June 1, 2015 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Office of the Comptroller of the Currency (OCC) gives notice of a proposed new system of records entitled ``Treasury/CC .800Office of Inspector General Investigations System.''

The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. NPF-90, issued to the Tennessee Valley Authority (TVA), for operation of the Watts Bar Nuclear Plant (WBN), Unit 1. The amendment request would revise the approved Cyber Security Plan for the WBN site, and clarify the demarcation point (so called Bright-Line) between digital components under NRC jurisdiction, and those under the jurisdiction of the Federal Energy Regulatory Commission (FERC). Specifically, certain equipment located within the WBN, but owned by the Transmission and Power Supply business unit, will be classified either as NRC-regulated or FERC-regulated. This demarcation will allow both the NRC and licensee to use the correct process for information associated with the specific equipment. For this amendment request, the NRC proposes to determine that it involves no significant hazards consideration. In addition, the amendment request contains sensitive unclassified non- safeguards information (SUNSI).

The Coast Guard has issued a temporary deviation from the operating schedule that governs the California Department of Transportation highway drawbridge across the Mokelumne River, mile 3.0, at East Isleton, CA. The deviation is necessary to allow the bridge owner to perform rehabilitation to the bridge control house. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

This notice sets forth the schedule and proposed agenda of a meeting of the Environmental Technologies Trade Advisory Committee (ETTAC).

The Federal Prevailing Rate Advisory Committee is issuing this notice to cancel the July 16, 2015, public meeting scheduled to be held in Room 5A06A, U.S. Office of Personnel Management Building, 1900 E Street NW., Washington, DC. The original Federal Register notice announcing this meeting was published Monday, December 8, 2014, at 79 FR 72714, with a correction published Wednesday, December 17, 2014, at 79 FR 75189.

The Coast Guard will enforce the safety zone for the Berkeley Marina Fourth of July Fireworks display in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to remove the Bone Cave harvestman (Texella reyesi) from the List of Endangered and Threatened Wildlife under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition does not present substantial scientific or commercial information indicating that the petitioned action may be warranted. Therefore, we are not initiating a status review in response to this petition. However, we ask the public to submit to us any new information that becomes available concerning the status of, or threats to, the Bone Cave harvestman or its habitat at any time.

The Coast Guard will enforce the safety zone for the Fourth of July Fireworks, City of Eureka in the Captain of the Port, San Francisco area of responsibility during the dates and times noted below. This action is necessary to protect life and property of the maritime public from the hazards associated with the fireworks display. During the enforcement period, unauthorized persons or vessels are prohibited from entering into, transiting through, or anchoring in the safety zone, unless authorized by the Patrol Commander (PATCOM).

The U.S. Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Fine Particulate Matter (PM2.5) NAAQS Implementation Rule (Renewal)'' (EPA ICR No. 2258.04, OMB Control No. 2060-0611), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed renewal of a currently approved information collection which was originally approved in conjunction with the EPA's now-remanded 2007 final rule addressing implementation-related requirements for the 1997 PM2.5 National Ambient Air Quality Standards (NAAQS) and renewed twice since then. On March 23, 2015, the EPA also proposed a new ICR associated with its Notice of Proposed Rulemaking that would replace the remanded 2007 PM2.5 NAAQS Implementation Rule. Until that ICR is approved, the existing ICR will remain in effect, subject to approval of this proposed renewal.

The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Montana on March 17, 2010, August 1, 2011, November 22, 2011, and September 19, 2014. The revisions are to the Administrative Rules of Montana (ARM) and include minor editorial and grammatical changes, updates to citations and references to federal and state laws and regulations, revisions to open burning rules, changes to the process for appealing air quality permits, and providing a process for revocation of air quality permits when owners cannot be found by mail. Also in this action, EPA is proposing to correct final rules pertaining to Montana's SIP. On January 29, 2010, EPA took direct final action to approve SIP revisions as submitted by the State of Montana on January 16, 2009 and May 4, 2009. EPA subsequently discovered an error in our January 29, 2010 direct final action related to ``incorporation by reference'' (IBR) materials and the associated regulatory text numbering. EPA is proposing to correct this error with today's action. This action is being taken under section 110 of the Clean Air Act (CAA).

In accordance with section 113(g) of the Clean Air Act (the ``Act''), 42 U.S.C. 7413(g), notice is hereby given of a proposed settlement agreement to address a lawsuit filed by National Parks Conservation Association, Minnesota Center for Environmental Advocacy, Friends of the Boundary Waters, Voyageurs National Park Association, Fresh Energy, and the Sierra Club (collectively, ``Plaintiffs'') and Intervenor Defendant Northern States Power Company Minnesota, d/b/a Xcel Energy in the United States District Court for the District of Minnesota: National Parks Conservation Association, et al. v. EPA, Civ. No. 12-3043 (D. Minn.). On December 5, 2012, Plaintiffs filed a complaint alleging that the Administrator of the United States Environmental Protection Agency (``EPA'') had failed to perform a mandatory duty to respond to a 2009 letter by the Department of the Interior (``DOI'') certifying that visibility impairment in Minnesota's Voyageurs National Park and Michigan's Isle Royale National Park is reasonably attributable to emissions from Xcel Energy's coal-fired Sherburne County Generating Station (``Sherco'') in Minnesota. The proposed settlement agreement addresses Plaintiffs' claims and establishes a deadline for EPA to take final action to revise the Minnesota Reasonably Attributable Visibility Impairment (``RAVI'') Federal Implementation Plan (``FIP'').

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Idaho National Laboratory. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: nimhprapubliccomments@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: The National Institute of Mental Health Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control Number 0925-0697. National Institute of Mental Health, National Institutes of Health. Need and Use of Information Collection: Recruitment Milestone Reporting (RMR) allows NIMH staff to monitor more accurately the required recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure proper use of the grant funds. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Studies that fail to meet their milestones may be requested to provide interim monthly reports. The primary use of this information is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, and potentially increase efficiency in our funding process. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2295.

The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The New England Fishery Management Council (Council) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products.'' The purpose of this guidance is to provide applicants of new drug applications, abbreviated new drug applications, and biologic license applications with FDA's current thinking on established conditions (i.e., the chemistry, manufacturing, and controls (CMC) information in a submission that would require reporting to FDA if changed for approved drug and biologic products, per the current regulations). This guidance also describes those sections of a common technical document formatted application that typically contain information that meets the definition of established conditions, and provides considerations for managing changes to established conditions over the life cycle of an approved product.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Section 6025 of the Agricultural Act of 2014 (2014 Farm Bill) enables the Secretary of Agriculture to provide priority to projects that support Strategic Economic and Community Development plans. This Notice invites applicants who have submitted or will be submitting applications for the programs (referred to as ``underlying programs'') in Fiscal Year 2015. For FY 2015, projects eligible for Section 6025 priority points will compete one time with all other projects eligible for the applicable underlying program's year-end pool of funds. These priority points are not eligible to projects competing for FY 2015 funding prior to the program's year-end pool of funds competition. All applicants are responsible for any additional expenses incurred in preparing and submitting Form RD 1980-88.