2016 – Federal Register Recent Federal Regulation Documents

Results 3,501 - 3,550 of 31,152
National Cancer Institute; Notice of Closed Meeting
Document Number: 2016-27874
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-27873
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27872
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-27871
Type: Notice
Date: 2016-11-21
Agency: Department of Health and Human Services, National Institutes of Health
2017 Exim Bank Advisory Committee Nomination Process
Document Number: 2016-27870
Type: Notice
Date: 2016-11-21
Agency: Export-Import Bank, Agencies and Commissions
Air Plan Approval/Disapproval; AL Infrastructure Requirements for the 2010 1-Hour NO2
Document Number: 2016-27862
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve in part, and disapprove in part, portions of the April 23, 2013, and December 9, 2015, of the State Implementation Plan (SIP) submissions, submitted by the State of Alabama, through the Alabama Department of Environmental Management (ADEM), to demonstrate that the State meets certain infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour nitrogen dioxide (NO2) national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. ADEM certified that the Alabama SIP contains provisions that ensure the 2010 1-hour NO2 NAAQS is implemented, enforced, and maintained in Alabama. With the exception of the provisions pertaining to prevention of significant deterioration (PSD) permitting, and visibility in other states, for which EPA is proposing no action through this notice, and the provisions respecting state boards, for which EPA is finalizing disapproval, EPA has determined portions of Alabama's infrastructure SIP submissions, provided to EPA on April 23, 2013, and updated on December 9, 2015, satisfy certain required infrastructure elements for the 2010 1-hour NO2 NAAQS.
Marine Mammals; File No. 20443
Document Number: 2016-27861
Type: Notice
Date: 2016-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that the Alaska Department of Fish and Game, PO Box 115526, Juneau, AK 99811-5526 [Responsible Party: Robert Small, Ph.D.], has applied in due form for a permit to conduct research on marine mammals.
Marine Mammals and Endangered Species; File Nos. 13927, 16553, and 20532
Document Number: 2016-27860
Type: Notice
Date: 2016-11-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that permits or permit amendments have been issued to the following entities:
Air Quality Plan; Georgia; Infrastructure Requirements for the 2012 PM2.5
Document Number: 2016-27857
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve a portion of the State Implementation Plan (SIP) submission, submitted by the State of Georgia, through the Georgia Department of Natural Resources, Environmental Protection Division, on December 14, 2015, to demonstrate that the State meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure SIP submission.'' Georgia certified that its SIP contains provisions that ensure the 2012 Annual PM2.5 NAAQS is implemented, enforced, and maintained in Georgia. EPA is approving portions of Georgia's infrastructure SIP submission, provided to EPA on December 14, 2015, as satisfying certain required infrastructure elements for the 2012 Annual PM2.5 NAAQS.
Revisions to the California State Implementation Plan; South Coast Air Quality Management District; Control of Oxides of Nitrogen Emissions From Off-Road Diesel Vehicles
Document Number: 2016-27853
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve South Coast Air Quality Management District (SCAQMD or ``the District'') Rule 2449, Control of Oxides of Nitrogen Emissions from Off-Road Diesel Vehicles, as a revision to the SCAQMD portion of the California State Implementation Plan (SIP). SCAQMD Rule 2449 adopts by reference title 13, chapter 9, section 2449.2 of the California Code of Regulations, ``Surplus Off-Road Opt-In for NOX (SOON) Program.'' SCAQMD Rule 2449 requires certain in-use off-road vehicle fleets to meet more stringent requirements in the South Coast area when funding is provided by the District in order to achieve additional reductions of oxides of nitrogen (NOX).
Designation of Areas for Air Quality Planning Purposes; Ohio; Redesignation of the Ohio Portion of the Campbell-Clermont KY-OH Sulfur Dioxide Nonattainment Area
Document Number: 2016-27852
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
In accordance with the Clean Air Act (CAA), the Environmental Protection Agency (EPA) is redesignating the Ohio portion of the Campbell-Clermont KY-OH sulfur dioxide (SO2) nonattainment area from nonattainment to attainment. The Ohio portion of this area consists of Pierce Township in Clermont County, Ohio. EPA is also approving Ohio's maintenance plan, submitted on August 11, 2015. The primary emission source in the area has permanently closed, and the air quality in the area is now meeting the SO2 standard. EPA received one comment in support of the redesignation.
Revisions to Procedure 2-Quality Assurance Requirements for Particulate Matter Continuous Emission Monitoring Systems at Stationary Sources
Document Number: 2016-27849
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking direct final action to update a procedure in the New Source Performance Standards (NSPS). The procedure provides the ongoing quality assurance/ quality control (QA/QC) procedures for assessing the acceptability of particulate matter (PM) continuous emissions monitoring systems (CEMS). The procedure explains the criteria for passing an annual response correlation audit (RCA) and the criteria for passing an annual relative response audit (RRA). The procedure currently contains a requirement that the annual QA/QC test results for affected facilities must fall within the same response range that was used to develop the existing PM CEMS correlation curve. As a result, some facilities are unable to meet the criteria for passing their annual QA/QC test because their emissions are now lower than the range previously set during their correlation testing. We are modifying the procedure to allow facilities to extend their PM CEMS correlation regression line to the lowest PM CEMS response obtained during the annual RCA or RRA, when these PM CEMS responses are less than the lowest response used to develop the existing correlation curve. This change will ensure that facilities that have reduced their emissions since completing their correlation testing will no longer be penalized because their lower emissions fall outside their initial response range. This action also corrects a typographical error in the procedure.
Revisions to Procedure 2-Quality Assurance Requirements for Particulate Matter Continuous Emission Monitoring Systems at Stationary Sources
Document Number: 2016-27847
Type: Proposed Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing revisions to a procedure in the New Source Performance Standards (NSPS). The procedure provides the ongoing quality assurance/quality control (QA/QC) procedures for assessing the acceptability of particulate matter (PM) continuous emissions monitoring systems (CEMS). The procedure explains the criteria for passing an annual response correlation audit (RCA) and the criteria for passing an annual relative response audit (RRA). The procedure currently contains a requirement that the annual QA/QC test results for affected facilities must fall within the same response range as was used to develop the existing PM CEMS correlation curve. As a result, some facilities are unable to meet the criteria for passing their annual QA/QC test simply because their emissions are now lower than the range previously set during correlation testing. We are proposing to modify the procedure to allow facilities to extend their PM CEMS correlation regression line to the lowest PM CEMS response obtained during the RCA or RRA, when these PM CEMS responses are less than the lowest response used to develop the existing correlation curve. We also propose to correct a typographical error in the procedure.
Clarifications and Revisions to Military Aircraft, Gas Turbine Engines and Related Items License Requirements
Document Number: 2016-27777
Type: Rule
Date: 2016-11-21
Agency: Department of Commerce, Bureau of Industry and Security
This rule modifies the Commerce Control List (CCL) entries for two types of items: Military aircraft and related items, and military gas turbine engines and related items. The rule adds clarifying text to the descriptions of the types of military aircraft controlled on the CCL. The lists of items that are subject only to the anti-terrorism reason for control are clarified and expanded. This rule, which is being published simultaneously with a rule by the Department of State, is based on a review of Categories VIII and XIX of the United States Munitions List (USML). This rule and the related Department of State rule are part of a plan to review rules published as part of the Export Control Reform Initiative (ECRI). This rule also furthers the retrospective regulatory review directed by the President in Executive Order 13563.
Amendment to the International Traffic in Arms Regulations: Revision of U.S. Munitions List Categories VIII and XIX
Document Number: 2016-27775
Type: Rule
Date: 2016-11-21
Agency: Department of State
As part of the President's Export Control Reform (ECR) initiative, the Department of State amends the International Traffic in Arms Regulations (ITAR) to revise Categories VIII (aircraft and related articles) and XIX (gas turbine engines and associated equipment) of the U.S. Munitions List (USML) to describe more precisely the articles warranting control on the USML. The revisions contained in this rule are part of the Department of State's retrospective plan under E.O. 13563.
Airworthiness Directives; Airbus Helicopters Deutschland GmbH
Document Number: 2016-27765
Type: Proposed Rule
Date: 2016-11-21
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) MBB-BK 117 D-2 helicopters. This proposed AD would require repetitively inspecting the bushings of the inner and outer forward trusses of both engines. This proposed AD is prompted by reports of delaminated and worn engine mount bushings. The proposed actions are intended to detect delaminated engine mount bushings, which can lead to excessive vibration, cracking, failure of the engine mount front support pins, and loss of helicopter control.
U.S. Fish and Wildlife Service Mitigation Policy
Document Number: 2016-27751
Type: Notice
Date: 2016-11-21
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce revisions to our Mitigation Policy, which has guided Service recommendations on mitigating the adverse impacts of land and water developments on fish, wildlife, plants, and their habitats since 1981. The revisions are motivated by changes in conservation challenges and practices since 1981, including accelerating loss of habitats, effects of climate change, and advances in conservation science. The revised Policy provides a framework for applying a landscape-scale approach to achieve, through application of the mitigation hierarchy, a net gain in conservation outcomes, or at a minimum, no net loss of resources and their values, services, and functions resulting from proposed actions. The primary intent of the Policy is to apply mitigation in a strategic manner that ensures an effective linkage with conservation strategies at appropriate landscape scales.
Proposed Exemptions From Certain Prohibited Transaction Restrictions
Document Number: 2016-27563
Type: Notice
Date: 2016-11-21
Agency: Employee Benefits Security Administration, Department of Labor
This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following proposed exemptions: D-11856, Deutsche Investment Management Americas Inc. and Certain Current and Future Asset Management Affiliates of Deutsche Bank AG; D-11859, Citigroup, Inc.; D-11861, JPMorgan Chase & Co.; D-11862, Barclays Capital Inc.; D-11906, JPMorgan Chase & Co.; D-11907, UBS Assets Management, UBS Realty Investors, UBS Hedge Fund Solutions LLC, UBS O'Connor LLC, and Certain Future Affiliates in UBS's Asset Management and Wealth Management Americas Divisions; D-11908, Deutsche Investment Management Americas Inc. and Certain Current and Future Asset Management Affiliates of Deutsche Bank; D-11909, Citigroup, Inc.; and, D-11910, Barclays Capital Inc.
Air Plan Approval; KY Infrastructure Requirements for the 2010 1-Hour NO2
Document Number: 2016-27538
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve portions of the State Implementation Plan (SIP) submission, submitted by the Commonwealth of Kentucky, Energy and Environment Cabinet, Department for Environmental Protection, through the Kentucky Division for Air Quality (KDAQ), on April 26, 2013, to demonstrate that the Commonwealth meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2010 1-hour nitrogen dioxide (NO2) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. KDAQ certified that Kentucky's SIP contains provisions that ensure the 2010 1-hour NO2 NAAQS is implemented, enforced, and maintained in Kentucky. EPA has determined that portions of Kentucky's infrastructure submission, submitted on April 26, 2013, addresses certain required infrastructure elements for the 2010 1-hour NO2 NAAQS.
Privacy Act System of Records, Amended System of Records
Document Number: 2016-27488
Type: Notice
Date: 2016-11-21
Agency: National Labor Relations Board, Agencies and Commissions
Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, the Agency publishes this notice of its intention to amend a system of records, NLRB-17, Personnel Security Records. All persons are advised that, in the absence of submitted comments considered by the Agency as warranting modification of the notice as here proposed, it is the intention of the Agency that the notice shall be effective upon expiration of the comment period without further action.
Rule Exempting an Amended System of Records From Certain Provisions of the Privacy Act
Document Number: 2016-27487
Type: Rule
Date: 2016-11-21
Agency: National Labor Relations Board, Agencies and Commissions
The National Labor Relations Board (NLRB) exempts an amended system of records, NLRB-17, Personnel Security Records, from certain provisions of the Privacy Act of 1974, 5 U.S.C. 552a, pursuant to sections (k)(1), (2), (3), (5), (6), and (7) of that Act.
Promulgation of Air Quality Implementation Plans; Arizona; Regional Haze Federal Implementation Plan; Reconsideration
Document Number: 2016-27422
Type: Rule
Date: 2016-11-21
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is revising portions of the Arizona Regional Haze Federal Implementation Plan (2014 FIP) applicable to the Phoenix Cement Company (PCC) Clarkdale Plant and the CalPortland Cement (CPC) Rillito Plant. This 2014 FIP was adopted earlier under the provisions of the Clean Air Act (CAA). We are finalizing without change our proposal to replace the control technology demonstration requirements for nitrogen oxides (NOX) applicable to Kiln 4 at the Clarkdale Plant and Kiln 4 at the Rillito Plant with a series of revised recordkeeping and reporting requirements. When EPA finalized the 2014 FIP, we had limited operating data for the use of Selective Non-Catalytic Reduction (SNCR) on cement plants. Therefore, we required that PCC and CPC perform control technology demonstration projects to support the control efficiencies for SNCR in the 2014 FIP, as well as to determine if more stringent control efficiencies were achievable. In early 2015, a control technology demonstration project was performed on the SNCR installed at another CalPortland Cement facility, the Mojave Plant. Our analysis of the SNCR control efficiency data from that project indicated that more stringent SNCR control efficiencies were not achievable at PCC and CPC. As a result, the additional information from the control technology demonstration projects required by the 2014 FIP is no longer needed because the PCC and CPC SNCR control efficiencies in the 2014 FIP are consistent with the SNCR performance at the Mojave Plant. In addition, the EPA is making a minor technical correction to change an equation to match the language in the regulatory text.
Airworthiness Directives; Gulfstream Aerospace Corporation Airplanes
Document Number: 2016-27309
Type: Proposed Rule
Date: 2016-11-21
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all Gulfstream Aerospace Corporation Model G-1159B airplanes. This proposed AD was prompted by a review of airplane maintenance records, which revealed that incorrect rudder assemblies were installed on certain airplanes. This proposed AD would require certain inspections, and replacement or modification of the rudder assembly if necessary. We are proposing this AD to address the unsafe condition on these products.
Safety Standard for Portable Generators
Document Number: 2016-26962
Type: Proposed Rule
Date: 2016-11-21
Agency: Consumer Product Safety Commission, Agencies and Commissions
The U.S. Consumer Product Safety Commission has determined preliminarily that there may be an unreasonable risk of injury and death associated with portable generators. To address this risk, the Commission proposes a rule that limits CO emissions from operating portable generators. Specifically, the proposed rule would require that portable generators powered by handheld spark-ignition (SI) engines and Class I SI engines not exceed a weighted CO emission rate of 75 grams per hour (g/hr); generators powered by one-cylinder, Class II SI engines must not exceed a weighted CO emission rate of 150 g/h; and generators powered by Class II SI engines with two cylinders must not exceed a weighted emission rate of 300 g/h.
Exemptions To Facilitate Intrastate and Regional Securities Offerings
Document Number: 2016-26348
Type: Rule
Date: 2016-11-21
Agency: Securities and Exchange Commission, Agencies and Commissions
We are adopting amendments to modernize Rule 147 under the Securities Act of 1933, which provides a safe harbor for compliance with the Section 3(a)(11) exemption from registration for intrastate securities offerings. We are also establishing a new intrastate offering exemption under the Securities Act, designated Rule 147A, which will be similar to amended Rule 147, but will have no restriction on offers and will allow issuers to be incorporated or organized outside of the state in which the intrastate offering is conducted provided certain conditions are met. The amendments to Rule 147 and new Rule 147A are designed to facilitate capital formation, including through offerings relying upon intrastate crowdfunding provisions under state securities laws, while maintaining appropriate investor protections and providing state securities regulators with the flexibility to add additional investor protections they deem appropriate for offerings within their state. We also are adopting amendments to Rule 504 of Regulation D under the Securities Act to facilitate issuers' capital raising efforts and provide additional investor protections. The amendments to Rule 504 will increase the aggregate amount of securities that may be offered and sold in any twelve-month period from $1 million to $5 million and disqualify certain bad actors from participation in Rule 504 offerings. In light of these amendments to Rule 504, we are also repealing Rule 505.
Reader Aids
Document Number: FR-2016-11-18-ReaderAids
Type: Reader Aids
Date: 2016-11-18
Sunshine Act Meeting Notice
Document Number: 2016-27999
Type: Notice
Date: 2016-11-18
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act; Notice of Board Member Meeting
Document Number: 2016-27980
Type: Notice
Date: 2016-11-18
Agency: Federal Retirement Thrift Investment Board, Agencies and Commissions
Sunshine Act Meeting: Board of Directors and Operations & Regulations Committee Telephonic Meetings
Document Number: 2016-27918
Type: Notice
Date: 2016-11-18
Agency: Legal Services Corporation, Agencies and Commissions
On November 6, 2016, the Legal Services Corporation (LSC) published a notice in the Federal Register (81 FR 80686) titled ``Board of Directors will meet telephonically on November 22, 2016. The meeting will commence at 2:00 Eastern Standard Time (EST). Immediately following the Board of Directors telephonic meeting, the Operations and Regulations Committee will hold a telephonic meeting.'' A correction to change item #2 on the Board of Directors Agenda to read; Consider and act on the Board of Directors' transmittal to accompany the Inspector General's Semiannual Report to Congress for the period of April 1, 2016 through September 30, 2016, all other items remain consecutively the same. This document changes the notice by revising the Board of Directors Agenda by changing item #2 of the agenda to read; Consider and act on the Board of Directors' transmittal to accompany the Inspector General's Semiannual Report to Congress for the period of April 1, 2016 through September 30, 2016
Government in the Sunshine Act Meeting Notice
Document Number: 2016-27913
Type: Notice
Date: 2016-11-18
Agency: International Trade Commission, Agencies and Commissions
Notice of Proposed Withdrawal and Notice of Public Meeting; California
Document Number: 2016-27869
Type: Notice
Date: 2016-11-18
Agency: Department of the Interior, Bureau of Land Management
On behalf of the National Park Service (NPS) and subject to valid existing rights, the Secretary of the Interior proposes to withdraw approximately 22,462 acres of public lands for 20 years from all forms of entry, appropriation, or disposal under the public land laws; from location, entry, and patent under the United States mining laws; and from disposition under all laws pertaining to mineral and geothermal leasing, and mineral materials, and all amendments thereto and to transfer administrative jurisdiction over such lands from the Bureau of Land Management (BLM) to the NPS for administration as part of Joshua Tree National Park (JTNP). This notice temporarily segregates the lands for up to 2 years, gives the public an opportunity to comment on the proposed withdrawal application, and announces the date and time of a public meeting.
Notice of Realty Action: Application for Conveyance of Federally Owned Mineral Interests in Lee County, FL
Document Number: 2016-27868
Type: Notice
Date: 2016-11-18
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) is processing an application under the Federal Land Policy and Management Act of 1976 (FLPMA), to convey the undivided phosphate mineral interest owned by the United States in 160 acres located in Lee County, Florida, to the surface owner, Stonewater II, LLC, a Michigan Limited Liability Company. The fair market value of the phosphate mineral interest has been determined to be $4,000.
Registration Review; Draft Malathion Human Health Risk Assessment; Extension of Comment Period
Document Number: 2016-27867
Type: Notice
Date: 2016-11-18
Agency: Environmental Protection Agency
EPA issued a notice in the Federal Register of September 22, 2016 (81 FR 65355) (FRL-9952-53), opening a 60-day comment period for the draft malathion human health risk assessment. This document extends that comment period for 30 days. The new closing date will be December 21, 2016 rather than November 21, 2016. The comment period is being extended in response to a request from FMC Corporation citing the scope and complexity of the assessments, including the use of new models, risk assessment approaches, and science policy issues that require additional review time.
Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses
Document Number: 2016-27865
Type: Notice
Date: 2016-11-18
Agency: Environmental Protection Agency
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations and to amend product registrations to terminate uses. EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw its requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.
Virginia Disaster Number VA-00065
Document Number: 2016-27864
Type: Notice
Date: 2016-11-18
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the Commonwealth of Virginia (FEMA-4291-DR), dated 11/02/2016. Incident: Hurricane Matthew. Incident Period: 10/07/2016 through 10/15/2016. Effective Date: 11/14/2016. Physical Loan Application Deadline Date: 01/03/2017. EIDL Loan Application Deadline Date: 08/02/2017.
North Carolina Disaster #NC-00086
Document Number: 2016-27863
Type: Notice
Date: 2016-11-18
Agency: Small Business Administration, Agencies and Commissions
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4285-DR), dated 11/10/2016. Incident: Hurricane Matthew. Incident Period: 10/04/2016 and continuing. Effective Date: 11/10/2016. Physical Loan Application Deadline Date: 01/09/2017. Economic Injury (EIDL) Loan Application Deadline Date: 08/10/2017.
Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-27855
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
Document Number: 2016-27851
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 medical device premarket notification.
Environmental Impact Statements; Notice of Availability
Document Number: 2016-27845
Type: Notice
Date: 2016-11-18
Agency: Environmental Protection Agency
Use of The Seafood List To Determine Acceptable Seafood Names; Draft Compliance Policy Guide; Availability
Document Number: 2016-27843
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names'' (the draft Compliance Policy Guide (CPG)). The draft CPG, when finalized, will provide guidance for FDA staff regarding use of The Seafood List to determine whether a seafood name is acceptable.
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-27842
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD).
Procurement List; Proposed Deletions
Document Number: 2016-27841
Type: Notice
Date: 2016-11-18
The Committee is proposing to delete products previously furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment
Document Number: 2016-27840
Type: Notice
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 in the guidance for industry on special protocol assessment.
Submission for OMB Review; 30-Day Comment Request: A National Survey of Nurse Coaches (NIH Clinical Center)
Document Number: 2016-27839
Type: Notice
Date: 2016-11-18
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2016, pages 56668-9 (81 FR 56668) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
Document Number: 2016-27838
Type: Rule
Date: 2016-11-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.
Submission for OMB Review; Comment Request
Document Number: 2016-27837
Type: Notice
Date: 2016-11-18
Agency: Department of the Treasury
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-27836
Type: Notice
Date: 2016-11-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Certificate of Alternative Compliance for the TUG MAXWELL PAUL MORAN
Document Number: 2016-27835
Type: Notice
Date: 2016-11-18
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces that the First District Prevention Department's Inspections and Investigations Division has issued a Certificate of Alternate Compliance (COAC) from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS) for the TUG MAXWELL PAUL MORAN as required by statue. Due to its operations as a harbor assistance and escort vessel it cannot fully comply with the sidelight, stern light, and towing light provisions of the 72 COLREGS without interfering with its ability to make up and assist other vessels. This notice promotes the Coast Guard's maritime safety and stewardship missions.
SJI Board of Directors Meeting, Notice
Document Number: 2016-27834
Type: Notice
Date: 2016-11-18
Agency: State Justice Institute, Agencies and Commissions
The SJI Board of Directors will be meeting on Monday, December 5, 2016 at 11:00 a.m. The meeting will be held at the Belmond Hotel in Charleston, South Carolina. The purpose of this meeting is to consider grant applications for the 1st quarter of FY 2017, and other business. All portions of this meeting are open to the public.
Fisheries of the Northeastern United States; Atlantic Herring Fishery; 2016 Management Area 1B Directed Fishery Closure
Document Number: 2016-27833
Type: Rule
Date: 2016-11-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is closing the directed herring fishery in management Area 1B, limiting catch from that area to 2,000 lb (907.2 kg) per trip and prohibiting landing more than once per calendar day, because it projects that 92 percent of the 2016 annual seasonal catch limit for that area will have been caught by the effective date. This action is necessary to comply with the regulations implementing the Atlantic Herring Fishery Management Plan and is intended to prevent over harvest of herring in Area 1B.
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