November 17, 2017 – Federal Register Recent Federal Regulation Documents

Results 101 - 124 of 124
Submission for OMB Review; Comment Request
Document Number: 2017-24901
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Administration for Children and Families
CSX Transportation, Inc.-Discontinuance of Service Exemption-in Dickenson County, VA
Document Number: 2017-24900
Type: Notice
Date: 2017-11-17
Agency: Surface Transportation Board, Department of Transportation
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2017-24899
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-24898
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-24897
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-24896
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-24895
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services
Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program; Withdrawal
Document Number: 2017-24894
Type: Rule
Date: 2017-11-17
Agency: Environmental Protection Agency
Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Kansas Air Quality State Implementation Plans; Construction Permits and Approvals Program, published in the Federal Register on September 21, 2017. Kansas's SIP revisions included revisions to Kansas' construction permit rules. Specifically, these revisions implemented the revised National Ambient Air Quality Standard (NAAQS) for fine particulate matter; clarified and refined applicable criteria for sources subject to the construction permitting program; updated the construction permitting program fee structure and schedule; and made minor revisions and corrections.
Air Quality Implementation Plans; Nebraska; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards; Withdrawal
Document Number: 2017-24893
Type: Rule
Date: 2017-11-17
Agency: Environmental Protection Agency
Due to adverse comments, the Environmental Protection Agency (EPA) is withdrawing the direct final rule Approval of Nebraska Air Quality Implementation Plans; Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide and Sulfur Dioxide and the 2012 Fine Particulate Matter National Ambient Air Quality Standards, published in the Federal Register on September 20, 2017. The direct final rule approved elements of a State Implementation Plan (SIP) submission from the State of Nebraska addressing the applicable requirements of Clean Air Act (CAA) section 110 for the 2010 Nitrogen Dioxide (NO2) and Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS), and the 2012 Fine Particulate Matter (PM2.5) NAAQS. Section 110 of the CAA requires that each state adopt and submit a SIP to support implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs.
State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) Withdrawal
Document Number: 2017-24891
Type: Rule
Date: 2017-11-17
Agency: Environmental Protection Agency
Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for Approval of Implementation Plans; State of Iowa; Elements of the Infrastructure SIP Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standard (NAAQS) published in the Federal Register on September 20, 2017. Infrastructure SIPs address the applicable requirements of Clean Air Act (CAA) section 110, which requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each new or revised NAAQS promulgated by the EPA. These SIPs are commonly referred to as ``infrastructure'' SIPs. The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Direct Final Rule for the Approval of an Alternative Volatile Organic Compound Emission Standard; Withdrawal
Document Number: 2017-24889
Type: Rule
Date: 2017-11-17
Agency: Environmental Protection Agency
Due to adverse comments received, the Environmental Protection Agency (EPA) is withdrawing the August 28, 2017 direct final rule that approved a revision to the Maryland state implementation plan (SIP) to incorporate by reference a Maryland Department of the Environment (MDE) order that establishes an alternative volatile organic compound (VOC) emission standard for National Gypsum Company (NGC) to ensure that it remains a minor VOC source. EPA stated in the direct final rule that if EPA received adverse comments by September 27, 2017, the rule would be withdrawn and not take effect. EPA subsequently received one adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on August 28, 2017. EPA will not institute a second comment period on this action.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2011 Base Year Inventory for the 2008 8-Hour Ozone National Ambient Air Quality Standard for the Maryland Portion of the Philadelphia-Wilmington-Atlantic City Nonattainment Area; Withdrawal
Document Number: 2017-24885
Type: Rule
Date: 2017-11-17
Agency: Environmental Protection Agency
Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 25, 2017 direct final rule that approved the 2011 base year inventory for the Maryland portion of the Philadelphia-Wilmington-Atlantic City marginal nonattainment area for the 2008 8-hour ozone national ambient air quality standard (NAAQS). EPA stated in the direct final rule that if EPA received adverse comments by October 25, 2017, the rule would be withdrawn and not take effect. EPA subsequently received an adverse comment. EPA will address the comment received in a subsequent final action based upon the proposed action also published on September 25, 2017. EPA will not institute a second comment period on this action.
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2017-24876
Type: Notice
Date: 2017-11-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will be held virtually by webcast.
Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability
Document Number: 2017-24839
Type: Rule
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception.'' The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-24838
Type: Rule
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff.'' The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability
Document Number: 2017-24837
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.'' The draft guidance, when finalized, will provide stakeholders engaged in the development of regenerative medicine therapies with FDA's current thinking on the expedited development and review of these products. The draft guidance describes the expedited programs available to sponsors of regenerative medicine therapies for serious or life-threatening diseases or conditions (referred to in the draft guidance as serious conditions), including those products designated as regenerative advanced therapies (which FDA refers to as ``regenerative medicine advanced therapy'' (RMAT) designation); describes how the Center for Biologics Evaluation and Research (CBER) will work with sponsors and encourage flexibility in clinical trial design to facilitate the development of data to demonstrate the safety and effectiveness of regenerative medicine therapies being developed to address unmet medical needs in patients with serious or life- threatening diseases or conditions; and describes the opportunities for sponsors of regenerative medicine therapies to interact with CBER review staff.
Evaluation of Devices Used With Regenerative Medicine Advanced Therapies; Draft Guidance for Industry; Availability
Document Number: 2017-24836
Type: Notice
Date: 2017-11-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Evaluation of Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidance for Industry.'' The draft guidance document, when finalized, will provide device manufacturers, applicants, and sponsors engaged in the development of regenerative medicine therapies, with our current thinking regarding evaluation of devices used in the recovery, isolation or delivery of regenerative advanced therapies, which FDA generally refers to as ``regenerative medicine advanced therapies'' or ``RMATs.'' Specifically, as required by the 21st Century Cures Act (Cures Act), the draft guidance addresses how FDA intends to simplify and streamline its application of regulatory requirements for combination device and cell or tissue products; what, if any, intended uses or specific attributes would result in a device used with a regenerative therapy product to be classified as a class III device; when a device may be limited to a specific intended use with only one particular type of cell; and application of the least burdensome approach to demonstrate how a device may be used with more than one cell type.
Notice of Availability of the Draft Ray Land Exchange/Plan Amendment Supplemental Environmental Impact Statement, Arizona
Document Number: 2017-24823
Type: Notice
Date: 2017-11-17
Agency: Department of the Interior, Bureau of Land Management
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM), Gila District, Tucson Field Office has prepared a Draft Supplemental Environmental Impact Statement (EIS) for the Ray Land Exchange/Plan Amendment and by this Notice is announcing its availability and the opening of the comment period.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2017-24814
Type: Proposed Rule
Date: 2017-11-17
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by several incidents of electrical shorting and sparks caused by de-icing fluid leaks between flight deck windshields and side windows. This proposed AD would require water spray tests and general visual inspections for water in the flight compartment, and water removal and sealant application if necessary. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2017-24809
Type: Proposed Rule
Date: 2017-11-17
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This proposed AD was prompted by reports of failures of the lip heater assemblies of the inlet ice protection system of the cabin air compressor (CAC) due to chafing. This proposed AD would require changing the airplane electrical connectors and the routes of certain wire bundles, and installing new or modified left and right CAC inlet duct assemblies. We are proposing this AD to address the unsafe condition on these products.
Texas Regulatory Program
Document Number: 2017-24620
Type: Rule
Date: 2017-11-17
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Texas regulatory program (Texas program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Texas proposed revisions to its regulations regarding annual permit fees. Texas revised its program at its own initiative to raise revenues sufficient to cover its anticipated share of costs to administer the coal regulatory program and to encourage mining companies to more quickly reclaim lands and request bond release, thereby fulfilling SMCRA's purpose of assuring the reclamation of mined land as quickly as possible.
Notice of Meeting: Summit on Trade-Related Standards Issues
Document Number: 2017-24605
Type: Notice
Date: 2017-11-17
Agency: Department of Commerce, International Trade Administration
The Department of Commerce International Trade Administration (ITA) is seeking input from U.S. stakeholders (companies, private sector organizations and trade associations active in trade-related standards work) on standards, conformity assessment and regulatory trends and challenges in foreign markets and the assistance they require from ITA to effectively address standards-related trade barriers and trends to take advantage of export opportunities. ITA will use this input in reviewing how to improve services and programs to best meet the needs of U.S. stakeholders in the standards area. In addition, ITA will convene an internal summit on how to improve such services and programs on March 6-7, 2018 in Washington, DC, and is soliciting private sector requests for limited opportunities to participate in portions of the summit.
Congressional Nullification of the Stream Protection Rule Under the Congressional Review Act
Document Number: 2017-24307
Type: Rule
Date: 2017-11-17
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
By operation of the Congressional Review Act, the Stream Protection Rule shall be treated as if it had never taken effect. The Office of Surface Mining Reclamation and Enforcement issues this document to effect the removal of any amendments, deletions or other modifications made by the nullified rule, and the reversion to the text of the regulations in effect immediately prior to the effective date of the Stream Protection Rule.
Payday, Vehicle Title, and Certain High-Cost Installment Loans
Document Number: 2017-21808
Type: Rule
Date: 2017-11-17
Agency: Bureau of Consumer Financial Protection
The Bureau of Consumer Financial Protection (Bureau or CFPB) is issuing this final rule establishing regulations creating consumer protections for certain consumer credit products and the official interpretations to the rule. First, the rule identifies it as an unfair and abusive practice for a lender to make covered short-term or longer- term balloon-payment loans, including payday and vehicle title loans, without reasonably determining that consumers have the ability to repay the loans according to their terms. The rule exempts certain loans from the underwriting criteria prescribed in the rule if they have specific consumer protections. Second, for the same set of loans along with certain other high-cost longer-term loans, the rule identifies it as an unfair and abusive practice to make attempts to withdraw payment from consumers' accounts after two consecutive payment attempts have failed, unless the consumer provides a new and specific authorization to do so. Finally, the rule prescribes notices to consumers before attempting to withdraw payments from their account, as well as processes and criteria for registration of information systems, for requirements to furnish and obtain information from them, and for compliance programs and record retention. The rule prohibits evasions and operates as a floor leaving State and local jurisdictions to adopt further regulatory measures (whether a usury limit or other protections) as appropriate to protect consumers.