Notice Number: NOT-OD-06-013

Key Dates
Release Date: November 30, 2005
Update: The following update relating to this notice has been issued:

• August 9, 2007 - See Notice (NOT-OD-07-083) Full Implementation to Shorten the Review Cycle for New Investigator R01 Applications.
• April 4, 2007 - See Notice (NOT-OD-07-058 ) Continuation of the Extension of the NIH Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications.
• January 8, 2007 - See Notice (NOT-OD-07-034) Extension of NIH Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications.
• April 13, 2006 (NOT-OD-06-060) - See this notice for Clarification of Submission Dates for the Pilot Study to Shorten the Review Cycle for New Investigator R01 Applications

Issued by
National Institutes of Health (NIH), (http://www.nih.gov)

Shortening the review cycle is a high priority for the National Institutes of Health and the biomedical and behavioral research communities. There is also great interest in the career development of scientists and NIH is committed to supporting new investigators* in their efforts to obtain R01 research grant funding. Since new investigators by definition do not have R01 support, any delay in the ability to submit an amended application could have a negative impact on their careers. Cognizant of the pressure on new investigators to obtain NIH R01 funding, the Center for Scientific Review convened a trans-NIH working group to develop a process to shorten the referral and review cycle in order to permit a new investigator to submit an amended application for the next submission date. Although the number of new investigators who will be able to take advantage of this rapid turnaround process will be relatively small, the impact on the careers of these new investigators could be significant. The working group recommended an initial pilot, followed by an evaluation phase before consideration of modification and/or expansion.

The results of this pilot will be analyzed and a determination made as to whether to expand this to all R01 applications submitted by new investigators. Further analysis will be done to determine if this should be expanded to all R01 applications and also to consider if other grant mechanisms should be included. Significant expansion of this pilot will be dependent on the full implementation of the electronic submission process. Notices about any extensions of this pilot and any expansions will be published in the NIH Guide for Grants and Contracts.

The pilot described in this notice is designed to shorten the time to the next review for some new investigators who are not successful in a R01 grant submission and are readily able to address the concerns raised and issues identified in the Summary Statement. Under carefully defined circumstances for this pilot, new investigators will be able to resubmit amended applications for the next review meeting, rather than waiting a cycle. This will shorten the time for the next consideration of the resubmission application by four months.

This pilot incorporates a number of features, including a shortened time for reviewers to consider applications, earlier study section meetings, accelerated production of Summary Statements, and a delayed submission date for these amended applications. Since NIH limits the number of resubmissions to two, new investigators will need to consider carefully whether this option is appropriate for their situation. Consultation with Institute/Center program staff and senior colleagues will be important in this process. In most cases resubmissions of R01 applications from new investigators utilizing this accelerated process may not be desirable.

The Study Sections that are participating in this pilot are listed at the end of this document.

Only R01 applications from investigators that meet the NIH definition of new investigators that are assigned to these study sections are included in this pilot. The Summary Statements for these applications will include an explicit note that identifies the application as being eligible for this pilot. Applications submitted for the February/March 2006 dates (cycle I) will be reviewed by June 15, 2006 and Summary Statements will be available in the NIH Commons no later than June 20, 2006 . Should new investigators choose to participate in this pilot, they will be able to send a resubmission application to NIH for a special July 20, 2006 receipt date to be reviewed at the next study section meeting in September/October 2006. The table below shows the overall schedule for resubmissions of new investigator R01 applications for the three NIH submission/review/award cycles:

To qualify for this expedited resubmission all of the following conditions must all be met:

• The Principal Investigator must meet the NIH definition of a new investigator*.
• A new or first resubmission of an R01 application must be submitted for the February 1 or March 1, 2006 date.
• The application must be reviewed in one of the participating Study Sections listed in this Notice.
• The Summary Statement must have the special note indicating eligibility to participate in the pilot.
• The Principal Investigator must determine that it is reasonable to prepare a resubmission application in a short time.
• The Principal Investigator must agree that the resubmitted application be assigned to the same Study Section; no change in review venue is permitted for the resubmission.
• The July 20, 2006 receipt date must be met; late applications will not be considered.

For further information please contact:

Division of Receipt and Referral
Center for Scientific Review
301-435-0715; 301-480-1987 (fax)

*NIH definition of new investigators:
For the purposes of review and funding, applicants are considered new investigators if they have not previously served as the Principal Investigators (PI) on any Public Health Service-supported research project other than a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or certain research career awards directed principally to physicians, dentists, or veterinarians at the beginning of their research career (K01, K08, and K12). Current or past recipients of Independent Scientist and other non-mentored career awards (K02, K04) are not considered new investigators.
http://grants.nih.gov/grants/guide/notice-files/not97-231.html

PARTICIPATING STUDY SECTIONS

Biochemistry and Biophysics of Membranes Study Section [BBM]
Biodata Management and Analysis Study Section [BDMA]
Bioengineering, Technology, and Surgical Sciences Study Section [BTSS]
Biomedical Imaging Technology Study Section [BMIT]
Cancer Molecular Pathobiology Study Section [ CAMP ]
Cardiovascular and Sleep Epidemiology Study Section [CASE]
Cellular Aspects of Diabetes and Obesity Study Section [CADO]
Clinical and Integrative Diabetes and Obesity Study Section [CIDO]
Clinical and Integrative Gastrointestinal Pathobiology Study Section [CIGP]
Clinical Research and Field Studies of Infectious Diseases Study Section [CRFS]
Community Influences on Health Behavior Study Section [CIHB]
Community-Level Health Promotion Study Section [CLHP]
Drug Discovery and Mechanisms of Antimicrobial Resistance Study Section [DDR]
Enabling Bioanalytical and Biophysical Technologies Study Section [EBT]
Gastrointestinal Cell and Molecular Biology Study Section [GCMB]
Gastrointestinal Mucosal Pathobiology Study Section [GMPB]
Gene and Drug Delivery Systems Study Section [GDD]
Gene Therapy and Inborn Errors Special Emphasis Panel [GTIE]
Genetic Variation and Evolution Study Section [ GVE ]
Genomics, Computational Biology and Technology Study Section [GCAT]
Hepatobiliary Pathophysiology Study Section [HBPP]
Infectious Diseases, Reproductive Health, Asthma and Pulmonary Conditions Study Section [IRAP]
Integrative and Clinical Endocrinology and Reproduction Study Section [ICER]
Lung Cellular, Molecular and Immunobiology Study Section [LCMI]
Lung Injury, Repair and Remodeling Study Section [LIRR]
Macromolecular Structure and Function A Study Section [MSFA]
Macromolecular Structure and Function C Study Section [MSFC]
Medical Imaging Study Section [ MEDI ]
Molecular Genetics A Study Section [ MGA ]
Molecular Genetics B Study Section [MGB]
Molecular Genetics C Study Section [MGC]
Nursing Science: Children and Families Study Section [NSCF]
Pathogenic Eukaryotes Study Section [PTHE]
Respiratory Integrative Biology and Translational Research Study Section [RIBT ]
Social Sciences and Population Studies Study Section [SSPS]
Surgery, Anesthesiology, and Trauma Study Section [ SAT ]
Synthetic and Biological Chemistry A Study Section [SBCA]
Synthetic and Biological Chemistry B Study Section [SBCB]
Tumor Progression and Metastasis Study Section [TPM]
Xenobiotic and Nutrient Disposition and Action Study Section [XNDA]