February 14, 2018 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 163
Procedures To Consider Additional Requests for Exclusion of Particular Products From the Solar Products Safeguard Measure
Document Number: 2018-03048
Type: Notice
Date: 2018-02-14
Agency: Office of the United States Trade Representative
On January 23, 2018, the President imposed a safeguard measure on imports of crystalline silicon photovoltaic (CSPV) cells, whether or not partially or fully assembled into other products such as modules (other CSPV products), consisting of (1) a tariff-rate quota on imports of CSPV cells not partially or fully assembled into other products, with an unchanged rate of duty for the within-quota quantity and an increase in the rate of duty applicable to articles entered in excess of that quantity; and (2) an increase in the rate of duty on imports of other CSPV products, as provided for in the Proclamation's annex. This notice establishes the procedures to request the exclusion of a particular product from the safeguard measure, the criteria for describing a particular product for which exclusion is sought, and identifies the factors that the Office of the United States Trade Representative (USTR) may take into consideration when determining whether to exclude a particular product. It also solicits requests for exclusion of a particular product from the safeguard measure.
Qualification of Drivers; Exemption Applications; Diabetes
Document Number: 2018-03047
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 186 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.
Qualification of Drivers; Exemption Applications; Diabetes Mellitus
Document Number: 2018-03046
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to exempt 27 individuals from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these individuals with ITDM to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Hearing
Document Number: 2018-03045
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to exempt 33 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Hearing
Document Number: 2018-03044
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to exempt 91 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Determination of Regulatory Review Period for Purposes of Patent Extension; BELEODAQ
Document Number: 2018-03041
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for BELEODAQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Amendment 16 to the Coastal Pelagic Species Fishery Management Plan
Document Number: 2018-03040
Type: Rule
Date: 2018-02-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is publishing this final rule to implement Amendment 16 of the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP). This rule will allow for very small amounts of directed, non-live bait fishing (referred to as ``minor directed fishing'') on CPS finfish to occur when a fishery is otherwise closed to directed fishing. Currently, when directed fishing is closed, a small sector of the CPS fishery that is not part of the primary commercial directed fishery has been precluded from landing even minor amounts because this activity does not fall under the existing exemptions for incidental harvest or for harvesting CPS to be sold as live bait. This rule allows this sector to continue directed fishing after other directed fisheries are closed, unless otherwise specified in a closure notice published by NMFS or if an applicable annual catch limit (ACL) is anticipated to be exceeded. To prevent exploitation of this rule to make large aggregate harvests, ``minor directed fishing'' would not be allowed to exceed landings of 1 metric ton (mt) per day per vessel or person or one fishing trip per day by any vessel. The purpose of this rule is to provide greater flexibility to small fishing operations, while continuing to conserve the target CPS fish stocks.
Environmental Management Site-Specific Advisory Board, Portsmouth
Document Number: 2018-03039
Type: Notice
Date: 2018-02-14
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Environmental Management Site-Specific Advisory Board, Northern New Mexico
Document Number: 2018-03038
Type: Notice
Date: 2018-02-14
Agency: Department of Energy
This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Environmental Management Site-Specific Advisory Board, Hanford
Document Number: 2018-03037
Type: Notice
Date: 2018-02-14
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Hanford. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Qualification of Drivers; Exemption Applications; Hearing
Document Number: 2018-03035
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA confirms its decision to exempt twenty six individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2018-03034
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from 23 individuals for an exemption from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions will enable these individuals to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Parts and Accessories Necessary for Safe Operation, Lamps and Reflective Devices; Application for an Exemption From STEMCO LP
Document Number: 2018-03033
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant STEMCO LP's (STEMCO) application for a limited 5-year exemption to allow motor carriers to operate certain commercial motor vehicles (CMVs) that are equipped with STEMCO's TrailerTail[supreg] aerodynamic device with rear identification lamps and rear clearance lamps that are mounted lower than currently permitted by the Agency's regulations. The Federal Motor Carrier Safety Regulations (FMCSRs) require rear identification lamps and rear clearance lamps to be located ``as close as practicable to the top of the vehicle.'' While the TrailerTail[supreg] aerodynamic device is currently mounted slightly below the roof of the vehicle, STEMCO states that this offset prevents the device from delivering the maximum available fuel economy benefit as opposed to mounting it flush with the top of the vehicle which may block the visibility of the rear identification lamps and rear clearance lamps. The Agency has determined that locating the rear identification lamps and rear clearance lamps lower on the trailers and semitrailers, mounted at the same level as the stop lamps, tail lamps, and turn signals will maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption.
Qualification of Drivers; Exemption Applications; Diabetes
Document Number: 2018-03032
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 53 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.
Qualification of Drivers; Exemption Applications; Diabetes Mellitus
Document Number: 2018-03031
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to exempt 27 individuals from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these individuals with ITDM to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Diabetes
Document Number: 2018-03030
Type: Notice
Date: 2018-02-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to deny applications from 97 individuals who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating a commercial motor vehicle (CMV) in interstate commerce.
Determination of Regulatory Review Period for Purposes of Patent Extension; IBRANCE
Document Number: 2018-03029
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IBRANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Reports, Forms, and Record Keeping Requirements Agency Information Collection Activity Under OMB Review
Document Number: 2018-03028
Type: Notice
Date: 2018-02-14
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 is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on October 20, 2017 (82 FR 48891). Two comments were received. The content of neither comment related to the proposed data collection.
Environmental Impact Statement for 2019 Update to the Integrated Resource Plan
Document Number: 2018-03027
Type: Notice
Date: 2018-02-14
Agency: Tennessee Valley Authority, Agencies and Commissions
The Tennessee Valley Authority (TVA) is conducting a study of its energy resources in order to update and replace the Integrated Resource Plan (IRP) and the associated Supplemental Environmental Impact Statement (EIS) that it completed in 2015. The IRP is a comprehensive study of how TVA will meet the demand for electricity in its service territory over the next 20 years. The 2015 IRP is being updated in response to major changes in electrical utility industry trends since 2015, including flat to slightly declining load growth, advances in the development of distributed energy resources and the integration of those resources in the electric grid. As part of the study, TVA intends to prepare a programmatic EIS to assess the impacts associated with the implementation of the updated IRP. TVA will use the EIS process to elicit and prioritize the values and concerns of stakeholders; identify issues, trends, events, and tradeoffs affecting TVA's policies; formulate, evaluate and compare alternative portfolios of energy resource options; provide opportunities for public review and comment; and ensure that TVA's evaluation of alternative energy resource strategies reflects a full range of stakeholder input. Public comment is invited concerning both the scope of the EIS and environmental issues that should be addressed as a part of this EIS.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-03026
Type: Proposed Rule
Date: 2018-02-14
Agency: Federal Aviation Administration, Department of Transportation
We propose to supersede Airworthiness Directive (AD) 2017-01- 02, which applies to certain The Boeing Company Model 787-8 and 787-9 airplanes. AD 2017-01-02 requires an inspection for discrepant inboard and outboard trailing edge flap rotary actuators. Since we issued AD 2017-01-02, we have determined that it is necessary to revise the applicability to include additional airplanes, and to reduce the number of affected actuators. This proposed AD would continue to require an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, and corrective actions if necessary. We are proposing this AD to address the unsafe condition on these products.
Tristate NLA, LLC; Notice of Petition for Declaratory Order
Document Number: 2018-03022
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2018-03021
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2018-03020
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Request for Public Comment: 30 Day Notice for Extension of the Indian Health Service Loan Repayment Program (LRP)
Document Number: 2018-03019
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act (PRA) of 1995, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, ``IHS Loan Repayment Program (LRP)'' (OMB Control Number 0917-0014), which expires July 31, 2018. This proposed information collection project was recently published in the Federal Register (82 FR 55107) on November 20, 2017, and allowed 60 days for public comment, as required by the PRA. The IHS received 20 anonymous comments regarding this collection but they did not pertain to the LRP notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Request for Public Comment: 30 Day Proposed Information Collection: Indian Health Service Information Security Ticketing and Incident Reporting
Document Number: 2018-03018
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917- XXXX, titled, Information Security Ticketing and Incident Reporting. This proposed information collection project was recently published in the Federal Register (82 FR 56832) on November 30, 2017, and allowed 60 days for public comment, as required by the PRA. The IHS received no comments on this notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Determination of Regulatory Review Period for Purposes of Patent Extension; JUVEDERM VOLUMA XC
Document Number: 2018-03017
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for JUVEDERM VOLUMA XC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2018-03016
Type: Notice
Date: 2018-02-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Scientific and Statistical Committee (SSC) of the Mid- Atlantic Fishery Management Council's (Council) will hold a meeting.
Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
Document Number: 2018-03015
Type: Notice
Date: 2018-02-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The SEDAR 56 assessment of the South Atlantic stock of Black Seabass will consist of a series webinars. See SUPPLEMENTARY INFORMATION.
Privacy Act of 1974; System of Records
Document Number: 2018-03014
Type: Notice
Date: 2018-02-14
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) proposes to modify all of its systems of records to add two security-related routine uses which are needed to improve federal agencies' ability to detect and address actual and suspected breaches of personally identifiable information (PII) in Privacy Act systems of records. The routine uses are explained in the Supplementary Information section of this notice.
East Cheyenne Gas Storage, LLC; Notice of Schedule for Environmental Review of the Lewis Creek Amendment
Document Number: 2018-03012
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
ISO New England Inc.; Notice of Filing
Document Number: 2018-03009
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Gulf South Pipeline Company, LP; Notice of Application
Document Number: 2018-03006
Type: Notice
Date: 2018-02-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Florida Power and Light Company; St. Lucie Plant, Unit Nos. 1 and 2
Document Number: 2018-03003
Type: Notice
Date: 2018-02-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of amendments to Renewed Facility Operating License Nos. DPR- 67 and NPF-16, issued on October 2, 2003, and held by Florida Power and Light Company (FPL or the licensee) for the operation of St. Lucie Plant, Unit Nos. 1 and 2 (St. Lucie), located on Hutchinson Island in St. Lucie County, Florida. The proposed amendments would revise the Emergency Plan for St. Lucie to adopt a limited scope of the Nuclear Energy Institute (NEl) Emergency Action Level (EAL) scheme for the fire-related notification of unusual event.
Notice of Intent To Seek Approval To Renew an Information Collection System
Document Number: 2018-03002
Type: Notice
Date: 2018-02-14
Agency: National Science Foundation, Agencies and Commissions
Under the Paperwork Reduction Act of 1995, and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public or other Federal agencies to comment on this proposed continuing information collection.
Information Collections Being Reviewed by the Federal Communications Commission
Document Number: 2018-03001
Type: Notice
Date: 2018-02-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Information Collection Approved by the Office of Management and Budget
Document Number: 2018-03000
Type: Notice
Date: 2018-02-14
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (Commission) has received Office of Management and Budget (OMB) approval, on an emergency basis, for a new, one-time information collection pursuant to the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number, and no person is required to respond to a collection of information unless it displays a currently valid control number. Comments concerning the accuracy of the burden estimates and any suggestions for reducing the burden should be directed to the person listed in the FOR FURTHER INFORMATION CONTACT section below.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2018-02999
Type: Notice
Date: 2018-02-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2018-02998
Type: Notice
Date: 2018-02-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
Document Number: 2018-02997
Type: Notice
Date: 2018-02-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Amendment to the International Traffic in Arms Regulations: Addition of South Sudan
Document Number: 2018-02995
Type: Rule
Date: 2018-02-14
Agency: Department of State
The Department of State is amending the International Traffic in Arms Regulations (ITAR) to include reference to South Sudan in its regulations on prohibited exports, imports, and sales to and from certain countries, and to update defense trade policy toward South Sudan by applying a policy of denial on the export of defense articles and defense services to South Sudan, except as otherwise provided. This amendment reflects a policy determination made by the Secretary of State.
Airworthiness Directives; GE Aviation Czech s.r.o. Turboprop Engines
Document Number: 2018-02994
Type: Rule
Date: 2018-02-14
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E- 11S, and M601F turboprop engines. This AD requires removal of certain power turbine (PT) disks installed on the affected engines. This AD was prompted by a design review by the manufacturer that determined PT rotors with certain disks have less overspeed margin than originally stated during product certification. We are issuing this AD to address the unsafe condition on these products.
Determination of Regulatory Review Period for Purposes of Patent Extension; KERYDIN
Document Number: 2018-02993
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KERYDIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; JARDIANCE
Document Number: 2018-02992
Type: Notice
Date: 2018-02-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for JARDIANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
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