NIH Director’s New Innovator Award

2009 Frequently Asked Questions

A. General Questions

1. What is the NIH Director’s New Innovator Award?
2. What distinguishes the NIH Director’s New Innovator Award from R01 grants and other traditional NIH grant programs?
3. How does the New Innovator Award program differ from other NIH programs targeting innovative research, such as the Pioneer, Transformative R01 (T-R01), and EUREKA programs?
4. How many awards will be made in 2009?
5. How many awards were made in 2007 and 2008?
6. I applied last year and was not successful. May I apply again? If yes, is this second application considered an amended application?
7. What is the definition of “new investigator”?
8. May two or more new investigators apply as a team for the NIH Director’s New Innovator Award?
9. What scientific areas are eligible under the New Innovator Award?
10. Will technology development be allowed, or just hypothesis-driven research?
11. Are women and members of underrepresented minority groups encouraged to apply?
12. What is the budget that I may request?
13. How do I determine the size of my budget request?
14. Do New Innovator Awards provide indirect costs?
15. Must the indirect costs related to subcontracts be included in the overall direct cost limit for the New Innovator Award?
16. May my collaborator be funded on my New Innovator Award?
17. May I request fewer than five years? My proposed project can be completed in less time.
18. Why is the budget request for this grant mechanism different from other NIH grants?
19. Why are the budget period and project period for this grant mechanism the same?
20. How much time/effort are recipients expected to devote?
21. 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?
22. I am working with a collaborator in another country. Would I be able to continue to spend some time conducting research there?
23. I am conducting epidemiologic research in another country. Would I be able to continue this research under a New Innovator Award?
24. What post-award requirements must I fulfill?
25. If I receive a New Innovator Award, will I still be considered a “new investigator” when I apply for my first R01 grant?
26. Are New Innovator Awards renewable?
27. Once awarded, is this award transferable if I change institutions next year?
28. Will the New Innovator Award program be offered again in 2010?
29. If I am not successful and the program is re-announced, may I reapply next year?

B. Eligibility

1. I finished my Ph.D. in November 1998 but didn’t graduate until the spring of 1999. Am I eligible to apply?
2. I received my Ph.D. in 1997, 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?
3. I received my Ph.D. in 1998, 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?
4. I received my Ph.D. in 1996 but spent four years in industry before taking my first academic position. Am I eligible to apply?
5. My Ph.D. degree was in 1997, but I had two years of postdoctoral training before beginning my independent research career. Am I eligible?
6. I received my M.D. in 1996 and spent several years in clinical training before commencing my research. Am I eligible to apply?
7. I received my M.D. in 1996 and my M.P.H. in 2001. Am I eligible?
8. What is meant by “independent research position”?
9. Do I have to be a U.S. citizen to apply?
10. May I apply from a foreign institution?
11. Are investigators at small businesses eligible to apply?
12. Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?
13. Are scientists in the NIH intramural program eligible?
14. I am currently a postdoctoral fellow. Am I eligible to apply for an NIH Director's New Innovator Award?
15. I will not be at my new institution in my first independent position until September 2009. Should I apply from my current institution or my new institution?
16. I’ve had a K award. Am I still eligible?
17. I had an R01 several years ago but have no R01 now. Am I 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?
19. I am the PI on an R21 grant. This provides a significant amount of support for my research. Am I eligible to apply?
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?
21. I applied for a Pioneer Award in November. May I also apply for a New Innovator Award if I qualify as a new investigator?
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?
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?
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?
25. Are individuals who have other outside sources of support eligible?
26. If I have a grant from an outside agency, will I be able to remain as the principal investigator on this grant?

C. The Competition Process for 2009

1. Are there significant changes from last year to the competition process?
2. What are the dates for submission of 2009 pre-applications?
3. Is there a limit to the number of pre-applications that can be submitted by an institution?
4. Can someone at NIH review my idea and let me know if it is a good fit for the New Innovator program?
5. Do I need or may I submit letters of reference?
6. Do I need or may I submit letters of collaboration?
7. 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?
8. What must be done before I submit a pre-application to Grants.gov?
9. Where can I find help registering for Grants.gov?
10. Where can I find help in submitting my pre-application to Grants.gov?
11. Where can I find help in registering for the eRA Commons?
12. Whom do I contact if I have questions about programmatic aspects of the New Innovator Awards?

D. Grants.Gov Application Documents

1. What format should I use for the documents submitted with my pre-application to Grants.gov (abstract, public health relevancy statement, essay, biographical sketch, current research support)?
2. How should I structure the 10-page essay? Should I include specific aims?
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?
4. In my essay, may I include citations (references) to key publications? If so, what is the appropriate format?
5. In my essay, may I include figures and illustrations?
6. May I include movies, either as a link to a website or as a CD, with my application?
7. The pre-application package that I downloaded from Grants.Gov does not include budget pages. Are detailed, annual budgets required? Where do I indicate indirect costs?
8. Where do I submit the various required sections of the pre-application?
9. The instructions in the FOA state that I have to designate a science area for my pre-application. What is the purpose of the science area?
10. Where do I designate the Area of Science for my pre-application?
11. What are the Areas of Science?
12. May I designate more than one area or science?
13. I cannot determine the best fit for my Area of Science. What should I do?
14. 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?
15. Where should a request for an exception to the time limitation post receipt of my doctoral degree (or internship/residency) be placed?
16. May I include additional information in an appendix? I need additional space for my list of references, etc.

E. 2009 Evaluation and Selection of Awardees

1. How will awardees be selected?
2. What criteria will be used to evaluate pre-applications?
3. Will I receive a summary statement or other comments?
4. I understand that no summary statement will be provided, but will I receive any information as to the outcome?
5. I have obtained important new preliminary data that will strengthen the pre-application I have already submitted. May I submit these data now?
6. When will the outside expert peer reviewer roster be posted on the New Innovator web site?
7. How can I assure that my pre-application will be reviewed by the appropriate group of reviewers?
8. Will the reviewers be experts in the topic of my pre-application?
9. May I request to exclude a specific reviewer with whom I have a conflict of interest?
10. When will I hear anything about the results of the review?
11. Can I get some preliminary indication if I will be notified to submit a full (DP2) application? I need to know if I should be preparing another grant application for the next deadline.
12. When will the 2009 awardees be notified?
13. Can the results of the review or funding decision be appealed?

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A. GENERAL QUESTIONS

1. What is 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, the NIH Director's New Innovator Award supports 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 potential impact. Preliminary data are not required, but may be included. No detailed, annual budget is requested in the application. The procedure for evaluating applicants' proposed projects and 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 or 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. How does the New Innovator Award program differ from other NIH programs targeting innovative research, such as the Pioneer, Transformative R01 (T-R01), and EUREKA programs?

   	Pioneer Award	New Innovator Award	T-R01	EUREKA
   Eligibility	Open to all career stages; early and middle career particularly encouraged to apply Must currently be engaged in research No citizenship or residency requirements Foreign (non-U.S.) institutions not eligible	Most recent doctoral degree (e.g., Ph.D., M.D., D.D.S., D.V.M., Pharm.D., or equivalent) or completion of medical internship and residency no earlier than 1999 and no later than the due date for pre-applications Must be a “new investigator” (never been awarded an R01 or equivalent NIH grant) No citizenship or residency Foreign (non-U.S.) institutions not eligible	Open to all career stages Foreign (non-U.S.) institutions eligible	Open to all career stages Foreign (non-U.S.) institutions eligible
   Preliminary Data	Not required; may be included	Not required; may be included	Not required; may be included	Not required; may be included
   Research plan	3–5 page essay includes response to questions about the challenge, potential impact, suitability for the Pioneer Award program; and how research qualifies as new research direction	10-page essay addresses significance and potential impact; innovativeness of approaches and how risks and challenges will be addressed; and investigator qualifications for the award	8-page limit; respond to questions about the challenge, potential impact, and appropriateness for the T-R01 program	8-page limit; respond to questions about the challenge, potential impact, appropriateness for the mechanism, and likelihood of success
   Effort	Minimum of 51% (major portion) of research effort must be devoted to activities supported by the award	Minimum of 25% of research effort must be devoted to activities supported by the award	Effort should be commensurate with project needs, and follow general guidelines for other NIH projects of similar size, complexity, and duration	Effort should be commensurate with project needs; no minimum effort
   Budget	For pre-applications (X02), no budget information submitted Awards will be for up to $500,000 per year for each of five years, plus standard F&A (indirect) costs	For pre-applications (X02), no budget information submitted Awards will be for up to $300,000 in direct costs each year for five years, plus standard F&A (indirect costs)	No limits up to maximum funds available for the program as a whole No prior approvals required for budgets over $500K (DC) per year	Limits on direct costs – total project $800K, and for any year $250K, plus standard F&A (indirect costs)
   Multiple PIs	Only one PD/PI may be designated on the application	Only one PD/PI may be designated on the application	More than one PD/PI allowed	More than one PD/PI allowed

4. How many awards will be made in 2009?
   The NIH Director expects to make up to 24 awards in FY 2009, depending on the quality of the applications and the availability of funds.
5. How many awards were made in 2007 and 2008?
   Thirty New Innovator Awards were made in September 2007, and 31 awards were made in September 2008. Information on the 2007 and 2008 New Innovator Awardees can be found on the New Innovator Award web site at http://nihroadmap.nih.gov/newinnovator/.
6. 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 2009 New Innovator Award competition will be considered new applications.
7. What is the definition of “new investigator”?
   For the purpose of this Funding Opportunity Announcement (FOA), 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 1999 and no later than the receipt date for the application.
8. 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.
9. 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.
10. 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.
11. Are women and members of underrepresented minority groups encouraged to apply?
    The NIHstrongly encourages women and members of groups that are underrepresented in biomedical or behavioral research to apply.
12. 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.
13. 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. A detailed budget is not required and should not be submitted.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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. Investigators should not apply if they are unable to commit this amount of effort to the project.
21. 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.
22. 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.
23. 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.
24. 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.
25. If I receive a New Innovator Award, will I still be considered a “new investigator” when I apply for my first R01 grant?
    No.
26. 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 through traditional routes, such as submission of an R01 or equivalent grant application.
27. 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.
28. Will the New Innovator Award program be offered again in 2010?
    NIH plans to announce the New Innovator Award program again next year, but we won't know the amount of funds available for the program until we receive our Fiscal Year 2010 appropriation from Congress.
29. If I am not successful and the program is re-announced, may I reapply next year?
    Yes, if you meet the eligibility criteria of a subsequent re-announcement.

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B. ELIGIBILITY

1. I finished my Ph.D. in November 1998 but didn’t graduate until the spring of 1999. 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 1999 or later, and you meet all of the other eligibility criteria, you are eligible to apply.
2. I received my Ph.D. in 1997, 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 pre-application; the format for this request is described in the FOA (see PAR-09-013, Section IV.2, Biographical Sketch.
3. I received my Ph.D. in 1998, 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 FOA (see PAR-09-013, 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 1996 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 1999, 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 1997, 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 1999, 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 1996 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 1999 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 FOA (see PAR-09-013, Section IV.2, Biographical Sketch).
7. I received my M.D. in 1996 and my M.P.H. in 2001. 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 1999 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 1999 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, 2009 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. Foreign scientists are eligible to apply if they are conducting their research and hold an independent position at a U.S. institution.
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 the FOA (PAR-09-013, Section III.1, 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 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.
13. 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.
14. 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, 2009. Since pre-applications are submitted by an institution on behalf of the principal investigator, the pre-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, 2009, you will not be eligible to receive a New Innovator Award.
15. I will not be at my new institution in my first independent position until September 2009. 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, 2009. 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.
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 2009 New Innovator Award competition, if a pending grant is awarded with a start date of September 30, 2009 or earlier, you are no longer eligible to receive the New Innovator Award.
21. I applied for a Pioneer Award in November. May I also apply for a New Innovator Award if I qualify as a new investigator?
    Yes. However, you may not submit essentially the same project to both the Pioneer and New Innovator programs. NIH policy does not allow multiple submissions of the same, or essentially the same, project. 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 apply for a New Innovator Award if you have other grant applications pending. However, you may not submit the same, or essentially the same, project to more than one program. NIH policy does not allow multiple submissions of the same, or essentially the same, project. 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 2009.
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 a pre-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?
    You may apply for an R01 or other grant while your New Innovator Award application is pending. However, NIH policy does not allow multiple submissions of the same, or essentially the same, project. You may either submit applications for two different projects concurrently or submit applications for essentially the same project at different times.
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.

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C. THE COMPETITION PROCESS FOR 2009

1. Are there significant changes from last year to the competition process?
   Yes, unlike the previous year, the 2009 competition will proceed in two formal stages, with two separate Funding Opportunity Announcements. The first stage is a pre-application stage. The pre-application must be submitted in response to PAR-09-013, which uses the X02 pre-application mechanism. The pre-applications will be assessed by a group of external reviewers. Only those investigators whose proposals are judged to be the most outstanding will be notified of the opportunity to submit full (DP2 applications) under RFA-RM-09-003. The full application represents the second stage of the process.
2. What are the dates for submission of 2009 pre-applications?
   Pre-applications may be submitted to Grants.gov beginning December 15, 2008 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on January 15, 2009. Application materials will not be accepted after that time, and applications that are not complete will not be reviewed. Full applications (DP2) will be submitted from the end of April to the end of May 2009.
3. Is there a limit to the number of pre-applications that can be submitted by an institution?
   There is no limit to the number of pre-applications that an institution can submit. However, an investigator may submit only one pre-application.
4. 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.
5. 5. Do I need or may I submit letters of reference?
   No. Letters of reference are not required and will not be accepted.
6. 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. 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 pre-application on your behalf, your institution is committing these facilities for the conduct of the research.
8. What must be done before I submit a pre-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.
9. 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.
10. Where can I find help in submitting my pre-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.
11. 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).
12. Whom do I contact if I have questions about programmatic aspects of the New Innovator Awards?
    For questions of a programmatic nature, contact Dr. Richard Okita at newinnovator@nih.gov or 301-594-4469. E-mail inquiries are strongly preferred.

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D. GRANTS.GOV SUBMISSION DOCUMENTS

1. What format should I use for the documents submitted with my pre-application to Grants.gov (abstract, public health relevancy statement, 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.
   
   For the biographical Sketch, use the sample format on the Biographical Sketch Format Page in Part I, Section 4.5.2 of the Application Guide (MS Word - 2.87 MB) or (PDF - 2.82 MB). Omit Section C, Research Support. The biographical sketch must not exceed two pages.
   
   For the List of Current and Pending Support, use the sample format shown in Part III, Section 1.8 in the Application Guide (MS Word - 2.87 MB) or (PDF - 2.82 MB). There is no page limit for the List of Current and Pending Support.
   
   Pre-applications 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 PAR-09-013, 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 PAR.
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. May I include movies, either as a link to a website or as a CD, with my application?
   No. Applications must be self-contained within the specified page limitations. Internet website addresses (urls) may not be used to provide information necessary to the review. However, applicants can list published articles that include movies/links to movies as citations in the essay. We cannot guarantee that reviewers will refer to citations, so any information critical to the evaluation of the research proposal should be included in the essay.
7. The pre-application package that I downloaded from Grants.Gov does not include budget pages. Are detailed, annual budgets required? Where do I indicate indirect costs?
   A budget of “0” (zero) must be entered. No awards will be made from the pre-application phase.
8. Where do I submit the various required sections of the pre-application?
   • Abstract – upload on Item 6, Research & Related Other Project Information Component form. The Abstract must contain the Area of Science.
   • Public Health Relevancy Statement – upload on Item 7, Project Narrative, on the Research & Related Other Project Information Component form.
   • Essay – upload as an attachment in the Research Design and Methods section of the Research Plan Component. Omit the Specific Aims, Background and Significance, and Preliminary Studies sections.
   • 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.
9. The instructions in the FOA state that I have to designate a science area for my pre-application. What is the purpose of the science area?
   The Area of Science designation is to assist in assigning pre-applications to reviewers. To select the most appropriate science area code for your pre-application, you should consider whether reviewers who are knowledgeable 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.
10. Where do I designate the Area of Science for my pre-application?
    You must designate your area of science by choosing one of ten pre-application packages in Grants.gov. After clicking “Apply for Grant Electronically,” you will be presented with a list of ten pre-application packages, each with a separate “Competition ID and Title.” Each pre-application package corresponds to one of the science areas. Download the pre-applications package that best describes your area of proposed research. You may download and submit only one of the ten pre-application packages. You must also include the Area of Science (two-digit code and title of the Science Area) at the top of the Abstract page. You must also verify that the pre-application has been submitted to the appropriate science area by checking the Competition ID Field on the transmittal sheet (first page of the application) in the Commons. If the Science Area is incorrect on the transmittal sheet, you must notify program staff immediately by e-mail to newinnovator@nih.gov.
11. 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
12. May I designate more than one area or science?
    No. Only one area may be designated.
13. I cannot determine the best fit for my Area of Science. What should I do?
    The designation of scientific area by applicants is used solely to aid in selection of the most appropriate group of peer reviewers. 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 pre-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.
14. 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.
15. 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.
16. 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.

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E. 2009 Evaluation and Selection of Awardees

1. How will awardees be selected?
   Pre-applications that are complete and responsive will be evaluated by a group of external reviewers. Those investigators whose submissions are judged to be the most outstanding will be notified of the opportunity to submit a full (DP2) application under RFA-RM-09-003.
2. What criteria will be used to evaluate pre-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 pre-application for the New Innovator Award process rather than the standard peer review process.
3. Will I receive a summary statement or other comments?
   A summary statement or other evaluative comments will not be provided, regardless of outcome.
4. I understand that no summary statement will be provided, but will I receive any information as to the outcome?
   Only those investigators whose projects are considered to be the most outstanding will be notified in April 2009 of the opportunity to submit a full (DP2) application under RFA-RM-09-003.
5. I have obtained important new preliminary data that will strengthen the pre-application I have already submitted. May I submit these data now?
   No. We cannot accept any additional information after a pre-application has been submitted. Only the information contained in the original pre-application will be reviewed.
6. When will the outside expert peer reviewer roster be posted on the New Innovator web site?
   The roster will be posted at the beginning of March 2009, before the start of the review. 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.
7. How can I assure that my pre-application will be reviewed by the appropriate group of reviewers?
   Pre-applications will be assigned to the review group for the Area of Science that you selected for your pre-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.
8. Will the reviewers be experts in the topic of my pre-application?
   Award pre-applications have been chosen for their breadth of scientific perspective, and will be able to review a broad range of pre-applications, but will not necessarily be experts in the topic of your proposal. 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 expert in the proposed area of research.
9. May I request to exclude a specific reviewer with whom I have a conflict of interest?
   Due to the volume of pre-applications and the way they are assigned, applicants cannot request who can or cannot review their pre-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.
10. When will I hear anything about the results of the review?
    Investigators whose submissions are judged to be the most outstanding will be notified in April 2009 of the opportunity to submit a full (DP2) application under RFA-RM-09-003.
11. Can I get some preliminary indication if I will be notified to submit a full (DP2) application? I need to know if I should be preparing another grant application for the next deadline.
    Investigators whose submissions are judged to be the most outstanding will be notified in April 2009 of the opportunity to submit a full (DP2) application under RFA-RM-09-003. You do not need to wait for information regarding your New Innovator Award pre-application to submit a new research grant application for the next deadline. You may submit any applications you wish while your DP2 pre-application is pending.
12. 12. When will the 2009 awardees be notified?
    The 2009 awardees will be notified in September 2009 and their names will be publicly announced at the Fifth Annual NIH Director’s Pioneer Award Symposium in late September 2009.
13. Can the results of the review or funding decision be appealed?
    No. There is no appeal process.

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