On January 29, 2015, the Federal Acquisition Regulation (“FAR”) Council published the long-awaited  final rule (“the Final Rule”) implementing Executive Order 13627 and title XVII of the National Defense Authorization Act of 2013, significantly augmenting existing human trafficking-related prohibitions for Federal contractors and subcontractors.  The Final Rule is similar to the previously summarized proposed rule.

The Final Rule is broadly applicable to all Federal contractors and subcontractors, regardless of contract type or dollar amount, including contractors providing commercial items, commercially-available off-the-shelf items, or goods on the Federal Supply Schedule.  In addition, certain contractors providing goods and services abroad will be required to make new certifications and implement compliance plans.  Failure to comply may result in financial penalties, termination for default, suspension or debarment, and potential litigation, including false claims suits.  Because of its breadth, severe penalties, and compliance costs, the rule may necessitate fundamental risk assessments about contractors’ business practices and the practices within their supply chains.

Our in-depth analysis of the Final Rule is available here.  Though the Final Rule’s aim of preventing human trafficking is undoubtedly praiseworthy, it addresses few of the ten lingering questions that we raised in November 2013.

The Final Rule will be effective on March 2, 2015.  The FAR Council urged Contracting Officers to include the Final Rule in Indefinite Delivery/Indefinite Quantity (“ID/IQ”) contracts with task orders remaining after March 2 through bilateral modification, so both new and existing contracts will be subject to the Final Rule after that date.

The Department of Defense also issued a final rule for its Defense Federal Acquisition Regulation Supplement (“DFARS”).  The DFARS final rule is unchanged from the proposed rule and adds a few noteworthy requirements to the FAR Final Rule, as we discussed here.

 

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Photo of Jennifer Plitsch Jennifer Plitsch

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…

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.