January 5, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The draft guidance document provides industry and Agency staff with updated recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices (IVDs) intended for the detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect at this time.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

The Veterans Benefits Administration (VBA), 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 extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to determine whether proprietary education institutions receiving Federal financial assistance comply with the applicable civil rights law and regulations.

The FHWA has forwarded the information collection request described in this notice to the Office of Management and Budget (OMB) for approval of a new information collection. We published a Federal Register Notice with a 60-day public comment period on this information collection on September 7, 2010. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.

The New England Fishery Management Council (Council) will hold a 3-day Council meeting on Tuesday-Thursday, January 25-27, 2011 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

This notice announces EPA's establishment of the Chesapeake Bay (Bay) TMDL on December 29, 2010 for nitrogen, phosphorus and sediment for the Chesapeake Bay and its tidal tributaries. EPA provided a 45-day public review of the Draft Bay TMDL which was held from September 24 through November 8 of 2010. Based on comments and information EPA received from the public and affected jurisdictions during the public review period, EPA has revised the draft TMDL as appropriate and established the Bay TMDL for nitrogen, phosphorus and sediment for each of the 92 segments in the tidal portion of the Chesapeake Bay watershed pursuant to Sections 117(g) and 303(d) of the Clean Water Act (CWA). The TMDL provides pollutant loads for nitrogen, phosphorus and sediment which can enter a waterbody without causing a violation in the water quality standards. The TMDL allocates that pollutant load between point and nonpoint sources. The Bay TMDL contains segment specific point (wasteload) and non-point (load) allocations for nitrogen, phosphorus and sediment that when met will assure the attainment and maintenance of all applicable water quality standards for each of the 92 segments. The Bay TMDL is a key part of the clean water commitment in the Federal Strategy developed as part of Executive Order 13508 on Chesapeake Bay Protection and Restoration. EPA has worked closely with its federal partners, the six watershed states, the District of Columbia, local governments and other parties to put in place a comprehensive, transparent and accountable set of commitments and actions that together ensure that pollution controls needed to restore Bay water quality are implemented by no later than 2025 (Executive Order, 13508). Additional information on the Bay TMDL can be found at: https:// www.epa.gov/chesapeakebaytmdl. Viewing: The TMDL can be viewed at https://www.epa.gov/ chesapeakebaytmdl, in person at EPA Region III, 1650 Arch Street, Philadelphia, PA 19103 with proper arrangements made in advance with the Region 3 library (215-814-5254 or library-reg3@epa.gov) or at the EPA Chesapeake Bay Program Office at 410 Severn Avenue, Suite 112, Annapolis, MD 21403 (Contact Debbie Embleton 410-267-9856 or Embleton.debbie@epa.gov).

This action is to extend the existing Central Arizona Project (CAP) formula rates through December 31, 2012. The existing Transmission Service Formula Rate Schedules CAP-FT2, CAP-NFT2, and CAP- NITS2 expire on December 31, 2010. These Transmission Service Rate Schedules contain formula rates that are recalculated from annual updated financial and load data.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Arizona (FEMA- 1950-DR), dated 12/21/2010. Incident: Severe Storms and Flooding. Incident Period: 10/03/2010 through 10/06/2010. Effective Date: 12/21/2010. Physical Loan Application Deadline Date: 02/21/2011. Economic Injury (EIDL) Loan Application Deadline Date: 09/21/2011.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment and Training Administration is soliciting comments concerning the collection of data about High Growth and Community-Based Job Training Grants OMB No. 1205-0465, which expires: 5/31/2011. A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below in the ADDRESSES section of this notice.

On Tuesday, December 28, 2010 (75 FR 81242), the Department of Defense published a notice seeking comment on a new proposed public information collection: Traumatic Brain Injury, Post-Traumatic Stress Disorder, and Long-Term Quality of Life Outcomes in Injured Tri-Service U.S. Military Personnel; OMB Control Number 0720-TBD. The notice contained an incomplete phone number in the FOR FURTHER INFORMATION CONTACT section. The correct information follows.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the extension of the information collection for notification, investigation, and reporting of accidents, injuries, illnesses, and fatalities at mines; mine employment; and coal production.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

EPA is planning the second National Bed Bug Summit to be held February 1 and 2, 2011, on the topic of the bed bug resurgence in the United States. The goal of this meeting is to review the current bed bug problem and identify and prioritize further actions to address the problem. The objectives of the summit are to identify knowledge gaps and barriers to effective community-wide bed bug control; propose the next steps in addressing knowledge gaps and eliminating barriers; and develop a framework for addressing the highest priority needs. The agenda for this meeting is under development and will be posted on our Web site and placed in the docket in advance of the meeting.

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.

EPA is proposing to disapprove a portion of the State Implementation Plan (SIP) revision submitted by the State of New Mexico for the purpose of addressing the ``good neighbor'' requirements of section 110(a)(2)(D)(i) of the Clean Air Act (CAA or Act) for the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and the 1997 fine particulate matter (PM2.5) NAAQS. The SIP revision addresses the requirement that New Mexico's SIP must have adequate provisions to prohibit emissions from adversely affecting another state's air quality through interstate transport. In this action, EPA is proposing to disapprove the New Mexico Interstate Transport SIP provisions that address the requirement of section 110(a)(2)(D)(i)(II) that emissions from New Mexico sources do not interfere with measures required in the SIP of any other state under part C of the CAA to protect visibility. In this action, EPA is also proposing to promulgate a Federal Implementation Plan (FIP) to prevent emissions from New Mexico sources from interfering with other states' measures to protect visibility, and to implement nitrogen oxides (NOX) and sulfur dioxide (SO2) emission limits necessary at one source to prevent such interference. In addition, EPA is proposing sulfuric acid (H2SO4) and ammonia (NH3) hourly emission limits at the same source, to minimize the contribution of these compounds to visibility impairment. EPA is proposing monitoring, recordkeeping and reporting requirements to ensure compliance with such emission limitations. EPA also proposes that compliance with the emission limits be within three (3) years of the effective date of our final rule. Furthermore, EPA is proposing the FIP to address the requirement for best available retrofit technology (BART) for NOX for this source. This action is being taken under section 110 and part C of the CAA.

We are superseding an existing airworthiness directive (AD) for the products listed above. That AD currently requires repetitive inspections for discrepancies of the fuse pins of the inboard and outboard midspar fittings of the nacelle strut, and corrective actions if necessary. This new AD requires replacing the midspar fuse pins with new, improved fuse pins, which would terminate the repetitive inspections. This AD was prompted by a report of corrosion damage of the chrome runout on the head side found on all four midspar fuse pins of the nacelle strut. Additionally, a large portion of the chrome plate was missing from the corroded area of the shank. We are issuing this AD to prevent damage of the fuse pins of the inboard and outboard midspar fittings of the nacelle strut, which could result in reduced structural integrity of the fuse pins, and consequent loss of the strut and separation of the engine from the airplane.