January 21, 2016 – Federal Register Recent Federal Regulation Documents

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/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). 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 Office of Workers' Compensation Programs is soliciting comments concerning the proposal to extend OMB approval of the information collection: Notice of Issuance of Insurance Policy (CM-921). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

The Department of Agriculture is adopting, as a final rule, without change, an interim rule that implemented a recommendation from the Washington Apricot Marketing Committee (Committee) to decrease the assessment rate from $1.50 to $0.75 per ton of Washington apricots handled for the 2015-2016 and subsequent fiscal periods. The Committee locally administers the marketing order and is comprised of apricot producers and handlers operating within designated counties in Washington. The interim rule was necessary to allow the Committee to reduce its financial reserve while still providing adequate funding to meet program expenses.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 15, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of ParkerVision, Inc. of Jacksonville, Florida. Supplements to the complaint were filed on December 23, 2015 and January 4, 2016. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain RF capable integrated circuits and products containing the same by reason of infringement of certain claims of U.S. Patent No. 6,879,817 (``the '817 patent''); U.S. Patent No. 7,929,638 (``the '638 patent''); U.S. Patent No. 8,571,135 (``the '135 patent''); and U.S. Patent No. 9,118,528 (``the '528 patent''). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

The United States Consumer Product Safety Commission (``Commission'' or ``CPSC'') is correcting a Notice of Proposed Rulemaking (``NPR'') that appeared in the Federal Register of November 9, 2015 (80 FR 69144). The document proposed a safety standard for high chairs. The Commission is correcting an error in the proposed regulatory text concerning rearward stability.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.

On December 19, 2012, the National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention announced in the Federal Register https://www.gpo.gov/fdsys/pkg/FR-2012-12-19/pdf/ 2012-30515.pdf plans to evaluate the scientific data on silver nanomaterials and to issue its findings on the potential health risks. A draft document entitled, Health Effects of Occupational Exposure to Silver Nanomaterials, has been developed which contains a review and assessment of the currently available scientific literature on the toxicological effects of exposure to silver nanoparticles in experimental animal and cellular systems, and on the occupational exposures to silver dust and fume and the associated health effects. An emphasis area of this review is evaluating the scientific evidence on the role of particle size on the toxicological effects of silver, including the evidence basis to evaluate the adequacy of the current NIOSH recommended exposure limit (REL) for silver (metal dust and soluble compounds, as Ag) [available at: https://www.cdc.gov/niosh/npg/ npgd0557.html]. Recommendations are provided for the safe handling of silver nanoparticles, and research needs are proposed to fill important data gaps in the current scientific literature on the potential adverse health effects of occupational exposure to silver nanoparticles. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. To view the notice and related materials, visit www.regulations.gov and enter CDC-2016-0001 in the field and click ``Search.'' This draft document does not have the force or effect of the law.

We are adopting a new airworthiness directive (AD) for all Airbus Model A319-113 and A319-114 airplanes; and Model A320-211 and A320-212 airplanes. This AD requires identifying affected engines, and doing a torque check of the forward engine bolts on affected engines. This AD would also require, for any bolt rotation that is found, torqueing the bolt and eventually replacing the forward engine mount bolts, nuts, and washers, doing a fluorescent penetrant inspection and dimensional check of the affected bolt holes for local deformation and cracks, and doing corrective actions if necessary. This AD was prompted by an incorrect torque unit for the CFM56-5A engine forward mount fasteners that was inadvertently introduced into a certain Airbus airplane maintenance manual. We are issuing this AD to prevent loose bolts, which, if combined with induced maintenance damage, could lead to forward engine mount failure. An engine mount failure can result in an engine detachment and consequent reduced control of the airplane, damage to the airplane, and injury to persons on the ground.

NMFS has received a request from the Washington State Department of Transportation (WSDOT) for an authorization to take small numbers of 10 species of marine mammals, by Level B harassment, incidental to proposed construction activities for the Coupeville Timber Tower Preservation Project in Washington State. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an authorization to WDOT to incidentally take, by harassment, small numbers of marine mammals for a period of 1 year.

The Food and Drug Administration (FDA) is providing notice that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #226 entitled ``Target Animal Safety Data Presentation and Statistical Analysis.'' The purpose of this document is to provide recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine (CVM) as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry).

The Food and Drug Administration (FDA or Agency) has determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the implanted blood access devices for hemodialysis into class II (special controls) and to assist industry in preparing premarket notification (510(k)) submissions for implanted blood access devices for hemodialysis.

The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

We propose to supersede Airworthiness Directive (AD) 2012-11- 15, for all BAE Systems (Operations) Limited Model 4101 airplanes. AD 2012-11-15 currently requires a one-time detailed inspection for cracks, corrosion, and other defects of the rear face of the wing rear spar, and repair if necessary. Since we issued AD 2012-11-15, we received new reports of cracking found in the wing rear spar and technical analysis results confirmed that the crack initiation and propagation are due to fatigue, with no indication of any other crack initiation mechanism (e.g. stress corrosion). This proposed AD would require repetitive detailed inspections, and repair if necessary. We are proposing this AD to detect and correct cracking in the wing rear spar, which could propagate to a critical length, possibly affecting the structural integrity of the area and resulting in a fuel tank rupture, with consequent damage to the airplane and possible injury to its occupants.

On December 29, 2015, the Postal Service filed the FY 2015 Performance Report and FY 2016 Performance Plan with its FY 2014 Annual Compliance Report. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Office of the Secretary of Defense proposes to alter a system of records notice DWHS P28, entitled ``Personnel Security Operations File'' to maintain security clearance and authorized access information.