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

Nociceptive GenitoUrinary Development Molecular Anatomy Projects (nGUDMAP)  (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of RFA-DK-11-001

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-024

Companion Funding Opportunity

None

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 purpose of this Funding Opportunity Announcement (FOA) is to seek applications for Research Projects and Atlas Assembly Projects that will build a murine molecular anatomy atlas of the nociceptors (pain receptors) and associated cell types in pain processing of the urinary tract and the pelvic region. It is anticipated that the detailed description of the developmental origins, and the anatomical and biochemical heterogeneity of the murine nociceptors (pain receptors) and associated cells, will lay a foundation to support the long-term goal of developing new therapies for urologic chronic pelvic pain syndromes (UCPPS), traditionally referred to as Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). The successful applications for this FOA will be considered part of the continuing GUDMAP effort supported by RFA-DK-11-001 and RFA-DK-10-005.

Key Dates
Posted Date

November 26, 2012

Open Date (Earliest Submission Date)

February 14, 2013

Letter of Intent Due Date(s)

February 14, 2013

Application Due Date(s)

March 14, 2013, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June-July 2013

Advisory Council Review

October, 2013

Earliest Start Date

December, 2013

Expiration Date

March 15, 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

Background

The perception of chronic pain in the region of the pelvis or urogenital floor is a defining feature of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). The bladder has been suggested as the origin of IC/PBS symptoms, while the prostate gland has traditionally been believed to be the source of CP/CPPS symptoms, no pathognomonic pathology has been conclusively identified for either disorder. Diagnosis of IC/PBS and CP/CPPS is based solely on patient-reported symptoms due to the absence of identifiable and correlative pathological findings or defined disease markers. Each syndrome might, in fact, represent a group of related conditions with differing etiologies. Based on their similar symptom profile, IC/PBS and CP/CPPS are here collectively termed urologic chronic pelvic pain syndromes (UCPPS). Despite intense study, the underlying etiology and pathophysiology of disease, as well as risk factors for development of disease, remain unclear and no generally effective clinical therapeutics exist for UCPPS patients.

The impact and burden of UCPPS to patients is enormous. UCPPS patients suffer considerable morbidity throughout their lives, resulting in a significant decrease in quality of life for both the patient and his/her partner due to the physical and physiological impact. Epidemiological data for UCPPS prevalence varies substantially based on method of collection. Recent studies from medical records and physician billings produce estimates of IC/PBS prevalence in the range of 67 to 865 per 100,000 adult women while studies based on self-reported IC/PBS symptoms show rates ranging from 1 percent to 6 percent of women and rates among men roughly ½ as great. However, prevalence estimates vary significantly based on definitions used in various studies. Overall patient spending in 2000 for the diagnosis and management of IC/PBS and CP/CPPS (along with prostatitis of a known bacterial origin) exclusive of pharmaceuticals was estimated as $66 million and $84 million, respectively.

To address these debilitating and burdensome disorders, the NIDDK developed and supported a number of clinical and epidemiological studies of UCPPS. These include the Interstitial Cystitis Database Study (ICDB), the Interstitial Cystitis Clinical Research Network (ICCRN), the Boston Area Community Health (BACH) Survey, the Rand IC Epidemiology (RICE) Study, the Chronic Prostatitis Clinical Research Network (CPCRN), and the Chronic Prostatitis Clinical Data Base. In addition, the NIDDK has funded many basic research studies focusing on the biology of the bladder and prostate in an attempt to better understand the underlying pathological basis of UCPPS. Despite these efforts much remains unknown regarding the underlying disease etiology and the natural history of disease. The current NIDDK-supported Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network is designed to address these long standing questions through a new integrated, multi-disciplinary approach. The MAPP network, however, does not include a focus on fine cellular and molecular characterizations of the pelvic neuroanatomy during development or maturation of the nociceptive systems.

A central characteristic of UCPPS is the perception of chronic pain in the lower urinary tract and the pelvic region. The absence of basic knowledge of pain pathogenesis and the organs involved has made it difficult to establish useful experimental in vivo or in silico models that can lead to testable hypotheses and be used to guide human UCPPS studies or develop therapies. To address this gap, this FOA seeks applications that will either generate comprehensive expression datasets or direct the assembly of these datasets to build a molecular anatomy atlas of nociceptive systems, primarily the nociceptors (pain receptors) and associated cell types within the urinary tract and the pelvic region. The long term goal of this FOA is to provide the research community fundamental knowledge of nociceptors and associated cell types necessary to develop strategies to reduce nociceptor activity or block their input to the CNS in order to attenuate or relieve the sensation of pain.

GUDMAP

The research groups of the Genitourinary Developmental Molecular Anatomy Project GUDMAP consortium are charged with the task of producing a high-quality molecular anatomy of the mammalian urogenital tract (UGT) through development and maturation. There are three components to GUDMAP; all of these are intended to provide resources that support research on the kidney and UGT. The first provides ontology of the cell types during UGT development and the molecular hallmarks of those cells as discerned by a variety of procedures, including in situ hybridization, transcriptional profiling, and immunostaining. The second generates novel mouse strains. In these strains, cell types of particular interest within an organ are labeled through the introduction of a specific marker into the context of a gene that exhibits appropriate cell type or structure-specific expression. In addition, the targeting construct enables genetic manipulation within the cell of interest in many of the strains. Finally, the information is annotated, collated, and promptly released at regular intervals, before publication, through a database that is accessed through a Web portal.

Nociceptive GUDMAP

nGUDMAP will use a GUDMAP approach to provide a comprehensive understanding of how nociceptive systems develop in the embryo and mature in the adult, as such nGUDMAP is focused on discover science and not hypothesis testing. Although it is conventional to categorize nociceptors according to the properties of the axons associated with them, this does not provide the granularity need for detailed cellular or molecular work. Studies reveal that nociceptors represent a heterogeneous class of neurons made up of overlapping subpopulations that can be categorized by their anatomy, biochemistry and physiology, and by function. There is also evidence that subpopulations of visceral nociceptors underlie different types of visceral pain such as hypersensitivity to organ filling, acidic or burning pain, bloating and gas sensations. The degree of heterogeneity among nociceptive afferents probably contributed to difficulties in identifying new therapeutic agents. It has also probably contributed to several of the most notable failures of preclinical data to translate to an effective clinical intervention (for example, substance P receptor antagonists as analgesics). Successful development of cell therapies to reduce nociceptor activity or block their input to the CNS will require knowledge of the catalog of subpopulations of nociceptor for each organ; the genes that mark these cells, as well as those that are required for their function; the regulatory factors that induce or maintain the various cell types; and the developmental and anatomic relationships of each cell type to its neighbor.

nGUDMAP will be composed of Research Projects and an Atlas Assembly Project which will work together and with the GUDMAP Website/Database Center and currently funded GUDMAP Atlas Projects as a consortium. Because the GUDMAP consortium is designed to serve as a resource to the research community, all of these components are expected to be well integrated, coordinated, and materials freely shared beyond the consortium members. All applicants for this FOA are expected to indicate their willingness to participate as active members of the GUDMAP consortium (see Cooperative Agreement Terms and Conditions of Award) and to work together to establish database vocabularies, annotation criteria, and to provide feedback regarding the utility of the GUDMAP database and the ease of use of the GUDMAP website. Applicants are also expected to indicate their willingness to distribute research tools to the wider community, including probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents, and to describe their willingness to submit data generated through this project to the GUDMAP database prior to publications. It is expected that data will be released to the database as soon as they are validated (see Special Instructions under Research Plan).

nGUDMAP Research Projects

nGUDMAP Research Projects will focus on generating comprehensive expression datasets that will be used to define the molecular anatomy of the murine embryonic origin and the development and maturation (including adults) of nociceptive systems of the urinary tract and pelvic region. Given the heterogeneity of nociceptors, it is expected that no single project can develop a low resolution gene expression atlas of all genes expressed in the nociceptors within the urinary tract and pelvic region nor perform high resolution anatomic gene expression studies for all nociceptors.  Rather, it is expected that individual projects will propose well-planned studies using defined sets of parameters. Because the goal of this FOA is to establish a nociceptive molecular anatomy atlas and the limitations of the funding period, studies utilizing murine pain models would only be responsive if they are highly reproducible at the cellular level and involved well-defined probe sets. Examples of the types of projects that may be supported include, but are not limited to:

This FOA will also support nGUDMAP Research Projects for the development of novel tools to support the molecular anatomy studies of the nociceptive system (e.g., tools to trace conductivity of nociceptive neurons), with the understanding that they are expected to be rapidly shared, prior to publication, with the general research community.

Atlas Assembly Project

The Atlas Assembly Project will work closely with the nGUDMAP Research Projects and with the parent GUDMAP consortium to build the murine molecular anatomy atlas of the nociceptive systems of the urinary tract and pelvic region. It is expected that the successful application for the Atlas Assembly Project will lead to the development and monitoring of the ontology to ensure the global integrity of the nociceptors and associated cells with components of the urogenital tract; develop strategies for visual presentation of nociceptors and associated cells, e.g., 3-D rendering; develop nociceptive atlas tutorials based on newly generated datasets; and ensure the utility and easily accessibility of the nGUDMAP datasets for the entire research community.

Applicants should propose either a Research Project or an Atlas Assembly Project in their application and indicate clearly which activity is being proposed. Because these are distinct research activities, investigators interested in both project types should submit two separate applications.  Combined applications for a Research Project and an Atlas Assembly Project will not be accepted.

During the course of the funding period, technologies will improve, and the rate of progress and focus of work supported by the cooperative agreement might change. It is expected that the Program Director(s)/Principal Investigator(s), in consultation with NIH program staff, the Steering Committee, and the External Expert Panel will make any necessary adjustments to accommodate the changing research environment, in order to remain focused on overall consortium goals; to maintain excellent coordination with the other projects; and to incorporate new technological advances.

It is expected that these studies will be very effective at generating new hypotheses. For example, discovery of sequential activation of gene expression in identical patterns might suggest a regulatory relationship between the first and subsequent genes. Hypothesis generation is a goal of this FOA. However, experiments to test these hypotheses are more suitable for investigator-initiated R01 applications and are beyond the scope of this FOA. Such applications will be considered non-responsive. Likewise, projects designed to test hypotheses based on previously generated data are also unsuitable for this solicitation.

To support the integration of the nGUDMAP participants with the parent GUDMAP team, the GUDMAP consortium will meet bi-annually in Bethesda, initially for a planning meeting (January 13-14, 2014) and subsequently to discuss progress. Applicants should budget for travel of the PI and key personnel to these meetings.

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 $1,500,000 in total cost in FY 2013.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project. The direct costs are expected to be in the range of $100,000 to $200,000  for one-year project period.  

Award Project Period

The maximum project period is one year.

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 must complete the following registrations as described in the SF424 (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.

All Program Directors/Principal Investigators (PD(s)/PI(s)) 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 completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

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 and previously supported GUDMAP investigators are eligible to apply provided that the nociceptive project is clearly distinct from currently support projects. Senior post-doctoral fellows and new investigators are encouraged to apply. It is anticipated that although this one-year funding opportunity is not to test hypotheses, that the data generated will support hypothesis-testing, investigator-initiated grant applications.

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 should be sent to:

Dr. Francisco O. Calvo
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752 MSC 5452
Bethesda, MD 20892-5452
(For express/courier service: Bethesda, MD   20817)
Telephone: 301- 594-8897
Email: fc15y@nih.gov

Required and Optional Components

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 all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

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

Modular Budget Component

To support the integration of the nGUDMAP participants with the parent GUDMAP team, the GUDMAP consortium will meet bi-annually in Bethesda, initially for a planning meeting (January 13-14, 2014) and subsequently to discuss progress. Applicants should budget for travel of the PI and key personnel to these meetings.

PHS 398 Research Plan Component

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

Research Strategy

Applicants should propose either a Research Project or an Atlas Assembly Project in their application and indicate clearly which activity is being proposed.

Applicants must indicate their willingness to be part of the GUDMAP consortium and be willing to participate on the Steering Committee for this consortium, which will meet monthly through telephone conference calls and semi-annually in person, and may meet additionally in subcommittees (see Cooperative Agreement Terms and Conditions of Award). Applicants must indicate their willingness to distribute research tools to the wider community, including probe sets, antibody libraries, transgenic or knock-in mouse strains, cell lines, and other reagents, and describe their willingness to submit data generated through this project to the GUDMAP database prior to publication.

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, with the following modifications:

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 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, 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.

Applicants are responsible for viewing their application before the deadline 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.

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.

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 (SAM). 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.  

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at fc15y@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115..

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?

For Research Project applications, do the genes chosen for high resolution analysis mark distinct cell populations?  Can the expression of these genes be correlated to anatomic landmarks? Are the gene sets chosen for high throughput studies well justified? Will the tools to be generated be useful for the community?

For Atlas Assembly project applications, does the application describe significant strategies for global integrity of the nGUDMAP projects with components of the urogenital tract and with the parent GUDMAP database/website? Are significant strategies described that will ensure the utility and easily accessibility of the nGUDMAP datasets for the entire research community.

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?   

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? 

For Atlas Assembly Project applications are novel strategies proposed to enhance the visual presentation of nociceptors and associated cells, e.g., 3-D rendering, or the development of nociceptive atlas tutorials?

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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

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.

Interactions

Are there adequate plans for effective interaction and coordination among Consortium components and the NIH? Do the investigators state their willingness to collaborate extensively and share information fully? Do the investigators state their willingness to abide by the priorities and policies agreed upon by the Steering Committee? Have the applicants proposed sound strategies for communication within the GUDMAP consortium and with the NIH?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and 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 project 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:

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 National Diabetes and Digestive and Kidney Diseases 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:

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

Areas of Joint Responsibility include:

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Deborah K. Hoshizaki, Ph.D
Program Director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7712
Email:deborah.hoshizaki@nih.gov

Peer Review Contact(s)

Dr. Francisco O. Calvo

Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
Email: fc15y@nih.gov

Financial/Grants Management Contact(s)

Charlette Kenley
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594- 8847
Email:ck128i@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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