October 17, 2018 – Federal Register Recent Federal Regulation Documents

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737 airplanes, excluding Model 737-100, -200, - 200C, -300, -400, and -500 series airplanes; all Model 757-200, -200PF, -200CB, and -300 series airplanes; and all Model 767-200, -300, -300F, and -400ER series airplanes. This AD was prompted by reports of latently failed motor-operated valve (MOV) actuators of the fuel shutoff valves. This AD requires replacing certain MOV actuators of the fuel shutoff valves for the left and right engines (on certain airplanes) and of the auxiliary power unit (APU) fuel shutoff valve (on Model 757 and Model 767 airplanes); and revising the maintenance or inspection program to incorporate certain airworthiness limitations (AWLs). We are issuing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

In accordance with the regulations implementing the individual fishing quota (IFQ) and Federal dealer reporting programs specific to the commercial reef fish fishery in the Gulf of Mexico (Gulf) and the coastal migratory pelagic (CMP) fisheries in the Gulf, the Regional Administrator (RA), Southeast Region, NMFS has determined that Hurricane Michael has caused catastrophic conditions in multiple counties. This temporary rule announcing the determination of catastrophic conditions and authorization to use alternative methods for completing required IFQ and other dealer reporting administrative functions is intended to facilitate continuation of IFQ and dealer reporting operations during the period of catastrophic conditions. NMFS will continue to monitor and evaluate conditions and a subsequent Federal Register document will be published, if needed to address any changes.

On September 18, 2018, the Department of Veterans Affairs (VA) published a final rule amending its regulations governing veterans' eligibility for VA pensions and other needs-based benefit programs. The final rule contained some errors in its preamble and in one amendment to the CFR. This document corrects those errors.

This proposed rule is intended to amend the rules that regulate vessel traffic and control navigation of portions of waterways during events that pose a hazard to public safety. This rule, if adopted, would add six new reoccurring special local regulations, remove six special local regulations, and amend the event, dates, and/ or regulated areas for the 15 recurring special local regulations that will be listed in a table. The permanent special local regulations established by this proposed rule are necessary to protect spectators, participants, and vessels from the hazards associated with the varying types of marine events. This proposed rulemaking would restrict vessel traffic in the designated areas during the events unless authorized by the Captain of the Port Detroit or a designated representative. We invite your comments on this proposed rulemaking.

In accordance with the Privacy Act of 1974, the Office of the Secretary of Defense is exempting records maintained in a new system of records, ``Personnel Vetting Records System,'' DUSDI 02-DoD, from certain requirements of the Act.

On October 10, 2018, the Postal Service filed a notice of mailing services price adjustments with the Postal Regulatory Commission (PRC), effective January 27, 2019. This proposed rule contains the revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) that we would adopt to implement related regulatory changes coincident with the price adjustments.

The Postal Service proposes to revise Mailing Standards of the United States Postal Service, International Mail Manual (IMM[supreg]), to reflect changes in the prices, product features, and classification changes to Mailing Services. These changes would also implement a lower maximum weight limit on First-Class Mail International[supreg] (FCMI) large envelopes (flats), to bring them closer to compliance with Universal Postal Union (UPU) standards.

The Department of Veterans Affairs (VA) proposes to amend its medical regulations to establish standards for VA clinical laboratories. The Department of Health and Human Services (HHS) has established standards for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings. VA is required, in consultation with HHS, to establish standards equal to those applicable to other clinical laboratories. As a matter of policy and practice VA has applied HHS standards to its VA laboratory operations, and this proposed rule would formalize this practice. The proposed rule would establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. Specifically, it would address how VA applies regulations as the controlling standards for VA medical facility laboratories.

As permissible under the Toxic Substances Control Act (TSCA or the Act), EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation. This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the final TSCA fees were determined. It identifies some factors and considerations for determining fees for subsequent fiscal years; and includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. As required in TSCA, EPA is also establishing standards for determining which persons qualify as ``small business concerns'' and thus would be subject to lower fee payments. Requiring manufacturers and processors of certain chemical substances to pay a fee for specific fee-triggering events under TSCA, will defray part of the EPA cost of administering TSCA.