Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
This FOA is developed as part of the Strategic Plan for Type 1 Diabetes Research (http://www.T1Diabetes.nih.gov/plan), and is supported by the Special Statutory Program for Type 1 Diabetes Research; all NIH Institutes and Centers are participating. This FOA is being administered by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on behalf of the NIH.

Title:  Type 1 Diabetes Pathfinder Award (DP2)

Announcement Type

New 

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request For Applications (RFA) Number: RFA-DK-08-001

Catalog of Federal Domestic Assistance Number(s)
93.847, 93.848, 93.849

Key Dates
Release/Posted Date: November 26, 2007
Opening Date:  March 10, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: March 13, 2008.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date:  April 10, 2008
Peer Review Date(s): June/July, 2008
Council Review Date: August, 2008 (New Date October 2008 per NOT-DK-08-017)
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available (Activation Date): November 23, 2007 - Frequently Asked Questions (FAQs) at:    http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm
Expiration Date: April 11, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Applicant PD/PIs must hold an independent research position at a domestic (U.S.) institution as of September 19, 2008 and must have received their most recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., or equivalent) or completed their medical internship and residency no earlier than 1998 and no later than the receipt date for applications. For the purpose of this FOA, “independent research position” means a position that automatically confers eligibility, by the applicant’s institutional policy, for an investigator to apply for R01 grants, with an appropriate commitment of facilities to be used for the conduct of the proposed research.  Investigators still in training or mentored status (postdoctoral fellows) are not eligible to apply unless they have a written commitment of an independent faculty position as of September 19, 2008 that is certified by submission of the application from that institution.

Applicants must meet the definition of “new investigator.” For the purpose of this FOA, “new investigators” are defined as those applicants who have never been PI on an R01 or equivalent NIH grant (e.g., R23, R29, R33, R37, DP1, DP2 ,U01, P01 or center grant), PI or sub-project director of a P01, or PI of a center grant peer-reviewed project.  Individuals who are PDs/PIs on multi-PI R01 or equivalent NIH grants are not eligible to apply for the Type 1 Diabetes Pathfinder Award. Current or past recipients of K awards are eligible except for the following: K99/R00 or other Independent Scientist and other non-mentored career awards (K02, K04, K05, K24, and K26).  Applicants may submit or have an R01 (or equivalent) grant application pending concurrently with their Type 1 Diabetes Pathfinder Award application. However, if that pending grant is awarded in Fiscal Year 2008 with a start date of September 30 or earlier, the applicant is no longer eligible to receive the Type 1 Diabetes Pathfinder Award. Awardees are required to commit at least 25% of their full-time professional effort (e.g., 3 calendar months) each year to activities supported by the Type 1 Diabetes Pathfinder Award.

There are no citizenship or residency requirements.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
         1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background

Type 1 diabetes is a disease caused by the autoimmune destruction of the insulin-secreting beta cells of the pancreas.  Type 1 diabetes requires daily insulin administration, but episodes of hyperglycemia and hypoglycemia are common, and as a result patients with type 1 diabetes may suffer devastating consequences including accelerated cardiovascular and peripheral vascular diseases, nephropathy, retinopathy, neuropathy, oral diseases and premature death.  The incidence of type 1 diabetes appears to be increasing worldwide.  Although the disease may occur at any age, the onset of type 1 diabetes peaks prior to twenty years of age.  In some populations, about one percent of all newborns will develop type 1 diabetes during their lifetime.

Recent advances in fundamental science and in our understanding of the pathogenic processes underlying type 1 diabetes and its complications in animal models offer tremendous promise for the development of new therapies.  Recently, a few immunoregulatory agents have shown promise for the delay of type 1 diabetes onset or progression in human studies.  However, for such agents to reach their full therapeutic potential, a number of obstacles must be overcome.  These include a better understanding of triggers of autoimmunity, immunoregulation and tolerance to self, mechanisms of immune-mediated destruction of pancreatic beta cells, and beta cell growth, function and regeneration.  Better understanding in these areas is needed to develop therapies that will block beta cell autoimmune destruction, spare normal immune responses to pathogens, and allow beta cells to recover function in already affected patients.  Research is needed for the development of improved models, in which to test new therapies and measures to predict or assess response to therapy in early trials of potential therapies.  Also needed are improved methods to monitor disease progression, such as methods to assess beta cell mass and inflammation non-invasively.

The success of islet transplantation in freeing individuals with established and brittle type 1 diabetes from the need for insulin therapy has yielded great excitement.  However, islet transplantation requires immunosuppression that is associated with significant side effects and long-term risks.  Moreover, protocols generally require two donor pancreata per recipient; therefore, current levels of organ donation do not provide sufficient organs for all of the people who could potentially benefit from this therapy.  Finally, the transplanted islets often are observed to decline in function with time, and many patients eventually need to resume some exogenous insulin therapy.  The recent success in islet transplantation provides additional impetus for research to develop methods to attain an unlimited supply of islets or beta cells for transplantation; to improve the viability of transplanted islets; and to minimize the toxicity of immunomodulation required for transplant acceptance and maintenance.

The complications of type 1 diabetes account for most of the burden of this disease.  Intensive insulin therapy and inhibitors of the angiotensin signaling pathway have led to a decrease in the incidence in some of the complications.  Yet, even with these therapies, individuals still face significant morbidity and premature death from diabetes complications.  Hyperglycemia induces a number of metabolic changes within the cell.  A better understanding is needed of the link among these molecular and cellular abnormalities and the pathophysiology of diabetes seen at the tissue and organ system levels.  Two emerging areas of interest are the role of reactive oxygen species and abnormal angiogenesis in the development of diabetes complications.  These areas and other emerging pathways provide multiple potential targets for therapeutic intervention.    

Hypoglycemia is a devastating complication of type 1 diabetes that often limits the ability to rigorously control blood glucose.  Research is needed to foster translation of new understandings about the mechanisms of hypoglycemia unawareness and defective counter-regulation into new approaches to reduce the occurrence of hypoglycemia and pharmacologic approaches to restore counter-regulation.  Improved devices for measuring and monitoring glycemia and/or development of closed loop systems linking glucose sensors and insulin delivery devices are needed.  Research is needed to improve the ability of health care providers, patients and parents to manage diabetes, maximizing glycemic control while minimizing the hypoglycemia and stress associated with diabetes control.  An opportunity exists to incorporate behavioral approaches into deployment of new devices through research that examines optimum patient and provider use of the information delivered by these new technologies.

Objectives and Scope

Research supported by these awards would be expected to address significant barriers to prevention and reversal of type 1 diabetes and its complications. Examples of opportunities that could be pursued to address current roadblocks to progress include, but are not limited to:

The Type 1 Diabetes Pathfinder Award (http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm) was created in 2008 to support exceptional new investigators who propose highly innovative new research approaches that have the potential to produce a major impact on important problems in biomedical and behavioral research related to type 1 diabetes and its complications.  The potential impact of the proposed research, if successful, is a major review criterion.  The term “award” is used to mean a grant for conducting research, rather than a reward for past achievements. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences.  While R01 grants will continue to be the primary source of NIH support for new investigators, the Type 1 Diabetes Pathfinder Award is designed to support a small number of exceptionally creative new investigators whose research is focused on type 1 diabetes research.  The research proposed need not be in a conventional biomedical or behavioral discipline but must be relevant to type 1 diabetes.  The purpose of this award is to provide a foundation for the investigator to develop an innovative approach to research questions in type 1 diabetes that are major obstacles to curing, preventing and treating individuals with type 1 diabetes.  The application should provide a brief overview of the future direction of work after completion of the research in the initial grant.

Investigators who have not previously studied diabetes are encouraged to apply.  Examples would be investigators with experience in vascular biology, immunology or neuroscience who would like to apply their expertise to type 1 diabetes research.  These investigators are strongly encouraged to obtain co-investigators with a strong background in diabetes research.  Diabetes Centers (http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DiabetesCenterProgram.htm) may be a resource for establishing these collaborations.

The proposed research must be directly relevant to type 1 diabetes.  Research on diabetes complications or the pancreatic beta cell does not have to focus exclusively on type 1 diabetes; it may include animal models of type 2 diabetes or humans with type 2 diabetes, if the results of the research would further our understanding of type 1 diabetes and the development of new therapies.

For Frequently Asked Questions, see: http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm

This FOA announces the Type 1 Diabetes Pathfinder Award competition for at least 8 awards of up to $1.5 million for a five-year period (an average annual budget of up to $300,000 direct costs) plus applicable Facilities and Administrative costs.  Awards will be made in Fiscal Year 2008.

This FOA uses “Just-in-Time” information concepts. For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the DP2 award mechanism.  The applicant will be solely responsible for planning, directing, and executing the proposed project. Applications proposing multiple PIs are not allowed. 

2. Funds Available

This is a Special Statutory Program for Type 1 Diabetes Research initiative. Total funding available for this five-year program is $20M dollars in FY2008 to fund at least 8 applications, contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. 

Awards will be for up to a total of $1.5 million in direct costs (average of $300,000 per year) for a five-year budget/project period, plus applicable Facilities and Administrative costs to be determined at the time of award.

NIH grant policies as described in the http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Applicants may submit only one application as a PD/PI in response to this FOA. There is no limit to the number of applications that institutions may submit.   

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site. See the detailed instructions below regarding choosing an application package (Section 1 – Request Application Information).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. After clicking “Apply for Grant Electronically,” applicants will be presented with a list of ten application packages corresponding to ten scientific areas, as described in the Special Instructions in Section 2 below. (The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers. The application requirements and instructions below are identical for all ten packages. All ten scientific areas are considered as a single competition, are reviewed in the same time period, and compete for a single source of funds.)

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Other Project Information
Research & Related Senior/Key Person

Optional Components:
PHS398 Cover Letter File (Note:  Cover letters should be included ONLY when submitting late applications.)

When submitting an initial application after the receipt date, include an explanation of the delay as part of the cover letter attachment. (See Late Application Policy in Section 2.14 of the Application Guide.)

When submitting a Changed/Corrected Application after the submission date, a cover letter is required explaining the reason for the Changed/Corrected Application. If you already submitted a cover letter with a previous submission and are now submitting a Changed/Corrected Application, you must include all previous cover letter text in the revised cover letter attachment. The system does not retain any previously submitted cover letters until after an application is verified; therefore, you must repeat all information previously submitted in the cover letter as well as any additional information. Cover letters are not required when submitting changed/corrected applications before the receipt deadline.

SPECIAL INSTRUCTIONS  

The Commons ID of the PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Applications proposing multiple PIs are not allowed.

The application to be submitted to Grants.gov must include:

Areas of Science:

01 Behavioral and Social Sciences

02 Chemical Biology

03 Clinical and Translational Research

04 Epidemiology

05 Immunology

06 Instrumentation and Engineering

07 Molecular and Cellular Biology

08 Neuroscience

09 Physiology and Integrative Systems

10 Quantitative and Computational Biology

Preliminary data are allowed but not required. Bibliographic citations (references), figures, and illustrations may be included, but must fit within the 10-page limit. The essay is uploaded on the Research & Related Other Project Information Component form, Item 7.

Special requirements for completing the SF424 (R&R) application are specified in Section IV.6, below. In addition:

Format specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications for PDF attachments in the Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: March 10, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: March 13, 2008
Application Submission/Receipt Date: April 10, 2008
Peer Review Date(s): June/July, 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 30, 2008

3.A.1. Letter of Intent

Prospective applicants may submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Francisco Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-7924 (use 20817 for courier/express  mail)
Telephone: 301-594-8897
Fax: 301-480-3505
Email: calvof@niddk.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Also see “Special Instructions” in Section IV.2 of this FOA. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date. (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIDDK.  Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on his/her application status in the Commons.

4. Intergovernmental Review

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.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Follow all application instructions outlined in the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf) incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for Type 1 Diabetes Pathfinder Award applications. Applications that do not conform to the specific instructions detailed below will not be reviewed.

1. SF424 (R&R) COVER COMPONENT:

Item Number and Title

Instructions

13. Proposed Project

Enter start date: 09/30/2008; Enter end date: 07/31/2013

16  Estimated Project Funding
16 a. Total Estimated Project Funding

Enter up to $1,500,000

16 b. Total Federal & Non-Federal Funds

Enter up to $1,500,000

2. RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1. Are Human Subjects Involved?

Check “Yes” or “No” (Human subjects information will be requested at the time of award)

2. Are Vertebrate Animals Used?

Check “Yes” or “No” (Animal assurance information will be requested at the time of award)

6. Project Summary/Abstract

Attach abstract. (Maximum of 300 words [not to exceed one page]; applicants should include a Public Health Relevance statement as a part of the project summary/abstract;PDF format)

7. Project Narrative

Attach essay (Maximum of ten pages; PDF format)

8. Bibliography & References Cited

Do not use. If you choose to include figures or reference citations, they must be included in the essay, subject to the 10-page limit.

9. Facilities & Other Resources

Do not use.

10. Equipment

Do not use.

11. Other Attachments

Do not use.

Note: Applications found not to comply with the page limit requirements or that contain attachments other than those specified may be rejected during the agency validation process.

3. SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:

Complete items only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.

Item Title

Instructions

Profile- PD/PI - Attach Biographical Sketch

Attach biographical sketch here (two-page maximum, PDF format). Use the form shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support (see below). Any request for an exception to the eligibility requirement of time from last doctoral degree or medical internship/residency must be specifically justified in this section of the application, as described in Section IV.2.

Profile- PD/PI - Attach Current & Pending Support

Attach a list of Current and Pending Support here (PDF format). Use the form shown in the URL in Section 3.1.1.8 of the Application Guide. Be sure to include a statement affirming that you will devote at least 25% of your full-time professional effort (e.g. 3 calendar months) to the Type 1 Diabetes Pathfinder Award project. Also, include in this section a brief statement of the facilities to be used for the conduct of the research.

Profile – Senior Key Person 1

Do not use.  Submit information only for PD/PI.  Information on collaborators may be included in the essay.

Note: Applications found not to comply with the page limit requirements may be rejected during the agency validation process.

4. PHS 398 Cover Letter File (Optional):

Cover letters should be included only when submitting late applications or Changed/Corrected applications after the submission deadline. Do not submit cover letters for initial submissions or for changed/corrected applications submitted before the submission deadline. The cover letter should contain only the following information:

1.   PD/PI name.

2.   Funding Opportunity Title: Type 1 Diabetes Pathfinder Award (DP2).

3.   For late applications, include an explanation of the delay. (See Late Application Policy in Section 2.14 of the Application Guide.)

4. For Changed/Corrected Applications submitted after the submission deadline, include an explanation of the reason for the Changed/Corrected Application.

(See full instructions for submitting the Cover Letter Component in Section 5.2 of the Application Guide. Note: Items 3 – 6 of the Guide do not apply to Type 1 Diabetes Pathfinder Award applications.)

Letters of Reference:

Letters of reference are not required and will not be accepted.

PHS398 Research Plan Component Sections:

Not applicable.

Appendix Materials:

Appendices are not allowed and will not be accepted. Applications that contain attachments other than those specified may be rejected during the agency validation process.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria       

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated by a specially constituted, multidisciplinary group of outside experts convened by NIDDK.  The reviews will be conducted electronically. The review criteria will emphasize the importance and potential impact of the scientific problem in type 1 diabetes research, the novelty and innovativeness of the approach, and evidence of the applicant’s potential for creative and innovative research as a “new investigator.” Specifically, reviewers will evaluate:

The NDDK National Advisory Council will conduct the second level of review.

The following will be considered in making funding decisions:

The Director, NIDDK, will make the final selection of awardees based on the evaluations by the outside experts, the recommendations of the NDDK National Advisory Council, and programmatic considerations.

Since the Type 1 Diabetes Pathfinder Award applications are reviewed differently from other NIH grant mechanisms, priority scores and percentiles are not assigned. Applicants will not receive review scores or comments. There is no appeals process.

Final selections will be publicly announced, and awards made, by the end of September 2008.

2.A. Additional Review Criteria:

None

2.B. Additional Review Considerations

NOTE: For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).   

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

NOTE: For this FOA, no specific budget information is to be submitted either with the application or just-in-time. 

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

Not Applicable.

3. Anticipated Announcement and Award Dates

Awardees will be notified in September, 2008, and awards will begin September 30, 2008.  

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. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., “Funding Restrictions.”       

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.

The following terms and conditions will be incorporated into the NoA and will be provided to the PD/PI and the appropriate institutional official at the time of award.

2a. When issuing statements, press releases, and other documents describing projects or programs funded as a Type 1 Diabetes Pathfinder Award, please use the following acknowledgement: "This work was funded by the National Institutes of Health through the Type 1 Diabetes Pathfinder Award, grant number DP2-DK-xxxxxx. Information on the Type 1 Diabetes Pathfinder Award is at http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm.”

2b. As indicated in the FOA, awardees are expected to commit at least 25% of their full-time professional effort (e.g. 3 calendar months) to the project supported by the Type 1 Diabetes Pathfinder Award.

2c. Awardees are expected to attend an annual symposium in the Bethesda, MD, area.

2d.  Since the full budget/project period funding for this award is issued from one fiscal year’s appropriation, an extension of time for a period after August 31, 2012 is not allowable.  Therefore, it is imperative that the Final Financial Status Report and the Federal Cash Transactions Report be submitted by September 30, 2012.

3. Reporting

Awardees will be required to submit a scientific progress report on September 1 of each year describing the progress made under this grant and to submit a final progress report, Final Invention Statement, and Financial Status Report at the end of the budget/project period.

Section VII. Agency Contacts


Many questions are addressed in the FAQs on the Type 1 Diabetes Pathfinder Award web site at:  http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htmWe encourage any remaining inquiries concerning this funding opportunity (e-mail is strongly preferred) and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

James F. Hyde, Ph.D.
Senior Advisor for Research Training and Career Development Programs
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 789
Bethesda, Maryland 20892-5460
Phone: 301-594-7692

Email:  pathfinder@mail.nih.gov   (e-mail is the strongly preferred method for inquiries)

2. Peer Review Contact:

Francisco Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 752
Bethesda, Maryland 20892-7924 (use 20817 for express/courier mail)
Phone: 301-594-8897; Fax: 301-480-3505
Email: calvof@niddk.nih.gov  (e-mail is the strongly preferred method for inquiries)

3. Financial/Grants Management Contact:

Shelley Carow
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health
6707 Democracy Boulevard, Room 735A
Bethesda, Maryland 20892-5455
Phone: 301-594-8853
FAX: 301-480-9523
Email: carows@niddk.nih.gov

Please see the Frequently Asked Questions (FAQs) on the Type 1 Diabetes Pathfinder Award (http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_T1D_Pathfinder_Award.htm).

Section VIII. Other Information


Required Federal Citations

Information responsive to the following federal citations should not be submitted with the application.  Just-in-time information will be requested for those applications being considered for funding.

Use of Animals in Research: 
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:

Not applicable.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Publicly accessible on-line journal articles or PubMed Central (PMC) articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the essay or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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