The December 3 Deadline for NIH Loan Repayment Applications is approaching!  Please ensure that your top researchers are submitting their applications.

QUESTIONS? Visit the LRP website at http://www.lrp.nih.gov for more information and to access the online application.  For additional assistance, call or e-mail the LRP Information Center at (866) 849-4047 or lrp@nih.gov.

Sincerely,

NIH Division of Loan Repayment

lrp@nih.gov

New NIH Policy on Resubmission (Amended) Applications

Purpose

NIH announces a change in the existing policy on resubmission (amended) applications (see http://grants.nih.gov/grants/policy/amendedapps.htm).  Beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment to the original application.  Failure to receive funding after two submissions (i.e., the original and the single amendment) will mean that the applicant should substantially re-design the project rather than simply change the application in response to previous reviews.  It is expected that this policy will lead to funding high quality applications earlier, with fewer resubmissions.

Background

Following the release of the Peer Review Report that was drafted with extensive consultation with the external community, Dr. Zerhouni, NIH Director, established a Peer Review Oversight Committee (PROC) to finalize the recommendations and begin immediate implementation of those recommendations.  Of particular concern was the marked reduction in the number of awards made in response to original applications.  An increasing number of projects were funded only after one or more resubmissions.  In periods of constricted funding, a greater number of projects require resubmission, and review committees are more likely to show greater preference for amended applications.  These trends have increased the time from original submission to award and the number of submissions per investigator. As a result, there has been greater burden placed on applicants and reviewers as well as a delay in funding for meritorious science.

To change this trend and increase the likelihood that meritorious original applications will be funded, the NIH will decrease the number of amendments allowed.  Accordingly, the NIH will begin to phase out second amendment applications starting with the January 25, 2009 due date.  This policy will increase the numbers of high quality original and first amendments that can be funded earlier. 

NIH Policy on Resubmission (Amended) Applications

Beginning with applications intended for the January 25, 2009 due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  For this and subsequent cohorts of original new and competing renewal applications, any second amendment (A2) will be administratively withdrawn and not accepted for review.  Applicants who fail to receive funding after two submissions may resubmit but only if the application is fundamentally revised to qualify as new.  A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in an amended application.  Note that there is no time limit for the submission of the original and subsequent A1.

Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. 

This policy applies to all applications, including applications submitted under the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, Career Development Awards, Individual Fellowships, Institutional Training Grants, Resource Grants, Program Projects, and Centers.  Currently no amendments are permitted for applications received in response to a Request for Applications (RFA) unless it is specified in the Funding Opportunity Announcement, in which case only one amendment will be permitted. 

Inquiries

Applicants are strongly encouraged to discuss their questions with their NIH IC contact.  For additional information or questions, please contact:

Division of Receipt and Referral
Center for Scientific Review
6701 Rockledge Drive MSC 7720
Bethesda, MD 20892-7720
Voice: (301) 435-0715
Fax: (301) 480-1987

Or send an email to EnhancingPeerReview@mail.nih.gov.

NIH Modifies New Investigator Policy to Identify Early Stage Investigators

Purpose

This notice describes a change in NIH New Investigator policies designed to encourage early transition to independence.  Under this policy, New Investigators within ten years of completing their terminal research degree or within ten years of completing their medical residency will be designated Early Stage Investigators (ESIs).  Traditional NIH research grant (R01s) applications from ESIs will be identified and the career stage of the applicant will be considered at the time of review and award. 

Background

For more than three decades the NIH has explicitly encouraged New Investigators to apply for NIH research grant support.  The involvement of New Investigators is considered essential to the vitality of health-related research and has been addressed by several important NIH programs and studies which are detailed on the New Investigator Website at http://grants.nih.gov/grants/new_investigators/resources.htm. 

In spite of persistent attention to the identification and funding of New Investigators, the duration of postdoctoral training has increased.  This is consistent with the observation that the average age at which an investigator first obtains R01 funding has increased by more than 5 years between 1980 to and 2001 (see http://grants.nih.gov/grants/new_investigators/Workforce_Info09072007.ppt).  Current New Investigator policies have encouraged entry into the PI pool of investigators but those policies have not addressed the problem of elongated periods of training or the delayed transition to independence. 

Accordingly, the NIH will more broadly adopt an approach piloted by the NIH Director’s New Innovator Award (DP2) (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-08-014.html).  This award is targeted to applicants within 10 years of completing their terminal degree or within 10 years of completing their medical residency.  Other features of the New Innovator Award may not apply to ESIs.

The NIH will continue to encourage all New Investigators to apply for NIH R01 awards.  However, under this new policy, those New Investigators who are within 10 years of their terminal research degree or within 10 years of completing a medical residency, will be identified as Early Stage Investigators. Their applications will be identified and their career stage will be considered at the time of review and award.  It is hoped that by providing an advantage for ESIs, the NIH will be able to directly encourage earlier application for NIH research grant support.  
  
Definitions

New Investigator:  An NIH research grant Program Director/Principal Investigator (PD/PI) who has not yet competed successfully for a substantial, competing NIH research grant is considered a New Investigator.  For example, a PD/PI who has previously received a competing NIH R01 research grant is no longer considered a New Investigator.  However, a PD/PI who has received a Small Grant (R03) or an Exploratory/Developmental Research Grant Award (R21) retains his or her status as a New Investigator.  A complete definition of a New Investigator along with a list of NIH grants that do not disqualify a PD/PI from being considered a New Investigator can be found at http://grants1.nih.gov/grants/new_investigators/resources.htm.  
  
Early Stage Investigator (ESI):  An individual who is classified as a New or First-Time Investigator and is within 10 years of completing his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent) is considered an Early Stage Investigator (ESI). 

Extension of ESI Eligibility:  The 10 year period after completion of the terminal degree or residency may be extended to accommodate special circumstances including various medical concerns, disability, pressing family care responsibilities, or active duty military service. Guidelines for requesting and considering such requests are being developed and will be announced. 

Planned Implementation

Beginning with traditional R01 applications received for the February 2009 receipt dates, the NIH will identify applications from ESIs and New Investigators and the career stage of the PD/PI will be considered at the time of review and award. Some of the details are still being worked out and will be announced as they become available.  At the current time it is expected that the implementation will include the following features:

• The NIH will modify the data collection related to degree dates and medical residency within the personal profile of the eRA Commons (https://commons.era.nih.gov/commons/).  When the revised data collection approach is announced PD/PIs must update their personal profile in the eRA Commons to provide information on degree and residency completion dates in order to be considered for the ESI classification. 

• New or First-Time Investigators will continue to be identified by determining whether the individual has had significant, previous NIH funding. The definition of New Investigator is described in detail on the New Investigator website at http://grants1.nih.gov/grants/new_investigators/resources.htm.  

• New Investigators within 10 years of their terminal research degree or within 10 years of completing their medical residency will be identified as ESIs using data entered in the eRA Commons. 

• Investigators who enter degree and residency completion dates will be notified of their ESI status by email.

• A procedure and guidelines for requesting an extension of the period of ESI eligibility will be developed and announced to accommodate individuals with various medical concerns, disability, pressing family care responsibilities, or active duty military service.  Once the procedure has been announced, applicants will be able to request an extension of the indicated 10 year period by providing an adequate justification.

• PD/PIs who receive a substantive, competing NIH research grant will lose their New Investigator status and hence their status as an ESI. 

• NIH will eliminate the New Investigator Check Box on the face page of PHS 398 and Form 424 R&R application.  New Investigators will be identified using data within the NIH administrative database. 

• Applications from ESIs and New Investigators will be identified to reviewers so that appropriate consideration of their career stage can be applied during review. 

• As in the past, an application with more than one Principal Investigator will be identified for consideration by reviewers if all of the listed Principal Investigators qualify as ESIs or New Investigators. 

• Staff in the NIH institutes and centers will be apprised of ESI and New Investigator status and this factor will be considered when applications are selected for award. 

• New Investigators as well as ESIs will be eligible for the “Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications Reviewed in Center for Scientific Review (CSR) Recurring Study Sections” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html ).

More complete information on the ESI-related features of the eRA Commons; instructions to reviewers for consideration of ESI applications; grouping of applications from ESIs during peer review; the process and criteria for requesting an extension of the period of eligibility; and a series of Frequently Asked Questions (FAQs) will be developed between the issuance of this announcement and the February R01 receipt dates. 

Inquiries

Direct inquiries regarding this Notice to:

Walter T. Schaffer, Ph.D.
Senior Scientific Advisor for Extramural Research
Office of Extramural Research
Building One, Room 138
Bethesda, MD 20892
Tel: (301) 402-2725
E-mail: schaffew@od.nih.gov

NIH Announces Transition Schedule to Adobe Acrobat Forms

Purpose:
This Notice provides the Transition Schedule for NIH/AHRQ/CDC/NIOSH/FDA from PureEdge to Adobe-based grant application forms for electronic submissions of SF424 Research and Related (R&R) applications. Please note the importance of this schedule, as Grants.gov will not accept PureEdge applications after the transition dates noted below. 

Most electronic submissions to NIH on or after January 1, 2009, must use Adobe application forms, except:

• Small Business Innovation Research (SBIR [R41/ R44])/Small Business Technology Transfer (STTR [R41/R42] and Conference (R13/U13) grant applications for the January 7, 2009, AIDS submission deadlines.
  
• Funding Opportunity Announcements (FOAs) with non-standard submission dates expiring on or before January 31, 2009, can use PureEdge until the expiration date (except RFA-AI-08-053 and RFA-RM-08-029, which use Adobe).

NIH Transition Schedule to Adobe for Standard Submission Dates

The following table provides the final standard submission dates for PureEdge applications, along with the first Adobe submission dates.

• The overall electronic submission process of finding opportunities, downloading application packages, preparing forms, preparing attachments, and submitting applications remains the same.
  
  
• Although the new Adobe forms have a slightly different look and feel from the PureEdge forms, the changes are mainly cosmetic.

IMPORTANT NOTES 

• It is crucial that applicants check the FOA in December to download the new Adobe application forms: Between now and December, NIH will publish new FOAs without accompanying application forms. We expect to have the forms for posting from Grants.gov by early December 2008; NIH will issue a Guide Notice when the Adobe forms are available. Adobe forms for small business applications and conference applications will be posted in early February 2009. 
  
• NIH currently has FOAs that are active for three years; these are also transitioning to Adobe.  Adobe forms will replace PureEdge forms in the December 2008 timeframe.  PureEdge forms will not be accepted by the Grants.gov system after the transition to Adobe.
  
• Grants.gov requires a specific version of Adobe Reader in order to open, download save and submit an Adobe application.  The latest versions are listed on the Grants.gov site and are updated as new editions are produced (see the Download Software page). 
  
  
  • CAUTION:  Applicants should make sure they are using the recommended versions of Adobe Reader.  Versions earlier than 8.1.2 should not be used and may corrupt when the completed application is uploaded. 

PLEASE BE ADVISED

• Applicants currently working on a PureEdge grant application to be submitted in January 2009, are advised to continue to develop their research plan components and other parts of the application that will be uploaded as attachments, but wait to complete the application forms until the Adobe forms become available in December (unless it is exempted as noted above).

More details will be provided in the coming weeks on the Resources for Adobe Transition Web page on the Electronic Submission of Grant Applications Web site at:  http://era.nih.gov/ElectronicReceipt/.

Support
During the transition to Adobe forms, applicants should follow the usual process for seeking support with any electronic submission issue. Questions on form functionality or submission of the forms to Grants.gov should be directed to the Grants.gov Contact Center.  If you encounter a technical issue that threatens NIH’s timely receipt of your application, work with the Grants.gov Contact Center and be sure to contact the eRA Help Desk at NIH to document the issue and provide us with the Grants.gov Contact Center tracking number.

Related Guide Notices:
Adobe Pilot Application Guide Available (August 1, 2008)
Pilot for Transition from PureEdge to Adobe-based forms (July 2, 2008)
NIH/AHRQ Set Transition to Adobe for Dec. 2008 (May 23, 2008)

Inquiries

Questions about this Notice should be directed to:

Grants Information
Office of Extramural Research
National Institutes of Health
Phone: 301-435-0714
TTY: 301-451-0088
Email: grantsinfo@nih.gov