Department of Health and Human Services February 13, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Establishment of the Coronavirus and Other Respiratory Viruses Division
CDC has modified its structure. This notice announces the establishment of the Coronavirus and other Respiratory Viruses Division and other organizational components within the National Center for Immunization and Respiratory Diseases (NCIRD), Deputy Director for Infectious Diseases (DDID), CDC.
CDC Moving Forward Reorganization
The Centers for Disease Control and Prevention (CDC), an agency within the Department of Health and Human Services (HHS), announces a reorganization. The CDC Director is modernizing the agency's organizational structure to better position the agency to respond to and tackle future public health threats.
Determination That ARISTOSPAN (Triamcinolone Hexacetonide) Injectable Suspension, 20 Milligrams/Milliliter and 5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ARISTOSPAN (triamcinolone hexacetonide) injectable suspension, 20 milligrams (mg)/milliliter (mL) and 5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for triamcinolone hexacetonide injectable suspension, 20 mg/mL and 5 mg/mL, if all other legal and regulatory requirements are met.
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.'' This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and/or developmental evaluations could be useful in supporting a determination of safety of a regulated product for use in neonates, and which domains of assessment may be most pertinent. Although short-term safety evaluations may be acceptable for adults or other populations, such short-term evaluations may not identify important adverse events in the neonatal population, as latent effects may follow early-life exposures and drug treatment during the neonatal period coincides with a time of critical growth and physiologic development. Consideration of these potential long-term neurologic, sensory, and development effects in the neonatal population early in a drug development program will help ensure a safer product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees
The Food and Drug Administration (FDA, the Agency, or we) 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 the information collection associated with certain FDA advisory committee activities.
Inflation Reduction Act (IRA) Initial Program Guidance; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' initial guidance for the Medicare Part B and Part D Prescription Drug Inflation Rebate Program for the implementation of the Inflation Reduction Act. CMS will be releasing additional Inflation Reduction Act-related guidance; all can be viewed on the dedicated Inflation Reduction Act section of the CMS website at https://www.cms.gov/inflation-reduction- act-and-medicare/.
Healthcare Infection Control Practices Advisory Committee; Notice of Charter Renewal
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the renewal of the charter of the Healthcare Infection Control Practices Advisory Committee (HICPAC).
Board of Scientific Counselors, National Center for Health Statistics; Notice of Charter Renewal
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS).
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person listed in the addresses section below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Medications for the Treatment of Opioid Use Disorder: Removal of the DATA-2000 Waiver Requirements
The Department of Health and Human Services (HHS or ``the Department'') is issuing this supplemental notice of proposed rulemaking (SNPRM) to solicit public comment on its proposal to remove provisions authorized under the Controlled Substances Act (CSA), as amended by the Drug Addiction Treatment Act of 2000 (DATA-2000). These changes are as a result of amendments made in the Consolidated Appropriations Act, 2023, which was enacted on December 29, 2022. Among other things, section 1262(a)(1) of this Act amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain schedule III-V medications for the treatment of opioid use disorder (OUD).
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
