Neuromyelitis Optica Consortium Act

I 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Neuromyelitis Optica 4 Consortium Act’’. 5 SEC. 2. FINDINGS. 6 Congress finds the following: 7 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 2 •HR 321 IH (1) Neuromyelitis optica (NMO) is a dev- 1 astating neurologic disease leading to blindness and 2 paralysis. 3 (2) There are an estimated 16,000 to 17,000 4 people with NMO in the United States and a quar- 5 ter-million worldwide. 6 (3) Women are affected 4 to 5 times more than 7 men, and Afro-Caribbeans are about 2.5 times more 8 predisposed to NMO than Caucasians. The reasons 9 why Blacks are disproportionately affected cannot be 10 fully understood without further studies. 11 (4) The average age at diagnosis is between 40 12 and 50 years, but the range is broad and includes 13 children as young as 3 years of age and adults as 14 old as 90 years of age. 15 (5) NMO incurs substantial costs for affected 16 patients and their families. 17 (6) The cause of NMO is unknown, but it is hy- 18 pothesized to be autoimmune in nature. 19 (7) More than 90 percent of NMO patients will 20 suffer recurrent disease and accumulate neurologic 21 disability. 22 (8) Because of their relatively low overall inci- 23 dence, orphan diseases like NMO frequently do not 24 receive sufficient attention and research funding. 25 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 3 •HR 321 IH (9) No single institution has a sufficient num- 1 ber of patients to independently conduct research 2 that will adequately address the cause of NMO. 3 (10) There has been no comprehensive study 4 analyzing all relevant clinical, biological, and epide- 5 miological aspects of NMO to identify potential risk 6 factors and biomarkers for NMO. 7 (11) We can apply our understanding of NMO 8 to the study of other autoimmune diseases, including 9 multiple sclerosis and systemic lupus erythematosus. 10 SEC. 3. SENSE OF CONGRESS. 11 It is the sense of Congress that there is a need— 12 (1) to establish and coordinate a multicenter re- 13 search effort based on collaboration between regional 14 consortia and governmental and nongovernmental 15 entities in order to— 16 (A) comprehensively study the causes of 17 NMO; and 18 (B) identify potential biomarkers of disease 19 activity; and 20 (2) to encourage a collaborative effort among 21 academic medical centers with epidemiological study 22 groups to gather comprehensive and detailed infor- 23 mation for each patient enrolled in those groups, in 24 order to investigate environmental, nutritional, and 25 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 4 •HR 321 IH genetic factors with respect to, and the pathological 1 and epidemiological characteristics of, NMO. 2 SEC. 4. ESTABLISHMENT OF THE NATIONAL NEUROMYELI- 3 TIS OPTICA CONSORTIUM. 4 Part B of title IV of the Public Health Service Act 5 (42 U.S.C. 284 et seq.) is amended by adding after section 6 409J the following new section: 7 ‘‘SEC. 409K. NATIONAL NEUROMYELITIS OPTICA CONSOR- 8 TIUM. 9 ‘‘(a) ESTABLISHMENT OF THE NATIONAL 10 NEUROMYELITIS OPTICA CONSORTIUM.— 11 ‘‘(1) IN GENERAL.—Not later than 1 year after 12 the date of the enactment of this section, the Sec- 13 retary, acting through the Director of NIH, and in 14 coordination with the Director of the National Insti- 15 tute on Minority Health and Health Disparities, 16 shall establish, administer, and coordinate a Na- 17 tional Neuromyelitis Optica Consortium (in this sec- 18 tion referred to as the ‘NNO Consortium’) for the 19 purposes described in paragraph (2). 20 ‘‘(2) PURPOSES.—The purposes of the NNO 21 Consortium shall be the following: 22 ‘‘(A) Providing grants of not fewer than 5- 23 years’ duration to eligible consortia for the pur- 24 pose of conducting research with respect to the 25 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 5 •HR 321 IH causes of, and the risk factors and biomarkers 1 associated with, NMO. 2 ‘‘(B) Assembling a panel of experts to pro- 3 vide, with respect to research funded by the 4 NNO Consortium, ongoing guidance and rec- 5 ommendations for the development of the fol- 6 lowing: 7 ‘‘(i) A common study design. 8 ‘‘(ii) Standard protocols, methods, 9 procedures, and assays for collecting from 10 individuals enrolled as study participants a 11 minimum dataset that includes the fol- 12 lowing: 13 ‘‘(I) Complete medical history. 14 ‘‘(II) Neurologic examination. 15 ‘‘(III) Biospecimens, including 16 blood, spinal fluid, DNA, and RNA. 17 ‘‘(IV) Radiological data, includ- 18 ing magnetic resonance imaging 19 (MRI). 20 ‘‘(iii) Specific analytical methods for 21 examining data. 22 ‘‘(iv) Provisions for consensus review 23 of enrolled cases. 24 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 6 •HR 321 IH ‘‘(v) An integrated data collection net- 1 work. 2 ‘‘(C) Designating a central laboratory to 3 collect, analyze, and aggregate data with re- 4 spect to research funded by the NNO Consor- 5 tium and to make such data and analysis avail- 6 able to researchers. 7 ‘‘(3) ELIGIBLE CONSORTIA.—To be eligible for 8 a grant under this section, a consortium shall dem- 9 onstrate the following: 10 ‘‘(A) The consortium has the capability to 11 enroll as research participants a minimum of 25 12 individuals with a diagnosis of NMO from the 13 consortium’s designated catchment area. 14 ‘‘(B) The designated catchment area of the 15 consortium does not overlap with the designated 16 catchment area of another consortium already 17 receiving a grant under this section. 18 ‘‘(4) REPORT.—Not later than 1 year after the 19 date of the enactment of this section, and annually 20 thereafter, the Secretary, acting through the Direc- 21 tor of NIH, shall submit to Congress a report with 22 respect to the NNO Consortium, to be made publicly 23 available, including a summary of research funded 24 by the NNO Consortium and a list of consortia re- 25 VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS 7 •HR 321 IH ceiving grants through the NNO Consortium. At the 1 discretion of the Secretary, such report may be com- 2 bined with other similar or existing reports. 3 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 4 ‘‘(A) IN GENERAL.—There is authorized to 5 be appropriated $25,000,000 for each of fiscal 6 years 2019 through 2022, to remain available 7 until expended, to carry out this section. 8 ‘‘(B) SENSE OF CONGRESS.—It is the 9 sense of Congress that funds appropriated to 10 carry out this section should be in addition to 11 funds otherwise available or appropriated to 12 carry out the activities described in this section. 13 ‘‘(b) DEFINITIONS.—For purposes of this section: 14 ‘‘(1) CATCHMENT AREA.—The term ‘catchment 15 area’ means a defined area for which population 16 data are available. 17 ‘‘(2) CONSORTIUM.—The term ‘consortium’ 18 means a partnership of two or more universities, 19 health care organizations, or government agencies, 20 or any combination of such entities, serving a des- 21 ignated catchment area.’’. 22 Æ VerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H321.IH H321 pamtmann on DSKBFK8HB2PROD with BILLS