2017 – Federal Register Recent Federal Regulation Documents
Results 1,351 - 1,400 of 27,453
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Hearings of the Judicial Conference Advisory Committees on the Federal Rules of Appellate and Criminal Procedure and Rules of Evidence
The January 5, 2018 public hearings in Phoenix, Arizona, on proposed amendments to the Appellate, Criminal and Evidence Rules, the Rules Governing Section 2254 Cases in the United States District Courts, and the Rules Governing Section 2255 Proceedings for the United States District Courts have been canceled.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Commercial Transportation of Equines for Slaughter
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the commercial transportation of equines to slaughtering facilities.
General Conference Committee of the National Poultry Improvement Plan; Solicitation for Membership
We are giving notice that the Secretary of Agriculture is soliciting nominations for the election of a member at-large and regional members and their alternates for the General Conference Committee of the National Poultry Improvement Plan.
Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing entitled, ``Opioid Policy Steering Committee: Prescribing InterventionExploring a Strategy for Implementation.'' The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the existing information Message Testing for Tobacco Communication Activities (MTTCA). CDC's Office on Smoking and Health has used the MTTCA clearance to support the development and testing of tobacco-related health messages, including messages supporting CDC's National Tobacco Education Campaign (NTEC) called the Tips from Former Smokers[supreg] campaign.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns. Thus, CDC seeks to request Office of Management and Budget (OMB) approval to reinstatement OMB Control Number 0920-0800.
Proposed Data Collections Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Vital Statistics Report Forms. These are the data collection forms used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths at the end of each month and (b) annual counts of marriages and divorces/ annulments in support of the National Vital Statistics System. This submission contains no changes to the actual data collection forms. However, the number of respondent for the monthly and annual forms have shifted from 91 and 58 respectively to 58 and 91, since the 33 New Mexico Counties only send marriage and divorce information that is now only captured in the annual report.
Agency Information Collection Activities; Safer Choice Product Recognition Program; Submitted to OMB for Review and Approval; Comment Request
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): ``Safer Choice Product Recognition Program'' and identified by EPA ICR No. 2302.03 and OMB Control No. 2070-0178. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA did not receive any comments in response to the previously provided public review opportunity issued in the Federal Register on March 8, 2016 (81 FR 12097). With this submission, EPA is providing an additional 30 days for public review.
Agency Information Collection Activities; TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions From Testing Requirements; Submitted to OMB for Review and Approval; Comment Request
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): ``TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions from Testing Requirements'' and identified by EPA ICR No. 1139.11, OMB Control No. 2070-0033. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA has addressed the comments received in response to the previously provided public review opportunity issued in the Federal Register on March 15, 2016 (81 FR 13790). With this submission, EPA is providing an additional 30 days for public review.
Agency Information Collection Activities; Compliance Requirement for Child-Resistant Packaging; Submitted to OMB for Review and Approval; Comment Request
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): ``Compliance Requirement for Child-Resistant Packaging'' and identified by EPA ICR No. 0616.12 and OMB Control No. 2070-0052. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA has addressed the comments received in response to the previously provided public review opportunity issued in the Federal Register on November 29, 2016 (81 FR 85951). With this submission, EPA is providing an additional 30 days for public review.
Noise Exposure Map Notice Louisville International Airport, Louisville, KY
The Federal Aviation Administration (FAA) announces its determination that the Noise Exposure Maps submitted by the Louisville Regional Airport Authority for the Louisville International Airport are in compliance with applicable requirements.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Drawbridge Operation Regulation; Carquinez Strait, at Martinez, CA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Benicia-Martinez Union Pacific Railroad Drawbridge across the Carquinez Strait, mile 7.0, at Martinez, CA. The deviation is necessary to allow the bridge owner to replace drawspan operational components. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control Techniques Guidelines for Control of Volatile Organic Compound Emissions From Miscellaneous Metal Parts Surface Coating, Miscellaneous Plastic Parts Surface Coating, and Pleasure Craft Surface Coatings; Withdrawal of Direct Final Rule
Due to receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 16, 2017 direct final rule (DFR) that approved a revision to the Commonwealth of Pennsylvania's state implementation plan (SIP). The revision included amendments to the Pennsylvania Department of Environmental Protection's (PADEP) regulations and addressed the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for the following categories: Miscellaneous metal parts surface coating, miscellaneous plastic parts surface coating, and pleasure craft surface coatings, as well as related cleaning activities. The SIP revision also amended regulations for graphic arts systems and mobile equipment repair and refinishing as well as made general administrative changes. EPA stated in the direct final rule that if EPA received adverse comments by November 15, 2017, the rule would be withdrawn and not take effect. EPA subsequently received adverse comments. EPA will address the comments received in a subsequent final action based upon the proposed action also published on October 16, 2017. EPA will not institute a second comment period on this action.
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Pennsylvania's Adoption of Control Techniques Guidelines for Automobile and Light-Duty Truck Assembly Coatings; Withdrawal of Direct Final Rule
Due to receipt of adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule published on Tuesday, October 24, 2017 to approve revisions to the Pennsylvania state implementation plan (SIP) pertaining to the addition of new regulations to address the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) for automobile and light-duty truck assembly coatings.
New Animal Drugs; Approval of New Animal Drug Applications
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 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 make technical amendments to improve the accuracy of the regulations.
Revenue Deficiency
The Postal Service is proposing to amend Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) to clarify the Postal Service revenue deficiency policy.
Airworthiness Directives; Airbus Airplanes
We propose to supersede Airworthiness Directive (AD) 2016-01- 11, which applies to certain Airbus Model A320-211, -212, and -231 airplanes. AD 2016-01-11 requires repetitive inspections for cracking of the radius of the front spar vertical stringers and the horizontal floor beam on frame 36, repetitive inspections for cracking of the fastener holes of the front spar vertical stringers on frame 36, and repair if necessary. Since we issued AD 2016-01-11, we received a report that, during a center fuselage certification full scale fatigue test, cracks were found on the front vertical stringer at a certain frame. This proposed AD would add new thresholds and intervals for the repetitive inspections; would require, for certain airplanes, a modification of the center wing box area; and would expand the applicability. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
We are adopting a new airworthiness directive (AD) for certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 and ATR72- 212A airplanes. This AD requires revising the airplane flight manual to provide procedures to the flightcrew for operational restrictions affecting in-flight use of the autopilot (AP) or yaw damper (YD) during single source operation. This AD was prompted by flight test evaluations that revealed discrepancies with the YD and AP when in single source operation on certain airplanes. We are issuing this AD to address the unsafe condition on these products.
Hazardous Materials: Announcement of the Department of Transportation's Decision on Electronically Controlled Pneumatic Braking
In this document, the Department of Transportation is announcing that after careful review, and as mandated by Section 7311 of the Fixing America's Surface Transportation (FAST) Act, the Department of Transportation has reviewed the final updated Regulatory Impact Analysis (RIA) and determined that the HM-251 Final Rule's electronically controlled pneumatic (ECP) brake requirements are not economically justified. As the expected benefits do not exceed the expected costs, PHMSA and the Federal Railroad Administration (FRA) will initiate a rulemaking to rescind the necessary regulatory provisions.
Service Contract Inventory for Fiscal Year (FY) 2016
Through this notice, the Secretary announces the availability of the Department of Education's service contract inventory on its website, at https://www2.ed.gov/fund/data/report/contracts/ servicecontractinventoryappendix/servicecontractinventory.htm l. A service contract inventory is a tool for assisting an agency in better understanding how contracted services are being used to support mission and operations and whether the contractors' skills are being utilized in an appropriate manner.
Notice of Opportunity for Public Comment on a Land Use Change From Aeronautical to Non-Aeronautical Use for 22.1 Acres of Airport Land for Solar Farm Use at Brunswick Executive Airport, Brunswick, ME
Notice is being given that the FAA is considering a request from the Midcoast Regional Redevelopment Authority (MRRA), to change the current land use from aeronautical use to non-aeronautical use of a 22.1-acre parcel of land. The parcel is located in the northern quadrant of the airport adjacent, but separate from the airside area. The Airport Layout Plan was updated with a Pen and Ink Change to designate the parcel for non-aeronautical use. The airport will obtain fair market value for the lease of the land. The income derived from this lease will be placed in the airport's operation and maintenance funds for the facility.
Notice of Opportunity for Public Comment on a Land Use Change From Aeronautical to Non-Aeronautical Use for 419 Acres of Airport Land for Solar Farm Use at Sanford Seacoast Regional Airport, Sanford, ME
Notice is being given that the FAA is considering a request from the Sanford Seacoast Regional Airport, to change the current land use from aeronautical use to non-aeronautical use of 419 acres of land. The parcels are located along the southwesterly side of Runway 07/25, the northerly end of Runway 25 and in a portion of the infield area between Runway 07/25 and Runway 14/32. There is adequate developable area on the airport to meet the future twenty year need for projected activity and the Airport Layout Plan was updated with a Pen and Ink change to designate the parcels for non-aeronautical use. The airport will obtain fair market value for the lease of the land and the income derived from this lease will be placed in the airport's operation and maintenance funds for the facility.
Notice of Opportunity for Public Comment on a Land Swap Between the Northern Maine Regional Airport and the Presque Isle Industrial Council, Presque Isle, ME
Notice is being given that the FAA is considering a request from the Northern Maine Regional Airport, for a land swap with the Presque Isle Industrial Council. The on-airport land, currently in use as non-aeronautical development, is to be swapped with four parcels of land along the northern ramp area of airport and land within the northern approach. The land swap will further enhance the protection of the northern approach area while also providing developable land for aeronautical uses.
Agency Information Collection Activities: Submission to the Office of Management and Budget for Review and Approval; Fee Collection and Coal Production Reporting and Form OSM-1, Coal Reclamation Fee Report
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE) are proposing to renew an information collection relating to the Abandoned Mine Reclamation FundFee Collection and Coal Production Reporting.
Production of Rates Based on Data for Repurchase Agreements
The Board of Governors of the Federal Reserve System (Board) is announcing the production and publication of three rates by the Federal Reserve Bank of New York (FRBNY), in coordination with the U.S. Office of Financial Research (OFR), based on data for overnight repurchase agreement transactions on Treasury securities.
Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports
This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
Agency Information Collection Activity Under OMB Review: Department of Veterans Affairs Acquisition Regulation (VAAR), Special Notes
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Office of Acquisition and Logistics, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Agency Information Collection Activity Under OMB Review: Information Regarding Apportionment of Beneficiary's Award
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Agency Information Collection Activity: Request for Approval of School Attendance and School Attendance Report
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.
Agency Information Collection Activity: Veterans Mortgage Life Insurance Change of Address Statement
Veterans Benefits Administrations, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to inquire about a veteran's continued ownership of the property issued under Veterans Mortgage Life Insurance when an address change for the veteran is received. The information obtained is used in determining whether continued Veterans Mortgage Life Insurance coverage is applicable since the law granting this insurance provides that coverage terminates if the veteran no longer owns the property. The information requested is required by law, 38 U.S.C. Section 2106.
Agency Information Collection Activity Under OMB Review: Agency Information Collection Activity: VetBiz Vendor Information Pages Verification Program
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Center for Verification and Evaluation, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
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