You’ve submitted an NIH SBIR grant application to meet the deadline, and a few days later receive news that your company’s research manuscript was accepted or claims in a patent application were finally granted. These are important achievements that can significantly strengthen an application. Happily, there is a way to submit such updated information to the granting agency after the grant deadline. The process is described in the Post-Submission Materials Policy, and we highlight a few critical details that applicants need to be aware of.
What Can Be Included in a Post-Submission?
Items acceptable for post-submission for an NIH SBIR grant are narrowly and precisely defined in the Post-Submission Materials Policy, and some examples are described below. In general, the policy allows for a response to unexpected events that occur after the submission deadline and at least 30 days prior to peer review. It is not intended to address inaccuracies or errors in the original grant submission.
– Acceptance of a research manuscript
Include only a reference citation with author(s) and affiliations, article title, journal, volume and pages (if known). Do not include a preprint, abstract or any figures.
– Issued Patents
Patents must be made publicly available on the US Patent and Trademark Office website (https://www.uspto.gov/). Similarly, foreign patents must be publicly available in English. Include only a citation with the inventor name(s), patent title, issued patent number, country designation, filing date and date the patent was issued. Do not include a copy of the patent.
– Change of an Investigator
Provide a biographical sketch for the new person; the 5-page limit still applies. Note that a submission with a change in Principal Investigator needs to copy the Division of Receipt and Referral (csdrr@mail.nih.gov).
– Support letters
Provide a document from a new investigator or collaborator.
– Videos
A short video (not longer than 2 minutes; maximum pdf file size of 25 MB) may be provided that more clearly demonstrates a key concept such as how a device/prototype functions, surgical procedure, or visualization of 3-D structures. There are special guidelines for this type of submission, and the applicant needs to include a cover letter in the original application stating the intent to submit a video file after the grant deadline. The Research Strategy section of the application should include a description of the video along with a few key images. Due to technical considerations, there is always the possibility that reviewers may not be able to view the video submission.
Where do I Send the Post-Submission Materials?
The document submission should be made directly to the Scientific Review Officer (SRO) by the Authorized Organization Representative. The contact information for the SRO handling the grant application is posted in the NIH eRA Commons accounts for the Principal Investigator and Signing Official. Alternatively the Authorized Organization Representative may send an indication of concurrence to the Principal Investigator, who can send the concurrence (not just a cc’d message) and post-submission material to the SRO. All documents need to be supplied as pdf attachments, with adherence to application guidelines for font style/size and formatting requirements. Importantly, post-submission materials must be received by the SRO at least 30 days before the grant review meeting. This allows for timely distribution of the grant application along with the post-submission materials to reviewers, and leaves adequate time for reviewers to prepare their critiques. It’s important to note that review meetings can occur over a period of several weeks and the 30-day advance deadline may come up very soon after the original grant submission deadline.
There are only a few situations that allow for post-submission supplementary documents to an original NIH SBIR grant application. Investigators should be aware of this option to make reviewers aware of unexpected changes to research personnel, collaborators, or patent and manuscript status.
Useful Sources
Update to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-083.html
NIH Post-Submission Materials Policy- Frequently Asked Questions
https://public.csr.nih.gov/FAQs/ApplicantsFAQs/PostSubmissionMaterialsPolicy
Interim Guidance for Videos Submitted as NIH Application Materials
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-141.html
NIH SBIR Grant Application Submission, Review and Award Dates
Grant Proposals – The Process