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)
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Clinical Trial Planning Grants in Type 1 Diabetes (R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

New

Related Notices

  • December 14, 2012 - See Issuance of RFA-DK-12-511; Limited Competition for Clinical Trials in Type 1 Diabetes (UC4).
  • June 23, 2011 - See Notice NOT-DK-11-012 The purpose of this Notice is to clarify the funding of applications submitted may be conducted by awardees of an R34 Clinical Trial Planning Grant under this FOA.

Funding Opportunity Announcement (FOA) Number

RFA-DK-11-010

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.847, 93.853, 93.887, 93.865

FOA Purpose

This FOA provides for planning grants for clinical trials related to type 1 diabetes. It is expected that these planning grants will lead to clinical trials to test interventions designed to improve glycemic control and/or to treat or reduce diabetes complications. The intent of this initiative is to improve the management and treatment of individuals with type 1 diabetes in the United States. If successful, the results of the future clinical trials should be of practical importance to clinical management and applicable immediately. The purpose of this FOA is not to validate new technologies or test new therapeutics.

Key Dates
Posted Date

May 2, 2011

Open Date (Earliest Submission Date)

February 15, 2012

Letter of Intent Due Date

February 16, 2012

Application Due Date(s)

March 15, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

June-July 2012

Advisory Council Review

October 2012

Earliest Start Date(s)

December 2012

Expiration Date

March 16, 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

Background

Type 1 diabetes is a serious chronic illness. New types of insulin, along with improved management and monitoring technologies, have the potential to improve outcomes.  However, diabetes management requires complex balancing of medication dosing, diet and exercise in order to achieve good glucose control while avoiding hypoglycemia. Achievement of good glucose control is also dependent on frequent self-monitoring of blood glucose values. The constant burden of the disease affects the quality of life of individuals with type 1 diabetes and their families, and may be associated with poor adherence to medical regimens.

The results of the Diabetes Control and Complications Trial and its long-term follow-up through the Epidemiology of Diabetes Interventions and Complications study clearly demonstrate the efficacy of good glucose control in preventing the long-term vascular complications of diabetes. Nevertheless, despite efforts of patients to keep their glucose levels as normal as possible, it is still nearly impossible for individuals with type 1 diabetes to achieve the precise level of glucose control attained by a healthy pancreas. Therefore, individuals with type 1 diabetes inevitably experience both hypo- and hyperglycemia; the latter may result in organ damage that produces morbidity for the individual and contributes to the high cost of health care for society.  In the United States, diabetes is the leading cause of new cases of blindness in working age adults, non-traumatic lower leg amputations and kidney failure. No organ system is immune from the microvascular damage caused by hyperglycemia. Heart disease is increased by up to ten-fold in people with type 1 diabetes compared to the general age-matched population. In addition, individuals with diabetes have a life span that is reduced by up to 15 years.

Therefore, NIH wishes to test interventions to improve clinical management of type 1 diabetes across the lifespan. These trials should be designed to improve glycemic control and/or treat or reduce diabetes complications. If successful, the results of such trials should be of practical importance to clinical management and applicable immediately. 

This FOA will utilize the NIH Clinical Trial Planning Grant (R34) to support the development of clinical trials in individuals with type 1 diabetes. Contingent on the merit of the proposed trials and the availability of funds, NIH anticipates funding of up to three full scale trials from the funded R34 planning grants.  During the early funding period of the R34 grant, the investigators will have the opportunity to revise the protocol based on considerations raised in peer review.  NIH will then seek external input that will guide priorities for the support of a limited number of full clinical trials selected from the funded R34 protocols.  Those clinical trials will be conducted in collaboration with a single data coordinating center that will be awarded through a future FOA. The data coordinating center will work with R34 awardees to finalize the protocol and budget, complete administrative tasks and recruit clinical sites.  The data coordinating center award will provide support for the conduct of the selected trials.  Clinical trials developed under R34 grants that are not prioritized for implementation through this data coordinating center may be appropriate for support through other funding sources or mechanisms.

Purpose

NIH intends to promote clinical research to improve the treatment of individuals with type 1 diabetes.  To accomplish this goal, this FOA uses the NIH Clinical Trial Planning Grant (R34; http://grants.nih.gov/grants/funding/r34.htm) to support the development of clinical trials with the characteristics described below.  The R34 Planning Grant is intended to support all administrative study group activities that are required in order to begin recruitment of subjects. These activities include, but are not limited to: establishing the research team, developing tools for data management and oversight of the research, defining recruitment strategies, finalizing the protocol, writing the Manual of Operations, establishing a data and safety monitoring plan, and initiating the IRB approval process. The R34 Planning Grant application should include a fully developed trial protocol and trial budget. The R34 Planning Grant is not for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial.

The application should include a rationale for the future clinical trial, documenting significance and need, and describe the potential impact of the clinical trial on health care and practice. Preliminary results and background to support the trial should be provided. The application should include the trial design, including a description of the study population with inclusion and exclusion criteria, a detailed power calculation, and outcomes measures. If surrogate end-points are proposed, a justification for their use should be included. The availability of the requisite patient population and plans for recruitment and retention should be described. Issues and challenges related to adherence to the proposed intervention should be addressed. The application should include a budget for the full trial. Finally, the application should describe the activities proposed to be conducted during the funding period.

A successful R34 will have the potential to lead to a clinical trial that meets the following criteria:

Specific Areas of Research Interest

Appropriate topics as a focus for a clinical trial include, but are not limited to:

Studies to promote adherence:

The proposed clinical trials may be aimed at developing and refining innovative strategies to improve adherence to medications and medical regimens. Intervention content and/or delivery methods should be informed by the existing body of clinical and behavioral research, as well as new or emerging basic behavioral or social science findings. Interventions may be targeted to any group across the lifespan, but interventions for adolescents or emerging young adults are of particular interest. Interventions may be targeted to the individual, family, social network, health provider, health system or any combination. The primary outcome for adherence studies must be a measure of glycemia (e.g., improved HbA1c, or decreased diabetic ketoacidosis or hypoglycemia). For adherence studies related to complications, the primary outcome must be an actual disease end-point or an established surrogate marker. Secondary outcomes should include a measure of adherence to the target behavior(s). Measurement of psychosocial outcomes is encouraged.  Research to improve adherence may focus on issues such as improving health literacy and/or numeracy; addressing health beliefs that may interfere with adherence; improving social or family support systems; enhancing uptake of technologies shown to be associated with improved glycemic control; and improving outcomes by addressing structure and communication of the health care provider team.

Studies to improve glycemic control using existing diabetes management technologies or medications:

The immediate goal of diabetes treatment is to maintain glucose values near normal. Individuals with type 1 diabetes must constantly balance the immediate danger of hypoglycemia with the long-term risk of developing complications due to hyperglycemia. There is a need for better medical regimens and tools to limit glycemic variability and to help patients achieve and sustain tight glucose control without developing hypoglycemia, which can be debilitating and life-threatening. While the development of new pharmacologic agents and new devices (improved continuous glucose monitoring systems and a closed loop or artificial pancreas) is highly desirable, such work is outside the scope of this FOA.  Studies submitted under this FOA must use currently available techniques and tools for proposed interventions. Any therapeutic agents or devices used must be FDA-approved. For example, studies may use approved insulin pumps or continuous glucose monitoring to improve glycemic control but may not propose to develop or use non-FDA approved devices to “close the loop.” Studies directed at decreasing the prevalence of hypoglycemia and diabetic ketoacidosis are encouraged.  Research to improve use of existing therapeutics and diabetes management technologies might include testing specific medical regimens, evaluating management approaches that involve the medical team and/or communication between the medical team and the individuals with diabetes, targeting lifestyle needs, or managing barriers to optimal care.

Studies to treat or reduce complications:

Until type 1 diabetes can be prevented or cured, intensive research is needed to prevent and treat the micro- and macrovascular complications of diabetes.  Applications may propose future trials to test interventions that improve glycemic control (see above), or address other risk factors associated with the development of complications (e.g., hypertension, dyslipidemia, and pro-inflammatory and coagulation pathways). Future clinical trials can focus on systemic or specific complications, including myocardial infarction, cardiomyopathy, heart failure, stroke, peripheral arterial disease, congenital cardiovascular malformations in offspring of mothers with T1D, sudden death in adults and children related to cardiac autonomic neuropathy, coagulopathies, altered clotting propensity, thrombotic abnormalities, cognitive impairment, depression, wound healing, peripheral sensory neuropathy, autonomic neuropathy, nephropathy, erectile dysfunction, gastroparesis, bladder dysfunction or hypoglycemia unawareness. Applications can also focus on sleep health issues for children with T1D and their parents, especially in relation to the management of nocturnal hypoglycemia, and subsequent impact on memory consolidation, learning and school performance, as well as on parental stress. The outcome measure should be either an actual disease end-point or an established surrogate marker. Studies to develop and/or validate new or emerging biomarkers are outside the scope of this FOA. 

Studies to inform the management of type 1 diabetes in subpopulations

If scientifically justified, future trials may focus on a specific age group (e.g., young children, adolescents or the elderly) in order to address management issues unique to the group, including the development of appropriate HbA1c targets. Proposed trials may also test interventions to improve outcomes in individuals at different stages of morbidity (e.g., optimizing glycemic control in the dialysis patient). Studies to optimize pre-conception and pregnancy care of women with type 1 diabetes to improve outcome in both mothers and offspring are also of interest.

In the event of an award, the NIDDK and the Principal Investigator will agree on a list of milestones to be completed during the R34 project period. Prospective applicants should note that funding of an R34 does not guarantee or imply funding for the future clinical trial.

Applicants are encouraged to contact NIH staff to discuss the applications process. 

Section II. Award Information
Funding Instrument

Grant

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

The NIDDK and NIH partner components will commit $1 million to fund up to 6 awards in Fiscal Year 2012.

Award Budget

Applications may request up to $100,000 in direct costs.

Award Project Period

The 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are 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 Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) 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/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for 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 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. NIH will not accept any application that is essentially the same as one already reviewed.    

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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Francisco Calvo, Ph.D.       
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: 301-594-8897
Email: calvof@mail.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 application submission. 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.

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.

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:

The following items should be submitted as part of the Appendix:

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/PIs 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 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 calvof@mail.nih.govwhen the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Research Strategy: This section should include a discussion of the significance of the problem being studied and the potential impact of the results of the trial; a description of the study design, including power analysis; a timeline for study conduct and a management plan for the conduct of the trial; feasibility of recruitment; plans for subject randomization and recruitment and retention; plans for monitoring of subject safety; and a description of the data monitoring and data analysis plan. 

Inclusion of Women and Minorities: Applicants should include a table describing the demographics of the available population at every site.

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?  

Investigator(s)    

Are the PD/PIs, 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? Does the PD/PI have experience in organizing and managing multi-center clinical studies? 

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? Since this FOA does not solicit trials for new technologies or new therapeutics, innovation should be judged by the potential changes in clinical practice that would result from a successful trial. 

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? Are the intervention and the outcome(s) of the proposed future clinical trial supported by strong preliminary data? If surrogate endpoints are proposed as outcomes measures, have they been established to be predictors of clinical outcome? If successful, will the proposed future clinical trial be of practical importance to clinical management and applicable immediately? 

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? Is the study population required for the proposed trial available?      

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:

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 appropriate National 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 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

Not Applicable.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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)

For inquiries regarding diabetes complications:

Teresa L. Z. Jones, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-2996
Email:jonester@mail.nih.gov

Abby G. Ershow, Sc.D., FAHA
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: ErshowA@nhlbi.nih.gov

Larissa Avilés-Santa, MD, MPH, FACP, FACE
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0450
Email: avilessantal@nhlbi.nih.gov

Andrei L. Kindzelski, M.D., Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-0658
Email: kindzelskial@nhlbi.nih.gov  

Daniel S. Lewin, Ph.D., D.ABSM
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-443-4027
Email: LewinDS@nhlbi.nih.gov

Katrina Gwinn, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email:gwinnk@ninds.nih.gov

For inquiries regarding adherence:

Christine Hunter, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4728
Email:hunterchristine@mail.nih.gov

For inquiries regarding diabetes management:

Barbara Linder, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-0021
Email:linderb@mail.nih.gov

Karen Winer, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6877
E-mail: winerk@mail.nih.gov

Peer Review Contact(s)

Francisco Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone: 301-594-8897
Email:calvof@mail.nih.gov.

Financial/Grants Management Contact(s)

Diana O'Donovan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8868
Email:O'DonovanD@mail.nih.gov

Mary S. Baylor
National Heart, Lung and Blood Institute (NHLBI)
Telephone: 301-435-0480
Email: baylorm@mail.nih.gov

Brian Clark
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
E-mail: clarkb1@mail.nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.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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NIH Funding Opportunities and Notices


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