I
107TH CONGRESS
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 re-
ferred 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 Representa-
tives 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 pro-
grams.
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 state-
ments.
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 diag-
nosed with cancer. Each year 560,000 Americans die
from cancer. Approximately 40 percent of all Ameri-
cans 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 de-
clared, the science of cancer has advanced dramati-
cally. The revolution in molecular and cellular biol-
ogy has created unprecedented opportunities for un-
derstanding cancer and the role of genetics, environ-
mental risk factors, and prevention lifestyle factors
in relation to cancer.
(3) Since 1971, mortality rates for some can-
cers have decreased, while such rates for other can-
cers have not.
(4) Since 1971, the Nation’s population has be-
come increasingly diverse and cancer affects various
minority, socioeconomic, and ethnic groups dis-
proportionately.
(5) Cancer screening can reduce cancer mor-
tality, 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 cer-
vical 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 cov-
erage 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 con-
siderations into medical decisionmaking, which can
affect the quality of all health care provided, includ-
ing 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 clin-
ical trials support required to advance scientific dis-
coveries 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 di-
agnoses 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 inci-
dence 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 enter-
ing 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 in-
patient to outpatient settings.
(13) Since 1971, the conduct of research has
involved more collaboration between the public and
private sectors and more multidisciplinary ap-
proaches. The biotechnology industry has grown and
provided a broad array of new treatment options and
scientific opportunities for cancer patients, pro-
viders, and researchers.
(14) Since 1971, technology and communica-
tions 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 CAN-
CER-RELATED 
RESEARCH,
PREVENTION, 
AND 
TREAT-
MENT 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 Na-
tional 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 iden-
tify 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 caus-
ing 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 popu-
lations;
‘‘(4) research regarding palliative care, pain
management;
‘‘(5) research regarding preserving and restor-
ing quality-of-life for cancer patients;
‘‘(6) research regarding environmental risk fac-
tors for cancer and gene-environment interactions;
‘‘(7) research regarding management of symp-
toms;
‘‘(8) research regarding tools for early detec-
tion, especially for which there currently is no ade-
quate 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 pro-
vider representatives, and prepare 1 or more strategic
plans by July 1, 2004.
‘‘SEC. 417D–2. GRANTS FOR TRANSLATIONAL CANCER RE-
SEARCH.
‘‘(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 re-
search centers to conduct translational, multidisci-
plinary cancer research;
‘‘(2) establish networks and partnerships link-
ing the translational cancer research centers de-
scribed in paragraph (1) to community cancer pro-
viders (hospitals, clinics, providers’ practices, par-
ticularly in underserved areas) and expand opportu-
nities for all cancer patients to participate in clinical
trials of new agents developed by these centers;
‘‘(3) facilitate the process to award grants, con-
tracts, and cooperative agreements to private entities
to conduct translational cancer research in the fol-
lowing 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 cen-
ters 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 es-
tablish translational cancer research centers to con-
duct translational, multidisciplinary cancer research.
Funds shall not be used for construction of new fa-
cilities.
‘‘(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 enti-
ty desiring a grant under this subsection shall sub-
mit 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 CEN-
TERS.—The translational research centers shall—
‘‘(1) perform research for discovery and pre-
clinical evaluation of drugs, biologics, devices, tech-
nologies, 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 prom-
ising cancer treatments or strategies, in appropriate
human populations;
‘‘(3) evaluate promising cancer diagnostic tests,
techniques, or technologies in individuals being eval-
uated 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 compa-
nies 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, in-
cluding 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 ef-
fects of a drug, biologic medical treatment, or med-
ical device for the prevention, diagnosis, or treat-
ment of cancer or the potential side effects of treat-
ment.
‘‘(2) TRANSLATIONAL
CANCER
RESEARCH.—
The term ‘translational cancer research’ means sci-
entific 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 sub-
section (a) shall include—
‘‘(1) an outreach program;
‘‘(2) a diversity assurance program;
‘‘(3) an assistance program, including recom-
mending sources of funding for patients support
costs; and
‘‘(4) culturally appropriate materials.
‘‘(c) OUTREACH PROGRAM.—In carrying out the out-
reach program described in subsection (a), the Director
shall regularly provide information to cancer care pro-
viders, 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 sub-
section (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 work-
force needs.
‘‘(b) PROGRAM.—The program described in sub-
section (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 pro-
fessions with the most severe shortages;
‘‘(3) award grants, scholarships, fellowships,
and loans to eligible individuals to increase the can-
cer care workforce;
‘‘(4) make awards to eligible individuals to in-
crease cancer care workforce training for all individ-
uals to become cancer care providers, especially but
not limited to, such individuals who make a commit-
ment 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, phar-
macists, nurses for all settings, allied health profes-
sionals, physicians, specialists, and public health
professionals; 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 Sec-
retary shall request the Institute of Medicine of the Na-
tional Academies of Sciences to initiate a study by Janu-
ary 1, 2003, of the feasibility and costs of providing medi-
care 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 es-
tablished 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 medi-
care coverage to such individuals;
‘‘(B) estimate the cost to the medicare pro-
gram 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 out-
comes and assess the feasibility of providing
medicare coverage to uninsured cancer patients
through 5 years of remission and make a rec-
ommendation to Congress about whether Medi-
care 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 pre-
scription drug benefits and benefits to improve
home care, symptom management, psychosocial
services, and palliative and hospice care;
‘‘(B) estimate the cost to the medicare pro-
gram and to beneficiaries; and
‘‘(C) assess the medical advantages and
disadvantages associated with expanding bene-
fits.
‘‘(4) DEADLINES.—The first part shall be com-
pleted 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 rel-
evant 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 de-
cisions; and
‘‘(3) guidelines for providing patients with
multi-disciplinary consultation before treatment is
initiated and with one physician, preferably a spe-
cialist 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 re-
search and other activities to build an evidence base
regarding effective clinical and organizational inter-
vention strategies to improve the quality and out-
comes 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 prac-
tice.
‘‘(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 inter-
ventions;
‘‘(3) ensure the targeted dissemination of the
most current scientific evidence in appropriate for-
mats for use by professional societies and organiza-
tions representing clinicians and other caregivers, or-
ganizations through which health care and support
services are delivered, and organizations rep-
resenting 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 improve-
ment strategies or other initiatives to improve prac-
tice;
‘‘(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 in-
dividual physician can provide overall coordination
and management of cancer care.
‘‘(c) COORDINATION
OF FEDERAL QUALITY IM-
PROVEMENT 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 collabora-
tion 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 PRE-
VENTION.
‘‘(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 organiza-
tions, 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 organi-
zations, and the District of Columbia will use treat-
ments to prevent and control cancer and so that dis-
parities in specific populations will be addressed;
‘‘(4) coordinate with the National Cancer Insti-
tute;
‘‘(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 dispropor-
tionate incidence of or death from cancer;
‘‘(6) promote cancer education, prevention, and
early detection of cancer; and
‘‘(7) award grants to public and nonprofit orga-
nizations 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 fu-
ture fiscal years, the Director of the National Cancer In-
stitute, in coordination with the Secretary of Veterans Af-
fairs, shall carry out activities to—
‘‘(1) increase the number and amount of insti-
tutional training grants to institutions supporting
cancer research; and
‘‘(2) increase the number of career development
awards for health professionals, particularly minori-
ties, who intend to have, or who expand, careers in
basic, clinical, and translational cancer research, in-
cluding cancer prevention, cancer information tech-
nology, bioinformatics, behavioral research, and re-
search on palliative, psychosocial, and end-of-life
care.
‘‘(b) LOAN REPAYMENT.—
‘‘(1) ESTABLISHMENT.—The Director, in con-
sultation with the Director of the National Institutes
of Health, shall establish a cancer research loan re-
payment program.
‘‘(2) CONTRACTS.—Under the program estab-
lished 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 Gov-
ernment 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 profes-
sionals obtained to support training for degrees or li-
censes, as determined appropriate by the Director.
‘‘(c) POSTDOCTORAL STIPENDS.—
‘‘(1) IN GENERAL.—The Director of the Na-
tional 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 ex-
perience comparable to grade 11 of the Federal gen-
eral schedule under title 5, United States Code (civil
service salary schedule) and that adequately reflects
training, education, experience, and comparable sala-
ries or stipends for comparable work in non-Federal
settings, and provides for annual cost-of-living ad-
justments.
‘‘(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 identi-
fies 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 Serv-
ice 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 in-
surance coverage, provides coverage to a qualified in-
dividual (as defined in subsection (b)), the plan or
issuer—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (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 in-
dividual on the basis of the enrollee’s participa-
tion in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses 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 con-
strued 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 quali-
fied individual from participating in a trial even if
the plan or issuer does not have an in-network pro-
vider participating.
‘‘(b) QUALIFIED INDIVIDUAL DEFINED.—For pur-
poses 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 pro-
tocol 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 partici-
pating 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 en-
rollee provides medical and scientific information es-
tablishing that the individual’s participation in such
trial would be appropriate based upon the individual
meeting the criteria described above in such para-
graphs.
‘‘(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 appro-
priate 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 pay-
ment 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 Adminis-
tration; or
‘‘(3) a qualified non-governmental research en-
tity that specifies compliance with the guidelines set
forth in section 46 of title 45, Code of Federal Reg-
ulations and whose research is reviewed and ap-
proved through an institutional review board that—
‘‘(A) has been registered with the Depart-
ment 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 compli-
ance with such section of such Code.
‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi-
tions described in the paragraph for a study or investiga-
tion conducted by a department, are that the study or in-
vestigation has been reviewed and approved through a sys-
tem of peer review that the appropriate Secretary
determines—
‘‘(1) to be comparable to the system of peer re-
view of studies and investigations used by the Na-
tional Institutes of Health; and
‘‘(2) assures unbiased review of the highest eth-
ical 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 Pub-
lic Health Service Act is amended by inserting after sec-
tion 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 pro-
visions 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 add-
ing 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 insur-
ance coverage, provides coverage to a qualified indi-
vidual (as defined in subsection (b)), the plan or
issuer—
‘‘(A) may not deny the individual partici-
pation in the clinical trial referred to in sub-
section (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 in-
dividual on the basis of the enrollee’s participa-
tion in such trial.
‘‘(2) EXCLUSION OF CERTAIN COSTS.—For pur-
poses 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
‘‘(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 Adminis-
tration; or
‘‘(3) a qualified non-governmental research en-
tity that specifies compliance with the guidelines set
forth in section 46 of title 45, Code of Federal Reg-
ulations, and whose research is reviewed and ap-
proved through an institutional review board that—
‘‘(A) has been registered with the Depart-
ment of Health and Human Services; and
‘‘(B) is an institutional review board of an
institution that has received an appropriate fed-
eral assurance from the Department of Health
and Human Services assuring compliance with
such section of such Code.
‘‘(e) CONDITIONS FOR DEPARTMENTS.—The condi-
tions described in the paragraph for a study or investiga-
tion conducted by a department, are that the study or in-
vestigation has been reviewed and approved through a sys-
tem of peer review that the appropriate Secretary
determines—
‘‘(1) to be comparable to the system of peer re-
view of studies and investigations used by the Na-
tional Institutes of Health; and
‘‘(2) assures unbiased review of the highest eth-
ical 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 con-
tents in section 1 of the Employee Retirement Income Se-
curity 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 Pro-
gram 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 De-
fense;
(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
AMEND-
MENTS.—
(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 sec-
tion 1861(jj) of the Social Security Act) conducted
by a facility that has a certificate (or provisional cer-
tificate) 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 (Papani-
colaou test) provided to a woman for the pur-
pose 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 PROCE-
DURES.—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 fur-
nished to the individual for the purpose of early de-
tection 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 bene-
ficiary, in consultation with the participant or bene-
ficiary.
‘‘(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 coun-
seling for cessation of tobacco use for individ-
uals 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 bene-
ficiaries, is authorized to receive pay-
ment for other services under this title
or is designated by the Secretary for
this purpose.
‘‘(B) LIMITATION.—Subject to subpara-
graph (C), such therapy and counseling are lim-
ited 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 coun-
seling services that the Secretary recog-
nizes 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
SERV-
ICES.—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
SERV-
ICES.—
‘‘(A) IN GENERAL.—Genetic tests and ge-
netic services provided by a licensed health care
professional to obtain predictive genetic infor-
mation about an individual at risk of cancer for
purposes of a health assessment, cancer man-
agement, 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 in-
dividual, including a child who is born
to or placed for adoption with the in-
dividual; and
‘‘(III) all other individuals re-
lated by blood to the individual or the
spouse or child described in subclause
(I) or (II).
‘‘(ii) GENETIC
INFORMATION.—The
term ‘genetic information’ means informa-
tion about genes, gene products, or inher-
ited 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 serv-
ices by such individual or family member
of such individual).
‘‘(iii) GENETIC SERVICES.—The term
‘genetic services’ means health services, in-
cluding 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 ‘ge-
netic 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 INFORMA-
TION.—
‘‘(I) IN
GENERAL.—The term
‘predictive 
genetic 
information’
means—
‘‘(aa) information about an
individual’s genetic tests;
‘‘(bb) information about ge-
netic tests of family members of
the individual; or
‘‘(cc) information about the
occurrence of a disease or dis-
order 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 organi-
zations 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 contin-
ued 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 bene-
ficiary 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 man-
ner 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 bene-
ficiary 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 im-
posing deductibles, coinsurance, or other cost-shar-
ing in relation to benefits described in subsection (a)
consistent with such subsection, except that such co-
insurance or other cost-sharing shall not discrimi-
nate 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 evi-
dence, 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 recog-
nized 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 recog-
nizes 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 in-
surance 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 individ-
uals who are participants or beneficiaries as of such
date), and at least annually thereafter, the informa-
tion described in subsection (b) in printed form;
‘‘(2) provide to participants and beneficiaries,
within a reasonable period (as specified by the ap-
propriate Secretary) before or after the date of sig-
nificant changes in the information described in sub-
section (b), information in printed form regarding
such significant changes; and
‘‘(3) upon request, make available to partici-
pants and beneficiaries, the applicable authority, and
prospective participants and beneficiaries, the infor-
mation described in subsection (b) in printed form.
‘‘(b) INFORMATION PROVIDED.—The information de-
scribed 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, co-
insurance, 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 applica-
ble 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 pro-
viders participating in the plan or issuer net-
work.
‘‘(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) pro-
vided 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 pro-
viders.
‘‘(E) The rights and procedures for obtain-
ing 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 enroll-
ees 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 sec-
tion 1861(jj) of the Social Security Act) conducted
by a facility that has a certificate (or provisional cer-
tificate) 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 (Papani-
colaou test) provided to a woman for the pur-
pose 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 PROCE-
DURES.—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 fur-
nished to the individual for the purpose of early de-
tection 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 bene-
ficiary, in consultation with the participant or bene-
ficiary.
‘‘(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 coun-
seling for cessation of tobacco use for individ-
uals 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 profes-
sional who—
‘‘(I) is legally authorized to fur-
nish such services under State law (or
the State regulatory mechanism pro-
vided 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 subpara-
graph (C), such therapy and counseling are lim-
ited 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 coun-
seling services that the Secretary recog-
nizes 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
SERV-
ICES.—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
SERV-
ICES.—
‘‘(A) IN GENERAL.—Genetic tests and ge-
netic services provided by a licensed health care
professional to obtain predictive genetic infor-
mation about an individual at risk of cancer for
purposes of a health assessment, cancer man-
agement, 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 in-
dividual, including a child who is born
to or placed for adoption with the in-
dividual; and
‘‘(III) all other individuals re-
lated by blood to the individual or the
spouse or child described in subclause
(I) or (II).
‘‘(ii) GENETIC
INFORMATION.—The
term ‘genetic information’ means informa-
tion about genes, gene products, or inher-
ited 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 serv-
ices by such individual or family member
of such individual).
‘‘(iii) GENETIC SERVICES.—The term
‘genetic services’ means health services, in-
cluding 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 ‘ge-
netic 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 INFORMA-
TION.—
‘‘(I) IN
GENERAL.—The term
‘predictive 
genetic 
information’
means—
‘‘(aa) information about an
individual’s genetic tests;
‘‘(bb) information about ge-
netic tests of family members of
the individual; or
‘‘(cc) information about the
occurrence of a disease or dis-
order 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 organi-
zations 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 contin-
ued 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 bene-
ficiary 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 man-
ner 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 bene-
ficiary 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 im-
posing deductibles, coinsurance, or other cost-shar-
ing in relation to benefits described in subsection (a)
consistent with such subsection, except that such co-
insurance or other cost-sharing shall not discrimi-
nate 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 treat-
ed as a material modification in the terms of the plan de-
scribed in section 102(a), for purposes of assuring notice
of such requirements under the plan; except that the sum-
mary description required to be provided under the last
sentence of section 104(b)(1) with respect to such modi-
fication shall be provided by not later than 60 days after
the first day of the first plan year in which such require-
ment 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 evi-
dence, 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 recog-
nized 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 recog-
nizes 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 in-
surance 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 individ-
uals who are participants or beneficiaries as of such
date), and at least annually thereafter, the informa-
tion described in subsection (b) in printed form;
‘‘(2) provide to participants and beneficiaries,
within a reasonable period (as specified by the ap-
propriate Secretary) before or after the date of sig-
nificant changes in the information described in sub-
section (b), information in printed form regarding
such significant changes; and
‘‘(3) upon request, make available to partici-
pants and beneficiaries, the applicable authority, and
prospective participants and beneficiaries, the infor-
mation described in subsection (b) in printed form.
‘‘(b) INFORMATION PROVIDED.—The information de-
scribed 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, co-
insurance, 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 applica-
ble 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 pro-
viders participating in the plan or issuer net-
work.
‘‘(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) pro-
vided 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 pro-
viders.
‘‘(E) The rights and procedures for obtain-
ing 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 enroll-
ees 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 strik-
ing ‘‘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 strik-
ing ‘‘section 711’’ and inserting ‘‘sections
711 and 715’’.
(iii) The table of contents in section 1
of the Employee Retirement Income Secu-
rity Act of 1974, as amended by section
202, is further amended by inserting after
the item relating to section 714 the fol-
lowing 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 indi-
vidual market with respect to an enrollee under such cov-
erage in the same manner as they apply to health insur-
ance coverage offered by a health insurance issuer in con-
nection 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 sec-
tion 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 in-
surance 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 para-
graph (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 be-
tween employee representatives and 1 or more em-
ployers 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 ter-
minates (determined without regard to any ex-
tension thereof agreed to after the date of en-
actment of this Act), or
(B) January 1, 2002.
For purposes of subparagraph (A), any plan amend-
ment 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 require-
ments 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 re-
garding such screening, such as the use of new tests
or other emerging technologies. Such modifications
shall not in any way diminish the coverage require-
ments 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 re-
quirements under paragraph (1), the Secretary of
Health and Human Services shall consult with ap-
propriate organizations, experts, and agencies.
(3) PETITIONS.—The Secretary of Health and
Human Services may issue requirements for the pe-
titioning process under paragraph (1), including re-
quirements that the petition be in writing and in-
clude scientific or medical bases for the modification
sought. Upon receipt of such a petition, the Sec-
retary 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 re-
quired, the Secretary shall propose such regulation
within 6 months of such determination. The Sec-
retary 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 insur-
ance 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 des-
ignated 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 bene-
ficiary 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 fol-
low the most current quality-of-care cancer care guide-
lines, as developed by medical professionals with expertise
in the field of medicine for which the guidelines are de-
signed 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 contin-
ued 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 bene-
ficiary 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 man-
ner 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 sub-
sections (a) or (b) consistent with such subsections, except
that such coinsurance or other cost-sharing shall not dis-
criminate 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 Pub-
lic Health Service Act is amended by inserting after sec-
tion 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 pro-
visions 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 EM-
PLOYEE 
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 sec-
tions 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 insur-
ance 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 des-
ignated at the time of diagnosis by the participant or bene-
ficiary involved to provide for the overall coordination and
management of the cancer care of the participant or bene-
ficiary among all providers who provide items or services
to the participant or beneficiary and paid for overall co-
ordination 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 fol-
low the most current quality-of-care cancer care guide-
lines, as developed by medical professionals with expertise
in the field of medicine for which the guidelines are de-
signed 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 contin-
ued 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 bene-
ficiary 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 man-
ner 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 sub-
sections (a) or (b) consistent with such subsections, except
that such coinsurance or other cost-sharing shall not dis-
criminate 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 con-
tents in section 1 of the Employee Retirement Income Se-
curity 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 REQUIRE-
MENTS.—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 physi-
cians at the time of diagnosis of the individual as the phy-
sician responsible for the overall coordination and manage-
ment 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 em-
ployer 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 other-
wise 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 Secu-
rity 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 fol-
lowing:
‘‘(66) provide—
‘‘(A) that the provisions of sections 2707,
2708, and 2710 of the Public Health Service
Act shall apply to individuals eligible for med-
ical 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 physi-
cians’ services that are related to that diag-
nosis, that there shall be paid to the physician
designated by such team of physicians at the
time of diagnosis of the individual as the physi-
cian 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 addi-
tional 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 PRO-
VISIONS.—
‘‘(A) IN GENERAL.—The provisions of sec-
tions 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 ex-
penses 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 coordina-
tion and management of the medical and other
health services provided to that individual dur-
ing the period in which that individual is under-
going treatment for such cancer, a separate and
additional payment amount for the services pro-
vided in addition to any amount otherwise paid
under the State child health plan.’’.
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 COV-
ERAGE.—Chapter 89 of title 5, United States Code, is
amended by adding at the end the following:
‘‘§ 8915. Standards relating to coverage of cancer-re-
lated 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 enti-
ty 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 per-
mitted 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 to-
bacco-dependent children and adults.
(2) A consensus exists within the scientific and
medical communities that tobacco products are in-
herently 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 con-
tribute 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 ade-
quately to curb tobacco use by adolescents, com-
prehensive 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 to-
bacco 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 Constitu-
tion, the Congress is vested with the responsibility
for regulating interstate commerce and commerce
with Indian tribes.
(10) The sale, distribution, marketing, adver-
tising, and use of tobacco products are activities in
and substantially affecting interstate commerce be-
cause they are sold, marketed, advertised, and dis-
tributed in interstate commerce on a nationwide
basis, and have a substantial effect on the Nation’s
economy.
(11) The sale, distribution, marketing, adver-
tising, and use of such products substantially affect
interstate commerce through the health care and
other costs attributable to the use of tobacco prod-
ucts.
(12) It is in the public interest to restrict
throughout the Nation the sale, distribution, mar-
keting, 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 at-
tract young persons to use tobacco products and
these efforts have resulted in increased use of such
products by youth. Past efforts to oversee these ac-
tivities have not been successful in adequately pre-
venting 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 spon-
sorship of sporting events, tobacco has become
strongly associated with sports and has become por-
trayed 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 favor-
able beliefs about tobacco use, plays a role in leading
young people to overestimate the prevalence of to-
bacco 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 to-
bacco products including increasing tobacco use by
young people.
(22) Children are more influenced by tobacco
advertising than adults, they smoke the most adver-
tised brands.
(23) Tobacco company documents indicate that
young people are an important and often crucial seg-
ment 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 un-
dermining legislation prohibiting access to young
people and providing for education about tobacco
use.
(26) International experience shows that adver-
tising regulations that are stringent and comprehen-
sive have a greater impact on overall tobacco use
and young people’s use than weaker or less com-
prehensive ones. Text-only requirements, while not
as stringent as a ban, will help reduce underage use
of tobacco products while preserving the informa-
tional 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 pic-
tures 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 pri-
mary Federal regulatory authority with respect to
the manufacture, marketing, and distribution of to-
bacco products;
(2) to ensure that the Food and Drug Adminis-
tration and the States may continue to address
issues of particular concern to public health officials,
especially the use of tobacco by young people and de-
pendence on tobacco;
(3) to impose financial surcharges on tobacco
product manufacturers if tobacco use by young peo-
ple does not substantially decline;
(4) to authorize appropriate agencies of the
Federal government to set national standards con-
trolling the manufacture of tobacco products and the
identity, public disclosure, and amount of ingredi-
ents used in such products;
(5) to provide new and flexible enforcement au-
thority to ensure that the tobacco industry makes ef-
forts to develop and introduce less harmful tobacco
products;
(6) to confirm the Food and Drug Administra-
tion’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 in-
formed, 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 under-
age 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 ac-
tion; 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 gov-
ernments with regard to taxation for tobacco or tobacco
products.
(c) AGRICULTURAL ACTIVITIES.—The provisions of
this title which authorize the Secretary to take certain ac-
tions 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 polit-
ical subdivisions, or the government of an Indian tribe
from adopting and enforcing additional measures that fur-
ther restrict or prohibit tobacco product sale to, use by,
and accessibility to persons under the legal age of pur-
chase 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, promul-
gate, and enforce any law, rule, regulation, or other meas-
ure 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 addi-
tion 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 super-
sede any State, local, or Tribal law that is not less strin-
gent than this title, or other Acts as amended by this title.
(d) STATE LAW NOT AFFECTED.—Except as other-
wise 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 vari-
ety of tobacco product distinguished by the tobacco
used, tar content, nicotine content, flavoring used,
size, filtration, or packaging, logo, registered trade-
mark 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 Fed-
eral 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, be-
cause 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 ciga-
rette 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 to-
bacco, 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 con-
sidered 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 Assist-
ance 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 cello-
phane), in which cigarettes or smokeless tobacco are
offered for sale, sold, or otherwise distributed to con-
sumers.
(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 op-
erates 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 label-
ing, 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 ‘‘smoke-
less 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 Common-
wealth of Puerto Rico, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, the Northern Mar-
iana Islands, and any other trust territory or posses-
sion of the United States.
(17) TOBACCO PRODUCT.—The term ‘‘tobacco
product’’ means cigarettes, cigarette tobacco, smoke-
less 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 smoke-
less 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 Common-
wealth of Puerto Rico, Guam, the Virgin Islands,
American Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, the Northern Mar-
iana Islands, and any other trust territory or posses-
sion 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 lim-
iting 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 dis-
approve, 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 fol-
lowing:
‘‘(kk) The term ‘tobacco product’ means any
product made or derived from tobacco that is in-
tended for human consumption, including any com-
ponent, part, or accessory of a tobacco product (ex-
cept 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 regu-
lated 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.—
100
‘‘(1) Nothing in this chapter, any policy issued
or regulation promulgated thereunder, or the Na-
tional Tobacco Policy and Youth Smoking Reduction
Act, shall be construed to affect the Secretary’s au-
thority 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 em-
ployee 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 pro-
ducer of tobacco leaf is also a tobacco product man-
ufacturer or controlled by a tobacco product manu-
facturer, the producer shall be subject to this chap-
ter 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
101
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 com-
mon 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 sub-
stance 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 perform-
102
ance 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 stor-
age are not in conformity with applicable require-
ments under section 906(e)(1) or an applicable con-
dition prescribed by an order under section
906(e)(2); or
‘‘(7) it is a tobacco product for which an ex-
emption 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 com-
ply 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;
103
‘‘(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 dis-
tributor; 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 para-
graph 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 informa-
tion required by or under authority of this chapter
to appear on the label or labeling is not prominently
placed thereon with such conspicuousness (as com-
pared 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 nonpropri-
etary name, its established name prominently print-
ed in type as required by the Secretary by regula-
tion;
104
‘‘(5) if the Secretary has issued regulations re-
quiring 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 regula-
tions;
‘‘(6) if it was manufactured, prepared, propa-
gated, 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 re-
specting it was not provided as required by such sec-
tion 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 dis-
tributed 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 vio-
lation 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 man-
105
ufacturer, packer, or distributor thereof includes in
all advertisements and other descriptive printed mat-
ter issued or caused to be issued by the manufac-
turer, packer, or distributor with respect to that to-
bacco product—
‘‘(A) a true statement of the tobacco prod-
uct’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 oppor-
tunity for a hearing;
‘‘(9) if it is a tobacco product subject to a per-
formance standard established under section 907,
106
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 pre-
scribed under section 904 or 908;
‘‘(B) to furnish any material or informa-
tion 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 Na-
tional 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).
107
‘‘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 man-
ufacturer or importer of tobacco products, or agents there-
of, shall submit to the Secretary the following information:
‘‘(1) A listing of all tobacco ingredients, sub-
stances and compounds that are, on such date,
added by the manufacturer to the tobacco, paper, fil-
ter, 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 sci-
entific information) relating to research activities,
and research findings, conducted, supported, or pos-
sessed by the manufacturer (or agents thereof) on
the health, behavioral, or physiologic effects of to-
bacco products, their constituents, ingredients, and
components, and tobacco additives, described in
paragraph (1).
‘‘(4) All documents (including underlying sci-
entific information) relating to research activities,
and research findings, conducted, supported, or pos-
108
sessed 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 sci-
entific 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 man-
ufacturer or importer that is required to submit informa-
tion 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 com-
merce 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 re-
quired under subsection (a) and such product shall
be subject to the annual submission under sub-
section (b).
109
‘‘(2) MODIFICATION OF EXISTING PRODUCTS.—
If at any time a tobacco product manufacturer adds
to its tobacco products a new tobacco additive, in-
creases or decreases the quantity of an existing to-
bacco additive or the nicotine content, delivery, or
form, or eliminates a tobacco additive from any to-
bacco product, the manufacturer shall within 60
days of such action so advise the Secretary in writ-
ing 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 repack-
aging or otherwise changing the container, wrapper,
or labeling of any tobacco product package in fur-
therance 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 con-
sumer 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 cor-
porate officer and director, and the State of incorpo-
ration.
110
‘‘(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 proc-
essing of a tobacco product or tobacco products shall reg-
ister with the Secretary the name, places of business, and
all such establishments of that person.
‘‘(c) REGISTRATION OF NEW OWNERS AND OPERA-
TORS.—Every person upon first engaging in the manufac-
ture, 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 addi-
tional establishment which that person owns or operates
in any State and in which that person begins the manufac-
ture, preparation, compounding, or processing of a tobacco
product or tobacco products.
‘‘(e) UNIFORM
PRODUCT
IDENTIFICATION
SYS-
TEM.—The Secretary may by regulation prescribe a uni-
form system for the identification of tobacco products and
may require that persons who are required to list such
111
tobacco products under subsection (i) of this section shall
list such tobacco products in accordance with such system.
‘‘(f) PUBLIC ACCESS TO REGISTRATION INFORMA-
TION.—The Secretary shall make available for inspection,
to any person so requesting, any registration filed under
this section.
‘‘(g) BIENNIAL INSPECTION OF REGISTERED ESTAB-
LISHMENTS.—Every establishment in any State registered
with the Secretary under this section shall be subject to
inspection under section 704, and every such establish-
ment engaged in the manufacture, compounding, or proc-
essing 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 es-
tablishment 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 establish-
ment to provide the information required by subsection (i)
of this section and shall include provisions for registration
112
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 to-
bacco 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 reg-
isters with the Secretary under subsection (b), (c),
or (d) of this section shall, at the time of registra-
tion under any such subsection, file with the Sec-
retary 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 pre-
scribe and shall be accompanied by—
‘‘(A) in the case of a tobacco product con-
tained in the applicable list with respect to
which a performance standard has been estab-
113
lished 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 prod-
uct 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 de-
termined that a tobacco product contained in
such list is not subject to a performance stand-
ard established under section 907, a brief state-
ment of the basis upon which the registrant
made such determination if the Secretary re-
quests 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 Sec-
retary once during the month of June of each year
114
and once during the month of December of each
year the following:
‘‘(A) A list of each tobacco product intro-
duced by the registrant for commercial distribu-
tion which has not been included in any list
previously filed by that person with the Sec-
retary under this subparagraph or paragraph
(1) of this subsection. A list under this sub-
paragraph shall list a tobacco product by its es-
tablished 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 dis-
tribution 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 estab-
lished name.
‘‘(C) If since the date the registrant re-
ported under subparagraph (B) a notice of dis-
continuance that person has resumed the manu-
facture, preparation, compounding, or proc-
essing for commercial distribution of the to-
115
bacco 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 para-
graph (1), unless the registrant has previously
reported such resumption to the Secretary
under this subparagraph.
‘‘(D) Any material change in any informa-
tion previously submitted under this paragraph
or paragraph (1).
‘‘(j) REPORT PRECEDING INTRODUCTION OF CER-
TAIN
SUBSTANTIALLY-EQUIVALENT
PRODUCTS
INTO
INTERSTATE COMMERCE.—
‘‘(1) IN
GENERAL.—Each person who is re-
quired to register under this section and who pro-
poses to begin the introduction or delivery for intro-
duction into interstate commerce for commercial dis-
tribution of a tobacco product intended for human
use that was not commercially marketed (other than
for test marketing) in the United States as of Au-
gust 11, 1995, as defined by the Secretary by regu-
lation shall, at least 90 days before making such in-
troduction or delivery, report to the Secretary (in
116
such form and manner as the Secretary shall by reg-
ulation prescribe)—
‘‘(A) the basis for such person’s determina-
tion 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 compli-
ance with the requirements of this Act; and
‘‘(B) action taken by such person to com-
ply 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 enact-
ment of the National Tobacco Policy and Youth
Smoking Reduction Act shall be submitted to the
Secretary within 6 months after the date of enact-
ment of that Act.
117
‘‘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, sec-
tion 910, or subsection (d) of this section, and any re-
quirement 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 COM-
MENT.—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 re-
spect 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 find-
118
ings (including the need therefor) orally or in writ-
ing, 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
INFORMA-
TION.—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 sub-
section (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, distribu-
tion, or use upon such conditions, including restric-
tions on the access to, and the advertising and pro-
motion of, the tobacco product, as the Secretary may
prescribe in such regulation if, because of its poten-
tiality for harmful effect or the collateral measures
119
necessary to its use, the Secretary determines that
such regulation would be appropriate for the protec-
tion of the public health. The finding as to whether
such regulation would be appropriate for the protec-
tion 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 to-
bacco 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 dis-
tribution of a tobacco product be limited to the writ-
ten 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 re-
quired 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-
120
face transactions by a specific category of retail out-
lets.
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.—
‘‘(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 fa-
cilities 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 manufac-
turing practice, as prescribed in such regula-
tions, to assure that the public health is pro-
tected and that the tobacco product is in com-
pliance with this chapter.
‘‘(B) The Secretary shall—
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford an ad-
visory committee an opportunity to submit
recommendations with respect to the regu-
lation proposed to be promulgated;
121
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing;
‘‘(iii) provide the advisory committee a
reasonable time to make its recommenda-
tion 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 dif-
ferences in the manner in which the dif-
ferent types of tobacco products have his-
torically been produced, the financial re-
sources of the different tobacco product
manufacturers, and the state of their exist-
ing manufacturing facilities; and shall pro-
vide for a reasonable period of time for
such manufacturers to conform to good
manufacturing practices.
‘‘(2) EXEMPTIONS; VARIANCES.—
‘‘(A) Any person subject to any require-
ment prescribed under paragraph (1) may peti-
tion the Secretary for a permanent or tem-
porary exemption or variance from such re-
quirement. Such a petition shall be submitted
122
to the Secretary in such form and manner as
the Secretary shall prescribe and shall—
‘‘(i) in the case of a petition for an ex-
emption 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 meth-
ods, 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 advi-
sory committee any petition submitted under
subparagraph (A). The advisory committee
shall report its recommendations to the Sec-
retary with respect to a petition referred to it
123
within 60 days after the date of the petition’s
referral. Within 60 days after—
‘‘(i) the date the petition was sub-
mitted to the Secretary under subpara-
graph (A); or
‘‘(ii) the day after the petition was re-
ferred 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 compli-
ance with this chapter; and
‘‘(ii) a petition for a variance for a to-
bacco 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 pre-
scribed by the requirement are sufficient to
124
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 manu-
facture, 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 pe-
titioner shall have an opportunity for an infor-
mal 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 Reduc-
tion Act.
‘‘(f) EXEMPTION FOR INVESTIGATIONAL USE.—The
Secretary may exempt tobacco products intended for in-
vestigational use from this chapter under such conditions
as the Secretary may prescribe by regulation.
125
‘‘(g) RESEARCH
AND DEVELOPMENT.—The Sec-
retary may enter into contracts for research, testing, and
demonstrations respecting tobacco products and may ob-
tain tobacco products for research, testing, and dem-
onstration 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, in-
cluding 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.
126
‘‘(2) CONTENT
OF
PERFORMANCE
STAND-
ARDS.—A performance standard established under
this section for a tobacco product—
‘‘(A) shall include provisions to provide
performance that is appropriate for the protec-
tion 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 compo-
nents of the product; or
‘‘(iii) relating to any other require-
ment under (B);
‘‘(B) shall, where necessary to be appro-
priate for the protection of the public health,
include—
‘‘(i) provisions respecting the con-
struction, components, ingredients, and
properties of the tobacco product;
‘‘(ii) provisions for the testing (on a
sample basis or, if necessary, on an indi-
vidual basis) of the tobacco product;
127
‘‘(iii) provisions for the measurement
of the performance characteristics of the
tobacco product;
‘‘(iv) provisions requiring that the re-
sults 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 prod-
uct be restricted but only to the extent
that the sale and distribution of a tobacco
product may be restricted under a regula-
tion under section 906(d); and
‘‘(C) shall, where appropriate, require the
use and prescribe the form and content of label-
ing for the proper use of the tobacco product.
‘‘(3) PERIODIC RE-EVALUATION OF PERFORM-
ANCE STANDARDS.—The Secretary shall provide for
periodic evaluation of performance standards estab-
lished under this section to determine whether such
standards should be changed to reflect new medical,
scientific, or other technological data. The Secretary
128
may provide for testing under paragraph (2) by any
person.
‘‘(4) INVOLVEMENT OF OTHER AGENCIES; IN-
FORMED
PERSONS.—In carrying out duties under
this section, the Secretary shall, to the maximum ex-
tent 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 na-
tionally or internationally recognized standard-
setting entities; and
‘‘(C) 
invite 
appropriate 
participation,
through joint or other conferences, workshops,
or other means, by informed persons represent-
ative of scientific, professional, industry, or con-
sumer 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 rule-
making for the establishment, amendment, or
129
revocation of any performance standard for a
tobacco product.
‘‘(B) A notice of proposed rulemaking for
the establishment or amendment of a perform-
ance standard for a tobacco product shall—
‘‘(i) set forth a finding with sup-
porting 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 sub-
mit an existing performance standard for
the tobacco product, including a draft or
proposed performance standard, for consid-
eration 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 nec-
essary to be appropriate for the protection of
the public health.
130
‘‘(D) The Secretary shall consider all infor-
mation submitted in connection with a proposed
standard, including information concerning the
countervailing effects of the performance stand-
ard on the health of adolescent tobacco users,
adult tobacco users, or non-tobacco users, such
as the creation of a significant demand for con-
traband 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 protec-
tion 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 per-
formance standard and after consideration of
such comments and any report from an advi-
sory committee, the Secretary shall—
‘‘(i) promulgate a regulation estab-
lishing a performance standard and pub-
131
lish 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 perform-
ance 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 pub-
lic health. Such date or dates shall be estab-
lished 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 CON-
TENT.—Because of the importance of a decision of
the Secretary to issue a regulation establishing a
performance standard—
132
‘‘(A) eliminating all cigarettes, all smoke-
less tobacco products, or any similar class of to-
bacco products, or
‘‘(B) requiring the reduction of nicotine
yields of a tobacco product to zero,
it is appropriate for the Congress to have the oppor-
tunity 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 ac-
cordance with the requirements of paragraphs
(1) and (2)(B) of this subsection, amend or re-
voke a performance standard.
‘‘(B) The Secretary may declare a pro-
posed 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 ef-
fective is in the public interest.
133
‘‘(5) REFERENCE TO ADVISORY COMMITTEE.—
The Secretary—
‘‘(A) may, on the Secretary’s own initia-
tive, refer a proposed regulation for the estab-
lishment, amendment, or revocation of a per-
formance standard; or
‘‘(B) shall, upon the request of an inter-
ested 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 mat-
ter involved in the proposed regulation which requires the
exercise of scientific judgment. If a proposed regulation
is referred under this subparagraph to the advisory com-
mittee, 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 fur-
nished to it by the Secretary and other data and informa-
tion before it, submit to the Secretary a report and rec-
ommendation respecting such regulation, together with all
underlying data and information and a statement of the