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

The Eunice Kennedy Shriver National Institute of Child Health and Human Development announced a closed meeting scheduled for April 17, 2025. The meeting will run from 10:00 a.m. to 5:00 p.m. and will be held virtually. It is organized to review and evaluate grant applications related to pregnancy, perinatology, and pediatrics. The discussions will include sensitive information, such as confidential trade secrets and personal information, hence the closure to the public.

The Food and Drug Administration (FDA) has calculated the regulatory review period for the human biological product ROCTAVIAN. This action is in relation to a request for patent term extension submitted to the U.S. Patent and Trademark Office by BioMarin Pharmaceutical, Inc. The total review period is 2,101 days, divided into 816 days for testing and 1,285 days for approval. The FDA encourages anyone who believes the dates are incorrect to submit comments or petitions by specified deadlines for consideration.

The National Institute of Allergy and Infectious Diseases is holding a closed meeting to discuss grant applications. This meeting, scheduled for January 28, 2025, will focus on the development of tools to combat antibiotic-resistant bacteria, and it will not be open to the public to protect confidential information. The meeting will take place online and is organized by Dr. Maryam Feili-Hariri, a Scientific Review Officer at the institute.

The National Institutes of Health (NIH) announced that a meeting of the National Center for Advancing Translational Sciences Special Emphasis Panel will take place on April 24, 2025. The meeting will be closed to the public to protect confidential information and personal privacy. During the meeting, the committee will review and evaluate contract proposals related to a benchtop device for batch evaporation. Dr. Rahat Khan will be the contact person for further inquiries.

The Center for Scientific Review within the National Institutes of Health announced a series of closed virtual meetings to evaluate grant applications between April 15 and April 24, 2025. These meetings are not open to the public to protect confidential information like trade secrets or personal details about individuals involved in the applications. Several specific study sections, including those focused on neurodegeneration, neurotoxicology, and healthcare disparities, will be reviewed. The meetings are conducted in adherence to federal regulations that safeguard sensitive information.

The National Institutes of Health (NIH) announced a virtual meeting of the Board of Scientific Counselors for the National Institute on Deafness and Other Communication Disorders (NIDCD). The meeting, scheduled for March 17, 2025, will be partially open to the public from 1:00 p.m. to 1:25 p.m., where reports from institute staff will be presented. Following this, the meeting will be closed to the public from 1:25 p.m. to 6:05 p.m. to review and evaluate the qualifications and performance of personnel. For those needing special assistance or accommodations, advance notification to the contact person, Dr. Lisa L Cunningham, is advised.

The National Cancer Institute (NCI), part of the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS), is planning to grant an exclusive license to StraightLine Bio, Inc. for certain anti-cancer inventions. These inventions involve patents related to T cell receptors targeting a cancer antigen called KK-LC-1, which is found in certain epithelial cancers. The proposed license would allow StraightLine Bio to develop and commercialize therapies using this technology worldwide, but with some specific exclusions. The public has a chance to comment or object to this plan until December 26, 2024.

The Food and Drug Administration (FDA) is conducting a survey to gather information from facilities that manufacture, process, or pack drug products. This survey aims to understand how these facilities manage risks related to the quality of drug components, containers, and supply chains. The data collected will help the FDA analyze potential updates to manufacturing regulations for drugs. The public is invited to submit comments on this information collection by February 16, 2021.

The National Institute of Allergy and Infectious Diseases has announced a closed meeting scheduled from January 17 to 24, 2025, to review contract proposals relating to new drug classes for HIV, Hepatitis B, and Tuberculosis. The meeting will be conducted via video at the National Institutes of Health in Rockville, MD. This meeting is closed to the public due to confidentiality concerns, as it may involve sensitive information such as trade secrets and personal data. For more details, interested parties can contact Dr. Barry J. Margulies at the provided email address.

The National Institutes of Health is announcing closed meetings for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The meetings are set for various dates in May 2025 and will be held virtually. These meetings will focus on reviewing and evaluating grant applications related to interdisciplinary science in diabetes and kidney diseases, HIV pathogenesis, and time-sensitive obesity research. Because discussions might reveal confidential information, the meetings will not be open to the public.