II 

114TH CONGRESS 

2D SESSION S. 3431 

To coordinate and advance fibrosis research activities at the National 

Institutes of Health, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 28, 2016 

Mrs. GILLIBRAND (for herself and Mr. SCHUMER) introduced the following 

bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To coordinate and advance fibrosis research activities at the 

National Institutes of Health, 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 ‘‘Scleroderma and Fi5 brosis Research Enhancement Act of 2016’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds as follows: 

8 (1) Scleroderma, or systemic sclerosis, is a 

9 chronic and potentially fatal rheumatic autoimmune 

10 disease of the connective tissue. 


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1 (2) About 100,000 Americans have systemic 

2 sclerosis, which causes fibrosis (very similar to scar3 ring where excess connective tissue is created). The 

4 symptoms of scleroderma vary greatly for each per5 son, and the effects of scleroderma can range from 

6 very mild to life-threatening. The seriousness of 

7 scleroderma depends on the parts of the body that 

8 are affected and the extent to which they are af9 fected. 

10 (3) Nearly 45 percent of all deaths in the devel11 oped world are attributed to some type of chronic 

12 fibroproliferative disease. As scleroderma impacts 

13 multiple organ systems, systemic sclerosis can be 

14 considered as a prototypical disease for study, and 

15 any insights into its causes are likely to be applica16 ble more broadly to other forms of organ fibrosis 

17 and fibrotic illnesses (such as pulmonary fibrosis 

18 and liver fibrosis). 

19 (4) Various institutes and centers of the Na20 tional Institutes of Health currently support re21 search into forms of fibrotic illness, but there is little 

22 coordination and limited cross-cutting opportunity 

23 between these research portfolios. Much scientific 

24 progress will be gained by taking a broad, collabo25 rative, and systematic approach to studying fibrosis. 


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1 SEC. 3. NATIONAL COMMISSION ON SCLERODERMA AND FI2 BROSIS RESEARCH. 

3 (a) ESTABLISHMENT.—Not later than 1 year after 

4 the date of enactment of this Act, the Director of the Na5 tional Institute of Arthritis and Musculoskeletal and Skin 

6 Diseases, acting jointly with the Director of the National 

7 Institutes of Health, shall establish a National Commis8 sion on Scleroderma and Fibrosis Research (in this section 

9 referred to as the ‘‘Commission’’) to develop the long-term 

10 plan under subsection (b). 

11 (b) LONG-TERM PLAN.— 

12 (1) IN GENERAL.—Not later than 18 months 

13 after the date of establishment of the Commission, 

14 the Commission shall develop and submit to Con15 gress a long-term plan on opportunities and chal16 lenges in scleroderma and fibrosis research. 

17 (2) RECOMMENDATIONS ON RESEARCH OPPOR18 TUNITIES.—The plan under paragraph (1) shall in19 clude recommendations on relevant research oppor20 tunities over the next decade, including— 

21 (A) a comprehensive research plan which 

22 prioritizes fibrosis research opportunities that 

23 have cross-cutting value and require coordina24 tion across multiple institutes and centers of 

25 the National Institutes of Health; 


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1 (B) topic-specific research recommenda2 tions for each organ or system; and 

3 (C) an overview of common themes and 

4 specific steps for implementation of scleroderma 

5 and fibrosis research. 

6 (c) WORKING GROUPS.—The Commission shall es7 tablish working groups— 

8 (1) to consider the various organs and systems 

9 impacted by fibrotic illness; and 

10 (2) to formulate the topic-specific research rec11 ommendations under subsection (b)(2)(B). 

12 (d) MEMBERSHIP.—The Commission shall be com13 posed of— 

14 (1) the Director of the National Institute of Ar15 thritis and Musculoskeletal and Skin Diseases (or 

16 the Director’s representative); 

17 (2) a representative of the Office of the Direc18 tor of the National Institutes of Health who can pro19 vide input on program coordination across the insti20 tutes and centers of the National Institutes of 

21 Health; 

22 (3) staff from institutes and centers of the Na23 tional Institutes of Health, as determined appro24 priate; and 


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1 (4) non-Federal medical experts and patient ad2 vocates representing the various manifestations of 

3 scleroderma and fibrosis, as determined necessary to 

4 form effective working groups under subsection (c). 

5 (e) TERMINATION.—The Commission shall terminate 

6 not later than 2 years after the date of its establishment. 

7 SEC. 4. SCLERODERMA AND FIBROSIS WORKING GROUP. 

8 (a) ESTABLISHMENT.—Not later than 180 days after 

9 the development and dissemination of the long-term plan 

10 under section 3(b), the Director of the National Institute 

11 of Arthritis and Musculoskeletal and Skins Diseases shall 

12 create a working group, to be known as the Scleroderma 

13 and Fibrosis Working Group (in this section referred to 

14 as the ‘‘Working Group’’). 

15 (b) RESPONSIBILITIES.—The Working Group shall— 

16 (1) oversee and assist with the implementation 

17 of the recommendations and research opportunities 

18 identified in the long-term plan under section 3(b); 

19 (2) coordinate with the Office of the Director of 

20 the National Institutes of Health and the various in21 stitutes and centers of the National Institutes of 

22 Health as appropriate to oversee and assist with 

23 such implementation; and 


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1 (3) report, as needed, to the advisory council of 

2 the National Institute of Arthritis and Musculo3 skeletal and Skin Diseases. 

4 (c) MEMBERSHIP.—The Working Group shall be 

5 composed of— 

6 (1) representatives of the institutes and centers 

7 at the National Institutes of Health with active or 

8 planned research projects in scleroderma or fibrosis, 

9 particularly staff who are serving or have served on 

10 the National Commission on Scleroderma and Fibro11 sis Research under section 3; and 

12 (2) patient advocates and extramural research13 ers who can provide meaningful input on the rec14 ommendations and research opportunities identified 

15 in the long-range plan under section 3(b), particu16 larly individuals who are serving or have served on 

17 the National Commission on Scleroderma and Fibro18 sis Research under section 3. 

19 (d) MEETINGS.—The Director of the National Insti20 tute of Arthritis and Musculoskeletal and Skin Diseases 

21 shall convene the Working Group for a meeting at least 

22 3 times each year. 

23 SEC. 5. REPORT TO CONGRESS. 

24 Not later than 2 years after the date of establishment 

25 of the National Commission on Scleroderma and Fibrosis 


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1 Research under section 3, the Director of the National In2 stitute of Arthritis and Musculoskeletal and Skin Diseases 

3 shall submit to Congress a report on implementation of 

4 the long-range plan under section 3(b). 

Æ 


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