Title: Neuromyelitis Optica Consortium Act
Policy area: Health

Summary:
Neuromyelitis Optica Consortium Act
This bill requires the National Institutes of Health to establish, administer, and coordinate a national consortium on neuromyelitis optica (NMO), which is a neurological disease that can cause blindness and paralysis.
The consortium must

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 321 Introduced in House (IH)]

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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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