Notice of Proposed Information Collection; Request for Comments for 1029-0120
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for the Nomination and Request for Payment Form for OSM's Technical Training Courses, has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection activity was previously approved by OMB, and assigned control number 1029-0120. The information collection request describes the nature of the information collection and its expected burden and cost.
Request for Information: Public-Private Collaborations in Pain Research
The Department of Veterans Affairs (VA) publishes this Request for Information (RFI) on public-private collaborations in pain research, seeking to connect the Veterans Health Administration's (VHA) Office of Research and Development (ORD) with commercial organizations that are conducting, or have an interest in conducting, pain research through a Cooperative Research and Development Agreement (CRADA). The CRADA is to develop public-private collaborations in pain research with the intent of developing novel therapies that will benefit Veterans suffering from chronic pain conditions.
Buy America Waiver Notification
This notice provides information regarding the FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic (1) Electrical Controls and Electrical Equipment; (2) Main Drive Electrical Motor; (3) Auxiliary Drive Electric Motor; (4) Span Lock Electric Motor & Controls for a specific project in the State of Washington.
Buy America Waiver Notification
This notice provides information regarding the FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic iron and steel products in (1) Auxiliary two speed motor, (2) Auxiliary back up drive clutch, (3) Main span and backup span motor, and (4) Brakes for the Memorial Bridge project in the State of New Hampshire.
Amendment to the Standards of Identity for Distilled Spirits
The Alcohol and Tobacco Tax and Trade Bureau is amending the regulations setting forth the standards of identity for distilled spirits to include ``Cacha[ccedil]a'' as a type of rum and as a distinctive product of Brazil. This amendment follows requests received from the Government of Brazil and subsequent discussions with the Office of the United States Trade Representative.
Notice of Proposed Information Collection; Request for Comments for 1029-0057
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for Reclamation on Private Land, has been forwarded to the Office of Management and Budget (OMB) for review and approval. This information collection activity was previously approved by OMB and assigned control number 1029-0057. This information collection request describes the nature of the information collection and its expected burden and cost.
Endangered Species; Marine Mammals; Issuance of Permits
We, the U.S. Fish and Wildlife Service (Service), have issued the following permits to conduct certain activities with endangered species, marine mammals, or both. We issue these permits under the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA).
Endangered Species; Marine Mammals; Receipt of Applications for Permit
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species, marine mammals, or both. With some exceptions, the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. 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.
Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as ``of record'' notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/ bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.
Environmental Management Site-Specific Advisory Board, Idaho National Laboratory
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.
United States v. Apple, Inc., Hachette Book Group, Inc., Harpercollins Publishers L.L.C., Verlagsgruppe Georg Von Holtzbrinck GMBH, Holtzbrinck Publishers, LLC d/b/a Macmillan, The Penguin Group, A Division of Pearson PLC, Penguin Group (USA), Inc., and Simon & Schuster, Inc.; Proposed Final Judgment and Competitive Impact Statement
Endangered and Threatened Species Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered or threatened species. The Endangered Species Act of 1973, as amended (Act), prohibits activities with endangered and threatened species unless a Federal permit allows such activities. The Act and the National Environmental Policy Act also require that we invite public comment before issuing these permits.
Airworthiness Directives; Agusta S.p.A. and Bell Helicopter Textron Helicopters
We propose to adopt a new airworthiness directive (AD) for Agusta S.p.A. (Agusta) Model AB412 and AB412 EP, and Bell Helicopter Textron (Bell) Model 412, 412CF, and 412EP helicopters with certain DART Aerospace Ltd. (Dart) high gear aft crosstubes (crosstube) installed. This proposed AD would require adding a life limit of 10,000 landings to the crosstube and removing from service any crosstubes with more than 10,000 accumulated landings. This proposed AD is prompted by five separate reports of crosstube failures. The actions in this proposed AD are intended to prevent failure of the crosstube and subsequent collapse of the landing gear.
VA Homeless Providers Grant and Per Diem Program
This document adopts as a final rule, with changes, the proposed rule to amend the Department of Veterans Affairs (VA) regulations concerning VA's Homeless Providers Grant and Per Diem Program (Program). This rulemaking updates and improves the clarity of these regulations, and implements and authorizes new VA policies.
504 and 7(a) Loan Programs Updates
The U.S. Small Business Administration (``SBA'') has determined that changing conditions in the American economy and persistent high levels of unemployment compel the agency to seek ways to improve access to its two flagship business lending programs: the 504 Loan Program and the 7(a) Loan Program. The purpose of this proposed rulemaking is to reinvigorate these programs as vital tools for creating and preserving American jobs. SBA proposes to strip away regulatory restrictions that detract from the 504 Loan Program's core job creation mission as well as the 7(a) Loan Program's positive job creation impact on the American economy. The 504 Loan Program and 7(a) Loan Program are SBA's two primary business loan programs authorized under the Small Business Investment Act of 1958 and the Small Business Act, respectively. This proposed rule will enhance job creation through increasing eligibility for loans under SBA's business loan programs, including its Microloan Program, and by modifying certain program participant requirements applicable to the 504 Loan Program. In addition, SBA proposes to revise Certified Development Company (CDC) operational requirements to clarify certain existing regulations.
Airworthiness Directives; Agusta S.p.A. Helicopters
We propose to supersede an existing airworthiness directive (AD) for Agusta S.p.A. (Agusta) Model A109E helicopters that requires reducing the tail rotor (T/R) blade life limit, modifying a T/R hub and grip assembly, re-identifying two T/R assemblies, clarifying the never- exceed speed (Vne) limitation and reducing the inspection interval. Since we issued that AD, the manufacturer has redesigned a T/R grip bushing (bushing) that reduces the loads, which caused the T/R cracking, on the T/R blades. This action would require installing the new bushing and re-identifying the T/R hub-and-grip and hub-and-blade assemblies and require a recurring inspection of each bushing. The proposed actions are intended to prevent fatigue failure of a T/R blade and subsequent loss of control of the helicopter.
Agency Information Collection Activities: Comment Request
To comply with the Paperwork Reduction Act of 1995 (PRA), the U.S. Geological Survey (USGS) is inviting comments on an information collection request (ICR) that we have sent to the Office of Management and Budget (OMB) for review and approval. The Information Collection, which is summarized below, describes the nature and the estimated burden of the collection. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR. This collection is scheduled to expire on February 28, 2013.
Safety Zone; Seafair Blue Angels Air Show Performance, Seattle, WA
The U.S. Coast Guard is amending the Seafair Blue Angels Air Show Performance safety zone on the waters of Lake Washington, Seattle, WA. This action is necessary to safeguard participants and spectators from the safety hazards associated with the Seafair Blue Angels Air Show Performance, which include low flying high speed aircraft, and will do so by prohibiting entry into the safety zone unless authorized by the Captain of the Port (COTP), Puget Sound or a Designated Representative.
Airworthiness Directives; Robinson Helicopter Company
We propose to supersede an existing airworthiness directive (AD) for Robinson Helicopter Company (Robinson) Model R22, R22 Alpha, R22 Beta, R22 Mariner, R44, and R44 II helicopters with certain main rotor blades (blade) installed. The existing AD currently requires inspecting each blade at the skin-to-spar line for debonding, corrosion, a separation, a gap, or a dent and replacing any damaged blade with an airworthy blade. Since we issued that AD, a terminating action for the inspection requirements of that AD has been developed. The proposed actions are intended to detect debonding of the blade skin, which could result in blade failure and subsequent loss of control of the helicopter, and to correct the unsafe condition by replacing the main rotor blades with new blades that do not require the AD inspection.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Seismic Survey in Cook Inlet, AK
In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the Apache Alaska Corporation (Apache) to take marine mammals, by harassment, incidental to a proposed 3D seismic survey in Cook Inlet, Alaska, between March 2013 and March 2014.
Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices
The Food and Drug Administration (FDA) is proposing to amend its regulations on acceptance of data from clinical studies for medical devices. We are proposing to require that clinical studies conducted outside the United States as support for an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of study subjects. The proposed rule is intended to update the standards for FDA acceptance of data from clinical studies conducted outside the United States and to help ensure the protection of human subjects and the quality and integrity of data obtained from these studies. As part of this proposed rule, we are also proposing to amend the IDE and 510(k) regulations to address the requirements for FDA acceptance of data from clinical studies conducted inside the United States. The proposed amendments are intended to provide consistency in FDA requirements for acceptance of clinical data, whatever the application or submission type.
Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Attachment to Guidance on Antiviral Product DevelopmentConducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of anti-HCV products.