I 116th CONGRESS 1st Session H. R. 321 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.

1. Short title This Act may be cited as the Neuromyelitis Optica Consortium Act . 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. 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. 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: 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. .