[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 315 Reported in Senate (RS)]

                                                       Calendar No. 478
113th CONGRESS
  2d Session
                                 S. 315

  To reauthorize and extend the Paul D. Wellstone Muscular Dystrophy 
   Community Assistance, Research, and Education Amendments of 2008.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 13, 2013

 Ms. Klobuchar (for herself, Mr. Wicker, Mr. Sanders, Ms. Collins, Mr. 
  Menendez, Mr. Isakson, Ms. Mikulski, Mr. Leahy, Mr. Lautenberg, Mr. 
Nelson, Mr. Schumer, Mr. Cochran, Mrs. Boxer, Mr. King, Mr. Bennet, Ms. 
  Stabenow, Mr. Blunt, Mrs. Shaheen, Mr. Markey, Mrs. Gillibrand, Mr. 
Brown, Mr. Tester, Mr. Graham, Mr. Coons, Ms. Warren, Ms. Cantwell, Mr. 
    Pryor, Mr. Booker, Mr. Franken, and Mr. Harkin) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

                             July 23, 2014

Reported by Mr. Harkin, with an amendment and an amendment to the title
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
  To reauthorize and extend the Paul D. Wellstone Muscular Dystrophy 
   Community Assistance, Research, and Education Amendments of 2008.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Paul D. Wellstone Muscular 
Dystrophy Community Assistance, Research and Education (MD-CARE) 
Amendments of 2013''.</DELETED>

<DELETED>SEC. 2. INITIATIVE THROUGH THE DIRECTOR OF THE NATIONAL 
              INSTITUTES OF HEALTH.</DELETED>

<DELETED>    Section 404E of the Public Health Service Act (42 U.S.C. 
283g) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(1)--</DELETED>
                <DELETED>    (A) by striking ``Muscoskeletal'' and 
                inserting ``Musculoskeletal''; and</DELETED>
                <DELETED>    (B) by inserting ``Becker, myotonic, 
                facioscapulohumeral muscular dystrophy (referred to in 
                this section as `FSHD'), Congenital muscular dystrophy, 
                Limb-girdle muscular dystrophy,'' after 
                ``Duchenne,'';</DELETED>
        <DELETED>    (2) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (2), by inserting 
                ``cardiac and pulmonary function,'' after ``imaging, 
                genetics,''; and</DELETED>
                <DELETED>    (B) in paragraph (3), by inserting ``and 
                sharing of data'' after ``regular 
                communication'';</DELETED>
        <DELETED>    (3) in subsection (d)--</DELETED>
                <DELETED>    (A) in paragraph (2)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by striking ``15'' and 
                        inserting ``18''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (A), by 
                        striking ``children with muscular dystrophy, 
                        such as the Department of Education'' and 
                        inserting ``children and adults with muscular 
                        dystrophy, such as the Department of Education, 
                        the Social Security Administration, the United 
                        States Administration for Community Living''; 
                        and</DELETED>
                <DELETED>    (B) in paragraph (4)(B), by inserting ``, 
                and shall meet no less than two times per calendar 
                year'' before the period;</DELETED>
        <DELETED>    (4) in subsection (e)--</DELETED>
                <DELETED>    (A) in paragraph (1)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by striking ``through the 
                        national research institutes'' and inserting 
                        ``through the represented Federal agencies''; 
                        and</DELETED>
                        <DELETED>    (ii) in subparagraph (A), by 
                        striking ``and rehabilitative issues, including 
                        studies of the impact of such diseases in rural 
                        and underserved communities'' and inserting 
                        ``public resources, and rehabilitative issues, 
                        including studies of the impact of such 
                        diseases in rural and underserved communities, 
                        health economic studies to demonstrate the 
                        cost-effectiveness of providing independent 
                        living resources and support to patients with 
                        various forms of muscular dystrophy, and 
                        studies to determine optimal clinical care 
                        interventions for adults with various forms of 
                        muscular dystrophy''; and</DELETED>
                <DELETED>    (B) in paragraph (2), by adding at the end 
                the following:</DELETED>
                <DELETED>    ``(F) The development of clinical 
                interventions to improve the health of adults with 
                various forms of muscular dystrophy.''; and</DELETED>
        <DELETED>    (5) in subsection (g), by striking ``for the 
        various forms of muscular dystrophy by prioritizing the 
        achievement of the goals related to this topic in the plan 
        under subsection (e)(1)'' and inserting ``and shall, not later 
        than 6 months after the date of enactment of the Paul D. 
        Wellstone Muscular Dystrophy Community Assistance, Research and 
        Education (MD-CARE) Amendments of 2013, in coordination with 
        appropriate Federal agencies, including relevant offices within 
        the Food and Drug Administration and supported by the National 
        Institutes of Health and Department of Defense, develop a plan 
        to expedite the evaluation and approval of emerging therapies 
        and personalized medicines that have the potential to decrease 
        fatal disease progression across the various forms of muscular 
        dystrophy''.</DELETED>

<DELETED>SEC. 3. SURVEILLANCE AND RESEARCH REGARDING MUSCULAR 
              DYSTROPHY.</DELETED>

<DELETED>    Section 317Q of the Public Health Service Act (42 U.S.C. 
247b-18) is amended--</DELETED>
        <DELETED>    (1) in the second sentence of subsection (b), by 
        inserting before the period the following: ``and ensure that 
        the program captures data from different racial and ethnic 
        populations, and that such data are made publicly available to 
        investigators conducting public or private research on muscular 
        dystrophy''; and</DELETED>
        <DELETED>    (2) in subsection (c), by adding at the end the 
        following: ``The Secretary shall also foster ongoing engagement 
        and collaboration between the surveillance program and centers 
        of excellence.''.</DELETED>

<DELETED>SEC. 4. INFORMATION AND EDUCATION.</DELETED>

<DELETED>    Section 5(c) of the Muscular Dystrophy Community 
Assistance, Research and Education Amendments of 2001 (42 U.S.C. 247b-
19(c)) is amended by adding at the end the following:</DELETED>
        <DELETED>    ``(4) Update and widely disseminate existing 
        Duchenne-Becker muscular dystrophy care considerations for 
        pediatric patients, develop and widely disseminate Duchenne-
        Becker muscular dystrophy care considerations for adult 
        patients, and develop and widely disseminate acute care 
        considerations for all muscular dystrophy populations. The care 
        considerations should build upon existing efforts currently 
        underway for congenital muscular dystrophy, 
        fascioscapulohumeral muscular dystrophy, limb-girdle muscular 
        dystrophy, and myotonic muscular dystrophy, and incorporate 
        strategies specifically responding to the findings of the 
        national transitions survey of minority, young adult and adult 
        communities of muscular dystrophy patients.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Paul D. Wellstone Muscular Dystrophy 
Community Assistance, Research and Education Amendments of 2014''.

SEC. 2. INITIATIVE THROUGH THE DIRECTOR OF THE NATIONAL INSTITUTES OF 
              HEALTH.

    Section 404E of the Public Health Service Act (42 U.S.C. 283g) is 
amended--
            (1) in subsection (a)(1)--
                    (A) by striking ``Muscoskeletal'' and inserting 
                ``Musculoskeletal''; and
                    (B) by inserting ``Becker, congenital muscular 
                dystrophy, limb-girdle muscular dystrophy,'' after 
                ``Duchenne,'';
            (2) in subsection (b)--
                    (A) in paragraph (2)--
                            (i) by striking ``genetics,'' at the second 
                        place it appears; and
                            (ii) by inserting ``cardiac and pulmonary 
                        function, and'' after ``imaging,''; and
                    (B) in paragraph (3), by inserting ``and sharing of 
                data'' after ``regular communication'';
            (3) in subsection (d)--
                    (A) in paragraph (2)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``15'' and inserting ``18''; 
                        and
                            (ii) in subparagraph (A)--
                                    (I) by striking ``and the Food and 
                                Drug Administration'' and inserting ``, 
                                the Food and Drug Administration, and 
                                the Administration for Community 
                                Living'';
                                    (II) by inserting ``and adults'' 
                                after ``children''; and
                                    (III) by striking ``such as the 
                                Department of Education'' and inserting 
                                ``including the Department of Education 
                                and the Social Security 
                                Administration''; and
                    (B) in paragraph (4)(B), by inserting ``, but shall 
                meet no fewer than two times per calendar year'' before 
                the period; and
            (4) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``through the national 
                        research institutes'' and inserting ``through 
                        the agencies represented on the Coordinating 
                        Committee pursuant to subsection (d)(2)(A)''; 
                        and
                            (ii) in subparagraph (A)--
                                    (I) by inserting ``public 
                                services,'' before ``and rehabilitative 
                                issues''; and
                                    (II) by inserting ``, studies to 
                                demonstrate the cost-effectiveness of 
                                providing independent living resources 
                                and support to patients with various 
                                forms of muscular dystrophy, and 
                                studies to determine optimal clinical 
                                care interventions for adults with 
                                various forms of muscular dystrophy'' 
                                after ``including studies of the impact 
                                of such diseases in rural and 
                                underserved communities''; and
                    (B) in paragraph (2)(D), by inserting after 
                ``including new biological agents'' the following: 
                ``and new clinical interventions to improve the health 
                of those with muscular dystrophy''.

SEC. 3. SURVEILLANCE AND RESEARCH REGARDING MUSCULAR DYSTROPHY.

    The second sentence of section 317Q(b) of the Public Health Service 
Act (42 U.S.C. 247b-18(b)) is amended by inserting before the period 
the following: ``and, to the extent possible, ensure that data be 
representative of all affected populations and shared in a timely 
manner''.

SEC. 4. INFORMATION AND EDUCATION.

    Section 5(c) of the Muscular Dystrophy Community Assistance, 
Research and Education Amendments of 2001 (42 U.S.C. 247b-19(c)) is 
amended--
            (1) in paragraph (2)--
                    (A) by inserting ``for pediatric and adult 
                patients, including acute care considerations,'' after 
                ``issuance of care considerations'';
                    (B) by inserting ``various'' before ``other forms 
                of muscular dystrophy''; and
                    (C) by striking ``and'' at the end;
            (2) by redesignating paragraph (3) as paragraph (4);
            (3) by inserting after paragraph (2) the following:
            ``(3) in developing and updating care considerations under 
        paragraph (2), incorporate strategies specifically responding 
        to the findings of the national transitions survey of minority, 
        young adult, and adult communities of muscular dystrophy 
        patients; and''; and
            (4) in paragraph (4), as redesignated, by inserting 
        ``various'' before ``other forms of muscular dystrophy''.
            Amend the title so as to read: ``A bill to amend the Public 
        Health Service Act relating to Federal research on muscular 
        dystrophy, and for other purposes.''.
                                                       Calendar No. 478

113th CONGRESS

  2d Session

                                 S. 315

_______________________________________________________________________

                                 A BILL

  To reauthorize and extend the Paul D. Wellstone Muscular Dystrophy 
   Community Assistance, Research, and Education Amendments of 2008.

_______________________________________________________________________

                             July 23, 2014

        Reported with an amendment and an amendment to the title