September 2016 – Federal Register Recent Federal Regulation Documents

The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the reinstatement and renewal of an existing information collection, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). On July 11, 2016, (81 FR 44863), the FDIC requested comment for 60 days on a proposal to reinstate and renew the information collection described below. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the reinstatement and renewal of this collection, and again invites comment on this proposal.

The Board approves the fourth quarter 2016 Rail Cost Adjustment Factor (RCAF) and cost index filed by the Association of American Railroads. The fourth quarter 2016 RCAF (Unadjusted) is 0.881. The fourth quarter 2016 RCAF (Adjusted) is 0.371. The fourth quarter 2016 RCAF-5 is 0.352.

The Commission announces the next meeting date, time, and agenda of its Consumer Advisory Committee (hereinafter the Committee). The mission of the Committee is to make recommendations to the Commission regarding consumer issues within the jurisdiction of the Commission and to facilitate the participation of consumers (including underserved populations, such as Native Americans, persons living in rural areas, older persons, people with disabilities, and persons for whom English is not their primary language) in proceedings before the Commission.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry to meet the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.

Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the new Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden. On June 3, 2016, FRA published a notice providing a 60-day period for public comment on the ICR.

The Food and Drug Administration (FDA) has determined the regulatory review period for BELVIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYALEPT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

We are advising the public that the Animal and Plant Health Inspection Service has reached a preliminary decision to extend our determination of nonregulated status of J.R. Simplot Company's (Simplot) InnateTM Potato designated as Russet Burbank event W8 (the antecedent potato event) to Simplot's Ranger Russet variety (X17) and Atlantic variety (Y9) potatoes. Simplot's X17 and Y9 potatoes have been genetically engineered for late blight resistance, low acrylamide potential, lowered reducing sugars, and reduced black spot using the same genetic constructs used to transform the antecedent potato event. We are making available for public comment our preliminary determination, preliminary plant pest risk similarity assessment, and preliminary finding of no significant impact for the proposed determination of nonregulated status.

The Office of the Comptroller of the Currency (OCC) announces a meeting of the Minority Depository Institutions Advisory Committee (MDIAC).

Berlaimont Estates LLC (Berlaimont) owns a 680-acre private inholding completely within the White River National Forest (WRNF) to the north of Interstate 70 in the vicinity of Edwards, Colorado. Berlaimont desires to develop the property as 19 individual residential lots. Currently, the subject property may be accessed by National Forest System Roads (NFSR) 774 and 780, which connect to the southeastern corner of the horseshoe-shaped subject property. Beyond the southeastern corner, NFSR 780 connects to the southwestern corner of the property and NFSR 783 connects to the northwestern corner and northern areas of the property from the west side. Additionally, the northern portion of the property may be accessed via NFSR 778 running up Berry Creek which connects with NFSR 783 providing access into the northern portion of the property from the east. All NFSR's in this area are currently low development, native surfaced roads. Berlaimont has applied for an easement to construct, improve, utilize, and maintain road segments across the National Forest System (NFS) lands in support of their desired development of their property. Specifically, Berlaimont is proposing to improve segments of the existing NFSR 774 and NFSR 780, as well as construct a new road segment across additional NFS lands in order to more directly access the northern portion of their property. Their proposed improvements would consist of constructing a paved asphalt road with a gravel shoulder, vehicle turnouts, retaining walls, traffic signs, guardrails, erosion control facilities, and drainage facilities. The Forest Service will be analyzing this proposal along with a wider range of potential alternatives.

This document extends the comment period in the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service announcement that was published in the Federal Register on June 3, 2016.

The Coast Guard is establishing a temporary safety zone on the South Branch of the Chicago River and the Chicago Sanitary and Ship Canal. This action is necessary to protect spectators, participants, and vessels from the hazards associated with the Tough Cup event on these navigable waters in Chicago, IL, on September 24, 2016. This regulation prohibits persons and vessels from being in the safety zone unless authorized by the Captain of the Port Lake Michigan or a designated representative.

The Coast Guard is changing the operating schedule that governs the Florida East Coast Railway (FEC) Railroad Bridge across the New River, mile 2.5, at Fort Lauderdale, FL. This rule implements requirements for the operator to ensure that adequate notice of bridge closure times are available to the waterway traffic. It also changes the schedule from requiring openings ``on demand'' to an operating regulation requiring the bridge to be open no fewer than 60 minutes in every 2 hour period. Changing the bridge operating schedule will allow the bridge owner to operate the Bridge remotely with assistance from the onsite bridge tender.

The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on extensions of previously approved collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).

NMFS issues a proposed rule to implement Amendment 47 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (Crab FMP) and to make minor clarifications to regulations implementing the Crab FMP. This proposed rule addresses how individual processing quota (IPQ) use caps apply to the Bering Sea Chionoecetes bairdi Tanner crab fisheries: The eastern C. bairdi Tanner (EBT) and the western C. bairdi Tanner (WBT). This proposed rule would exempt EBT and WBT IPQ crab that is custom processed at a facility through contractual arrangements with the processing facility owners from being applied against the IPQ use cap of the processing facility owners, thereby allowing a facility to process more crab without triggering the IPQ use cap. This proposed exemption is necessary to allow all of the EBT and WBT Class A individual fishing quota crab to be processed at the facilities currently processing EBT and WBT crab, and would have significant positive economic effects on the fishermen, processors, and communities that participate in the EBT and WBT fisheries. This proposed rule is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Crab FMP, and other applicable law.

In accordance with section 812 of the Bipartisan Budget Act of 2015 (BBA section 812), these rules explain how we will address evidence furnished by medical sources that meet one of BBA section 812's exclusionary categories (excluded medical sources of evidence) as described below. Under these new rules, we will not consider evidence furnished by an excluded medical source of evidence unless we find good cause to do so. We identify five circumstances in which we may find good cause. In these rules, we also require excluded medical sources of evidence to notify us of their excluded status under section 223(d)(5)(C)(i) of the Social Security Act (Act), as amended, in writing each time they furnish evidence to us that relates to a claim for initial or continuing benefits under titles II or XVI of the Act. These rules will allow us to fulfill obligations that we have under BBA section 812.

Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, and Office of Management and Budget (OMB) Circular No. A-130, notice is hereby given that the Office of the Secretary of Defense (OSD) proposes to alter a system of records, DUSDI 01-DoD, ``Department of Defense (DoD) Insider Threat Management and Analysis Center (DITMAC) and DoD Component Insider Threat Records System,'' last published at 81 FR 31614, May 19, 2016. This system of records exists to: Analyze, monitor, and audit insider threat information for insider threat detection and mitigation within the DoD on threats that persons who have or had been granted eligibility for access to classified information or eligibility to hold sensitive positions may pose to DoD and U.S. Government installations, facilities, personnel, missions, or resources. The system of records will support the DITMAC and DoD Component insider threat programs, enable the identification of systemic insider threat issues and challenges, and provide a basis for the development and recommendation of solutions to deter, detect, and/or mitigate potential insider threats. It will assist in identifying best practices among other Federal Government insider threat programs, through the use of existing DoD resources and functions and by leveraging existing authorities, policies, programs, systems, and architectures. This alteration reflects a change to the categories of individuals by removing the phrase: And who have exhibited actual, probable, or possible indications of insider threat behaviors or activities. Public Law 112-81, 10 U.S.C. 2224 note, Insider Threat Detection, requires the Department to detect and prevent insider threats in order to protect sensitive information and information systems. This authority requires the Department to employ anomaly detection techniques, which logically require ingestion of non-anomalous information in order to identify anomalous information. Accordingly, the individuals subject to the DoD Insider Threat program are those individuals who had or have been granted eligibility or access to classified information.