| TITLE
III -- GENERAL POWERS AND DUTIES OF PUBLIC HEALTH
SERVICE PART M -- NATIONAL PROGRAM
OF CANCER REGISTRIES
SEC.
399H. [280e] NATIONAL PROGRAM OF CANCER
REGISTRIES.
(a)
IN GENERAL. -- The Secretary, acting through the
Director of the Centers for Disease Control, may
make grants to States, or may make grants or
enter into contracts with academic or non-profit
organizations designated by the State to operate
the State's cancer registry in lieu of making a
grant directly to the State, to support the
operation of population-based, statewide cancer
registries in order to collect, for each form of
in-situ and invasive cancer (with the exception
of basal cell and squamous cell carcinoma of the
skin), data concerning --
(1)
demographic information about each case of
cancer;
(2)
information on the industrial or occupational
history of the individuals with the cancers, to
the extent such information is available from the
same record;
(3)
administrative information, including date of
diagnosis and source of information;
(4)
pathological data characterizing the cancer,
including the cancer site, stage of disease
(pursuant to Staging Guide), incidence, and type
of treatment; and
(5)
other elements determined appropriate by the
Secretary.
(b)
MATCHING FUNDS. --
(1)
IN GENERAL. -- The Secretary may make a grant
under subsection (a) only if the State, or the
academic or nonprofit private organization
designated by the State to operate the cancer
registry of the State, involved agrees, with
respect to the costs of the program, to make
available (directly or through donations from
public or private entities) non-Federal
contributions toward such costs in an amount that
is not less than 25 percent of such costs or $1
for every $3 of Federal funds provided in the
grant.
(2)
DETERMINATION OF AMOUNT OF NON-FEDERAL
CONTRIBUTION; MAINTENANCE OF EFFORT. --
(A)
Non-Federal contributions required in paragraph
(1) may be in cash or in kind, fairly evaluated,
including plant, equipment, or services. Amounts
provided by the Federal Government, or services
assisted or subsidized to any significant extent
by the Federal Government, may not be included in
determining the amount of such non-Federal
contributions.
(B)
With respect to a State in which the purpose
described in subsection (a) is to be carried out,
the Secretary, in making a determination of the
amount of non-Federal contributions provided
under paragraph (1), may include, only such
contributions as are in excess of the amount of
such contributions made by the State toward the
collection of data on cancer for the fiscal year
preceding the first year for which a grant under
subsection (a) is made with respect to the State.
The Secretary may decrease the amount of
non-Federal contributions that otherwise would
have been required by this subsection in those
cases in which the State can demonstrate that
decreasing such amount is appropriate because of
financial hardship.
(C)
ELIGIBILITY FOR GRANTS. --
(1)
IN GENERAL. -- No grant shall be made by the
Secretary under subsection (a) unless an
application has been submitted to, and approved
by, the Secretary. Such application shall be in
such form, submitted in such a manner, and be
accompanied by such information, as the Secretary
may specify. No such application may be approved
unless it contains assurances that the applicant
will use the funds provided only for the purposes
specified in the approved application and in
accordance with the requirements of this section,
that the application will establish such fiscal
control and fund accounting procedures as may be
necessary to assure proper disbursement and
accounting of Federal funds paid to the applicant
under subsection (a) of this section, and that
the applicant will comply with the peer review
requirements under sections 491 and 492.
(2)
ASSURANCES.-- Each applicant, prior to receiving
Federal funds under subsection (a), shall provide
assurances satisfactory to the Secretary that the
applicant will --
(A)
provide for the establishment of a registry in
accordance with subsection (a);
(B)
comply with appropriate standards of
completeness, timeliness, and quality of
population-based cancer registry data;
(C)
provide for the annual publication of reports of
cancer data under subsection (a); and
(D)
provide for the authorization under State law of
the statewide cancer registry, including
promulgation of regulations providing --
(i) a
means to assure complete reporting of cancer
cases (as described in subsection (a)) to the
statewide cancer registry by hospitals or other
facilities providing screening, diagnostic or
therapeutic services to patients with respect to
cancer;
(ii)
a means to assure the complete reporting of
cancer cases (as defined in subsection (a)) to
the statewide cancer registry by physicians,
surgeons, and all other health care practitioners
diagnosing or providing treatment for cancer
patients, except for cases directly referred to
or previously admitted to a hospital or other
facility providing screening, diagnostic or
therapeutic services to patients in that State
and reported by those facilities;
(iii)
a means for the statewide cancer registry to
access all records of physicians and surgeons,
hospitals, outpatient clinics, nursing homes, and
all other facilities, individuals, or agencies
providing such services to patients which would
identify cases of cancer or would establish
characteristics of the cancer, treatment of the
cancer, or medical status of any identified
patient;
(iv)
for the reporting of cancer case data to the
statewide cancer registry in such a format, with
such data elements, and in accordance with such
standards of quality timeliness and completeness,
as may be established by the Secretary;
(v)
for the protection of the confidentiality of all
cancer case data reported to the statewide cancer
registry, including a prohibition on disclosure
to any person of information reported to the
statewide cancer registry that identifies, or
could lead to the identification of, an
individual cancer patient, except for disclosure
to other State cancer registries and local and
State health officers;
(vi)
for a means by which confidential case data may
in accordance with State law be disclosed to
cancer researchers for the purposes of cancer
prevention, control and research;
(vii)
for the authorization or the conduct, by the
statewide cancer registry or other persons and
organizations, of studies utilizing statewide
cancer registry data, including studies of the
sources and causes of cancer, evaluations of the
cost, quality, efficacy, and appropriateness of
diagnostic, therapeutic, rehabilitative, and
preventative services and programs relating to
cancer, and any other clinical, epidemiological,
or other cancer research; and
(viii)
for protection for individuals complying with the
law, including provisions specifying that no
person shall be held liable in any civil action
with respect to a cancer case report provided to
the statewide cancer registry, or with respect to
access to cancer case information provided to the
statewide cancer registry.
(d)
RELATIONSHIP TO CERTAIN PROGRAMS.--
(1)
IN GENERAL. -- This section may not be construed
to act as a replacement for or diminishment of
the program carried out by the Director of the
National Cancer Institute and designated by such
Director as the Surveillance, Epidemiology, and
End Results Program (SEER).
(2)
SUPPLANTING OF ACTIVITIES.-- In areas where both
such programs exist, the Secretary shall ensure
that SEER support is not supplanted and that any
additional activities are consistent with the
guidelines provided for in subsection (c)(2) (C)
and (D) and are appropriately coordinated with
the existing SEER program.
(3)
TRANSFER OF RESPONSIBILITY. -- The Secretary may
not transfer administration responsibility for
such SEER program from such Director.
(4)
COORDINATION.-- To encourage the greatest
possible efficiency and effectiveness of
Federally supported efforts with respect to the
activities described in this subsection, the
Secretary shall take steps to assure the
appropriate coordination of programs supported
under this part with existing Federally supported
cancer registry programs.
(e)
REQUIREMENT REGARDING CERTAIN STUDY ON BREAST
CANCER. -In the case of a grant under subsection
(a) to any State specified in section 399K(b),
the Secretary may establish such conditions
regarding the receipt of the grant as the
Secretary determines are necessary to facilitate
the collection of data for the study carried out
under section 399C.
SEC.
399I. [280e-1] PLANNING GRANTS REGARDING
REGISTRIES
(a)
IN GENERAL. --
(1)
STATES. -- The Secretary, acting through the
Director of the Centers for Disease Control, may
make grants to States for the purpose of
developing plans that meet the assurances
required by the Secretary under section
399B(c)(2).
(2)
OTHER ENTITIES. -- For the purpose described in
paragraph (1), the Secretary may make grants to
public entities other than States and to
nonprofit private entities. Such a grant may be
made to an entity only if the State in which the
purpose is to be carried out has certified that
the State approves the entity as qualified to
carry out the purpose.
(b)
APPLICATION. -- The Secretary may make a grant
under subsection (a) only if an application for
the grant is submitted to the Secretary, the
application contains the certification required
in subsection (a)(2) (if the application is for a
grant under such subsection), and the application
is in such form, is made in such manner, and
contains such agreements, assurances, and
information as the Secretary determines to be
necessary to carry out this section.
SEC.
399J. [280-2] TECHNICAL ASSISTANCE IN OPERATIONS
OF STATEWIDE CANCER REGISTRIES.
The
Secretary, acting through the Director of the
Centers for Disease Control, may, directly or
through grants and contracts, or both, provide
technical assistance to the States in the
establishment and operation of statewide
registries, including assistance in the
development of model legislation for statewide
cancer registries and assistance in establishing
a computerized reporting and data processing
system.
SEC. 399K [280-3] STUDY IN
CERTAIN STATES TO DETERMINE FACTORS CONTRIBUTING
TO THE ELEVATED BREAST CANCER MORTALITY RATES
(a)
IN GENERAL. -- Subject to subsections (c) and
(d), the Secretary, acting through the Director
of the National Cancer Institute, shall conduct a
study for the purpose of determining the factors
contributing to the fact that breast cancer
mortality rates in the States specified in
subsection (b) are elevated compared to rates in
other States.
(b)
RELEVANT STATES. -- The States referred to in
subsection (a) are Connecticut, Delaware,
Maryland, Massachusetts, New Hampshire, New
Jersey, New York, Rhode Island, Vermont, and the
District of Columbia.
(c)
COOPERATION OF STATE. -- The Secretary may
conduct the study required in subsection (a) in a
State only if the State agrees to cooperate with
the Secretary in the conduct of the study,
including providing information from any registry
operated by the State pursuant to section
399H(a).
(d)
PLANNING, COMMENCEMENT, AND DURATION. -- The
Secretary shall, during each of the fiscal years
1993 and 1994, develop a plan for conducting the
study required in subsection (a). The study shall
be initiated by the Secretary not later than
fiscal year 1994, and the collection of data
under the study may continue through fiscal year
1998.
(e)
REPORT. -- Not later than September 30, 1999, the
Secretary shall complete the study required in
subsection (a) and submit to the Committee on
Energy and Commerce of the House of
Representatives' and to the Committee on Labor
and Human Resources of the Senate, a report
describing the findings and recommendations made
as a result of the study.
SEC
399 [280e- 4] AUTHORIZATION OF APPROPRIATIONS.
(a)
REGISTRIES. -- For the purpose of carrying out
this part, there are authorized to be
appropriated $30,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the
fiscal years 1995 through 1998. Of the amounts
appropriated under the preceding sentence for any
such fiscal year, the Secretary may obligate not
more than 25 percent for carrying out section
3991, and not more than 10 percent may be
expended for assessing the accuracy, completeness
and quality of data collected, and not more than
10 percent of which is to be expended under
subsection 399J.
(b)
BREAST CANCER STUDY. -- Of the amounts
appropriated for the National Cancer Institute
under subpart 1 of part C of title IV for any
fiscal year in which the study required in
section 399K is being carried out, the Secretary
shall expend not less than $1,000,000 for the
study.
TITLE IV - NATIONAL RESEARCH
INSTITUTES
PART
B - GENERAL PROVISIONS RESPECTING NATIONAL
RESEARCH INSTITUTES
APPOINTMENT
AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL
RESEARCH INSTITUTES
SEC.
405. [284] (a) The Director of the National
Cancer Institute shall be appointed by the
President and the Directors of the other national
research institutes shall be appointed by the
Secretary. Each Director of a national research
institute shall report directly to the Director
of NIH.
(b)(l)
In carrying out the purposes of section 301 with
respect to human diseases or disorders or other
aspects of human health for which the national
research institutes were established, the
Secretary, acting through the Director of each
national research institute--
(A)
shall encourage and support research,
investigations, experiments, demonstrations, and
studies in the health sciences related to--
(i)
the maintenance of health,
(ii)
the detection, diagnosis, treatment, and
prevention of human diseases and disorders,
(iii)
the rehabilitation of individuals with human
diseases, disorders, and disabilities, and
(iv)
the expansion of knowledge of the processes
underlying human diseases, disorders, and
disabilities, the processes underlying the normal
and pathological functioning of the body and its
organ systems, and the processes underlying the
interactions between the human organism and the
environment;
(B)
may, subject to the peer review prescribed under
section 492(b) and any advisory council review
under section 406(a)(3)(A)(i), conduct the
research, investigations, experiments,
demonstrations, and studies referred to in
subparagraph (A);
(C)
may conduct and support research training (i) for
which fellowship support is not provided under
section 487 and (ii) which is not residency
training of physicians or other health
professionals;
(D)
may develop, implement, and support
demonstrations and programs for the application
of the results of the activities of the institute
to clinical practice and disease prevention
activities;
(E)
may develop, conduct, and support public and
professional education and information programs;
(F)
may secure, develop and maintain, distribute, and
support the development and maintenance of
resources needed for research;
(G)
may make available the facilities of the
institute to appropriate entities and individuals
engaged in research activities and cooperate with
and assist Federal and State agencies charged
with protecting the public health;
(H)
may accept unconditional gifts made to the
institute for its activities, and, in the case of
gifts of a value in excess of $50,000, establish
suitable memorials to the donor;
(I)
may secure for the institute consultation
services and advice of persons from the United
States or abroad;
(J)
may use, with their consent, the services,
equipment, personnel, information, and facilities
of other Federal, State, or local public
agencies, with or without reimbursement therefor;
(K)
may accept voluntary and uncompensated services;
and
(L)
may perform such other functions as the Secretary
determines are needed to carry out effectively
the purposes of the institute.
The
indemnification provisions of section 2354, title
10, United States Code, shall apply with respect
to contracts entered into under this subsection
and section 402(b).
(2)
Support for an activity or program under this
subsection may be provided through grants,
contracts, and cooperative agreements. The
Secretary, acting through the Director of each
national research institute--
(A)
may enter into a contract for research, training,
or demonstrations only if the contract has been
recommended after technical and scientific peer
review required by regulations under section 492;
(B)
may make grants and cooperative agreements under
paragraph (1) for research, training, or
demonstrations, except that-
(i)
if the direct cost of the grant or cooperative
agreement to be made does not exceed $50,000,
such grant or cooperative agreement may be made
only if such grant or cooperative agreement has
been recommended after technical and scientific
peer review required by regulations under section
492, and
(ii)
if the direct cost of the grant or cooperative
agreement to be made exceeds $50,000, such grant
or cooperative agreement may be made only if such
grant or cooperative agreement has been
recommended after technical and scientific peer
review required by regulations under section 492
and is recommended under section 406(a)(3)(A)(ii)
by the advisory council for the national research
institute involved; and
(C)
shall, subject to section 2353(d)(2), receive
from the President and the Office of Management
and Budget directly all funds appropriated by the
Congress for obligation and expenditure by the
Institute.
(c)
In carrying out subsection (b), each Director of
a national research institute-
(1)
shall coordinate, as appropriate, the activities
of the institute with similar programs of other
public and private entities;
(2)
shall cooperate with the Directors of the other
national research institutes in the development
and support of multidisciplinary research and
research that involves more than one institute;
(3)
may, in consultation with the advisory council
for the Institute and with the approval of the
Director of NIH-
(A)
establish technical and scientific peer review
groups in addition to those appointed under
section 402(b)(6); and
(B)
appoint the members of peer review groups
established under subparagraph (A); and
(4)
may publish, or arrange for the publication of,
information with respect to the purpose of the
Institute without regard to section 501 of title
44, United States Code.
The
Federal Advisory Committee Act shall not apply to
the duration of a peer review group appointed
under paragraph (3).
ADVISORY COUNCILS
SEC.
406. [284a] (a)(1) Except as provided in
subsection (h), the Secretary shall appoint an
advisory council for each national research
institute which (A) shall advise, assist, consult
with, and make recommendations to the Secretary
and the Director of such institute on matters
related to the activities carried out by and
through the institute and the policies respecting
such activities, and (B) shall carry out the
special functions prescribed by part C.
(2)
Each advisory council for a national research
institute may recommend to the Secretary
acceptance, in accordance with section 231, of
conditional gifts for study, investigation, or
research respecting the diseases, disorders, or
other aspect of human health with respect to
which the institute was established, for the
acquisition of grounds, or for the construction,
equipping, or maintenance of facilities for the
institute.
(3)
Each advisory council for a national research
institute--
(A)(1)
may on the basis of the materials provided under
section 492(b)(2) respecting research conducted
at the institute, make recommendations to the
Director of the institute respecting such
research,
(ii)
may review applications for grants and
cooperative agreements for research or training
and for which advisory council approval is
required under section 405(b)(2) and recommend
for approval applications for projects which show
promise of making valuable contributions to human
knowledge, and
(iii)
may review any grant, contract, or cooperative
agreement proposed to be made or entered into by
the institute;
(B)
may collect, by correspondence or by personal
investigation, information as to studies which
are being carried on in the United States or any
other country as to the diseases disorders, or
other aspect of human health with respect to
which the institute was established and with the
approval of the Director of the institute make
available such information through appropriate
publications for the benefit of public and
private health entities and health professions
personnel and scientists and for the information
of the general public; and
(C)
may appoint subcommittees and convene workshops
and conferences.
(b)(1)
Each advisory council shall consist of ex officio
members and not more than eighteen members
appointed by the Secretary. The ex officio
members shall be nonvoting members.
(2)
The ex officio members of an advisory council
shall consist of-
(A)
the Secretary, the Director of NIH, the Director
of the national research institute for which the
council is established, the Chief Medical
Director of the Department of Veterans Affairs or
the Chief Dental Director of the Department of
Veterans Affairs, and the Assistant Secretary of
Defense for Health Affairs (or the designees of
such officers), and
(B)
such additional officers or employees of the
United States as the Secretary determines
necessary for the advisory council to effectively
carry out its functions.
(3)
The members of an advisory council who are not ex
officio members shall be appointed as follows:
(A)
Two-thirds of the members shall be appointed by
the Secretary from among the leading
representatives of the health and scientific
disciplines (including not less than two
individuals who are leaders in the fields of
public health and the behavioral or social
sciences) relevant to the activities of the
national research institute for which the
advisory council is established.
(B)
One-third of the members shall be appointed by
the Secretary from the general public and shall
include leaders in fields of public policy, law,
health policy, economics, and management.
(4)
Members of an advisory council who are officers
or employees of the United States shall not
receive any compensation for service on the
advisory council. The other members of an
advisory council shall receive, for each day
(including travel time) they are engaged in the
performance of the functions of the advisory
council, compensation at rates not to exceed the
daily equivalent of the annual rate in effect for
grade GS-18 of the General Schedule.
(c)
The term of office of an appointed member of an
advisory council is four years, except that any
member appointed to fill a vacancy for an
unexpired term shall be appointed for the
remainder of such term and the Secretary shall
make appointments to an advisory council in such
a manner as to ensure that the terms of the
members do not all expire in the same year. A
member may serve after the expiration of the
member's term for 180 days after the date of such
expiration. A member who has been appointed for a
term of four years may not be reappointed to an
advisory council before two years from the date
of expiration of such term of office. If a
vacancy occurs in the advisory council among the
appointed members, the Secretary shall make an
appointment to fill the vacancy within 90 days
from the date the vacancy occurs.
(d)
The chairman of an advisory council shall be
selected by the Secretary from among the
appointed members, except that the Secretary may
select the Director of the national research
institute for which the advisory council is
established to be the chairman of the advisory
council. The term of office of the chairman shall
be two years.
(e)
The advisory council shall meet at the call of
the chairman or upon the request of the Director
of the national research institute for which it
was established, but at least three times each
fiscal year. The location of the meetings of each
advisory council is subject to the approval of
the Director of the national research institute
for which the advisory council was established.
(f)
The Director of the national research institute
for which an advisory council is established
shall designate a member of the staff of the
institute to serve as the executive secretary of
the advisory council. The Director of such
institute shall make available to the advisory
council such staff, information, and other
assistance as it may require to carry out its
functions. The Director of such institute shall
provide orientation and training for new members
of the advisory council to provide them with such
information and training as may be appropriate
for their effective participation in the
functions of the advisory council.
(g)
Each advisory council may prepare, for inclusion
in the biennial report made under section 407,
(1) comments respecting the activities of the
advisory council in the fiscal years respecting
which the report is prepared, (2) comments on the
progress of the national research institute for
which it was established in meeting its
objectives, and (3) recommendations respecting
the future directions and program and policy
emphasis of the institute. Each advisory council
may prepare such additional reports as it may
determine appropriate.
(h)(1)
Except as provided in paragraph (2), this section
does not terminate the membership of any advisory
council for a national research institute which
was in existence on the date of enactment of the
Health Research Extension Act of 1985. After such
date--
(A)
the Secretary shall make appointments to each
such advisory council in such a manner as to
bring about as soon as practicable the
composition for such council prescribed by this
section;
(B)
each advisory council shall organize itself in
accordance with this section and exercise the
functions prescribed by t his section; and
(C)
the Director of each national research institute
shall perform for such advisory council the
functions prescribed by this section.
(2)(A) The National Cancer
Advisory Board
shall
be the advisory council for the National Cancer
Institute. This section applies to the National
Cancer Advisory Board, except that --
(i)
appointments to such Board shall be made by the
President;
(ii)
the term of office of an appointed member shall
be 6 years;
(iii)
of the members appointed to the Board not less
than five members shall be individuals
knowledgeable in environmental carcinogenesis
(including carcinogenesis involving occupational
and dietary factors);
(iv)
the chairman of the Board shall be selected by
the President from the appointed members and
shall serve as chairman for a term of two years;
(v)
the ex officio members of the Board shall be
nonvoting members and shall be the Secretary, the
Director of the Office of Science and Technology
Policy, the Director of NIH, the Chief Medical
Director of the Department of Veterans Affairs,
the Director of the National Institute for
Occupational Safety and Health, the Director of
the National Institute of Environmental Health
Sciences, the Secretary of Labor,
the-Commissioner of the Food and Drug
Administration, the Administrator of the
Environmental Protection Agency, the Chairman of
the Consumer Product Safety Commission, the
Assistant Secretary of Defense for Health
Affairs, and the Director of the Office of Energy
Research of the Department of Energy (or the
designees of such officers); and
(vi)
the Board shall meet at least four times each
fiscal year.
(B)
This section applies to the advisory council to
the National Heart, Lung, and Blood Institute,
except that the advisory council shall meet at
least four times each fiscal year.
PART C -- SPECIFIC
PROVISIONS RESPECTING NATIONAL RESEARCH
INSTITUTES
Subpart
1 -- National Cancer Institute
PURPOSE
OF INSTITUTE
SEC.
410. [285] The general purpose of the National
Cancer Institute (hereafter in this subpart
referred to as the "Institute") is the
conduct and support of research, training, health
information dissemination, and other programs
with respect to the cause, diagnosis, prevention,
and treatment of cancer, rehabilitation from
cancer, and the continuing care of cancer
patients and the families of cancer patients.
NATIONAL
CANCER PROGRAM
SEC.
411. [285a] The National Cancer Program shall
consist of (1) an expanded, intensified, and
coordinated cancer research program encompassing
the research programs conducted and supported by
the Institute and the related research programs
of the other national research institutes,
including an expanded and intensified research
program for the prevention of cancer caused by
occupational or environmental exposure to
carcinogens, and (2) the other programs and
activities of the Institute.
CANCER CONTROL PROGRAMS
SEC.
412. [285a-1] The Director of the Institute shall
establish and support demonstration, education,
and other programs for the detection, diagnosis,
prevention, and treatment of cancer and for
rehabilitation and counseling respecting cancer.
Programs established and supported under this
section shall include--
(1)
locally initiated education and demonstration
programs (and regional networks of such programs)
to transmit research results and to disseminate
information respecting--
(A)
the detection, diagnosis, prevention, and
treatment of cancer,
(B)
the continuing care of cancer patients and the
families of cancer patients, and
(C)
rehabilitation and counseling respecting cancer,
to physicians and other health professionals who
provide care to individuals who have cancer;
(2)
the demonstration of and the education of
students of the health professions and health
professionals in--
(A)
effective methods for the prevention and early
detection of cancer and the identification of
individuals with a high risk of developing
cancer, and
(B)
improved methods of patient referral to
appropriate centers for early diagnosis and
treatment of cancer; and
(3)
the demonstration of new methods for the
dissemination of information to the general
public concerning the prevention, early
detection, diagnosis, and treatment and control
of cancer and information concerning unapproved
and ineffective methods, drugs, and devices for
the diagnosis, prevention, treatment, and control
of cancer.
SPECIAL AUTHORITIES OF THE
DIRECTOR
SEC.
413. [285a-2] (a)(1) The Director of the
Institute shall establish an information and
education program to collect, identify, analyze,
and disseminate on a timely basis, through
publications and other appropriate means, to
cancer patients and their families, physicians
and other health professionals, and the general
public, information on cancer research,
diagnosis, prevention, and treatment (including
information respecting nutrition programs for
cancer patients and the relationship between
nutrition and cancer). The Director of the
Institute may take such action as may be
necessary to insure that all channels for the
dissemination and exchange of scientific
knowledge and information are maintained between
the Institute and the public and between the
Institute and other scientific, medical, and
biomedical disciplines and organizations
nationally and internationally.
(2)
In carrying out paragraph (1), the Director of
the Institute shall --
(A)
provide public and patient information and
education programs, providing information that
will help individuals take personal steps to
reduce their risk of cancer, to make them aware
of early detection techniques and to motivate
appropriate utilization of those techniques, to
help individuals deal with cancer if it strikes,
and to provide information to improve long-term
survival;
(B)
continue and expand programs to provide
physicians and the public with state-of-the-art
information on the treatment of particular forms
of cancers, and to identify those clinical trials
that might benefit patients while advancing
knowledge of cancer treatment;
(C)
assess the incorporation of state-of-the-art
cancer treatments into clinical practice and the
extent to which cancer patients receive such
treatments and include the results of such
assessments in the biennial reports required
under section 407;
(D)
maintain and operate the International Cancer
Research Data Bank, which shall collect, catalog,
store, and disseminate insofar as feasible the
results of cancer research and treatment
undertaken in any country for the use of any
person involved in cancer research and treatment
in any country; and
(E)
to the extent practicable, in disseminating the
results of such cancer research and treatment,
utilize information systems available to the
public.
(b)
The Director of the Institute in carrying out the
National Cancer Program--
(1)
shall establish or support the large-scale
production or distribution of specialized
biological materials and other therapeutic
substances for cancer research and set standards
of safety and care for persons using such
materials;
(2)
shall, in consultation with the advisory council
for the Institute, support (A) research in the
cancer field outside the United States by highly
qualified foreign nationals which can be expected
to benefit the American people, (B) collaborative
research involving American and foreign
participants, and (C) the training of American
scientists abroad and foreign scientists in the
United States;
(3)
shall, in consultation with the advisory council
for the Institute, support appropriate programs
of education and training (including continuing
education and laboratory and clinical research
training);
(4)
shall encourage and coordinate cancer research by
industrial concerns where such concerns evidence
a particular capability for such research;
(5)
may obtain (after consultation with the advisory
council for the Institute and in accordance with
section 3109 of title 5, United States Code, but
without regard to the limitation in such section
on the period of service) the services of not
more than one hundred and fifty-one experts or
consultants who have scientific or professional
qualifications;
(6)(A)
may, in consultation with the advisory council
for the Institute, acquire, construct, improve,
repair, operate, and maintain laboratories, other
research facilities, equipment and such other
real or personal property as the Director
determines necessary;
(B)
may, in consultation with the advisory council
for the Institute, make grants for construction
or renovation of facilities; and
(C)
may, in consultation with the advisory council
for the Institute, acquire, without regard to the
Act of March 3, 1877 (40 U.S.C. 34), by lease or
otherwise through the Administrator of General
Services, buildings or parts of buildings in the
District of Columbia or communities located
adjacent to the District of Columbia for the use
of the Institute for a period not to exceed ten
years;
(7)
may, in consultation with the advisory council
for the Institute, appoint one or more advisory
committees composed of such private citizens and
officials of Federal, State, and local
governments to advise the Director with respect
to the Director's functions;
(8)
may, subject to section 405(b)(2) and without
regard to section 3324 of title 31, United States
Code, and section 3709 of the Revised Statutes
(41 U.S.C. 5), enter into such contracts, leases,
cooperative agreements, as may be necessary in
the conduct of functions of the Director, with
any public agency, or with any person, firm,
association, corporation, or educational
institution; and
(9)
shall, notwithstanding section 405(a), prepare
and submit, directly to the President for review
and transmittal to Congress, an annual budget
estimate (including an estimate of the number and
type of personnel needs for the Institute) for
the National Cancer Program, after reasonable
opportunity for comment (but without change) by
the Secretary, the Director of NIH, and the
Institute's advisory council.
Except
as otherwise provided, experts and consultants
whose services are obtained under paragraph (5)
shall be paid or reimbursed, in accordance with
title 5, United States Code, for their travel to
and from their place of service and for other
expenses associated with their assignment. Such
expenses shall not be allowed in connection with
the assignment of an expert or consultant whose
services are obtained under paragraph (5) unless
the expert or consultant has agreed in writing to
complete the entire period of the assignment or
one year of the assignment, whichever is shorter,
unless separated or reassigned for reasons which
are beyond the control of the expert or
consultant and which are acceptable to the
Director of the Institute. If the expert or
consultant violates the agreement, the money
spent by the United States for such expenses is
recoverable from the expert or consultant as a
debt due the United States. The Secretary may
waive in whole or in part a right of recovery
under the preceding sentence.
NATIONAL CANCER RESEARCH AND
DEMONSTRATION CENTERS
SEC.
414. [285a-3] (a)(l) The Director of the
Institute may enter into cooperative agreements
with and make grants to public or private
nonprofit entities to pay all or part of the cost
of planning, establishing, or strengthening, and
providing basic operating support for centers for
basic and clinical research into, training in,
and demonstration of advanced diagnostic,
prevention, control, and treatment methods for
cancer.
(2) A
cooperative agreement or grant under paragraph
(1) shall be entered into in accordance with
policies established by the Director of NIH and
after consultation with the Institute's advisory
council.
(b)
Federal payments made under a cooperative
agreement or grant under subsection (a) may be
used for --
(1)
construction (notwithstanding any limitation
under section 496);
(2)
staffing and other basic operating costs,
including such patient care costs as are required
for research;
(3)
clinical training, including training for allied
health professionals, continuing education for
health professionals and allied health
professions personnel, and information programs
for the public respecting cancer; and
(4)
demonstration purposes. As used in this
paragraph, the term "construction" does
not include the acquisition of land, and the term
"training" does not include research
training for which National Research Service
Awards may be provided under section 487.
(c)
Support of a center under subsection (a) may be
for a period of not to exceed five years. Such
period may be extended by the Director for
additional periods of not more than five years
each if the operations of such center have been
reviewed by an appropriate technical and
scientific peer review group established by the
Director and if such group has recommended to the
Director that such period should be extended.
PRESIDENT'S CANCER PANEL
SEC.
415. [285a -4] (a)(l) The President's Cancer
Panel (hereafter in this section referred to as
the "Panel") shall be composed of three
persons appointed by the President who by virtue
of their training, experience, and background are
exceptionally qualified to appraise the National
Cancer Program. At least two members of the Panel
shall be distinguished scientists or physicians.
(2)(A)
Members of the Panel shall be appointed for
three-year terms, except that (i) any member
appointed to fill a vacancy occurring prior to
the expiration of the term for which the member's
predecessor was appointed shall be appointed only
for the remainder of such term, and (ii) a member
may serve until the member's successor has taken
office. If a vacancy occurs in the Panel, the
President shall make an appointment to fill the
vacancy not later than 90 days after the date the
vacancy occurred.
(B)
The President shall designate one of the members
to serve as the chairman of the Panel for a term
of one year.
(C)
Members of the Panel shall each be entitled to
receive the daily equivalent of the annual rate
of basic pay in effect for grade GS- 18 of the
General Schedule for each day (including travel
time) during which they are engaged in the actual
performance of duties as members of the Panel and
shall be paid or reimbursed, in accordance with
title 5, United States Code, for their travel to
and from their place of service and for other
expenses associated with their assignment.
(3)
The Panel shall meet at the call of the chairman,
but not less often than four times a year. A
transcript shall be kept of the proceedings of
each meeting of the Panel, and the chairman shall
make such transcript available to the public.
(b)
The Panel shall monitor the development and
execution of the activities of the National
Cancer Program, and shall report directly to the
President. Any delays or blockages in rapid
execution of the Program shall immediately be
brought to the attention of the President. The
Panel shall submit to the President periodic
progress reports on the National Cancer Program
and shall submit to the President, the Secretary,
and the Congress an annual evaluation of the
efficacy of the Program and suggestions for
improvements, and shall submit such other reports
as the President shall direct.
ASSOCIATE
DIRECTOR FOR PREVENTION
SEC.
416. [285a-5] (a) There shall be in the Institute
an Associate Director for Prevention to
coordinate and promote the programs in the
Institute concerning the prevention of cancer.
The Associate Director shall be appointed by the
Director of the Institute from individuals who
because of their professional training or
experience are experts in public health or
preventive medicine.
(b)
The Associate Director for Prevention shall
prepare for inclusion in the biennial report made
under section 407 a description of the prevention
activities of the Institute, including a
description of the staff and resources allocated
to those activities.
BREAST AND GYNECOLOGICAL
CANCERS
SEC.
417. [285a-6] (a) EXPANSION AND COORDINATION OF
ACTIVITIES. The Director of the Institute, in
consultation with the National Cancer Advisory
Board, shall expand, intensify, and coordinate
the activities of the Institute with respect to
research on breast cancer, ovarian cancer, and
other cancers of the reproductive system of
women.
(b)
COORDINATION WITH OTHER INSTITUTES.-- The
Director of the Institute shall coordinate the
activities of the Director under subsection (a)
with similar activities conducted by other
national research institutes and agencies of the
National Institutes of Health to the extent that
such Institutes and agencies have
responsibilities that are related to breast
cancer and other cancers of the reproductive
system of women.
(C)
PROGRAMS FOR BREAST CANCER. -- (1) IN GENERAL.--
In carrying out subsection (a), the Director of
the Institute shall conduct or support research
to expand the understanding of the cause of, and
to find a cure for, breast cancer. Activities
under such subsection shall provide for an
expansion and intensification of the conduct and
support of --
(A)
basic research concerning the etiology and causes
of breast cancer;
(B)
clinical research and related activities
concerning the causes, prevention, detection and
treatment of breast cancer;
(C)
control programs with respect to breast cancer in
accordance with section 412, including
community-based programs designed to assist women
who are members of medically underserved
populations, low-income populations, or minority
groups;
(D)
information and education programs with respect
to breast cancer in accordance with section 413;
and
(E)
research and demonstration centers with respect
to breast cancer in accordance with section 414,
including the development and operation of
centers for breast cancer research to bring
together basic and clinical, biomedical and
behavioral scientists to conduct basic, clinical,
epidemiological, psychosocial, prevention and
treatment research and related activities on
breast cancer.
Not
less than six centers shall be operated under
subparagraph (E). Activities of such centers
should include supporting new and innovative
research and training programs for new
researchers. Such centers shall give priority to
expediting the transfer of research advances to
clinical applications.
(2)
IMPLEMENTATION OF PLAN FOR PROGRAMS.--
(A)
The Director of the Institute shall ensure that
the research programs described in paragraph (1)
are implemented in accordance with a plan for the
programs. Such plan shall include comments and
recommendations that the Director of the
Institute considers appropriate, with due
consideration provided to the professional
judgment needs of the Institute as expressed in
the annual budget estimate prepared in accordance
with section 413(9) The Director of the
Institute, in consultation with the National
Cancer Advisory Board, shall periodically review
and revise such plan.
(B)
Not later than October 1, 1993, the Director of
the Institute shall submit a copy of the plan to
the President's Cancer Panel, the Secretary and
the Director of NIH.
(C)
The Director of the Institute shall submit any
revisions of the plan to the President's Cancer
Panel, the Secretary, and the Director of NIH.
(D)
The Secretary shall provide a copy of the plan
submitted under subparagraph (A), and any
revisions submitted under subparagraph (C), to
the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and
Human Resources of the Senate.
(d)
OTHER CANCERS.--In carrying out subsection (a),
the Director of the Institute shall conduct or
support research on ovarian cancer and other
cancers of the reproductive system of women.
Activities under such subsection shall provide
for the conduct and support of--
(1)
basic research concerning the etiology and causes
of ovarian cancer and other cancers of the
reproductive system of women;
(2)
clinical research and related activities into the
causes, prevention, detection and treatment of
ovarian cancer and other cancers of the
reproductive system of women;
(3)
control programs with respect to ovarian cancer
and other cancers of the reproductive system of
women in accordance with section 412;
(4)
information and education programs with respect
to ovarian cancer and other cancers of the
reproductive system of women in accordance with
section 413; and
(5)
research and demonstration centers with respect
to ovarian cancer and cancers of the reproductive
system in accordance with section 414.
(e)
REPORT.-- The Director of the Institute shall
prepare, for inclusion in the biennial report
submitted under section 407, a report that
describes the activities of the National Cancer
Institute under the research programs referred to
in subsection (a), that shall include --
(1) a
description of the research plan with respect to
breast cancer prepared under subsection (c);
(2)
an assessment of the development, revision, and
implementation of such plan;
(3) a
description and evaluation of the progress made,
during the period for which such report is
prepared, in the research programs on breast
cancer and cancers of the reproductive system of
women;
(4) a
summary and analysis of expenditures made, during
the period for which such report is made, for
activities with respect to breast cancer and
cancers of the reproductive system of women
conducted and supported by the National
Institutes of Health; and
(5)
such comments and recommendations as the Director
considers appropriate.
PROSTATE CANCER
SEC.
417A. 1286a-71 (a) EXPANSION AND COORDINATION OF
ACTIVITIES.-- The Director of the Institute, in
consultation with the National Cancer Advisory
Board, shall expand, intensify, and coordinate
the activities of the Institute with respect to
research on prostate cancer.
(b)
COORDINATION WITH OTHER INSTITUTES. -- The
Director of the Institute shall coordinate the
activities of the Director under subsection (a)
with similar activities conducted by other
national research institutes and agencies of the
National Institutes of Health to the extent that
such Institutes and agencies have
responsibilities that are related to prostate
cancer.
(C)
PROGRAMS.--
(1)
IN GENERAL. -- In carrying out subsection (a),
the Director of the Institute shall conduct or
support research to expand the understanding of
the cause of, and to find a cure for, prostate
cancer. Activities under such subsection shall
provide for an expansion and intensification of
the conduct and support of --
(A)
basic research concerning the etiology and causes
of prostate cancer;
(B)
clinical research and related activities
concerning the causes, prevention, detection and
treatment of prostate cancer;
(C)
prevention and control and early detection
programs with respect to prostate cancer in
accordance with section 412, particularly as it
relates to intensifying research on the role of
prostate specific antigen for the screening and
early detection of prostate cancer;
(D)
an Inter-Institute Task Force, under the
direction of the Director of the Institute, to
provide coordination between relevant National
Institutes of Health components of research
efforts on prostate cancer;
(E)
control programs with respect to prostate cancer
in accordance with section 412;
(F)
information and education programs with respect
to prostate cancer in accordance with section
413; and
(G)
research and demonstration centers with respect
to prostate cancer in accordance with section
414, including the development and operation of
centers for prostate cancer research to bring
together basic and clinical, biomedical and
behavioral scientists to conduct basic, clinical,
epidemiological, psychosocial, prevention and
control, treatment, research, and related
activities on prostate cancer.
Not
less than six centers shall be operated under
subparagraph (G). Activities of such centers
should include supporting new and innovative
research and training programs for new
researchers. Such centers shall give priority to
expediting the transfer of research advances to
clinical applications.
(2)
IMPLEMENTATION OF PLAN FOR PROGRAMS.
(A)
The Director of the Institute shall ensure that
the research programs described in paragraph (1)
are implemented in accordance with a plan for the
programs. Such plan shall include comments and
recommendations that the Director of the
Institute considers appropriate, with due
consideration provided to the professional
judgment needs of the Institute as expressed in
the annual budget estimate prepared in accordance
with section 413(9) The Director of the
Institute, in consultation with the National
Cancer Advisory Board, shall periodically review
and revise such plan.
(B)
Not later than October 1, 1993, the Director of
the Institute shall submit a copy of the plan to
the President's Cancer Panel, the Secretary, and
the Director of NIH.
(C)
The Director of the Institute shall submit any
revisions of the plan to the President's Cancer
Panel, the Secretary, and the Director of NIH.
(D)
The Secretary shall provide a copy of the plan
submitted under subparagraph (A), and any
revisions submitted under subparagraph (C), to
the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and
Human Resources
of the Senate.
AUTHORIZATION
OF APPROPRIATIONS
SEC.
417B. [286a-8] (a) ACTIVITIES GENERALLY. -- For
the purpose of carrying out this subpart, there
are authorized to be appropriated $2,728,000,000
for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and
1996.
(b)
BREAST CANCER AND GYNECOLOGICAL CANCERS. --
(1)
BREAST CANCER. --
(A)
For the purpose of carrying out subparagraph (A)
of section 417(c)(1), there are authorized to be
appropriated $225,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the
fiscal years 1995 and 1996. Such authorizations
of appropriations are in addition to the
authorizations of appropriations established in
subsection (a) with respect to such purpose.
(B)
For the purpose of carrying out subparagraphs (B)
through (E) of section 417(c)(1), there are
authorized to be appropriated $100,000,000 for
fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and
1996. Such authorizations of appropriations are
in addition to the authorizations of
appropriations established in subsection (a) with
respect to such purpose.
(2)
OTHER CANCERS. -- For the purpose of carrying out
subsection (d) of section 417, there are
authorized to be appropriated $75,000,000 for
fiscal year 1994, and such sums as are necessary
for each of the fiscal years 1995 and 1996. Such
authorizations of appropriations are in addition
to the authorizations of appropriations
established in subsection (a)with respect to such
purpose.
(c)
PROSTATE CANCER. -- For the purpose of carrying
out section 417A, there are authorized to be
appropriated $72,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the
fiscal years 1995 and 1996. Such authorizations
of appropriations are in addition to the
authorizations of appropriations established in
subsection (a) with respect to such purpose.
(d) ALLOCATION REGARDING
CANCER CONTROL. --
(1)
IN GENERAL. -- If the amounts appropriated for
the National Cancer Institute for a fiscal year,
the Director of the Institute shall make
available not less than the applicable percentage
specified in paragraph (2) for carrying out the
cancer control activities authorized in section
412 and for which budget estimates are made under
section 413(b)(9) for the fiscal year.
(2)
APPLICABLE PERCENTAGE. -- The percentage referred
to in paragraph (1) is --
(A) 7
percent, in the case of fiscal year 1994;
(B) 9
percent, in the case of fiscal year 1995; and
(C)
10 percent, in the case of fiscal year 1996 and
each subsequent fiscal year.
PART H -- GENERAL PROVISIONS
INSTITUTIONAL
REVIEW BOARDS; ETHICS GUIDANCE PROGRAM
SEC.
491. 12891 (a) The Secretary shall by regulation
require that each entity which applies for a
grant, contract, or cooperative agreement under
this Act for any project or program which
involves the conduct of biomedical or behavioral
research involving human subjects submit in or
with its application for such grant, contract, or
cooperative agreement assurances satisfactory to
the Secretary that it has established (in
accordance with regulations which the Secretary
shall prescribe) a board (to be known as an
"Institutional Review Board") to review
biomedical and behavioral research involving
human subjects conducted at or supported by such
entity in order to protect the rights of the
human subjects of such research.
(b)(1)
The Secretary shall establish a program within
the Department of Health and Human Services under
which requests for clarification and guidance
with respect to ethical issues raised in
connection with biomedical or behavioral research
involving human subjects are responded to
promptly and appropriately.
(2)
The Secretary shall establish a process for the
prompt and appropriate response to information
provided to the Director of NIH respecting
incidences of violations of the rights of human
subjects of research for which funds have been
made available under this Act. The process shall
include procedures for the receiving of reports
of such information from recipients of funds
under this Act and taking appropriate action with
respect to such violations.
PEER
REVIEW REQUIREMENTS
SEC.
492. [289a] (a)(l) The Secretary, acting through
the Director of NIH, shall by regulation require
appropriate technical and scientific peer review
of --
(A)
applications made for grants and cooperative
agreements under this Act for biomedical and
behavioral research; and
(B)
applications made for biomedical and behavioral
research and development contracts to be
administered through the National Institutes of
Health.
(2)
Regulations promulgated under paragraph (1) shall
require that the review of applications made for
grants, contracts, and cooperative agreements
required by the regulations be conducted --
(A)
to the extent practical, in a manner consistent
with the system for technical and scientific peer
review applicable on the date of the date of
enactment of the Health Research Extension Act of
1985 to grants under this Act for biomedical and
behavioral research, and
(B)
to the extent practical, by technical and
scientific peer review groups performing such
review on or before such date, and shall
authorize such review to be conducted by groups
appointed under sections 402(b)(6) and 405(c)(3).
(b)
The Director of NIH shall establish procedures
for periodic technical and scientific peer review
of research at the National Institutes of Health.
Such procedures shall require that --
(1)
the reviewing entity be provided a written
description of the research to be reviewed, and
(2)
the reviewing entity provide the advisory council
of the national research institute involved with
such description and the results of the review by
the entity, and shall authorize such review to be
conducted by groups appointed under sections
402(b)(6) and 405(c)(3).
(c)(1)
In technical and scientific peer review under
this section of proposals for clinical research,
the consideration of any such proposal (including
the initial consideration) shall, except as
provided in paragraph (2), include an evaluation
of the technical and scientific merit of the
proposal regarding compliance with section 492B.
(2)
Paragraph (1) shall not apply to any proposal for
clinical research that, pursuant to subsection
(b) of section 492B, is not subject to the
requirement of subsection (a) of such section
regarding the inclusion of women and members of
minority groups as subjects in clinical research.
PL 103-43 TITLE XIX --
STUDIES
SEC.
1911-- POTENTIAL ENVIRONMENTAL AND OTHER RISKS
CONTRIBUTING TO INCIDENCE OF BREAST CANCER
(a)
REQUIREMENT OF STUDY
(1)
In General -- The Director of the National Cancer
Institute (in this section referred to as the
"Director"), in collaboration with the
Director of the National Institute of
Environmental Health Sciences, shall conduct a
case-control study to assess biological markers
of environmental and other potential risk factors
contributing to the incidence of breast cancer --
(A)
the Counties of Nassau and Suffolk, in the State
of New York; and
(B)
the 2 counties in the northeastern United States
that, as identified in the report specified in
paragraph (2), had the highest age adjusted
mortality rate of such cancer that reflected not
less than 30 deaths during the 5 year period for
which findings are made in the report.
(2)
RELEVANT REPORT. --The report to in paragraph
(1)(B) is the report of the findings made in the
study entitled "Surveillance, Epidemiology,
and End Results", relating to cases of
cancer during the years 1983 through 1987.
(B)
CERTAIN ELEMENTS OF STUDY -- The Director in
carrying out the study under subsection (a) shall
include the use of a geographic system to
evaluate the current and past exposure of
individuals, including direct monitoring and
cumulative estimates of exposure, to --
(1)
contaminated drinking water;
(2)
sources of indoor and ambient air pollution,
including emissions from aircraft;
(3)
electromagnetic fields;
(4)
pesticides and other toxic chemicals;
(5)
hazardous and municipal waste; and
(6)
such other factors as the Director determines to
be appropriate.
(C)
REPORT. --Not later than 30 months after the date
of the enactment of this act, the Director shall
complete the study required in subsection (a) and
submit to the Committee on Energy and Commerce of
the House of Representatives, and to the
Committee on Labor and Human Resources of the
Senate, a report describing the findings made as
a result of the study.
(d)
FUNDING -- Of the amounts appropriated for fiscal
years 1994 and 1995 for the National Institute of
Environmental Health Sciences and the National
Cancer Institute, the Director of the National
Institutes of Health shall make available amounts
for carrying out the study required in subsection
(a).
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