PKG00264065-instructions.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research

Program Office

Epidemiologic Cohort Study of Interstitial Cystitis

RFA-DP-21-002

Application Due Date: 01/14/2021

Epidemiologic Cohort Study of Interstitial Cystitis

RFA-DP-21-002

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 and Prevention 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-21-002

Assistance Listings (CFDA) Number(s) 93.283 Category of Funding Activity:

Health NOFO Purpose The purpose of this research NOFO is to obtain estimates of incidence of IC comorbidities, define the demographic, treatment, and clinical patterns of IC, examine health disparities, and document IC's impact on the health of affected people over time. In addition, the focus of this NOFO will include translating the scientific knowledge on IC to support public health practice, including: (1) patient strategies for improving quality of life, (2) provider awareness and education, and (3) medical and self-management of IC.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-21-002, 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: 12/10/2020

Application Due Date: 01/14/2021

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 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the https://www.grants.gov preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

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: 03/08/2021

Secondary Review: 04/19/2021

Estimated Start Date: 09/30/2021

Expiration Date: 01/15/2021 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

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.

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Applicants must use ASSIST at https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply-and-register/submission-options/assist.htm to prepare and submit applications electronically through Grants.gov to CDC.

In addition, a letter of support, memorandum of agreement, or other documentation is required providing evidence of access to an established cohort of at least 200 IC participants that can be followed over time to accomplish the goals and objectives of this NOFO. This documentation should be placed in Appendix A of the application. The applicant does not have to have collected data on IC, previously. The applicant must demonstrate that they have access to an IC dataset with participants at baseline that have been followed or will be followed in 2021.

If the responsiveness information requested is incomplete or non-responsive to these requirements, the application will not enter into the review process.

Executive Summary

1. Purpose. The purpose of the research NOFO is: (1) to obtain estimates of the incidence of IC comorbidities, (2) define the demographic, treatment, and clinical patterns of IC, (3) examine health disparities, and (4) document IC's impact on the health of affected people over time. This must be achieved using data from an existing and established baseline cohort of IC participants.

In addition, the purpose includes translating the scientific knowledge on IC to support public health action, including; patient strategies for improving quality of life: provider awareness and education; and medical and self-management of 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 $2,490,000 to support up to 1 award.

4. Budget and Period of Performance. The estimated total funding (direct and indirect) for the first budget period (9/30/2021 to 9/29/2022) is $830,000. The estimated total funding (direct and indirect) for the entire performance period (9/30/2021 to 9/29/2024) is $2,490,000. The estimated award ceiling is $900,000 for the first 12-month budget period (9/30/2021 to 9/29/2022).

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 http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A

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-to-apply-application-guide/forms-e/general-forms-e.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: 1- 888-232-6348.

A link to this NOFO on Grants.gov is available at https://www.cdc.gov/chronicdisease/programs-impact/nofo/index.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Section 301(a) of the Public Health Service, 42 U.S.C. 241(a), 317(k)(2) of the Public Health Service Act, 42 U.S.C. 247b(k)(2).

1. Background and Purpose Background 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, this results in a high misdiagnosis rate (1). 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.

Depending on the type of study and diagnostic criteria used, estimates of IC prevalence vary widely from as low as 0.045% to 6.5% in the US. (2,3) The CDC-funded study estimates the prevalence of IC to be about 1% (1.4% in women and 0.55% in men) nationally and uses robust and rigorous diagnostic criteria. (4) In terms of comorbidities, the CDC-funded study reports an estimated 2.72 comorbidities per patient with IC (significantly higher than patients without IC).

(5) Most studies examining the association between IC and other conditions are cross-sectional, and thus, the temporal association between IC and these conditions cannot be ascertained.

Data from the current CDC-funded Epidemiological Study of Interstitial Cystitis (DP15-010) has 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) (5), http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1 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 and generate the national prevalence of IC (close to 1%). (4) However, more research is needed to understand IC demographics, clinical patterns, and treatment type, as well as health disparities by sex, race, socioeconomic status, and geography, and the longitudinal impact of IC on important health outcomes.

Purpose 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 demographics, clinical patterns, health disparities, and treatment type in the US population are needed. More robust diagnostic criteria are needed, as well as patient and healthcare interactions regarding the condition. 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). This study will build on current epidemiological research supported by CDC's cooperative agreement entitled "Epidemiological Study of Interstitial Cystitis". The primary purpose of that study was to establish a cohort of IC patients and estimate the prevalence of IC. This study will work towards establishing rigorous and standardized diagnostic criteria for IC in order to better estimate the incidence of IC in the US population. It will examine how an IC diagnosis may impact a multitude of other health outcomes over time. The results from this study will provide a better understanding of the epidemiology, healthcare utilization, health disparities, clinical patterns and treatment of the disease.

The proposed NOFO will generate longitudinal follow-up data spanning from the current NOFO (2015 to 2021) entitled "Epidemiological Study of Interstitial Cystitis" and allow for the ascertainment of prospective outcomes as well as the evaluation of temporal relationship between IC and incident outcomes such as cardiovascular disease, cancer, and mortality over time.

The grantee should support public health practice by having a plan to partner with a stakeholder who can translate scientific knowledge of IC into public health action for increased awareness and education among the provider and patient population.

Healthy People 2030 and other National Strategic Priorities https://health.gov/healthypeople/objectives-and-data/browse-objectives This program addresses the Healthy People 2030 focus areas of Health Communication and Health Care Access and Quality. Specifically, it addresses the following Healthy People objectives: 1) AHS-8:Increase the proportion of adults who get recommended evidence-based preventive health, 2) HC/HIT-R01: Increase the health literacy of the population, and 3) AHS- R01: Increase the ability of primary care and behavioral health professionals to provide high-quality care to patients who need it.

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 best clinical practices, improve health equity among populations heavily impacted by IC, and educate providers, researchers, and patients.

Relevant Work CDC has previously funded work on a variety of IC-relevant activities, including NOFO # DP15-010 (The Epidemiological Study of Interstitial Cystitis), which addressed IC epidemiological research and programmatic outreach and awareness of IC. The epidemiological work focused on recruitment of baseline participants with and without IC, estimation of the national prevalence of IC, documenting the misdiagnosis of IC, and quantifying the prevalence of comorbid conditions among adults with 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 (DP15-

010) 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 This NOFO will focus on collecting follow-up data from existing IC cohorts 3-5 years after baseline 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 comes 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.

(6) 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.

Objectives/Outcomes The research objectives are to:

1: Document the demographics, clinical patterns, and treatment type for people with IC.

2: Longitudinally follow patients from baseline with IC over a 3-year period to determine the natural history (severity, progression, morbidity, mortality, etc.) of people with IC.

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).

4: Partner with a key stakeholder to help 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 patient and provider awareness and education.

Expected outcomes:

Develop the research protocol, data analysis plan, and data management plan by 6-month 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 the 6-month 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. The results from the study population chosen should be extrapolated to the entire US population, so the study design must be amenable to generating valid national estimates.

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 is 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. 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 it 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 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.

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

OMB/PRA will not apply References:

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. Clemens, J. Q., Meenan, R. T., Rosetti, M. C., Gao, S. Y. & Calhoun, E. A. Prevalence and incidence of interstitial cystitis in a managed care population. The Journal of urology 173, 98- 102; discussion 102, doi:10.1097/01.ju.0000146114.53828.82 (2005).

3. Suskind, A. M. et al. The prevalence and overlap of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome in men: results of the RAND Interstitial Cystitis Epidemiology male study. The Journal of urology 189, 141- 145, doi:10.1016/j.juro.2012.08.088 (2013).

4. Anger, J, Dallas, K, Bresee, C, et al. Estimated National Prevalence of IC/BPS Utilizing Veterans Health Administration Data. American Urological Association's 2020 Annual Meeting, May 15-19. Washington, DC, USA

5. Laden BF, Hoedt AD, Scharfenberg A, Saxena R, Senechal JF, Bresee CT, Barbour KE, Kim J, Freedland SJ, Anger JT. Comorbid Conditions in a Nationwide, Heterogenous Population of Veterans with Interstitial Cystitis/Bladder Pain Syndrome. American Urology Association Conference. May 3rd-6th, 2019 in Chicago, IL, USA.

6. Andersson C et al. 70-year legacy of the Framingham Heart Study. Nat Rev Cardiol. 2019 Nov;16(11):687-698.

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: $2,490,000

Anticipated Number of Awards: 1

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $900,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 3 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 (http://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) Private institutions of higher education For profit organizations other than small businesses Small businesses 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:

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

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 Special Eligibility. For an application to be considered, the application must be responsive to these Special Eligibility Requirements. If your application is incomplete or non-responsive to the special eligibility requirements listed in this section, it will not enter into the review process.

Applicants must have access to an existing and established baseline cohort of IC.

The Sample size of the cohort to be used for this study should include a minimum of

200 IC participants to insure sufficient statistical power to analyze longitudinal data and account for loss to follow-up of participants over time.

Letter of support, memorandum of agreement, or other documentation is required providing evidence of access to an established cohort of at least 200 IC participants that can be followed over time to accomplish the goals and objectives of this NOFO. This documentation should be placed in Appendix A of the application. The applicant does not have to have collected data on IC, previously. The applicant must demonstrate that they have access to an IC dataset with participants at baseline that have been followed or will be followed in 2021. If the responsiveness information requested below is incomplete or non-responsive to these https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true requirements, the application will not enter into the review process.

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://cage.dla.mil/

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/index.html .

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

https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform

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.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist 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:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk 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://public.era.nih.gov/assist is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.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 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 (R&R) 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.

3. Letter of Intent Due Date for Letter of Intent: 12/10/2020 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 Number and title of this funding opportunity The letter should be emailed to:

Dionne Godette-Greer, PhD Scientific Program Official Telephone: 404-498-3213 Email: DGodette@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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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:

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf

• 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).

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

CDC requires awardees to submit a Data Management Plan (DMP) prior to the initiation of generating or collecting public health data.

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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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.

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm must be followed along with any additional instructions provided in the NOFO.

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?

4. Include details about data collection. Does data collection occur over the phone, mail, in-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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf 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 variable, 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 participant, 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. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available.