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	Evaluating Natural Experiments in Healthcare to Improve Diabetes Prevention and Treatment (R18)
Activity Code	R18 Research Demonstration and Dissemination Projects
Announcement Type	New
Related Notices	February 28, 2017 - This PAR has been reissued as PAR-17-178. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) 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-13-365
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.847
Funding Opportunity Purpose	The purpose of this Research Demonstration and Disseminations Projects (R18) Funding Opportunity Announcement (FOA) is to support research to evaluate large scale policies or programs related to healthcare delivery that are expected to influence diabetes prevention and care. This FOA is not intended to support the initiation and delivery of new policies or programs. Research support is for the evaluation of the effectiveness of healthcare programs and/or policies implemented independent of NIH grant funding. The goal is to support research that meaningfully informs clinical practice and health policy related to prevention or management of diabetes.

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	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 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, research has 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 adherence and lifestyle interventions are not offered as a part of routine care for most individuals with or at risk for diabetes.

The increasing challenges of diabetes and obesity in our society coincide with a dynamic time for healthcare in the United States, including changing consumer demands (employers and individuals) and the pressing need to deliver evidence-based care, improve health outcomes for all Americans, and control costs. Healthcare delivery organizations are implementing new models of care (e.g., innovative teams, appointment models, registries, or referral patterns), treatment supports (e.g., patient navigators, reminders for more rapid medication intensification), and incentive strategies (e.g., pay for performance, reduced co-pay). These healthcare changes include rapidly evolving electronic resources in healthcare and increasingly sophisticated methods to validate, link and analyze these large data sets. Also, many employers are making changes or implementing programs designed to complement healthcare coverage to improve health, lower costs, reduce absenteeism, and increase productivity (e.g., worksite wellness programs, incentives).

The changes in healthcare are being made with the intent of improving health and reducing costs, but often, little is known about the effectiveness of these healthcare policies and programs. Rigorous scientific evaluation of these natural experiments in healthcare can help to more rapidly build an evidence base to inform diabetes prevention and treatment in routine clinical practice, as well as future health policy. Research is needed to evaluate how well these changes in healthcare delivery work to improve diabetes prevention and treatment and provide data important for implementation and scalability beyond the research period.

For the purposes of this FOA, health policies and/or programs are defined as laws, regulations, formal and informal rules, and systematic processes or care programs that are adopted or instituted to affect system functioning and collective behavior in the healthcare setting. Policies and/or programs may involve expanding, changing, or re-organizing services or increasing or redirecting resources in some way to change behavior at the individual, healthcare team or system level to improve care and clinical outcomes.

The goal of research supported by this FOA is to maximize what can be learned from healthcare policies and programs that are planned or recently implemented. This FOA is not intended to support the initiation and delivery of new policies or programs. Research support is for the evaluation of the effectiveness of programs and/or policies that are being or will be implemented regardless of NIH grant funding. Further, the intent is to support evaluation of policies or programs that are large enough in scale to allow the results to have some generalizability outside of the specific setting of implementation.

Evaluation research that has the potential to inform healthcare policy or practice in other types of payment or clinical practice settings is encouraged. Research in response to this FOA may focus on programs or policies that target the patient, family, healthcare team, healthcare system, or some combination. Research can also focus on linkages between the healthcare delivery setting and community health efforts. Healthcare referral to community programs alone is not an adequate linkage. There should be 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.

This FOA is intended to fund natural experiments where comparable control data can be assembled and confounders and biases can be limited through study design, sample selection, and statistical analysis. This FOA is not intended to fund cross-sectional cohort studies.

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

Research examples include, but are not limited to, evaluation of healthcare policies and/or large scale healthcare programs designed to improve diabetes prevention or treatment through:

• Innovative models of health care delivery, including team approaches, Patient Centered Medical Homes, inclusion of care extenders (such as pharmacy support, patient navigators), models of care coordination/integration, group medical visits, pharmacy/pharmacist based initiatives, or use of eHealth, mHealth, or health information technology (such as EMR alerts decision tools).
• The use of patient and/or physician incentives, insurance or employer reimbursement or cost-sharing polices, or benefit designs to alter health outcomes.
• Changes in healthcare policy such as reimbursement for lifestyle intervention or obesity medications for patients at risk for diabetes.
• Healthcare or employer-based disease management and health promotion approaches.
• Programs designed to improve weight loss, patient self-management or adherence to efficacious treatments, such as medications, blood glucose monitoring, lifestyle change, or other aspect of diabetes prevention or care. Such programs and/or policies could target patient, provider, and/or healthcare system provider or some combination.
• Programs designed to improve physician, healthcare team/system adherence to established clinical care guidelines or evidence based screening and/or intervention.

Primary study endpoints should be diabetes-related health outcomes that are relevant to key stakeholders (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). Researchers are encouraged, where possible, to use electronic medical records or registries to ascertain study outcomes. Patient-centered outcomes are encouraged as additional primary or secondary outcomes (http://www.pcori.org/research-we-support/pcor/). If using more than one primary outcome, applicants should attend to appropriate analytical adjustments to accommodate for multiple primary end points.

Given the possibility for changes in policy or program implementation that are beyond the control of the grantee, grant awards may be terminated early if these changes limit the possibility to collect meaningful outcome data.

The focus of this FOA is on research in humans. Studies in animals are not appropriate for 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 Renewal Resubmission Revision 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	Application budgets are not limited, but need to reflect the actual needs of the proposed project. Direct costs should generally be less than $500,000.
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.

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: If recently implemented, a justification of the quality and relevance of the baseline data available should be included in the research strategy.

Grant applications should evaluate potential scalability, sustainability, and generalizability of the program and/or policy (e.g., consideration to cost, reimbursement, personnel and other resources), unintended consequences, fidelity of implementation, and an assessment of barriers and facilitators associated with implementation. This includes measures that will help identify why the healthcare policy or program succeeds or does not succeed. Investigators are also encouraged to include an evaluation of acceptability by relevant stakeholders in the program or policy implementation such as patients, clinical staff, caregivers, employers, healthcare systems or health policy makers.

This FOA encourages innovative scientific partnerships between researchers and public or private partners (e.g., healthcare delivery organizations and employers). Applicants must demonstrate that those who hold ownership or management of the program and/or policy will support access to the data required for the evaluation, including access to the data for the comparison group/s. Where appropriate, agreements must also be in place that allow for unrestricted publication of findings regardless of study outcomes.

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 fc15y@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

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? Is the research proposed for the evaluation of the effectiveness of programs and/or policies that are being or will be implemented regardless of NIH grant funding? Will the evaluation proposed meaningfully inform diabetes related healthcare practice or policy? If so, do the research findings have the potential to generalize to other settings and types of payment/ clinical practice situations?

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? Are the study endpoints objective diabetes related health outcomes that are relevant to key stakeholders? Is the feasibility clear--e.g., are the measures practical and feasibly collected; are the appropriate partnerships in place, is the setting clearly committed to the research goals? Will the plan for baseline data collection and comparison group/s included provide sufficiently rigorous and relevant data to answer the primary research questions? Are patients and key stakeholders meaningfully and consistently involved?

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?

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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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 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 on the basis of established PHS referral guidelines 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 Service Desk (Questions regarding ASSIST, 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: commons@od.nih.gov

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-945-7573
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Andrew A. Bremer, MD, PhD
National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 827-2555
E-mail: Andrew.bremer@nih.gov

Christine Hunter, Ph.D (for behavioral research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-4728
Email: hunterchristine@niddk.nih.gov

Barbara Linder, M.D., Ph.D. (for pediatric medical research)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-0021
Email: bl99n@nih.gov

Michele L. Barnard, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8898
Email: mb316j@nih.gov

Natasha Loveless
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 594-8853
Email: Natasha.Loveless@nih.gov

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.