The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Willis Reed 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 Mr. Reed was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reed was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 10, 2024 (30 days after receipt of the notice), Mr. Reed has not responded. Mr. Reed’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA or Agency) 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 reporting, recordkeeping, and third-party disclosure burden associated with the veterinary feed directive regulations.

​Federal Register Documents from Food and Drug Administration

 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 reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA).

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making these changes to allow FDA to respond better to new information on the safety and use of food contact substances (FCSs), as well as manufacturers’ business decisions, and also improve the efficiency of the premarket notification program.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for two chapters of a multichapter draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry,” which were announced in the Federal Register of September 27, 2023. The relevant draft chapters are entitled “Chapter 11– Food Allergen Program” and “Chapter 16–Acidified Foods.” We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Martin Valdes, M.D., 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. Valdes was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Dr. Valdes was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of January 7, 2023 (30 days after receipt of the notice), Dr. Valdes had not responded. Dr. Valdes’s failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This proposal follows a court decision vacating a prior ban and amendment to the Federal Food, Drug, and Cosmetic Act clarifying our authority to ban a device for one or more intended uses. This action, if finalized, will mean ESDs for SIB and AB are adulterated and not legally marketed.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

​Federal Register Documents from Food and Drug Administration

 The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Phillip Leonowens 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. Leonowens was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Leonowens’ conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Leonowens 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 December 31, 2023 (30 days after receipt of the notice), Mr. Leonowens had not responded. Mr. Leonowens’s failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

​Federal Register Documents from Food and Drug Administration