Tag Archive for Department of Health and Human Services

Operation Warp Speed Therapeutics: Monoclonal Antibody Playbook Version 2.0

This playbook is intended to support sites interested in administering COVID-19 treatment under EUA including:
• Existing hospital or community-based infusion centers
• Existing clinical space (e.g. urgent care, emergency depts)
• Ad hoc new infusion sites (e.g. “hospitals without walls”)
• Long-term care facilities or home infusions with infusion delivery capability

DHS Privacy and Civil Liberties Assessment Report on Executive Order 13636

Section 5 of Executive Order 13636 (Executive Order) requires the DHS Chief Privacy Officer and Officer for Civil Rights and Civil Liberties to assess the privacy and civil liberties impacts of the activities the Department of Homeland Security (DHS, or Department) undertakes pursuant to the Executive Order and to provide those assessments, together with recommendations for mitigating identified privacy risks, in an annual public report. In addition, the DHS Privacy Office and the Office for Civil Rights and Civil Liberties (CRCL) are charged with coordinating and compiling the Privacy and Civil Liberties assessments conducted by Privacy and Civil Liberties officials from other Executive Branch departments and agencies with reporting responsibilities under the Executive Order.

U.S. Postal Service Operation Medicine Delivery Exercise Outcomes Summary

On May 5-6, 2012, the Minneapolis-St. Paul area conducted a major test of the National Postal Model for distribution of medicine to the public in an emergency, using U.S. Postal Service assets to supplement mass dispensing sites and other strategies. The May exercise, known as Operation Medicine Delivery, was the culmination of planning efforts that began in February 2004, with a memorandum of agreement signed by the U.S. Secretary of Health and Human Services, the U.S. Secretary of Homeland Security and the Postmaster General. Parties to the 2004 MOA agreed to make USPS resources available for distributing emergency medicine in response to a bioterrorist attack. A subsequent presidential executive order (December 2009) called for the development of a federal capability to distribute medical countermeasures (MCM) in response to a bioterrorist attack.

Project Bioshield: HHS Can Improve Agency Internal Controls for Its New Contracting Authorities

Since 2004, HHS has awarded nine contracts using its Special Reserve Fund (Fund) purchasing authority under the BioShield Act to procure countermeasures that address anthrax, botulism, smallpox, and radiation poisoning. HHS may procure countermeasures that are approved by the Food and Drug Administration and ones that are unapproved, but are within 8 years of approval.

Executive Order 13375

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 361(b) of the Public Health Service Act (42 U.S.C. 264(b)), it is hereby ordered as follows Based upon the recommendation of the Secretary of Health and Human Services, in consultation with the Surgeon General, and for the purpose set forth in section 1 of Executive Order 13295 of April 4, 2003, section 1 of such order is amended by adding at the end thereof the following new subsection: (c) Influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic.