September 6, 2017 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 123
Special Local Regulation; Atlantic Ocean, Ft. Lauderdale, FL
Document Number: 2017-18829
Type: Proposed Rule
Date: 2017-09-06
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to establish a recurring special local regulation for navigable waters of the Atlantic Ocean in the vicinity of the Fort Lauderdale for the Grand Prix of the Seas. The Fort Lauderdale Grand Prix of the Seas race course is located east of South Beach Park and North of the Port Everglades inlet. Approximately one hundred high-speed personal watercraft are expected to participate in this annual event. The special local regulation is needed to protect personnel, vessels, and the marine environment from potential hazards during the race event. All vessels and persons in the regulated area must follow the direction of Coast Guard personnel, law enforcement, and race officials. We invite your comments on this proposed rulemaking.
Reports, Forms, and Record Keeping Requirements
Document Number: 2017-18827
Type: Notice
Date: 2017-09-06
Agency: National Highway Traffic Safety Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review. The ICR describes the nature of the information collection and its expected burden.
Qualification of Drivers; Exemption Applications; Diabetes
Document Number: 2017-18826
Type: Notice
Date: 2017-09-06
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 134 individuals from its prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals with ITDM to continue to operate CMVs in interstate commerce.
Light-Walled Rectangular Pipe and Tube From Mexico: Preliminary Results of Antidumping Duty Administrative Review; 2015-2016
Document Number: 2017-18825
Type: Notice
Date: 2017-09-06
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on light-walled rectangular pipe and tube (LWRPT) from Mexico. The period of review is August 1, 2015, through July 31, 2016. The review covers one producer/ exporter of the subject merchandise, Productos Laminados de Monterrey S.A. de C.V (Productos Laminados). We preliminarily determine that sales of subject merchandise by Productos Laminados and affiliated reseller, Aceros Cuatros Caminos S.A. de C.V. (A4C) (collectively, Prolamsa), were not made at less than normal value during the period of review. Interested parties are invited to comment on these preliminary results.
Certain Cut-to-Length Carbon-Quality Steel Plate Products From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2015-2016
Document Number: 2017-18824
Type: Notice
Date: 2017-09-06
Agency: Department of Commerce, International Trade Administration
On March 3, 2017, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain cut-to-length carbon-quality steel plate products (CTL plate) from the Republic of Korea (Korea). Based on our analysis of the comments received, we continue to find that subject merchandise has been sold at less than normal value.
Drawbridge Operation Regulation; Newtown Creek, New York, NY
Document Number: 2017-18822
Type: Rule
Date: 2017-09-06
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Pulaski Bridge across Newtown Creek, mile 0.6 at New York City, New York. This deviation is necessary to facilitate planned repairs and will allow the owner to temporarily close the draw during weeknights for periods not to exceed five hours.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Giovanni Bellini: Landscapes of Faith in Renaissance Venice” Exhibition
Document Number: 2017-18821
Type: Notice
Date: 2017-09-06
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Giovanni Bellini: Landscapes of Faith in Renaissance Venice,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum at the Getty Center, Los Angeles, California, from on or about October 10, 2017, until on or about January 14, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
United States Travel and Tourism Advisory Board Charter Renewal
Document Number: 2017-18820
Type: Notice
Date: 2017-09-06
Agency: Department of Commerce, International Trade Administration
The Chief Financial Officer and Assistant Secretary of Commerce for Administration, with the concurrence of the General Services Administration, renewed the Charter for the United States Travel and Tourism Advisory Board on August 17, 2017.
Proposed Information Collection; Comment Request; Steel Import License
Document Number: 2017-18819
Type: Notice
Date: 2017-09-06
Agency: Department of Commerce, International Trade 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.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska
Document Number: 2017-18818
Type: Rule
Date: 2017-09-06
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is opening directed fishing for Pacific cod by catcher/ processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to fully use the 2017 total allowable catch apportioned to catcher/processors using trawl gear in the Central Regulatory Area of the GOA.
Determination That RITALIN LA (Methylphenidate Hydrochloride) Extended-Release Capsules, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-18817
Type: Notice
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that RITALIN LA (methylphenidate hydrochloride) extended- release capsules, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride extended-release capsules, 60 mg, if all other legal and regulatory requirements are met.
Determination That GYNOREST (Dydrogesterone) Oral Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-18816
Type: Notice
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that GYNOREST (dydrogesterone) oral tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GYNOREST (dydrogesterone) oral tablets, 5 mg and 10 mg, if all other legal and regulatory requirements are met.
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-18815
Type: Notice
Date: 2017-09-06
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 ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.'' FDA is issuing this guidance to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in the development and design of interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-18814
Type: Notice
Date: 2017-09-06
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 Mobile Proximity Initial User Feedback information collection project.
B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application; Correction
Document Number: 2017-18813
Type: Notice
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a document entitled ``B. Braun Medical, Inc.; Withdrawal of Approval of Three New Drug Applications and One Abbreviated New Drug Application'' that appeared in the Federal Register of August 3, 2017 (82 FR 36150). The document was published with the incorrect docket number. This document corrects that error.
Development of a List of Pre-Dietary Supplement Health and Education Act Dietary Ingredients; Public Meeting; Request for Comments
Document Number: 2017-18812
Type: Notice
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the following public meeting entitled ``Development of a List of Pre-DSHEA Dietary Ingredients.'' The purpose of the meeting is to give interested stakeholders an opportunity to discuss issues related to FDA's future development of such a list.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2017-18811
Type: Rule
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.''
Food and Drug Administration, Center for Drug Evaluation and Research Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development
Document Number: 2017-18810
Type: Notice
Date: 2017-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is sponsoring a public workshop entitled ``CDER Rare Diseases Public Workshop: Strategies, Tools, and Best Practices for Effective Advocacy in Rare Diseases Drug Development.'' This public workshop builds upon previous CDER patient advocacy public workshops and is primarily for the rare disease community to help them effectively understand what FDA needs to enhance drug development. This effort is consistent with FDA's efforts to support the integration of patient experience in drug development programs, including through implementation of the ``Patient-Focused Drug Development'' provisions of the 21st Century Cures Act (Cures Act). This public workshop will include case studies demonstrating the beneficial overlap of effective advocacy techniques and FDA regulations in rare disease drug development.
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Immigration Bond
Document Number: 2017-18809
Type: Notice
Date: 2017-09-06
Agency: Department of Homeland Security, U.s. Immigration and Customs Enforcement
Certain Microfluidic Devices; Institution of Investigation
Document Number: 2017-18808
Type: Notice
Date: 2017-09-06
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on July 31, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Bio-Rad Laboratories, Inc. of Hercules, California and Lawrence Livermore National Security, LLC of Livermore, California. A supplement to the complaint was filed on August 22, 2017. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain microfluidic devices by reason of infringement of one or more of U.S. Patent No. 9,500,664 (``the '664 patent''); U.S. Patent No. 9,089,844 (``the '844 patent''); U.S. Patent No. 9,636,682 (``the '682 patent''); U.S. Patent No. 9,649,635 (``the '635 patent''); and U.S. Patent No. 9,126,160 (``the '160 patent). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-18806
Type: Notice
Date: 2017-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-18805
Type: Notice
Date: 2017-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended Notice of Meeting
Document Number: 2017-18804
Type: Notice
Date: 2017-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2017-18803
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Siegfried USA, LLC
Document Number: 2017-18802
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc.
Document Number: 2017-18801
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2017-18789
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Spex Certiprep Group, LLC
Document Number: 2017-18788
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: KVK-Tech, Inc.
Document Number: 2017-18787
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Entergy Operations, Inc.; River Bend Station, Unit 1; Correction
Document Number: 2017-18786
Type: Notice
Date: 2017-09-06
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 August 14, 2017, regarding the NRC's consideration of an application for the renewal of operating license NPF-47, which authorizes Entergy Operations, Inc., (the applicant), to operate River Bend Station, Unit 1 (RBS). The renewed license would authorize the applicant to operate RBS for an additional 20 years beyond the period specified in the current license. The current operating license for RBS expires at midnight on August 29, 2025. This action is necessary to correct the location where local residents can view a paper copy of the license renewal application.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Document Number: 2017-18785
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Marcus W. Anderson, M.D.; Decision and Order
Document Number: 2017-18784
Type: Notice
Date: 2017-09-06
Agency: Drug Enforcement Administration, Department of Justice
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
Document Number: 2017-18781
Type: Notice
Date: 2017-09-06
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Certain New Chemicals; Receipt and Status Information for May 2017
Document Number: 2017-18779
Type: Notice
Date: 2017-09-06
Agency: Environmental Protection Agency
EPA is required under the Toxic Substances Control Act (TSCA) to publish in the Federal Register a notice of receipt of a premanufacture notice (PMN); an application for a test marketing exemption (TME), both pending and/or expired; and a periodic status report on any new chemicals under EPA review and the receipt of notices of commencement (NOC) to manufacture those chemicals. This document covers the period from May 1, 2017 to May 31, 2017.
Nominations to the Augmented Science Advisory Committee on Chemicals (SACC); Extension of Comment Period
Document Number: 2017-18778
Type: Notice
Date: 2017-09-06
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency published a notice with the names and affiliations of additional candidates for consideration for the Science Advisory Committee on Chemicals (SACC) on August 3, 2017. Public comments were requested to be received by the Docket Identification Number: EPA-HQ-OPPT-2016-0713. This document extends the public comment period from September 5, 2017 to September 17, 2017.
SL Advisors, LLC, et al.
Document Number: 2017-18777
Type: Notice
Date: 2017-09-06
Agency: Securities and Exchange Commission, Agencies and Commissions
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-18776
Type: Notice
Date: 2017-09-06
Agency: Bureau of Consumer Financial Protection
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is proposing a new information collection titled, ``Student Loan Servicing Market Monitoring.''
Air Plan Approval; New Hampshire; Rules for Open Burning and Incinerators
Document Number: 2017-18775
Type: Proposed Rule
Date: 2017-09-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of New Hampshire on August 9, 2011, and July 23, 2013. These SIP revisions establish rules for open burning and establish emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to federal incinerator standards. We are also proposing to approve revisions to the definitions of ``Incinerator'' and ``Wood Waste Burner,'' submitted by the State on July 23, 2013 and October 26, 2016, respectively. This action will have a beneficial effect on air quality. This action is being taken in accordance with the Clean Air Act.
Air Plan Approval; New Hampshire; Rules for Open Burning and Incinerators
Document Number: 2017-18774
Type: Rule
Date: 2017-09-06
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) revisions submitted by the State of New Hampshire on August 9, 2011, and July 23, 2013. These SIP revisions establish rules for open burning and establish emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to federal incinerator standards. We are also approving revisions to the definitions of ``Incinerator'' and ``Wood Waste Burner,'' submitted by the State on July 23, 2013 and October 26, 2016, respectively. This action is being taken in accordance with the Clean Air Act.
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