April 1, 2019 – Federal Register Recent Federal Regulation Documents

This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, we also are issuing a final rule which responds to comments on the definition and identification of line extension drugs for which we requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.

The Department of Justice is amending the regulations of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) to remove the reference to an outdated guidance document in an explanatory note following the table of separation distances of ammonium nitrate and blasting agents from explosives or blasting agents. This final rule also clarifies that those separation distance requirements apply to all ammonium nitrate.

This final rule makes technical amendments to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) regulations in the Code of Federal Regulations (CFR). These technical changes are being made to remove expired, obsolete, or unnecessary regulations; correct specific headings; and to reflect changes to nomenclature resulting from the transfer of ATF to the Department of Justice from the Department of the Treasury pursuant to the Homeland Security Act of 2002. The changes are designed to update and provide clarity throughout these regulations.

The Securities and Exchange Commission (the ``Commission'') adopted revisions to the Electronic Data Gathering, Analysis, and Retrieval System (``EDGAR'') Filer Manual (``EDGAR Filer Manual'' or ``Filer Manual'') and related rules. The EDGAR system is scheduled to be upgraded on March 11, 2019.

DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the final rule published by the Small Business Administration implementing a section of the National Defense Authorization Act for Fiscal Year 2013 that provided revised and standardized limitations on subcontracting, including the nonmanufacturer rule, that apply to small business concerns, including participants in the 8(a) Program.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2019 to require, for DoD contracts with contractors that have approved purchasing systems, that a contracting officer have written approval from the program manager prior to withholding a consent to subcontract.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2019 that requires the DFARS to be updated to include an instruction on a demonstration project for contractors employing persons with disabilities.

DOD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2017 that requires the preference for the use of fixed-price contracts in the determination of contract type, requires review and approval for certain cost- reimbursement contract types at specified thresholds and established time periods, and requires the use of firm fixed-price contract types for foreign military sales unless an exception or waiver applies.

The Coast Guard proposes to change the special local regulation for the Charlevoix Venetian Night Boat Parade in Michigan by increasing the length of effective period of the existing special local regulation to allow the Patrol Commander additional time to clear vessels from anchoring in the regulated area during the event. In order for the Coast Guard to clear vessel traffic to ensure safety in sufficient time in advance of the event, the Coast Guard proposes to change the effective period broadly to ``a date in late July.'' We invite your comments on this proposed rulemaking.

This action establishes the FAA's policy for issuing air traffic control (ATC) authorizations to persons seeking to operate aircraft that are not equipped with Automatic Dependent Surveillance- Broadcast (ADS-B) Out equipment in ADS-B airspace after January 1, 2020.

The Department of Defense is issuing this final rule to adjust each of its statutory civil monetary penalties (CMP) to account for inflation. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996 and the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), requires the head of each agency to adjust for inflation its CMP levels in effect as of November 2, 2015, under a revised methodology that was effective for 2016 and for each year thereafter.

The Department of the Navy (DoN) proposes to revise portions of its internal regulations that establish the responsibilities and procedures for complying with the National Environmental Policy Act (NEPA). An agency may determine that certain classes of actions normally do not individually or cumulatively have significant environmental impacts and therefore do not require further review under NEPA. Establishing these categories of activities, called categorical exclusions (CATEXs), in the agency's NEPA implementing procedures is a way to reduce unnecessary paperwork and delay. This revision clarifies what types of activities fall under CATEXs and normally do not require additional NEPA analysis.

The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The United Kingdom (``UK'') has provided formal notice of its intention to withdraw from the European Union (``EU''). The withdrawal may happen as soon as April 12, 2019 and may transpire without a negotiated agreement between the UK and EU (``No-deal Brexit''). To the extent there is a No-deal Brexit, affected swap dealers (``SDs'') and major swap participants (``MSPs'') may need to effect legal transfers of uncleared swaps that were entered into before the relevant compliance dates under the CFTC Margin Rule or Prudential Margin Rule (each, as defined herein) and that are not now subject to such rules, in whole or in part. The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is adopting, and invites comments on, an interim final rule amending its margin requirements for uncleared swaps for SDs and MSPs for which there is no prudential regulator (``CFTC Margin Rule'') such that the date used for purposes of determining whether an uncleared swap was entered into prior to an applicable compliance date will not change under the CFTC Margin Rule if the swap is transferred, and thereby amended, in accordance with the terms of the interim final rule in respect of any such transfer, including that the transfer be made solely in connection with a party to the swap's planning for or response to a No-deal Brexit. The interim final rule is designed to allow an uncleared swap to retain its legacy status under the CFTC Margin Rule or Prudential Margin Rule when so transferred.

The Coast Guard is establishing a temporary safety zone on the navigable waters of the Missouri River from mile marker (MM) 226 to MM 360 between Glasgow, MO and Kansas City, MO. This action is necessary to provide for the safety of persons, vessels, and the marine environment on these navigable waters as a result of increasing flood conditions on the river that is threatening to overtop levees. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Upper Mississippi River (COTP) or a designated representative.

We propose to supersede Airworthiness Directive (AD) 2005-20- 01, which applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. AD 2005-20-01 requires repetitive inspections of the vertical stiffeners at left buttock line (LBL) and right buttock line (RBL) 6.15 for cracks; and replacement of both stiffeners with new, improved stiffeners if any stiffener is found cracked. Since we issued AD 2005-20-01, we have received reports of cracks found in the left and right side keel beam upper chords when replacing vertical stiffeners. In addition, we have determined that the replacement stiffener installation degraded the fault current bonding path and could introduce an ignition source in the fuel tank in the event of an electrical hot short or a lightning strike. This proposed AD would require, depending on airplane configuration, replacing the vertical stiffeners at LBL and RBL 6.15 on the rear spar of the wing center section, installing angle and bonding jumpers, installing brackets, applying sealant, and applying paint. We are proposing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term ``posterior cervical screw systems'' is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend and repeal parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.