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	Planning Grants for Pragmatic Research in Healthcare Settings to Improve Diabetes Prevention and Care (R34)
Activity Code	R34 Planning Grant
Announcement Type	New
Related Notices	March 26, 2015 - This PA has been reissued as PAR-15-158. March 6, 2015 - Notice of Expiration of PAR-13-367. See Notice NOT-DK-15-008. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PAR -13-367
Companion Funding Opportunity	PAR-13-366, R18 Research Demonstration and Disseminations Projects
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 Planning Grant (R34) is to support research to develop and pilot test approaches to improve diabetes treatment and prevention in existing healthcare settings. Applications should pilot test practical and potentially sustainable strategies, delivered in routine clinical care settings, to improve processes of care and health outcomes of individuals who are at risk for or have diabetes. The goal is that, if the pilot study shows promise, the data from the R34 will be used to support a full scale trial that could improve routine clinical practice and inform policy in representative healthcare settings.

Posted Date	September 27, 2013
Open Date (Earliest Submission Date)	February 3, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	March 3, 2014, July 1, 2014, November 3, 2014, March 2, 2015 , July 1, 2015, November 2, 2015, March 1, 2016, July 1, 2016, and November 1, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June/July 2014, October/November 2014, February/March 2015, June/July 2015, October/November 2015, February/March 2016, June/July 2016, October/November 2016, and February/March 2017
Advisory Council Review	October 2014, January 2015, May 2015, October 2015, January 2016, May 2016, October 2016, January 2017, and May 2017
Earliest Start Date	December, 2014, April 2015, July 2015, December 2015, April 2016, July 2016, December 2016, April 2017, July 2017
Expiration Date	New Date March 3, 2015 per issuance of NOT-DK-15-008. (Original Expiration Date: November 2, 2016)
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.

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

Diabetes is a common chronic disease that imposes considerable demands on the individual as well as the U.S. healthcare system. People with diabetes have a higher rate of cardiovascular disease than those without diabetes and are at increased risk for kidney failure, lower limb amputation, and blindness. Obesity is a significant risk factor for diabetes and the prevalence of obesity in children and adults in the United States has dramatically increased in the past four decades. Diabetes currently affects an estimated 25.8 million people in the United States. Another 79 million Americans are estimated to be at greatly increased risk of developing diabetes in the next several years. Type 1 and type 2 diabetes in youth are also on the rise. Overweight, obesity, and/or excessive weight gain during pregnancy are also contributing to rising rates of gestational diabetes mellitus which in turn increases risk of future type 2 diabetes in the mother and child. The CDC estimates that one in three American children born in 2000 will develop diabetes at some point in their lives. Although diabetes occurs in all populations in the U.S., many minority racial and ethnic groups and individuals with low education and income are at higher risk for diabetes and its complications. The estimated current annual cost of diabetes in the U.S. is $245 billion dollars per year, with $176 billion in direct medical costs and the remainder related to reduced productivity.

Large clinical trials have demonstrated that glycemic control and cardiovascular risk factor modification can reduce the risk of diabetes complications. Although there have been considerable improvements in diabetes treatment options and in risk-factor control over the past three decades, recent research demonstrates that most U.S. adults with diabetes do not meet the recommended goals for diabetes care. Further, it is well established that behavioral lifestyle interventions, with modest (5-7%) weight loss, can prevent or delay development of type 2 diabetes in individuals at high risk for the disorder and, in individuals who already have type 2 diabetes, can decrease sleep apnea, reduce the need for diabetes medications, help maintain physical mobility, and improve quality of life. Despite these findings, behavioral lifestyle interventions have yet to become part of routine care for most overweight or obese individuals at risk for diabetes. To address the growing problem of diabetes in the nation and improve the quantity and quality of life for Americans, we must find efficient ways to close the gap between outcomes achieved in clinical trials and the outcomes achieved in actual healthcare practice.

Most individuals are already seen in some type of healthcare setting but, as noted, achievement of appropriate preventive and diabetes care goals remains elusive for many. This FOA seeks research to test the effectiveness of practical and potentially sustainable strategies to modify healthcare delivery to prevent diabetes in at-risk individuals, improve diabetes care, and reduce long term complications. Pragmatic research designs in response to this funding announcement are strongly encouraged. Pragmatic trials evaluate the effectiveness of interventions or therapies in research designed to maximize applicability of the trial’s results to routine healthcare conditions. As such, the research should leverage staff and facilities in routine and representative healthcare settings. This supports the practicality of the intervention and, if effective, approaches tested under routine conditions will have greater potential to be adopted by similar healthcare providers and systems.

Pilot and feasibility research/planning grants in response to this FOA may include approaches focused on the patient, provider, healthcare team, and/or healthcare system. Studies that focus on providers may target physicians as well as non-physician healthcare professionals or staff within the healthcare system being studied. Areas of research focus should have the potential to generalize to other settings and types of payment and clinical practice situations. Trials that include community resources to augment healthcare are permissible but the community resources must be well integrated into healthcare delivery. Referral to community programs by the healthcare system of staff is not, in itself, an adequate linkage. There should also be some evidence that the community program or policy is directly linked to healthcare delivery through a formal agreement, reimbursement, and regular communication about patient progress and outcomes.

Studies including low income/resource and diverse populations at disproportionate risk of diabetes and diabetes complications are encouraged.

Research examples include, but are not limited to:

• Studies of innovative models of healthcare delivery including Patient Centered Medical Homes, shared medical appointment/group visits, team care approaches, care coordination, integrated care, shared decision making, pharmacy/pharmacist based initiatives, or use of eHealth, mHealth, or health information technology.
• Studies of incentives to improve diabetes prevention, treatment, and/or outcomes. Examples include physician incentives to follow clinical care guidelines, provide weight loss therapy/intervention, and achieve target clinical outcomes in their enrolled patient panels or patient incentives to adhere to prescribed medications or follow prevention and treatment recommendations.
• Studies to improve patient adherence to efficacious self-management and treatments, such as medications, blood glucose monitoring, lifestyle change, or other aspect of diabetes care or prevention. Such interventions could target patient, provider, and/or healthcare system provider or some combination.
• Redesign of workflow in physician’s office to improve screening, initial counseling, and follow-up of patients with diabetes or at risk for diabetes to enhance adherence to guidelines, weight loss or improve glycemic control

Interventions testing new or unapproved drugs, or interventions designed with a placebo comparison are not appropriate for the FOA.

The focus of this FOA is on research in humans. Animal studies are not consistent with the intent of this FOA.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Direct costs of up to $150,000 per year are allowed.
Award Project Period	The maximum project period is two 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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.

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

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

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.

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

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

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

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

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

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

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

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

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

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

Research Strategy: The research strategy must include a discussion of how integration into the existing clinical setting will be accomplished, as well as the potential scalability, sustainability, and dissemination potential of the approach should it prove successful in an eventual full scale trial. This discussion should include, where applicable, issues related to appropriate partnerships, cost, potential for reimbursement, personnel, and other necessary resources for implementation and maintenance. While most research requires some infrastructure support and staffing, grant expenditures for these functions should be minimized. Research that evaluates effectiveness using existing healthcare staff or resources to deliver an intervention or make system changes is encouraged. If grant funding will be used to support intervention staff, the applicant must make a strong justification that, if the study achieves its aims, these personnel and their associated costs have the potential to be sustained in the healthcare setting beyond the research funding period. Some research funding can also go toward enhancement activities such as adapting or enhancing electronic resources or training personnel but, again, the sustainability of these investments beyond the research period should be justified. A full cost effectiveness analysis is not required but research funded implementation costs should be measured and considered in the study analyses.

Researchers are encouraged, where possible, to use registries and electronic medical records to identify potential participants and ascertain study outcomes. Study endpoints should be diabetes-related outcomes that are relevant to key stakeholders such as patients, clinicians, caregivers, health systems and health policy makers (e.g., HbA1c, weight/BMI change, diabetes risk factor control, screening and prescribing appropriate medication, patient adherence to effective therapies, hospitalizations, ER visits, healthcare utilization, healthcare cost). Patient-centered outcomes are encouraged as additional primary outcomes or secondary outcomes (http://www.pcori.org/research-we-support/pcor/). If using more than one primary outcome, applicants should apply appropriate analytical adjustments required for multiple comparisons. Investigators are also encouraged to include an evaluation of acceptability by clinical staff and patients.

Since this FOA is designed to support pilot and feasibility, an efficacy based power analysis is not necessary. However, applicants must detail their plan for determining feasibility and evaluating whether the approach is successful enough to warrant moving to a full scale trial. Also, the sample size needed to pilot the proposed approach, including the assumptions used when estimating the sample size, should be detailed in relation to the analysis plan.

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.

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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.

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the National Institute of Diabetes and Digestive and Kidney Diseases Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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.

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).

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? If successful, will the proposed research design, methods, and measures provide the necessary data to support a full scale trial? Will the research question and design meaningfully inform healthcare practice or policy? Does the research setting generalize to other healthcare settings?

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?

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? Has the investigator demonstrated appropriate partnerships with the key decision makers and staff in the healthcare setting to justify that the proposed research is feasible? Have the researchers justified the sustainability and dissemination potential of the approach beyond the research period, including appropriate partnerships and consideration of cost and resources such as personnel and infrastructure? If so, was the plan for sustainability compelling--i.e. if successful would these research findings be likely to improve patient outcomes in routine care settings? Is there a sufficient evaluation of the implementation costs and implementation process to meaningfully inform scalability and sustainability? This evaluation should include, where applicable, issues related to cost, reimbursement, personnel and other resources.

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?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves 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 Guidelines for the Review of Inclusion in Clinical Research.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

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

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Diabetes and Digestive and Kidney Diseases (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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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.

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

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.

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

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

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Andrew A. Bremer, MD, PhD
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 827-2555
E-mail: [email protected]

Christine Hunter, Ph.D (for behavioral research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301)594-4728
Email: [email protected]

Barbara Linder, M.D., Ph.D. (for pediatric medical research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-0021
E-mail: [email protected]

Michele L. Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8898
Email: [email protected]

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8853
Email: [email protected]

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.

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.