October 26, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for in vitro diagnostic devices for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Thermo Fisher Scientific and The Center for Infection and Immunity, Columbia University. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

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

In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0040, Application for Merchant Mariner Credential (MMC), Application for Merchant Mariner Medical Certificate, Applications for Merchant Mariner Medical Certificate for Entry Level Ratings, Small Vessel Sea Service Form, DOT/USCG Periodic Drug Testing Form, Disclosure Statement for Narcotics, DWI/DUI, and/or Other Convictions, Merchant Mariner Medical Certificates, Recognition of Foreign Certificate. This is a resubmission of this ICR. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.

The Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to schedule the synthetic opioids, N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide (ortho-fluorofentanyl or 2-fluorofentanyl), N-(1-phenethylpiperidin-4- yl)-N-phenyltetrahydrofuran-2-carboxamide (tetrahydrofuranyl fentanyl), and 2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (methoxyacetyl fentanyl), into Schedule I. This action is based on a finding by the Administrator that the placement of ortho- fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle, ortho- fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl.

The Department of the Treasury's Office of Foreign Assets Control (OFAC) has removed from the Specially Designated Nationals and Blocked Persons List (SDN List) the names of persons whose property and interests in property had been blocked pursuant to Sudan sanctions authorities.

The United States Copyright Office (``Copyright Office'' or ``Office'') is conducting the seventh triennial rulemaking proceeding under the Digital Millennium Copyright Act (``DMCA''), concerning possible temporary exemptions to the DMCA's prohibition against circumvention of technological measures that control access to copyrighted works. In this proceeding, the Copyright Office has established a new, streamlined procedure for the renewal of exemptions that were granted during the sixth triennial rulemaking. It is also considering petitions for new exemptions to engage in activities not currently permitted by existing exemptions. On June 30, 2017, the Office published a Notice of Inquiry requesting petitions to renew existing exemptions and comments in response to those petitions, as well as petitions for new exemptions to engage in activities not currently permitted by existing exemptions. The Office has carefully considered the comments received in response to that Notice. With this Notice of Proposed Rulemaking (``NPRM''), the Office intends to recommend each of the existing exemptions for readoption. This NPRM also initiates three rounds of public comment on the newly-proposed exemptions. Interested parties are invited to make full legal and evidentiary submissions in support of or in opposition to the proposed exemptions, in accordance with the requirements set forth below.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. This AD was prompted by reports of skin doublers that disbonded from their skin panels. This AD requires repetitive inspections of fuselage skin panels, and applicable on-condition actions. We are issuing this AD to address the unsafe condition on these products.

This document corrects a correction to a notice of proposed rulemaking (REG-134247-16) that was published in the Federal Register on Friday, September 15, 2017. The notice of proposed rulemaking, published on January 6, 2017, under section 1441 of the Internal Revenue Code of 1986 (Code), relates to withholding of tax on certain U.S. source income paid to foreign persons and requirements for certain claims for refund or credit of income tax made by foreign persons.