Department of Health and Human Services February 8, 2007 – Federal Register Recent Federal Regulation Documents
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Guidance for Industry on User Fee Waivers for Fixed Dose Combination and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This guidance describes the circumstances under which user fees will not be assessed for certain applications for fixed dose combination (FDC) and co-packaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance also describes some circumstances under which most of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver.
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening to February 26, 2007, the comment period for the proposed rule published in the Federal Register of August 29, 2006 (71 FR 51276). The proposed rule would amend the agency's current regulations governing establishment registration and drug listing. The initial comment period was extended (71 FR 63726, October 31, 2006) until January 26, 2007. We recently learned that, on January 26, 2007, the last day of the comment period, technical problems prevented some persons from submitting electronic comments. Therefore, FDA is reopening the comment period until February 26, 2007, to allow interested persons to submit comments for this rulemaking.
Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin and Betamethasone Spray
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for topical use of a gentamicin sulfate and betamethasone valerate topical spray on dogs for the treatment of infected superficial lesions.
Program Exclusions: Correction
The HHS Office of Inspector General Published a document in the Federal Register of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions.
Prospective Grant of Co-Exclusive License
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a limited field of use, exclusive license in China, and a co-exclusive worldwide (excluding China) license to practice the invention embodied in the patent application referred to below to Ringpu (Baoding) Biologics and Pharmaceuticals Co. LTD., having a place of business in Baoding City, Hebel Province, PR China. CDC intends to grant rights to practice this invention (in territories other than China) to no more than two other co-licensees. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application to be licensed is:
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