1 Analyses of this federal-register by attorneys

  1. Health Care Week in Review: CMMI Announces Three New Models, President Biden Issues Executive Order

    Alston & BirdRobert StoneFebruary 20, 2023

    nts (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023- 2027 (GDUFA III commitment letter). This draft guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter.On February 17, 2023, FDA issued a withdrawal of guidance entitled, Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance. FDA is withdrawing this guidance because the compliance policy guide (CPG) identified in this notice contains policies that have been superseded by a subsequent FDA action. On January 20, 2023, FDA issued a final rule entitled, Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products (88 FR 3638). The final rule repealed 21 CFR 1050.10, which includes performance standards for ultrasonic therapy products. Therefore, the policies in CPG Sec. 397.100 are no longer applicable, and this CPG is being withdrawn.Event NoticesFebruary 27, 2023: The National Institutes of Health (NIH) announced a public meeting of the Frederick National Laboratory Advisory Committee (FNLAC). The meeting agenda will include a discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research (FNLCR).March 16, 2023: AHRQ announced a public meeting hosted by the AHRQ Center for Quality Improvement and Patient Safety (CQuIPS). The meeting is being held to discuss implementation of sets of standardized definitions and formats (Common Formats) with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those ent