March 15, 2011 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 167
Notice of Submission for OMB Review
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Aviation Rulemaking Advisory Committee Meeting on Transport Airplane and Engine Issues
This notice announces a public meeting of the FAA's Aviation Rulemaking Advisory Committee (ARAC) to discuss transport airplane and engine (TAE) issues.
Notice of Receipt of Petition for Decision That Nonconforming 2005-2006 Porsche Carrera (997) Passenger Cars Manufactured Prior to September 1, 2006 Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2005-2006 Porsche Carrera (997) passenger cars manufactured prior to September 1, 2006, that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2005-2006 Porsche Carrera (997) passenger cars manufactured prior to September 1, 2006), and they are capable of being readily altered to conform to the standards.
Proposed Information Collection; Comment Request; 2012 Economic Census Covering the Construction Sector
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Proposed Information Collection; Comment Request; 2012 Economic Census Covering the Information, etc.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Commerce has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Advisory Committee Meeting Notice
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3, 140 through 160), the Department of the Army announces the following committee meeting: Name of Committee: U.S. Army Command & General Staff College Subcommittee. Date: April 5-6, 2011. Place: U.S. Army Command and General Staff College, Ft. Leavenworth, KS, Lewis & Clark Center 66027. Time: 8:30 a.m. to 4 p.m. (April 5, 2010). 8:30 a.m. to 12 p.m. (April 6, 2010). Proposed Agenda: Starting point of the meeting will be an update overview of the CGSC, as well as its constituent schools, especially the Command and General Staff School and the School of Advanced Military Studies. Subcommittee members will gather information from students, staff and faculty. General deliberations leading to provisional findings for referral to the Army Education Advisory Committee will follow on 6 April beginning at about 0900.
Notice of Receipt of Petition for Decision That Nonconforming 2002 Kawasaki Ninja ZX-6R Motorcycles Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2002 Kawasaki Ninja ZX-6R motorcycles that were not originally manufactured to comply with all applicable Federal Motor Vehicle Safety Standards (FMVSS) are eligible for importation into the United States because they have safety features that comply with, or are capable of being altered to comply with, all such standards.
United States Warehouse Act; Export Food Aid Commodities Licensing Agreement
The Farm Service Agency (FSA) proposes adding export food aid commodities (EFAC) to the agricultural products for which warehouse licenses may be issued under the United States Warehouse Act (USWA). Through this notice, FSA is providing an opportunity for anyone to provide comments on this proposal to offer a license for EFAC. EFAC might include corn soy blend, vegetable oil, or pulses such as peas, beans and lentils. Current USWA licenses for agricultural products include grain, cotton, nuts, cottonseed, and dry beans. Warehouse operators that apply voluntarily agree to be licensed, observe the rules for licensing, and pay associated user fees.
United States Warehouse Act; Processed Agricultural Products Licensing Agreement
The Farm Service Agency (FSA) proposes adding processed agricultural products to the agricultural products for which warehouse licenses may be issued under the United States Warehouse Act (USWA). Through this notice, FSA is providing an opportunity for anyone to provide comments on this proposal to offer a license for the processed agricultural products that are stored in climate controlled, cooler, and freezer warehouses. An example of a processed agricultural product is apple juice concentrate. In the past, USDA has issued USWA licenses for syrup or sirup, dried fruit, canned foods, cold-pack fruit, seeds, and cherries-in-brine. Current USWA licenses for agricultural products include grain, cotton, nuts, cottonseed, and dry beans. Warehouse operators voluntarily agree to be licensed, observe the rules for licensing, and pay associated user fees.
Importation of Bromeliad Plants in Growing Media From Belgium, Denmark, and the Netherlands
We are proposing to amend the regulations governing the importation of plants and plant products to add Bromeliad plants of the genera Aechmea, Cryptanthus, Guzmania, Hohenbergia, Neoregelia, Tillandsia, and Vriesea from Belgium, Denmark, and the Netherlands to the list of plants that may be imported into the United States in an approved growing medium, subject to specified growing, inspection, and certification requirements. We are taking this action in response to requests from those three countries and after determining that the plants could be imported, under certain conditions, without resulting in the introduction into, or the dissemination within, the United States of a plant pest or noxious weed.
Importation of Tomatoes With Stems From the Republic of Korea Into the United States
We are proposing to amend the fruits and vegetables regulations to allow, under certain conditions, the importation into the United States of commercial consignments of tomatoes with stems from the Republic of Korea. The conditions for the importation of tomatoes with stems from the Republic of Korea include requirements for pest exclusion at the production site, fruit fly trapping inside and outside the production site, and pest-excluding packinghouse procedures. The tomatoes would also be required to be accompanied by a phytosanitary certificate issued by the national plant protection organization of the Republic of Korea with an additional declaration confirming that the tomatoes had been produced in accordance with the proposed requirements. This action would allow for the importation of tomatoes with stems from the Republic of Korea while continuing to provide protection against the introduction of injurious plant pests into the United States.
Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Papaya Fruit From Malaysia Into the Continental United States
We are advising the public that we have prepared a pest risk analysis for the purpose of evaluating the pest risks associated with the importation of fresh papaya (Carica papaya) fruit from Malaysia into the continental United States. Based on our analysis, we have concluded that the application of one or more designated phytosanitary measures will be sufficient to mitigate the pest risk. We are making the pest risk analysis available to the public for review and comment.
Notice of Request for Extension of Approval of an Information Collection; Importation of Fruits and Vegetables
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of fruits and vegetables.
Notice of Request for Extension of Approval of an Information Collection; Black Stem Rust; Identification Requirements for Addition of Rust-Resistant Varieties
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with the black stem rust quarantine and regulations.
Notice of Request for Extension of Approval of an Information Collection; Pine Shoot Beetle; Host Material From Canada
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of pine nursery stock and various pine products from Canada to prevent the spread of pine shoot beetle into noninfested areas of the United States.
Notice of Request for Approval of an Information Collection; National Animal Health Monitoring System; Needs Assessments
In accordance with the Paperwork Reduction Act, this notice announces the Animal and Plant Health Inspection Service's intention to initiate an information collection to support the research and development phase of surveys entitled National Animal Health Monitoring System needs assessments.
Outer Continental Shelf (OCS), Central and Western Gulf of Mexico, Oil and Gas Lease Sales for Years 2012-2017
This Call for Information and Nominations (hereinafter referred to as ``Call'') is the initial step in a single multisale process covering all lease sales in the Central and Western Gulf of Mexico (GOM) Planning Areas to be included in the OCS Oil and Gas Leasing Program for 2012-2017. Ten lease sales are specifically covered by this Call: five in the Central GOM Planning Area and five in the Western GOM Planning Area. Concurrent with this Call, BOEMRE is preparing a multisale Environmental Impact Statement (EIS) covering the same ten sales in the Central and Western GOM Planning Areas. For each of the ten individual lease sales associated with this Call, BOEMRE will comply with the National Environmental Policy Act (NEPA), the Outer Continental Shelf Lands Act (OCSLA), and the Coastal Zone Management Act (CZMA).
Notice of Request for Revision of a Currently Approved Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces Rural Development's intention to request a revision for a currently approved information collection in support of loan programs administered by the Rural Housing Service, Business- Cooperative Service, and Rural Utilities Service.
Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.
Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers in assessing whether separate facilities should be used based on the relative health risk of cross-reactivity.
Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined ROCEPHIN (ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for any of these products if all other legal and regulatory requirements are met.
Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations and abbreviated new drug application regulations to correct inaccurate cross-references to the IND regulations and the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is being taken to ensure accuracy and clarity in the Agency's regulations.
Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Agency believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.
Extension of Memorandum of Understanding Between the Food and Drug Administration and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States Concerning Entry of Mexican Cantaloupes Into the United States of America
The Food and Drug Administration (FDA) is providing notice of an extension of memorandum of understanding (MOU) between FDA and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States. The purpose of the MOU is to establish, and build confidence in, a system that increases the likelihood that cantaloupes from Mexico offered for import into the United States comply with U.S. law. This MOU also establishes a risk-based classification system for firms in Mexico producing cantaloupes for import into the United States to protect the public health.
Agency Information Collection Activities: Final Collection; Comment Request
The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. The collection provides Ex-Im Bank staff with the information necessary to monitor the borrower's payments for exported goods covered under its short and medium-term export credit insurance policies. It also alerts Ex-Im Bank staff of defaults, so they can manage the portfolio in an informed manner. Form can be viewed at https://www.exim.gov/pub/pending/EIB92_ 27.pdf.
Meeting of the Ocean Research and Resources Advisory Panel
The Ocean Research and Resources Advisory Panel (ORRAP) will hold a meeting. The meeting will be open to the public.
Proposed Information Collection; Comment Request; Complaint of Discrimination Against the U.S. Department of Commerce
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
San Luis Valley National Wildlife Refuge Complex, Alamosa, CO; Comprehensive Conservation Plan and Environmental Impact Statement
We, the U.S. Fish and Wildlife Service (Service), intend to prepare a Comprehensive Conservation Plan (CCP) and an Environmental Impact Statement (EIS) for the San Luis Valley National Wildlife Refuge Complex (Complex) in Alamosa, Colorado. The Complex comprises Baca, Monte Vista, and Alamosa National Wildlife Refuges (NWRs).We provide this notice in compliance with our CCP policy to advise other Federal and State agencies, Tribes, and the public of our intentions, and to obtain suggestions and information on the scope of issues to consider in the planning process.
Trinity Adaptive Management Working Group
The Trinity Adaptive Management Working Group (TAMWG) affords stakeholders the opportunity to give policy, management, and technical input concerning Trinity River (California) restoration efforts to the Trinity Management Council (TMC). The TMC interprets and recommends policy, coordinates and reviews management actions, and provides organizational budget oversight. This notice announces a TAMWG meeting, which is open to the public.
Fresh Garlic from the People's Republic of China: Court Decision Not in Harmony With Final Results and Amended Final Results of Review
On March 1, 2011, the United States Court of International Trade (``CIT'') sustained in an unpublished judgment the Department of Commerce's (``the Department'') final results of redetermination as applied to respondent Shenzhen Greening Trading Co., Ltd. (``Greening'') pursuant to the CIT's order granting the Department's voluntary remand request in Shandong Chenhe International Trading Co., Ltd. and Shenzhen Greening Trading Co., Ltd. v. United States, Court No. 09-00246 (Ct. Int'l Trade April 22, 2010). See Final Results of Redetermination Pursuant to Voluntary Remand, Court No. 09-00246, dated July 30, 2010, available at https://ia.ita.doc.gov/remands (``Remand Results''); Shandong Chenhe International Trading Co., Ltd. and Shenzhen Greening Trading Co., Ltd. v. United States, Court No. 09- 00246 (Ct. Int'l Trade March 1, 2011) (``Judgment''). Consistent with the decision of the United States Court of Appeals for the Federal Circuit (``CAFC'') in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (``Timken''), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (``Diamond Sawblades''), the Department is notifying the public that the final judgment in this case is not in harmony with the Department's final results and is amending the final results of the administrative review of the antidumping duty order on fresh garlic from the People's Republic of China (``PRC'') covering the period of review (``POR'') of November 1, 2006, through October 31, 2007 with respect to Greening. See Fresh Garlic From the People's Republic of China: Final Results and Partial Rescission of the 13th Antidumping Duty Administrative Review and New Shipper Reviews, 74 FR 29174 (June 19, 2009) (``Final Results''), and accompanying Issues and Decision Memorandum at Comment 11.
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