Health and Public Welfare

Health and Public Welfare

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PublishedTypeAgencyAgency_NameTitleExcerptsFRDocPDFHTMLAbstract
PublishedTypeAgencyAgency_NameTitleExcerptsFRDocPDFHTMLAbstract
04/05/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNew Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and AddressThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and...2018-06961FR-Doc-2018-06961new-animal-drugs-approval-of-new-animal-drug-applications-changes-of-sponsorship-change-of-aThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
04/05/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentRelease of Information From Department of Veterans Affairs' RecordsThis document amends the Department of Veterans Affairs' (VA) regulations governing the submission and processing of requests for information under the Freedom of Information Act (FOIA) and the Privacy Act in order to reorganize, streamline, and...2018-06097FR-Doc-2018-06097release-of-information-from-department-of-veterans-affairs-recordsThis document amends the Department of Veterans Affairs' (VA) regulations governing the submission and processing of requests for information under the Freedom of Information Act (FOIA) and the Privacy Act in order to reorganize, streamline, and clarify existing regulations.
04/04/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNational Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury TableAs required by a recent amendment to the VICP's authorizing statute, the Secretary of the Department of Health and Human Services (Secretary) proposes to amend the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table (Table) to...2018-06770FR-Doc-2018-06770national-vaccine-injury-compensation-program-adding-the-category-of-vaccines-recommended-forAs required by a recent amendment to the VICP's authorizing statute, the Secretary of the Department of Health and Human Services (Secretary) proposes to amend the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table (Table) to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women. Thus, the Secretary is only seeking public comment on how the addition of this new category is proposed to be formatted on the Table.
04/04/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-06818FR-Doc-2018-06818suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
04/03/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPrivacy Act; ImplementationThe Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is issuing this final rule to make effective the exemptions that HHS/NIH proposed for a subset of records covered in a new Privacy Act...2018-06676FR-Doc-2018-06676privacy-act-implementationThe Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is issuing this final rule to make effective the exemptions that HHS/NIH proposed for a subset of records covered in a new Privacy Act system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records). The new system covers records used in managing NIH research and development applications and awards throughout the award lifecycle. The listed exemptions are necessary to maintain the integrity of the NIH extramural peer review and award processes, and will enable the agency to prevent, when appropriate, individual record subjects from having access to, and other rights under the Privacy Act with respect to, confidential source-identifying material in the records.
04/03/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentFood and Nutrition Service Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards; CorrectionThis document contains technical corrections to the Code of Federal Regulations regarding the Final rule published in the Federal Register on September 28, 2016, ``Food and Nutrition Service Regulatory Implementation of Office of Management and...2018-06519FR-Doc-2018-06519food-and-nutrition-service-regulatory-implementation-of-office-of-management-and-budgets-uniformThis document contains technical corrections to the Code of Federal Regulations regarding the Final rule published in the Federal Register on September 28, 2016, ``Food and Nutrition Service Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.''
04/02/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Technical AmendmentThe Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.2018-06308FR-Doc-2018-06308medical-devices-technical-amendmentThe Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.
04/02/2018RuleSocial Security AdministrationSocial Security AdministrationExtension of Expiration Dates for Two Body System ListingsWe are extending the expiration dates of the following body systems in the Listing of Impairments (listings) in our regulations: Special Senses and Speech and Congenital Disorders That Affect Multiple Body Systems. We are making no other revisions to...2018-06671FR-Doc-2018-06671extension-of-expiration-dates-for-two-body-system-listingsWe are extending the expiration dates of the following body systems in the Listing of Impairments (listings) in our regulations: Special Senses and Speech and Congenital Disorders That Affect Multiple Body Systems. We are making no other revisions to these body systems in this final rule. This extension ensures that we will continue to have the criteria we need to evaluate impairments in the affected body systems at step three of the sequential evaluation processes for initial claims and continuing disability reviews.
04/02/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentCivil PenaltiesThis document proposes a civil penalty rate applicable to automobile manufacturers that fail to meet applicable corporate average fuel economy (CAFE) standards and are unable to offset such a deficit with compliance credits. The agency is proposing...2018-06550FR-Doc-2018-06550civil-penaltiesThis document proposes a civil penalty rate applicable to automobile manufacturers that fail to meet applicable corporate average fuel economy (CAFE) standards and are unable to offset such a deficit with compliance credits. The agency is proposing this civil penalty rate based on a tentative determination regarding the applicability of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and in accordance with the Energy Policy and Conservation Act of 1975 (EPCA) and the Energy Independence and Security Act of 2007 (EISA).
03/30/2018RuleAMERICAN BATTLE MONUMENTS COMMISSIONAmerican Battle Monuments CommissionABMC Privacy ProgramThis rule provides guidance and assigns responsibility for the privacy program under the American Battle Monuments Commission (ABMC) pursuant to the Privacy Act of 1974 and applicable Office of Management Budget (OMB) guidance.2018-06528FR-Doc-2018-06528abmc-privacy-programThis rule provides guidance and assigns responsibility for the privacy program under the American Battle Monuments Commission (ABMC) pursuant to the Privacy Act of 1974 and applicable Office of Management Budget (OMB) guidance.
03/30/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentSupplemental Nutrition Assistance Program (SNAP): Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation and Energy Act of 2008; CorrectionThis document contains technical corrections to the Code of Federal Regulations regarding the final rule and interim final rule published in the Federal Register on January 6, 2017, ``Supplemental Nutrition Assistance Program (SNAP): Eligibility,...2018-06520FR-Doc-2018-06520supplemental-nutrition-assistance-program-snap-eligibility-certification-and-employment-and-trainingThis document contains technical corrections to the Code of Federal Regulations regarding the final rule and interim final rule published in the Federal Register on January 6, 2017, ``Supplemental Nutrition Assistance Program (SNAP): Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation and Energy Act of 2008.''
03/30/2018RuleNATIONAL ARCHIVES AND RECORDS ADMINISTRATIONNational Archives and Records AdministrationRecords ManagementNARA is revising these regulations to make administrative changes, such as updating office names and organizational codes, updating URLs, and updating links to NARA's records management web pages, to reflect organizational and contact changes, and...2018-06174FR-Doc-2018-06174records-managementNARA is revising these regulations to make administrative changes, such as updating office names and organizational codes, updating URLs, and updating links to NARA's records management web pages, to reflect organizational and contact changes, and revising the incorporation by reference language to make it consistent with newer regulations and to reflect contact changes.
03/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNew Animal Drugs; Withdrawal of Approval of New Animal Drug ApplicationsThe Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.2018-06357FR-Doc-2018-06357new-animal-drugs-withdrawal-of-approval-of-new-animal-drug-applicationsThe Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
03/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and AddressThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and...2018-06358FR-Doc-2018-06358new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drugThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
03/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary UtilizationThis document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of...2018-06552FR-Doc-2018-06552medicare-program-prior-authorization-process-for-certain-durable-medical-equipment-prostheticsThis document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
03/29/2018Proposed RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentImportation of Pummelo From Thailand Into the Continental United StatesWe are proposing to amend the regulations to allow the importation of fresh pummelo fruit from Thailand into the continental United States. As a condition of entry, fresh pummelo fruit from Thailand would be subject to a systems approach that would...2018-06288FR-Doc-2018-06288importation-of-pummelo-from-thailand-into-the-continental-united-statesWe are proposing to amend the regulations to allow the importation of fresh pummelo fruit from Thailand into the continental United States. As a condition of entry, fresh pummelo fruit from Thailand would be subject to a systems approach that would include irradiation treatment, packinghouse processing requirements, and port of entry inspection. The fruit would also be required to be imported in commercial consignments and be accompanied by a phytosanitary certificate issued by the national plant protection organization of Thailand. This action would allow for the importation of fresh pummelo fruit from Thailand while continuing to provide protection against the introduction of plant pests into the continental United States.
03/29/2018Proposed RuleDEPARTMENT OF JUSTICEJustice DepartmentBump-Stock-Type DevicesThe Department of Justice (Department) proposes to amend the Bureau of Alcohol, Tobacco, Firearms, and Explosives regulations to clarify that ``bump fire'' stocks, slide-fire devices, and devices with certain similar characteristics (bump-stock-type...2018-06292FR-Doc-2018-06292bump-stock-type-devicesThe Department of Justice (Department) proposes to amend the Bureau of Alcohol, Tobacco, Firearms, and Explosives regulations to clarify that ``bump fire'' stocks, slide-fire devices, and devices with certain similar characteristics (bump-stock-type devices) are ``machineguns'' as defined by the National Firearms Act of 1934 (NFA) and the Gun Control Act of 1968 (GCA), because such devices allow a shooter of a semiautomatic firearm to initiate a continuous firing cycle with a single pull of the trigger. Specifically, these devices convert an otherwise semiautomatic firearm into a machinegun by functioning as a self-acting or self-regulating mechanism that harnesses the recoil energy of the semiautomatic firearm in a manner that allows the trigger to reset and continue firing without additional physical manipulation of the trigger by the shooter. Hence, a semiautomatic firearm to which a bump-stock-type device is attached is able to produce automatic fire with a single pull of the trigger. With limited exceptions, primarily as to government agencies, the GCA makes it unlawful for any person to transfer or possess a machinegun unless it was lawfully possessed prior to the effective date of the statute. The bump-stock-type devices covered by this proposed rule were not in existence prior to the GCA's effective date, and therefore would fall within the prohibition on machineguns if this Notice of Proposed Rulemaking (NPRM) is implemented. Consequently, current possessors of these devices would be required to surrender them, destroy them, or otherwise render them permanently inoperable upon the effective date of the final rule.
03/29/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-06279FR-Doc-2018-06279suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
03/29/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Gas Regulation; Public Workshop; Request for CommentsThe Food and Drug Administration (FDA, the Agency, or we) is announcing an additional public workshop on medical gas regulation entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously held two public workshops entitled ``Medical Gas...2018-06251FR-Doc-2018-06251medical-gas-regulation-public-workshop-request-for-commentsThe Food and Drug Administration (FDA, the Agency, or we) is announcing an additional public workshop on medical gas regulation entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously held two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.
03/29/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentImportation of Fresh Cherimoya Fruit From Chile Into the United StatesWe are amending the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States in accordance with a systems approach as an alternative to the current required treatment. Commercial consignments of fresh...2018-06289FR-Doc-2018-06289importation-of-fresh-cherimoya-fruit-from-chile-into-the-united-statesWe are amending the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States in accordance with a systems approach as an alternative to the current required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment. The systems approach includes requirements for production site registration, low pest prevalence area certification, post-harvest processing, and inspection at the packinghouse. The fruit will also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach or is imported into locations outside the continental United States will continue to be allowed to be imported into the United States subject to the current soapy water and wax treatment. This will allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.
03/29/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentGood Guidance Practices; Technical AmendmentThe Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive.2018-06252FR-Doc-2018-06252good-guidance-practices-technical-amendmentThe Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive.
03/29/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentRequest for Information on Regulatory Challenges to Safely Transporting Hazardous Materials by Surface Modes in an Automated Vehicle Environment; CorrectionThis request for information notice replaces the version published in the Federal Register on March 22, 2018 (83 FR 12529), to make technical corrections to the prior version. The Pipeline and Hazardous Materials Safety Administration (PHMSA) requests...2018-06290FR-Doc-2018-06290request-for-information-on-regulatory-challenges-to-safely-transporting-hazardous-materials-byThis request for information notice replaces the version published in the Federal Register on March 22, 2018 (83 FR 12529), to make technical corrections to the prior version. The Pipeline and Hazardous Materials Safety Administration (PHMSA) requests information on matters related to the development and potential use of automated technologies for surface modes (i.e., highway and rail) in hazardous materials transportation. In anticipation of the development, testing, and integration of Automated Driving Systems in surface transportation, PHMSA is issuing this request for information on the factors the Agency should consider to ensure continued safe transportation of hazardous materials without impeding emerging surface transportation technologies.
03/28/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCigarettes, Smokeless Tobacco, and Covered Tobacco Products; Change of Office Name and Address; Technical AmendmentThe Food and Drug Administration (FDA or Agency) is amending its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products regulations to reflect a change of office name and mailing address for the Center for Tobacco Products' (CTP's) Office of...2018-06164FR-Doc-2018-06164cigarettes-smokeless-tobacco-and-covered-tobacco-products-change-of-office-name-and-addressThe Food and Drug Administration (FDA or Agency) is amending its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products regulations to reflect a change of office name and mailing address for the Center for Tobacco Products' (CTP's) Office of Compliance and Enforcement. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
03/28/2018Proposed RuleDEPARTMENT OF JUSTICEJustice DepartmentPrivacy Act of 1974; ImplementationElsewhere in this issue of the Federal Register, the Office of Inspector General (OIG), a component within the United States Department of Justice (DOJ or Department), has published a new system of records notice, ``Data Analytics Program Records...2018-05657FR-Doc-2018-05657privacy-act-of-1974-implementationElsewhere in this issue of the Federal Register, the Office of Inspector General (OIG), a component within the United States Department of Justice (DOJ or Department), has published a new system of records notice, ``Data Analytics Program Records System,'' JUSTICE/ OIG-006. In this notice of proposed rulemaking, OIG proposes to exempt this system of records from certain provisions of the Privacy Act in order to avoid interference with the law enforcement functions and responsibilities of OIG. For the reasons provided below, the Department proposes to amend its Privacy Act regulations by establishing an exemption for records in this system from certain provisions of the Privacy Act. Public comment is invited.
03/27/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRevision of Organization; Technical AmendmentThe Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking...2018-06065FR-Doc-2018-06065revision-of-organization-technical-amendmentThe Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.
03/26/2018Proposed RuleBUREAU OF CONSUMER FINANCIAL PROTECTIONConsumer Financial Protection BureauRequest for Information Regarding the Bureau's Inherited Regulations and Inherited Rulemaking AuthoritiesThe Bureau of Consumer Financial Protection (Bureau) is seeking comments and information from interested parties to assist the Bureau in considering whether, consistent with its statutory authority to prescribe rules pursuant to the Federal consumer...2018-06027FR-Doc-2018-06027request-for-information-regarding-the-bureaus-inherited-regulations-and-inherited-rulemakingThe Bureau of Consumer Financial Protection (Bureau) is seeking comments and information from interested parties to assist the Bureau in considering whether, consistent with its statutory authority to prescribe rules pursuant to the Federal consumer financial laws, the Bureau should amend the regulations or exercise the rulemaking authorities that it inherited from certain other Federal agencies.
03/26/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRegulation of Premium CigarsThe Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family...2018-06047FR-Doc-2018-06047regulation-of-premium-cigarsThe Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to premium cigars.
03/26/2018Proposed RuleDEPARTMENT OF LABORLabor DepartmentExposure of Underground Miners to Diesel ExhaustIn response to requests from the public, the Mine Safety and Health Administration (MSHA) is reopening the rulemaking record for public comments on the Agency's request for information on Exposure of Underground Miners to Diesel Exhaust.2018-05978FR-Doc-2018-05978exposure-of-underground-miners-to-diesel-exhaustIn response to requests from the public, the Mine Safety and Health Administration (MSHA) is reopening the rulemaking record for public comments on the Agency's request for information on Exposure of Underground Miners to Diesel Exhaust.
03/26/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentRevise and Streamline VA Acquisition Regulation-Parts 811 and 832The Department of Veterans Affairs (VA) is proposing to amend and update its VA Acquisition Regulation (VAAR) in phased increments to revise or remove any policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any...2018-04002FR-Doc-2018-04002revise-and-streamline-va-acquisition-regulation-parts-811-and-832The Department of Veterans Affairs (VA) is proposing to amend and update its VA Acquisition Regulation (VAAR) in phased increments to revise or remove any policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any procedural guidance internal to VA into the VA Acquisition Manual (VAAM), and to incorporate any new agency specific regulations or policies. These changes seek to streamline and align the VAAR with the FAR and remove outdated and duplicative requirements and reduce burden on contractors. The VAAM incorporates portions of the removed VAAR as well as other internal agency acquisition policy. VA will rewrite certain parts of the VAAR and VAAM, and as VAAR parts are rewritten, we'll publish them in the Federal Register. VA will combine related topics, as appropriate. In particular, this rulemaking revises VAAR Parts 811-- Describing Agency Needs and Part 832--Contract Financing, as well as affected parts 801--Department of Veterans Affairs Acquisition Regulation System, 852--Solicitation Provisions and Contract Clauses, and 870--Special Procurement Controls.
03/26/2018Proposed RuleFEDERAL ELECTION COMMISSIONFederal Election CommissionInternet Communication Disclaimers and Definition of \u201cPublic Communication\u201dThe Federal Election Commission requests comment on two alternative proposals to amend its regulations concerning disclaimers on public communications on the internet that contain express advocacy, solicit contributions, or are made by political...2018-06010FR-Doc-2018-06010internet-communication-disclaimers-and-definition-of-public-communicationThe Federal Election Commission requests comment on two alternative proposals to amend its regulations concerning disclaimers on public communications on the internet that contain express advocacy, solicit contributions, or are made by political committees. The Commission is undertaking this rulemaking in light of technological advances since the Commission last revised its rules governing internet disclaimers in 2006, and questions from the public about the application of those rules to internet communications. The Commission's goal is to promulgate a rule that in its text and interpretation recognizes the paramount importance of providing the public with the clearest disclosure of the payor or sponsor of these public communications on the internet. Both proposals are intended to give the American public easy access to information about the persons paying for and candidates authorizing these internet communications, pursuant to the Federal Election Campaign Act. Both proposals would continue to require disclaimers for certain internet communications, and both would allow certain internet communications to provide disclaimers through alternative technology. The proposals differ, however, in their approach. The Commission requests comment on all elements of both proposals. The two proposals need not be considered as fixed alternatives; commenters are encouraged to extract the best elements of each, or suggest improvements or alternatives, to help the Commission fashion the best possible rule. The Commission also requests comment on proposed changes to the definition of ``public communication.'' The Commission has not made any final decisions on any of the issues or proposals presented in this rulemaking.
03/23/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentTruth in Lending-Real Estate Settlement ProceduresThe Rural Housing Service (RHS or Agency) will obsolete (and reserve) the Truth in Lending--Real Estate Settlement Procedures regulation to ensure compliance with the Truth in Lending Act (TILA) and Real Estate Settlement Procedures Act (RESPA)...2018-05999FR-Doc-2018-05999truth-in-lending-real-estate-settlement-proceduresThe Rural Housing Service (RHS or Agency) will obsolete (and reserve) the Truth in Lending--Real Estate Settlement Procedures regulation to ensure compliance with the Truth in Lending Act (TILA) and Real Estate Settlement Procedures Act (RESPA) Integrated Mortgage Disclosures rule, commonly referred to as the TRID rule. This direct final rule will eliminate the functionally obsolete regulation in order to ensure compliance with the TRID rule, as the standard to follow.
03/23/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentHours of Service; Electronic Logging Devices; Limited 90-Day Waiver for the Transportation of Agricultural CommoditiesFMCSA grants a limited 90-day waiver from the Federal hours- of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for the transportation of agricultural commodities as defined in the Federal Motor Carrier Safety Regulations...2018-05865FR-Doc-2018-05865hours-of-service-electronic-logging-devices-limited-90-day-waiver-for-the-transportation-ofFMCSA grants a limited 90-day waiver from the Federal hours- of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for the transportation of agricultural commodities as defined in the Federal Motor Carrier Safety Regulations (FMCSRs). The Agency has determined that the waiver is in the public interest and will likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption, based on the terms and conditions imposed. The waiver provides the Agency additional time to complete its analysis of the public responses to its December 20, 2017, notice of proposed regulatory guidance to clarify the applicability of the ``Agricultural commodity'' exception to the hours- of-service regulations and issue final guidance which in turn, would have an impact on which drivers transporting agricultural commodities are required to use ELDs, and the public responses to its October 31, 2017, document announcing receipt of the NPPC's application for an exemption from the ELD requirements and to issue a decision whether to grant NPPC's request for longer-term relief from the ELD rule. The Agency has determined through its preliminary analysis of the public comments submitted to the public dockets that the issues raised by transporters of agricultural commodities are more complex than those raised by other segments of the industry seeking relief from the ELD requirements and that it is appropriate to take additional time to bring these matters to closure.
03/23/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicaid Program; Methods for Assuring Access to Covered Medicaid Services-Exemptions for States With High Managed Care Penetration Rates and Rate Reduction ThresholdThis proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute. States have...2018-05898FR-Doc-2018-05898medicaid-program-methods-for-assuring-access-to-covered-medicaid-services-exemptions-for-states-withThis proposed rule would amend the process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with the statute. States have raised concerns over the administrative burden associated with the current requirements, particularly for states with high rates of Medicaid managed care enrollment. This proposed rule would provide burden relief and address those concerns.
03/22/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators; Technical AmendmentsThe Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should...2018-05775FR-Doc-2018-05775clarification-of-post-approval-testing-standards-for-closed-circuit-escape-respirators-technicalThe Department of Health and Human Services (HHS) proposes to modify current language found in Title 42 of the Code of Federal Regulations which addresses post-approval testing of closed-circuit escape respirators (CCERs). The revised language should clarify that post-approval testing of CCERs may exclude human subject testing and environmental conditioning, at the discretion of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS. The revision to the text in this paragraph will clarify the scope of post-approval testing conducted by NIOSH.
03/22/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentApplication of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry.''...2018-05843FR-Doc-2018-05843application-of-the-foreign-supplier-verification-program-regulation-to-the-importation-of-liveThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry.'' The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard.
03/22/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentRequest for Information on Regulatory Challenges to Safely Transporting Hazardous Materials by Surface Modes in an Automated Vehicle EnvironmentThe Pipeline and Hazardous Materials Safety Administration (PHMSA) requests information on matters related to the development and potential use of automated technologies for surface modes (i.e., highway and rail) in hazardous materials transportation....2018-05785FR-Doc-2018-05785request-for-information-on-regulatory-challenges-to-safely-transporting-hazardous-materials-byThe Pipeline and Hazardous Materials Safety Administration (PHMSA) requests information on matters related to the development and potential use of automated technologies for surface modes (i.e., highway and rail) in hazardous materials transportation. In anticipation of the development, testing, and integration of Automated Driving Systems in surface transportation, PHMSA is issuing this request for information on the factors the Agency should consider to ensure continued safe transportation of hazardous materials without impeding emerging surface transportation technologies.
03/21/2018Proposed RuleDEPARTMENT OF THE INTERIORInterior DepartmentEducation Contracts Under Johnson-O'Malley ActThis proposed rule would update one section of the regulation regarding when Indian students are eligible for benefits of education contracts under the Johnson-O'Malley Act (JOM), to codify past practice and a Federal District Court ruling by deleting...2018-05749FR-Doc-2018-05749education-contracts-under-johnson-omalley-actThis proposed rule would update one section of the regulation regarding when Indian students are eligible for benefits of education contracts under the Johnson-O'Malley Act (JOM), to codify past practice and a Federal District Court ruling by deleting the requirement that the Indian student must have \\1/4\\ or more degree of Indian blood.
03/21/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPostmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Postmarketing Safety Reporting for Combination Products.'' This draft guidance addresses certain means by which...2018-05687FR-Doc-2018-05687postmarketing-safety-reporting-for-combination-products-draft-guidance-for-industry-and-food-andThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Postmarketing Safety Reporting for Combination Products.'' This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time.
03/21/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentImmediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; AvailabilityThe Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's...2018-05688FR-Doc-2018-05688immediately-in-effect-guidance-for-industry-compliance-policy-for-combination-product-postmarketingThe Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
03/21/2018Proposed RuleFEDERAL ELECTION COMMISSIONFederal Election CommissionRulemaking Petition: Former Candidates' Personal UseOn February 5, 2018, the Federal Election Commission received a Petition for Rulemaking, which asks the Commission to revise and amend the existing rules concerning the personal use of campaign funds, specifically to clarify the application of those...2018-05644FR-Doc-2018-05644rulemaking-petition-former-candidates-personal-useOn February 5, 2018, the Federal Election Commission received a Petition for Rulemaking, which asks the Commission to revise and amend the existing rules concerning the personal use of campaign funds, specifically to clarify the application of those rules to former candidates and officeholders. The Commission seeks comments on the petition.
03/21/2018RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionLabeling of Certain Household Products Containing Methylene Chloride; Supplemental GuidanceThe Halogenated Solvents Industry Alliance petitioned the Consumer Product Safety Commission to amend its 1987 policy statement regarding the labeling of certain products containing methylene chloride to address acute hazards from inhaling methylene...2018-05580FR-Doc-2018-05580labeling-of-certain-household-products-containing-methylene-chloride-supplemental-guidanceThe Halogenated Solvents Industry Alliance petitioned the Consumer Product Safety Commission to amend its 1987 policy statement regarding the labeling of certain products containing methylene chloride to address acute hazards from inhaling methylene chloride vapors in addition to the chronic hazards addressed in the policy statement. In this document, the Commission updates the 1987 policy statement to provide guidance regarding the labeling to warn of acute hazards associated with paint strippers containing methylene chloride.
03/20/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentDetermining the Number of Employees for Purposes of the \u201cSmall Business\u201d Definition in Parts 117 and 507: Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business''...2018-05705FR-Doc-2018-05705determining-the-number-of-employees-for-purposes-of-the-small-business-definition-in-parts-117-andThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for human and animal food rules. The draft guidance, when finalized, will help industry subject to those rules determine the number of employees for purposes of the ``small business'' definition.
03/19/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentRestructuring of Regulations on the Importation of Plants for PlantingWe are restructuring the regulations governing the importation of plants for planting. In the new structure, restrictions on the importation of specific types of plants for planting will no longer be found in the regulations, but instead will be found...2018-05424FR-Doc-2018-05424restructuring-of-regulations-on-the-importation-of-plants-for-plantingWe are restructuring the regulations governing the importation of plants for planting. In the new structure, restrictions on the importation of specific types of plants for planting will no longer be found in the regulations, but instead will be found in the Plants for Planting Manual. We will make changes to the restrictions in the manual after taking public comment through notices published in the Federal Register. As part of this restructuring, we are grouping together restrictions in the plants for planting regulations that apply to the importation of most or all plants for planting, and we are adding general requirements for the development of integrated pest risk management measures that we may use to mitigate the risk associated with the importation of a specific type of plants for planting. We are also amending our foreign quarantine regulations to remove various provisions regarding the importation of specific types of plants for planting that are not currently subject to the general plants for planting regulations; these provisions will also be found in the Plants for Planting Manual. This action does not make any major changes to the restrictions that currently apply to the importation of plants for planting. These changes will make restrictions on the importation of specific types of plants for planting easier for readers to find and less cumbersome for us to change.
03/19/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentHispanic-Serving Agricultural Colleges and Universities (HSACU) Certification ProcessThis amendment to NIFA regulations updates the list of institutions that are granted Hispanic-Serving Agricultural Colleges and Universities (HSACU) certification by the Secretary and are eligible for HSACU programs for the period starting October 1,...2018-05541FR-Doc-2018-05541hispanic-serving-agricultural-colleges-and-universities-hsacu-certification-processThis amendment to NIFA regulations updates the list of institutions that are granted Hispanic-Serving Agricultural Colleges and Universities (HSACU) certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2017, and ending September 30, 2018.
03/16/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentFees for Official Inspection and Official Weighing Services Under the United States Grain Standards Act (USGSA); CorrectionThis document corrects an error introduced into our regulations by a final rule that was published in the February 14, 2018, Federal Register. The final rule used the Roman numeral (v) consecutively in a table. This document corrects the table by...2018-05315FR-Doc-2018-05315fees-for-official-inspection-and-official-weighing-services-under-the-united-states-grain-standardsThis document corrects an error introduced into our regulations by a final rule that was published in the February 14, 2018, Federal Register. The final rule used the Roman numeral (v) consecutively in a table. This document corrects the table by renumbering the last six items in the table.
03/16/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentTobacco Product Standard for Nicotine Level of Combusted CigarettesThe Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because...2018-05345FR-Doc-2018-05345tobacco-product-standard-for-nicotine-level-of-combusted-cigarettesThe Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term ``nonaddictive'' in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.
03/16/2018Proposed RuleDEPARTMENT OF THE INTERIORInterior DepartmentSpecial Regulations, Areas of the National Park System, Pea Ridge National Military Park; BicyclesThe National Park Service proposes to promulgate special regulations for Pea Ridge National Military Park to allow bicycle use on two proposed multi-use trails located within the park. One trail will be approximately 0.55 miles in length and the other...2018-05414FR-Doc-2018-05414special-regulations-areas-of-the-national-park-system-pea-ridge-national-military-park-bicyclesThe National Park Service proposes to promulgate special regulations for Pea Ridge National Military Park to allow bicycle use on two proposed multi-use trails located within the park. One trail will be approximately 0.55 miles in length and the other will be approximately 1.17 miles in length. Both trails will require trail construction activities to accommodate bicycles and are therefore considered new trails that will be opened to bicycles. National Park Service regulations require promulgation of a special regulation to designate new trails for bicycle use off park roads and outside developed areas.
03/16/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding \u201cIntended Uses\u201d; Partial Delay of Effective DateThe Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product ``intended use'' regulations, contained in the final rule published January 9, 2017, until...2018-05347FR-Doc-2018-05347clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-orThe Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product ``intended use'' regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains March 19, 2018.
03/15/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentAdoption and Foster Care Analysis and Reporting SystemThe Children's Bureau proposes to delay the compliance and effective dates in the Adoption and Foster Care Analysis and Reporting System (AFCARS) 2016 final rule for title IV-E agencies to comply with agency rules for an additional two fiscal years. We...2018-05038FR-Doc-2018-05038adoption-and-foster-care-analysis-and-reporting-systemThe Children's Bureau proposes to delay the compliance and effective dates in the Adoption and Foster Care Analysis and Reporting System (AFCARS) 2016 final rule for title IV-E agencies to comply with agency rules for an additional two fiscal years. We propose to delay the compliance and effective dates at the same time we seek public comment through an Advance Notice of Proposed Rulemaking (ANPRM), published elsewhere in this issue of the Federal Register, on suggestions to streamline the AFCARS data elements and remove any undue burden related to reporting AFCARS.
03/15/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentImportation of Campanula spp. Plants for Planting in Approved Growing Media From Denmark Into the United StatesWe are amending the regulations governing the importation of plants for planting by authorizing the importation of Campanula spp. plants for planting from Denmark in approved growing media into the United States, subject to a systems approach. The...2018-05267FR-Doc-2018-05267importation-of-campanula-spp-plants-for-planting-in-approved-growing-media-from-denmark-into-theWe are amending the regulations governing the importation of plants for planting by authorizing the importation of Campanula spp. plants for planting from Denmark in approved growing media into the United States, subject to a systems approach. The systems approach will include measures that are currently specified in the regulations as generally applicable to all plants for planting authorized importation into the United States in approved growing media. This action will allow for the importation of Campanula spp. plants for planting from Denmark in approved growing media, while providing protection against the introduction of plant pests.
03/15/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentAdoption and Foster Care Analysis and Reporting SystemACF is seeking public suggestions, in particular from state and tribal title IV-E agencies and Indian tribes and tribal consortiums and other stakeholders, for streamlining the Adoption and Foster Care Analysis and Reporting System (AFCARS) data...2018-05042FR-Doc-2018-05042adoption-and-foster-care-analysis-and-reporting-systemACF is seeking public suggestions, in particular from state and tribal title IV-E agencies and Indian tribes and tribal consortiums and other stakeholders, for streamlining the Adoption and Foster Care Analysis and Reporting System (AFCARS) data elements and removing any undue burden related to reporting AFCARS.
03/15/2018RuleDEPARTMENT OF LABORLabor DepartmentVinyl ChlorideThe Federal Housing Finance Agency (FHFA) is issuing notice and providing an opportunity for the public to comment on proposed amendments to its regulation on the Federal Home Loan Banks' (Banks) Affordable Housing Program (AHP or Program). The...2018-05312FR-Doc-2018-05312vinyl-chloride 
03/14/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentViruses, Serums, Toxins, and Analogous Products; Expiration Date Required for Serial and Subserials and Determination of Expiration Date of ProductWe are amending the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We are also requiring the expiration dating period...2018-05143FR-Doc-2018-05143viruses-serums-toxins-and-analogous-products-expiration-date-required-for-serial-and-subserials-andWe are amending the regulations to clarify that the expiration date of a serial or subserial of a veterinary biologic should be computed from the date of the initiation of the first potency test. We are also requiring the expiration dating period (stability) of a product to be confirmed by conducting a real-time stability study with a stability-indicating assay, stability monitoring of products after licensing, and specifying a single standard for determining the expiration date for veterinary biologics
03/14/2018RuleNATIONAL ARCHIVES AND RECORDS ADMINISTRATIONNational Archives and Records AdministrationFeesNARA is amending our Fees regulation to shorten the period in which people who request copies of archival records may request a refund. This shorter period is in line with other similar research and archival institutions and is designed to reduce the...2018-05088FR-Doc-2018-05088feesNARA is amending our Fees regulation to shorten the period in which people who request copies of archival records may request a refund. This shorter period is in line with other similar research and archival institutions and is designed to reduce the administrative costs of processing a large number of refund requests that fall outside the permitted bases.
03/14/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair KitThe Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of...2018-05116FR-Doc-2018-05116medical-devices-exemption-from-premarket-notification-class-ii-devices-over-the-counter-dentureThe Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
03/14/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems; CorrectionThe Food and Drug Administration is correcting a final order entitled ``Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems'' that appeared in the Federal Register of February 27, 2018. The document was...2018-05115FR-Doc-2018-05115medical-devices-hematology-and-pathology-devices-classification-of-lynch-syndrome-test-systemsThe Food and Drug Administration is correcting a final order entitled ``Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems'' that appeared in the Federal Register of February 27, 2018. The document was published with the incorrect docket number. This document corrects that error.
03/14/2018RuleSocial Security AdministrationSocial Security AdministrationRevised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases)On February 21, 2018, the Department of Veterans Affairs (VA) published a final rule prescribing five new Economic Price Adjustment clauses for firm-fixed-price contracts, identifying VA's task-order and delivery-order ombudsman, clarifying the nature...2018-05240FR-Doc-2018-05240revised-medical-criteria-for-evaluating-cancer-malignant-neoplastic-diseases 
03/12/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentExcentials B.V.; Withdrawal of Food Additive Petition (Animal Use)The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (animal use) proposing that the food additive regulations be amended to provide for the safe use of...2018-04775FR-Doc-2018-04775excentials-bv-withdrawal-of-food-additive-petition-animal-useThe Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (animal use) proposing that the food additive regulations be amended to provide for the safe use of L-selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.
03/12/2018RuleDEPARTMENT OF EDUCATIONEducation DepartmentFederal Preemption and State Regulation of the Department of Education's Federal Student Loan Programs and Federal Student Loan ServicersRecently, several States have enacted regulatory regimes that impose new regulatory requirements on servicers of loans under the William D. Ford Federal Direct Loan Program (Direct Loan Program). States also impose disclosure requirements on loan...2018-04924FR-Doc-2018-04924federal-preemption-and-state-regulation-of-the-department-of-educations-federal-student-loanRecently, several States have enacted regulatory regimes that impose new regulatory requirements on servicers of loans under the William D. Ford Federal Direct Loan Program (Direct Loan Program). States also impose disclosure requirements on loan servicers with respect to loans made under title IV of the Higher Education Act of 1965, as amended (HEA). Finally, State regulations impact Federal Family Education Loan (FFEL) Program servicing. The Department believes such regulation is preempted by Federal law. The Department issues this notice to clarify further the Federal interests in this area.
03/12/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentRevise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002); CorrectionThe Department of Veterans Affairs (VA) is correcting a final rule regarding Federal Acquisition Regulation Principles. This correction addresses minor technical errors in the final rule.2018-04883FR-Doc-2018-04883revise-and-streamline-va-acquisition-regulation-to-adhere-to-federal-acquisition-regulationThe Department of Veterans Affairs (VA) is correcting a final rule regarding Federal Acquisition Regulation Principles. This correction addresses minor technical errors in the final rule.
03/12/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-04783FR-Doc-2018-04783suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.
03/12/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentElectronic Submission of Certain Servicemembers' Group Life Insurance, Family Servicemembers' Group Life Insurance, and Veterans' Group Life Insurance FormsThe Department of Veterans Affairs (VA) in this final rule amends its regulations governing the Servicemembers' and Veterans' Group Life Insurance programs to provide that certain Servicemembers' Group Life insurance (SGLI), Family SGLI (FSGLI), and...2018-04877FR-Doc-2018-04877electronic-submission-of-certain-servicemembers-group-life-insurance-family-servicemembers-groupThe Department of Veterans Affairs (VA) in this final rule amends its regulations governing the Servicemembers' and Veterans' Group Life Insurance programs to provide that certain Servicemembers' Group Life insurance (SGLI), Family SGLI (FSGLI), and Veterans' Group Life Insurance (VGLI) applications, elections, and beneficiary designations, required by statute to be ``written'' or ``in writing,'' would include those that are digitally or electronically signed and submitted via an agency-approved electronic means. This document adopts as a final rule, with minor changes, the proposed rule published in the Federal Register on September 6, 2017.
03/09/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I; CorrectionOn February 1, 2018, the Drug Enforcement Administration placed seven fentanyl-related substances temporarily in schedule I of the Controlled Substances Act. Incorrect drug codes were assigned to valeryl fentanyl and ocfentanil. This document corrects...2018-04765FR-Doc-2018-04765schedules-of-controlled-substances-temporary-placement-of-seven-fentanyl-related-substances-inOn February 1, 2018, the Drug Enforcement Administration placed seven fentanyl-related substances temporarily in schedule I of the Controlled Substances Act. Incorrect drug codes were assigned to valeryl fentanyl and ocfentanil. This document corrects the drug codes for those two substances.
03/09/2018RuleFEDERAL ELECTION COMMISSIONFederal Election CommissionChange of Address; Technical AmendmentThe relocation of the Federal Election Commission (``FEC'' or ``Commission'') to a new building with a different street address has been delayed by two weeks. The Commission is updating its regulations to reflect the new relocation date.2018-04698FR-Doc-2018-04698change-of-address-technical-amendmentThe relocation of the Federal Election Commission (``FEC'' or ``Commission'') to a new building with a different street address has been delayed by two weeks. The Commission is updating its regulations to reflect the new relocation date.
03/07/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentGW Cosmetics GmbH; Filing of Color Additive PetitionThe Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in...2018-04619FR-Doc-2018-04619gw-cosmetics-gmbh-filing-of-color-additive-petitionThe Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by GW Cosmetics GmbH, proposing that the color additive regulations be amended to provide for the safe use of silver nitrate in professional-use only cosmetics to color eyebrows and eyelashes.
03/07/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic WoundsThe Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will...2018-04616FR-Doc-2018-04616medical-devices-general-and-plastic-surgery-devices-classification-of-the-extracorporeal-shock-waveThe Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds 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 extracorporeal shock wave device for treatment of chronic wounds' 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.
03/06/2018Proposed RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentUpdates to Floodplain Management and Protection of Wetlands Regulations To Implement Executive Order 13690 and the Federal Flood Risk Management StandardThe Federal Emergency Management Agency (FEMA) withdraws a notice of proposed rulemaking (NPRM) that published on August 22, 2016. The NPRM proposed changes to FEMA's ``Floodplain Management and Protection of Wetlands'' regulations to implement...2018-04495FR-Doc-2018-04495updates-to-floodplain-management-and-protection-of-wetlands-regulations-to-implement-executive-orderThe Federal Emergency Management Agency (FEMA) withdraws a notice of proposed rulemaking (NPRM) that published on August 22, 2016. The NPRM proposed changes to FEMA's ``Floodplain Management and Protection of Wetlands'' regulations to implement Executive Order 13690, which established the Federal Flood Risk Management Standard (FFRMS). FEMA also withdraws the proposed supplementary policy (FEMA Policy: 078-3), which clarified how FEMA would apply the FFRMS. On August 15, 2017, the President issued Executive Order 13807, which revoked Executive Order 13690. Accordingly, the NPRM and supplementary policy are withdrawn.
03/06/2018Proposed RulePRESIDIO TRUSTPresidio TrustFreedom of Information Act; Privacy Act; Federal Tort Claims Act; Debt CollectionThe Presidio Trust (Trust) proposes revisions to its regulations addressing requests under the Freedom of Information Act (FOIA), requests under the Privacy Act, administrative claims under the Federal Tort Claims Act (FTCA), and Debt Collection. The...2018-03939FR-Doc-2018-03939freedom-of-information-act-privacy-act-federal-tort-claims-act-debt-collectionThe Presidio Trust (Trust) proposes revisions to its regulations addressing requests under the Freedom of Information Act (FOIA), requests under the Privacy Act, administrative claims under the Federal Tort Claims Act (FTCA), and Debt Collection. The Trust is revising these regulations to update and streamline the language of several procedural provisions, and to reflect amendments pursuant to the FOIA Improvement Act of 2016 and the Digital Accountability and Transparency Act of 2014.
03/06/2018Proposed RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentHiring Flexibility Under Professional StandardsThis proposed rule would add four flexibilities to the hiring standards for new school nutrition program directors in small local educational agencies (LEAs) and new school nutrition program State directors under the professional standards regulations...2018-04233FR-Doc-2018-04233hiring-flexibility-under-professional-standardsThis proposed rule would add four flexibilities to the hiring standards for new school nutrition program directors in small local educational agencies (LEAs) and new school nutrition program State directors under the professional standards regulations for the National School Lunch and School Breakfast Programs. First, to address the hiring challenge faced by small LEAs, those with 2,499 or fewer students, this rule would require relevant food service experience rather than school nutrition program experience for new directors. Second, it would provide State agencies with discretion to consider volunteer or unpaid work as relevant food service experience for new school nutrition program directors in small LEAs. Third, to further assist LEAs with less than 500 students, this proposed rule would expand the existing regulatory flexibility which gives State agencies discretion to accept less than the required years of food service experience when an applicant for a new director position has the minimum required education. Fourth, this rule would also add flexibility to the hiring standards for State directors of school nutrition programs by considering applicants with either a bachelor's or a master's degree in specific, relevant fields. These proposed changes are expected to expand the pool of candidates qualified to serve as leaders in the school nutrition programs while continuing to ensure that school nutrition professionals are able to perform their duties effectively and efficiently.
03/05/2018RuleDEPARTMENT OF EDUCATIONEducation DepartmentInnovation for Teacher Quality; Troops-to-Teachers ProgramThe Department of Education (Department) is rescinding its Troops-to-Teachers (TTT) regulations because that program has been transferred to the Department of Defense (DoD) and is no longer administered or managed by the Department. Therefore, the...2018-04437FR-Doc-2018-04437innovation-for-teacher-quality-troops-to-teachers-programThe Department of Education (Department) is rescinding its Troops-to-Teachers (TTT) regulations because that program has been transferred to the Department of Defense (DoD) and is no longer administered or managed by the Department. Therefore, the associated regulations are outdated and unnecessary.
03/05/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentReimbursement of Qualifying Adoption Expenses for Certain VeteransThe Department of Veterans Affairs (VA) amends its regulation to provide for reimbursement of qualifying adoption expenses incurred by a veteran with a service-connected disability that results in the inability of the veteran to procreate without the...2018-04245FR-Doc-2018-04245reimbursement-of-qualifying-adoption-expenses-for-certain-veteransThe Department of Veterans Affairs (VA) amends its regulation to provide for reimbursement of qualifying adoption expenses incurred by a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. Under the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act, VA may use funds appropriated or otherwise made available to VA for the ``Medical Services'' account to provide adoption reimbursement to these veterans. Under the law, reimbursement may be for the adoption-related expenses for an adoption that is finalized after the date of the enactment of this Act under the same terms as apply under the adoption reimbursement program of the Department of Defense (DoD), as authorized in DoD Instruction 1341.09, including the reimbursement limits and requirements set forth in such instruction. This rulemaking implements the new adoption reimbursement benefit for covered veterans.
03/02/2018Proposed RuleDEPARTMENT OF THE INTERIORInterior DepartmentTransporting Bows and Crossbows Across National Park System UnitsThe National Park Service proposes to allow individuals to carry or possess a bow or crossbow within the National Park System when accessing otherwise inaccessible lands or waters contiguous to a park area when other means of access are otherwise...2018-04247FR-Doc-2018-04247transporting-bows-and-crossbows-across-national-park-system-unitsThe National Park Service proposes to allow individuals to carry or possess a bow or crossbow within the National Park System when accessing otherwise inaccessible lands or waters contiguous to a park area when other means of access are otherwise impracticable or impossible.
03/02/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.'' The draft guidance,...2018-04281FR-Doc-2018-04281the-declaration-of-added-sugars-on-honey-maple-syrup-and-certain-cranberry-products-draft-guidanceThe Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products: Guidance for Industry.'' The draft guidance, when finalized, will advise food manufacturers of our intent to exercise enforcement discretion related to the use in the Nutrition Facts label of a symbol ``[dagger]'' immediately after the added sugars percent Daily Value information on certain foods. The symbol would lead the reader to truthful and non-misleading statements outside the Nutrition Facts label to provide additional information regarding the added sugars present in particular foods.
03/02/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentSpecial Regulations, Areas of the National Park System, Rocky Mountain National Park; BicyclingThe National Park Service amends the special regulations for Rocky Mountain National Park to allow bicycle use on a 2-mile segment of the East Shore Trail located within the park. A portion of this 2- mile segment will require trail construction to...2018-04309FR-Doc-2018-04309special-regulations-areas-of-the-national-park-system-rocky-mountain-national-park-bicyclingThe National Park Service amends the special regulations for Rocky Mountain National Park to allow bicycle use on a 2-mile segment of the East Shore Trail located within the park. A portion of this 2- mile segment will require trail construction to accommodate bicycles and is therefore considered a new trail. National Park Service regulations require promulgation of a special regulation to designate new trails for bicycle use off park roads and outside developed areas.
03/02/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentFederal Civil Penalties Inflation Adjustment Act AmendmentsThe Department of Veterans Affairs (VA) is providing public notice of inflationary adjustments to the maximum civil monetary penalties assessed or enforced by VA, as implemented by the Federal Civil Penalties Inflation Adjustment Act Improvements Act...2018-04241FR-Doc-2018-04241federal-civil-penalties-inflation-adjustment-act-amendmentsThe Department of Veterans Affairs (VA) is providing public notice of inflationary adjustments to the maximum civil monetary penalties assessed or enforced by VA, as implemented by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, for calendar year 2018. VA may impose civil monetary penalties for false loan guaranty certifications. Also, VA may impose civil monetary penalties for fraudulent claims or written statements made in connection with VA programs generally. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, sets forth a formula that increases the maximum statutory amounts for civil monetary penalties and directs VA to give public notice of the new maximum amounts by regulation. Accordingly, VA is providing notice of the calendar year 2018 inflationary adjustments that increase maximum civil monetary penalties from $21,916 to $22,363 for false loan guaranty certifications and from $10,957 to $11,181 for fraudulent claims or written statements made in connection with VA programs generally.
02/28/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentRemoving Regulatory Barriers for Vehicles With Automated Driving Systems; Extension of Comment PeriodIn response to a request, NHTSA is extending the comment period on the Removing Regulatory Barriers for Vehicles with Automated Driving Systems Request for Comment (RFC) to March 20, 2018. The RFC was published in the Federal Register on January 18,...2018-04063FR-Doc-2018-04063removing-regulatory-barriers-for-vehicles-with-automated-driving-systems-extension-of-comment-periodIn response to a request, NHTSA is extending the comment period on the Removing Regulatory Barriers for Vehicles with Automated Driving Systems Request for Comment (RFC) to March 20, 2018. The RFC was published in the Federal Register on January 18, 2018. The comment period for the RFC was originally scheduled to end on March 5, 2018.
02/28/2018Proposed RuleDEPARTMENT OF THE INTERIORInterior DepartmentSpecial Regulations of the National Park Service; Glen Canyon National Recreation Area; Motor VehiclesThe National Park Service proposes to amend its special regulations for Glen Canyon National Recreation Area to manage the use of motor vehicles on and off park roads. The rule would require a permit to operate a motor vehicle off roads in selected...2018-04030FR-Doc-2018-04030special-regulations-of-the-national-park-service-glen-canyon-national-recreation-area-motor-vehiclesThe National Park Service proposes to amend its special regulations for Glen Canyon National Recreation Area to manage the use of motor vehicles on and off park roads. The rule would require a permit to operate a motor vehicle off roads in selected locations, designate routes and areas where motor vehicles may be used off roads, and allow the superintendent to establish closures and restrictions based upon specific criteria. The rule would also allow certain types of off-road vehicles on some paved and unpaved roads in the recreation area. Unless provided for by special regulation, operating a motor vehicle off roads within areas of the National Park System is prohibited.
02/28/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentTribal Transportation Program; Delay of Compliance DateThe Bureau of Indian Affairs (BIA) is confirming the interim final rule published on October 31, 2017, that delayed the deadline for Tribes to comply with Tribal Transportation Program requirements to collect data on proposed roads for the National...2018-04103FR-Doc-2018-04103tribal-transportation-program-delay-of-compliance-dateThe Bureau of Indian Affairs (BIA) is confirming the interim final rule published on October 31, 2017, that delayed the deadline for Tribes to comply with Tribal Transportation Program requirements to collect data on proposed roads for the National Tribal Transportation Facility Inventory (NTTFI).
02/27/2018Proposed RuleDEPARTMENT OF EDUCATIONEducation DepartmentAssistance to States for the Education of Children With Disabilities; Preschool Grants for Children With DisabilitiesIn order to ensure the Department's ``Equity in IDEA'' or ``significant disproportionality'' regulations effectively address significant disproportionality, the Department proposes to postpone the compliance date by two years, from July 1, 2018, to...2018-04102FR-Doc-2018-04102assistance-to-states-for-the-education-of-children-with-disabilities-preschool-grants-for-childrenIn order to ensure the Department's ``Equity in IDEA'' or ``significant disproportionality'' regulations effectively address significant disproportionality, the Department proposes to postpone the compliance date by two years, from July 1, 2018, to July 1, 2020. The Department also proposes to postpone the date for including children ages three through five in the analysis of significant disproportionality with respect to the identification of children as children with disabilities and as children with a particular impairment from July 1, 2020, to July 1, 2022.
02/27/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test SystemsThe Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems 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...2018-03924FR-Doc-2018-03924medical-devices-hematology-and-pathology-devices-classification-of-lynch-syndrome-test-systemsThe Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems 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 Lynch syndrome test systems' 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.
02/27/2018RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionHazardous Substances and Articles; Administration and Enforcement Regulations: Corrections to Animal Testing RegulationsThe Consumer Product Safety Commission (CPSC or Commission) is issuing a direct final rule to correct its animal testing regulations under the Federal Hazardous Substances Act (FHSA). The rule reinserts text that was inadvertently omitted and corrects...2018-03916FR-Doc-2018-03916hazardous-substances-and-articles-administration-and-enforcement-regulations-corrections-to-animalThe Consumer Product Safety Commission (CPSC or Commission) is issuing a direct final rule to correct its animal testing regulations under the Federal Hazardous Substances Act (FHSA). The rule reinserts text that was inadvertently omitted and corrects references.
02/27/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentExpanding the Size of the Board of Immigration AppealsThis final rule amends the Executive Office for Immigration Review (EOIR) regulations relating to the organization of the Board of Immigration Appeals (Board) by adding four additional Board member positions, thereby expanding the Board to 21 members.2018-03980FR-Doc-2018-03980expanding-the-size-of-the-board-of-immigration-appealsThis final rule amends the Executive Office for Immigration Review (EOIR) regulations relating to the organization of the Board of Immigration Appeals (Board) by adding four additional Board member positions, thereby expanding the Board to 21 members.
02/26/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentFederal Motor Vehicle Safety Standard No. 141, Minimum Sound Requirements for Hybrid and Electric VehiclesThis document responds to petitions for reconsideration regarding NHTSA's December 2016 final rule which established new Federal motor vehicle safety standard (FMVSS) No. 141, ``Minimum sound for hybrid and electric vehicles.'' The agency received...2018-03721FR-Doc-2018-03721federal-motor-vehicle-safety-standard-no-141-minimum-sound-requirements-for-hybrid-and-electricThis document responds to petitions for reconsideration regarding NHTSA's December 2016 final rule which established new Federal motor vehicle safety standard (FMVSS) No. 141, ``Minimum sound for hybrid and electric vehicles.'' The agency received submissions from three petitioners requesting six discrete changes to the final rule, and also received technical questions from the petitioners. After consideration of the petitions and all supporting information, NHTSA has decided to grant the petitions for four of the discrete changes, deny one, and request comment in a separate document for the sixth proposed change.
02/23/2018Proposed RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentSupplemental Nutrition Assistance Program: Requirements and Services for Able-Bodied Adults Without Dependents; Advance Notice of Proposed RulemakingThe Food and Nutrition Act of 2008, as amended (the Act), limits the amount of time an able-bodied adult without dependents (ABAWD) can receive Supplemental Nutrition Assistance Program (SNAP) benefits to 3 months in a 36-month period, unless the...2018-03752FR-Doc-2018-03752supplemental-nutrition-assistance-program-requirements-and-services-for-able-bodied-adults-withoutThe Food and Nutrition Act of 2008, as amended (the Act), limits the amount of time an able-bodied adult without dependents (ABAWD) can receive Supplemental Nutrition Assistance Program (SNAP) benefits to 3 months in a 36-month period, unless the individual is working and/or participating in a work program half-time or more, or participating in workfare. The Act exempts individuals from the time limit for several reasons, including age, unfitness for work, or having a dependent child. The Act also provides State agencies with flexibility to request a waiver of this time limit if unemployment is high or the area does not have a sufficient number of jobs to provide employment. Moreover, the Act gives States discretion to exempt 15 percent of the individuals who would otherwise be subject to the time limit. The Department of Agriculture's (Department's) policy goal is to address food insecurity by providing supplemental food assistance and helping able-bodied SNAP participants move out of poverty and into work in a manner that is consistent with the structure and the intent of the Act. As described in Sections 2 and 6(d) of the Act, the goals of the program are to promote food security, self-sufficiency, well-being, and economic mobility. In this Notice, the Department is seeking public input to inform potential policy, program, and regulatory changes to more consistently advance this goal.
02/23/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-03738FR-Doc-2018-03738suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
02/21/2018Proposed RuleOFFICE OF PERSONNEL MANAGEMENTPersonnel Management OfficeFederal Employees Health Benefits Program Regulations: Revised Guaranteed Issue Conversion Requirements and Technical UpdatesThe Office of Personnel Management proposes to amend the guaranteed issue conversion requirements for the Federal Employees Health Benefits (FEHB) Program. Guaranteed issue insurance policies are available in all 50 states and the District of Columbia....2018-03510FR-Doc-2018-03510federal-employees-health-benefits-program-regulations-revised-guaranteed-issue-conversionThe Office of Personnel Management proposes to amend the guaranteed issue conversion requirements for the Federal Employees Health Benefits (FEHB) Program. Guaranteed issue insurance policies are available in all 50 states and the District of Columbia. These rules update the requirements and timeframes for FEHB Carriers to offer assistance to enrollees who may wish to enroll in guaranteed issue conversion contracts and ensure that terminating enrollees are able to receive assistance from FEHB Carriers if they choose to enroll in guaranteed issue non-group policies. This rule also updates the title of the Director for Retirement and Insurance.
02/21/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentRevise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002)The Department of Veterans Affairs (VA) adopts as final the proposed amendments to VA regulations. This rulemaking prescribes five new Economic Price Adjustment clauses for firm-fixed-price contracts, identifies VA's task-order and delivery-order...2018-03164FR-Doc-2018-03164revise-and-streamline-va-acquisition-regulation-to-adhere-to-federal-acquisition-regulationThe Department of Veterans Affairs (VA) adopts as final the proposed amendments to VA regulations. This rulemaking prescribes five new Economic Price Adjustment clauses for firm-fixed-price contracts, identifies VA's task-order and delivery-order ombudsman, clarifies the nature and use of consignment agreements, adds policy coverage on bond premium adjustments and insurance under fixed-price contracts, and provides for indemnification of contractors for medical research or development contracts. This document adopts the proposed rule published on March 13, 2017, as a final rule with five technical non-substantive changes.
02/21/2018RuleDEPARTMENT OF HOUSING AND URBAN DEVELOPMENTHousing and Urban Development DepartmentStreamlining the Office of Inspector General's Freedom of Information Act Regulations and Implementing the FOIA Improvement Act of 2016This final rule amends the Freedom of Information Act (FOIA) regulations for the U.S. Department of Housing and Urban Development (HUD) Office of Inspector General (OIG) to align with HUD's FOIA regulations, to implement the FOIA Improvement Act of...2018-03400FR-Doc-2018-03400streamlining-the-office-of-inspector-generals-freedom-of-information-act-regulations-andThis final rule amends the Freedom of Information Act (FOIA) regulations for the U.S. Department of Housing and Urban Development (HUD) Office of Inspector General (OIG) to align with HUD's FOIA regulations, to implement the FOIA Improvement Act of 2016, and to explain current OIG policies and practices with respect to FOIA.
02/21/2018Proposed RuleDEPARTMENT OF THE TREASURYTreasury DepartmentShort-Term, Limited-Duration InsuranceThis rule contains proposals amending the definition of short- term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of...2018-03208FR-Doc-2018-03208short-term-limited-duration-insuranceThis rule contains proposals amending the definition of short- term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of short-term, limited- duration insurance, which will provide more affordable consumer choice for health coverage.
02/21/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentHuman Subject Protection; Acceptance of Data From Clinical Investigations for Medical DevicesThe Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States...2018-03244FR-Doc-2018-03244human-subject-protection-acceptance-of-data-from-clinical-investigations-for-medical-devicesThe Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.
02/20/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentNicotine Steering Committee; Establishment of a Public Docket; Request for CommentsThe Food and Drug Administration (FDA or Agency) is establishing a public docket to receive suggestions, recommendations, and comments on topics or policy issues for consideration by FDA's Nicotine Steering Committee (NSC). FDA would like to receive...2018-03341FR-Doc-2018-03341nicotine-steering-committee-establishment-of-a-public-docket-request-for-commentsThe Food and Drug Administration (FDA or Agency) is establishing a public docket to receive suggestions, recommendations, and comments on topics or policy issues for consideration by FDA's Nicotine Steering Committee (NSC). FDA would like to receive feedback from interested parties, including academic institutions, regulated industries, patient representatives, and other interested organizations. These comments will help the Agency identify and address priorities related to the use of therapeutic nicotine for combustible tobacco product cessation.
02/16/2018Proposed RuleDEPARTMENT OF THE TREASURYTreasury DepartmentProposal of Special Measure Against ABLV Bank, AS as a Financial Institution of Primary Money Laundering ConcernFinCEN is issuing a notice of proposed rulemaking (NPRM), pursuant to Section 311 of the USA PATRIOT Act, to prohibit the opening or maintaining of a correspondent account in the United States for, or on behalf of, ABLV Bank, AS.2018-03214FR-Doc-2018-03214proposal-of-special-measure-against-ablv-bank-as-as-a-financial-institution-of-primary-moneyFinCEN is issuing a notice of proposed rulemaking (NPRM), pursuant to Section 311 of the USA PATRIOT Act, to prohibit the opening or maintaining of a correspondent account in the United States for, or on behalf of, ABLV Bank, AS.
02/15/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal UseThe Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be...2018-03135FR-Doc-2018-03135medical-devices-general-and-plastic-surgery-devices-classification-of-the-non-absorbable-hemostaticThe Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use 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 non-absorbable, hemostatic gauze for temporary internal use's 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.
02/14/2018Proposed RuleCORPORATION FOR NATIONAL AND COMMUNITY SERVICECorporation for National and Community ServiceSenior Corps: Senior Companion Program, Foster Grandparent Program, Retired and Senior Volunteer ProgramThe Corporation for National and Community Service (CNCS) proposes changes to existing regulations under the Domestic Volunteer Service Act of 1973, as amended, for the following Senior Corps programs: Foster Grandparent Program (FGP), Senior Companion...2018-01462FR-Doc-2018-01462senior-corps-senior-companion-program-foster-grandparent-program-retired-and-senior-volunteerThe Corporation for National and Community Service (CNCS) proposes changes to existing regulations under the Domestic Volunteer Service Act of 1973, as amended, for the following Senior Corps programs: Foster Grandparent Program (FGP), Senior Companion Program (SCP), and the Retired Senior Volunteer Program (RSVP). These amendments will increase flexibility in program administration while maintaining accountability at the local level, correct grammatical errors, update language that is currently used by CNCS, and streamline requirements for more effective administration of projects in local communities.
02/14/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentCLASS Condition of the Head Start Designation Renewal SystemOHS withdraws the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments, published in the Federal Register on December 8, 2017. OHS simultaneously issues the ``Head Start Designation Renewal System Improvements'' request...2018-02901FR-Doc-2018-02901class-condition-of-the-head-start-designation-renewal-systemOHS withdraws the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments, published in the Federal Register on December 8, 2017. OHS simultaneously issues the ``Head Start Designation Renewal System Improvements'' request for comments, located elsewhere in the same issue of the Federal Register. The ``Head Start Designation Renewal System Improvements'' request for comments contains information we inadvertently omitted from the ``CLASS Condition of the Head Start Designation Renewal System'' request for comment publication.
02/14/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentHead Start Designation Renewal System ImprovementsOHS issues this request for comments to invite public feedback on information we inadvertently omitted from the ``CLASS Condition of the Head Start Designation Renewal System,'' request for comments, published on December 8, 2017. The document...2018-02902FR-Doc-2018-02902head-start-designation-renewal-system-improvementsOHS issues this request for comments to invite public feedback on information we inadvertently omitted from the ``CLASS Condition of the Head Start Designation Renewal System,'' request for comments, published on December 8, 2017. The document withdrawing the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments is published elsewhere in this issue of the Federal Register. This request for comments is similar to the withdrawn publication in that it invites the public to comment on specific changes OHS is considering for the CLASS condition, as well as other Designation Renewal System (DRS) conditions and processes more broadly. Additionally, OHS seeks comments on ways it can: Incentivize robust competition to include new applicants, facilitate smooth transitions when there is a new grantee as a result of competition, and improve the DRS processes. The comment period is 30 days to allow for the public to address the additional issues in this reissued request for comments. We will consider comments submitted under the ``CLASS Condition of the Head Start Designation Renewal System'' request for comments.
02/14/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPostmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission RequirementsThe Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be...2018-02757FR-Doc-2018-02757postmarketing-safety-reports-for-approved-new-animal-drugs-electronic-submission-requirementsThe Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.
02/14/2018RuleDEPARTMENT OF EDUCATIONEducation DepartmentStudent Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant ProgramThe Secretary delays, until July 1, 2019, the effective date of selected provisions of the final regulations entitled Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan (FFEL) Program, William D. Ford...2018-03090FR-Doc-2018-03090student-assistance-general-provisions-federal-perkins-loan-program-federal-family-education-loanThe Secretary delays, until July 1, 2019, the effective date of selected provisions of the final regulations entitled Student Assistance General Provisions, Federal Perkins Loan Program, Federal Family Education Loan (FFEL) Program, William D. Ford Federal Direct Loan Program, and Teacher Education Assistance for College and Higher Education Grant Program (the 2016 final regulations), published in the Federal Register on November 1, 2016. The Secretary is delaying the 2016 final regulations to ensure that there is adequate time to conduct negotiated rulemaking and develop revised regulations. The provisions for which the effective date is being delayed are listed in the SUPPLEMENTARY INFORMATION section of this document. The original effective date of the 2016 final regulations, published November 1, 2016, was July 1, 2017. The effective date was delayed by a document issued under section 705 of the Administrative Procedure Act (the 705 Document). The Department announced in an interim final rule (IFR) issued on October 24, 2017, that, under the Department's interpretation of the Higher Education Act, the effective date could be no earlier than July 1, 2018.
02/14/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentFees for Official Inspection and Official Weighing Services Under the United States Grain Standards Act (USGSA)USDA, on behalf of the Agricultural Marketing Service (AMS) is announcing the fee schedule for official inspection and weighing services performed under the United States Grain Standards Act (USGSA), as amended, in order to comply with FGIS regulations...2018-02884FR-Doc-2018-02884fees-for-official-inspection-and-official-weighing-services-under-the-united-states-grain-standardsUSDA, on behalf of the Agricultural Marketing Service (AMS) is announcing the fee schedule for official inspection and weighing services performed under the United States Grain Standards Act (USGSA), as amended, in order to comply with FGIS regulations and the Agriculture Reauthorizations Act of 2015, and publishing the annual review of Schedule A fees calculation and the resulting fees that went into effect on January 1, 2018.
02/13/2018Proposed RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentEgg Products Inspection RegulationsThe Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products (herein also referred to as ``egg products plants'' or ``plants'') to develop and...2018-00425FR-Doc-2018-00425egg-products-inspection-regulationsThe Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products (herein also referred to as ``egg products plants'' or ``plants'') to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations. FSIS is proposing to eliminate those current regulatory provisions that are inconsistent with HACCP, Sanitation SOPs, and the proposed sanitation requirements. FSIS is also proposing to specify in the regulations that official plants are required to process egg products to be edible without additional preparation to achieve food safety. In addition, FSIS is proposing to: Provide for generic approval as part of the prior label approval system for egg products; make changes to labeling requirements for shell eggs consistent with those in the Food and Drug Administration's (FDA's) regulations; require special handling instructions on egg products; eliminate the requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment; incorporate egg products plants into the coverage of the ``Rules of Practice'' that the Agency follows when initiating administrative enforcement actions; and change the Agency's interpretation of the requirement for continuous inspection in agency law. FSIS is also announcing that it is seeking public comment on draft guidance designed to help small and very small plants producing egg products to meet the new regulatory requirements being proposed in this rulemaking. Should the rule become final, FSIS intends to finalize this guidance.
02/13/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentRemoving Regulatory Barriers for Vehicles With Automated Driving SystemsNHTSA is announcing a public meeting as part of the Agency's effort to seek public comments to identify any regulatory barriers in the existing Federal Motor Vehicle Safety Standards (FMVSS) to the testing, compliance certification, and compliance...2018-02895FR-Doc-2018-02895removing-regulatory-barriers-for-vehicles-with-automated-driving-systemsNHTSA is announcing a public meeting as part of the Agency's effort to seek public comments to identify any regulatory barriers in the existing Federal Motor Vehicle Safety Standards (FMVSS) to the testing, compliance certification, and compliance verification of vehicles with Automated Driving Systems (ADSs) and certain unconventional interior designs. The Agency published a Federal Register Notice of Request for Comments (RFC) titled Removing Regulatory Barriers for Vehicles with Automated Driving Systems on January 18, 2018, that included specific questions for which the Agency seeks comment (83 FR 2607, Docket No. NHTSA-2018-0009). NHTSA is holding this public meeting to present to the public a summary of the RFC and activities underway at NHTSA and across the industry regarding the identification and removal of barriers that might impede safe deployment of ADSs. This material is intended to better inform the public as they prepare comments in response to the RFC. Public comments are welcome at this meeting, but all should be oral, and any supporting presentations or materials should be submitted to the docket for consideration.
02/12/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentStandardizing Phytosanitary Treatment Regulations: Approval of Cold Treatment and Irradiation Facilities; Cold Treatment Schedules; Establishment of Fumigation and Cold Treatment Compliance AgreementsWe are amending the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, will allow us to...2018-02694FR-Doc-2018-02694standardizing-phytosanitary-treatment-regulations-approval-of-cold-treatment-and-irradiationWe are amending the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, will allow us to approve new cold treatment facilities without rulemaking and facilitate the importation of fruit requiring cold treatment while continuing to provide protection against the introduction of pests of concern into the United States. We are also amending the fruit cutting and inspection requirements in the cold treatment regulations in order to expand cutting and inspection to commodities that have been treated for a wider variety of pests of concern. This action will provide for a greater degree of phytosanitary protection. We are also adding requirements concerning the establishment of compliance agreements for U.S. entities that operate fumigation facilities. Finally, we are harmonizing language concerning State compliance with facility establishment and parameters for the movement of consignments from the port of entry or points of origin in the United States to the treatment facility in the irradiation treatment regulations with language in the cold treatment regulations. These actions will serve to codify and make enforceable existing procedures concerning compliance agreements for these facilities.
02/09/2018RuleFEDERAL HOUSING FINANCE AGENCYFederal Housing Finance AgencyFreedom of Information Act ImplementationThe Federal Housing Finance Agency (FHFA) is finalizing its interim final rule that amended its Freedom of Information Act (FOIA) regulation. The amendments to FHFA's regulation incorporate the requirements of the FOIA Improvement Act of 2016 by giving...2018-02338FR-Doc-2018-02338freedom-of-information-act-implementationThe Federal Housing Finance Agency (FHFA) is finalizing its interim final rule that amended its Freedom of Information Act (FOIA) regulation. The amendments to FHFA's regulation incorporate the requirements of the FOIA Improvement Act of 2016 by giving notice of the circumstances under which FHFA may extend the time limit for responding to a FOIA request due to unusual circumstance; notifying a requester of their right to seek dispute resolution services; affording a requester a minimum of 90 days to file an administrative appeal; and clarifying and updating the existing regulation. The interim final rule became effective on March 15, 2017. This final rule finalizes the interim final rule with minor revisions for consistency and clarification.
02/08/2018RuleDEPARTMENT OF COMMERCECommerce DepartmentFinal 2020 Census Residence Criteria and Residence SituationsThe Bureau of the Census (U.S. Census Bureau) is providing notification of the Final 2020 Census Residence Criteria and Residence Situations. In addition, this document contains a summary of comments received in response to the June 30, 2016, Federal...2018-02370FR-Doc-2018-02370final-2020-census-residence-criteria-and-residence-situationsThe Bureau of the Census (U.S. Census Bureau) is providing notification of the Final 2020 Census Residence Criteria and Residence Situations. In addition, this document contains a summary of comments received in response to the June 30, 2016, Federal Register document, as well as the Census Bureau's responses to those comments. The residence criteria are used to determine where people are counted during each decennial census. Specific residence situations are included with the criteria to illustrate how the criteria are applied.
02/06/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentCivil Penalties Inflation Adjustments; Annual AdjustmentsThis rule provides for annual adjustments to the level of civil monetary penalties contained in Bureau of Indian Affairs (Bureau) regulations to account for inflation under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015...2018-02200FR-Doc-2018-02200civil-penalties-inflation-adjustments-annual-adjustmentsThis rule provides for annual adjustments to the level of civil monetary penalties contained in Bureau of Indian Affairs (Bureau) regulations to account for inflation under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget (OMB) guidance.
02/06/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule IThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters,...2018-02319FR-Doc-2018-02319schedules-of-controlled-substances-temporary-placement-of-fentanyl-related-substances-in-schedule-iThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA) and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl-related substances.
02/06/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentSupplemental Requirements for Importation of Fresh Citrus From Colombia Into the United StatesWe are notifying the public of our decision to supplement our requirements governing the importation of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States and are requesting public comment on...2018-02382FR-Doc-2018-02382supplemental-requirements-for-importation-of-fresh-citrus-from-colombia-into-the-united-statesWe are notifying the public of our decision to supplement our requirements governing the importation of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia into the United States and are requesting public comment on these changes. We have determined that, in order to mitigate the current pest risks posed by the importation of these commodities from Colombia into the United States, it is necessary to supplement the phytosanitary requirements now in place with additional requirements. This action will help to protect the United States against plant pests while allowing the resumption of imports of fresh sweet orange, grapefruit, mandarin, clementine, and tangerine fruit from Colombia, which were suspended in 2016 due to the discovery of new plant pests in South America.
02/05/2018Proposed RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionAmendments to Fireworks Regulations; Notice of Opportunity for Oral Presentation of CommentsThe Consumer Product Safety Commission (Commission or CPSC) will be holding a meeting to provide interested parties with an opportunity to present oral comments on the notice of proposed rulemaking (NPR) the Commission issued regarding amendments to...2018-02258FR-Doc-2018-02258amendments-to-fireworks-regulations-notice-of-opportunity-for-oral-presentation-of-commentsThe Consumer Product Safety Commission (Commission or CPSC) will be holding a meeting to provide interested parties with an opportunity to present oral comments on the notice of proposed rulemaking (NPR) the Commission issued regarding amendments to the fireworks regulations. Any oral comments will be part of the rulemaking record.
02/05/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentGeneral Information, Regulations, and DefinitionsThe Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part...2018-02303FR-Doc-2018-02303general-information-regulations-and-definitions 
02/01/2018Proposed RuleLEGAL SERVICES CORPORATIONLegal Services CorporationRequests for Documents and TestimonyThe Legal Services Corporation (LSC) proposes to create a rule governing subpoenas and requests for LSC documents and testimony by non-federal litigants in cases in which LSC is not a party. Currently, LSC has no internal or external procedures in...2018-01731FR-Doc-2018-01731requests-for-documents-and-testimonyThe Legal Services Corporation (LSC) proposes to create a rule governing subpoenas and requests for LSC documents and testimony by non-federal litigants in cases in which LSC is not a party. Currently, LSC has no internal or external procedures in place to process such requests. This rule provides the public with guidance on where to send requests and establishes procedures by which those requests will be processed.
02/01/2018Proposed RuleLEGAL SERVICES CORPORATIONLegal Services CorporationState Advisory CouncilsThis proposed rulemaking would remove the Legal Services Corporation's (LSC) regulation on state advisory councils. LSC believes this action is appropriate because the state advisory councils are no longer active and their oversight functions have been...2018-01733FR-Doc-2018-01733state-advisory-councilsThis proposed rulemaking would remove the Legal Services Corporation's (LSC) regulation on state advisory councils. LSC believes this action is appropriate because the state advisory councils are no longer active and their oversight functions have been replaced adequately by other offices and processes established by Congress or LSC. Executive Orders 13563, ``Improving Regulation and Regulatory Review,'' and 13771, ``Reducing Regulation and Controlling Regulatory Costs,'' direct agencies to review their existing regulations and repeal or revise any that are obsolete or unnecessarily burdensome. Although LSC is not an agency of the Federal government subject to either executive order, LSC regularly reviews its regulations and has determined that this regulation can be eliminated.
02/01/2018Proposed RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentModernization of Swine Slaughter InspectionThe Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide public health protection at...2018-01256FR-Doc-2018-01256modernization-of-swine-slaughter-inspectionThe Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide public health protection at least equivalent to the existing inspection system. Market hog slaughter establishments that do not choose to operate under the new swine inspection system may continue to operate under their existing inspection system. The Agency is also proposing several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These proposed changes would allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus be more effective in monitoring their specific process control. These proposed changes also would ensure that before the start of slaughter operations, food-contact surfaces are sanitary and free of enteric pathogens.
02/01/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule IThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule seven fentanyl- related substances in schedule I. These seven substances are: N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide (valeryl...2018-02008FR-Doc-2018-02008schedules-of-controlled-substances-temporary-placement-of-seven-fentanyl-related-substances-inThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule seven fentanyl- related substances in schedule I. These seven substances are: N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide (valeryl fentanyl), N-(4- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide (para- fluorobutyryl fentanyl), N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4- yl)butyramide (para-methoxybutyryl fentanyl), N-(4-chlorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide (para-chloroisobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide (isobutyryl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide (cyclopentyl fentanyl), and N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide (ocfentanil). This action is based on a finding by the Administrator that the placement of these seven synthetic opioids in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, valeryl fentanyl, para-fluorobutyryl fentanyl, para-methoxybutyryl fentanyl, para-chloroisobutyryl fentanyl, isobutyryl fentanyl, cyclopentyl fentanyl, and ocfentanil.
02/01/2018RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionCPSC Acceptance of Third Party Laboratories: Revision to the Notice of Requirements for Prohibitions of Children's Toys and Child Care Articles Containing Specified PhthalatesThis final rule updates the notice of requirements (NOR) for the accreditation of third party laboratories to assess conformity with the prohibitions of children's toys and child care articles containing specified phthalates. The NOR provides the...2018-01452FR-Doc-2018-01452cpsc-acceptance-of-third-party-laboratories-revision-to-the-notice-of-requirements-for-prohibitionsThis final rule updates the notice of requirements (NOR) for the accreditation of third party laboratories to assess conformity with the prohibitions of children's toys and child care articles containing specified phthalates. The NOR provides the criteria and process for Commission acceptance of accreditation under the Consumer Product Safety Act (CPSA). This rule makes the NOR consistent with the regulated phthalates in children's toys and child care articles in the phthalates final rule published in the Federal Register on October 27, 2017.
01/31/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentMedical Care in Foreign Countries and Filing for Reimbursement for Community Care Not Previously Authorized by VAThe Department of Veterans Affairs (VA) proposes to amend its medical regulations related to hospital care and medical services in foreign countries. We would amend the regulations to simplify and clarify the scope of these rules. We would address...2018-01865FR-Doc-2018-01865medical-care-in-foreign-countries-and-filing-for-reimbursement-for-community-care-not-previouslyThe Department of Veterans Affairs (VA) proposes to amend its medical regulations related to hospital care and medical services in foreign countries. We would amend the regulations to simplify and clarify the scope of these rules. We would address medical services provided to eligible veterans in the Republic of the Philippines, and remove regulations related to grants to the Republic of the Philippines that are no longer supported by statutory authority. VA also proposes to amend its medical regulations related to filing claims for reimbursement of medical expenses incurred for VA care not previously authorized.
01/31/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsThe Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use...C1-2017-27949FR-Doc-C1-2017-27949https://www.federalregister.gov/documents/2018/01/31/C1-2017-27949/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment 
01/30/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Extension of Temporary Placement of MAB-CHMINACA in Schedule I of the Controlled Substances ActThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl-...2018-01746FR-Doc-2018-01746schedules-of-controlled-substances-extension-of-temporary-placement-of-mab-chminaca-in-schedule-i-ofThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, N-(1-amino-3,3-dimethyl- 1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of MAB-CHMINACA currently is in effect through February 4, 2018. This temporary order will extend the temporary scheduling of MAB- CHMINACA for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
01/30/2018Proposed RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Placement of MAB-CHMINACA Into Schedule IThe Drug Enforcement Administration proposes placing N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its salts, isomers, and salts of isomers whenever the...2018-01747FR-Doc-2018-01747schedules-of-controlled-substances-placement-of-mab-chminaca-into-schedule-iThe Drug Enforcement Administration proposes placing N-(1- amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- carboxamide (other names: MAB-CHMINACA; ADB-CHMINACA), including its 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. If finalized, this action would impose 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 MAB-CHMINACA.
01/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic LocationsThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida,...2018-01783FR-Doc-2018-01783medicare-medicaid-and-childrens-health-insurance-programs-announcement-of-the-extension-of-temporaryThis document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of these moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered ``newly enrolling'' when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.
01/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke PrecipitatorThe Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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...2018-01639FR-Doc-2018-01639medical-devices-general-and-plastic-surgery-devices-classification-of-the-surgical-smokeThe Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator's 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.
01/30/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac ProceduresThe Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified...2018-01638FR-Doc-2018-01638medical-devices-cardiovascular-devices-classification-of-the-temporary-catheter-for-embolicThe Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures 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 temporary catheter for embolic protection during transcatheter intracardiac procedures' 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.
01/30/2018RuleDEPARTMENT OF AGRICULTUREAgriculture DepartmentImportation of Orchids in Growing Media From TaiwanWe are amending the regulations governing the importation of plants for planting to add orchid plants of the genus Dendrobium from Taiwan to the list of plants that may be imported into the United States in an approved growing medium, subject to...2018-01737FR-Doc-2018-01737importation-of-orchids-in-growing-media-from-taiwanWe are amending the regulations governing the importation of plants for planting to add orchid plants of the genus Dendrobium from Taiwan to the list of plants that may be imported into the United States in an approved growing medium, subject to specified growing, inspection, and certification requirements. We are taking this action in response to a request from the Taiwanese Government and after determining that the plants could be imported, under certain conditions, without resulting in the introduction into, or the dissemination within, the United States of a quarantine plant pest or noxious weed.
01/29/2018Proposed RuleFEDERAL ELECTION COMMISSIONFederal Election CommissionIndependent Expenditures by Authorized Committees; Reporting Multistate Independent Expenditures and Electioneering CommunicationsThe Federal Election Commission requests comments on proposed changes to its regulations concerning independent expenditures by candidates. The Commission also requests comments on proposed changes to its regulations to address reporting of independent...2018-01074FR-Doc-2018-01074independent-expenditures-by-authorized-committees-reporting-multistate-independent-expenditures-andThe Federal Election Commission requests comments on proposed changes to its regulations concerning independent expenditures by candidates. The Commission also requests comments on proposed changes to its regulations to address reporting of independent expenditures and electioneering communications that relate to presidential primary elections and that are publicly distributed in multiple states but that do not refer to any particular state's primary election. The Commission has made no final decision on the issues and proposals presented in this rulemaking.
01/29/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentCivil Monetary Penalties Inflation AdjustmentThe Department of Justice is adjusting for inflation the civil monetary penalties assessed or enforced by components of the Department, in accordance with the provisions of the Bipartisan Budget Act of 2015, for penalties assessed after January 29,...2018-01464FR-Doc-2018-01464civil-monetary-penalties-inflation-adjustmentThe Department of Justice is adjusting for inflation the civil monetary penalties assessed or enforced by components of the Department, in accordance with the provisions of the Bipartisan Budget Act of 2015, for penalties assessed after January 29, 2018, with respect to violations occurring after November 2, 2015.
01/26/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoval of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Companion to Direct Final RuleThe Food and Drug Administration (FDA, Agency, or we) is proposing to amend the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is proposing this action to remove...2018-01467FR-Doc-2018-01467removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-productsThe Food and Drug Administration (FDA, Agency, or we) is proposing to amend the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is proposing this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
01/26/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-01463FR-Doc-2018-01463suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
01/26/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2018-01461FR-Doc-2018-01461suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
01/26/2018RuleNATIONAL INDIAN GAMING COMMISSIONNational Indian Gaming CommissionFreedom of Information Act ProceduresThis rule amends the procedures followed by the National Indian Gaming Commission when processing a request under the Freedom of Information Act, as amended. These amendments update certain Commission information, conform to changes made in the Freedom...2018-01433FR-Doc-2018-01433freedom-of-information-act-proceduresThis rule amends the procedures followed by the National Indian Gaming Commission when processing a request under the Freedom of Information Act, as amended. These amendments update certain Commission information, conform to changes made in the Freedom of Information Act Improvements Act of 2016, and streamline how the Commission processes its Freedom of Information Act requests.
01/26/2018RuleDEPARTMENT OF HOUSING AND URBAN DEVELOPMENTHousing and Urban Development DepartmentFederal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human SubjectsOn January 19, 2017, HUD and other federal departments and agencies published a final rule which revised the Federal Policy for the Protection of Human Subjects (2018 Requirements). Most of the 2018 Requirements were scheduled to become effective on...2018-01497FR-Doc-2018-01497federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-forOn January 19, 2017, HUD and other federal departments and agencies published a final rule which revised the Federal Policy for the Protection of Human Subjects (2018 Requirements). Most of the 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018. On January 22, 2018, the Federal departments and agencies that adopted the 2018 Requirements published an interim final rule (``the interagency interim final rule'') that delays the effective date and general compliance date of the 2018 Requirements for six months, to July 19, 2018. The purpose of the delay is to provide additional time to regulated entities for the preparations necessary to implement the 2018 requirements. Due to statutory prepublication requirements applicable to HUD rules, HUD was unable to be a signatory to the interagency interim final rule. Through this interim final rule, HUD adopts the interagency interim final rule.
01/26/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRemoval of Certain Time of Inspection and Duties of Inspector Regulations for Biological ProductsThe Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated...2018-01468FR-Doc-2018-01468removal-of-certain-time-of-inspection-and-duties-of-inspector-regulations-for-biological-productsThe Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
01/26/2018RuleDEPARTMENT OF LABORLabor DepartmentHonoring Investments in Recruiting and Employing American Military Veterans (HIRE Vets) Medallion Program; Agency Information Collection Activities; OMB ApprovalsThis document announces that the Office of Management and Budget (OMB) has approved the information collections associated with the Honoring Investments in Recruiting and Employing American Military Veterans (HIRE Vets) Medallion Program rule under the...2018-01262FR-Doc-2018-01262honoring-investments-in-recruiting-and-employing-american-military-veterans-hire-vets-medallionThis document announces that the Office of Management and Budget (OMB) has approved the information collections associated with the Honoring Investments in Recruiting and Employing American Military Veterans (HIRE Vets) Medallion Program rule under the Paperwork Reduction Act of 1995 (PRA).
01/26/2018RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionProhibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Revision of Determinations Regarding Certain PlasticsOn August 30, 2017, the Commission issued a final rule determining that certain plastics and additives would not contain the phthalates that the Consumer Product Safety Improvement Act of 2008 (CPSIA) prohibits from use in children's toys and child...2018-01451FR-Doc-2018-01451prohibition-of-childrens-toys-and-child-care-articles-containing-specified-phthalates-revision-ofOn August 30, 2017, the Commission issued a final rule determining that certain plastics and additives would not contain the phthalates that the Consumer Product Safety Improvement Act of 2008 (CPSIA) prohibits from use in children's toys and child care articles. Subsequently, the Commission issued a final rule that removes some phthalates from the statutory prohibition and adds others. This direct final rule revises the determinations rule to cover the phthalates that the phthalates final rule prohibits from use in children's toys and child care articles.
01/26/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentProtecting Statutory Conscience Rights in Health Care; Delegations of AuthorityIn the regulation of health care, the United States has a long history of providing conscience-based protections for individuals and entities with objections to certain activities based on religious belief and moral convictions. Multiple such statutory...2018-01226FR-Doc-2018-01226protecting-statutory-conscience-rights-in-health-care-delegations-of-authorityIn the regulation of health care, the United States has a long history of providing conscience-based protections for individuals and entities with objections to certain activities based on religious belief and moral convictions. Multiple such statutory protections apply to the Department of Health and Human Services (HHS, or the Department) and the programs or activities it funds or administers. The Department proposes to revise regulations previously promulgated to ensure that persons or entities are not subjected to certain practices or policies that violate conscience, coerce, or discriminate, in violation of such Federal laws. Through this rulemaking, the Department proposes to grant overall responsibility to its Office for Civil Rights (OCR) for ensuring that the Department, its components, HHS programs and activities, and those who participate in HHS programs or activities comply with Federal laws protecting the rights of conscience and prohibiting associated discriminatory policies and practices in such programs and activities. In addition to conducting outreach and providing technical assistance, OCR will have the authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by the Department and its components, and use enforcement tools otherwise available in civil rights law to address violations and resolve complaints. In order to ensure that recipients of Federal financial assistance and other Department funds comply with their legal obligations, the Department will require certain recipients to maintain records; cooperate with OCR's investigations, reviews, or other enforcement actions; submit written assurances and certifications of compliance to the Department; and provide notice to individuals and entities about their conscience and associated anti-discrimination rights, as applicable.
01/26/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentFederal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices, and Associated Equipment; Denial of Petition for RulemakingThis document denies a petition for rulemaking submitted by Mr. William H. Thompson III requesting NHTSA amend Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, reflective devices, and associated equipment. Specifically, Mr. Thompson...2018-01403FR-Doc-2018-01403federal-motor-vehicle-safety-standard-no-108-lamp-reflective-devices-and-associated-equipment-denialThis document denies a petition for rulemaking submitted by Mr. William H. Thompson III requesting NHTSA amend Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, reflective devices, and associated equipment. Specifically, Mr. Thompson requested we revise the activation process for red and amber signal warning lamps on school buses to require a new intermediate step during which both colors are activated simultaneously and flash in an alternating pattern and that we decouple the process by which lamps transition to the red-only configuration from the opening of the bus entrance door. NHTSA is denying this petition because Mr. Thompson has not identified a safety need to justify making changes he requested, and Mr. Thompson did not provide persuasive quantitative data to show adopting his requested changes would result in a net benefit to safety.
01/26/2018Proposed RuleDEPARTMENT OF HOUSING AND URBAN DEVELOPMENTHousing and Urban Development DepartmentRegulatory Review of Manufactured Housing RulesConsistent with Executive Order 13771 entitled ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' and as part of the efforts of HUD's Regulatory Reform Task Force,...2018-01276FR-Doc-2018-01276regulatory-review-of-manufactured-housing-rulesConsistent with Executive Order 13771 entitled ``Reducing Regulation and Controlling Regulatory Costs,'' and Executive Order 13777 entitled, ``Enforcing the Regulatory Reform Agenda,'' and as part of the efforts of HUD's Regulatory Reform Task Force, this document informs the public that HUD is reviewing its existing and planned manufactured housing regulatory actions to assess their actual and potential compliance costs and reduce regulatory burden. HUD invites public comment to assist in identifying regulations that may be outmoded, ineffective or excessively burdensome and should be modified, streamlined, replaced or repealed.
01/25/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentHazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for...2018-01299FR-Doc-2018-01299hazard-analysis-and-risk-based-preventive-controls-for-human-food-draft-guidance-for-industryThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter 15--Supply-Chain Program for Human Food Products.''
01/25/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConsiderations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding...2018-01296FR-Doc-2018-01296considerations-for-determining-whether-a-measure-provides-the-same-level-of-public-health-protectionThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.'' The draft guidance describes FDA's current thinking on the concept of ``same level of public health protection'' (SLPHP), and FDA's expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under (part 112) 21 CFR part 112 or the preventive controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 meets the SLPHP threshold under the foreign supplier verification program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.
01/25/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentForeign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.'' The draft guidance, once...2018-01297FR-Doc-2018-01297foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals-draft-guidanceThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.'' The draft guidance, once finalized, will provide our thinking on how importers of human or animal food can comply with the regulation on foreign supplier verification programs (FSVPs) issued on November 27, 2015.
01/25/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentApplication of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance...2018-01298FR-Doc-2018-01298application-of-the-foreign-supplier-verification-program-regulation-to-importers-of-grain-rawThe Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry.'' This guidance is intended to explain our intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing.
01/25/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentForeign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; AvailabilityThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA...2018-01300FR-Doc-2018-01300foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals-what-you-need-toThe Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.''
01/25/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentUniform Procedures for State Highway Safety Grant ProgramsThis final rule makes changes and clarifications to the revised uniform procedures implementing State highway safety grant programs in response to comments received on the interim final rule published May 23, 2016.2018-01266FR-Doc-2018-01266uniform-procedures-for-state-highway-safety-grant-programsThis final rule makes changes and clarifications to the revised uniform procedures implementing State highway safety grant programs in response to comments received on the interim final rule published May 23, 2016.
01/23/2018RuleLEGAL SERVICES CORPORATIONLegal Services CorporationIncome Level for Individuals Eligible for AssistanceThe Legal Services Corporation (LSC) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty...2018-01138FR-Doc-2018-01138income-level-for-individuals-eligible-for-assistanceThe Legal Services Corporation (LSC) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines issued by the U.S. Department of Health and Human Services (HHS).
01/23/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentImplementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Dispensing of Narcotic Drugs for Opioid Use DisorderThe Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a...2018-01173FR-Doc-2018-01173implementation-of-the-provision-of-the-comprehensive-addiction-and-recovery-act-of-2016-relating-toThe Comprehensive Addiction and Recovery Act (CARA) of 2016, which became law on July 22, 2016, amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services, by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The Drug Enforcement Administration (DEA) is hereby amending its regulations to incorporate these statutory and regulatory changes.
01/23/2018RuleOFFICE OF PERSONNEL MANAGEMENTPersonnel Management OfficeFederal Employees Health Benefits Program: Removal of Eligible and Ineligible Individuals From Existing EnrollmentsThe United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as...2018-01174FR-Doc-2018-01174federal-employees-health-benefits-program-removal-of-eligible-and-ineligible-individuals-fromThe United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as family members from FEHB enrollments. This process would apply to individuals for whom there is a failure to provide adequate documentation of eligibility when requested. This action also amends Federal Employees Health Benefits (FEHB) Program regulations to allow certain eligible family members to be removed from existing self and family or self plus one enrollments.
01/22/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentDevices Proposed for a New Use With an Approved, Marketed Drug; Public Hearing; Reopening of the Comment PeriodThe Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to...2018-00991FR-Doc-2018-00991devices-proposed-for-a-new-use-with-an-approved-marketed-drug-public-hearing-reopening-of-theThe Food and Drug Administration (FDA, the Agency, or we) is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. In the document, in addition to seeking comments on the potential approach, FDA also welcomed comments on public health, scientific, regulatory, or legal considerations relating to other medical products intended for new uses with approved, marketed medical products of a different type where the sponsor for the approved, marketed product does not wish to pursue or collaborate on the new use. We are reopening the comment period in response to a request for an extension to allow interested persons additional time to submit comments.
01/22/2018RuleARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARDArchitectural and Transportation Barriers Compliance BoardInformation and Communication Technology (ICT) Standards and GuidelinesThe Architectural and Transportation Barriers Compliance Board (we, Access Board, or Board) is issuing this direct final rule to amend its regulations addressing accessibility requirements for information and communication technology to correct several...2018-00848FR-Doc-2018-00848information-and-communication-technology-ict-standards-and-guidelinesThe Architectural and Transportation Barriers Compliance Board (we, Access Board, or Board) is issuing this direct final rule to amend its regulations addressing accessibility requirements for information and communication technology to correct several inadvertent drafting errors in a final rule published in the Federal Register on January 18, 2017. Specifically, this direct final rule corrects two typographical errors and the unintentional deletion of longstanding requirements for TTY compatibility and functionality that have been in place for nearly two decades. These minor amendments neither establish new substantive accessibility requirements, nor impose any costs on regulated entities. The Access Board is issuing these amendments directly as a final rule because we believe they are noncontroversial, unlikely to receive adverse comment, and will prevent confusion.
01/22/2018RuleNATIONAL INDIAN GAMING COMMISSIONNational Indian Gaming CommissionFeesThe National Indian Gaming Commission is amending its fee regulations. The rule amends the regulations that describe when the Commission adopts annual fee rates, defines the fiscal year of the gaming operation that will be used for calculating the fee...2018-00877FR-Doc-2018-00877feesThe National Indian Gaming Commission is amending its fee regulations. The rule amends the regulations that describe when the Commission adopts annual fee rates, defines the fiscal year of the gaming operation that will be used for calculating the fee payments, and includes additional revisions clarifying the fee calculation and submission process for gaming operations.
01/22/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentFederal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human SubjectsIn a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory...2018-00997FR-Doc-2018-00997federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-forIn a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the ``2018 Requirements.'' The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.
01/19/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentHours of Service of Drivers of Commercial Motor Vehicles; Proposed Regulatory Guidance Concerning the Transportation of Agricultural Commodities; Extension of Comment PeriodFMCSA extends the public comment period for the Agency's December 20, 2017, notice announcing the proposed regulatory guidance concerning the transportation of agricultural commodities. On December 22, 2017, the American Trucking Associations, Inc....2018-00847FR-Doc-2018-00847hours-of-service-of-drivers-of-commercial-motor-vehicles-proposed-regulatory-guidance-concerning-theFMCSA extends the public comment period for the Agency's December 20, 2017, notice announcing the proposed regulatory guidance concerning the transportation of agricultural commodities. On December 22, 2017, the American Trucking Associations, Inc. (ATA) requested a 30-day extension of the comment period. Additional requests for extension of the comment period have been received. The Agency extends the January 19, 2018, deadline for the submission of public comments to February 20, 2018.
01/19/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentConsent for Release of VA Medical RecordsThe Department of Veterans Affairs (VA) proposes to amend its regulations to clarify that a valid consent authorizing the Department to release the patient's confidential VA medical records to a health information exchange (HIE) community partner may...2018-00758FR-Doc-2018-00758consent-for-release-of-va-medical-recordsThe Department of Veterans Affairs (VA) proposes to amend its regulations to clarify that a valid consent authorizing the Department to release the patient's confidential VA medical records to a health information exchange (HIE) community partner may be established not only by VA's physical possession of the written consent form, but also by the HIE community partner's written (electronic) attestation that the patient has, in fact, provided such consent. This proposed rule would be a reinterpretation of an existing, long-standing regulation and is necessary to facilitate modern requirements for the sharing of patient records with community health care providers, health plans, governmental agencies, and other entities participating in electronic HIEs. This revision would ensure that more community health care providers and other HIE community partners can deliver informed medical care to patients by having access to the patient's VA medical records at the point of care.
01/19/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPublic Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.'' The draft guidance,...2018-00918FR-Doc-2018-00918public-warning-and-notification-of-recalls-under-21-cfr-part-7-subpart-c-draft-guidance-for-industryThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Draft Guidance for Industry and FDA Staff.'' The draft guidance, when finalized, establishes official guidance for industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notification of voluntary recalls under Federal regulations. The intent of the draft guidance is to increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled. The draft guidance clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.
01/19/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentHours of Service of Drivers; Electronic Logging Devices; Limited 90-Day Waiver for Old Dominion and Other Motor Carriers Experiencing Problems Integrating PeopleNet ELD System Updates Into Their Fleet Management SystemsFMCSA grants a limited 90-day waiver from the Federal hours- of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for Old Dominion Freight Lines, Inc. (Old Dominion) and other motor carriers in similar situations due to issues...2018-00842FR-Doc-2018-00842hours-of-service-of-drivers-electronic-logging-devices-limited-90-day-waiver-for-old-dominion-andFMCSA grants a limited 90-day waiver from the Federal hours- of-service (HOS) regulations pertaining to electronic logging devices (ELDs) for Old Dominion Freight Lines, Inc. (Old Dominion) and other motor carriers in similar situations due to issues concerning the integration of PeopleNet's ELD software into fleet management systems. The Agency has initiated this action in response to a waiver request from Old Dominion.
01/19/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentSecretarial Determination To Lower Head Start Center-Based Service Duration RequirementWith this document, the Secretary exercises his authority to waive the August 1, 2019 Head Start center-based service duration requirements, effectively lowering this requirement from 50 percent to 0 percent. However, the requirement that Early Head...2018-00897FR-Doc-2018-00897secretarial-determination-to-lower-head-start-center-based-service-duration-requirementWith this document, the Secretary exercises his authority to waive the August 1, 2019 Head Start center-based service duration requirements, effectively lowering this requirement from 50 percent to 0 percent. However, the requirement that Early Head Start programs provide 1,380 annual hours of planned class operations for all center- based enrollment by August 1, 2018 remains in effect.
01/19/2018RuleNATIONAL INDIAN GAMING COMMISSIONNational Indian Gaming CommissionMinimum Technical Standards for Class II Gaming Systems and Equipment; CorrectionOn December 27, 2017, the National Indian Gaming Commission published a rule amending its minimum technical standards for Class II gaming systems and equipment. This document corrects the preamble regarding the OMB Control Number and OMB Control Number...2018-00936FR-Doc-2018-00936minimum-technical-standards-for-class-ii-gaming-systems-and-equipment-correctionOn December 27, 2017, the National Indian Gaming Commission published a rule amending its minimum technical standards for Class II gaming systems and equipment. This document corrects the preamble regarding the OMB Control Number and OMB Control Number expiration date.
01/18/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentRemoving Regulatory Barriers for Vehicles With Automated Driving SystemsNHTSA seeks public comments to identify any regulatory barriers in the existing Federal Motor Vehicle Safety Standards (FMVSS) to the testing, compliance certification and compliance verification of motor vehicles with Automated Driving Systems (ADSs)...2018-00671FR-Doc-2018-00671removing-regulatory-barriers-for-vehicles-with-automated-driving-systemsNHTSA seeks public comments to identify any regulatory barriers in the existing Federal Motor Vehicle Safety Standards (FMVSS) to the testing, compliance certification and compliance verification of motor vehicles with Automated Driving Systems (ADSs) and certain unconventional interior designs. NHTSA is focusing primarily, but not exclusively, on vehicles with ADSs that lack controls for a human driver; e.g., steering wheel, brake pedal or accelerator pedal. The absence of manual driving controls, and thus of a human driver, poses potential barriers to testing, compliance certification and compliance verification. For example, many of the FMVSS refer to the ``driver'' or ``driver's seating position'' in specifying where various vehicle features and systems need to be located so that they can be seen and/or used by a person sitting in that position. Further, the compliance test procedures of some FMVSS depend on the presence of such things as a human test driver who can follow instructions on test driving maneuvers or a steering wheel that can be used by an automated steering machine. NHTSA also seeks comments on the research that would be needed to determine how to amend the FMVSS in order to remove such barriers, while retaining those existing safety requirements that will be needed and appropriate for those vehicles. In all cases, the Agency's goal would be to ensure the maintenance of currently required levels of safety performance. These comments will aid the Agency in setting research priorities as well as inform its subsequent actions to lay a path for innovative vehicle designs and technologies that feature ADSs.
01/18/2018RuleEQUAL EMPLOYMENT OPPORTUNITY COMMISSIONEqual Employment Opportunity CommissionThe 2018 Adjustment of the Penalty for Violation of Notice Posting RequirementsIn accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990, this final rule adjusts for inflation the civil monetary penalty for...2018-00815FR-Doc-2018-00815the-2018-adjustment-of-the-penalty-for-violation-of-notice-posting-requirementsIn accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990, this final rule adjusts for inflation the civil monetary penalty for violation of the notice-posting requirements in Title VII of the Civil Rights act of 1964, the Americans with Disabilities Act, and the Genetic Information Non-Discrimination Act.
01/17/2018Proposed RuleCONSUMER PRODUCT SAFETY COMMISSIONConsumer Product Safety CommissionClothing Storage Unit Tip Overs; Extension of Comment PeriodThe Consumer Product Safety Commission (Commission or CPSC) published an advance notice of proposed rulemaking (ANPR) regarding clothing storage unit (CSU) tip overs in the Federal Register on November 30, 2017. The ANPR invited the public to submit...2018-00552FR-Doc-2018-00552clothing-storage-unit-tip-overs-extension-of-comment-periodThe Consumer Product Safety Commission (Commission or CPSC) published an advance notice of proposed rulemaking (ANPR) regarding clothing storage unit (CSU) tip overs in the Federal Register on November 30, 2017. The ANPR invited the public to submit written comments during a 60-day comment period, beginning on the ANPR publication date. In response to a request for an extension of the comment period, the Commission is extending the comment period by 75 days.
01/17/2018RuleOFFICE OF GOVERNMENT ETHICSGovernment Ethics OfficeCivil Monetary Penalties Inflation Adjustments for Ethics in Government Act ViolationsIn accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, the U.S. Office of Government Ethics (OGE) is issuing this final rule to make the 2018 annual adjustments to the Ethics in Government Act civil monetary...2018-00688FR-Doc-2018-00688civil-monetary-penalties-inflation-adjustments-for-ethics-in-government-act-violationsIn accordance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, the U.S. Office of Government Ethics (OGE) is issuing this final rule to make the 2018 annual adjustments to the Ethics in Government Act civil monetary penalties.
01/17/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentCivilian Health and Medical Program of the Department of Veterans AffairsThe Department of Veterans Affairs (VA) proposes to amend its regulations governing the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA). The proposed revisions would clarify and update these regulations to conform to...2018-00332FR-Doc-2018-00332civilian-health-and-medical-program-of-the-department-of-veterans-affairsThe Department of Veterans Affairs (VA) proposes to amend its regulations governing the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA). The proposed revisions would clarify and update these regulations to conform to changes in law and policy that control the administration of CHAMPVA and would include details concerning the administration of CHAMPVA that are not reflected in current regulations. The proposed revisions would also expand covered services and supplies to include certain preventive services and eliminate cost-share amounts and deductibles for certain covered services.
01/17/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentFood Labeling: Health Claims; Soy Protein and Coronary Heart Disease; Extension of Comment PeriodThe Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of October 31, 2017. We are taking this action in response to requests for an extension to allow interested persons...2018-00683FR-Doc-2018-00683food-labeling-health-claims-soy-protein-and-coronary-heart-disease-extension-of-comment-periodThe Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of October 31, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
01/17/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentInternal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological HealthThe Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food,...2018-00646FR-Doc-2018-00646internal-agency-review-of-decisions-requests-for-supervisory-review-of-certain-decisions-made-by-theThe Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.
01/16/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentClarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding \u201cIntended Uses\u201d; Proposed Partial Delay of Effective DateThe Food and Drug Administration (FDA, the Agency, or we) is proposing to delay the effective date of certain portions of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until...2018-00555FR-Doc-2018-00555clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-orThe Food and Drug Administration (FDA, the Agency, or we) is proposing to delay the effective date of certain portions of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. In the Federal Register of March 20, 2017, we further delayed the effective date of the final rule until March 19, 2018, and invited public comment on the rule. This action, if finalized, will delay until further notice the effective date of the portions of the final rule amending FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses. FDA received a number of comments on the final rule that raise questions about the amendments to the existing medical product ``intended use'' regulations. FDA is proposing to delay the effective date of the amendments to the existing medical product ``intended use'' regulations to allow further consideration of the substantive issues raised in the comments received. This action, if finalized, will not further delay the effective date of the new regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
01/16/2018RuleCORPORATION FOR NATIONAL AND COMMUNITY SERVICECorporation for National and Community ServiceAnnual Civil Monetary Penalties Inflation AdjustmentThe Corporation for National and Community Service (CNCS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation...2018-00558FR-Doc-2018-00558annual-civil-monetary-penalties-inflation-adjustmentThe Corporation for National and Community Service (CNCS) is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
01/16/2018RuleNATIONAL FOUNDATION FOR THE ARTS AND HUMANITIESNational Foundation on the Arts and the HumanitiesCivil Penalties Adjustment for 2018The National Endowment for the Arts (NEA) is adjusting the maximum civil monetary penalties (CMPs) that may be imposed for violations of the Program Fraud Civil Remedies Act (PFCRA) and the NEA's Restrictions on Lobbying to reflect the requirements of...2018-00537FR-Doc-2018-00537civil-penalties-adjustment-for-2018The National Endowment for the Arts (NEA) is adjusting the maximum civil monetary penalties (CMPs) that may be imposed for violations of the Program Fraud Civil Remedies Act (PFCRA) and the NEA's Restrictions on Lobbying to reflect the requirements of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act). The 2015 Act further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. This final rule provides the 2018 annual inflation adjustments to the initial ``catch-up'' adjustments made on June 15, 2017.
01/16/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentRights of Way; Removal of Outdated ReferenceThis rule removes an outdated reference to a document establishing environmental criteria for electric transmissions lines that is no longer used by the National Park Service to evaluate applications for right-of-way permits.2018-00516FR-Doc-2018-00516rights-of-way-removal-of-outdated-referenceThis rule removes an outdated reference to a document establishing environmental criteria for electric transmissions lines that is no longer used by the National Park Service to evaluate applications for right-of-way permits.
01/16/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentGeneral Regulations; Areas of the National Park System, Free Distribution of Other Message-Bearing ItemsThe National Park Service revises its general rule governing the sale or distribution of printed matter to include the free distribution of message-bearing items that do not meet the regulatory definition of ``printed matter.'' This change gives...2018-00515FR-Doc-2018-00515general-regulations-areas-of-the-national-park-system-free-distribution-of-other-message-bearingThe National Park Service revises its general rule governing the sale or distribution of printed matter to include the free distribution of message-bearing items that do not meet the regulatory definition of ``printed matter.'' This change gives visitors an additional channel of communication while protecting the resources and values of the National Park System.
01/16/2018RuleDEPARTMENT OF EDUCATIONEducation DepartmentAdjustment of Civil Monetary Penalties for InflationThe Department of Education (Department) issues these final regulations to adjust the Department's civil monetary penalties (CMPs) for inflation. An initial ``catch-up'' adjustment was required by the Federal Civil Penalties Inflation Adjustment Act...2018-00614FR-Doc-2018-00614adjustment-of-civil-monetary-penalties-for-inflationThe Department of Education (Department) issues these final regulations to adjust the Department's civil monetary penalties (CMPs) for inflation. An initial ``catch-up'' adjustment was required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Inflation Adjustment Act). These final regulations provide the 2018 annual inflation adjustments being made to the penalty amounts in the Department's final regulations published in the Federal Register on April 20, 2017 (2017 final rule).
01/16/2018RuleDEPARTMENT OF THE INTERIORInterior DepartmentAnnual Adjustment of Civil Monetary Penalty To Reflect InflationIn compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the Act) and Office of Management and Budget (OMB) guidance, the National Indian Gaming Commission (NIGC or Commission) is amending its civil monetary...2018-00505FR-Doc-2018-00505annual-adjustment-of-civil-monetary-penalty-to-reflect-inflationIn compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the Act) and Office of Management and Budget (OMB) guidance, the National Indian Gaming Commission (NIGC or Commission) is amending its civil monetary penalty rule to reflect an annual adjustment for inflation in order to improve the penalty's effectiveness and maintain its deterrent effect. The Act provides that the new penalty level must apply to penalties assessed after the effective date of the increase, including when the penalties whose associated violation predate the increase.
01/16/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentUnique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; AvailabilityThe Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance for industry and FDA Staff entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in...2018-00550FR-Doc-2018-00550unique-device-identification-policy-regarding-compliance-dates-for-class-i-and-unclassified-devicesThe Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance for industry and FDA Staff entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for certain class I and unclassified devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022. The policy described in this guidance does not apply to implantable, life-supporting, or life-sustaining devices. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
01/12/2018RuleDEPARTMENT OF EDUCATIONEducation DepartmentNational Institute on Disability and Rehabilitation Research (NIDRR) and Independent Living Programs, Outdated, Superseded RegulationsThe Secretary removes outdated, superseded regulations for five programs no longer administered by the Department: The Disability and Rehabilitation Research Projects and Centers Program, the Research Fellowships program, the Special Projects and...2018-00475FR-Doc-2018-00475national-institute-on-disability-and-rehabilitation-research-nidrr-and-independent-living-programsThe Secretary removes outdated, superseded regulations for five programs no longer administered by the Department: The Disability and Rehabilitation Research Projects and Centers Program, the Research Fellowships program, the Special Projects and Demonstrations for Spinal Cord Injuries program, the State Independent Living Services program, and the Centers for Independent Living program. In 2014, the Workforce Innovation and Opportunity Act transferred these programs to the Department of Health and Human Services, which has adopted regulations for them.
01/12/2018RuleBUREAU OF CONSUMER FINANCIAL PROTECTIONConsumer Financial Protection BureauCivil Penalty Inflation AdjustmentsThe Bureau of Consumer Financial Protection (Bureau) is adjusting for inflation the maximum amount of each civil penalty within the Bureau's jurisdiction. These adjustments are required by the Federal Civil Penalties Inflation Adjustment Act of 1990,...2018-00399FR-Doc-2018-00399civil-penalty-inflation-adjustmentsThe Bureau of Consumer Financial Protection (Bureau) is adjusting for inflation the maximum amount of each civil penalty within the Bureau's jurisdiction. These adjustments are required by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act). The inflation adjustments mandated by the Inflation Adjustment Act serve to maintain the deterrent effect of civil penalties and to promote compliance with the law.
01/11/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentRevise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V005-Parts 812, 813)The Department of Veterans Affairs (VA) is proposing to amend and update its VA Acquisition Regulation (VAAR) in phased increments to revise or remove any policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove procedural...2018-00169FR-Doc-2018-00169revise-and-streamline-va-acquisition-regulation-to-adhere-to-federal-acquisition-regulationThe Department of Veterans Affairs (VA) is proposing to amend and update its VA Acquisition Regulation (VAAR) in phased increments to revise or remove any policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove procedural guidance internal to VA into the VAAM, and to incorporate any new agency specific regulations or policies. These changes seek to streamline and align the VAAR with the FAR and remove outdated and duplicative requirements and reduce burden on contractors. The VAAM incorporates portions of the removed VAAR as well as other internal agency acquisition policy. VA will rewrite certain parts of the VAAR and VAAM, and as VAAR parts are rewritten, will publish them in the Federal Register. To minimize the number of rules published, VA will combine related topics.
01/10/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentHours of Service of Drivers: Application for Exemption; STC, Inc.FMCSA announces that the STC, Inc (STC) has requested an exemption from the requirement that motor carriers and their drivers of commercial motor vehicles (CMVs) use an electronic logging device (ELD) to record driver hours-of-service (HOS). STC is a...2018-00248FR-Doc-2018-00248hours-of-service-of-drivers-application-for-exemption-stc-incFMCSA announces that the STC, Inc (STC) has requested an exemption from the requirement that motor carriers and their drivers of commercial motor vehicles (CMVs) use an electronic logging device (ELD) to record driver hours-of-service (HOS). STC is a motor carrier that uses up to 75 CMVs to transport propane fuel and anhydrous ammonia. It states that because STC's CMV operations are seasonal and dependent on the weather, the ELD requirement creates an undue financial burden on its business. STC states that its operations under the exemption would achieve a level of safety equivalent to, or greater than, the level that would be achieved absent the proposed exemption. FMCSA requests public comment on STC's application for exemption.
01/10/2018Proposed RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentHours of Service of Drivers: Application for Exemption; Towing and Recovery Association of America, Inc. (TRAA)FMCSA announces that the Towing and Recovery Association of America, Inc. (TRAA) has requested an exemption from the requirement that a motor carrier install and require each of its drivers to use an electronic logging device (ELD) to record the...2018-00247FR-Doc-2018-00247hours-of-service-of-drivers-application-for-exemption-towing-and-recovery-association-of-america-incFMCSA announces that the Towing and Recovery Association of America, Inc. (TRAA) has requested an exemption from the requirement that a motor carrier install and require each of its drivers to use an electronic logging device (ELD) to record the driver's hours-of-service (HOS) TRAA has requested a 5-year exemption for all operators of commercial motor vehicles (CMVs) owned or leased to providers of motor vehicle towing, recovery and roadside repair services while providing such services. TRAA states that towing industry operations represent a unique and vital segment of the overall transportation industry in America that warrants exemption from the ELD regulations, and the failure to grant this exemption will cause confusion and create an overly complex regulatory framework which will pose an undue burden on towers and their customers without any measurable benefit to public safety. TRAA believes that granting this exemption will have a positive impact on highway safety by assuring that towing operators can still respond to service requests in the most expeditious and effective manner possible. FMCSA requests public comment on TRAA's application for exemption.
01/10/2018Proposed RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentVA Veteran-Owned Small Business (VOSB) Verification GuidelinesThe Department of Veterans Affairs (VA) is proposing to amend its regulations governing VA's Veteran-Owned Small Business (VOSB) Verification Program. The National Defense Authorization Act for Fiscal Year 2017 (``the NDAA''), Public Law 114-840,...2017-27715FR-Doc-2017-27715va-veteran-owned-small-business-vosb-verification-guidelinesThe Department of Veterans Affairs (VA) is proposing to amend its regulations governing VA's Veteran-Owned Small Business (VOSB) Verification Program. The National Defense Authorization Act for Fiscal Year 2017 (``the NDAA''), Public Law 114-840, placed the responsibility for issuing regulations relating to ownership and control for the verification of VOSBs with the United States Small Business Administration (SBA). This proposed regulation seeks to remove all references to ownership and control and to add and clarify certain terms and references that are currently part of the verification process. The NDAA also provides that in certain circumstances a firm can qualify as VOSB or Service-Disabled Veteran Owned Small Business (SDVOSB) when there is a surviving spouse or an employee stock ownership plan (ESOP).
01/09/2018Proposed RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentRequest for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been...2017-27887FR-Doc-2017-27887request-for-information-revisions-to-personnel-regulations-proficiency-testing-referralThis request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments of 1988 (CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its PT samples to another laboratory and has reported the other laboratory's result as their own. This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions. We intend to consider public comments (including information such as evidence, research, and trends) received in response to this request for information when we draft proposals, in consultation, as appropriate, with the Centers for Disease Control and Prevention (CDC), to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.
01/09/2018RuleDEPARTMENT OF VETERANS AFFAIRSVeterans Affairs DepartmentReimbursement for Emergency TreatmentThe Department of Veterans Affairs (VA) revises its regulations concerning payment or reimbursement for emergency treatment for non-service-connected conditions at non-VA facilities to implement the requirements of a recent court decision....2018-00232FR-Doc-2018-00232reimbursement-for-emergency-treatmentThe Department of Veterans Affairs (VA) revises its regulations concerning payment or reimbursement for emergency treatment for non-service-connected conditions at non-VA facilities to implement the requirements of a recent court decision. Specifically, this rulemaking expands eligibility for payment or reimbursement to include veterans who receive partial payment from a health-plan contract for non-VA emergency treatment and establishes a corresponding reimbursement methodology. This rulemaking also expands the eligibility criteria for veterans to receive payment or reimbursement for emergency transportation associated with the emergency treatment, in order to ensure that veterans are adequately covered when emergency transportation is a necessary part of their non-VA emergency treatment.
01/08/2018RuleSocial Security AdministrationSocial Security AdministrationExtension of Sunset Date for Attorney Advisor ProgramWe are extending for six months our rule authorizing attorney advisors to conduct certain prehearing proceedings and to issue fully favorable decisions. The current rule is scheduled to expire on February 5, 2018. In this final rule, we are extending...2018-00058FR-Doc-2018-00058extension-of-sunset-date-for-attorney-advisor-programWe are extending for six months our rule authorizing attorney advisors to conduct certain prehearing proceedings and to issue fully favorable decisions. The current rule is scheduled to expire on February 5, 2018. In this final rule, we are extending the sunset date to August 3, 2018. We are making no other substantive changes.
01/05/2018Proposed RuleDEPARTMENT OF LABORLabor DepartmentDefinition of \u201cEmployer\u201d Under Section 3(5) of ERISA-Association Health PlansThis document contains a proposed regulation under Title I of the Employee Retirement Income Security Act (ERISA) that would broaden the criteria under ERISA section 3(5) for determining when employers may join together in an employer group or...2017-28103FR-Doc-2017-28103definition-of-employer-under-section-35-of-erisa-association-health-plansThis document contains a proposed regulation under Title I of the Employee Retirement Income Security Act (ERISA) that would broaden the criteria under ERISA section 3(5) for determining when employers may join together in an employer group or association that is treated as the ``employer'' sponsor of a single multiple-employer ``employee welfare benefit plan'' and ``group health plan'' as those terms are defined in Title I of ERISA. By treating the association itself as the employer sponsor of a single plan, the regulation would facilitate the adoption and administration of such arrangements. The regulation would modify the definition of ``employer,'' in part, by creating a more flexible ``commonality of interest'' test for the employer members than the Department of Labor (DOL or Department) had adopted in sub- regulatory interpretive rulings under ERISA section 3(5). At the same time, the regulation would continue to distinguish employment-based plans, the focal point of Title I of ERISA, from mere commercial insurance programs and administrative service arrangements marketed to employers. For purposes of Title I of ERISA, the proposal would also permit working owners of an incorporated or unincorporated trade or business, including partners in a partnership, to elect to act as employers for purposes of participating in an employer group or association sponsoring a health plan and also to be treated as employees with respect to a trade, business or partnership for purposes of being covered by the employer group's or association's health plan. The goal of the rulemaking is to expand access to affordable health coverage, especially among small employers and self-employed individuals, by removing undue restrictions on the establishment and maintenance of association health plans under ERISA. The proposed regulation would affect such association health plans, health coverage under these health plans, groups and associations of employers sponsoring such plans, participants and beneficiaries with health coverage under these plans, health insurance issuers, and purchasers of health insurance not purchased through association health plans.
01/05/2018RuleDEPARTMENT OF TRANSPORTATIONTransportation DepartmentFees for the Unified Carrier Registration Plan and AgreementThis rule establishes reductions in the annual registration fees collected from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies for the Unified Carrier Registration (UCR) Plan and Agreement for the...2017-28509FR-Doc-2017-28509fees-for-the-unified-carrier-registration-plan-and-agreementThis rule establishes reductions in the annual registration fees collected from motor carriers, motor private carriers of property, brokers, freight forwarders, and leasing companies for the Unified Carrier Registration (UCR) Plan and Agreement for the registration years 2018, 2019 and subsequent years. For the 2018 registration year, the fees will be reduced below the current level by approximately 9.10% to ensure that fee revenues do not exceed the statutory maximum, and to account for the excess funds held in the depository. For the 2019 registration year and subsequent years, the fees will be reduced below the current level by approximately 4.55% to ensure the fee revenues in that and future years do not exceed the statutory maximum.
01/05/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Radiology Devices; Classification of the Absorbable Perirectal SpacerThe Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer 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...2018-00051FR-Doc-2018-00051medical-devices-radiology-devices-classification-of-the-absorbable-perirectal-spacerThe Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer 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 absorbable perirectal spacer's 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.
01/05/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentPolicy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; AvailabilityThe Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or...2018-00050FR-Doc-2018-00050policy-regarding-certain-entities-subject-to-the-current-good-manufacturing-practice-and-preventiveThe Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs.'' This guidance states agency compliance policy regarding certain entities and/or activities related to the ``farm'' definition, written assurances, food contact substances, and human food by-products for use as animal food.
01/04/2018RuleDEPARTMENT OF JUSTICEJustice DepartmentSchedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule IThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers,...2017-28470FR-Doc-2017-28470schedules-of-controlled-substances-temporary-placement-of-cyclopropyl-fentanyl-in-schedule-iThe Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide (cyclopropyl fentanyl), and its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers in schedule I. This action is based on a finding by the Administrator that the placement of cyclopropyl fentanyl in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, cyclopropyl fentanyl.
01/04/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentRevisions to the Public Assistance Program and Policy GuideThis document provides notice of the availability of the final policy Public Assistance Program and Policy Guide (PAPPG).2018-00044FR-Doc-2018-00044revisions-to-the-public-assistance-program-and-policy-guideThis document provides notice of the availability of the final policy Public Assistance Program and Policy Guide (PAPPG).
01/03/2018RuleDEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentSuspension of Community EligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the...2017-28429FR-Doc-2017-28429suspension-of-community-eligibilityThis rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-status-book.
01/03/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentConfidentiality of Substance Use Disorder Patient RecordsThis final rule makes changes to the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes are intended to better align the regulations...2017-28400FR-Doc-2017-28400confidentiality-of-substance-use-disorder-patient-recordsThis final rule makes changes to the Substance Abuse and Mental Health Services Administration's (SAMHSA) regulations governing the Confidentiality of Substance Use Disorder Patient Records. These changes are intended to better align the regulations with advances in the U.S. health care delivery system while retaining important privacy protections for individuals seeking treatment for substance use disorders. This final rule addresses the prohibition on re-disclosure notice by including an option for an abbreviated notice. This final rule also addresses the circumstances under which lawful holders and their legal representatives, contractors, and subcontractors may use and disclose patient identifying information for purposes of payment, health care operations, and audits and evaluations. Finally, this final rule is making minor technical corrections to ensure accuracy and clarity in SAMHSA's regulations.
01/03/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test SystemThe Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of...2017-28342FR-Doc-2017-28342medical-devices-hematology-and-pathology-devices-classification-of-a-cervical-intraepithelialThe Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system 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 CIN test system's 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.
01/02/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor DeviceThe Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device 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...2017-28255FR-Doc-2017-28255medical-devices-general-and-plastic-surgery-devices-classification-of-the-irrigating-wound-retractorThe Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device 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 irrigating wound retractor device's 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.
01/02/2018RuleDEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentMedical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging SystemThe Food and Drug Administration (FDA or we) is classifying the whole slide imaging system 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...2017-28262FR-Doc-2017-28262medical-devices-hematology-and-pathology-devices-classification-of-the-whole-slide-imaging-systemThe Food and Drug Administration (FDA or we) is classifying the whole slide imaging system 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 whole slide imaging system's 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.
01/02/2018RuleDEPARTMENT OF LABORLabor DepartmentDepartment of Labor Federal Civil Penalties Inflation Adjustment Act Annual Adjustments for 2018The U.S. Department of Labor (Department) is publishing this final rule to adjust for inflation the civil monetary penalties assessed or enforced in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by...2017-28224FR-Doc-2017-28224department-of-labor-federal-civil-penalties-inflation-adjustment-act-annual-adjustments-for-2018The U.S. Department of Labor (Department) is publishing this final rule to adjust for inflation the civil monetary penalties assessed or enforced in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Inflation Adjustment Act). The Inflation Adjustment Act requires the Department to annually adjust its civil money penalty levels for inflation no later than January 15 of each year. The Inflation Adjustment Act provides that agencies shall adjust civil monetary penalties notwithstanding Section 553 of the Administrative Procedure Act (APA). Additionally, the Inflation Adjustment Act provides a cost- of-living formula for adjustment of the civil penalties. Accordingly, this final rule sets forth the Department's 2018 annual adjustments for inflation to its civil monetary penalties.