October 16, 2018 – Federal Register Recent Federal Regulation Documents

Drawbridge Operation Regulation; Dutch Kills, Queens, NY
Document Number: 2018-22448
Type: Rule
Date: 2018-10-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Borden Avenue Bridge across Dutch Kills, mile 1.2, at Queens, NY. The deviation is necessary to facilitate bridge repairs. This temporary deviation allows the bridge to remain in the closed-to-navigation position during bridge repairs.
60-Day Notice of Proposed Information Collection: Brokering Prior Approval (License)
Document Number: 2018-22447
Type: Notice
Date: 2018-10-16
Agency: Department of State
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. 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 60 days for public comment preceding submission of the collection to OMB.
Agency Information Collection Activities: Submission for Office of Management and Budget (OMB) Review; Comment Request
Document Number: 2018-22446
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Common Core of Data (CCD) School-Level Finance Survey (SLFS) 2018-2020
Document Number: 2018-22445
Type: Notice
Date: 2018-10-16
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Proposed Collection; Comment Request for Revenue Procedure
Document Number: 2018-22444
Type: Notice
Date: 2018-10-16
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning information collection requirements related to guidance for qualification as an acceptance agent, and execution of an agreement between an acceptance agent and the Internal Revenue Service relating to the issuance of certain taxpayer identifying numbers.
Proposed Information Collection; Comment Request; The American Community Survey
Document Number: 2018-22443
Type: Notice
Date: 2018-10-16
Agency: Census Bureau, Department of Commerce
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection Activity
Document Number: 2018-22441
Type: Notice
Date: 2018-10-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks to continue data collection for the Annual Survey of Refugees with minor updates to improve survey administration procedures. The Annual Survey of Refugees is a yearly sample survey of refugees entering the U.S. in the previous five fiscal years. No changes to the survey instrument or estimated response burden are proposed. Data from the Annual Survey of Refugees are used to meet the Office of Refugee Resettlement's Congressional reporting requirements, as set forth in the Refugee Act of 1980 (Section 413(a) of the Immigration and Nationality Act). The ACF Office of Refugee Resettlement makes aggregated survey findings available to the general public and uses findings for the purposes of program planning, policy-making, and budgeting. Respondents: The Annual Survey of Refugees secures a nationally- representative sample of refugee households arriving in the United States in the previous five fiscal years.
National Environmental Policy Act Implementing Procedures
Document Number: 2018-22439
Type: Notice
Date: 2018-10-16
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, National Endowment for the Humanities
The National Endowment for the Humanities (``NEH'') proposes to promulgate procedures implementing the National Environmental Policy Act of 1969 (``NEPA''), Executive Order (``E.O.'') 11514 (as amended), and Council on Environmental Quality (``CEQ'') NEPA implementing regulations. Pursuant to CEQ regulations, NEH is soliciting comments on its proposed procedures.
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry; Availability
Document Number: 2018-22437
Type: Notice
Date: 2018-10-16
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 final guidance for industry entitled ``Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.'' This final guidance incorporates public comments to the draft guidance published in the Federal Register of December 18, 2017. The pharmacological effect of a targeted therapy is often related to a particular molecular alteration, and many diseases are caused by a range of different molecular alterations (some of which may be rare). Therefore, a targeted therapy may have differential effects among patients with the same disease who have different molecular alterations. The purpose of this guidance is to describe general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-22436
Type: Notice
Date: 2018-10-16
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 guidance for industry entitled ``Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.'' This draft guidance is intended to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies.
Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings; Draft Guidance for Industry; Availability
Document Number: 2018-22435
Type: Notice
Date: 2018-10-16
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 guidance for industry entitled ``Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.'' The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Youth CareerConnect Grant Program Participant Tracking System
Document Number: 2018-22434
Type: Notice
Date: 2018-10-16
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the information collection request (ICR) titled, ``Youth CareerConnect Grant Program Participant Tracking System,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Hazardous Materials: Emergency Waiver No. 7
Document Number: 2018-22423
Type: Notice
Date: 2018-10-16
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
PHMSA is issuing an emergency waiver order to persons conducting operations under the direction of Environmental Protection Agency (EPA) Region 4 or United States Coast Guard (USCG) Seventh or Eighth Districts within the Hurricane Michael emergency area of Florida. The Waiver is granted to support the EPA and USCG in taking appropriate actions to prepare for, respond to, and recover from a threat to public health, welfare, or the environment caused by actual or potential oil and hazardous materials incidents resulting from Hurricane Michael. This Waiver Order is effective immediately and shall remain in effect for 30 days from the date of issuance.
Agency Information Collection Activity Under OMB Review: Claim for Disability Insurance Benefits, Government Life Insurance
Document Number: 2018-22419
Type: Notice
Date: 2018-10-16
Agency: Department of Veterans Affairs
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 Under OMB Review: Survey of Veteran Enrollees' Health and Use of Health Care
Document Number: 2018-22418
Type: Notice
Date: 2018-10-16
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health 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.
Export Trade Certificate of Review
Document Number: 2018-22417
Type: Notice
Date: 2018-10-16
Agency: Department of Commerce, International Trade Administration
The Secretary of Commerce, through the Office of Trade and Economic Analysis (OTEA), issued an amended Export Trade Certificate of Review to FCE on October 4, 2018. A previous amended Export Trade Certificate of Review was issued to FCE on July 17, 2017, and a notice of its issuance was published in the Federal Register on July 31, 2017.
Outdated Regulations-Teacher Quality Enhancement Grants Program and Preparing Tomorrow's Teachers to Use Technology (PT3) Program
Document Number: 2018-22413
Type: Rule
Date: 2018-10-16
Agency: Department of Education
The Secretary removes outdated regulations for two programs no longer authorized by Federal law: The Teacher Quality Enhancement Grants (TQE) program and the Preparing Tomorrow's Teachers to Use Technology (PT3) program. Therefore, the associated regulations are unnecessary.
Significant New Use Rules on Certain Chemical Substances
Document Number: 2018-22397
Type: Proposed Rule
Date: 2018-10-16
Agency: Environmental Protection Agency
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 13 chemical substances which are the subject of premanufacture notices (PMNs). This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these 13 chemical substances for an activity that is designated as a significant new use by this proposed rule. If this proposed rule is made final, persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice, and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any actions as are required as a result of that determination.
Air Quality Designations for the 2015 Ozone National Ambient Air Quality Standards; Corrections
Document Number: 2018-22396
Type: Rule
Date: 2018-10-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is correcting errors in the regulatory text regarding the designation of certain areas in nine states for the 2015 ozone national ambient air quality standards (NAAQS). The designation rules were signed by the EPA Administrator on November 6, 2017, and April 30, 2018. The errors include typographical and formatting errors and the omission from the regulatory tables of several counties designated as attainment/unclassifiable. The EPA is correcting the errors consistent with the rulemaking record. The affected areas are located in California, Illinois, Indiana, Kentucky, Michigan, Montana, Ohio, Pennsylvania and Virginia.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-22278
Type: Proposed Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This proposed AD was prompted by reports of cracking in the frame web, frame integral inboard chord, and fail-safe chord on multiple airplanes in multiple locations below the passenger floor, in addition to an evaluation by the design approval holder (DAH) indicating that certain fuselage frame splices are subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections of certain fuselage upper frames, side frames, fail-safe chords, inboard chords, frame webs, and stringers; an inspection for the presence of repairs in certain inspections zones and open tooling holes; and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-22277
Type: Proposed Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This proposed AD was prompted by reports that frame web and frame integral inboard chord cracking is occurring on multiple airplanes in multiple locations below the passenger floor. This proposed AD would require repetitive detailed, general visual, and high frequency eddy current (HFEC) inspections of the section 43 lower lobe frames at certain stations; an inspection to determine if certain repairs are installed; and applicable on-condition actions. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2018-22275
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variants) airplanes. This AD was prompted by reports of floodlight lamps found burned and the corresponding circuit breaker tripped as a result of fluid entering the cockpit floodlight fixtures. This AD requires installation of new gasket seals on floodlight fixtures. We are issuing this AD to address the unsafe condition on these products.
Amendment of Class E Airspace for Lancaster, PA; and Williamsport, PA
Document Number: 2018-22254
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
This action amends the legal description of Class E surface airspace at Lancaster Airport, Lancaster, PA, by removing the Lancaster VORTAC from the header, and rewording the description for clarity. Also, this action amends the legal description of Class E surface airspace at Williamsport Regional Airport, Williamsport, PA, by removing the Williamsport Regional Airport ILS localizer from the header, and rewording the description for clarity. Finally, this action amends the legal description of Class E airspace designated as an extension to Class D airspace at Williamsport Regional Airport by rewording the description for clarity. This action does not affect the boundaries or operating requirements of the airspace.
Water Quality Standards; Withdrawal of Certain Federal Water Quality Criteria Applicable to California: Lead, Chlorodibromomethane, and Dichlorobromomethane
Document Number: 2018-22170
Type: Rule
Date: 2018-10-16
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking final action to amend the Federal regulations to withdraw certain freshwater acute and chronic aquatic life water quality criteria and certain human health (water and organisms) water quality criteria, applicable to certain waters of California because California adopted, and the Agency approved, criteria for these parameters that are protective of the uses for the waterbodies. In this action, the EPA is amending the Federal regulations to withdraw those certain criteria applicable to California as described in the December 11, 2017 proposed rule. The withdrawal will enable California to implement their EPA-approved water quality criteria.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2018-22154
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. This AD was prompted by a report of cracking at the fastener holes of the left- hand-side support bracket of the elevator bell crank for the control linkage in the vertical stabilizer. This AD requires an eddy current inspection on certain support brackets of the elevator bell crank for any cracking at the fastener holes, a measurement to confirm that the fastener hole diameters are within tolerance, and replacement with a new support bracket of the elevator bell crank if necessary. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
Document Number: 2018-22153
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are superseding Airworthiness Directive (AD) 2006-07-26, which applied to all ATR-GIE Avions de Transport R[eacute]gional Model ATR42 airplanes. AD 2006-07-26 required a one-time inspection to detect discrepancies (e.g., cracking, loose/sheared fasteners, distortion) on the left-hand and right-hand wings, of the outer wing box upper skin and upper rib feet, and repair if necessary. Since we issued AD 2006- 07-26, after initial findings had suggested the cracking was isolated to a few airplanes, we received reports of cracking in these same areas on other Model ATR42 airplanes. This AD requires repetitive inspections to detect discrepancies on the left-hand and right-hand wings, of the outer wing box upper skin and upper rib feet, and repair if necessary. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-22152
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are superseding Airworthiness Directive (AD) 2015-09-07, which applied to all The Boeing Company Model 787 airplanes. AD 2015- 09-07 required a repetitive maintenance task for electrical power deactivation. This AD requires installing new software for the generator control unit (GCU). This AD also removes certain airplanes from the applicability. This AD was prompted by the determination that a Model 787 airplane that has been powered continuously for 248 days can lose all alternating current (AC) electrical power due to the GCUs simultaneously going into failsafe mode. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2018-22147
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are superseding Airworthiness Directive (AD) 2017-16-07, which applied to certain Airbus SAS Model A330-200, A330-200 Freighter, A330-300, A340-500, and A340-600 series airplanes; and Model A340-313 airplanes. AD 2017-16-07 required inspection of the fuselage bulk cargo door frames at specific locations, and corrective action if necessary. This AD requires new inspections of certain attachment holes for residual surface treatment and cracking, and corrective action if necessary; and provides an optional terminating action for the inspections. This AD also revises the applicability to add certain airplanes and remove others. This AD was prompted by a determination that only airplanes having certain manufacturer serial numbers (MSNs) are affected by tartaric sulfuric anodizing (TSA)/chromic acid anodizing (CAA) surface treatment in the door fitting attachment holes, and that airplanes having certain MSNs were excluded. This AD is intended to complete certain mandated programs intended to support the airplane reaching its limit of validity (LOV) of the engineering data that support the established structural maintenance program. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2018-22144
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model DHC-8-400 series airplanes. This AD was prompted by a report of uncommanded deployment of the ground spoilers when the power levers were advanced for takeoff, which was caused by faulty switches in the power lever module. This AD requires revising the maintenance or inspection program, as applicable. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
Document Number: 2018-22140
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 airplanes. This AD was prompted by a determination that more restrictive maintenance requirements and airworthiness limitations are necessary. This AD requires revising the maintenance or inspection program, as applicable, to incorporate new and/or more restrictive maintenance requirements and airworthiness limitations. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2018-22136
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are superseding Airworthiness Directive (AD) 2012-22-10, which applied to certain Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. AD 2012-22-10 required repetitive inspections to determine that cotter pins are installed at affected wing-to-fuselage attachment joints and replacement if necessary. This AD retains the initial inspection of the wing-to-fuselage attachment joints, and removes the repetitive inspections of all but the forward keel beam attachment joint. This AD also changes the repetitive inspection interval for the forward keel beam attachment joint. This AD was prompted by a determination that additional nuts of the forward keel beam attachment joint should be inspected, and that repetitive inspections of certain wing-to-fuselage attachment joints are not necessary. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2018-21965
Type: Rule
Date: 2018-10-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-100, -200, -200C, -300, -400, -500 series airplanes. This AD was prompted by the results of a fleet survey that revealed cracking in the bulkhead frame web at a certain body station. This AD requires repetitive inspections of the bulkhead frame web at a certain station, and applicable on-condition actions. We are issuing this AD to address the unsafe condition on these products.
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