Department of Health and Human Services October 20, 2020 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention, within the Department of Health and Human Services, announces the opening of a public docket to obtain public comment on proposed changes in assisted reproductive technology (ART) data validation selection process; data validation approach; and data discrepancy reporting.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Keith Komar 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. Komar was convicted of one felony count under Federal law for mail fraud. The factual basis supporting Mr. Komar's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Komar 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 30 days after receipt of the notice (July 22, 2020), Mr. Komar had not responded. Mr. Komar's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.