February 21, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. FDA is also proposing new device classification regulations along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

EPA is requesting comment on applications from Hyundai Motor Company (``Hyundai'') and Kia Motors Corporation (``Kia'') for off- cycle carbon dioxide (CO2) credits under EPA's light-duty vehicle greenhouse gas emissions standards. ``Off-cycle'' emission reductions can be achieved by employing technologies that result in real-world benefits, but where that benefit is not adequately captured on the test procedures used by manufacturers to demonstrate compliance with emission standards. EPA's light-duty vehicle greenhouse gas program acknowledges these benefits by giving automobile manufacturers several options for generating ``off-cycle'' CO2 credits. Under the regulations, a manufacturer may apply for CO2 credits for off-cycle technologies that result in off-cycle benefits. In these cases, a manufacturer must provide EPA with a proposed methodology for determining the real-world off-cycle benefit. Hyundai and Kia have submitted applications that describe methodologies for determining off-cycle credits from technologies described in their applications. Pursuant to applicable regulations, EPA is making these off-cycle credit calculation methodologies available for public comment.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term ``protein.'' Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing a new information collection. Note: This is a long-term existing collection previously without an OMB number.

The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty order on certain cold- rolled steel flat products (CR Steel) from the United Kingdom (UK) for the period September 1, 2018, through August 31, 2019, based on the timely withdrawal of the request for review.

The Gulf of Mexico Fishery Management Council will hold a meeting via webinar of its Standing, Reef Fish, Mackerel, Shrimp and Socioeconomic Scientific and Statistical Committees (SSC).

The SEDAR 68 assessment process of Gulf of Mexico and Atlantic scamp will consist of a Data Workshop, and a series of assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.

The Coast Guard is requesting applications from persons interested in serving in membership on the National Commercial Fishing Safety Advisory Committee (``Committee''). This recently established Committee will advise the Secretary of the Department of Homeland Security on matters relating to national commercial fishing safety. Please read this notice for a description of the 18 Committee positions we are seeking to fill.

The National Science Foundation (NSF) is announcing plans to renew this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.

The National Science Foundation (NSF) is announcing plans to establish this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.

NMFS has received a request from the United States Navy (Navy) for the re-issuance of a previously issued incidental harassment authorization (IHA) with the change being a minor modification to the effective dates. The initial IHA authorizes take of one species of marine mammal, by Level B harassment only, incidental to pile driving associated with the South Quay Wall Recapitalization Project, Naval Station Mayport, Florida. The project has been delayed and none of the work covered in the initial IHA has been conducted. The initial IHA has an effective period from February 15, 2020, through February 14, 2021. The Navy has requested re-issuance with new effective dates of July 1, 2020 through June 30, 2021. The scope of the activities and anticipated effects remain the same, authorized take numbers are not changed, and the required mitigation, monitoring, and reporting remains the same as included in the initial IHA. Therefore, NMFS re-issued the IHA.

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). This meeting will be held for soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.

The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and must be submitted (no later than March 23, 2020) to be assured of consideration.

The Department of Commerce (Commerce) is initiating a changed circumstances review (CCR) of the antidumping duty (AD) order on large diameter welded pipe from Greece.

This action establishes Class E airspace extending upward from 700 feet or more above the surface of the earth at Alpine Airport, Alpine, WY. The first area extends upward from 700 feet above the surface and a second area extends upward from 1,200 feet above the surface. The airspace is designed to accommodate new IFR area navigation (RNAV) approaches and IFR departure procedures at the airport, supporting the airport's transition from VFR to IFR operations