Department of Health and Human Services September 14, 2010 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors that appeared in the notice with comment period published in the Federal Register on July 22, 2010 entitled, ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2011.''

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2010 (FY10) to the World Health Organization (WHO). One of the primary goals of the WHO is to provide for timely collaboration on multinational cooperative activities.

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 of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 61/241,620 entitled ``Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0- US-01], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/ 0-US-01], U.S. Patent Application 60/160,071 entitled ``Immunoconjugates Having High Binding Affinity'' [HHS Ref. E-139-1999/ 0-US-01], U.S. Patent Application 60/067,175 entitled ``Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and Methods for Their Use'' [HHS Ref. E-021- 1998/0-US-01], U.S. Patent Application 60/010,166 entitled ``Molecular Cloning of Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref. E-002-1996/ 0-US-01], PCT Application PCT/US97/00224 entitled ``Mesothelin Antigen and Methods and Kits for Targeting It'' [HHS Ref. E-002-1996/1-PCT-01], U.S. Patent 5,747,654 entitled ``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' [HHS Ref. E-163- 1993/0-US-01], PCT application PCT/US96/16327 entitled ``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' [HHS Ref. E-163- 1993/2-PCT-01], U.S. Patent Application 07/596,291 entitled ``A Monoclonal Antibody'' [HHS reference E-195-1990/0-US-01], and all continuing applications and foreign counterparts, to Morphotek, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent 6, 984, 517, entitled ``AAV5 and Uses Thereof,'' U.S. Patent 7, 479, 554, entitled ``AAV5 Nucleic Acids'' and PCT Application Serial No. PCT/US99/11958 and foreign equivalents thereof, entitled ``AAV5 and Uses Thereof'' [HHS Ref. No. E-127-1998/0]; and U.S. Patent 6, 855, 314 entitled ``AAV5 Vector for Transducing Brain Cells and Lung Cells'' [HHS Ref. No. E-072-2000/0] to Amsterdam Molecular Therapeutics, which is located in Amsterdam, The Netherlands. The Government of the United States of America has the right to license these patent rights. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the development and sale of AAV5 based therapeutic products to be delivered to the brain, eyes and liver for treatment of diseases originated from these organs, as claimed in the Licensed Patent Rights.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing that North American Bioproducts Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of penicillin G procaine as an antimicrobial processing aid in fuel- ethanol fermentations with respect to its consequent presence in by- product distiller grains used as an animal feed or feed ingredient.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of four new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment.'' The purpose of this guidance is to assist sponsors in all phases of development of direct-acting antiviral agents (DAAs), defined as agents that interfere with specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of treatments for chronic hepatitis C (CHC), including in patients with compensated and decompensated cirrhosis and those co-infected with human immunodeficiency virus (HIV). The guidance also addresses pre-approval access in the form of treatment investigational new drug applications (INDs) and intermediate-sized safety protocols.