[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1158 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1158

  To authorize the Secretary of Health and Human Services to conduct 
 activities to rapidly advance treatments for spinal muscular atrophy, 
  neuromuscular disease, and other pediatric diseases, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 21, 2009

Ms. Stabenow (for herself, Mr. Isakson, and Mr. Whitehouse) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To authorize the Secretary of Health and Human Services to conduct 
 activities to rapidly advance treatments for spinal muscular atrophy, 
  neuromuscular disease, and other pediatric diseases, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``SMA Treatment Acceleration Act of 
2009''.

SEC. 2. CLINICAL TRIALS NETWORK FOR SPINAL MUSCULAR ATROPHY.

    Part B of title IV of the Public Health Service Act is amended by 
adding at the end the following new section:

``SEC. 409J. CLINICAL TRIALS NETWORK FOR SPINAL MUSCULAR ATROPHY.

    ``(a) Clinical Trials Network.--The Director of NIH, in 
coordination with the Directors of the National Institute of 
Neurological Disorders and Stroke, the National Institute of Child 
Health and Human Development, and such other Institutes and Centers as 
specified by the Director shall provide for the upgrading and 
unification of spinal muscular atrophy clinical trial sites and the 
recruitment of new investigators and sites to establish a national 
clinical trials network for spinal muscular atrophy. The Director of 
NIH shall ensure that such network--
            ``(1) conducts coordinated, multisite, clinical trials of 
        therapies and clinical approaches to the treatment of spinal 
        muscular atrophy; and
            ``(2) rapidly and efficiently disseminates scientific 
        findings to the field.
    ``(b) Data Coordinating Center.--The Director of NIH, in 
coordination with the Commissioner of Food and Drugs and the Directors 
of the National Institute of Neurological Disorders and Stroke, the 
National Institute of Child Health and Human Development, and such 
other Institutes and Centers as specified by the Director, shall 
establish a data coordinating center with respect to spinal muscular 
atrophy to--
            ``(1) provide expert assistance in the design, conduct, 
        data analysis, data management, and data warehousing of 
        collaborative clinical and descriptive research projects;
            ``(2) organize and conduct multi-site monitoring 
        activities;
            ``(3) provide regular reports to the National Institute of 
        Neurological Disorders and Stroke, the National Institute of 
        Child Health and Human Development, such other Institutes and 
        Centers as specified by the Director, and the Food and Drug 
        Administration on enrollment and the allocation of resources; 
        and
            ``(4) conduct such other activities as are deemed necessary 
        by the Secretary.
    ``(c) Pre-Clinical Activities.--The Director of NIH, in 
coordination with the Directors of the National Institute of 
Neurological Disorders and Stroke and the National Institute of Child 
Health and Human Development, shall expand and intensify programs of 
such Institutes with respect to pre-clinical translation research 
related to spinal muscular atrophy.''.

SEC. 3. NATIONAL PATIENT REGISTRY.

    Part P of title III of the Public Health Service Act is amended by 
adding at the end the following new section:

``SEC. 399S. NATIONAL SPINAL MUSCULAR ATROPHY PATIENT REGISTRY.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in coordination with 
the Director of the NIH, shall enhance and provide ongoing support to a 
spinal muscular atrophy patient registry to provide for expanded 
epidemiological research towards improving awareness, management, 
treatment, and prevention of spinal muscular atrophy.
    ``(b) Longitudinal Data.--In carrying out subsection (a), the 
Secretary shall ensure the collection and analysis of longitudinal data 
related to individuals of all ages with spinal muscular atrophy, 
including infants, young children, adolescents, and adults of all 
ages.''.

SEC. 4. INTERAGENCY SPINAL MUSCULAR ATROPHY RESEARCH COORDINATING 
              COMMITTEE.

    Part B of title IV of the Public Health Service Act, as amended by 
section 2, is further amended by adding at the end the following new 
section:

``SEC. 409K. INTERAGENCY SPINAL MUSCULAR ATROPHY RESEARCH COORDINATING 
              COMMITTEE.

    ``(a) Establishment.--Not later than 6 months after the date of the 
enactment of this section, the Secretary shall establish a committee, 
to be known as the Interagency Spinal Muscular Atrophy Research 
Coordinating Committee (in this section referred to as the 
`Committee').
    ``(b) Duties.--The Committee shall--
            ``(1) share and coordinate information on existing research 
        activities, and make recommendations to the National Institutes 
        of Health and other Federal agencies regarding how to improve 
        existing research programs, that are related to spinal muscular 
        atrophy research and other related neurological diseases and 
        disorders;
            ``(2) develop a comprehensive strategy related to spinal 
        muscular atrophy research and other related neurological 
        diseases and disorders and advise the National Institutes of 
        Health and other Federal agencies, expanding proposals for 
        collaborative, multidisciplinary research, including proposals 
        for Common Fund research described in section 402(b)(7) and 
        other proposals that involve collaboration between 2 or more 
        national research institutes or national centers;
            ``(3) provide annual reports to the Secretary regarding the 
        National Institutes of Health and other Federal agencies' 
        collaborative multidisciplinary research efforts to support 
        spinal muscular atrophy, including the Spinal Muscular Atrophy 
        Project at the National Institute of Neurological Disorders and 
        Stroke, the ongoing and future research needs to advance 
        therapies for spinal muscular atrophy, and recommendations on 
        how to strengthen the collaboration of research activities by 
        the institutes and agencies to improve the results;
            ``(4) develop a summary of advances in research related to 
        spinal muscular atrophy research and other related neurological 
        diseases and disorders research supported or conducted by 
        Federal agencies; and
            ``(5) not later than 1 year after the date of the 
        establishment of the Committee, make recommendations to the 
        Secretary--
                    ``(A) regarding any appropriate changes to research 
                activities, including recommendations to improve the 
                research portfolio of the National Institutes of Health 
                to ensure that scientifically-based strategic planning 
                is implemented in support of research priorities that 
                impact research activities related to spinal muscular 
                atrophy and other related neurological diseases and 
                disorders;
                    ``(B) identifying barriers to the development of 
                new treatments and cures for spinal muscular atrophy 
                and other related neurological diseases and disorders;
                    ``(C) regarding public participation in decisions 
                relating to spinal muscular atrophy research and other 
                related neurological diseases and disorders to increase 
                the involvement of patient advocacy and community 
                organizations representing a broad geographical area;
                    ``(D) on how best to disseminate information on 
                spinal muscular atrophy progress; and
                    ``(E) on how to expand partnerships between public 
                entities, including Federal agencies, and private 
                entities to expand collaborative, cross-cutting 
                research.
    ``(c) Rule of Construction.--In carrying out the duties described 
in subsection (b) with respect to research on spinal muscular atrophy, 
nothing in this section shall be construed to restrict the Secretary 
from including other neurological or genetic disorders, as appropriate, 
in such research if doing so may advance research in spinal muscular 
atrophy or other related neurological diseases and disorders.
    ``(d) Membership.--
            ``(1) In general.--The Committee shall be composed of the 
        following voting members:
                    ``(A) Not more than 11 voting Federal 
                representatives as follows:
                            ``(i) The Director of the Centers for 
                        Disease Control and Prevention.
                            ``(ii) The Director of the National 
                        Institutes of Health and the directors of such 
                        national research institutes and national 
                        centers (which shall include the National 
                        Institute of Neurological Disorders and Stroke, 
                        the National Institute of Child Health and 
                        Human Development, and the National Center for 
                        Research Resources) as the Secretary determines 
                        appropriate.
                            ``(iii) The Commissioner of Food and Drugs.
                            ``(iv) The heads of such other agencies and 
                        advisory committees as the Secretary determines 
                        appropriate, including the Health Resources and 
                        Services Administration, the Agency for 
                        Healthcare Research and Quality, and the 
                        Advisory Committee on Heritable Disorders and 
                        Genetic Diseases in Newborns and Children.
                            ``(v) Representatives of other Federal 
                        agencies that conduct or support neurological 
                        research, or provide support services and 
                        resources for individuals with spinal muscular 
                        atrophy, such as the Department of Education 
                        and the Social Security Administration.
                    ``(B) 9 additional voting members appointed under 
                paragraph (2).
            ``(2) Additional members.--The Committee shall include 
        additional voting members appointed by the Secretary as 
        follows:
                    ``(A) 6 members shall be appointed from among 
                scientists, physicians, and other health professionals, 
                who--
                            ``(i) are not officers or employees of the 
                        United States;
                            ``(ii) represent multiple disciplines, 
                        including clinical, basic, and public health 
                        sciences;
                            ``(iii) represent different geographical 
                        regions of the United States;
                            ``(iv) are from practice settings, 
                        academia, or other research settings; and
                            ``(v) are experienced in scientific peer 
                        review process.
                    ``(B) 3 members shall be appointed from members of 
                the general public, who represent individuals with 
                spinal muscular atrophy.
            ``(3) Nonvoting members.--The Committee shall include such 
        nonvoting members as the Secretary determines to be 
        appropriate.
    ``(e) Chairperson.--The voting members of the Committee shall 
select a chairperson from among the Federal members of the Committee 
described in subsection (d)(1)(A). The selection of a chairperson may 
be subject to the approval of the Secretary. The chairperson shall 
serve for a term of not to exceed 2 years, but may be re-elected as 
provided for in the first sentence.
    ``(f) Meetings.--The Committee shall meet at the call of the 
chairperson of the Committee or upon the request of the Secretary, but 
in no case less often than once each year.
    ``(g) Review.--In 2012, and biennially thereafter, the Secretary 
shall review the necessity of the Committee.''.

SEC. 5. EDUCATION AND AWARENESS ON SMA FOR HEALTH CARE PROFESSIONALS.

    Part P of title III of the Public Health Service Act, as amended by 
section 3, is further amended by adding at the end the following new 
section:

``SEC. 399T. INFORMATION AND EDUCATION ON SMA.

    ``The Secretary shall establish and implement a program to provide 
information and education on spinal muscular atrophy to health 
professionals and the general public, including information and 
education on advances in the screening, diagnosis, and treatment of 
spinal muscular atrophy and training and continuing education through 
programs for scientists, physicians, medical students, and other health 
professionals who provide care for patients with spinal muscular 
atrophy.''.
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