Notice Number: NOT-OD-16-130
Key Dates
Release Date: August 12, 2016
Implementation Date: Applications submitted for the January 25, 2017 due date and thereafter.
NOT-OD-16-129
NOT-OD-12-111
NOT-OD-12-141
Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
National Institute for Occupational Safety and Health (NIOSH)
Purpose
This Notice simplifies and consolidates current NIH and AHRQ policy concerning post-submission materials, and extends this policy to NIOSH. Post-submission application materials are those submitted after submission of the grant application but prior to the initial peer review. The policy is based on the principle that, for the majority of applications, the only post-submission materials that these agencies will accept are those resulting from an unforeseen event. The policy on post-submission application materials is not intended to correct oversights/errors discovered after submission of the application.
Policy
Allowable Post-Submission Materials for All Applications
- Revised budget page(s) (e.g., due to new funding or institutional acquisition of equipment)
- Biographical sketches (e.g., due to the hiring, replacement, or loss of an investigator)
- Letters of support or collaboration 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., Program Director/Principal Investigator (PD/PI) moves to another university]
- News of professional promotion or positive tenure decision for any PD/PI or Senior/Key Personnel
- Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application (see NOT-OD-12-111)
- 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-12-141 for submitting videos to accompany grant applications
- Other post-submission materials specified in the FOA for which the application was submitted or in a special Guide Notice.
- News of an article accepted for publication since submission of the application, which must include only:
- List of authors and institutional affiliations
- Title of the article
- Journal or citation (if available)
Copies of articles, links to articles, or any other materials related to an article accepted for publication will not be accepted as post-submission materials, unless specified in the Funding Opportunity Announcement (FOA) for which the application was submitted or a special Guide Notice.
Additional Materials for Certain Applications
Institutional Training and Training-related Grants (e.g., T32, T34, T35, T90, TU2, T15, D43, K12, KM1, UR2): in addition to the materials for All Applications above, news - since the training grant application was submitted - of:
- a trainee's or former trainee's graduation, employment, promotion, funding, or publications;
- a faculty member's promotion, funding, or publications; and
- the addition or removal of any faculty member who will be involved in the training program (mentors or senior/key persons).
Individual Fellowship (F-Series) and Individual Career Development Award (K-series) Applications: in addition to the materials for All Applications listed above:
- New information on the Sponsor/Mentor funding, limited to the project title, funding source (e.g., NIH/AHRQ/NIOSH grant number), a brief description of specific aims, and relevance to the fellowship or career development application under review.
- News of change in Mentor(s) or other Senior/Key Persons specified in the original application.
Applications submitted to Requests for Applications (RFAs): the same post-submission materials as other applications (see "All Applications" above), for all due dates in the RFA.
Conference Grant Applications (R13, U13): a one-page explanation of all speakers who accepted invitations to participate in the proposed conference after the application was submitted, plus a one-page explanation of all speakers who declined such invitations after the application was submitted. Alternatively the PD/PI may consider submitting a one-page explanation for each plenary slot on the agenda.
Any other types of post-submission materials are not likely to be accepted.
Requirements for Submitting Post-Submission Materials
All post-submission materials must conform to NIH/AHRQ/NIOSH policies on font size, margins, and paper size as referenced in the applicable application instructions.
- Any specified formats (e.g., budgets, biographical sketches) and page limits referenced in the applicable application instructions apply.
- If post-submission material is not required on a specific format page and does not have a specified page limit, each explanation or letter is limited to one page.
- If the application has multiple components (subprojects or cores), each subproject or core is allowed explanations or letters, but each explanation or letter is limited to one page.
Post-submission materials must be received by the NIH, AHRQ, or NIOSH Scientific Review Officer (SRO) no later than 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, unless specifically stated otherwise in the FOA for which the application was submitted or in a special Guide Notice.
Concurrence from the Authorized Organization Representative (AOR) of the applicant organization is required. Although the post-submission materials may originate from the PD/PI, Contact PD/PI, 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.
Post-submission materials can only be submitted as a PDF attachment. 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 procedure provides the information to reviewers in a secure manner.
Inquiries
Please direct all inquiries to:
Division of Receipt and Referral
Center for Scientific Review (CSR)
National Institutes of Health
Telephone: 301-435-0715
Email: csrdrr@mail.nih.gov
Sally A. Amero, Ph.D.
NIH Review Policy Officer
ReviewPolicyOfficer@mail.nih.gov
Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Telephone: 301-427-1521
Email: Francis.Chesley@ahrq.hhs.gov
Viji Potula, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Telephone: 404-498-2551
Email: VPotula@cdc.gov
and Human Services (HHS)
