Search Results for agency_names:"Health and Human Services Department"

The National Institutes of Health announced a change to a meeting initially scheduled by the Integrative and Clinical Endocrinology and Reproduction Study Section. The meeting, which was to occur over two days (February 18-19, 2021), will now take place only on February 18, 2021. The meeting will be held at NIH in Bethesda, MD, and will not be open to the public. This update was filed by Tyeshia M. Roberson, a Program Analyst at the Office of Federal Advisory Committee Policy.

The Food and Drug Administration (FDA) has issued five Emergency Use Authorizations (EUAs) for drugs and biological products during the COVID-19 pandemic. These authorizations, allowed under the Federal Food, Drug, and Cosmetic Act, aim to help address public health emergencies by making medical products available when there are no adequate alternatives. The products authorized include those requested by Baxter Healthcare, the U.S. Department of Health and Human Services, Eli Lilly and Company, and Regeneron Pharmaceuticals. The FDA ensures that these authorizations are based on scientific evidence indicating that the benefits of using these products outweigh the risks.

The Food and Drug Administration (FDA) has calculated the regulatory review period for the human drug product VEOZAH, which is used to treat menopause-related symptoms. This review period consists of 2,573 days, split between the drug testing phase (2,248 days) and the approval phase (325 days). The announcement is necessary due to requests for patent term extensions filed with the U.S. Patent and Trademark Office. The FDA invites comments and petitions regarding the accuracy of these dates and the diligence of the applicant during the review process.

The Health Resources and Services Administration (HRSA) is planning to submit an Information Collection Request to the Office of Management and Budget. This is part of their procedure under the Paperwork Reduction Act, which allows for public input on such requests. The focus is on deeming health centers as Public Health Service employees, providing them with Federal Tort Claims Act (FTCA) coverage. HRSA seeks public comments on the related burden estimates or other aspects, and there are no proposed changes to the application process for 2022 and beyond.

The National Institute of Environmental Health Sciences (NIEHS) is hosting a closed virtual meeting on April 17-18, 2025, to discuss and evaluate grant applications. The meeting will not be open to the public to protect confidential information, such as trade secrets and personal privacy. Discussions will focus on the NIH Pathway to Independence and Mentored Research Scientist Development Award. For more details, individuals can contact Dr. Murali Ganesan.

The National Institutes of Health (NIH) is holding a series of closed meetings to review and evaluate grant applications. These meetings will not be open to the public due to concerns about revealing confidential information and personal privacy. Various committees, such as the Biobehavioral and Behavioral Processes Integrated Review Group and the Oncology 1-Basic Translational Integrated Review Group, will participate virtually in the evaluations. The meetings span several dates in February 2021, each focusing on different scientific areas.

The National Institute of Diabetes and Digestive and Kidney Diseases has scheduled a closed meeting for the Kidney, Urologic, and Hematologic Diseases D Study Section. This meeting will take place virtually from June 24 to June 26, 2025, and it aims to review and evaluate grant applications. The meeting is closed to the public to protect confidential information, such as trade secrets and personal details, related to the grant applications. For more information, Jason D. Hoffert, Ph.D., the Scientific Review Officer, can be contacted via email or phone.

The Centers for Medicare & Medicaid Services (CMS) is inviting public comments on its plan to collect information as required by the Paperwork Reduction Act of 1995. CMS aims to enhance the quality and utility of the information collected and reduce the burden on participants using technology. Two key projects are included in this request: the Monitoring and Audit Process for PACE Organizations to ensure compliance, and the Part B Immunosuppressive Drug Coverage application process to determine eligibility for beneficiaries after a kidney transplant. Public comments are welcomed until February 21, 2025.

Notice has been given for a closed meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel on February 24-25, 2025. The Centers for Disease Control and Prevention (CDC) will use a video-assisted format to review grant applications related to Occupational Safety and Health Education and Research Centers. The meeting will remain private to protect trade secrets and personal information. Concerns or inquiries can be directed to Dr. Michael Goldcamp, the Scientific Review Officer at the CDC.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development has announced a closed meeting of its Initial Review Group for the Biobehavioral and Behavioral Sciences Study Section. The meeting is scheduled for March 25, 2025, from 9:00 a.m. to 5:00 p.m. It will take place virtually and is not open to the public to protect confidential information related to grant applications. Participants will review and evaluate these applications during the meeting.