August 2, 2013 – Federal Register Recent Federal Regulation Documents

NMFS proposes regulations to implement Framework Adjustment 2 to the Atlantic herring Fishery Management Plan and the 2013-2015 fishery specifications for the Atlantic herring fishery. Framework 2 would allow the New England Fishery Management Council to split annual catch limits seasonally for the four Atlantic herring management areas, and the carryover of unharvested catch, up to 10 percent for each area's annual catch limit. The specifications would set catch specifications for the herring fishery for the 2013-2015 fishing years and would establish seasonal splits for management areas 1A and 1B as recommended to NMFS by the New England Fishery Management Council.

The Department of Commerce's Chief Financial Officer and Assistant Secretary for Administration has renewed the charter for the NOAA Science Advisory Board (SAB) for a period of two years from the date of the filing of the charter with the appropriate U.S. Senate and House of Representatives oversight committees. The NOAA SAB is a federal advisory committee under the Federal Advisory Committee Act (Pub. L. 92-463).

The Committee is proposing to delete products and services from the Procurement List that were previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Department of the Navy hereby gives notice of its intent to grant to Safe Environment Engineering a revocable, nonassignable, exclusive license to practice Safe Environment Engineering's proprietary sensor systems for the field of use of public safety for protection from events involving chemical, biological or radiological (CBR) airborne plumes that could endanger the safety of the general public from significant danger, injury/harm, or damage; the field of use of industrial safety and monitoring to ensure plant and factory worker protection from hazards involving CBR airborne plumes that could cause injury to personnel; the field of use of environmental monitoring for the assessment of environmental impacts of CBR airborne plumes on the local environment in the United States, the Government-owned inventions described in U.S. Patent No. 7,542,884: System and Method for Zero Latency, High Fidelity Emergency Assessment of Airborne Chemical, Biological and Radiological Threats by Optimizing Sensor Placement, Navy Case No. 097,281.//U.S. Patent Application No. 13/ 629,842: Method for Depicting Plume Arrival Times, Navy Case No. 101,728 and any continuations, divisionals or re-issues thereof.

The Ocean Research Advisory Panel (ORAP) will hold a regularly scheduled meeting. The meeting will be open to the public.

Previously, the Department allocated $5.4 billion of Community Development Block Grant disaster recovery (CDBG-DR) funds appropriated by the Disaster Relief Appropriations Act, 2013 for the purpose of assisting recovery in the most impacted and distressed areas declared a major disaster due to Hurricane Sandy (see 78 FR 14329, published in the Federal Register on March 5, 2013). This notice provides additional waivers and alternative requirements.

Under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense (DoD) announces that the following Federal advisory committee meeting of the National Commission on the Structure of the Air Force (``the Commission'') will take place.

The Federal Geographic Data Committee (FGDC) is soliciting public comments on the draft strategic plan for the National Spatial Data Infrastructure (NSDI). The draft strategic plan, along with instructions for submitting comments, is posted at: www.fgdc.gov/nsdi- plan. Comments should be submitted by August 21, 2013. The FGDC is the interagency committee that promotes the coordinated use, sharing and dissemination of geospatial data in the United States. The FGDC operates under the authority of Office of Management and Budget (OMB) Circular A-16 and Executive Order 12906. One of the FGDC's responsibilities under Circular A-16 is to ``prepare and maintain a strategic plan for the development and implementation of the NSDI.'' Executive Order 12906 describes the NSDI as ``the technology, policies, standards, and human resources necessary to acquire, process, store, distribute, and improve utilization of geospatial data.'' The draft NSDI strategic plan has been developed with inputs from a variety of sources, including FGDC member agencies, the National Geospatial Advisory Committee, and geospatial partner organizations. The plan describes a broad national vision for the NSDI, and includes goals and objectives for the Federal government's role in continued sustainable development of the NSDI. Following the public comment period, a revised draft of the plan will be prepared for final review and adoption by the FGDC Steering Committee. Following adoption of the strategic plan, the FGDC will develop more detailed project plans for the goals and objectives in the strategic plan.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for award of a cooperative agreement in fiscal year 2013 to the Food and Agriculture Organization (FAO) of the United Nations to support global strategies that address food safety and public health. The goal of this collaborative project between FDA and FAO is to contribute to the knowledge base and development of food safety systems globally due to the increasingly diverse and complex food supply. The project is also designed to enhance and broaden FDA's ability to address global food safety and public health issues associated with food as well as provide opportunities to leverage additional resources of other countries. The collaborative project will also support the FDA's implementation of the FDA Food Safety Modernization Act (FSMA), including FDA's International Food Safety Capacity Building Plan, which emphasizes the concept of preventing food safety-related problems before they occur and the importance of establishing strong relationships and mutual support among all stakeholders, including multilateral organizations, to improve worldwide food safety. In addition, the collaborative project will support food safety, nutrition, and public health programs that align with FDA's mission.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Mesalamine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a previously issued draft guidance on the same subject.

This rule proposes five amendments to Marketing Order No. 920 (order), which regulates the handling of kiwifruit grown in California, and provides growers with the opportunity to vote in a referendum to determine if they favor the changes. The amendments are based on proposals by the Kiwifruit Administrative Committee (Committee or KAC), which is responsible for the local administration of the order. The five amendments would provide authority to recommend and conduct production and postharvest research, to recommend and conduct market research and development projects, to receive and expend voluntary contributions, to specify that recommendations for production research and market development be approved by eight members of the Committee, and to update provisions regarding alternate members' service on the Committee. These amendments are intended to improve administration of and compliance with the order, as well as reflect current industry practices.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2014 for application fees for an application requiring clinical data ($2,169,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,084,550), for establishment fees ($554,600), and for product fees ($104,060). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014. For applications and supplements that are submitted on or after October 1, 2013, the new fee schedule must be used. Invoices for establishment and product fees for FY 2014 will be issued in August 2013 using the new fee schedule.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2014 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2014 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013, which was signed by the President on June 13, 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2014.

The Coast Guard will enforce special local regulations for one regatta and seven safety zones for five fireworks displays and two swim events in the Sector Long Island Sound area of responsibility on the dates and times listed in the tables below. This action is necessary to provide for the safety of life on navigable waterways during the events. During the enforcement period, no person or vessel may enter the regulated area or safety zones without permission of the Captain of the Port (COTP) Sector Long Island Sound or designated representative.

The Coast Guard proposes to establish a temporary safety zone on the navigable waters of Greenport Harbor near Greenport, NY for the East End Maritime Foundation fireworks display. This action is necessary to provide for the safety of life on navigable waters during the event. Entering into, transiting through, remaining, anchoring or mooring within this regulated area would be prohibited unless authorized by the Captain of the Port Sector Long Island Sound.

The Coast Guard is establishing a temporary safety zone in Sturgeon Bay, WI. This temporary safety zone will restrict vessels from a portion of Sturgeon Bay due to a fireworks display. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the fireworks display.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from May 1, 2013, to May 31, 2013.

The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0136, Designation of Beneficiary: Federal Employees' Group Life Insurance, SF 2823. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104- 13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility; 2. Evaluate the accuracy of OPM's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

National Healthcare Operations, Office of Personnel Management (OPM), offers the general public and other Federal agencies the opportunity to comment on a new information collection request (ICR) 3206-NEW, Request for External Review. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate 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. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.