dp15010amendthrepublication.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Interstitial Cystitis Epidemiologic Study, Translation, and Education

RFA-DP-15-010

Application Due Date: 02/24/2015

Interstitial Cystitis Epidemiologic Study, Translation, and Education

RFA-DP-15-010

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 Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Interstitial Cystitis Epidemiologic Study, Translation, and Education Activity Code U01 Cooperative Agreement

AMENDMENT 2: QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES

added to Section VIII. Other Information, Cleared on February 13, 2015

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-010

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.068 Category of Funding Activity:

Health FOA Purpose AMENDMENT 1: Title change, budget, and description changes.

The purpose of this funding opportunity is to support research that will expand on preliminary findings on interstitial cystitis (IC) in the United States and enhance our understanding of the demographic and clinical characteristics of IC, variation in clinical practices, and the impact of the disease. The FOA also includes development of a national surveillance model for IC. The results from this study will provide a better understanding of the epidemiology of the disease and be used to target interventions for groups at high risk for IC and inform best clinical practices.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-010, 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: 01/23/2015

Application Due Date: 02/24/2015

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

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

Scientific Merit Review: 04/01/2015

Secondary Review: 05/01/2015

Estimated Start Date: 09/30/2015

Expiration Date: 02/25/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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

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

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

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

Executive Summary

Purpose. This FOA solicits applications for conducting an epidemiological research study to obtain estimates of the prevalence and incidence of Interstitial Cystitis (IC) in adult populations, and to define the demographic and clinical characteristics of IC and its impact on the health from a population perspective. The FOA also includes development and recommending a model for national surveillance of IC. The results from this study will provide a better understanding of the epidemiology of the disease and be used to improve approaches for gathering information on those affected by IC in order to better target interventions for groups at high risk for IC and to inform best clinical practices.

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

Funds Available and Anticipated Number of Awards. Total funding available for this cooperative agreement is expected to be $ 3,000,000 over the five year project period. It is anticipated that one award will be made to a single recipient for approximately $450,000 in FY 2015.

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

The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. Total estimated funding (direct and indirect) for the first year (12 month budget period) is approximately $450,000 for one award. The total funding expected to be available for the project period will be $3,000,000. The project period will run from September 30, 2015 to September 29, 2020.

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

Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1 are eligible to http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIII1A apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

Number of Applications. Only one application per institution (normally identified by having a unique Data Universal Numbering System [DUNS] number).

Application Type. New Special Date(s). None Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: (770) 488-2783.

This FOA will be posted at http://www.cdc.gov/chronicdisease/about/foa.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

The CDC seeks research to expand knowledge of the incidence (new cases), prevalence (existing cases), and demographic and clinical characteristics of interstitial cystitis (IC) in the general population, the variations in clinical practice, and the impact of the disease. This announcement will build on previous epidemiology studies. The results from this study will provide a better understanding of the epidemiology of the disease and be used to identify groups at high risk for IC and inform best clinical practices.

At least 4 million people in the United States are estimated to have IC based on small clinical patient studies and registries.1 Three to eight million women may be affected2 and one to four million men may be affected.3 Little is know about the burden of IC within geographic or racial groups. However IC has not been extensively measured in the general population; therefore, it is unknown whether these numbers over – or under-estimate the actual IC burden. Estimates of healthcare utilization, diagnosis, and treatment in the US population are also unknown. Therefore, research to find latest IC incidence and prevalence is essential for informing public health practice.

Research Goals and Objectives:

The purpose of the project is to obtain population based estimates of the prevalence and incidence of Interstitial Cystitis (IC) in adult populations, define the demographic and clinical patterns of IC, document its impact on the health of affected persons and adapt and expand current population-based studies to capture an increasingly socio-economically, racially and geographically diverse population.

Historically, two kinds of data have been used to study disease outcomes in IC and the factors associated with these outcomes. These include:

Administrative data collected in insured populations in the course of routine healthcare, and co-opted for outcomes studies; and

1.

More detailed, direct, and occasionally prospective data of health outcomes and risk factors for these2.

http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIII1A http://grants.nih.gov/grants/guide/pa-files/PAR-11-022.html#SectionIV1 http://www.cdc.gov/chronicdisease/about/foa.htm outcomes in cohorts arising from tertiary care centers. This FOA is focused on prospective data collection and the use of direct methods to contact and follow up individuals with IC in order to determine disease outcomes and associated risk factors for these outcomes.

Applications fully responsive to this FOA will incorporate elements of prospective data collection through direct contact with and follow up of individuals with IC to determine disease outcomes and associated risk factors for these outcomes. Such factors may include:

Detailed demographic, socioeconomic, and familial factors;1.

Healthcare resource utilization, including medication use, imaging, pathology, hospitalization and surgery;

2.

Patient-reported outcomes, including generic and health-related quality of life; sexual and reproductive function; work productivity and impairment and disability; outcomes related to specific therapies; and psychosocial factors, including depression; and

3.

Biological determinants of disease that may include genetic, serologic, and other qualitative and quantitative biologic factors that may be predictors of disease outcomes.

4.

The successful applicant is expected to propose an appropriate population-based study that will collect data necessary to achieve the project research goals and objectives. Registries of all new cases or longitudinal cohort studies would be appropriate tools to capture this information. The study is expected to achieve the following research goals:

Conduct a population-based study to describe the incidence, prevalence, demographic and clinical characteristics of persons with IC; assess the impact of the disease; and examine variations in clinical practices in the management of IC

1.

Adapt and expand on results of prior population-based studies to capture an increasingly socio-economically, racially and geographically diverse population.

2.

Conduct feasibility of scaling up the proposed project in order to recommend an IC national surveillance program to gather national prevalence and incidence data, potentially based on utilizing an existing surveillance system.

3.

Scientific Knowledge to be achieved through this Funding Opportunity

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

Prevalence and incidence of IC at a state or regional level.

Impact of the disease on the health of affected persons.

Practice variations in the management of IC.

Impact of various clinical practices on outcome of the disease.

Feasibility of scaling to a national level.

Healthy People 2020 and other National Strategic Priorities

This program addresses the “Healthy People 2020” focus areas of: Access to Health Care Services and Health-Related Quality of Life and Well-Being.www.healthypeople.gov

Division/Center priorities: This program addresses following Division/Center priorities:

Collect, analyze, and disseminate surveillance data to document the burden of IC.

Monitor, prevent, delay, detect, and control chronic diseases.

Collaborate with partners from all sectors of society to increase the reach and effectiveness of public health programs.

Public Health Impact http://www.healthypeople.gov/

The results from this study will provide a better understanding of the epidemiology and treatment of the disease. It will describe risk factors which may be affected by variations in clinical practice. The finding from this study will contribute to advancing our understanding of the epidemiology of IC in the United States. Further, the study findings will be used to target interventions for groups at high risk for IC, inform best clinical practices, and explore new approaches to improve the availability of data on those affected by

IC.

Relevant Work

2. Approach

The approach is expected to include a plan that:

Defines the geographic population to determine the estimated population prevalence of IC in that population. IC patients must be selected from multiple clinical sources to help provide diversity in treatment outcomes and to achieve a sufficient sample size with patient diversity.

Specifies a process for developing the protocol, methods, and quality assurance to be used for this study that includes an Advisory Committee.

Identifies the data to be collected and methodology.

Specifies how the study would be implemented, including plans for acquiring the needed data, the number and type of project staff that would be involved, and potential barriers (e.g., IRB, patient consent, resistance/inability of primary care and other providers to share needed data) to be addressed.

Objectives/Outcomes

Using a population-based approach in population area that is large enough to capture a sufficient sample size (large city, metropolitan area, region, state, etc.), the objectives of this research program are:

I. Establish an advisory or multidisciplinary workgroup

a) Create a multidisciplinary workgroup of 10 or more expert IC partners, collaborators, and stakeholders with clinical, research, academic and public health backgrounds to define research activities and provide expert assistance to implement work plan activities.

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

II. Design study for prevalence/characteristics

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

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

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

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

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

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

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

h) Describe stakeholder engagement in the research activities.

III. Develop and recommend a national survey program

a) Using evidence-based strategies, develop and recommend a model national surveillance program for IC to gather national prevalence and incidence data.

IV. Disseminate findings

a) Establish a dissemination plan for study findings targeting professional and general audiences through journal articles, fact sheets, conference presentations and training programs.

b) Describe the role of the multidisciplinary workgroup and other external partners in the dissemination and translation of the research findings.

V. Evaluate project activities and report on findings

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

I. A logic model, II. Broad goals, objectives, and activities that are Specific, Measurable, Achievable, Realistic, and Time-limited (SMART), III. A description of mechanisms for engaging stakeholders in evaluation activities, IV. Key local-level or activity-specific evaluation questions, V. Evaluation methods, and VI. A description of how evaluation results are intended to be used to overcome any barriers identified and improving efficiencies

b) Identify and describe participating clinical/research sites and their roles/responsibilities in the evaluation.

Target Population

The target population is a large US-based, population area (e.g., large city, metropolitan area, region, state, etc.) that is large enough to capture a sufficient adult sample size of people of all ages with IC.

Population-based is defined as a general population delineated by geopolitical boundaries, e.g., state or region. Diversity of the selected population with sufficient study sample size will augment the ability to determine racial/ethnic-specific prevalence and incidence rates.

Collaboration/Partnerships

In order to target a population area that is large enough to capture a sufficient adult sample size (large city, metropolitan area, region, state, etc.), collaboration or partnerships will be needed. Partners or collaborators will help provide access to the required data (both existing and follow-up data), and to those individuals with the requisite expertise in lC, data management, and longitudinal data analysis needed to achieve the objectives of this FOA. Collaboration/partnerships with other funding sources may promote achievement of the core objectives of the FOA more quickly. Applicants are expected to recruit and partner with IC experts and hospital systems to effectively develop and implement work plan activities. Recruitment of 10 or more members for an IC advisory group to help guide research activities and inform development of recommended actions for a national surveillance program for IC to gather national prevalence and incidence data perhaps by utilizing a new or an existing surveillance system is expected.

Evaluation/Performance Measurement

The applicant is expected to monitor and document the success of the various stages of follow-up activities, monitor and document the quantity and quality of the follow-up data obtained, and identify and quantify any gaps in these measures. The evaluation plan should include:

I. A logic model, II. Broad goals, objectives, and activities that are Specific, Measurable, Achievable, Realistic, and Time-limited (SMART), III. A description of mechanisms for engaging stakeholders in evaluation activities, IV. Key local-level or activity-specific evaluation questions, and V. Evaluation methods Budget MUST include up to 10% of requested funding for evaluation of activities on yearly basis.

Letters of commitment from partners and/or collaborating sites with specifics of technical expertise volunteered are expected.

Translation Plan

A detailed dissemination plan that demonstrates how data and information collected will serve as a resource to key public health practitioners, academic researchers, governmental agencies, private organizations, and the public is expected. Describe how target population will be identified and activities to increase education and awareness about the study findings particularly effective strategies to increase IC awareness in general population, targeted subgroups and health care providers. The plan for dissemination and translation of research findings should be developed with input from the multidisciplinary advisory workgroup and other external partners. The plan should also include a variety of approaches for increasing IC education and awareness (website, webinars, an electronic chart book, conference presentations, reports/ fact sheets, and manuscripts submitted to peer-reviewed journals). It is estimated that at least two scientific or professional products should be developed and disseminated each year. At least one peer reviewed scientific product should be developed and published every year.

OMB/PRA may apply.

References:

Interstitial Cystitis Association retrieved at: http://www.ichelp.org/page.aspx?pid=9171.

Sandra H. Berry, Marc N. Elliott, Marika Suttorp, Laura M. Bogart, Michael A. Stoto, Paul Eggers , Leroy Nyberg, J. Quentin Clemens. Prevalence of Symptoms of Bladder Pain Syndrome/Interstitial Cystitis among Adult Females in the United States. The Journal of Urology, 186 (2011), pp. 540-544.

2.

J.Q. Clemens, C.L. Link, P.W. Eggers, et al. Prevalence of painful bladder symptoms and effect on quality of life in black, Hispanic and white men and women. The Journal of Urology, 177 (2007), p. 1390.

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:

http://www.ichelp.org/page.aspx?pid=917 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452 http://www.sciencedirect.com/science/article/pii/S0022534711035452

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

Estimated Total Funding: $3,000,000

Anticipated Number of Awards: 1

Total estimated funding (direct and indirect) for the first year (12 month budget period) is $450,000 for one award.

Estimated total funding for the entire five year project (09/30/2015 to 09/29/2020) will be $3,000,000 (direct and indirect).

Applications with budget requests greater than the ceiling will be considered non-responsive and will not be reviewed. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

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

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

Award Ceiling: $600,000 Per Budget Period Award Floor: $300,000 Per Budget Period Total Project Period Length: 5 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

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:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

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

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

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

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Eligible applicants must meet the following criteria:

A. Access to a large diverse U.S. patient population (for example one which includes a variety of race/ethnic groups) with IC and/or related conditions.

B. The research team must have experience in conducting and analyzing population based research as well as clinically oriented research on IC and/or related conditions.

4. Justification for Less than Maximum Competition

N/A

5. Responsiveness

A. Access to a large diverse U.S. patient population (for example one which includes a variety of race/ethnic groups) with IC or related conditions, as evidenced by letters of commitment or other documents granting access from source controlling access to the patient population. Patient population characteristics, including race/ethnicity, should be included in the letter(s)

B. Experience in conducting and analyzing population based research as well as clinically oriented research on IC and/or related conditions must be demonstrated by publications or reports of such research as evidenced in the Research & Related Senior/Key Person Section of the SF424(R&R).

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

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

Additionally, all applicant organizations must register in the System for Award Management (SAM).

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

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

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/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

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

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

2. Content and Form of Application Submission http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.Grants.gov mailto:pgotim@cdc.gov

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

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

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 01/23/2015

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

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

Name of the applicant Institution Descriptive title of the proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel and institutional affiliations Other participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Michael A. Brown, M.P.H.

Scientific Program Official Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Hwy, NE Mailstop F-80 Atlanta, GA 30341 Telephone: (770) 488-5118 E-mail: mab5@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

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

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

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

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

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

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

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

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

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan:

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

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

1.

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

2.

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

3.

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

4.

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

5.

Describe access to existing and new data sources and patient populations with IC. Include any letters of support defining access to the data source and/or population.

6.

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

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

8.

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

9.

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

10.

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

11.

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

12.

Describe the existing or new data sources that will be used in the proposed research activities.

Include any descriptions or reports from existing data that describe the incidence, prevalence, or other descriptors of persons with IC disease for the state or region under study.

13.

Describe the project team’s expertise, including:14.

a. Leadership in coordinating a network of IC researchers in studies of IC epidemiology and surveillance;

b. Subject matter expertise in designing epidemiologic studies, case definitions, disease registries, and surveillance systems relating to IC; and

c. Track record of coordinating efforts which have led to publication of studies in major peer reviewed journals.

Describe the partnership’s or collaborator’s expertise, including:15.

a. Role in supporting research activities proposed by the applicant

b. Partner or collaborator’s subject matter expertise in designing epidemiologic studies, case definitions, disease registries, and surveillance systems relating to IC, and

c. Track record of supporting or coordinating similar research efforts which have led to publication of studies in scientific journals.

Describe plan to participate in monthly program monitoring, technical assistance (TA) calls, and providing information as requested by CDC.

16.

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

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

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

c. Provide evaluation plan on monitoring outcomes of proposed activities

17. Identify and describe the proposed study population. Include demographic and other characteristics of the population and describe how this population will enable the calculation of population-based rates. Also provide the case definition or other defined approach to identifying IC.

18. Budget MUST include up to 10% of requested funding for evaluation of activities on yearly basis.

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

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

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

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

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

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/ be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

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

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

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

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

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

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

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status…