NIST has recently announced significant changes to utilization reporting that will impact technology transfer compliance in all institutions engaged in federally-funded research. The deadline to comply with these changes is rapidly approaching in 2023. In order to prepare for what will be new requirements for information that involve both licensees and collaborators on research initiatives, our Michele O’Shea, compliance guru and Nikki Borman, our CEO, sat down to tackle the salient points concerning this NIST announcement.
How will utilization reporting change with the recent NIST announcement? What are the deadlines to comply?
Starting on October 1, 2023, all required entities participating in iEdison will be asked for annual utilization reporting. Users will see notifications requesting utilization reports on all subject inventions to which they have elected title, regardless of the funding agency, starting on that date. It’s important to note that iEdison will not trigger utilization notifications retroactively for subject inventions funded by agencies who did not previously request utilization reporting within the iEdison system. Notifications prior to this October date will not be affected. As for timeframe, those 2023 utilization reports will not be considered "overdue" until January 1, 2024. Therefore, contractors will have through December 31, 2023, to submit timely utilization reporting for 2023.
NIST has organized the questions for utilization reporting for funded inventions into three categories:
1. not licensed or commercialized
It is the latter category that may present the greatest challenge for grantees. Details about the required information can be found here: https://www.nist.gov/iedison/2023-utilization-questions-update
How will the new reporting requirements impact TTO’s, grantees and licensees?
Currently, most institutions do not have the information on hand to comply with the new information required in iEdison and they will need to obtain it. For example, grantees will now be required to provide:
a list of products commercialized as a result of federally funded research and
where these products are manufactured (in which states/countries)
Also, it is important to know that new licensing agreements will need to be modified to include requirements for this information. Keep in mind that changes in products and manufacturing locations are likely to occur over time and this information needs to be kept up to date.
Do these changes apply to agencies that do not use iEdison to report?
Agencies that do not report using iEdison, such as the Navy, Air Force, and NASA, will still be required to submit the new utilization reporting information pursuant to their reporting requirements and systems. It will be important to track these data separately to support accurate and timely reporting.
What don’t we know about how the changes will be implemented?
As of June, NIST has not finalized the exact fields in iEdison that will be used to submit the required utilization reporting. Look forward to the October announcement on the NIST website. NIST will offer training on how to report the data and navigate the system for that reporting at the AUTM University conference in October. That said, now is the time to be sure the required information is at hand and entered into institution or company databases, since this will allow for an orderly transition to the new requirements.
The definition of “substantial requirement of US manufacturing” has not, at this time been codified by NIH or NIST, and we await their conclusion. It is therefore important to maintain data that will allow compliance when codification has been achieved, and not endeavor to collect that information post hoc. NIST and agencies have left this deliberately vague, and that will likely not change. Anyone with questions should contact specific agencies to ask for further clarification.
What should TTO’s do now to prepare for compliance with the new regulations?
Current communications indicate that institutions will be required to provide a list of products, country of manufacture, whether in the US or offshore, and what state the product or practice was created or reduced to practice if in the US. Importantly, this information needs to be obtained from the licensees so that the information can be reported accurately in a timely fashion on an annual basis. Unless institutions put mechanisms in place to gather this information, they will not be able to comply with iEdison requirements.
What will NIST require when institutions collaborate on inventions?
An additional point to consider is the instance when inventions are developed in collaboration with other institutions. In this case, the lead institution, currently reporting under iEdison, will need to obtain information needed from their collaborating institution(s).
How do these utilization reporting changes impact risk management?
There may be risk at the agency level. NIST however, will be monitoring how aggressively agencies will be in securing the required information. NIST have begun to monitor outstanding utilization reports, focusing first upon institutions that have a substantial backlog of overdue reports.