August 2016 – Federal Register Recent Federal Regulation Documents

Results 751 - 800 of 2,867
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2016-20237
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2016-20236
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-20235
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Buy America Waiver Notification
Document Number: 2016-20234
Type: Notice
Date: 2016-08-24
Agency: Federal Highway Administration, Department of Transportation
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic submersible pumps; 1,200 GPM, 6'' diameter discharge with 42.4 ft. head compatible, with current well lift station 1 at I-94 in Fargo, North Dakota.
Emergency Route Working Group (ERWG)-Federal Advisory Committee
Document Number: 2016-20233
Type: Notice
Date: 2016-08-24
Agency: Federal Highway Administration, Department of Transportation
FHWA announces the establishment of the Emergency Route Working Group (ERWG) for a 2-year period. The ERWG will provide the U.S. Secretary of Transportation, through the Administrator of the FHWA, with advice and recommendations for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG will provide the U.S. Secretary of Transportation a written report by December 4, 2016, on its findings and recommendation for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG's advice and recommendations will work within existing legal authorities and not require changes in State or Federal law for DOT to implement.
Drawbridge Operation Regulation; Trent River, New Bern, NC
Document Number: 2016-20232
Type: Rule
Date: 2016-08-24
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70/Alfred A. Cunningham Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to facilitate safe participation in the Multiple Sclerosis Society's Historic New Bern Bike Ride. This deviation allows the bridge to remain in the closed-to-navigation position.
Notice of Intent To Prepare a Supplemental Environmental Impact Statement (EIS) to the Land Acquisition and Airspace Establishment Final EIS at the Marine Corps Air Ground Combat Center, Twentynine Palms, California
Document Number: 2016-20231
Type: Notice
Date: 2016-08-24
Agency: Department of Defense, Department of the Navy
Pursuant to Section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations (40 CFR parts 1500-1508), the Department of the Navy (DON) announces its intent to prepare a Supplemental Environmental Impact Statement (EIS) to evaluate the potential environmental impacts that may result from implementing alternative desert tortoise translocation plans at the Marine Corps Air Ground Combat Center, Twentynine Palms (hereinafter ``the Combat Center''). The Supplemental EIS is a supplement to the Final EIS for ``Land Acquisition and Airspace Establishment to Support Large-Scale Marine Air Ground Task Force Live Fire and Maneuver Training'' dated July 2012 (hereinafter ``2012 Final EIS'') (77 FR 44234).
Buy America Waiver Notification
Document Number: 2016-20230
Type: Notice
Date: 2016-08-24
Agency: Federal Highway Administration, Department of Transportation
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic iron and steel components of casings, housings, electrical, and mechanical equipment needed for rehabilitation of Isthmus Bridge in the State of Oregon.
Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting
Document Number: 2016-20228
Type: Notice
Date: 2016-08-24
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products
Document Number: 2016-20227
Type: Notice
Date: 2016-08-24
Agency: Department of Agriculture, Food Safety and Inspection Service
The Food Safety and Inspection Service (FSIS) is announcing the availability of the Agency's compliance guidance on how companies can make label or labeling claims concerning the fact that bioengineered or genetically modified (GM) ingredients or animal feed were not used in the production of meat, poultry, or egg products. For purposes of this guidance document, these claims will be referred to as ``negative claims.''
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel KIA ORA; Invitation for Public Comments
Document Number: 2016-20226
Type: Notice
Date: 2016-08-24
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel OCEANFLYER; Invitation for Public Comments
Document Number: 2016-20224
Type: Notice
Date: 2016-08-24
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel JULIA; Invitation for Public Comments
Document Number: 2016-20223
Type: Notice
Date: 2016-08-24
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ANGARI; Invitation for Public Comments
Document Number: 2016-20222
Type: Notice
Date: 2016-08-24
Agency: Maritime Administration, Department of Transportation
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability
Document Number: 2016-20221
Type: Notice
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Patient Preference InformationVoluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.'' This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect patient preference information (PPI), which may inform FDA's benefit-risk determinations in the premarket review of premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, and de novo classification requests. This guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. FDA is also issuing a Level 2 updated version of the guidance document entitled ``Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,'' originally issued on March 28, 2012, that has been edited to be consistent with this guidance document.
Privacy Act of 1974; System of Records
Document Number: 2016-20217
Type: Notice
Date: 2016-08-24
Agency: Department of Veterans Affairs
As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records currently entitled ``My HealtheVet Administrative Records-VA'' (130VA19) as set forth in the Federal Register 75 FR 70365. VA is amending the system by revising the System Number, System Location, Categories of Individuals Covered by the System, Categories of Records in the System, Records Source Categories, Routine Uses of Records Maintained in the System, Retention and Disposal, System Manager, Record Access Procedure, and Notification Procedure. VA is republishing the system notice in its entirety.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-20216
Type: Notice
Date: 2016-08-24
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies
Document Number: 2016-20202
Type: Notice
Date: 2016-08-24
Agency: Federal Reserve System, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2016-20201
Type: Notice
Date: 2016-08-24
Agency: Federal Reserve System, Agencies and Commissions
Certain Inflatable Products With Tensioning Structures and Processes for Making the Same; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on a Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the Investigation
Document Number: 2016-20200
Type: Notice
Date: 2016-08-24
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 6) of the presiding administrative law judge (``ALJ'') terminating the above-captioned investigation based upon a consent order stipulation and proposed consent order. The Commission has also determined to issue a consent order.
Certain Nanopores and Products Containing Same Commission Determination Not To Review an Initial Determination Terminating the Investigation Based Upon Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the Investigation
Document Number: 2016-20199
Type: Notice
Date: 2016-08-24
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 13) granting a joint motion to terminate the investigation based upon a consent order stipulation and proposed consent order. The Commission has issued the consent order. The investigation is terminated.
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
Document Number: 2016-20198
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of the following meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT).
Louisiana Disaster Number LA-00066
Document Number: 2016-20195
Type: Notice
Date: 2016-08-24
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Louisiana (FEMA-4277-DR), dated 08/16/2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/16/2016. Physical Loan Application Deadline Date: 10/17/2016. Economic Injury (EIDL) Loan Application Deadline Date: 05/16/2017.
Louisiana Disaster Number LA-00065
Document Number: 2016-20194
Type: Notice
Date: 2016-08-24
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/ 2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/16/2016. Physical Loan Application Deadline Date: 10/13/2016. EIDL Loan Application Deadline Date: 05/15/2017.
West Virginia Disaster Number WV-00043
Document Number: 2016-20193
Type: Notice
Date: 2016-08-24
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4273-DR), dated 06/ 25/2016. Incident: Severe Storms, Flooding, Landslides, and Mudslides. Incident Period: 06/22/2016 through 06/29/2016. Effective Date: 07/06/2016. Physical Loan Application Deadline Date: 09/07/2016. EIDL Loan Application Deadline Date: 03/27/2017.
LOUISIANA Disaster #LA-00065
Document Number: 2016-20192
Type: Notice
Date: 2016-08-24
Agency: Small Business Administration, Agencies and Commissions
This is a Notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/2016. Incident: Severe Storms and Flooding. Incident Period: 08/11/2016 and continuing. Effective Date: 08/14/2016. Physical Loan Application Deadline Date: 10/13/2016. Economic Injury (EIDL) Loan Application Deadline Date: 05/15/2017.
Privacy Act of 1974; Notice of an Updated System of Records of Records
Document Number: 2016-20191
Type: Notice
Date: 2016-08-24
Agency: General Services Administration, Agencies and Commissions
GSA proposes a new system of records subject to the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
Revision of Information Collection: Combined Federal Campaign Applications
Document Number: 2016-20190
Type: Notice
Date: 2016-08-24
Agency: Office of Personnel Management
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management intends to submit to the Office of Management and Budget (OMB) a request for clearance to revise an information collection. Combined Federal Campaign Applications, OMB Control No. 3206-0131, which include OPM Forms 1647-A, -B, and -E, are used to review the eligibility of national, international, and local charitable organizations and Department of Defense morale, welfare, and recreation (MWR)/Family Support and Youth Activities/Programs (FSYA/FSYP) organizations that wish to participate in the Combined Federal Campaign. The proposed revisions reflect changes in eligibility guidance from the Office of Personnel Management. On March 10, 2016, we published a 60-day notice and request for comments. We received two comments recommending the addition of a ``thank you statement'' field that would facilitate immediate acknowledgement of electronic pledges. This recommended revision is included below. We estimate 20,500 responses to this information collection annually. Each form takes approximately three hours to complete. The annual estimated burden is 40,500 hours.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-20188
Type: Notice
Date: 2016-08-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Health Insurance MarketplaceSM
Document Number: 2016-20187
Type: Notice
Date: 2016-08-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\ and the Medicare, Medicaid, and Children's Health Insurance Programs consumer education strategies. This meeting is open to the public.
Lyon-Mineral Resource Advisory Committee
Document Number: 2016-20185
Type: Notice
Date: 2016-08-24
Agency: Department of Agriculture, Forest Service
The Lyon-Mineral Resource Advisory Committee (RAC) will meet in Yerington, Nevada. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. RAC information can be found at the following Web site: http:// www.fs.usda.gov/main/pts/specialprojects/racweb.
Agency Information Collection Activities: Application To Use the Automated Commercial Environment (ACE)
Document Number: 2016-20184
Type: Notice
Date: 2016-08-24
Agency: Department of Homeland Security, U.S. Customs and Border Protection
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Application to Use the Automated Commercial Environment (ACE). CBP is proposing that this information collection be extended with a change to the burden hours resulting from the addition of a new application for brokers, importers, sureties, attorneys and other parties to establish an ACE Portal account to file protests. There are no proposed changes to the existing ACE Portal application for imported merchandise. This document is published to obtain comments from the public and affected agencies.
SJI Board of Directors Meeting, Notice
Document Number: 2016-20181
Type: Notice
Date: 2016-08-24
Agency: State Justice Institute, Agencies and Commissions
The SJI Board of Directors will be meeting on Monday, September 12, 2016 at 1:00 p.m. The meeting will be held at the Multnomah County Circuit Court in Portland, Oregon. The purpose of this meeting is to consider grant applications for the 4th quarter of FY 2016, and other business. All portions of this meeting are open to the public.
Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage Areas
Document Number: 2016-20179
Type: Proposed Rule
Date: 2016-08-24
Agency: Office of Personnel Management
The U.S. Office of Personnel Management (OPM) is issuing a proposed rule that would define Kent County, Michigan, as an area of application county to the Macomb, MI, nonappropriated fund (NAF) Federal Wage System (FWS) wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area. These changes are necessary because there are NAF FWS employees working in Kent and Cameron Counties, and the counties are not currently defined to NAF wage areas.
Opportunity for Designation in Amarillo, TX Area; Request for Comments on the Official Agency Servicing This Area
Document Number: 2016-20178
Type: Notice
Date: 2016-08-24
Agency: Department of Agriculture, Grain Inspection, Packers and Stockyards Administration
The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Amarillo Grain Exchange, Inc. (Amarillo).
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
Document Number: 2016-20177
Type: Proposed Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.''
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Document Number: 2016-20176
Type: Rule
Date: 2016-08-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
Notice of Intent To Grant an Exclusive License
Document Number: 2016-20175
Type: Notice
Date: 2016-08-24
Agency: National Aeronautics and Space Administration, Agencies and Commissions
This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The National Aeronautics and Space Administration (NASA) hereby gives notice of its intent to grant an exclusive license in the United States to practice the inventions described and claimed in U.S. Patent Number 8,401,217, titled ``Extreme Low Frequency Acoustic Measurement System,'' NASA Case Number LAR- 17317-1, and U.S. Patent Application Serial Number 13/771,735, titled ``Extreme Low Frequency Acoustic Measurement System,'' NASA Case Number LAR-17317-2, to Infrasonix Inc., having its principal place of business in Lawrenceville, GA. The fields of use may be limited to, but not necessarily limited to, human and/or animal healthcare. Certain patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Notice of Intent To Certify Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin); Request for Comments
Document Number: 2016-20173
Type: Notice
Date: 2016-08-24
Agency: Department of Agriculture
We are asking for comments on the quality of services provided by this Delegated State: Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin).