RFA-DP-18-001.pdf

Centers for Disease Control

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Etiology and Outcome of Inflammatory Bowel Disease

RFA-DP-18-001

Application Due Date: 02/09/2018

Etiology and Outcome of Inflammatory Bowel Disease

RFA-DP-18-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office (NCCDPHP ERPO) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Notice of Funding Opportunity (NOFO) Title Etiology and Outcome of Inflammatory Bowel Disease Activity Code U01 Amendment I. made January 19, 2018 Section I.2 Approach, Objectives/Outcomes - Provides clarification language on the registry age requirements.

Section VIII. Other Information - Added Appendix A. Questions from Potential Applicants and CDC Responses

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-DP-18-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.945 Category of Funding Activity:

Health NOFO Purpose To establish a surveillance program to obtain regional or state-level incidence of inflammatory bowel disease (IBD) to extrapolate to the U.S. population, and to determine the impact of demographic and clinical factors on the detection and management of IBD.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-18-001, 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.

Letter of Intent Due Date: 01/10/2018

Application Due Date: 02/09/2018 https://www.grants.gov

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).

Scientific Merit Review: 04/04/2018

Secondary Review: 05/09/2018

Estimated Start Date: 09/30/2018

Expiration Date: 02/10/2018 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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 NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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 Apply Electronically

Executive Summary

Purpose. The purpose of this Notice of Funding Opportunity (NOFO) is to establish a surveillance program to obtain regional or state-level incidence of inflammatory bowel disease (IBD) to extrapolate to the U.S. population, and to determine the impact of demographic and clinical factors on the detection and management of IBD.

Mechanism of Support. Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total funding

(direct and indirect) for the 5-year period of performance is $3,250,000, to fund one award. Awards issued under this announcement 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period, September 30, 2018 to September 29, 2019, is $800,000. The estimated total funding (direct and indirect) for the 5-year period of performance, September 30, 2018 to September 29, 2023, is $3,250,000.

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.A.

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 include more than one PI; however, the first PI listed on the application will be the "contact PI" for all correspondence. Any additional PIs are permitted, but would be referred to as Co-PIs.

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

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials. Please note that the SF424 (R&R) Version E is to be used when downloading the application package https://grants.nih.gov/grants/how-to-apply-application-guide.html

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

A link to this Notice of Funding Opportunity (NOFO) on the Grants.gov website may be found at Funding Opportunities Announcements | Chronic Disease Prevention and Health Promotion |

CDC

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a)

1. Background and Purpose In 2015, approximately three million US adults reported having a diagnosis of inflammatory bowel disease (IBD) [1]. The estimated number has increased greatly from 1.8 million since 1999 [2] which does not include children who may be affected by IBD as well. Crohn's disease http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/chronicdisease/about/foa.htm https://www.cdc.gov/chronicdisease/about/foa.htm and ulcerative colitis are two common types of IBD that are characterized by chronic inflammation of the gastrointestinal tract. Some common symptoms include persistent diarrhea, abdominal pain, bloody stools, weight loss, and fatigue. The exact cause of IBD is not well understood. Genetic predisposition and environmental triggers may play a role. Additionally, diagnosis of IBD is not a straightforward process. A series of blood and stool tests, endoscopies, radiology scans or diagnostic imaging are usually performed to make a diagnosis of Crohn's disease or ulcerative colitis.

IBD is usually a lifetime chronic condition. The severity and progression of the disease largely impacts patients' quality of life through the ongoing symptoms. Furthermore, the disease also causes complications and is related to other comorbidities. For instance, hospitalization rate for Crohn's disease increased significantly when it was listed as a primary or any secondary diagnosis indicated by the ICD-9 diagnosis codes [3].

IBD is known to be more prevalent among the white population. However, incidence and prevalence of IBD is increasing among minorities [4]. Trends of hospitalizations showed that a discharge diagnosis of IBD increased from 1994 to 2006 among non-white populations in the US [5], which may suggest an increase of IBD burden among minorities. In addition, geographic variation was also detected in the prevalence of IBD for both children and adults. In a previous study reported by Kappelman et al [6], the prevalence of IBD was lower in the South and West compared to the rest of the U.S. regions. Geographic variation is usually associated with racial and ethnic disparity of disease detection and management [7, 8]. Understanding the racial difference in the prevalence of IBD helps elucidate the socio-environmental and genetic attributes related to the disease [9], as well as inform health policies aimed at addressing disparities in healthcare access.

Through this announcement, CDC seeks research proposals aimed at expanding knowledge of demographic and clinical characteristics of IBD in the general population. It is important to recruit minority races and ethnicities in the new IBD registry as the information in the current literature is fragmented. Comparing the clinical outcomes involving non-Hispanic white and other races and ethnicities helps understand genetic and socio-environmental factors accounting for the disease. Furthermore, although IBD is an uncommon disease, it imposes a huge financial burden to the US healthcare system resulting from the outcomes of the disease. For instance, the total annual direct costs attributable to Crohn's disease and ulcerative colitis in the US are estimated to be between $11 billion to $28 billion [10]. To address the important public health problem, the research findings will provide a better understanding of etiology of the disease, identify high-risk populations, help improve healthcare access among IBD patients, and inform better clinical practice.

This research will augment previous epidemiologic studies of IBD, by establishing and maintaining a surveillance program to obtain incidence of IBD, describing the natural history and outcomes of the disease, and assessing impact of IBD on minorities and affected people.

This NOFO is to address establishment and use of an IBD registry for conducting population-based studies. The project goals will be achieved by collecting patients' demographic and clinical data, extrapolating incidence to the U.S. population, disseminating study findings through peer-reviewed journals, conference presentations, training programs, and fact sheets.

The purpose of this research is to:

Establish a new IBD registry to estimate incidence of IBD in the adult and pediatric populations from the IBD registry and extrapolate to the US population.

Describe natural history and outcomes of IBD.

Determine racial/ethnic variation in the detection and management of IBD.

Identify evidence-based strategies to improve disease outcomes.

Disseminate study findings to medical professionals, researchers, and public health practitioners.

Healthy People 2020 and other National Strategic Priorities This announcement supports Healthy People 2020 Objective, AHS-5 Access to Health Service, "Increase the proportion of persons who have a specific source of ongoing care." Since IBD requires an ongoing care, proper healthcare access among affected persons may improve disease outcomes.

Public Health Impact The study is expected to add knowledge of the natural history of IBD to the existing literature.

The results will enhance understanding of the impact of IBD on the overall health of affected persons (pediatric and adult patients) and the impact of various clinical practices and healthcare delivery approaches on the outcome of the diseases. The results will also inform healthcare professionals of evidence-based strategies that can be used to improve disease outcomes in terms of early diagnosis, proper treatment, and timely prevention of complications.

Relevant Work Since 2005, CDC has collaborated with Crohn's & Colitis Foundation to develop a state registry, the Ocean State Crohn's and Colitis Area Registry (OSCCAR), which is a population-based cohort of newly diagnosed patients in Rhode Island. The study objective for that registry includes establishing and maintaining the prospective cohort of pediatric and adult IBD patients in the state of Rhode Island, determining the incidence rate of IBD and extrapolating to the U.S.

population, defining the natural history of IBD, and identifying clinical and genetic factors associated with the disease [11]. The collaboration has resulted in numerous publications [12- 15]. Additional information about the collaboration is available on the CDC website [16].

2. Approach The purpose of this NOFO is to better understand the cause of the disease and how to improve diagnosis and clinical outcomes.

Objectives/Outcomes

1. Establish an IBD registry that includes all age groups to enable estimation of the incidence of IBD in both the adult and pediatric populations; describe the natural history and outcomes of IBD; determine racial/ethnic variation in the detection and management of IBD; and identify strategies to improve disease outcomes.

2. Create a multidisciplinary expert panel to provide consultation and advice on the surveillance program. The panel should include at least 15 experts with backgrounds in medicine and epidemiology specific to IBD or gastroenterology from both clinic and academic settings.

3. Develop a strategic plan to enroll patients with newly diagnosed IBD in the registry. The plan should include strategies to ensure diverse racial/ethnic groups to be enrolled. The plan should also ensure a sufficient number of newly diagnosed IBD patients to be enrolled into the registry in order to obtain estimation of the incidence of IBD and key risk factors.

4. The study should be designed to characterize IBD incidence, to determine etiology and risk factors (e.g., biological plausibility of the genetic causes, environmental risk factors, and health-risk behaviors), to evaluate healthcare utilization (e.g., receipt of preventive care), and to identify effective approaches of disease detection and management (e.g., clinical practice) in order to achieve optimal disease outcomes.

5. Develop a dissemination plan of study findings including publishing peer-reviewed journal articles, presenting at scientific conferences, and generating fact sheets and disseminating to the appropriate audience.

Target Population The target population is children and adults newly diagnosed with IBD.

Collaboration/Partnerships Applicants are expected to establish or enhance partnerships with experts with IBD background from clinic and academic settings to achieve the objectives in this announcement.

Evaluation/Performance Measurement Applicants are expected to develop an evaluation plan that includes process evaluation of key milestones of the project, including providing a realistic and focused evaluation plan that demonstrates how the recipient will fulfill the requirements of this announcement.

The evaluation plan should include the following:

A logic model describing the research plan;

Specific research objectives and activities to be aligned with this NOFO purpose;

Key research activity questions of evaluation;

Mechanisms for engaging stakeholders in evaluation activities; and Manuscripts shared with CDC for comments before submitted to peer-reviewed journals.

Translation Plan Develop a dissemination plan of study findings including publishing peer-reviewed journal articles, presenting at scientific conferences, and generating fact sheets and disseminating to the appropriate audience.

OMB/PRA is expected to apply.

References

1. Dahlhamer, J.M., et al., Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep, 2016. 65(42): p.

1166-1169.

2. Nguyen, G.C., C.A. Chong, and R.Y. Chong, National estimates of the burden of inflammatory bowel disease among racial and ethnic groups in the United States. J Crohns Colitis, 2014. 8(4): p. 288-95.

3. Malarcher, C.A., et al., Hospitalizations for Crohn's Disease - United States, 2003-2013.

MMWR Morb Mortal Wkly Rep, 2017. 66(14): p. 377-381.

4. Afzali, A. and R.K. Cross, Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. Inflamm Bowel Dis, 2016. 22(8): p. 2023-40.

5. Sewell, J.L., H.F. Yee, Jr., and J.M. Inadomi, Hospitalizations are increasing among minority patients with Crohn's disease and ulcerative colitis. Inflamm Bowel Dis, 2010.

16(2): p. 204-7.

6. Kappelman, M.D., et al., Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci, 2013. 58(2): p.

519-25.

7. Nguyen, G.C., et al., Racial and geographic variations in colectomy rates among hospitalized ulcerative colitis patients. Clin Gastroenterol Hepatol, 2006. 4(12): p. 1507- 1513.

8. Semrad, T.J., et al., Geographic variation of racial/ethnic disparities in colorectal cancer testing among medicare enrollees. Cancer, 2011. 117(8): p. 1755-63.

9. Sewell, J.L. and F.S. Velayos, Systematic review: The role of race and socioeconomic factors on IBD healthcare delivery and effectiveness. Inflamm Bowel Dis, 2013. 19(3):

p. 627-43.

10. Foundation, C.s.a.C. The facts about inflammatory bowel diseases. 2014 [cited 2017 August]; Available from: http://www.crohnscolitisfoundation.org/assets/pdfs/ibdfactboo k.pdf.

11. Sands, B.E., et al., OSCCAR: Ocean State Crohn's and Colitis Area Registry. Med Health R I, 2009. 92(3): p. 82-5, 88.

12. Kochar, B., et al., Achieving Synergy: Linking an Internet-Based Inflammatory Bowel Disease Cohort to a Community-Based Inception Cohort and Multicentered Cohort in Inflammatory Bowel Disease. J Med Internet Res, 2016. 18(6): p. e124.

13. Grand, D.J., et al., Risk factors for radiation exposure in newly diagnosed IBD patients.

Abdom Radiol (NY), 2016. 41(7): p. 1363-9.

14. Shapiro, J.M., et al., Corticosteroid Use in a Prospective, Community-Based Cohort of Newly Diagnosed Inflammatory Bowel Disease Patients. Dig Dis Sci, 2016. 61(6): p.

1635-40.

15. Shapiro, J.M., et al., Incidence of Crohn's Disease and Ulcerative Colitis in Rhode Island: Report from the Ocean State Crohn's and Colitis Area Registry. Inflamm Bowel Dis, 2016. 22(6): p. 1456-61.

16. CDC. Inflammatory Bowel Disease Projects & Partners. 2017 [cited 2017 August 14];

http://www.crohnscolitisfoundation.org/assets/pdfs/ibdfactbook.pdf http://www.crohnscolitisfoundation.org/assets/pdfs/ibdfactbook.pdf

Available from: https://www.cdc.gov/ibd/projects-partners.htm.

Section II. Award Information Funding Instrument Type: 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.

Estimated Total Funding: $3,250,000 The estimated total funding of $3,250,000 includes direct and indirect costs for the entire 5-year Period of Performance.

Anticipated Number of Awards: 1 The estimated total funding (direct and indirect costs) for the first budget period is $800,000.

If an applicant requests a funding amount greater than the $800,000 ceiling for the first year, 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.

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.

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

Award Ceiling: $800,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, 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 https://www.cdc.gov/ibd/projects-partners.htm

(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

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 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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)

Governments:

Eligible Agencies of the Federal

Government U.S. Territory or Possession

Other:

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.

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

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

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements None

4. Justification for Less than Maximum Competition N/A

5. Responsiveness N/A

6. 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.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.

int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

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.

7. Universal Identifier Requirements and System for Award Management (SAM) 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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.Grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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). 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 recipient 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 recipient organization.

8. 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.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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

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 https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.Grants.gov forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf, except where instructed in this Notice of Funding Opportunity 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 NOFO 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 NOFO. 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 from http://grants.nih.gov/grants/funding/424/index.htm.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

3. Letter of Intent mailto:pgotim@cdc.gov https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf http://grants.nih.gov/grants/funding/424/index.htm

Due Date for Letter of Intent: 01/10/2018 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 CDC staff to estimate the potential review workload and plan the review.

By January 10, 2018, 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:

Sue Shaw, MPH Scientific Program Official Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE., Mailstop F-80 Atlanta, GA 30341 Telephone: (770) 488-6142 Email: zgx7@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, 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 Notices of Funding Opportunities(NOFOs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guidehttps://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 (R&R) unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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 mailto:xxxx@cdc.gov https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf requirements of the NOFO.

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)

5. Progress Report Publication List (for Continuation ONLY)

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 (R&R) Application Guide unless otherwise specified in the NOFO. All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf confidentiality, security, intellectual property, or other rights)

• Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

RESEARCH PLAN

The research plan should address activities that will be conducted over the entire 5-year period of performance and should include the following items:

1. Management and Staffing

Provide a staffing plan that defines the roles, responsibilities, and qualifications of the principal investigator and the team.

Describe the organizational structure, key personnel, work environment, and infrastructural capacity to accomplish the research objectives in this NOFO.

Describe the specific roles and responsibilities of staff including, but not limited to, establishing the registry, identification and recruitment of enrollees, identifying analysis priorities, developing analysis plans, analyzing data, and disseminating the results.

Provide an organizational chart and identify the location of the research program within the organization.

2. Partnership and Collaboration

Describe plans for developing partnerships, and proposed or existing collaborations to address the objectives and the intent of this NOFO. Include a description of the expected roles and responsibilities of proposed partners and collaborators.

Provide letters of agreement, memoranda of understanding, or other official documentation from health care providers/practices indicating they will refer newly diagnosed IBD patients for inclusion in the registry and will provide access to identifiable patient information and necessary permission to contact patients. Include these documents in Appendix A of the application.

Describe a strategic plan to enroll patients with newly diagnosed IBD into the registry.

The plan should include strategies to ensure diverse racial/ethnic groups to be enrolled.

The plan should also ensure a sufficient number of newly diagnosed IBD patients that can be recruited into the registry to enable estimation of the incidence of IBD and key risk factors.

Describe plans for establishing and convening a multidisciplinary expert panel to provide consultation and advice on the surveillance program. Provide, at minimum, the panel structure, proposed membership, and the contribution of the panel to the surveillance program. Provide letters of commitment in Appendix A, from proposed panel members demonstrating their agreement to serve on the expert panel.

https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php

Describe approach and plans for the overall coordination and communication with CDC.

3. Research Activities

Describe and justify the selected geographic area identified for establishment of the IBD registry.

Describe the approach for accessing health care providers for referral of newly diagnosed IBD patients to enroll in the registry.

Describe the methodologic approach for designing and implementing the population-based study to identify patient characteristics and environmental and clinical factors associated with IBD, and to assess the incidence of IBD, impact of disease on affected persons, variations in clinical practice, and the innovative disease management to improve IBD outcomes.

Describe the registry enrollment plan. Provide a power calculation that demonstrates the ability to achieve stable estimates for all enrollees, including minorities and children.

Provide an estimation of annual registry enrollees, based on the current incidence rate of IBD, number of newly diagnosed patients from the healthcare providers, and the demographic distribution of the selected geographic region or state.

4. Translation Plan

Describe plans for producing and disseminating results such as technical reports, scientific presentations, and peer-reviewed manuscripts.

5. Evaluation Plan

Provide a logic model describing research objectives and activities.

Describe a plan for the development of a full evaluation plan.

6. Project Timeline

Provide a detailed timeline for key milestones to occur in the first 12 months of the project and provide key milestones for years 2 through 5. Include milestones that demonstrate progress toward having an Institutional Review Board (IRB) approved protocol and, if required, an OMB approved protocol.

7. Budget

Provide a detailed budget and line-item justification of all operating expenses that are consistent with the planned activities and milestones of the project for the first 12-months.

Include travel to CDC once per year to discuss the project.

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 NOFO must be followed. For this specific NOFO, 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 25 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf.

9. Submission Dates & 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 (https://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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 https://www.grants.gov/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 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 TIMS at 770-488-2700; ogstims@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).

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

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

a. If the deadline has passed, he/she should email the Grant Management Specialist listed in the NOFO (ogstims@cdc.gov) explaining why the submission failed. b. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Due Date for Applications: 02/09/2018

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application…