I 
113TH CONGRESS 
1ST SESSION 
H. R. 842 
To expand the research activities of the National Institutes of Health with 
respect to functional gastrointestinal and motility disorders, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 26, 2013 
Mr. SENSENBRENNER (for himself and Mr. MORAN) introduced the following 
bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To expand the research activities of the National Institutes 
of Health with respect to functional gastrointestinal and 
motility disorders, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Functional Gastro-
intestinal and Motility Disorders Research Enhancement 
Act of 2013’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) Functional gastrointestinal and motility dis-
orders (FGIMDs) are chronic conditions associated 
with increased sensitivity of the GI tract, abnormal 
motor functioning, and brain-gut dysfunction. 
(2) FGIMDs are characterized by symptoms in 
the GI tract including pain or discomfort, nausea, 
vomiting, diarrhea, constipation, incontinence, prob-
lems in the passage of food or feces, or a combina-
tion of these symptoms. 
(3) FGIMDs include conditions such as dys-
phagia, gastroesophageal reflux disease, dyspepsia, 
cyclic vomiting syndrome, gastroparesis, irritable 
bowel syndrome (IBS), Hirschsprung’s disease, 
chronic intestinal pseudo-obstruction, bowel inconti-
nence, and many others, which affect the esophagus, 
stomach, gallbladder, small and large intestine, and 
anorectal areas of the body. 
(4) The severity of FGIMDs ranges from mildly 
uncomfortable to debilitating and in some cases life- 
threatening. 
(5) Effective treatments for the multiple symp-
toms of FGIMDs are lacking, and while sufferers 
frequently use a variety of medications and therapies 
for symptoms, few patients report satisfaction with 
available treatments. 
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(6) Patients with FGIMDs frequently suffer for 
years before receiving an accurate diagnosis, expos-
ing them to unnecessary and costly tests and proce-
dures including surgeries, as well as needless suf-
fering and expense. 
(7) The economic impact of FGIMDs is high. 
The annual cost in the United States for IBS alone 
is estimated to be between $1.7 billion and $10 bil-
lion in direct medical costs (excluding prescription 
and over-the-counter medications) and $20 billion in 
indirect medical costs. 
(8) FGIMDs frequently take a toll on the work-
place, as reflected in work absenteeism, lost produc-
tivity, and lost opportunities for the individual and 
society. 
(9) Gastrointestinal symptoms consistent with 
functional gastrointestinal disorders such as IBS 
and functional dyspepsia have been recognized as a 
serious and disabling issue for military veterans, 
particularly those who have been deployed. 
(10) FGIMDs affect individuals of all ages in-
cluding children, and pediatric FGIMDs can be par-
ticularly serious, leading to a lifetime of painful 
symptoms and medical expenses associated with 
management of chronic illness or death. 
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(11) The National Institutes of Health’s Na-
tional Commission on Digestive Diseases identified 
comprehensive research goals related to FGIMDs in 
its April 2009 report to Congress and the American 
public entitled ‘‘Opportunities and Challenges in Di-
gestive Diseases Research: Recommendations of the 
National Commission on Digestive Diseases’’. 
SEC. 3. FUNCTIONAL GASTROINTESTINAL AND MOTILITY 
DISORDERS RESEARCH ENHANCEMENT. 
Part B of title IV of the Public Health Service Act 
(42 U.S.C. 284 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 409K. FUNCTIONAL GASTROINTESTINAL AND MOTIL-
ITY DISORDERS. 
‘‘The Director of NIH may expand, intensify, and co-
ordinate the activities of the National Institutes of Health 
with respect to functional gastrointestinal and motility dis-
orders (in this section referred to as ‘FGIMDs’) by— 
‘‘(1) expanding basic and clinical research into 
FGIMDs 
by 
implementing 
the 
research 
rec-
ommendations of the National Commission on Di-
gestive Diseases relating to FGIMDs; 
‘‘(2) providing support for the establishment of 
up to five centers of excellence on FGIMDs at lead-
ing academic medical centers throughout the country 
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to carry out innovative basic, translational, and clin-
ical research focused on FGIMDs; 
‘‘(3) exploring collaborative research opportuni-
ties among the National Institute of Diabetes and 
Digestive and Kidney Diseases, the Office of Re-
search on Women’s Health, the Office of Rare Dis-
ease Research, and other Institutes and Centers of 
the National Institutes of Health; 
‘‘(4) directing the National Institute of Diabe-
tes and Digestive and Kidney Diseases to provide 
the necessary funding for continued expansion and 
advancement of the FGIMDs research portfolio 
through intramural and extramural research; 
‘‘(5) directing the National Institute of Diabe-
tes and Digestive and Kidney Diseases and the Eu-
nice Kennedy Shriver National Institute of Child 
Health and Human Development to expand research 
into FGIMDs that impact children, such as 
Hirschsprung’s disease and cyclic vomiting syn-
drome, and maternal health, such as fecal inconti-
nence; and 
‘‘(6) exploring opportunities to partner with the 
Department of Defense and the Department of Vet-
erans Affairs to increase research and improve pa-
tient care regarding FGIMDs that commonly impact 
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veterans and active duty military personnel, such as 
IBS and dyspepsia.’’. 
SEC. 4. PROMOTING PUBLIC AWARENESS OF FUNCTIONAL 
GASTROINTESTINAL 
AND 
MOTILITY 
DIS-
ORDERS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 320B. PUBLIC AWARENESS OF FUNCTIONAL GASTRO-
INTESTINAL AND MOTILITY DISORDERS. 
‘‘The Secretary may engage in public awareness and 
education activities to increase understanding and recogni-
tion of functional gastrointestinal and motility disorders 
(in this section referred to as ‘FGIMDs’). Such activities 
may include the distribution of print, film, and web-based 
materials targeting health care providers and the public 
and prepared and disseminated in conjunction with pa-
tient organizations that treat FGIMDs. The information 
expressed through such activites should emphasize— 
‘‘(1) basic information on FGIMDs, their symp-
toms, prevalence, and frequently co-occurring condi-
tions; and 
‘‘(2) the importance of early diagnosis, and 
prompt and accurate treatment of FGIMDs.’’. 
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SEC. 5. SENSE OF CONGRESS ON THE DEVELOPMENT AND 
OVERSIGHT OF INNOVATIVE TREATMENT OP-
TIONS FOR FUNCTIONAL GASTROINTESTINAL 
AND MOTILITY DISORDERS. 
It is the sense of Congress that, considering the cur-
rent lack of effective treatment options for the global 
symptoms of functional gastrointestinal and motility dis-
orders (in this section referred to as ‘‘FGIMDs’’) and the 
inherent challenges of developing and bringing such treat-
ments to market, the Commissioner of Food and Drugs 
should continue and accelerate important efforts to im-
prove the development and oversight of treatment options 
for FGIMDs by— 
(1) enhancing the commitment to emerging ef-
forts like the Patient Reported Outcomes Consor-
tium to expedite medical device and drug develop-
ment, study appropriate balances between risk and 
patient benefit, and identify proper endpoints for 
conditions without clear, biological indicators; 
(2) enhancing the commitment to broad efforts 
like the Critical Path Initiative focused on ensuring 
that scientific breakthroughs are quickly translated 
into safe and beneficial treatment options; and 
(3) continuing collaboration with patient orga-
nizations that treat FGIMDs so that the patient 
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perspective is considered when determining the need 
for innovative treatments. 
Æ 
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