January 2015 – Federal Register Recent Federal Regulation Documents

This is a notice of an Administrative declaration of a disaster for the State of Mississippi dated 01/20/2015. Incident: Severe Weather and Tornadoes. Incident Period: 12/23/2014. Effective Date: 01/20/2015. Physical Loan Application Deadline Date: 03/23/2015. Economic Injury (EIDL) Loan Application Deadline Date: 10/20/2015.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).'' The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease.

The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).

The Office of Management and Budget revised Circular A-94 in 1992. The revised Circular specified certain discount rates to be updated annually when the interest rate and inflation assumptions used to prepare the Budget of the United States Government were changed. These discount rates are found in Appendix C of the revised Circular. The updated discount rates are shown below. The discount rates in Appendix C are to be used for cost-effectiveness analysis, including lease-purchase analysis, as specified in the revised Circular. They do not apply to regulatory analysis.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Commission will consider a Report and Order to ensure that accurate caller location information is automatically provided to public safety officials for all wireless calls to 911, including for indoor calls, to meet consumer and public safety needs and expectations, and to take advantage of new technological developments. 2..................... WIRELINE COMPETITION. TITLE: Inquiry Concerning the Development of Advanced Telecommunications Capability to All Americans in a Reasonable and Timely Fashion, and Possible Steps to Accelerate Such Deployment Pursuant to section 706 of the Telecommunications Act of 1996, as Amended by the Broadband Data Improvement Act (GN Docket No. 14-126). SUMMARY: The Commission will consider a 2015 Broadband Progress Report examining whether advanced telecommunications capability is being deployed to all Americans in a reasonable and timely fashion; and a Notice of Inquiry asking what immediate action the Commission should take to accelerate the deployment of such capability by removing barriers to infrastructure investment and by promoting competition in the telecommunications market. 3..................... WIRELINE COMPETITION. TITLE: Inquiry Concerning the Development of Advanced Telecommunications Capability to All Americans in a Reasonable and Timely Fashion, and Possible Steps to Accelerate Such Deployment Pursuant to section 706 of the Telecommunications Act of 1996, as Amended by the Broadband Data Improvement Act (GN Docket Nos. 12-228 and 14-126). SUMMARY: The Commission will consider an Order announcing the conclusion of the Ninth Notice of Inquiry. 4..................... CONSUMER & PRESENTATION: The GOVERNMENTAL AFFAIRS. Commission will hear a presentation on the new Consumer Help Center that provides an easier- to-use, more consumer- friendly portal for filing and monitoring informal consumer complaints, as well as accessing educational materials. 5..................... ENFORCEMENT BUREAU... TITLE: Enforcement Bureau Action SUMMARY: The Commission will consider whether to take an enforcement action.

The Environmental Protection Agency has submitted an information collection request (ICR), ``Partial Update of the TSCA Sec. 8(b) Inventory Data Base, Production and Site Reports (Chemical Data Reporting)'' (EPA ICR No. 1884.08, OMB Control No. 2070-0162) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed revision of the ICR, which is currently approved through January 31, 2015. Public comments were previously requested via the Federal Register (79 FR 29442) on May 22, 2014, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

We propose to adopt a new airworthiness directive (AD) for PILATUS Aircraft Ltd. Model PC-7 airplanes. This proposed 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 potential for a spring on the compressor clutch plate to shear the oil cooler inlet-hose due to the close routing of these parts without a protective cover. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

This document makes amendments to the Federal Acquisition Regulation (FAR) in order to make editorial changes.

DoD, GSA, and NASA are issuing a final rule amending the Federal Acquisition Regulation (FAR) to strengthen protections against trafficking in persons in Federal contracts. These changes are intended to implement Executive Order (E.O.) 13627, entitled ``Strengthening Protections Against Trafficking in Persons in Federal Contracts,'' and title XVII of the National Defense Authorization Act for Fiscal Year 2013.

The Environmental Protection Agency (EPA) is taking final action to approve State Implementation Plan (SIP) revisions submitted by the State of Montana on June 4, 2013. This submission revises the Administrative Rules of Montana that pertain to the issuance of Montana air quality permits. The June 4, 2013 revisions contain amended and renumbered rules that, among other things, address the proper treatment of air pollutants under the State's prevention of significant deterioration (PSD) program. In this rulemaking, we are taking final action on all of the June 4, 2013 submittal, with the exception of one small portion. This action is being taken under section 110 of the Clean Air Act (CAA).

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to require contracting officers to consider information in the Statistical Reporting module of the Past Performance Information Retrieval System when evaluating past performance of offerors under competitive solicitations for supplies using simplified acquisition procedures.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update the descriptions of Federal supply groups (now identified as product service groups) subject to trade agreements to conform to the current Federal Procurement Data System Product and Service Codes Manual.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to require that scientific and technical reports be submitted in electronic format.

The FAA is correcting the final rule, ``Harmonization of Airworthiness StandardsGust and Maneuver Load Requirements'' (79 FR 73462), published December 11, 2014. In the rule, the FAA amended certain airworthiness regulations for transport category airplanes to eliminate regulatory differences between the airworthiness standards of the FAA and European Aviation Safety Agency (EASA). It does not add new requirements beyond what manufacturers currently meet for EASA certification and does not affect current industry design practices. This final rule revises the pitch maneuver design loads criteria; revises the gust and turbulence design loads criteria; revises the application of gust loads to engine mounts, high lift devices, and other control surfaces; adds a ``round-the-clock'' discrete gust criterion and a multi-axis discrete gust criterion for airplanes equipped with wing-mounted engines; revises the engine torque loads criteria; adds an engine failure dynamic load condition; revises the ground gust design loads criteria; revises the criteria used to establish the rough air design speed; and requires the establishment of a rough air Mach number. This document corrects errors in the rule by ensuring that certain letters in the included equations have the right formatting and therefore the correct meaning.

In March 2012, the Department of Health and Human Services (HHS) published a final rule establishing new standards for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standards were designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad, and other industries. Pursuant to this interim final rule, NIOSH will extend the phase-in period until 6 months after the date that the first approval is granted to certain CCER models.

We are adopting a new airworthiness directive (AD) for certain Airbus Model A300 B4-601, B4-603, B4-605R, F4-605R, and C4-605R Variant F airplanes. This AD was prompted by reports of cracking found in the pylon box, which was due to the stresses resulting from the pressure applied by the thrust reverser cowl bumpers. This AD requires repetitive high frequency eddy current (HFEC) inspections for cracking; and replacement of all fittings if necessary, which terminates the repetitive HFEC inspections for the modified side only. We are issuing this AD to detect and correct cracks of the pylon rib 5, which could result in reduced structural integrity of the airplane.

We are superseding airworthiness directive (AD) 2011-23-01 for all Technify Motors GmbH (TMG) models TAE 125-01 and TAE 125-02-99 reciprocating engines with certain part number (P/N) and serial number (S/N) clutch assemblies installed. AD 2011-23-01 required replacement of certain P/N and S/N clutch assemblies. This AD requires the same actions but expands the population of affected P/N and S/N clutch assemblies. This AD was prompted by an additional report of a clutch assembly that malfunctioned due to disk springs that received a nonconforming heat treatment process. We are issuing this AD to prevent failure of the clutch assembly, which could lead to failure of the engine, in-flight shutdown, and loss of control of the airplane.

We, the U.S. Fish and Wildlife Service, correct a typographical error in a recently published notice that announced our receipt of applications. Due to the inadvertent typographical error, the prior notice mischaracterized the area of translocation for a species for which the applicant seeks a permit. The error is not in the application materials, but only in one section of our previous Federal Register notice. If you requested documents for review, you need not request them again.

The Coast Guard is seeking public comment on the policy clarification proposed in this Notice regarding the criteria for granting medical waivers to mariners who require the use of potentially impairing prescription medications. The Coast Guard is also seeking input regarding effective methods of risk evaluation of such mariners. Current Coast Guard guidance states that the ``use of certain medications is considered disqualifying for the issuance of credentials,'' and that ``the underlying cause or need for use of these medications and potential side effects may result in denial of a credential application or require a waiver.'' Current guidance specifically identifies that use of benzodiazepine medications, opioid and opiate medications, non-benzodiazepine sedative hypnotic medications, and barbiturate medications require a waiver, but does not specify the factors that the Coast Guard will consider in making its determination on whether the risks associated with use of these medications are low enough to warrant consideration for a waiver. The Coast Guard is proposing additions to the current medication policy that will clarify the circumstances that the Coast Guard will consider when determining whether to grant a medical waiver for use of these medications. Additionally, the Coast Guard is proposing to include a safety warning to mariners advising them to refrain from use of impairing medications while operating under the authority of their credential. The Coast Guard is seeking comments from the public on whether the proposed policy adequately addresses safety concerns regarding merchant mariners whose medical conditions require the use of medications that have the potential to impair cognitive ability, judgment or reaction time.

The Secretaries propose to revise the regulations governing the rural determination process for the Federal Subsistence Program in Alaska. Under current regulations, the Federal Subsistence Board (Board) defines which community or area of Alaska is rural using guidelines and characteristics defined by the Secretaries. This new process will enable the Board to be more flexible in making decisions and take into account the regional differences found throughout the State.