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Federal Register Highlights – 9/25/15

September 25, 2015

Unpublished, time-sensitive and proposed rules for September 25, 2015:

TEMPORARY RULE: The Coast Guard has extended and modified a temporary deviation from the operating schedule that governs the Hood Canal Floating Drawbridge across Hood Canal (Admiralty Inlet), mile 5.0, near Port Gamble, WA. The temporary deviation is now effective until 7 p.m. on October 19, 2015 and allows the bridge to open the draw span half-way, 300 feet; as opposed to all the way, which is 600 feet, with at least one hour’s notice and only at or near slack tide. The temporary deviation published in the Federal Register on August 21, 2015 (80 FR 50768), and as modified herein, is effective from September 25, 2015, until 7 p.m. on October 19, 2015.

TEMPORARY RULE: The Coast Guard is temporarily changing the enforcement periods of special local regulations for a recurring marine event in the Fifth Coast Guard District. These regulations apply to the Ocean City Maryland Offshore Grand Prix, a recurring marine event, which will take place this year on October 3–4, 2015. Special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in a portion of the North Atlantic Ocean near Ocean City, MD, during the event. This rule is effective from October 3, 2015, to October 4, 2015.

PROPOSED RULE: The Environmental Protection Agency (EPA or the Agency) is proposing to revise the hazardous waste generator regulations under the Resource Conservation and Recovery Act (RCRA) to improve compliance and thereby enhance protection of human health and the environment. Specifically, EPA proposes to revise certain components of the hazardous waste generator regulatory program; address gaps in the regulations; provide greater flexibility for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner; reorganize the hazardous waste generator regulations to make them more user-friendly and thus improve their usability by the regulated community; and make technical corrections and conforming changes to address inadvertent errors, remove obsolete references to programs that no longer exist, and improve the readability of the regulations. These proposed changes are both a result of EPA’s experience in implementing and evaluating the hazardous waste generator program over the last 30 years, as well as a response to concerns and issues identified by the states and regulated community. Comments must be received on or before November 24, 2015. (To submit comments, visit www.regulations.gov, reference docket number EPA-HQ-RCRA-2012-0121.)

PROPOSED RULE: Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but are often involved in the implementation of the regulations. Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts. To facilitate compliance and to respond to these concerns, the U.S. Environmental Protection Agency (EPA or the Agency) is proposing to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals. Comments must be received on or before November 24, 2015. (To submit comments, visit www.regulations.gov, reference docket number EPA-HQ-RCRA-2007-0932.)

PROPOSED RULE: In this document, the Commission takes further action on a rulemaking it initiated in January 6, 2015, to help guide and accelerate the technological revolutions that are underway involving the transitions from networks based on TDM circuit-switched voice services running on copper loops to all-IP multi-media networks using copper, co-axial cable, wireless, and fiber as physical infrastructure. This Further Notice of Proposed Rulemaking (FNPRM) is only one of a series of Commission actions to protect core values and ensure the success of these technology transitions. In this FNPRM, we take steps to ensure that competition continues to thrive and to protect consumers during transitions. These steps will help to ensure that the technology transitions continue to succeed. Submit comments on or before October 26, 2015. Submit reply comments on or before November 24, 2015. (To submit comments, visit www.regulations.gov, reference GN Docket No. 13-5.)

PROPOSED RULE: The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion. Submit either electronic or written comments on this proposed rule by November 24, 2015. (To submit comments, visit www.regulations.gov, reference docket number FDA-2015-N-2002.)

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