2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry entitled ``Arsenic in Apple Juice: Action Level'' that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance identifies for the industry an action level for inorganic arsenic in apple juice that FDA considers protective of human health and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach. In the notice, we requested comments on the draft guidance. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioanalytical Method Validation.'' The draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) for therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs (INADs), New Animal Drug Applications (NADAs), and Abbreviated New Animal Drug Applications (ANADAs)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is revising the guidance to reflect advancements in the science and technology of bioanalytical method validation.

Pursuant to section 102(2)(c) of the National Environmental Policy Act of 1969, and regulations implemented by the Council on Environmental Quality (40 Code of Federal Regulations Parts 1500-1508), and Presidential Executive Order 12114, the Department of the Navy (DoN) has prepared and filed with the U.S. Environmental Protection Agency a Draft Environmental Impact Statement/Overseas Environmental Impact Statement (EIS/OEIS). The Draft EIS/OEIS evaluates the potential environmental effects associated with military readiness training and research, development, test, and evaluation activities (training and testing) conducted within the Mariana Islands Training and Testing (MITT) Study Area. The National Marine Fisheries Service (NMFS), the U.S. Air Force, and the U.S. Coast Guard are cooperating agencies for this EIS/OEIS. The MITT Study Area is composed of established ranges (at-sea ranges and land based training areas on Guam and the Commonwealth of Northern Mariana Islands [CNMI]); operating areas; and special use airspace in the region of the Mariana Islands that are part of the Mariana Islands Range Complex (MIRC) and its surrounding seas; includes a transit corridor between the MIRC and the Hawaii Range Complex; and Navy pierside locations where sonar maintenance and testing activities occur. With the filing of the Draft EIS/OEIS, the DoN is initiating a 60- day public comment period and has scheduled four public meetings to receive comments on the Draft EIS/OEIS. This notice announces the dates and locations of the public meetings and provides supplementary information about the environmental planning effort. DATES and ADDRESSES: The 60-day Draft EIS/OEIS public review period will begin September 13, 2013 and end November 12, 2013. The DoN will hold four public meetings to inform the public about the Proposed Action and alternatives under consideration, and to provide an opportunity for the public to comment on the Proposed Action, alternatives, and the adequacy and accuracy of the analysis in the Draft EIS/OEIS. Each of the public meetings will include an open house information session and an opportunity to present oral comments. DoN representatives will be available during the public meetings to clarify information related to the Draft EIS/OEIS. Federal and local agencies and officials, and interested organizations and individuals are encouraged to provide comments in writing during the public review period or in person at one of the scheduled public meetings. The public meetings will be held between 5:00 p.m. and 8:00 p.m. on the following dates: 1. October 7, 2013, at the University of Guam, Leon Guerrero School of Business and Public Administration Building, Anthony Leon Guerrero Multi-Purpose Room 129, Mangilao, Guam 96923. 2. October 8, 2013, at the Pedro P. Tenorio Multi-Purpose Center in Susupe, Saipan, MP 96950. 3. October 9, 2013, at the Tinian High School Cafeteria, San Jose Village, Tinian, MP 96952. 4. October 10, 2013, at the Sinapalo Elementary School Cafeteria, Sinapalo I, Songsong Village, Rota, MP 96951. Attendees will be able to submit oral and written comments during the public meetings. Oral comments from the public will be recorded by a court reporter. In the interest of available time, and to ensure all who wish to provide an oral comment to the court reporter have the opportunity to do so, each speaker's comments will be limited to three (3) minutes, which may be extended if meeting attendance permits. Equal weight will be given to oral and written statements. Comments may also be submitted via the U.S. Postal Service to Naval Facilities Engineering Command Pacific, Attention: MITT EIS/OEIS Project Manager, 258 Makalapa Drive, Suite 100, Pearl Harbor, HI 96860-3134, or electronically via the project Web site (www.MITT-EIS.com). All comments, oral or written, submitted during the public review period will become part of the public record on the Draft EIS/OEIS and will be responded to in the Final EIS/OEIS. All public comments must be postmarked or received by November 12, 2013, Chamorro Standard Time (ChST) to ensure they become part of the official record.

The Pacific Fishery Management Council's (Pacific Council) Groundfish Management Team (GMT) will hold a working meeting, which is open to the public.

This action deletes products from the Procurement List previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Forest Service intends to prepare an environmental impact statement to analyze and disclose the environmental effects of amending the 2001 Thunder Basin National Grassland Plan to modify Categories 1 and 2 of the 2009 Prairie Dog Management Strategy. The amendment is being proposed to address continuing concerns regarding prairie dog management, raised by the State of Wyoming (April 17, 2013). The Forest Service also proposes to make minor modifications to the 2009 Prairie Dog Management Strategy, as detailed below in the Proposed Action section.

Pursuant to Section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, as amended, the U.S. Army Corps of Engineers (Corps), Seattle District, as lead Federal agency, will prepare a Supplemental Environmental Impact Statement (SEIS) evaluating the Grays Harbor Navigation Improvement Project. The purpose of this supplement is to address proposed changes to the Grays Harbor and Chehalis River Navigation Project developed since the Corps prepared the 1982 Grays Harbor, Chehalis and Hoquiam Rivers, Washington Channel Improvements for Navigation Interim Feasibility Report and Final Environmental Impact Statement (EIS) and its 1989 supplement. The SEIS updates the original EIS and its supplement with more recent relevant environmental information, and updates the description of effects that may potentially occur from implementing the proposed action. The SEIS will evaluate the practicality and potential environmental impacts of three alternatives: two with varying channel depths and no action.

In accordance with Section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department. The public was notified of the availability of the Safety and Security funds with PIH Notice 2013-10 (Notice), which was issued May 3, 2013. Public Housing Authorities (PHAs) were funded in accordance with the terms of the Notice. This announcement contains the consolidated names and addresses of this year's award recipients under the Capital Fund Safety and Security grant program.

The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 670 of the Code of Federal Regulations. This is the required notice of permit applications received.

The Coast Guard is modifying its drawbridge operation regulations by replacing the reference to the SR 310 (Larose Pontoon) Bridge with the LA 657 (Larose) Vertical Lift Bridge. The SR 310 bridge has been taken out of service and has been replaced by the LA 657 bridge. This substitution will also permit the LA 657 bridge to operate under the same schedule as the five other bridges in this area, as opposed to its current open-on-demand schedule.

The Commander, First Coast Guard District, has issued a temporary deviation from the regulations governing the operation of the Atlantic Beach Bridge, mile 0.4, across Reynolds Channel, at Lawrence, New York. This temporary deviation authorizes the Atlantic Beach Bridge to operate under an alternate schedule for 92 days, to facilitate electrical and structural rehabilitation at the bridge.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

Concurrently with the publication of this second notice of request for comments, the National Indian Gaming Commission (NIGC or Commission) intends to submit the following information collections to the Office of Management and Budget (OMB) for review and approval of 3- year extensions under the Paperwork Reduction Act of 1995. The Commission is seeking comments on the renewal of information collections for the following activities: (i) Compliance and enforcement actions under the Indian Gaming Regulatory Act as authorized by OMB Control Number 3141-0001; (ii) tribal gaming ordinance approvals, background investigations, and issuance of licenses as authorized by OMB Control Number 3141-0003; (iii) National Environmental Policy Act submissions as authorized by OMB Control Number 3141-0006; and (iv) issuance to tribes of certificates of self- regulation for Class II gaming as authorized by OMB Control Number 3141-0008. These information collections all expire on October 31, 2013.