During his first State of the Union address on January 30, 2018, President Trump informed the country that “it is time to rebuild our crumbling infrastructure.”  He called on Congress to “produce a bill that generates at least $1.5 trillion for the new infrastructure investment we need.”  And, the President suggested that “every Federal dollar should be leveraged by partnering with State and local governments and, where appropriate, tapping into private sector investment — to permanently fix the infrastructure deficit.”

The President’s full infrastructure plan has yet to be unveiled, but a leaked summary of the plan from January 22 suggests that the plan will heavily depend upon encouraging “state, local and private investment” by providing incentives in the forms of grants.  Fixing federal infrastructure may be made difficult, however, due to the budgetary scoring rules implemented by the Office of Management & Budget (“OMB”).
Continue Reading Will President Trump’s Infrastructure Plan Address OMB Scoring?

On January 9, 2018, Department of Defense (“DoD”) issued Class Deviation 2018-O0009, designed to reduce barriers to entry for innovative entities through streamlining the awards process for research and development contracts. This Class Deviation allows for the use of simplified acquisition procedures and excuses certain procurement obligations when DoD…
Continue Reading DoD Implements Streamlining Awards for Innovative Technology Projects

Federal contractors may be subject to a slate of new regulations in 2018, including rules that increase cyber reporting burdens, expand small business competition, and change the procedures for competitively awarding IDIQ contracts.

Among the proposed rules, announced in the Semiannual Regulatory Agenda of the FAR Council and the General Services Administration (“GSA”), are changes that would affect nearly every segment of the government contracts industry.  Although some of the rules may simplify the burdens on contractors, most come with enhanced compliance obligations, particularly with respect to data security and cyber incidents.Continue Reading Changes Coming to the FAR: Government Proposes New Rules on Data Breaches, Cost Evaluation of IDIQ Proposals, and Overseas Small Business Contracting

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness.

Now, over the past two weeks, a two-part congressional hearing has suggested that recent efforts may soon be accompanied by key legislative changes, including much needed funding authorizations and incentives. As a result, the upcoming reauthorization of the Pandemic and All-Hazards Preparedness Act (“PAHPA”), and its prior reauthorization, may present a critical opportunity to continue to improve public-private relationships in countermeasure development.

Continue Reading Recent Support of Countermeasure Development Poised to Continue in Reauthorization of PAHPA

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.
Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers

On January 19, the Defense Advanced Research Projects Agency (“DARPA”) issued a new solicitation in the form of a broad agency announcement for the Preventing Emerging Pathogenic Threats—or “PREEMPT”—program. The program will be managed by the DARPA Biological Technologies Office, which generally supports activities that integrate biology, engineering, computer science, physical sciences, and mathematics.

The goal of the program is to support research and development relating to new tools, models, and technologies that are focused on preventing the transition of viral threats from animals to humans. In contrast to recent biodefense efforts that have largely been initiated in response to significant human outbreaks, such as in connection with Ebola, influenza, and Zika, the program targets animal-based viruses that have yet to become an active threat to humans. In addition, consistent with DARPA’s mission, the program targets animal-based viruses that have a potential to impact deployed U.S. military forces, particularly with respect to remote geographic areas associated with prevalent endemic and emerging diseases.Continue Reading DARPA Targets Animal-Based Viral Threats in Solicitation for PREEMPT Program

As Congress scrambles in a last ditch attempt to pass a funding proposal to keep the government operating, government contractors face the various employment law implications of potential furloughs caused by a government shutdown. Of particular concern to private employers is how to furlough employees who are exempt from overtime…
Continue Reading Beware of Employment Law Issues Amidst a Potential Government Shutdown

Following recent efforts by Democrats to push for “Buy American” action, on January 9, 2018, Senator Chris Murphy (D-CT) proudly announced via Twitter that there now is “bipartisan support for strengthening our Buy American laws” and that he is “excited to have the Trump admin[istration] and partners like [Senators Rob Portman (R-OH), Lindsey Graham (R-SC) and Sherrod Brown (D-OH)] working together to get this done.” That same day, these senators reached across the aisle to sponsor the BuyAmerican.gov Act of 2018 (S.2284) to “strengthen Buy American requirements.”

This proposed legislation may be the most significant “Buy American” development since President Donald J. Trump issued his “Buy American” Executive Order (E.O. 13788, April 2017), which set forth a policy and action plan to “maximize . . . the use of goods, products and materials produced in the United States” through federal procurements and federal financial assistance awards to “support the American manufacturing and defense industrial bases” (and which we analyzed in a prior blog post).Continue Reading Key Takeaways from Bipartisan Bill to “Strengthen Buy American Requirements”

As part of ongoing efforts to create an online marketplace for government purchasers, GSA officials held a public meeting yesterday to discuss potential market structures and legal requirements.

A wide range of stakeholders attended the hearing, responding to questions from GSA on issues such as how many online portals should be implemented, who should have privity of contract with the government, and whether certain federal procurement requirements should be waived for program participants.  GSA had previously published its discussion topics in a Federal Register notice on December 15, 2017.Continue Reading GSA Hears Comments from Industry About e-Commerce Portals

Last week, the RAND Corporation published a report entitled “Assessing Bid Protests of U.S. Department of Defense Procurements: Identifying Issues, Trends, And Drivers.”  In it, RAND analyzed the prevalence and impact of bid protests of U.S. Department of Defense (“DoD”) acquisitions, and concluded that DoD bid protests are both “exceedingly uncommon” and, on the whole, effective in prompting DoD to take remedial actions to address issues identified in the protests.  The report, which was commissioned by Congress in Section 885 of the 2017 National Defense Authorization Act (“NDAA”) Pub. L. No. 114-238, is expected to be a driver of changes to the protest process, and includes several recommendations counseling against significant changes that appear to be favorable to protesters.
Continue Reading RAND Report Concludes That Protests of Department of Defense Procurements Are Rare, Effective