August 26, 2011 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Conjugate Vaccines Against B. anthracis
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 (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-146-2004/0, Purcell et al., ``Monoclonal Antibodies That Neutralize Anthrax Protective Antigen (PA) Toxin'', U.S. Patent Application Number 60/ 639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/ 046/790, filed on December 21, 2005, and U.S. Patent Application Number 11/793,735, filed on December 8, 2009, (2) E-123-2007/0, Purcell et al., ``Monoclonal Antibodies that Neutralize B. anthracis Protective Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)'', U.S. Patent Application Number 60/903,022, filed on February 23, 2007, PCT Application Number PCT/US2008/054609, filed on February 21, 2008, and U.S. Patent Application Number 12/528,427, filed on August 24, 2009, and European Patent Application Number 08730415.0, filed on September 23, 2009, (3) E-125-2008/0, Purcell et al., ``Monoclonal Antibodies That React With the Capsule of Bacillus anthracis'', U.S. Patent Application Number 61/116,222, filed on November 19, 2008, PCT Application Number PCT/US2009/065198, filed on November 19, 2009, and U.S. Patent Application Number 13/130,044, filed on May 18, 2011, (4) E-343-2002/0, Schneerson et al., ``gammaPGA Conjugates for Eliciting Immune Responses Directed Against Bacillus anthracis and Other Bacilli'', U.S. Patent Application Number 60/476,598, filed on June 5, 2003, PCT Application Number PCT/US2004/17736, filed on June 4, 2004, U.S. Patent Application Number 10/559,825, filed December 2, 2005, now U.S. Patent Number 7,803,386, European Patent Application Number 04754360.8, filed June 4, 2004, Canadian Patent Application Number 2,528,067, filed June 4, 2004, and Australian Patent Application Number 2004252091, filed June 4, 2004, now Australian Patent Number 2004252091, and (5) E-040-2005/0, Schneerson et al., ``Methods for Preparing Immunogenic Conjugates'', U.S. Patent Application Number 11/ 005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736, PCT Application Number PCT/US2005/19678, filed June 3, 2005, European Patent Application Number 05758048.2, filed June 3, 2005, now European Patent Number 1765394 (rights were validated in Germany (Patent Number 602005015855), France (Patent Number 1765394), Great Britain (Patent Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent Application Number 200580018108.2, filed June 3, 2005, Australian Patent Application Number 2005249571, filed June 3, 2005, now Australian Patent Number 2005249571, Canadian Patent Application Number 2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/ 582,420, filed October 20, 2009, to Biologics Resources LLC, having a place of business in Boyds, Maryland, United States of America. The patent rights in these inventions have been assigned to the United States of America.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Protection of Voluntarily Submitted Information
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on June 21, 2011, vol. 76, no. 119, pages 36168-36169. One of the ways to have an information program designated as protected under Section 40123 is for an air carrier or other person to submit an application for an individual program. The FAA evaluates the application and either publishes a designation based on the application for public comment or denies the application.
Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Aircraft Registration
In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval for to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on June 21, 2011, vol. 76, no. 119, page 36167. The information collected is used by the FAA to register aircraft or hold an aircraft in trust. The information required to register and prove ownership of an aircraft is required by any person wishing to register an aircraft.
Proposed Information Collection; Comment Request; Alaska Commercial Operator's Annual Report (COAR)
The Department of Commerce, 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.
Rescinding the Notice of Intent for an Environmental Impact Statement (EIS): Hancock and Pearl River Counties, MS
This notice rescinds the Notice of Intent for preparing an Environmental Impact Statement (EIS) for proposed highway, State Route 603/43, to provide a connection between Interstate 10 south of Kiln and Interstate 59 in the City of Picayune, Hancock and Pearl River Counties, Mississippi. The original Notice of Intent for this EIS process was published in the Federal Register on October 26, 2009.
2-(Hydroxymethyl)-2-nitro-1,3-propanediol (Tris Nitro); Amendments To Terminate Uses for Certain Pesticide Registrations
This notice announces EPA's order for the amendments to terminate uses, voluntarily requested by the registrant and accepted by the Agency, of products containing the pesticide listed in Table 1, pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This cancellation order follows a June 8, 2011 Federal Register Notice of Receipt of Requests from the registrant listed in Table 1 to voluntarily amend to terminate uses of these product registrations. These are not the last products containing these pesticides registered for use in the United States. In the June 8, 2011 notice, EPA indicated that it would issue an order implementing the amendments to terminate uses, unless the Agency received substantive comments within the 30-day comment period that would merit its further review of these requests, or unless the registrant withdrew their requests within this period. The Agency did not receive any comments on the notice. Further, the registrant did not withdraw their requests. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested amendments to terminate uses. Any distribution, sale, or use of the products subject to this cancellation order is permitted only in accordance with the terms of this order, including any existing stocks provisions.
Oil and Natural Gas Sector: New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants Reviews
The EPA published in the Federal Register on August 23, 2011, the proposed rule, ``Oil and Natural Gas Sector: New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants Reviews.'' The EPA is announcing three public hearings to be held for the proposed rule.
Notice of Availability of the Supplement to the Draft Environmental Impact Statement for the Draft San Juan Land Management Plan, Colorado
In accordance with the National Environmental Policy Act of 1969, as amended, the Forest and Rangeland Renewable Resources Planning Act of 1974, as amended by the National Forest Management Act of 1976, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) and the U.S. Forest Service (USFS) have prepared a Supplement to the Draft Environmental Impact Statement (EIS) and the Draft Land Management Plan (LMP) for the San Juan Public Lands that was published on December 14, 2007, and by this notice, are announcing the opening of the comment period. The San Juan Public Lands Center (SJPLC) is the joint USFS/BLM Service First Office responsible for the management of BLM and USFS lands covered in the Draft LMP.
Notice of Availability of the Draft Resource Management Plan/Draft Environmental Impact Statement for the Lower Sonoran and Sonoran Desert National Monument, AZ
In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a Draft Resource Management Plan (RMP) and Draft Environmental Impact Statement (EIS) for the Lower Sonoran (LS) and Sonoran Desert National Monument (SDNM) Planning Area, and by this notice, is announcing the opening of a 90-day comment period.
Black Hills National Forest, SD; Thunder Basin National Grassland, WY; Teckla-Osage-Rapid City Transmission 230 kV Project
The Forest Service will prepare an environmental impact statement (EIS) on a proposal by Black Hills Power (BHP) to construct and operate a 230 kilovolt (kV) transmission line between the Teckla and Osage Substations in northeastern Wyoming to the Lange Substation in Rapid City, South Dakota. The Bureau of Land Management (BLM) will be a cooperating agency on this EIS. The Teckla-Osage-Rapid City Transmission 230 kV Project would be approximately 150 miles long. It would cross portions of the Black Hills National Forest and private lands in South Dakota and portions of the Thunder Basin National Grasslands, private lands, BLM lands, and state lands in Wyoming. The line would be constructed on wood or steel H-frame structures for most of its length with possibly some steel monopole structures in the Rapid City area. The structures would be 65 to75 feet tall and the line would require a right-of-way approximately 125 feet wide.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee; Cancellation of the September 21, 2011 Meeting
This notice announces the cancellation of the September 21, 2011 public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the July 22, 2011 Federal Register (76 FR 44011 through 44012). This notice also announces a public meeting on Wednesday, March 21, 2012. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding antivascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-November 9, 2011
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 9, 2011. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of electrocardiogram (ECG) based signal analysis technologies to detect myocardial ischemia or coronary artery disease. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Pure Magnesium From the People's Republic of China: Rescission of Antidumping Duty Administrative Review
On June 28, 2011, the U.S. Department of Commerce (``the Department'') published a notice of initiation of an administrative review of the antidumping duty order on pure magnesium from the People's Republic of China (``PRC'').\1\ The review covers one manufacturer/exporter of subject merchandise from the PRC, Tianjin Magnesium International Co., Ltd. (``TMI''). The period of review (``POR'') is May 1, 2010 through April 30, 2011. Following the receipt of a certification of no shipments from TMI, we notified all interested parties of the Department's intent to rescind this review and provided an opportunity to comment on the rescission.\2\ We received no comments. Therefore, we are rescinding this administrative review.
Funding and Fiscal Affairs, Loan Policies and Operations, and Funding Operations; Capital Adequacy Risk-Weighting Revisions: Alternatives to Credit Ratings
Farm Credit Administration (FCA or Agency) regulations on the capital adequacy of Farm Credit System (FCS or System) institutions include various references to and requirements of reliance on credit ratings of a security or money-market instrument. Section 939A of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank or DFA), enacted on July 21, 2010, requires Federal agencies to remove any reference to or requirement of reliance upon such credit ratings, and substitute in their place standards of creditworthiness that they deem appropriate for such regulations. The FCA seeks public comment on alternatives to the use of credit ratings in these regulations.
Airworthiness Directives; Airbus Model A330-200 and -300 Series Airplanes
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated 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: * * * * * The airworthiness limitations applicable to the Safe Life Airworthiness Limitation Items (SL ALI) are given in Airbus A330 ALS Part 1 and A340 ALS Part 1, which are approved by the European Aviation Safety Agency (EASA). The revision 05 of Airbus A340 ALS Part 1 introduces more restrictive maintenance requirements and/or airworthiness limitations. Failure to comply with this revision constitutes an unsafe condition. For A330 aeroplanes, this EASA AD retains the requirements of EASA AD 2010-0131, which it supersedes. For A340 aeroplanes, this EASA AD supersedes EASA AD 2009-0192, and requires the implementation of the new or more restrictive maintenance requirements and/or airworthiness limitations as specified in Airbus A340 ALS Part 1, revision 05.
Airworthiness Directives; Airbus Model A330-200 and -300 Series Airplanes
We are superseding an existing airworthiness directive (AD) that applies to the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated 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:
Airworthiness Directives; Saab AB, Saab Aerosystems Model SAAB 2000 Airplanes
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated 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:
Airworthiness Directives; The Boeing Company Model 737-600, -700, -700C, -800, and -900 Series Airplanes
We are adopting a new airworthiness directive (AD) for the products listed above. This AD requires installation of an automatic shutoff system for the center tank fuel boost pumps, and installation of a placard in the airplane flight deck if necessary. This AD also requires revisions to the Limitations and Normal Procedures sections of the airplane flight manual to advise the flightcrew of certain operating restrictions for airplanes equipped with an automated center tank fuel pump shutoff control. This AD further requires installation of a secondary control relay for the electrical control circuit of each of the two center tank fuel boost pumps. Additionally, this AD requires a revision to the maintenance program to incorporate Airworthiness Limitation (AWL) No. 28-AWL-23. This AD also provides an option of installation and maintenance of universal fault interrupters using a certain supplemental type certificate, which terminates certain requirements of this AD. This AD was prompted by fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent center tank fuel pump operation with continuous low pressure, which could lead to friction sparks or overheating in the fuel pump inlet that could create a potential ignition source inside the center fuel tank. These conditions, in combination with flammable fuel vapors, could result in a center fuel tank explosion and consequent loss of the airplane.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Endangered and Threatened Wildlife and Plants; Termination of the Southern Sea Otter Translocation Program
We, the U.S. Fish and Wildlife Service (Service), propose to remove the regulations that govern the southern sea otter (Enhydra lutris nereis) translocation program, including the establishment of an experimental population of southern sea otters, and all associated management actions. We are also proposing to amend the Authority citation for 50 CFR part 17 by removing the reference to Public Law 99- 625, the statute that authorized the Secretary to promulgate regulations establishing the southern sea otter translocation program. Removal of the regulations will terminate the program. We are proposing this action because we believe that the southern sea otter translocation program has failed to fulfill its purpose, as outlined in the southern sea otter translocation plan, and that our recovery and management goals for the species cannot be met by continuing the program. Our conclusion is based, in part, on an evaluation of the program against specific failure criteria established at the program's inception. This proposed action would terminate the designation of the experimental population of southern sea otters, abolish the southern sea otter translocation and management zones, and eliminate the current requirement to remove southern sea otters from San Nicolas Island and the management zone. This proposed rule would also eliminate future actions, required under the current regulations, to capture and relocate southern sea otters for the purpose of establishing an experimental population, and to remove southern sea otters in perpetuity from an ``otter-free'' management zone. As a result, it would allow southern sea otters to expand their range naturally into southern California waters. We have prepared a revised draft supplemental environmental impact statement (SEIS) and an initial regulatory flexibility analysis (IRFA) to accompany this proposed rule.
Migratory Bird Hunting; Proposed Frameworks for Late-Season Migratory Bird Hunting Regulations
The Fish and Wildlife Service (hereinafter Service or we) is proposing to establish the 2011-12 late-season hunting regulations for certain migratory game birds. We annually prescribe frameworks, or outer limits, for dates and times when hunting may occur and the number of birds that may be taken and possessed in late seasons. These frameworks are necessary to allow State selections of seasons and limits and to allow recreational harvest at levels compatible with population and habitat conditions.
Airworthiness Directives; Eurocopter France Model SA-365N and SA-365N1 Helicopters
This amendment adopts a new airworthiness directive (AD) for the specified Eurocopter France (Eurocopter) model helicopters. This action requires you to disconnect the high level fuel switches in the fuel tanks on the affected helicopters. In addition, for helicopters without a crossfeed between the fuel filler necks, you must install a placard on or near the center console fuel panel that specifies fuel transfer limitations. This amendment is prompted by a report that a high level fuel switch probe unit installed on a Model SA-365N helicopter in the rear (right-hand) auxiliary fuel tank group separated, causing damage to the insulation of the electrical wires which supply electrical power to the high level indicator light on the fuel control panel during a fuel transfer. This condition, if not corrected, could lead to exposure of the electrical wires, which could lead to a short circuit and activation of the indicator light without the high fuel level actually being reached. Additionally, a short circuit could become an ignition source inside the fuel tank, and result in a fuel tank explosion and subsequent loss of control of the helicopter.
Airworthiness Directives; Agusta S.p.A. Model A109A, A109A II, A109C, and A109K2 Helicopters
This amendment supersedes an existing emergency airworthiness directive (EAD) for the specified Agusta S.p.A. (Agusta) model helicopters. That EAD currently requires inspecting the main rotor scissor fitting assembly to determine if there are 2 washers installed under the head of each main rotor scissor fitting assembly fixing bolt (fixing bolt). If there are not 2 washers installed under the head of each fixing bolt, that EAD requires replacing each fixing bolt and installing 2 washers under the head of each fixing bolt. This superseding airworthiness directive (AD) is prompted by the determination that a wrong part number (P/N) for the main rotor scissor fitting assembly was listed in the EAD. This AD retains the requirements of the EAD and corrects a P/N for the main rotor scissor fitting assembly. The actions specified by this AD are intended to prevent a crack in a fixing bolt, failure of a fixing bolt, and subsequent loss of control of the helicopter.
Airworthiness Directives; Agusta S.p.A. Model A109A and A109AII Helicopters
This amendment adopts a new airworthiness directive (AD) for the specified Agusta S.p.A. (Agusta) helicopters with a certain tail rotor special hub plug (hub plug) installed. This action requires a one-time inspection to determine the tightening torque value of the hub plug, and depending on the inspection results, replacing certain parts or disassembling the tail rotor hub and blades assembly and inspecting for damage. If the tightening torque value is between 600 kgcm and 700 kgcm, the lock washer and o-ring must be replaced with airworthy parts, and no further action is required. If the tightening torque value is greater than 700 kgcm, the hub plug must be replaced with an airworthy part. Torque the new hub plug to the specified tightening torque between 600 and 700 kgcm. If the tightening torque value of the hub plug is less than 600 kgcm, the tail rotor hub and blades assembly must be disassembled and inspected for damage. If a part is found that is outside allowable damage tolerances, that part must be replaced with an airworthy part. This amendment is prompted by the discovery that a wrong tightening torque value for the hub plug was contained in a revision to the helicopter maintenance manual. The actions specified in this AD are intended to detect an improperly torqued hub plug that could lead to tail rotor failure and subsequent loss of control of the helicopter.
Airworthiness Directives; Eurocopter France (ECF) Model EC120B Helicopters
This amendment adopts a new airworthiness directive (AD) for ECF Model EC120B helicopters. This action requires inserting an emergency procedure appendix from an ECF Emergency Alert Service Bulletin into the Rotorcraft Flight Manual (RFM). This action also requires modifying the emergency switch electrical wiring and performing tests to ensure correct operation of the emergency switch. This action also requires removing the emergency procedure appendix from the RFM after modifying the emergency switch electrical wiring and performing tests to ensure correct operation. This amendment is prompted by the discovery that simultaneously setting the emergency switch to the low position ``CUT-OFF'' and the generator (GENE) pushbutton to ``OFF'' position caused the starter-generator to restart. Investigation revealed that cross-wiring at the emergency switch caused this malfunction. This condition, if not corrected, could lead to the inability to isolate electrical equipment during an emergency, creating the risk of an uncontrolled electrical fire and subsequent loss of control of the helicopter.
Rules of Practice and Procedure
The Federal Housing Finance Agency (FHFA) is adopting a final rule to implement the Housing and Economic Recovery Act of 2008 (HERA) amendments to the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (Safety and Soundness Act) and the Federal Home Loan Bank Act (Bank Act) governing civil administrative enforcement actions by FHFA, under which FHFA's authority was consolidated to initiate enforcement proceedings against the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac) (together, the Enterprises), the Federal Home Loan Banks (the Banks) (collectively, the regulated entities), and their entity- affiliated parties. This rule removes the existing Rules of Practice and Procedure of the Federal Housing Finance Board (Finance Board) and the Office of Federal Housing Enterprise Oversight (OFHEO), and establishes new FHFA regulations.
Airworthiness Directives; Cessna Aircraft Company Airplanes
We are revising an existing airworthiness directive (AD) for certain Cessna Aircraft Company (Cessna) Models 150F, 150G, 150H, 150J, 150K, 150L, 150M, A150K, A150L, A150M, F150F, F150G, F150H, F150J, F150K, F150L, F150M, FA150K, FA150L, FRA150L, FA150M, FRA150M, 152, A152, F152, and FA152 airplanes. That AD currently requires either installing a placard prohibiting spins and other acrobatic maneuvers in the airplane or replacing the rudder stop, the rudder stop bumper, and the attachment hardware with a rudder stop modification kit. This new AD requires a change to the modification kit and removal of a small amount of material from the rudder horn assembly for those that have not yet complied with the existing AD or for those who can not comply with the existing AD (because they were unable to obtain full rudder travel with the existing kits). This AD was prompted by operators who have reported difficulty in obtaining full rudder travel with the existing modification kit. We are issuing this AD to revise the kits to use longer rivets and allow a small amount of material to be removed from the rudder horn assembly, which allows operators to obtain full rudder travel.
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