Since its creation in 2006, the Biomedical Advanced Research and Development Authority has funded the development of medical countermeasures for pandemic influenza, anthrax, smallpox, Ebola virus disease, Zika virus, and, of course, COVID-19. In just the last year, BARDA has made more than 35 new awards to partners, assisted its partners in achieving 20 FDA
Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.
She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.
For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:
- the Department of Veterans Affairs (VA);
- the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
- the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
the U.S. Agency for International Development (USAID).
She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.
Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.
The requirement to pay “prevailing wages” to covered workers is a perennial aspect of many types of government contracting, including construction contracts subject to the Davis-Bacon Act (“DBA”) and certain related laws (collectively referred to as the Davis-Bacon and Related Acts or “DBRA”). In recent years, Congress has also expanded the reach of prevailing wage requirements to new industries: clean energy projects seeking to take advantage of federal tax credits under the Inflation Reduction Act are required to ensure that prevailing wages are paid or may be forced to forfeit valuable credits. Semiconductor manufacturers — as well as manufacturers of materials and equipment used to make semiconductors — that seek to take advantage of the incentives established by the CHIPS Act are likewise required to follow the prevailing wage requirements of the DBA.
It was in this context that the Department of Labor (“DOL”) introduced a 222-page final rule, “Updating the Davis-Bacon and Related Acts Regulations,” that substantially rewrote the implementing regulations under the DBRA. Among other things, the final rule alters how DOL calculates the prevailing wage rates for each locality, and expands the definition of the “site of work” and categories of workers subject to the DBA. Moreover, the final rule imposes the DBA by operation of law on federal construction contracts that would otherwise be covered, but that nevertheless do not include the requisite FAR clauses and wage determinations used to inform contractors of the DBA’s requirements. The potential impact of these changes has not gone unnoticed: last month, two trade associations — the Associated Builders and Contractors of Southeast Texas, Inc. (“ABCSETX”) and the Associated General Contractors of America (“AGC”) — filed separate suits challenging multiple aspects of the final rule, including the changes to prevailing wage calculation methodology and the revised definition of the site of work. We expand on the final rule’s changes — and on the pending legal challenges — below. Continue Reading Whose Site Is It Anyway: Trade Groups Challenge DOL’s Prevailing Wage Calculation and Expanded Definition of the Site of Work Under the Davis-Bacon Act
Echoing the Obama Administration’s Better Buying Initiative, the Biden Administration announced the Better Contracting Initiative (“BCI”), a four-pronged initiative designed to ensure the Federal Government gets better, and more consistent, terms and prices when purchasing commercial goods and services, while enhancing support for small and disadvantaged businesses. The Initiative’s four prongs include:Continue Reading More Bang for the Government’s Buck: The Biden Administration Announces the Better Contracting Initiative
In August 2020, the Office of Management and Budget (“OMB”) amended its Guidance for Grants and Agreements set forth under 2 CFR (commonly referred to as the “Uniform Guidance”). The Covington team wrote about that amendment, and in particular, the implementation of Section 889 requirements, here. Now, almost three years later, OMB is requesting feedback in anticipation of further amending the Uniform Guidance. Continue Reading Opportunity to Comment on OMB Efforts to Amend Compliance Requirements for Grant Agreements
The Department of Defense is seeking early input on implementation of the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (the “FY2023 NDAA”) in the Federal Acquisition Regulation and Defense Federal Acquisition Regulation. Although this early engagement process will not replace the formal rulemaking process, it presents a significant opportunity for government contractors, technology providers, industry associations, and other interested parties to provide their perspectives on acquisition-related provisions of this year’s NDAA. Providing early input can ensure that industry’s perspective is heard. Indeed, providing input at this stage may impact the future rulemaking process by guiding areas of focus and influencing ways the rule makers ask for input during the rulemaking process.
Continue Reading DoD Seeks Early Input Regarding FY2023 NDAA Implementation in Acquisition Regulations
President Biden recently signed bipartisan legislation reinforcing anti-human trafficking prohibitions. The End Human Trafficking in Government Contracts Act of 2022 builds on the existing anti-human trafficking framework at Federal Acquisition Regulation (“FAR”) § 52.222-50 (Combatting Trafficking in Persons) by requiring agencies to refer contractor reports of potential human trafficking activity directly to an agency suspension and debarment official (“SDO”). Prior to this legislation, contractors have been required to notify their contracting officer and the agency inspector general upon receiving “[a]ny credible information” that a human trafficking violation had occurred. See FAR § 52.222-50(d)(1). Now agencies will be required to refer these reports to their SDOs, creating additional risk for contractors that disclose potential violations. Continue Reading New Law Increases Government Scrutiny of Contractor Compliance with Anti-Trafficking Provisions
On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security. The White House subsequently announced that the Initiative would cost $2 billion. If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle. A summary of the E.O., its requirements, and key takeaways are set forth below.Continue Reading President Biden Issues Executive Order on National Biotechnology and Biomanufacturing Initiative
Update as of September 15, 2022: OFCCP has extended the deadline by one month for contractors to submit objections to the FOIA request described in this article. The new deadline is October 19, 2022. Additionally, in an effort to clarify which government contractors are covered by this FOIA request, OFCCP has indicated that it will be reaching out to “contractors that OFCCP believes are covered by this FOIA request” using the “email addresses provided as a contact for the EEO-1 report” through OFCCP’s Contractor Portal.
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In response to a broad Freedom of Information Act (“FOIA”) request the Office of Federal Contract Compliance Programs (“OFCCP”) may produce the Employment Information (“EEO-1”) Type 2 filings of up to 15,000 government contractors unless written objections are filed by September 19, 2022. This blog post explains the information that OFCCP has been asked to release and factors that government contractors should consider in deciding whether an objection to the release of this information is appropriate and advisable.Continue Reading OFCCP Seeks Input On Potential FOIA Disclosure of Contractor Employment Information
UPDATED AS OF 10/26/2022:
Changing course after its August 31 announcement that it would not enforce the federal government contractor vaccination mandate absent further written notice, on October 14, 2022, OMB and the Task Force published an update stating that they plan to issue at least three new guidance documents with an eye toward potentially resuming enforcement of the mandate:
- First, OMB plans to notify Federal agencies about compliance with applicable injunctions and whether contract clauses implementing the mandate should be included in new solicitations and contracts.
- Second, the Task Force plans to update its November 2021 workplace safety protocols guidance related to the mandate. The updated guidance will provide a timeline for any implementation long enough to ensure that covered contractors can come into compliance as needed.
- Third, OMB will review the safety protocols guidance and make a determination on whether it promotes economy and efficiency in government contracting. If OMB makes such a determination, it will provide additional guidance to agencies on timing and considerations for providing written notice to contractors regarding enforcement, except as barred by any injunction.
On August 25, 2022, President Biden announced a new Executive Order (“EO”) addressing the Implementation of the CHIPS Act of 2022 (“CHIPS Act”). The CHIPS Act was signed by President Biden on August 9, 2022, and, among other things, authorizes $39 billion in funding for new projects to establish semiconductor production facilities within the United States. The new EO identifies the Administration’s implementation priorities for this CHIPS Act funding and creates the CHIPS Implementation Steering Council to aid with the rollout of administrative guidance. In connection with the EO, the Department of Commerce launched CHIPS.gov, which is intended to be a centralized resource for potential applicants of CHIPS funding. The EO and new website reflect the Administration’s intent to swiftly implement the CHIPS Act and increase the domestic production of semiconductors. Continue Reading Biden Administration Announces Priorities for the Implementation of the CHIPS Act of 2022