November 2018 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HHS published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to consider alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. On November 2, 2018, HHS issued a proposed rule to solicit comments to change the effective date from July 1, 2019, to January 1, 2019, and to cease any further delay of the rule. HHS proposed this action because it determined that the January 5, 2017, final rule has been subject to extensive public comment, and had been delayed several times. HHS has considered the full range of comments on the substantive issues in the January 5, 2017, final rule. After consideration of the comments received on the effective date of the proposed rule, HHS is changing the effective date of the January 5, 2017, final rule, to January 1, 2019.

As a result of the determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on xanthan gum from the People's Republic of China (China) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, Commerce is publishing a notice of continuation of the AD duty order.

This action proposes an in-season adjustment to the Atlantic herring specifications and sub-annual catch limits for 2019. These adjustments are necessary to reduce 2018 herring catch limits that would otherwise remain in effect for 2019. This action is intended to prevent overfishing of the herring resource while minimizing negative social and economic impacts of reduced catch limits.

The Acting Assistant Deputy Secretary for Innovation and Improvement announces priorities, requirements, definitions, and selection criteria for Grants to Charter Management Organizations for the Replication and Expansion of High-Quality Charter Schools (CMO grants or CMO grant program) under the Expanding Opportunity Through Quality Charter Schools Program (CSP), Catalog of Federal Domestic Assistance (CFDA) number 84.282M. We may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2019 and later years. We take this action to support the replication and expansion of high-quality charter schools by charter management organizations (CMOs) throughout the Nation, particularly those that serve educationally disadvantaged students, such as students who are individuals from low-income families, students with disabilities, and English learners; and students who traditionally have been underserved by charter schools, such as Native American students and students in rural communities.

In accordance with the National Environmental Policy Act of 1969, as amended, the Bureau of Land Management (BLM) has prepared a Draft Environmental Impact Statement (EIS) for the proposed Caldwell Canyon Mine Project, and by this notice is announcing the opening of the comment period.

The U.S. Copyright Office is amending its regulations governing the group registration options for newsletters and serials. With respect to group newsletters, the final rule amends the definition of ``newsletter,'' eliminating the requirement that each issue must be a work made for hire, and the provision stating that group newsletter claims must be received within three months after publication. Under the final rule, newsletter publishers now should register their issues with the online application and upload a digital copy of each issue through the electronic registration system instead of submitting them in a physical form. With respect to group serials, the final rule clarifies that serials governed by the rule generally must be published at intervals of a week or longer, and that the publication dates provided in the application need not match the dates appearing on the issues themselves. In addition, the rule phases out the paper application for group serials and the submission of physical copies. Beginning one year after the rule goes into effect, serial publishers will be required to use the online application for group serials and to upload a digital copy of each issue, rather than submitting them in a physical form. The final rule updates the regulations for both newsletters and serials by confirming that publishers do not need to provide the Library of Congress with complimentary subscriptions to or microfilm of each issue as a condition for registering their works with the Office, but newsletter and serial issues that are submitted for purposes of registration will no longer satisfy the mandatory deposit requirement. Publishers will be expected to separately provide the Library with two complimentary subscriptions if the newsletter or serial is published in the United States in a physical format (unless the publisher is informed that the publication is not needed for the Library's collections). If the newsletter or serial is published solely in electronic form, the publisher will remain exempt from mandatory deposit unless the Office issues a formal demand for copies of that publication.

The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Application to Become a Savings and Loan Holding Company or to Acquire a Savings Association or Savings and Loan Holding Company (FR LL-10(e); OMB No. 7100-0336).

The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, without revision, the Domestic Branch Notification (FR 4001; OMB No. 7100- 0097).

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during October 2018, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), and vacating prior authorization. These orders are summarized in the attached appendix and may be found on the FE website at https://www.energy.gov/fe/listing- doefe-authorizationsorders-issued-2018-0. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

In this action, the EPA proposes to amend the 2015 New Source Performance Standards (NSPS) for new residential hydronic heaters and new forced-air furnaces by adding a two-year ``sell-through'' period for all affected new hydronic heaters and forced-air furnaces that are manufactured or imported before the May 2020 compliance date to be sold at retail through May 2022. This will allow retailers additional time, after the May 2020 effective date of the ``Step 2'' standards, for the sale of ``Step 1'' compliant hydronic heaters and forced-air furnaces remaining in inventory. The EPA is also taking comment on whether a sell-through period for all affected new residential wood heaters is appropriate following the May 2020 compliance date and, if so, how long a sell-through period is needed and why. In addition, this action is taking comment on whether the current minimum pellet fuel requirements should be retained and, if so, whether they should be revised.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NESHAP for Industrial, Commercial, and Institutional Boilers and Process Heaters (EPA ICR No. 2028.09, OMB Control No. 2060-0551), 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.

This document corrects an error that appeared in the final rule with comment period published in the Federal Register on November 21, 2018, entitled ``Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.'' Specifically, this document corrects the public comment period end date. The corrected date is January 2, 2019.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons 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.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), Council on Environmental Quality NEPA implementing regulations, and FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, the FAA is announcing the availability of and requesting comment on the Draft Environmental Assessment for Issuing SpaceX a Launch License for an In-flight Dragon Abort Test, Kennedy Space Center, Brevard County, Florida (Draft EA).

Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is proposing to approve a portion of the revision to the Arkansas State Implementation Plan (SIP) that addresses certain requirements of the CAA and the EPA's regional haze rules for the protection of visibility in mandatory Class I Federal areas (Class I areas) for the first implementation period. The EPA is proposing to approve the portions of the SIP revision addressing the best available retrofit technology (BART) requirements for sulfur dioxide (SO2), particulate matter (PM) and nitrogen oxide (NOX) for seven electric generating units (EGUs) in Arkansas. The EPA is also proposing to approve the determination that no additional controls at any Arkansas sources are necessary under reasonable progress; calculation of the revised reasonable progress goals (RPGs) for Arkansas' Class I areas; certain components of the long-term strategy for making reasonable progress; the clarification that both the 6A and 9A Boilers at the Georgia-Pacific Crossett Mill are BART-eligible; and the additional information and technical analysis in support of the determination that the Georgia-Pacific Crossett Mill 6A and 9A Boilers are not subject to BART. In conjunction with our proposed approval of portions of the SIP revision, we are proposing to withdraw the corresponding federal implementation plan (FIP) provisions established in a prior action to address regional haze requirements for Arkansas.

We are adopting a new airworthiness directive (AD) for Leonardo S.p.A. (Leonardo) Model AW189 helicopters. This AD requires replacing the tail plane lower fitting with an improved tail plane lower fitting. This AD was prompted by reports of cracks on the tail plane fittings of Model AW189 helicopters. The actions of this AD are intended to correct an unsafe condition on these products.

This notice advises the public of the Animal and Plant Health Inspection Service's record of decision for the final environmental impact statement titled ``Cattle Fever Tick Eradication ProgramTick Control Barrier: Maverick, Starr, Webb, and Zapata Counties, Texas.''

The Committee is proposing to delete a product and services from the Procurement List that was previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that certain model year (MY) 2016 Chevrolet Equinox multipurpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and were certified by their manufacturer as complying with the safety standards (the U.S.-certified 2016 Chevrolet Equinox MPVs) and are capable of being readily altered to conform to the standards.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that certain model year (MY) 2016 Mercedes-Benz GL500 multipurpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and were certified by their manufacturer as complying with the safety standards (the U.S.-certified 2016 Mercedes-Benz GL550 MPV) and are capable of being readily altered to conform to the standards.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that certain model year (MY) 2011 Mercedes-Benz GL550 multipurpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), but that are certified by their original manufacturer as complying with all applicable Canadian motor vehicle safety standards (CMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified 2011 Mercedes-Benz GL550 MPVs and are capable of being readily altered to conform to the standards.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that certain model year (MY) 2008 Jeep Grand Cherokee multipurpose passenger vehicles (MPVs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified 2008 Jeep Grand Cherokee MPV) and are capable of being readily altered to conform to the standards.

In accordance with the Paperwork Reduction Act of 1995, the U.S. Geological Survey is proposing to renew an information collection.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the S168/Great Bridge bridge. This bridge carries SR168 (Battlefield Boulevard South) over the Atlantic Intracoastal Waterway (AICW), Albemarle and Chesapeake Canal, mile 12.0, at Chesapeake, VA. The deviation is necessary to facilitate the Annual Chesapeake Rotary Christmas Parade. This deviation allows the bridge to remain in the closed-to-navigation position.