Shu Bei Yuan: 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 Shu Bei Yuan for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Yuan was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Yuan was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 31, 2012 (30 days after receipt of the notice), Ms. Yuan had not responded. Ms. Yuan's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Medicare Program; Part B Inpatient Billing in Hospitals
The proposed rule would revise Medicare Part B billing policies when a Part A claim for an hospital inpatient admission is denied as not medically reasonable and necessary.
Medicare Program; Medicare Hospital Insurance (Part A) and Medicare Supplementary Medical Insurance (Part B)
This notice announces a CMS Ruling that establishes a policy that revises the current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary. This revised policy is intended as an interim measure until CMS can finalize a policy to address the issues raised by the Administrative Law Judge and Medicare Appeals Council decisions going forward. To that end, elsewhere in this issue of the Federal Register, we published a proposed rule entitled, ``Medicare Program; Part B Inpatient Billing in Hospitals,'' to propose a permanent policy that would apply on a prospective basis.
International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals; Request for Comments
The Food and Drug Administration (FDA or the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2- year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2-year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospective evaluation period intended to test this new approach, and on the proposed weight-of-evidence factors for carcinogenicity assessment.
Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams
The Food and Drug Administration (FDA) is withdrawing approval of Bupropion Hydrochloride (HCl) Extended-Release Tablets, 300 Milligrams (mg) (Bupropion HCl Extended-Release Tablets 300 mg), under Abbreviated New Drug Application (ANDA) 77-415, held by Impax Laboratories, Inc. (Impax), 30831 Huntwood Ave., Hayward, CA 94544, and marketed under the name BUDEPRION XL. Impax has voluntarily requested that approval for this product be withdrawn and waived its opportunity for a hearing.
Center for Drug Evaluation and Research Medical Policy Council; Request for Comments
The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion PumpPremarket Notification [510(k)] Submissions.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 submission of rotational plans for health warning label statements for smokeless tobacco products.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Start-Up Option Exclusive License: The Development of Liposomal Therapeutic Agents for the Treatment of Human Epithelial Cancers and Liposarcomas
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to ZoneOne Pharma, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent (and all foreign counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [HHS Ref. E-050-2000/0-US- 15]. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to: