March 19, 2012 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 110
Oral Dosage Form New Animal Drugs; Pergolide
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Boehringer Ingelheim Vetmedica, Inc. The NADA provides for the veterinary prescription use of pergolide mesylate tablets in horses for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).
Information Collection Being Submitted for Review and Approval to the Office of Management and Budget
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3502-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Southern Region Recreation Resource Advisory Committee
The Southern Region Recreation Resource Advisory Committee will hold a meeting via teleconference. The purpose of the teleconference is to discuss committee roles and responsibilities and to set a meeting date to consider fee proposals for areas managed by the Forest Service in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, and the territory of Puerto Rico; and to discuss other items of interest related to the Federal Lands Recreation Enhancement Act of 2004. A final agenda will be sent to regional media sources at least 7 days before the teleconference, and hard copies can also be mailed or sent via FAX. Individuals who need special, or who wish a hard copy of the agenda, should contact Caroline Mitchell at PO Box 1270, Hot Springs, AR 71902 or by phone at 501-321-5318 prior to the meeting.
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, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.
Endangered and Threatened Wildlife and Plants; Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for permits to conduct activities with the purpose of enhancing the survival of endangered species. The Endangered Species Act of 1973, as amended (Act), prohibits certain activities with respect to endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing such permits.
Willapa National Wildlife Refuge, Pacific County, WA; Record of Decision for Final Environmental Impact Statement
We, the U.S. Fish and Wildlife Service, announce the availability of the Willapa National Wildlife Refuge final comprehensive conservation plan (CCP) and record of decision (ROD). We completed a thorough analysis of the environmental, social, and economic considerations and presented it in our Final CCP and environmental impact statement (EIS), which we released to the public on August 12, 2011. The ROD documents our decision to implement Alternative 2, as it is described in the Final CCP/EIS.
Agency Information Collection; Activity Under OMB Review; Report of Extension of Credit to Political Candidates-Form 183
In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, the Bureau of Transportation Statistics invites the general public, industry and other governmental parties to comment on the continuing need and usefulness of BTS collecting reports from air carriers on the aggregated indebtedness balance of a political candidate or party for Federal office. The reports are required when the aggregated indebtedness is over $5,000 on the last day of a month.
National Medal of Technology and Innovation Nomination Evaluation Committee Charter Renewal
The Chief Financial Officer and Assistant Secretary of Commerce for Administration, with the concurrence of the General Services Administration, renewed the Charter for the National Medal of Technology and Innovation Nomination Evaluation Committee on March 1, 2012.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens from class III into class II. These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis. This draft guidance document describes a means by which in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens may comply with the requirement of special controls for class II devices.
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis
The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Revision of Organization and Conforming Changes to Regulations
The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organizational change in the Agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Wildlife and Hunting Heritage Conservation Council
The Secretary of the Interior and the Secretary of Agriculture seek nominations for individuals to be considered as members of the Wildlife and Hunting Heritage Conservation Council (Council). The Council provides advice about wildlife and habitat conservation endeavors that (a) benefit wildlife resources; (b) encourage partnership among the public, sporting conservation organizations, the States, Native American tribes, and the Federal Government; and (c) benefit recreational hunting. Nominations should describe and document the proposed member's qualifications for membership to the Council, and include a resume listing their full name, address, telephone, and fax number.
Airworthiness Directives; Pratt & Whitney Turbofan Engines
We are superseding an existing airworthiness directive (AD) for all Pratt & Whitney (PW) JT9D series turbofan engines. That AD currently requires revisions to the Airworthiness Limitations Section (ALS) of the manufacturer's Instructions for Continued Airworthiness (ICA) to include required enhanced inspection of selected critical life-limited parts at each piece-part opportunity. This new AD requires additional revisions to the JT9D series engines ALS sections of the manufacturer's ICA. This AD was prompted by the need to require enhanced inspection of selected critical life-limited parts of JT9D series engines. We are issuing this AD to prevent critical life-limited rotating engine part failure, which could result in an uncontained engine failure and damage to the airplane.
Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program.'' This guidance document is intended to provide information on the implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This guidance document describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) are implementing this provision of the law. The Pilot Program will be effective June 5, 2012.
Determination That CITANEST (Prilocaine Hydrochloride) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (Prilocaine Hydrochloride) Injection, 4%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CITANEST (prilocaine hydrochloride (HCl)) Injection, 1%, 2%, and 3%, and CITANEST PLAIN (prilocaine HCl) Injection, 4%, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for prilocaine HCl injection, 1%, 2%, and 3%, and prilocaine HCl injection, 4%, if all legal and regulatory requirements are met.
Special Local Regulations; OPSAIL 2012 Connecticut, Niantic Bay, Long Island Sound, Thames River and New London Harbor, New London, CT
The Coast Guard proposes to establish temporary special local regulations on the navigable waters of Niantic Bay, Long Island Sound, the Thames River and New London Harbor, New London, Connecticut for OPSAIL 2012 Connecticut (CT) activities. This action is necessary to provide for the safety of life on navigable waters during OPSAIL 2012 CT. This action would restrict vessel traffic in portions of Niantic Bay, Long Island Sound, the Thames River, and New London Harbor unless authorized by the Captain of the Port (COTP) Sector Long Island Sound (SLIS).
Commercial Fishing Safety Advisory Committee; Vacancies
The Coast Guard seeks applications for membership on the Commercial Fishing Safety Advisory Committee (CFSAC). The CFSAC provides advice and makes recommendations to the Coast Guard and the Department of Homeland Security on matters relating to the safe operation of commercial fishing industry vessels.
Information Collection Requests to Office of Management and Budget.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit Information Collection Requests (ICRs) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0095, Oil and Hazardous Material Pollution Prevention and Safety Records, Equivalents/Alternatives and Exemptions. Additionally, the U.S. Coast Guard requests approval of a revision to the following collections of information: 1625-0099, Requirements for the Use of Liquefied Petroleum Gas and Compressed Natural Gas as Cooking Fuel on Passenger Vessels and 1625-0103, Mandatory Ship Reporting System for the Northeast and Southeast Coasts of the United States. Our ICRs describe the information we seek to collect from the public. Before submitting these ICRs to OIRA, the Coast Guard is inviting comments as described below.
Proposed Collection; Comment Request
The U.S. Department of the Treasury, 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)). Currently, the Community Development Financial Institutions (CDFI) Fund, a wholly owned government corporation within the Department of the Treasury, is soliciting comments concerning the CDFI Program Application.
Privacy Act of 1974; System of Records
The U.S. Central Command proposes to add a new system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Science Advisory Board (SAB); Notice of Open Meeting
The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management. Time and Date: The meeting will be held Thursday, April 5, 2012 from 9 a.m. to 5:15 p.m. and Friday, April 6, 2012, from 9:15 a.m. to 2:30 p.m. These times and the agenda topics described below are subject to change. Please refer to the Web page https://www.sab.noaa.gov/ Meetings/meetings.html for the most up-to-date meeting agenda. Place: The meeting will be held at the Washington Plaza Hotel, 10 Thomas Circle, Washington, DC 20005 Please check the SAB Web site https://www.sab.noaa.gov for directions to the meeting location. Status: The meeting will be open to public participation with a 15 minute public comment period on April 5 at 5 p.m. (check Web site to confirm time). The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of five (5) minutes. Individuals or groups planning to make a verbal presentation should contact the SAB Executive Director by March 29, 2012 to schedule their presentation. Written comments should be received in the SAB Executive Director's Office by March 29, 2012 to provide sufficient time for SAB review. Written comments received by the SAB Executive Director after March 29, 2012 will be distributed to the SAB, but may not be reviewed prior to the meeting date. Seating at the meeting will be available on a first-come, first-served basis. Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed no later than 12 p.m. on March 29, 2012, to Dr. Cynthia Decker, SAB Executive Director, SSMC3, Room 11230, 1315 East-West Hwy., Silver Spring, MD 20910. Matters To Be Considered: The meeting will include the following topics: (1) Update from the SAB Research and Development Portfolio Review Task Force; (2) External Review of the Cooperative Institute for Climate Science (CICS), Princeton University; (3) Proposed New Members for the Data Archive and Access Requirements Working Group (DAARWG); (4) Update from the SAB Satellite Task Force; (5) NOAA Response to the SAB Report on Fisheries Enterprise Data Management; (6) NOAA Response to Congress on Compensation Policy for Specialized Satellite Data Products and Services; (7) NOAA Report on Needs Assessment for Science Advisory Board Working Groups; (8) Use of the NOAA Logo by Affiliated Partners; and (9) Updates from SAB Working Groups.
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