September 15, 2014 – Federal Register Recent Federal Regulation Documents

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/844,027 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2006 [HHS Ref. No. E- 160-2006/0-US-01], PCT Application No. PCT/US2007/078233 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E-160-2006/0-PCT-02], European Patent Application No. 7842310.0 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed September 12, 2007 [HHS Ref. No. E- 160-2006/0-EP-03], and U.S. Patent Application No. 12/441,029 entitled, ``Azonafide derived tumor and cancer targeting compounds,'' filed March 12, 2009 now US Patent No. 8,008,316 issued August 30, 2011 [HHS Ref. No. E-160-2006/0-US-04], and all related continuing and foreign patents/patent applications for the technology family, to Oncolinx, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the development and use of the licensed patent rights as a component of an antibody-drug conjugate for the treatment of human cancers. Upon expiration or termination of the exclusive evaluation option license, Oncolinx will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no broader territory than granted in the exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to accommodate the Architect-Engineer Contract Administration Support System (ACASS) and Construction Contractor Appraisal Support System (CCASS) modules within the Contractor Performance Assessment Reporting System (CPARS) database.

The OCC, 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 a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning its information collection titled, ``Loans in Areas Having Special Flood Hazards.'' The OCC is also giving notice that it has sent the collection to OMB for review.

The Food and Drug Administration (FDA) is withdrawing the proposed rule the Agency issued in the Federal Register of October 17, 2011. In that document, FDA proposed to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls). In response to the requirements under the Food and Drug Administration Safety and Innovation Act (FDASIA) and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed administrative order to reclassify EPPGs.

The Food and Drug Administration (FDA) is proposing in this administrative order to reclassify the external pacemaker pulse generator (EPPG) devices, a preamendments class III device into class II (special controls), and to amend the device identification and reclassify the pacing system analyzers (PSAs) into class II (special controls). Specifically, single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are postamendments class III devices, are proposed to be reclassified to class II devices. FDA is proposing this reclassification based on new information pertaining to the device. This proposed action would implement certain statutory requirements.

These special conditions are issued for the AgustaWestland Model AW189 helicopter. This model helicopter will have the novel or unusual design feature of a 30-minute all engines operating (AEO) power rating, generally intended to be used for hovering at increased power for search and rescue missions. 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.

We are adopting a new airworthiness directive (AD) for all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This AD was prompted by reports of a manufacturing defect in the charge indicator on fire extinguisher bottles. This AD requires repetitive weighing of fire extinguisher bottles having a certain part number, and eventual replacement of those bottles to terminate the repetitive weighing. We are issuing this AD to detect and correct a dormant failure in the fire suppression system, which could result in the inability to put out a fire in an engine, auxiliary power unit, or rear compartment.

We are revising an airworthiness directive (AD) 2013-22-14 for any DG Flugzeugbau GmbH Model DG-1000T glider equipped with a Solo Kleinmotoren Model 2350 C engine. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as engine shaft failure and consequent propeller detachment. We are issuing this AD to require actions to address the unsafe condition on these products.

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Wyoming. The revision affects Wyoming's Air Quality Standards and Regulations (WAQSR) regarding ambient standards for nitrogen oxides (NOX) and for ozone. This action is being taken under section 110 of the Clean Air Act (CAA).

In accordance with the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank Act'') and to enhance oversight, the Securities and Exchange Commission (``Commission'') is: adopting amendments to existing rules and new rules that apply to credit rating agencies registered with the Commission as nationally recognized statistical rating organizations (``NRSROs''); adopting a new rule and form that apply to providers of third-party due diligence services for asset-backed securities; and adopting amendments to existing rules and a new rule that implement a requirement added by the Dodd-Frank Act that issuers and underwriters of asset-backed securities make publicly available the findings and conclusions of any third-party due diligence report obtained by the issuer or underwriter. The Commission also is adopting certain technical amendments to existing rules.