2018 – Federal Register Recent Federal Regulation Documents
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Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Guide to Minimize Food Safety Hazards of Fresh-cut Produce.'' The draft guidance, when finalized, will supersede a previous guidance, entitled ``Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' that we issued in 2008. The draft guidance is intended to explain our current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under our regulation entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' during the production of fresh-cut produce.
Certain New Chemical Substances; Receipt and Status Information for July 2018
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the Federal Register pertaining to submissions under TSCA section 5, including notice of receipt of a Premanufacture Notice (PMN), Significant New Use Notice (SNUN) or Microbial Commercial Activity Notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a Test Marketing Exemption (TME), both pending and/or concluded; a Notice of Commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. This document covers the period from July 1, 2018 to July 31, 2018.
Meeting of the Mobile Sources Technical Review Subcommittee
Pursuant to the Federal Advisory Committee Act, the Environmental Protection Agency's (EPA's), Mobile Sources Technical Review Subcommittee (MSTRS) will meet on January 10, 2019. The MSTRS is a subcommittee under the Clean Air Act Advisory Committee. This is an open meeting. The meeting will include discussion of current topics and presentations about activities being conducted by EPA's Office of Transportation and Air Quality. The preliminary agenda for the meeting and any notices about change in venue will be posted on the subcommittee's website: https://www2.epa.gov/caaac/mobile-sources- technical-review-subcommittee-mstrs-caaac. MSTRS listserv subscribers will receive notification when the agenda is available on the subcommittee website. To subscribe to the MSTRS listserv, send an email to mccubbin.courtney@epa.gov.
60-Day Notice of Proposed Information Collection: Revitalization Area Designation and Management
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Statutorily Mandated Designation of Difficult Development Areas and Qualified Census Tracts for 2019
This document designates ``Difficult Development Areas'' (DDAs) and ``Qualified Census Tracts'' (QCTs) for purposes of the Low- Income Housing Tax Credit (LIHTC) under Internal Revenue Code (IRC) Section 42, as enacted by the Tax Reform Act of 1986. The United States Department of Housing and Urban Development (HUD) makes new DDA and QCT designations annually.
National Emission Standards for Hazardous Air Pollutants; Delegation of Authority to Oklahoma
The Oklahoma Department of Environmental Quality (ODEQ) has submitted updated regulations for receiving delegation and approval of its program for the implementation and enforcement of certain National Emission Standards for Hazardous Air Pollutants (NESHAP) for all sources (both part 70 and non-part 70 sources), as provided for under previously approved delegation mechanisms. The updated state regulations incorporate by reference certain NESHAP promulgated by the EPA at parts 61 and 63, as they existed through September 1, 2016. The EPA is providing notice that it is taking final action to approve the delegation of certain NESHAP to ODEQ.
Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Contract Financing
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection for use through January 31, 2019. DoD proposes that OMB extend its approval for use for three additional years beyond the current expiration date.
Gulf of Mexico Fishery Management Council; Public Meeting
The Gulf of Mexico Fishery Management Council (Council) will hold a meeting of its Ad Hoc Red Snapper and Grouper-Tilefish Individual Fishing Quota (IFQ) Advisory Panel.
Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 63 assessment of the Gulf of Mexico stock of Menhaden will be reviewed by an independent Panel at the Review Workshop. See SUPPLEMENTARY INFORMATION.
Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
On May 31, 2018, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) requested comments on a plan to (1) revise the definition and characterization of Assisted Reproductive Technology (ART) success rates and (2) introduce clinic validation footnotes for the annual ART Fertility Clinic Success Rates Report. In the plan, CDC proposed to include the footnotes to identify clinics selected by CDC to participate in the validation process of the National ART Surveillance System (NASS) data and: (a) Do participate, (b) do participate and have major data discrepancies identified through this process, or (c) decline to participate in the data validation process. This notice responds to the comments received in response to the notice published on May 31, 2018 and announces the availability of the revised process for ART Success Rates Reporting and plans for revising Data Validation Procedures.
South Atlantic Fishery Management Council; Public Meetings
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Habitat Protection and Ecosystem-Based Management Advisory Panel (AP).
Pipeline Safety: Information Collection Activities; Revision of the Hazardous Liquid Annual Report
On July 13, 2018, in accordance with the Paperwork Reduction Act of 1995, PHMSA published a notice in the Federal Register (83 FR 32710) inviting comments on a revision to form PHMSA F 7000-1.1Annual Report for Hazardous Liquid Pipeline Systems, which is currently collected under the Office of Management and Budget (OMB) Control Number 2137-0614. This information collection expires on October 31, 2018. During the public comment period, PHMSA received two comments in response to the proposed revision to this information collection. PHMSA is publishing this notice to respond to the comments received and to announce that the Information Collection Request will be submitted to OMB for approval.
Mine Safety and Health Research Advisory Committee (MSHRAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 38 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov, or Sayeedha Uddin, 301-458-4303, isx9@cdc.gov at least 10 days in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal or international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulation, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.
Exelon Generation Company, LLC; Oyster Creek Nuclear Generating Station Request for Exemptions Regarding Emergency Planning Requirements
The U.S. Nuclear Regulatory Commission (NRC) has issued exemptions in response to a request from Exelon Generation Company, LLC (Exelon or the licensee) regarding certain emergency planning (EP) requirements. The exemptions eliminate the requirements to maintain an offsite radiological emergency preparedness plan and reduce the scope of onsite EP activities at the Oyster Creek Nuclear Generating Station (Oyster Creek), based on the reduced risks of accidents that could result in an offsite radiological release at a decommissioning nuclear power reactor.
Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and Acceptance Criteria
The U.S. Nuclear Regulatory Commission (NRC) staff has determined that the inspections, tests, and analyses have been successfully completed, and that the specified acceptance criteria are met for the Vogtle Electric Generating Plant (VEGP), Units 3 and 4.
Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Containment Sump Level Instrumentation
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic design control document (DCD) and is issuing License Amendment Nos. 140 and 139 to Combined Licenses (COLs), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (collectively SNC); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
Presidential Declaration of a Major Disaster for Public Assistance Only for the Commonwealth of Virginia
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Virginia (FEMA-4401-DR), dated 10/15/2018. Incident: Hurricane Florence. Incident Period: 09/08/2018 through 09/21/2018.
Presidential Declaration Amendment of a Major Disaster for the State of Florida
This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/ 2018. Incident: Hurricane Michael. Incident Period: 10/07/2018 and continuing.
Notice of Availability of the Draft Environmental Impact Statement for the Proposed Deep South Expansion Project, Lander and Eureka Counties, Nevada
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Mount Lewis Field Office, Battle Mountain, Nevada, has prepared a Draft Environmental Impact Statement (DEIS) and is announcing the beginning of the public comment period to solicit public comments on the DEIS. Barrick Cortez, Inc. (BCI) is proposing to expand its existing Cortez Hills Project mining operations, which would require a modification to the Plan of Operations to increase the plan boundary by 4,279 acres: From 58,093 acres to 62,372 acres.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Donor Certification Form
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Financial Management are proposing to renew an information collection.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 050'' (Recognition List Number: 050), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks
This document corrects information in the proposed rule published in the August 24, 2018 issue of the Federal Register entitled The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks. Specifically, a table in the Paperwork Reduction Act section is corrected; two minor changes are made to one amendatory instruction in NHTSA's regulatory text, and the coefficients specifying the proposed carbon dioxide standards in EPA's regulatory text have been corrected to reflect EPA's proposal to exclude credits for direct A/C emissions for purposes of compliance with carbon dioxide standards after model year 2020, as explained in Section III of the proposed rule. This document contains only clerical corrections and makes no updates to either the proposal or to the analysis underlying the proposal. For the reader's information, an updated Preliminary Regulatory Impact Assessment (PRIA) will also be made available concurrent with this notice; that document will include descriptions starting on the second page detailing the corrections to various tables and figures therein.
Export Trade Certificate of Review
The Secretary of Commerce, through the Office of Trade and Economic Analysis (``OTEA''), issued an amended Export Trade Certificate of Review to NFE on October 9, 2018. A previous amended Export Trade Certificate of Review was issued to NFE on October 24, 2016, and a notice of its issuance was published in the Federal Register on November 7, 2016.
Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Office of Engineering and Technology Releases and Seeks Comment on Updated OET-69 Software; Office of Engineering and Technology Seeks To Supplement the Incentive Auction Proceeding Record Regarding Potential Interference Between Broadcast Television and Wireless Services
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, Third Report and Order and First Order on Reconsideration (Order)'s no harmful interference rule. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the rule.
Certain Activated Carbon From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2016-2017
The Department of Commerce (Commerce) determines that Datong Juqiang Activated Carbon Co. Ltd. (Datong Juqiang) and Carbon Activated Tianjin Co., Ltd. (Carbon Activated) sold activated carbon from the People's Republic of China at less than normal value (NV) during the period of review (POR) April 1, 2016, through March 31, 2017.
Endangered and Threatened Species; Receipt of Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered species under the Endangered Species Act of 1973, as amended. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
Notice of Stakeholder Roundtable on Coin Circulation
The United States Mint announces an invitation stakeholder roundtable for the purpose of exchanging facts and information on the circulation of coinage. The Mint seeks information and advice on an individual basis about how coin can better circulate to reduce the commercial demand for newly minted coinage. The Mint intends to issue invitations to up to 35 participants with the objective of creating a diverse cross-section of stakeholder interests including, but not limited to, those associated with armored car carriers, coin processors, national and regional coin aggregators, financial institutions, and large retailers. Date: December 5, 2018. Time: 8:00 a.m. to 5:00 p.m. Location: United States Mint, 801 9th Street NW, Second Floor Conference Room, Washington, DC 20220. Subject: The Mint is interested in both short-term and long-term ideas to reduce the commercial demand for newly minted coinage. In service toward this objective, the Mint will conduct a facilitated discussion about coin circulation patterns and stakeholder concerns. This is not a public meeting. Any member of the public interested in participating in this roundtable discussion should use the contact information in this notice to request an invitation and obtain additional meeting information. Please include a description of your interest in the subject matter and a brief description of the individual perspective that you would bring to the roundtable discussion. The Mint intends to issue invitations on a rolling basis, and thus encourages interested parties to submit requests in a timely manner and no later than close of business on Friday, November 9, 2018.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Family Educational Loan Program-Servicemembers Civil Relief Act (SCRA)
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Servicemembers Civil Relief Act (SCRA): Interest Rate Limitation Request
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict of Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the ``Collection of Conflict of Interest Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Labeling of Red Blood Cell Units With Historical Antigen Typing Results
The Food and Drug Administration (FDA, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; BESPONSA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BESPONSA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; TECENTRIQ
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECENTRIQ 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TYMLOS 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements associated with our Foreign Supplier Verification Programs (FSVP) for Food Importers.
Solicitation of Veterinary Shortage Situation Nominations for the Veterinary Medicine Loan Repayment Program (VMLRP)
The National Institute of Food and Agriculture (NIFA) is soliciting nominations of veterinary service shortage situations for the Veterinary Medicine Loan Repayment Program (VMLRP) for fiscal year (FY) 2019, as authorized under the National Veterinary Medical Services Act (NVMSA). This notice initiates the nomination period and prescribes the procedures and criteria to be used by eligible nominating officials (State, Insular Area, DC and Federal Lands) to nominate veterinary shortage situations. Each year all eligible nominating officials may submit nominations, up to the maximum indicated for each entity in this notice. NIFA is conducting this solicitation of veterinary shortage situation nominations under an approved information collection (OMB Control Number 0524-0050).
Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “The Jeweled Isle: Art From Sri Lanka” Exhibition
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``The Jeweled Isle: Art from Sri Lanka,'' 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 Los Angeles County Museum of Art, Los Angeles, California, from on or about December 9, 2018, until on or about June 23, 2019, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.
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