May 10, 2016 – Federal Register Recent Federal Regulation Documents

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of eight individuals and 69 entities whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (Kingpin Act), 21 U.S.C. 1901-1908, 8 U.S.C. 1182.

Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning freight classification description. A notice was published in the Federal Register at 80 FR 74105 on November 27, 2015. No comments were received.

We, the U.S. Fish and Wildlife Service (Service), announce the availability for comment of a proposed ``Gopher Tortoise Conservation and Crediting Strategy'' to be implemented in Alabama, Georgia, Florida, and South Carolina, where the gopher tortoise occurs but is unlisted.

This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The National Aeronautics and Space Administration (NASA) hereby gives notice of its intent to grant an exclusive license in the United State to practice the inventions described and claimed in U.S. Patent Application Number 14/658,584, titled ``Infrasonic Stethoscope for Monitoring Physiological Processes,'' NASA Case Number LAR-18509-1, to Infrasonix, Inc., having its principal place of business in Lawrenceville, GA. Certain patent rights in this invention have been assigned to the United States of America, as represented by the Administrator of the National Aeronautics and Space Administration. The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 27 CFR 404.7.

In accordance with the requirement of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. 1. Title and purpose of information collection: Repayment of Debt; OMB 3220-0169. When the Railroad Retirement Board (RRB) determines that an overpayment of Railroad Retirement Act or Railroad Unemployment Insurance Act benefits has occurred, it initiates prompt action to notify the annuitant of the overpayment and to recover the money owed the RRB. To effect payment of a debt by credit card, the RRB utilizes Form G-421F, Repayment by Credit Card. The RRB's procedures pertaining to benefit overpayment determinations and the recovery of such benefits are prescribed in 20 CFR 255 and 340. One form is completed by each respondent. Completion is voluntary. The RRB proposes no changes to Form G-421F.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Additive Manufactured Devices.'' FDA has developed this draft leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3- dimensional (3D) printing. Specifically, this draft guidance outlines technical considerations associated with additive manufacturing processes, and testing and characterization for final finished devices fabricated using additive manufacturing. This draft guidance is not final nor is it in effect at this time.

The Coast Guard is modifying the operating schedule that governs the Snake Creek Bridge across Snake Creek, at Islamorada, FL. This final rule changes the drawbridge operating schedule for the Snake Creek Bridge by requiring it to open once an hour between 7 a.m. and 6 p.m. The Bridge Owner, Florida Department of Transportation and Local officials requested this action to assist in reducing vehicle traffic backups caused by bridge openings.

The Coast Guard proposes to modify the operating schedule that governs the Lady's Island Bridge, across the Beaufort River, Mile 536.0 at Beaufort, SC. This modification would allow Lady's Island Bridge to remain closed during peak vehicular traffic times. The bridge owner, South Carolina Department of Transportation, requested this action to assist in reducing traffic caused by bridge openings.

The Food and Drug Administration (FDA) is announcing a public workshop regarding clinical trial design considerations for malaria drug development. FDA is interested in discussing the scientific challenges pertaining to malaria drug development and malaria parasite detection methods used as endpoints in clinical trials. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of the design of clinical trials evaluating new drugs to treat malaria. The input from this public workshop will also help in developing topics for future discussion. Dates and Times: The public workshop will be held on June 30, 2016, from 8:30 a.m. to 4 p.m. Location: The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Bldg. 31 Great Rm., Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.ht m. Seating is limited and available only on a first-come, first-served basis. Contact Persons: Ms. Lori Benner and/or Ms. Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 22, Rm. 6221, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to Malariaworkshop2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. Persons needing a sign language interpreter or other special accommodations should notify Ms. Jessica Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in advance.

The NMFS Southeast Region, in collaboration with the Gulf of Mexico Fishery Management Council (Council), intends to prepare a DEIS to describe and analyze a range of alternatives for management actions to be included in Amendment 42 to the Fishery Management Plan (FMP) for the Reef Fish Resources of the Gulf of Mexico (Amendment 42). Amendment 42 will consider an allocation-based management program for the headboat component of the reef fish recreational fishery in the Gulf of Mexico (Gulf). The purpose of this NOI is to solicit public comments on the scope of issues to be addressed in the DEIS.

The Environmental Protection Agency (EPA) is proposing to approve, in part, and disapprove, in part, changes to the North Carolina State Implementation Plan (SIP), provided by the North Carolina Department of Environmental Quality (NC DEQ) through the Division of Air Quality, to EPA in submittals dated May 16, 2011 (two separate submittals), and September 5, 2013. These SIP submittals modify North Carolina's New Source Review (NSR)Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR)permitting regulations and include the adoption of some federal requirements regarding implementation of the fine particulate matter (PM2.5) national ambient air quality standards (NAAQS) through the NSR permitting program. As a result of the proposed disapproval of a portion of the State's NSR requirements, EPA is also proposing to approve, in part, and disapprove, in part, the PSD elements of North Carolina's infrastructure SIP submittals for the 2008 lead, 2008 8-hour ozone, 2010 sulfur dioxide (SO2), 2010 nitrogen dioxide (NO2) and the 2012 PM2.5 NAAQS, and to convert the Agency's previous conditional approvals of the PSD elements of North Carolina's infrastructure SIP submittals for the 1997 Annual PM2.5 and 2006 24-hour PM2.5 NAAQS to partial approvals and partial disapprovals. This proposed partial disapproval, if finalized, will trigger the requirements for EPA to promulgate a Federal Implementation Plan (FIP) no later than two years from the date of the disapproval unless the State corrects the deficiencies through a SIP revision and EPA approves the SIP revision before EPA promulgates such a FIP.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.