[Congressional Record Volume 140, Number 45 (Thursday, April 21, 1994)]
[Senate]
[Page S]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]
[Congressional Record: April 21, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]
TRAUMATIC BRAIN INJURY ACT OF 1993
Mr. KENNEDY. Madam President, I ask unanimous consent that the Senate
proceed to the immediate consideration of Calendar No. 397, S. 725, the
Traumatic Brain Injury Act.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
A bill (S. 725) to amend the Public Health Service Act to
provide for the conduct of expanded studies and the
establishment of innovative programs with respect to
traumatic brain injury, and for other purposes.
The PRESIDING OFFICER. Is there objection to the immediate
consideration of the bill?
There being no objection, the Senate proceeded to consider the
bill which was reported from the Committee on Labor and Human Resources
with an amendment to strike out all after the enacting clause and
inserting in lieu thereof the following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Traumatic Brain Injury Act
of 1993''.
SEC. 2. FINDINGS AND PURPOSE.
(a) Findings.--Congress finds that--
(1) each year 2,000,000 individuals suffer serious head
injuries resulting from automobile accidents, sports,
recreational activities, assaults, violence and other falls
and incidents;
(2) a majority of all head injuries are caused by motor
vehicle accidents;
(3) individuals between the ages of 15 and 24 are at
greatest risk for sustaining head injuries;
(4) of the individuals who sustain head injuries each year,
approximately 500,000 require hospitalization, and 75,000 to
100,000 of such individuals die within hours of the injury;
(5) of the individuals who survive head injuries each year,
approximately 70,000 to 90,000 will suffer irreversible
debilitating loss of function, 5,000 will develop epilepsy as
a result of the injury, and 2,000 will exist in a coma;
(6) a significant number of individuals with traumatic
brain injury are not easily restored to society and require
years of rehabilitation, medical follow-up and integrated
community services, which are costly and frequently not
readily available;
(7) individuals sustaining traumatic brain injury require
coordinated and specialized services, including post-injury
supervised programs facilitating reentry into the community;
(8) many health and social service agencies, both public
and private, overlook, exclude or inadequately serve
individuals surviving traumatic brain injury;
(9) society bears an economic cost of approximately
$25,000,000,000 per year for the direct and indirect costs of
traumatic brain injury, which include medical treatment,
rehabilitative and support services and lost income; and
(10) prevention efforts will reduce the mortality,
morbidity, disability and costs associated with traumatic
brain injury.
(b) Purpose.--It is the purpose of this Act to--
(1) facilitate the conduct of research and the collection
and compiling of accurate statistical data on traumatic brain
injury;
(2) raise public awareness concerning the risks and
consequences of such injuries;
(3) promote the creation of innovative programs and
policies to prevent traumatic brain injury and to
rehabilitate those individuals who have survived such
injuries;
(4) designate a Federal agency to oversee and promote
projects relating to the prevention of, and rehabilitation
from, traumatic brain injury;
(5) establish State advisory boards to coordinate citizen
participation in community programs dealing with traumatic
brain injury;
(6) determine the incidence and prevalence of traumatic
brain injury; and
(7) encourage States to develop or adopt marketing
standards for brain injury rehabilitation services.
SEC. 3. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.
Title XII of the Public Health Service Act (42 U.S.C. 300d
et seq.) is amended--
(1) by redesignating part C as part D;
(2) in section 1232(a) (42 U.S.C. 300d-32(a)), by inserting
``other than part C,'' after ``carrying out this title,'';
and
(3) by inserting after part B, the following new part:
``Part C--Traumatic Brain Injury
``SEC. 1225A. AGENCY FOR HEALTH CARE POLICY AND RESEARCH
STUDY OF EFFECTIVENESS OF TRAUMATIC BRAIN
INJURY INTERVENTIONS.
``(a) In General.--The Secretary, acting through the
Administrator of the Agency for Health Care Policy and
Research and subject to the availability of appropriations,
shall conduct a study concerning traumatic brain injury. The
Secretary shall ensure that activities carried out under this
section will be coordinated with activities of other agencies
of the Public Health Service.
``(b) Major Findings.--The study conducted under subsection
(a) shall seek to--
``(1) identify common therapeutic interventions which are
used for the rehabilitation of individuals with traumatic
brain injuries, and shall, subject to the availability of
information, include an analysis of--
``(A) the effectiveness of each such intervention in
improving the functioning of individuals with brain injuries;
``(B) the comparative effectiveness of interventions
employed in the course of rehabilitation of individuals with
brain injuries to achieve the same or similar clinical
outcome; and
``(C) the adequacy of existing measures of outcomes and
knowledge of factors influencing differential outcomes; and
``(2) develop practice guidelines for the rehabilitation of
traumatic brain injury at such time as appropriate scientific
research becomes available.
``(c) Reporting Requirements.--Not later than 4 years after
the date of enactment of this part, the Secretary shall
prepare and submit to the Energy and Commerce Committee of
the House of Representatives and the Labor and Human
Resources Committee of the Senate, and a report containing
the results of the studies conducted under this section.
``(d) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$2,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 through 1996.
``SEC. 1225B. PREVENTION OF TRAUMATIC BRAIN INJURY.
``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
may conduct, support and provide technical assistance to
public and private nonprofit entities to reduce the incidence
of traumatic brain injury through the establishment of
prevention projects. The Secretary shall ensure that
activities carried out under this section will be coordinated
with activities of the agencies of the Public Health Service.
``(b) Grants.--In carrying out this section, the Secretary
may award grants to State and local entities, and to public
or non-profit private entities, to support--
``(1) the conduct of research into identifying effective
strategies to prevent traumatic brain injury; and
``(2) the implementation of public information and
education programs for the prevention of traumatic brain
injury and to broaden the awareness of the public concerning
the public health consequences of traumatic brain injury.
``(c) Study.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
shall collaborate with appropriate State and local health-
related agencies, to conduct a study on the incidence and
prevalence of traumatic brain injury. In conducting such
study the Secretary may develop a uniform reporting system
under which States report incidences of traumatic brain
injury.
``(2) Report.--Not later than 3 years after the date of
enactment of this part, the Secretary shall prepare and
submit to State health departments a report that contains the
results of the study conducted under paragraph (1).
``(d) Application.--To be eligible to receive assistance
under subsections (a) and (b), an entity shall prepare and
submit to the Secretary an application, at such time, in such
manner, and containing such information as the Secretary may
require.
``(e) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$6,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996. The
Secretary shall ensure that activities carried out under this
section will be coordinated with activities of other agencies
of the Public Health Service.
``SEC. 1225C. BASIC AND APPLIED RESEARCH.
``(a) In General.--The Secretary, acting through the
Director of the National Institutes of Health, may provide
assistance to public and private nonprofit entities to
conduct basic and applied research concerning traumatic brain
injury. The Secretary shall ensure that activities carried
out under this section will be coordinated with activities of
the agencies of the Public Health Service.
``(b) Grants.--In carrying out this section, the Secretary
may award grants to public or nonprofit entities for--
``(1) the development of new methods and modalities for the
more effective diagnosis, measurement of degree of injury,
post-injury monitoring and prognostic assessment of head
injury for acute, subacute and later phases of care;
``(2) the development, modification and evaluation of
therapies that retard, prevent or reverse brain damage after
acute head injury, that arrest further deterioration
following injury and that provide the restitution of function
for individuals with long-term injuries;
``(3) the development of research on a continuum of care
from acute care through rehabilitation, designed, to the
extent practicable, to integrate rehabilitation and long-term
outcome evaluation with acute care research; and
``(4) the development of programs that increase the
participation of academic centers of excellence in head
injury treatment and rehabilitation research and training.
``(c) Consensus Conference.--The Secretary, acting through
the Director of the National Center for Medical
Rehabilitation Research within the National Institute for
Child Health and Human Development, shall conduct a national
consensus conference on managing head injury and related
rehabilitation concerns. The findings of such conference
shall be provided to the Agency for Health Care Policy and
Research.
``(d) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$5,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.
``SEC. 1225D. STATEWIDE DEMONSTRATION PROJECTS FOR TRAUMATIC
BRAIN INJURY.
``(a) Grants.--The Secretary, acting through the Director
of Health Resources and Services Administration, may award
grants to States for the purpose of assisting grantees in
carrying out demonstration projects for the--
``(1) establishment of policies for coordinating services
within the State for individuals with traumatic brain injury;
``(2) establishment of standards, or adoption of nationally
recognized standards, regarding the marketing of
rehabilitation services (by hospitals and other providers) to
traumatic brain injury patients or family members,
dissemination of the standards to case management programs,
and furnishing of information on such standards to
individuals who sustain traumatic brain injuries (and the
family members of such individuals) at the earliest
appropriate opportunity after the individual has sustained
the injury (such standards to include (at a minimum) a rule
prohibiting payments under a case management program under
this section for referring patients);
``(3) coordination of legal, administrative and other
appropriate remedies or approaches to ensure the protection
of, and advocacy for, the rights of individuals with
traumatic brain injury within the State who are or may be
eligible for treatment, services, or rehabilitation, such
treatment, services or rehabilitation to be coordinated with
existing protection and advocacy systems through the State;
``(4) the provision to persons with traumatic brain injury
of information regarding appropriate public or private
agencies that provide rehabilitative services so that injured
persons or individuals responsible for such persons may
obtain needed service to alleviate injuries and avoid
secondary problems; and
``(5) identification of the services required to prevent
the institutionalization or to minimize the need for
residential rehabilitation in the case of traumatic brain
injury.
``(b) General Eligibility Requirements.--To be eligible to
receive a grant under subsection (a), a State shall prepare
and submit to the Secretary an application, at such time, in
such manner, and containing such information as the Secretary
may require.
``(c) State Advisory Board.--
``(1) In general.--To be eligible to receive a grant under
subsection (a), a State shall establish an advisory board
within the appropriate health department of the State or
within another department as designated by the chief
executive officer of the State.
``(2) Functions.--An advisory board established under
paragraph (1) shall assist the State in developing and
implementing State programs to carry out activities under
this section. The advisory board shall be cognizant of
findings and concerns of Federal, State and local agencies,
citizens groups, and private industry (such as insurance,
health care, automobile, and other industry entities). Such
advisory boards shall encourage citizen participation through
the establishment of public hearings and other types of
community outreach programs.
``(3) Competition.--An advisory board established under
paragraph (1) shall be composed of--
``(A) representatives of--
``(i) the corresponding States agencies involved;
``(ii) public and nonprofit private health related
organizations;
``(iii) other disability advisory or planning groups within
the State;
``(iv) members of an organization or foundation
representing traumatic brain injury survivors in that State;
and
``(v) injury control programs at the State or local level
if such programs exist; and
``(B) a substantial number of individuals who are survivors
of traumatic brain injury, or the family members of such
individuals.
``(d) Requirement of Matching Funds.--
``(1) In general.--With respect to the costs to be incurred
by a State in carrying out the purpose described in
subsection (a), the Secretary may not make a grant under such
subsection unless the State agrees to provide non-Federal
contributions toward such costs, in cash, in an amount that
is not less than $1 for each $2 of Federal funds provided
under the grant.
``(2) Determination of amount contributed.--In determining
the amount of non-Federal contributions in cash that a State
has provided pursuant to paragraph (1), the Secretary may not
include any amounts provided to the State by the Federal
Government.
``(e) Report.--Not later than 2 years after the date of
enactment of this part, the Secretary shall prepare and
submit to the appropriate committees of Congress a report
concerning the findings and results of the programs
established under this section, including measures of
outcomes and consumer and surrogate satisfaction.
``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$20,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.
``SEC. 1225E. DEFINITION.
``As used in this part, the term `traumatic brain injury'
means an acquired injury to the brain. Such term does not
include brain dysfunction caused by congenital or
degenerative disorders, nor birth trauma, but may include
brain injuries caused by anoxia due to near drowning. Such
term is synonymous with the term `traumatic head injury'. The
Secretary, acting through the Director of the National Center
for Injury Prevention and Control within the Centers for
Disease Prevention and Control, may modify the definition of
`traumatic brain injury'.''.
SEC. 4. NATIONAL HEAD INJURY PREVENTION AND AWARENESS MONTH.
The month of October, 1994, is hereby designated as
``National Head Injury Prevention and Awareness Month'' and
the President is requested to issue a proclamation calling on
the people of the United States to observe such month with
appropriate ceremonies and activities.
SEC. 5. EFFECTIVE DATE.
This Act and the amendments made by this Act shall take
effect on October 1, 1994, or upon the date of enactment of
this Act, whichever occurs later.
amendment no. 1657
(Purpose: To provide for a substitute amendment)
Mr. KENNEDY. Madam President, I send a substitute amendment to the
desk, and ask for its immediate consideration.
The PRESIDING OFFICER. The clerk will report.
The legislative clerk read as follows:
The Senator from Massachusetts [Mr. Kennedy], for himself
and Mr. Hatch, proposes an amendment numbered 1657.
Strike out all after the enacting clause and insert in lieu
thereof the following:
SECTION 1. PROGRAMS OF CENTERS FOR DISEASE CONTROL AND
PREVENTION.
Part B of title III of the Public Health Service Act (42
U.S.C. 241 et seq.), as amended by section 703 of Public Law
103-183 (107 Stat. 2240), is amended by inserting after
section 317F the following section:
``prevention of traumatic brain injury
``Sec. 317G. The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may carry out
projects to reduce the incidence of traumatic brain injury.
Such projects may be carried out by the Secretary directly or
through awards of grants or contracts to public or nonprofit
private entities. The Secretary may directly or through such
awards provide technical assistance with respect to the
planning, development, and operation of such projects.
``(b) Certain Activities.--Activities under subsection (a)
may include--
``(1) the conduct of research into identifying effective
strategies for the prevention of traumatic brain injury; and
``(2) the implementation of public information and
education programs for the prevention of such injury and for
broadening the awareness of the public concerning the public
health consequences of such injury.
``(c) Coordination of Activities.--The Secretary shall
ensure that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding traumatic brain injury.
``(d) Definition.--For purposes of this section, the term
`traumatic brain injury' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.''.
SEC. 2. PROGRAMS OF NATIONAL INSTITUTES OF HEALTH.
Section 1261 of the Public Health Service Act (42 U.S.C.
300d-61) is amended--
(1) in subsection (d)--
(A) in paragraph (2), by striking ``and'' after the
semicolon at the end;
(B) in paragraph (3), by striking the period and inserting
``; and''; and
(C) by adding at the end the following paragraph:
``(4) the authority to make awards of grants or contracts
to public or nonprofit private entities for the conduct of
basic and applied research regarding traumatic brain injury,
which research may include--
``(A) the development of new methods and modalities for the
more effective diagnosis, measurement of degree of injury,
post-injury monitoring and prognostic assessment of head
injury for acute, subacute and later phases of care;
``(B) the development, modification and evaluation of
therapies that retard, prevent or reverse brain damage after
acute head injury, that arrest further deterioration
following injury and that provide the restitution of function
for individuals with long-term injuries;
``(C) the development of research on a continuum of care
from acute care through rehabilitation, designed, to the
extent practicable, to integrate rehabilitation and long-term
outcome evaluation with acute care research; and
``(D) the development of programs that increase the
participation of academic centers of excellence in head
injury treatment and rehabilitation research and training.'';
and
(2) in subsection (h), by adding at the end the following
paragraph:
``(4) The term `traumatic brain injury' means an acquired
injury to the brain. Such term does not include brain
dysfunction caused by congenital or degenerative disorders,
nor birth trauma, but may include brain injuries caused by
anoxia due to near drowning. The Secretary may revise the
definition of such term as the Secretary determines
necessary.''.
SEC. 3. PROGRAMS OF HEALTH RESOURCES AND SERVICES
ADMINISTRATION.
Part E of title XII of the Public Health Service Act (42
U.S.C. 300d-51 et seq.) is amended by adding at the end the
following section:
``SEC. 1252. STATE GRANTS FOR DEMONSTRATION PROJECTS
REGARDING TRAUMATIC BRAIN INJURY.
``(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make grants to States for the purpose of
carrying out demonstration projects to improve access to
health and other services regarding traumatic brain injury.
``(b) State Advisory Board.--
``(1) In general.--The Secretary may make a grant under
subsection (a) only if the State involved agrees to establish
an advisory board within the appropriate health department of
the State or within another department as designated by the
chief executive officer of the State.
``(2) Functions.--An advisory board established under
paragraph (1) shall advise and make recommendations to the
State on ways to improve services coordination regarding
traumatic brain injury. Such advisory boards shall encourage
citizen participation through the establishment of public
hearings and other types of community outreach programs.
``(3) Composition.--An advisory board established under
paragraph (1) shall be composed of--
``(A) representatives of--
``(i) the corresponding State agencies involved;
``(ii) public and nonprofit private health related
organizations;
``(iii) other disability advisory or planning groups within
the State;
``(iv) members of an organization or foundation
representing traumatic brain injury survivors in that State;
and
``(v) injury control programs at the State or local level
if such programs exist; and
``(B) a substantial number of individuals who are survivors
of traumatic brain injury, or the family members of such
individuals.
``(c) Matching Funds.--
``(1) In general.--With respect to the costs to be incurred
by a State in carrying out the purpose described in
subsection (a), the Secretary may make a grant under such
subsection only if the State agrees to make available, in
cash, non-Federal contributions toward such costs in an
amount that is not less than $1 for each $2 of Federal funds
provided under the grant.
``(2) Determination of amount contributed.--In determining
the amount of non-Federal contributions in cash that a State
has provided pursuant to paragraph (1), the Secretary may not
include any amounts provided to the State by the Federal
Government.
``(d) Application for Grant.--The Secretary may make a
grant under subsection (a) only if an application for the
grant is submitted to the Secretary 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.
``(e) Coordination of Activities.--The Secretary shall
ensure that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding traumatic brain injury.
``(f) Report.--Not later than 2 years after the date of the
enactment of this section, the Secretary shall 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
results of the programs established under this section,
including measures of outcomes and consumer and surrogate
satisfaction.
``(g) Definition.--For purposes of this section, the term
`traumatic brain injury' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.
``(h) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such
sums as may be necessary for each of the fiscal years 1995
through 1997.''.
SEC. 4. STUDY; CONSENSUS CONFERENCE.
(a) Study.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary''), acting
through the appropriate agencies of the Public Health
Service, shall conduct a study for the purpose of carrying
out the following with respect to traumatic brain injury:
(1) In collaboration with appropriate State and local
health-related agencies--
(A) determine the incidence and prevalence of traumatic
brain injury; and
(B) develop a uniform reporting system under which States
report incidences of traumatic brain injury, if the Secretary
determines that such a system is appropriate.
(2) Identify common therapeutic interventions which are
used for the rehabilitation of individuals with such
injuries, and shall, subject to the availability of
information, include an analysis of--
(A) the effectiveness of each such intervention in
improving the functioning of individuals with brain injuries;
(B) the comparative effectiveness of interventions employed
in the course of rehabilitation of individuals with brain
injuries to achieve the same or similar clinical outcome; and
(C) the adequacy of existing measures of outcomes and
knowledge of factors influencing differential outcomes.
(3) Develop practice guidelines for the rehabilitation of
traumatic brain injury at such time as appropriate scientific
research becomes available.
(2) Dates certain for reports.--
(A) Not later than 18 months after the date of the
enactment of this Act, the Secretary shall 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 carrying out paragraph (1)(A).
(B) Not later than 3 years after the date of the enactment
of this Act, the Secretary shall submit to the Committees
specified in subparagraph (A) a report describing the
findings made as a result of carrying out subparagraphs (B)
and (C) of paragraph (1).
(b) Consensus Conference.--The Secretary, acting through
the Director of the National Center for Medical
Rehabilitation Research within the National Institute for
Child Health and Human Development, shall conduct a national
consensus conference on managing traumatic brain injury and
related rehabilitation concerns.
(c) Definition.--For purposes of this section, the term
``traumatic brain injury'' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 1995 through 1997.
SEC. 5. MAPLE SYRUP.
(a) Preemption.--Section 403A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
(1) in paragraph (1), by inserting at the end the
following: ``except that this paragraph does not apply to a
standard of identity of a State or political subdivision of a
State for maple syrup which is of the type required by
sections 401 and 403(g),'',
(2) in paragraph (2), by inserting at the end the
following: ``except that this paragraph does not apply to a
requirement of a State or political subdivision of a State
which is of the type required by section 403(c) and which is
applicable to maple syrup,'', and
(3) in paragraph (3), by inserting at the end the
following: ``except that this paragraph does not apply to a
requirement of a State or political subdivision of a State
which is of the type required by section 403(h)(1) and which
is applicable to maple syrup,''.
(b) Procedure.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is
amended by striking ``or maple syrup (regulated under section
168.140 of title 21, Code of Federal Regulations).''.
Mr. KENNEDY. Madam President, I ask unanimous consent that the
substitute amendment, as amended be agreed to, and that the motion to
reconsider be laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. Madam President: I am very pleased to be an original
cosponsor of the Traumatic Brain Injury Act and I rise to confirm my
support for the proposal and its goals.
Two million persons suffer major head injuries every year, and of
these 100,000 die. More young Americans in the 15- to 24-year age group
die or sustain disabilities from such injuries than from any other
cause. The many survivors of these traumatic occurances, of all ages,
often face irreversible loss of functions, including epilepsy or
sustained coma. The victims, and their families, suffer emotional and
financial devastation.
In February 1989, the Department of Health and Human Services issued
an interagency report that underlined the need for development of a
national strategy to address the issues of prevention of traumatic
brain injuries [TBI] and care of TBI survivors and their reintegration
into society.
The bill before us represents a necessary step towards making such a
national strategy reality. Under the provisions of S. 725 we seek
better coordination of existing resources for TBI survivors, expansion
of our knowledge of effective treatments and, most important of all,
more effective TBI prevention modalities. There will be increased
services coordination at the Federal and State level which should
assure greater and more effective access to care by TBI survivors and
their families. Our knowledge of TBI will be improved through a data
base system developed from uniform reporting.
In these various ways this legislation will act to prevent the
further deterioration of the condition of present TBI survivors and
improve their quality of life and that of their families. And, looking
to the future, hopefully we will be able to reduce the too great
incidence of TBI and the crushing consequences.
As we turn to address the broader issues of health care reform, we
must not neglect targeted, necessary and reasonable initiatives such as
the Traumatic Brain Injury Act. I urge the support of all my colleagues
for this measure.
The bill will also make a small but important change in the area of
nutrition labelling. One effect of the Nutrition Labeling and Education
Act was to preempt State standards. Congress did recognize the unique
problems this posed for the small maple syrup industry that exists in a
few of our States and acted on a temporary basis to maintain State
standards.
Since the 1920's, various States have regulated the manufacture of
maple syrup. It is a small market, with production centered in the
northeast. States have attempted to clarify with the Food and Drug
Administration their ability to maintain State standards which are more
stringent than federal standards with regard to impurities, imitations
and grading. These efforts have so far produced no response.
The provision is designed to preserve State purity and other
standards that consumers have come to associate with maple syrup from
those same States. Doing so will not result in any appreciable burden
on interstate commerce. Nor will it deprive consumers of protection
against false claims or deny them nutritional information. But it will
preserve the hard-earned and well-deserved reputation that our States'
sugarmakers have built up for their product over the years.
Mr. KENNEDY. Madam President, I urge the Senate to support the
Traumatic Brain Injury Act of 1994. This legislation establishes new
initiatives for preventing traumatic brain injury, enhancing basic and
applied research, and improving the quality of care.
Traumatic brain injury has become the number one killer and cause of
disability of young people in the United States, far outdistancing all
other causes. Every year 90,000 people sustain a severe brain injury
leading to irreversible and debilitating loss of function. Automobile
accidents, sports accidents, falls, and increasing violence are the
major causes of traumatic brain injury.
Medical treatment, rehabilitative efforts and disability payments for
such injuries cost $25 billion a year, and the emotional and financial
burden for families is often unbearable.
In 1988, Congress recommended that the Secretary of Health and Human
Services establish an Interagency Head Injury Task Force to identify
gaps in research, training, medical management and rehabilitation. This
legislation responds to the needs identified by the task force.
This bill will promote the coordination of health, social, vocational
and educational services at the State level and assure greater access
to such services for victims suffering from these injuries. By
improving the quality of care and access to a broad range of services,
we can reduce the severe disabling effects and the heavy toll of these
injuries.
The best treatment is still prevention. More effective strategies to
avoid these injuries are critical. The community education program
established under this bill will broaden public awareness of the
consequences of traumatic brain injury and encourage prevention
activities.
The bill will also expand efforts by the National Institutes of
Health to identify effective therapeutic interventions and the
development of practice guidelines for the rehabilitation of traumatic
brain injury.
Finally, other provisions in this legislation will coordinate data
collection and reporting of injuries through the Centers for Disease
Control and Prevention.
This measure has great potential for saving lives, reducing
disabilities and controlling health care costs. I urge the Senate to
support its passage.
Madam President, I ask unanimous consent that a summary of the Act be
printed in the Record.
There being no objection, the summary was ordered to be printed in
the Record, as follows:
Summary of Traumatic Brain Injury Act--S. 725
section 1. programs of centers for disease control and prevention
Adds a new section, 317G, to the Public Health Service Act.
The CDC may provide grants or carry out projects to reduce
the incidence of traumatic brain injury which may include
identifying effective prevention strategies and implementing
public information and education programs.
section 2. national institutes of health
Amends section 1261 of the Public Health Service Act to
allow NIH to award grants or contracts to support basic and
applied research which may include (1) development of new
methods for effective diagnosis, measurement of degree of
injury, and post-injury monitoring; (2) evaluation of
therapies that retard, prevent or reverse brain damage; (3)
research on the continuum of care and (4) increase
participation of academic centers of excellence in head
injury treatment and rehabilitation research and training.
section 3. program of health resources and services administration
Amends title XII of the Public Health Service Act by adding
new section, ``Section 1252. State Grants for Demonstration
Projects Statewide Program for Traumatic Brain Injury''. The
Administrator of Health Resources and Services Administration
may make grants to States for demonstration projects to
improve the availability of health services to traumatic
brain injury survivors. The States are required to establish
a State Advisory Board. The Board will encourage citizen
participation through public hearings and community outreach.
Requires matching funds, $1 State dollar for every $2 in
Federal support. Authorizes such sum as may be necessary for
FY94, FY95 and FY96.
section 4. study; consensus conference
Determine the incidence and prevalence of traumatic brain
injury and develop a uniform reporting system. Identify
common therapeutic interventions used for the rehabilitation
and assess it's effectiveness. Develop practice guidelines
for the rehabilitation of traumatic brain injury at such time
as appropriate scientific research becomes available. The
National Center for Medical Rehabilitation Research within
the National Institute for Child Health and Human Development
will conduct a national consensus conference on managing
traumatic brain injury. Authorizes such sum as may be
necessary for FY94, FY95 and FY96.
section 5. maple syrup (senators jeffords and mitchell amendment)
Since the 1920's, various states have regulated the
manufacture of maple syrup. It is a small market, with
production centered in the northeast. States have attempted
to clarify with the Food and Drug Administration their
ability to maintain state standards which are more stringent
than federal standards with regard to impurities, imitations
and grading. These efforts have so far produced no response.
The provision is designed to preserve state purity and other
standards that consumers have come to associate with maple
syrup. Doing so will not result in any appreciable burden on
interstate commerce.
differences between s. 725 and chairman's substitute amendment
1. Chairman's Substitute Amendment only authorizes two
programs; the NIH Consensus Reports and the State
Demonstration Service Coordination Program for such sums as
may be necessary for FY94, FY95 and FY96. S. 725 authorizes a
total of $40 million in FY95 and such as may be necessary for
FY95 and FY96.
2. New Section 5 of the Chairman's substitute contains
Senators Jefford and Mitchell Amendment on Maple Syrup.
The PRESIDING OFFICER. Without objection, the bill is considered read
the third time, and passed.
So the bill (S. 725), as amended was passed, as follows:
S. 725
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. PROGRAMS OF CENTERS FOR DISEASE CONTROL AND
PREVENTION.
Part B of title III of the Public Health Service Act (42
U.S.C. 241 et seq.), as amended by section 703 of Public Law
103-183 (107 Stat. 2240), is amended by inserting after
section 317F the following section:
``prevention of traumatic brain injury
``Sec. 317G. The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may carry out
projects to reduce the incidence of traumatic brain injury.
Such projects may be carried out by the Secretary directly or
through awards of grants or contracts to public or nonprofit
private entities. The Secretary may directly or through such
awards provide technical assistance with respect to the
planning, development, and operation of such projects.
``(b) Certain Activities.--Activities under subsection (a)
may include--
``(1) the conduct of research into identifying effective
strategies for the prevention of traumatic brain injury; and
``(2) the implementation of public information and
education programs for the prevention of such injury and for
broadening the awareness of the public concerning the public
health consequences of such injury.
``(c) Coordination of Activities.--The Secretary shall
ensure that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding traumatic brain injury.
``(d) Definition.--For purposes of this section, the term
`traumatic brain injury' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.''.
SEC. 2. PROGRAMS OF NATIONAL INSTITUTES OF HEALTH.
Section 1261 of the Public Health Service Act (42 U.S.C.
300d-61) is amended--
(1) in subsection (d)--
(A) in paragraph (2), by striking ``and'' after the
semicolon at the end;
(B) in paragraph (3), by striking the period and inserting
``; and''; and
(C) by adding at the end the following paragraph:
``(4) the authority to make awards of grants or contracts
to public or nonprofit private entities for the conduct of
basic and applied research regarding traumatic brain injury,
which research may include--
``(A) the development of new methods and modalities for the
more effective diagnosis, measurement of degree of injury,
post-injury monitoring and prognostic assessment of head
injury for acute, subacute and later phases of care;
``(B) the development, modification and evaluation of
therapies that retard, prevent or reverse brain damage after
acute head injury, that arrest further deterioration
following injury and that provide the restitution of function
for individuals with long-term injuries;
``(C) the development of research on a continuum of care
from acute care through rehabilitation, designed, to the
extent practicable, to integrate rehabilitation and long-term
outcome evaluation with acute care research; and
``(D) the development of programs that increase the
participation of academic centers of excellence in head
injury treatment and rehabilitation research and training.'';
and
(2) in subsection (h), by adding at the end the following
paragraph:
``(4) The term `traumatic brain injury' means an acquired
injury to the brain. Such term does not include brain
dysfunction caused by congenital or degenerative disorders,
nor birth trauma, but may include brain injuries caused by
anoxia due to near drowning. The Secretary may revise the
definition of such term as the Secretary determines
necessary.''.
SEC. 3. PROGRAMS OF HEALTH RESOURCES AND SERVICES
ADMINISTRATION.
Part E of title XII of the Public Health Service Act (42
U.S.C. 300d-51 et seq.) is amended by adding at the end the
following section:
``SEC. 1252. STATE GRANTS FOR DEMONSTRATION PROJECTS
REGARDING TRAUMATIC BRAIN INJURY.
``(a) In General.--The Secretary, acting through the
Administrator of the Health Resources and Services
Administration, may make grants to States for the purpose of
carrying out demonstration projects to improve access to
health and other services regarding traumatic brain injury.
``(b) State Advisory Board.--
``(1) In general.--The Secretary may make a grant under
subsection (a) only if the State involved agrees to establish
an advisory board within the appropriate health department of
the State or within another department as designated by the
chief executive officer of the State.
``(2) Functions.--An advisory board established under
paragraph (1) shall advise and make recommendations to the
State on ways to improve services coordination regarding
traumatic brain injury. Such advisory boards shall encourage
citizen participation through the establishment of public
hearings and other types of community outreach programs.
``(3) Composition.--An advisory board established under
paragraph (1) shall be composed of--
``(A) representatives of--
``(i) the corresponding State agencies involved;
``(ii) public and nonprofit private health related
organizations;
``(iii) other disability advisory or planning groups within
the State;
``(iv) members of an organization or foundation
representing traumatic brain injury survivors in that State;
and
``(v) injury control programs at the State or local level
if such programs exist; and
``(B) a substantial number of individuals who are survivors
of traumatic brain injury, or the family members of such
individuals.
``(c) Matching Funds.--
``(1) In general.--With respect to the costs to be incurred
by a State in carrying out the purpose described in
subsection (a), the Secretary may make a grant under such
subsection only if the State agrees to make available, in
cash, non-Federal contributions toward such costs in an
amount that is not less than $1 for each $2 of Federal funds
provided under the grant.
``(2) Determination of amount contributed.--In determining
the amount of non-Federal contributions in cash that a State
has provided pursuant to paragraph (1), the Secretary may not
include any amounts provided to the State by the Federal
Government.
``(d) Application for Grant.--The Secretary may make a
grant under subsection (a) only if an application for the
grant is submitted to the Secretary 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.
``(e) Coordination of Activities.--The Secretary shall
ensure that activities under this section are coordinated as
appropriate with other agencies of the Public Health Service
that carry out activities regarding traumatic brain injury.
``(f) Report.--Not later than 2 years after the date of the
enactment of this section, the Secretary shall 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
results of the programs established under this section,
including measures of outcomes and consumer and surrogate
satisfaction.
``(g) Definition.--For purposes of this section, the term
`traumatic brain injury' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.
``(h) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section such
sums as may be necessary for each of the fiscal years 1995
through 1997.''.
SEC. 4. STUDY; CONSENSUS CONFERENCE.
(a) Study.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary''), acting
through the appropriate agencies of the Public Health
Service, shall conduct a study for the purpose of carrying
out the following with respect to traumatic brain injury:
(1) In collaboration with appropriate State and local
health-related agencies--
(A) determine the incidence and prevalence of traumatic
brain injury; and
(B) develop a uniform reporting system under which States
report incidences of traumatic brain injury, if the Secretary
determines that such a system is appropriate.
(2) Identify common therapeutic interventions which are
used for the rehabilitation of individuals with such
injuries, and shall, subject to the availability of
information, include an analysis of--
(A) the effectiveness of each such intervention in
improving the functioning of individuals with brain injuries;
(B) the comparative effectiveness of interventions employed
in the course of rehabilitation of individuals with brain
injuries to achieve the same or similar clinical outcome; and
(C) the adequacy of existing measures of outcomes and
knowledge of factors influencing differential outcomes.
(3) Develop practice guidelines for the rehabilitation of
traumatic brain injury at such time as appropriate scientific
research becomes available.
(2) Dates certain for reports.--
(A) Not later than 18 months after the date of the
enactment of this Act, the Secretary shall 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 carrying out paragraph (1)(A).
(B) Not later than 3 years after the date of the enactment
of this Act, the Secretary shall submit to the Committees
specified in subparagraph (A) a report describing the
findings made as a result of carrying out subparagraphs (B)
and (C) of paragraph (1).
(b) Consensus Conference.--The Secretary, acting through
the Director of the National Center for Medical
Rehabilitation Research within the National Institute for
Child Health and Human Development, shall conduct a national
consensus conference on managing traumatic brain injury and
related rehabilitation concerns.
(c) Definition.--For purposes of this section, the term
``traumatic brain injury'' means an acquired injury to the
brain. Such term does not include brain dysfunction caused by
congenital or degenerative disorders, nor birth trauma, but
may include brain injuries caused by anoxia due to near
drowning. The Secretary may revise the definition of such
term as the Secretary determines necessary.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each of the fiscal years 1995 through 1997.
SEC. 5. MAPLE SYRUP.
(a) Preemption.--Section 403A(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343-1(a)) is amended--
(1) in paragraph (1), by inserting at the end the
following: ``except that this paragraph does not apply to a
standard of identity of a State or political subdivision of a
State for maple syrup which is of the type required by
sections 401 and 403(g),'',
(2) in paragraph (2), by inserting at the end the
following: ``except that this paragraph does not apply to a
requirement of a State or political subdivision of a State
which is of the type required by section 403(c) and which is
applicable to maple syrup,'', and
(3) in paragraph (3), by inserting at the end the
following: ``except that this paragraph does not apply to a
requirement of a State or political subdivision of a State
which is of the type required by section 403(h)(1) and which
is applicable to maple syrup,''.
(b) Procedure.--Section 701(e)(1) (21 U.S.C. 371(e)(1)) is
amended by striking ``or maple syrup (regulated under section
168.140 of title 21, Code of Federal Regulations).''.
Mr. KENNEDY. Madam President, I move to reconsider the vote, and I
move to lay that motion on the table.
The motion to lay on the table was agreed to.
____________________