January 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507.'' The draft guidance describes FDA's current thinking on the concept of ``same level of public health protection'' (SLPHP), and FDA's expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under (part 112) 21 CFR part 112 or the preventive controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 meets the SLPHP threshold under the foreign supplier verification program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.

This final rule makes changes and clarifications to the revised uniform procedures implementing State highway safety grant programs in response to comments received on the interim final rule published May 23, 2016.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend the licensing, inspection, special project, and annual fees charged to its applicants and licensees. These proposed amendments are necessary to implement the Omnibus Budget Reconciliation Act of 1990, as amended (OBRA-90), which requires the NRC to recover approximately 90 percent of its annual budget through fees; amounts appropriated for Waste Incidental to Reprocessing (WIR), generic homeland security activities, and Inspector General (IG) services for the Defense Nuclear Facilities Safety Board, as well as any amounts appropriated from the Nuclear Waste Fund, are excluded from this fee-recovery requirement. The NRC is issuing the fiscal year (FY) 2018 proposed fee rule based on the FY 2018 budget request since full-year appropriations have not yet been enacted for FY 2018. The NRC is using $967.0 million for the total budget authority in the proposed fee rule because it has included an adjustment to account for funding of $15.0 million for the Integrated University Program, which was not included in the budget request, but has historically been included by Congress in the final appropriations bill. Based on that total budget authority, the NRC is proposing to collect $826.7 million in fees in FY 2018. If the NRC receives an appropriation providing a different total budget authority, the final fee rule will reflect the final appropriation.

NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 60 feet (18.3 meters (m)) length overall (LOA) using pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the A season apportionment of the 2018 Pacific cod total allowable catch allocated to catcher vessels greater than or equal to 60 feet (18.3m) LOA using pot gear in the BSAI.

NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod total allowable catch apportioned to trawl catcher vessels in the Central Regulatory Area of the GOA.

The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to clarify the authority to acquire order-level materials (OLMs) when placing an individual task or delivery order against a Federal Supply Schedule (FSS) contract or FSS blanket purchase agreement (BPA). OLMs are supplies and/or services acquired in direct support of an individual task or delivery order placed against an FSS contract or BPA, when the supplies and/or services are not known at the time of contract or BPA award.

NMFS is prohibiting directed fishing for Pacific cod by catcher/processors using pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the A season apportionment of the 2018 Pacific cod total allowable catch allocated to catcher/processors using pot gear in the BSAI.

This document is issued under the joint authority of DOD, GSA, and NASA. This Small Entity Compliance Guide has been prepared in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of the rule appearing in Federal Acquisition Circular (FAC) 2005-97, which amends the Federal Acquisition Regulation (FAR). An asterisk (*) next to a rule indicates that a regulatory flexibility analysis has been prepared. Interested parties may obtain further information regarding this rule by referring to FAC 2005-97, which precedes this document. These documents are also available via the internet at https:// www.regulations.gov.

This document summarizes the Federal Acquisition Regulation (FAR) rule agreed to by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) in this Federal Acquisition Circular (FAC) 2005-97. A companion document, the Small Entity Compliance Guide (SECG), follows this FAC. The FAC, including the SECG, is available via the internet at https://www.regulations.gov.

We propose to adopt a new airworthiness directive (AD) for GE Aviation Czech s.r.o. M601D-11, M601E-11, M601E-11A, M601E-11AS, M601E- 11S, M601F, H80, H80-100, H80-200, H75-100, H75-200, H85-100, and H85- 200 turboprop engines. This proposed AD was prompted by a review by the manufacturer that identified the possibility of a power turbine (PT) rotor overspeed and the uncontained release of PT blades. This proposed AD would require installing a modified engine outlet system. We are proposing this AD to address the unsafe condition on these products.

The Commission amends the Rules and Regulations Under the Textile Fiber Products Identification Act (``Textile Rules'') to delete the requirement that an owner of a registered word trademark, used as a house mark, furnish the FTC with a copy of the mark's registration with the United States Patent and Trademark Office (``USPTO'') before using the mark on labels.

The United States Office of Personnel Management (OPM) is issuing a final rule amending Federal Employees Health Benefits (FEHB) Program regulations to provide a process for removal of certain identified individuals who are found not to be eligible as family members from FEHB enrollments. This process would apply to individuals for whom there is a failure to provide adequate documentation of eligibility when requested. This action also amends Federal Employees Health Benefits (FEHB) Program regulations to allow certain eligible family members to be removed from existing self and family or self plus one enrollments.

This action amends the legal description of the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, by correcting the geographic coordinates of the heliport and point in space coordinates. This action does not affect the boundaries or operating requirements of the airspace.

Whenever a new or revised National Ambient Air Quality Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires states to submit a plan for the implementation, maintenance, and enforcement of the standard, commonly referred to as infrastructure requirements. The Environmental Protection Agency (EPA) is proposing to approve the Alaska State Implementation Plan (SIP) as meeting specific infrastructure requirements for the fine particulate matter (PM2.5) NAAQS.

We, the U.S. Fish and Wildlife Service (Service), determine the eastern puma (=cougar) (Puma (=Felis) concolor couguar) to be extinct, based on the best available scientific and commercial information. This information shows no evidence of the existence of either an extant reproducing population or any individuals of the eastern puma subspecies; it also is highly unlikely that an eastern puma population could remain undetected since the last confirmed sighting in 1938. Therefore, under the authority of the Endangered Species Act of 1973 (Act), as amended, we remove this subspecies from the Federal List of Endangered and Threatened Wildlife.

The Postal Service is adding language for clarification purposes to ensure that the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.

NMFS establishes the annual harvest guideline for the commercial lobster fishery in the Northwestern Hawaiian Islands for calendar year 2018 at zero lobsters.

This action proposes to amend Class D airspace, and Class E airspace extending upward from 700 feet above the surface at Castle Airport, Atwater, CA, to accommodate airspace redesign due to the decommissioning of the El Nido VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME) as the FAA transitions from ground-based to satellite-based navigation. Also, this action would update the airport's geographic coordinates to match the FAA's aeronautical database. This action also would make an editorial change to the Class D airspace legal description replacing ``Airport/Facility Directory'' with the term ``Chart Supplement''. These actions are necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are announcing receipt of a proposed amendment to the Alabama regulatory program (Alabama program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Alabama proposes revisions to its program regarding annual permit fees. Alabama revised its program at its own initiative to raise revenues sufficient to fund the Alabama Surface Mining Commission's (ASMC) share of costs to administer their coal regulatory program, including the cost of reviewing, administering, inspecting, and enforcing surface coal mining permits in Alabama. This document gives the locations and times where the Alabama program documents and proposed amendment to that program are available for your inspection, establishes the comment period during which you may submit written comments on the amendment, and describes the procedures we will follow for the public hearing, if one is requested.

The Environmental Protection Agency (EPA) is proposing to approve revisions to the portions of Idaho's State Implementation Plan (SIP) related to agricultural crop residue burning. The Director of the Idaho Department of Environmental Quality (IDEQ) submitted the revisions to EPA on September 22, 2017. IDEQ supplemented the original submission with photochemical modeling analyses on October 23, 2017. The revisions change the ambient ozone concentration level at which IDEQ may approve a permittee's request to burn. EPA is proposing to approve the revisions because they satisfy the requirements of the Clean Air Act. This action is being taken under section 110 of the Clean Air Act (the Act or CAA).

We, NMFS, announce a final rule to list the giant manta ray (Manta birostris) as threatened under the Endangered Species Act (ESA). We have reviewed the status of the giant manta ray, including efforts being made to protect this species, and considered public comments submitted on the proposed rule as well as new information received since publication of the proposed rule. We have made our final determinations based on the best scientific and commercial data available. At this time, we conclude that critical habitat is not determinable because data sufficient to perform the required analyses are lacking; however, we solicit information on habitat features and areas in U.S. waters that may meet the definition of critical habitat for the giant manta ray.

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the ``2018 Requirements.'' The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

The Federal Trade Commission (``FTC'' or ``Commission'') is implementing adjustments to the civil penalty amounts within its jurisdiction to account for inflation, as required by law.

We are superseding Airworthiness Directive (AD) 2008-06-20 R1, which applied to all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes, and certain Model F28 Mark 1000, 2000, 3000, and 4000 airplanes. AD 2008-06-20 R1 required revising the Airworthiness Limitations Section (ALS) of the Instructions for Continued Airworthiness for certain airplanes, and the maintenance or inspection program, as applicable, for certain other airplanes, to incorporate new limitations for fuel tank systems. AD 2008-06-20 R1 also clarified the intended effect on spare and on-airplane fuel tank system components, regarding the use of maintenance manuals and instructions for continued airworthiness. This new AD was prompted by revised fuel airworthiness limitation items (ALI) tasks, and critical design configuration control limitations (CDCCL) items, and associated thresholds, intervals, and instructions. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition on these products, and doing the actions specified in those instructions. We are issuing this AD to address the unsafe condition on these products.

The Coast Guard is reopening the comment period to solicit additional comments concerning its Notice of Temporary Deviation from the operating schedule that governs the DELAIR Memorial Railroad Bridge across the Delaware River, mile 104.6, at Pennsauken Township, NJ. This document is to provide additional opportunity for public comment.