June 8, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This is an amendment of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-1974-DR), dated 05/01/ 2011. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Associated Flooding. Incident Period: 04/25/2011 through 04/28/2011. Effective Date: 05/27/2011. Physical Loan Application Deadline Date: 06/30/2011. EIDL Loan Application Deadline Date: 02/01/2012.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Oklahoma (FEMA 1988DR), dated 05/27/2011. Incident: Severe Storms and Flooding. Incident Period: 04/21/2011 through 04/28/2011. Effective Date: 05/27/2011. Physical Loan Application Deadline Date: 07/26/2011. Economic Injury (EIDL) Loan Application Deadline Date: 02/27/2012.

The purpose of this notice is to request public nominations for certain Bureau of Land Management (BLM) Resource Advisory Councils (RAC) that have member terms expiring this year. The RACs provide advice and recommendations to the BLM on land use planning and management of the National System of Public Lands within their geographic areas.

The U. S. Army Corps of Engineers filed an application with the Bureau of Land Management (BLM) proposing to extend the Fort Carson-Pi[ntilde]on Canyon Military Lands Withdrawal created by Subtitle A of Public Law 104-201 of September 23, 1996 (110 Stat 2807), for an additional 15 years. A withdrawal extension would continue to protect the following lands and minerals and reserve them for use by the Secretary of the Army Fort Carson Military Reservation which includes 3,133 acres of public lands and 11,415 acres of federally owned minerals; and Pi[ntilde]on Canyon Maneuver Site which includes 2,517 acres of public lands and approximately 130,139 acres of federally owned minerals. The withdrawal extension would protect the surface and mineral estates from all forms of appropriation under the public land laws including mining and mineral laws, geothermal leasing laws and mineral materials disposal laws. The withdrawal created by Public Law 104-201 will expire on September 22, 2011, unless extended. This notice gives the public an opportunity to comment on the proposed action to extend the withdrawal and gives notice of the opportunity for a public meeting.

In accordance with the Marine Mammal Protection Act (MMPA), as amended, and implementing regulations, notification is hereby given that NMFS has issued three one-year Letters of Authorization (LOAs) to take marine mammals by harassment incidental to the U.S. Navy's training activities within the Navy's Virginia Capes (VACAPES), Jacksonville (JAX), and Cherry Point (CHPT) Range Complexes to the Commander, U.S. Fleet Forces Command, 1562 Mitscher Avenue, Suite 250, Norfolk, VA 23551-2487 and persons operating under his authority.

The FAA is amending its lightning commit criteria to account for new information about the risks of natural and triggered lightning. This action amends flight criteria for mitigating against naturally occurring lightning and lightning triggered by the flight of an expendable launch vehicle through or near an electrified environment in or near a cloud. These changes will increase launch availability and implement changes already adopted by the United States Air Force.

This notice contains a summary of a petition seeking relief from specified requirements of Title 14, Code of Federal Regulations (14 CFR). The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.

The Federal Aviation Administration (FAA) amends the lightning protection airworthiness standards by establishing new lightning protection regulations for electrical and electronic systems installed on aircraft certificated under parts 23, 27, and 29, and revises lightning protection regulations for electrical and electronic systems installed on airplanes certificated under part 25. This rule establishes two levels of lightning protection for aircraft systems based on consequences of system function failure: Catastrophic consequences which would prevent continued safe flight and landing; and hazardous or major consequences which would reduce the capability of the aircraft or the ability of the flightcrew to respond to an adverse operating condition. This rule also establishes lightning protection for aircraft systems according to the aircraft's potential for lightning exposure. The airworthiness standards establish consistent lightning protection requirements for aircraft electrical and electronic systems.

The Coast Guard is establishing safety zones in Holmes Harbor, Boston Harbor, Port Gardner, Shilshole Bay, Port Ludlow, and Spieden Island for various summer fireworks displays. The safety zones are necessary to help ensure the safety of the maritime public during the displays and will do so by prohibiting all persons and vessels from entering the safety zones unless authorized by the Captain of the Port or his designated representative.

NMFS apportions amounts of the non-specified reserve to the initial total allowable catch of Alaska plaice in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the Bering Sea and Aleutian Islands management area.

The Coast Guard will enforce various safety zones for annual fireworks events in the Captain of the Port Detroit zone from 9:40 p.m. on May 27, 2011 through 9:45 p.m. on September 4, 2011. This action is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after fireworks events. This rule will establish restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after fireworks events. During each enforcement period, no person or vessel may enter the respective safety zone without permission of the Captain of the Port.

NMFS is prohibiting directed fishing for Alaska plaice in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2011 Alaska plaice total allowable catch (TAC) specified for the BSAI.

This notice clarifies the use of Small Area Fair Market Rents (SAFMRs) for Project-Based Vouchers (PBVs) located in the Dallas, TX, metropolitan area. This notice follows Federal Register notices published on August 4, 2010, and October 4, 2010, that proposed and established, respectively, Fiscal Year (FY) 2011 SAFMRs for the Housing Choice Voucher (HCV) program in the Dallas, TX, HUD Metropolitan Fair Market Rent Area (MHFA). The October 4, 2010, notice provides that all public housing agencies (PHAs) in the 8-county Dallas, TX, MHFA are required to use SAFMRs for the voucher program. Today's notice clarifies the use of the SAFMRs by PBV projects located in the 8-county Dallas, TX, MHFA.

The Food and Drug Administration (FDA) is extending the comment period for the notice of public meeting, that appeared in the Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA requested comments to gather stakeholder input on the development of a generic drug user fee program. The Agency is taking this action to allow interested persons additional time to submit comments.

The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed collection in use without an OMB number, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to monitor the progress of NPC programs.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA-1982-DR), dated 05/10/2011. Incident: Severe Storms and Flooding. Incident Period: 03/16/2011 through 05/25/2011. Effective Date: 05/25/2011. Physical Loan Application Deadline Date: 07/11/2011. Economic Injury (EIDL) Loan Application Deadline Date: 02/10/2012.

DoD is issuing this final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 826 of the National Defense Authorization Act for Fiscal Year 2011. Section 826 amended the DoD pilot program for transition to follow-on contracting after use of other transaction authority, to establish that the threshold limitation of $50 million for contracts and subcontracts under the program includes the dollar value of all options.

On November 18, 2010, the National Indian Gaming Commission (NIGC) issued a Notice of Inquiry and Notice of Consultation advising the public that the NIGC was conducting a comprehensive review of all its regulations and requesting public comment on the process for conducting the regulatory review. On April 4, 2011, after holding eight consultation meetings and reviewing all comments, NIGC published a Notice of Regulatory Review Schedule setting out detailed consultation schedules and review processes. NIGC divided the regulations to be reviewed into five groups, and each group will be reviewed in three phases, the Drafting Phase, the Notice of Proposed Rulemaking phase, and the Notice of Final Rule Phase. The purpose of this document is to add regulatory groups to five scheduled tribal consultations.