COVID-19 Toolkit: U.S. Government News & Resources

(Page last updated: July 24, 2020)

On this section of the online toolkit, we provide U.S. Government resources, links, and other critical information related to the government’s response to COVID-19 at the federal, state, and local level. This content will be updated on a frequent basis, so be sure to refresh your web browser to see all the latest news and information.

U.S. Government – COVID-19 Table of Contents

U.S. Government News & Resources

U.S. DHS CISA Declares Medical Gases and Other CGA Member Activities “Essential” to COVID-19 Response

Updated: May 22, 2020

On March 18, 2020 (updated April 28, 2020), the U.S. Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) published Identifying Critical Infrastructure During COVID-19 as a part of its response to the COVID-19 pandemic.

DHS also published the related Guidance on the Essential Critical Infrastructure Workforce on March 19, 2020 (updated May 19, 2020).

In this guidance, DHS provides a list of “Essential Critical Infrastructure Workers…to help state and local officials as they work to protect their communities, while ensuring continuity of functions critical to public health and safety, as well as economic and national security.”

DHS defines “Manufacturers, technicians, logistics and warehouse operators, and distributors of … medical gases” as “essential.” Other CGA member activities are also identified as essential in the CISA guidance, such as food manufacturer employees and their supplier employees…

U.S. DHS S&T Provides “Master Question List” Summarizing What’s Known About  COVID-19 (Caused by SARS-CoV-2)

Posted April 22, 2020

The Department of Homeland Security Science and Technology Directorate (DHS S&T) has developed a “Master Question List for COVID-19 (caused by SARS-CoV-2).” This resource is designed to quickly summarize what is known, what additional information is needed, and who may be working to address such fundamental questions as, “What is the infectious dose?” and “How long does the virus persist in the environment?”

As DHS S&T explains, “the Master Question List (MQL) is intended to quickly present the current state of available information…and allow structured and scientifically guided discussions…”

U.S. CDC News & Resources

We provide here news, links, and resources related to the U.S. Centers For Disease Control and Prevention (CDC) response to COVID-19.

U.S. CDC Issues Reopening Guidance for Cleaning and Disinfecting Workplaces, Businesses, and Public Spaces

Posted May 5, 2020

This guidance from the U.S. Centers For Disease Control and Prevention (CDC) focuses on cleaning and disinfecting public spaces, workplaces, businesses, schools, and can also be applied to homes. Cleaning and disinfecting spaces including your workplace, school, home, and business will require you to:

  • Develop a plan
  • Implement your plan
  • Maintain and revise your plan

This guidance provides a general framework for cleaning and disinfection practices.

U.S. DOT FMCSA News & Resources

We provide here news, links, and resources related to the U.S. Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) response to COVID-19.

DOT FMCSA Issues Notice of Enforcement Discretion Determination for Random Controlled Substance and Alcohol Testing

Posted: July 24, 2020

In its July 6, 2020 Notice, the U.S. Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) notes motor carrier employers subject to controlled substance (drug) and alcohol testing under 49 CFR part 382 may be unable to comply with certain testing requirements due to the ongoing impacts of the COVID-19 global pandemic.

In recognition of the barriers to full compliance in some locations, FMCSA may exercise discretion to determine not to enforce the minimum annual percentage random testing rates for drugs and alcohol, and the requirement that each employer ensure that the dates for administering random drug and alcohol tests are spread reasonably throughout the calendar year. FMCSA emphasizes, however, that employers capable of meeting these requirements must continue to do so…

DOT FMCSA Issues Waiver in Response to COVID-19 National Emergency – For States, CDL Holders, CLP Holders, and Interstate Drivers Operating Commercial Motor Vehicles

Posted: July 24, 2020

In its July 1, 2020 Waiver, the U.S. Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) grants, until September 30, 2020, a waiver from certain regulations applicable to interstate and intrastate commercial driver’s license (CDL) and commercial learner’s permit (CLP) holders and to other interstate drivers operating commercial motor vehicles (CMVs).

In response to the COVID 19 global pandemic and to continue the ability of intrastate and interstate CDL and CLP holders and interstate non-CDL drivers to transport goods in response to the COVID-19 public health emergency, the waiver…

DOT FMCSA Extends Emergency Declaration for Transportation of Essential Medical Supplies

Update: June 8, 2020

PLEASE NOTE: FMCSA has extended its Emergency Declaration 2020-002 to July 14, 2020. “FMCSA is continuing the exemption because the presidentially declared emergency remains in place and because a continued exemption is needed to support direct emergency assistance for some supply chains,” the agency stated in the latest extension notice.

On March 13, 2020, the U.S. Department of Transportation (DOT) Federal Motor Carrier Safety Administration (FMCSA) issued Emergency Declaration 2020-002 providing regulatory relief for commercial motor vehicle operations engaged in direct assistance in transportation of essential supplies, equipment, and persons related to the COVID-19 outbreaks in the 50 states.

In its Emergency Declaration, DOT identifies as “essential” the transportation of “medical supplies and equipment related to the testing, diagnosis, and treatment of COVID-19.” Therefore, any state or local quarantine or shelter in place declarations should include medical gas transportation “essential” to the treatment of COVID-19.

FMCSA has also published a Frequently Asked Questions (FAQ) related to this Emergency Declaration.

DOT FMCSA Issues Guidance on Certain Pre-Employment Drug Testing Requirements

On June 5, 2020, the U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (FMCSA) granted a three-month waiver from certain pre-employment testing requirements applicable to employers of drivers subject to 49 CFR part 382. In response to the COVID-19 pandemic, employers have imposed layoffs, furloughs, or otherwise temporarily removed employees from performing safety-sensitive functions, resulting in their removal from the random pool for controlled substances and alcohol testing for a period greater than 30 days.

This waiver would extend, from 30 days to 90 days, the period under which drivers would qualify for a pre-employment testing exception. This relief would allow employers to forego pre-employment testing for drivers who have participated in a controlled substances testing program that meets the requirements of 49 CFR part 382 within the previous 90 days of hire or rehire.

U.S. DOT PHMSA News & Resources

We provide here news, links, and resources related to the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) response to COVID-19.

DOT PHMSA Extends Notice of Extension of Enforcement Discretion on Cylinders That Have Exceeded Their Periodic Requalification Test Date

Updated: July 24, 2020

On July 2, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a notice extending their enforcement discretion for filling DOT specification cylinders containing Division 2.2 non-flammable gas 12 months or less past their requalification expiration date until October 31, 2020.

The original enforcement discretion period was effective until July 5. Comments made by William Schoonover, Associate Administrator for Hazardous Materials Safety, indicate this enforcement discretion may not be extended beyond the October 31 expiration date.

*****

On April 6, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a Notice of Enforcement Discretion Regarding Cylinders That Have Exceeded Their Periodic Requalification Test Dates. In this Notice, PHMSA states it will not take enforcement action against any person who fills a DOT specification cylinder for transport of a Division 2.2 gas, provided the cylinder meets all HMR (Hazardous Materials Regulations) requirements except that the cylinder is overdue for periodic requalification by no more than 12 months. This Notice may replace the need to request party status to Special Permit 21025 (see CGA COVID-19 toolkit item immediately below).

DOT PHMSA Reissues Revised Special Permit SP21025 Authorizing Cylinder Requalification

Updated: July 24, 2020

On July 6, 2020, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) reissued a revised Special Permit, SP21025, which authorizes the filling and offering for transportation of certain DOT specification cylinders that are up to 12 months overdue for periodic requalification. In this revision, PHMSA has limited gases authorized to Hazard Class/ Division 2.1, flammable gases. 

The previous version of this Special Permit authorized both Hazard Class/ Division 2.1 and 2.2 gases.  On July 2, 2020, PHMSA issued a Notice of Extension of Enforcement Discretion Regarding Cylinders That Have Exceeded Their Periodic Requalification Test Date covering Hazard Class/ Division 2.2, non-flammable gases. (See CGA COVID-19 toolkit item immediately above).

CGA members can request party status to Special Permit 21025 by completing an application for party status and submitting it to DOT…

DOT PHMSA Extends Enforcement Discretion on HMR Training Requirements

Posted: July 2, 2020

On June 24, 2020, the U.S. Department of Transportation’s Pipeline and Hazardous Materials Safety Administration (PHMSA) published a Notice of Extension of Enforcement Policy Regarding Training Requirements. This Notice states that PHMSA will continue to not take enforcement action against any offeror or carrier who is unable to provide recurrent training consistent with HMR (Hazardous Materials Regulations) training requirements until October 31, 2020. The original Notice was issued on March 25, 2020.

Summary of Actions Taken by DOT PHMSA to Help Ensure Safe Transportation and Continued Accessibility of Hazardous Materials

Posted: April 24, 2020

In response to the on-going COVID-19 public health emergency, the U.S. Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA) has taken a number of actions to help ensure the safe transportation and continued accessibility of hazardous materials (dangerous goods), including:

For additional information, visit PHMSA’s COVID-19 webpage.

U.S. FDA News & Resources

We provide here news, links, and resources related to the U.S. Food and Drug Administration (FDA) response to COVID-19.

FDA Issues Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing

On June 19, 2020, the U.S. Food and Drug Administration (FDA) issued a Guidance Document providing recommendations to drug and biological product manufacturers regarding manufacturing controls to prevent contamination of drugs, risk assessment of SARS-CoV-2 as it relates to drug safety or quality, and continuity of manufacturing operations.

FDA Provides Guidance: Notifying FDA of a Permanent Discontinuation or Interruption in Manufacturing

The Food and Drug Administration (FDA) has published a Level 1 guidance document titled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act”.  The requirement for reporting was included in FDASIA in 2012 so has been in effect for several years but this final guidance was just published (in late March 2020) without the opportunity for comment as a result of COVID-19…

U.S. FEMA News & Resources

We provide here news, links, and resources related to the U.S. Federal Emergency Management Agency (FEMA) response to COVID-19.

FEMA Provides Fact Sheet on Planning Considerations for Restarting Operations

Updated: July 24, 2020
Posted: May 5, 2020

Although many parts of company operations may have remained open during government shelter orders, others were either conducted remotely or curtailed.

On April 29, 2020, the U.S. Federal Emergency Management Agency (FEMA) published a new fact sheet, “Planning Considerations for Organizations in Reconstituting Operations During the COVID-19 Pandemic.”

This FEMA publication provides factors to consider when planning for resumption of more normal operations.

FEMA Provides FAQs to Answer Questions, Share Best Practices, and Provide Resources to Consider When Reopening Facilities, Offices, and Other Operations

Posted: July 24, 2020

National Continuity Programs (NCP) within the U.S. Federal Emergency Management Agency (FEMA), sponsored regional webinars to share information about best practices for the reconstitution of operations to enable organizations to return to normal following coronavirus (COVID-19) social distancing requirements. These webinars included factors to consider when reopening, and ideas on how to bring resources back to the workplace while preserving the integrity of essential functions, based on the NCP Fact Sheet, “Planning Considerations for Organizations in Reconstituting Operations During the COVID-19 Pandemic” (see CGA COVID-19 toolkit item immediately above for more information about this Fact Sheet).

On July 21, 2020, NCP published a new FAQ Sheet, which includes responses to frequently asked questions from the regional reconstitution webinars. NCP suggests that stakeholders review the Planning Considerations guidance, as well as guidance posted by the Centers for Disease Control and Prevention (CDC), and by the relevant state and local public health departments.

FEMA Publishes Fact Sheet on Addressing PPE Needs in Non-Healthcare Setting

April 24, 2020

On April 22, 2020, FEMA published a new fact sheet, “Addressing PPE Needs in Non-Healthcare Setting.”

This guidance summarizes how organizations should consider and manage their personal protective equipment (PPE) needs while ensuring the protection of workers during the COVID-19 pandemic response. This guidance provides PPE preservation strategies to consider for non-healthcare settings.

Other U.S. Federal Government News & Resources

We provide here news, links, and resources related to the U.S. federal government response to COVID-19.

U.S. HHS Provides Website for Ordering Cloth Facial Coverings

June 26, 2020

The U.S. Department of Health and Human Services has provided a website for ordering cloth facial coverings. These washable cotton masks are not medical grade personal protective equipment. CGA is not collecting or coordinating orders. If you are interested in ordering these facial coverings, click the button below to access the HHS information sheet.

U.S. & U.K. Security Agencies Warn of Malicious Cyber Actors Exploiting COVID-19

On April 8, 2020, the U.S. Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and the United Kingdom’s National Cyber Security Centre (NCSC), issued a joint alert with information on exploitation by cybercriminals of the COVID-19 global pandemic.

Both CISA and NCSC report seeing a growing use of COVID-19-related themes by malicious cyber actors. At the same time, the surge in teleworking has increased the use of potentially vulnerable services, such as virtual private networks (VPNs), amplifying the threat to individuals and organizations. Malicious actors are targeting individuals, small and medium enterprises, and large organizations with COVID-19-related scams and phishing emails.

This alert provides an overview of COVID-19-related malicious cyber activity and offers practical advice that individuals and organizations can follow to reduce the risk of being impacted. Individuals and organizations should remain alert to increased activity relating to COVID-19 and take proactive steps to protect themselves.

TSA Issues Exemption from Renewal of Hazardous Materials Endorsement Security Threat Assessment for Certain Individuals

On April 2, 2020, the Transportation Security Administration (TSA) of the U.S. Department of Homeland Security issued a temporary exemption from requirements in 49 CFR part 1572 regarding expiration of TSA security threat assessments (STAs) for Hazardous Material Endorsement (HME) holders. On April 8, 2020, TSA published its Exemption From Renewal of the Hazardous Materials Endorsement Security Threat Assessment for Certain Individuals to the Federal Register.

For the duration of this exemption, a state may grant an extension of up to 180 days for an HME that expired or would otherwise expire between March 1, 2020 and the end date of this exemption, even if the individual was unable to initiate or complete the required STA before the expiration date.  If the state grants an extension, the individual with an expired HME must initiate the process of renewing his or her STA for an HME no later than 60 days before the end of the state-granted extension. TSA may extend this exemption at a future date depending on the status of the COVID-19 crisis.

This exemption becomes effective on April 2, 2020, and remains in effect through July 31, 2020, unless otherwise modified by TSA through a notice published in the Federal Register.

Other U.S. Federal Links

Environmental Protection Agency

List N: Disinfectants for Use Against SARS-CoV-2
All products on this list meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.

Occupational Safety and Health Administration

OSHA Guidance on Preparing Workplaces for COVID-19

U.S. State & Local Government News & Resources

We provide here news, links, and resources related to the U.S. state and local government response to COVID-19.

U.S. State & Local Government COVID-19 Response Trackers

Updated: May 22, 2020

NAM Tools Track Emerging U.S. State and Local Emergency Response/Reopening Affecting Manufacturing Operations

The National Association of Manufacturers (NAM) provides an online interactive map, showing COVID-19 resources gathered from its state partners and local governments across all 50 U.S. states.

NAM State Partners and Local Governments Resource Map
(scroll down to see the map)

As U.S. cities, states, and counties issue and revise emergency orders to stop the spread of COVID-19, and gradually to reopen, NAM has been working to help manufacturers nationwide assess and understand the implications of these orders. The following NAM resource provides a snapshot to help U.S. manufacturers understand how various emergency orders affect their ability to operate.

NAM U.S. State COVID Operations Snapshot (PDF)

MultiState Assoc. Emerging U.S. State and Local Government Response/Reopening Tracker

MultiState Associates, a state and local government relations firm, is maintaining a google sheet Dashboard to track U.S. state and local government response to COVID-19, including reopening orders. The company also provides maps and other resources for tracking how states and localities are responding to the crisis.

MultiState Associates COVID-19 U.S. Gov Activity Dashboard (Google Sheet)

U.S. States Controlled Substance Pharmacy Law Waivers and COVID-19 Response

On April 2, 2020, the following excerpts originally appeared on the FDA Law Blog in a post entitled, “Update: State Controlled Substance Pharmacy Law Waivers and COVID-19 Response.” We provide them here as a resource for affected CGA member companies:

“[The FDA Law Blog has previously] blogged on a number of pharmacy law waivers issued by state pharmacy regulators in response to COVID-19. Waivers are being updated and added to state pharmacy websites daily to address the constantly changing public health and regulatory landscape. This blog post addresses a few recent waivers related to the controlled substances distribution and inventory requirements and a waiver related to non-resident facility licensing…”

Controlled Substances: Distribution

Michigan

“On March 30, Michigan Governor Gretchen Whitmer issued Executive Order 2020-30 (COVID-19), which provides temporary relief from certain restrictions and requirements pertaining to the provision of medical services in connection with COVID-19 response. The Executive Order authorizes any drug manufacturer or wholesale distributer licensed in good standing in another state to temporarily distribute controlled substances in Michigan to a hospital, manufacturer, or wholesale distributor…”

Ohio

On March 31 (updated on April 9, 2020), “the State of Ohio Board of Pharmacy also issued a guidance on the temporary off-site storage of dangerous drugs by a terminal distributor of dangerous drugs (TDDD). Ohio regulations define “dangerous drug” as any drug or drug product whose commercial package bears a label containing the symbol “Rx only”, the legend “Caution: Federal Law Prohibits Dispensing Without Prescription” or “Caution: Federal Law Restricts This Drug To Use By Or On The Order Of A Licensed Veterinarian,” or any similar restrictive statement and, thus, includes both drugs that are controlled substances and non-controlled substances…

Under the new guidance, Ohio facilities licensed as a TDDD may maintain possession, custody, or control of dangerous drugs for the treatment of COVID-19 patients at a satellite location other than or in addition to its actual licensed location, subject to certain requirements…”

Facility Licensing

South Carolina

On March 16, 2020, “The South Carolina Board of Pharmacy issued an Order Regarding Temporary Non-Resident Permits that directs Board staff to issue 90-day temporary permits to non-resident facilities that are permitted in good standing in with states. The order applies to out-of-state pharmacies, manufacturers, wholesale distributors, 3PLs, and FDCA Section 503B outsourcing facilities. Typically, applicants must personally appear before the Non-Resident Application Review Committee, but this Order allows for a remote interview of the applicant by Board staff. Temporary permits are to be issued within 24 hours of receipt of a completed application.”