[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 725 Engrossed Amendment House (EAH)]

                In the House of Representatives, U. S.,

                                                        August 8, 1994.
      Resolved, That the bill from the Senate (S. 725) entitled ``An 
Act 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'', do pass 
with the following

                               AMENDMENT:

        Strike out all after the enacting clause, and insert:

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:
                    (A) In collaboration with appropriate State and 
                local health-related agencies--
                            (i) determine the incidence and prevalence 
                        of traumatic brain injury; and
                            (ii) develop a uniform reporting system 
                        under which States report incidences of 
                        traumatic brain injury, if the Secretary 
                        determines that such a system is appropriate.
                    (B) 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--
                            (i) the effectiveness of each such 
                        intervention in improving the functioning of 
                        individuals with brain injuries;
                            (ii) 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
                            (iii) the adequacy of existing measures of 
                        outcomes and knowledge of factors influencing 
                        differential outcomes.
                    (C) 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. STATE STANDARDS.

    (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) a State or political subdivision of a State 
                for maple syrup which is of the type required by 
                sections 401 and 403(g), or
                    ``(B) a State for fluid milk which is of the type 
                required by sections 401 and 403(g) and which specifies 
                a higher minimum level of milk components than is 
                provided for in the corresponding standard of identity 
                promulgated under section 401,'',
            (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,'',
            (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,'', and
            (4) by adding at the end the following: ``For purposes of 
        paragraph (1)(B), the term `fluid milk' means liquid milk in 
        final packaged form for beverage use and does not include dry 
        milk, manufactured milk products, or tanker bulk milk.''.
    (b) Procedure.--Section 701(e)(1) of such Act (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)''.

SEC. 6. SELENIUM.

    The stay (published at 58 Fed. Reg. 47962) of the 1987 food 
additive regulation relating to selenium (21 Code of Federal 
Regulations 573.920) is suspended until December 31, 1995.

            Attest:






                                                                 Clerk.
                                     

103d CONGRESS

  2d Session

                                 S. 725

_______________________________________________________________________

                               AMENDMENT