NIST Draft Guidance on Exercising March-in Rights

The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency review of the march-in guidance, which was announced in tandem with the NIH’s rejection of the Xtandi march-in petition in March 2023.

When the comment period was announced, KEI published a brief FAQ to provide an overview of march-in rights.

KEI Comments to NIST

KEI submitted a series of comments on several different important topics for NIST to consider as they finalize the guidance:

All of the comments received are publicly available on at docket NIST–2023–0008. Below are a selection of comments from notable organizations:

Select Comments Submitted to NIST

Civil Society:


University-related Associations:



Under the Trump Administration, NIST had previously sought to alter regulations pertaining to march-in rights. After receiving over 80,000 submissions during that public comment period, the Biden Administration declined to enact those proposed changes. KEI’s page of comments submitted to that round of proposed NIST changes is available here.