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

Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-12-016

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

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

93.847 

Funding Opportunity Purpose

The purpose of this FOA is to advance the treatment of Chronic Kidney Disease (CKD) through pilot studies that seek to optimize critical elements of a full-scale randomized control trial design.   Various treatments to slow or reverse progression of CKD have been tested in small trials with limited numbers of participants, but there still remain questions of the optimum agent(s), target population, dosing, data collection, and appropriate outcomes.  This FOA solicits applications from investigators willing to collaborate on the design and conduct of pilot studies that will better inform the design of a full-scale randomized, controlled clinical trial(s) in CKD.     

Key Dates
Posted Date

August 30, 2012

Open Date (Earliest Submission Date)

October 19, 2012

Letter of Intent Due Date

October 19, 2012

Application Due Date(s)

November 21, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February 2013

Advisory Council Review

May 2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

November 22, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA 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

Chronic Kidney Disease (CKD), particularly resulting from hypertension and/or diabetes, often progresses to end stage renal disease that requires renal replacement therapy for continuation of life.  This occurs despite therapies with ACE Inhibitors (ACEI) or angiotensin receptor blockers (ARB), blood glucose control, or lowering of blood pressure (BP).  CKD is associated with decreased quality of life and increased morbidity and mortality from cardiovascular disease.  Newer therapies to slow progression of CKD have been tested in small studies, but each requires further preliminary investigation prior to a full scale Phase 3 study.

The purpose of this FOA is to form a multi-center, collaborative study group that will carry out pilot studies that optimize critical elements of the study design of subsequent randomized trial(s) of new treatment(s) for CKD. This consortium may include industry participation (i.e., advisory, donation of drug, or other) and will communicate with the Food and Drug Administration (FDA) concerning its activities. 

The following define elements of this FOA:

a.         Each agent or non-pharmacologic maneuver must be off-patent or repurposed from its original use.   Agents may be drawn from the following but are not limited to: allopurinol, pirfenidone, pentoxifylline, phosphate binders, spironolactone, vitamin D or from the NCATS list of repurposed drugs (http://www.ncats.nih.gov/research/tools/preclinical/npc/pharmaceutical-collection.html).  Since angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) are currently the standard of care for CKD patients, it is anticipated that all participants will be taking ACEI and/or ARB during pilot studies and the subsequent randomized trial(s).

b.         Drug dosing/dose-ranging studies should be proposed to establish the toxicity and safety of specific therapeutic interventions.  Within the study, protocols should be used to examine biomarker(s) for each drug proposed for study.

c.         The target population for the pilot studies and for the future randomized controlled trial should be carefully defined with respect to such variables as: level of kidney function (eGFR), amount of urine protein excretion, age, co-morbidities of diabetes and hypertension, gender and racial/ethnic composition, future CKD biomarkers, and other factors deemed important by the investigators.

d.         The investigators should demonstrate their ability to recruit a diverse population for the pilot trials and for any subsequent randomized trial.  Pilot trials may be designed with a length appropriate to the purpose.   If appropriate, participants may take part in more than one shorter-term study.

e.         The sampling strategy and collection methods should be clearly defined. 

f.          Costs for all data and biological samples that will be deposited in the NIDDK Repository should be estimated in the application.

g.         Renal and non-renal outcomes including measures of CKD progression should be specified.  Alternative endpoint markers of progression should be acceptable to the FDA or should be qualified within this study.

h.         Awardees will be contacted by NIDDK prior to award in order to set up tentative dates for weekly teleconferences immediately after award to develop study protocols.  Within two months after the award, the successful awardees will meet face-to-face for two days to finalize the study protocol(s).  All awardees must commit to joint recruitment and completion of all approved protocols.

A Steering Committee will serve as the governing board for the Consortium; its actions and decisions will be determined by majority vote.  Membership on the Steering Committee will include a Steering Committee Chair (appointed by the NIDDK), the Participating Clinical Centers (PCC) and Data Coordinating Center (DCC) PD(s)/PI(s), a NIDDK Project Scientist, and other participating stakeholders, as appropriate.   The FDA will be contacted to advise the steering committee concerning protocol development, and qualification of biomarkers and alternative outcomes.

The responsibilities of the Steering Committee include: Development of the common protocol(s) that will address points a-h above; Providing input on and approval of all studies developed by the Consortium members prior to or after study implementation; Review and approval of all data analyses, public presentations and publications of research conducted within the consortium; Development of policies and procedures for submission and approval of ancillary research  applications using Consortium resources. 

The responsibilities of each PCC are: local institutional review board (IRB) approval, recruitment of participants, collection of data according to the common protocol(s), timely transmission of data to the DCC, joint analysis, interpretation and publication of study data, and participation in steering committee meetings and annual meetings with the Data Safety and Monitoring Board (DSMB) and the NIDDK. 

The responsibilities of the DCC include: standardization of data collection forms in accordance with the protocol(s), tabulation of collected data, analyses of data, coordination of PCCs including monthly meetings of the steering committee and other committees that are deemed necessary by the entire steering committee, publication of the annual progress report, and response to DSMB queries.

NIDDK will appoint an independent DSMB to monitor all study activities that impact participants.  The DSMB will meet at intervals of not greater than 12 months to approve study protocols, review study progress, adverse events that occur in the course of the study, protocol changes suggested by the Steering Committee, and any other items relevant to the safety of participants and the successful completion of the study.    

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

It is anticipated that there will be 3 PCC awards and one DCC with a total budget of $1.5 million for the 4 applicants.   Future year amounts will depend on annual appropriations.

Award Budget

An applicant may request a project period of up to 5 years and a budget for direct costs in the first year for a PCC up to $250,000 and for a DCC up to $350,000.   Applicants should specify whether they propose to be a PCC or the DCC.

Award Project Period

The maximum project period is five 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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

All Program Director(s)/Principal Investigator(s) (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 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. 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 Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, MD  20892-5452
Bethesda, MD  20817 (express/courier service)
Telephone:  (301) 594-8897
FAX:  (301) 480-3505
Email: calvof@niddk.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.

PHS 398 Research Plan Component

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.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, 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 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 SF 424 (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 SF 424(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 Central Contractor Registration (CCR). 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 NIDDK, 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-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/priority 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?  Will the proposed study adequately inform an effective design of a randomized clinical trial of agent(s) that will slow, prevent or reverse progression of CKD? 

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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Have these investigators demonstrated commitment to working together with other centers to design a common protocol, recruit participants, and implement the protocols that are not their own? 

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?  Are appropriate biomarkers and alternative outcomes proposed in the design of the study?  If these alternative markers and outcomes have not been qualified by the FDA, does the application include plans to qualify or demonstrate their validity? 

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?  Does the proposed recruitment plan include a viable approach toward recruitment of subjects with a broad range of eGFRs (and postulated rates of progression) for the proposed pilot studies?  Do they include backup plans in case the primary recruitment plan fails?  Have they documented how they would cooperate with other centers in the consortium to accomplish the goals?

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/priority score, but will not give separate scores for these items.  

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/priority score.   

Applications from Foreign Organizations

Not Applicable.

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. Review assignments 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.l 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(s)/PI(s) 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, CCR 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 OMB administrative guidelines, HHS 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:  
The PD(s)/PI(s) at each PCC and the DCC will have the primary responsibility for working together to define the protocols, approaches and details of the project within the guidelines of this FOA.  Each PCC and DCC PD/PI will be a voting member of the Consortium Steering Committee and will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee.   A representative from FDA will be designated to provide regulatory guidance in protocol, biomarker, and surrogate outcome development.

PD(s)/PI(s) at PCCs Clinical Center will have primary responsibility for recruiting participants, collecting data, and providing study data to the DCC for management, quality control and analysis.  PD(s)/PI(s) responsibility regarding Steering Committee membership, protocol development and conduct are described under Collaborative Responsibilities.  The NIDDK has established Central Biosample, Genetic, and Data Repositories for the archival and storage of data and biosamples collected in large, multi-site studies funded by NIDDK. The PD(s)/PI(s) will work with the NIDDK Biosamples Repository to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repository.   Biorepository costs should be included within each proposed budget.

The PD(s)/PI(s) at the DCC will be responsible for data coordination of all trial sites, including data form changes, protocol changes, oversight of all sub-contracts, quality control, assistance with retention of study subjects, analysis of study results and close-out activities.  In addition, the DCC will coordinate with the NIDDK Repository to prepare the collected data for eventual archiving and distribution.  All samples and data transferred to the Repositories will be under the custodianship of the NIDDK, although the Consortium Steering Committee will have proprietary control of and exclusive access to the samples and data for an agreed-upon period of time.   

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 HHS, PHS, and NIH policies.

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

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

The NIDDK Project Scientist will serve as a voting member of the Steering Committee and will participate in all Committee activities, serving as a resource with respect to the study design and implementation.   The NIDDK will select members of the DSMB that will carry out monitoring activities for the consortium's activities, as stated above.

The NIDDK Project Scientist, together with the Steering Committee, will review the performance of each participating Center through consideration of the annual reports, sites visits, compliance with the Consortium procedures, meeting timeliness, adherence to uniform data collection procedures, and the timeliness and quality of data reporting.  The NIDDK Project Scientist may contribute, through review, comment, analysis, and/or authorship, to reporting results of consortium studies to the investigator community and other interested scientific and lay organizations.

The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.     

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The Steering committee will be the governing board of the Consortium; its actions and decisions will be determined by majority vote. Voting members of the Steering Committee include a Steering Committee Chair, PCC and the DCC PD(s)/PI(s), the NIDDK Project Scientist; other stakeholders, if any, will not have voting status.  A Chair will be chosen from among the Steering Committee member (but not the NIDDK Project Scientist or DCC PD/PI) or alternatively, from among experts in the field of clinical trials in kidney diseases who are not participating directly in the study. The Committee has the primary responsibility for determining the study protocol(s), monitoring the conduct of the study and reviewing data prior to reporting of study results. It will also be responsible for determining study policies in such areas as access to participant data, ancillary studies, publication and presentations, recruitment and quality standards. Each PD/PI will be responsible for close coordination and cooperation with other Consortium investigators and with NIH staff.  The PD/PI will participate in regular (monthly) Steering Committee telephone calls and attend two Steering Committee meetings per year in the Washington DC Metro area.

The NIDDK Project Scientist (and other NIDDK scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g. issues of recruitment, follow-up, quality control, standards and methods, adherence to protocol, assessment of problems affecting the study and potential changes in the protocol, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant participation.  Regardless of the number of NIH staff participating in technical advisory roles, the NIDDK will be limited to one vote on the Steering Committee.   

Each full member will have one vote.  Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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)

Dr. Michael F. Flessner
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Telephone: (301) 594-7717
FAX: (301) 480-3510
Email: flessnermf@niddk.nih.gov

Peer Review Contact(s)

Dr. Francisco Calvo
Chief, Review Branch
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8897
FAX: (301) 480-3505
Email: calvof@niddk.nih.gov).

Financial/Grants Management Contact(s)

Ms. Pamela Love
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 435-6198
FAX: (301) 594-9523
Email: lovepa2@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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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