“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944), which required the U.S. government to purchase “essential” medicines and medical supplies produced domestically, rather than abroad. We previously wrote about this Executive Order in August (available here), expecting that once the list was issued, government agencies would begin implementing the “Buy American” priorities for these products and materials. The FDA has identified around 227 drugs and 96 devices, along with their respective critical inputs or active ingredients, that the FDA believes “are medically necessary to have available at all times” for the public health. Agencies across the federal government should now begin making non-competitive awards “to the maximum extent permitted by law,” for drugs and medical supplies on this list that are produced in the United States. We have yet to see how agencies will implement these requirements in regulations or class deviations, but publication of this list is an important first step in implementing the rest of the “Buy American” priorities in the Executive Order. Continue Reading

NIST Issues Long-Awaited Final Guidance on Security and Privacy Controls – SP 800-53

After many years of being in draft form, NIST recently released its final version of Revision 5 of Special Publication 800-53, Security and Privacy Controls for Information Systems and Organizations to address a need for a more proactive and systematic approach to cybersecurity. With the release of Revision 5, NIST hopes to provide updated security and privacy controls that will make information systems more penetration resistant, limit damages from cyber-attacks, make systems more cyber-resilient, and protect individuals’ privacy. NIST intends this update to be usable by a more diverse set of consumer groups than previous iterations of the document permitted. Continue Reading

DoD’s Long Awaited Rule on CMMC – Plus a New Cybersecurity Assessment Methodology for Contractors to Start Right Now

At long last, the Department of Defense (“DoD”) has provided its interim rule, published in the Federal Register on September 29, 2020, amending the Defense Federal Acquisition Regulation Supplement (“DFARS”) to set forth requirements for the Cybersecurity Maturity Model Certification (“CMMC”) program, as well as new requirements for a “NIST SP 800-171 DoD Assessment Methodology.”  The interim rule is effective November 30, 2020, and comments to the interim rule should be submitted by November 30 as well.  Continue reading for our breakdown of key provisions. Continue Reading

Proposed Changes to the Buy American Act Regulations Implementing Trump Executive Orders

On September 14, 2020, the Federal Acquisition Regulatory Council published the long anticipated proposed rule amending the Federal Acquisition Regulation (“FAR”) in accordance with President Trump’s Executive Order 13881, “Maximizing Use of American-Made Goods, Products, and Materials.” As previously discussed here, the Executive Order, signed on July 15, 2019, required significant changes to the implementing regulations of the Buy American Act, 41 U.S.C. §§ 8301-8305, changing policies dating back nearly 70 years. Accordingly, the proposed rule seeks to increase both the domestic content requirements and the evaluation preferences provided by the FAR for domestically manufactured goods, particularly with regard to domestic content requirements for steel or iron end products and products made predominantly from iron or steel. Most significantly, however, the proposed rule will revive heightened restrictions for commercially available-off-the-shelf (“COTS”) products that are made predominantly of iron or steel, requiring both the end product and 95 percent of the component parts be domestically sourced in order to qualify under the rule. The COTS exception remains available for other end products (that are not made predominantly of iron or steel), but the proposed rule still will impose heightened obligations and vendors now need to scrutinize their supply chains even more closely, even for COTS items. The FAR Council is accepting comments through November 13, 2020. A final rule is likely by early-2021. Continue Reading

GSA’s Take on Implementation of Section 889

On September 10, 2020, the General Services Administration (“GSA”) hosted a webinar related to its implementation of Section 889 of the 2019 NDAA – the ban relating to certain Chinese telecom companies – and associated updated FAR clauses.  (We previously have written about Section 889 here, here, here, and here).  Below we provide highlights from the meeting.  Slides presented at the meeting also are available here. Continue Reading

Women-Owned Small Business Self-Certification Ends October 15, 2020 When SBA Begins Requiring Formal Government-Issued Or Third-Party Certifications for Awards

Beginning October 15, 2020, the U.S. Small Business Administration (“SBA”), implementing the 2015 National Defense Authorization Act (“NDAA”), will begin requiring women-owned small businesses (“WOSBs”) and economically disadvantaged WOSBs (“EDWOSBs”) to undergo a formal certification process to be eligible under the Procurement Program for Women-Owned Small Business Concerns (the “Program”). Thus, WOSBs and EDWOSBs no longer will be allowed to self-certify that they meet the Program requirements to compete for set-aside or sole source contracts, as has been the case for the last few decades. Instead, WOSBs and EDWOSBs now must apply for a formal government-issued certification at https://beta.certify.sba.gov/, which includes creating an account and uploading the necessary paperwork to establish eligibility. 13 C.F.R. Subpart C (§§ 127.300 – 127.356). Continue Reading

IoT Legislation Advances in Congress

Congress recently advanced legislation that directs the National Institute of Standards and Technology (NIST) to create standards and guidelines for securing Internet of Things (“IoT”) devices used by Federal agencies and their contractors. We previously reported on this legislation in April of 2019 when it was introduced in the House (H.R. 1668) and the Senate (S. 734). On September 14, 2020, the House of Representatives passed the legislation on a voice vote. Continue Reading

Ninth Circuit Reverses SEC Disgorgement Award and Remands in First Decision Post-Liu

For the first time outside of the originating case itself, a federal appeals court was called upon to apply the principles governing disgorgement in SEC enforcement actions established by the United States Supreme Court’s high-profile decision in Liu v. Securities & Exchange Comm’n, No. 18-1501, 2020 WL 3405845 (U.S. June 22, 2020) (see our prior blog article here).  In Securities & Exchange Comm’n v. Yang, No. 19-55289, 2020 WL 4530630 (9th Cir. Aug. 6, 2020), the United States Court of Appeals for the Ninth Circuit reviewed a district court order, issued eighteen months before the Supreme Court spoke in Liu, awarding the SEC disgorgement.  In an unpublished memorandum decision, the Court of Appeals reversed the disgorgement awards and remanded the case to the district court to explicitly determine whether the awards comported with the requirements for such relief under Liu.  The Yang decision drew attention because it served as an example of how the high court’s decision is impacting appellate review of disgorgement awards.  If Yang is any indication, courts of appeal will be remanding cases to district courts with instruction to reach specific findings regarding compliance with Liu’s disgorgement requirements. Continue Reading

“You Got To Know When To Protest” Part II: Federal Circuit Holds Blue & Gold Waiver Rule For Bid Protests Inapplicable When Pre-Award Objection Would Have Been “Futile”

In our previous blog article, we discussed the Federal Circuit’s decision in Inserso Corp. v. United States, 961 F.3d 1343 (Fed. Cir. 2020), in which a split panel held a protest cannot be brought in the U.S. Court of Federal Claims (“COFC”) if, before the time of proposal submission, “the law and facts” made it reasonably known to the contractor that a procurement error was likely to occur under the terms of the solicitation.  We analogized the Inserso decision’s application of this waiver rule – known in government contracts law parlance as the Blue & Gold rule – as creating a kind of gambling transaction for government contractors, forcing them to predict what “law” and what “facts” can reasonably be known before proposal submission, lest they risk forfeiting any opportunity for challenging an erroneous procurement decision based on that “law” and those “facts.”  In our prior posting, we suggested that Inserso seems to advise offerors to adopt a fairly expansive approach in assessing whether the available “law and facts” merit the filing of an early protest.  To wait is to risk the dismissal of your protest; to file may result in otherwise avoidable legal fees and a dismissal of your protest as premature, but – in that event – you will still be “in the game.” Continue Reading

Government Small Business Contracting Continues to Increase: Creating Opportunities and Potential Pitfalls

The U.S. Small Business Administration (“SBA”) recently announced that the federal government exceeded its small business contracting goal by awarding $132.9 billion dollars in federal contracts – 26.5% of the government’s total procurement spending – to small businesses last fiscal year, with at least an additional $90.7 billion in subcontracts.  The SBA recently released statistics in its FY 2019 Small Business Procurement Scorecard, available here and here.  Also notable in these reports: (a) for only the second time ever the government met the 5% woman-owned small business goal; (b) the government met the service-disabled veteran-owned small business goal (3%, awarded 4.39%); and (c) the government also met the small disadvantaged business goal (5%, awarded 10.2%).  The government did not, however, meet the 3% HUBZone goal, coming in at 2.28%.  That said, small business contracting was up across all categories.  Here we provide a summary of the SBA’s findings, noting some of the potential opportunities available for small business contractors, while also highlighting some of the risks inherent in doing business with the U.S. government. Continue Reading

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