January 23, 2020 – Federal Register Recent Federal Regulation Documents

U.S. Citizenship and Immigration Services (USCIS) in the Department of Homeland Security (DHS) is announcing that nationals of Iran and their dependents are no longer eligible to change to or extend their stay in E-1 or E-2 nonimmigrant status on the basis of the 1955 Treaty of Amity, Economic Relations, and Consular Rights between the United States and Iran (the Treaty of Amity) due to the treaty's termination.

NMFS is prohibiting directed fishing for Pacific cod by catcher vessels less than 60 feet (18.3 meters (m)) length overall (LOA) using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2020 Pacific cod total allowable catch allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

The United States Copyright Office is issuing a supplemental interim rule amending its regulations governing recordation of transfers of copyright ownership, notices of termination, and other documents pertaining to a copyright. This rule supplements the Office's current interim recordation regulations in anticipation of the Office's forthcoming pilot program through which participating remitters will be able to record certain types of documents electronically online. The supplemental interim rule and pilot program are the next step in the recordation modernization process, which will lead to a full public release of the Office's electronic recordation system in the future.

The Mid-Atlantic Fishery Management Council's (Council) Atlantic Mackerel, Squid, and Butterfish (MSB) Advisory Panel will hold a meeting.

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

The Pacific Fishery Management Council's (Pacific Council) Southern Resident Killer Whale Workgroup (Workgroup) will host a webinar, which is open to the public.

NMFS announces that the Commonwealth of Virginia is transferring a portion of its 2019 commercial summer flounder quota to the State of New York. This retroactive adjustment to the 2019 fishing year quota is necessary to comply with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan quota transfer provisions. This announcement informs the public of the retroactively revised 2019 commercial quotas for Virginia and New York.

The National Marine Fisheries Service (NMFS) publishes this proposed Annual Determination (AD) for 2020, pursuant to its authority under the Endangered Species Act (ESA). Through the AD, NMFS identifies U.S. fisheries operating in the Atlantic Ocean, Gulf of Mexico, and Pacific Ocean that will be required to take fisheries observers upon NMFS' request. The purpose of observing identified fisheries is to learn more about sea turtle interactions in a given fishery, evaluate measures to prevent or reduce sea turtle takes, and implement the prohibition against sea turtle takes. Fisheries identified on the 2020 AD (see Table 1) will remain on the AD for a five-year period from the effective date of the final rule and will be required to carry observers upon NMFS' request.

NorthPoint Energy Solutions Inc. (Applicant or NorthPoint) has applied to renew its authorization to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.

The Department of Energy (DOE)/National Nuclear Security Administration (NNSA) is announcing this amendment to the July 2004 Record of Decision (ROD) for the Final Environmental Impact Statement for Construction and Operation of a Depleted Uranium Hexafluoride Conversion Facility at the Portsmouth, Ohio, Site (FEIS) (DOE/EIS- 0360). In this amended ROD, DOE/NNSA is announcing its decision to implement its preferred alternative for the construction and operation of a depleted uranium hexafluoride (DUF6) conversion facility at the Portsmouth, Ohio, a DOE Office of Environmental Management (EM) site. This amended ROD addresses DOE/NNSA's intent to construct and operate a fourth process line within the conversion facility, as previously analyzed in the aforementioned FEIS.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled ``Draft Guidance for Levonorgestrel.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device.

The Office of Fossil Energy (FE) of the Department of Energy gives notice that during November 2019, it issued orders granting authority to import and export natural gas, to export liquefied natural gas (LNG), and to vacate 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- 2019. 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.

The 21st Century Integrated Digital Experience Act requires any public website of an executive agency to comply with GSA's website standards. GSA publishes the standards at https:// designsystem.digital.gov/website-standards. To notify agencies of revisions to the website standards, GSA will periodically update the U.S. Web Design System website and publish notices in the Federal Register.

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final guidances for industry entitled ``Clinical Drug Interaction StudiesCytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions'' and ``In Vitro Drug Interaction StudiesCytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.'' These guidances finalize the draft guidances entitled ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' and ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' published in October 2017. The final guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that VYONDYS 53 (golodirsen), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher.

The U.S. Small Business Administration (SBA) is considering granting a request for a class waiver of the Nonmanufacturer Rule (NMR) for leather holsters (M18 System) and accessories. According to the request, no small business manufacturers can manufacture and supply a specific proprietary holster system to the Federal government. If granted, the class waiver would allow otherwise qualified regular dealers to supply the waived item(s), regardless of the business size of the manufacturer, on a Federal contract set aside for small business, service-disabled veteran-owned small business (SDVOSB), women-owned small business (WOSB), economically disadvantaged women-owned small business (EDWOSB), historically underutilized business zones (HUBZone), or participants in the SBA's 8(a) Business Development (BD) program.