The recent AUTM Operations and Compliance Course in Kansas City provided an excellent opportunity to assess our current situation in the evolving landscape of NIST utilization reporting. While the training covered essential topics such as the new utilization questions, when notifications deadlines post and how to complete the new reports in iEdison. The roundtables covered more general topics for compliance staff at all levels (beginner to advanced). Regulatory questions could be discussed one-on-one or in a small group with our NIST presenter.
Time to Develop a Solid Plan
Keeping in mind that the deadline for the new reports is coming up quickly at the end of December, most institutions are now faced with the task of establishing an effective plan to comply with the new regulations. The information that is now required from licensees includes: a list of products commercialized as a result of federally funded research, the country of manufacture (whether in the US or offshore), the number of units sold and gross revenues for the year. As this is a new set of data not readily available, several questions must be addressed to put a comprehensive plan in place:
1. Process for Obtaining Manufacturing Information: What will be the process for collecting the required information from licensees?
2. Responsibilities within the Research Institution: Who will be responsible for reaching out to licensees to gather the required data?
3. Data Submission to iEdison: How will this sensitive information be submitted to iEdison and in what format? Regarding sensitive data NIST referred us to the regulatory language that covers the requirement for agencies to keep the information in confidence. That has always applied.
Who will be assigned to gather the required information from licensees will depend on the size and staffing of the organization. It makes sense that individuals that already have a relationship with the licensees could be best suited to the task. Gathering essential financial utilization information from offshore manufacturing licensees can be a time-consuming task, which further complicates the effort.
Commercial databases such as Wellspring and Inteum are in the process of updating their systems to reflect the new reporting requirements. In the meantime, the information can be submitted via batch uploads to iEdison. Instructions about how to do this can be found on the iEdison website.
What about Federal Agencies that Do Not Use iEdison?
It is worth noting that NASA and some DOD agencies do not currently use iEdison. Per the recent Executive order of 7/23, these agencies are required to transition to iEdison by 2025. To date, information has been sent via email and there were concerns expressed about the security of email channels, emphasizing the importance of marking emails as confidential. As email addresses change, it is recommended to use the ones indicated in the award agreements and confirm that they are current prior to reporting.
A step-by-step plan specific to each institution, must be created (per their federal award requirements) and communicated to the licensees. One of the most crucial steps that TTO operations staff can take is to educate their counterparts within the institution about the new mandate for utilization reports. Not everyone has had the opportunity to attend compliance training, so sharing the knowledge we’ve gained will help our licensing and tech transfer operations adapt to the new reporting requirements efficiently.