[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.

                          ____________________