FDA Coronavirus COVID-19 Update - - - January 26, 2021

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 26, 2021 | site |




(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 26, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA's response efforts.

• FDA has posted a CDER Conversation with Katie Gray, Pharm.D., acting director of CDER’s Office of Prescription Drug Promotion (OPDP). This Conversation describes OPDP’s COVID-19 response, which has focused on compliance actions regarding prescription drug promotional materials making false or misleading claims about COVID-19 prevention or treatment. The Conversation also discusses OPDP’s 2020 achievements and 2021 goals, and the way

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Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers | site |




(Information contained in U.S. Food and Drug Administration [FDA] news release dated: January 26, 2021)

As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination....

Census Bureau Update on 2020 Census | site |


(Information contained in U.S. Census Bureau press release dated: January 21, 2021)

Jan. 21, 2021 - - The U.S. Census Bureau is implementing the President’s Executive Order “Ensuring a Lawful and Accurate Enumeration and Apportionment Pursuant to the Decennial Census,” released January 20, 2021. The 2020 Census data products including the P.L. 94-171 Redistricting Summary Data File will not include information on citizenship or immigration status. The Census Redistricting and Voting Rights Data Office will reengage the Department of Justice’s Voting Section to confirm that Citizen Voting Age Population (CVAP) data produced from the American Community Survey (ACS) continue to meet its statistical needs. The Census Bureau has released this product annually since 2011. All work on the immigration status of the population of the United States regarding the 2020 Census was suspended on January 12, 2021....

Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |



(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)

• The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simula

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U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 19, 2021 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: January 19, 2021)


The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, to help protect consumers from methanol poisoning, the FDA issued a new guidance, “Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19),” to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects.
• To accelerate the adoption of advanced and smart manufacturing

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U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, the FDA issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency.
• On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement

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U.S. Department of State publishes Update on Department Transition Efforts and Travel| site |

(Information contained in U.S. Department of State's press release press statement attributed to Morgan Ortagus, Department Spokesperson: January 12, 2021)


January 12, 2021
Press Statement
Morgan Ortagus, Department Spokesperson

The Department of State is well along in its transition efforts with President-elect Biden’s team. We are fully committed to the completion of a smooth and orderly transition process to be finalized over the next 8 days. Both the Department and the President-elect’s team have been fully engaged for several weeks toward this end, and we are pleased with the level of cooperation and professionalism that has been displayed. We are expecting shortly a plan from the incoming administration identifying the career officials who will remain in positions of responsibility on an acting basis until the Senate ...

Coronavirus (COVID-19) Update: January 8, 2021 | site |



(The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)


The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false negative results with molecular tests, including:
  • Details on the effect of genetic variants on test performance.
  • Recommendations for clinical laboratory staff and health care providers.
  • Actions the FDA has taken.
  • Instructions for reporting problems with a test.
• This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently

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U.S. Internal Revenue Service releases 2020 Progress Update | site |


IRS says "Annual report details unprecedented year"


(Information contained in U.S. Internal Revenue Service [IRS] press release dated: January 5, 2021)

Washington - - The Internal Revenue Service today released its 2020 annual report describing the agency's work delivering taxpayer service and compliance efforts during COVID-19 while spotlighting actions taken by IRS employees to help people during the challenging year.

"Internal Revenue Service Progress Update/Fiscal Year 2020 – Putting Taxpayers First " outlines how the agency overcame difficulties during the pandemic to deliver Economic Impact Payments in record time. At the same time, IRS employees made adjustments to complete a successful filing season despite office closures and the latest tax deadline ever. "The COVID-19 pandemic presented some of the greatest challenges to the IRS in ...

Transcript of Centers for Disease Control and Prevention Update on COVID-19 - - January 6, 2021 | site |




(Information contained in Centers for Disease Control and Prevention [CDC] press release dated: January 6, 2021)

Please Note: This transcript is not edited and may contain errors.

OPERATOR: AT THIS TIME, ALL PARTICIPANTS ARE ON LISTEN-ONLY MODE. SO, IF YOU WOULD LIKE TO ASK A QUESTION, PLEASE PRESS STAR AND THEN ONE.

TODAY’S CONFERENCE IS BEING RECORDED. IF YOU HAVE ANY OBJECTIONS, YOU MAY DISCONNECT AT THIS TIME. AND NOW I WOULD LIKE TO TURN THE MEETING OVER TO MR. BENJAMIN HAYNES. SIR YOU MAY BEGIN.

HAYNES: THANK YOU, BRITTANY. AND THANKS TO EVERYONE WHO HAS JOINED US FOR TODAY’S BRIEFING TO DISCUSS VACCINE SAFETY. WE ARE JOINED BY THE DIRECTOR OF CDC’S NATIONAL CENTER AND IS SENIOR FEDERAL OFFICIAL LEADING TODAY’S VACCINE EFFORTS. WE WILL BE JOINED BY DR. TOM CLARK,...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |



(Information included in U.S. Food and Drug Administration [FDA] press release dated: January 5, 2021)


The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.

The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:

Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include

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Census Bureau Update on 2020 Census | site |


(Information contained in U.S. Census Bureau press release dated: December 30, 2020)

DEC. 30, 2020 - - Data collection is just one part of producing a complete and accurate 2020 Census. Since mid-October, Census Bureau experts have been hard at work on processing the data.

As issues that could affect the accuracy of the data are detected, they are corrected. This important process, which has been a part of every decennial census, is critical to produce data that can be used for apportioning seats in the House of Representatives among the states.

The schedule for reporting this data is not static. Projected dates are fluid. We continue to process the data collected and plan to deliver a complete and accurate state population count for apportionment in early 2021, as close to the statutory deadline as possible....

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• Today, the FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.

• In a new FDA Voices entitled, 2020 at FDA: A Year of Unparalleled Contributions to Public Health, FDA Commissioner

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Transcript: Centers for Disease Control and Prevention Update on COVID-19 - - December 30, 2020 | site |




(Information contained in Centers for Disease Control and Prevention [CDC] press release: December 30, 2020)

Please Note: This transcript is not edited and may contain errors.

OPERATOR: WELCOME AND THANK YOU FOR STANDING BY. ALL LINES HAVE BEEN PLACED IN A LISTEN ONLY MODE FOR TODAY’S PREPARATION. THE CALL IS BEING RECORDED. IF YOU HAVE ANY OBJECTIONS, YOU MAY DISCONNECT AT THIS TIME. I WILL NOW INTRODUCE YOUR CONFERENCE HOST, MR. BENJAMIN HAYNES. YOU MAY BEGIN.

HAYNES: THANK YOU EVERYONE WHO HAS JOINS US TO DISCUSS TWO, NEW VARIANTS OF THE VIRUS THAT CAUSES COVID-19 AS WELL AS COVID-19 VACCINES. WE ARE JOINED BY DR. HENRY WALKE, THE INCIDENT MANAGER FOR CDC’S COVID-19 RESPONSE AND DR. NANCY MESSONNIER, DIRECTOR CDC’S NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES, AND THE SENIOR FEDERAL...

U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 28, 2020 | site |



(Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of

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