Department of Health and Human Services September 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.

The Food and Drug Administration (FDA) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by title XI of the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsor of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee to be submitted to FDA with applications using a priority review voucher is determined each fiscal year (FY) based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the priority review fee rate for FY 2011.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health. Type of Information Collection Request: NEW. Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds . To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. Frequency of Response: 1 Response. Affected Public: Individuals. Type of Respondents: Science professionals (applicants, reviewers, Institutional Officials), adult science trainees, and the general public. The annual reporting burden is as follows: Quantitative surveys: Estimated Number of Respondents per Survey: 9,820; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.25; Estimated Total Annual Burden Hours Requested per Quantitative Survey: 2,455; Estimated Total Annual Burden Hours Requested for 10 Quantitative Surveys: 24,550. Qualitative surveys: Estimated Number of Respondents per Survey: 30; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 1.0; Estimated Total Annual Burden Hours Requested per Qualitative Survey: 30; Estimated Total Annual Burden Hours Requested for 4 Qualitative Surveys: 120. Based on an estimated 10 quantitative and 4 qualitative surveys per year: Estimated Total Combined Annual Hours of Burden Requested in Each of 3 years: 24,670. Estimated Total Combined Cost to Respondents: $728,326. Based on an estimated 10 quantitative and 4 qualitative surveys per year over 3 years: Estimated Total Hours of Burden to Respondents for 2011, 2012, and 2013 Combined: 74,010. Estimated Total Cost to Respondents for 2011, 2012, and 2013 Combined: $2,184,978. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.