October 8, 2015 – Federal Register Recent Federal Regulation Documents

The Animal and Plant Health Inspection Service proposes to revise an existing system of records in its inventory of record systems subject to the provisions of the Privacy Act of 1974, as amended. The Animal and Plant Health Inspection Service is revising Wildlife Services Management Information System, USDA-APHIS-9, to revise the routine uses, expand the categories of records in the system, and the location of the system. This notice is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of record systems maintained by the agency.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Integrated Summary of Effectiveness.'' This guidance describes how an integrated summary of effectiveness (ISE) should be prepared by industry for new drug applications (NDAs) and biologics license applications (BLAs). This guidance is intended to improve the quality of drug applications by describing what efficacy information should be submitted so that FDA can make a regulatory decision on an application. This guidance finalizes the draft guidance issued August 28, 2008.

The U.S. Department of Transportation's (DOT), Federal Transit Administration (FTA) announces the selection of projects for the Fiscal Year (FY) 2015 Innovative Public Transportation Workforce Development Program (Workforce Development Program). Under the prior authorization, the Workforce Development Program was authorized under 49 U.S.C. 5322. Under the Moving Ahead for Progress in the 21st Century (MAP-21) Act, the program is authorized at 49 U.S.C. 5322(b). These projects are funded with a combination of $4 million of unallocated Section 5314 Federal funds appropriated in FY 2012, and a total of $5.5 million authorized under MAP-21 and appropriated in FYs 2013, 2014, and 2015 for Section 5322. These program dollars will provide financial assistance to promote diverse and innovative workforce development models and programs that specifically target unemployment training programs, outreach to increase minority and female employment, and training for minority business opportunities.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (``CPSC'' or ``Commission'') requests comments on a proposed extension of approval of a collection of information under the safety standard for swings, approved previously under OMB Control No. 3041-0155. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (``OMB'').

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for these outsourcing facilities.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement section 814 of the Carl Levin and Howard P. `Buck' McKeon National Defense Authorization Act for Fiscal Year 2015 that requires the head of the contracting activity to approve any determinations to select more than five offerors to submit phase-two proposals for a two-phase design-build construction acquisition that is valued at greater than $4 million.

The National Urban and Community Forestry Advisory Council (Council) will meet in Denver, Colorado. The Council is authorized under section 9 of the Cooperative Forestry Assistance Act, as amended by title XII, section 1219 of Public Law 101-624 (the Act) (16 U.S.C. 2105g) and the Federal Advisory Committee Act (FACA) (5 U.S.C. App. II). Additional information concerning the Council, can be found by visiting the Council's Web site at: https://www.fs.fed.us/ucf/ nucfac.shtml.

The Federal Trade Commission published final rules on May 6, 2015, revising certain of its rules of practice. This document makes a technical correction to those final rules.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

This document provides the public notice that by a document dated September 19, 2015, the Southern California Regional Rail Authority (SCRRA) submitted to FRA its Positive Train Control Safety Plan (PTCSP) Version 1.7 for approval under the Federal railroad safety regulations in Title 49 Code of Federal Regulations (CFR) Part 236, Subpart I, Positive Train Control Systems. SCRRA asks FRA to approve its PTCSP and to provide PTC System Certification for SCRRA's implementation of its Interoperable-Electronic Train Management System (I-ETMS). In its PTCSP, SCRRA asserts that its I-ETMS is designed as a vital overlay PTC system in compliance with the PTCSP requirements. The PTCSP describes the SCRRA I-ETMS implementation and the associated I- ETMS safety processes; safety analyses; and test, validation, and verification processes used during development of I-ETMS. The PTCSP also contains SCRRA operational and support requirements and procedures. SCCRA's PTCSP and the accompanying request for approval are available for review online at www.regulations.gov (Docket No. FRA- 2010-0048) and in person at the U.S. Department of Transportation's (DOT) Docket Operations Facility, 1200 New Jersey Avenue SE., W12-140, Washington, DC 20590. The Docket Operations Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except Federal Holidays. Interested parties are invited to comment on the PTCSP by submitting written comments or data. During its review of the PTCSP, FRA will consider any comments or data submitted. However, FRA may not respond to any comment and, under 49 CFR 236.1009(d)(3), FRA maintains the authority to approve or disapprove the PTCSP at its sole discretion. FRA does not anticipate scheduling a public hearing regarding these proceedings because the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA in writing before the end of the comment period and specify the basis for their request.

We are adopting a new airworthiness directive (AD) for all Model FAN JET FALCON, FAN JET FALCON SERIES C, D, E, F, and G airplanes; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This AD was prompted by reports of defective fire extinguisher tubes. It was determined the defects were caused by corrosion. This AD requires repetitive general visual inspections of the fire extinguisher tubes for cracking and corrosion, and replacement of any cracked tube with a serviceable tube, if necessary. We are issuing this AD to detect and correct cracking and corrosion in the fire extinguisher tubes, which could impact the capability to extinguish an engine fire, and possibly result in damage to the airplane and injury to the passengers.