🏥TRICARE Regulation Expands Coverage for Clinical Trials
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this final rule regarding circumstances under which services and supplies related to emerging treatments may be covered under the TRICARE program. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigational drugs under U.S. Food and Drug Administration (FDA)-authorized expanded access (EA) programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19. This final rule discusses the DoD's decision not to make permanent the coverage of treatment use of investigational drugs under FDA EA programs while updating language for care associated with their administration and broadens the COVID-19 clinical trial benefit to include coverage of clinical trials sponsored or approved by any National Institutes of Health (NIH) Center or Institute to treat or prevent infectious diseases associated with a pandemic or epidemic. Lastly, the final rule expands TRICARE's clinical trial benefit by covering services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials that are NIH-sponsored or approved and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life- threatening, or a rare disease.
Learn More🏥Meeting Notice
The Department of Health and Human Services announces a public meeting of the AIDS Research Advisory Committee at the National Institutes of Health. The meeting will be videocast and provide reports from the Division Director and Staff, addressing key research initiatives and accommodations for attendees.
Learn More🏥NIH Meeting Notice on Allergy and Infectious Diseases Grants
The NIH announces meetings of the National Advisory Allergy and Infectious Diseases Council, open to public participation and videocasting. The sessions will focus on reviewing grant applications and reports from NIH leadership, providing an opportunity for stakeholders in allergy and infectious diseases to engage with funding discussions.
Learn More🧬Government-Owned Inventions Available for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More💉Government-Owned EV-D68 Antibodies Now Available for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Learn More📊CDC Invites Comments on Health Message Data Collection
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled NCEZID Rapid Message Testing & Development System. This program will enable the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) to test health messages and gather information to inform the development of health messages.
Learn More💰NIH Closed Meetings for Review of Grant Applications
The Department of Health and Human Services announces closed meetings by the National Institutes of Health's Center for Scientific Review to evaluate grant applications for various health research projects. Key topics include cancer research and infectious diseases, with potential funding opportunities for associated entities.
Learn More🏥Notice of Closed Meeting - National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases announces a closed meeting for a special emphasis panel focused on evaluating contract proposals for medical countermeasures related to biodefense and emerging infectious diseases. The meeting emphasizes confidentiality regarding potentially sensitive information discussed during the evaluation.
Learn More🩺FDA Notice on Xenotransplantation and Infectious Disease Guidelines
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled "PHS Guideline on Infectious Disease Issues in Xenotransplantation" dated January 19, 2001.
Learn More💰NIH Meeting on Grant Applications for Allergy and Infectious Diseases
The notice outlines a public meeting of the National Advisory Allergy and Infectious Diseases Council, including details on grant evaluations related to allergy and infectious diseases. Closed sessions will discuss confidential information, while open sessions will report on activities from Division Directors. Public participation and comments are encouraged.
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