I 111th CONGRESS 1st Session H. R. 2275 IN THE HOUSE OF REPRESENTATIVES May 6, 2009 Mr. Jackson of Illinois (for himself, Mr. Crenshaw, and Mr. Castle) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To support research and public awareness activities with respect to inflammatory bowel disease, and for other purposes.

1.

Short title

This Act may be cited as the Inflammatory Bowel Disease Research and Awareness Act.

2.

Findings

The Congress finds as follows: (1)Crohn’s disease and ulcerative colitis are serious inflammatory diseases of the gastrointestinal tract. (2)Crohn’s disease may occur in any section of the gastrointestinal tract but is predominately found in the lower part of the small intestine and the large intestine. Ulcerative colitis is characterized by inflammation and ulceration of the innermost lining of the colon. Complete removal of the colon in patients with ulcerative colitis can potentially alleviate and cure symptoms. (3)Because Crohn’s disease and ulcerative colitis behave similarly, they are collectively known as inflammatory bowel disease. Both diseases present a variety of symptoms, including severe diarrhea; abdominal pain with cramps; fever; arthritic joint pain, inflammation of the eye, and rectal bleeding. There is no known cause of inflammatory bowel disease, or medical cure. (4)It is estimated that up to 1,400,000 people in the United States suffer from inflammatory bowel disease, 30 percent of whom are diagnosed during their childhood years. (5)Children with inflammatory bowel disease miss school activities because of bloody diarrhea and abdominal pain, and many adults who had onset of inflammatory bowel disease as children had delayed puberty and impaired growth and have never reached their full genetic growth potential. (6)Inflammatory bowel disease patients are at high risk for developing colorectal cancer. (7)The total annual medical costs for inflammatory bowel disease patients are estimated at more than $2,000,000,000. (8)The average time from presentation of symptoms to diagnosis in children is three years. (9)Delayed diagnosis of inflammatory bowel disease frequently results in more-active disease associated with increased morbidity and complications. (10)The National Institutes of Health National Commission on Digestive Diseases issued comprehensive research goals related to inflammatory bowel disease in its April 2009 report to Congress and the American public entitled Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases.

3.

Enhancing CDC’s public health activities on inflammatory bowel disease

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 320A the following:

320B.

Inflammatory bowel disease epidemiology research and pediatric patient registry program

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall conduct, support, and expand epidemiology research on inflammatory bowel disease in both pediatric and adult populations and establish a registry of pediatric IBD patients. (b)

Cooperative agreement

In carrying out subsection (a), the Secretary shall enter into a cooperative agreement with a nonprofit organization with expertise and experience in conducting inflammatory bowel disease research to develop and administer the epidemiology research and registry program, including— (1)expansion of existing IBD epidemiology program research activities within the National Center for Chronic Disease Prevention and Health Promotion; and (2)establishment, within one year of enactment of this section, of a population-based registry of pediatric IBD patients for the purposes of data collection, research, and patient services. (c)

Pediatric IBD registry

(1)

Focus

The pediatric IBD registry established under this section shall focus on, but not be limited to, data collection, storage and analysis regarding— (A)the incidence and prevalence of pediatric IBD in the United States; (B)genetic and environmental factors associated with pediatric IBD; (C)age, race or ethnicity, gender, and family history of individuals diagnosed with pediatric IBD; and (D)treatment approaches and outcomes in pediatric IBD. (2)

Additional requirements

In establishing the pediatric IBD registry under this section, the Secretary shall— (A)identify, build-upon, and coordinate with existing public and private surveillance systems related to pediatric IBD; and (B)establish a secure communication mechanism within the registry to facilitate patient contact with researchers studying the environmental and genetic causes of pediatric IBD or conducting clinical trials on pediatric IBD. (d)

Definition

In this section, the term IBD means inflammatory bowel disease. (e)

Authorization of appropriations

To carry out this section, there is authorized to be appropriated $3,500,000 for each of the fiscal years 2010 through 2014.

320C.

Increasing public awareness of inflammatory bowel disease and improving health professional education

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to eligible entities for the purpose of increasing awareness of inflammatory bowel disease among the general public and health care providers. (b)

Use of funds

The Secretary may not award a grant under this section to an eligible entity unless the entity agreed to use the grant to develop educational materials and conduct awareness programs focused on inflammatory bowel disease, including with respect to the following subjects: (1)Crohn’s disease and ulcerative colitis and their symptoms. (2)Testing required for appropriate diagnosis and the importance of accurate and early diagnosis. (3)Key differences between pediatric and adult disease. (4)Specific physical and psychosocial issues impacting pediatric patients, including stunted growth, malnutrition, delayed puberty, and depression. (5)Treatment options for both adult and pediatric patients. (6)The importance of identifying aggressive disease in children at an early stage in order to implement the most effective treatment protocol. (7)Complications of inflammatory bowel disease and related secondary conditions, including colorectal cancer. (8)Federal and private information resources for patients and physicians. (9)Incidence and prevalence data on pediatric and adult inflammatory bowel disease. (c)

Report to Congress

Not later than September 30, 2010, the Secretary shall report to the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committees on Appropriations of the House of Representatives and the Senate regarding the status of activities under this section. (d)

Eligible entity

To carry out this section, the term eligible entity means a nonprofit patient or professional organization with experience in serving adults and children with inflammatory bowel disease. (e)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated $2,000,000 for each of fiscal years 2010 through 2014.

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4.

Sense of Congress on expansion of biomedical research on inflammatory bowel disease

It is the sense of the Congress that— (1)the Secretary, acting through the Director of the National Institutes of Health and the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (in this section referred to as the Institute) should aggressively support basic, translational, and clinical research designed to meet the research goals for inflammatory bowel disease (in this section referred to as IBD) included in the National Institutes of Health National Commission on Digestive Diseases report entitled Opportunities and Challenges in Digestive Diseases Research: Recommendations of the National Commission on Digestive Diseases, including by— (A)establishing an objective basis for determining clinical diagnosis, detailed phenotype, and disease activity in IBD; (B)developing an individualized approach to IBD risk evaluation and management based on genetic susceptibility; (C)modulating the intestinal microflora to prevent or control IBD; (D)effectively modulating the mucosal immune system to prevent or ameliorate IBD; (E)sustaining the health of the mucosal surface; (F)promoting regeneration and repair of injury in IBD; (G)providing effective tools for clinical evaluation and intervention in IBD; and (H)ameliorating or preventing adverse effects of IBD on growth and development in children and adolescents; (2)the Institute should support the training of qualified health professionals in biomedical research focused on IBD, including pediatric investigators; and (3)the Institute should continue its strong collaboration with medical and patient organizations concerned with IBD and seek opportunities to promote research identified in the scientific agendas Challenges in Inflammatory Bowel Disease Research (Crohn’s and Colitis Foundation of America) and Chronic Inflammatory Bowel Disease (North American Society for Pediatric Gastroenterology, Hepatology and Nutrition).

5.

Biennial reports

Section 403(a)(5) of the Public Health Service Act (42 U.S.C. 283(a)(5)) is amended— (1)by redesignating subparagraph (L) as subparagraph (M); and (2)by inserting after subparagraph (K) the following: (L)Inflammatory bowel disease. .