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June 3 -- The Technology Partnerships Office in the National Institute of Standards and Technology (NIST), Commerce, invites comments to OMB by July 5, 2022 regarding implementation 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.

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. Historically, the National Institutes of Health (NIH) has collected this information via their on-line portal, iEdison; however, the responsibility for this data collection will be taken over by NIST. Agencies that do not register with iEdison are required to collect this information independently.

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.

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, 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.

NIH, iEdison, the Invention Reporting System, Transitioning to NIST This Summer (3.30.22) https://nexus.od.nih.gov/all/2022/03/30/iedison-the-invention-reporting-system-transitioning-to-nist-this-summer/
NIST, iEdison Rebuild (4.19.22) https://www.nist.gov/tpo/bayh-dole/iedison-rebuild
NIST, The New iEdison is Launching This Summer (4.28.22) https://www.nist.gov/news-events/news/2022/03/new-iedison-launching-summer

iEdison submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0693-002 Click IC List for data collection instruments, View Supporting Statement for technical documentation. Submit comments through this site.
FRN: https://www.federalregister.gov/d/2022-11960

For AEA members wishing to submit comments to OMB, the AEA Committee on Economic Statistics offers "A Primer on How to Respond to Calls for Comment on Federal Data Collections" at https://www.aeaweb.org/content/file?id=5806

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