and Human Services (HHS)
EXPIRED
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.
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 NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
For
this FOA, Facilities and Administrative (F&A) costs requested by consortium
participants must be included in the total direct costs requested. The F&A
costs for the primary grantee institution will be
added at the time of award, and will be based on the grantee institution s
current negotiated rate.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit an
application(s) if your institution/organization is a domestic institution that has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI), and who meets the eligibility criteria below, is invited to work with his/her organization to develop an application for support. Women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply.
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. Any request for an exception to the eligibility requirement of time from last doctoral degree must be based upon additional medical training (e.g., clinical fellowship) or unusual circumstances. For requests based on clinical fellowship training, only the time spent in clinical training, not in research training, will be considered. Requests must be specifically justified in the Biographical Sketch in the application and will be considered on a case-by-case basis. Applicants who do not meet these eligibility requirements and whose applications lack an explicit and justified request for an exception in the Biographical Sketch will be considered ineligible.
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 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 that was reviewed in the applicant’s name. Multiple PIs have the same leadership status on grants as individual PIs; therefore, applicants who have served as one of multiple PIs on any ineligible grant are no longer considered new investigators and are not eligible to apply for a 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, they may not have received the Notice of Grant Award for that pending grant at the time of the start date for the Type 1 Diabetes Pathfinder Award.
The proposed research need not be in a conventional biomedical or behavioral discipline but must be relevant to type 1 diabetes. This initiative is to support new investigators proposing new and innovative research with potential for exceptionally high impact on type 1 diabetes. Awardees are required to commit at least 25% of their full-time professional effort (e.g., 3 calendar months) each year to the project supported by the Type 1 Diabetes Pathfinder Award. There are no citizenship or residency requirements.
For more detail regarding eligibility requirements, see FAQs on the Type 1 Diabetes Pathfinder Award web site at 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
301-710-0267, Email: [email protected].
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: [email protected]
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 |
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.
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.htm. We 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: [email protected]
(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: [email protected]
(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: [email protected]
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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