected 
                within a reasonable time after receipt of written 
                notice from the Secretary of such fact; or
                    ``(F) on the basis of new information before the 
                Secretary, evaluated together with the evidence before 
                the Secretary when the application was approved, that 
                such tobacco product is not shown to conform in all 
                respects to a performance standard which is in effect 
                under section 907, compliance with which was a 
                condition to approval of the application, and that 
                there is a lack of adequate information to justify the 
                deviation from such standard.
            ``(2) Appeal.--The holder of an application subject to an 
        order issued under paragraph (1) withdrawing approval of the 
        application may, by petition filed on or before the thirtieth 
        day after the date upon which he receives notice of such 
withdrawal, obtain review thereof in accordance with subsection (e) of 
this section.
            ``(3) Temporary suspension.--If, after providing an 
        opportunity for an informal hearing, the Secretary determines 
        there is reasonable probability that the continuation of 
        distribution of a tobacco product under an approved application 
        would cause serious, adverse health consequences or death, that 
        is greater than ordinarily caused by tobacco products on the 
        market, the Secretary shall by order temporarily suspend the 
        approval of the application approved under this section. If the 
        Secretary issues such an order, the Secretary shall proceed 
        expeditiously under paragraph (1) to withdraw such application.
    ``(e) Service of Order.--An order issued by the Secretary under 
this section shall be served--
            ``(1) in person by any officer or employee of the 
        department designated by the Secretary; or
            ``(2) by mailing the order by registered mail or certified 
        mail addressed to the applicant at the applicant's last known 
        address in the records of the Secretary.

``SEC. 911. JUDICIAL REVIEW.

    ``(a) In General.--Not later than 30 days after--
            ``(1) the promulgation of a regulation under section 907 
        establishing, amending, or revoking a performance standard for 
        a tobacco product; or
            ``(2) a denial of an application for approval under section 
        910(c),
any person adversely affected by such regulation or order may file a 
petition with the United States Court of Appeals for the District of 
Columbia or for the circuit wherein such person resides or has his 
principal place of business for judicial review of such regulation or 
order. A copy of the petition shall be transmitted by the clerk of the 
court to the Secretary or other officer designated by the Secretary for 
that purpose. The Secretary shall file in the court the record of the 
proceedings on which the Secretary based the Secretary's regulation or 
order and each record or order shall contain a statement of the reasons 
for its issuance and the basis, on the record, for its issuance. For 
purposes of this section, the term `record' means all notices and other 
matter published in the Federal Register with respect to the regulation 
or order reviewed, all information submitted to the Secretary with 
respect to such regulation or order, proceedings of any panel or 
advisory committee with respect to such regulation or order, any 
hearing held with respect to such regulation or order, and any other 
information identified by the Secretary, in the administrative 
proceeding held with respect to such regulation or order, as being 
relevant to such regulation or order.
    ``(b) Court May Order Secretary To Make Additional Findings.--If 
the petitioner applies to the court for leave to adduce additional 
data, views, or arguments respecting the regulation or order being 
reviewed and shows to the satisfaction of the court that such 
additional data, views, or arguments are material and that there were 
reasonable grounds for the petitioner's failure to adduce such data, 
views, or arguments in the proceedings before the Secretary, the court 
may order the Secretary to provide additional opportunity for the oral 
presentation of data, views, or arguments and for written submissions. 
The Secretary may modify the Secretary's findings, or make new findings 
by reason of the additional data, views, or arguments so taken and 
shall file with the court such modified or new findings, and the 
Secretary's recommendation, if any, for the modification or setting 
aside of the regulation or order being reviewed, with the return of 
such additional data, views, or arguments.
    ``(c) Standard of Review.--Upon the filing of the petition under 
subsection (a) of this section for judicial review of a regulation or 
order, the court shall have jurisdiction to review the regulation or 
order in accordance with chapter 7 of title 5, United States Code, and 
to grant appropriate relief, including interim relief, as provided in 
such chapter. A regulation or order described in paragraph (1) or (2) 
of subsection (a) of this section shall not be affirmed if it is found 
to be unsupported by substantial evidence on the record taken as a 
whole.
    ``(d) Finality of Judgment.--The judgment of the court affirming or 
setting aside, in whole or in part, any regulation or order shall be 
final, subject to review by the Supreme Court of the United States upon 
certiorari or certification, as provided in section 1254 of title 28, 
United States Code.
    ``(e) Other Remedies.--The remedies provided for in this section 
shall be in addition to and not in lieu of any other remedies provided 
by law.
    ``(f) Regulations and Orders Must Recite Basis in Record.--To 
facilitate judicial review under this section or under any other 
provision of law of a regulation or order issued under section 906, 
907, 908, 909, 910, or 914, each such regulation or order shall contain 
a statement of the reasons for its issuance and the basis, in the 
record of the proceedings held in connection with its issuance, for its 
issuance.

``SEC. 912. POSTMARKET SURVEILLANCE

    ``(a) Discretionary Surveillance.--The Secretary may require a 
tobacco product manufacturer to conduct postmarket surveillance for a 
tobacco product of the manufacturer if the Secretary determines that 
postmarket surveillance of the tobacco product is necessary to protect 
the public health or is necessary to provide information regarding the 
health risks and other safety issues involving the tobacco product.
    ``(b) Surveillance Approval.--Each tobacco product manufacturer 
required to conduct a surveillance of a tobacco product under 
subsection (a) of this section shall, within 30 days after receiving 
notice that the manufacturer is required to conduct such surveillance, 
submit, for the approval of the Secretary, a protocol for the required 
surveillance. The Secretary, within 60 days of the receipt of such 
protocol, shall determine if the principal investigator proposed to be 
used in the surveillance has sufficient qualifications and experience 
to conduct such surveillance and if such protocol will result in 
collection of useful data or other information necessary to protect the 
public health. The Secretary may not approve such a protocol until it 
has been reviewed by an appropriately qualified scientific and 
technical review committee established by the Secretary.

``SEC. 913. REDUCED RISK TOBACCO PRODUCTS.

    ``(a) Requirements.--
            ``(1) In general.--For purposes of this section, the term 
        `reduced risk tobacco product' means a tobacco product 
        designated by the Secretary under paragraph (2).
            ``(2) Designation.--
                    ``(A) In general.--A product may be designated by 
                the Secretary as a reduced risk tobacco product if the 
                Secretary finds that the product will significantly 
                reduce harm to individuals caused by a tobacco product 
                and is otherwise appropriate to protect public health, 
                based on an application submitted by the manufacturer 
                of the product (or other responsible person) that--
                            ``(i) demonstrates through testing on 
                        animals and short-term human testing that use 
                        of such product results in ingestion or 
                        inhalation of a substantially lower yield of 
                        toxic substances than use of conventional 
                        tobacco products in the same category as the 
                        proposed reduced risk product; and
                            ``(ii) if required by the Secretary, 
                        includes studies of the long-term health 
                        effects of the product.
                If such studies are required, the manufacturer may 
                consult with the Secretary regarding protocols for 
                conducting the studies.
                    ``(B) Basis for finding.--In making the finding 
                under subparagraph (A), the Secretary shall take into 
                account--
                            ``(i) the risks and benefits to the 
                        population as a whole, including both users of 
                        tobacco products and non-users of tobacco 
                        products;
                            ``(ii) the increased or decreased 
                        likelihood that existing users of tobacco 
                        products will stop using such products 
                        including reduced risk tobacco products;
                            ``(iii) the increased or decreased 
                        likelihood that those who do not use tobacco 
                        products will start to use such products, 
                        including reduced risk tobacco products; and
                            ``(iv) the risks and benefits to consumers 
                        from the use of a reduced risk tobacco product 
                        as compared to the use of products approved 
                        under chapter V to reduce exposure to tobacco.
            ``(3) Marketing requirements.--A tobacco product may be 
        marketed and labeled as a reduced risk tobacco product if it--
                    ``(A) has been designated as a reduced risk tobacco 
                product by the Secretary under paragraph (2);
                    ``(B) bears a label prescribed by the Secretary 
                concerning the product's contribution to reducing harm 
                to health; and
                    ``(C) complies with requirements prescribed by the 
                Secretary relating to marketing and advertising of the 
                product, and other provisions of this chapter as 
                prescribed by the Secretary.
    ``(b) Revocation of Designation.--At any time after the date on 
which a tobacco product is designated as a reduced risk tobacco product 
under this section the Secretary may, after providing an opportunity 
for an informal hearing, revoke such designation if the Secretary 
determines, based on information not available at the time of the 
designation, that--
            ``(1) the finding made under subsection (a)(2) is no longer 
        valid; or
            ``(2) the product is being marketed in violation of 
        subsection (a)(3).
    ``(c) Limitation.--A tobacco product that is designated as a 
reduced risk tobacco product that is in compliance with subsection (a) 
shall not be regulated as a drug or device.
    ``(d) Development of Reduced Risk Tobacco Product Technology.--A 
tobacco product manufacturer shall provide written notice to the 
Secretary upon the development or acquisition by the manufacturer of 
any technology that would reduce the risk of a tobacco product to the 
health of the user for which the manufacturer is not seeking 
designation as a `reduced risk tobacco product' under subsection (a).

``SEC. 914. PRESERVATION OF STATE AND LOCAL AUTHORITY.

    ``(a) Additional Requirements.--
            ``(1) In general.--Except as provided in paragraph (2), 
        nothing in this Act shall be construed as prohibiting a State 
        or political subdivision thereof from adopting or enforcing a 
        requirement applicable to a tobacco product that is in addition 
        to, or more stringent than, requirements established under this 
        chapter.
            ``(2) Preemption of certain state and local requirements.--
                    ``(A) Except as provided in subparagraph (B), no 
                State or political subdivision of a State may establish 
                or continue in effect with respect to a tobacco product 
                any requirement which is different from, or in addition 
                to, any requirement applicable under the provisions of 
                this chapter relating to performance standards, 
                premarket approval, adulteration, misbranding, 
                registration, reporting, good manufacturing standards, 
                or reduced risk products.
                    ``(B) Subparagraph (A) does not apply to 
                requirements relating to the sale, use, or distribution 
                of a tobacco product including requirements related to 
                the access to, and the advertising and promotion of, a 
                tobacco product.
    ``(b) Rule of Construction Regarding Product Liability.--No 
provision of this chapter relating to a tobacco product shall be 
construed to modify or otherwise affect any action or the liability of 
any person under the product liability law of any State.
    ``(c) Waivers.--Upon the application of a State or political 
subdivision thereof, the Secretary may, by regulation promulgated after 
notice and an opportunity for an oral hearing, exempt from subsection 
(a), under such conditions as may be prescribed in such regulation, a 
requirement of such State or political subdivision applicable to a 
tobacco product if--
            ``(1) the requirement is more stringent than a requirement 
        applicable under the provisions described in subsection (a)(3) 
        which would be applicable to the tobacco product if an 
        exemption were not in effect under this subsection; or
            ``(2) the requirement--
                    ``(A) is required by compelling local conditions; 
                and
                    ``(B) compliance with the requirement would not 
                cause the tobacco product to be in violation of any 
                applicable requirement of this chapter.

``SEC. 915. EQUAL TREATMENT OF RETAIL OUTLETS.

    ``The Secretary shall issue regulations to require that retail 
establishments for which the predominant business is the sale of 
tobacco products comply with any advertising restrictions applicable to 
retail establishments accessible to individuals under the age of 18.''.

SEC. 402. CONFORMING AND OTHER AMENDMENTS TO GENERAL PROVISIONS.

    (a) Amendment of Federal Food, Drug, and Cosmetic Act.--Except as 
otherwise expressly provided, whenever in this section an amendment is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference is to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
    (b) Section 301.--Section 301 (21 U.S.C. 331) is amended--
            (1) by inserting ``tobacco product,'' in subsection (a) 
        after ``device,'';
            (2) by inserting ``tobacco product,'' in subsection (b) 
        after ``device,'';
            (3) by inserting ``tobacco product,'' in subsection (c) 
        after ``device,'';
            (4) by striking ``515(f), or 519'' in subsection (e) and 
        inserting ``515(f), 519, or 909'';
            (5) by inserting ``tobacco product,'' in subsection (g) 
        after ``device,'';
            (6) by inserting ``tobacco product,'' in subsection (h) 
        after ``device,'';
            (7) by striking ``708, or 721'' in subsection (j) and 
        inserting ``708, 721, 904, 905, 906, 907, 908, or 909'';
            (8) by inserting ``tobacco product,'' in subsection (k) 
        after ``device,'';
            (9) by striking subsection (p) and inserting the following:
    ``(p) The failure to register in accordance with section 510 or 
905, the failure to provide any information required by section 510(j), 
510(k), 905(i), or 905(j), or the failure to provide a notice required 
by section 510(j)(2) or 905(J)(2).'';
            (10) by striking subsection (q)(1) and inserting the 
        following:
    ``(q)(1) The failure or refusal--
            ``(A) to comply with any requirement prescribed under 
        section 518, 520(g), 906(f), or 908;
            ``(B) to furnish any notification or other material or 
        information required by or under section 519, 520(g), 904, 
        906(f), or 909; or
            ``(C) to comply with a requirement under section 522 or 
        912.'';
            (11) by striking ``device,'' in subsection (q)(2) and 
        inserting ``device or tobacco product,'';
            (12) by inserting ``or tobacco product'' in subsection (r) 
        after ``device'' each time that it appears; and
            (13) by adding at the end thereof the following:
            ``(aa) The sale of tobacco products in violation of a no-
        tobacco-sale order issued under section 303(f).''.
    (c) Section 303.--Section 303(f) (21 U.S.C. 333(f)) is amended--
            (1) by amending the caption to read as follows:
    ``(f) Civil Penalties; No-Tobacco-Sale Orders.--'';
            (2) by inserting ``or tobacco products'' after ``devices'' 
        in paragraph (1)(A);
            (3) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), and inserting after paragraph (2) 
        the following:
            ``(3) If the Secretary finds that a person has committed 
        repeated violations of restrictions promulgated under section 
        906(d) at a particular retail outlet then the Secretary may 
        impose a no-tobacco-sale order on that person prohibiting the 
        sale of tobacco products in that outlet. A no-tobacco-sale 
        order may be imposed with a civil penalty under paragraph 
        (1).'';
            (4) by striking ``assessed'' the first time it appears in 
        subparagraph (A) of paragraph (4), as redesignated, and 
        inserting ``assessed, or a no-tobacco-sale order may be 
        imposed,'';
            (5) by striking ``penalty'' in such subparagraph and 
        inserting ``penalty, or upon whom a no-tobacco-order is to be 
        imposed,'';
            (6) by inserting after ``penalty,'' in subparagraph (B) of 
        paragraph (4), as redesignated, the following: ``or the period 
        to be covered by a no-tobacco-sale order,'';
            (7) by adding at the end of such subparagraph the 
        following: ``A no-tobacco-sale order permanently prohibiting an 
        individual retail outlet from selling tobacco products shall 
        include provisions that allow the outlet, after a specified 
        period of time, to request that the Secretary compromise, 
        modify, or terminate the order.'';
            (8) by adding at the end of paragraph (4), as redesignated, 
        the following:
                    ``(D) The Secretary may compromise, modify, or 
                terminate, with or without conditions, any no-tobacco-
                sale order.'';
            (9) by striking ``(3)(A)'' in paragraph (5), as 
        redesignated, and inserting ``(4)(A)'';
            (10) by inserting ``or the imposition of a no-tobacco-sale 
        order'' after ``penalty'' the first 2 places it appears in such 
        paragraph;
            (11) by striking ``issued.'' in such paragraph and 
        inserting ``issued, or on which the no-tobacco-sale order was 
        imposed, as the case may be.''; and
            (12) by striking ``paragraph (4)'' each place it appears in 
        paragraph (6), as redesignated, and inserting ``paragraph 
        (5)''.
    (d) Section 304.--Section 304 (21 U.S.C. 334) is amended--
            (1) by striking ``and'' before ``(D)'' in subsection 
        (a)(2);
            (2) by striking ``device.'' in subsection (a)(2) and 
        inserting a comma and ``(E) Any adulterated or misbranded 
        tobacco product.'';
            (3) by inserting ``tobacco product,'' in subsection (d)(1) 
        after ``device,'';
            (4) by inserting ``or tobacco product'' in subsection 
        (g)(1) after ``device'' each place it appears; and
            (5) by inserting ``or tobacco product'' in subsection 
        (g)(2)(A) after ``device'' each place it appears.
    (e) Section 702.--Section 702(a) (21 U.S.C. 372(a)) is amended--
            (1) by inserting ``(1)'' after ``(a)''; and
            (2) by adding at the end thereof the following:
    ``(2) For a tobacco product, to the extent feasible, the Secretary 
shall contract with the States in accordance with paragraph (1) to 
carry out inspections of retailers in connection with the enforcement 
of this Act.''.
    (f) Section 703.--Section 703 (21 U.S.C. 373) is amended--
            (1) by inserting ``tobacco product,'' after ``device,'' 
        each place it appears; and
            (2) by inserting ``tobacco products,'' after ``devices,'' 
        each place it appears.
    (g) Section 704.--Section 704 (21 U.S.C. 374) is amended--
            (1) by inserting ``tobacco products,'' in subsection 
        (a)(1)(A) after ``devices,'' each place it appears;
            (2) by inserting ``or tobacco products'' in subsection 
        (a)(1)(B) after ``restricted devices'' each place it appears; 
        and
            (3) by inserting ``tobacco product,'' in subsection (b) 
        after ``device,''.
    (h) Section 705.--Section 705(b) (21 U.S.C. 375(b)) is amended by 
inserting ``tobacco products,'' after ``devices,''.
    (i) Section 709.--Section 709 (21 U.S.C. 379) is amended by 
inserting ``or tobacco product'' after ``device''.
    (j) Section 801.--Section 801 (21 U.S.C. 381) is amended--
            (1) by inserting ``tobacco products,'' after ``devices,'' 
        in subsection (a) the first time it appears;
            (2) by inserting ``or subsection (j) of section 905'' in 
        subsection (a) after ``section 510'';
            (3) by striking ``drugs or devices'' each time it appears 
        in subsection (a) and inserting ``drugs, devices, or tobacco 
        products'';
            (4) by inserting ``tobacco product,'' in subsection (e)(1) 
        after ``device,''; and
            (5) by redesignating paragraph (4) of subsection (e) as 
        paragraph (5) and inserting after paragraph (3), the following:
            ``(4) Paragraph (1) does not apply to any tobacco product--
                    ``(A) which does not comply with an applicable 
                requirement of section 907 or 910; or
                    ``(B) which under section 906(f) is exempt from 
                either such section.
        This paragraph does not apply if the Secretary has determined 
        that the exportation of the tobacco product is not contrary to 
        the public health and safety and has the approval of the 
        country to which it is intended for export or the tobacco 
        product is eligible for export under section 802.''.
    (k) Section 802.--Section 802 (21 U.S.C. 382) is amended--
            (1) by striking ``device--'' in subsection (a) and 
        inserting ``device or tobacco product--'';
            (2) by striking ``and'' after the semicolon in subsection 
        (a)(1)(C);
            (3) by striking subparagraph (C) of subsection (a)(2) and 
        all that follows in that subsection and inserting the 
        following:
                    ``(C) is a banned device under section 516; or
            ``(3) which, in the case of a tobacco product--
                    ``(A) does not comply with an applicable 
                requirement of section 907 or 910; or
                    ``(B) under section 906(f) is exempt from either 
                such section,
        is adulterated, misbranded, and in violation of such sections 
        or Act unless the export of the drug, device, or tobacco 
        product is, except as provided in subsection (f), authorized 
        under subsection (b), (c), (d), or (e) of this section or 
        section 801(e)(2) or 801(e)(4). If a drug, device, or tobacco 
        product described in paragraph (1), (2), or (3) may be exported 
        under subsection (b) and if an application for such drug or 
        device under section 505, 515, or 910 of this Act or section 
        351 of the Public Health Service Act (42 U.S.C. 262) was 
        disapproved, the Secretary shall notify the appropriate public 
        health official of the country to which such drug, device, or 
        tobacco product will be exported of such disapproval.'';
            (4) by inserting ``or tobacco product'' in subsection 
        (b)(1)(A) after ``device'' each time it appears;
            (5) by inserting ``or tobacco product'' in subsection (c) 
        after ``device'' and inserting ``or section 906(f)'' after 
        ``520(g).'';
            (6) by inserting ``or tobacco product'' in subsection (f) 
        after ``device'' each time it appears; and
            (7) by inserting ``or tobacco product'' in subsection (g) 
        after ``device'' each time it appears.
    (l) Section 1003.--Section 1003(d)(2)(C) (as redesignated by 
section 101(a)) is amended--
            (1) by striking ``and'' after ``cosmetics,''; and
            (2) inserting a comma and ``and tobacco products'' after 
        ``devices''.
    (m) Effective Date for No-Tobacco-Sale Order Amendments.--The 
amendments made by subsection (c), other than the amendment made by 
paragraph (2) thereof, shall take effect only upon the promulgation of 
final regulations by the Secretary--
            (1) defining the term ``repeated violation'', as used in 
        section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 333(f)) as amended by subsection (c), by identifying the 
        number of violations of particular requirements over a 
        specified period of time that constitute a repeated violation;
            (2) providing for notice to the retailer of each violation 
        at a particular retail outlet;
            (3) providing that a person may not be charged with a 
        violation at a particular retail outlet unless the Secretary 
        has provided notice to the retailer of all previous violations 
        at that outlet;
            (4) establishing a period of time during which, if there 
        are no violations by a particular retail outlet, that outlet 
        will not be considered to have been the site of repeated 
        violations when the next violation occurs; and
            (5) providing that good faith reliance on false 
        identification does not constitute a violation of any minimum 
        age requirement for the sale of tobacco products.

SEC. 403. FDA RULE IN EFFECT.

    The final regulations promulgated by the Secretary in the August 
28, 1996, issue of the Federal Register (62 Fed. Reg. 44615-44618) and 
codified at part 897 of title 21, Code of Federal Regulations, are 
hereby deemed to be lawful and to have been lawfully promulgated by the 
Secretary under chapter IX and section 701 of the Federal Food, Drug, 
and Cosmetic Act, as amended by this title, and not under chapter V of 
the Federal Food, Drug, and Cosmetic Act. Such regulations shall apply 
to all tobacco products and shall take effect upon such date as the 
Secretary determines by order, not later than 12 months after enactment 
of this title. The Secretary shall amend the designation of authority 
in such regulations in accordance with this subsection.

   TITLE V--TOBACCO PRODUCT WARNINGS AND SMOKE CONSTITUENT DISCLOSURE

         Subtitle A--Product Warnings, Labeling, and Packaging

SEC. 501. CIGARETTE LABEL AND ADVERTISING WARNINGS.

    (a) In General.--Section 4 of the Federal Cigarette Labeling and 
Advertising Act (15 U.S.C. 1333) is amended to read as follows:

``SEC. 4. LABELING.

    ``(a) Label Requirements.--
            ``(1) In general.--It shall be unlawful for any person to 
        manufacture, package, or import for sale or distribution within 
        the United States any cigarettes the package of which fails to 
        bear, in accordance with the requirements of this section, one 
        of the following labels:
        ``WARNING: Cigarettes are addictive''
        ``WARNING: Tobacco smoke can harm your children''
        ``WARNING: Cigarettes cause fatal lung disease''
        ``WARNING: Cigarettes cause cancer''
        ``WARNING: Cigarettes cause strokes and heart disease''
        ``WARNING: Smoking during pregnancy can harm your baby''
        ``WARNING: Smoking can kill you''
        ``WARNING: Tobacco smoke causes fatal lung disease in non-
        smokers''
        ``WARNING: Quitting smoking now greatly reduces serious risks 
        to your health''
            ``(2) Placement; typography; etc.--
                    ``(A) In general.--Each label statement required by 
                paragraph (1) shall be located in the upper portion of 
                the front and rear panels of the package, directly on 
                the package underneath the cellophane or other clear 
                wrapping. Except as provided in subparagraph (B), each 
                label statement shall comprise at least the top 25 
percent of the front and rear panels of the package. The word 
``WARNING'' shall appear in capital letters and all text shall be in 
conspicuous and legible 17-point type, unless the text of the label 
statement would occupy more than 70 percent of such area, in which case 
the text may be in a smaller conspicuous and legible type size, 
provided that at least 60 percent of such area is occupied by required 
text. The text shall be black on a white background, or white on a 
black background, in a manner that contrasts, by typography, layout, or 
color, with all other printed material on the package, in an 
alternating fashion under the plan submitted under subsection (b)(4).
                    ``(B) Flip-top boxes.--For any cigarette brand 
                package manufactured or distributed before January 1, 
                2000, which employs a flip-top style (if such packaging 
                was used for that brand in commerce prior to June 21, 
                1997), the label statement required by paragraph (1) 
                shall be located on the flip-top area of the package, 
                even if such area is less than 25 percent of the area 
                of the front panel. Except as provided in this 
                paragraph, the provisions of this subsection shall 
                apply to such packages.
            ``(3) Does not apply to foreign distribution.--The 
        provisions of this subsection do not apply to a tobacco product 
        manufacturer or distributor of cigarettes which does not 
        manufacture, package, or import cigarettes for sale or 
        distribution within the United States.
    ``(b) Advertising Requirements.--
            ``(1) In general.--It shall be unlawful for any tobacco 
        product manufacturer, importer, distributor, or retailer of 
        cigarettes to advertise or cause to be advertised within the 
        United States any cigarette unless its advertising bears, in 
        accordance with the requirements of this section, one of the 
        labels specified in subsection (a) of this section.
            ``(2) Typography, etc.--Each label statement required by 
        subsection (a) of this section in cigarette advertising shall 
        comply with the standards set forth in this paragraph. For 
        press and poster advertisements, each such statement and (where 
        applicable) any required statement relating to tar, nicotine, 
        or other constituent yield shall comprise at least 20 percent 
        of the area of the advertisement and shall appear in a 
        conspicuous and prominent format and location at the top of 
        each advertisement within the trim area. The Secretary may 
        revise the required type sizes in such area in such manner as 
        the Secretary determines appropriate. The word ``WARNING'' 
        shall appear in capital letters, and each label statement shall 
        appear in conspicuous and legible type. The text of the label 
        statement shall be black if the background is white and white 
        if the background is black, under the plan submitted under 
        paragraph (4) of this subsection. The label statements shall be 
        enclosed by a rectangular border that is the same color as the 
        letters of the statements and that is the width of the first 
        downstroke of the capital ``W'' of the word ``WARNING'' in the 
        label statements. The text of such label statements shall be in 
        a typeface pro rata to the following requirements: 45-point 
        type for a whole-page broadsheet newspaper advertisement; 39-
        point type for a half-page broadsheet newspaper advertisement; 
        39-point type for a whole-page tabloid newspaper advertisement; 
        27-point type for a half-page tabloid newspaper advertisement; 
        31.5-point type for a double page spread magazine or whole-page 
        magazine advertisement; 22.5-point type for a 28 centimeter by 
        3 column advertisement; and 15-point type for a 20 centimeter 
by 2 column advertisement. The label statements shall be in English, 
except that in the case of--
                    ``(A) an advertisement that appears in a newspaper, 
                magazine, periodical, or other publication that is not 
                in English, the statements shall appear in the 
                predominant language of the publication; and
                    ``(B) in the case of any other advertisement that 
                is not in English, the statements shall appear in the 
                same language as that principally used in the 
                advertisement.
            ``(3) Adjustment by secretary.--The Secretary may, through 
        a rulemaking under section 553 of title 5, United States Code, 
        adjust the format and type sizes for the label statements 
        required by this section or the text, format, and type sizes of 
        any required tar, nicotine yield, or other constituent 
        disclosures, or to establish the text, format, and type sizes 
        for any other disclosures required under the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 301 et. seq.). The text of 
        any such label statements or disclosures shall be required to 
        appear only within the 20 percent area of cigarette 
        advertisements provided by paragraph (2) of this subsection. 
        The Secretary shall promulgate regulations which provide for 
        adjustments in the format and type sizes of any text required 
        to appear in such area to ensure that the total text required 
        to appear by law will fit within such area.
            ``(4) Marketing requirements.--
                    ``(A) The label statements specified in subsection 
                (a)(1) shall be randomly displayed in each 12-month 
                period, in as equal a number of times as is possible on 
                each brand of the product and be randomly distributed 
                in all areas of the United States in which the product 
                is marketed in accordance with a plan submitted by the 
                tobacco product manufacturer, importer, distributor, or 
                retailer and approved by the Secretary.
                    ``(B) The label statements specified in subsection 
                (a)(1) shall be rotated quarterly in alternating 
                sequence in advertisements for each brand of cigarettes 
                in accordance with a plan submitted by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer to, and approved by, the Secretary.
                    ``(C) The Secretary shall review each plan 
                submitted under subparagraph (B) and approve it if the 
                plan--
                            ``(i) will provide for the equal 
                        distribution and display on packaging and the 
                        rotation required in advertising under this 
                        subsection; and
                            ``(ii) assures that all of the labels 
                        required under this section will be displayed 
                        by the tobacco product manufacturer, importer, 
                        distributor, or retailer at the same time.''.
    (b) Repeal of Prohibition on State Restriction.--Section 5 of the 
Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1334) is 
amended--
            (1) by striking ``(a) Additional statements.--'' in 
        subsection (a); and
            (2) by striking subsection (b).

SEC. 502. AUTHORITY TO REVISE CIGARETTE WARNING LABEL STATEMENTS.

    Section 4 of the Federal Cigarette Labeling and Advertising Act ( 
15 U.S.C. 1333), as amended by section 301 of this title, is further 
amended by adding at the end the following:
    ``(c) Change in Required Statements.--The Secretary may, by a 
rulemaking conducted under section 553 of title 5, United States Code, 
adjust the format, type size, and text of any of the warning label 
statements required by subsection (a) of this section, or establish the 
format, type size, and text of any other disclosures required under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), if the 
Secretary finds that such a change would promote greater public 
understanding of the risks associated with the use of smokeless tobacco 
products.''.

SEC. 503. SMOKELESS TOBACCO LABELS AND ADVERTISING WARNINGS.

    Section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402) is amended to read as follows:

``SEC. 3. SMOKELESS TOBACCO WARNING.

    ``(a) General Rule.--
            ``(1) It shall be unlawful for any person to manufacture, 
        package, or import for sale or distribution within the United 
        States any smokeless tobacco product unless the product package 
        bears, in accordance with the requirements of this Act, one of 
        the following labels:
        ``WARNING: This product can cause mouth cancer''
        ``WARNING: This product can cause gum disease and tooth loss''
        ``WARNING: This product is not a safe alternative to 
        cigarettes''
        ``WARNING: Smokeless tobacco is addictive''
            ``(2) Each label statement required by paragraph (1) shall 
        be--
                    ``(A) located on the 2 principal display panels of 
                the package, and each label statement shall comprise at 
                least 25 percent of each such display panel; and
                    ``(B) in 17-point conspicuous and legible type and 
                in black text on a white background, or white text on a 
                black background, in a manner that contrasts by 
                typography, layout, or color, with all other printed 
                material on the package, in an alternating fashion 
                under the plan submitted under subsection (b)(3), 
                except that if the text of a label statement would 
                occupy more than 70 percent of the area specified by 
                subparagraph (A), such text may appear in a smaller 
                type size, so long as at least 60 percent of such 
                warning area is occupied by the label statement.
            ``(3) The label statements required by paragraph (1) shall 
        be introduced by each tobacco product manufacturer, packager, 
        importer, distributor, or retailer of smokeless tobacco 
        products concurrently into the distribution chain of such 
        products.
            ``(4) The provisions of this subsection do not apply to a 
        tobacco product manufacturer or distributor of any smokeless 
        tobacco product that does not manufacture, package, or import 
        smokeless tobacco products for sale or distribution within the 
        United States.
    ``(b) Required Labels.--
            ``(1) It shall be unlawful for any tobacco product 
        manufacturer, packager, importer, distributor, or retailer of 
        smokeless tobacco products to advertise or cause to be 
        advertised within the United States any smokeless tobacco 
        product unless its advertising bears, in accordance with the 
        requirements of this section, one of the labels specified in 
        subsection (a).
            ``(2) Each label statement required by subsection (a) in 
        smokeless tobacco advertising shall comply with the standards 
        set forth in this paragraph. For press and poster 
        advertisements, each such statement and (where applicable) any 
        required statement relating to tar, nicotine, or other 
        constituent yield shall--
                    ``(A) comprise at least 20 percent of the area of 
                the advertisement, and the warning area shall be 
                delineated by a dividing line of contrasting color from 
                the advertisement; and
                    ``(B) the word ``WARNING'' shall appear in capital 
                letters and each label statement shall appear in 
                conspicuous and legible type. The text of the label 
                statement shall be black on a white background, or 
                white on a black background, in an alternating fashion 
                under the plan submitted under paragraph (3).
            ``(3)(A) The label statements specified in subsection 
        (a)(1) shall be randomly displayed in each 12-month period, in 
        as equal a number of times as is possible on each brand of the 
        product and be randomly distributed in all areas of the United 
        States in which the product is marketed in accordance with a 
        plan submitted by the tobacco product manufacturer, importer, 
        distributor, or retailer and approved by the Secretary.
            ``(B) The label statements specified in subsection (a)(1) 
        shall be rotated quarterly in alternating sequence in 
        advertisements for each brand of smokeless tobacco product in 
        accordance with a plan submitted by the tobacco product 
        manufacturer, importer, distributor, or retailer to, and 
        approved by, the Secretary.
            ``(C) The Secretary shall review each plan submitted under 
        subparagraph (B) and approve it if the plan--
                    ``(i) will provide for the equal distribution and 
                display on packaging and the rotation required in 
                advertising under this subsection; and
                    ``(ii) assures that all of the labels required 
                under this section will be displayed by the tobacco 
                product manufacturer, importer, distributor, or 
                retailer at the same time.
    ``(c) Television and Radio Advertising.--It is unlawful to 
advertise smokeless tobacco on any medium of electronic communications 
subject to the jurisdiction of the Federal Communications 
Commission.''.

SEC. 504. AUTHORITY TO REVISE SMOKELESS TOBACCO PRODUCT WARNING LABEL 
              STATEMENTS.

    Section 3 of the Comprehensive Smokeless Tobacco Health Education 
Act of 1986 (15 U.S.C. 4402), as amended by section 303 of this title, 
is further amended by adding at the end the following:
    ``(d) Authority To Revise Warning Label Statements.--The Secretary 
may, by a rulemaking conducted under section 553 of title 5, United 
States Code, adjust the format, type size, and text of any of the 
warning label statements required by subsection (a) of this section, or 
establish the format, type size, and text of any other disclosures 
required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.), if the Secretary finds that such a change would promote 
greater public understanding of the risks associated with the use of 
smokeless tobacco products.''.

SEC. 505. TAR, NICOTINE, AND OTHER SMOKE CONSTITUENT DISCLOSURE TO THE 
              PUBLIC.

    Section 4(a) of the Federal Cigarette Labeling and Advertising Act 
(15 U.S.C. 1333 (a)), as amended by section 301 of this title, is 
further amended by adding at the end the following:
            ``(4)(A) The Secretary shall, by a rulemaking conducted 
        under section 553 of title 5, United States Code, determine (in 
        the Secretary's sole discretion) whether cigarette and other 
        tobacco product manufacturers shall be required to include in 
        the area of each cigarette advertisement specified by 
        subsection (b) of this section, or on the package label, or 
        both, the tar and nicotine yields of the advertised or packaged 
        brand. Any such disclosure shall be in accordance with the 
        methodology established under such regulations, shall conform 
        to the type size requirements of subsection (b) of this 
        section, and shall appear within the area specified in 
        subsection (b) of this section.
            ``(B) Any differences between the requirements established 
        by the Secretary under subparagraph (A) and tar and nicotine 
        yield reporting requirements established by the Federal Trade 
        Commission shall be resolved by a memorandum of understanding 
        between the Secretary and the Federal Trade Commission.
            ``(C) In addition to the disclosures required by 
        subparagraph (A) of this paragraph, the Secretary may, under a 
        rulemaking conducted under section 553 of title 5, United 
        States Code, prescribe disclosure requirements regarding the 
        level of any cigarette or other tobacco product smoke 
        constituent. Any such disclosure may be required if the 
        Secretary determines that disclosure would be of benefit to the 
        public health, or otherwise would increase consumer awareness 
        of the health consequences of the use of tobacco products, 
        except that no such prescribed disclosure shall be required on 
        the face of any cigarette package or advertisement. Nothing in 
this section shall prohibit the Secretary from requiring such 
prescribed disclosure through a cigarette or other tobacco product 
package or advertisement insert, or by any other means under the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).''.

Subtitle B--Testing and Reporting of Tobacco Product Smoke Constituents

SEC. 511. REGULATION REQUIREMENT.

    (a) Testing, Reporting, and Disclosure.--Not later than 24 months 
after the date of enactment of this title, the Secretary, through the 
Commissioner of the Food and Drug Administration, shall promulgate 
regulations under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301 et seq.) that meet the requirements of subsection (b).
    (b) Contents of Rules.--The rules promulgated under subsection (a) 
of this section shall require the testing, reporting, and disclosure of 
tobacco product smoke constituents and ingredients that the Secretary 
determines should be disclosed to the public in order to protect the 
public health. Such constituents shall include tar, nicotine, carbon 
monoxide, and such other smoke constituents or ingredients as the 
Secretary may determine to be appropriate. The rule may require that 
tobacco product manufacturers, packagers, or importers make such 
disclosures relating to tar and nicotine through labels or advertising, 
and make such disclosures regarding other smoke constituents or 
ingredients as the Secretary determines are necessary to protect the 
public health.
    (c) Authority.--The Food and Drug Administration shall have 
authority to conduct or to require the testing, reporting, or 
disclosure of tobacco product smoke constituents.

SEC. 512. FDA AMENDMENT.

    Section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb(a)(2)) is amended by inserting ``or targets and mechanisms 
of pathogenesis of diseases'' after ``disease or condition''.
                                 <all>