Department of Health and Human Services December 19, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MEPHYTON (phytonadione) tablets, 5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of calcium formate as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. This action is in response to a food additive petition filed by LANXESS Corp.
Jeremy Walenty: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jeremy Walenty 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. Walenty was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Walenty's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Walenty 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 October 15, 2023 (30 days after receipt of the notice), Mr. Walenty had not responded. Mr. Walenty's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
James Funaro: 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 James Funaro 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. Funaro was convicted of one felony count under Federal law for conspiracy to launder money. The factual basis supporting Mr. Funaro's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Funaro 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 October 11, 2023 (30 days after receipt of the notice), Mr. Funaro had not responded. Mr. Funaro's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight 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.
Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' FDA is issuing this draft guidance to clarify how FDA evaluates real- world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance proposes expanded recommendations to the 2017 guidance entitled ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' This draft guidance is not final nor is it for implementation at this time.
Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Registration and Listing of Cosmetic Product Facilities and Products.'' The guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This guidance also includes a new draft section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions. Aside from that section, this guidance finalizes the draft guidance that was published on August 8, 2023.
Reimbursement Rates for Calendar Year 2024
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 2024.
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.
Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 11, 2009. The document announced the withdrawal of approval of 103 new drug applications and 35 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of March 13, 2009. The document erroneously included ANDA 75-108. The correct ANDA is ANDA 76-108 for Amiodarone hydrochloride (HCl) injection, 50 milligrams (mg)/milliliter (mL), held by Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046. This document corrects that error.
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