2018 – Federal Register Recent Federal Regulation Documents

Results 2,351 - 2,400 of 27,748
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Plating and Polishing Area Sources (Renewal)
Document Number: 2018-25771
Type: Notice
Date: 2018-11-30
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Plating and Polishing Area Sources (EPA ICR Number 2294.05, OMB Control Number 2060-0623), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through November 30, 2018. Public comments were previously requested, via the Federal Register, on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Friction Materials Manufacturing (Renewal)
Document Number: 2018-25768
Type: Notice
Date: 2018-11-30
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR)NESHAP for Friction Materials Manufacturing (EPA ICR Number 2025.07, OMB Control Number 2060-0481) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through August 31, 2018. Public comments were requested previously, via the Federal Register on June 29, 2017 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Airworthiness Directives; Dassault Aviation Airplanes
Document Number: 2018-25658
Type: Rule
Date: 2018-11-30
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Dassault Aviation Model Falcon 10 airplanes. This AD was prompted by a determination that new and more restrictive maintenance requirements and airworthiness limitations are necessary. This AD requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations. We are issuing this AD to address the unsafe condition on these products.
Notice of Availability of the Draft Environmental Assessment (Draft EA) for Palmetto Railways Camp Hall Rail Line
Document Number: 2018-25446
Type: Notice
Date: 2018-11-30
Agency: Surface Transportation Board, Department of Transportation
On August 3, 2017, Palmetto Railways (Applicant) filed an exemption petition with the Board pursuant to 49 U.S.C. 10502 to construct and operate approximately 28 miles of new rail line between the Cross Subdivision of CSX Transportation, Inc. (CSXT) rail network near the Santee Cooper Cross Generating Station and the Camp Hall Commerce Park in Berkeley County, South Carolina. Implementation of the proposed rail line would bring industrial rail service to the Volvo Cars facility, as well as areas being developed by Santee Cooper. FRA and the Coast Guard are cooperating agencies in the preparation of this Draft EA pursuant to CEQ NEPA implementing regulations (40 CFR 1501.6). The purpose of this Notice of Availability (NOA) is to notify individuals and agencies interested in or affected by the proposed action of the availability of the Draft EA for review and comment on November 30, 2018. The Draft EA analyzes the potential environmental impacts of the proposed action and alternatives, including the no- action alternative. The Draft EA addresses environmental issues and concerns identified during the scoping process. It also contains OEA's preliminary recommendations for environmental mitigation measures, and Palmetto Railways' voluntary mitigation measures. The Draft EA will be available on November 30, 2018 through the Board's website at https://www.stb.gov by following the decisions link, through the project website at https://www.CampHallRailNEPA.com, and at all public libraries in Berkeley County, South Carolina. Next Steps: Following the close of the 30-day comment period on December 30, 2018 of the Draft EA, OEA, the Corps, and the cooperating agencies will issue a Final EA that considers comments on the Draft EA. The Board will then issue a final decision based on the Draft and Final EAs and all public and agency comments in the public record for this proceeding. The final decision will address the transportation merits of the proposed project and the entire environmental record. That final decision will take one of three actions: Approve the proposed project, deny it, or approve it with mitigation conditions, including environmental conditions. Written Comments: Any interested party may submit written comments on the Draft EA. The procedures for submitting written comments are outlined below:
Collection of Checks and Other Items by Federal Reserve Banks and Funds Transfers Through Fedwire
Document Number: 2018-25267
Type: Rule
Date: 2018-11-30
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors of the Federal Reserve System (Board) is publishing final amendments to Regulation J. The amendments clarify and simplify certain provisions Regulation J, remove obsolete provisions, and align the rights and obligations of sending banks, paying banks, and Federal Reserve Banks (Reserve Banks) with the Board's recent amendments to Regulation CC to reflect the virtually all-electronic check collection and return environment. The final rule also amends Regulation J to clarify that terms used in financial messaging standards, such as ISO 20022, do not confer legal status or responsibilities.
Post-Trade Name Give-Up on Swap Execution Facilities
Document Number: 2018-24643
Type: Proposed Rule
Date: 2018-11-30
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (Commission or CFTC) is requesting public comment regarding the practice of ``post-trade name give-up'' on swap execution facilities.
Swap Execution Facilities and Trade Execution Requirement
Document Number: 2018-24642
Type: Proposed Rule
Date: 2018-11-30
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is proposing amendments to regulations relating to the trade execution requirement under the Commodity Exchange Act (``CEA'' or ``Act'') and amendments to existing regulations relating to swap execution facilities (``SEFs'') and designated contract markets (``DCMs''). Among other amendments, the proposed rules apply the SEF registration requirement to certain swaps broking entities and aggregators of single-dealer platforms; broaden the scope of the trade execution requirement to include all swaps subject to the clearing requirement under the Act that a SEF or a DCM lists for trading; allow SEFs to offer flexible execution methods for all swaps that they list for trading; amend straight-through processing requirements; and amend the block trade definition. The proposed rules, which also include non- substantive amendments and various conforming changes to other Commission regulations, reflect the Commission's enhanced knowledge and experience with swaps trading characteristics and would further the Dodd-Frank Act's statutory goals for SEFs, i.e., promote more SEF trading and pre-trade price transparency in the swaps market. Further, the proposed rules are intended to strengthen the existing swaps regulatory framework by reducing unnecessary complexity, costs, and other burdens that impede SEF development, innovation, and growth.
Updated Disclosure Requirements and Summary Prospectus for Variable Annuity and Variable Life Insurance Contracts
Document Number: 2018-24376
Type: Proposed Rule
Date: 2018-11-30
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission is proposing rule and form amendments that are intended to help investors make informed investment decisions regarding variable annuity and variable life insurance contracts. The proposal would modernize disclosures by using a layered disclosure approach designed to provide investors with key information relating to the contract's terms, benefits, and risks in a concise and more reader-friendly presentation, with access to more detailed information available online and electronically or in paper format on request. The proposed new rule would permit a person to satisfy its prospectus delivery obligations under the Securities Act of 1933 for a variable annuity or variable life insurance contract by sending or giving a summary prospectus to investors and making the statutory prospectus available online. The proposed rule also would consider a person to have met its prospectus delivery obligations for any portfolio companies associated with a variable annuity or variable life insurance contract if the portfolio company prospectuses are posted online. In addition, we are proposing amendments to the registration forms for variable annuity and variable life insurance contracts to update and enhance the disclosures to investors in these contracts, and to implement the proposed summary prospectus framework. We are further proposing to require variable contracts to use the Inline eXtensible Business Reporting Language (``Inline XBRL'') format for the submission of certain required disclosures in the variable contract statutory prospectus. We are also proposing certain technical and conforming amendments to our rules and forms, including amendments to rules relating to variable life insurance contracts, as well as rescission of certain related rules and forms. Lastly, we are seeking comments regarding parallel amendments to rules governing mutual fund summary prospectuses and registration forms applicable to other types of registered investment companies.
Reader Aids
Document Number: FR-2018-11-29-ReaderAids
Type: Reader Aids
Date: 2018-11-29
Blocking Property of Certain Persons Contributing to the Situation in Nicaragua
Document Number: 2018-26156
Type: Executive Order
Date: 2018-11-29
Agency: Executive Office of the President
Sunshine Act Meeting
Document Number: 2018-26108
Type: Notice
Date: 2018-11-29
Agency: Federal Election Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2018-26069
Type: Notice
Date: 2018-11-29
Agency: International Trade Commission, Agencies and Commissions
Schedules of Controlled Substances: Placement of Furanyl Fentanyl, 4-Fluoroisobutyryl Fentanyl, Acryl Fentanyl, Tetrahydrofuranyl Fentanyl, and Ocfentanil in Schedule I
Document Number: 2018-26045
Type: Rule
Date: 2018-11-29
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances furanyl fentanyl [N-(1-phenethylpiperidin- 4-yl)-N-phenylfuran-2-carboxamide], 4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl [N-(4-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide], acryl fentanyl or acryloylfentanyl [N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide], tetrahydrofuranyl fentanyl [N-(1-phenethylpiperidin-4-yl)-N- phenyltetrahydrofuran-2-carboxamide], and ocfentanil [N-(2- fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamid e], including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States obligations under the Single Convention on Narcotic Drugs (1961). This action continues to 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 or conduct instructional activities with, or possess), or propose to handle, furanyl fentanyl, 4-fluoroisobutyryl fentanyl, acryl fentanyl, tetrahydrofuranyl fentanyl, and ocfentanil.
Sunshine Act Meetings
Document Number: 2018-26025
Type: Notice
Date: 2018-11-29
Agency: International Trade Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2018-26024
Type: Notice
Date: 2018-11-29
Agency: International Trade Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2018-26023
Type: Notice
Date: 2018-11-29
Agency: International Trade Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2018-25983
Type: Notice
Date: 2018-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Regulated Navigation Area; Upper Mississippi River, Sabula Railroad Bridge, Mile Marker 535, Sabula, IA
Document Number: 2018-25981
Type: Rule
Date: 2018-11-29
Agency: Coast Guard, Department of Homeland Security
The Coast Guard established a temporary regulated navigation area for certain navigable waters of the Upper Mississippi River under one of the navigable spans of the Sabula Railroad Drawbridge at mile marker (MM) 535. The RNA is necessary to protect persons, vessels, and the marine environment from potential hazards associated with emergency repair work to the Sabula Railroad Bridge following a vessel's allision with the bridge. The regulation applies only to southbound vessel transits through the RNA, and depending on the water flow as measured from Lock and Dam 12, this regulation either prohibits transit or establishes operating requirements unless a deviation is authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-25980
Type: Notice
Date: 2018-11-29
Agency: Bureau of Consumer Financial Protection
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, ``Registration of Mortgage Loan Originators (Regulation G).''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-25979
Type: Notice
Date: 2018-11-29
Agency: Bureau of Consumer Financial Protection
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, ``Mortgage Assistance Relief Services (Regulation O).''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-25978
Type: Notice
Date: 2018-11-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Petition for Exemption; Summary of Petition Received; Beverly Hills Aerials, LLC
Document Number: 2018-25977
Type: Notice
Date: 2018-11-29
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Petition for Exemption; Summary of Petition Received; Overwatch Aero, LLC
Document Number: 2018-25976
Type: Notice
Date: 2018-11-29
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Notice of Agreements Filed
Document Number: 2018-25975
Type: Notice
Date: 2018-11-29
Agency: Federal Maritime Commission, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2018-25974
Type: Notice
Date: 2018-11-29
Agency: Federal Reserve System, Agencies and Commissions
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-25973
Type: Notice
Date: 2018-11-29
Agency: Bureau of Consumer Financial Protection
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, ``Mortgage Acts And Practices (Regulation N) 12 CFR 1014.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-25972
Type: Notice
Date: 2018-11-29
Agency: Bureau of Consumer Financial Protection
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, ``Consumer Leasing Act (Regulation M) 12 CFR 1013.''
Common Formats for Patient Safety Data Collection
Document Number: 2018-25971
Type: Notice
Date: 2018-11-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for SurveillanceHospital Version 0.2 Beta.
Privacy Act of 1974; System of Records
Document Number: 2018-25970
Type: Notice
Date: 2018-11-29
Agency: National Intelligence, Office of the National Director, Agencies and Commissions
ODNI provides notice that it is establishing one new Privacy Act system of records at the National Counterintelligence and Security Center (NCSC). This new system of records is titled the NCSC Continuous Evaluation System, also identified as ODNI/NCSC-003. This notice is necessary to inform the public of the existence and character of records that the agency maintains. Continuous Evaluation (CE) is a personnel security investigative process used to review the continued eligibility of individuals who have been determined eligible for access to classified information or to hold a sensitive position. Individuals subject to CE include current Executive Branch employees, detailees, contractors, and other sponsored individuals who are cleared for access to classified information or to hold a sensitive position. The Departments and Agencies (D/As) that sponsor these individuals for access to classified information or to hold a sensitive position ``enroll'' the individuals (enrollees) for CE by electronically entering their identifying information into a technical system that carries out the CE capability. All D/As are required to submit their qualifying populations to CE. D/As may choose to develop a technical CE system of their own, or subscribe to CE services provided by another agency. The ODNI/NCSC will provide CE services to subscribing agencies. The NCSC CE System leverages electronic checks of government and commercial databases and, based on automated business rules, transmits alerts and reports to the enrolling D/A. Datasets queried in the CE process are those that contain security-relevant information, e.g., government-owned financial, law enforcement, terrorism, foreign travel, and current clearance status information. Credit data and commercially-obtained aggregated data also is utilized. On receipt of the electronic prompt, the personnel security function at the enrolling agency verifies that the alert or report received pertains to the enrollee (the subject of the electronic queries). Where the agency verifies that the alert or report pertains to the enrollee, appropriate personnel security officials review the nature of the alert or report to determine the need for further investigation, as dictated by Federal Investigative Standards requirements. Information obtained through the follow-on investigation is considered in adjudicating the enrollee's continued eligibility for access to classified information or to hold a sensitive position. The NCSC CE System retains the enrollment information (personal identifiers as provided by the enrolling D/A) in order to facilitate ongoing CE checks. The system does not retain the records returned from the electronic database queries beyond the time needed to ensure proper electronic delivery to the enrolling agency. Data necessary to implement CE business rules, to perform program assessments, and to satisfy auditing requirements will be retained. D/As conducting CE will adhere to the principles articulated in the Security Executive Agent Directive (SEAD) relating to CE (i.e., SEAD 6). A SEAD provides high level guidance and instruction for the conduct of a personnel security process. SEAD 6 establishes policy and requirements specifically related to CE.
30-Day Notice of Proposed Information Collection: Nonimmigrant Treaty Trader/Investor Application
Document Number: 2018-25968
Type: Notice
Date: 2018-11-29
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Membership of the National Endowment for the Arts Senior Executive Service Performance Review Board
Document Number: 2018-25967
Type: Notice
Date: 2018-11-29
Agency: National Endowment for the Arts
This notice announces the membership of the National Endowment for the Arts (NEA) Senior Executive Service (SES) Performance Review Board (PRB).
Submission for OMB Review; Comment Request
Document Number: 2018-25966
Type: Notice
Date: 2018-11-29
Agency: Department of Agriculture
Notice of Request for Comment on the Annual Report for Fiscal Year 2018 and Three-Year Plan
Document Number: 2018-25965
Type: Notice
Date: 2018-11-29
Agency: Federal Accounting Standards Advisory Board, Agencies and Commissions
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension
Document Number: 2018-25964
Type: Notice
Date: 2018-11-29
Agency: Federal Trade Commission, Agencies and Commissions
The information collection requirements described below will be submitted to the Office of Management and Budget (``OMB'') for review, as required by the Paperwork Reduction Act (``PRA''). The FTC seeks public comments on its proposal to extend for an additional three years the current PRA clearance for information collection requirements contained in its Alternative Fuels Rule (``Rule''). That clearance expires on May 31, 2019.
Proposed Extension of Information Collection; Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines
Document Number: 2018-25963
Type: Notice
Date: 2018-11-29
Agency: Department of Labor, Mine Safety and Health Administration
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Ground Control for Surface Coal Mines and Surface Work Areas of Underground Coal Mines.
Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-25960
Type: Notice
Date: 2018-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' It describes study designs for generating data that supports both 510(k) clearance and CLIA waiver. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver in addition to 510(k) clearance for new in vitro diagnostic (IVD) devices. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA waived settings, which will better serve patients and providers. This draft guidance is not final nor is it in effect at this time.
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-25959
Type: Notice
Date: 2018-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has developed this draft guidance to implement the 21st Century Cures Act (the Cures Act), which requires FDA to revise ``Section V. Demonstrating Insignificant Risk of an Erroneous ResultAccuracy'' of the guidance ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was issued on January 30, 2008. This draft guidance represents FDA's current thinking regarding ``the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.'' The 2008 CLIA Waiver Guidance remains in effect, in its current form, until this draft guidance is finalized, at which time the updates in section III of this draft guidance will supersede the recommendations in section V of the 2008 CLIA Waiver Guidance. This draft guidance is not final nor is it in effect at this time.
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments
Document Number: 2018-25958
Type: Notice
Date: 2018-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' FDA is also requesting public comments on the subject. The purpose of the meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards initiatives, the FDA Information Technology (IT) Strategic Plan, and electronic submissions gateway target timeframes.
Submission for OMB Review; Comment Request
Document Number: 2018-25957
Type: Notice
Date: 2018-11-29
Agency: Department of Agriculture
Endangered Species; File Nos. 19641-01, 20340-05, 20347-03, 20528-02, and 22671
Document Number: 2018-25955
Type: Notice
Date: 2018-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that five applicants have applied in due form for a permit or permit modification to take shortnose (Acipenser brevirostrum) and Atlantic (Acipenser oxyrinchus) sturgeon for purposes of scientific research and enhancement.
Technical Corrections to the Vessel Repair Unit Regulations
Document Number: 2018-25953
Type: Rule
Date: 2018-11-29
Agency: Department of Homeland Security, U.S. Customs and Border Protection
This document amends the U.S. Customs and Border Protection (CBP) regulations to update provisions relating to the declaration, entry and dutiable status of repair expenditures made abroad for certain vessels to reflect the port of New Orleans, Louisiana as the only Vessel Repair Unit (VRU) location. The amendment will improve the efficiency of vessel repair entry processing, ensure the proper assessment and collection of duties, and make the regulations more transparent.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2018-25950
Type: Notice
Date: 2018-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Voluntary Chemist Certification Program Applications, Notices, and Records
Document Number: 2018-25949
Type: Notice
Date: 2018-11-29
Agency: Department of the Treasury
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Tax and Trade Bureau Information Collection Requests
Document Number: 2018-25948
Type: Notice
Date: 2018-11-29
Agency: Department of the Treasury
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple FinCEN Information Collection Requests
Document Number: 2018-25947
Type: Notice
Date: 2018-11-29
Agency: Department of the Treasury
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Notice of Allotment Percentages to States for Child Welfare Services State Grants; CFDA Number: 93.645
Document Number: 2018-25932
Type: Notice
Date: 2018-11-29
Agency: Department of Health and Human Services, Administration for Children and Families
As required by section 423(c) of the Social Security Act, the Department is publishing the allotment percentage for each State under the Title IV-B Subpart 1, Stephanie Tubbs Jones Child Welfare Services Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.
Title I-Improving the Academic Achievement of the Disadvantaged; Education of Migratory Children
Document Number: 2018-25931
Type: Proposed Rule
Date: 2018-11-29
Agency: Department of Education
The Department proposes to modify the current requirements related to the responsibilities of State educational agency (SEA) recipients of funds under title I, part C, of the Elementary and Secondary Education Act of 1965, as amended (ESEA), to conduct annual prospective re-interviews to confirm the eligibility of children under the Migrant Education Program (MEP). Based on input from MEP stakeholders, we propose to clarify who constitutes an independent re- interviewer, and to reduce the costs and burden of prospective re- interviews conducted by independent re-interviewers, while maintaining adequate quality control measures to safeguard the integrity of program eligibility determinations.
Air Plan Approval; California; South Coast Air Quality Management District
Document Number: 2018-25899
Type: Rule
Date: 2018-11-29
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to approve a revision to the South Coast Air Quality Management District (SCAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from architectural coatings. We are approving a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act).
30-Day Notice of Proposed Information Collection: Iraqi Citizens and Nationals Employed by U.S. Federal Contractors and Grantees
Document Number: 2018-25889
Type: Notice
Date: 2018-11-29
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
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