COVID-19 Authorities, Contract Vehicles, and Initiatives

This page is intended to provide up-to-date information regarding federal authorities, contractual vehicles, and initiatives available to support the COVID-19 response.

Last Updated: 17 April 2020 

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Call to Action

Existing contracts, broad agency announcements, other transaction consortia, and grants applicable to COVID-19 response.

Department of Defense (DoD)
OSD

DoD/DHHS via Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND)
Medical CBRN Defense Consortium (MCDC)
Request for Information DoD JATF Search for Sources of Critical Material in Support of COVID Response

The continuing national demand for medical resources to address the current 2019-nCoV pandemic is increasing daily. To support this, the DoD has established a Joint Acquisition Task Force (JATF) to address needs not only within the DoD but more broadly with the Federal Emergency Management Agency (FEMA), Health and Human Services (HHS), the Department of Homeland Security (DHS) and other Federal agencies.

In support of this need at the request of the JATF and through the coordination of the JPEO-CBRND, this survey is seeking information for DoD and Federal Agency leadership to determine the capability of the industrial bse to respond to the 2019-nCoV pandemic. All acquisition options will be explored.

Responses are requested from non-Government sources (US and International) capable of provide the products listed in the survey. All products must be authorized for use in the USA.

 

Office of the Secretary of Defense (OSD) Request for Information 

“As the impact of COVID-19 unfolds domestically and in global supply chains, the Department of Defense would like to hear from you on potential disruptions or risk to your business. To that end, the Office of the Deputy Assistant Secretary of Defense for Industrial Policy has established an email address for industry to submit tips and leads, included here: osd.pentagon.ousd-a-s.mbx.covid-19-industry@mail.mil” 

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Air Force

Commercial Solutions Opening (CSO) COVID-19 Response Due Date: 9/30/2020
Notice ID: FA300220S0002

This CSO solicitation is a competition seeking solution briefs/proposals from all interested offerors, to include a variety of organizations, including defense contractors as defined in 10 U.S.C. 2302 large and small businesses and research institutions as defined in 15 U.S.C. 632. This CSO seeks innovative, commercial technologies that propose new solutions and/or potentially new capabilities that fulfill requirements, close capability gaps, or provide potential technological advancements in support of the COVID-19 Response Acquisition Task Force (DAF ACT) mission to provide relief, resilience, recovery, and stability to the nation in response to the COVID-19 pandemic.

CSO Focus Areas:

  • Combating the Spread (predictive analytics, next hotspot, threat to current activities, decision support, etc.)
  • Welfare of Citizens (effects to transportation, movement of people and goods, education and development, physical training, regular HR functions, job transition, etc.)
  • Readiness (continuing operations through the outbreak, coordinating with allies and partners, continuing long term projects, etc.)
  • Logistics (security and protection, supply chain protection and assessment, etc.)
  • Industrial Base Impacts (impacts on small businesses, payments, contracts, large system programs, protection and expansion of critical assets, etc.)
  • Medical (telehealth, medical capacity and sustainment, medical supplies and equipment, etc.)
  • Other – Any solution/proposal that is not covered by the above topic areas but support the national response to the COVID-19 pandemic

 

 

SBIR X20.R COMMERCIAL SOLUTIONS OPENING (CSO) AF VENTURES DIRECT TO PHASE II Due Date: 4/30/2020
Notice ID: AF20R-DCSO1

The Air Force invites small business firms to submit proposals under this CSO for the Small Business Innovation Research (SBIR) Program.  Firms with the capability to conduct research and development (R&D) to create new AF solutions or potential new capabilities fulfilling requirements, closing capability gaps, or providing potential technological advancements AND to commercialize the results of that R&D are encouraged to participate. 

COVID-19 Focus Area Interests:

Focus Area 1: Decision Support in Combating the Virus
Focus Area 2: Personnel Needs
Focus Area 3: Readiness
Focus Area 4: Logistics
Focus Area 5: Medical
     5a. Air & Surface Cleansing
     5b. COVID-19 Testing & Management
     5c. COVID-19 Medical Supply Chain

 

Air Force Ventures/AFWERX COVID-19 Response Team
Request for Industry Information
Notice ID: COVID19CRTRFI

RFI for Industry Partners
RFI for Military & Government Civilians

Register for AFWERX Air Force Ventures “Ask Me Anything” webinars.

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Army

Army Medical Technology Enterprise Consortium (MTEC) – “National Emergency Telecritical Care Network (NETCCN)
Request for Project Proposals: MTEC-20-10-COVID-19_NETCCN_TATRC Number W81XWH-15-9-0001 Due Date: 4/27/2020

The goal of this RPP is to support the rapid development, deployment and testing of the National Emergency Telecritical Care Network (NETCCN) – a cloudbased, low-resource, stand-alone health information management system for the creation and coordination of flexible and extendable “virtual critical care wards.” These high acuity, virtual wards would bring high-quality critical care capability to nearly every bedside, be it healthcare facility, field hospital, or gymnasium.
 
Proposers Conference: Monday, April 20, 2020 at 3:00pm ET Register here

 

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Defense Logistics Agency (DLA)

DLA Request for Information for Contract Impacts
Notice ID: COVID19_RFI_DLA

Request for Information regarding potential impacts to the welfare and safety of supplier workforce and/or overall contract performance.

 

 

Department of Homeland Security (DHS)

Federal Emergency Management Agency (FEMA) Open Solicitation through 9/25

COVID-19 PPE and Medical Supplies
Notice ID :70FA2020R00000011

Combined synopsis/solicitation for commercial items under FAR Part 12. The Government contemplates multiple awards of IDIQs and/or Direct Contracts (under FAR Part 15), Purchase Orders (under FAR Part 13), and Blanket Purchase Agreements under FAR Part 13 for Personal Protective Equipment (PPE) and medical supplies.

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Emergency Management Performance Grant Program (EMPG)
Notice of Funding Opportunity (NOFO) Fiscal Year (FY) 2020

The EMPG Program supports the goals of Building a Culture of Preparedness and Readying the Nation for Catastrophic Disasters. FY 2020 EMPG program will provide funds to assist State, local, tribal, and territorial emergency management agencies to implement the National Preparedness System and the National Preparedness Goal (the Goal) of a secure and resilient nation.

Health and Human Services (HHS)

COVID-19 EZ BAA
BARDA’s Division of Research, Innovation & Ventures (DRIVe) Easy Broad Agency Announcement
Notice ID: BAA-20-100-SOL-0002

Areas of Interest :

  • AOI #4.1-A: Molecular Diagnostic Assay for SARS-CoV-2 virus on existing FDAcleared platform
  • AOI #4.1-B: Point-of-Care Diagnostic Assay for detection of SARS-CoV-2 virus
  • AOI #4.1-C: Diagnostic Assay for detection of COVID-19 disease
  • AOI #4.3: COVID-19 Vaccine
  • AOI #4.4: Advanced Manufacturing Technologies

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Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
Notice ID: BARDABAA

COVID-19 response related Areas of Interest:

  • AOI 7.7.1 Diagnostic assay for human coronavirus using existing FDA-cleared platforms
  • AOI 7.7.2 Point-of-care diagnostic assay for detection of SARS-CoV-2 virus
  • AOI 7.7.3 Diagnostic assay for detection of COVID-19 disease (SARS-CoV-2 infection)
  • AOI 8.3 COVID-19 Vaccine
  • AOI 9.2 COVID-19 Therapeutics
  • AOI 9.3 Immunomodulators or therapeutics targeting lung repair
  • AOI 9.5 Pre-exposure and post-exposure prophylaxis
  • AOI 10 Respiratory protective devices
  • AOI 11 Ventilators
  • AOI 17 Advanced Manufacturing Technologies

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Request for Information (RFI) – Ventilators COVID-19

The purpose of this notice is to:

  1. Identify manufacturers who have current capability to produce ventilators in the quantity requested in the attachments;
  2. Identify manufacturers who are able to quickly modify their current capabilities to produce ventilators in the quantity requested in the attachments; and
  3. Make use of this information to inform acquisition strategies that may be used to support COVID-19 emergency response efforts.
Food and Drug Administration (FDA)

COVID-19 Inquiry

Email Deviceshortages@fda.hhs.gov with COVID-19-related inquiries if:

  • You do not normally manufacture masks/gowns/gloves/PPE but might have capabilities to do so (e.g., have a 3D printer, have a factory) and want to help (“Helper Companies and Individuals”), inside or outside the US
  • You need information on importing masks/gowns/gloves/PPE/ventilators/diagnostics from outside the US
  • You are outside the US and want to ship masks/gowns/gloves/PPE/ventilators/diagnostics to hospitals in the US
  • You would like to fast-track a new product to get on the US market (including Emergency Use Authorizations)
  • You have questions related to reuse, resterilization, or substitution/modification of PPE/ventilators/diagnostics/accessories 
Center for Disease Control (CDC)

COVID-19 Grant: CDC-RFA-OT18-18020202SUPP20

Supplemental funding for the organizations that were previously awarded funding under Funding Strategy 1 of CDC-RFA-OT18-1802: “Strengthening Public Health Systems and Services through National Partnerships to Improve and Protect the Nation’s Health” in FY18. 

This supplemental funding opportunity enables recipients to provide capacity-building assistance (CBA) activities in support of COVID-19 preparedness and response efforts. The goal is to fund recipients that have the capability, expertise, resources, reach, and history of providing capacity building relevant to implementing this program’s key strategies, activities, and outcomes, as they relate to the following emergency preparedness domains:

  • Strengthen Incident Management for Early Crisis Response
  • Strengthen Jurisdictional Recovery
  • Strengthen Bio-surveillance
  • Strengthen Information Management
  • Strengthen Countermeasures and Mitigation
  • Strengthen Surge Management
  • Strengthen Communications
  • Achieve Incident Management System Response Objectives

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State, Local, Territory, and Tribe (SLTT) funding through Crisis Cooperative Agreement (CoAg):

Resources directed for grants or cooperative agreements to states, localities, territories, and tribes to accelerate planning and operational readiness for COVID-19 preparedness and response, as well as develop tools and strategies, provide technical assistance and program support, as well as ensure ongoing communication and coordination among public health agencies and partners throughout the response

National Science Foundation (NSF)

Request for SBIR/STTR Phase I Proposals Addressing COVID-19
Division of Innovation and Industrial Partnerships (IIP) of the Engineering Directorate

US-based small businesses invited to submit Phase I proposals focused on the development and deployment of new technologies, products, processes, and services with the potential to positively impact the nation’s and world’s ability to respond to the COVID-19 crisis.

Areas of research that might be considered include, but are not limited to:

  • Artificial Intelligence
  • Digital Health
  • Diagnostics
  • Distributed Ledger
  • Environmental Technologies
  • Medical Devices
  • Pharmaceutical Technologies
  • Disinfection and Sterilization
  • Filtration and Separations
Veterans Affairs (VA)

VA Federal Supply Schedule
Under delegated authority by GSA, the VA manages multiple award contracts for medical equipment, supply, pharmaceutical, and service Schedule programs.

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State and Local Government Ordering Procedures
On March 13, 2020, the President declared the ongoing Coronavirus Disease 2019 (COVID-19) pandemic of sufficient severity and magnitude to warrant an emergency declaration for all states, tribes, territories, and the District of Columbia pursuant to section 501 (b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”).

Based upon this declaration, full access to order against Federal Supply Schedules, including VA Schedules, is available to State and Local Governments.  Information on the GSA Disaster Program

General Services Administration (GSA)

Purchasing for Disaster Recovery
Federal agencies, state, and local agencies, under the GSA Disaster Recovery Purchasing Program, can acquire supplies and equipment from our online shopping and ordering system at GSAAdvantage!®

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Allows state and local governments to buy supplies and services directly from all GSA Schedules to facilitate disaster preparation, response, or major disaster recovery.

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GSA Pandemic Purchasing
GSA can assist federal agencies find the policies, products, and services they need in a time of national crisis or emergency.

Online shopping for Supplies and Services through GSAAdvantage!® Disaster Relief Products and Services

  • Medical Supplies (first aid kits, resuscitation products, wound care products, body bags, lifts/ stretchers)
  • Personal Safety & Protection (safety apparel/footwear; respiratory, vision, hearing, and head protection)
  • Cleanup Supplies (disinfectants, water treatments, brooms/mops, waste containers, buckets, trash bags)
  • Medical and Laboratory Services (technical, professional, general support)
  • Environmental Services (chemical analysis, waste management, recycling)

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IMPORTANT: COVID-19 Fraud and Price Gouging
GSA Warns of COVID-19 Contracting Scam and Price Gouging

State and Local Agencies

COVID-19 Emergency Supply Sourcing & Manufacturing
New York City

Seeking businesses with the ability to source and/or make products to support the City’s COVID-19 response work.
Sourcing COVID-19 Products

Support can include: 

  • Sourcing or production of medical supplies and equipment (e.g., masks, gowns, face shields, ventilators, and other products as needed)
  • Production or distribution of food
  • Sharing connections to people willing and able to work on response efforts

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COVID-19 PPE Procurement and Donation Program
Commonwealth of Massachusetts

Donate or sell personal protective equipment to support Massachusetts’ COVID-19 response efforts

PPE Procurement
PPE Donation

Public-Private Partnerships

COVID-19 High Performance Computing (HPC) Consortium
White House Office of Science and Technology, Dept of Energy, IBM

Private-public effort to bring together federal government, industry, and academic leaders who are volunteering free compute time and resources on their world-class machines. Consortium partners from industry, academia, Dept of Energy Labs, and federal agencies are listed here.

The COVID-19 HPC Consortium encompasses computing capabilities from some of the most powerful and advanced computers in the world. We hope to empower researchers around the world to accelerate understanding of the COVID-19 virus and the development of treatments and vaccines to help address infections. Consortium members manage a range of computing capabilities that span from small clusters to some of the very largest supercomputers in the world.

Researchers are invited to submit COVID-19 related research proposals to the consortium via this online portal. An expert panel of top scientists and computing researchers will work with proposers to assess the public health benefit of the work, with emphasis on projects that can ensure rapid results.

Proposals will be evaluated on the following criteria:

  • Potential benefits for COVID-19 response
  • Feasibility of the technical approach
  • Need for high-performance computing
  • High-performance computing knowledge and experience of the proposing team
  • Estimated computing resource requirements

Contracting Authorities

Contracting authorities that are applicable to COVID-19 response.

CARES Act - Contracting Authority Relief & Flexibilities

The following are contracting flexibilities provided in the CARES Act passed 27 March 2020.  Full text of Act here. Summary below courtesy of Greenberg Traurig, LLP.

Expanded BARDA Other Transaction Authority

Section 3301 provides expanded Other Transaction Authority (OTA) to the Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) by removing the requirement for a written determination to approve OTAs expected to cost more than $100 million during a public health emergency. BARDA Other Transaction Agreements support development and procurement of needed medical countermeasures, including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, against a broad array of public health threats. 

 

Relaxation of DoD Other Transaction Authority Requirements

Section 13006 relaxes 10 U.S.C. § 2371b statutory requirements that high-level DoD officials authorize OT awards in excess of $500 million in writing and provide 30-day advance written notice to Congress. Section 13006 relaxes these requirements by authorizing DoD to delegate OTA approval authority to lower level officials and requiring congressional notification only “as soon as practicable after the commencement” of performance when the OTA is related to the COVID-19 pandemic national emergency.

OSD A&S Memo, dated 5 April 2020

Contracting Cone – Other Transaction Authority
More information on OTAs curated by the MITRE Corporation here.

 

Expansion of Strategic National Stockpile Procurements

Section 3102 expands the statutory definition of materials to be maintained in the National Stockpile to specifically include “personal protective equipment, ancillary medical supplies, and other applicable supplies required for the administration of drugs, vaccines and other biological products, medical devices, and diagnostic tests.”  This amendment clarifies that certain personal protective equipment (PPE) and other identified supplies and equipment will be mandatory to stockpile to the extent determined to be appropriate and practicable by the Secretary of HHS.

 

Federal Contractor Authority

Section 3610 authorizes an agency to modify the terms and conditions of a contract, or other agreement, without consideration, to reimburse at the minimum applicable contract billing rates not to exceed an average of 40 hours per week any paid leave, including sick leave, a contractor provides to keep its employees or subcontractors in a ready state, including to protect the life and safety of Government and contractor personnel, but in no event beyond September 30, 2020. Such authority shall apply only to a contractor whose employees or subcontractors cannot perform work on a site that has been approved by the Federal Government, including a federally-owned or leased facility or site, due to facility closures or other restrictions, and who cannot telework because their job duties cannot be performed remotely during the public health emergency declared on January 31, 2020 for COVID–19: Provided, That the maximum reimbursement authorized by this section shall be reduced by the amount of credit a contractor is allowed pursuant to division G of Public Law 116–127 and any applicable credits a contractor is allowed under this Act.

DoD Implementation Guidance here.

 

Relaxation of Undefinitized Contract Action Limits and Restrictions

Section 13004 waives the requirement that an agency obligate no more than 75% of a UCA’s ceiling price before definitizing the contract. 

Section 13005 authorizes the head of an agency to waive all of the deadlines and spending caps for UCAs set out in 10 U.S.C. § 2326(b), if the agency head determines that the waiver is necessary due to the COVID-19 pandemic national emergency.

Contracting Cone – Letter Contracts

 

 

Federal Procurement Process Relief & Flexibility

OMB: Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations

 

 

  1. Flexibility with SAM registration. (2 CFR § 200.205) Awarding agencies can relax the requirement for active System for Award Management (SAM) registration at time of application in order to expeditiously issue funding. At the time of award, the requirements of 2 CFR § 200.205, Federal awarding agency review of risk posed by applicants, continue to apply. Current registrants in SAM with active registrations expiring before May 16, 2020 will be afforded a one-time extension of 60 days.

 

  1. Flexibility with application deadlines. (2 CFR § 200.202) Awarding agencies may provide flexibility with regard to the submission of competing applications in response to specific announcements, as well as unsolicited applications. As appropriate, agencies should list specific guidance on their websites and/or provide a point of contact for an agency program official.

 

  1. Waiver for Notice of Funding Opportunities (NOFOs) Publication. (2 CFR § 200.203) For competitive grants and cooperative agreements, awarding agencies can publish emergency Notice of Funding Opportunities (NOFOs) for less than thirty (30) days without separately justifying shortening the tiineframe for each NOFO. Awarding agencies would still be required to document and track NOFOs published for less than thirty (30) days under this emergency waiver.

 

  1. No-cost extensions on expiring awards. (2 CFR § 200.308) To the extent permitted by law, awarding agencies may extend awards which were active as of March 31, 2020 and scheduled to expire prior or up to December 31, 2020, automatically at nocost for a period of up to twelve (12) months. This will allow time for recipient assessments, the resumption of many individual projects, and a report on program progress and financial status to agency staff. Project-specific financial and performance reports will be due 90 days following the end date of the extension. Awarding agencies will examine the need to extend other project reporting as the need arises. 

 

  1. Abbreviated non-competitive continuation requests. (2 CFR § 200.308) For continuation requests scheduled to come in from April 1, 2020 to December 31, 2020, from projects with planned future support, awarding agencies may accept a brief statement from recipients to verify that they are in a position to: 1) resume or restore their project activities; and 2) accept a planned continuation award. Awarding agencies should post any specific instructions on their website. Awarding agencies will examine the need to extend this approach on subsequent continuation award start dates as recipients have an opportunity to assess the situation.

 

  1. Allowability of salaries and other project activities. (2 CFR § 200.403, 2 CFR § 200.404, 2 CFR § 200.405) Awarding agencies may allow recipients to continue to charge salaries and benefits to currently active Federal awards consistent with the recipients’ policy of paying salaries (under unexpected or extraordinary circumstances) from all funding sources, Federal and non-Federal. Awarding agencies may allow other costs to be charged to Federal awards necessary to resume activities supported by the award, consistent with applicable Federal cost principles and the benefit to the project. Awarding agencies may also evaluate the grantee’s ability to resume the project activity in the future and the appropriateness of future funding, as done under normal circumstances based on subsequent progress reports and other communications with the grantee. Awarding agencies must require recipients to maintain appropriate records and cost documentation as required by 2 CFR § 200.302 – Financial management and 2 CFR § 200.333 – Retention requirement of records to substantiate the charging of any salaries and other project activities costs related to interruption of operations or services.

 

  1. Allowability of Costs not Normally Chargeable to Awards. (2 CFR § 200.403, 2 CFR § 200.404, 2 CFR § 200.405) Awarding agencies may allow recipients who incur costs related to the cancellation of events, travel, or other activities necessary and reasonable for the performance of the award, or the pausing and restarting of grant funded activities due to the public health emergency, to charge these costs to their award without regard to 2 CFR § 200.403, Factors affecting allowability of costs, 2 CFR § 200.404, Reasonable costs, and 2 CFR § 200.405, Allocable costs. Awarding agencies may allow recipients to charge full cost of cancellation when the event, travel, or other activities are conducted under the auspices of the grant. Awarding agencies must advise recipients that they should not assume additional funds will be available should the charging of cancellation or other fees result in a shortage of funds to eventually carry out the event or travel. Awarding agencies must require recipients to maintain appropriate records and cost documentation as required by 2 CFR § 200.302 – Financial management and 2 CFR § 200.333 – Retention requirement of records, to substantiate the charging of any cancellation or other fees related to interruption of operations or services. As appropriate, awarding agencies may list additional guidance on specific types of costs on their websites and/or provide a point of contact for an agency program official. 

 

  1. Prior approval requirement waivers. (2 CFR § 200.407) Awarding agencies are authorized to waive prior approval requirements as necessary to effectively address the response. All costs charged to Federal awards must be consistent with Federal cost policy guidelines and the terms of the award, except where specified in this memorandum.

 

  1. Exemption of certain procurement requirements. (2 CFR§ 200.319(b), 2 CFR§ 200.321) Awarding agencies may waive the procurement requirements contained in 2 CFR§ 200.319(b) regarding geographical preferences and 2 CFR§ 200.321 regarding contracting small and minority businesses, women’s business enterprises, and labor surplus area firms.

 

  1. Extension of financial, performance, and other reporting. (2 CFR§ 200.327, 2 CFR§ 200.328) Awarding agencies may allow grantees to delay submission of financial, performance and other reports up to three (3) months beyond the normal due date. If an agency allows such a delay, grantees will continue to draw down Federal funds without the timely submission of these reports. However, these reports must be submitted at the end of the postponed period. In addition, awarding agencies may waive the requirement for recipients to notify the agency of problems, delays or adverse conditions related to COVID-19 on a grant by grant basis (2 CFR 200.328(d)(l).

 

  1. Extension of currently approved indirect cost rates. (2 CFR§ 200.414 (c)) Awarding agencies may allow grantees to continue to use the currently approved indirect cost rates (i.e., predetermined, fixed, or provisional rates) to recover their indirect costs on Federal awards. Agencies may approve grantee requests for an extension on the use of the current rates for one additional year without submission of an indirect cost proposal. Agencies may also approve grantee requests for an extension of the indirect cost rate proposal submission to finalize the current rates and establish future rates.

 

  1. Extension of closeout. (2 CFR§ 200.343) A warding agencies may allow the grantee to delay submission of any pending financial, performance and other reports required by the terms of the award for the closeout of expired projects, provided that proper notice about the reporting delay is given by the grantee to the agency. This delay in submitting closeout reports may not exceed one year after the award expires. 

 

  1. Extension of Single Audit submission. (2 CFR § 200.512) Awarding agencies, in their capacity as cognizant or oversight agencies for audit, should allow recipients and sub-recipients that have not yet filed their single audits with the Federal Audit Clearinghouse as of the date of the issuance of this memorandum that have fiscal year-ends through June 30, 2020, to delay the completion and submission of the Single Audit reporting package, as required under Subpart F of 2 CFR § 200.501 -Audit Requirements, to six (6) months beyond the normal due date. No further action by awarding agencies is required to enact this extension.This extension does not require individual recipients and sub-recipients to seek approval for the extension by the cognizant or oversight agency for audit; however, recipients and subrecipients should maintain documentation of the reason for the delayed filing. Recipients and sub-recipients taking advantage of this extension would still qualify as a “low-risk auditee” under the criteria of 2 CFR § 200.520 (a)– Criteria for a low-risk auditee. 

 

AbilityOne Procurement List Notice of Change – Special Authority for Expanded Scope:

  • Make-To-Order (MTO) medical kits – sourcing and kitting of medical and non-medical components. Scope expanded to include the ability to source and fulfill any medical/surgical, personal protective equipment, cleaning-related, or other public safety product deemed necessary by the requiring government agency
  • Manufacturing and Development (M&D): allows for the prototyping and manufacture of products to specific customer
    designs. Scope expanded to include the development, manufacturing and supply of medical and emergency clothing, Personal Protective Equipment (examples include but are not limited to face masks, shields, eyewear, gowns, caps, coveralls, scrubs, protective outer garments, etc.) and other public safety-related supplies as required by federal agencies.

 

AbilityOne Contingency Support Operations and Communications (CSOC) Team and COVID-19 National Emergency Guidance

  • Contracting activities are encouraged to consider AbilityOne nonprofit agencies – members of the Defense Industrial Base Essential Critical Infrastructure Workforce – to meet COVID-19 response and recovery requirements. A list of broad AbilityOne supply and service capabilities is included in the memo.
  • Under the AbilityOne Program’s enabling legislation and FAR 8.7, products and services on the AbilityOne Procurement List are mandatory source items when available in the timeframe needed. The CSOC Team is closely monitoring inventory levels and will ensure that any purchase exceptions needed are promptly issued.
  • Contracting officers are not held to the notification required when changes to existing AbilityOne Procurement List specifications or descriptions are required to meet emergency needs. (See FAR 18.107 and FAR 8.712 (d)).
  • Contracting activities using authorities available to award contracts supporting the COVID-19 national emergency or recovery period may contract directly with AbilityOne Nonprofit Agencies for products and services that are not on the Procurement List, as well.
    • As such, new requirements awarded to AbilityOne nonprofit agencies supporting the national emergency or recovery period will not be placed on the Procurement List and ARE NOT subject to the mandatory requirements of the Javits-Wagner-O’Day Act.
    • Contracting activities will not be obligated to participate in a subsequent Procurement List addition for those requirements.
Managing Federal Contract Performance (COVID-19) - FAQs

From 20 March 2020 OMB Memo – Managing Federal Contract Performance Issues Associated with the Novel Coronavirus (COVID-19)

 

Teleworking

 

1. Should agencies be directing their Federal contractors to follow the lead of the Federal Government in their use of telework for their  contract employees in connection with COVID-19?

A: The Federal Government’s telework law and recent announcements cover only Federal managers and employees, not contractors or their employees. Federal contractors are responsible for managing their workforces, including how telework is used by their employees, consistent with their own telework policies and the contract terms they have negotiated with Federal agencies. However, in the spirit of OMB’s guidance, which seeks to maximize the use of telework, and FAR § 7 .108, which instructs agencies not to discourage contractor use of telework when consistent with contractual requirements, agencies are strongly encouraged to work with their contractors to evaluate and maximize telework for their contractor employees, wherever possible, as a way to enable continued contract performance consistent with the health and safety of their contractor and government personnel. This includes modifying contracts that do not currently allow for telework. If a contract does not lend itself to telework, for example, because it must be performed at a government facility, agencies should consider being flexible on delivery schedule contract completion dates.

 

Mitigating the Impact of COVID-19 on Contractors

 

2. If contractor personnel must be quarantined due to exposure to the virus, whether or not related to performance of the contract, and this action results in a slip in the contract schedule, may contracts be extended or otherwise altered?

A:  Yes. Government contracts provide for excusable delays, which may extend to quarantine restrictions due to exposure to COVID-19. For example, see FAR clauses 52.249-14, 52.212-4(±), and 52.211-13. In determining the best course of action, the contracting officer should discuss the situation with the contractor to determine if other options are available (e.g., ability of employee to telework or to find a substitute employee). If other options with the existing contractor aren’t feasible, it may be appropriate to re-procure elsewhere if possible. Such actions should be taken for the convenience of the government (e.g., through use of the relevant convenience termination clause or a no-cost settlement) and without negatively impacting the contractor’s performance rating. Excusable delays that result in adjustments to the contractor’s delivery schedule should not negatively impact a contractor’s performance ratings. Agencies are encouraged to be as flexible as possible in finding solutions.

 

3. How should agencies address requests for equitable adjustment associated with costs related to safety measures taken by contractors to protect their employees from COVID-19, including costs associated with performance disruptions caused by the government (e.g., closure of an office building) when performance doesn’t allow for telework (e.g., work requires access to secure location, or involves building maintenance)?

A: Requests for equitable adjustment should be considered on a case-by-case basis in accordance with existing agency practices, taking into account, among other factors, whether the requested costs would be allowable and reasonable to protect the health and safety of contract employees as part of the performance of the contract. The standard for what is “reasonable,” according to FAR § 31.201-3, is what a prudent person would do under the circumstances prevailing at the time the decision was made to incur the cost (e.g., did the contractor take actions consistent with CDC guidance; did the contractor reach out to the contracting officer or the contracting officer representative to discuss appropriate actions). Agencies may take into consideration whether it is beneficial to keep skilled professionals or key personnel in a mobile ready state for activities the agency deems critical to national security or other high priorities (e.g. , national security professionals, skilled scientists). Agencies should also consider whether contracts that possess capabilities for addressing impending requirements such as security, logistics, or other function may be retooled for pandemic response consistent with the scope of the contract. A number of contract clauses may be helpful in managing COVID-19 issues as they arise. The government may make changes to the contract using the appropriate changes clause that applies to the contract (see FAR clauses 52.243-1 through 52.243-3 or clause 52.212-4(c)). If necessary, generally after considering other alternatives, they may suspend or stop performance through clause 52.242-14, Suspension of Work, and clause 52.242-15, Stop Work Order.

 

4. If a Federal building, such as a museum, is closed to the general public in order to further the practice of social distancing, should repair work to the building be halted until the building is reopened?

A: Whether work is continued or stopped should be addressed on a case-by-case basis, taking into consideration the health and safety of government and contractor employees. These discussions should include consideration of guidance from CDC and local public health officials to determine if there is a risk-based reason to stop work and, if work continues, steps that might need to be taken to address the health and safety of workers.

 

5. Should agencies postpone or virtually conduct acquisition-related activities that are typically performed face-to-face, such as industry days, contractor debriefings, or inspections?

A: Agencies should evaluate, on a case-by-case basis, whether to proceed with in-person activities, taking into account guidance from the CDC and advice or direction from state and local public health authorities. Consistent with CDC recommendations, agencies should consider steps such as practicing appropriate social distancing and following other guidance if in-person or face-to-face interaction is essential. The CDC has provided additional interim guidance for businesses, and agencies should consider virtual activities, such as online industry conferences, video proposals, and other innovative steps in planning their acquisitions. Sample use cases and examples can be reviewed at
https://www.fai.gov/periodic-table/, and brief how-to applications of these proven flexible business practices can be accessed at https://www.fai.gov/medialibrary/item/procurement-innovation-lab-pil-primer.

 

6. How can agencies enhance communications with their industry partners?

A: Clear and timely communication between agencies and their industry partners is critical to supporting the government’s response to COVID-19 and to meeting other mission needs during this highly dynamic situation. In addition to promoting this engagement between contracting officers and contractors, agencies can augment their communications efforts by coordinating timely outreach activities with their industry liaisons (for contact information, go to https://hallways.cap.gsa.gov/app/#/gateway/acquisitioninnovation/42767/agency-industry-liaisons-directory), offices of small and disadvantaged business utilization, acquisition innovation advocates (for contact information, go to
https://hallways.cap.gsa.gov/app/#/gateway/acquisition-innovation/7822/acquisitioninnovation-advocates-aia-directory), and other agency resources.

 

7. In light of the pandemic, will any relief be offered regarding re-registration in the System for Award Management?

A: Yes. Current registrants in SAM with active registrations expiring before May 17, 2020 will be afforded a one-time extension of 60 days.

 
Procurement Flexibilities

 

8. Are the special emergency procurement flexibilities of FAR§ 18.202 available for use in addressing COVID-19 requirements?

A: Yes. The President has declared a national emergency concerning the novel coronavirus disease under the Stafford Act. As a result of this emergency declaration, the flexibilities identified in FAR§ 18.202, “Defense or recovery from certain events,” are available for use in supporting response efforts to COVID-19. These flexibilities include increases to the micro-purchase threshold, the simplified acquisition threshold, and the threshold for using simplified procedures for certain commercial items. Specifically,

(1) The micro-purchase threshold is raised from $10,0001 to $20,000 for domestic purchases and to $30,000 for purchases outside the U.S.;

(2) The simplified acquisition threshold is raised from $250,000 to $750,000 for domestic purchases and $1. 5 million for purchases outside the U.S.; and

(3) Agencies may use simplified acquisition procedures up to $13 million for purchases of commercial item buys. In conducting acquisitions to support response efforts, agencies are expected to use sound fiscal prudence to maximize value for each taxpayer dollar spent. The availability of the flexibility does not mean it must be used, but agencies should feel fully empowered to use the acquisition flexibilities, as needed, consistent with good business judgment in response to the national emergency.

 

9. How can agencies leverage existing category management solutions and expertise across government?

A: A number of category management resources and tools are available to help agencies quickly determine where existing contract solutions for common goods and services may meet the many pressing requirements in connection with the COVID-19 response. They
include the following:

• Category Manager Points of Contact: https://hallways.cap.gsa.gov/app/#/gateway/category-management/45771/cms-andpms-contact-list
• Tools and Dashboards: https://d2d.gsa.gov/report/government-wide-category-management-category-reports
• How to use category management tools to find existing solutions (searchable by PSC/NAICS, vendors, solutions, etc.): https://hallways.cap.gsa.gov/app/#/gateway/category-management/21999/acquisitionplaybooks

 

10. How should agencies address preferences and set-asides for local firms set forth under the Stafford Act?

A: When an emergency declaration is made under the Stafford Act, contracting officers are typically expected, to the extent feasible and practicable, to give preference to local firms in the area designated in the declaration. However, in this case, the declaration makes clear that the emergency created by the pandemic exists nationwide. As a result, there is Sections 805 and 806 of the National Defense Authorization Act for Fiscal Year 2018, Pub. L. No. 115-91, increased the micro-purchase threshold to $10,000 (formerly $3,500) and the simplified acquisition threshold (SAT) to $250,000 (formerly $150,000). The FAR Council is in the process of finalizing changes to the FAR to update
these thresholds.

 
Tracking Activities

 

11. What steps should the acquisition workforce be taking to facilitate tracking of contract spend related to COVID-19 using emergency procurement authorities?

A: The General Services Administration (GSA) has added a new National Interest Action (NIA) Code to the NIA field in the Federal Procurement Data System (FPDS) as a means of tracking acquisition costs of the multiple Federal agencies involved in the response to
COVID-19, an incident of great national interest. ***The NIA Code will be used strictly for reporting purposes related to COVID-19 and
involves the exercise of the emergency authorities identified in FAR § 18.2. (See question 8) FPDS system details for this NIA Code are as follows:

NIA Value Name: COVID-19 2020
 • Web Portal/Graphical User Interface (GUI) service users may select the value “COVID-19 2020” in the NIA drop-down field.
 • Contract Writing Systems (CWS) shall use the code of “P20C” when creating or updating documents associated with the COVID-19     response through Business Services.
NIA Start Date: 03/13/2020
NIA End Date: 07/01/2020

Agencies should consult their internal policy offices regarding compliance with this and related FPDS requirements.

***Effective immediately (as of 6 April 2020), regarding National Interest Action (NIA) code (P20C)***
Update to Guidance on Application of National Interest Action (NIA) Code to Increase Transparency

  • Agencies should assign this NIA code to all procurement actions reported into FPDS that are issued in response to the pandemic. This includes new awards for supplies and services as well as modifications that are issued to address COVID-19, irrespective of whether the contract being modified was originally awarded to address COVID-19.
  • The code should also be used in connection with any procurement authority, including but not limited to special emergency procurement authorities identified under FAR Subpart 18.2.

 

12. What, if any, steps should agencies take to facilitate tracking of contract spending related to COVID-19 that are not conducted using emergency procurement authorities?

A: Contracting officials are encouraged to use “COVID-19” or “Coronavirus” in their solicitation and related documentation to support easy key word searching for sharing buys when possible and recording contracts once awarded.

Question 12 is superceded by the Update to Guidance on Application of National Interest Action (NIA) Code to Increase Transparency

FAR Exceptions/Waivers

DOL: Limited Exemption and Waiver from Certain Federal Contracting Federal Acquisition Regulation (FAR) Requirements  

In view of the special circumstances in the national interest presented by the novel coronavirus outbreak, the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) has granted a limited exemption and waiver from certain federal contracting Federal Acquisition Regulation (FAR) requirements. The Coronavirus exemption and waiver period is granted from March 17, 2020 to June 17, 2020, subject to extension by OFCCP.

Pursuant to the OFCCP March 17, 2020, memorandum, for the period of the exemption, new Federal contracts providing relief efforts for the Coronavirus should contain a provision exempting the contractor from all affirmative action obligations and other obligations, as outlined below, as required by Executive Order 11246 (EO 11246); Section 4212 of the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA); and Section 503 of the Rehabilitation Act of 1973 (Section 503).

When agencies enter into contracts which specifically provide relief efforts for the Coronavirus, the contracts are required to contain FAR clause 52.222-26, 52.222-35 and/or 52.222-36. The agencies should use the following clauses:

Alternate I of 52.222-26 with the following fill in:
Notice: The following terms of this clause are waived for this contract: subparagraph (c)(2), (c)(3), (c)(4), (c)(5)(ii), (c)(6), (c)(8), and the phrase “on-site compliance evaluations and” in (c)(9).

Alternate I of 52.222-35 with the following fill in:
Notice: The following terms of this clause are waived for this contract: in subparagraph (b), the phrase “and requires affirmative action by the Contractor to employ and advance in employment qualified protected veterans”; additionally, in subparagraph (b), the phrase “requirements of the equal opportunity clause at 41 CFR 60-300.5(a)” shall be interpreted to exclude in full paragraphs 2-7, 9-10, and 12 of 41 CFR 60-300.5(a), and the phrase “take affirmative action to employ, advance in employment and otherwise” from paragraph 1 of 41 CFR 60-300.5(a).

Alternate I of 52.222-36 with the following fill in:
Notice: The following terms of this clause are waived for this contract: in subparagraph (a), the phrase “and requires affirmative action by the Contractor to employ and advance in employment qualified individuals with disabilities”; additionally, in subparagraph (a), the phrase “requirements of the equal opportunity clause at 41 CFR 60-741.5(a)” shall be interpreted to exclude in full paragraphs 4-5 and 7 of 41 CFR 60-741.5(a), and the phrase “take affirmative action to employ and advance in employment individuals with disabilities, and to” from paragraph 1 of 41 CFR 60-741.5(a).

Contractors continue to be subject to the processing of complaints of discrimination requirements of under 41 CFR 60-1.21-1.24, 41 CFR 60-300.61 and 41 CFR 60-741.61. The exemptions and waivers also do not exempt a covered contractor from their obligation to comply with other federal, state and local civil rights laws.

Visit OFCCP’s website for additional information regarding National Interest Exemptions.

OUSD(A&S) DPC Contact Information:
DPC Contract Policy (703) 693-0497 (DSN 223)

FAR - Emergency Acquisitions

FAR Part 18.202 Defense or recovery from certain events.

      (a) Micro-purchase threshold. The threshold increases when the head of the agency determines the supplies or services are to be used to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See 2.101)

      (b) Simplified acquisition threshold. The threshold increases when the head of the agency determines the supplies or services are to be used to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See 2.101)

      (c) Treating certain items as commercial. Contracting officers may treat any acquisition of supplies or services as an acquisition of commercial items if the head of the agency determines the acquisition is to be used to facilitate the defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack. (See 12.102(f)(1) and 13.500(c))

      (d) Simplified procedures for certain commercial items. The threshold limits authorized for use of this authority may be increased when it is determined the acquisition is to facilitate defense against or recovery from cyber, nuclear, biological, chemical, or radiological attack; to facilitate provision of international disaster assistance; or to support response to an emergency or major disaster. (See 13.500(c))

 

——————————————

DFARS Part 2182.03 – Incidents of national significance, emergency declaration, or major disaster declaration.

      (1)  Establishing or maintaining alternative sources.  PGI contains a sample format for Determination and Findings citing the authority of FAR 6.202(a), regarding exclusion of a particular source in order to establish or maintain an alternative source or sources.  Alternate 2 of the sample format addresses having a supplier available for furnishing supplies or services in case of a national emergency.  See PGI 206.202 (DFARS/PGI view). 

      (2)  Electronic submission and processing of payment requests.  Contractors do not have to submit payment requests in electronic form for contracts awarded by contracting officers in the conduct of emergency operations, such as responses to natural disasters or national or civil emergencies.  See 232.7002(a)(4).

National Interest Action (NIA) value ‘COVID-19 2020’ added to track relief contracts. ‘P20C’ for contracting writing systems. FPDS-NG ***Update to Guidance on Application of National Interest Action (NIA) Code to Increase Transparency***

DoD Specific Authorities

DoD Emergency Acquisition Flexibilities

A&S Memo

Coronavirus Disease 2019 (COVID-19) Emergency Acquisition Flexibilities

1. An emergency determination was made by the President on March 13, 2020, under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”) in response to the Coronavirus Disease 2019 (COVID-19) pandemic. This emergency determination authorizes federal assistance to supplement State and local response efforts and meets the definition of “emergency” at 42 U.S.C. 5122. For additional information, please see the President’s letter containing this emergency determination

 

2. Pursuant to Class Deviation 2018-O0018, “Micro-Purchase Threshold, Simplified Acquisition Threshold, and Special Emergency Procurement Authority”, the following applies to DoD acquisitions of supplies or services funded by DoD appropriations that the Head of the Contracting Activity determines are to be used to support COVID-19 emergency assistance activities:

a. The “micro-purchase threshold” and the “simplified acquisition threshold” are increased as follows:

– For any contract to be awarded and performed, or purchase to be made, inside the United States, the “micro-purchase threshold” is $20,000 and the “simplified acquisition threshold” is $750,000;

– For any contract to be awarded and performed, or purchase to be made, outside the United States, the “micro-purchase threshold” is $30,000 and the “simplified acquisition threshold” is $1,500,000; and

– For the acquisition of commercial items, the threshold for use of simplified acquisition procedures for certain commercial items is $13M

NOTE: For purposes of acquisition threshold increases authorized by Class Deviation 2018-O0018 the term “United States” includes the 50 States and the District of Columbia (FAR 2.101). Therefore, the outlying areas of Puerto Rico and U.S. Virgin Islands are considered outside the United States.

b. The limitation for convenience checks may not be in an amount in excess of one-half of the applicable micro-purchase threshold.

 

3. Please be aware of the applicable emergency acquisition flexibilities identified in FAR 18.203, “Emergency Declaration or Major Disaster Declaration” and DFARS 218.203 “Incidents of national significance, emergency declaration, or major disaster declaration” as they relate to the COVID-19 pandemic. Additionally, FAR Subpart 18.1 and DFARS Subpart 218.1 provide contracting officers other available acquisition flexibilities when certain conditions are met.

 

4. Additional guidance for use of the purchase card may be found in the DoD Charge Card Guidebook

****DoD SmartPay® 3 Government-wide Commercial Purchase Card Guidance for the Coronavirus Disease 2019 (COVID-19), dated 2 April 2020****

 

5. A new National Interest Action (NIA) Code has been established for the NIA field in the Federal Procurement Data System-Next Generation (FPDS-NG) as a means of tracking acquisition costs for COVID-19 related assistance activities. FPDS-NG system details for this NIA follow:

NIA Code: P20C
NIA Description: COVID-19 2020
Start Date: 03/13/2020
End Date: 07/01/2020

 

6. Continue to monitor the Defense Pricing and Contracting (DPC) Contingency Contracting website for additional information pertaining to COVID-19.

 

7. OUSD(A&S) DPC Contact Information:
DPC Contract Policy (703) 693-0497 (DSN 225)

 

****Change to the Delegation of Authority for Use of Other Transactions for Prototype Projects in Response to Coronavirus Disease 2019, dated 5 April 2020****

Managing Defense Contracts Impacts of the Novel Coronavirus

OSD A&S Memo: Managing Defense Contracts Impacts of the Novel Coronavirus

DoD contracts contain clauses that excuse performance delays, including Federal Acquisition Regulation (FAR) 52.249-14, Excusable Delays; various “Termination” clauses; and FAR 52.212-4 for commercial contracts. Each of these clauses provides that a contractor will not be in default because of a failure to perform the contract if the failure arises beyond the control and without the fault or negligence of the contractor. In the event of such a delay, the contractor is entitled to an equitable adjustment of the contract schedule. Where the contracting officer directs changes in the terms of contract performance, which may include recognition of COVID-19 impacts on performance under that contract, the contractor may also be entitled to an equitable adjustment to contract price using the standard FAR changes clauses (e.g., FAR 52.243-1 or FAR 52.243-2).

Requests for equitable adjustment must be considered on a case-by-case basis, in consideration of the particular circumstances of each contract, impacts realized from COVID-19, applicable law, and regulations, and inclusive of any relief that may be authorized by laws enacted in response to this national emergency. When reviewing requests for equitable adjustment, contracting officers are to take into account, among other factors, whether the requested costs would be allowable, allocable and reasonable to protect the health and safety of contract employees as part of the performance of the contract. Equitable adjustments to the contract or reliance on an excusable delay should not negatively affect contractor performance ratings.

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES). Most notable within the act is Section 3610, Federal Contractor Authority, which provides discretion for the agency to modify the terms and conditions of the contract to reimburse paid leave where contractor employees could not access work sites or telework but actions were needed to keep such employees in a ready state.

 

CARES Act Implementation

OSD A&S Issued Implementation Guidance for for Section 3610 of the Coronavirus Aid, Relief, and Economic Security Act on 9 April.

Section 3610 of the CARES Act allows agencies to reimburse, at the minimum applicable contract billing rates (not to exceed an average of 40 hours per week), any paid leave, including sick leave, a contractor provides to keep its employees or subcontractors in a ready state, including to protect the life and safety of Government and contractor personnel, during the public health emergency declared for COVID-19 on January 31, 2020, through September 30, 2020. Contractors usually include employee leave in calculating their indirect rates. Therefore, leave is included in any fixed-price, or  labor hour rate (under Time and Materials or Labor Hour contracts), or as an element of cost on cost-reimbursement contracts. Deviation 2020-O0013 establishes a new cost principle that will allow recovery of such costs where appropriate.

Implementation of section 3610 will vary based on contract type. Details for fixed-price (including those with incentive provisions), cost-reimbursement, and time & materials/labor hour contract types are addressed in the memo. Collaboration with CORs and DCAA as well as administrative matters, to include payment instructions for visibility and auditing purposes, are also addressed.

As additional information is available, updates will be provided to the Frequently Asked Questions document for Section 3610 of the CARES Act on the Defense Pricing and Contracting (DPC) page.

Class Commercial Item Determination (CID)

Effective 27 March, the DCMA Commercial Item Group prepared a Class Commercial Item Determination (CID) pertaining to COVID-19 commercial item procurements. The items listed in the Class CID meet the requirements of the commercial item definition under FAR Part 2.101 and are determined to be commercial items.

The class CID is intended to allow Contracting Officers maximum flexibility in awarding critical contracts for supplies and services addressing the COVID-19 pandemic in a streamlined manner. The CID is limited to awarding contracts for supplies and services in resolving the COVID-19 pandemic.

Class Deviation—Justification and Approval Threshold for 8(a) Contracts

Effective March 17, 2020, Class Deviation 2020-O0009, implementing Section 823 of the National Defense Authorization Act for Fiscal Year 2020 (Pub. L. 116-92), authorizes sole source 8(a) awards valued at $100 million or less without a justification and approval.

The deviation establishes the $100 million threshold in lieu of $22 million at FAR Part 6.302-5(b)(4)6.303-1(b)6.303-2(d), and 19.808-1(a)

Additionally, in lieu of the approval requirements at FAR Part 6.304(a), the approval authority for justifications of 8(a) sole source awards exceeding $100 million is the head of the procuring activity.

Contracting Cone – Small Business (FAR Part 19): Direct 8(a)

Class Deviation - Undefinitized Contract Actions During the National Emergency for the Coronavirus Disease 2019

Effective April 3, 2020, for undefinitized contract actions (UCAs):

  • The requirement at DFARS 217.7404-4(a) to limit obligations, after receipt of a qualifying proposal, to 75 percent of the not-to-exceed price before definitization does not apply to UCAs related to the national emergency for the Coronavirus Disease 2019 (COVID-19), as determined by the head of the contracting activity.
  • The head of the contracting activity may waive the limitations in DFARS 217.7404(a)(1)(i), 217.7404-3(a), and 217.7404-4(a) for a UCA, if the head of the contracting activity determines that the waiver is necessary due to the national emergency for COVID-19. The words “without power of redelegation” at DFARS 217.7404-3(a)(1) are deleted.

This class deviation implements sections 13004 and 13005 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136) and remains in effect until rescinded. 

Contracting Cone – Letter Contracts

Class Deviation - CARES Act Section 3610 Implementation (Contract Reimbursements)

Effective April 8, 2020, Class Deviation 2020-O0013 to FAR Part 31 and DFARS Part 231, is effective immediately in response to the CARES Act enacted on March 27, 2020 in response to the Coronavirus Disease 2019 (COVID-19) national emergency. This deviation authorizes contracting officers to use the clause DFARS 231.205-79, CARES Act Section 3610 Implementation, as a framework for implementation of section 3610, Federal Contractor Authority, of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136).

Section 3610 seeks to provide many flexibilities for contracting officers, including the authority to:

  • Enable the contractor to stay in a ready state (i.e., able to mobilize in a timely manner) by treating as allowable paid leave costs a contractor incurs to keep its employees and subcontractor employees in such a state.
  • Use any “funds made available to the agency” by Congress to reimburse contractors for workers’ lost time, not otherwise reimbursable, between January 31, 2020, and September 30, 2020, if the contractor provides leave to its employees or subcontractor
    employees “to maintain a ready state, including to protect the life and safety of Government and contractor personnel,” which include, but are not limited to, quarantining, social distancing, or other COVID-19 related interruptions, as discussed in Office of Management and Budget Memorandum M-20-18, Managing Federal Contract  Performance Issues Associated with the Novel Coronavirus, dated March 20, 2020;
  • Modify contracts to provide for reimbursement of allowable paid leave costs, not otherwise reimbursable, without securing additional consideration; and
  • Provide such reimbursement on any contract type.

 

Section 3610 also provides limitations on reimbursements:

  • A contractor may only receive reimbursement if its employees or subcontractor employees:
    • Cannot perform work on a government-owned, government-leased, contractorowned, or contractor-leased facility or site approved by the Federal Government for contract performance due to closures or other restrictions; and
    • Are unable to telework because their job duties cannot be performed remotely during the public health emergency declared on January 31, 2020, for COVID–19.
  • Reimbursement is authorized only:
    • At the appropriate rates under the contract for up to an average of 40 hours per week; and
    • For contractor or subcontractor payments made for costs incurred, not otherwise reimbursable, not earlier than January 31, 2020, and not later than September 30, 2020;
  • The Government must reduce the maximum reimbursement authorized by the amount of credit the contractor is allowed pursuant to division G of the Families First Coronavirus Response Act (Pub. L. 116–127) and any applicable credits the contractor is allowed
    Class Deviation 2020-O0013 CARES Act Section 3610 Implementation under the CARES Act or other credit allowed by law that is specifically identifiable with the public health emergency declared on January 31, 2020 for COVID–19; and
  • Reimbursement is contingent upon the availability of funds.

 

Frequently Asked Questions on Defense Pricing and Contracting (DPC) COVID-19 webpage.

FAQs as of April 9, 2020.

 

 

Class Deviation—Progress Payment Rates

***Effective April 16,2020, Revision 1 supersedes and revises Class Deviation 2020-O0010, Progress Payment Rates, to remove the Alternate II of FAR clause 52.232-16 from the deviation clauses provided for use.***

Effective March 20, 2020, Class Deviation 2020-O0010, in response to the Coronavirus Disease 2019 (COVID-19) national emergency, increases progress payment rates at Defense Federal Acquisition Regulation Supplement (DFARS) 232.501-1 to 90 percent for large business concerns and 95 percent for small business concerns.

Therefore, when implementing this deviation, contracting officers shall use the attached deviation clauses as follows:

Contracting officers shall use the attached deviation clauses as follows:

Contracting officers shall use Alternate II and III of FAR clause 52.232-16 as prescribed at FAR 32.502-4(d) with the deviation for FAR clause 52.232-16 provided in the attachment.

 

FAQs

Q1: The Contract Note accompanying the modification implementing the Deviation states that “This deviation is not retroactive and is prospective only.” Use of the term “prospective” has caused confusion throughout industry. Please clarify that the SF1443 should continue to be completed based on inception to date cost.

A1: The Deviation for the increased progress payment rate applies to prospective Progress Payment Requests (PPRs) only and not to prior requests. However, 52.232-16 (DEVIATION 2020-O0010), paragraph (a)(1), explicitly states, “Unless the Contractor requests a smaller amount, the Government will compute each progress payment at 90 percent of the Contractor’s total costs incurred under this contract whether or not actually paid, plus financing payments to subcontractors (see paragraph (j) of this clause), less the sum of all previous progress payments made by the Government under this contract.” Therefore, there is no need to resubmit adjustments to previous PPRs. The SF1443 should continue to be completed based upon inception to date cost. As a result, the first post-modification PPR will result in the application of the higher progress payment rate against all qualified costs, including costs that have been incurred prior to the issuance of the Deviation.

 

Q2: Please clarify that adjustments to liquidations taken on previously delivered items is not required. Rather, financing limitations will be accomplished through Section III of the SF1443.

A2: Financing limitations will be accomplished through Section III of the SF1443.

 

Q3: If progress payments turn negative (i.e., the increase in financing requested is offset by the increase in required liquidations placing a limit on the PPR in Section III), is the contractor expected to issue a check back to the U.S. Government or just stop progress billing until the progress payment calculation turns positive?

A3: The contractor should stop progress billing until the progress payment calculation turns positive.

 

Q4: When is the Deviation effective? Does it apply only to new contracts?

A4: The Deviation applies to new contracts that include the Deviation clause and to existing contracts that have been modified to include the Deviation clause. Contractors must wait until their contracts are modified or contact the Administrative Contracting Office before submitting
requests for progress payments at the higher rate. 

 

Q5: Does the Deviation apply to performance-based payments?

A5: No. Only to contracts or orders that include the Progress Payment clause, FAR 52.232-16.

 

Q6: Can a small business with a DoD contract that doesn’t have the progress payment clause formally ask the contracting officer for progress payments?

A6: Yes.

 

Q7: How does the recent progress payment deviation impact currently reduced/suspended progress payments? We want to confirm the Deviation does not just alleviate the contractor from performing/proving progress or lessen the authority the administrative contracting officer has to approve progress payments, based on the accountabilities of both parties.

A7: The deviation provides a temporary substitute for the current progress payment clause. Any withholds from the previous rate, would now be applied against the higher rate, at the Contracting Officer’s discretion. Even with a mass modification, the contracting officer still
retains the authority to adjust rates in accordance with 252.232-16(c), Reduction or Suspension. That subparagraph was not eliminated from the deviation language.

 

Q8: How was the mass mod prepared and to whom was it issued?

A8: DCMA issued a mass administrative modification to implement the Deviation efficiently and expediently for contracts administered by DCMA. Excluded from the mass mod were contracts for which DCMA had not been delegated administration office authority, shipbuilding
contacts issued by the Naval Sea Systems Command, contracts for which a “stop payment” had been issued, and any contract for which an alternate liquidation rates has already been established. DCMA provided the Services with a listing of all contracts containing the progress
payment clause, but where DCMA has not been delegated contract administration authority. This will enable the Services to modify contracts individually or, potentially, delegate authority to DCMA. If there are any questions regarding eligibility to receive the higher progress payment rate, contact the contracting administration office listed on the face of your contract/order.

 

Q9: Is it possible to request advance payments using this clause?

A9: No, the deviation does not apply to advance payments.

Class Deviation - Submission of Interim Vouchers Under Classified Contracts

***Effective April 3, 2020, Revision 1 revises and supersedes the class deviation issued on March 27, 2020. The revision is necessary to change the reference to the office, to which interim vouchers are submitted, from “disbursing office” to “payment office.”***

Effective March 27, 2020, in accordance with Class Deviation 2020-O0011,  contracting officers shall direct contractors to submit interim vouchers under classified contracts, using an appropriate method, directly to the disbursing office listed in the contract. Interim vouchers under classified contracts are considered provisionally approved by the Defense Contract Audit Agency (DCAA). 

Effective immediately, in response to the Coronavirus Disease 2019 (COVID-19) national emergency, contracting officers shall direct contractors to submit interim vouchers under classified contracts, using an appropriate method, directly to the payment office listed in the contract. Interim vouchers under classified contracts are considered provisionally approved by the Defense Contract Audit Agency (DCAA). 

Contractors have been required to submit interim vouchers to the Defense Contract Audit Agency (DCAA) in accordance with Federal Acquisition Regulation (FAR) 42.803(b)(1) and Defense Federal Acquisition Regulation Supplement (DFARS) 242.803(b)(i)(A) and (B). For some classified contracts, contractors submit interim vouchers outside the Procurement Integrated Enterprise Environment (PIEE) or other authorized unclassified system because of security restrictions. This deviation relieves the requirement for the interim voucher to be submitted to DCAA prior to payment. 

***National Interest Action (NIA) value ‘COVID-19 2020’ added to track relief contracts. ‘P20C’ for contracting writing systems.  Memo: Reporting COVID-19 Related Actions to the Federal Procurement Data System

COVID-19 Contracting Strategies

What the contracting workforce is doing, right now.

Contracting In Action!

For the DoD: DCMA Commercial Item Group prepared a Class Commercial Item Determination (CID) for COVID related supplies and services to streamline COVID-19 related commercial items procurements. Combine with the emergency acquisition flexibilities authorized by the Stafford Act Emergency Determination authorizing use of FAR Part 18.2 and DFARS Part 218.2, increasing the micro-purchase and simplified acquisition thresholds and the simplified acquisition procedures for certain commercial items (FAR Part 13.5) threshold, for streamlined procurement processes for commercial items:

For non-DoD Agencies: OMB authorized agencies to use simplified acquisition procedures up to $13 million for purchases of commercial item buys.

Contracting Cone – Commercial Items
Contracting Cone – Simplified Acquisition

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Issue a standing solicitation for commercial items under FAR Part 12 and unusual and compelling needs from which the Government contemplates multiple awards of IDIQs and/or Direct Contracts (under FAR Part 15) for awards exceeding $13 million, Purchase Orders (under FAR Part 13) and Blanket Purchase Agreements (under FAR Part 13) for awards less than $13 million, and orders under FAR Part 8 if contractor is a GSA or VA FSS Schedule holder.

FEMA COVID-19 PPE and Medical Supplies
Notice ID :70FA2020R00000011

Contracting Cone – Federal Supply Schedule (FAR Part 8.4)
Contracting Cone – Commercial Items (FAR Part 12)
Contracting Cone – Simplified Acquisition Procedures (FAR Part 13)
Contracting Cone – Contracting by Negotiation (FAR Part 15)

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Use a Broad Agency Announcement as a solicitation mechanism for basic and applied research directed toward advancing the state-of-the-art or increasing knowledge or understanding and that part of development not related to the development of a specific system or hardware procurement. Proposals are NOT evaluated against each other since they are not submitted in accordance with a common SOW issued by the Government. Instead, Research and Technical Objectives are provided in the BAA that describe individual Research Areas in which the Government is interested. Proposals received in response to the BAA are evaluated in accordance with the Evaluation Factors for Award specified for the COVID-19 announcement. The Government reserves the right to conduct discussions with all, some, one, or none of the proposals received.

NIAID Omnibus Broad Agency Announcement
Notice ID: HHS-NIH-NIAID-BAA2020-1

BARDA DRIVe COVID-19 EZ Broad Agency Announcment
Notice ID: BAA-20-100-SOL-0002

Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)
Notice ID: BARDABAA

Contracting Cone – Broad Agency Announcement

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Leverage existing Other Transaction Consortium to develop prototypes aimed to develop therapeutic(s) that can treat COVID-19. 

Development of Treatments for COVID-19
Solicitation Number: MTEC-20-09-COVID-19_Treatment_MIDRP

Contracting Cone – Other Transactions
Existing Other Transaction Consortia

 

Leverage Other Transaction Authority* and issue a request for white papers (including a process to evaluate and select awardees) for prototype projects in response to COVID-19 problem statements. 

DLA Technology Accelerator Other Transaction Program
Request for White Papers: COVID-19 Prototype PPE and Decontamination Equipment

*Agencies with Other Transaction Authority are identified here.

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Leverage the SBIR program which encourages small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization. (See SBIR/STTR page for participating agencies)

NSF Division of Innovation and Industrial Partnerships (IIP) of the Engineering Directorate
Request for SBIR/STTR Phase I Proposals Addressing COVID-19

Contracting Cone – SBIR/STTR
SBIR/STTR Program

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*DoD: Leverage Commercial Solutions Opening (CSO) Procedures to competitively select proposals received in response to a general solicitation, similar to a Broad Agency Announcement, based on a review of proposals by Government scientific, technological, or other subject-matter experts.  Use of a CSO in accordance with Class Deviation 2018-O0016 is considered a competitive procedure for the purposes of 10 U.S.C. chapter 127 and FAR 6.102.  Contracting officers shall treat items, technologies, and services acquired using a CSO as commercial items.  The full definition of commercial items (products and services) under FAR 2.101 applies to this solicitation. 

X20.R SBIR COMMERCIAL SOLUTIONS OPENING (CSO) AF VENTURES DIRECT TO PHASE II
Notice ID: AF20R-DCSO1

Contracting Cone – Defense CSO Pilot Program
SBIR/STTR Program

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*DoD: Since this is medical and we need to test and evaluate supplies, we are looking at 10 U.S.C. §2373, Procurement for Experimental Purposes, to move quickly with a simple Other Transaction-like agreement instead of a FAR contract.

Contracting Cone – Procurement for Experimental Purposes

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Buying off a multiple-award IDIQ with established prices. Will probably need to exceed our ceiling so will use a J&A for Unusual and Compelling Urgency.

Contracting Cone – IDIQ

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Just learned about 8(a) through the new J&A deviation announcement and planning to go direct to an 8(a) company.

Contracting Cone – Small Business Direct 8(a)

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Standard deviation by the heads of the agencies to provide interpretation that purchases up to $19 million can be done IAW FAR Part 12 commercial acquisitions. (FAR 12.102 (f)(1) authorizes commercial acquisition for “biological…attack [s]”). In this case, an Act of God should be cited as an underlying interpretation due to the spirit and nature of this event which would coincide with the purpose and intent of this regulation… in the best interest of public safety i.e. black swan event. 

Contracting Cone – Commercial Items

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If above $19M, all the contractor needs to supply is Certified Cost and Pricing Data i.e. “show us the books” after the fact. This shouldn’t be a problem and such numbers should be compared to their normal commercial rates and margins… NOT gov’t 10% margins but their normal market rates.

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(Example) Non-DoD Template for Justification & Approval for Other Than Full and Open Competition

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(Example) HHS Justification & Approval to Extend MAC IDIQ POP by 6 months 

Contracting Strategies for Urgent Capabilities

The contracting strategies highlighted in the DoD Adaptive Acquisition Framework (AAF) Urgent Capability Acquisition pathway may be particularly well-suited for supplies, products, or services in support of a contingency operation to include national disaster response.

Examples include:

 

DoD organizations may also consider:

 

*Agencies must be explicitly authorized by Congress to use Other Transactions and Contracting Officers must have Agreement Officer authority to execute OTs. Agencies with Other Transaction Authority are identified here. Other Transaction Consortia may also be well-positioned to respond to prototyping solutions for COVID-19 supply and equipment needs.

Market Research on COVID-19 Suppliers

Public Spend Forum’s GovShop maintains a list of suppliers and inventory here.

Initiatives addressing COVID-19 Supply and Equipment Shortfalls

Open challenges and newly emerging efforts

Ventilators

Columbia DIY Ventilator Challenge
Columbia University

Objective:We invite students, faculty, and staff from all Columbia schools, as well as external makers, inventors, and clinicians, to participate in the Columbia DIY Ventilator challenge. The goal of this challenge is to design a DIY (do-it-yourself) emergency ventilator. Specifically we are interested in a device that will inflate and deflate an Ambu-bag in a systematic manner, as an emergency stop-gap while critical patients are waiting for care that may not be immediately available. Experienced clinicians, engineers, and makers are also needed to advise teams and to help judge and improve entries.

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Innovate2Ventilate – Open Innovation Effort to Design a Rapidly Deployable Mechanical Ventilator
Massachusetts General Hospital

Objective: The CoVent-19 Challenge is an open innovation 8-week Grand Challenge for engineers, innovators, designers, and makers. We will be launching the Challenge on the GrabCAD Challenges platform on April 1, 2020. We welcome all who are interested to join a two round challenge that aims to create CAD assemblies by May 1, 2020 (Round 1: General Admission) and functional prototypes demonstrating acceptable performance by June 1, 2020 (Round 2: Invitation Only).

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Ventilator Design Specification Sharing
Medtronic

Objective: Medtronic is responding to this crisis by making the design files for the PB560 ventilator system available to the public. Our hope is that manufacturers and engineers will use this intellectual property to inspire their own potentially lifesaving innovations.

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Emergency Ventilator (E-VENT) Project
Massachusetts Institute of Technology (MIT)

Objective: Produce and release open source material with the intent to provide those with the ability to make or manufacture ventilators, the tools needed to do so in a manner that seeks to ensure patient safety. Four sets of material will be released and updated in an open-source fashion:

  1. Minimum safe ventilator functionality based on clinical guidance
  2. Reference hardware design for meeting minimum clinical requirements
  3. Reference control strategies and electronics designs and supporting insights
  4. Results from testing in animal models

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The Ventilator Project
MassRobotics

Objective: To Rapidly Create And Manufacture A Low Cost Ventilator For Covid-19 Patients Worldwide.

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Air Driven Ventilator Prototype
OxVent

Objective: Develop a Prototype Air-Driven Ambu box for COVID-19 ventilation. Multidisciplinary team of engineers and medics at the University of Oxford and King’s College London.

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Additive Manufacturing with 3D Printing Ventilator Challenge
National Security Innovation Network (NSIN)

Objective: Capture the nationwide capacity to manufacture and ship parts from distributed 3D printer capabilities throughout the country. NSIN has asked its innovative community to identify:

  • 3D Printer locations/capabilities: Where are 3D printers located and what are their capabilities? What type of materials are they able to print?
  • 3D Printer access/capacity: How can we access 3D printers remotely? What is the capacity to print (parts per day)?
  • How do we recruit volunteers? We need people with access to 3D printers and people to collect/store parts.
  • Where and how do we ship parts? We need to identify those who need the parts the most and how to get them there.

 

Personal Protective Equipment / Medical Equipment

3D Print Exchange
National Institutes of Health (NIH)

Objective: The NIH 3D Print Exchange provides models in formats that are readily compatible with 3D printers, and offers a unique set of tools to create and share 3D-printable models related to biomedical science.

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COVID-19 Supply Chain Response
Curated by NIH/NIAID in collaboration with the U.S. Food and Drug Administration, the Veterans Healthcare Administration, and America Makes

Objective: Collection of designs created to support the manufacturing of personal protective equipment (PPE) or other necessary medical devices that are in short supply due to the COVID-19 outbreak.

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N95 Face Shield 3D Printing Design
Created by Mr. Jeremy Filko (Booz Allen Hamilton)

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Surgical Mask Manufacturing Initiative
Defense Innovation Lab (DiLAb)

Objective: Meet critical demand for surgical masks and other critical items.Leverage open source surgical mask design to U.S. manufacturers and acquire surgical mask machines to scale and automate mask production.

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3D Printing Protective Masks
Lowell Makes 

Objective: Produce and donate open source personal protective equipment to local healthcare facilities who specifically request equipment.

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3D Printed Medical Parts
Rapid Medical Parts

Objective: Rapidly produce needed medical parts to sustain equipment and improve patient care, during this epidemic and beyond. Give healthcare professionals the ability to produce 3D printed rapid parts in as little as 24 hours. Provide a full lifecycle of production technologies, from 3D printed rapid productions to advanced prototyping and appearance modeling.

 

Other Initiatives/Challenges/Hackathons

Some key initiatives are listed below.  Many more listed here at Luminary Labs COVID-19 Open Innovation Index

COVID-19 Healthcare Coalition

Objective: Private-industry led response to that urgent Coronavirus (COVID-19) pandemic. Bringing together healthcare organizations, technology firms, nonprofits, academia, and startups and coordinating their collective expertise, capabilities, data and insights to flatten the pandemic’s curve in order to preserve the healthcare delivery system.

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Numerous COVID-19 Related Hackathons/Challenges/Partnerships located at this Confluence site. Some examples below:

Fight COVID-19 Open Challenge
Objective: An open collaboration effort in which volunteers, designers, students, researchers, computer scientists, health workers, startups, software developers, business developers and others will cooperate and produce creative solutions which can help fight against the current epidemic of COVID-19.

 

Codevid-19
Objective: The purpose of the hackathon ultimately isn’t to win prizes, it’s to build useful apps that people can use to manage and survive during the COVID-19 pandemic. What started in Edmonton, Canada as a discussion among developers on the Dev Edmonton Society Slack has exploded into a global initiative to improve people’s quality of live and fight the pandemic.

 

CoronaWhy
Objective: CoronaWhy is a volunteer organization (anyone can join) focused on coordinating the collection, analysis and reporting on all available data relevant to COVID-19.  With over 300 members across 17 time zones, CoronaWhy is accepting volunteers with a wide range of skill sets – we focus on data analysis, machine learning and natural language processing, and data visualization with the aim of supporting the public, the medical community and policy makers in answering important questions regarding COVID-19.

 

Helpful Engineering
Objective: Helpful Engineering is designing, sourcing and executing projects to help people suffering from the COVID-19 crisis worldwide.

 

#BuildforCOVID19 Global Online Hackathon by Devpost
Objective:
The COVID-19 Global Hackathon is an opportunity for developers to build software solutions that drive social impact, with the aim of tackling some of the challenges related to the current coronavirus (COVID-19) pandemic.

 

COVID-19 Open Research Dataset Challenge (CORD-19)
AI challenge with AI2, CZI, MSR, Georgetown, NIH & The White House

Objective: In response to the COVID-19 pandemic, the White House and a coalition of leading research groups have prepared the COVID-19 Open Research Dataset (CORD-19). CORD-19 is a resource of over 45,000 scholarly articles, including over 33,000 with full text, about COVID-19, SARS-CoV-2, and related coronaviruses. This freely available dataset is provided to the global research community to apply recent advances in natural language processing and other AI techniques to generate new insights in support of the ongoing fight against this infectious disease.

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Multiple InnoCentive Challenges

InnoCentive Challenge: Useful Solutions or Services People Are Offering in Support of Those Impacted by COVID-19

Objective: Asking Solvers to share detailed examples of any solutions or services they have seen offered by individuals or companies in response to the global Coronavirus pandemic.Asking for all and any examples of offers being made by companies, individuals, governments, etc. in response to COVID-19 and that might help anyone in need. Validated submissions will be featured on a single, aggregated open and free to access COVID-19 specific solutions marketplace launched by Wazoku and shared with key contacts globally involved in various aspects of tackling COVID-19. $2500.00 prize.  Due by 26 June 2020.

Challenge: What Should We Know to Better Treat Coronavirus?
Objective: Asking Solvers to formulate well-defined problems or hypotheses aimed at advancing our knowledge about Coronavirus. Define problems or areas requiring further exploration and research. Ideal problems are those whose eventual solution will greatly expand our knowledge of Coronavirus. $2500.00 prize. Due by 24 May 2020.


Challenge: A Chance to Post a COVID-19 Challenge at No Cost

Objective: Do you have an idea for the basis of an InnoCentive Challenge? We want to harness the creativity of our Solvers and ask you to propose a COVID-19 Challenge that could help mitigate this global outbreak. $2500.00 prize. Due by 25 May 2020.

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Important Considerations for 3D Printing of Medical Supplies and Devices

If you are interested in designing or manufacturing medical equipment or supplies for the COVID-19 pandemic, here are some steps to consider from the FDA’s Frequently Asked Questions page.

  1. Follow FDA-issued guidance on the Technical Considerations for Additive Manufactured Medical Devices. This outlines the FDA recommendations for 3D-printed devices from the device stage to process validation and acceptance activities of finished devices.
  2. Monitor FDA Emergency Use Authorizations (EUA) to assess if your product is authorized in a medical setting.
  3. Submit a request to have your product added to the EUA at CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.
  4. Use original parts or those with the same specifications, dimensions, and performance, if available. It may help to use plans from original parts when available and verify that any 3D-printed products fit and work properly before they are used in a clinical setting.
  5. If applicable, work with relevant medical device manufacturers to ensure your product meets original specifications.
  6. Email COVIDManufacturing@fda.hhs.gov if you have questions. 
  7. Follow FDA’s collaboration with the Department of Veterans Affairs (VA) Innovation Ecosystem, America Makes Public-Private Partnership, and the National Institutes of Health (NIH) 3D Print Exchange to see how you can potentially help.

 

Q. Can 3D printing be used to make gowns, masks, respirators, and other types of personal protective equipment (PPE)?

A. PPE includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome to be effective enough. For example, 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators. The CDC has recommendations for how to optimize the supply of face masks.

Additional Resources

The FDA has included external websites from organizations that are being used to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19:

 

Contact Information

If you have questions about 3D printing to meet product demand during the COVID-19 emergency, please email COVIDManufacturing@fda.hhs.gov. For general questions, contact the Division of Industry and Consumer Education (DICE) or email DICE@fda.hhs.gov.

Medical Equipment Port of Entry Delays

For assistance, visit the FDA Import Offices and Ports of Entry page for contact information and instructions.

To speed assistance to importers during the COVID-19 pandemic with an urgent need of supplies, please have the necessary information available when you call, such as the:

  • entry number (which you can get from your entry filer),
  • port of entry, and
  • other shipment details.

The FDA receives many different types of entries (consumption, informal, warehouse, import for export, etc.). Most questions revolve around the difference between commercial and personal shipments. 

For import assistance regarding personal protective equipment or test kits, email: COVID19FDAImportInquiries@fda.hhs.gov

Federal Authorities

Authorities that have been activated for COVID-19.

CARES Act - Funding Breakout By Agency

The following are general breakouts of funding by agency expected to be distributed from the CARES Act passed 27 March 2020. Full text of Act here. Summary below courtesy of Steptoe.

FOOD AND DRUG ADMINISTRATION

  • Additional $80 million in funding to develop necessary medical countermeasures and vaccines, advance manufacturing for medical products, and monitor medical product supply chains in response to COVID-19.

DEPARTMENT OF COMMERCE 

  • $50 million for Hollings Manufacturing Extension Partnership, run by the National Institute of Standards and Technology Manufacturing Extension Partnership (NIST MEP).
  • Provided funds are to remain available until September 30, 2021.
  • Statutory cost-match requirements are waived for all FY2020 funding.

NATIONAL SCIENCE FOUNDATION (NSF)

  • $75 million dollars to prevent, prepare for, and respond to coronavirus, domestically or internationally, including to fund the Rapid Response Research program (RAPID), which is run by the Division of Grants and Agreements.  Provided funds are to remain available until September 30, 2021.

DEPARTMENT OF DEFENSE

  • $10.5 billion for a variety of purposes, including $1.45 billion for Defense Working Capital Funds, $1 billion for the Defense Production Act, and $3.4 billion for the Defense Health Program.

FEDERAL EMERGENCY MANAGEMENT AGENCY

  • $45 billion for the Disaster Relief Fund to fund federal response operations across federal departments and agencies pursuant to mission assignments issued by FEMA, as well as reimbursements to state, local, territorial, and tribal governments, as well as private non-profit organizations like universities, utilities, and hospitals, as well as nursing homes, food and sheltering operations, and other critical and essential services, pursuant to the Stafford Act. These reimbursements are made under the emergency declarations currently in place for all 50 states, as well as the major disaster declaration in place for New York, for eligible categories of activities, including emergency protective measures such as medical response, personal protective equipment, and other types of personnel and procurement costs.
    • $25 billion shall be for major disasters declared pursuant to the Stafford Act.
    • $15 million may be used for all purposes.
    • $100 million will be for assistance to Firefighter Grants to provide personal protective equipment, supplies, and reimbursements.
    • $100 million will be for Emergency Management Performance Grants which focus on emergency preparedness.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

  • The Public Health and Social Services Emergency Fund will receive just over $27 billion through September 30, 2024 for medical response efforts, including:
    • At least $16 billion for the Strategic National Stockpile to procure personal protective equipment and other medical supplies for federal and state response efforts;
    • At least $250 million for grants/cooperative agreements to expand the Hospital Preparedness Program’s support of emergency preparedness; and
    • At least $3.5 billion for the Biomedical Advanced Research and Development Authority to advance the manufacture, production, and purchase of vaccines, therapeutics, diagnostics, and small molecule active pharmaceutical ingredients.
  • Centers for Disease Control (CDC)
    • The CDC will receive $4.3 billion through September 30, 2024 to support activities and programs to prevent, prepare for, and respond to COVID-19, including:
      • $1.5 billion is for state and local grants/cooperative agreements to carry out surveillance for COVID-19, laboratory capacity to test for COVID-19, infection control and mitigation, and other preparedness response activities, with $125 million allocated to tribes and tribal organizations.
      • $500 million is for public health data surveillance and analytics infrastructure modernization.

DEPARTMENT OF HOMELAND SECURITY

  • $178 million for headquarters operations or to DHS’s operating components for personal protective equipment and sanitization materials.
Defense Production Act of 1950

The Defense Production Act (DPA) of 1950, as amended (50 U.S.C. 4501 et seq.) is the primary source of presidential authorities to expedite and expand the critical supplies and services from the private sector that are needed to promote national defense.  This includes both emergency preparedness and response activities conducted pursuant to title VI of The Robert T. Stafford Disaster Relief and Emergency Assistance Act as well as for the protection and restoration of critical infrastructure operations.

The Act requires companies to prioritize government orders and contracts that are necessary to meet the response efforts associated with the coronavirus COVID-19 pandemic. Authorities can also be used to provide financial incentives and assistance to private industry to expand production and capacity for necessary supplies and resources.  Four Defense Production Act authorities could be important tools in ongoing efforts to combat the threat of the coronavirus.

Resource: The Defense Production Act of 1950: Vital Defense and Emergency Acquisition

Stafford Act

In accordance with section 501 (b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the “Stafford Act”).  State, Territorial, Tribal, local government entities and certain private non-profit (PNP) organizations are eligible to apply for Public Assistance.  

In accordance with section 502 of the Stafford Act, eligible emergency protective measures taken to respond to the COVID-19 emergency at the direction or guidance of public health officials’ may be reimbursed under Category B of the agency’s Public Assistance program. 

This declaration increases federal support to HHS in its role as the lead federal agency for the federal government’s response to COVID-19. 

Official Government Guidance

Memorandums issued by Government agencies.

Official Memorandums and Guidance
Implementation Guidance for Supplemental COVID-19 Funding

Agency Reporting Instructions for COVID-19-Related Funding (OMB Memo)

This guidance allows agencies and recipients to meet the CARES Act reporting requirements by utilizing, with minimal modifications, existing reporting requirements within agency financial systems and existing reporting processes under the Federal Funding and Transparency Act (FFATA), as amended by the Digital Accountability and Transparency Act (DATA Act).

Highlights include:

 

Expand Usage of the Disaster Emergency Fund Code (DEFC) for Tracking COVID-19 Supplemental Funding

Agencies should use the following DEFC codes for COVID-19 supplemental funding:

• DEFC “L” – PL 116-123, designated as emergency
• DEFC “M” – PL 116-127, designated as emergency
• DEFC “N” – PL 116-136 (CARES Act), designated as emergency
• DEFC “0” – PL 116-136 (CARES Act), not designated as emergency
• DEFC “Q” – Excluded from tracking, continue to use (non-emergency/non-disaster designated appropriations).

 

Extending DEFC Requirements to Data Provided for USASpending.gov

Agencies are required to report financial and award data to USASpending.gov via the DATA Act broker. These submissions include summary financial data (“File A”), obligation and outlay data by program activity and budget object class (“File B”), and summary award-level obligation data (“File C”). Effective for the June 2020 reporting period, all agencies are required to add the DEFC attribute to Files B and C.

 

New Monthly and Outlay Reporting Requirements on Financial Data Spending for USASpending.gov

Effective for the June 2020 reporting period, agencies with COVID-19 relief funding must submit DATA Act Files A, B and C on a monthly basis.

 

Program Activity Reporting

To better achieve the objectives of both the DATA Act and the COVID-19 relief legislation, for all spending and activities related to COVID-19 relief and non-COVID-19 relief, agencies must include “Program Activity” in File C for the FY 2021 Quarter 1 submission date.

 

Management of Reporting and Data Integrity Risk Related to COVID-19 Response Funding

In order to meet the reporting objectives of the CARES Act, agencies should continue to leverage the existing requirements in M-18-16 for
Data Quality Plans until they expend their funds related to the COVID-19 response.

 

National Interest Action Code for Procurement

On March 13, 2020, a National Interest Action (NIA) code (P20C) was added to the Federal Procurement Data System to help identify procurement actions related to COVID-19 response. To promote full, clear, and consistent transparency in the tracking of COVID-related
procurement actions, agencies are directed to assign this NIA code to all procurement actions reported into FPDS that are issued in response to the pandemic. This includes new awards for supplies and services as well as modifications that are issued to address COVID-19, irrespective of whether the contract being modified was originally awarded to address COVID-19. The code should also be used in connection with any procurement authority, including but not limited to special emergency procurement authorities identified under FAR Subpart 18.2. (Note: This guidance modifies and supersedes guidance provided in Question 11 of OMB Memorandum M-20-18, Managing Federal Contract Performance Issues Associated with the Novel Coronavirus (March 20, 2020).)

 ***Update to Guidance on Application of National Interest Action (NIA) Code to Increase Transparency (6 April 2020)***

 

Agency Requirements to Capture Reporting of Purchase Card Use

Effective with the issuance of this Memorandum, OMB hereby instructs agencies using the General Services Administration’s (GSA’s) SmartPay® program must identify relevant transactions in their servicing bank’s Electronic Access System (EAS) during the reconciliation process by adding “COVID” as the identifier for transactions. Agencies not using an EAS must apply the “COVID” identifier to appropriate transactions in internal systems in anticipation of providing such information as requested by OMB. GSA is developing training and additional instructions to facilitate data capture in anticipation of future reporting.

DoD SmartPay® 3 Government-wide Commercial Purchase Card Guidance for the Coronavirus Disease 2019 (COVID-19)

 

Timeline and Requirements

 

Appendix B – Timeline and Requirements
Reporting Requirement This applies to: Timeline
P.L. 116-123, Emergency: DEFC value ” L” Existing reporting requirement for accounts designated as emergency. Currently reported to GTAS.
P.L. 116-127, Emergency: DEFC value “M” Existing reporting requirement for accounts designated as emergency. Currently reported to GTAS.
P.L 116-136, Emergency: DEFC value “N” Existing reporting requirement for accounts designated as emergency. Currently reported to GTAS.
P.L. 116-136, Non-emergency: DEFC value “O” Most accounts that received non-emergency funding in the CARES Act. Immediately. Aligned with GTAS reporting windows.
Outlays in DATA Act File C (a running total of outlays by award) All agencies subject to DATA Act reporting required to report under the CARES Act provisions.

DATA Act Q3 reporting schedule will not change, which is to include outlays for FY 2020Q3.

Monthly reporting will begin in July for the month of June. Monthly submission will align to the GTAS reporting schedule.

Agencies will not report outlays in Files A and B for Period 1.

Monthly Reporting for DATA Act Files A, B and C, including all DEFC values in Files B and C All agencies subject to DATA Act reporting required to report under the CARES Act provisions.

DATA Act Q3 reporting schedule will not change, which is to include the DEFC code for FY 2020 Q3.

Monthly reporting will begin in July for the month of June.

Monthly submission will align to the GTAS reporting schedule.

DEFC Code in DATA Act Files B and C, including DEFC values “L” through “O” and subsequent COVID-19-related values All agencies subject to DATA Act reporting. No later than with the monthly June 2020 DATA Act submission.
Twice monthly reporting Files D2 All agencies subject to DATA Act reporting. No later than with the monthly June 2020 DATA Act submission.
Program Activity in DATA Act File C All agencies subject to DATA Act reporting. FY 2021 Q1
Monthly Reporting for DATA Act Files A, B, and C All agencies subject to DATA Act reporting. FY 2022 Q1
Outlays in DATA Act File C All agencies subject to DATA Act reporting. FY 2022 Q1
NIAC Consistent with the FAR and OMB guidance, agency procurement actions supporting COVID-19. Through duration of NIA designated reporting period, directly in FPDS.
Purchase Cards All agencies required to report under the CARES Act provisions. Monthly submission will align to the GTAS reporting schedule.
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