January 24, 2020 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 108
Prospective Grant of Exclusive Patent License: Antibody-Based Therapeutics and Chimeric Antigen Receptors Targeting Glypican-2
The National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Stanford University, (``Stanford''), a non-profit university located in California, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Airworthiness Directives; Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes, type certificated in any category; and Model C-130A, C-130B, C-130BL, C-130E, C-130H, C-130H-30, C-130J, C-130J-30, EC-130Q, HC-130H, KC-130H, NC-130B, NC-130, and WC- 130H airplanes, type certificated in the restricted or amateur category. This AD was prompted by a report indicating that two elevator booster assemblies experienced significant hydraulic fluid leaks, caused by fatigue cracks in the actuator cylinder. This AD requires an inspection to determine the part number of the elevator booster actuator, repetitive ultrasonic inspections of the actuator to detect cracking, and replacement of cracked elevator booster assemblies. The FAA is issuing this AD to address the unsafe condition on these products.
Notice of Intent To Prepare an Environmental Impact Statement for Navy Old Town Campus Revitalization at Naval Base Point Loma, California, and To Announce Public Scoping Meetings
Pursuant to Section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations, the Department of the Navy (Navy) announces its intent to prepare an Environmental Impact Statement (EIS) to evaluate the potential environmental effects associated with revitalization of the Navy Old Town Campus (OTC) to support Naval Information Warfare Systems Command's (NAVWAR) current and future operational readiness. This EIS will also address provisions of the California Environmental Quality Act (CEQA) as it relates to non- federal development within the proposed alternatives. An EIS is considered the appropriate document for comprehensively analyzing the proposed action to demolish and construct buildings, utilities, and infrastructure at the OTC, Naval Base Point Loma, California. Specific proposed actions within the OTC proposal could include Navy recapitalization of the site or redevelopment through a public-private partnership.
Certificate of Alternate Compliance for USS OAKLAND (LCS 24)
The U.S. Navy hereby announces that a Certificate of Alternate Compliance has been issued for USS OAKLAND (LCS 24). Due to the special construction and purpose of this vessel, the Deputy Assistant Judge Advocate General (DAJAG)(Admiralty and Maritime Law) has determined it is a vessel of the Navy which, due to its special construction and purpose, cannot comply fully with the navigation lights provisions of the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS) without interfering with its special function as a naval ship. The intended effect of this notice is to warn mariners in waters where 72 COLREGS apply.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
FY 2020 Competitive Funding Opportunity: Low or No Emission Grant Program
The Federal Transit Administration (FTA) announces the opportunity to apply for $130 million in competitive grants under the fiscal year (FY) 2020 Low or No Emission Grant Program (Low-No Program) (Catalog of Federal Domestic Assistance number: 20.526). As required by Federal public transportation law, funds will be awarded competitively for the purchase or lease of low or no emission vehicles that use advanced technologies for transit revenue operations, including related equipment or facilities. Projects may include costs incidental to the acquisition of buses or to the construction of facilities, such as the costs of related workforce development and training activities, and project administration expenses. FTA may award additional funding that is made available to the program prior to the announcement of project selections.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Arms Sales Notification
The Department of Defense is publishing the unclassified text of an arms sales notification.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Infant Mortality
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Committee on Infant Mortality (ACIM). The ACIM provides advice to the Secretary of HHS on Department activities and programs directed at reducing infant mortality and improving the health status of pregnant women and infants. With a focus on life course, ACIM addresses disparities in maternal health to improve maternal health outcomes, including preventing and reducing maternal mortality and severe maternal morbidity. HRSA is seeking nominations of qualified candidates to fill positions on the ACIM.
U.S. Integrated Ocean Observing System (IOOS®) Advisory Committee
Notice is hereby given of a public in-person meeting of the U. S. Integrated Ocean Observing System (IOOS[supreg]) Advisory Committee (Committee).
Advisory Committee on the Medical Uses of Isotopes: Meeting Notice
The U.S. Nuclear Regulatory Commission (NRC) will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on March 11, 2020, to discuss the draft report of the ACMUI Regulatory Guide 8.39 Subcommittee. A phased approach is being conducted by the NRC staff to comprehensively update Regulatory Guide 8.39, ``Release of Patients Administered Radioactive Material.'' Phase 1 of the revision provides licensees with more detailed instructions to patients before and after they have been administered radioactive material than what is currently provided in Regulatory Guide 8.39. The ACMUI subcommittee's report will include its comments and recommendations on the draft final Phase 1 revisions to Regulatory Guide 8.39. Meeting information, including a copy of the agenda and handouts, will be available at https://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2020.html. The agenda and handouts may also be obtained by contacting Ms. Kellee Jamerson using the information below.
Division of Federal Employees Compensation (DFEC); Proposed Extension of Existing Collection; Comment Request
The Department of Labor (DOL) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ``Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Submission for OMB Review; Form ACF-196, TANF Quarterly Financial Report (OMB #0970-0247)
The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to revise expenditure data for fiscal years (FYs) prior to FY 2015. ACF will use the financial data provided by states to assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Program To Prevent Smoking in Hazardous Areas of Underground Coal Mines
The Department of Labor (DOL) is submitting the Mining Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, Program to Prevent Smoking in Hazardous Areas of Underground Coal Mines to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Bureau of Health Workforce (BHW) Substance Use Disorder (SUD) Evaluation, OMB No. 0906-xxxx-New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed New Fee Sites
The Bridger-Teton National Forest is proposing to add two campgrounds and one guard station as fee sites. The campgrounds are currently in use by the public but had improvements made in the past years that justify a standard amenity fee. The proposed rental cabin is not open to the public currently, but would provide a recreation opportunity that is not currently offered in the area. A review of visitor use data and fee collection information for existing fee campgrounds and rental cabins on the Forest demonstrate public need and demand for the variety of recreation opportunities these facilities provide.
Approval of Laboratories To Conduct Official Testing; Consolidation of Regulations
We are consolidating the regulations governing diagnostic laboratory approval authorities for select animal diseases into a single regulation and establishing a set of standard procedures that we will use to conduct future diagnostic laboratory approvals. These consolidated regulations will provide for consistent inspection protocols, proficiency testing methods, quality system guidelines, and definitions and will facilitate the approval of additional laboratories in emergency situations. The consolidated regulations will serve to simplify regulatory oversight and compliance.
Agricultural Conservation Easement Program
On January 6, 2020, CCC and NRCS published an interim rule in the Federal Register that made changes to the Agricultural Conservation Easement Program (ACEP) regulations. This correction is being published to address minor errors in the preamble portion of the ACEP interim rule published on January 6, 2020. There are no changes to the ACEP regulations as published on January 6, 2020. CCC and NRCS are also extending the comment period and asking for public input on additional specific questions.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 and -1041 airplanes. This AD was prompted by reports of sealant bead damage caused by rotation of the attachment fitting bearing assembly of a trimmable horizontal stabilizer (THS). This AD requires repetitive detailed inspections, and applicable corrective action(s) if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. In addition, as specified in the EASA AD, this AD provides an optional modification that would terminate the inspections. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A300 series airplanes. This AD was prompted by a report that indicated that bleed and air conditioning systems were contaminated by hydraulic fluid, and by an investigation that revealed that hydraulic fluid contaminations caused the failure of check valves installed on the hydraulic reservoir air pressurization system. This AD requires repetitive functional tests of the hydraulic reservoir air pressurization lines, and repair or replacement if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Proposed Amendment, Establishment, and Revocation of Multiple Air Traffic Service (ATS) Routes in the Vicinity of Waukon, IA
This action proposes to amend six VHF Omnidirectional Range (VOR) Federal airways, V-2, V-77, V-138, V-218, V-246 and V-398; establish two low altitude Area Navigation (RNAV) routes, T-348 and T- 389; and remove one VOR Federal airway, V-411, in the vicinity of Waukon, IA. The Air Traffic Service (ATS) route modifications are necessary due to the planned decommissioning of the VOR portion of the Waukon, IA, VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID). The NAVAIDs provide navigation guidance for portions of the affected air traffic service (ATS) routes. The VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Proposed Amendment of Class E Airspace; Tahlequah, OK
This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Tahlequah Municipal Airport in Tahlequah, OK. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Tahlequah non- directional radio beacon (NDB). The geographic coordinates for the airport in the associated airspace would be updated to coincide with the FAA's aeronautical database. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of the OU1 of the Libby Asbestos Superfund Site
The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete Operable Unit 1 (OU1), Former Export Plant, of the Libby Asbestos Superfund Site (Site), located in Lincoln County, Montana, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Montana (State), through the Department of Environmental Quality (DEQ), have determined that all appropriate response actions at OU1 under CERCLA, other than operation and maintenance and five-year reviews (FYR), have been completed. However, this partial deletion does not preclude future actions under Superfund. This partial deletion pertains only to OU1. Operable Unit 2 (OU2), Former Screening Plant, was deleted from the NPL on April 10, 2019. Operable Unit 3 (OU3), Former Vermiculite Mine; Operable Unit 4 and Operable Unit 7 (OU4/OU7), Residential/Commercial Properties of Libby and Troy; Operable Unit 5 (OU5), Former Stimson Lumber Mill; Operable Unit 6 (OU6), BNSF Rail Corridor; and Operable Unit 8 (OU8), Highways and Roadways, are not being considered for deletion as part of this proposed action and will remain on the NPL.
International Fisheries; Pacific Tuna Fisheries; Fishing Restrictions for Silky Shark, Fish Aggregating Device, and Observer Safety in the Eastern Pacific Ocean
NMFS proposes regulations under the Tuna Conventions Act to implement Resolutions C-19-01 (Amendment to Resolution C-18-05 on the Collection and Analyses of Data on Fish-Aggregating Devices); C-19-05 (Amendment to the Resolution C-16-06 Conservation Measures for Shark Species, with Special Emphasis on the Silky Shark (Carcharhinus Falciformis), for the Years 2020 and 2021); and C-18-07 (Resolution on Improving Observer Safety at Sea: Emergency Action Plan) of the Inter- American Tropical Tuna Commission (IATTC). NMFS also proposes regulations under the Marine Mammal Protection Act to implement Resolution A-18-03 (On Improving Observer Safety At Sea: Emergency Action Plan) of the Agreement on the International Dolphin Conservation Program (AIDCP). This proposed rule is necessary for the United States to satisfy its obligations as a member of the IATTC and Party to the AIDCP.
Vessel Monitoring Systems; Requirements for Type-Approval of Cellular Transceiver Units
The U.S. Vessel Monitoring System (VMS) program type-approves enhanced mobile transceiver units (EMTUs) for use in U.S. fisheries. Currently, the only approved method for transferring VMS data from a vessel to NMFS is by satellite-linked communication services. This proposed rule would amend the existing VMS type-approval regulations to add cellular-based EMTUs (EMTU-Cs) type-approval application and testing procedures; compliance and revocation processes; and technical, service, and performance standards. This proposed rule is necessary to allow for the use of EMTU-Cs and cellular communication service, in addition to satellite-only models, in federally managed fisheries.
Schedules of Controlled Substances: Placement of Brexanolone in Schedule IV
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on June 17, 2019. That interim final rule placed the substance brexanolone (3[alpha]-hydroxy-5[alpha]-pregnan-20-one), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains brexanolone in schedule IV of the Controlled Substances Act.
Schedules of Controlled Substances: Placement of 5F-ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA in Schedule I
The Drug Enforcement Administration places methyl 2-(1-(5- fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoat e [5F-ADB; 5F-MDMB-PINACA]; methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate [5F-AMB]; N-(adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3-carboxamide [5F-APINACA, 5F-AKB48]; N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-ind azole-3- carboxamide [ADB-FUBINACA]; methyl 2-(1-(cyclohexylmethyl)-1H-indole-3- carboxamido)-3,3-dimethylbutanoate [MDMB-CHMICA, MMB-CHMINACA]; and methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate [MDMB-FUBINACA], including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. This action continues the imposition of the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 5F- ADB, 5F-AMB, 5F-APINACA, ADB-FUBINACA, MDMB-CHMICA, and MDMB-FUBINACA.
Schedules of Controlled Substances: Removal of 6β-Naltrexol From Control
With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes (5[alpha],6[beta])-17- (cyclopropylmethyl)-4,5-epoxymorphinan-3,6,14-triol (6[beta]-naltrexol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, 6[beta]-naltrexol was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle 6[beta]-naltrexol.
Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard
This final rule adopts a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs, by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification enables covered entities to distinguish whether a prescription is a ``partial fill,'' where less than the full amount prescribed is dispensed, or a refill, where the full amount prescribed is dispensed, in the HIPAA retail pharmacy transactions. This modification is important to ensure the availability of a greater quantum of data that may help prevent impermissible refills of Schedule II drugs, which will help to address the public health concerns associated with prescription drug abuse in the United States.
Air Plan Approval; Washington; Update to the Adoption by Reference, Energy Facility Site Evaluation Council
The Environmental Protection Agency (EPA) is revising the Washington State Implementation Plan (SIP) to approve updates to the Energy Facility Site Evaluation Council (EFSEC) air quality regulations. The EFSEC regulations apply to major energy facilities in the State of Washington and establish permitting requirements and emissions standards for such facilities. The EFSEC regulations primarily adopt by reference the Washington Department of Ecology (Ecology) general air quality regulations for program implementation. We are approving EFSEC's updated adoption by reference to include certain changes to Ecology's general air quality regulations since EFSEC's last adoption by reference, consistent with prior approvals.
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