Department of Health and Human Services November 29, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.'' The purpose of this draft guidance is to provide recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human insulin mix products, and recombinant insulin analog products that are intended for the treatment of patients with Type 1 or Type 2 diabetes mellitus.

The Food and Drug Administration (FDA or we) is announcing that the Zinpro Corp. (Zinpro) has amended their pending petition proposing that the food additive regulations be amended to provide for the safe use of chromium DL-methionine as a nutritional source of chromium in cattle feed. The amendment provides for a change in the feeding rate.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) 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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OZEMPIC 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 Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Tzvi Lexier for a period of 10 years from importing any drug into the United States. FDA bases this order on a finding that Mr. Lexier was convicted, as defined in the FD&C Act, of one felony count under Federal law for conspiracy to smuggle into and distribute within the United States misbranded drugs and one felony count under Federal law for unlicensed wholesale distribution of prescription drugs. The factual basis supporting both felony convictions, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lexier was given notice of the proposed debarment and, in accordance with the FD&C Act, was given an opportunity to request a hearing to show why he should not be debarred. As of August 2, 2019 (30 days after receipt of the notice), Mr. Lexier had not responded. Mr. Lexier's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.