October 8, 2015 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 107
Privacy Act Systems of Records; Wildlife Services Management Information System
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.
Integrated Summary of Effectiveness; Guidance for Industry; Availability
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 This guidance finalizes the draft guidance issued August 28, 2008.
Fiscal Year 2015 Innovative Public Transportation Workforce Development Program Project Selections
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.
General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. The proposed regulation for both pediatric medical cribs and medical bassinets would also include the Consumer Product Safety Commission's (CPSC) mattress flammability standards for the mattresses intended for use with these devices. In addition, this proposed rule would require prescription use of pediatric medical cribs and bassinets.
Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Standard for Infant Swings
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'').
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information associated with the Food Contact Substance Notification Program.
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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.
Agency Information Collection Activities; Proposed Collection; Submission for Office of Management and Budget Review; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level
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.
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
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.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection; Comments Requested: Generic Clearance for Cognitive, Pilot and Field Studies for Bureau of Justice Statistics Data Collection Activities
The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Statistics (BJS) intends to request approval from the Office of Management and Budget (OMB) for a generic information collection clearance that will allow BJS to conduct a variety of cognitive, pilot, and field test studies. BJS will submit the request for review and approval in accordance with the Paperwork Reduction Act of 1995. Over the next three years, BJS anticipates undertaking a variety of new surveys and data collections, as well as reassessing ongoing statistical projects, across a number of areas of criminal justice, including law enforcement, courts, corrections, and victimization. This work will entail development of new survey instruments, redesigning and/or modifying existing surveys, procuring administrative data from state and local government entities, and creating or modifying establishment surveys. In order to inform BJS data collection protocols, to develop accurate estimates of respondent burden, and to minimize respondent burden associated with each new or modified data collection, BJS will engage in cognitive, pilot and field test activities to refine instrumentation and data collection methodologies. BJS envisions using a variety of techniques, including but not limited to tests of different types of survey and data collection operations, focus groups, cognitive testing, pilot testing, exploratory interviews, experiments with questionnaire design, and usability testing of electronic data collection instruments. Following standard Office of Management and Budget (OMB) requirements, BJS will submit a change request to OMB individually for every group of data collection activities undertaken under this generic clearance. BJS will provide OMB with a copy of the individual instruments or questionnaires (if one is used), as well as other materials describing the project.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change, of a Previously Approved Collection Federal Firearms License (FFL) RENEWAL Application
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.
Sanctions Actions Pursuant to Executive Order 13224
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of 3 individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''
Federal Acquisition Regulation; Simplified Acquisition Threshold for Overseas Acquisitions in Support of Humanitarian or Peacekeeping Operations
DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a higher simplified acquisition threshold for overseas acquisitions in support of humanitarian or peacekeeping operations.
Federal Acquisition Regulation; Improvement in Design-Build Construction Process
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.
Projects Approved for Consumptive Uses of Water
This notice lists the projects approved by rule by the Susquehanna River Basin Commission during the period set forth in DATES.
National Urban and Community Forestry Advisory Council
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.
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish a notice of permit applications received 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 permit applications received.
Aviation Rulemaking Advisory Committee Meeting on Transport Airplane and Engine Issues
This notice announces a public meeting of the FAA's Aviation Rulemaking Advisory Committee (ARAC) Transport Airplane and Engine (TAE) Subcommittee to discuss TAE issues.
Miscellaneous Rules
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.
Wright Medical Group, Inc. and Tornier N.V.; Analysis To Aid Public Comment
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.
Privacy Act of 1974, as Amended; Computer Matching Program (SSA/Office of Personnel Management (OPM))-Match Numbers 1005, 1019, 1020, and 1021
In accordance with the provisions of the Privacy Act, as amended, this notice announces a renewal of existing computer matching programs that we are currently conducting with OPM.
Assessment and Collection of Regulatory Fees for Fiscal Year 2015
In this document the Commission revises its Schedule of Regulatory Fees to recover an amount of $339,844,000 that Congress has required the Commission to collect for fiscal year 2015. Section 9 of the Communications Act of 1934, as amended, provides for the annual assessment and collection of regulatory fees under sections 9(b)(2) and 9(b)(3), respectively, for annual ``Mandatory Adjustments'' and ``Permitted Amendments'' to the Schedule of Regulatory Fees.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
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.
Approval and Promulgation of Implementation Plans; Kentucky: New Sources in or Impacting Nonattainment Areas
The Environmental Protection Agency (EPA) is taking final action to approve the Commonwealth of Kentucky's September 23, 2011, State Implementation Plan (SIP) revision, submitted through the Kentucky Division for Air Quality (KY DAQ), which modifies the SIP by making changes to Kentucky regulation, ``Review of new sources in or impacting upon nonattainment areas.'' EPA has determined that Kentucky's requested SIP revision meets the applicable provisions of the Clean Air Act (CAA or Act) and EPA regulations regarding Nonattainment New Source Review (NNSR) permitting.
Positive Train Control Safety Plan for the Southern California Regional Rail Authority
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.
Security Zone: Escorted Vessels, Los Angeles-Long Beach, CA, Captain of the Port Zone
The Coast Guard is establishing a security zone around any vessel escorted by one or more Coast Guard, State, or local law enforcement assets on the navigable waters of the Captain of the Port (COTP) Zone, Los Angeles-Long Beach, California. This action is necessary to protect personnel, vessels, and facilities from sabotage or other subversive acts, accidents, or other events of a similar nature. No vessel or person is allowed in this zone unless authorized by the Captain of the Port or a designated representative.
Airworthiness Directives; Dassault Aviation Airplanes
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.
Administrative Wage Garnishment Procedures
This rule will allow the U.S. Department of Labor (Department) to garnish the disposable wages of non-federal workers who are indebted to the Department without first obtaining a court order. It implements the administrative wage garnishment provisions contained in the Debt Collection Improvement Act of 1996 (DCIA) in accordance with the regulations issued by the Secretary of the Treasury.
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