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

The Food and Drug Administration (FDA) has filed a petition from Monterey Mushrooms, LLC to amend the regulations for vitamin D2 mushroom powder. The change would allow for the production of the additive by exposing mushrooms to ultraviolet light. The petitioner claims that this amendment does not require an environmental assessment because the additive will remain in food as consumed, not replacing other nutrients. If the FDA agrees, no further environmental review will be necessary.

The Center for Scientific Review of the National Institutes of Health has announced several closed meetings scheduled for February 2021. These meetings will evaluate and review grant applications and will be closed to the public to protect confidential information, including trade secrets and personal privacy. Numerous committees will participate in these meetings, covering a broad range of scientific topics such as neuroscience, endocrinology, oncology, and vascular research. The virtual meetings will be held across multiple dates, and scientific review officers are listed for each committee.

The National Institute on Aging has announced a closed meeting scheduled for February 20, 2025. The meeting will be held virtually to review grant applications, specifically focusing on research about age-related changes in gait biomechanics and their impact on walking. The closure is due to the potential discussion of confidential information and personal privacy concerns. Interested parties may contact Nesar Uddin Akanda for further details.

The National Institute of Biomedical Imaging and Bioengineering is holding a closed meeting to review grant applications. This meeting will take place virtually on February 11, 2025, from 11:00 a.m. to 2:00 p.m. Due to the confidential nature of the discussions, including trade secrets and personal information, it is not open to the public. Tianhong Wang, a scientific review officer, is the point of contact for this meeting.

The Department of Health and Human Services (HHS) announced changes to the way it manages records about unaccompanied children in federal custody due to their immigration status. The updated system, now called the ORR Unaccompanied Children Bureau (UCB) Administrative Program Records, aims to enhance privacy protections and clarify routine uses of data, especially concerning law enforcement and child welfare investigations. The revisions prohibit using children's information for immigration enforcement purposes without consent and specify situations where information can be shared, like health care coordination or missing children investigations. These changes are part of HHS's ongoing efforts to ensure the safety and well-being of unaccompanied children.

The National Institutes of Health has announced a closed meeting for the National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, scheduled for February 19, 2025. This meeting will be held virtually and is intended for reviewing grant applications. The meeting will be closed to the public to protect sensitive information, including confidential trade secrets and personal details related to grant applicants. Queries can be directed to Nisan Bhattacharyya, Ph.D., the Scientific Review Officer at the National Institutes of Health.

The Food and Drug Administration (FDA) has announced the issuance of a priority review voucher to SpringWorks Therapeutics, Inc. for their drug GOMEKLI (mirdametinib). This drug is used to treat adults and children 2 years and older who have neurofibromatosis type 1 with symptomatic plexiform neurofibromas. The priority review voucher is awarded under the Federal Food, Drug, and Cosmetic Act to incentivize companies to develop treatments for rare pediatric diseases. The notice was officially filed on March 12, 2025.

The Food and Drug Administration (FDA) announced the determination of the regulatory review period for the drug SOHONOS, which is used to treat fibrodysplasia ossificans progressiva in certain children and adults. This determination is related to a patent extension application made to the U.S. Patent and Trademark Office (USPTO). FDA found that the drug underwent a lengthy review process, including 6,657 days of testing and 869 days of approval proceedings. People who believe any of the review dates are incorrect can submit comments to FDA, and petitioners can also request a review of the applicant's diligence during this period.

The Food and Drug Administration (FDA) is updating animal drug regulations to reflect actions related to new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) from October to December 2024. Some approvals for specific animal drugs have been withdrawn because they are no longer manufactured or marketed. Additionally, the FDA is making technical amendments to enhance the accuracy and clarity of the regulations, updating sponsor information, and making adjustments in drug sponsorships and addresses. These changes take effect on January 21, 2025.

The Department of Health and Human Services (HHS) has finalized a rule updating the list of select agents and toxins that could be used as biological threats, effective January 16, 2025. The changes include removing certain Brucella species from the list, updating the nomenclature for several agents, increasing the permissible limit for a specific toxin, and designating Nipah virus as a Tier 1 select agent due to its high risk of misuse. The decision to retain or modify agents like the botulinum neurotoxin-producing species of Clostridium reflects considerations of public health, security, and regulatory compliance. These adjustments aim to align with current scientific understanding and reduce regulatory burdens while maintaining necessary security measures.