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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Neuromyelitis Optica 

5 Consortium Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Neuromyelitis optica (NMO) is a dev2 astating neurologic disease leading to blindness and 

3 paralysis. 

4 (2) There are an estimated 16,000 to 17,000 

5 people with NMO in the United States and a quar6 ter-million worldwide. 

7 (3) Women are affected 4 to 5 times more than 

8 men, and Afro-Caribbeans are about 2.5 times more 

9 predisposed to NMO than Caucasians. The reasons 

10 why Blacks are disproportionately affected cannot be 

11 fully understood without further studies. 

12 (4) The average age at diagnosis is between 40 

13 and 50 years, but the range is broad and includes 

14 children as young as 3 years of age and adults as 

15 old as 90 years of age. 

16 (5) NMO incurs substantial costs for affected 

17 patients and their families. 

18 (6) The cause of NMO is unknown, but it is hy19 pothesized to be autoimmune in nature. 

20 (7) More than 90 percent of NMO patients will 

21 suffer recurrent disease and accumulate neurologic 

22 disability. 

23 (8) Because of their relatively low overall inci24 dence, orphan diseases like NMO frequently do not 

25 receive sufficient attention and research funding. 


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1 (9) No single institution has a sufficient num2 ber of patients to independently conduct research 

3 that will adequately address the cause of NMO. 

4 (10) There has been no comprehensive study 

5 analyzing all relevant clinical, biological, and epide6 miological aspects of NMO to identify potential risk 

7 factors and biomarkers for NMO. 

8 (11) We can apply our understanding of NMO 

9 to the study of other autoimmune diseases, including 

10 multiple sclerosis and systemic lupus erythematosus. 

11 SEC. 3. SENSE OF CONGRESS. 

12 It is the sense of Congress that there is a need— 

13 (1) to establish and coordinate a multicenter re14 search effort based on collaboration between regional 

15 consortia and governmental and nongovernmental 

16 entities in order to— 

17 (A) comprehensively study the causes of 

18 NMO; and 

19 (B) identify potential biomarkers of disease 

20 activity; and 

21 (2) to encourage a collaborative effort among 

22 academic medical centers with epidemiological study 

23 groups to gather comprehensive and detailed infor24 mation for each patient enrolled in those groups, in 

25 order to investigate environmental, nutritional, and 


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1 genetic factors with respect to, and the pathological 

2 and epidemiological characteristics of, NMO. 

3 SEC. 4. ESTABLISHMENT OF THE NATIONAL NEUROMYELI4 TIS OPTICA CONSORTIUM. 

5 Part B of title IV of the Public Health Service Act 

6 (42 U.S.C. 284 et seq.) is amended by adding after section 

7 409J the following new section: 

8 ‘‘SEC. 409K. NATIONAL NEUROMYELITIS OPTICA CONSOR9 TIUM. 

10 ‘‘(a) ESTABLISHMENT OF THE NATIONAL

11 NEUROMYELITIS OPTICA CONSORTIUM.— 

12 ‘‘(1) IN GENERAL.—Not later than 1 year after 

13 the date of the enactment of this section, the Sec14 retary, acting through the Director of NIH, and in 

15 coordination with the Director of the National Insti16 tute on Minority Health and Health Disparities, 

17 shall establish, administer, and coordinate a Na18 tional Neuromyelitis Optica Consortium (in this sec19 tion referred to as the ‘NNO Consortium’) for the 

20 purposes described in paragraph (2). 

21 ‘‘(2) PURPOSES.—The purposes of the NNO 

22 Consortium shall be the following: 

23 ‘‘(A) Providing grants of not fewer than 5- 

24 years’ duration to eligible consortia for the pur25 pose of conducting research with respect to the 


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1 causes of, and the risk factors and biomarkers 

2 associated with, NMO. 

3 ‘‘(B) Assembling a panel of experts to pro4 vide, with respect to research funded by the 

5 NNO Consortium, ongoing guidance and rec6 ommendations for the development of the fol7 lowing: 

8 ‘‘(i) A common study design. 

9 ‘‘(ii) Standard protocols, methods, 

10 procedures, and assays for collecting from 

11 individuals enrolled as study participants a 

12 minimum dataset that includes the fol13 lowing: 

14 ‘‘(I) Complete medical history. 

15 ‘‘(II) Neurologic examination. 

16 ‘‘(III) Biospecimens, including 

17 blood, spinal fluid, DNA, and RNA. 

18 ‘‘(IV) Radiological data, includ19 ing magnetic resonance imaging 

20 (MRI). 

21 ‘‘(iii) Specific analytical methods for 

22 examining data. 

23 ‘‘(iv) Provisions for consensus review 

24 of enrolled cases. 


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1 ‘‘(v) An integrated data collection net2 work. 

3 ‘‘(C) Designating a central laboratory to 

4 collect, analyze, and aggregate data with re5 spect to research funded by the NNO Consor6 tium and to make such data and analysis avail7 able to researchers. 

8 ‘‘(3) ELIGIBLE CONSORTIA.—To be eligible for 

9 a grant under this section, a consortium shall dem10 onstrate the following: 

11 ‘‘(A) The consortium has the capability to 

12 enroll as research participants a minimum of 25 

13 individuals with a diagnosis of NMO from the 

14 consortium’s designated catchment area. 

15 ‘‘(B) The designated catchment area of the 

16 consortium does not overlap with the designated 

17 catchment area of another consortium already 

18 receiving a grant under this section. 

19 ‘‘(4) REPORT.—Not later than 1 year after the 

20 date of the enactment of this section, and annually 

21 thereafter, the Secretary, acting through the Direc22 tor of NIH, shall submit to Congress a report with 

23 respect to the NNO Consortium, to be made publicly 

24 available, including a summary of research funded 

25 by the NNO Consortium and a list of consortia reVerDate Sep 11 2014 23:12 Jan 18, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H321.IH H321

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1 ceiving grants through the NNO Consortium. At the 

2 discretion of the Secretary, such report may be com3 bined with other similar or existing reports. 

4 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 

5 ‘‘(A) IN GENERAL.—There is authorized to 

6 be appropriated $25,000,000 for each of fiscal 

7 years 2019 through 2022, to remain available 

8 until expended, to carry out this section. 

9 ‘‘(B) SENSE OF CONGRESS.—It is the 

10 sense of Congress that funds appropriated to 

11 carry out this section should be in addition to 

12 funds otherwise available or appropriated to 

13 carry out the activities described in this section. 

14 ‘‘(b) DEFINITIONS.—For purposes of this section: 

15 ‘‘(1) CATCHMENT AREA.—The term ‘catchment 

16 area’ means a defined area for which population 

17 data are available. 

18 ‘‘(2) CONSORTIUM.—The term ‘consortium’ 

19 means a partnership of two or more universities, 

20 health care organizations, or government agencies, 

21 or any combination of such entities, serving a des22 ignated catchment area.’’. 

Æ 


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