Office of Research and Project Administration

 

This notice is a follow-up to the orpa-ls sent on May 27, 2010 and June 11, 2010.  Please review notice below for specific details.

Please contact your ORPA Research Administrator with any questions.

Donna Beyea - x5-8037

Anne Corriveau – x3-2137 

Gayle Elledge - x 5-1502

Brenda Kavanaugh - x5-1504

Tammie Martin - x3-3960

Laurie Naber –x5-4210

Cheryl Williams - x5-1503

Gayle Elledge, JD
Research Administrator II
Office of Research & Project Administration
University of Rochester
501 Hylan Building
RC Box 270140
Rochester, New York  14627
Phone:  (585) 275-1502
Fax:  (585) 275-9492
E-mail:  gelledge@orpa.rochester.edu

 Enhancing Peer Review: New NIH Policy on Post-Submission Application Materials

Notice Number: NOT-OD-10-115

Related Notices

·       June 11, 2010 - NOT-OD-10-104 Enhancing Peer Review: Advance Notice on Post-Submission Application Materials for NIH Training and Related Applications.

·       May 21, 2010 - NOT-OD-10-091: Enhancing Peer Review Advance Notice: New NIH Policy on Post-Submission Application materials

·       March 24, 2010 - NOT-RR-10-006 Notice of a Change in NCRR Policy on Accepting Appendix Material

·       March 19, 2010 - NOT-OD-10-070 Amended NIH Policy on Submission of Late Grant Application Materials Prior to Initial Peer Review

·       June 25, 2009 - NOT-OD-08-082 NIH Policy on Submission of Additional Grant Application Materials

Key Dates
Release Date: July 23, 2010

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

Effective Date
Applications submitted to the NIH for the September 25, 2010 due date and thereafter

Purpose

This Notice serves to announce that the new NIH policy on post-submission grant application materials (NOT-OD-10-070; NOT-OD-10-104) will be effective for applications submitted for the September 25, 2010 receipt date and thereafter.  The NIH Best Practice Guidelines for Accepting Additional Grant Application Materials (Revised 03/19/2010) will be rescinded at that time.  This policy does not modify the existing Just-In-Time requirements or any other requests for additional information after the initial peer review. 

Policy

For the majority of applications submitted for the September 25, 2010 receipt date and thereafter, the only post-submission grant application materials that the NIH will accept are those resulting from unforeseen administrative issues.  Post-submission grant application materials are those submitted after submission of the grant application but prior to the initial peer review.  This option is to be used when an unexpected event such as the departure of a participant, natural disaster, etc. has occurred, not to correct oversights/errors discovered after submission of the application.

Acceptable post-submission materials include:

·       Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

·       Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

·       Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

·       Adjustments resulting from natural disasters (e.g., loss of an animal colony)

·       Adjustments resulting from change of institution (e.g., PI moves to another university)

·       News of an article accepted for publication (a copy of the article should not be sent)

All post-submission materials must conform to NIH policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions.  NIH additional form pages such as budget, biographical sketches, and other required forms must follow NIH standards for required NIH form pages.  

·       If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).  

·       If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.

Unacceptable post-submission materials (for all applications except those listed under Exceptions below) include:

·       Updated Specific Aims or Research Strategy pages

·       Late-breaking research findings

·       New letters of support or collaboration that do not result from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

Exceptions:

1.      Applications submitted in response to Requests for Applications (RFAs) that have only one due date:

·       Updated Specific Aims or Research Strategy pages, late-breaking research findings and new letters of support or collaboration will be allowed.

·       If additional material is not required on a form page, the page limits below apply:

Page Limit for Research Strategy Section        Page Limit for Post-Submission Materials       
More than 12 pages      3 printed pages
12 pages        2 printed pages
Fewer than 12 pages     1 printed page 
·       If the application has subprojects or cores, the page limits for post-submission materials follow the page limit of the Research Strategy of each subproject or core, as indicated above.

2.  Certain NIH Funding Opportunity Announcements (FOAs) may allow specific other types of post-submission materials to facilitate the goals of the program.  Such stipulations must be specified in the FOA in the NIH Guide for Grants and Contracts (The Guide).
3.  Applications for institutional training and training-related grants only [not fellowships (F series) or career (K series) applications (NOT-OD-10-104)].  The following guidelines apply:

Activity Codes  Page Limit for Post-Submission Materials        Acceptable Post-Submission Materials   
·       T32, T34, T35, T90, TU2, T15, D43, K12, KM1, U2R

·       U54 with Kirschstein-NRSA training or institutional career development activities       3 printed pages ·       Updated information and data on:

·       applicant pool

·       admissions

·       enrollment

·       appointments and/or achievements

·       Updated faculty research support       
Other training-related activity codes (e.g., R25)       Specified in the FOA   
4.  Materials such as devices, videos, or other media that are considered essential to the review and generally are accepted by the NIH Institute/Center (IC) for that type of application will be accepted at the discretion of the NIH Scientific Review Officer (SRO) managing the review.

Deadline

Post-submission materials must be received by the NIH Scientific Review Officer one month (30 calendar days) prior to the peer review meeting. Post-submission materials will not be accepted if fewer than 30 calendar days remain before the peer review meeting.

Authorized Organization Representative (AOR) concurrence:

Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is required.  Although the content of post-submission materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the SRO, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO.  A communication from the PD/PI only or with a “cc” to the AOR will not be accepted.

Instructions

·       Submission via email of post-submission materials as a PDF attachment is strongly encouraged, whether the original application was submitted on paper or through Grants.gov. NIH recommends producing the documents electronically using text or word-processing software and then converting the documents to PDF. This will allow the text to be searched electronically (i.e., do not scan files that have text as an image, scan as text file only).

·       The SRO is responsible for uploading acceptable materials into the official electronic grant file maintained in the eRA Commons. The PD/PI can check his/her application via the Commons to see these materials in the section titled “Additions for Review”. This allows the information to be available to reviewers in a secure manner.