1. Why has the NIH Director established the NIH Director’s New Innovator Award?
   The NIH Director's New Innovator Award addresses two important goals: stimulating highly innovative research that has the potential for significant impact, and supporting promising new investigators. As part of NIH's commitment to increasing opportunities for new scientists, it has created the NIH Director's New Innovator Award to support a small group of exceptionally creative new investigators who propose bold new approaches that have the potential to produce a major impact on a broad area of biomedical or behavioral research. This award complements ongoing efforts by NIH and its institutes and centers to fund new investigators through R01 grants and other mechanisms, which continue to be the major sources of support for new investigators.
   
   

2. What distinguishes the NIH Director’s New Innovator Award from R01 grants and other traditional NIH grant programs?
   The NIH Director's New Innovator Award program is different from traditional NIH grants in several ways. It is designed specifically to support only a small group of unusually creative new investigators with highly innovative research ideas at an early stage of their career. The emphasis is on innovation and creativity. Preliminary data are not required, but may be included. No detailed, annual budget is requested in the application. The procedure for evaluating applicants' qualifications is distinct from the traditional NIH peer review “study section” process. (See Section E: Review Process, below.) The review is conducted electronically. The review criteria emphasize the importance and potential impact of the scientific problem in biomedical and behavioral research, the novelty and innovativeness of the approach, and evidence of the applicant’s potential for creative and innovative research as a “new investigator.”  
   

3. Is the New Innovator Award replacing the Pioneer Award?    
   No. These are distinct programs, as described below.
   
   
4. What distinguishes the new NIH Director’s New Innovator Award from the existing NIH Director’s Pioneer Award?
   Both NIH Director's Awards focus on creativity and innovation. The New Innovator Award is specifically targeted to new investigators who have not yet received an R01 or equivalent type of NIH grant and who have had a relatively short time since receipt of the doctoral degree. The Pioneer Award program is open to all investigators regardless of career stage. There are other differences in eligibility requirements. Although both programs require only a brief application, details of the application formats are different.
   

5. What changes were made to the New Innovator Award RFA this year from that published in 2007?
   The most significant changes are listed below. Other changes may be included in the application. You should read the full RFA with careful attention to all detail.
   • Language has been changed to state more clearly the strong emphasis on bold new approaches that have the potential to produce a major impact on a broad area of biomedical or behavioral research.
   • Language has been modified to state more clearly the eligibility requirements and to clarify the process for requesting an exception to the eligibility requirements in the grant application.
   • Time/effort requirement has been reduced from 30% to 25% (3 calendar months) of research time/effort.
   • The Areas of Science have been modified to create new categories for Immunology and Neuroscience; Cellular and Molecular Biology have been combined; Pathogenesis has been eliminated as a separate Area of Science.
   • Applicants will now designate the Area of Science for their proposed project by choosing one of ten separate application packages in Grants.gov.  Each application package corresponds to one of the ten science areas.  This process replaces the previous procedure of including the Area of Science coding in the application title and abstract.
   • The organizational structure for the 10-page essay is now specified.
   • Reviewers’ comments will not be available and summary statements will not be provided to applicants. This practice is consistent with the review process used for NIH Director’s Pioneer Awards for several years.

6. How many awards will be made in 2008? The NIH Director expects to make up to 24 awards in FY 2008, depending on the quality of the applications and the availability of funds.
   
   
7. How many awards were made in 2007?
   Thirty New Innovator Awards were made in September 2007, the end of fiscal year 2007. Information on the 2007 New Innovator Awardees can be found on the New Innovator web site at http://grants.nih.gov/grants/new_investigators/innovator_award/.
   
   
8. How many applications does NIH expect to receive this year?
   Last year was the first competition for this new program. We received over 2100 applications. We cannot predict the number of applications that will be submitted in 2008.
   
   
9. I applied last year and was not successful. May I apply again? If yes, is this second application considered an amended application?
   You may apply again this year if you were not successful last year and you still meet the eligibility requirements. However, all applications submitted for the 2008 New Innovator Award competition will be considered new applications.  You should consider the previous reviewers’ comments in the context of the strong emphasis on innovation and potential for broad impact as you decide whether to apply again for a New Innovator Award.  
   
   
10. 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) or one of multiple PIs on an R01 or equivalent NIH grant (e.g., R23, R29, R33, R37, DP1, DP2, U01, P01 or center grant) or the leader of a P01 or center grant peer-reviewed project reviewed in the applicant’s name. Also, 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. Individuals who have led time-limited pilot projects in center grants are eligible to apply. 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.
    
    
11. May two or more new investigators apply as a team for the NIH Director’s New Innovator Award?
    No. Since the NIH Director's New Innovator Award considers the creativity and potential for innovation of the PI as a very significant part of the review of the application, only one PI is allowed on a New Innovator 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 New Innovator Award.
    
    
12. What scientific areas are eligible under the New Innovator Award?
    The proposed research may be in any scientific area relevant to the mission of NIH (biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences), but need not be in a conventional biomedical or behavioral discipline.
    
    
13. Will technology development be allowed, or just hypothesis-driven research?
    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. 
    
    
14. 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.
    
    
15. 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 for how to determine your budget request.)
    
    
16. Do New Innovator Awards provide indirect costs?
    Yes. In addition to the direct costs, applicable facilities and administrative costs (indirect costs) will be allowed and will be determined at the time of award based on the institution’s negotiated rate.
    
    
17. 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 New Innovator 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 for how to determine budget request.)
    
    
18. 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 New Innovator Award, NIH will commit all five years of funding for each grant from this fiscal year's budget (i.e., multiyear funding). This is an unusual feature for NIH grants, but it will have no effect on your ability to conduct your research.
    
    
19. How much time/effort are recipients expected to devote?
    Awardees are expected to commit at least 25 percent of their research time/effort, to the project supported by the New Innovator Award. This is a decrease from the 30 percent time/effort requirement for applications last year. Investigators should not apply if they are unable to commit this amount of effort to the project.
    
    
20. 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 expected to devote to New Innovator Award activities?
    If you spend 50 percent of your time doing research, you would be required to devote the least 25 percent of your research time, or 12.5 percent of your total time, to New Innovator Award activities.
    
    
21. 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 a New Innovator 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 studies involving a foreign population or a collaborative research project, in which the PI of a New Innovator Award must conduct part of the research outside 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 New Innovator Award, appointment of a temporary PI is not allowable.
    
    
22. I am conducting epidemiologic research in another country. Would I be able to continue this research under a New Innovator Award?
    The PI of a New Innovator 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 a New Innovator Award must conduct part of the research outside 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 New Innovator Award, appointment of a temporary PI is not allowable.
    
    
23. What post-award requirements must I fulfill?
    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. In addition, to help NIH evaluate this program, awardees may be contacted periodically for at least five years and asked to report on their latest research efforts.
    
    
24. If I receive a New Innovator Award, will I still be considered a “new investigator” when I apply for my first R01 grant?
    No.
    
    
25. Are New Innovator Awards renewable?
    No. Competing renewal applications for a New Innovator Award will not be allowed. At the end of the five-year New Innovator Award project period, awardees are expected to seek support to continue their research though traditional routes, such as submission of an R01 or equivalent grant application.
    
    
26. Once awarded, is this award transferable if I change institutions next year?
    Yes. 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.
    
    
27. Will the New Innovator Award program be offered again in 2009?
    NIH hopes to announce the New Innovator Award program again next year, but we won't know if funds are available until we receive our Fiscal Year 2009 appropriation from Congress.
    
    
28. If I am not successful and the program is reannounced, may I reapply next year?
    Yes, if you meet the eligibility criteria of a subsequent reannouncement.
    
    
29. How will the program be administered?
    Until the time that the awards are made the NIH Director's New Innovator Award Program will be administered by the National Institute of General Medical Sciences on behalf of the NIH Office of the Director. Following award, the New Innovator Awards will be administered by the institute or center (IC) whose mission most closely matches that of the research area of the grant. Awardees will be notified of their funding IC and their grants management and program contacts.
    

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 New Innovator 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 had a hiatus in my research career to take care of family members. Can 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 additional medical 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.  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).
   
   
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 exception from the time requirement due to the time lost in my research career during the replacement of my experimental mouse colony?
   A request for an exception to the eligibility requirement of time from last doctoral degree or internship/residency must be based upon additional medical training or unusual circumstances and will be considered on a case-by-case basis. In the case where an unusual external circumstance has caused a serious setback in your research, you must indicate how much research time was actually lost. The format for this request is described in the full RFA. (See RFA Section IV.2, Biographical Sketch). You may want to mention this interruption of your research 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 had 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 medical 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 and 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 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.
   
   
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 types of eligible domestic institutions, please (See RFA Section IV.2, Biographical Sketch).
    
    
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 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 NIH Director's New Innovator Award.
    
    
15. I am currently a postdoctoral fellow. Am I eligible to apply for an NIH Director's New Innovator 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 New Innovator 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 does not disqualify you from eligibility to apply.
    
    
17. I had an R01 several years ago but have no R01 now. Am I eligible to apply?
    No. If you were ever the PI or one of multiple PIs of an R01 (or equivalent) NIH grant that was reviewed in your name, you are not eligible to apply.
    
    
18. I became the principal investigator on an R01 grant after a colleague in my department, who was awarded the grant, retired. Am I still considered a new investigator, and am I eligible to apply for a New Innovator Award?
    Yes.  You are considered a new investigator if you were not the submitting (applicant) principal investigator, and you are otherwise eligible to apply for a New Innovator Award.
    
    
19. I am the PI on 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 this project will be taken into consideration in review and funding decisions.
    
    
20. After I submitted the New Innovator 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 New Innovator 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 New Innovator 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 2008 New Innovator 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 the New Innovator Award.
    
    
21. I applied for a Pioneer Award in January.  May I also apply for a New Innovator Award if I qualify as a new investigator?
    Yes. You may apply for a New Innovator Award if you plan to submit or have other grant applications pending. However, the New Innovator Award will not be awarded if you have already accepted any grant that would make you ineligible.
    
    
22. I applied for an R01 grant in January. I have never had an R01 grant before. May I also apply to the New Innovator Award program if I qualify as a new investigator?
    Yes. You may submit an application for a New Innovator Award if you have other grant applications pending. However, you will not be selected for a New Innovator Award if you have accepted any grants that would make you ineligible at the time of award in September 2008.
    
    
23. I have never had an R01 grant, and I plan to submit an application for an R01 grant in June. Will this jeopardize my eligibility for a New Innovator Award?
    You may submit an R01 or other grant application after you have submitted an application for a New Innovator Award. You may accept an R01 or other grant subsequent to a New Innovator Award only if it supports a different research project. You may not have two grants to support the same research.
    
    
24. Since I do not know if I will receive a New Innovator 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 New Innovator 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 New Innovator application is under review. However, you may accept only one grant to support the same research. 
    
    
25. Are individuals who have other outside sources of support eligible?
    You are eligible to apply for a New Innovator 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 this project.
    
    
26. 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 research effort to the New Innovator 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 New Innovator 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 hold an independent position and conduct the research. This may 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. Can someone at NIH review my idea and let me know if it is a good fit for the New Innovator program?
   No. NIH staff cannot provide comments on specific ideas or plans for individual research grant applications. The peer review process will evaluate the merit of your application.
   
   
4. How do I determine the size of my budget request?
   Funds may be requested for personnel (including co-investigators, collaborators, and consultants), 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 it must not add up to more than $1.5 million.  Budget detail is not required and should not be submitted.
   
   
5. May I request fewer than five years? My proposed 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 in less time. You should provide an explanation for the requested 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.
   
   
6. May my collaborator be funded on my New Innovator Award?
   Yes. Collaborators and consultants may be funded on a New Innovator Award, either directly or by a subcontract. Collaborators need not meet the definition of "new investigator." If you want to discuss the role of collaborators, consultants and/or your 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.
    
   
7. 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.
   
   
8. Must the indirect costs related to subcontracts be included in the overall direct cost limit for the New Innovator Award?
   Yes. For the New Innovator 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.
   
   
9. 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 research. By submitting this application on your behalf, your institution is committing these facilities for the conduct of the research.
   
   
10. What are the dates for submission of applications?
    The Grants.gov application may be submitted beginning March 3, 2008, and must be successfully received by Grants.gov no later than 5:00 p.m. local time of the applicant institution/organization on March 31, 2008. Application materials will not be accepted after that time, and applications that are not complete will not be reviewed.
    
    
11. 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/GetStarted.Both the institution and the applicant must also complete a 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 own institution's process for registration.
    
    
12. Where can 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.
    
    
13. Where can 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 Web site 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.
    
    
14. Where can I find help in registering for the eRA Commons?  
    Step-by-step directions for registering with eRA Commons are available at http://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. For questions regarding the 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).
    
    
15. Whom do I contact if I have questions about programmatic aspects of the New Innovator Awards?
    For questions of a programmatic nature, contact Dr. Judith Greenberg at newinnovator@nih.gov or 301-594-4469. E-mail inquiries are strongly preferred.
    
    
16. Is there a limit to the number of applications that can be submitted by an institution? 
    There is no limit to the number of applications that an institution can submit. However, an investigator may submit only one application.
    
    
17. May I submit the identical or similar application for both the 2008 NIH Director’s New Innovator Award (RFA RM-08-014) and the Type 1 Diabetes Pathfinder Award (RFA DK-08-001)?
    No, the NIH will not accept similar grant applications with essentially the same research focus for these two funding opportunities.  Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator have not been used elsewhere in the preparation and submission of a similar grant 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). 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 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 New Innovator 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 detail about the content of the 10-page essay.
   
   
3. Does the 10-page essay replace the traditional “Research Plan” (with “Specific Aims”) or is it to be submitted in addition to that section?
   The 10-page essay replaces the traditional 25-page “Research Plan” section required for most other NIH grant applications. The requirements for a New Innovator 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 (references) 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 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. The Abstract must contain the Area of Science.

   •  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. The Area of Science also should be designated in the Abstract.
   
   
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 selection 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 New Innovator Award applications have been 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. My research is relevant to more than one Area of Science. May I submit more than one application package?
    No.  Only one application package, corresponding to one Area of Science, may be submitted.  The selection of an application package is to identify the most appropriate Area of Science for assigning applications to reviewers.
    
    
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 research efforts to New Innovator 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.
    No. 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 and Selection of Awardees

1. When will my application be reviewed?
   Peer review will take place in May-June over a 3-week period.  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?
   No. 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 will then be forwarded to the Advisory Committee to the Director, NIH, which will conduct the second level of review.
   
   
4. When will the outside expert peer reviewer roster be posted on the New Innovator web site?
   The roster will be posted in May 2008, before the start of the review.
   
   
5. How can I assure that my applications will be reviewed by the appropriate group of reviewers?
   Applications will be assigned to the review group for the Area of Science that you selected for your application. Your assignment notification may initially indicate a generic review group number, but the Area of Science for all applications will be verified before assignment to the appropriate review group. Please note that the initial posting of rosters of outside expert peer reviewers web is tentative; rosters are likely to be modified up to the time that the reviews take place. The final rosters will be posted in May, before the start of the review. 
   
   
6. May I request to exclude a specific reviewer with whom I have a conflict of interest?
   Due to the volume of applications and the way they are assigned, applicants cannot request who can or cannot review their application. The policies regarding conflict of interest are no different for the New Innovator 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 a bold new approach that has the potential to produce a major impact on a broad area of biomedical or behavioral research. They will also assess the appropriateness of this application for the New Innovator Award process rather than the standard peer review process. For more detail, see RFA Section V.2. Review and Selection Process.
   
   
8. The New Innovator 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 New Innovator 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 2008 New Innovator Award will receive a request for just-in-time information. 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 New Innovator Award application to submit a new research grant application for the next deadline. You may submit any applications you wish while your DP2 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 had 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.
    
    
13. 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.
    
    
14. What specific information is required for human subjects research?
    You should review the information on human subjects in research at http://grants1.nih.gov/grants/funding/phs398/HumanSubjects.pdf (PDF - 534 KB) 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, including a full description of the research to be performed using the required human subjects sections of the grant application, verification of the institutional Federal Wide Assurance number for human subjects protection, date of IRB approval, and appropriate signatures.
    
    
15. What specific information is required for vertebrate animal research?
    You should review the information on vertebrate animal subjects in research at http://grants1.nih.gov/grants/funding/phs398/HumanSubjects.pdf (PDF - 534 KB) 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, including a full description of the research to be performed, verification of the institutional Animal Welfare Assurance number, date of IACUC approval, and appropriate signatures.