Department of Health and Human Services February 6, 2024 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Request. 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medicare and Medicaid Programs; Application by DNV Healthcare USA Inc. (DNV) for Continued CMS Approval of Its Psychiatric Hospital Accreditation Program
This proposed notice acknowledges the receipt of a deeming application from DNV Healthcare USA Inc. (DNV) for continued Centers for Medicare & Medicaid Services (CMS) approval of its psychiatric hospital accreditation program. The statute requires that within 60 days of receipt of an organization's complete application, CMS must publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting-FSYX Ocular Pressure Adjusting Pump System
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Ophthalmic 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Pediatric Mental Health Care Access Program National Impact Study
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUAs) (the Authorizations) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.'' This guidance addresses the process through which registrants of drug establishments should submit reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title published on November 1, 2021. To allow for the transition of technical updates to the NextGen Portal, FDA will delay implementation of the final guidance until February 26, 2024. The draft guidance will remain available until that date.
Ryan White HIV/AIDS Program Part C Early Intervention Services
HRSA expects the availability of additional funds for the RWHAP Part C Early Intervention Services (EIS) Program due to relinquishments, reductions, closeouts, and unawarded fiscal year (FY) 2023 new service area competition funds in the estimated amount of $4.2 million and intends to distribute these supplemental funds across the current cohort of RWHAP Part C EIS recipients. The amount is subject to change depending on the availability of additional funds.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the 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 entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.
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