Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?

Merle M. DeLancey, Jr. ●

On November 27, the Administration announced another blue-ribbon panel to bolster the domestic manufacturing of pharmaceuticals. This one is called the Supply Chain Resilience Council. Co-chairs of the Council are Lael Brainard, Director of the White House National Economic Council, and Jake Sullivan, the White House National Security Advisor. Among the other 25 Council members are multiple agency Secretaries; the U.S. Trade Representative; the Chair of the White House Council of Economic Advisers; and the Directors of National Intelligence, the Office of Management and Budget, and the Office of Science and Technology Policy. The Council does not include any industry representatives.

A major part of the Council’s plan to bolster domestic manufacturing is providing the Department of Health and Human Services (“HHS”) with expanded authorities under Title III of the Defense Production Act (“DPA”) to invest in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs deemed crucial for national security. HHS will be granted DPA authority beyond what it was given during the COVID pandemic.

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FY2023 GAO Protest Statistics: Dramatic Increase in Sustain Rate Is Illusory, but Increase in Overall Filings Is Real

Luke W. Meier and Carolyn R. Cody-Jones ●

The Government Accountability Office (“GAO”) has released its Annual Report to Congress summarizing bid protest activity for Fiscal Year 2023 (GAO-24-900538). Although there is a seemingly drastic increase in the number of protests sustained, the real trend worth noting is an uptick in protests filed at GAO—reversing a recent trend that had seen GAO protest numbers falling.

With the full context in hand, the FY 2023 GAO protest data mostly show a steady continuation of recent trends: the number of sustains and sustain rate remains largely the same as FY 2022, “effectiveness” remains high and stable (57 percent), and the hearing rate remains low at two percent (22 for the year). The meaningful increase in cases filed at GAO shows that protesters still view GAO as a valuable protest forum, even as an increasing number of protesters opt for the more fulsome document production and (at times) less deferential analysis they expect at the U.S. Court of Federal Claims.

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Starting December 4th, Contractors Must Rid Supply Chains of Covered Articles and Sources Subject to FASC Orders

Robyn N. Burrows ●

Effective December 4, 2023, a new interim rule will prohibit contractors from delivering or using covered articles and sources subject to exclusion or removal orders issued under the Federal Acquisition Supply Chain Security Act of 2018 (“FASCSA”). The rule is intended to eliminate certain technology from the federal supply chain that foreign adversaries might exploit to commit malicious cyber acts. The interim rule allows the executive branch through the Federal Acquisition Security Council (“FASC”) to exclude certain technologies and manufacturers from federal procurements and even to require removal of covered articles from federal or contractor information systems during performance.

The rule imposes a host of new obligations, including certification, monitoring, and reporting requirements. This post provides practical guidance on the rule and several compliance tips to help contractors prepare for the December deadline.

Background

Congress passed Section 202 of the FASCSA to protect the information and communications technology (“ICT”) supply chain against threats and vulnerabilities that may lead to data and intellectual property theft, damage to critical infrastructure, or national security harm. The Act established the FASC as an interagency council authorized to make recommendations for orders that would require the removal of covered articles from agency information systems (removal orders) or the exclusion of sources or covered articles from agency procurement actions (exclusion orders) (collectively referred to as “FASCSA orders”).

In August 2021, the FASC issued a final rule establishing procedures for recommending removal and exclusion orders. The FASC evaluates supply chain risk based on several non-exclusive factors and sends its recommendations to the Secretaries of Homeland Security and Defense and the Director of National Intelligence to consider when deciding whether to issue a FASCSA order. If a FASCSA order is issued, agencies are required to implement the exclusion or removal order.

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The FAR Council Proposes Standardizing Cybersecurity Requirements

Michael Joseph Montalbano and Oliver E. Jury ●

On October 3, 2023, the FAR Council proposed two potentially significant cybersecurity rules. We discussed FAR Case No. 2021-017, which would impose a range of new cyber incident reporting requirements on nearly all government contractors, earlier this week. This post discusses FAR Case No. 2021-019, which seeks to standardize cybersecurity contractual requirements across federal agencies.

Who Will the Standardization of Cybersecurity Contractual Requirements Affect?

Under the proposed rule, the FAR Council would promulgate two new FAR clauses, FAR 52.239-YY (Federal Information Systems Using Non-Cloud Computing Systems) and FAR 52.239-XX (Federal Information Systems Using Cloud Computing Services). As drafted, the rule would affect contracts that involve the development and maintenance of federal information systems (“FIS”).

What is an FIS? The proposed rule defines FIS as “an information system used or operated by an executive agency, by a contractor of an executive agency, or by another organization, on behalf of a government agency.”

FAR 52.239-YY would be required in contracts acquiring FIS services that include (or are anticipated to use) non-cloud computing services during contract performance. The proposed clause would require flowdown to subcontractors at all tiers (provided those subcontractors may use non-cloud computing services). There would be no exception for acquisitions below the simplified acquisition threshold or acquisitions for commercial products, including commercially available off-the-shelf (“COTS”) items and commercial services, “because Government data and systems require protection regardless of dollar value.”

The FAR 52.239-XX requirements would largely mirror those in FAR 52.239-YY, albeit for contractors using cloud-based computing services during performance. Contractors would need to comply with both proposed clauses if they use both non-cloud and cloud-based computing services in support of contract performance.

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The FAR Council Proposes New Cyber Incident Reporting Requirements

Michael Joseph Montalbano and Oliver E. Jury ●

On October 3, 2023, the FAR Council issued two proposed cybersecurity rules that could have significant implications for both Government prime and subcontractors. This post discusses the first rule, FAR Case No. 2021-017, which, if implemented, will impose an array of new cyber incident reporting requirements on nearly all government contractors. The second rule, FAR Case No. 2021-019, seeks to standardize cybersecurity contractual requirements across Federal agencies. We discuss the first rule in further detail here.

Who Would Have to Comply with the New Cyber Incident Reporting Rule?

Under the proposed cyber incident rule, the FAR Council intends to promulgate a new FAR clause, FAR 52.239-ZZ. In its current form, FAR 52.239-ZZ would apply to all contracts where “information and communications technology” (“ICT”) is used or provided in the performance of the contract.

What is ICT? ICT is just about anything computer related. ICT includes computers and their peripheral equipment, telecommunications equipment, computer software, and electronic documents. In other words, if a contractor uses a computer or related device in the performance of a government contract, then FAR 52.239-ZZ would likely apply.

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PLI Chronicle: Towards a “Reverse CFIUS”? President Biden’s Executive Order on Outbound Investment and Related Congressional Proposals

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Anthony Rapa ● PLI Chronicle: Insights and Perspectives for the Legal Community ● September 22, 2023 ●

Should the U.S. government regulate U.S. investments in other countries?

The Biden Administration resoundingly answered that question in the affirmative on August 9, 2023, when the President issued an executive order (EO) providing for official oversight of certain U.S. tech-related investments in China and Chinese-linked companies. The EO followed years of national security experts and congressional leadership calling for the regulation of U.S. investment in China and other countries of concern, and came amidst intensive efforts by Congress to legislate in the area.

To continue reading, visit our website.

Blank Rome Attorneys Appointed to American Bar Association’s Public Contract Law Section Leadership for the 2023–2024 Term

Blank Rome LLP is pleased to announce that nine attorneys from the firm’s nationally recognized Government Contracts group have been appointed to leadership roles in the American Bar Association’s (“ABA”) Public Contract Law Section for the 2023–2024 term, marking the highest number of ABA Public Contract Law Section leadership positions held by our attorneys in the firm’s history.

Visit our website to learn more about their roles and the Section of Public Contract Law.

3 Tips to Reduce False Claims Act Exposure in the Wake of United States ex rel. Schutte v. SuperValu, Inc.

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Justin A. Chiarodo, Jennifer A. Short, Stephanie M. Harden, Samarth Barot, and Oliver E. Jury ●

2023 is shaping up to be a major year in False Claims Act (“FCA”) practice, with the Supreme Court weighing in on both FCA scienter (in SuperValu) and the reach of the government’s dismissal authority (in Polansky), and the government focusing its enforcement efforts around antitrust, cyber, and national security. We focus today on the United States ex rel. Schutte v. SuperValu, Inc. decision, in which the Supreme Court held that a contractor’s subjective belief about its compliance at the time it submitted claims for payment is relevant to whether it had the requisite scienter for FCA liability. Much has been written on this case, with most articles exploring esoteric concepts like “scienter,” “falsity,” and the “objectively reasonable person.” But assuming—as we do—that the decision will reduce the prospect of successful early dispositive motions, what practical steps can contractors take to reduce their False Claims Act exposure and avoid litigation in the first place? We offer three suggestions.

We begin with a basic refresher on the issue presented in SuperValu. A defendant is not liable under the False Claims Act unless it “knowingly” (including acting with “reckless disregard”) submits a false claim to the government. The “knowing” scienter element—particularly around reckless disregard—can be difficult to prove in the world of complex and often ambiguous laws and regulations that govern contractors’ compliance. The federal circuits had split on the issue of whether a defendant’s subjective interpretation at the time it submitted claims for payment to the government was relevant to determining FCA “knowledge” if the defendant could later show that the underlying rule was ambiguous and its conduct (regardless of its contemporaneous understanding or belief) was consistent with an objective, reasonable interpretation of the unsettled requirement. SuperValu resolved the debate by holding that whether a defendant knowingly violated the FCA—and satisfied the scienter element—must consider the defendant’s real-time “knowledge and subjective beliefs.” United States ex rel. Schutte v. SuperValu, Inc., 143 S. Ct. 1391 (2023).

Continue reading “3 Tips to Reduce False Claims Act Exposure in the Wake of United States ex rel. Schutte v. SuperValu, Inc.“

10 Key Takeaways: Biden Administration Sets the Stage for Regulation of U.S. Investments in China

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Anthony Rapa, George T. Boggs, and Alan G. Kashdan ●


President Biden recently issued an executive order (“EO”) establishing a framework to regulate certain U.S. investments with a nexus to China, taking initial steps towards what eventually could be unprecedented regulation of outbound U.S. investment. Specifically, the order directs the U.S. Department of the Treasury (“Treasury”) to issue regulations requiring notification of, and in some cases outright prohibition of, certain U.S. investments in Chinese and Chinese-owned companies relating to semiconductors, quantum technology, and artificial intelligence. The EO also covers investments in Hong Kong and Macau.

Concurrent with the August 9, 2023, executive order, Treasury unveiled an “Outbound Investment Program” website, along with a fact sheet and an Advance Notice of Proposed Rulemaking (“ANPRM”).

In the months ahead, it will be critical for observers to keep apprised of Congress’s reaction to President Biden’s EO and Treasury’s ANPRM, especially among members who have been particularly involved in advancing legislation on outbound investment. Congress may yet legislate on the issue, and such legislation could differ in scope from the Biden Administration’s executive action.

This alert provides background regarding the Biden Administration’s executive action, along with 10 key takeaways.

Background

Geopolitical risk commentators have anticipated an EO relating to U.S. outbound investment for some time, based on policymakers’ stated concerns around the role of U.S. investment capital in developing sensitive technologies in China. Proposals in this context have tended to focus on the establishment of a multi-agency body (akin to the Committee on Foreign Investment in the United States) to review outbound investment in sensitive technologies or “critical capabilities” with a nexus to certain countries of concern, including China.

To read the full client alert, please visit our website. 

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