October 2016 – Federal Register Recent Federal Regulation Documents

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This action proposes to revise and extend information collection for the American lobster fishery Trap Transfer Program.

In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection [FERC-725I (Mandatory Reliability Standards for the Northeast Power Coordinating Council)] to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the Federal Register (81 FR 54571, 8/16/2016) requesting public comments. The Commission received no comments in response to the RD16-8-000 60-day notice and is making this notation in its submittal to OMB.

Notice is hereby given that the U.S. International Trade Commission has determined not to review the final initial determination (``ID'') issued by the presiding administrative law judge (``ALJ'') on August 23, 2016, finding no violation of section 337 of the Tariff Act of 1930, as amended, in connection with alleged misappropriation of certain trade secrets.

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 the 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 the petition or its final disposition.

This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2014 and the preliminary federal share DSH allotments for FY 2016, and corresponding limitations on aggregate state DSH payments to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.

This action proposes special conditions for the Bombardier Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is a fuselage fabricated using aluminum-lithium materials instead of conventional aluminum. The applicable airworthiness regulations do not contain adequate or appropriate fire-safety standards for this design feature. These proposed special conditions contain the additional fire-safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

This document announces a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries' access to frequently abused drugs to certain prescribers and pharmacies. Medicare beneficiaries with Part A or Part B, advocacy groups representing Medicare beneficiaries, physicians, pharmacists, and other clinicians (particularly other lawful prescribers of controlled substances), retail pharmacies, plan sponsors, entities delegated by plan sponsors (such as pharmacy benefit managers), biopharmaceutical manufacturers, and other interested parties are invited to participate. The Listening Session will be held via teleconference and is open to the public.

Volkswagen Group of America , Inc. (Volkswagen), has determined that certain model year (MY) 2016 Volkswagen eGolf motor vehicles do not fully comply with paragraph S6.5.3.2 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, reflective devices and associated equipment. Volkswagen filed a report dated September 16, 2016, pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility and Reports. Volkswagen then petitioned NHTSA under 49 CFR part 556 for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the information collection activities required to administer the Environmental and Historic Preservation Environmental Screening Form.

In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Technology, Innovation and Engineering (TI&E) Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.

The Department of Health and Human Services (HHS), Administration for Children and Families (ACF), is issuing guidelines stating principles for working with federally recognized Indian tribes.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/ or arousal in women. Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions.

These special conditions are issued for the modification of the Airbus Helicopters Model EC120B helicopter. This model helicopter will have a novel or unusual design feature after installation of the S-TEC Corporation (S-TEC) HeliSAS helicopter autopilot/stabilization augmentation system (AP/SAS) that has potential failure conditions with more severe adverse consequences than those envisioned by the existing applicable airworthiness regulations. These special conditions contain the added safety standards the Administrator considers necessary to ensure the failures and their effects are sufficiently analyzed and contained.