Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Expansion of the MAPP Research Network (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-13-025

Companion Funding Opportunity

RFA-DK-13-507, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.847

Funding Opportunity Purpose

The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network (www.mappnetwork.org conducts multi-center studies of urologic chronic pelvic pain syndromes (UCPPS) commonly known as interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The goal of the MAPP Research Network is to provide new insights into underlying etiology, natural history, and risk factors in order to provide a translational foundation to facilitate future clinical intervention efforts and improve clinical management for the syndromes. The MAPP Research Network is currently comprised of six Discovery Sites, a Data Coordination Core (DCC), and a Tissue and Technology Core (TATC). In a second project period, the MAPP Research Network will continue analyses of clinical data and assays of biological samples collected in the first project period and develop and implement a second phase of collaborative protocols. Another goal will be to generate a resource of clinical data and biological samples for sharing with the community in support of future studies designed to further advance discovery in this area. The purpose of this Funding Opportunity Announcement (FOA) is to expand the MAPP Research Network by adding new Discovery Sites.

Key Dates
Posted Date

August 23, 2013

Open Date (Earliest Submission Date)

October 27, 2013

Letter of Intent Due Date(s)

October 27, 2013

Application Due Date(s)

November 27, 2013, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

November 27, 2013

Scientific Merit Review

February/March, 2014

Advisory Council Review

May, 2014

Earliest Start Date

July, 2014

Expiration Date

November 28, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
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 2. Full Text of Announcement


Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) will provide funds to support the addition of new Discovery Sites to the current Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network to augment current expertise and enhance scientific efforts in key areas, including studies of molecular markers, assessments of potential contributions of microorganisms and infectious agents, and neurobiology/neuroimaging.

The MAPP Research Network (www.mappnetwork.org) is a multi-center research group that conducts studies of urologic chronic pelvic pain syndromes (UCPPS), a term used by the network to encompass interstitial cystitis/bladder pain syndrome (IC/BPS) and chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). The goal of the MAPP Research Network is to provide new insights into underlying etiology, natural history, and risk factors for UCPPS in order to provide a translational foundation to inform future clinical intervention efforts and improve clinical management. The MAPP Research Network was initiated under a cooperative agreement in 2008 for a five year funding period and is comprised of six Discovery Sites, a Data Coordination Core (DCC), and a Tissue and Technology Core (TATC). The principal research effort conducted by the MAPP Research Network is a prospective, epidemiological study of male and female UCPPS patients and controls to assess a wide range of urologic and non-urologic patient-reported measures (the Trans-MAPP Epidemiology/Phenotyping Study [Trans-MAPP EPS]) and integrated assessments of disease biomarkers, central nervous system structure/function, potential contributions of infectious agents, symptom variation (i.e., flare), and contributions of co-morbid non urologic pain syndromes, as well as initial efforts to develop new patient reported outcome measures. A number of other focused studies, including use of relevant animal models to study potential pathophysiology, are also being conducted. To date the network has recruited over a thousand study participants who are undergoing extensive phenotypic characterization as part of these multiple, integrated network protocols. Clinical data generated by the MAPP Research Network is centrally stored, managed and analyzed by the DCC and biological samples collected at the Discovery Sites are centrally stored and managed at the TATC.

MAPP Research Network Goals and Objectives

The goal of the MAPP Research Network is to advance our understanding of disease phenotypes; underlying pathophysiology; treated natural history; and biologic, genetic, and behavioral risk factors for UCPPS (i.e. IC/BPS and CP/CPPS). An important objective of this program is to better understand the biologic and behavioral relationships between UCPPS and co-morbid non urologic pain syndromes. Co-morbid pain syndromes of primary interest are fibromyalgia, irritable bowel syndrome, chronic fatigue syndrome, vulvodynia, and migraine headache. The MAPP Research Network undertakes multidisciplinary, multi-site, and highly interactive basic, translational, and clinical science research that utilizes new and novel approaches to investigate questions of significant clinical relevance. These efforts are expected to provide findings useful for designing future clinical studies of disease prevention and/or treatment. UCPPS is considered a systemic disorder that extends beyond the lower urinary tract (LUT). MAPP Network studies primarily focus on clinical phenotyping of patients and the use of human study materials (e.g. biological specimens). Another goal of the MAPP Network is to generate a resource of clinical data and biological samples for sharing with the community in support of future studies designed to further advance discovery in this area.

The current six Discovery Sites and two shared Core Sites (the DCC and TATC) will be supported for a second project period through RFA-DK-13-507, "Limited Competition of the MAPP Research Network". New Discovery Sites invited through the present FOA will be integrated into the MAPP Research Network and participate in collaborative scientific efforts with the current sites in the network's second project period. While the specific scientific interests of each MAPP Research Network site may differ, they all must demonstrate a dedication to the study of UCPPS as a central focus.

All proposed clinical studies in the second funding period of the MAPP Research Network will be Trans-MAPP (i.e., collaborative across most/all sites and using common participants and/or biological samples) and integrated into a central longitudinal phenotyping study, the UCPPS Symptoms Patterns Study.  This effort will be designed to identify factors associated with - and potentially predictive of – symptom change and may involve in clinic, web-based, and/or device-based methods to characterize symptom variation and associated clinical features, risk, predictors, and physiological changes over time using diverse measures, methods, and approaches. The UCPPS Symptoms Patterns Study will also provide a platform for standardized recruitment and core phenotyping and for integrating more specified patient phenotyping through associated, collaborative protocols (for a complete list of MAPP Research Network scientific priorities for the second funding period see RFA-DK-13-507). Integrated basic cellular, molecular, and biochemical studies addressing the underlying pathology and mechanisms of UCPPS using established in vitro methods will be supported primarily through NIH Funding Opportunity Announcement RFA-DK-13-501, “Limited Competition of the MAPP Research Network Data Coordinating Core (U01),” and through other future, integrated awards (e.g., ancillary study awards and investigator-initiated R01s).

The MAPP Research Network fosters collaborations between network investigators within each site; across the network; and through numerous, more specialized/focused working groups. The MAPP Research Network is intended to be flexible and to rapidly integrate evolving information in the design of studies. It is anticipated some research efforts newly initiated in the second project period will conclude and be replaced by to be defined studies that extend upon scientific insights. Network investigators will collectively prioritize final studies from those proposed and design final Trans-MAPP protocols. It is anticipated that not all proposed studies will be prioritized for immediate implementation, but might be performed in later stages of the second funding period. Patient data and samples collected in all efforts will be shared between all network sites and studies.

Scientific Priorities for New Discovery Sites

Highest priority research areas for new Discovery Sites include studies of UCPPS patients and/or patient-derived biological samples to identify and characterize molecular markers, assess potential contributions of microorganisms and infectious agents, and examine neurobiology structure-function (as outlined below). Research studies are not necessarily limited to these topics, although these areas will receive priority. Applicants must describe multiple Specific Aims to address these priorities. All studies should enhance network efforts to assess UCPPS symptom variation and will be integrated into the Trans-MAPP UCPPS Symptom Patterns Study.

Highest priority research areas:  

The scope of scientific efforts proposed for new Discovery Sites should be appropriate for the award level, which will be less than the current Discovery Sites. It is, therefore, expected that Discovery Sites invited through this FOA will propose more focused efforts to augment select scientific priorities in the MAPP Network. The inclusion of patient/control recruitment strategies, while allowable, is not necessarily required (for example if the focus of the site is examination of biological samples).

All proposed scientific studies must be Trans-MAPP in design, though some variation in scientific approaches at various participating sites is acceptable. Applicants are encouraged to consider diverse, novel strategies in the development of study concepts. Studies that bring new ideas and approaches and incorporate insights from the MAPP Research Network or from the general scientific community are highly encouraged in an effort to integrate diverse phenotyping information into a systemic characterization of UCPPS. Clinical trials or other clinical intervention/treatment studies are not within the scope of this FOA.

As part of the application, Discovery Sites should describe robust and supporting preliminary data in research area(s) relevant to the overall goals of the MAPP Research Network; previous productive collaboration in broad, multi-site research efforts; and previous productive interactions with common core resources. All new Discovery Sites will be integrated into broad MAPP Research Network efforts and will operate according to MAPP Network policies.

An information teleconference for potential applicants will be conducted by the NIDDK on September 18th at 1:00pm (Eastern Time).

Administration and Meetings

A MAPP Research Network Steering Committee will be composed of Discovery Site and Core Site Directors and NIDDK Program Staff. The Steering Committee will meet regularly in-person and by telephone conference calls as a whole and in sub-working groups to develop and implement MAPP Research Network study protocols, review progress of individual projects, discuss results, interpret findings, and develop manuscripts for peer reviewed publications. The Steering Committee Chairman will lead an Executive Committee that will be comprised of the Chairman of the Steering Committee, representatives from the Core Sites, NIDDK staff, and additional MAPP Research Network investigators and support personnel, as needed. The Executive Committee will make operational decisions for the MAPP Research Network between Steering Committee meetings by means of telephone conference calls.

The NIDDK will assist the Steering Committee in the development of MAPP Research Network study protocols; will monitor the progress of projects and functioning of all network activities; will assist investigators in the analysis and interpretation of MAPP Network data; and will aid in preparation of manuscripts for publication.

The NIDDK will continue to utilize the External Experts Panel (EEP) established during the first project period of the MAPP Network to monitor research efforts and advise the Institute on the progress of network studies.  Discovery Site and Core Site applicants should not suggest potential participants for the EEP in their applications.   

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIDDK intends to commit up to $700,000 Total Costs in Fiscal Year 2014 to support 2-3 new MAPP Research Network Discovery Sites through this FOA.

Award Budget

Applications for new Discovery Sites may request budgets up to $250,000 in Total Costs per year.  

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Current MAPP Research Network grantee organizations and new grantee organizations are eligible to apply for new Discovery Sites, though personnel may only be named on one application. Grantee organizations with current MAPP Network Sites may not propose scientifically overlapping applications or duplicative personnel for new Discovery Site applications. Discovery Sites should include appropriate basic, translational, and clinical expertise aligning with the proposed research studies. Discovery Sites must include clinical urology expertise in a senior role.  Discovery Sites proposing patient recruitment must name clinical research expertise that includes a proven track record of patient recruitment for UCPPS and at least one health care professional (e.g., clinician, advanced practice nurse, physician's assistant, or psychologist) whose primary responsibility is direct patient care of UCPPS patients. Discovery Sites may utilize the Multiple Program Director/Principal Investigator (i.e. Multi-PD/PI) concept (see NOT-OD-06-036) to establish a collaborative team of two Program Directors/Principal Investigators who will serve as Co-Directors. 

Because all relevant expertise may not be present at a single institution investigators may establish a multi-disciplinary team through collaborations with researchers outside their own institution. It is highly recommended that Discovery Sites centralize recruitment efforts and studies directly assessing patients to a single geographical location (e.g., the same institution or institutions within the same city). If Discovery Sites propose collaborations involving recruitment and/or patient phenotyping at sub-sites the need for the sub-site must be highly justified and a description of the sub-site’s ability to recruit and participate in all phenotyping assessments must be included. Collaborations with sub-sites that do not directly phenotype participants but provide specialized analyses of data or biological samples collected are permitted. Such arrangements must be highly justified and add important additional scientific capability to the network.

Investigators from diverse fields and those who have not been traditionally involved in studies of UCPPS, but who have expertise in relevant disciplines, are strongly encouraged to apply as Discovery Site Directors or as other key personnel in the study.  MAPP Research Network Sites are encouraged to include in their grant application the involvement of junior faculty and new investigators both in urological sciences and in related fields of study. Investigators may not be listed as participants in more than one application.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC 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:

The letter of intent, preferably electronic, should be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752, MSC 5452
Bethesda, MD 20892-5452
(express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
E-mail: FC15Y@NIH.GOV  

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions:

Discovery Sites must describe the roles and responsibilities of senior/key personnel, including in relation to the individual Specific Aims. Sites should note the relevant basic and/or translational expertise and for sites proposing participant recruitment, the health care expertise in the direct care of UCPPS patients. A plan for how these site investigators will interact through regular site meetings should be noted. 

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the additional instructions:

Discovery Sites must provide a detailed budget to allow for determination of respective funding for each proposed Specific Aim.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit electronic applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, this must be stated in Section VI.1.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post-Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

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

Is the central focus of the proposed studies urologic chronic pelvic pain syndromes (UCPPS) (i.e., interstitial cystitis /painful bladder syndrome [IC/BPS] and/or chronic prostatitis/chronic pelvic pain syndrome [CP/CPPS])? If successful, would the study provide new and significant insights into the pathophysiology and natural history of UCPPS, as well as co-morbid non-urologic pain syndromes in men and women? Does the study have potential to inform on symptom variation and associated phenotypic factors? Does the study have the potential to provide insights with the potential to lead to the development of future clinical prevention and therapeutic interventions and ultimately improve clinical management? Are studies designed to address questions of important clinical relevance? Will the proposed studies provide new and significant insights into UCPPS molecular markers, contributions of infectious agents/the microbiome, and neurobiology structure-function and augment existing MAPP Network scientific capabilities?

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Is appropriate research and clinical expertise represented at the Discovery site and its collaborating institutions (if any)? Do the proposed Discovery Site Director(s) and other listed key personnel have strong research and/or clinical experience and expertise with a track record of important contributions in the area of UCPPS or other relevant fields? Is a strategy in place to integrate investigators from relevant scientific disciplines, including those who may not have been traditionally involved in the study of UCPPS? Is a plan in place to allow regular meetings of funded researchers and staff at the respective Discovery Site in order to address administrative and scientific issues, progress, and planning? Does the applicant(s) describe the integration of promising new or junior investigators? Is clinical urology expertise represented within the Discovery Site either as a Director or in another senior role? Is appropriate, relevant basic or translational science expertise included? Is one or more health care professional (e.g., clinician, advanced practice nurse, physician's assistant, or psychologist) whose primary responsibility is direct care of UCPPS patients included for any new Discovery Site proposing patient recruitment?  

Innovation

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

Does the application address the MAPP Network research priorities through novel, multi-disciplinary approaches? Does the proposed scientific plan, if successful, have the potential to significantly increase and enhance our foundation of knowledge of UCPPS and offer insights that can be directly incorporated into the design of clinical efforts and testing of potential therapies to prevent or treat relevant disorders?

Approach

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

If the project involves humans subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children justified in terms of the scientific goals and research strategy proposed?

Do Discovery Sites address a high priority research area: UCPPS molecular markers, contributions of infectious agents/the microbiome, and neurobiology structure-function? If areas of investigation beyond these general priorities are proposed do they address the overall goals of the MAPP Network? Do Discovery Sites present robust and supporting preliminary data relevant to the study(s) proposed and the overall goal of the MAPP Network; have a track-record of productivity and cooperation within a broad, multi-site research effort; and have a track-record of productive interactions with common core resources? Are all proposed studies collaborative, multi-site (i.e., Trans-MAPP) in design or potential? Are all proposed studies appropriate for integration into a central prospective clinical phenotyping study (i.e., the UCPPS Symptom Patterns Study) and will they inform on questions of UCPPS symptom variation? Does the research design integrate use of the common MAPP Network Core resources? Do new Discovery Sites proposing recruitment have a demonstrated ability to recruit, retain, and phenotype male and female UCPPS patients and control cohorts in the context of a prospective phenotyping protocol?

Environment

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

Additional Review Criteria

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

Proposed plan for collaboration for all MAPP Network Discovery Sites: Is a suitable plan in place for integration, communication, resource and data sharing, and collaboration between investigators within a Discovery Site and between the Discovery Site and its collaborating institutions (if any)? Does the Discovery Site have a stated commitment to multi-site integration, communication, sharing, and collaboration with other MAPP Network Discovery Sites and the MAPP Network Cores? How will the researchers with diverse expertise cooperate in conducting Discovery Site scientific efforts? Is there language in the application indicating willingness to share data and resources within the MAPP Research Network and ultimately provide relevant materials to the NIDDK Data and Biorepositories?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information, see the Human Subjects Inclusion Guidelines .

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Reviewers will assess whether the study presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NDDK Advisory Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.

2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Awardee(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Awardees will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.

3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.

4. Implementing collection of data specified by the study protocol. For a multi-center study, each awardee/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.

5. Establishing procedures for data quality and completeness. Awardees are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.

6. Submitting interim progress reports, when requested, to the NIDDK Program Director including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Director may require additional information from individual awardees/sites. Such reports are in addition to the required annual noncompeting continuation progress report.

7. Establishing procedures, where applicable, for all participating institutions in coordinated awards to comply with FDA regulations for studies involving investigational agents or devices and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects, and the NIH policy requirements for the inclusion of women, minorities and children.

8. Reporting of the study findings. Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. The awardee must also be adherent to Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with awardees consistent with NIH and study policies.

9. Involving third parties in the study. This could entail involvement of industry or other entities as participants, sharing resources, providing access to results such as primary data or summaries.  However, except for licensing of patents or copyrights, support or involvement of any third party is permitted only after concurrence by NIDDK.

10. Publishing and releasing publicly and disseminating results and other products of the study, in accordance with study protocols and steering committee policies on publications.

11. Maintaining confidentiality of information: The awardee(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of a company collaborating with the study.

12. Coordinating with the NIDDK's Central Biosample, Genetic, and Data Repositories to prepare the collected data and samples for eventual archiving and distribution.  In addition, if applicable, the PI or his/her designee will work with the NIDDK Biosample Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository. All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the study’s Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time. Subsequently samples and data will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/  and,

http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#goals , and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

13. Registering the study with clinicaltrials.gov if necessary. The Food and Drug Administration Amendments Act of 2007 (FDAAA or US Public Law 110-85) was passed on September 27, 2007. The law requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. If trials conducted under this grant are applicable clinical trials subject to FDAAA, the sponsor or his/her designee will perform the mandatory study registration and reporting of study results to ClinicalTrials.gov. For more information about this law and requirements for sponsors and/or investigators, visit the PRS and U.S. Public Law 110-85 Information Page at http://prsinfo.clinicaltrials.gov/fdaaa.html. In addition, grantees should be aware that clinical trials not covered by FDAAA may still require registration in an approved registry in order to be published, according to the guidelines issued by the International Committee of Medical Journal Editors (http://www.icmje.org/publishing_10register.html).

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

An NIDDK Project Scientist with substantial involvement will:

1. Serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist or designee will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

4. Have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:

a. Provide advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.

b. The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.

c. Review procedures for assessing data quality and study performance monitoring.

d. The NIDDK Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

The NIDDK Program Official identified in the Notice of Award will:

1. Interact with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

2. Review and approve study protocols prior to implementation.

3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) patient safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.

4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

5. Appoint a Data and Safety Monitoring Board (DSMB) as appropriate; the NIDDK Program Official or their designee will serve as the Executive Secretary and/or NIDDK program representative on the DSMB.

Areas of Joint Responsibility:

In addition to the interactions defined above, NIDDK Project Scientist and Awardees shall share responsibility for the following activities:

1. Steering Committee.

A Steering Committee organized by the study investigator(s) will be the main governing body of the study.

The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among awardees, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official, and will provide periodic supplementary reports upon request.

The Steering Committee will be composed of all Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.

A Chairperson of the Steering Committee, other than the NIDDK Project Scientist, will be selected by the NIDDK. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings, representing the study group to the External Oversight

Committee established by the NIDDK (see item D2 below) and by interacting closely with the awardees during protocol development and implementation.

2. External Study Oversight.

An independent Data and Safety Monitoring Board will be established by the NIDDK for Phase III clinical trials or other high risk studies as appropriate. An Observational Study Monitoring Board (OSMB) will be established for observational/epidemiologic studies. These Boards will review study progress, safety data and interim results, as appropriate, and provide guidance to the NIDDK.

Dispute Resolution

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the awardee (or the Steering Committee, with the NIDDK member not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Chris Mullins, Ph.D.
Director of Basic Cell Biology Programs
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4902
FAX: 301-480-3510
E-Mail: mullinsC@mail.nih.gov

Peer Review Contact(s)

Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
E-mail: FC15Y@NIH.GOV

Financial/Grants Management Contact(s)

Ms. Pamela Love
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6198
Email: lovepa@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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