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	Translational Research to Improve Obesity and Diabetes Outcomes (R18)
Activity Code	R18 Research Demonstration and Disseminations Projects
Announcement Type	Reissue of PAR-09-176
Related Notices	September 20, 2013 - See Notice NOT-DK-13-021. Notice of Early Termination. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PAR-12-172
Companion Funding Opportunity	PAR-12-173, R34 Planning Grants for Translational Research to Improve Obesity and Diabetes Outcomes
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages NIH Research Demonstration and Dissemination Project grant (R18) applications from institutions/ organizations to test practical, sustainable, acceptable, and cost efficient adaptations of efficacious strategies or approaches prevent and treat diabetes and/or obesity. Research must target the prevention or reversal of obesity, prevention of type 2 diabetes, improved care of type 1 and type 2 diabetes, or the prevention or delay of the complications of these conditions. The approaches tested should have the potential to be widely disseminated to clinical practice, individuals and communities at risk.

Posted Date	April 24, 2012
Open Date (Earliest Submission Date)	June 2, 2012
Letter of Intent Due Date	Not Applicable.
Application Due Date(s)	July 2, 2012 , November 1, 2012 , March 1, 2013, July 1, 2013, November 1, 2013, March 3, 2014, July 1, 2014, November 3, 2014, and March 2, 2015 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable.
Scientific Merit Review	October 2012, March 2013, July 2013, October 2013, March 2014, July 2014, October 2014, March 2015, and July 2015
Advisory Council Review	January 2013, May 2013, October 2013, January 2014, May 2014, October 2014, January 2015, May 2015 and October 2015
Earliest Start Date(s)	April 1, 2013
Expiration Date	(Now Expiring March 4, 2014 per NOT-DK-13-021), Originally March 3, 2015
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.

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

Benefits of approaches proven efficacious in clinical trials for diabetes and obesity are often not fully realized because the therapies are not implemented in many healthcare settings or communities. For example, 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. Further, large clinical trials have demonstrated that glycemic control and cardiovascular risk factor modification can reduce the risk of diabetes complications. Large controlled trials have also consistently demonstrated success in achieving weight loss though lifestyle approaches, although maintenance of weight loss remains a challenge. Despite these advances, the efficacious interventions from these trials are rarely translated into widespread practice. Often this is because they lack adaptation and testing to be feasible, acceptable, cost effective and sustainable outside of tightly controlled research settings and populations. Closing the gap between clinical efficacy research and adoption and application of these approaches in community and healthcare settings is a complex challenge but an important focus of necessary research to improve the health of the nation.

Research in response to this announcement must test sustainable, acceptable, and cost efficient adaptations of efficacious strategies or approaches prevent and treat diabetes and/or obesity. Areas of research included in this FOA include:

• Testing innovative strategies to promote the implementation of evidence-based health practices within applied practice or community settings. Examples include testing approaches designed to achieve more rapid medication intensification in patients with diabetes, improve adherence to diabetes medications and blood glucose monitoring, or increase adherence to screening guidelines such as screening for gestational diabetes, assessing body mass index in healthcare practice, or screening high risk individuals for type 2 diabetes.
• Testing novel adaptation, or translation, of evidence based interventions to evaluate effectiveness within applied practice or community settings. Such evidence based interventions could include behavioral lifestyle counseling for weight management in both children and adults or diabetes self management approaches to improve adherence and tighten glucose control.
• Adaptations should retain core strategies from the evidence based intervention (e.g. inclusion of both dietary and physical activity changes as well as core behavioral strategies for weight loss). Innovations in delivery frequency, intensity and/or modality are encouraged, particularly if they are aimed at overcoming barriers to wide implementation or unique barriers in high risk communities. Amount of adaptation should be balanced with maintaining core elements of an evidence based approach. A less expensive and more adoptable approach only benefits public health if it also achieves meaningful health outcomes.

All grant applications must specifically include a description of the tested approach’s capacity to address the following questions:

a) Could it be applied to a significant number of at risk individuals?

b) Could it be widely disseminated (widely adopted) and implemented (put into practice)?

c) Would the approach be sustainable once the research is concluded?

• In addressing this question, grant applications must include an evaluation of the implementation costs for the tested approach. Full cost effectiveness evaluations are not required but the application must include a plan to assess cost of implementation beyond the research setting including accounting for resources such as personnel and infrastructure.
• The application must also include an evaluation of cost related to health benefit achieved (e.g. intervention X costs Y for Z number of lbs./kg. of weight loss; % body weight lost; % change in HbA1C).
• In demonstrating sustainability, applicants are particularly encouraged to partner with community organizations, employers, insurers, health care providers, pharmacies, electronic medical/health record developers or other organizations that might provide a venue for continued dissemination and implementation if the intervention or approach is proven effective.

Studies addressing diverse populations at disproportionate risk for obesity, diabetes, and diabetes complications are encouraged. However, research where the main focus is on development and validation of culturally appropriate materials such as translation into another language or some relatively superficial tailoring of a program (racially and ethnically consonant pictures, food, and exercises) is not consistent with the focus of this FOA. Translation to a different population requires that the adaptation or modification to the evidence based approach must be based on meaningful differences between the target population and the population addressed in the clinical efficacy research. For example, research testing adaptations that address unique barriers or differences in lifestyle and beliefs. Also, the proposed research must demonstrate that the approach has the potential to be generalized across a reasonably large segment of the at risk population.

Research addressing high risk populations is encouraged. Research is particularly encouraged in American Indians and/or Alaskan Native populations residing on reservations or in more urban settings. The prevalence of diabetes among the 3.3 million American Indians and Alaska Natives 20 years of age and older is 16.3% with an additional 30% having pre-diabetes as reported in the most recent 2008 update. These disparities are over two times higher than seen in non-Hispanic whites and the outcome of this is a death rate that is three times higher.

The primary outcomes in these studies should include objective endpoints such as improvement in glycemia, and/or weight change expressed as BMI, percent weight or body fat decrease, etc. Change in patient behavior is important but will best improve health if it also results in clinically meaningful outcomes related to obesity and/or diabetes.

In some cases behavior change would be acceptable as the primary outcome if it is objectively measured. Changes in healthcare provider assessment or intervention behavior are acceptable as a primary outcome if there is an objective endpoint such as chart or electronic health record review or pharmacy data. A self-reported outcome may not be included as the primary outcome. Also, changes in diet composition and/or physical activity patterns or knowledge acquisition may be included as secondary or intermediate outcomes but should not be used as primary outcome measures.

Study design and the accompanying analysis plan must be linked to the research question. The research designs employed do not necessarily have to be randomized controlled trials. However, researchers should choose the most rigorous design that is still feasible and relevant to the questions posed.

Research that is not appropriate for this funding opportunity includes:

• Testing approaches that simply provide advice about dietary intake or exercise unless this advice is included as part of an evidence-based weight management intervention. Further, testing changes in micro or macro nutrients is not a targeted area of research unless these changes are part of an intervention to reduce energy intake for weight management.
• Testing mediators, moderators, or mechanisms of change is encouraged for inclusion in secondary aims, but may not be the primary focus of the research.
• Although important for infant health, testing approaches to increase breastfeeding are also not a research target.
• Animal based research is not permitted for this funding opportunity announcement. All studies must be in humans.

Investigators who require a planning and pilot testing prior to a full scale trial are encouraged to consider applying for an R34 (PAR-12-173) prior to submission of an R18 proposal.

Applicants may be interested in the messages and resources already developed by the National Diabetes Advisory Board (NDEP) and available on the NDEP web site at http://www.ndep.nih.gov/.

Funding Instrument	Grant
Application Types Allowed	New Renewal Resubmission Revision 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 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 actual needs of the proposed project. Budgets over $500,000 in direct costs per year must receive prior approval as noted in Section IV.6.
Award Project Period	The maximum period is 5 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

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 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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 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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

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.

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

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

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

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.

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.

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.

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 SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the NIDDK 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 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 SF 424 (R&R) Application Guide.

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

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/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).

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(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?

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

Translation

Is the approach to be tested novel and/or significant in relation to its potential to meaningfully improve healthcare or public health? Does the approach to be tested have the potential to reach and/or be generalized to a reasonably large segment of at risk individuals? If the translation is to a new population, is the adaptation or modification to the evidence based approach directed toward meaningful differences between the target population and the population addressed in the clinical efficacy research? For example, does the proposed intervention address unique barriers or differences in lifestyle and beliefs? Does the approach to be tested have the potential for wide dissemination and implementation at the conclusion of the research? Have the researchers justified the sustainability of the approach beyond the research period, including appropriate partnerships and consideration of cost and resources such as personnel and infrastructure? Is there a sufficient evaluation of the implementation costs in relation to sustainability and the health benefit achieved?

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

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/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.

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:

• 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/priority 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 (NDDKAC). 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(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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: [email protected]

Christine M. Hunter, Ph.D. (for psychological or behavioral research in diabetes and obesity)
Division of Diabetes, Endocrinology and Metabolic Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 594-4728
Fax: (301) 480-0475
Email: [email protected]

Myrlene Staten, M.D. (for adult medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 402-7886
FAX: (301) 480-3503
E-mail: [email protected]

Sanford Garfield, Ph.D (for American Indian/prevention research)
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 594-8803
E-mail: [email protected]

Barbara Linder, M.D., Ph.D. (for pediatric medical research)
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 594-0021
E-mail: [email protected]

Robert Kuczmarski, Ph.D (for obesity trial research)
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 451-8354
E-mail: [email protected]

Mary Horlick, M.D. (for pediatric obesity research in clinical settings)
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 594-4726
E-mail:[email protected]

Michele L. Barnard, Ph.D.
Deputy Chief, Review Branch
Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard
Bethesda, MD 20892-5460
Telephone: (301) 594-8898
Email: [email protected]

Natasha Loveless, MBA
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 2DEM RM 720C
6707 Democracy Blvd
Bethesda, MD 20892
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.