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Federal Register Highlights – 5/20/15

May 20, 2015

Unpublished, time-sensitive and proposed rules for May 20, 2015:

TEMPORARY RULE: The Coast Guard is establishing a safety zone for underwater detonation operations in the waters of Apra Outer Harbor, Guam. This rule is effective from 10 a.m. until 4 p.m. on May 15, 2015 and May 21, 2015 (kilo, Local Time). The enforcement period for this rule is from 10 a.m. to 4 p.m. on May 15, 2015 and May 21, 2015. The Coast Guard believes this safety zone regulation is necessary to protect all persons and vessels that would otherwise transit or be within the affected area from possible safety hazards associated with underwater detonation operations. This rule is effective without actual notice from May 20, 2015 through 4 p.m. May 21, 2015 (kilo, Local Time).

PROPOSED RULE: The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA’s understanding of antimicrobial animal drug sales intended for use in specific food-producing animal species. Submit either electronic or written comments on the proposed rule by August 18, 2015.  (To submit comments, visit http://www.regulations.gov. Click here to be taken directly to the commenting page.)

PROPOSED RULE: The Bureau of Industry and Security (BIS) proposes to implement the agreements by the Wassenaar Arrangement (WA) at the Plenary meeting in December 2013 with regard to systems, equipment or components specially designed for the generation, operation or delivery of, or communication with, intrusion software; software specially designed or modified for the development or production of such systems, equipment or components; software specially designed for the generation, operation or delivery of, or communication with, intrusion software; technology required for the development of intrusion software; Internet Protocol (IP) network communications surveillance systems or equipment and test, inspection, production equipment, specially designed components therefor, and development and production software and technology therefor. BIS proposes a license requirement for the export, reexport, or transfer (in-country) of these cybersecurity items to all destinations, except Canada. Although these cybersecurity capabilities were not previously designated for export control, many of these items have been controlled for their “information security” functionality, including encryption and cryptanalysis. This rule thus continues applicable Encryption Items (EI) registration and review requirements, while setting forth proposed license review policies and special submission requirements to address the new cybersecurity controls, including submission of a letter of explanation with regard to the technical capabilities of the cybersecurity items. BIS also proposes to add the definition of “intrusion software” to the definition section of the EAR pursuant to the WA 2013 agreements. Submit comments on or before July 20, 2015. (To submit comments, visit http://www.regulations.gov. Click here to be taken directly to the commenting page.)

PROPOSED RULE: This document contains proposed regulations under section 597 of the Internal Revenue Code (the “Code”). The proposed regulations, which will apply to banks and domestic building and loan associations (and related parties) that receive Federal financial assistance (“FFA”), will modify and clarify the treatment of transactions in which FFA is provided to such institutions. This document also invites comments from the public and requests for a public hearing regarding these proposed regulations. Written or electronic comments and requests for a public hearing must be received by August 18, 2015. (To submit comments, visit http://www.regulations.gov. Click here to be taken directly to the commenting page.)

EDITOR’S NOTE: Please visit my Code of Federal Regulations page to view/download the latest updates to Title 7, Volume 14.

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