I 

110TH CONGRESS 

1ST SESSION H. R. 1113 

To expand the research, prevention, and awareness activities of the National 

Institute of Diabetes and Digestive and Kidney Diseases and the Centers 

for Disease Control and Prevention with respect to inflammatory bowel 

disease, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 16, 2007 

Mr. JACKSON of Illinois (for himself and Mr. CASTLE) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To expand the research, prevention, and awareness activities 

of the National Institute of Diabetes and Digestive and 

Kidney Diseases and the Centers for Disease Control 

and Prevention with respect to inflammatory bowel disease, 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 ‘‘Inflammatory Bowel 

5 Disease Research Enhancement Act’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 

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1 (1) Crohn’s disease and ulcerative colitis are se2 rious inflammatory diseases of the gastrointestinal 

3 tract. 

4 (2) Crohn’s disease may occur in any section of 

5 the gastrointestinal tract but is predominately found 

6 in the lower part of the small intestine and the large 

7 intestine. Ulcerative colitis is characterized by in8 flammation and ulceration of the innermost lining of 

9 the colon. Complete removal of the colon in patients 

10 with ulcerative colitis can potentially alleviate and 

11 cure symptoms. 

12 (3) Because Crohn’s disease and ulcerative coli13 tis behave similarly, they are collectively known as 

14 inflammatory bowel disease. Both diseases present a 

15 variety of symptoms, including severe diarrhea; ab16 dominal pain with cramps; fever; and rectal bleeding. 

17 There is no known cause of inflammatory bowel dis18 ease, or medical cure. 

19 (4) It is estimated that up to 1,400,000 people 

20 in the United States suffer from inflammatory bowel 

21 disease, 30 percent of whom are diagnosed during 

22 their childhood years. 

23 (5) Children with inflammatory bowel disease 

24 miss school activities because of bloody diarrhea and 

25 abdominal pain, and many adults who had onset of 

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1 inflammatory bowel disease as children had delayed 

2 puberty and impaired growth and have never 

3 reached their full genetic growth potential. 

4 (6) Inflammatory bowel disease patients are at 

5 high risk for developing colorectal cancer. 

6 (7) The total annual medical costs for inflam7 matory bowel disease patients is estimated at more 

8 than $2,000,000,000. 

9 SEC. 3. NATIONAL INSTITUTE OF DIABETES AND DIGES10 TIVE AND KIDNEY DISEASES; INFLAMMATORY 

11 BOWEL DISEASE RESEARCH EXPANSION. 

12 (a) IN GENERAL.—The Director of the National In13 stitute of Diabetes and Digestive and Kidney Diseases 

14 shall expand, intensify, and coordinate the activities of the 

15 Institute with respect to research on inflammatory bowel 

16 disease, with particular emphasis on the following areas: 

17 (1) Genetic research on susceptibility for in18 flammatory bowel disease, including the interaction 

19 of genetic and environmental factors in the develop20 ment of the disease. 

21 (2) Research targeted to increase knowledge 

22 about the causes and complications of inflammatory 

23 bowel disease in children. 

24 (3) Animal model research on inflammatory 

25 bowel disease, including genetics in animals. 

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1 (4) Clinical inflammatory bowel disease re2 search, including clinical studies and treatment 

3 trials. 

4 (5) Expansion of the Institute’s Inflammatory 

5 Bowel Disease Centers program with a focus on pe6 diatric research. 

7 (6) Other research initiatives identified by the 

8 scientific document entitled ‘‘Challenges in Inflam9 matory Bowel Disease’’ and the research agenda for 

10 pediatric gastroenterology, hepatology, and nutrition 

11 entitled ‘‘Chronic Inflammatory Bowel Disease’’. 

12 (b) AUTHORIZATION OF APPROPRIATIONS.— 

13 (1) IN GENERAL.—For the purpose of carrying 

14 out subsection (a), there are authorized to be appro15 priated $80,000,000 for fiscal year 2008, 

16 $90,000,000 for fiscal year 2009, and $100,000,000 

17 for fiscal year 2010. 

18 (2) RESERVATION.—Of the amounts authorized 

19 to be appropriated under paragraph (1), not more 

20 than 20 percent shall be reserved for the training of 

21 qualified health professionals in biomedical research 

22 focused on inflammatory bowel disease, including pe23 diatric investigators. 

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1 SEC. 4. AMENDMENT TO THE PUBLIC HEALTH SERVICE 

2 ACT. 

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

4 (42 U.S.C. 243 et seq.) is amended by inserting after sec5 tion 317S the following: 

6 ‘‘SEC. 317T. PEDIATRIC INFLAMMATORY BOWEL DISEASE 

7 REGISTRY. 

8 ‘‘(a) ESTABLISHMENT.— 

9 ‘‘(1) IN GENERAL.—Not later than 6 months 

10 after the receipt of the report described in sub11 section (b)(3), the Secretary, acting through the Di12 rector of the Centers for Disease Control and Pre13 vention and in consultation with a national voluntary 

14 patient organization with experience serving the pop15 ulation of individuals with pediatric inflammatory 

16 bowel disease and organizations representing physi17 cians and other health professionals specializing in 

18 the treatment of this population, shall— 

19 ‘‘(A) develop a system to collect data on 

20 pediatric IBD; and 

21 ‘‘(B) establish a national registry, to be 

22 known as the National Pediatric IBD Registry, 

23 for the collection and storage of such data. 

24 ‘‘(2) PURPOSES OF REGISTRY.—The National 

25 Pediatric IBD Registry— 

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1 ‘‘(A) shall include a population-based reg2 istry of cases of pediatric IBD in the United 

3 States; 

4 ‘‘(B) shall be used to gather data con5 cerning— 

6 ‘‘(i) pediatric IBD, including the inci7 dence and prevalence of pediatric IBD in 

8 the United States; 

9 ‘‘(ii) the genetic and environmental 

10 factors that may be associated with pedi11 atric IBD; 

12 ‘‘(iii) the age, race or ethnicity, gen13 der, and family history of individuals who 

14 are diagnosed with pediatric IBD; 

15 ‘‘(iv) treatment approaches and out16 comes; and 

17 ‘‘(v) other matters as recommended 

18 by the Advisory Committee established 

19 under subsection (b); and 

20 ‘‘(C) shall be used to establish a secure 

21 method to put patients in contact with sci22 entists studying the environmental and genetic 

23 causes of pediatric IBD or conducting clinical 

24 trials on pediatric IBD. 

25 ‘‘(b) ADVISORY COMMITTEE.— 

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1 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

2 after the date of the enactment of this section, the 

3 Secretary, acting through the Director of the Cen4 ters for Disease Control and Prevention, shall estab5 lish a committee to be known as the Advisory Com6 mittee on Pediatric Inflammatory Bowel Disease. 

7 ‘‘(2) MEMBERS.—The members of the Advisory 

8 Committee shall be appointed by the Secretary, act9 ing through the Director of the Centers for Disease 

10 Control and Prevention, and shall include at least 

11 one representative of each of the following: 

12 ‘‘(A) A national voluntary patient organi13 zation that focuses on pediatric IBD and has 

14 demonstrated experience in pediatric IBD re15 search, care, and patient services. 

16 ‘‘(B) A professional pediatric gastro17 enterology organization with expertise in pedi18 atric research, care, and patient services. 

19 ‘‘(C) The National Institutes of Health. 

20 ‘‘(D) If recommended by the Director of 

21 the National Institutes of Health— 

22 ‘‘(i) the National Institute of Diabetes 

23 and Digestive and Kidney Diseases; 

24 ‘‘(ii) the National Institute of Allergy 

25 and Infectious Diseases; 

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1 ‘‘(iii) the National Institute of Child 

2 Health and Human Development; and 

3 ‘‘(iv) any other appropriate national 

4 research institute or national center. 

5 ‘‘(E) The Centers for Disease Control and 

6 Prevention. 

7 ‘‘(F) Pediatric gastroenterologists and 

8 other clinicians who have experience with data 

9 registries. 

10 ‘‘(G) Epidemiologists who have experience 

11 with data registries. 

12 ‘‘(H) Geneticists or experts in genetics who 

13 have experience with the genetics of pediatric 

14 IBD. 

15 ‘‘(I) Other individuals with an interest in 

16 developing and maintaining the National Pedi17 atric IBD Registry. 

18 ‘‘(3) STUDY.—The Advisory Committee shall 

19 conduct a study and make recommendations on— 

20 ‘‘(A) the development and maintenance of 

21 the National Pediatric IBD Registry; 

22 ‘‘(B) the type of information to be col23 lected and stored in the Registry; 

24 ‘‘(C) the manner in which such data is to 

25 be collected; and 

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1 ‘‘(D) the use and availability of such data 

2 including guidelines for such use. 

3 ‘‘(4) REPORT.—Not later than 6 months after 

4 the date on which the Advisory Committee is estab5 lished, the Advisory Committee shall submit a report 

6 to the Secretary and the Congress on the results of 

7 the study conducted under paragraph (3), including 

8 the recommendations of the Advisory Committee 

9 with respect to such results. 

10 ‘‘(c) GRANTS.—The Secretary, acting through the 

11 Director of the Centers for Disease Control and Preven12 tion, may award grants to, and enter into contracts and 

13 cooperative agreements with, public or private nonprofit 

14 entities for the collection, analysis, and reporting of data 

15 on pediatric IBD. 

16 ‘‘(d) COORDINATION WITH EXISTING REGISTRIES

17 AND DATA REPOSITORIES.— 

18 ‘‘(1) IN GENERAL.—In establishing the Na19 tional Pediatric IBD Registry under subsection (a), 

20 the Secretary, acting through the Director of the 

21 Centers for Disease Control and Prevention, shall 

22 identify, build upon, expand, and coordinate among 

23 existing public and private surveillance systems, and 

24 registries concerning pediatric IBD. 

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1 ‘‘(2) COORDINATION WITH NIH.—The Secretary 

2 shall ensure that epidemiological and other types of 

3 information obtained under subsection (a) are made 

4 available to the National Institutes of Health. 

5 ‘‘(e) DEFINITIONS.—In this section: 

6 ‘‘(1) The term ‘Advisory Committee’ means the 

7 Advisory Committee on Pediatric Inflammatory 

8 Bowel Disease established under subsection (b). 

9 ‘‘(2) The terms ‘national research institute’ and 

10 ‘national center’ have the meanings given to those 

11 terms in section 401(g). 

12 ‘‘(3) The term ‘national voluntary patient orga13 nization’ means a national non-profit patient organi14 zation with chapters in States throughout the 

15 United States. 

16 ‘‘(4) The term ‘pediatric IBD’ means pediatric 

17 inflammatory bowel disease. 

18 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—To 

19 carry out this section, there are authorized to be appro20 priated $5,000,000 for fiscal year 2008 and such sums 

21 as may be necessary for each of fiscal years 2009 and 

22 2010.’’. 

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1 SEC. 5. CENTERS FOR DISEASE CONTROL AND PREVEN2 TION; NATIONAL INFLAMMATORY BOWEL DIS3 EASE ACTION PLAN. 

4 (a) IN GENERAL.— 

5 (1) PREPARATION OF PLAN.—The Director of 

6 the Centers for Disease Control and Prevention, in 

7 consultation with the inflammatory bowel disease 

8 community, shall prepare a comprehensive plan to 

9 address the burden of inflammatory bowel disease in 

10 both adult and pediatric populations (which plan 

11 shall be designated by the Director as the ‘‘National 

12 Inflammatory Bowel Disease Action Plan’’). 

13 (2) REPORT TO CONGRESS.—Not later than 12 

14 months after the date of the enactment of this Act, 

15 the Director of the Centers for Disease Control and 

16 Prevention shall submit the Plan referred to in para17 graph (1) to the Committee on Energy and Com18 merce and the Committee on Appropriations of the 

19 House of Representatives and to the Committee on 

20 Health, Education, Labor and Pensions and the 

21 Committee on Appropriations of the Senate. 

22 (b) CONTENT.— 

23 (1) IN GENERAL.—The National Inflammatory 

24 Bowel Disease Action Plan shall address strategies 

25 for determining the unique demographic, geographic, 

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1 flammatory bowel disease population through the ex2 pansion of appropriate epidemiological activities. 

3 (2) CERTAIN REQUIREMENTS.—The Plan re4 ferred to in paragraph (1) shall— 

5 (A) focus on strategies for increasing 

6 awareness about inflammatory bowel disease 

7 within the general public and the health care 

8 community in order to facilitate more timely 

9 and accurate diagnoses; and 

10 (B) address mechanisms designed to pre11 vent the progression of the disease and the de12 velopment of complications, such as colorectal 

13 cancer, and other strategies and activities as 

14 deemed appropriate. 

15 (c) AUTHORIZATION OF APPROPRIATIONS.—For the 

16 purpose of carrying out this section, there is authorized 

17 to be appropriated $750,000 for fiscal year 2008. 

Æ 

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