🧬NIH Meeting Notice
The Department of Health and Human Services announces a closed meeting for the Scientific & Technical Review Board on Biomedical & Behavioral Research Facilities. The board will evaluate grant applications which include confidential discussions on potential funding for research facilities, highlighting critical support for advancements in healthcare research.
Learn More💡NIH Announces Closed Meetings for Grant Application Review
The Department of Health and Human Services announces several upcoming closed meetings by the National Institutes of Health's Center for Scientific Review. These meetings will evaluate grant applications on various topics, ensuring that scientific advancements in health and medicine are reviewed with confidentiality for trade secrets and personal information.
Learn More📄Medicare & Medicaid Agency Information Collection Notice for Businesses
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Learn More🏥TRICARE Competitive Plans Demonstration
The Assistant Secretary of Defense for Health Affairs (ASD(HA)) issues this notice announcing the creation of a demonstration to offer additional opportunities for contractors of local, regional, and national plans to compete with managed care support contractors (MCSCs) under the TRICARE program and to evaluate impacts of competition in these designated markets on costs, outcomes and satisfaction. The Defense Health Agency (DHA) has awarded contracts to CareSource Military & Veterans (CSMV) in both the Atlanta, Georgia market and the Tampa, Florida market and intends to evaluate the impact of having two MCSCs (the Competitive Plans Demonstration (CPD) contractors and Humana Government Business (HGB), the current East region MCSC) providing services in these markets. Eligible beneficiaries will be provided with the opportunity to enroll in TRICARE Prime with CSMV in these markets. This demonstration will also help the DHA assess the efficacy of paying a TRICARE MCSC using a risk-adjusted, population-based capitation methodology for non-pharmacy health care and variable ongoing administrative costs and the efficacy of separately contracting for certain health care administrative tasks (e.g., eligibility, enrollment, and encounter data management functions) rather than including such requirements in the MCS contract.
Learn More💊Siemens Healthcare Diagnostics Applies for Controlled Substances Registration
Siemens Healthcare Diagnostics, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Issues Priority Review Voucher for EBANGA Medical Countermeasure
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EBANGA (ansuvimab-zykl) for injection, approved on December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher.
Learn More🏭FDA Announces QMM Assessment Protocol Evaluation Program for Drug Manufacturers
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.
Learn More⚖️DEA Revocation Decision Impacting De Novo Services, LLC
The Drug Enforcement Administration (DEA) has issued an order revoking the registration of De Novo Services, LLC due to substantial violations in managing controlled substances and maintaining proper recordkeeping. The decision underscores the stringent compliance requirements enforced by federal regulations to protect public health and safety, highlighting the consequences of non-adherence.
Learn More⚖️DEA Decision on Svetlana Burtman
The Department of Justice's ruling on Svetlana Burtman highlights numerous violations of the Controlled Substances Act, including operating an unregistered practice and failing to maintain adequate records. This decision underscores the rigorous compliance requirements for healthcare providers regarding controlled substances. The ramifications may extend beyond individual practitioners, influencing broader regulatory practices in the healthcare industry.
Learn More🏥Notice of Meeting for National Advisory Council on Nursing Research
The National Advisory Council for Nursing Research will hold a virtual meeting open to the public. The agenda includes discussions and reviews of grant applications relevant to nursing research, providing an opportunity for interested individuals to engage and submit comments on the council's work. Special accommodations will be available for attendees needing assistance.
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