2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Moving Forward: Collaborative Approaches to Medical Device Cybersecurity.'' FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services, and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts; increase awareness of existing maturity models (i.e. frameworks leveraged for benchmarking an organization's processes) which are used to evaluate cybersecurity status, standards, and tools in development; and to engage the multi- stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity.

Free Atlantic Shark Identification Workshops and Protected Species Safe Handling, Release, and Identification Workshops will be held in January, February, and March of 2016. Certain fishermen and shark dealers are required to attend a workshop to meet regulatory requirements and to maintain valid permits. Specifically, the Atlantic Shark Identification Workshop is mandatory for all federally permitted Atlantic shark dealers. The Protected Species Safe Handling, Release, and Identification Workshop is mandatory for vessel owners and operators who use bottom longline, pelagic longline, or gillnet gear, and who have also been issued shark or swordfish limited access permits. Additional free workshops will be conducted during 2016 and will be announced in a future notice.

On November 18, 2015, the United States Air Force signed the ROD for the Gulf Regional Airspace Strategic Iniitative, Landscape Initiative Eglin Air Force Base, Florida Final Environmental Impact Statement (EIS). This ROD states the Air Force decision is to select Subalternative 1. The decision means that the Air Force will request a more limited set of specific training and emitter activities from its GRASI partner agencies. The selection of Subalternative 1 reduces the amount of training, frequencies, and geographic extent of training that will be requested of partner organizations to reduce the potential for recreational conflicts identified by the public and the potential for environmental impacts. Training and emitter activities, if approved by GRASI GLI partners, would occur in Blackwater River and Tate's Hell State Forests and other select locations in Northwest Florida. The decision was based on matters discussed in the Final EIS; inputs from the public, Native American tribes, and Federal, State and local units of government, and regulatory agencies; and other relevant factors. The Final EIS was made available to the public on June 5, 2015, 2015, through a NOA in the Federal Register (Volume 80, Number 108, Page 32114) with a post-filing waiting period that ended on July 6, 2015. This ROD documents only the Air Force decision on the proposed actions analyzed in the Final EIS. Authority: This NOA is published pursuant to the regulations (40 CFR Sec. 1506.6) implementing the provisions of the National Environmental Policy Act of 1969 (42 U.S.C. 4321, et seq.) and the Air Force's Environmental Impact Analysis Process (32 CFR Secs. 989.21(b) and 989.24(b)(7)).

On November 16, 2015, the Government of the United States received a request from Swimsuit Commission Corporation (SCC) to initiate consultations with the Government of Morocco under Article 4.3.3 of the USMFTA. SCC is requesting that the United States and Morocco consider revising the rules of origin for certain women's and girls' swimwear to address availability of supply of certain printed and piece-dyed warp knit fabrics of polyester or nylon fibers in the territories of the Parties. The President may proclaim a modification to the USMFTA rules of origin for textile and apparel products after reaching an agreement with the Government of Morocco on the modification. CITA hereby solicits public comments on this request, in particular with regard to whether certain printed and piece-dyed warp knit fabrics of polyester or nylon fibers classified under Harmonized Tariff Schedule of the United States (HTSUS) subheading 6004.10 containing between 3 percent and 41 percent elastomeric yarns, in which the elastomeric yarns were engineered for chlorine resistance, can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be submitted by January 6, 2016 to the Chairman, Committee for the Implementation of Textile Agreements, Room 3001, United States Department of Commerce, Washington, DC 20230.

The Department of Transportation (``Department'' or ``DOT'') announces that it is exploring the feasibility of conducting a negotiated rulemaking (Reg Neg) concerning accommodations for air travelers with disabilities addressing inflight entertainment, supplemental medical oxygen, service animals, accessible lavatories on single-aisle aircraft, seating accommodations, and carrier reporting of disability service requests. The Department has hired a convener to speak with interested parties about the feasibility of conducting this Reg Neg. The Department anticipates that the interested parties may include disability advocacy organizations, airlines, airports, airline vendors providing wheelchair assistance, aircraft manufacturers, IFE system manufacturers, movie studios, other IFE content providers, service animal training organizations, and other Federal agencies that have a regulatory interest in these issues such as the Department of Justice, the Federal Communications Commission, and the United States Access Board.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register 80 FR 58791, on September 19, 2015, allowing for a 60 day comment period.

On November 16, 2015, the Government of the United States received a request from American Eagle Outfitters (AEO) to initiate consultations with the Government of Morocco under Article 4.3.3 of the USMFTA. AEO is requesting that the United States and Morocco consider revising the rules of origin for women's and girls' woven garments to address availability of supply of 100% rayon woven fabric in the territories of the Parties. The President may proclaim a modification to the USMFTA rules of origin for textile and apparel products after reaching an agreement with the Government of Morocco on the modification. CITA hereby solicits public comments on this request, in particular with regard to whether 100% rayon woven fabric of Harmonized Tariff Schedule of the United States (HTSUS) subheading 5408 can be supplied by the U.S. domestic industry in commercial quantities in a timely manner. Comments must be submitted by January 6, 2016 to the Chairman, Committee for the Implementation of Textile Agreements, Room 3001, United States Department of Commerce, Washington, DC 20230.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute (NCI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to ElexiMed LLC, a company having a place of business at 5003 Green Mountain Circle, Suite 4, Columbia, MD 21044, USA, to practice the inventions embodied in the following patent applications. Intellectual PropertyPCT Patent Application No. PCT/US2015/ 014601, entitled ``Aza-Englerin AnaloguesNovel Natural Product-Based Nitrogen-Containing Anti-Cancer Agents'' filed February 5, 2015 (HHS Ref. No.: E-090-2014/2-PCT-01); US Provisional Patent Application No. 62/018,381, entitled ``Aza-epoxy-guaiane derivatives and treatment of cancer'' filed June 27, 2014 (HHS Ref. No. E-090-2014/ 1-US-01); and US Provisional Patent Application No. 61/936,285, entitled ``Aza-englerin analogues and use in cancer therapy'' filed February 5, 2014 (HHS Ref. No. E-090-2014/0-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America and the University of Hawaii. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``Development and commercialization of aza-epoxy guaiane derivatives for treatment of renal cancer.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, ElexiMed LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to construction activities as part of a wharf recapitalization project. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting public comment on its proposal to issue an incidental harassment authorization (IHA) to the Navy to incidentally take marine mammals, by Level B harassment only, during the specified activity.

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in this investigation and has issued a limited exclusion order prohibiting respondents Garmin International, Inc. and Garmin USA, Inc., both of Olathe, Kansas, and Garmin (Asia) Corporation of New Taipei City, Taiwan (collectively, ``Garmin''), from importing certain marine sonar imaging devices, including downscan and sidescan devices, products containing the same, and components thereof that infringe certain claims of U.S. Patent Nos. 8,305,840 (``the '840 patent'') and 8,605,550 (``the '550 patent''). The Commission has also issued a cease and desist order against Garmin prohibiting the sale and distribution within the United States of articles that infringe certain claims of the '840 and '550 patents. The Commission has found no violation based on U.S. Patent No. 8,300,499 (``the '499 patent''). The investigation is terminated.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA; 42 United States Code 4321 et seq.), Council on Environmental Quality NEPA implementing regulations (40 Code of Federal Regulations parts 1500 to 1508), and FAA Order 1050.1E, Change 1, Environmental Impacts: Policies and Procedures, the FAA is announcing the availability of and requesting comments on the Second Draft Environmental Assessment for the Kodiak Launch Complex Launch Pad 3 (Second Draft EA). On September 15, 2014, the FAA issued a Draft EA for public review and comment and received 54 written comments and 26 oral comments over the public comment and review period that was extended to November 1, 2014. After taking into consideration the nature of public comments received on the Draft EA, the FAA is providing the public with an opportunity to review and comment on updates and clarification information that have since been added to the EA in response to public comments. The FAA is issuing an updated version of the Draft EA for a second public review and comment period.

Pursuant to section 9(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.) and its implementing regulations, 41 CFR 102-3.65, the National Endowment for the Humanities (NEH) gives notice that the Charter for the Humanities Panel advisory committee was renewed for an additional two-year period on November 25, 2015. The Chairman of NEH determined that the renewal of the Humanities Panel is necessary and in the public interest in connection with the performance of duties imposed upon the Chairperson of NEH by the National Foundation on the Arts and the Humanities Act of 1965, 20 U.S.C. 951 et seq., as amended.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.