September 26, 2019 – Federal Register Recent Federal Regulation Documents
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Airworthiness Directives; Pratt & Whitney Turbofan Engines
The FAA is adopting a new airworthiness directive (AD) for certain Pratt & Whitney (PW) PW1519G, PW1521G, PW1521GA, PW1524G, PW1525G, PW1521G-3, PW1524G-3, PW1525G-3, PW1919G, PW1921G, PW1922G, PW1923G, and PW1923G-A model turbofan engines. This AD requires initial and repetitive inspections of the low-pressure compressor (LPC) inlet guide vane (IGV) and the LPC rotor 1 (R1) and, depending on the results of the inspections, possible replacement of the LPC. This AD was prompted by two recent in-flight shutdowns (IFSDs) that occurred as the result of failures of the LPC R1. The FAA is issuing this AD to address the unsafe condition on these products.
Monsanto Company; Availability of Petition for Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Monsanto Company seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects, primarily Lygus spp. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Data Requirements Rule for the 1-Hour Sulfur Dioxide Primary National Ambient Air Quality Standard (Renewal)
The Environmental Protection Agency (EPA) has submitted a renewal of an information collection request (ICR), Data Requirements Rule for the 1-Hour Sulfur Dioxide Primary National Ambient Air Quality Standard (EPA ICR Number 2495.03, Office of Management and Budget (OMB) Control Number 2060-0696) to OMB for review and approval in accordance with the Paperwork Reduction Act (PRA). This is a proposed extension of the existing ICR for the Data Requirements Rule for the 1-Hour Sulfur Dioxide Primary NAAQS (SO2 Data Requirements Rule), which is currently approved through September 30, 2019. Public comments were previously requested via the Federal Register on July 12, 2019, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the proposed ICR renewal is given below, including the estimated burden and cost to respondents to meet the requirements of the SO2 Data Requirements Rule. An agency may not conduct or 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 Iron and Steel Foundries (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Iron and Steel Foundries (EPA ICR Number 2096.07, OMB Control Number 2060-0543), 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, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 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 Automobile and Light-Duty Truck Surface Coating (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Automobile and Light- duty Truck Surface Coating (EPA ICR Number 2045.08, OMB Control Number 2060-0550), 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, 2019. Public comments were previously requested, via the Federal Register (84 FR 19777), on May 6, 2019 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 Commercial Ethylene Oxide Sterilization and Fumigation Operations (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Commercial Ethylene Oxide Sterilization and Fumigation Operations (EPA ICR Number 1666.11, OMB Control Number 2060-0283), 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, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 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.
Providing Regulatory Submissions for Medical Devices in Electronic Format-Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Providing Regulatory Submissions for Medical Devices in Electronic FormatSubmissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.'' Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the FDA Reauthorization Act of 2017 (FDARA) require that certain presubmissions and submissions for devices be submitted in electronic format specified by FDA beginning on such date as specified in final guidance. It also mandates that FDA issue draft guidance not later than October 1, 2019, providing for further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements. In addition, in the Medical Device User Fee Amendments of 2017 (MDUFA IV) Commitment Letter from the Secretary of Health and Human Services to Congress, FDA committed to developing electronic submission templates and issuing a draft guidance on the topic. This guidance is intended to satisfy the draft guidance documents referenced in FDA regulations and the MDUFA IV Commitment Letter. This draft guidance is not final nor is it in effect at this time.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Registration of Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Registration of Fuels and Fuel Additives: Health-Effects Research Requirements for Manufacturers (EPA ICR Number 1696.10, OMB Control Number 2060-0297) 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, 2019. Public comments were previously requested via the Federal Register on May 21, 2019 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 not conduct or 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; NSPS for Commercial and Industrial Solid Waste Incineration (CISWI) Units (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Commercial and Industrial Solid Waste Incineration (CISWI) Units (EPA ICR Number 1926.08, OMB Control Number 2060-0450), 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, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 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 Gasoline Distribution Facilities (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Gasoline Distribution Facilities (40 CFR part 63, subpart R) (Renewal)'' (EPA ICR No. 1659.10, OMB Control No. 2060-0325), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through November 30, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 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; NSPS for Incinerators (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Incinerators, (EPA ICR Number 1058.13, OMB Control Number 2060-0040), 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, 2019. Public comments were previously requested, via the Federal Register, on May 6, 2019 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; EPA's ENERGY STAR Program in the Commercial and Industrial Sectors (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), EPA's ENERGY STAR Program in the Commercial and Industrial Sectors (EPA ICR Number 1772.08, OMB Control Number 2060-0347), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed revision of the ICR, which is currently approved through September 30, 2019. Public comments were previously requested via the Federal Register on December 13, 2018 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 not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Notice of Proposed Declaration of Dividend (FR 1583; OMB No. 7100- 0339). The revisions are applicable immediately.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Notice of Proposed Stock Redemption (FR 4008; OMB No. 7100-0131).
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Payments Systems Surveys (FR 3054; OMB No. 7100-0332). The revisions are applicable immediately.
Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection provisions of our regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing of fruit and vegetable juices.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials; Public Meeting
The Food and Drug Administration (FDA or Agency) is announcing a public meeting entitled ``International Council on Harmonisation (ICH) Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials.'' The purpose of the public meeting is to provide information on the draft revised E8(R1) Guideline ``General Considerations for Clinical Trials'' (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Proposed Revocation of Class E Airspace; Alpine, TX: Withdrawal
The FAA is withdrawing the NPRM published in the Federal Register on August 12, 2019, to amend Class E airspace extending upward from 700 feet above the surface at Alpine-Casparis Municipal Airport, Alpine, TX.
Production of Confidential Business Information in Civil Litigation; Transfer of Information Claimed as Confidential Business Information to the United States Department of Justice and Parties to Certain Litigation
The U.S. Environmental Protection Agency (EPA) is providing notice of disclosure of information which has been submitted to the EPA by owners/operators of oil and natural gas facilities that is claimed to be, or has been determined to be, confidential business information (CBI), in civil litigation styled State of New York. et al. v. EPA, No. 18-cv-773, pending in the United States District Court for the District of Columbia (Litigation). Disclosure is in response to discovery requests from Plaintiffs in this Litigation. The court has entered a Protective Order applicable to all parties that governs the treatment of CBI during and after this Litigation.
Deepwater Port License Application: West Delta LNG LLC
The Maritime Administration (MARAD) and the U.S. Coast Guard (USCG) announce they have received an application from West Delta LNG LLC (Applicant) for the licensing of a deepwater port and that the application for the West Delta LNG deepwater port (West Delta LNG) contains information sufficient to commence processing. This notice summarizes the Applicant's plans and the procedures that will be followed in considering the application.
Proposed Agency Information Collection Activities; Comment Request
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Financial Statements for Holding Companies (FR Y-9 Reports; OMB No. 7100-0128).
Ambient Air Monitoring Reference and Equivalent Methods; Designation of One New Reference Method and One Reference Method Amendment
Notice is hereby given that the Environmental Protection Agency (EPA) has designated one new reference method for measuring concentrations of nitrogen dioxide (NO2), and one amendment to an existing reference method for measuring PM10 in ambient air.
Integrated Science Assessment for Ozone and Related Photochemical Oxidants (External Review Draft)
The Environmental Protection Agency (EPA) is announcing a public comment period for the draft document titled, ``Integrated Science Assessment for Ozone and Related Photochemical Oxidants (External Review Draft)'' (EPA/600/R-19/093). The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD) as part of the review of the primary (health-based) and secondary (welfare-based) ozone national ambient air quality standards (NAAQS). The Integrated Science Assessment (ISA), in conjunction with additional technical and policy assessments, provides the scientific basis for EPA's decisions on the adequacy of the current review of the ozone NAAQS and the appropriateness of possible alternative standards. EPA is releasing this draft document to seek review by the Clean Air Scientific Advisory Committee (CASAC) and the public. In addition, the date and location of a public meeting for CASAC review of this document will be specified in a separate Federal Register document. This draft document is not final, and it does not represent, and should not be construed to represent, any final Agency policy or views. When revising the document, EPA will consider any public comments submitted during the public comment period specified in this document.
Notice of OFAC Sanctions Action
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of three entities that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities: Proposed Collection Renewal; Comment Request (OMB No. 3064-0200)
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collection described below (3064-0200).
Agency Information Collection Activities; Comment Request; Accrediting Agencies Reporting Activities for Institutions and Programs-Database of Accredited Postsecondary Institution and Programs (DAPIP)
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Mail Classification Schedule
The Commission is acknowledging a recent Postal Service filing of its intention to clarify that it may alter the age requirements for Adult Signature Services pursuant to a Negotiated Service Agreement. This document informs the public of the filing, invites public comment, and takes other administrative steps.
30-Day Notice of Proposed Information Collection: U.S. Passport Renewal Application for Eligible Individuals
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.
Notice of a Federal Advisory Committee Meeting Manufactured Housing Consensus Committee
This notice sets forth the schedule and proposed agenda for a meeting of the MHCC. The meeting is open to the public and the site is accessible to individuals with disabilities. The agenda provides an opportunity for citizens to comment on the business before the MHCC.
Parts and Accessories Necessary for Safe Operation; Vision Systems North America, Inc. Application for an Exemption
The Federal Motor Carrier Safety Administration (FMCSA) requests public comment on an exemption application from Vision Systems North America, Inc. (VSNA) to allow motor carriers to operate commercial motor vehicles (CMVs) equipped with the company's Smart- Vision high definition camera monitoring system (Smart-Vision) as an alternative to the two rear-vision mirrors required by the Federal Motor Carrier Safety Regulations (FMCSRs). VSNA states that its Smart- Vision system provides the same functionality and view as traditional mirrors but with high-definition cameras and interior displays. VSNA believes the exemption would maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption because the Smart-Vision system meets or exceeds the performance requirements for traditional mirrors under the National Highway Traffic Safety Administration (NHTSA)'s standards, which are cross-referenced by the FMCSRs.
Notice of Filing of Plat of Survey, New Mexico
The plat of survey of the following described land is scheduled to be officially filed 30 days after the date of this publication in the Bureau of Land Management (BLM), New Mexico Office, Santa Fe, New Mexico. The survey announced in this notice is necessary for the management of lands administered by the agency indicated.
Agency Information Collection Activities: Requests for Comments; Clearance of a Renewed Approval of Information Collection: Alternative Pilot Physical Examination and Education Requirements
In accordance with the Paperwork Reduction Act of 1995, the FAA invites public comments about our intention to request Office of Management and Budget (OMB) approval to renew an information collection. The Federal Aviation Administration Extension, Safety, and Security Act of 2016 was enacted on July 15, 2016. Section 2307 of FESSA, Medical Certification of Certain Small Aircraft Pilots, directed the FAA to ``issue or revise regulations to ensure that an individual may operate as pilot in command of a covered aircraft'' without having to undergo the medical certification process prescribed by FAA regulations if the pilot and aircraft meet certain prescribed conditions as outlined in FESSA. This collection enables those eligible airmen to establish their eligibility with the FAA.
Modified Risk Tobacco Product Applications for VLNTM
The Food and Drug Administration is correcting a document entitled ``Modified Risk Tobacco Product Applications for VLN\TM\ King and VLN\TM\ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group, Inc.'' that published in the Federal Register of July 25, 2019. The document announced the availability of modified risk tobacco product applications for public comment. The document published with incorrect submission tracking numbers. This document corrects that error.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain Airbus SAS Model A318-112, -121, and -122; A319-111, -112, - 115, -131, -132, and -133; A320-214, -216, -232, -233, -251N, and - 271N; and A321-211, -212, -213, -231, -232, -251N, -253N, -271N, and - 272N airplanes. This AD was prompted by reports of missing or loosened fasteners on connecting brackets of overhead stowage compartments (OHSC) and pivoting OHSC (POHSC). This AD requires modification of the OHSC and POHSC attachments, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; De Havilland Aircraft of Canada Limited (Type Certificate Previously Held by Bombardier, Inc.) Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain De Havilland Aircraft of Canada Limited (Type Certificate Previously Held by Bombardier, Inc.) Model DHC-8-400 series airplanes. This AD was prompted by reports of the nose landing gear (NLG) locking in a partially extended position due to loose bushings on the lock link of the NLG locking mechanism. This AD requires repetitive inspections of the bushings and the lower lock link of the NLG for discrepancies, and corrective actions if necessary. This AD also requires replacement of the lower lock link of the NLG, which terminates the repetitive inspections. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. This AD was prompted by reports of cracks in the o-ring groove of magnetic fuel level indicators. This AD requires a one-time detailed inspection of the magnetic fuel level indicator for cracks and replacement of cracked magnetic fuel level indicators. The FAA is issuing this AD to address the unsafe condition on these products.
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