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

The Food and Drug Administration (FDA) has announced the availability of a final guidance titled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance details FDA's temporary rules for licensed pharmacists and physicians who are compounding drugs using bulk substances, while the agency works on creating a list of approved substances. The updated guidance finalizes the draft that was issued in December 2023 and replaces the previous 2017 guidance, ending the categorization of substances into different groups and outlining conditions under which the FDA will not take action against compounding that does not meet full compliance, while the list is still being developed. This guidance is issued as part of FDA's regulatory framework, but it does not establish any binding rights or obligations.

The National Center for Complementary and Integrative Health announced a closed meeting to review grant applications. This meeting, held virtually on February 18th-19th, 2021, will be restricted to protect confidential trade secrets and personal information related to the grant applications. The purpose of the meeting is to evaluate these applications without public access to ensure privacy. For further information, Patrick Colby Still, Ph.D., can be contacted via email.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that they will hold several closed meetings this February to review and evaluate contract proposals for developing pediatric formulations of tuberculosis drugs. These meetings are held under the Federal Advisory Committee Act and are closed to the public to protect confidential information and personal privacy. The meetings will be virtual, and they are occurring on February 22 and February 24, 2021, with participation led by Scientific Review Officer Mario Cerritelli. The announcements are being made less than 15 days before the meetings due to scheduling requirements aligned with the review and funding process.

The National Institutes of Health has announced a change in the previously scheduled meeting for the Oncology 2—Translational Clinical Integrated Review Group. The meeting will take place from May 1 to May 2, 2025, at their Rockledge Drive location in Bethesda, Maryland. This amendment updates the contact for the Scientific Review Officer, replacing Lawrence Ka-Yun Ng with Victor Panchenko, Ph.D. The meeting is closed to the public.

The Centers for Medicare & Medicaid Services (CMS) is seeking public comments on its plan to collect information as required by the Paperwork Reduction Act of 1995. This process involves gathering feedback about the necessity, usefulness, and clarity of the proposed information collection, along with suggestions on reducing the burden on those who must provide it. The highlight of this announcement is the Review Choice Demonstration for Inpatient Rehabilitation Facility (IRF) Services, aimed at tackling Medicare fraud by improving procedures for identifying and investigating potential fraud. The demonstration will take place in several states and will impact both for-profit and non-profit organizations, with an estimated 526 respondents providing 179,910 responses annually.

The Food and Drug Administration (FDA) has released a revised guidance for companies about submitting plans for cigarette packaging and advertising. This update, stemming from a court order, suggests that companies send their plans to the FDA by March 16, 2021, following a change in the effective date of related regulations to January 14, 2022. The guidance is part of the Tobacco Control Act's requirements, ensuring cigarette packages and advertisements carry new warning labels and graphics to inform the public about health risks. The FDA clarifies that this guidance reflects current thinking but is not binding, allowing companies to take different approaches if they meet legal requirements.

The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, is considering granting sublicensable patent licenses to Simon Fraser University in Canada and Le Centre National de la Recherche Scientifique in France. These licenses relate to a technology involving fluorescent RNA-fluorophore complexes, useful for studying RNA in live cells. The aim is to consolidate patent rights to expedite the development and marketing of this technology. Interested parties can submit comments or license applications by March 16, 2021, to object to the granting of the exclusive patent license.

The Agency for Healthcare Research and Quality (AHRQ) will hold a Special Emphasis Panel (SEP) meeting on January 10, 2025, focused on implementing and evaluating patient-centered clinical decision support strategies in real-world settings. This meeting, which will review grant applications, is closed to the public because it may involve confidential information. The discussions could involve trade secrets or private information that cannot be shared publicly to avoid privacy violations. The meeting will take place via video review at their location in Rockville, Maryland.

The Center for Scientific Review of the National Institutes of Health is holding several closed meetings to review and evaluate grant applications. These meetings are scheduled from April 23 to May 1, 2025, and will cover topics like neurodegenerative disorders, environmental determinants of diseases, innate immunity, and bacterial virulence. Due to the sensitive nature of the discussions, which may include confidential information or personal details, the meetings will be closed to the public. All meetings will be conducted virtually.