As we near the end of the first year of the Biden administration, we wanted to highlight a Department of Justice (DOJ or "the Department") action that may become increasingly relevant in the federal research space in 2022. Through the so-called "Garland Memo," DOJ rescinded two Trump-era Memoranda—the Sessions Memo and the Brand Memo—that had restricted DOJ attorneys from using noncompliance with agency sub-regulatory guidance as a basis for False Claims Act (FCA) cases and other enforcement actions. The Garland Memo indicated that the previous memoranda had "hampered Department attorneys when litigating cases where there is relevant agency guidance," and instructed Department attorneys in all pending and future actions to rely on guidance documents in "appropriate circumstances," including when they may be entitled to deferential or persuasive weight. Finally, it incorporated these changes into the Justice Manual and the Code of Federal Regulations.
The Sessions Memo (published on November 16, 2017) had restricted the creation of, and reliance on, DOJ guidance documents, and stated that previously published DOJ guidance had effectively bound private parties without undergoing the necessary rulemaking process. It directed the Department attorneys to no longer use guidance documents to impose new requirements, create binding standards or to determine compliance with existing standards. New guidance documents were required to clearly state their voluntary nature, prohibited from using mandatory language and had to identify themselves as non-binding without any force or effect.
The Brand Memo (published on January 25, 2018) had expanded the scope of the Sessions Memo by applying it not just to DOJ guidance documents, but to all agencies' guidance documents. The Memo stated, "Guidance documents cannot create binding requirements that do not already exist by statute or regulation. . . . [T]he Department may not use its enforcement authority to effectively convert agency guidance documents into binding rules." Under the Brand policy, the purpose of guidance documents was solely to explain or paraphrase existing regulations, or to use a party's knowledge of a guidance document as indicia that the party had the requisite knowledge of a regulation.
The Garland Memo's expansion signals a potentially more aggressive approach by DOJ in bringing enforcement actions against federal grantees and contractors, and enables the Department to rely more heavily on agency guidance in proving non-compliance. Specifically, DOJ attorneys "may rely on relevant guidance documents in any appropriate and lawful circumstances, including when a guidance document may be entitled to deference or otherwise carry persuasive weight with respect to the meaning of the applicable legal requirement" and can cite or rely on such documents when they are "relevant to claims or defenses in litigation."
This is notable, particularly in the federal research space, where government sponsors such as the National Institutes of Health (NIH) and National Science Foundation (NSF) frequently promulgate guidance in the form of notices, blog posts, frequently asked questions (FAQs), etc. to communicate interpretations of, and elaborate on, regulations or award terms and conditions that govern a federal funding recipient's obligations and compliance requirements.
As we enter 2022, one area where this shift may be particularly relevant relates to current and pending support disclosures generally and those bearing on questions of possible foreign influence specifically. Deciding what must be included in such disclosures can be a challenge given the fluidity of the regulatory regime. Indeed, over the past couple of years, sponsors such as NSF and NIH have issued numerous guidance documents addressing the subject of foreign influence. Under the Garland memo, federal grantees may find DOJ attorneys more open to enforcement actions relying at least in part on FAQs, blog posts and the like. As a result, an already challenging compliance environment may become more so.
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