Department of Health and Human Services January 4, 2022 – Federal Register Recent Federal Regulation Documents
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William Kulakevich: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring William Kulakevich 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. Kulakevich was convicted of one felony count under Federal law for conspiracy to commit offenses against the United States. The factual basis supporting Mr. Kulakevich's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Kulakevich 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 September 16, 2021 (30 days after receipt of the notice), Mr. Kulakevich had not responded. Mr. Kulakevich's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
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