October 16, 2018 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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 This final guidance incorporates public comments to the draft guidance published in the Federal Register of December 18, 2017.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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.