Amendment I: Section Key Dates and Section IV. 3.A 03/26/10
Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)
Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)
Components of Participating Organizations
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), (http://www.cdc.gov/nccdphp/), Division of Adult and Community Health (DACH), (http://www.cdc.gov/nccdphp/dach)
Title: Epidemiologic Study of Inflammatory Bowel Disease (U-01)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.
Authority:
Section 301(a) of the Public Health Service, 42 U.S.C. 241(a), 317(k)(2) of the Public Health Service Act, 42 U.S.C. 247b(k)(2).
Announcement Type: New
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)
A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number:
RFA-DP-10-006
Catalog of Federal Domestic Assistance Number(s):
93.945
Key Dates
Release/Posted Date:
Letter of Intent Receipt Date: 01/27/10
Application Submission Receipt Date(s): 03/26/10
Peer Review Date(s): 05/10/10
Council Review Date(s): 06/10/10
Earliest Anticipated Start Date(s): 09/19/10
Expiration Date: 03/26/2010
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
· This FOA solicits an application for conducting an epidemiological research study to obtain estimates of the prevalence and incidence of Inflammatory Bowel Disease (IBD) in populations and to define the demographic and clinical characteristics of IBD and its impact on the health of affected persons.
· CDC will award $450,000 in FY 2010 to fund one cooperative agreement for this project.
· This funding opportunity will use the cooperative agreement funding mechanism (CDC U-01).
· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
· Budget Period, Project Period, and Award Amounts: The budget period will begin September 19, 2010 and end September 18, 2011. The project period will begin September 19, 2010 and end September 18, 2015. Funding for the budget and project periods is expected to be $450,000 and $2,250,000, respectively.
· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF)
· For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Access to Quality Health Care and is in alignment with NCCDPHP’s performance goal(s) to increase the number of adults who are healthy and able to participate fully in life activities and enter their later years with optimum health. For more information, go to www.healthypeople.gov. and http://intra-apps.cdc.gov/fmo/
Nature of Research Opportunity
The CDC seeks research to expand knowledge of the incidence, prevalence, demographic and clinical characteristics of IBD in the general population, the variations in clinical practice and the impact of the disease. This announcement will build on previous epidemiology studies. The results from this study will provide a better understanding of the epidemiology of the disease and be used to target interventions for groups at high risk for IBD and inform best clinical practices.
Background
An estimated 1 to 2 million people in the United States live with inflammatory bowel disease (IBD). IBD can impose a lifelong burden on affected individuals, their families, and society. IBD is characterized by an inflammation of the gastro-intestinal tract, affecting the entire digestive tract in Crohn’s Disease, or only the large intestine in ulcerative colitis.
In the past several years, CDC epidemiologists have worked in conjunction with the Crohn’s and Colitis Foundation of America (CCFA) and a large health maintenance organization to better understand the natural history of IBD and factors that predict the course of disease. Recent projects have addressed questions of practice variations, such as: variability in quality of treatment given to patients with IBD in the community setting; patient, provider, or clinic predictors of treatment variability; and possible effects of this variability, if any, on patient outcomes.
CDC epidemiologists and CCFA have also supported the Ocean State Crohn’s and Colitis Registry. This project is a registry of all newly diagnosed adult and child IBD patients in the state of Rhode Island. Each patient is interviewed extensively at the onset of enrollment in regards to exposure to potential disease risk factors, clinical characteristics of disease, and measures of disease impact. In addition to assessing the incidence of IBD in this population, the purpose of the registry is also to gain insight into the etiology of IBD, to learn why the course of illness varies among individuals, and to determine what factors may improve outcomes.
The current announcement is responsive to a congressional mandate to continue and augment these previous epidemiological studies in IBD.
Research Goals and Objectives:
o Conduct population based studies to describe the incidence, prevalence, demographic and clinical characteristics of persons with IBD, to assess the impact of the disease and the impact of various clinical practices in the management of IBD.
o Adapt and expand current population based studies to capture an increasingly socio-economical, racial and geographical diverse population.
o Develop and pilot a national surveillance program for IBD to gather national prevalence and incidence data perhaps by utilizing an existing surveillance system.
Scientific Knowledge to be achieved through this Funding Opportunity
Findings from this epidemiological study are expected to add to the understanding of the:
• Prevalence and incidence of IBD in the United States
• Impact of the disease on the health of affected persons.
• Practice variations in the management of IBD.
• Impact of various clinical practices on outcome of the disease.
Experimental Approach and Research Objectives
Using a population-based approach in a diverse population, the objectives of this research program are:
• Convene an advisory workgroup to define research priorities.
Design a population based study to assess the prevalence and demographic characteristics of IBD and its impact on general health.
Develop and pilot a national surveillance program for IBD to gather national prevalence and incidence data perhaps by utilizing an existing surveillance system.
Collaborate with CDC on the design of the study, data analysis, report writing and dissemination of the findings.
· Obtain population-based estimates of IBD through a population-based study
• Describe the demographic and clinical characteristics of persons with IBD through population based studies
Assess the impact of IBD on the health of the population.
Develop the methodology to assess the demographic and clinical characteristics of IBD and its impact on the health of persons with IBD.
• Develop the methodology to assess variation in clinical practice in the management of IBD patients
• Assess the impact of various clinical practices in the management of IBD.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the CDC (U-01) cooperative agreement award mechanism. The applicant organization will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if an applicant submits an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), they should use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
The HHS/CDC U-01 is a cooperative agreement assistance instrument. Under the U-01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The participating Center, NCCDPHP, intends to commit approximately $450,000, including both direct and indirect costs, dollars in FY2010 to fund one application. The average award amount will be $450,000. An applicant may request a project period of up to 5-years. An applicant may request up to $450,000 for the first 12-month budget period, including both direct and indirect costs. The approximate total project period funded amount is $2,250,000, including both direct and indirect costs. The anticipated start date for new awards is September 19, 2010 with the project performance period between September 2010 and August 2015.
Although the financial plans of the NCCDPHP provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.
If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization has any of the following characteristics:
· Public nonprofit organizations
· Private nonprofit organizations
· For profit organizations
· Small, minority, and women-owned businesses
· Universities
· Colleges
· Research institutions
· Hospitals
· Community-based organizations
· Faith-based organizations
· Federally recognized or state-recognized American Indian/Alaska Native tribal governments
· American Indian/Alaska Native tribally designated organizations
· Alaska Native health corporations
· Urban Indian health organizations
· Tribal epidemiology centers
· State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
· Political subdivisions of States (in consultation with States)
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
2. Cost Sharing or Matching
Cost sharing is not required.
The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
3. Other-Special Eligibility Criteria
Eligible applicants must meet the following criteria: