May 4 -- The National Institute of Standards and Technology (NIST), Commerce, invites public comments on the proposed expansion of the iEdison System by July 3, 2023.
iEdison (or interagency Edison) is an online, relational database designed around the reporting requirements of the Bayh-Dole Act and its implementing regulations. It allows recipients of federal research funding to report subject inventions and patents to the federal funding agency that issued the funding award. Several federal agencies use iEdison, so this single online resource lets funding recipients report to many different funding agencies. The system is used by both the funding recipients to report information and documentation into iEdison as well as by the funding agencies to receive and review the information and documentation submitted.
The Bayh-Dole Act (35 U.S.C. 18) and its implementing regulations (37 CFR 401) allow for recipients of federal research funding (Contractors) to retain ownership of inventions developed under federal funding agreements. In exchange, the government retains certain rights to the invention, including a world-wide right to use by or on behalf of the U.S. government. The law also requires the Contractor to obtain permission for certain actions and fulfill reporting requirements including:
a. Initial reporting of invention.
b. Decision to retain title to invention.
c. Filing of patent protection.
d. Evidence of government support clause within patents.
e. Submission of a license confirming the government's rights.
f. Notice if the Contractor is going to discontinue the pursuit or continuance of patent protection.
g. Information related to the development and utilization of invention.
h. Permission to assign to a third party; and
i. Permission to waive domestic manufacturing requirements.
This information is used for a variety of reasons. It allows the government to identify technologies to which the government has rights to use without additional payment or licensing. This acts as a time and cost-saving mechanism to avoid unnecessary negotiating and payment. It also provides data for calculation of return on investment (ROI) from federal funding and identifies successful research programs. Thirdly, it allows the government the opportunity to timely protect inventions which the Contractor declines title or discontinues patent protection. Many agencies utilize the iEdison system, managed by NIST, to collect this information. Agencies that do not register with iEdison are required to collect this information independently.
Historically, only NIH and DOE regularly requested that Contractors submit requests for reports on the development and utilization of an invention (utilization reports) within iEdison. However, there has been an increased interest across the government in the impact of federally funded research and resulting inventions as well as compliance with the Bayh-Dole requirements, especially as it relates to domestic manufacturing requirements. As a result, the interagency working group for Bayh-Dole decided that all agencies would begin to request this information, and the questions would be amended and expanded upon so that the agencies could get a clear picture of the commercialization plans for subject inventions, what the licensing landscape looked like, what products were resulting, and where those products were being manufactured.
Another data point of particular interest across government relates to gender, and specifically how gender disparity may be present within the inventing and commercialization space. Collecting gender of the inventors within iEdison provides agencies previously unavailable data that they may use to conduct assessments under administrative policy guidance outlined in Executive Order 13985. NIST does not anticipate that the collection of this data will significantly affect the reporting burden.
iEdison was originally developed as “Edison” by the National Institutes of Health (NIH) in 1995. Two years later, NIH began offering iEdison to other agencies and changed the name to “interagency Edison” or “iEdison”. In 2018, after NIST's findings in the Green Paper, Unleashing American Innovation, available here
https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.1234.pdf and the U.S. National Academies' recommendation that iEdison be modernized and transferred to the Department of Commerce, the interagency community agreed that the iEdison system should be transferred to NIST. NIST was a natural choice to redesign and manage iEdison as the agency that issues the Bayh-Dole regulations and co-chairs the National Science and Technology Council’s Lab-to-Market subcommittee. NIST collected agency and funding recipients' needs for the new iEdison system through engagement with the Interagency Working Group for Bayh-Dole and a Request for Information published in the Federal Register on December 19, 2019. NIST began development of the new iEdison system in December of 2019, and the new system launched on August 9, 2022.
Federal agencies currently using iEdison:
https://www.nist.gov/iedison/agency-contact-list
Changes to iEdison Utilization Reporting in 2023:
The Bayh-Dole Act allows agencies to ask for periodic reports on the utilization or attempts at obtaining the utilization of subject inventions. Utilization reporting provides funding agencies with valuable information on the outputs of their extramural research programs. They allow the agencies to track successes, ensure compliance with specific statutory requirements, and realize the full impact of federal funding and the return on investment for taxpayer investment in research. In the past, some agencies would ask for these utilization reports regularly via iEdison at the end of the contractor’s/awardee’s fiscal year, while others might ask for them outside of iEdison on an ad hoc basis. Recently the Interagency Working Group for Bayh-Dole (IAWGBD) has agreed to make specific changes in utilization reporting.
Starting on October 1, 2023, all agencies participating in iEdison will begin asking for annual utilization reporting. Users will see notifications requesting utilization reports on all subject inventions to which they have elected titles, regardless of the funding agency, starting on that date. iEdison will not trigger utilization notifications retroactively for inventions funded by agencies who did not previously ask for utilization reporting within the iEdison system. The IAWGBD is developing a standard set of questions to be asked by every participating agency. However, each agency can ask for supplemental questions related to inventions made with funding from that agency. The standard questions are modeled after the existing iEdison utilization questions. They will be announced in the coming weeks to allow contractors/awardees adequate time to gather any needed information and update their internal records and databases accordingly. The new utilization questions will also be timely published in the Federal Register and reviewed by OMB as required under the Paperwork Reduction Act. NIST is updating the utilization functionality in the iEdison system to make entry of the new utilization reporting as streamlined as possible.
All annual utilization reporting will be due on October 1st, aligning with the federal fiscal year instead of the individual contractor’s/awardee’s fiscal year. Under regulations at 37 CFR 401.14(h), utilization reporting can be requested no more than annually. Therefore, the iEdison system is not sending new notifications for utilization reporting with due dates between October 2, 2022, and September 30, 2023. The system will continue to send notifications for utilization reporting due before October 2, 2022. The previous due dates for those overdue utilization reports due before October 2, 2022) will remain aligned with the contactor’s/awardee’s fiscal year.
NIST will be providing additional information on the changes in utilization reporting leading up to the implementation on October 1, 2023.
iEdison:
https://www.nist.gov/iedison
Draft data collection instruments and technical documentation requested from NIST by AEAStat.
2022 approved ICR:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0693-002
FRN:
https://www.federalregister.gov/d/2023-09477