The National Institute of Diabetes & Digestive & Kidney Diseases

Type 1 Diabetes Pathfinder Award

Type 1 Diabetes Pathfinder Award (DP2):   RFA-DK-08-001

 Key RFA Dates:

Letter of Intent Receipt Date:  March 13, 2008
Application Submission/Receipt Date:  April 10, 2008

 Reviewers for Type 1 Diabetes Pathfinder Award:  Final Meeting Roster  (Initial Posting: July 1, 2008; Updated: August 11, 2008)

  Ten New Investigators Earn Type 1 Diabetes Pathfinder Awards  (September 2008)

 Frequently Asked Questions (Initial Posting: November 26, 2007)

A.  General Questions

B. Eligibility

E.  Evaluation of Applications

1. When will my application be reviewed?
2. I have obtained important new preliminary data that will strengthen the application I have already submitted. May I submit these data now?
3. Will my application be reviewed by a special group of reviewers? Will they be experts in my field?
4. When will the outside expert peer reviewer roster be posted on the Type 1 Diabetes Pathfinder Award web site?
5. How can I assure that my application will be reviewed by the appropriate reviewers?
6. May I request to exclude a specific reviewer with whom I have a conflict of interest?
7. What criteria will be used to assess applications?
8. The Type 1 Diabetes Pathfinder Award application is so different from the usual type of NIH grant application. Will reviewers be reminded that the application requirements and review criteria are different, so they do not revert to an R01-type review?
9. When will I hear anything about the results of the review?
10. Can I get some preliminary indication if I am even being considered for funding? I need to know if I should be preparing another grant application for the next deadline.
11. How can I tell how well I did in peer review if there is no priority score assigned to my application?
12. I have changes to my funding status from that indicated in the list of current and pending support that was submitted with my application. Should I send in an update?

F.  Selection of Awardees

1. How will final decisions for awards be made?
2. What will be included in a request for just-in-time (JIT) information?
3. What specific information is required for human subjects in research?
4. What specific information is required for vertebrate animal research?
5. When will the Type 1 Diabetes Pathfinder awardees be notified?
6. Will I receive a summary statement or a priority score?
7. Can the results of the review or funding decision be appealed?
   

   ---

A. General Questions

1.  Why was the Type 1 Diabetes Pathfinder Award established?

The Type 1 Diabetes Pathfinder Award program addresses two important goals: supporting creative new investigators and stimulating innovative research in type 1 diabetes. Many new investigators have innovative research ideas, but not the preliminary data required to fare well in the traditional NIH peer review system. The Type 1 Diabetes Pathfinder Award was established to support exceptionally creative new investigators who propose innovative research projects that have the potential for unusually high impact in type 1 diabetes. This award complements ongoing efforts by NIH and its Institutes and Centers to fund new investigators through R01 grants and other mechanisms.

2. How many awards will be made in 2008?

It is anticipated that at least 8 awards will be made in Fiscal Year 2008, depending on the quality of the applications and the availability of funds.

3. How many applications does NIH expect to receive for the Type 1 Diabetes Pathfinder Award?

This is a new program and we cannot predict the number of applications that will be submitted.

4. What is the definition of “new investigator”?

For the purpose of this RFA, a “new investigator” is defined as an applicant who has never been the principal investigator (PI) on an R01 or equivalent grant (e.g., R23, R29, R33, R37, DP1, DP2, or U01), PI or sub-project PI of a P01, or PI of a center grant peer-reviewed project. Individuals who have led time-limited pilot projects in center grants are eligible to apply. Current or past recipients of K awards are eligible except for the following: K99/R00 or other Independent Scientist awards, and other non-mentored career awards (K02, K04, K05, K24, and K26). In addition, applicants 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/residency no earlier than 1998 and no later than the receipt date for the application.

5. May two or more new investigators apply as a team for the Type 1 Diabetes Pathfinder Award?

No. Since the Type 1 Diabetes Pathfinder Award considers the creativity and potential for innovation of the PI as a very significant part of the review, only one PI is allowed on a Type 1 Diabetes Pathfinder Award. The PI may collaborate with others, but only one person may be the PI. Co-investigators, collaborators and consultants are allowed and may be funded on a Type 1 Diabetes Pathfinder Award.

6. What scientific areas are eligible under the Type 1 Diabetes Pathfinder Award?

The proposed research may be in any scientific area relevant to type 1 diabetes research (biological, behavioral, clinical, social, physical, chemical, computational, engineering and mathematical sciences), but need not be in a conventional biomedical or behavioral discipline.

7. Will applications focused on technology development be allowed, or will only hypothesis-driven research applications be allowed?

Applications proposing hypothesis-driven research and those proposing the development of new tools and technologies are both encouraged. The focus is on creativity and innovation; preliminary data are not required, but may be included.

8. Are women and members of underrepresented groups encouraged to apply?

Yes. We strongly encourage women and members of groups that are underrepresented in biomedical or behavioral research to apply.

9. What is the budget that I may request?

You may request up to $1.5 million in direct costs for the five-year budget/project period. (See FAQ Section C: Application Process and how to determine your budget request.)

10. Do Type 1 Diabetes Pathfinder Awards include facilities and administrative (indirect) costs?

Yes. In addition to the direct costs, applicable facilities and administrative (indirect) costs will be allowed and will be determined at the time of award.

11. Why is the budget request for this grant mechanism different from other NIH grants?

Most other NIH grants require you to request an annual budget, either modular or detailed. For the Type 1 Diabetes Pathfinder Award application, you are asked to request only the total five-year budget. We do not require, and will not accept, budgetary details (See FAQ Section C: Application Process and for how to determine the budget request.)

12. Why are the budget period and project period for this grant mechanism the same?

For most NIH grants, funds are made available to the institution on a yearly basis. For the Type 1 Diabetes Pathfinder Award, NIH will commit all five years of funding for each grant from the FY2008 budget (i.e. multi-year funding). This is an unusual feature for NIH grants, but it will have no effect on your ability to conduct your research.

13. How much time/effort are recipients expected to devote?

Awardees are expected to commit at least 25 percent of their full-time professional effort (e.g., 3 calendar months) to the project supported by the Type 1 Diabetes Pathfinder Award. Investigators should not apply if they are unable to commit this amount of effort to the project.

14. If 50 percent of my time is devoted to clinical and/or teaching duties and 50 percent to research, how much time/effort would I be required to devote to the Type 1 Diabetes Pathfinder Award?

If you spend 50 percent of your time doing research (6 calendar months), you would be required to devote at least 25 percent of your full-time professional effort (e.g., 3 calendar months) to the Type 1 Diabetes Pathfinder Award.

15. I am working with a collaborator in another country. Would I be able to continue to spend some time conducting research there?

The PI of the Type 1 Diabetes Pathfinder Award must be employed by a U.S. institution and the research must be conducted at that institution. However, there may be circumstances, such as epidemiologic studies in other countries, in which the PI of the Type 1 Diabetes Pathfinder Award must conduct part of the research outside of the United States. This research is allowable. However, the length of any single foreign research stay should not exceed the time allowable under NIH Grants Policy for a PI to be away from his/her laboratory without appointing a temporary PI (i.e. three months). Due to the special nature of the Type 1 Diabetes Pathfinder Award, appointment of a temporary PI is not allowable.

16. What post-award requirements must I fulfill?

Awardees will be required to submit a scientific progress report on June 1 of each year describing the progress made under this grant. A final progress report, Final Invention Statement, and Financial Status Report must be submitted at the end of the budget/project period. In addition, to help NIH evaluate this program, awardees may be contacted periodically for at least five subsequent years and asked to report on their latest research efforts.

17. If I receive a Type 1 Diabetes Pathfinder Award, will I still be considered a “new investigator” when I apply for my first R01 grant?

No.

18. Are Type 1 Diabetes Pathfinder Awards renewable?

No. Competing renewal applications for a Type 1 Diabetes Pathfinder Award will not be allowed. At the end of the five-year Type 1 Diabetes pathfinder Award project period, awardees are expected to seek support to continue their research through traditional routes, such as submission of an R01 grant application.

19. Once awarded, is this award transferable if I change institutions next year?

This award may be transferred to another eligible institution according to the same policies and procedures as for traditional research grants. Please note, however, that awards may not be transferred to foreign institutions.

B.  Eligibility

1. I finished my Ph.D. in November 1997, but didn’t graduate until the spring of 1998.  Am I eligible to apply?

The formal date of receipt of your Ph.D. is the date the degree was conferred, as indicated on your diploma and/or transcript. That date determines your eligibility to apply for a Type 1 Diabetes Pathfinder Award. If your Ph.D. was conferred in 1998 or later, and you meet all of the other eligibility criteria, you are eligible to apply.

2. I received my Ph.D. in 1996, but I have had a hiatus during my research career to take care of family members.  May I get an exception to the time from degree requirement?

Any request for an exception to the eligibility requirement of time from last doctoral degree or internship/residency must be based upon clinical training or unusual circumstances, and will be considered on a case-by-case basis. A hiatus in research due to time off for care of family members is an acceptable justification for an exception to the time requirement for eligibility. However, the overall length of the hiatus should be commensurate with the deviation from the date required for this eligibility criterion. The format for this request is described in the full request for applications (RFA). (See RFA Section IV.2, Biographical Sketch.)

3. I received my Ph.D. in 1997, but I had a delay in my research due to a flood in our animal facility that resulted in the loss of my valuable mutant mouse colony. May I request an exemption from the time requirement due to the time lost in my research career during the replacement of my experimental mouse colony?

Applicants 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/residency in 1998 or later. A request for an exception to the eligibility requirement of time from last doctoral degree or internship/residency must be based upon additional clinical training or unusual circumstances and will be considered on a case-by case basis. The format for this request is described in the full RFA. (See RFA Section IV.2, Biographical Sketch.) In the case where an unusual circumstance has caused a serious setback in your research you must indicate how much research time was actually lost. You may want to mention this in your essay also.

4. I received my Ph.D. in 1995 but spent four years in industry before taking my first academic position.  Am I eligible to apply?

No. There is no distinction between time spent in industry and time spent in academia. If your Ph.D. was awarded earlier than 1998, unless you have a hiatus in your research due to unusual circumstances, you are not eligible to apply.

5. My Ph.D. degree was in 1996, but I had two years of postdoctoral training before beginning my independent research career.  Am I eligible?

No. If your Ph.D. was awarded earlier than 1998, unless you had a hiatus in your research due to unusual circumstances, you are not eligible to apply.

6. I received my M.D. in 1995 and spent several years in clinical training before commencing my research.  Am I eligible to apply?

Applicants 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/residency in 1998 or later. Any request for an exception to the eligibility requirement of time from last doctoral degree or internship/residency must be based upon additional clinical training or unusual circumstances and will be considered on a case-by case basis. For requests based on clinical fellowship training, only the time spent in clinical training, not in research training, will be considered. Any requests for an exception to this eligibility requirement of time must be made in the actual application; the format for this request is described in the full RFA. (See RFA Section IV.2, Biographical Sketch.)

7. I received my M.D. in 1995 and my M.P.H. in 2000.  Am I eligible?

Applicants 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/residency in 1998 or later. The M.P.H. is not a doctoral degree and does not extend the time limit for eligibility. However, if you completed a medical internship/residency in 1998 or later, you are eligible to apply.

8. What is meant by “independent research position”?

For the purpose of this award, “independent research position” means a position that is held by an investigator who is permitted by his/her institutional policy to apply for R01 grants, with an appropriate commitment of institutional 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.

9. Do I have to be a U.S. citizen to apply?

No. There are no citizenship or residency requirements.

10. May I apply from a foreign institution?

No. You may apply only if you are at an institution in the United States or its territories. For the type of eligible domestic institutions, please see the RFA. (See RFA Section III.1.A, Eligible Institutions.)

11. Are investigators at small businesses eligible to apply?

Yes, if the small business is a U.S. company and the research is conducted within the United States or its territories.

12. Are foreign scientists eligible?

Yes, but only if they are conducting their research and hold an independent research position at a U.S. institution that is eligible to apply. There are no citizenship or residency requirements.

13.  Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?

Individuals from all U.S. organizations that can otherwise apply to the NIH for funding and are willing to abide by the terms and conditions that NIH requires are eligible for this award if they meet the other eligibility requirements.

14.  Are scientists in the NIH intramural program eligible?

No. Because intramural scientists may not receive extramural NIH grants, they may not apply for the Type 1 Diabetes Pathfinder Award.

15. I am currently a postdoctoral fellow. Am I eligible to apply for a Type 1 Diabetes Pathfinder Award?

To be eligible to apply, you must have an independent research position (defined above in Section B) by September 19, 2008. Since applications are submitted by an institution on behalf of the principal investigator, the application must be submitted by the institution where you will conduct the research. This can be done in advance of your actual appointment date if the receipt deadline is before that date. You should consult the sponsored research office at your new institution about this. Investigators in postdoctoral training positions are not considered “independent” and are not eligible to apply unless they have accepted their first independent appointment that starts no later than September 19, as confirmed by submission of the application from the new institution. If you have not been appointed to an independent research position by September 19, 2008, you will not be eligible to receive a Type 1 Diabetes Pathfinder Award.

16. I’ve had a K award. Am I still eligible?

For the purpose of this RFA, current or past recipients of a K99/R00 Pathway to Independence Award, or Independent Scientist and other non-mentored career awards (K02, K05, K24, and K26) are not considered new investigators. Having any other K award (e.g., mentored K awards) does not disqualify you from eligibility to apply.

17. I had an R01 grant several years ago but have no R01 grant now. Am I eligible to apply?

No. If you were ever the PI of an R01 (or equivalent) NIH grant, you are not eligible to apply.

18. I am the PI of an R21 grant. This provides a significant amount of support for my research. Am I eligible to apply?

Yes. An investigator who is the PI on an R21 or other significant but allowable research grant is eligible to apply if he/she meets all of the other eligibility criteria. However, recipients of an R21/R33 Phased Innovation Award, which combines the review of the R21 and R33 phases of the award, are not considered “new investigators” and are not eligible to apply. Also, other peer-reviewed grants that support work closely related to the proposed Type 1 Diabetes Pathfinder Award project will be taken into consideration in review and funding decisions.

19. I applied for, but did not receive, an NIH Director’s New Innovator Award in 2007. May I apply for a Type 1 Diabetes Pathfinder Award if I still qualify as a new investigator and meet the other eligibility criteria?

Yes, you may apply for a Type 1 Diabetes Pathfinder Award if you plan to submit or have other grant applications pending. However, the Type 1 Diabetes Pathfinder Award will not be awarded if you have already accepted any grant that would make you ineligible.

20. May I submit the identical or similar application for both the Type 1 Diabetes Pathfinder Award (RFA-DK-08-001) and the 2008 NIH Director’s New Innovator Award (RFA-RM-08-014)?

No, the NIH will not accept similar grant applications with essentially the same research focus for these two funding opportunities.

21. After I submitted the Type 1 Diabetes Pathfinder Award application, but before finding out whether I would receive the award, I was awarded an R01 (or equivalent) NIH grant. May I cancel that grant and accept the Type 1 Diabetes Pathfinder Award?

No. Once you have received a Notice of Award naming you as the principal investigator of an R01 (or equivalent) grant for which you were the submitting (applicant) PI, you are ineligible for a Type 1 Diabetes Pathfinder Award, even if you only held the award for a short time and no funds were drawn down from the grant payment system. For the Type 1 Diabetes Pathfinder Award competition, if a pending grant is awarded with a start date of September 30, 2008 or earlier, you are no longer eligible to receive a Type 1 Diabetes Pathfinder Award.

22. I applied for an R01 grant in February 2008. I have never had an R01 grant before. May I also apply to the Type 1 Diabetes Pathfinder Award program if I qualify as a new investigator?

Yes. You may submit an application for the Type 1 Diabetes Pathfinder Award if you have other grant applications pending. However, you will not be selected for a Type 1 Diabetes Pathfinder Award if you have accepted any grants that would make you ineligible at the time of award in September 2008.

23. Since I do not know if I will receive a Type 1 Diabetes Pathfinder Award, may I apply for an R01 or other grant in the same area of research before I know the outcome of this competition?

Yes. Since the review criteria for a Type 1 Diabetes Pathfinder Award are very different from those for a more traditional NIH research grant, you may apply for another grant in the same area of research while your Pathfinder application is under review. However, you may accept only one grant to support the same research.

24. Are individuals who have other outside sources of support eligible?

You are eligible to apply for a Type 1 Diabetes Pathfinder Award if you have grant support from sources other than NIH and have never been PI on any NIH grants that would disqualify you as a “new investigator.” However, allowable peer-reviewed grants will be taken into consideration in review and funding decisions, especially if they support work closely related to the Type 1 Diabetes Pathfinder research project.

25. If I have a grant from an outside agency, will I be able to remain as the principal investigator on this grant?

Other grant support may be continued if the grant is for an unrelated research project and if you are able to commit the required 25 percent of full-time professional effort (e.g. 3 calendar months) to the Type 1 Diabetes Pathfinder Award.

C.   Application Process

1. I will not be at my new institution in my first independent position until September 2008. Should I apply from my current institution or my new institution?

To be eligible to receive a Type 1 Diabetes Pathfinder Award, you must have an independent research position at an eligible institution by September 19, 2008. Since applications are submitted by an institution on behalf of the principal investigator, the application must be submitted by the institution where you will conduct the research. This can be done in advance of your actual appointment date if the receipt deadline is before that date. You should consult the sponsored research office at your new institution about this.

2. Do I need or may I submit letters of reference?

No. Letters of reference are not required and will not be accepted.

3. How do I determine the size of my budget request?

Funds may be requested for personnel, supplies, equipment, subcontracts, and other allowable costs. You should estimate the direct costs for each year and sum them to derive the five-year total. Note that the direct and indirect costs for any subcontract must be included within the direct cost cap ($1.5 million over five years) for the budget from your institution. Only the five-year total should be requested, and in must not add up to more than $1.5 million. Budget detail is not required and should not be submitted.

4. May I request fewer than five years? My proposed research project can be completed in less time.

Yes. You may request a project period of fewer than five years if your proposed project can be completed is less time. You should provide an explanation for the request project period within the ten-page essay. The maximum allowable budget request is reduced proportionately from the maximum allowed for a five-year project period.

5. May my collaborator be funded on my Type 1 Diabetes Pathfinder Award?

Yes. Collaborators and consultants may be funded on a Type 1 Diabetes Pathfinder Award, either directly or by a subcontract. Collaborators need not meet the definition of “new investigator.” If you want to discuss the role(s) of collaborators, consultants and/or access to resources, you may do so in the essay. The application does not have a place to list key personnel other than the PI. There is also no place for letters of collaboration or other biographical sketches, and these will not be accepted.

6. Do I need or may I submit letters of collaboration?

No. Letters of collaboration are not required and will not be accepted. If you want to discuss the role of collaborators, you may do so in the essay.

7. Must the indirect costs related to subcontracts be included in the overall direct cost limit of the Type 1 Diabetes Pathfinder Award?

Yes. For the Type 1 Diabetes Pathfinder Award, the direct and indirect costs for any subcontracts must be included within the direct cost cap ($1.5 million over five years) for the budget from your institution.

8. The definition of “independent research position” requires an appropriate commitment of institutional facilities. What information do I need to provide to demonstrate this institutional commitment?

Applicants must include, in the list of current and pending research support, a brief statement of the facilities to be used for the conduct of the proposed research. By submitting this application on your behalf, your institution is committing these facilities for the conduct of the research.

9. What are the dates for submission of applications?

The Grants.gov application may be submitted beginning March 10, 2008, and must be successfully received by Grants.gov no later than 5:00 p.m. local time of the applicants institution/organization on April 10, 2008. Application materials will not be accepted after that time, and applications that are not complete will not be reviewed.

10. What must be done before I submit an application to Grants.gov?

Important: You should immediately check with your sponsored research office to determine whether your institution is registered with Grants.gov. Please note that the registration process could take up to two weeks. The institution’s Authorized Organizational Representative (AOR) is responsible for completing the registration process. If your institution is not already registered, it must first register with the Central Contractor Registry (the Credential Provider) at http://www.ccr.gov/ and then with Grants.gov at http://www.grants.gov/applicants/get_registered.jsp. Both the institution and the applicant must also complete one-time registration in the NIH eRA Commons (https://commons.era.nih.gov/commons/) in order to submit applications to NIH. Institutional officials are responsible for registering investigators in the eRA Commons. You should work with your AOR (also known as the Signing Official in the eRA Commons) to determine your institution’s process for registration.

11. Where may I find help registering for Grants.gov?

For help with the Grants.gov registration process, contact Grants.gov customer support at 1-800-518-4726 (toll free), Monday through Friday, 7:00 a.m. to 9:00 p.m. (Eastern Time), or at support@grants.gov.

12. Where may I find help in submitting my application to Grants.gov?

For help with the technical aspects of submitting an application to Grants.gov, check the resources available on the Grants.gov website first (http://grants.gov). If you need assistance, contact Grants.gov customer support at 1-800-518-4726 (toll free), Monday through Friday, 7:00 a.m. to 9:00 p.m. (Eastern Time), or at support@grants.gov.

13. Where may I find help in registering for the eRA Commons?

Step-by-step directions for registering with the eRA Commons are available at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp.

For questions regarding the eRA Commons registration process, contact the NIH eRA Commons help desk at 301-402-7469, 1-866-504-9552 (toll free), or 301-451-5939 (TTY), Monday through Friday, 7:00 a.m. to 8:00 p.m. (Eastern Time).

14. Whom do I contact if I have questions about programmatic aspects of the Type 1 Diabetes Pathfinder Award?

For questions of a programmatic nature, contact Dr. James Hyde at pathfinder@mail.nih.gov or 301-594-7692. E-mail inquires are preferred.

15. Is there a limit to the number of applications that may be submitted by an institution?

There is no limit to the number of applications that an institution may submit. However, an investigator may submit only one application.

D.  Grant Application Format and Content

1. What format should I use for the documents submitted with my application to Grants.gov (abstract, essay, biographical sketch, current research support)?

All documents must be in PDF format. Other formatting requirements are in the Application Guide (MS Word-2.87 MB) or (PDF – 2.82 MB), Section 2.6, Format Specifications for Text (PDF) Attachments. The abstract must be no more than 300 words (no more than one page).  Applicants should include a Public Health Relevance Statement as part of the abstract. For the biographical sketch, use the format shown in the Application Guide (MS Word-2.87 MB) or (PDF – 2.82 MB) Part III, omitting Section C, Research Support. The biographical sketch must not exceed two pages. For the list of current and pending support, use the format shown in the Application Guide (MS Word – 2.87 MB) or (PDF – 2.82 MB), Part III.

Applicants with documents that exceed the page limits will be considered non-responsive and will not be evaluated.

2. How should I structure the 10-page essay? Should I include specific aims?

The essay should include the following sections, in order, to facilitate the review: Project Description, Innovativeness, and Investigator Qualifications. To focus the essay on the goals of the Type 1 Diabetes Pathfinder Award program and the specific review criteria, presentation of the proposed research as a series of specific aims is discouraged. As indicated in the RFA, the description of the scientific project in the essay should be written with a level of detail appropriate for reviewers who are broadly knowledgeable but who may not be directly involved in the proposed area of research. See RFA Section IV.2: Special Instructions for more details about the content of the 10-page essay.

3. Does the ten-page essay replace the traditional “Research Plan” (with “Specific Aims”) or is it to be submitted in addition to that section?

The ten-page essay replaces the traditional 25-page “Research Plan” section for most other NIH grant applications. The requirements for a Type 1 Diabetes Pathfinder Award application are very different from those for most other NIH grants. Read carefully the application instructions and review criteria in the RFA.

4. In my essay, may I include citations to key publications? If so, what is the appropriate format?

Yes, you may include citations in the essay, as long as they fit within the ten-page limit. The citations may be in any format.

5. In my essay, may I include figures and illustrations?

Yes, you may include figures and illustrations in the essay, as long as they fit within the ten-page limit.

6. The application package that I downloaded from Grants.Gov does not include budget pages. Are detailed, annual budgets required? Where do I indicate indirect (facilities & administrative) costs?

Detailed, annual budgets are not required and will not be accepted. Indirect (facilities and administrative) costs will be determined at the time the award is made.

7. Where do I submit the various required sections of the application?

• Abstract – upload on Item 6, Research & Related Other Project Information Component form.  Applicants should include a Public Health Relevance Statement as part of the abstract.

• Essay – upload on Item 7, Research & Related Other Project Information Component Form.

• Biographical sketch – upload on Senior/Key Person Profile Component where indicated.

• List of current and pending support – upload on Senior/Key Person Profile Component where indicated.

8. Where do I designate the Area of Science for my application?

After clicking “Apply for Grant Electronically” to download the application, applicants will be presented with a list of ten application packages, each with a separate “Competition ID and Title.” Each application package corresponds to one of the science areas listed below. The application requirements and instructions are identical for all ten packages. The only difference between the packages is the indicated category of scientific research. You should determine which Area of Science best describes your proposed research. You may download and submit only one of the ten application packages.

9. What are the 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

10. I cannot determine the best fit for my Area of Science. What should I do? What is the Area of Science coding used for?

The designation of scientific area by applicants is used solely to aid in selection of the most appropriate group of peer reviewers and does not in itself affect an application’s funding potential. 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.

NIH staff cannot advise you on the specific selection of an Area of Science for your project. We understand that for interdisciplinary and multidisciplinary research projects, more than one Area of Science might be appropriate. To select the most appropriate Area of Science for your proposed research (by selection of one of the ten application packages), you should consider whether reviewers with expertise in one or another Area of Science would be most likely to appreciate the significance of the project, the innovativeness of its approaches, and its potential impact.

The Areas of Science listed are very broad and frequently overlapping. The reviewers for the Type 1 Diabetes Pathfinder Award applications are chosen for their breadth of knowledge and expertise, and will be able to review a broad range of applications. The description of the scientific project in the essay should be written with a level of detail appropriate for reviewers who are broadly knowledgeable but not who may not be directly involved in the proposed area of research.

11. May I designate more than one Area of Science?

No. Only one area may be designated. This is to assist in assigning applications to evaluators for review.

12. Where should the effort commitment statement (statement confirming that if chosen to receive an award, the applicant will commit a minimum of 25 percent of his/her full-time professional effort to Type 1 Diabetes Pathfinder Award activities) be placed?

The statement should be placed in the list of current and pending support.

13. Where should a request for an exception to the time limitation post receipt of my doctoral degree (or internship/residency) be placed?

The request and justification should be placed in the biographical sketch.

14. May I include additional information in an appendix? I need additional space for my list of references, etc.

All information submitted for the review of your application must be included in the allowed sections of the application, within the specified limits of space. Appendices will not be accepted. There is no place for appendix material in the application format.

E.   Evaluation of Applications

1. When will my application be reviewed?

Peer review will take place in June-July over a period of several weeks. The review period is the same for all scientific areas.

2. I have obtained important new preliminary data that will strengthen the application I have already submitted. May I submit these data now?

We cannot accept any additional information after an application has been submitted. Only the information contained in the original application will be reviewed.

3. Will my application be reviewed by a special group of reviewers? Will they be experts in my field?

Applications will be reviewed first by NIH staff for eligibility and then by a specially constituted, multidisciplinary group of outside experts who are broadly knowledgeable but may not be directly involved in your proposed area of research. Applications identified as the most outstanding by the peer reviewers will be forwarded to the National Diabetes and Digestive and Kidney Diseases Advisory Council, which will conduct the second level of review.

4. When will the outside expert peer reviewer roster be posted on the Type 1 Diabetes Pathfinder Award web site?

The roster will be posted in June/July 2008, shortly before the start of the review.

5. How can I assure that my application will be reviewed by the appropriate reviewers?

Applications will be assigned to the review group for the Area of Science that you selected for your application. Your assignment notification may indicate a generic review group number, but the Area of Science for all applications will be verified before assignment to the appropriate reviewers. Please note that the rosters of outside expert peer reviewers posted on the Type 1 Diabetes Pathfinder Award web are still tentative and are likely to be modified up to the time that the reviews take place. The final rosters will be posted in July, shortly before the start of the review.

6. May I request to exclude a specific reviewer with whom I have a conflict of interest?

Applicants cannot request who can or cannot review their application. The policies regarding conflict of interest are no different for the Type 1 Diabetes Pathfinder Award than they are for any other NIH application. In addition, as for all NIH reviews, reviewers are instructed in their orientation to recuse themselves from reviews with which they have any of a variety of clearly delineated conflicts.

7. What criteria will be used to assess applications?

The reviewers are looking for convincing evidence that the applicant is an exceptionally creative new investigator who is proposing an innovative approach with the potential to produce results that will have an unusually high impact on a significant problem in type 1 diabetes research. They will also assess the appropriateness of this application for the Type 1 Diabetes Pathfinder Award process rather than the standard peer review process. For more detail, see RFA Section V.2. Review and Selection Process.

8. The Type 1 Diabetes Pathfinder Award application is so different from the usual type of NIH grant application. Will reviewers be reminded that the application requirements and review criteria are different, so they do not revert to an R01-type review?

Yes. The reviewers will receive an in-depth orientation about the specific goals, requirements and review criteria for the Type 1 Diabetes Pathfinder Award prior to the start of their review.

9. When will I hear anything about the results of the review?

Applicants being considered for a Type 1 Diabetes Pathfinder Award will receive a request for just-in-time information at the end of August or beginning of September. Just-in-time information includes updated other support and animal and human subjects assurances, if applicable. Since the applications will be reviewed differently from other NIH grant mechanisms, priority scores and percentiles are not assigned. Applicants will not receive review scores or comments.

10. Can I get some preliminary indication if I am even being considered for funding? I need to know if I should be preparing another grant application for the next deadline.

Successful and unsuccessful applicants will be notified by mid-September. We are unable to provide you with any information regarding the potential for funding prior to this formal notification.

You do not need to wait for information regarding your Type 1 Diabetes Pathfinder Award application to submit a new research grant application for the next deadline. You may submit any applications you wish while your Type 1 Diabetes Pathfinder Award application is pending.

11. How can I tell how well I did in peer review if there is no priority score assigned to my application?

For administrative reasons, all applications except those selected for funding will be designated as “unscored.” Those selected for funding will be arbitrarily assigned a score of 100. No other information will be available.

12. I have changes to my funding status from that indicated in the list of current and pending support that was submitted with my application. Should I send in an update?

No. An update of your funding status should not be submitted unless specifically requested. If you are being considered for funding, you will receive a request for just-in-time information, and you can update your current and pending funding at that time.

F.  Selection of Awardees

1. How will final decisions for awards be made?

After initial review first by NIH staff for eligibility and then by a multidisciplinary group of outside experts for peer review, all applications will be forwarded to the National Diabetes and Digestive and Kidney Diseases Advisory Council, which will conduct the second level of review. The Director, NIDDK, will make the final selection of awardees based on the evaluations by the outside experts, the recommendations of the Advisory Council, and programmatic considerations.

Applicants being considered for an award will receive a request for just-in-time (JIT) information. This request is not a commitment of funding. Many more requests for JIT information are made than applications funded. (See below for detail about JIT information.)

2. What will be included in a request for just-in-time (JIT) information?

Just-in-time information includes an up-to-date list of your current and pending research support and, if relevant to your project, full descriptions of research involving vertebrate animals and/or human subjects with required information and assurances.

3. What specific information is required for human subjects in research?

You should review the information on human subjects in research at  http://grants.nih.gov/grants/funding/phs398/phs398.html and prepare your submitted information based on these guidelines. Before any research involving human subjects can be initiated, we will need the information detailed in the PHS398 Grant Application instructions.  This information includes: a) a full description of the research to be performed using the required human subjects sections of the grant application; b) verification of the institutional Federal Wide Assurance number for human subjects protection; c) date of IRB approval, and d) appropriate signatures.

4. What specific information is required for vertebrate animal research?

You should review the information on vertebrate animal in research at http://grants.nih.gov/grants/funding/phs398/phs398.html and prepare your submitted information based on these guidelines. Before any research involving vertebrate animals can be initiated, we will need the information detailed in the PHS398 Grant Application instructions.  This information includes:  a) a full description of the research to be performed (including the required five points); b) verification of the institutional Animal Welfare Assurance number; c) date of IACUC approval, and d) appropriate signatures.

5. When will the Type 1 Diabetes Pathfinder awardees be notified?

The awardees will be notified in September 2008.

6. Will I receive a summary statement or a priority score?

No. You will not receive a summary statement or a priority score. Since the applications will be reviewed differently from other NIH grant mechanisms, priority scores and percentiles are not assigned.

7. Can the results of the review or funding decision be appealed?

No. There is no appeal process.

* Documents in PDF format require the free Adobe Acrobat Reader application for viewing.