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Bayh-Dole Regulations for Federally Funded Inventions
Interagency Domestic Manufacturing Waiver Request Update
In accordance with Executive Order 14104 Sec. 7(e), NIST has worked with the Interagency Working Group for Bayh-Dole to develop a new interagency form to be used by Bayh-Dole contractors when seeking a waiver to the Preference for United States Industry under 37 CFR 401.14(i). This domestic manufacturing waiver request form should be adopted by all agencies identified in the Executive Order and aims to provide clarity and streamline the domestic manufacturing waiver process. A 60-day Federal Register Notice for this form was published on December 7, 2023. On May 24, 2024, NIST published a 30-day Federal Register Notice as required under the Paperwork Reduction Act, allowing the public to comment on the form before it can be adopted and used by agencies.
After the 30-day comment period closes, if the form is finalized, users will be able to upload this form as an attachment to their Domestic Manufacturing Waiver Request within iEdison for any iEdison-participating agency who has appropriately adopted the form. Bayh-Dole contractors seeking a waiver from agencies that adopt the form but do not yet participate in iEdison, will need to contact that agency to determine how to submit the form.
The current version of the form: Interagency Domestic Manufacturing Waiver Request Form
Draft Interagency March-In Framework RFI
NIST appreciates the engagement and interest of the community in the Request for Information on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights. The comment period closed on February 6, 2024. NIST is currently reviewing the comments received.
The National Institute of Standards and Technology (NIST) is seeking comments on its Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which is designed to help agencies evaluate when it might be appropriate to exercise march-in rights under the Bayh-Dole Act. The draft guidance offers a series of questions to help agencies work through a range of policy considerations relevant to a potential march-in decision. The draft Framework was published in the Federal Register on Friday, December 8, 2023. The 60-day comment period will be open until February 6, 2024.
NIST hosted an informational webinar on Wednesday, December 13, 2023, from 1 p.m. to 2 p.m. Eastern time to walk through the framework and provide information on the RFI and how to submit comments. See the slides from the Draft Interagency March-In Framework presentation and a recording of the webinar below.
2023 Final Rule
NIST published a Final Rule to the regulations that support the University and Small Business Patent Procedures Act of 1980, commonly known as the “Bayh-Dole Act,” in Federal Register on March 24, 2023. This rulemaking, which went into effect on April 24, 2023, made several revisions to regulations in order to make technical corrections; reorganize subsections; remove outdated, redundant, and/or unnecessary sections; institute a reporting requirement on federal agencies; and provide clarifications on definitions, communications, process for exercising march-in rights, filing of provisional patent applications, electronic filing of Bayh-Dole related reporting, the purpose of royalties on licenses from the Federal Government, and the processes for granting exclusive, co-exclusive, and partially exclusive licenses and for appeals.
Notice of Proposed Rulemaking
As part of the Return of Investment Initiative, NIST requested feedback on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, commonly known as the “Bayh-Dole Act". A notice of Proposed Rulemaking was published in the Federal Register on January 4, 2021, seeking public comments on the revised regulations.
The public comment period closed on April 5, 2021. Submitted comments can be viewed in the Federal e-Rulemaking Portal.
Public Meeting
NIST held a public webinar on the Notice of Proposed Rule Making on Thursday, February 25th, 2021, from 3:05-4:35 pm ET. During the webinar, NIST reviewed the proposed changes to 37 CFR 401 and 404 and took 18 public statements on the proposed rule in the time allotted, in the order they were requested. Meeting slides can be downloaded on the Notice of Proposed Rulemaking: Regulatory Updates to 37 CFR 401 and 404 webpage. The recording of the webinar is available below.