Short title

This Act may be cited as the

Inflammatory Bowel Disease Research Enhancement Act

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; 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 is estimated at more than $2,000,000,000.

National Institute of Diabetes and Digestive and Kidney Diseases; inflammatory bowel disease research expansion

(a)

In general

The Director of the National Institute of Diabetes and Digestive and Kidney Diseases shall expand, intensify, and coordinate the activities of the Institute with respect to research on inflammatory bowel disease, with particular emphasis on the following areas: (1)Genetic research on susceptibility for inflammatory bowel disease, including the interaction of genetic and environmental factors in the development of the disease. (2)Research targeted to increase knowledge about the causes and complications of inflammatory bowel disease in children. (3)Animal model research on inflammatory bowel disease, including genetics in animals. (4)Clinical inflammatory bowel disease research, including clinical studies and treatment trials. (5)Expansion of the Institute’s Inflammatory Bowel Disease Centers program with a focus on pediatric research. (6)Other research initiatives identified by the scientific document entitled Challenges in Inflammatory Bowel Disease and the research agenda for pediatric gastroenterology, hepatology, and nutrition entitled Chronic Inflammatory Bowel Disease. (b)

Authorization of appropriations

(1)

In general

For the purpose of carrying out subsection (a), there are authorized to be appropriated $80,000,000 for fiscal year 2008, $90,000,000 for fiscal year 2009, and $100,000,000 for fiscal year 2010. (2)

Reservation

Of the amounts authorized to be appropriated under paragraph (1), not more than 20 percent shall be reserved for the training of qualified health professionals in biomedical research focused on inflammatory bowel disease, including pediatric investigators.

Amendment to the public health service act

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317S the following:

317T.

Pediatric inflammatory bowel disease registry

(a)

Establishment

(1)

In general

Not later than 6 months after the receipt of the report described in subsection (b)(3), the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with a national voluntary patient organization with experience serving the population of individuals with pediatric inflammatory bowel disease and organizations representing physicians and other health professionals specializing in the treatment of this population, shall— (A)develop a system to collect data on pediatric IBD; and (B)establish a national registry, to be known as the National Pediatric IBD Registry, for the collection and storage of such data. (2)

Purposes of Registry

The National Pediatric IBD Registry— (A)shall include a population-based registry of cases of pediatric IBD in the United States; (B)shall be used to gather data concerning— (i)pediatric IBD, including the incidence and prevalence of pediatric IBD in the United States; (ii)the genetic and environmental factors that may be associated with pediatric IBD; (iii)the age, race or ethnicity, gender, and family history of individuals who are diagnosed with pediatric IBD; (iv)treatment approaches and outcomes; and (v)other matters as recommended by the Advisory Committee established under subsection (b); and (C)shall be used to establish a secure method to put patients in contact with scientists studying the environmental and genetic causes of pediatric IBD or conducting clinical trials on pediatric IBD. (b)

Advisory Committee

(1)

Establishment

Not later than 90 days after the date of the enactment of this section, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish a committee to be known as the Advisory Committee on Pediatric Inflammatory Bowel Disease. (2)

Members

The members of the Advisory Committee shall be appointed by the Secretary, acting through the Director of the Centers for Disease Control and Prevention, and shall include at least one representative of each of the following: (A)A national voluntary patient organization that focuses on pediatric IBD and has demonstrated experience in pediatric IBD research, care, and patient services. (B)A professional pediatric gastroenterology organization with expertise in pediatric research, care, and patient services. (C)The National Institutes of Health. (D)If recommended by the Director of the National Institutes of Health— (i)the National Institute of Diabetes and Digestive and Kidney Diseases; (ii)the National Institute of Allergy and Infectious Diseases; (iii)the National Institute of Child Health and Human Development; and (iv)any other appropriate national research institute or national center. (E)The Centers for Disease Control and Prevention. (F)Pediatric gastroenterologists and other clinicians who have experience with data registries. (G)Epidemiologists who have experience with data registries. (H)Geneticists or experts in genetics who have experience with the genetics of pediatric IBD. (I)Other individuals with an interest in developing and maintaining the National Pediatric IBD Registry. (3)

Study

The Advisory Committee shall conduct a study and make recommendations on— (A)the development and maintenance of the National Pediatric IBD Registry; (B)the type of information to be collected and stored in the Registry; (C)the manner in which such data is to be collected; and (D)the use and availability of such data including guidelines for such use. (4)

Report

Not later than 6 months after the date on which the Advisory Committee is established, the Advisory Committee shall submit a report to the Secretary and the Congress on the results of the study conducted under paragraph (3), including the recommendations of the Advisory Committee with respect to such results. (c)

Grants

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for the collection, analysis, and reporting of data on pediatric IBD. (d)

Coordination With Existing Registries and Data Repositories

(1)

In general

In establishing the National Pediatric IBD Registry under subsection (a), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall identify, build upon, expand, and coordinate among existing public and private surveillance systems, and registries concerning pediatric IBD. (2)

Coordination with NIH

The Secretary shall ensure that epidemiological and other types of information obtained under subsection (a) are made available to the National Institutes of Health. (e)

Definitions

In this section: (1)The term Advisory Committee means the Advisory Committee on Pediatric Inflammatory Bowel Disease established under subsection (b). (2)The terms national research institute and national center have the meanings given to those terms in section 401(g). (3)The term national voluntary patient organization means a national non-profit patient organization with chapters in States throughout the United States. (4)The term pediatric IBD means pediatric inflammatory bowel disease. (f)

Authorization of Appropriations

To carry out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2008 and such sums as may be necessary for each of fiscal years 2009 and 2010.

Centers for Disease Control and Prevention; national inflammatory bowel disease action plan

(a)

In general

(1)

Preparation of plan

The Director of the Centers for Disease Control and Prevention, in consultation with the inflammatory bowel disease community, shall prepare a comprehensive plan to address the burden of inflammatory bowel disease in both adult and pediatric populations (which plan shall be designated by the Director as the National Inflammatory Bowel Disease Action Plan). (2)

Report to congress

Not later than 12 months after the date of the enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit the Plan referred to in paragraph (1) to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and to the Committee on Health, Education, Labor and Pensions and the Committee on Appropriations of the Senate. (b)

Content

(1)

In general

The National Inflammatory Bowel Disease Action Plan shall address strategies for determining the unique demographic, geographic, and environmental-exposure characteristics of the inflammatory bowel disease population through the expansion of appropriate epidemiological activities. (2)

Certain requirements

The Plan referred to in paragraph (1) shall— (A)focus on strategies for increasing awareness about inflammatory bowel disease within the general public and the health care community in order to facilitate more timely and accurate diagnoses; and (B)address mechanisms designed to prevent the progression of the disease and the development of complications, such as colorectal cancer, and other strategies and activities as deemed appropriate. (c)

Authorization of appropriations

For the purpose of carrying out this section, there is authorized to be appropriated $750,000 for fiscal year 2008.