February 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes an existing collection of information for 49 CFR part 574, Tire Identification and Recordkeeping, for which NHTSA intends to seek renewed OMB approval. The Federal Register notice with a 60-day comment period was published on November 25, 2014 (79 FR 70271).

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on November 25, 2014 [79 FR 70272]. The 60-day comment period ended on January 25, 2015. The agency received no comment.

This proposed rule would implement a recommendation from the Cherry Industry Administrative Board (Board) to establish free and restricted percentages for the 2014-15 crop year under the marketing order for tart cherries grown in the states of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin (order). The Board locally administers the marketing order and is comprised of producers and handlers of tart cherries operating within the production area. This action would establish the proportion of tart cherries from the 2014 crop which may be handled in commercial outlets at 80 percent free and 20 percent restricted. In addition, this action would increase the carry-out volume of fruit to 50 million pounds for this season. These percentages should stabilize marketing conditions by adjusting supply to meet market demand and help improve grower returns.

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.

The U.S. Office of Personnel Management announces the renewal of the Hispanic Council on Federal Employment (Council). The Commission shall advise the Director of the U.S. Office of Personnel Management (OPM) on the implementation of leading employment practices in an effort to remove any unnecessary barriers to the recruitment, hiring, retention and advancement of Hispanics in the Federal workplace. The Council is an advisory committee composed of Federal employees and Hispanic organizations.

The Agricultural Marketing Service (AMS) is announcing that a referendum will be conducted among eligible sorghum producers and importers regarding the Sorghum Promotion, Research, and Information Order (Order), as authorized under the Commodity Promotion, Research, and Information Act of 1996 (Act).

NMFS issues regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act) to implement decisions of the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Commission or WCPFC) on fishing restrictions related to the oceanic whitetip shark (Carcharhinus longimanus), the whale shark (Rhincodon typus), and the silky shark (Carcharhinus falciformis). The regulations apply to owners and operators of U.S. fishing vessels used for commercial fishing for highly migratory species (HMS) in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention). The regulations for oceanic whitetip sharks and silky sharks prohibit the retention, transshipment, storage, or landing of oceanic whitetip sharks or silky sharks, and require the release of any oceanic whitetip shark or silky shark as soon as possible after it is caught, with as little harm to the shark as possible. The regulations for whale sharks prohibit setting a purse seine on a whale shark and specify certain measures to be taken and reporting requirements in the event a whale shark is encircled in a purse seine net. This action is necessary for the United States to satisfy its obligations under the Convention, to which it is a Contracting Party.

The Rural Utilities Service (RUS) is extending the public comment period for an Environmental Assessment (EA) related to a proposed project by Basin Electric Power Cooperative (Basin Electric). The Western Area Power Administration (Western) and the Bureau of Indian Affairs (BIA) are cooperating agencies in preparation of the EA. The proposed Big Bend to Witten Transmission Line Project (proposed action) consists of an approximately 70-mile long 230-kV single-circuit transmission line, a new Western switchyard called Lower Brule Switchyard, an addition to the existing Witten Substation, and approximately two miles of 230-kV double-circuit transmission line between Big Bend Dam and the new Lower Brule Switchyard. Communications facilities including a microwave relay tower and associated building will also be constructed at the Lower Brule Switchyard and Witten Substation. A portion of the proposed transmission line crosses Indian trust lands of the Lower Brule Sioux Tribe, and the agencies have closely cooperated with the Tribe in preparation of the EA. Basin Electric is requesting RUS financial assistance for the proposed action. To ensure that parties interested in the proposed action are provided adequate opportunity for comment, notices are being reissued and the public comment period is being extended for 30 days.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 4, 2014 (Vol. 79, No. 233, pages 720034) and allowed 60 days for public comment. A total of five public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on November 26, 2014 (Federal Register 70611, Vol. 79, No. 228).

In accordance with the Paperwork Reduction Act of 1995, the Pipeline and Hazardous Materials Safety Administration (PHMSA) invites comments on its intent to request from the Office of Management and Budget (OMB) a three year renewal of form PHMSA F 7000-1.1Annual Report for Hazardous Liquid Pipeline Systems which is currently collected under OMB Control number 2137-0614.

The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each extension collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed for Veterans, Veteran Representatives and health care providers to request reimbursement from the federal government for emergency services at a private institution.

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.

The Notice is hereby given that the U.S. Geological Survey intends to grant to Alpha Mach, Inc., 101-2205 Bombardier, Ste-Julie, Qc, Canada, J3E 2J9, an exclusive license to practice the following: A device for monitoring subsurface temperatures.

The Coast Guard will enforce one safety zone for a fireworks display in the Sector Long Island Sound area of responsibility on the dates and times listed in the table below. This action is necessary to provide for the safety of life on navigable waterways during the event. During the enforcement period, no person or vessel may enter the safety zone without permission of the Captain of the Port (COTP) Sector Long Island Sound or designated representative.

The Coast Guard announces its intent to enter into a cooperative research and development agreement (CRADA) to prepare for a demonstration, the ``Ohio River eNav Technology Demonstration'' of electronic navigation (eNav) technology to be conducted by the Coast Guard, U.S. Army Corps of Engineers, and the National Oceanic Atmospheric Administration. The eNav demonstration will involve the transmission of navigation safety and environmental information via automatic identification system (AIS) technology to the electronic charting system (ECS) displays on bridges of commercial vessels that are operating in the test area. The purpose of the demonstration is to identify the extent to which mariners would benefit from the distribution of e-AtoN information; and the policy changes, the infrastructure, and level of effort needed by the Coast Guard and its partner agencies to operate and maintain this technology. The geographic area to be covered by the Ohio River eNav Technology Demonstration includes the Ohio River from Markland Lock (north of Louisville, KY) to the mouth of the Ohio River, and reaches of the Mississippi River within 45 statute miles of its confluence with the Ohio River. The Coast Guard needs end user participants, who are commercial operators that regularly operate in the Ohio River eNav Technology Demonstration test area, to receive the information via AIS. While the Coast Guard is currently considering partnering with Rose Point Navigation Systems (Rose Point), and CNS, Inc. (CNS), it solicits public comment on the possible participation of other parties in the proposed CRADA, and the nature of that participation.

The Coast Guard proposes to issue a special local regulation on the waters of Charleston Harbor in Charleston, SC during the Charleston Race Week on April 17, 2015 through April 19, 2015. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. The special local regulation would temporarily restrict vessel traffic in a portion of Charleston Harbor, preventing non-participant vessels from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.