April 12, 2010 – Federal Register Recent Federal Regulation Documents

We propose to adopt a new airworthiness directive (AD) for certain Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747- 200F, 747-300, 747-400, 747-400F, 747SR, and 747SP series airplanes. This proposed AD would require reworking or replacing certain duct assemblies in the environmental control system (ECS). This proposed AD results from reports of duct assemblies in the ECS with burned Boeing Material Specification (BMS) 8-39 polyurethane foam insulation. This proposed AD also results from a report from the airplane manufacturer that airplanes were assembled with duct assemblies in the ECS wrapped with BMS 8-39 polyurethane foam insulation, a material of which the fire retardant properties deteriorate with age. We are proposing this AD to prevent a potential electrical arc from igniting the BMS 8-39 polyurethane foam insulation on the duct assemblies of the ECS, which could propagate a small fire and lead to a larger fire that might spread throughout the airplane through the ECS.

In accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(I)(i), announcement is made of the intent to grant an exclusive, royalty- bearing, revocable license to U.S. Patent application 12/421,124 filed on April 9, 2009, entitled ``System and Method for the Deconvolution of Mixed DNA Profiles Using a Proportionately Shared Allele Approach'' to Niche Vision Forensics, LLC, with its principal place of business at 526 South Main Street Suite 714 G, Akron, OH 44311.

In accordance with the requirements of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) described below is being forwarded to the Office of Management and Budget (OMB) for approval for an extension of a currently approved information collection related to the use of and satisfaction with the nation's transportation system. The ICR describes the nature of the information collection and its expected burden. The Federal Register notice with a 60-day comment period soliciting comments on the following collection of information was published on February 2, 2010 (75 FR 5370) and the comment period ended on April 5, 2010. The 60-day notice produced no comments.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors.'' The purpose of the public workshop is to initiate constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care professionals, and others from the general public about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop proprietary names to reduce medication errors. The input from this workshop will be used to develop draft guidance for industry on practices for naming, labeling, and packaging of drugs and biologics to reduce the potential for medication errors. FDA is also opening a public docket to receive comments on this topic to assist in the development of draft guidance.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (207) entitled ``Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods,'' (VICH GL48). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill this recommendation.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (206) entitled ``Draft Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals,'' VICH GL47. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary food animal drugs in laboratory animals used for toxicological testing for the purpose of comparison to the residues of the drugs in food animals.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 10: Polyacrylamide Gel Electrophoresis General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Polyacrylamide Gel Electrophoresis General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. In the Federal Register of February 21, 2008 (73 FR 9575), FDA made available a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''

These special conditions are issued for the Boeing 737-600/- 700/-700C/-800/-900 and -900ER Series airplanes (hereafter referred to as ``Boeing 737NG''). These airplanes, as modified by the Boeing Company, will have a novel or unusual design feature associated with the installation of rechargeable lithium batteries and rechargeable lithium-battery systems. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Coast Guard proposes to change the Regulated Navigation Area (RNA) covering the Umpqua River Bar in Oregon so that it does not include those waters between ``Navigation Aid Number 8'' and ``Navigation Aid Number 6'' on the Umpqua River. The change has been requested by a number of individuals and organizations that believe they are able to safely use those waters when the bar is restricted or closed.

Notice is hereby given that the U.S. International Trade Commission has determined to affirm an initial determination (``ID'') (Order No. 26) granting a joint motion to terminate the investigation as to respondent Ethical Naturals, Inc. from the investigation based upon a settlement agreement. The investigation is terminated.

The Coast Guard proposes to establish temporary safety and security zones around each Tall Ship visiting the Great Lakes during the Tall Ships Challenge 2010 race series. These safety and security zones will provide for the regulation of vessel traffic in the vicinity of each Tall Ship in the navigable waters of the United States. The Coast Guard is taking this action to safeguard participants and spectators from the hazards associated with the limited maneuverability of these Tall Ships and to ensure public safety during Tall Ships events.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).