December 5, 2016 – Federal Register Recent Federal Regulation Documents
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Compliance Policy Guide Sec. 615.115 on Extralabel Use of Medicated Feeds for Minor Species; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised Compliance Policy Guide (CPG) 615.115 entitled ``Extralabel Use of Medicated Feeds for Minor Species.'' In advance of the January 1, 2017, date on which we anticipate that a number of drugs will convert from over-the-counter (OTC) to veterinary feed directive (VFD) status, this revised CPG clarifies policy and regulatory action guidance to FDA staff on the Agency's exercise of regulatory discretion with regard to the extralabel use of medicated feeds containing those drugs in minor species.
United States Rail Service Issues-Performance Data Reporting
The Surface Transportation Board (STB or Board) is adopting a final rule to establish new regulations requiring all Class I railroads and the Chicago Transportation Coordination Office (CTCO), through its Class I members, to report certain service performance metrics on a weekly, semiannual, and occasional basis.
Excepted Service
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from June 1, 2016 to June 30, 2016.
Excepted Service
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from April 1, 2016, to April 30, 2016.
Submission for OMB Emergency Review: OPM Form SF 15, Application for 10-Point Veteran Preference, OMB No. 3206-0001
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces the Office of Personnel Management (OPM) submitted a request to the Office of Management and Budget (OMB) for emergency clearance and review for OPM Form SF 15, Application for 10-Point Veteran Preference. Emergency clearance is required as the current form approval expired October 31, 2016. OPM will publish a 60-notice requesting comments on proposed revisions to the SF 15 at a later date. The SF 15 is used by agencies, OPM examining offices, and agency appointing officials to adjudicate individuals' claims for veterans' preference in accordance with the Veterans' Preference Act of 1944. Public burden reporting for this collection of information is estimated to take approximately 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Comments are invited on: Whether this information is necessary for the proper performance of functions on the Office of Personnel Management, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology. For copies of this proposal, contact CIO PRA Officer on (202) 606- 0125 or via email to formsmanager@opm.gov. Please include your complete mailing address with your request.
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and form at of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the CLINICAL PHARMACOLOGY section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This guidance finalizes the 2014 revised draft guidance entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological ProductsConsiderations, Content, and Format.''
30-Day Notice of Proposed Information Collection: Financial Statement of Corporate Applicant for Cooperative Housing Mortgage
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
60-Day Notice of Proposed Information Collection: Affirmative Fair Housing Marketing Plan
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
30-Day Notice of Proposed Information Collection: Uniform Physical Standards and Physical Inspection Requirements
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
30-Day Notice of Proposed Information Collection: FHA Adjustable Rate Mortgages (ARMS)
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
30-Day Notice of Proposed Information Collection: Family Report, Moving to Work (MTW) Family Report
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Health Document Submission Requirements for Tobacco Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``Health Document Submission Requirements for Tobacco Products.'' The guidance provides information to assist persons making health document submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act. We received several comments to the draft guidance, and those comments were considered as the guidance was finalized.
Advisory Board on Toxic Substances and Worker Health: Subcommittee on Evidentiary Requirements for Part B Lung Disease
The subcommittee will meet via teleconference on December 21, 2016, from 2:30 p.m. to 6:00 p.m. Eastern Time.
Notification of Submission to the Secretary of Agriculture; Pesticides; Removal of Obsolete Information
This document notifies the public as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document concerning removal of obsolete information. The draft regulatory document is not available to the public until after it has been signed and made available by EPA.
Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has added the title Deputy Assistant Secretary for Native American Affairs to Commissioner, Administration for Native Americans position.
Tau-Fluvalinate; Pesticide Tolerance
This regulation establishes a tolerance for residues of tau- fluvalinate in or on wine grapes. Makhteshim Agan of North America, Inc., d/b/a ADAMA requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Special Local Regulation; Southern California Annual Marine Events for the San Diego Captain of the Port Zone-San Diego Parade of Lights
The Coast Guard will enforce the San Diego Parade of Lights special local regulations on the waters of San Diego Bay, California on December 11, 2016 and December 18, 2016. These special local regulations are necessary to provide for the safety of the participants, crew, spectators, sponsor vessels, and general users of the waterway. During the enforcement period, persons and vessels are prohibited from anchoring, blocking, loitering, or impeding within this regulated area unless authorized by the Captain of the Port, or his designated representative.
Oxathiapiprolin; Pesticide Tolerances
This regulation establishes tolerances for residues of oxathiapiprolin in or on multiple commodities which are identified and discussed later in this document. In addition, this regulation amends the established tolerance for vegetable, tuberous and corm, subgroup 1C; and removes existing tolerances for Brassica, head and stem, subgroup 5A, and leafy greens subgroup 4A that are superseded by this action. Interregional Research Project Number 4 (IR-4), E.I. du Pont de Nemours & Company (DuPont), and Syngenta Crop Protection, LLC (Syngenta) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Peer Review of EPA's Biologically Based Dose-Response (BBDR) Model for Perchlorate in Drinking Water-Final List of Peer Reviewers, Notice of the Public Peer Review Meeting and Final Peer Review Charge Questions
The U.S. Environmental Protection Agency (EPA) is announcing the final peer reviewers assembled by Versar, Inc., an EPA contractor, for the external peer review of EPA's draft Biologically Based Dose- Response (BBDR) Model for perchlorate in drinking water and an accompanying draft model report. The draft model report is entitled ``Biologically Based Dose-Response Models for the Effect of Perchlorate on Thyroid Hormones in the Infant, Breast Feeding Mother, Pregnant Mother, and Fetus: Model Development, Revision, and Preliminary Dose- Response Analyses.'' EPA is also announcing availability of the final peer review charge. The charge provides the purpose and context for the assessment and will guide the peer review experts by identifying the key scientific issues associated with the review of the model and report. EPA is also announcing that Versar, Inc., will organize and conduct the public peer review meeting for the draft BBDR model and draft model report on January 10 and 11, 2017, in Arlington, Virginia. The meeting will be devoted to discussion and deliberation of major issues identified by the peer reviewers regarding EPA's draft BBDR model and draft model report and will be guided by the final charge questions. Versar, Inc., invites the public to register to attend this two-day meeting as observers, either in-person or via teleconference. Time will be set aside at the meeting for brief oral statements from the public regarding the draft BBDR model and model report.
Area Maritime Security Advisory Committee (AMSC), Eastern Great Lakes and Regional Sub-Committee Vacancies
This notice requests individuals interested in serving on the Area Maritime Security Committee (AMSC), Eastern Great Lakes, and the four regional sub-committees: Northeast Ohio Region, Northwestern Pennsylvania Region, Western New York Region, and Eastern New York Region submit their applications for membership to the Captain of the Port, Buffalo. The Committee assists the Captain of the Port, Buffalo, in developing, reviewing, and updating the Area Maritime Security Plan for their area of responsibility.
Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices
The Food and Drug Administration (FDA) 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 information collection regarding ``Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
The Food and Drug Administration (FDA) 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 recommended glossary and educational outreach to support use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use.
Notice of Intent To Collect Fees on Public Land in Douglas County, Oregon, Roseburg District, Scaredman Recreation Site
Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (FLREA), the Bureau of Land Management (BLM), Roseburg District Office, is proposing to begin collecting fees for overnight camping at Scaredman Recreation Site, located in Douglas County, Oregon.
Notice of Intent To Grant an Exclusive Patent License
Pursuant to the Bayh-Dole Act and implementing regulations, the Department of the Air Force hereby gives notice of its intention to grant an exclusive patent license agreement to The University of Utah, an educational institution duly organized, validly existing, and in good standing in the State of Utah, having a place of business at 615 Arapeen Drive, Suite 310, Salt Lake City, UT 84108. Authority: 35 U.S.C. 209; 37 CFR 404.
Notice of Intent To Grant an Exclusive Patent License
Pursuant to the Bayh-Dole Act and implementing regulations, the Department of the Air Force hereby gives notice of its intent to grant an exclusive patent license agreement to Protective Innovations, LLC, a corporation of the State of Delaware.
Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the public meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products that was announced in the Federal Register on October 6, 2016. In that Federal Register notice, FDA requested comments on the approach to testing FDA recommended in its draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products'' and FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Succession, Delegations of Authority, and Signature Authorities, No. IG-1313, Change 8
On November 9, 2016, USDA Inspector General Phyllis K. Fong, pursuant to authority vested in her by the Federal Vacancies Reform Act (5 U.S.C. 3345-3349d) and the Inspector General Act of 1978, as amended (5 U.S.C. app. 3), issued IG-1313, Change 8, Succession, Delegations of Authority, and Signature Authorities. This directive is a revised succession order and reflects delegations of authority for the Office of Inspector General. This directive has been revised to update the lines of succession and delegation, and to clarify procedures to be followed in the event the Office of Inspector General (OIG) headquarters must be relocated. This directive provides guidance on the transfer of functions and duties of the Inspector General (IG), as well as other OIG central management functions, regardless of what events necessitate such transfer.
Native American Tribal Insignia Database
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, (44 U.S.C. 3506(c)(2)(A), is proposing an extension of an existing information collection; the Native American Tribal Insignia Database.
Delegation of Authority
This document provides the public with notice of the delegation of authority for certain activities related to the licensing of small business investment companies by the Administrator of the Small Business Administration (SBA) to the Agency Licensing Committee.
Environmental Impact Statement for Cumberland Fossil Plant Coal Combustion Residual Management
The Tennessee Valley Authority (TVA) intends to prepare an Environmental Impact Statement (EIS) to address the potential environmental effects associated with management of coal combustion residual (CCR) material produced at the Cumberland Fossil Plant (CUF) located near Cumberland City, Stewart County, Tennessee. The purpose of the proposed EIS is to address long-term management of CCR produced at CUF. The project will help TVA comply with state and federal regulatory requirements related to CCR production and management, including the requirements of U.S. Environmental Protection Agency (EPA's) CCR Rule and Effluent Limitations Guidelines. TVA will evaluate the potential environmental impacts of construction and operation of a new bottom ash dewatering facility and options for management and disposal of dry CCR produced at CUF. TVA will also evaluate closure of the Bottom Ash and the Main Ash Impoundments. TVA will develop and evaluate various alternatives to these actions, including the No Action Alternative. Public comments are invited concerning both the scope of the review and environmental issues that should be addressed.
Energy Conservation Program: Energy Conservation Standards for Residential Furnaces
On September 23, 2016, the U.S. Department of Energy (DOE) published a supplemental notice of proposed rulemaking (SNOPR) and announcement of public meeting pertaining to proposed energy conservation standards for residential furnaces in the Federal Register. The notice provided an opportunity for submitting written comments, data, and information by November 22, 2016. This document announces a reopening of the public comment period for submitting comments and data on the SNOPR or any other aspect of the rulemaking for residential furnaces. The comment period is reopened until January 6, 2017.
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