Aug 24 -- The National Institute of Standards and Technology (NIST), Commerce, invites public comments to OMB by September 25, 2023 regarding the proposed expansion of the iEdison System.
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.
The information collected is either required by the Bayh-Dole Act and its regulations or they help advance, track compliance and/or measure impact related to the Act’s purpose and objectives. Agreement to provide the information is essentially a requirement to receive the benefit of federal research dollars. The information is used by federal agencies in the following ways:
-- To ensure that federal agencies are made of aware of the inventions and patents, and the utilization thereof, associated with its funding programs and to which the government has certain rights;
-- To tie inventions and patents to their associated federal funding programs;
-- To allow inventions resulting from federal research the opportunity to be protected and commercialized either by the Contractor or (if the Contractor does not pursue or continue to pursue protection) the government;
-- To track compliance with the Bayh-Dole Act and its implementing regulations;
-- To track ROI from federal research funding in a number of ways, including inventions, patents, revenue, licenses, products, jobs, etc.
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.
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. With the 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, 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. Agencies that do not register with iEdison are required to collect this information independently.
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.
The table below details the information/data fields being requested as well as the statute or regulation(s) authorizing the collection of this information and the needs or uses for collection of this piece of information. The information will be collected in one of three major record categories within iEdison: Invention, Patent, or Utilization Records. . . .
The information detailed above will be collected from recipients of federal funding with resulting inventions, including universities, research institutions, hospitals, non-profit organizations, for-profit businesses, etc. Information will also be collected from individual inventors who, with federal agency approval in accordance with the Bayh-Dole Act and associated regulations, had patent rights assigned back to them by the organization that received federal funding. . . .
In general, we only anticipate that limited data derived from the information entered into the system will be made public, specifically the number of subject inventions, patent applications, issued patents, requests, and conveyances to the government. However, the specifics of the information in general is not anticipated to the released publicly. Certain information is subject to confidentiality requirements (see answer to question 10), but might be released to individuals under a FOIA request if certain requirements are met. The exception to this statement is NIH-funded FDA-approved products. These products are routinely published on a public website by the NIH to inform the public which FDA-approved products were developed with NIH funding.
Information will be primarily entered electronically via NIST’s iEdison website. NIST has also implemented a number of technological features to minimize the burden on users. NIST has made an Application Programming Interface (API) available for users to connect the system to their own internal intellectual property database. The API allows certain information to be reported automatically from the Contractor’s database into the iEdison system without having to manually enter the information via the iEdison website. NIST is also utilizing drag and drop technology to allow for easier and more efficient upload of documentation into the iEdison records. Additionally, when associated patent records are generated, certain information is auto-populated from existing records. If this information is not accurate, the Contractor can correct the information, but the auto-population feature saves time for the Contractor by avoiding the manual entry of similar information. Finally, NIST has implemented API integrations with other government websites, such as the USPTO and sam.gov, so that if certain information is available for a patent application (such as the Title, Inventors, Issued Patent Number, and Issued Patent Date) or for a company (such as the Company Name and Address), this information can be auto-populated and/or updated in the iEdison records.
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.
iEdison:
https://www.nist.gov/iedison
Changes Coming to Utilization Reporting on October 1, 2023:
https://www.nist.gov/iedison/2023-utilization-questions-update
Federal agencies currently using iEdison:
https://www.nist.gov/iedison/agency-contact-list
NIST submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202308-0693-004 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN:
https://www.federalregister.gov/d/2023-18160
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806