July 7, 2015 – Federal Register Recent Federal Regulation Documents

The Department of Defense announces the following Federal advisory committee meeting of the Threat Reduction Advisory Committee.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Oklahoma Advisory Committee (Committee) will hold a meeting on Friday, July 31, 2015, at 1:30 p.m. CST for the purpose of voting on the final agenda of speakers and other logistics for the September 11, 2015, meeting on the school to prison pipeline in Oklahoma. The Committee approved a project proposal on the topic at its March 27, 2015, meeting. Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-337-8169, conference ID: 9565292. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Member of the public are also entitled to submit written comments; the comments must be received in the regional office by August 31, 2015. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at callen@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// facadatabase.gov/committee/meetings.aspx?cid=269 and clicking on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning delivery schedules. A notice was published in the Federal Register at 80 FR 22735, on April 23, 2015. No comments were received.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Qualification of BiomarkerPlasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease.'' This draft guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This draft guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. In the Federal Register of January 7, 2014, FDA announced the availability of a final guidance for industry entitled ``Qualification Process for Drug Development Tools'' that described the process that would be used to qualify drug development tools (DDTs) and to make new DDT qualification recommendations available on FDA's Web site. The qualification recommendations in this draft guidance were developed using the process described in that guidance.

The Food and Drug Administration (FDA) is denying Chung Po Liu's (Liu) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Liu for 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Liu was convicted of a felony for conduct relating to the importation of an article of food into the United States. In determining the appropriateness and period of Liu's debarment, FDA has considered the relevant factors listed in the FD&C Act. Liu has failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.

This notice announces the availability of and request comments on the proposed authorization of Alaska Fixed Wing External Loads (FWEL) as a new restricted category special purpose operation, pursuant to Title 14 of the Code of Federal Regulations (14 CFR) 21.25(b)(7), for operations within the State of Alaska.

This notice announces the Federal Aviation Administration's (FAA) intent to cancel AC 20-159. This cancellation will result in no new approval of technical standard order authorizations (TSOA) for an ``incomplete system'' issued for Technical Standard Order (TSO) C-165, Electronic Map Display Equipment for Graphical Depiction of Aircraft Position. Therefore, the guidance contained in AC 20-159 allowing applicants to obtain a design and production approval using the software and database for an airport moving map display (AMMD) intended for use on a Class 2 electronic flight bag (EFB) for ground operations, will no longer be available. FAA AC 120-76C, Guidelines for the Certification, Airworthiness, and Operational Use of Electronic Flight Bags, dated May 9, 2014, replaces AC 20-159 and provides guidance for applicants seeking authorization to display an own-ship symbol limited to the airport surface as a Type B application for use on any EFB.

The Department of Justice, Office of Tribal Justice, 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. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the FR 80 23287, on April 27, 2015, allowing for a 60 day comment period.

Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.

This is a notice of the Presidential declaration of a major disaster for the State of Nebraska (FEMA-4225-DR), dated June 25, 2015, and related determinations.

The U.S. Nuclear Regulatory Commission (NRC) is announcing the availability of Interim Staff Guidance (ISG) for Natural Phenomena Hazards (NPH) in Fuel Cycle Facilities. Fuel cycle facility licensees are required to conduct and maintain an Integrated Safety Analysis (ISA). This analysis must examine potential accident sequences caused by process deviations or other events internal to the facility and credible external events, including natural phenomena. The staff is issuing this ISG to provide additional guidance to the NRC staff for the review of fuel cycle facilities ISA evaluation of accident sequences that may result from NPH. This ISG will be incorporated into future revisions of Appendix D of Chapter 3 of NUREG 1520, ``Standard Review Plan for the Review of a License Application for a Fuel Cycle Facility.'' Specific emphasis was provided on seismic hazards due to recent events such as the Fukushima Dai-ichi accident and recent updates to the U.S. Geological Survey hazard curves.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft NUREG-1927, Revision 1, ``Standard Review Plan for Renewal of Specific Licenses and Certificates of Compliance for Dry Storage of Spent Nuclear Fuel.'' The draft NUREG provides guidance to the NRC staff for the safety review of renewal applications for specific licenses of independent spent fuel storage installations (ISFSIs) and certificates of compliance (CoCs) of spent fuel storage casks. The NRC is soliciting public comments on this draft NUREG and will consider received comments as it finalizes the guidance.

The OCC, 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 continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The OCC is soliciting comment concerning the renewal of its information collection titled, ``Procedures to Enhance the Accuracy and Integrity of Information Furnished to Consumer Reporting Agencies under Section 312 of the Fair and Accurate Credit Transactions Act (FACT Act).''

The Office of the Comptroller of the Currency (OCC) announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).

This document corrects a technical error that appeared in the final rule published in the February 27, 2015 Federal Register (80 FR 10749) entitled ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2016.''

The Committee For Purchase from People Who Are Blind Or Severely Disabled (Committee) has announced appointments to the Committee Performance Review Board.

The Federal Transit Administration (FTA) announces establishment of the Pilot Program for Expedited Project Delivery (Pilot Program) authorized by Section 20008 of the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, July 6, 2012, and solicits expressions of interest to participate. The Pilot Program is aimed at increasing innovation, improving efficiency and timeliness of project implementation, and encouraging new revenue streams for new fixed guideway projects and core capacity improvement projects. FTA plans to use the lessons learned from the Pilot Program to assist other project sponsors to develop more effective approaches to project planning, project development, finance, design, and construction. Additionally, FTA anticipates that the Pilot Program will help to identify impediments in current laws, regulations, and practices to the greater use of innovative project development and delivery methods or innovative financing arrangements. Participants selected for the Pilot Program may receive enhanced technical assistance and expedited FTA reviews to speed up planning, development, and delivery of eligible Capital Investment Grant (CIG) program projects and ultimately receive Full Funding Grant Agreements under that program. Should legislation be enacted for the Pilot Program that would allow projects to proceed outside of the normal CIG program processes and criteria, participants also may be able to receive a Full Funding Grant Agreement under the terms of that legislation. Lastly, participants selected for the Pilot Program also may benefit from technical assistance provided by the Department of Transportation's Build America Transportation Investment Center (BATIC). This announcement is available on the FTA's Web site at: www.fta.dot.gov.

The National Institute of Standards and Technology (NIST) seeks comments on the NIST Plan for Providing Public Access to the Results of Federally Funded Research (NIST Public Access Plan). NIST is taking steps to make its scientific data and publications more readily available and accessible by the public, as directed in several recent White House memoranda. The NIST Public Access Plan applies to the results of research funded wholly or in part by NIST, presented in peer-reviewed scholarly publications and as research data. This document outlines NIST's plan for implementing new responsibilities and procedures to manage the public access of scientific data and publications. The NIST Public Access Plan was reviewed by the Office of Science and Technology Policy and the Office of Management and Budget; they approved it on December 4, 2014. Comments received on the NIST Public Access Plan will inform NIST as it revises its directives that implement the Plan.