I 

112TH CONGRESS 

2D SESSION H. R. 4138 

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 

MARCH 5, 2012 

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 11,000 patients 

5 with NMO in the United States. 

6 (3) Women are affected 7 to 9 times more than 

7 men, and a large proportion of NMO patients are 

8 African-American. 

9 (4) The average age at diagnosis is 41 years, 

10 but the range is broad and includes children as 

11 young as 2 years of age and adults as old as 89 

12 years of age. 

13 (5) NMO incurs substantial costs for affected 

14 patients and their families. 

15 (6) The cause of NMO is unknown, but it is hy16 pothesized to be autoimmune in nature. 

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

18 suffer recurrent disease and accumulate neurologic 

19 disability. 

20 (8) Because of their relatively low overall inci21 dence, orphan diseases like NMO frequently do not 

22 receive sufficient attention and research funding. 

23 (9) No single institution has a sufficient num24 ber of patients to independently conduct research 

25 that will adequately address the cause of NMO. 


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1 (10) There has been no comprehensive study 

2 analyzing all relevant clinical, biological, and epide3 miological aspects of NMO to identify potential risk 

4 factors and biomarkers for NMO. 

5 (11) We can apply our understanding of NMO 

6 to the study of other autoimmune diseases, including 

7 multiple sclerosis and systemic lupus erythematosus. 

8 SEC. 3. SENSE OF CONGRESS. 

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

10 (1) to establish and coordinate a multicenter re11 search effort based on collaboration between regional 

12 consortia and governmental and nongovernmental 

13 entities in order to— 

14 (A) comprehensively study the causes of 

15 NMO; and 

16 (B) identify potential biomarkers of disease 

17 activity; and 

18 (2) to encourage a collaborative effort among 

19 academic medical centers with epidemiological study 

20 groups to gather comprehensive and detailed infor21 mation for each patient enrolled in those groups, in 

22 order to investigate environmental, nutritional, and 

23 genetic factors with respect to, and the pathological 

24 and epidemiological characteristics of, NMO. 


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1 SEC. 4. ESTABLISHMENT OF THE NATIONAL 

2 NEUROMYELITIS OPTICA CONSORTIUM. 

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

4 (42 U.S.C. 284 et seq.) is amended by adding after section 

5 409J the following new section: 

6 ‘‘SEC. 409K. NATIONAL NEUROMYELITIS OPTICA CONSOR7 TIUM. 

8 ‘‘(a) ESTABLISHMENT OF THE NATIONAL

9 NEUROMYELITIS OPTICA CONSORTIUM.— 

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

11 the date of the enactment of this section, the Sec12 retary, acting through the Director of NIH, and in 

13 coordination with the Director of the National Insti14 tute on Minority Health and Health Disparities, 

15 shall establish, administer, and coordinate a Na16 tional Neuromyelitis Optica Consortium (in this sec17 tion referred to as the ‘NNO Consortium’) for the 

18 purposes described in paragraph (2). 

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

20 Consortium shall be the following: 

21 ‘‘(A) Providing grants of not fewer than 5 

22 years duration to eligible consortia for the pur23 pose of conducting research with respect to the 

24 causes of, and the risk factors and biomarkers 

25 associated with, NMO. 


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1 ‘‘(B) Assembling a panel of experts to pro2 vide, with respect to research funded by the 

3 NNO Consortium, ongoing guidance and rec4 ommendations for the development of the fol5 lowing: 

6 ‘‘(i) A common study design. 

7 ‘‘(ii) Standard protocols, methods, 

8 procedures, and assays for collecting from 

9 individuals enrolled as study participants a 

10 minimum dataset that includes the fol11 lowing: 

12 ‘‘(I) Complete medical history. 

13 ‘‘(II) Neurologic examination. 

14 ‘‘(III) Biospecimens, including 

15 blood, spinal fluid, DNA, and RNA. 

16 ‘‘(IV) Radiological data including 

17 magnetic resonance imaging (MRI). 

18 ‘‘(iii) Specific analytical methods for 

19 examining data. 

20 ‘‘(iv) Provisions for consensus review 

21 of enrolled cases. 

22 ‘‘(v) An integrated data collection net23 work. 

24 ‘‘(C) Designating a central laboratory to 

25 collect, analyze, and aggregate data with reVerDate Mar 15 2010 23:53 Mar 05, 2012 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4138.IH H4138

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1 spect to research funded by the NNO Consor2 tium and to make such data and analysis avail3 able to researchers. 

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

5 a grant under this section, a consortium shall dem6 onstrate the following: 

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

8 enroll as research participants a minimum of 25 

9 individuals with a diagnosis of NMO from the 

10 consortium’s designated catchment area. 

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

12 consortium does not overlap with the designated 

13 catchment area of another consortium already 

14 receiving a grant under this section. 

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

16 date of the enactment of this section and annually 

17 thereafter, the Secretary, acting through the Direc18 tor of NIH, shall submit to Congress a report with 

19 respect to the NNO Consortium, to be made publicly 

20 available, including a summary of research funded 

21 by the NNO Consortium and a list of consortia re22 ceiving grants through the NNO Consortium. At the 

23 discretion of the Secretary, such report may be com24 bined with other similar or existing reports. 

25 ‘‘(5) AUTHORIZATION OF APPROPRIATIONS.— 


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

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

3 years 2013 through 2017, to remain available 

4 until expended, to carry out this section. 

5 ‘‘(B) SENSE OF CONGRESS.—It is the 

6 sense of Congress that funds appropriated to 

7 carry out this section should be in addition to 

8 funds otherwise available or appropriated to 

9 carry out the activities described in this section. 

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

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

12 area’ means a defined area for which population 

13 data are available. 

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

15 means a partnership of 2 or more universities, 

16 health care organizations, or government agencies, 

17 or any combination of such entities, serving a des18 ignated catchment area.’’. 

Æ 


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