Tag: Regulatory Compliance and Ethics

GSA Federal Supply Schedules Contracts and the Coronavirus: Risks and Rewards

Merle M. DeLancey Jr.

On March 19, 2020, the General Services Administration (“GSA”) issued guidance regarding its process for issuing Defense Priorities and Allocation System (“DPAS”) Rated Orders. Significantly, however, GSA reminded its contracting officers that “[e]xisting Government sources of supply and contract vehicles should be considered first. Check to see if the required supplies are available.” See gsa.gov/buying-selling/purchasing-programs/gsa-schedules/gsa-schedule-offerings/consolidated-schedule/industrial-products-services-category and gsaadvantage.gov/advantage/search/specialCategory.do?cat=ADV.DR. GSA federal supply schedules (“FSS”) can be a contracting officer’s one-stop shop for protective equipment, disinfectants, hand sanitizers, and other products and supplies to combat the coronavirus COVID-19. The GSA FSS also offers a variety of solutions for agencies looking for teleworking options. See gsa.gov/buying-selling/purchasing-programs/gsa-schedules/gsa-schedule-offerings/consolidated-schedule/professional-services-category.

The largest active buyer in the market right now remains the federal government. FSS is an important tool for the government to get supplies and services, but do not be fooled. With these potential opportunities, there also are potential risks for FSS contractors that fail to follow the terms and conditions of their FSS contracts and/or seek to cut corners.

As is often the case, FSS vendors go above and beyond to provide services or deliver supplies to federal agencies to respond to emergency situations like the COVID-19 pandemic. As is also the case, months later, after the dust settles, agency offices of inspector general arrive to audit contracts. Inevitably, in the effort to expeditiously fill government orders, things get overlooked or ignored, and “but I was helping the agency fulfill its mission in response to a pandemic” is not a defense that will resonate with government auditors.

Based upon our experience, here are some tips for FSS vendors to follow and/or traps to avoid: Continue reading “GSA Federal Supply Schedules Contracts and the Coronavirus: Risks and Rewards”

Defense Production Act: Government Contractor Cheat Sheet

Merle M. DeLancey Jr.

On March 18, 2020, by Executive Order (“E.O.”), President Trump invoked the Defense Production Act of 1950 (“DPA”). The E.O. delegates DPA authority to the Secretary of the Department of Health and Human Services with respect to “all health and medical resources needed to respond to the spread of COVID-19 within the United States.” This means that the performance of rated contracts and orders (i.e., certain contracts and orders in support of programs covered by the DPA, as explained below) must be prioritized over competing commercial or non-rated governmental obligations—even if doing so could result in a breach of other obligations.

Set forth below is a checklist for contractors that have received (or believe they may receive) a rated order from a federal government agency:

1. Memorialize Standard Operating Procedures (“SOP”)

Effectively managing rated orders requires careful attention, particularly given the operational disruptions from coronavirus COVID-19. A company should consider establishing (or updating) SOPs for rated orders covering the following:

      • Designating a Point of Contact (“POC”) Responsible for Rated Orders. Publicize the POC within the company so that management and employees (e.g., C-Suite, Sales, and Marketing) who do not normally handle government contracting matters know who to contact.
      • Establish a Process to Communicate with Subcontractors. A prime contractor in receipt of a rated order stands in the shoes of the federal government and is required to notify applicable subcontractors of compliance with the rated order. Consider notifying subcontractors of the possibility of receiving a rated order and provide background on the DPA so they are not caught by surprise.
      • Establish a Commercial Customer Communications Plan. Because a rated order can delay or interfere with performance of commercial contracts, consider keeping commercial customers aware of potential impacts in the event that the government issues a rated order.
      • Frequent Communication with Contracting Officers. If the company believes it might receive a rated order, establish clear lines of communication with your Contracting Officers. Provide or re-confirm contact information for the company’s POC for rated orders.

Continue reading “Defense Production Act: Government Contractor Cheat Sheet”

New DoD Cybersecurity Regulations Are Coming—Is Your Company Ready?

Michael Joseph Montalbano

In January, the Department of Defense (“DoD”) released more information on its much-anticipated Cybersecurity Maturity Model Certification (“CMMC”) framework. While a final rule is not expected until the fall, contractors need to begin preparing now so they do not miss out on DoD contract opportunities.

What Is the CMMC?

The CMMC is a certification system that all DoD prime and subcontractors must comply with to be eligible to compete for and perform future DoD contracts. Under the new CMMC requirements, an accreditation body tapped by DoD will begin training third-party assessors in the spring of 2020, who will in turn certify defense contractors under the CMMC. There will be five CMMC certification levels, of ascending sophistication:

    • Level 1 – Basic Cyber Hygiene
    • Level 2 – Intermediate Cyber Hygiene
    • Level 3 – Good Cyber Hygiene
    • Level 4 – Proactive
    • Level 5 – Advanced / Progressive

The contractor must comply with a combination of the following cybersecurity safeguards, depending on the certification level a contractor wants to achieve: (1) FAR 52.204 (Basic Safeguarding of Covered Contractor Information Systems); (2) NIST Special Publication 800-171 Revision 1 (“NIST Requirements”); (3) select subsets of a supplement to the NIST Requirements called NIST SP 800-171B; and (4) up to 171 “practices” identified in the CMMC. Though this may sound like a lot for contractors to process, DoD has released helpful appendices that put many of the requirements in easy-to-understand terms. Continue reading “New DoD Cybersecurity Regulations Are Coming—Is Your Company Ready?”

For Part B of Section 889, Is Compliance by August 13, 2020, Realistic?

Merle M. DeLancey Jr., Justin A. Chiarodo, and Robyn N. Burrows


On March 10, 2020, the Department of Commerce extended the deadline for U.S. companies to stop doing business with Huawei Technologies Co. Ltd. and its non-U.S. affiliates. The deadline has been extended multiple times and is now May 15, 2020. Under the extension, U.S. businesses can continue to work with Huawei on the operation of existing networks and mobile services, including cybersecurity research considered critical for network reliability.

Huawei was added to the Commerce Department’s Bureau of Industry and Security “Entity List” in May 2019. The Entity List includes foreign entities who have engaged in activities sanctioned by the State Department and activities contrary to U.S. national security and/or foreign policy interests.

In addition to the extension, the Commerce Department is seeking public comments through March 25, 2020, regarding the continuing need for, and scope of, possible future extensions concerning Huawei. The multiple extensions and new request for public comments are intended to allow time for companies and persons to shift from Huawei or its affiliates to alternative sources of equipment, software, and technology.

Continue reading “For Part B of Section 889, Is Compliance by August 13, 2020, Realistic?”

Five Steps to Take to Prepare for Part B of the Section 889 Ban

Merle M. DeLancey Jr., Justin A. Chiarodo, and Robyn N. Burrows


Part B of Section 889 takes effect August 13, 2020. The ban prohibits the federal government from contracting with any “entity that uses” telecommunications and video surveillance products or services from Huawei Technologies Company Ltd. (Huawei) and four other Chinese entities, including their affiliates and subsidiaries (we’ve previously covered Section 889 here and here). This post examines recent industry feedback during a public meeting with the Department of Defense (“DoD”) and provides five compliance recommendations pending forthcoming rulemaking.

On March 2, 2020, DoD held a public meeting on Part B. Several trade associations gave feedback, and raised five major concerns: 1) the broad scope of the rule; 2) the inability of many contractors to meet the August 2020 compliance deadline; 3) whether the rule will apply outside the United States; 4) whether the term “use” would include a reseller’s commercial sales of prohibited products, thus precluding a supplier from contracting with the federal government; and 5) whether the “entity” subject to the ban includes only the legal entity executing the contract with the federal government, or also its affiliates and subsidiaries. Unfortunately, DoD did not indicate when an interim rule might issue.

Continue reading “Five Steps to Take to Prepare for Part B of the Section 889 Ban”

Are You Prepared to Comply with the Fast Approaching Prohibition on the Use of Banned Telecommunications Equipment?

Merle M. DeLancey Jr., Justin A. Chiarodo, and Robyn N. Burrows


Background      

Section 889 of the 2019 National Defense Authorization Act (“NDAA”) imposed major new supply chain restrictions on the use of “covered” telecommunications products and services from Huawei Technologies Company Ltd. and several other Chinese entities and their affiliates.

Part A of Section 889 became effective in August 2019 and bans companies from providing covered technology to the Federal Government. Under Part A, a company cannot sell any product or provide any service to the government that uses covered technology. Compliance with Part A requires contractors to flow down the prohibition to subcontractors.

Continue reading “Are You Prepared to Comply with the Fast Approaching Prohibition on the Use of Banned Telecommunications Equipment?”

After Acetris Decision, Trade Agreements Act Compliance Questions Abound: Contractors Need Guidance

Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger

The Federal Circuit’s recent decision in Acetris has left many contractors scratching their heads and asking questions. To recap, on February 10, 2020, the Federal Circuit held that, under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the Trade Agreements Act (“TAA”), a drug must be either “manufactured” in the United States or “substantially transformed” in the United States. (See Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade Agreements Act (Acetris Decision).) This is a stark change from the Government’s long-held position that manufacturing and substantial transformation were one in the same.

As a result of the Acetris decision, federal contractors seeking to comply with or maintain compliance with the TAA are facing many questions. Some of the more prominent questions are below. Continue reading “After Acetris Decision, Trade Agreements Act Compliance Questions Abound: Contractors Need Guidance”

Federal Circuit Holds Generic Drugs Manufactured in the U.S. from API Produced in India Qualify for Sale to U.S. under Trade Agreements Act (Acetris Decision)

Merle M. DeLancey Jr., Jay P. Lessler, and James R. Staiger

Earlier today, the United States Court of Appeals for the Federal Circuit issued a decision that is sure to send shockwaves through the generic drug industry. In Acetris, the Federal Circuit held that a generic drug manufactured in the United States complied with the Trade Agreements Act (“TAA”) and could be sold to the Department of Veterans Affairs. The court made this determination even though the drug’s active pharmaceutical ingredient (“API”) came from a non-designated country, India. In reaching its decision, the court broke away from longstanding Customs and Border Protection (“CBP”) precedent that the country where the API was produced dictated the location of “substantial transformation” and thus the country of origin for any resulting drug. The court held that under the Federal Acquisition Regulation (“FAR”), to qualify as a “U.S.-made end product” under the TAA, a drug must be either “manufactured” in the United States or “substantially transformed” in the United States—but not be both.

For years, generic drug manufacturers that manufacture drugs in the United States from API produced in India and China have been precluded from selling their drugs to the U.S. Government under the TAA. The Federal Circuit’s Acetris decision opens up the U.S. Government market for generic drugs manufactured in the U.S. from API produced in India and China.

 

 

A DoD New Year’s Resolution: No More Chinese (and Possibly Russian) Products and Services in Support of Key Missions

Justin A. Chiarodo and Robyn N. Burrows

A very Happy New Year to our GovCon Navigator readers! Further expanding recent supply chain restrictions across federal procurement, the Department of Defense (“DoD”) issued an interim rule prohibiting DoD from procuring equipment or services from certain Chinese entities (and possibly Russian) if used to carry out DoD nuclear deterrence or homeland defense missions. The rule builds on the Section 889 supply chain restrictions we previously covered in a prior blog post.

What should contractors do now given the interim rule is already in effect? Contractors should first evaluate their existing contract portfolios for covered missions and take immediate steps to eliminate all covered products from their supply chain (and find alternate sources of supply). If the rule might impact contract performance, you should be prepared to address this with the appropriate counterparty. And given the requirement for compliance certifications that mirror Section 889, contractors should also harmonize monitoring and compliance with their existing supply chain compliance programs. Among other things, this should address the requirement to obtain compliance certifications from downstream subcontractors and suppliers.

Read on for the specifics.

Continue reading “A DoD New Year’s Resolution: No More Chinese (and Possibly Russian) Products and Services in Support of Key Missions”

5 Tips for Complying with New Section 889 Supply Chain Regulations

Justin A. Chiarodo and Robyn N. Burrows

As part of a recent wave of supply chain requirements, Section 889 of the 2019 National Defense Authorization Act (“NDAA”) imposed major new limitations on the use of certain Chinese telecommunications products and services in federal procurement, and recent implementing regulations mandate a range of compliance actions relating to the ban. This blog post provides practical guidance on the new rules and five compliance tips.

Ban against Procuring “Covered Telecommunications Equipment or Services”

The Department of Defense (“DoD”), General Services Administration (“GSA”), and National Aeronautics and Space Administration (“NASA”) recently released an interim rule implementing the first part of Section 889. This ban, which became effective August 13, 2019, sweeps broadly by prohibiting agencies from procuring the following “covered telecommunications equipment or services”:

    1. Telecommunications equipment produced by Huawei and ZTE Corporation;
    2. Video surveillance and telecommunications equipment used for public safety, surveillance of “critical infrastructure,” or national security purposes and produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company;
    3. Telecommunications or video surveillance services provided by such entities for any purpose; or
    4. Telecommunications or video surveillance equipment produced or provided by an entity that the Secretary of Defense determines is owned or controlled by, or otherwise connected to, the government of the People’s Republic of China.

The ban includes all affiliates and subsidiaries of the listed companies. Continue reading “5 Tips for Complying with New Section 889 Supply Chain Regulations”

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