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

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

...

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

...

U.S. Small Business Administration Re-Opening Paycheck Protection Program to Small Lenders on Friday, January 15 and All Lenders on Tuesday, January 19 | site |



Lenders with $1 Billion or Less in Assets Will be Able to Submit First and Second Draw PPP Applications on Friday – Continuing Dedicated Access for Community-Based Lenders


(Information contained in U.S. Small Business Administration [SBA] press release: January 13, 2021)

Washington - - The U.S. Small Business Administration, in consultation with the U.S. Treasury Department, will re-open the Paycheck Protection Program (PPP) loan portal to PPP-eligible lenders with $1 billion or less in assets for First and Second Draw applications on Friday, January 15, 2021 at 9 am ET. The portal will fully open on Tuesday, January 19, 2021 to all participating PPP lenders to submit First and Second Draw loan applications to SBA. Earlier in the week, SBA granted dedicated P...

Bahraini MOI – U.S. DHS Joint Statement on Acting Secretary Wolf’s Trip to Bahrain January 2021 | site |




(Information contained in U.S. Depaartment of Homeland Security [DHS] press release dated: January 11, 2021)

The Kingdom of Bahrain’s Ministry of Interior, led by His Excellency Minister Lt. General Shaikh Rashid bin Abdulla Al Khalifa, provided a warm welcome to U.S. Department of Homeland Security’s Acting Secretary Chad F. Wolf in Manama on January 5-6, 2021. H.E. Minister Al Khalifa and Acting Secretary Wolf discussed ways to bolster cyber resilience, combat cybercrime, and strengthen critical infrastructure protection measures between Bahrain’s National Cybersecurity Centre (NCSC) and DHS’s Cybersecurity and Infrastructure Security Agency (CISA) and other operational components. In addition, the two nations explored ways to fortify their relationship on emerging threats. To ensure maximum security and stability ...

Walgreens Expects to Complete Administration of COVID-19 Vaccine First Doses in Skilled Nursing Facilities by January 25 | site |


Walgreens continues to accelerate access to COVID-19 vaccinations among additional vulnerable populations as part of state and local jurisdictions distribution plans


(Information contained in Walgreens press release dated: January 6, 2021)

Deerfield, Ill., January 06, 2021 - Walgreens expects to complete the administration of COVID-19 vaccine first doses in skilled nursing facilities by Monday, Jan. 25. The company is also rapidly expanding access to vaccinations among assisted living facilities and additional vulnerable populations outlined by states and local jurisdictions as part of expanded distribution plans. “Since receiving our first allotments of vaccines in late December, Walgreens has remained on track in vaccinating our most vulnerable populations, and we are steadfast in our comm...

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

...

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

...

Federal Communications Commission announces tentative Agenda for January Open Meeting | site |



(Information contained in Federal Communications Commission [FCC] press release dated: December 23, 2020) Washington, December 23, 2020 - - —Federal Communications Commission Chairman Ajit Pai announced the tentative agenda for the January Open Commission Meeting scheduled for Wednesday, January 13, 2021. Bureau, Office, and Task Force leaders will summarize the work their teams have done over the last four years in a series of presentations: Panel One – The Commission will hear presentations from the Wireless Telecommunications Bureau, International Bureau, Office of Engineering and Technology, and Office of Economics and Analytics. Panel Two – The Commission will hear presentations from the Wireline Competition Bureau and the Rural Broadband Auctions Task Force. Panel Three – The Commission will hear presentations from the Media Bureau and the Inc...

Federal Reserve extends Termination Date of Main Street Lending Program Facilities to January 8, 2021 | site |



To allow more time to process and fund loans that were submitted to Main Street lender portal on or before December 14, 2020


(Information contained in Board of Governors of the Federal Reserve System press release: December 29, 2020)

In order to allow more time to process and fund loans that were submitted to the Main Street lender portal on or before December 14, 2020, the Federal Reserve Board on Tuesday extended the termination date of the Main Street Lending Program facilities to January 8, 2021.

As described in new frequently asked questions and program term sheets, the extension is consistent with section 1005 of the Consolidated Appropriations Act and was also approved by the Secretary of the Treasury.


Main Street New Loan Facility Term Sheet (PDF)

Main Street Priority...

U.S. Education Secretary DeVos Extends Student Loan Forbearance Period Through January 31, 2021, in Response to COVID-19 National Emergency | site |


(Information contained in U.S. Department of Education press release: December 4, 2020) Washington - - U.S. Secretary of Education Betsy DeVos announced today the extension of the federal student loan administrative forbearance period, the pause in interest accrual, and the suspension of collections activity through January 31, 2021. Federal student loan borrowers will not be expected to make payments through January of next year, though they will continue to be able to do so and benefit from the 0% interest rate as they pay down principal. Non-payments will continue to count toward the number of payments required under an income-driven repayment plan, a loan rehabilitation agreement, or the Public Service Loan Forgiveness program. "The coronavirus pandemic has presented challenges for many students and borrowers,...

U.S. Internal Revenue Service provides Tax Relief for Victims of September Wildfires in California; Oct. 15 Deadline, other Dates Extended to Jan. 15 | site |




(October 19, 2020) - - Today, October 19, 2020, the U.S. Internal Revenue Service (IRS) published the following information:

WASHINGTON — Victims of the California wildfires that began on September 4 now have until January 15, 2021, to file various individual and business tax returns and make tax payments, the Internal Revenue Service announced today.

The IRS is offering this relief to any area designated by the Federal Emergency Management Agency (FEMA) as qualifying for individual assistance. Currently this includes Fresno, Los Angeles, Madera, Mendocino, San Bernardino, San Diego and Siskiyou counties in California, but taxpayers in localities added later to the disaster area will automatically receive the same filing and payment relief. The current list of eligible...

Minutes of the Board's Discount Rate Meetings from January 21 and January 29, 2020| site |




February 25, 2020) - - Today, the Board of Governors of the Federal Reserve System published the following information:

The Federal Reserve Board on Tuesday released the minutes of its interest rate meetings on January 21 and January 29, 2020.

The minutes are attached.


Attachment (PDF)...

Minutes of the Federal Open Market Committee, January 28-29, 2020| site |



(February 19, 2020) - - Today (February 19, 2020), the Board of Governors of the Federal Reserve System published the following information:

The Federal Reserve Board and the Federal Open Market Committee on Wednesday released the attached minutes of the Committee meeting held on January 28-29, 2020.

The minutes for each regularly scheduled meeting of the Committee ordinarily are made available three weeks after the day of the policy decision and subsequently are published in the Board's Annual Report. The descriptions of economic and financial conditions contained in these minutes are based solely on the information that was available to the Committee at the time of the meeting.

FOMC minutes can be viewed on the Board's website at http://www.federalreserve.gov/moneta...ccalendars.htm Minutes of the Federal Open Market Committee January 28-29, 20...

Transcript for Centers for Disease Control and Prevention Media January 31, 2020 Telebriefing: Update on 2019 Novel Coronavirus (2019-nCoV)| site |




(January 31, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following Transcript for CDC Media January 31, 2020 Telebriefing: Update on 2019 Novel Coronavirus (2019-nCoV).

Operator: Welcome and thank you all for standing by. All participants will be on a listen-only mode until the question and answer session of today’s call. At that time, you can press star one to ask a question from the phone line. And I’d also like to inform parties that the call is being recorded. If you have any objections you may disconnect at this time. I’d now like to turn the call over to Mr. Benjamin Haynes. You may begin.

Ben Haynes: Thank you, Sarah. And thank you all for joining us for this briefing to update you on the 2019 Novel Coronavirus Response. We’re joined...