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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)

Funding Opportunity Title

Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-09-247

Related Notices

  • November 6, 2015 - This PA has been reissued as PAR-16-034.
  • July 9, 2015 - Notice to Extend PAR-12-265. See Notice NOT-DK-15-014.
  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • 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.
  • July 3, 2013 - See Notice NOT-DK-13-013. Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies.

Funding Opportunity Announcement (FOA) Number

PAR-12-265

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 Funding Opportunity Announcement (FOA) is to encourage Research Project Grant (R01) applications from qualified investigators to conduct ancillary studies to major ongoing research studies, including clinical trials, epidemiological studies and disease databases (described as parent studies) supported by the National Institute of Diabetes and Digestive and Kidney Diseases, other Institutes and Centers of the National Institutes of Health, other government agencies and the private sector. The proposed ancillary study must be designed to advance the scientific research mission of the NIDDK by focusing on diseases and areas of direct interest of the Institute. The scientific areas funded by the NIDDK may be found at the following website: htttp:www2.niddk.nih.gov/research. Important elements of this FOA are that the parent study must be ongoing, the subject of inquiry must be within the mission and interest of the NIDDK, the ancillary study must be approved by the appropriate governing body of the parent study, and the proposed study collects new information from enrolled study participant and/or assays of existing or new biologic samples.

Key Dates
Posted Date

August 17, 2012

Open Date (Earliest Submission Date)

September 5, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

New Date November 6, 2015 per issuance of PAR-16-034. (Original Expiration Date: January 8, 2016)
New Date January 8, 2016 per issuance of NOT-DK-15-014. (Original Expiration Date: September 8, 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

Purpose/Research Objectives. This Funding Opportunity Announcement issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) invites investigator initiated research project applications (R01) for ancillary studies to major ongoing clinical trials, epidemiological studies and disease databases (described as parent studies) supported by the Institute, other Institutes and Centers of the National Institutes of Health, other government agencies and the private sector to capitalize on the already established infrastructure of the parent study to enhance the breadth and depth of its scientific output. Major studies include multi-center clinical research investigations, national databases and Phase 3 clinical trials. An ongoing study is one that is currently following and assessing study participants. In some cases grant applications may be submitted prior to implementation of a study (before the study is ongoing) with the anticipation by the applicant that funding will coincide with the beginning of recruitment.

Ancillary studies proposed under this FOA must be of scientific interest and within the mission of the NIDDK. Such studies may be proposed from both NIDDK supported parent studies and parent studies funded from other sources as described above. Typically, but not exclusively, ancillary studies are proposed for NIDDK supported parent studies. The NIDDK-supported parent studies are focused on a wide range of diseases and conditions including diabetes, obesity, acute and chronic liver disease, chronic kidney disease, acute kidney injury, benign prostatic hyperplasia and other lower urinary disorders, among others. Examples of NIDDK-supported parent studies for which ancillary studies may be conducted may be found at the following website: http://www2.niddk.nih.gov/Research/ClinicalResearch/AncillaryStudies/. These studies are typically supported by cooperative agreements or contracts. This FOA also invites applications from investigators who plan to conduct ancillary studies utilizing major ongoing clinical research studies (multi-center clinical research investigations, national databases and Phase 3 clinical trials) supported by other Institutes and Centers of the NIH, other government agencies and the private sector. However, to be eligible for this FOA the ancillary study proposed must be clearly within the scientific mission of the NIDDK and focused on diseases and conditions of direct interest to the Institute. The scientific areas funded by the NIDDK may be found at http://www2.niddk.nih.gov/Research/. Irrespective of the original goals of the parent study, the diseases or conditions of interest to NIDDK must have been rigorously defined and present in a sufficient number of study participants. It is strongly recommended that the applicant contact NIDDK program staff prior to submission of their grant application to verify that the proposed ancillary study addresses research goals within the mission and interest of the Institute. While it is recognized that ongoing studies funded by NIDDK may be useful for studying diseases outside the mission of the NIDDK, this FOA may not be used to support such studies. Applications addressing the research goals of other NIH Institutes may be submitted using the NIH parent R01 FOA (PA-11-260), or relevant FOAs from other Institutes.

The NIDDK supports a large number of major multi-center clinical trials to determine the beneficial effect of therapies and interventions. In addition, the Institute supports a number of large-scale multi-institution epidemiological studies and disease databases to better characterize the natural history and response to treatment of a wide range of diseases and conditions. Each of these studies represents a substantial financial commitment from the NIDDK to establish an infrastructure for participant recruitment, examination, data collection and follow-up. These studies offer unique opportunities to conduct additional investigations to fully exploit the research potential of these established cohorts to study the diseases for which these studies were originally designed. These studies may also provide the opportunity to learn more about diseases and conditions outside the original scope of the study protocol but within the mission and interest of the NIDDK. It is also recognized that studies supported by other Institutes and Centers of the NIH, other government agencies and the private sector may also lend themselves to ancillary studies which will advance the research mission of the NIDDK.

The goal of this FOA is to obtain additional scientific information for the diseases and conditions of interest and within the mission of the NIDDK. It is recognized that there is considerable potential for obtaining new knowledge beyond the core activities of the parent study by means of ancillary studies. For this FOA, core activities are considered the measures described in the parent study protocol and are being carried out; having been previously approved by the group responsible for conducting the study-e.g., the Steering Committee-and/or the study's oversight body-e.g., the Data and Safety Monitoring Board. This knowledge may include identification of additional risk factors for disease or genetic factors related to the development, diagnosis, or progression of disease or to the response to therapy. This FOA may also be used to extend the scope of participant data collection and assessment to identify co-morbidities and their impact on the primary disease/condition under study. It is also recognized that a parent study not originally designed to address diseases and scientific areas of responsibility of the NIDDK may yield important insights and additional information of interest to the Institute through ancillary studies. Generally, this FOA is not applicable to small and/or single center studies. For studies supported by Research Project Grants (R01) ancillary study grant applications may be submitted under the Funding Opportunity for Research Project Grants (Parent R01, PA-11-260). However, to determine eligibility of a parent study it is recommended that interested investigators contact NIDDK staff prior to submission of their grant application. Applications to this FOA must include a letter from the appropriate committee (e.g., Ancillary Study Committee) or person (e.g., Chairman of the Steering Committee) indicating that the parent study investigators have approved the ancillary study. In order to take advantage of new data and/or sample collection at the beginning of recruitment of study participants (at baseline) grant applications may be submitted prior to study implementation (before the study is considered ongoing). In those instances the applicant must include a letter from the parent study sponsoring organization/Project Scientist indicating the timetable for its implementation.

Areas of Research Interest: It is anticipated that grant applications may include but are not limited to identification of additional and/or unique/emerging risk factors, pathogenic mechanisms, genetic factors, predictors of drug response (pharmacogenetics, pharmacogenomics), proteomics, metabolomics, biomarker discovery and/or validation as well as better characterization of the co-morbid illnesses suffered by the subjects enrolled in the parent studies. The natural history, risk factors and effect of clinical trial interventions of diseases and conditions for which the parent study was not originally designed may also be studied by means of additional data collection and/or assay of already collected or newly obtained biological samples as long as new questions being addressed are within the scientific mission of NIDDK.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revisions

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.

Award Project Period

Scope of the proposed project should determine the project period. The maximum project 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.

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 eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

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

All Program 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:

Letters of Support

A letter indicating approval of the ancillary study by the appropriate committee or person from the parent study must be included in the grant application. This information should be uploaded as an attachment in the Other Project Information Component .

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.

Foreign Institutions

Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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.

Requests of $500,000 or more for direct costs in any year

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.

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.

Has the burden of the proposed ancillary study on the parent study participants been adequately described?

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.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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


As part of the scientific peer review, all applications:

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

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 Service Desk (Questions regarding ASSIST, 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)

Mary Evans, Ph.D.
Director, Special Projects in Nutrition, Obesity, and Digestive Diseases
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 681
Bethesda, MD 20892-5450
Telephone: (301) 594-4578
Fax: (301) 480-8300
Email: evansmary@niddk.nih.gov

Saul Malozowski, M.D., Ph.D., M.B.A.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 607
6707 Democracy Boulevard, MSC 5450
Bethesda, MD 20892-5450
Telephone: 301-451-4683
Email: sm007@nih.gov

John W. Kusek, Ph.D.
Division of Kidney, Urologic and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 617
6707 Democracy Boulevard, MSC 5450
Bethesda, MD 20892-5450
Telephone: 301-594-7735
Email: jk61x@nih.gov

Peer Review Contact(s)

Michele Barnard, Ph.D.
Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 751
6707 Democracy Boulevard, MSC 5450
Bethesda, MD 20892-5450
Telephone: 301-594-8898
Email: barnardm@mail.nih.gov

Financial/Grants Management Contact(s)

Carolyn Kofa
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and
Kidney Diseases
Two Democracy Plaza, Room 746
6707 Democracy Boulevard, MSC5450
Bethesda, MD 20892-5450
Telephone: 301-594-7687
Email: kofac@mail.nih.gov

Diana O'Donovan
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and
Kidney Diseases
Two Democracy Plaza, Suite 709A
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456
Telephone: 301-594-9523
Email: odonovand@extra.niddk.nih.gov

Kieran Kelley
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and
Kidney Diseases
Two Democracy Plaza, Room 724
6707 Democracy Boulevard, MSC 5456
Bethesda, MD 20892-5456
Telephone: 301-594-2193
Email: kelleykieran@niddk.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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