June 16, 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 108
Fisheries of the Exclusive Economic Zone Off Alaska; Chinook Salmon Bycatch Management in the Gulf of Alaska Trawl Fisheries; Amendment 103
NMFS proposes regulations to implement Amendment 103 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). If approved, Amendment 103 and this proposed rule would allow NMFS to reapportion unused Chinook salmon prohibited species catch (PSC) within and among specific trawl sectors in the Central and Western Gulf of Alaska (GOA), based on specific criteria and within specified limits. This proposed rule would not increase the current combined annual PSC limit of 32,500 Chinook salmon that applies to Central and Western GOA trawl sectors under the FMP. This proposed rule would provide for more flexible management of GOA trawl Chinook salmon PSC, increase the likelihood that groundfish resources are more fully harvested, reduce the potential for fishery closures, and maintain the overall Chinook salmon PSC limits in the Central and Western GOA. Amendment 103 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Tribal Management Grant Program; Extension of Due Dates
This document extends due dates in the Fiscal Year 2016 Tribal Management Grant Program funding announcement that was published in the Federal Register (81 FR 20396) on April 7, 2016. Several key dates have been extended.
Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Correction
The Indian Health Service published a document in the Federal Register on June 3, 2016, for the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service. The notice contained the incorrect U.S. Code regarding consultation.
Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Prior Notice of Imported Food Questions and Answers (Edition 3): Guidance for Industry.'' The guidance provides updated information pertaining to prior notice of imported food under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food Safety Modernization Act (FSMA) on January 4, 2011. The guidance is intended to help the food industry and others comply with prior notice requirements.
Pediatric Clinical Investigator Training; Public Workshop
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are announcing a 2-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Although we have learned a lot about conducting pediatric trials over the past two decades, there are still challenges that need to be addressed. The training course is intended to provide investigators with: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: Pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
Information Collections Being Submitted for Review and Approval to the Office of Management and Budget
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 Communication 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.
New Date for the October 2016 Customs Broker License Examination
This document announces that U.S. Customs and Border Protection has changed the date on which the semi-annual written examination for an individual broker's license will be held in October 2016.
Information Collection Request; Submission for OMB Review
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 60 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
International Product Change-Global Plus 3 Contracts
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add the Global Plus 3 product to the Competitive Products List.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Projects Rescinded for Consumptive Uses of Water
This notice lists the approved by rule projects rescinded by the Susquehanna River Basin Commission during the period set forth in DATES.
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.
Factors To Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.'' This draft guidance, when finalized, is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Although product availability and other medical device compliance and enforcement decisions are generally fact-specific, FDA believes that consideration of the factors listed in the draft guidance, when relevant, will improve the consistency and transparency of those decisions and that a shared understanding of benefit and risk will better align industry's and FDA's focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients. This draft guidance is not final nor is it in effect at this time.
Equity Market Structure Advisory Committee Meeting
The Securities and Exchange Commission Equity Market Structure Advisory Committee is providing notice that it will hold an open, public telephone meeting on Friday, July 8, 2016, beginning at 2:00 p.m. (EDT). Members of the public may attend the meeting by listening to the webcast accessible on the Commission's Web site at www.sec.gov. Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The agenda for the meeting includes presentations by the Regulation NMS and Trading Venues Regulations subcommittee chairs and consideration of a recommendation for an access fee pilot and recommendations related to trading venues regulation. The public is invited to submit written statements to the Committee.
Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process”; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Use of International Standard ISO 10993-1, `Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process.' '' FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993- 1, ``Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process'' to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing.' ''
Hazardous Materials: Information Collection Activities
In accordance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Requests (ICRs) discussed below will be forwarded to the Office of Management and Budget (OMB) for renewal and extension. These ICRs describe the nature of the information collections and their expected burdens. A Federal Register notice with a 60-day comment period soliciting comments on these ICRs was published in the Federal Register on March 24, 2016 [81 FR 15785] under Docket No. PHMSA-2016-0027 (Notice No. 2016-2). PHMSA did not receive any comments in response to the March 24, 2016 notice.
Approval and Promulgation of Air Quality Implementation Plans; Virginia Infrastructure Requirements for the 2012 Fine Particulate Matter National Ambient Air Quality Standards
The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the Commonwealth of Virginia (Virginia) pursuant to the Clean Air Act (CAA). Whenever new or revised national ambient air quality standards (NAAQS) are promulgated, the CAA requires states to submit a plan to address basic program elements, including but not limited to regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure implementation, maintenance, and enforcement of the NAAQS. These elements are referred to as infrastructure requirements. The Commonwealth of Virginia made a submittal addressing the infrastructure requirements for the 2012 fine particulate matter (PM2.5) NAAQS.
Proposed Establishment of Class E Airspace; Jetmore, KS
This action proposes to establish Class E airspace at Jetmore, KS. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures developed at Jetmore Municipal Airport, for the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Air Plan Approval; UT; Revised Format for Material Incorporated by Reference
The Environmental Protection Agency (EPA) is revising the format of materials submitted by the State of Utah that are incorporated by reference (IBR) into its State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by Utah and approved by the EPA.
Approval of California Air Plan Revisions, Eastern Kern Air Pollution Control District and Yolo-Solano Air Quality Management District
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Yolo-Solano Air Quality Management District (YSAQMD) and Eastern Kern Air Pollution Control District (EKAPCD) portions of the California State Implementation Plan (SIP). These revisions concern, respectively, the definition of volatile organic compounds (VOCs), and emissions of VOCs from the surface coating operations of wood products. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).
Approval of California Air Plan Revisions, Eastern Kern Air Pollution Control District and Yolo-Solano Air Quality Management District
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Yolo-Solano Air Quality Management District (YSAQMD) and Eastern Kern Air Pollution Control District (EKAPCD) portions of the California State Implementation Plan (SIP). These revisions concern, respectively, the definition of volatile organic compounds (VOCs), and emissions of VOCs from the surface coating operations of wood products. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).
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