Department of Health and Human Services March 23, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TEGSEDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is proposing to collect data for a new Operation Allies Welcome (OAW) Afghan Supplement Survey.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECELL AUTOLOGOUS CELL HARVESTING DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological device.

The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) about a potential Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey to assess patients' prenatal care and childbirth care experiences in ambulatory and inpatient care settings. Currently, no CAHPS instrument is available that is specifically designed to measure prenatal and childbirth care from the patient's perspective in these settings. Accordingly, this RFI seeks comments regarding methodologically sound approaches to assessing prenatal and childbirth care experiences in healthcare settings about topics such as communication with providers, respect, access to services, and patients' perceptions of bias in receiving care. This RFI also seeks comments about any (1) existing patient experience surveys or survey items that might be incorporated into public domain CAHPS ambulatory and inpatient prenatal and childbirth experience surveys; and, (2) special considerations or concerns associated with the collection of such information. This RFI will help inform the development of scientifically sound surveys to potentially measure the experience of patients receiving prenatal and childbirth care.

The Food and Drug Administration (FDA, Agency, or we) is announcing the establishment of a docket to solicit comments on factors that generally should be considered by the Secretary of Health and Human Services (Secretary) when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to aid in implementation and management of the strategies.