January 2017 – Federal Register Recent Federal Regulation Documents

Results 801 - 850 of 1,882
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2017-00846
Type: Notice
Date: 2017-01-17
Agency: Federal Reserve System, Agencies and Commissions
Sudanese Sanctions Regulations
Document Number: 2017-00844
Type: Rule
Date: 2017-01-17
Agency: Department of the Treasury, Office of Foreign Assets Control
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Sudanese Sanctions Regulations to authorize all prohibited transactions, including transactions involving property in which the Government of Sudan has an interest. OFAC is issuing this general license in connection with ongoing U.S.-Sudan bilateral engagement and in response to positive developments in the country over the past six months related to bilateral cooperation, the ending of internal hostilities, regional cooperation, and improvements to humanitarian access.
Ammonium Sulfate From the People's Republic of China: Final Affirmative Countervailing Duty Determination
Document Number: 2017-00843
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of ammonium sulfate from the People's Republic of China (PRC). The period of investigation is January 1, 2015 through December 31, 2015.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
Document Number: 2017-00842
Type: Notice
Date: 2017-01-17
Agency: Federal Reserve System, Agencies and Commissions
Notice is hereby given of the final approval of a proposal to extend for three years, without revision, the intermittent survey of business (FR 1374; OMB No. 7100-0302) and to extend for three years, without revision, the domestic finance company report of consolidated assets and liabilities (FR 2248; OMB No. 7100-0005) by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
Document Number: 2017-00841
Type: Notice
Date: 2017-01-17
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to extend for three years, without revision the following reporting and recordkeeping requirements related to amendments made by the Gramm-Leach-Bliley Act, to the Bank Holding Company Act, the Federal Reserve Act, and related regulations. On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Delayed Effective Date for Modifications of the National Customs Automation Program Tests Regarding Reconciliation, Post-Summary Corrections, and Periodic Monthly Statements
Document Number: 2017-00837
Type: Notice
Date: 2017-01-17
Agency: Department of Homeland Security, U.S. Customs and Border Protection
This notice announces that the effective date for the modifications to the National Customs Automation Program (NCAP) tests regarding Reconciliation, Post-Summary Corrections, and Periodic Monthly Statements is delayed until further notice. On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice in the Federal Register announcing modifications to the National Customs Automation Program (NCAP) test regarding reconciliation, and the transition of the test from the Automated Commercial System (ACS) to the Automated Commercial Environment (ACE). The modifications made by this notice were to be effective on January 14, 2017. On December 12, 2016, U.S. Customs and Border Protection (CBP) published in the Federal Register a document announcing CBP's plans to modify and clarify the National Customs Automation Program (NCAP) test regarding Post-Summary Correction (PSC) claims to entry summaries that are filed in the Automated Commercial Environment (ACE), as well as the Periodic Monthly Statement (PMS) test. The notice liberalized and eliminated some requirements needed for the filing of PSCs; however, it also placed burdens on the importer in the form of a restriction and a prohibition. Subsequently, CBP published a notice in the Federal Register on January 9, 2017, to remove the restriction imposed on all PSC filings to make payments within three business days of submitting the PSC, with the exception of entry type 03 filings, and to remove the prohibition of filing additional PSCs until additional duties, fees and taxes are deposited. The changes to the PSC and PMS tests were to have been effective January 14, 2017. This notice announces that the effective date for the modifications to these NCAP tests has been delayed until further notice.
Revisions to Sudan Licensing Policy
Document Number: 2017-00836
Type: Rule
Date: 2017-01-17
Agency: Department of Commerce, Bureau of Industry and Security
This rule revises the policy of review for applications for licenses to export or reexport to Sudan certain items that are intended to ensure the safety of civil aviation or the safe operation of fixed- wing, commercial passenger aircraft. Such applications will now be reviewed under a general policy of approval rather than a general policy of denial. This rule also revises the review policy from a general policy of denial to a general policy of approval for applications for licenses to export or reexport to Sudan certain items for use to inspect, design, construct, operate, improve, maintain, repair, overhaul or refurbish railroads in Sudan. This rule does not create any new license requirements or remove any existing license requirements for exports or reexports to Sudan. BIS is making these licensing policy changes in connection with ongoing U.S.-Sudan bilateral engagement, and with the aim of enhancing the safety of Sudan's civil aviation and improving the country's railroads. This action takes into account the United States' goals to improve regional peace and security. This rule also removes two instances of ``contract sanctity dates'' pertaining to the export and reexport of certain items to Sudan from the EAR that currently serve no practical purpose. BIS is taking these actions in coordination with the Department of the Treasury's Office of Foreign Assets Control (OFAC), which is amending the Sudanese Sanctions Regulations.
Public Land Order No. 7860; Partial Revocation of a Secretarial Order and a Bureau of Reclamation Order; Montana
Document Number: 2017-00835
Type: Notice
Date: 2017-01-17
Agency: Department of the Interior, Bureau of Land Management
This order partially revokes a withdrawal created by a Secretarial Order and a Bureau of Reclamation Order, insofar as they affect 2,643.25 acres withdrawn for the Bureau of Reclamation's Lonesome Lake Reservoir, a sub-unit of the Pick-Sloan Missouri Basin Program. The Bureau of Reclamation has determined that the lands are no longer needed for reclamation purposes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-00833
Type: Notice
Date: 2017-01-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection titled ``Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications.'' From this information collection project, NIOSH seeks to provide insight into what the most important barriers are from the perspective of the organizations that must purchase, use, approve, and manufacture these safety technologies.
Announcement of Application Deadlines and Requirements for Section 313A Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes Loan Program for Fiscal Year (FY) 2017
Document Number: 2017-00831
Type: Notice
Date: 2017-01-17
Agency: Department of Agriculture, Rural Utilities Service
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), announces the application window, requirements and funding for loans that may become available for Fiscal Year (FY) 2017 under the Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes Program (the 313A Program) authorized under the Rural Electrification Act of 1936, as amended, and related terms. Under the 313A Program, the Federal Financing Bank (FFB) will make loans to the selected applicant(s) and RUS will guarantee the applicant(s)'s repayment of the loans to FFB. Selected applicants may use the proceeds of loan funds made available under the 313A Program to make loans to borrowers for electrification or telecommunications purposes, or to refinance bonds or notes previously issued by applicants for such purposes. The proceeds of the guaranteed bonds and notes are not to be used by applicants to directly or indirectly fund projects for the generation of electricity. This notice is based on loan levels contemplated by the FY 17 Continuing Resolution and on information available to the agency at the time of this notice. The final amount of funding made available under this notice could be affected by subsequent Congressional action or subsidy rate calculations. Last year, the RUS obligated $750 million in loan funds for this program. It is necessary to publish this notice at this time to ensure that applicants have sufficient time to prepare applications and to ensure that the agency has sufficient time and resources to evaluate applications.
Submission for OMB Review; Comment Request
Document Number: 2017-00829
Type: Notice
Date: 2017-01-17
Agency: Department of Defense, Office of the Secretary
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Hazardous Materials: Information Collection Activities
Document Number: 2017-00828
Type: Notice
Date: 2017-01-17
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
This notice announces Office of Management and Budget (OMB) approval and extension for four Information Collection Requests (ICRs). Specifically, this notice announces the following: OMB approval and extension until February 28, 2018 for OMB Control No. 2137-0586, ``Hazardous Materials Public Sector Training & Planning Grants''; OMB approval and extension until March 31, 2019 for OMB Control No. 2137- 0628, ``Flammable Hazardous Materials by Rail Transportation''; and OMB approval and extension until June 30, 2019 for both OMB Control No. 2137-0613, ``Subsidiary Hazard Class and Number/Type of Packagings,'' and OMB Control No. 2137-0510, ``Radioactive (RAM) Transportation Requirements.''
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Antidumping Duty Administrative Review, and Rescission of New Shipper Review; 2014-2015
Document Number: 2017-00827
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, International Trade Administration
On July 14, 2016, the Department of Commerce (Department) published the preliminary results of the 28th administrative and new shipper reviews of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (PRC). The period of review (POR) is June 1, 2014, through May 31, 2015. After analyzing the comments received, we made no changes to the margin calculations in the administrative review and we are rescinding the new shipper review (NSR). The final weighted- average dumping margins for the reviewed firms are listed below in the section entitled ``Final Results of the Review.''
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Changed Circumstances Review and Reinstatement of Shanghai General Bearing Co., Ltd. in the Antidumping Duty Order
Document Number: 2017-00826
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, International Trade Administration
On July 13, 2016, the Department of Commerce (the Department) published the preliminary results of the changed circumstances review and intent to reinstate Shanghai General Bearing Co., Ltd. (SGBC/SKF) in the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished, (TRBs) from the People's Republic of China (PRC). This review covers TRBs from the PRC manufactured and exported by SGBC/SKF. The period of review is June 1, 2014, through May 31, 2015. Based on our analysis of the comments received, we made changes to the margin calculations. Therefore, the final results differ from the preliminary results. Further, we continue to determine that SGBC/SKF sold TRBs at less than normal value (NV), and, as a result, we are reinstating SGBC/SKF in the antidumping order on TRBs from the PRC. The final weighted-average dumping margin is listed below in the section entitled ``Final Results of Review.''
Chlorinated Isocyanurates From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2014-2015
Document Number: 2017-00825
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, International Trade Administration
On July 12, 2016, the Department of Commerce (``the Department'') published its Preliminary Results of the administrative review of the antidumping duty order on chlorinated isocyanurates (``chloro isos'') from the People's Republic of China (``the PRC''). The period of review (POR) is June 1, 2014, through May 31, 2015. This review covers three producers/exporters: (1) Heze Huayi Chemical Co., Ltd. (``Heze Huayi''); (2) Hebei Jiheng Chemical Co., Ltd. (``Jiheng''); and (3) Juancheng Kangtai Chemical Co., Ltd. (``Kangtai''). We invited parties to comment on our Preliminary Results. Based on our analysis of the comments received, we made certain changes to our margin calculations for all three respondents. The final dumping margins for this review are listed in the ``Final Results'' section below.
Solicitation of Proposals for Designation of Beyond Traffic Innovation Centers
Document Number: 2017-00824
Type: Notice
Date: 2017-01-17
Agency: Department of Transportation
Beyond Traffic is the Department of Transportation's (``DOT'' or the ``Department'') draft 30-year framework for the future (the full report can be found here: https://www.transportation.gov/ BeyondTraffic). It lays out key trends that will affect the future of our transportation system. To further this understanding, the DOT is requesting proposals from applicants to form an initial network of multiple centers, focusedthrough academic activities and programson delivering solutions to the challenges outlined in Beyond Traffic. These entities will be designated as ``USDOT Beyond Traffic Innovation Centers'' and will serve as thought leaders responsible for continuing the conversation surrounding the future of transportation. USDOT Beyond Traffic Innovation Center activities could include identifying possible solutions in their megaregion (Beyond Traffic, p. 25), including but not limited to: Evaluating and researching new technologies relevant to tackling transportation challenges with the megaregion, identification and development of training approaches for the megaregion's future transportation workforce, and convening practitioners, public and private leaders within the megaregion to help identify specific actions that can be taken in the megaregion to address its challenges over the 30 years.
Category 3 Source Security and Accountability; Correction
Document Number: 2017-00822
Type: Notice
Date: 2017-01-17
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the Federal Register (FR) on January 9, 2017, regarding Category 3 source security and accountability. This action is necessary to delete erroneous text in the paragraph under the heading ``IV. Public Comments Process.''
Public Hearing: Strategic Partnerships To Enhance the Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition; Request for Comments
Document Number: 2017-00821
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public hearing regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. The hearing will focus on partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk- based decisionmaking; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation's entire food safety system. In addition, we are seeking information from a variety of viewpoints, including from competent authorities in other countries and from private entities, to help inform FDA regarding risk-based decisionmaking, commodity-specific export control programs in other countries, and systems recognition.
Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability
Document Number: 2017-00820
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Referencing Approved Drug Products in ANDA Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in an ANDA submission.
Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for Industry; Availability
Document Number: 2017-00819
Type: Proposed Rule
Date: 2017-01-17
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 revised draft guidance for industry entitled ``Control of Listeria monocytogenes in Ready-To-Eat Foods.'' The revised draft guidance is intended for any person who is subject to our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and who manufactures, processes, packs, or holds ready-to-eat (RTE) foods. The revised draft guidance is intended to help such persons comply with the requirements of that regulation with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2017-00818
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Tilefish Advisory Panel of the Mid-Atlantic Fishery Management Council (Council) will hold a meeting.
Multistakeholder Process on Internet of Things Security Upgradability and Patching
Document Number: 2017-00817
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Telecommunications and Information Administration
The National Telecommunications and Information Administration (NTIA) will convene a virtual meeting of a multistakeholder process concerning Internet of Things Security Upgradability and Patching on January 31, 2017.
Proposed Information Collection; Comment Request; Atlantic Sea Scallops Amendment 10 Data Collection
Document Number: 2017-00816
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-00815
Type: Notice
Date: 2017-01-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Release of Waybill Data
Document Number: 2017-00814
Type: Notice
Date: 2017-01-17
Agency: Surface Transportation Board, Department of Transportation
Notice of Availability of Government-Owned Inventions; Available for Licensing
Document Number: 2017-00813
Type: Notice
Date: 2017-01-17
Agency: Department of Defense, Department of the Navy
The inventions listed below are assigned to the United States Government, as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy. The following patents are available for licensing: Patent No. 9,536,620 (Navy Case No. 200321): METHOD AND SYSTEM FOR IMPROVING THE RADIATION TOLERANCE OF FLOATING GATE MEMORIES// and Patent No. 9,535,562 (Navy Case No. 101979): COGNITIVE LOAD REDUCTION AND FIELD OF VIEW ENHANCING STANDARDIZED GRAPHICAL USER INTERFACE (GUI) OVERLAY GENERATING SYSTEM OR SYSTEMS THAT INCLUDE ELEMENTS THAT CORRELATE VARIOUS DEVICE, EVENT, OR OPERATION INPUTS WITH COMMON GUI OVERLAY GENERATION MODULES AND GROUP RELATED GUI ELEMENTS ACROSS OVERLAYS ALONG WITH ASSOCIATED METHODS.
Meeting of the Ocean Research Advisory Panel
Document Number: 2017-00812
Type: Notice
Date: 2017-01-17
Agency: Department of Defense, Department of the Navy
The Ocean Research Advisory Panel (ORAP) will hold a regularly scheduled meeting. The meeting will be open to the public.
Endangered Species; File No. 19508
Document Number: 2017-00811
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Katherine Mansfield, Ph.D., University of Central Florida, 4000 Central Florida Boulevard, Building 20, BIO301, Orlando, FL 32825, has applied in due form for a permit to take loggerhead (Caretta caretta), Kemp's ridley (Lepidochelys kempii), green (Chelonia mydas), hawksbill (Eretmochelys imbricata) and leatherback (Dermochelys coraicea) sea turtles for purposes of scientific research.
Supplemental Environmental Impact Statement: Hillsborough County, Florida
Document Number: 2017-00810
Type: Notice
Date: 2017-01-17
Agency: Federal Highway Administration, Department of Transportation
The Federal Highway Administration (FHWA) in cooperation with the Florida Department of Transportation (FDOT) is issuing this notice to advise the public that a Supplemental Environmental Impact Statement/Section 4(f) Evaluation (SEIS/4f) will be prepared to evaluate new significant environmental impacts since the November 1996 approval of the Final Environmental Impact Statement/Section 4(f) Evaluation (FEIS) for the Tampa Interstate Study proposed highway project in Hillsborough County, Florida.
Marine Mammals; File Nos. 19703 and 20993
Document Number: 2017-00807
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Fred Sharpe, Ph.D., Alaska Whale Foundation, 4739 University Way NE., #1230, Seattle, WA 98105 (File No. 19703) has applied in due form for a permit to conduct research on cetaceans and Christopher Cilfone, Be Blue, 2569 Douglas Hwy. Unit 1, Juneau, AK 99801 (File No. 20993) has applied in due form to conduct commercial/educational photography on humpback whales (Megaptera novaeangliae).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death
Document Number: 2017-00806
Type: Notice
Date: 2017-01-17
Agency: Department of Labor, Office of the Secretary
The Department of Labor is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ``Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
Marine Mammals; File No. 20043
Document Number: 2017-00802
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Whitlow Au, Ph.D., University of Hawaii, P.O. Box 1346, Kaneohe, HI 96744, has applied in due form for a permit to conduct research on marine mammals in Hawaii.
Pacific Fishery Management Council; Public Meetings and Hearings
Document Number: 2017-00801
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Pacific Fishery Management Council (Pacific Council) has announced its annual preseason management process for the 2017 ocean salmon fisheries. This notice informs the public of opportunities to provide comments on the 2017 ocean salmon management measures.
Loan Guaranty: Specially Adapted Housing Assistive Technology Grant Program
Document Number: 2017-00797
Type: Notice
Date: 2017-01-17
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA), is announcing the availability of funds for the Specially Adapted Housing Assistive Technology (SAHAT) Grant Program for fiscal year (FY) 2017. The objective of the grant is to encourage the development of new assistive technologies for specially adapted housing. This Notice is intended to provide applicants with the information necessary to apply for the SAHAT Grant Program. Registration will be available at www.Grants.gov. VA strongly recommends referring to the Loan GuarantySpecially Adapted Housing Assistive Technology Grant Program final rule (38 CFR 36.4412) in conjunction with this Notice. The registration process described within this Notice applies only to applicants who will register to submit project applications for FY 2017 SAHAT Grant Program funds.
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability
Document Number: 2017-00795
Type: Notice
Date: 2017-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.'' This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: Office for Victims of Crime Training and Technical Assistance Center-Trafficking Information Management System (TIMS)
Document Number: 2017-00794
Type: Notice
Date: 2017-01-17
Agency: Department of Justice
The Department of Justice (DOJ), Office of Justice Programs, Office for Victims of Crime, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Proposed General Directive 17-1; Stop Signal Overruns on Rail Fixed Guideway Public Transportation Systems
Document Number: 2017-00793
Type: Notice
Date: 2017-01-17
Agency: Federal Transit Administration, Department of Transportation
FTA has placed in the docket and on its Web site a proposed General Directive to address safety risks associated with stop signal overruns. The proposed directive follows FTA's review and analysis of data and information submitted in response to the agency's Safety Advisory 16-1: Stop Signal Overruns, for Rail Fixed Guideway Public Transportation System operations during calendar year 2015.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Hospital Organ Donation Campaign's Activity Scorecard
Document Number: 2017-00792
Type: Notice
Date: 2017-01-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Atlantic Highly Migratory Species; Exempted Fishing Permits
Document Number: 2017-00791
Type: Notice
Date: 2017-01-17
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces the receipt of an application for an exempted fishing permit (EFP) from Dr. David Kerstetter of Nova Southeastern University to evaluate pelagic longline (PLL) catch and bycatch rates from within two different sub-areas in the northern portion of the East Florida Coast Pelagic Longline (PLL) Closed Area (north and south of 29[deg]50' N. lat.) and compare those rates to rates obtained by authorized samplers from outside the EFC PLL Closed Area and the availability of a draft Environmental Assessment (EA) analyzing the impacts of granting the application to conduct the research using commercial PLL vessels, with certain terms and conditions. The overall purpose of the research project would be to evaluate PLL catches and catch rates of target and non-target species within a portion of the EFC PLL Closed Area to evaluate the effectiveness of existing area closures at meeting current conservation and management goals under current conditions using standardized PLL gear on a specified number of commercial vessels.
National Nanotechnology Initiative Meetings
Document Number: 2017-00790
Type: Notice
Date: 2017-01-17
Agency: Office of Science and Technology Policy
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will hold one or more webinars to share information with the general public and the nanotechnology research and development community. Topics covered may include technical subjects; environmental, health, and safety issues; business case studies; or other areas of potential interest to the nanotechnology community.
National Infrastructure Advisory Council
Document Number: 2017-00789
Type: Notice
Date: 2017-01-17
Agency: Department of Homeland Security
The National Infrastructure Advisory Council (NIAC) will meet Thursday, February 16, 2017, at 1331 F Street NW., Suite 1000, Washington, DC 20004. This meeting will be open to the public.
Certain Industrial Control System Software, Systems Using Same and Components Thereof; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on a Settlement Agreement; Termination of the Investigation
Document Number: 2017-00787
Type: Notice
Date: 2017-01-17
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 on a settlement agreement. The Commission has determined to terminate the investigation.
Brown Advisory LLC; Notice of Application
Document Number: 2017-00778
Type: Notice
Date: 2017-01-17
Agency: Securities and Exchange Commission, Agencies and Commissions
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability
Document Number: 2017-00773
Type: Notice
Date: 2017-01-17
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 industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
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