September 2015 – Federal Register Recent Federal Regulation Documents

The Coast Guard has extended and modified a temporary deviation from the operating schedule that governs the Hood Canal Floating Drawbridge across Hood Canal (Admiralty Inlet), mile 5.0, near Port Gamble, WA. The temporary deviation is now effective until 7 p.m. on October 19, 2015 and allows the bridge to open the draw span half- way, 300 feet; as opposed to all the way, which is 600 feet, with at least one hour's notice and only at or near slack tide.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2016. The calendar year 2016 AIC threshold amounts are $150 for ALJ hearings and $1,500 for judicial review.

This final notice announces our decision to approve the American Association of Diabetes Educators (AADE) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The FTC intends to ask the Office of Management and Budget (``OMB'') to extend for an additional three years the current Paperwork Reduction Act (``PRA'') clearance for information collection requirements contained in the Children's Online Privacy Protection Act Rule (``COPPA Rule'' or ``Rule''), which will expire on February 29, 2016.

This document contains final regulations regarding the standards for making a good faith determination that a foreign organization is a charitable organization that is not a private foundation, so that grants made to that foreign organization may be qualifying distributions and not taxable expenditures. The regulations also make additional changes to conform the final regulations to statutory amendments made by the Deficit Reduction Act of 1984 and the Pension Protection Act of 2006. The regulations will affect private foundations seeking to make good faith determinations.

We are revising an earlier proposed airworthiness directive (AD) for The Boeing Company Model 777-200 and -300 series airplanes, equipped with Rolls-Royce Model RB211-Trent 800 engines. The notice of proposed rulemaking (NPRM) proposed to require repetitive inspections of the thrust reverser (T/R) structure and sealant, and related investigative and corrective actions if necessary. The NPRM was prompted by reports of T/R events related to thermal damage of the T/R inner wall. This action revises the NPRM by proposing to add different repetitive inspections requirements for T/R halves with a thermal protective system installed. This action also revises the NPRM by proposing to require installation of serviceable T/R halves, which would terminate the repetitive inspections in this SNPRM. This SNPRM also proposes to revise the inspection or maintenance program by incorporating new airworthiness limitations. We are proposing this SNPRM to detect and correct a degraded T/R inner wall panel, which could lead to failure of the T/R and adjacent components and their consequent separation from the airplane, and which could result in a rejected takeoff (RTO) and cause asymmetric thrust and consequent loss of control of the airplane during reverse thrust operation. If a T/R inner wall overheats, separated components could cause structural damage to the airplane, damage to other airplanes, or possible injury to people on the ground. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for renewal of an existing information collection titled, ``Generic Information Collection Plan for the Development and/or Testing of Model Forms, Disclosures, Tools, and Other Similar Related Materials.''

On June 27, 2014, Coast Guard Sector Puget Sound received a Letter of Intent (LOI) and Waterway Suitability Assessment (WSA) from Washington State Ferries (WSF) for a proposal to modify existing Washington State Ferry marine terminal operations to include the handling of Liquefied Natural Gas (LNG). The LNG would be transferred to and used as a marine fuel by six Issaquah Class Ferries converted to use LNG propulsion systems. In accordance with regulation and policy guidance, the Captain of the Port (COTP), Coast Guard Sector Puget Sound, in cooperation with key port stakeholders, will review and validate the information in the WSA. The COTP will then issue a Letter of Recommendation (LOR) to the State of Washington Department of Transportation that conveys the Coast Guard's recommendation on the suitability of the following waterways for LNG marine traffic as it relates to safety and security: Guemes Channel, Rosario Strait, Thatcher Pass, Harney Channel, Upright Channel, Wasp Channel, San Juan Channel, Spieden Channel, Haro Strait, Sidney Channel, Possession Sound, Admiralty Inlet, Puget Sound, Sinclair Inlet, Rich Passage, Elliot Bay, Admiralty Passage, North East Passage, and Colvos Passage. As part of this validation process, the Coast Guard, on November 12, 2014, published a ``Notice and Request for Comments'' in the Federal Register which solicited public comments to inform the COTP's recommendation. A number of comments were received, including two outside the comment period. This document summarizes those comments, explains whether or not they are appropriate for consideration under regulation, and provides additional information to help inform the public about the various issues raised in them.

The purpose of this notice is to inform the public that the Coast Guard has recertified the Cook Inlet Regional Citizen's Advisory Council (CIRCAC) as an alternative voluntary advisory group for Cook Inlet, Alaska. This certification allows the CIRCAC to monitor the activities of terminal facilities and crude oil tankers under the Cook Inlet Program established by statute.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Angio360 Diagnostics, LLC, a company having a place of business in Wauwatosa, Wisconsin, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 858,068, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed November 9, 2006 (HHS Ref. No.: E- 285-2006/0-US-01); US Provisional Patent Application No. 60/879,457, entitled ``Organ And Tumor Associated Endothelial Markers,'' filed January 8, 2007 (HHS Ref. No. E-285-2006/1-US-01); PCT Application No. PCT/US2007/072395, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 8, 2007 (HHS Ref. No. E-285-2006/2-PCT-01); U.S. Patent Application No. 12/514,297, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed May 8, 2009 (HHS Ref No. E-285-2006/ 2-US-02); Australian Patent No. 2007-317753, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref No. E-285-2006/2-AU-03); Canadian Patent Application No. 2,669,260, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed June 28, 2007 (HHS Ref. No. E-285-2006/2-CA-04); U.S. Patent No.: 8,440,411, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed March 21, 2011 (HHS Ref. No. E-285-2006/2-US-05); U.S. Patent Application No. 13/052,878, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed April 16, 2013 (HHS Ref. No.: E-285-2006/2-US-06); and Australian Application Patent No.: 2014-200453, entitled ``Differential Gene Expression in Physiological and Pathological Angiogenesis,'' filed January 28, 2014 (HHS Ref No. E-285-2006/2-AU-07). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development of diagnostic tests and kits to determine or monitor pathological angiogenesis related to cancer in animals or humans.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Angio360 Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

The Environmental Protection Agency (EPA) is approving portions of a State Implementation Plan (SIP) revision submitted by the Mississippi Department of Environmental Quality (MDEQ), to EPA on July 25, 2010. The SIP revision includes multiple changes to Mississippi's SIP to add definitions in accordance with federal regulations and to implement clarifying language.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Interim Staff Guidance (ISG), FCSE ISG-14, ``Acute Uranium Standards for Workers,'' dated June 15, 2015. The ISG provides guidance to the NRC staff when reviewing licensee-proposed standards in the Integrated Safety Analysis Summary for determining worker uranium exposures that would result in high or intermediate consequences consistent with the general definition of these events in NRC regulations.

The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at title 45, part 670 of the Code of Federal Regulations. This is the required notice of a requested permit modification.

The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 142 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on a draft regulatory issue summary (RIS), RIS 2015-XX, ``Review and Submission of Updates to the Final Safety Analysis Reports, Emergency Preparedness Documents, and Fire Protection Documents.'' This RIS reminds addressees of the review and submission requirements regarding information to be withheld from public disclosure, and recommends a format for submission of updates to the Final Safety Analysis Reports (FSARs).

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 Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.

The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 143 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Federal Energy Regulatory Commission approves Reliability Standard PRC-002-2 (Disturbance Monitoring and Reporting Requirements) submitted by the North American Electric Reliability Corporation. The purpose of Reliability Standard PRC-002-2 is to have adequate data available to facilitate analysis of bulk electric system disturbances.

The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the U.S. Army War College Board of Visitors, a subcommittee of the Army Education Advisory Committee. This meeting is open to the public.