May 8, 2013 – Federal Register Recent Federal Regulation Documents
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David Freeman: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring David Freeman for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Freeman was convicted of introducing and delivering for introduction into interstate commerce of a misbranded drug, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, FDA determined that the type of conduct that served as the basis for Mr. Freeman's conviction undermines the process for the regulation of drugs. Mr. Freeman was given notice of the proposed debarment and an opportunity to request a hearing within the prescribed timeframe by regulation, but failed to respond. Mr. Freeman's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Summary of Responses To Request for Information (RFI): Opportunities To Apply a Department of Health and Human Services Message Library To Advance Understanding About Toddler and Preschool Nutrition and Physical Activity
On January 29, 2013, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) to solicit ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply TXT4Tots, a library of short, evidence-based messages on nutrition and physical activity targeted to parents, caregivers, and health care providers of children ages 1-5 years. HRSA released the TXT4Tots library in English and Spanish on February 19, 2013; and followed with an Open Forum on February 20, 2013, to provide further opportunity for input on dissemination and application of the library of messages. HHS received over 25 written responses to the RFI, and approximately 100 individuals participated in the Open Forum. Comments and Responses: The written responses to the RFI as well as the comments received through the Open Forum indicate that TXT4Tots aligns with the activities of many existing organizations and programs. Several of the respondents expressed an interest in collaborative opportunities to incorporate the messages into current outreach and educational efforts. Some examples of current programs that could leverage the TXT4Tots messages include initiatives at the federal, state, and local levels. The majority of the suggested organizations and programs focus on promoting healthy choices for children and their families. Recommendations included integrating the TXT4Tots messages into their programs and services or using the internet to disseminate the information through Web sites and social media. Respondents also emphasized that mobile health, social media, and other innovative strategies are a valuable resource to reach a diverse population and can be effectively leveraged to support equitable access to health information. With regard to vehicles for dissemination of the TXT4Tots messages, respondents suggested that they needn't be complicated, but should be user friendly. In addition, respondents noted that the most effective tools for dissemination are those that can fully engage the end users. Specific suggestions for dissemination of the TXT4Tots messages included social media, existing tools and applications, existing Web sites and web services, and text messages, as well incorporating messages into baby product packaging, curricula, health fairs, emails, newsletters, and print materials. Emphasis was placed on leveraging existing platforms that promote healthy choices for young children and could readily integrate the TXT4Tots message content. Respondents also recommended that the TXT4Tots messages be linked to additional sources of information; for example, if utilized as a text message program, URLs could be included to link the message recipients to Web sites with additional information. In addition, social media posts could link to Web sites with ideas for healthy recipes and age-appropriate activities to compliment the messages. Some respondents indicated that the use of certain technology-based platforms may restrict access to the underserved, who might have limited access to smartphones or the internet. One additional concern that was voiced by numerous respondents was confusion regarding the purpose of TXT4Tots and how it is intended to be used. Specifically, it was unclear that this is a library of messages that could be used in a variety of existing platforms and products and not exclusively a text messaging service. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https:// www.hrsa.gov/healthit/txt4tots). HRSA appreciates all of the thoughtful comments received either via the RFI or Open Forum. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). It is our hope that the thoughtful recommendations and comments will spur others to explore innovative ways for disseminating the TXT4Tots content.
Commission Information Collection Activities (FERC Form 580); Comment Request; Revision
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 USC 3506(c)(2)(A), the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC Form No. 580 (Interrogatory on Fuel and Energy Purchase Practices).
Certain Activated Carbon From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2011-2012
In response to requests from interested parties, the Department of Commerce (``Department'') is conducting the administrative review of the antidumping duty order on certain activated carbon from the People's Republic of China (``PRC'') for the period of review (``POR'') April 1, 2011, through March 31, 2012. The Department has preliminarily determined that sales have been made below normal value (``NV''). Additionally, the Department has preliminarily determined not to revoke the order, in part, with respect to Jacobi Carbons AB (``Jacobi'').
Notice of Submission of Proposed Information Collection to OMB; Section 901 Notice of Intent and Fungibility Plan for Combining Public Housing Capital or Operating Funds, or Housing Choice Voucher Funds To Assist Displaced Families and Address Damages
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. HUD is soliciting public comments on the subject proposal.
Amendment to Notice of Funding Availability for the Rural Energy for America Program
The Rural Business-Cooperative Service (Agency) published a notice in the Federal Register of March 29, 2013, (78 FR Doc. 2013- 07275) announcing the acceptance of applications for funds available under the Rural Energy for America Program (REAP) for Fiscal Year 2013. The Consolidated and Further Continuing Appropriations Act, 2013 (Pub. L. 113-6), provides additional funding for REAP. To provide the public additional opportunity to apply for these additional funds, this Notice extends the application period from April 30, 2013, to May 31, 2013, for renewable energy systems and energy efficiency improvement projects grants and grant and loan combination applications and for renewable energy system feasibility study applications. The Agency is also adding a provision to ensure consistency with the intent of 2 CFR 25.205. A separate notice will be published to amend the funding available under REAP.
Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIIDs)
This notice revises the Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIIDs). The Model Specifications are guidelines for the performance and uniform testing of BAIIDs. These devices are designed to prevent a driver from starting a motor vehicle when the driver's breath alcohol concentration (BrAC) is at or above a set alcohol level. Every State in the United States has enacted a law providing for the use of BAIIDs as a sanction for drivers convicted of driving while intoxicated offenses. This notice revises the 1992 Model Specifications, to test BAIIDs for conformance. These Model Specifications are based, in part, on input from interested parties during an open comment period. This notice also indicates that NHTSA will delay rendering a decision about the feasibility and timing of a Conforming Products List (CPL) until more information is available. Accordingly, NHTSA plans to conduct an assessment to determine whether establishing and maintaining a CPL is feasible, prior to rendering a decision.
Pacific Halibut Fisheries; Catch Sharing Plan; Correcting Amendment
This action corrects the text of a final rule published on March 15, 2013, that implemented annual management measures governing the Pacific halibut fishery. This final rule established season dates off of Alaska, Washington, Oregon and California. This action is necessary to correct an error in the days of the week listed for the fishing season in the area from Leadbetter Point, WA to Cape Falcon, OR.
Proposed Information Collection Request; Comment Request; Willingness To Pay Survey for Santa Cruz River Management Options in Southern Arizona
The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Willingness To Pay Survey for Santa Cruz River Management Options in Southern Arizona'' (EPA ICR No. 2484.01, OMB Control No. 2080-NEW) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a request for approval of a new collection. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries
NMFS is adjusting the Atlantic bluefin tuna (BFT) General category daily retention limit to three large medium or giant BFT for June 1 through August 31, 2013. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments, and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.
Reports, Forms, and Recordkeeping Requirements
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 (44 U.S.C. 3501 et seq.), before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.
Announcement of Requirements and Registration for the National Radiological and Nuclear Detection Challenge
DNDO announces the National Radiological and Nuclear Detection (Rad/Nuc) Challenge, a participation challenge being conducted under the America Competes Reauthorization Act, for state, local, and tribal law enforcement, other first responders, public safety officials, and Civil Support Team members.
Dow Chemical Company, Dow TRIGA Research Reactor; License Renewal for the Dow Chemical TRIGA Research Reactor; Supplemental Information and Correction
The U.S. Nuclear Regulatory Commission (NRC) published a notice in the Federal Register on July 20, 2012 (77 FR 42771), ``License Renewal for the Dow Chemical TRIGA Research Reactor,'' to inform the public that the NRC is considering issuance of a renewed Facility License No. R-108 for Dow Chemical Company which would authorize continued operation of the Dow TRIGA Research Reactor. The notice provided the NRC staff's review of the Environmental Assessment and Finding of No Significant Impact for the Dow TRIGA Research Reactor. This action is necessary to (1) correct a typographical error in Section II.A., ``Radiological Impact;'' and (2) provide the public with supplemental information regarding the U.S. Court of Appeals Waste Confidence Ruling and NRC staff review of the ruling showing the non- applicability to research and test reactor licensing.
University of California, Irvine; License Renewal for University of California, Irvine Nuclear Reactor Facility; Supplemental Information
The Nuclear Regulatory Commission (NRC) published a notice in the Federal Register on February 13, 2012 (77 FR 7610-7613), ``Notice of Availability of Environmental Assessment and Finding of No Significant Impact for the License Renewal for University of California, Irvine Nuclear Reactor Facility,'' to inform the public that the NRC is considering issuance of a renewed Facility License No. R-116 for the Regents of the University of California (the licensee) which would authorize continued operation of the University of California, Irvine Nuclear Reactor Facility. The notice provided the NRC staff's review of the Environmental Assessment and Finding of No Significant Impact for the University of California, Irvine Nuclear Reactor Facility. This action is necessary to provide the public with supplemental information regarding the U.S. Court of Appeals Waste Confidence Ruling and NRC staff review of the ruling showing the non- applicability to research and test reactor licensing.
Land Acquisitions; Cowlitz Indian Tribe
The Assistant SecretaryIndian Affairs made a final agency determination to acquire approximately 151.87 acres of land into trust for gaming and other purposes for the Cowlitz Indian Tribe on April 22, 2013.
Indian Gaming
This notice publishes the approval of an amendment to the Class III Tribal-State Gaming Compact between the Menominee Indian Tribe of Wisconsin and the State of Wisconsin (Amendment).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Program Report
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Adequacy of Design Features and Functional Capabilities Identified and Described for Withstanding Aircraft Impacts
The U.S. Nuclear Regulatory Commission (NRC) is issuing a new section of NUREG-0800, ``Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition.'' The new section, designated as Revision 0, is Section 19.5, ``Adequacy of design features and functional capabilities identified and described for withstanding aircraft impacts.''
Application to Export Electric Energy; ALLETE, Inc., d/b/a Minnesota Power
ALLETE, Inc., d/b/a Minnesota Power (Minnesota Power) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Test Procedures for Showerheads, Faucets, Water Closets, Urinals and Commercial Prerinse Spray Valves
On April 8, 2013, the U.S. Department of Energy (DOE) published a supplemental notice of proposed rulemaking (SNOPR) for test procedures for showerheads, faucets, water closets, urinals and commercial prerinse spray valves in the Federal Register. This document announces an extension of the public comment period for submitting comments on the SNOPR or any other aspect of this test procedure rulemaking. The comment period is extended to June 7, 2013.
Vista Grande Drainage Basin Improvement Project, Fort Funston, Golden Gate National Recreation Area, San Francisco County, CA
In accordance with Sec. 102(2)(C) of the National Environmental Policy Act (NEPA), and the California Environmental Quality Act (CEQA) Guidelines Section 15082, the National Park Service, together with the City of Daly City, intends to prepare a joint Environmental Impact Statement (EIS) and Environmental Impact Report (EIR) to evaluate the potential environmental effects of the proposed Vista Grande Drainage Basin Improvement Project (Project). The EIS/EIR will address proposed improvements to Daly City's infrastructure to address storm-related flooding in the Vista Grande Watershed Drainage Basin and the effects of coastal erosion. The National Park Service (NPS) is the lead agency for the environmental review under NEPA. The City of Daly City is the lead agency for the environmental review under CEQA.
Taking of Threatened or Endangered Marine Mammals Incidental to Commercial Fishing Operations; Issuance of Permit
NMFS plans to issue a permit for a period of three years to authorize the incidental, but not intentional, taking of three stocks of marine mammals listed as threatened or endangered under the Endangered Species Act (ESA) by the California (CA) thresher shark/ swordfish drift gillnet (DGN) fishery (>=14 inch mesh) and the Washington/Oregon/California (WA/OR/CA) sablefish pot fishery. In accordance with the Marine Mammal Protection Act (MMPA), NMFS has made a preliminary determination that incidental taking from commercial fishing will have a negligible impact on the endangered fin whale, CA/ OR/WA stock; humpback whale, CA/OR/WA stock; and sperm whale, CA/OR/WA stock. Recovery plans have been completed for these endangered species. This authorization is based on a determination that this incidental take will have a negligible impact on the affected marine mammal stocks. NMFS must issue this permit provided that we can make the determinations that: the incidental take will have a negligible impact on the affected marine mammal stocks; a recovery plan for all affected stocks of threatened or endangered marine mammals has been developed or is being developed; and as required by the MMPA, a take reduction plan and monitoring program have been implemented and vessels in the CA thresher shark/swordfish DGN fishery (>=14 inch mesh) and WA/OR/CA sablefish pot fishery are registered. NMFS solicits public comments on the draft negligible impact determination and on the proposal to issue a permit to these fisheries for the taking of affected threatened or endangered stocks of marine mammals.
U.S. Air Force Scientific Advisory Board; Notice of Meeting
Under the provisions of the Federal Advisory Committee Act 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 announces that the United States Air Force Scientific Advisory Board (SAB) meeting will take place 25 June 2013 at the Secretary of the Air Force Technical and Analytical Support Conference Center, 1550 Crystal Drive, Arlington, VA 22202. The meeting will be from 7:45 a.m.-4:45 p.m. on Tuesday, 25 June 2013, with the sessions from 7:45 a.m.-09:45 a.m. open to the public. The purpose of this Air Force Scientific Advisory Board quarterly meeting is to discuss and deliberate on the findings and recommendations of the FY13 SAB studies covering airborne networking and communications in a contested environment, electro-optical and laser threat warning/countermeasures, and micro-satellite mission applications. The draft FY14 SAB study topics and potential sites for the FY14 Spring Board quarterly meeting will also be discussed. In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102-3.155, the Administrative Assistant of the Air Force, in consultation with the Air Force General Counsel, has agreed that the public interest requires some sessions of the United States Air Force Scientific Advisory Board meeting be closed to the public because they will discuss information and matters covered by section 5 U.S.C. 552b(c)(1). Any member of the public wishing to provide input to the United States Air Force Scientific Advisory Board should submit a written statement in accordance with 41 CFR 102-3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act and the procedures described in this paragraph. Written statements can be submitted to the Designated Federal Officer at the address detailed below at any time. Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Officer at the address listed below at least five calendar days prior to the meeting which is the subject of this notice. Written statements received after this date may not be provided to or considered by the United States Air Force Scientific Advisory Board until its next meeting. The Designated Federal Officer will review all timely submissions with the United States Air Force Scientific Advisory Board Chairperson and ensure they are provided to members of the United States Air Force Scientific Advisory Board before the meeting that is the subject of this notice. FOR FURTHER INFORMATION CONTACT: The United States Air Force Scientific Advisory Board Executive Director and Designated Federal Officer, Lt Col Darek Lincoln, 240-612-5502, United States Air Force Scientific Advisory Board, 1500 West Perimeter Road, Ste. 3300, Joint Base Andrews, MD 20762, Derek.Lincoln@pentagon.af.mil.
Airworthiness Directives; Eurocopter Deutschland GmbH Helicopters
We propose to adopt a new airworthiness directive (AD) for Eurocopter Deutschland GmbH (ECD) Model EC135P1, EC135P2, EC135P2+, EC135T1, EC135T2, and EC135T2+ helicopters with certain fire extinguishing systems installed. This proposed AD would require modifying the fire extinguishing system injection tubes. This proposed AD is prompted by a report that the injection tubes are deforming due to heat. The proposed actions are intended to prevent deformation of the fire extinguishing system injection tubes during a fire, which could result in impaired distribution of the fire extinguishing agent, failure of the fire extinguishing system to contain an engine fire, and subsequent loss of control of the helicopter.
Including Specific Pavement Types in Federal-aid Highway Traffic Noise Analyses
The FHWA requests input from stakeholders and interested parties on expanding the specific pavement types used in Federal-aid highway traffic noise analyses. Current highway traffic noise analyses rely on data from three pavement types: dense-graded asphaltic concrete (DGAC), open-graded asphaltic concrete (OGAC), and Portland cement concrete (PCC). Prediction of future noise levels is based on the ``average'' pavement type, calculated as the average of the DGAC and PCC vehicle noise emission levels. The FHWA is issuing this Federal Register Notice to invite stakeholders and interested parties to provide comments and suggestions on whether and how to include additional pavement types in Federal-aid highway traffic noise analyses.
Airworthiness Directives; Eurocopter France Helicopters
We propose to adopt a new airworthiness directive (AD) for Eurocopter France (Eurocopter) Model EC 155B, EC155B1, SA-365N, SA- 365N1, AS-365N2, AS 365 N3, and SA-366G1 helicopters. This proposed AD would require inspecting the collective pitch lever for correct locking and unlocking conditions. This proposed AD is prompted by two separate reports of inadvertent collective pitch lever locking and unlocking. The proposed actions are intended to detect an incorrectly adjusted collective pitch lever, which could result in loss of control of the helicopter.
Airworthiness Directives; Airbus Airplanes
We propose to supersede an existing airworthiness directive (AD) that applies to all Airbus Model A330-200 and -300 series airplanes, and Model A340-200 and -300 series airplanes. The existing AD currently requires a repetitive inspection program on certain check valves in the hydraulic systems that includes, among other things, inspections for lock wire presence and integrity, traces of seepage or black deposits, proper torque, alignment of the check valve and manifold, installing new lock wire, and corrective actions if needed. Since we issued that AD, additional in-service reports of check valves loosening at lower flight cycle thresholds than previously reported have been received. This proposed AD would expand the applicability, reduce the compliance time, change torque values of the check valve tightening, and require a repetitive inspection program for certain check valves in the hydraulic systems on airplanes that have had a certain modification embodied during production or in-service. We are proposing this AD to detect and correct such check valve loosening, which could result in hydraulic leaks, possibly leading to the loss of all three hydraulic systems and consequent loss of control of the airplane.
Notice of Filing of Plats of Survey, New Mexico
The plats of survey described below are scheduled to be officially filed in the New Mexico State Office, Bureau of Land Management, Santa Fe, New Mexico, thirty (30) calendar days from the date of this publication.
Airworthiness Directives; The Boeing Company Airplanes
We propose to supersede an existing airworthiness directive (AD) that applies to certain The Boeing Company Model 747-100, 747- 100B, 747-100B SUD, 747-200B, 747-200C, 747-300, 747-400, 747-400D, and 747SR series airplanes. The existing AD requires, for certain airplanes, inspection to determine the material of a main entry door (MED) reveal; repetitive inspections of certain reveals for cracking; a detailed inspection of certain reveals for a sharp edge and cracking; and corrective action if necessary. That AD also allows a certain replacement as an optional action for certain inspections of certain airplanes. Since we issued that AD, an operator reported a crack found in a 6061 machined aluminum one-piece corner reveal. This proposed AD would add, for certain airplanes, an inspection to determine material type of MED reveals, repetitive inspections for cracking of 6061 machined aluminum one-piece corner reveals, and replacement with 6061 machined aluminum two-piece corner reveals if necessary. This proposed AD would also allow replacement with two-piece corner reveals as an option for certain repetitive inspections. This proposed AD would also revise the applicability by removing a certain airplane. We are proposing this AD to detect and correct fatigue cracking of the lower forward corner reveal of the number 3 MEDs, which could lead to the door escape slide departing the airplane when the door is opened and the slide is deployed, and consequent injuries to passengers and crew using the door escape slide during an emergency evacuation.
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