NIH Director’s New Innovator Award

2010 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 2010?
5. I applied last year and was not successful. May I apply again? If yes, is this second application considered an amended application?
6. May two or more new investigators apply as a team for the NIH Director’s New Innovator Award?
7. What scientific areas are eligible under the New Innovator Award?
8. Will technology development be allowed, or just hypothesis-driven research?
9. Are women and members of underrepresented minority groups encouraged to apply?
10. What is the budget that I may request?
11. How do I determine the size of my budget request?
12. Do New Innovator Awards provide indirect costs?
13. Must the indirect costs related to subcontracts be included in the overall direct cost limit for the New Innovator Award?
14. May my collaborator be funded on my New Innovator Award?
15. May I request fewer than five years? My proposed project can be completed in less time.
16. Why is the budget request for this grant mechanism different from other NIH grants?
17. Why are the budget period and project period for this grant mechanism the same?
18. How much time/effort are recipients expected to devote?
19. 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?
20. I am working with a collaborator in another country. Would I be able to continue to spend some time conducting research there?
21. I am conducting epidemiologic research in another country. Would I be able to continue this research under a New Innovator Award?
22. What post-award requirements must I fulfill?
23. If I receive a New Innovator Award, will I still be considered an “early stage investigator” when I apply for my first R01 grant?
24. Are New Innovator Awards renewable?
25. Once awarded, is this award transferable if I change institutions next year?
26. Will the New Innovator Award program be offered again in 2011?
27. If I am not successful and the program is re-announced, may I reapply next year?

B. Eligibility

1. What is the definition of “early stage investigator”?
2. How can I ensure that I will be identified as an early stage investigator?
3. Are there exceptions to the 10-year time period that would allow me to extend my ESI status?
4. What is meant by “independent research position”?
5. Do I have to be a U.S. citizen to apply?
6. May I apply from a foreign institution?
7. Are investigators at small businesses eligible to apply?
8. Are individuals employed by government agencies, non-academic, and/or for-profit organizations eligible?
9. Are scientists in the NIH intramural program eligible?
10. I am currently a postdoctoral fellow. Am I eligible to apply for an NIH Director's New Innovator Award?
11. I will not be at my new institution in my first independent position until September 2010. Should I apply from my current institution or my new institution?
12. I’ve had a K award. Am I still eligible?
13. I had an R01 several years ago but have no R01 now. Am I eligible to apply?
14. 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 an early stage investigator, and am I eligible to apply for a New Innovator Award?
15. I am the PI on an R21 grant. This provides a significant amount of support for my research. Am I eligible to apply?
16. 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?
17. I applied for a Pioneer Award this year. May I also apply for a New Innovator Award if I qualify as a new investigator?
18. I have never had an R01 grant before; however, I currently have an R01 grant pending. May I also apply to the New Innovator Award program if I qualify as an early stage investigator?
19. I plan to submit an application for an R01 grant in January. Will this jeopardize my eligibility for a New Innovator Award?
20. 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?
21. Are individuals who have other outside sources of support eligible?
22. If I have a grant from an outside agency, will I be able to remain as the principal investigator on this grant?
23. If I received an RC1, RC2, or GO grant, am I still eligible to apply for a New Innovator Award?

C. The Competition Process for 2010

1. Are there significant changes from last year to the competition process?
2. What are the dates for submission of 2010 applications?
3. Is there a limit to the number of 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 an application to Grants.gov?
9. Where can I find help registering for Grants.gov?
10. Where can I find help in submitting my 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 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 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 application?
9. The instructions in the FOA state that I have to designate a science area for my application. What is the purpose of the science area?
10. Where do I designate the Area of Science for my application?
11. What are the Areas of Science?
12. May I designate more than one Area of Science?
13. I cannot determine the best fit for my Area of Science. What should I do?
14. Will the reviewers be experts in the topic of my application?
15. 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?
16. Where should a request for an extension to the time limitation post receipt of my doctoral degree (or internship/residency) be placed?
17. May I include additional information in an appendix? I need additional space for my list of references, etc.
18. I have obtained important new preliminary data that will strengthen the application I have already submitted. May I submit these data now?

E. 2010 Evaluation and Selection of Awardees

1. How will awardees be selected?
2. What criteria will be used to evaluate applications?
3. Will I receive a summary statement or other comments?
4. When will the outside expert peer reviewer roster be posted on the New Innovator web site?
5. May I request to exclude a specific reviewer with whom I have a conflict of interest?
6. When will the 2010 awardees be notified?
7. 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 early stage 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 early stage 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 and early stage investigators through R01 grants and other mechanisms, which continue to be the major sources of support for new and early stage 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 early stageinvestigators 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 2000 and no later than the due date for applications Must be “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	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	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 2010?
   The NIH Director expects to make at least 33 awards in FY2010, depending on the quality of the applications and the availability of funds.
5. 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 2010 New Innovator Award competition will be considered new applications.
6. 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.
7. 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.
8. 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 innovation and potential impact.
9. Are women and members of underrepresented minority groups encouraged to apply?
   The NIH strongly encourages women and members of groups that are underrepresented in biomedical or behavioral research to apply.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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 " early stage 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. If I receive a New Innovator Award, will I still be considered an “early stage investigator” when I apply for my first R01 grant?
    No.
24. 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.
25. 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.
26. Will the New Innovator Award program be offered again in 2011?
    NIH plans to announce the New Innovator Award program in 2011, but we won't know the amount of funds available for the program until we receive our Fiscal Year 2011 appropriation from Congress.
27. 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. What is the definition of “early stage investigator”?
   An “early stage investigator” is a new investigator (defined as a PD/PI who has not been awarded a substantial, competing NIH independent research grant) who is within 10 years of completing his/her terminal research degree or is within 10 years of completing his/her medical residency (or the equivalent). Frequently Asked Questions about the NIH Early Stage Investigator (ESI) Policy can be found at http://grants.nih.gov/grants/new_investigators/investigator_policies_faqs.htm.
2. How can I ensure that I will be identified as an early stage investigator?
   To ensure that NIH recognizes your ESI status, you MUST update your eRA Commons profile to reflect the date of completion of your terminal research degree. If you are not identified as an ESI in the eRA Commons, it may result in your application not being reviewed.
3. Are there exceptions to the 10-year time period that would allow me to extend my ESI status?
   Yes. After you have entered the date of your terminal research degree and/or the date of residency completion in your eRA Commons profile, the data system will calculate the end date of ESI status. If there has been a lapse in your research during the ten year period after your terminal research degree or the end of medical residency you can request an extension. In general, the NIH will consider request s to extend the ESI period for reasons that can include medical concerns, disability, family care responsibilities, extended periods of clinical training, natural disasters, and active duty military service. Any such request will be considered on a case-by-case basis. To request an extension, you MUST complete the “Form for Requesting an Extension in the Early Stage Investigator (ESI) Period .” Allow at least two weeks for an extension request to be processed.
   
   The policies and procedures for requesting an extension of the period of ESI status are detailed at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-034.html.
4. 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, 2010 that is certified by submission of the application from that institution.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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, 2010. 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, 2010, you will not be eligible to receive a New Innovator Award.
11. I will not be at my new institution in my first independent position until September 2010. 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, 2010. 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.
12. I’ve had a K award. Am I still eligible?
    Independent Scientist and other non-mentored career awards (K02, K05, K24, and K26) are not considered early stage investigators and are therefore not eligible to apply. Having a current or past K99/R00 Pathway to Independence Award does not disqualify you from eligibility to apply.
13. 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.
14. 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 an early stage investigator, and am I eligible to apply for a New Innovator Award?
    Yes. You are considered early stage investigator if you were not the submitting (applicant) principal investigator, and you are otherwise eligible to apply for a New Innovator Award.
15. 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 early stage 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.
16. 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 2010 New Innovator Award competition, if a pending grant is awarded with a start date of September 30, 2010 or earlier, you are no longer eligible to receive the New Innovator Award.
17. I applied for a Pioneer Award this year. 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.
18. I have never had an R01 grant before; however, I currently have an R01 grant pending. May I also apply to the New Innovator Award program if I qualify as an early stage 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.
19. I plan to submit an application for an R01 grant in January. 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.
20. 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.
21. 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 the PI on any NIH grants that would disqualify you as an “early stage 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.
22. 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.
23. If I received an RC1, RC2, or GO grant, am I still eligible to apply for a New Innovator Award?
    No. If you have received an RC1, RC2, GO grant, or a 2-year R01 with ARRA funds, you are no longer considered an early stage investigator and are therefore not eligible to apply for a 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, please read the instructions in the RFA carefully. Unlike the 2009 competition, the 2010 competition will not require a pre-application (X02). Additionally, applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion to ensure they are correctly identified as an early stage investigator (refer to NIH Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-021.html). There are other minor changes to the submission instructions, so please read the RFA carefully.
2. What are the dates for submission of 2010 applications?
   Applications may be submitted to Grants.gov beginning September 27, 2009 and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the investigator’s institution/organization) on October 27, 2009.
3. 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.
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. Do I need or may I submit letters of reference?
   No. Letters of reference are not required and will not be accepted.
6. Do I need or may I submit letters of collaboration?
   No. Letters of collaboration are not required and will not be accepted. If you want to discuss the role of collaborators, you may do so in the essay.
7. 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 the application on your behalf, your institution is committing these facilities for the conduct of the research.
8. 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.
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 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 Peggy Schnoor at schnoorp@nigms.nih.gov or at 301-594-2749. Email inquiries are strongly preferred.

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D. GRANTS.GOV APPLICATION DOCUMENTS

1. What format should I use for the documents submitted with my 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.
   
   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 the RFA 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. 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 application package that I downloaded from Grants.Gov does not include budget pages. Are detailed, annual budgets required? Where do I indicate indirect costs?
   Budgets are not required. Indirect costs will be determined at the time of award.
8. 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.
   • Public Health Relevancy Statement – upload on Item 7, Project Narrative, on the Research & Related Other Project Information Component form.
   • Essay – upload on Item 11 – Other Attachments on the Research & Related Other Project Information Component.
   • Biographical sketch – upload on Research & Related Senior/Key Person Profile Component where indicated.
   • List of Current and Pending Support – upload on Research & Related Senior/Key Person Profile Component where indicated.
   • Human/Animal Subjects Plan: If appropriate, human subjects and animal subjects plans should be uploaded as separate documents on Item 11, Other Attachments, on the Research & Related Other Project Information Component. (Upload one document containing the human subjects plan and a separate document containing the animal subjects plan.)
     
     

   Note: Up to three attachments may be uploaded to Item 11, Other Attachments, on the Research & Related Other Project Information Component as follows: 1) Essay; 2) if appropriate, Human Subjects Plan; and 3) if appropriate, Animal Subjects Plan. Uploading more than three attachments to this field will cause the application to be rejected.

9. The instructions in the FOA state that I have to designate a science area for my application. What is the purpose of the science area?
   The Area of Science designation is to assist in assigning applications to reviewers. To select the most appropriate science area code for your 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 application?
    You must designate your area of science by choosing one of ten application packages in Grants.gov. After clicking “Apply for Grant Electronically,” you 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. Download the application package that best describes your area of proposed research. You may download and submit only one of the ten 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 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 of 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.
14. Will the reviewers be experts in the topic of my application?
    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 who may not be directly involved in the proposed area of research.
15. 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.
16. Where should a request for an extension to the time limitation post receipt of my doctoral degree (or internship/residency) be placed?
    To request an extension, an applicant MUST complete the “Form for Requesting an Extension in the Early Stage Investigator (ESI) Period.” Allow at least two weeks for an extension request to be processed. The request for an extension is not included in the application.
17. 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.
18. 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.

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E. 2009 Evaluation and Selection of Awardees

1. How will awardees be selected?
   Applications will be reviewed in two phases by a multidisciplinary scientific review group of outside experts. Applications will initially be evaluated for scientific and technical merit. Subsequently, an editorial-style panel will consider the applications and the comments of the initial reviewers to select those applications that they deem to be the most meritorious. The Advisory Committee to the Director (ACD), NIH will conduct the final level of review. The Director, NIH, will make the final selection of awardees based on the results of the peer review, the recommendations of the ACD, and programmatic considerations.
2. What criteria will be used to evaluate 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 the application for the New Innovator Award process rather than the standard peer review process. Please see the detailed description of research criteria in Section V.2 of the RFA.
3. Will I receive a summary statement or other comments?
   All applicants will receive summary statements with brief reviewer comments. Additionally, applicants selected for the second phase of review will receive overall impact/priority scores. No criterion scores will be provided to either finalists or non-finalists.
4. When will the outside expert peer reviewer roster be posted on the New Innovator web site?
   The roster for the first phase of review will be posted toward the end of December 2009/beginning of January 2010, before the start of the review. The roster for the second phase of review will be posted at the beginning of March 2010. Please note that the initial posting of rosters of outside expert peer reviewers on the web is tentative; rosters are likely to be modified up to the time that the reviews take place.
5. 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 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.
6. When will the 2010 awardees be notified?
   The 2010 awardees will be notified in June 2010.
7. Can the results of the review or funding decision be appealed?
   No. There is no appeal process.

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