Department of Health and Human Services February 27, 2023 – Federal Register Recent Federal Regulation Documents

This notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Shaun Thaxter (Thaxter) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Thaxter for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Thaxter was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Thaxter's debarment, FDA has considered the applicable factors listed in the FD&C Act. Thaxter has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Wojciech Lesniak for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lesniak engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with his personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Mr. Lesniak was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of November 21, 2022 (30 days after receipt of the notice), Mr. Lesniak had not responded. Mr. Lesniak's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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.

Notice is provided that the Director of the Indian Health Service (IHS) has approved the rates for inpatient and outpatient medical care provided by the IHS facilities for Calendar Year 2023.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.'' This guidance is intended to provide recommendations to sponsors developing drugs intended to treat neovascular age-related macular degeneration focusing on eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and to foster greater efficiency in development programs.

The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Dr. Timothy Baxter (Dr. Baxter) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Baxter for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Baxter was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Dr. Baxter's debarment, FDA has considered the applicable factors listed in the FD&C Act. Dr. Baxter has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.

The Food and Drug Administration (FDA, 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 provisions of our regulations requiring that the Agency receive prior notice before food is imported or offered for import into the United States.