[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6884 Introduced in House (IH)]
110th CONGRESS
2d Session
H. R. 6884
To amend the Public Health Service Act to provide for the establishment
of a National Acquired Bone Marrow Failure Disease Registry, to
authorize research on acquired bone marrow failure diseases, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 11, 2008
Ms. Matsui (for herself, Mr. Van Hollen, Mr. Bishop of Georgia, Mr.
Doolittle, Mr. Etheridge, Mr. Ramstad, Mr. Stark, Mrs. Emerson, Mr.
Altmire, Mr. Waxman, Mr. King of New York, Ms. Schakowsky, Ms.
Bordallo, Ms. DeGette, Mr. McGovern, and Mr. McDermott) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for the establishment
of a National Acquired Bone Marrow Failure Disease Registry, to
authorize research on acquired bone marrow failure 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 ``Bone Marrow Failure Disease Research
and Treatment Act of 2008''.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Between 20,000 and 30,000 Americans are diagnosed each
year with myelodysplastic syndromes, aplastic anemia,
paroxysmal nocturnal hemoglobinuria, and other acquired bone
marrow failure diseases.
(2) Acquired bone marrow failure diseases have a
debilitating and often fatal impact on those diagnosed with
these disease.
(3) While some treatments for acquired bone marrow failure
diseases can prolong and improve the quality of patients'
lives, there is no single cure for these diseases.
(4) The prevalence of acquired bone marrow failure diseases
in the United States will continue to grow as the general
public ages.
(5) Evidence exists suggesting that acquired bone marrow
failure diseases occur more often in minority populations,
particularly in Asian American and Hispanic/Latino populations.
(6) The National Heart, Lung, and Blood Institute and the
National Cancer Institute have conducted important research
into the causes of and treatments for acquired bone marrow
failure diseases.
(7) The National Marrow Donor Program Registry has made
significant contributions to the fight against bone marrow
failure diseases by connecting millions of potential marrow
donors with individuals and families suffering from these
conditions.
(8) Despite these advances, a more comprehensive Federal
strategic effort among numerous Federal agencies is needed to
discover a cure for acquired bone marrow failure disorders.
(9) Greater Federal surveillance of acquired bone marrow
failure diseases is needed to gain a better understanding of
the causes of acquired bone marrow failure diseases.
(10) The Federal Government should increase its research
support for and engage with public and private organizations in
developing a comprehensive approach to combat and cure acquired
bone marrow failure diseases.
SEC. 3. NATIONAL ACQUIRED BONE MARROW FAILURE DISEASE REGISTRY.
Part B of the Public Health Service Act (42 U.S.C. 311 et seq.) is
amended by inserting after section 317S the following:
``SEC. 317T. NATIONAL ACQUIRED BONE MARROW FAILURE DISEASE REGISTRY.
``(a) Establishment of Registry.--
``(1) In general.--Not later than 6 months after the date
of the enactment of this section, the Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall--
``(A) develop a system to collect data on acquired
bone marrow failure diseases; and
``(B) establish and maintain a national and
publicly available registry, to be known as the
National Acquired Bone Marrow Failure Disease Registry,
in accordance with paragraph (3).
``(2) Recommendations of advisory committee.--In carrying
out this subsection, the Secretary shall take into
consideration the recommendations of the Advisory Committee on
Acquired Bone Marrow Failure Diseases established under
subsection (b).
``(3) Purposes of registry.--The National Acquired Bone
Marrow Failure Disease Registry--
``(A) shall identify the incidence and prevalence
of acquired bone marrow failure diseases in the United
States;
``(B) shall be used to collect and store data on
acquired bone marrow failure diseases, including data
concerning--
``(i) the age, race or ethnicity, general
geographic location, sex, and family history of
individuals who are diagnosed with acquired
bone marrow failure diseases, and any other
characteristics of such individuals determined
appropriate by the Secretary;
``(ii) the genetic and environmental
factors that may be associated with developing
acquired bone marrow failure diseases;
``(iii) treatment approaches for dealing
with acquired bone marrow failure diseases;
``(iv) outcomes for individuals treated for
acquired bone marrow failure diseases,
including outcomes for recipients of stem cell
therapeutic products as contained in the
database established pursuant to section 379A;
and
``(v) any other factors pertaining to
acquired bone marrow failure diseases
determined appropriate by the Secretary; and
``(C) shall be made available--
``(i) to the general public; and
``(ii) to researchers to facilitate further
research into the causes of, and treatments
for, acquired bone marrow failure diseases in
accordance with standard practices of the
Centers for Disease Control and Preventions.
``(b) Advisory Committee.--
``(1) Establishment.--Not later than 6 months after the
date of the enactment of this section, the Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, shall establish an advisory committee, to be known
as the Advisory Committee on Acquired Bone Marrow Failure
Diseases.
``(2) Members.--The members of the Advisory Committee on
Acquired Bone Marrow Failure Diseases shall be appointed by the
Secretary, acting through the Director of the Centers for
Disease Control and Prevention, and shall include at least one
representative from each of the following:
``(A) A national patient advocacy organization with
experience advocating on behalf of patients suffering
from acquired bone marrow failure diseases.
``(B) The National Institutes of Health, including
at least one representative from each of--
``(i) the National Cancer Institute;
``(ii) the National Heart, Lung, and Blood
Institute; and
``(iii) the Office of Rare Diseases.
``(C) The Centers for Disease Control and
Prevention.
``(D) Clinicians with experience in--
``(i) diagnosing or treating acquired bone
marrow failure diseases; and
``(ii) medical data registries.
``(E) Epidemiologists who have experience with data
registries.
``(F) Publicly or privately funded researchers who
have experience researching acquired bone marrow
failure diseases.
``(G) The entity operating the C.W. Bill Young Cell
Transplantation Program established pursuant to section
379 and the entity operating the C.W. Bill Young Cell
Transplantation Program Outcomes Database.
``(3) Responsibilities.--The Advisory Committee on Acquired
Bone Marrow Failure Diseases shall provide recommendations to
the Secretary on the establishment and maintenance of the
National Acquired Bone Marrow Failure Disease Registry,
including recommendations on the collection, maintenance, and
dissemination of data.
``(4) Public availability.--The Secretary shall make the
recommendations of the Advisory Committee on Acquired Bone
Marrow Failure Disease publicly available.
``(c) Grants.--The Secretary, acting through the Director of the
Centers for Disease Control and Prevention, may award grants to, and
enter into contracts and cooperative agreements with, public or private
nonprofit entities for the management of, as well as the collection,
analysis, and reporting of data to be included in, the National
Acquired Bone Marrow Failure Disease Registry.
``(d) Definition.--In this section, the term `acquired bone marrow
failure disease' means--
``(1) myelodysplastic syndromes (MDS);
``(2) aplastic anemia;
``(3) paroxysmal nocturnal hemoglobinuria (PNH);
``(4) pure red cell aplasia;
``(5) acute myeloid leukemia that has progressed from
myelodysplastic syndromes; or
``(6) large granular lymphocytic leukemia.
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $3,000,000 for each of fiscal
years 2009 through 2013.''.
SEC. 4. PILOT STUDIES THROUGH THE AGENCY FOR TOXIC SUBSTANCES AND
DISEASE REGISTRY.
(a) Pilot Studies.--The Secretary of Health and Human Services,
acting through the Administrator of the Agency for Toxic Substances and
Disease Registry, shall conduct pilot studies to determine which
environmental factors, including exposure to toxins, may cause acquired
bone marrow failure diseases.
(b) Collaboration With the Radiation Injury Treatment Network.--In
carrying out the directives of this section, the Secretary may
collaborate with the Radiation Injury Treatment Network of the C.W.
Bill Young Cell Transplantation Program established pursuant to section
379 of the Public Health Service Act (42 U.S.C. 274j) to--
(1) augment data for the pilot studies authorized by this
section;
(2) access technical assistance that may be provided by the
Radiation Injury Treatment Network; or
(3) perform joint research projects.
(c) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $1,000,000 for each of fiscal
years 2009 through 2013.
SEC. 5. MINORITY-FOCUSED PROGRAMS ON ACQUIRED BONE MARROW FAILURE
DISEASES.
Title XVII of the Public Health Service Act (42 U.S.C. 300u et
seq.) is amended by inserting after section 1707 the following:
``minority-focused programs on acquired bone marrow failure diseases
``Sec. 1707A. (a) Information and Referral Services.--
``(1) In general.--Not later than 6 months after the date
of the enactment of this section, the Secretary, acting through
the Deputy Assistant Secretary for Minority Health, shall
establish and coordinate outreach and informational programs
targeted to minority populations affected by acquired bone
marrow failure diseases.
``(2) Program requirements.--Minority-focused outreach and
informational programs authorized by this section--
``(A) shall make information about treatment
options and clinical trials for acquired bone marrow
failure diseases publicly available, and
``(B) shall provide referral services for treatment
options and clinical trials,
at the national minority health resource center supported under
section 1707(b)(8) (including by means of the center's website,
through appropriate locations such as the center's knowledge
center, and through appropriate programs such as the center's
resource persons network) and through minority health
consultants located at each Department of Health and Human
Services regional office.
``(b) Hispanic and Asian American and Pacific Islander Outreach.--
``(1) In general.--The Secretary, acting through the Deputy
Assistant Secretary for Minority Health, shall undertake a
coordinated outreach effort to connect Hispanic, Asian
American, and Pacific Islander communities with comprehensive
services focused on treatment of, and information about,
acquired bone marrow failure diseases.
``(2) Collaboration.--In carrying out this subsection, the
Secretary may collaborate with public health agencies,
nonprofit organizations, community groups, and online entities
to disseminate information about treatment options and clinical
trials for acquired bone marrow failure diseases.
``(c) Grants and Cooperative Agreements.--
``(1) In general.--Not later than 6 months after the date
of the enactment of this section, the Secretary, acting through
the Deputy Assistant Secretary for Minority Health, shall award
grants to, or enter into cooperative agreements with, entities
to perform research on acquired bone marrow failure diseases.
``(2) Requirement.--Grants and cooperative agreements
authorized by this subsection shall be awarded or entered into
on a competitive, peer-reviewed basis.
``(3) Scope of research.--Research funded under this
section shall examine factors affecting the incidence of
acquired bone marrow failure diseases in minority populations.
``(d) Definition.--In this section, the term `acquired bone marrow
failure disease' has the meaning given to such term in section 317T(d).
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $2,000,000 for each of fiscal
years 2009 through 2013.''.
SEC. 6. DIAGNOSIS AND QUALITY OF CARE FOR ACQUIRED BONE MARROW FAILURE
DISEASES.
(a) Grants.--The Secretary of Health and Human Services, acting
through the Director of the Agency for Healthcare Research and Quality,
shall award grants to entities to improve diagnostic practices and
quality of care with respect to patients with acquired bone marrow
failure diseases.
(b) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section $2,000,000 for each of fiscal
years 2009 through 2013.
SEC. 7. DEFINITION.
In this Act, the term ``acquired bone marrow failure disease''
means--
(1) myelodysplastic syndromes (MDS);
(2) aplastic anemia;
(3) paroxysmal nocturnal hemoglobinuria (PNH);
(4) pure red cell aplasia;
(5) acute myeloid leukemia that progressed from
myelodysplastic syndromes; or
(6) large granular lymphocytic leukemia.
<all>