Department of Health and Human Services April 12, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Radiation Sterilization Master File Pilot Program (``Radiation Pilot Program''). The Radiation Pilot Program is voluntary and intends to allow companies that terminally sterilize single-use medical devices (``sterilization providers'') using gamma radiation or ethylene oxide (EO) to submit Master File(s) when making certain changes to sterilization sites, methods, or processes under the specific conditions outlined in this notice. Under this voluntary pilot program, manufacturers of class III devices subject to premarket approval (``PMA holders'') who have been granted a right of reference by a sterilization provider may, upon notification from FDA that a manufacturer may do so, include references to Master File(s) accepted into the Radiation Pilot Program in postapproval reports describing the particular changes noted above affecting the sterilization sites, methods, or processes of their class III devices, in lieu of submitting premarket approval application (PMA) supplements for such changes. By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices and, through evaluation of data from pilot participants, provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts and facilitate supply chain resiliency.
Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.
A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``A Risk- Based Approach to Monitoring of Clinical InvestigationsQuestions and Answers.'' This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled ``Oversight of Clinical InvestigationsA Risk-Based Approach to Monitoring'' (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled ``A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,'' issued on March 15, 2019.
Proposed Collection; 60-Day Comment Request; Specimen Resource Locator (National Cancer Institute)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling Requirements
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection activity associated with statutory and regulatory food labeling requirements.
Olga L. Torres: Final Debarment Order
The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Olga L. Torres from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Torres was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Ms. Torres was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of January 20, 2023 (30 days after receipt of the notice), Ms. Torres had not responded. Ms. Torres' failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for attending in person and required for viewing the webcast and presenting oral statements. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ iccvamforum-2023.
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