March 13, 2013 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Lysando AG of Triesenberg, Liechtenstein, an exclusive license to U.S. Patent Application Serial No. 12/470,321, ``LAMBDASA2 ENDOLYSIN TRUNCATION'', filed on May 21, 2009; U.S. Patent Application Serial No. 12/874,138, ``BACTERIOPHAGE LYTIC ENZYMES AS ALTERNATIVE ANTIMICROBIALS'', filed on September 1, 2010; U.S. Patent Application Serial No. 12/460,812, ``TRIPLE ACTING ANTIMICROBIALS THAT ARE REFRACTORY TO RESISTANCE DEVELOPMENT'', filed on July 24, 2009; and U.S. Patent Application Serial No. 12/784,675, ``FUSION OF PEPTIDOGLYCAN HYDROLASE ENZYMES TO A PROTEIN TRANSDUCTION DOMAIN ALLOWS ERADICATION OF BOTH EXTRACELLULAR AND INTRACELLULAR GRAM POSITIVE'', filed on July 24, 2009.

This document grants in full the Jaguar Land Rover North America LLC's, (Jaguar) petition for an exemption of the F-Type vehicle line in accordance with 49 CFR Part 543, Exemption from the Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the Theft Prevention Standard (49 CFR Part 541).

Notice is hereby given that Daniel P. Costa, Ph.D., Department of Biology and Institute of Marine Sciences, University of California, Santa Cruz, CA 95064, has applied in due form for a permit to conduct research on California sea lions (Zalophus californianus) in California, Oregon and Washington.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to OMB for review and comments. A Federal Register notice (77 FR 11621) with a 60- day comment period soliciting comments on the proposed information collection for the agency's new consumer Vehicle-child restraint system (CRS) Fit program and consolidation of existing collection of vehicle safety information (OMB Control Number 2127-0629) was published on February 27, 2012. The February 2012 ``Request for comments'' notice described a new collection of information for which NHTSA intend to seek OMB approval concerning recommendations from vehicle manufacturers regarding child restraint systems (CRSs) that fit in their individual vehicles. Furthermore, NHTSA planned to combine the new information collection with an existing collection for obtaining vehicle information for consumer information purposes. The agency received comments from the public on the new and existing collection of information. However, since the agency has not published its final decision on the new consumer information program, it is not able at this time to address comments received from the public regarding the new provisions for the collection of information on vehicle-CRS matchups from vehicle manufacturers. Thus, this ``Correction'' notice now focuses on renewing the existing collection of vehicle safety information and only addresses comments received from that information collection. Comments pertaining to the new Vehicle-CRS Fit Program will be addressed at a later time in a new submission, when the agency publishes its final decision on the new program.

The FAA is issuing this notice to advise the public of the fourth meeting of the RTCA Special Committee 227, Standards of Navigation Performance.

FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 5 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to or greater than the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.

This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Reference: AP087073XX. Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S. manufactured commercial aircraft to the Philippines. Brief non-proprietary description of the anticipated use of the items being exported: To be used for long-haul passenger air service between the Philippines and destinations in Asia, Canada, and other routes. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties: Principal Supplier: The Boeing Company. Obligor: Philippine Airlines, Inc. Guarantor(s): N/A. Description of Items Being Exported: Boeing 777 aircraft. Information On Decision: Information on the final decision for this transaction will be available in the ``Summary Minutes of Meetings of Board of Directors'' on https://www.exim.gov/newsandevents/ boardmeetings/board/ Confidential information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.

FMCSA announces receipt of applications from 19 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through June 30, 2013. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.

The Food and Drug Administration (FDA or ``we'') is reopening the comment period for a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm'' (the draft RA) that we made available for public comment in the Federal Register of January 16, 2013. We are reopening the comment period to update comments and to receive any new information.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes presentations from key FDA officials and industry experts with small group breakout sessions. The conference is intended for companies of all sizes and employees at all levels. Date and Time: The public conference will be held on May 1, 2013, from 8:30 a.m. to 5 p.m.; May 2, 2013, from 8:30 a.m. to 5 p.m.; and May 3, 2013, from 8:30 a.m. to 1 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Gina Brackett, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, Fax: 513-679-2771, Gina.Brackett@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, and lunches for the 3 days of the conference. Early registration ends March 13, 2013. Standard registration ends April 9, 2013. There will be onsite registration. The cost of registration is as follows:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.'' This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets. This guidance does not address specific finished-product release testing, where additional requirements may apply to scored tablets. This guidance does not describe the medical practice conditions under which tablet splitting is considered or recommended.

Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, notice is hereby given that a meeting of the National Council on the Arts will be held at the Nancy Hanks Center, 1100 Pennsylvania Avenue NW., Washington, DC 20506. Agenda times are approximate.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.

The Coast Guard has issued a temporary deviation from the operating regulation that governs the Tower Drawbridge across the Sacramento River, mile 59.0, at Sacramento, CA. The deviation is necessary to allow the community to participate in the First Annual ``Biggest Loser'' 5K walk and run event. This deviation allows the bridge to remain in the closed-to-navigation position during the event.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Broadway Bridge across the Willamette River, mile 11.7, at Portland, OR. This deviation is necessary to accommodate the Race for the Roses and the Bridge to Brews Run & Walk events. This deviation allows the bridge to remain in the closed position to allow for the safe movement of event participants.