Foa_Content_of_RFA-DP-24-031.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH

PROMOTION

Epidemiologic Cohort Study of Interstitial Cystitis

RFA-DP-24-031

01/12/2024

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for Chronic Disease Prevention and Health Promotion Notice of Funding Opportunity (NOFO) Title Epidemiologic Cohort Study of Interstitial Cystitis Activity Code U01

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

RFA-DP-24-031

Assistance Listings Number(s) 93.945 Category of Funding Activity HL - Health NOFO Purpose The purpose of this research NOFO is to follow a cohort of interstitial cystitis (IC) patients over time, define the demographic and clinical patterns of IC, and document its impact on the health of affected people. In addition, the focus of this NOFO will include translating the scientific knowledge on IC extracted from previously funded and other studies so it can be used to support public health action, including patient strategies for improving quality of life, provider awareness and education, and medical and self-management of IC; strengthen clinical, community, and public health linkages; and target groups disproportionately impacted by IC.

Key Dates Publication Date:

To receive notification of any changes to RFA-DP-24-031, 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:

01/10/2024 01/10/2024

Application Due Date:

02/09/2024 02/09/2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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:

03/25/2024 Secondary Review:

05/06/2024 Estimated Start Date:

09/30/2024 Expiration Date:

02/10/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html 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.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

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

Executive Summary

1. Purpose. The purpose of this research NOFO is to follow a cohort of IC patients over time, define the demographic and clinical patterns of IC, and document its impact on the health of affected people. In addition, the focus of this NOFO will include translating the scientific knowledge on IC extracted from previously funded and other studies so it can be used to support public health action, including patient strategies for improving quality of life, provider awareness and education, and medical and self-management of IC; strengthen clinical, community, and public health linkages; and target groups disproportionately impacted by IC.

2. Mechanism of Support. Cooperative Agreement

3. Funds Available and Anticipated Number of Awards. The estimated total funding (direct and indirect) for the entire period of performance is $4,150,000 to support up to 1 award.

4. Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period (9/30/2024 to 9/29/2025) is $830,000. The estimated total funding (direct and indirect) for the entire performance period (9/30/2024 to 9/29/2029) is $4,150,000. The estimated award ceiling is $900,000 for the first 12-month budget period (9/30/2024 to 9/29/2025).

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

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

7. 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 highly encouraged to apply through their organization.

8. Number of PDs/PIs. Applications may include more than one PD/PI; however, the first 4 of 44 PD/PI listed on the application will be the contact PI for all correspondence. Additional PIs are permitted; but they will be referred to as Co-PIs.

9. Number of Applications. One application per eligible institution (normally identified by having a unique DUNS number) is allowed.

10. Application Type. New

11. Special Date(s). None

12. Application Materials. See Section IV.1 for application materials. Please note that Form E is to be used when downloading the application package. https://grants.nih.gov/grants/how-toapply-application-guide/forms-e/general-forms-e.pdf

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

Section I. Funding Opportunity Description Statutory Authority This program is authorized under 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2) and 301(a) of the PHS act, 42 U.S.C. 241(a)

1. Background and Purpose Interstitial cystitis (IC) is recurring pelvic pain, pressure, or discomfort in the bladder and pelvic region, and is associated with urinary frequency and urgency. IC is also referred to as painful bladder syndrome and bladder pain syndrome—however, not all IC patients have pain; some only have urinary symptoms. The exact cause of IC is not known. Because there is no definitive test to identify IC, resulting in a high misdiagnosis rate1, many patients suffer for years before being diagnosed and receiving appropriate treatment. Living with IC is challenging. For many, IC negatively impacts work life, psychological well-being, personal relationships, and general health.

Data from past (DP15-010) and current (DP21-002) interstitial cystitis research cooperative agreements have been used to show the high misdiagnosis rate of IC (over 40%)1, estimate the high prevalence of comorbidities among adults with IC (about 2.72 comorbidities per person)2, generate the national prevalence of IC (0.87%)3, show that Black and Hispanic patients are diagnosed with IC at a younger age than whites4, identify metabolites that could be used to improve IC diagnoses and understanding of IC pathophysiology5, estimate the prevalence of overactive bladder symptoms (69%),6 document prescription prevalence of oral bladder pain medications among women with IC7, estimate the high prevalence of food sensitives (over 70%)in the IC population8, and perform genetic sequencing to identify mendelian disorders in patients with IC.9

Despite these initial epidemiological findings, more scientific knowledge of IC is needed to further advance our understanding of IC and any public health role for managing this condition.

Estimates of healthcare utilization and treatment in the US population remain unknown. More robust diagnostic criteria are needed. Additionally, longitudinal associations between IC and many health outcomes of interest are unknown. Therefore, surveillance and epidemiology of IC is essential for informing public health burden and educating the scientific community (those who treat and study this debilitating condition), affected individuals (patients and families who live with IC), and the public.

To address gaps in IC literature and build on current epidemiological research supported by CDC’s DP21-002, and past research supported by CDC’s DP15-010, the approach being used in this NOFO involves having a robust cohort of IC patients that are followed over time. The results from this new NOFO will provide a better understanding of the epidemiology, healthcare utilization, health disparities, and treatment of the disease. Data will be collected longitudinally, and associations between IC and health outcomes of interest will be evaluated over time. The proposed NOFO will address gaps of longitudinal follow-up from the current NOFO and allow for the ascertainment of prospective outcomes as well as the evaluation of temporal relationships between IC and incident outcomes such as cardiovascular disease, cancer, and mortality over time. This study will work towards establishing rigorous and standardized diagnostic criteria for IC. Healthcare utilization and treatment patterns in IC patients will be evaluated. Health disparities by different demographic groups will be assessed. Findings will be used to increase education and awareness of IC among providers and patients by targeting interventions to improve quality of life and management of IC. Research will be used to inform the best clinical practice that providers can use to improve health outcomes in their patient populations.

The purpose of this research NOFO is to follow a cohort of IC patients over time, define the demographic and clinical patterns of IC, and document its impact on the health of affected people. In addition, the focus of this NOFO will include translating the scientific knowledge on IC extracted from previously funded and other studies so it can be used to support public health action, including patient strategies for improving quality of life, provider awareness and education, and medical and self-management of IC; strengthen clinical, community, and public health linkages; and target groups disproportionately impacted by IC. Findings should be documented through presentations and publications, as well as communication products for the affected patient population and providers.

The successful applicant will be expected to include a plan for translation of the findings by having a plan to partner with a stakeholder who can translate scientific knowledge of IC into public health action for increased awareness, outreach and education among the provider and patient population.

1. Skove SL, Howard LE, Senechal J, Hoedt AD, Bresee C, Cunningham TJ, Barbour KE, Kim J, Freedland SJ, Anger JT. The Misdiagnosis of Interstitial Cystitis/Bladder Pain Syndrome in a VA Population. Neurourol Urodyn. 2019 Sep;38(7):1966-1972

2. Laden BF, Bresee C, De Hoedt A, et al. Comorbidities in a Nationwide, Heterogenous Population of Veterans with Interstitial Cystitis/Bladder Pain Syndrome. Urology.

2021;156:37-43. doi:10.1016/j.urology.2021.04.015

3. Anger JT, Dallas KB, Bresee C, et al. National prevalence of IC/BPS in women and men utilizing veterans health administration data. Front Pain Res (Lausanne). 2022;3:925834.

Published 2022 Aug 24. doi:10.3389/fpain.2022.925834

4. Dallas KB, Bresee C, De Hoedt A, et al. Demographic Differences and Disparities in the Misdiagnosis of Interstitial Cystitis/Bladder Pain Syndrome in a National Cohort of VA Patients. Urology. 2022;163:22-28. doi:10.1016/j.urology.2021.07.019

5. Kim J, De Hoedt A, Wiggins E, et al. Diagnostic Utility of Serum and Urinary Metabolite Analysis in Patients with Interstitial Cystitis/Painful Bladder Syndrome. Urology.

2021;157:85-92. doi:10.1016/j.urology.2021.05.005

6. Dubinskaya A, Tholemeier LN, Erickson T, et al. Prevalence of Overactive Bladder Symptoms Among Women With Interstitial Cystitis/Bladder Pain Syndrome. Female Pelvic Med Reconstr Surg. 2022;28(3):e115-e119. doi:10.1097/SPV.0000000000001166

7. Tholemeier LN, Bresee C, De Hoedt AM, et al. Do medication prescription patterns follow guidelines in a cohort of women with interstitial cystitis/bladder pain syndrome?.

Neurourol Urodyn. 2022;41(5):1121-1126. doi:10.1002/nau.24923

8. Jarman A, Janes JL, Shorter B, et al. Food Sensitivities in a Diverse Nationwide Cohort of Veterans With Interstitial Cystitis/Bladder Pain Syndrome. J Urol. 2023;209(1):216-

224. doi:10.1097/JU.0000000000002938

9. Estrella E, Rockowitz S, Thorne M, et al. Mendelian Disorders in an Interstitial Cystitis/Bladder Pain Syndrome Cohort. Adv Genet (Hoboken). 2022;4(1):2200013.

Published 2022 Nov 27. doi:10.1002/ggn2.202200013

Healthy People 2030 and other National Strategic Priorities This NOFO supports the following HP2030 Objectives:

• OHM-6: Free of activity limitation (all ages).

• OHM-8: Respondent-assessed health status — in good or better health.

Website: Overall Health and Well-Being Measures - Healthy People 2030 | health.gov

Public Health Impact The results from this study will provide a better understanding of the epidemiology, clinical patterns, treatment of the disease, and identification of populations at greatest risk for IC and IC-related morbidity and mortality. Findings will be used to target interventions, inform the best clinical practices, improve health equity among populations heavily impacted by IC, and educate providers, researchers, and patients.

Relevant Work CDC has previously funded two NOFOs on a variety of IC-relevant activities, including NOFO # DP15-010 (The Epidemiological Study of Interstitial Cystitis) and DP-21-002 (Epidemiologic Cohort Study of Interstitial Cystitis), which both addressed IC epidemiological research and programmatic outreach and awareness of IC. The epidemiological work focused on recruitment of IC participants, estimation of the national prevalence of IC, documenting the misdiagnosis of IC, and quantifying the prevalence of comorbid conditions among adults with IC, examining quality of life and symptoms of IC, addressing issues related to the treatment of IC, and understanding the genetics of IC. The programmatic outreach has focused primarily on social media advertising, virtual patient education, and other activities to increase awareness and education of IC burden and treatment to the patient population. The proposed NOFO will address gaps of longitudinal follow-up from the current NOFO (DP21- 002) and allow for the ascertainment of prospective outcomes as well as the evaluation of temporal relationships between IC and incident outcomes such as cardiovascular disease, cancer, and mortality over time.

2. Approach

Objectives/Outcomes https://health.gov/healthypeople/objectives-and-data/overall-health-and-well-being-measures

This NOFO will focus on collecting follow-up data from existing IC cohorts to extend our knowledge of the natural history of IC, treatment, clinical patterns, health disparities, and longitudinal impact of IC on other health outcomes. In any longitudinal cohort study the greatest new knowledge and value come from continued follow-up. NOFO applicants should have access to a cohort of IC participants who are eligible for follow-up or have been followed up. Because IC is a rare condition with little existing epidemiologic information, it is beneficial and efficient in terms of both cost and data collection to continue collecting information on an already existing cohort for which epidemiologic data has already been collected. Further, longer-term follow-up of an existing IC cohort is critical to achieving the objectives of epidemiologic research and addressing current gaps in the literature. Numerous longitudinal studies of other chronic diseases demonstrate that longer-term follow-up of specific people with the disease provides greater understanding of disease natural history as well as clinical and treatment features impacting quality of life and medical management of disease. Therefore, addressing research questions on natural history requires applicants to have established a cohort of people with well-defined IC from which a smaller subset of people can be identified and tracked longitudinally. In addition, the focus of this NOFO will include translating the scientific knowledge on IC extracted from previously funded and other studies so it can be used to support public health action, including patient strategies for improving quality of life, provider awareness and education, and medical and self-management of IC; strengthen clinical, community, and public health linkages; and target groups disproportionately impacted by IC.

The research objectives are to:

• Objective 1: Document the treatment (e.g., type) of people with IC

• Objective 2: Longitudinally follow patients with IC to determine the natural history

(severity, progression, morbidity, mortality, etc.) of people with IC

• Objective 3: Examine potential disparities and other factors associated with IC by categories of interest (e.g., age, sex, race/ethnic group, geography (e.g., urban/rural), and socioeconomic status)

• Objective 4: Improve the surveillance case definition for IC by improving sensitivity and specificity.

• Objective 5: Improve diagnostic criteria for IC, and the ability to detect true cases.

• Objective 6: Improve understanding of the genetics of IC

• Objective 7: Translate the scientific knowledge on IC extracted from this study and others into tools and products that can be used to support public health action and provider awareness and education.

Expected outcomes:

• Develop the research protocol, data analysis plan, and data management plan by 6 months post-award to be updated annually by the end of the calendar year.

• Develop a secure database where all data will be stored and maintained, with de-identified data available to the public in a public use dataset after the implementation of a data management plan.

• Develop all research questions to address during funding period by 6 months post-award.

• Develop and follow an existing cohort, analyze data with each round of data collection, and publish results in peer-reviewed publications. Publish a minimum of 2 publications annually.

• Create communication and education products targeted at the affected IC patient population and providers to help increase IC awareness and education. To implement this, the grantee should develop a plan describing the approach to partner with a key stakeholder to help translate key research findings from this study and others into communication products for dissemination.

• Participate in routine conference calls to discuss operational and analytic activities with

CDC.

• Participate in conferences and webinars to promote IC study findings and data source.

Target Population Applicants are expected to target adult patients impacted by IC. The study population chosen should be as representative of the US population as possible and include ethnic/racial minorities, urban/rural populations, individuals of low socioeconomic status, those with disabilities, and sexual and gender minority populations.

Collaboration/Partnerships Applicants are expected to collaborate with stakeholders that can work to promote increased IC education, outreach, and awareness. Furthermore, collaborating with outside subject matter experts in the field of IC epidemiology is also encouraged. Finally, collaborations with organizations focused on social determinants of health, health equity, and health disparities are highly encouraged.

Evaluation/Performance Measurement The awardees are expected to create an evaluation plan by the 6th month post-award. This plan should align with the stated purpose and outcomes of the NOFO, which includes participant follow-up, progress towards meeting study objectives, and implementing an increase in awareness, outreach, and education regarding IC. The evaluation plan should be used to monitor data collection, analysis, and publication status of proposed research articles. Recipient should specify specifics related to scale, staffing, or resources in the evaluation plan. Evaluation plans can be refined with CDC post-award. Specific information regarding evaluation can be found at:

https://www.cdc.gov/eval/index.htm

Translation Plan The applicant is expected to include a plan for translation of the findings to: influence public health practice; and disseminate findings for education, outreach and awareness to scientific researchers, clinical practitioners, and the affected population. Findings should be documented through presentations and peer-reviewed publications, as well as communication and educational products for the affected patient population and providers. Examples of data translation plans include: 1) Disseminate data in a form that can be translated by applicant partner(s) on a medical or IC website, 2) Translate findings and disseminate on IC social media channels, and 3) Translate findings and disseminate on email via IC health communication channels.

Data Management Plan (DMP): CDC requires awardees for projects that involve the collection or generation of public health data with federal funds to submit a DMP prior to the initiation of https://www.cdc.gov/eval/index.htm generating or collecting public health data unless CDC will aggregate and disseminate the data.

Public health data means digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation. In initial funding applications, the DMP should be addressed within the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application, either as a stand-alone DMP within this section or with a statement explaining why a DMP is not included. The DMP must be updated and submitted to CDC at least annually, or whenever plans for data collection or generation activities change. Costs associated with developing and implementing a DMP, including costs of sharing, archiving and long-term preservation, may be included in the budget submissions for grants and cooperative agreements. The contents of the DMP are described in AR-25. Visit link https ://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm for DMP Template and Guidance.

Public health data are expected to be made freely available to the public (in a de-identified format) and archived long-term unless there are compelling reasons not to do so. When it is not feasible to make data freely available to the public, it may be possible to make data available to users on a restricted basis. The DMP should describe the expected level of public access, if any, and must justify the planned access level and describe how privacy and confidentiality will be protected. The final version of a collected and/or generated data set intended for release or sharing should be made available within thirty (30) months after the end of the data collection or generation, except surveillance data from ongoing surveillance systems which should be made accessible within 12 months of the end of a collection cycle. Awardees who fail to release public health data in a timely fashion may be subject to procedures normally used to address lack of compliance consistent with applicable authorities, regulations, policies or terms of their award.

For data underlying scientific publications such as peer-review journal articles, awardee should make the data available coincident with publication of the paper, unless the data set is already available via a release or sharing mechanism. At a minimum, release of the data set accompanying a scientific paper should consist of a machine-readable version of the data tables shown in the paper.

OMB/PRA will not apply

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (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:

$4,150,000 Estimated Total Funding for the First Budget Period: $830,000.

Estimated Total Funding for the Entire Period: $4,150,000

Anticipated Number of Awards:

Estimated Total Funding for the First Budget Period: $830,000.

Estimated Total Funding for the Entire Period: $4,150,000

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

Award Ceiling:

$900,000 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.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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

99 (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

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:

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."

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 https://gov.ecfr.io/cgi-bin/searchECFR.

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. Additional Information on Eligibility This NOFO is open competition

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If the application is incomplete or non-responsive to the requirement listed in this section, it will not enter into the review process.

Applicants must have access to an existing and established baseline cohort of at least 200 IC participants that has been followed previously or will be followed in 2024, and that the applicant can follow over time to accomplish the goals and objectives of this NOFO. Applicants must provide evidence such as a letter of commitment, memorandum of agreement, memorandum of understanding, or other documentation providing evidence of access to the established cohort that can be followed over time. This evidence should be placed in Appendix A of the application.

The applicant does not have to have collected data on IC previously.

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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/

• (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

• System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

• 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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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.gov 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 SAM.gov and the SAM.gov Knowledge Base.

https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

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 UEI 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 NOFO 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 UEI number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

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://public.era.nih.gov http://grants.nih.gov/support/index.html

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide 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 package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please use the form and instructions for SF 424 (R&R) FORMS-H for applications due on or after January 25, 2023.

3. Letter of Intent Due Date for Letter Of Intent 01/10/2024

01/10/2024 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information it contains allows CDC staff to plan the review. By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

Place the number and title of this funding opportunity in the subject line

The letter should be emailed to:

Natalie Brown, MPH Scientific Program Official Telephone: 404-639-4601 Email: Nbrown3@cdc.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html mailto:Nbrown3@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. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

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 components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at How to Apply

- Application Guide 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 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 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 time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide 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:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

• Statement of the 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; and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

Please use the form and instructions for SF424 (R&R) FORMS-H for applications due on or after January 25, 2023.

RESEARCH PLAN

The applicant's research plan should address activities that will be performed over the entire performance period and should include the following items:

1. State the study design (e.g., a prospective cohort study) and the outcomes to be achieved.

2. Describe in detail how participants are sampled so that obtained estimates can be generalized to the US population.

3. Does the study sample size comprise at least 200 participants with IC?

https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

4. Include details about data collection. Does data collection occur over the phone, mail, in-person, or a hybrid process? What variables will you ascertain and how many? Describe each variable in detail. Which variables are measured via self-report and which are objectively measured? Which variables examine sociodemographic patterns, healthcare access, quality of life, other chronic conditions, and mortality? Include variables that align with the purpose of the

NOFO.

5. Describe the proposed data collection methods (e.g., over the phone, mail, in-person).

6. Describe in detail the variables, in alignment with the NOFO purpose, and how they are measured using self-reports or other methods such as those used to examine sociodemographic patterns, healthcare access, quality of life, chronic conditions, or mortality

Management and Staffing Plan

1. Describe the proposed management and staffing plan of the study. Include a staffing plan that describes the roles and percentage of time on the project.

2. Describe plans for maintaining project activities when staff vacancies occur.

3. Document (with resumes) and describe experience and expertise of proposed staff, including their ability to manage this study. Include a description of the staff experience with data collection, managing data, follow-up of participants, using appropriate analytic methods. What experience do they have collecting IC-related data?

4. Describe plans for ensuring that program maintains local IRB approval and new key personnel, or other significant contributors involved in the design or conduct of research involving human subjects meet educational program requirement in the protection of human subjects.

5. Describe the process of recruiting participants, their follow-up and data collection frequency over the three-year period. Also describe how often participants are contacted for each visit.

6. Describe the proposed analytic or statistical methods for all study objectives. Describe the statistical tests and software to be used.

Translation Plan

1. Include a plan for translation of the findings to: influence public health practice; and disseminate findings for education, outreach and awareness to scientific researchers, clinical practitioners, and the affected population.

2. Document findings through presentations and publications, as well as communication products for the affected patient population and providers.

Collaboration

1. Describe plans for developing collaborations with stakeholders that can work to promote increased IC education, outreach, and awareness.

2. Describe plans for collaborating with outside subject matter experts in the field of IC epidemiology to enhance quality of research.

3. Describe plans for collaborating with organizations focused on social determinants of health, health equity, and health disparities to target groups disproportionately impacted by IC and improve their health outcomes.

6. Appendix Do not use the appendix to circumvent page limits.