II
Calendar No. 478
113th CONGRESS
2d Session
S. 315
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.
Short title
This Act may be cited as
the
Paul D. Wellstone Muscular
Dystrophy Community Assistance, Research and Education (MD–CARE)
Amendments of
2013
.
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—
in subsection (a)(1)—
by striking
Muscoskeletal
and inserting Musculoskeletal
;
and
by inserting
Becker, myotonic, facioscapulohumeral muscular dystrophy (referred to in
this section as
after FSHD
), Congenital muscular dystrophy,
Limb-girdle muscular dystrophy,Duchenne,
;
in subsection (b)—
in paragraph (2),
by inserting cardiac and pulmonary function,
after
imaging, genetics,
; and
in paragraph (3),
by inserting and sharing of data
after regular
communication
;
in subsection (d)—
in paragraph (2)—
in
the matter preceding subparagraph (A), by striking 15
and
inserting 18
; and
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
in paragraph
(4)(B), by inserting , and shall meet no less than two times per
calendar year
before the period;
in subsection (e)—
in paragraph (1)—
in
the matter preceding subparagraph (A), by striking through the national
research institutes
and inserting through the represented
Federal agencies
; and
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
in paragraph (2), by adding at the end the following:
The development of clinical interventions to improve the health of adults with various forms of muscular dystrophy.
; and
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
.
Surveillance and research regarding muscular dystrophy
Section 317Q of the Public Health Service Act ( 42 U.S.C. 247b–18) is amended—
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
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.
.
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 by adding at the end the following:
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.
.
Short title
This Act may be cited as the
Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments of
2014
.
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—
in subsection (a)(1)—
by striking Muscoskeletal
and inserting Musculoskeletal
; and
by inserting Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy,
after Duchenne,
;
in subsection (b)—
in paragraph (2)—
by striking genetics,
at the second place it appears; and
by inserting cardiac and pulmonary function, and
after imaging,
; and
in paragraph (3), by inserting and sharing of data
after regular communication
;
in subsection (d)—
in paragraph (2)—
in the matter preceding subparagraph (A), by striking 15
and inserting 18
; and
in subparagraph (A)—
by striking and the Food and Drug Administration
and inserting , the Food and Drug Administration, and the Administration for Community Living
;
by inserting and adults
after children
; and
by striking such as the Department of Education
and inserting including the Department of Education and the Social Security Administration
; and
in paragraph (4)(B), by inserting , but shall meet no fewer than two times per calendar year
before the period; and
in subsection (e)—
in paragraph (1)—
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
in subparagraph (A)—
by inserting public services,
before and rehabilitative issues
; and
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
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
.
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
.
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—
in paragraph (2)—
by inserting for pediatric and adult patients, including acute care considerations,
after issuance of care considerations
;
by inserting various
before other forms of muscular dystrophy
; and
by striking and
at the end;
by redesignating paragraph (3) as paragraph (4);
by inserting after paragraph (2) the following:
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
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.
.
July 23, 2014
Reported with an amendment and an amendment to the title
