November 29, 2016 – Federal Register Recent Federal Regulation Documents

This notice announces that the Department of the Treasury's Advisory Committee on Risk-Sharing Mechanisms (``Committee'') will convene a meeting on Thursday, December 15, 2016, in Room 4121, 1500 Pennsylvania Avenue NW., Washington, DC 20220, from 1:30-4:30 p.m. Eastern Time. The meeting is open to the public, and the site is accessible to individuals with disabilities.

The Western Pacific Fishery Management Council (Council) announces a change in location for its Hilo, HI public meetings and scoping sessions to discuss fishery management regulations for the Monument Expanded Area in the Northwestern Hawaiian Islands.

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 an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the State Administrative Plan for the procedural guide that details how the State will administer the Hazard Mitigation Grant Program.

The Surface Transportation Board (Board) adopts final rules to implement passenger rail-related dispute resolution provisions under the Fixing America's Surface Transportation Act of 2015 (FAST Act).

The Department of Justice (DOJ), Civil Rights Division, Federal Coordination and Compliance Section, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This collection was previously published in the Federal Register at 81 FR 64512, on September 20, 2016, allowing for a 60 day public comment period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Council for Harmonisation (ICH) (formerly International Conference on Harmonisation) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. Periodic adverse drug experience report (PADER), or U.S. Periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.'' Flexible gastrointestinal endoscopes and accessories are class II devices and identified with product codes such as FDF, FDS, and OCX. When using these devices during an entire day of procedures (e.g., colonoscopies), clinicians typically use one irrigation system (i.e., one water bottle, one set of tubing and valves, etc.) without cleaning and sterilizing all the system components between patients. This guidance highlights the cross-contamination risk associated with day-use of irrigation systems used with flexible gastrointestinal endoscopes; clarifies terminology used to describe these devices; and outlines strategies to mitigate the risk of cross-contamination between patients during these procedures.

On July 29, 2016, President Obama signed into law the Housing Opportunity Through Modernization Act of 2016 (HOTMA). One of the statutory amendments made by HOTMA adds an income limit to the Public Housing program. This notice informs the public of how HUD proposes to implement that income limit and solicits comments on that methodology.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.

The Office of Operations, Security, and Preparedness (OSP), Department of Veterans Affairs 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 without change of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to determine an applicant's qualification and suitability as a VA police officer.

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 revision of a currently approved collection, and allow 60 days for public comment in response to the notice. The holder of a vendee account which has been guaranteed by the Department of Veterans Affairs (VA) may request VA to repurchase a loan as provided in 38 CFR 36.

New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a section of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016. This rule clarifies that agency acquisition personnel are permitted and encouraged to engage in responsible and constructive exchanges with industry, so long as those exchanges are consistent with existing law and regulation and do not promote an unfair competitive advantage to particular firms.

We are adopting a new airworthiness directive (AD) for certain Fokker Services B.V. Model F28 airplanes. This AD was prompted by reports indicating that the main landing gear (MLG) could not be extended and locked down during approach. This AD requires inspection of the restrictor check valve filter screens to detect any degraded or failed filter screens, and installation of serviceable parts. We are issuing this AD to address the unsafe condition on these products.

We are superseding Airworthiness Directive (AD) 2014-12-06 for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. AD 2014-12-06 required repetitive ultrasonic or detailed inspections of the external area of the aft cargo door sill beam for cracking, and repair if necessary, and provided an optional one-time high frequency eddy current (HFEC) inspection that would terminate the repetitive inspections. This new AD requires the previously optional terminating HFEC inspection, and requires that it be done repetitively. This AD was prompted by findings of multiple fatigue cracks in the aft cargo door that indicated the need for additional, repetitive, HFEC inspections. We are issuing this AD to address the unsafe condition on these products.