Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss
The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Request for Information on Obtaining Input From Rural Schools and Local Educational Agencies
In accordance with section 5005 of the Every Student Succeeds Act (ESSA), the Secretary seeks information from the public regarding actions the Department of Education (Department) can take to improve how it considers the unique needs of rural schools and local educational agencies (LEAs) as it develops and implements its policies and programs. The Secretary intends to use this information in issuing a final report, required under section 5005, describing the actions it will take to increase the consideration and participation of rural schools and LEAs in the development and execution of the Department's processes, procedures, policies, and regulations.
Draft Habitat Conservation Plan for the Desert Tortoise and Mohave Ground Squirrel and Draft Environmental Assessment; Hinkley Groundwater Remediation Project; San Bernardino County, California
We, the U.S. Fish and Wildlife Service, announce the receipt and availability of a draft Habitat Conservation Plan (HCP) and draft environmental assessment (EA), which evaluates the impacts of, and alternatives to, the proposed Hinkley Groundwater Remediation Project. The Hinkley HCP was submitted by Pacific Gas & Electric Company (PG&E) in support of an application under the Endangered Species Act of 1973, as amended, for a permit authorizing the incidental take of covered species resulting from covered activities. PG&E's application is for a 50-year incidental take permit to cover groundwater remediation activities within a plan area of approximately 29,927 acres in and around Hinkley, California. We request review and comment on the Hinkley HCP and the draft EA from local, State, and Federal agencies; Tribes; and the public.
AREVA, Inc.; Richland, Washington; Indirect Transfer of License; Order
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order approving the indirect transfer of several licenses. AREVA, Inc., is the holder of materials license no. SNM-1227, which authorizes the possession and use of special nuclear material (SNM) at the AREVA, Inc. site in Richland, Washington. AREVA, Inc. is also the holder of export license nos. XSNM3551, XSNM3697, XSNM3747, XSOU8833, XCOM1202, XW015, XCOM1304, XSNM3780, XSNM3781, XSNM3782, and import license no. IW009 which authorize the import and export of licensed materials/components to and from facilities in the United States. The Order approves the indirect transfer of control of the above licenses resulting from a planned reorganization of AREVA, Inc.'s parent company and the sale of part of the parent company. There will be no direct transfer of control because AREVA, Inc. will continue to be the license holder. The Order became effective upon issuance.
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA intends to no longer grant orphan drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of over 200,000 in the United States), unless the use of the drug in the pediatric subpopulation meets the regulatory criteria for an orphan subset, or unless the disease in the pediatric subpopulation is considered a different disease from the disease in the adult population. This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric-subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.
Authorizing Permissive Use of the “Next Generation” Broadcast Television Standard
In this document, we seek further comment on issues related to exceptions to and waivers of the local simulcasting requirement, whether we should let full power broadcasters use channels in the television broadcast band that are vacant to facilitate the transition to 3.0, and finally, we tentatively conclude that local simulcasting should not change the significantly viewed status of a Next Gen TV station.
Approval of California Air Plan Revisions, San Diego County Air Pollution Control District
The Environmental Protection Agency (EPA) is proposing to approve revisions to the San Diego County Air Pollution Control District (SDCAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from polyester resin operations. We are proposing to approve a local rule to regulate these emission sources under the Clean Air Act (CAA or ``the Act''), as well as a rule rescission. We are taking comments on this proposal and plan to follow with a final action.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2018 Gulf of Alaska Pollock and Pacific Cod Total Allowable Catch Amounts
NMFS is adjusting the 2018 total allowable catch (TAC) amounts for the Gulf of Alaska (GOA) pollock and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the GOA pollock and Pacific cod TACs are the appropriate amounts based on the best available scientific information for pollock and Pacific cod in the GOA. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2018 Bering Sea and Aleutian Islands Pollock, Atka Mackerel, and Pacific Cod Total Allowable Catch Amounts
NMFS is adjusting the 2018 total allowable catch (TAC) amounts for the Bering Sea and Aleutian Islands (BSAI) pollock, Atka mackerel, and Pacific cod fisheries. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the BSAI pollock, Atka mackerel, and Pacific cod TACs are the appropriate amounts based on the best available scientific information. Also, NMFS is announcing the Aleutian Islands Catcher Vessel (CV) Harvest Set- Aside and Bering Sea Trawl CV A-Season Sector Limitation will be in effect for 2018, and TACs in this inseason adjustment will apply for 2018. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.
Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Atka Mackerel in the Bering Sea and Aleutian Islands Management Area
NMFS is reallocating the projected unused amount of the 2017 Bering Sea subarea and Eastern Aleutian Island District (BS/EAI) Atka mackerel total allowable catch (TAC) assigned to the Bering Sea and Aleutian Islands (BSAI) trawl limited access sector to the Amendment 80 cooperative in the BS/EAI of the BSAI. This action is necessary to allow the 2017 TAC of Atka mackerel in the BSAI to be fully harvested.
Agency Information Collection Activities; Proposed Collection (EPA ICR No. 1710.08); Comment Request
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: ``Residential Lead-Based Paint Hazard Disclosure Requirements'' and identified by EPA ICR No. 1710.08 and OMB Control No. 2070-0151, represents the renewal of an existing ICR that is scheduled to expire on October 31, 2018. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.
Retail Commodity Transactions Involving Virtual Currency
The Commodity Futures Trading Commission (the ``Commission'' or ``CFTC'') is issuing this proposed interpretation of the term ``actual delivery'' as set forth in a certain provision of the Commodity Exchange Act (``CEA'') pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act''). Specifically, this proposed interpretation is being issued to inform the public of the Commission's views as to the meaning of actual delivery within the specific context of retail commodity transactions in virtual currency. The Commission requests comment on this proposed interpretation and further invites comment on specific questions related to the Commission's treatment of virtual currency transactions.
Notice of Opportunity for Public Comment on the Release of Deed Restrictions at the Yellowstone Airport, West Yellowstone, MT
The FAA is considering a request from the State of Montana to release certain deed restrictions at the Yellowstone Airport, MT.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of an Exclusive Patent License: The Development of an Anti-CD30 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA.
Proposed Collection; 60-Day Comment Request Division of Cancer Epidemiology and Genetics Fellowship Program and Summer Student Applications (DCEG) (National Cancer Institute)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Notice of Realty Action: Proposed Non-Competitive (Direct) Sale of Public Land in Santa Barbara County, CA
The Bureau of Land Management (BLM) is proposing to sell 5.93 acres of public land to resolve an unauthorized use and occupancy in Santa Barbara County, California, to Arc Vineyards, LLC, under the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, at not less than the fair market value of $19,500.
Final Supplementary Rules for Guffey Gorge in Park County, Colorado
The Bureau of Land Management (BLM) Royal Gorge Field Office is implementing supplementary rules to regulate certain activities on public lands within Guffey Gorge in Park County, Colorado. These supplementary rules are necessary to implement decisions found in the Guffey Gorge Management Plan approved on June 29, 2015, to provide for the protection of persons, property, and public lands and resources located within the 80-acre site. These supplementary rules will result in changes to some currently authorized activities related to the possession or use of alcohol, amplified music, vehicle parking, and visitors with dogs.
The NCUA Board (``Board'') is issuing a final rule to implement certain features of the NCUA reorganization that the Board announced earlier this year. This rule amends the NCUA's regulations related to the organization of the NCUA's Central Office.
Emergency Mergers-Chartering and Field of Membership
The NCUA Board (Board) is issuing this final rule to amend, in its Chartering and Field of Membership Manual, the definition of the term ``in danger of insolvency'' for emergency merger purposes. The previous definition, adopted in 2010 (2010 definition), required a credit union to fall into at least one of three net worth categories over a period of time to be ``in danger of insolvency.'' For two of those three categories, the final rule lengthens by six months the forecast horizons, the time periods in which the NCUA projects a credit union's net worth will decline to the point that it falls into one of the categories. This extends the time period in which a credit union's net worth is projected to either render it insolvent or drop below two percent from 24 to 30 months and from 12 to 18 months, respectively. Additionally, the final rule adds a fourth category to the three existing net worth categories to include credit unions that have been granted or received assistance under section 208 of the Federal Credit Union Act (FCU Act) in the 15 months prior to the NCUA regional office's determination that the credit union is in danger of insolvency.
2016 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and for which timely publication in the Federal Register was not possible.
Information Collection: Registration Certificate-In Vitro Testing With Byproduct Material Under General License
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, NRC Form 483, Registration Certificate``In Vitro Testing With Byproduct Material Under General License.''
Certain Crystalline Silicon Photovoltaic Products From Taiwan: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review; 2016-2017
The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty (AD) order on certain crystalline silicon photovoltaic products (solar products) from Taiwan. The period of review (POR) is February 1, 2016, through January 31, 2017. This administrative review covers 11 exporters of the subject merchandise, including one mandatory respondent, Motech Industries, Inc. (Motech). The Department preliminarily determines that Motech made sales of subject merchandise at less than normal value during the POR. Additionally, we are rescinding this administrative review with respect to 23 companies that timely withdrew their requests for administrative review. Interested parties are invited to comment on these preliminary results.
2016 Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation Regulations and Regulated Navigation Areas
This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This document lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and for which timely publication in the Federal Register was not possible.
Drawbridge Operation Regulation; Quantuck Canal, Westhampton Beach, NY
The Coast Guard is modifying the operating schedule that governs the Beach Lane Bridge across Quantuck Canal, mile 1.1, at Westhampton Beach, New York. This action is necessary to allow for an unexpected delay in the rehabilitation of the bascule leaves and painting of the bridge. A temporary deviation was previously granted for a length of 180 days. As the Coast Guard may not approve extensions beyond that allotted timeframe nor approve back-to-back or sequential deviations, it is necessary to issue this rule in order to allow the bridge owner to complete the remaining work items.
Removal of Conditions of Entry for Certain Vessels Arriving to the United States From Two Port Facilities in Côte d'Ivoire
The Coast Guard announces that it is modifying the conditions of entry for vessels arriving to the United States from C[ocirc]te d'Ivoire by adding an exception to the conditions of entry for two facilities in the Republic of C[ocirc]te d'Ivoire.
Rules of Practice and Procedures To Formulate or Amend a Marketing Agreement or a Marketing Order, or Certain Research and Promotion Orders; Correction
This document contains a correction to the final rule which was published on December 11, 2017. In the final rule, the Regulatory Information Number (RIN) appears as RIN 0581-AD74. This number is incorrect. The correct number is 0581-AD76. This document corrects the final rule.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Department of Health and Human Services, The Office of the Secretary (OS), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection.
U.S. Endangered Species; Receipt of Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits to conduct activities intended to enhance the propagation or survival of endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits certain activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA also requires that we invite public comment before issuing these permits.
Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act
On October 26, 2017, APV Renaissance Opco, LLC, as owner and operator of a new baseload electric generating powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations. The FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the Federal Register.
Agency Information Collection Activity; Extension
EIA, pursuant to the Paperwork Reduction Act of 1995, intends to extend with changes for three years with the Office of Management and Budget (OMB), Form EIA-886, Annual Survey of Alternative Fueled Vehicles. Form EIA-886 collects information on the number of alternative fuel vehicles (AFVs) made available, the distribution of AFVs in use, and alternative transportation fuels (ATFs) consumed.
Revision of a Currently Approved Information Collection for the Energy Efficiency and Conservation Block Grant Financing Programs
The Department of Energy (DOE) invites public comment on a revision of a currently approved collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. The information collection requests a revision and three-year extension of its Energy Efficiency and Conservation Block Grant Program, OMB Control Number 1910-5150. The proposed action will continue the collection of information on the status of financing program activities, expenditures, and results, to ensure that program funds are being used appropriately, effectively and expeditiously. No changes to the collection instrument are being proposed. Comments are invited on: (a) Whether the revision of the currently approved collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden pertaining to the approved collection of information, including the validity of the methodology and assumptions used; (c) ways to further enhance the quality, utility, and clarity of the information being collected; and (d) ways to further minimize the burden regarding the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Regulation D: Reserve Requirements of Depository Institutions
The Board of Governors of the Federal Reserve System (``Board'') is amending Regulation D (Reserve Requirements of Depository Institutions) to revise the rate of interest paid on balances maintained to satisfy reserve balance requirements (``IORR'') and the rate of interest paid on excess balances (``IOER'') maintained at Federal Reserve Banks by or on behalf of eligible institutions. The final amendments specify that IORR is 1.50 percent and IOER is 1.50 percent, a 0.25 percentage point increase from their prior levels. The amendments are intended to enhance the role of such rates of interest in moving the Federal funds rate into the target range established by the Federal Open Market Committee (``FOMC'' or ``Committee'').
Regulation A: Extensions of Credit by Federal Reserve Banks
The Board of Governors of the Federal Reserve System (``Board'') has adopted final amendments to its Regulation A to reflect the Board's approval of an increase in the rate for primary credit at each Federal Reserve Bank. The secondary credit rate at each Reserve Bank automatically increased by formula as a result of the Board's primary credit rate action.
Endangered and Threatened Wildlife and Plants; 90-Day Findings for Five Species
We, the U.S. Fish and Wildlife Service (Service), announce 90- day findings on several petitions to list or reclassify wildlife or plants under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petitions present substantial scientific or commercial information indicating that the petitioned actions may be warranted with respect to the species mentioned in this notification. Therefore, with the publication of this document, we announce that we plan to initiate a review of the status of each of these species to determine if the petitioned actions are warranted. To ensure that these status reviews are comprehensive, we are requesting scientific and commercial data and other information regarding these species. After completing the status reviews, we will issue 12-month findings on the petitions, which will address whether or not the petitioned action is warranted, in accordance with the Act. In addition, we announce a correction to information contained in the 90- day petition finding for the leopard (Panthera pardus), which clarifies the range and entity we are evaluating in our status review of the species.
Addition of Certain Entities to the Entity List
This rule amends the Export Administration Regulations (EAR) by adding two entities to the Entity List. The two entities being added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These two entities will be listed on the Entity List under the destination of Russia.
Environmental Assessment (EA) for the Proposed New Space Lease for the Geophysical Fluid Dynamics Laboratory in Princeton, NJ
NOAA announces its intention to prepare an EA, in accordance with the National Environmental Policy Act of 1969, for a new space lease to be occupied by the NOAA/OAR Geophysical Fluid Dynamics Laboratory.
Drawbridge Operation Regulation; San Leandro Bay, Between Alameda and Bay Farm Island, CA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the California Department of Transportation Highway and Bicycle drawbridges across San Leandro Bay, mile 0.0 and mile 0.1, between Alameda and Bay Farm Island, CA. The deviation is necessary to allow the bridge owner to perform major rehabilitation and maintenance. This deviation allows the bridges to remain in the closed-to-navigation position during the deviation period.
Notice of Permits Issued Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.
30-Day Notice of Proposed Information Collection: Training/Internship Placement Plan
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Information Collection: Request for Approval of Official Foreign Travel
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, ``NRC Form 445, ``Request for Approval of Official Foreign Travel.''