Department of Health and Human Services July 29, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Medicare and Medicaid Programs; Application From DNV GL Healthcare USA Inc. for Initial CMS Approval of Its Psychiatric Hospital Accreditation Program
This final notice announces our decision to approve DNV GL Healthcare USA Inc. (DNV GL) for initial recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Request for Information on Innovative Programs To Reconnect Youth to Education and Employment and Promote Self-Sufficiency
HHS issues this Request for Information (RFI) in order to seek information about programs that provide services to help young people, ages 16 to 24, advance on education and employment pathways. This project is focused on the population of young people who are out of work and/or out of school, particularly those from lower income families and communities, sometimes called disconnected or opportunity youth. The information gathered will result in a public compendium that profiles selected programs operating in this area, particularly innovative programs.
Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.'' This final guidance provides FDA's regulatory approach for device products with multiple functions including at least one device function and includes such device products that are part of combination products, in accordance with the 21st Century Cures Act (Cures Act).
Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.'' This guidance describes FDA's current recommendations about endotoxin limits in certain investigational oncology drugs and biological products. This guidance looks at a risk- based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases.
Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
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