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Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Planning Grants for Translational Research to Improve Obesity and Diabetes Outcomes (R34)

Activity Code

R34 Clinical Trial Planning Grant Program

Announcement Type

Reissue of PAR-09-177

Related Notices

  • August 30, 2013 - See Notice NOT-DK-13-019. 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-12-173

Companion Funding Opportunity

PAR-12-172, R18 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, 93.242

Funding Opportunity Purpose

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Mental Health (NIMH) encourage NIH Clinical Trial Planning Grant Program grant (R34) applications from institutions/ organizations to develop and pilot 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. NIMH encourages research focused on people with severe mental illness (SMI), whose risk for obesity and type 2 diabetes is twice that of the general population. The approaches tested should have the potential to be widely disseminated to clinical practice, individuals and communities at risk.

Key Dates
Posted Date

April 24, 2012

Open Date (Earliest Submission Date)

June 2, 2012

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

(See Notice NOT-DK-13-019 for revised dates), Originally July 2, 2012 , November 1, 2012 , March 1, 2013, July 1, 2013, November 1, 2013, March 3, 2014, July 1, 2014, November 3, 2014, 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, July 2015

Advisory Council Review

January 2013, May 2013, October 2013, January 2014, May 2014, October 2014, January 2015, May 2015, October 2015

Earliest Start Date(s)

April 1, 2013

Expiration Date

(Now Expiring March 4, 2014 per NOT-DK-13-019), 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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 should propose pilot and feasibility studies to 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:

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?

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 and mutable differences between the target population and the population addressed in the clinical efficacy research (e.g., 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 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.

NIMH encourages research focused on people with severe mental illness (SMI), whose risk for obesity and type 2 diabetes is twice that of the general population. For purposes of this announcement, NIMH defines people with severe mental illness as adults who have a diagnosable psychiatric disorder that has resulted in significant impairment which substantially interferes with or limits major life activities. While schizophrenia, bipolar disorder and major depression are commonly considered SMI, this funding opportunity includes as SMI those mental disorders with equivalent symptom severity and/or functional impairment. In the 50-state Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study, 41% of participants with schizophrenia had metabolic syndrome, though few received appropriate treatment. Lifestyle behaviors associated with poor health outcomes, such as inactivity and poor diet, are more prevalent in persons with SMI, and these factors may combine with metabolic side effects of antipsychotic medications to produce the high rates of diabetes, heart disease and obesity found in persons with SMI.

Persons with SMI who are often already receiving mental health services represent an identifiable high-risk population with potential for engagement in evidence-based obesity and diabetes care through these service settings. Accordingly, NIMH seeks services research applications that employ population-based approaches to delivering evidence-based screening and care for obesity and type 2 diabetes in persons with SMI.

The primary outcomes in all studies submitted to this funding announcement 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 question/s posed.

Funding for this R34 is designed to provide pilot and feasibility data to be used in developing full-scale studies that would be submitted ***EITHER TO NIDDK as R18 research demonstration and dissemination projects (PAR-12-172), OR TO NIMH AS R01 applications for full-scale services research studies that target people with SMI (please see link to PA-11-260 http://grants.nih.gov/grants/guide/pa-files/PA-11-260.html). It is recommended that investigators review the guidance regarding requirements for the R18 (or R01 if submitting applications in populations with SMI that would be directed to NIMH) to help understand the long-terms goals of the R34 project. For example, an R18 must consider capacity for wide dissemination, sustainability, and implementation costs. Additionally, an outline of the key features of the subsequent full-scale study resulting from the R34, including biostatistical considerations should be included along with a discussion of how the R34 will lead to a subsequent R18 or R01 proposal. Applicants who do not require support for a pilot and feasibility study may apply for an R18 directly (PAR-12-172) or an R01 if submitting to NIMH.

The sample size needed to pilot the proposed study, including the assumptions used when estimating the sample size, should be detailed in relation to the analysis plan. 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 an R18 effectiveness trial.

Research that is not appropriate for this funding opportunity includes:

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/.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Resubmission

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

Direct costs of up to $150,000 per year are allowed.

Award Project Period

The maximum period is 2 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Required Registrations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. 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.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

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

Page Limitations

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

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, 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 fc15y@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

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?

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

Not Applicable.

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDDK or the NIMH,,in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council or the National Advisory Mental Health Council, depending on primary assignment. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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)
Telephone: (301) 594-4728
Fax: (301) 480-0475
Email: ch514c@nih.gov

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)
Telephone: (301) 402-7886
Fax: (301) 480-3503
E-mail: ms808k@nih.gov

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)
Telephone: (301) 594-8803
E-mail: sg50o@nih.gov

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)
Telephone: (301) 594-0021
E-mail: bl99n@nih.gov

Robert Kuczmarski, Ph.D (for obesity trial research)
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: (301) 451-8354
E-mail: rk191r@nih.gov

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)
Telephone: (301) 594-4726
E-mail:mh559n@nih.gov

Susan Azrin, PhD (for research targeting people with severe mental illness)
Division of Services and Intervention Research
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3267
E-mail: susan.azrin@nih.gov

Peer Review Contact(s)

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

David Armstrong, Ph.D.
Chief, Extramural Review Branch
National Institute of Mental Health
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

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

Rebecca Claycamp
Chief, Grants Management Officer
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
E-mail: rclaycam@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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