1. NIH/AHRQ/NIOSH UPDATES effective January 25, 2017
2016
Office of Research Administration
Villanova University

2. DISCUSSION
Effective for applications submitted for due dates on or after January 25, 2017
Appendix Materials
Post-Submission Materials

3. Appendix Material for NIH/AHRQ/NIOSH Applications
NOT-OD : New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017
This Notice alerts the scientific research community of plans to eliminate most appendix materials for applications submitted to the NIH, AHRQ or NIOSH.
All information submitted with an application except the cover letter, assignment request form and appendix information are assembled into a single application image for funding consideration.
All information required for the peer review process must be contained in those designated sections.
Information that expands upon information provided in another section is not allowed, unless it is required per the FOA.

4. Appendix Material for NIH/AHRQ/NIOSH Applications - continued
Allowable appendix materials:
Clinical trail protocols
Investigator's brochure from Investigational New Drug (IND)
Blank informed consent/assent forms
Blank surveys, questionnaires, data collection instruments
FOA-specific items – applications submitted without those appendix materials will considered incomplete and will not be reviewed.

5. Appendix Material for NIH/AHRQ/NIOSH Applications - continued
Related Notices
NOT-OD : Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017
NOT-OD : Appeals of NIH Initial Peer Review
NOT-OD : Reminder: Compliance with NIH Application Format and Content Instructions

6. Policy on Post-Submission Materials
NOT-OD : Changes to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017
This Notice simplifies and consolidates current policy concerning post-submission materials.
The only post-submission materials that will be accepted are those resulting from an unforeseen event.
The opportunity to submit post-submission application materials is not intended to correct oversights/errors discovered after submission of the application.

7. Policy on Post-Submission Materials - continued
Allowable post-submission materials:
Revised budget – due to new funding or institutional acquisition of equipment
Biosketches or letters of support due to hiring, replacement, loss of an investigator
Adjustments due to natural disasters or changes in institutions
News of promotion or tenure decision of PI or key personnel
News of an article accepted for publication prior to submission of the application. Include ONLY:
List of authors and institutional affiliations
Title of the article
Journal or citation (if available)

8. Policy on Post-Submission Materials - continued
Additional allowable post-submission materials:
Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application
Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change. Applicants must follow the directions in NOT-OD
Other post-submission materials specified in the FOA for which the application was submitted or in a special Guide Notice

9. Policy on Post-Submission Materials - continued
See full notice for more information about:
Institutional Training and Training –related Grants
Individual Fellowship (F-Series) and Individual Career Development Award (K-series) Applications
Conference Grant Applications (R13, U13)

10. Policy on Post-Submission Materials - continued
Requirements for submitting:
All formatting and page limit requirements from the application guide must be followed.
Must be submitted to the Scientific Review Officer (SRO) no later than 30 days PRIOR to the peer review meeting
Villanova’s Authorized Organization Representative (AOR) must concur with the submission. The AOR is the Director, Office of Research Administration:
1. The AOR submits the material(s) to the SRO
2. The AOR’s concurrence is included with the materials.

11. Policy on Post-Submission Materials - continued
The AOR will not agree to the submission of post-submission materials if the materials are not allowed or if it is later than 30 days prior to the peer review meeting date.

12. Appendix Material for NIH/AHRQ/NIOSH Applications - continued
Related Notices
NOT-OD : New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017
NOT-OD : Peer Review Criteria and Submission Requirements for NIH Applications Involving Human Embryonic Stem Cells
NOT-OD : Interim Guidance for Videos Submitted as NIH Application Materials