[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 321 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 321
To amend the Public Health Service Act to create a National
Neuromyelitis Optica Consortium to provide grants and coordinate
research with respect to the causes of, and risk factors associated
with, neuromyelitis optica, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 8, 2019
Ms. Lee of California introduced the following bill; which was referred
to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to create a National
Neuromyelitis Optica Consortium to provide grants and coordinate
research with respect to the causes of, and risk factors associated
with, neuromyelitis optica, 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 ``Neuromyelitis Optica Consortium
Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Neuromyelitis optica (NMO) is a devastating neurologic
disease leading to blindness and paralysis.
(2) There are an estimated 16,000 to 17,000 people with NMO
in the United States and a quarter-million worldwide.
(3) Women are affected 4 to 5 times more than men, and
Afro-Caribbeans are about 2.5 times more predisposed to NMO
than Caucasians. The reasons why Blacks are disproportionately
affected cannot be fully understood without further studies.
(4) The average age at diagnosis is between 40 and 50
years, but the range is broad and includes children as young as
3 years of age and adults as old as 90 years of age.
(5) NMO incurs substantial costs for affected patients and
their families.
(6) The cause of NMO is unknown, but it is hypothesized to
be autoimmune in nature.
(7) More than 90 percent of NMO patients will suffer
recurrent disease and accumulate neurologic disability.
(8) Because of their relatively low overall incidence,
orphan diseases like NMO frequently do not receive sufficient
attention and research funding.
(9) No single institution has a sufficient number of
patients to independently conduct research that will adequately
address the cause of NMO.
(10) There has been no comprehensive study analyzing all
relevant clinical, biological, and epidemiological aspects of
NMO to identify potential risk factors and biomarkers for NMO.
(11) We can apply our understanding of NMO to the study of
other autoimmune diseases, including multiple sclerosis and
systemic lupus erythematosus.
SEC. 3. SENSE OF CONGRESS.
It is the sense of Congress that there is a need--
(1) to establish and coordinate a multicenter research
effort based on collaboration between regional consortia and
governmental and nongovernmental entities in order to--
(A) comprehensively study the causes of NMO; and
(B) identify potential biomarkers of disease
activity; and
(2) to encourage a collaborative effort among academic
medical centers with epidemiological study groups to gather
comprehensive and detailed information for each patient
enrolled in those groups, in order to investigate
environmental, nutritional, and genetic factors with respect
to, and the pathological and epidemiological characteristics
of, NMO.
SEC. 4. ESTABLISHMENT OF THE NATIONAL NEUROMYELITIS OPTICA CONSORTIUM.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding after section 409J the following new
section:
``SEC. 409K. NATIONAL NEUROMYELITIS OPTICA CONSORTIUM.
``(a) Establishment of the National Neuromyelitis Optica
Consortium.--
``(1) In general.--Not later than 1 year after the date of
the enactment of this section, the Secretary, acting through
the Director of NIH, and in coordination with the Director of
the National Institute on Minority Health and Health
Disparities, shall establish, administer, and coordinate a
National Neuromyelitis Optica Consortium (in this section
referred to as the `NNO Consortium') for the purposes described
in paragraph (2).
``(2) Purposes.--The purposes of the NNO Consortium shall
be the following:
``(A) Providing grants of not fewer than 5-years'
duration to eligible consortia for the purpose of
conducting research with respect to the causes of, and
the risk factors and biomarkers associated with, NMO.
``(B) Assembling a panel of experts to provide,
with respect to research funded by the NNO Consortium,
ongoing guidance and recommendations for the
development of the following:
``(i) A common study design.
``(ii) Standard protocols, methods,
procedures, and assays for collecting from
individuals enrolled as study participants a
minimum dataset that includes the following:
``(I) Complete medical history.
``(II) Neurologic examination.
``(III) Biospecimens, including
blood, spinal fluid, DNA, and RNA.
``(IV) Radiological data, including
magnetic resonance imaging (MRI).
``(iii) Specific analytical methods for
examining data.
``(iv) Provisions for consensus review of
enrolled cases.
``(v) An integrated data collection
network.
``(C) Designating a central laboratory to collect,
analyze, and aggregate data with respect to research
funded by the NNO Consortium and to make such data and
analysis available to researchers.
``(3) Eligible consortia.--To be eligible for a grant under
this section, a consortium shall demonstrate the following:
``(A) The consortium has the capability to enroll
as research participants a minimum of 25 individuals
with a diagnosis of NMO from the consortium's
designated catchment area.
``(B) The designated catchment area of the
consortium does not overlap with the designated
catchment area of another consortium already receiving
a grant under this section.
``(4) Report.--Not later than 1 year after the date of the
enactment of this section, and annually thereafter, the
Secretary, acting through the Director of NIH, shall submit to
Congress a report with respect to the NNO Consortium, to be
made publicly available, including a summary of research funded
by the NNO Consortium and a list of consortia receiving grants
through the NNO Consortium. At the discretion of the Secretary,
such report may be combined with other similar or existing
reports.
``(5) Authorization of appropriations.--
``(A) In general.--There is authorized to be
appropriated $25,000,000 for each of fiscal years 2019
through 2022, to remain available until expended, to
carry out this section.
``(B) Sense of congress.--It is the sense of
Congress that funds appropriated to carry out this
section should be in addition to funds otherwise
available or appropriated to carry out the activities
described in this section.
``(b) Definitions.--For purposes of this section:
``(1) Catchment area.--The term `catchment area' means a
defined area for which population data are available.
``(2) Consortium.--The term `consortium' means a
partnership of two or more universities, health care
organizations, or government agencies, or any combination of
such entities, serving a designated catchment area.''.
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Neuromyelitis Optica Consortium Act
#321 | HR Congress #116
Policy Area: Health
Last Action: Referred to the Subcommittee on Health. (1/25/2019)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text