II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Paul D. Wellstone 

3 Muscular Dystrophy Community Assistance, Research and 

4 Education (MD–CARE) Amendments of 2013’’. 

5 SEC. 2. INITIATIVE THROUGH THE DIRECTOR OF THE NA6 TIONAL INSTITUTES OF HEALTH. 

7 Section 404E of the Public Health Service Act (42 

8 U.S.C. 283g) is amended— 

9 (1) in subsection (a)(1)— 

10 (A) by striking ‘‘Muscoskeletal’’ and in11 serting ‘‘Musculoskeletal’’; and 

12 (B) by inserting ‘‘Becker, myotonic, 

13 facioscapulohumeral muscular dystrophy (re14 ferred to in this section as ‘FSHD’), Congenital 

15 muscular dystrophy, Limb-girdle muscular dys16 trophy,’’ after ‘‘Duchenne,’’; 

17 (2) in subsection (b)— 

18 (A) in paragraph (2), by inserting ‘‘cardiac 

19 and pulmonary function,’’ after ‘‘imaging, ge20 netics,’’; and 

21 (B) in paragraph (3), by inserting ‘‘and 

22 sharing of data’’ after ‘‘regular communica23 tion’’; 

24 (3) in subsection (d)— 

25 (A) in paragraph (2)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘15’’ and inserting 

3 ‘‘18’’; and 

4 (ii) in subparagraph (A), by striking 

5 ‘‘children with muscular dystrophy, such as 

6 the Department of Education’’ and insert7 ing ‘‘children and adults with muscular 

8 dystrophy, such as the Department of 

9 Education, the Social Security Administra10 tion, the United States Administration for 

11 Community Living’’; and 

12 (B) in paragraph (4)(B), by inserting ‘‘, 

13 and shall meet no less than two times per cal14 endar year’’ before the period; 

15 (4) in subsection (e)— 

16 (A) in paragraph (1)— 

17 (i) in the matter preceding subpara18 graph (A), by striking ‘‘through the na19 tional research institutes’’ and inserting 

20 ‘‘through the represented Federal agen21 cies’’; and 

22 (ii) in subparagraph (A), by striking 

23 ‘‘and rehabilitative issues, including studies 

24 of the impact of such diseases in rural and 

25 underserved communities’’ and inserting 


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1 ‘‘public resources, and rehabilitative issues, 

2 including studies of the impact of such dis3 eases in rural and underserved commu4 nities, health economic studies to dem5 onstrate the cost-effectiveness of providing 

6 independent living resources and support 

7 to patients with various forms of muscular 

8 dystrophy, and studies to determine opti9 mal clinical care interventions for adults 

10 with various forms of muscular dys11 trophy’’; and 

12 (B) in paragraph (2), by adding at the end 

13 the following: 

14 ‘‘(F) The development of clinical interven15 tions to improve the health of adults with var16 ious forms of muscular dystrophy.’’; and 

17 (5) in subsection (g), by striking ‘‘for the var18 ious forms of muscular dystrophy by prioritizing the 

19 achievement of the goals related to this topic in the 

20 plan under subsection (e)(1)’’ and inserting ‘‘and 

21 shall, not later than 6 months after the date of en22 actment of the Paul D. Wellstone Muscular Dys23 trophy Community Assistance, Research and Edu24 cation (MD–CARE) Amendments of 2013, in coordi25 nation with appropriate Federal agencies, including 


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1 relevant offices within the Food and Drug Adminis2 tration and supported by the National Institutes of 

3 Health and Department of Defense, develop a plan 

4 to expedite the evaluation and approval of emerging 

5 therapies and personalized medicines that have the 

6 potential to decrease fatal disease progression across 

7 the various forms of muscular dystrophy’’. 

8 SEC. 3. SURVEILLANCE AND RESEARCH REGARDING MUS9 CULAR DYSTROPHY. 

10 Section 317Q of the Public Health Service Act (42 

11 U.S.C. 247b–18) is amended— 

12 (1) in the second sentence of subsection (b), by 

13 inserting before the period the following: ‘‘and en14 sure that the program captures data from different 

15 racial and ethnic populations, and that such data 

16 are made publicly available to investigators con17 ducting public or private research on muscular dys18 trophy’’; and 

19 (2) in subsection (c), by adding at the end the 

20 following: ‘‘The Secretary shall also foster ongoing 

21 engagement and collaboration between the surveil22 lance program and centers of excellence.’’. 

23 SEC. 4. INFORMATION AND EDUCATION. 

24 Section 5(c) of the Muscular Dystrophy Community 

25 Assistance, Research and Education Amendments of 2001 


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1 (42 U.S.C. 247b–19(c)) is amended by adding at the end 

2 the following: 

3 ‘‘(4) Update and widely disseminate existing 

4 Duchenne-Becker muscular dystrophy care consider5 ations for pediatric patients, develop and widely dis6 seminate Duchenne-Becker muscular dystrophy care 

7 considerations for adult patients, and develop and 

8 widely disseminate acute care considerations for all 

9 muscular dystrophy populations. The care consider10 ations should build upon existing efforts currently 

11 underway for congenital muscular dystrophy, 

12 fascioscapulohumeral muscular dystrophy, limb-gir13 dle muscular dystrophy, and myotonic muscular dys14 trophy, and incorporate strategies specifically re15 sponding to the findings of the national transitions 

16 survey of minority, young adult and adult commu17 nities of muscular dystrophy patients.’’. 

18 SECTION 1. SHORT TITLE. 

19 This Act may be cited as the ‘‘Paul D. Wellstone Mus20 cular Dystrophy Community Assistance, Research and 

21 Education Amendments of 2014’’. 

22 SEC. 2. INITIATIVE THROUGH THE DIRECTOR OF THE NA23 TIONAL INSTITUTES OF HEALTH. 

24 Section 404E of the Public Health Service Act (42 

25 U.S.C. 283g) is amended— 


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1 (1) in subsection (a)(1)— 

2 (A) by striking ‘‘Muscoskeletal’’ and insert3 ing ‘‘Musculoskeletal’’; and 

4 (B) by inserting ‘‘Becker, congenital mus5 cular dystrophy, limb-girdle muscular dys6 trophy,’’ after ‘‘Duchenne,’’; 

7 (2) in subsection (b)— 

8 (A) in paragraph (2)— 

9 (i) by striking ‘‘genetics,’’ at the second 

10 place it appears; and 

11 (ii) by inserting ‘‘cardiac and pul12 monary function, and’’ after ‘‘imaging,’’; 

13 and 

14 (B) in paragraph (3), by inserting ‘‘and 

15 sharing of data’’ after ‘‘regular communication’’; 

16 (3) in subsection (d)— 

17 (A) in paragraph (2)— 

18 (i) in the matter preceding subpara19 graph (A), by striking ‘‘15’’ and inserting 

20 ‘‘18’’; and 

21 (ii) in subparagraph (A)— 

22 (I) by striking ‘‘and the Food and 

23 Drug Administration’’ and inserting ‘‘, 

24 the Food and Drug Administration, 


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1 and the Administration for Commu2 nity Living’’; 

3 (II) by inserting ‘‘and adults’’ 

4 after ‘‘children’’; and 

5 (III) by striking ‘‘such as the De6 partment of Education’’ and inserting 

7 ‘‘including the Department of Edu8 cation and the Social Security Admin9 istration’’; and 

10 (B) in paragraph (4)(B), by inserting ‘‘, 

11 but shall meet no fewer than two times per cal12 endar year’’ before the period; and 

13 (4) in subsection (e)— 

14 (A) in paragraph (1)— 

15 (i) in the matter preceding subpara16 graph (A), by striking ‘‘through the na17 tional research institutes’’ and inserting 

18 ‘‘through the agencies represented on the Co19 ordinating Committee pursuant to sub20 section (d)(2)(A)’’; and 

21 (ii) in subparagraph (A)— 

22 (I) by inserting ‘‘public services,’’ 

23 before ‘‘and rehabilitative issues’’; and 

24 (II) by inserting ‘‘, studies to 

25 demonstrate the cost-effectiveness of 


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1 providing independent living resources 

2 and support to patients with various 

3 forms of muscular dystrophy, and 

4 studies to determine optimal clinical 

5 care interventions for adults with var6 ious forms of muscular dystrophy’’ 

7 after ‘‘including studies of the impact 

8 of such diseases in rural and under9 served communities’’; and 

10 (B) in paragraph (2)(D), by inserting after 

11 ‘‘including new biological agents’’ the following: 

12 ‘‘and new clinical interventions to improve the 

13 health of those with muscular dystrophy’’. 

14 SEC. 3. SURVEILLANCE AND RESEARCH REGARDING MUS15 CULAR DYSTROPHY. 

16 The second sentence of section 317Q(b) of the Public 

17 Health Service Act (42 U.S.C. 247b–18(b)) is amended by 

18 inserting before the period the following: ‘‘and, to the extent 

19 possible, ensure that data be representative of all affected 

20 populations and shared in a timely manner’’. 

21 SEC. 4. INFORMATION AND EDUCATION. 

22 Section 5(c) of the Muscular Dystrophy Community 

23 Assistance, Research and Education Amendments of 2001 

24 (42 U.S.C. 247b–19(c)) is amended— 

25 (1) in paragraph (2)— 


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1 (A) by inserting ‘‘for pediatric and adult 

2 patients, including acute care considerations,’’ 

3 after ‘‘issuance of care considerations’’; 

4 (B) by inserting ‘‘various’’ before ‘‘other 

5 forms of muscular dystrophy’’; and 

6 (C) by striking ‘‘and’’ at the end; 

7 (2) by redesignating paragraph (3) as para8 graph (4); 

9 (3) by inserting after paragraph (2) the fol10 lowing: 

11 ‘‘(3) in developing and updating care consider12 ations under paragraph (2), incorporate strategies 

13 specifically responding to the findings of the national 

14 transitions survey of minority, young adult, and 

15 adult communities of muscular dystrophy patients; 

16 and’’; and 

17 (4) in paragraph (4), as redesignated, by insert18 ing ‘‘various’’ before ‘‘other forms of muscular dys19 trophy’’. 

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.’’. 


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Calendar No. 478 

113TH CONGRESS 

2D SESSION S. 315 

A BILL 

To reauthorize and extend the Paul D. Wellstone 

search, and Education Amendments of 2008. Muscular Dystrophy Community Assistance, ReJULY 23, 2014 

Reported with an amendment and an amendment to the 

title 


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