dp13-001 foa final amendment 1 02.07.13.docx

Amendment I made on February 7, 2013:

· Questions and Answers (Attachment 1), page 39

Table of Contents

Part 1. Overview Information

Division of Population Health

Funding Opportunity Announcement Type

New

Key Dates Publication Date

December 18, 2012

To receive notification of any changes to RFA-DP-13-001, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Purpose. This FOA solicits applications for conducting an epidemiological research study to obtain estimates of the prevalence and incidence of IBD in pediatric and adult populations and to define the demographic and clinical characteristics of IBD and its impact on the health of affected persons. 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.

Findings from this epidemiological study are expected to add to the understanding of the:

· Prevalence and incidence of IBD in the U.S.

· 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

· Mechanism of Support. This funding opportunity will use the cooperative agreement funding mechanism (CDC U-01).

· Funds Available and Anticipated Number of Awards. Total funding available for this cooperative agreement is expected to be $2,250,000 over the five year project period. It is anticipated that one award will be made to a single recipient for approximately $450,000 in FY 2013.

Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

· Budget and Project Period. The estimated total funding (direct and indirect) for the first year (12 month budget period from September 30, 2013 to September 29, 2014) will be $450,000. The total funding available for the project period will be $2,250,000. The project period will run from September 30, 2013 to September 29, 2018.

· Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

· Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 are eligible to apply.

· Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply. Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

· Number of Applications. Only one application per institution (normally identified by having a unique DUNS Number) is allowed.

· Application Type. New (Type1).

· Special Date(s). N/A.

· Application Materials. See Section IV.1 for application materials.

· Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory 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).

1. Background and Purpose The CDC seeks research to expand knowledge of the incidence (new cases), prevalence (existing cases), demographic and clinical characteristics of Inflammatory Bowel Disease (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 identify groups at high risk (e.g. pediatric and adult populations) for IBD and inform best clinical practices.

Approximately 1 to 2 million people in the United States are estimated to live with 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. Historically, two kinds of data have been used to study disease outcomes in IBD and the factors associated with these outcomes in the existing literature. These include 1) administrative data collected in insured populations in the course of routine healthcare, and assimilated into outcomes studies; and 2) more detailed, direct, and occasionally prospective data of health outcomes and risk factors for these outcomes in cohorts arising from tertiary care centers.

Since 2005, CDC has worked with several national partners to better understand the natural history of IBD and factors that predict the course of disease. Recent projects have addressed questions of practice variations in a managed care patient population, such as variability in quality of treatment given to patients with IBD; patient, provider, or clinic predictors of treatment variability; and possible effects of this variability, if any, on patient outcomes (REF 1-3).

CDC, in collaboration with a nationwide, geographically diverse network of large managed health care delivery systems, has led an epidemiological study of IBD to better understand the incidence, prevalence, demographics, and healthcare utilization of IBD. This study found an average annual incidence rate of 8.4 per 100,000 people for Crohn’s disease and 12.4 per 100,000 for Ulcerative Colitis (REF 4).

An additional source of data on IBD, the Ocean State Crohn’s and Colitis Registry, has been developed. 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 prevalence and incidence of IBD in the Rhode Island population, the purpose of the registry is to gain insight into the etiology of IBD, to learn why the course of illness varies among individuals, and to determine what factors (including physician attitudes and knowledge) may improve outcomes (REF 5, 6).

The current announcement is responsive to Senate Committee on Appropriations which recommended to restore funds for FY 2012 to continue and augment previous epidemiological studies in IBD (REF 7).

Research Goals and Objectives:

• Conduct population-based studies, including an IBD registry, 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—preferably at a state or regional level.

• Adapt and expand current population based studies to capture socio-economical, racial and geographical diverse population

• Develop and pilot the prototype for 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 at state or regional level

• 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

• Feasibility of scaling to a national level

Applications fully responsive to this FOA will incorporate elements of prospective data collection through direct contact with and follow up of individuals with IBD to determine disease outcomes and associated risk factors for these outcomes. Such factors may include 1) detailed demographic, socioeconomic, and familial factors; 2) healthcare resource utilization, including medication use, imaging, endoscopy and pathology, hospitalization and surgery; 3) patient-reported outcomes, including generic and health-related quality of life; sexual and reproductive function; work productivity and impairment and disability; outcomes related to specific therapies such as corticosteroids, immunomodulators and biologic therapies; and psychosocial factors, including depression; and 4) biological determinants of disease that may include genetic, serologic, metabolomic, and other qualitative and quantitative biologic factors that may be predictors of disease outcomes.

Healthy People 2020 and other National strategic priorities This FOA addresses “Healthy People 2020” priority area(s) of Access to Health Services 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/

Public Health Impact This study will describe the history of IBD in a state or regional population. The study is also expected to describe factors which are affected by variations in clinical practice. Results from this study are expected to contribute to the understanding of the epidemiology of IBD in the United States, including:

· Prevalence and incidence of IBD in the United States

· Impact of the disease on the well-being, quality of life, and perception of disability among affected persons

· Practice variations in the evaluation and management of IBD

· Impact of various clinical practices on outcome of the disease

Such information is expected to contribute to professional education efforts to improve the evaluation, diagnosis, and timely management of the disease—particularly in adolescence.

Findings from this study are expected to improve the delivery and outcome of IBD public health programs and practice through early detection, treatment and prevention of complications from IBD.

2. Approach Objectives/Outcomes Using a population-based approach in adult and pediatric populations, the objectives of this research program are:

Create an advisory or multidisciplinary workgroup

a) Create a multidisciplinary workgroup of at least 15 experts with clinical, research, academic and public health backgrounds to define research activities and provide expert assistance to implement work plan activities.

b) Workgroup will define specific studies conducted and guide technical approaches that will be used.

Design study for prevalence/characteristics

a) Using evidence-based strategies design a population based study to assess the prevalence and demographic characteristics of IBD and its impact on general health.

b) Obtain population-based estimates of IBD through a population-based study.

c) Describe the demographic and clinical characteristics of persons with IBD through population based studies.

d) Assess the impact of IBD on the health of the population.

e) Develop the methodology to assess the demographic and clinical characteristics of IBD and its impact on the health of persons with IBD.

f) Develop the methodology to assess variation in clinical practice in the management of IBD patients.

g) Assess the impact of various clinical practices in the management of IBD.

h) Describe stakeholder engagement in the research activities.

Develop and pilot national survey program

a) Using evidence-based strategies develop and pilot a prototype for a national surveillance program for IBD to gather national prevalence and incidence data.

Disseminate findings

a) Disseminate study findings targeting professional and general audience through journal articles, fact sheets, conference presentations and training programs.

b) Applicants are expected to develop a plan for dissemination and translation of the research findings with assistance from the multidisciplinary workgroup and other external partners.

Evaluate project activities and report on findings

a) Develop a realistic and focused evaluation plan. The evaluation plan should include:

i. A logic model,

ii. Broad goals, objectives, and activities that are Specific, Measurable, Achievable, Realistic, and Time-limited (SMART),

iii. A description of mechanisms for engaging stakeholders in evaluation activities,

iv. Key local-level or activity-specific evaluation questions,

v. Evaluation methods, and

vi. A description of how evaluation results are intended to be used to overcome any barriers identified and improving efficiencies next year

Target population Despite previous epidemiologic studies, identification of population-based estimates of the incidence (new cases) and prevalence (existing cases) in the general US population is lacking. Furthermore, there is little information about racial/ethnic disparities in the disease burden. Target population can be persons with IBD within a state or a region.

Collaboration/Partnerships Recruit and partner with IBD experts and hospital systems to effectively develop and implement work plan activities. Applicant is expected to recruit at least 15 members for IBD work-group to help guide research activities and develop and pilot a national surveillance program for IBD to gather national prevalence and incidence data perhaps by utilizing a new or an existing surveillance system.

Section II. Award Information

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Funds Available and Anticipated Number of Awards

Total estimated funding (direct and indirect costs) for the first year (12 month budget period) $450,000. Estimated total funding for the entire project $2,250,000.

Single award Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed.

The floor (minimum amount) of this award will be $300,000 (including direct and indirect costs) for the first 12 month budget period.

Applications with budget requests less than the floor will be considered non-responsive and will not be reviewed.

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education Nonprofits (Other than Institutions of Higher Education)

For- Profit Organizations For-Profit Organizations (Other than Small Businesses)

Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U.S. Territory or Possession

Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: 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 applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

· Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

3. Responsiveness:

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

4. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

5. Universal Identifier Requirements and Central Contractor Registration All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM), the replacement system for the Central Contractor Registration (CCR) database. Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

6. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

7. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

8. Number of Applications Only one application per institution (normally identified by having a unique DUNS number) is allowed.

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

3. Letter of Intent Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Natalie J. Darling, MPH National Center for Chronic Disease and Health Promotion Extramural Research Program Office Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-46 Atlanta, GA 30341 Telephone: (770) 488-5740 Email: ndarling@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description). Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA. (N/A)

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY) (N/A)

5. Progress Report Publication List (for Continuation ONLY) (N/A)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan The applicant’s research plan should address activities that will be conducted over the entire 5 year project period and should include the following items:

1. A staffing plan that defines the roles, responsibilities and qualifications of team and expected contributions of key/collaborative partners.

2. Provide evidence of demonstrated partnerships and proposed or existing collaborations to address the goals, objectives, and intent of the FOA.

3. Describe the approach for convening a multidisciplinary workgroup of experts to develop and implement a prototype for a national surveillance system to collect national estimates of the disease.

4. Describe the methodologic approach for designing and implementing a population-based study to assess the prevalence and incidence of IBD, impact of disease on affected persons, and variations in clinical practice at the state or regional level.

5. Describe the analytic process for IBD identification and inclusion and exclusion criteria for numerators (IBD cases) and denominators of the populations at risk. Include a rationale for selection of identification or tracking criteria.

6. Describe access to existing and new data sources and patient populations with IBD.

7. Describe the coordination and communication approach for working with CDC.

8. Describe the approach to be used to compile and analyze data and information and disseminate research findings.

9. Provide detailed timeline including realistic and measurable milestones for proposed project activities and include a budget plan that is linked to activities and milestones.

10. Describe plans for producing reports: interim progress reports and a final report, as well as technical reports, professional presentations, and publications that will be produced collaboratively with CDC.

11. Document your institution’s leadership in identifying and supporting research that could lead to understanding the causes, pathology, and complications of Crohn's disease and Ulcerative Colitis. This includes effective and well-defined working relationships with any organization and/or outside entities expected to participate in the proposed research that will ensure implementation of the proposed activities, goals, and objectives.

12. Describe the infrastructure and work environment to be used to access existing data sources or to create new data sources to accomplish the research goals and objectives in this funding opportunity announcement.

13. Describe the existing or new data sources that will be used in the proposed research activities. Include any descriptions or reports from existing data that describe the incidence, prevalence, or other descriptors of persons with Ulcerative Colitis or Crohn's disease for the state or region under study.

14. Describe the project team’s expertise, including a) leadership in coordinating a network of IBD researchers in studies of Ulcerative Colitis and Crohn's disease epidemiology and surveillance; b) subject matter expertise in designing epidemiologic studies, case definitions, disease registries, and surveillance systems relating to IBD; and c) track record of coordinating efforts which have led to publication of studies in major peer reviewed journals.

15. Describe timelines and milestones for accomplishing various activities proposed.

16. Describe plan for collaboration with CDC staff on study design, data analysis, report writing and dissemination of findings. Include plans to participate in monthly program monitoring, technical assistance (TA) calls, and provide information as requested by the program.

17. Describe plans to evaluate funded activities and report on findings, including how you plan to:

a. Track process, outcome, and the impact of supported activities, focusing on outcomes and stated goals;

b. Report process and outcome data on activities and evaluation findings using written report(s), and peer-reviewed journals.

c. Provide evaluation plan on monitoring outcomes of proposed activities.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

9. Submission Dates and Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; www.pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

0. If the status states “rejected,” do #2a or #2b.

1. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

1. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

1. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

10. Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

11. Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

12. Other Submission Requirements and Information Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

What is the potential or actual impact of the research on public health in the US?

Will the work be influential in that it will lead others to investigate the problem, open new areas of research, or change the scientific approach or public health practice, and how will this improve and be of value to public health?

If successful, do the research results have the potential to be scalable and reach a large portion of the population at risk?

Investigator(s) Are the PD/PIs, collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Does the principal Investigator have previous experience and success in leading complex projects?

Do the investigators have a successful track record in public health research?

Is there evidence of past collaborations with the proposed research team?

Have previous research results provided high quality outputs and contributed to improvements in public health practice and population health?

Innovation Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Is the proposed research innovative and yet offer reasonable potential for concrete applications of interest and value to CDC?

Approach Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are there plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Does the project utilize critical partnerships or collaborations?

Does the project support key stakeholder involvement throughout the research process?

2. Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects If…