2008 – Federal Register Recent Federal Regulation Documents

Results 1,401 - 1,450 of 32,078
The Treatment of Data Influenced by Exceptional Events (Exceptional Event Rule): Revised Exceptional Event Data Flagging Submittal and Documentation Schedule To Support Initial Area Designations for the 2008 Ozone NAAQS
Document Number: E8-29747
Type: Rule
Date: 2008-12-16
Agency: Environmental Protection Agency
The EPA issued ``The Treatment of Data Influenced by Exceptional Events (Exceptional Event Rule): Revised Exceptional Event Data Flagging Submittal and Documentation Schedule for Monitoring Data Used in Designations for the 2008 Ozone NAAQS'' as a direct final rule on October 6, 2008, 73 FR 58042. Because EPA received an adverse comment, we are withdrawing the direct final rule amendments to ``The Treatment of Data Influenced by Exceptional Events (Exceptional Event Rule): Revised Exceptional Event Data Flagging Submittal and Documentation Schedule to Support Initial Area Designations for the 2008 Ozone NAAQS'' published in the Federal Register on October 6, 2008 (73 FR 58042).
National Institute of Standards and Technology
Document Number: E8-29746
Type: Notice
Date: 2008-12-16
Agency: Department of Commerce, National Institute of Standards and Technology
The inventions listed below are owned in whole or part by the U.S. Government, as represented by the Secretary of Commerce. The U.S. Government's interest in these inventions is available for licensing in accordance with 35 U.S.C. 207 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally funded research and development.
Technology Innovation Program (TIP) Seeks White Papers
Document Number: E8-29745
Type: Notice
Date: 2008-12-16
Agency: Department of Commerce, National Institute of Standards and Technology
The National Institute of Standards and Technology's (NIST) Technology Innovation Program (TIP) announces that it is seeking white papers from any interested party, including academia; federal, state, and local governments; industry; national laboratories; and professional organizations/societies. White papers will be used to identify and select areas of critical national need to be addressed in future TIP competitions.
Exxon Valdez Oil Spill Trustee Council; Notice of Meeting
Document Number: E8-29744
Type: Notice
Date: 2008-12-16
Agency: Office of the Secretary, Department of the Interior
The Department of the Interior, Office of the Secretary is announcing a public meeting of the Exxon Valdez Oil Spill Public Advisory Committee.
Exxon Valdez Oil Spill Trustee Council; Notice of Meeting
Document Number: E8-29743
Type: Notice
Date: 2008-12-16
Agency: Office of the Secretary, Department of the Interior
The Department of the Interior, Office of the Secretary is announcing a public meeting of the Exxon Valdez Oil Spill Public Advisory Committee.
Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
Document Number: E8-29742
Type: Notice
Date: 2008-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during the Federal Government Response Stages of an influenza pandemic. The agency makes recommendations to industry for focusing limited resources on reports related to influenza-related products and other specific types of reports indicated in the draft guidance.
Microbiological Testing for Contact Lens Care Products; Public Workshop
Document Number: E8-29741
Type: Notice
Date: 2008-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Microbiological Testing for Contact Lens Care Products.'' FDA is co-sponsoring the public workshop with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists. The purpose of the public workshop is to discuss test method parameters for evaluating the activity of contact lens care products against Acanthamoeba and to discuss elements of microbiological test methods that simulate ``real world'' consumer use conditions. Date and Time: The public workshop will be held on January 22 and 23, 2009, from 8 a.m. to 5 p.m. Participants are encouraged to arrive by 7:30 a.m. to allow enough time for parking and security screening. Security Screening will begin at 7 a.m. Location: The public workshop will be held at the Food and Drug Administration, White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 2 (Central Shared Use Building), Silver Spring, MD. Attendees should follow the directions provided in the Registration Information section of this document. Contact: Daryl L. Kaufman, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Daryl.Kaufman@fda.hhs.gov, or Marc Robboy, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4200, FAX: 240-276-4234, e-mail: Marc.Robboy@fda.hhs.gov. Agenda: The purpose of the conference is to discuss test methods for evaluating the anti-microbial activity of contact lens care products. On January 22, 2008, we hope to reach consensus on critical test method parameters for evaluating the activity of contact lens care products against Acanthamoeba. These parameters include organism species and strain, trophozoite culture and cyst production, microbial challenge level, and assay method for survivors. On January 23, 2008, we hope to present and discuss critical elements for new or modified disinfection efficacy test methods that simulate ``real world'' consumer use conditions. These elements include contact lens and lens case uptake of preservative and other solution ingredients, solution evaporation, minimal consumer compliance, biofilm formation and clinical isolates as challenge organisms. Background information on the public workshop, registration information, the agenda, information about lodging, and other relevant information will be posted on the Internet at www.jcahpo.org/clmw. Registration Information: Registration must be completed online at www.jcahpo.org/clmw. Please pre-register no later than January 8, 2009 (see instructions in this paragraph). There will be no onsite registration. Non-U.S. citizens are subject to additional security screening and should pre-register at least 3 weeks in advance. There is a registration fee of $250 for this workshop. Early registration is recommended because seating is limited. If you need special accommodations due to a disability, please contact Ms. Janice Prestwood at 800-284-3937, ext. 229 (toll free), 651-731-7229 (direct) or 651-731-0410 (fax) at least 7 days before the public workshop. Lodging, travel, and security clearance information are also available from the registration Web site. Persons without Internet access may contact Ms. Janice Prestwood for help in completing the registration form.
Submission for OMB Review; Comment Request
Document Number: E8-29739
Type: Notice
Date: 2008-12-16
Agency: Department of the Treasury, Department of Treasury
Submission for OMB Review; Comment Request
Document Number: E8-29738
Type: Notice
Date: 2008-12-16
Agency: Department of the Treasury, Department of Treasury
Towing Safety Advisory Committee; Vacancies
Document Number: E8-29735
Type: Notice
Date: 2008-12-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard seeks applications for membership on the Towing Safety Advisory Committee (TSAC). TSAC advises the Coast Guard on matters relating to shallow-draft inland and coastal waterway navigation and towing safety.
Proposed Information Collection; Comment Request; Manufacturers' Shipments, Inventories, and Orders (M3) Survey
Document Number: E8-29734
Type: Notice
Date: 2008-12-16
Agency: Department of Commerce, U.s. Census Bureau, Census Bureau
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)).
Drawbridge Operation Regulations; Wabash River; Activity Identifier; Permanent Change to Operating Schedule
Document Number: E8-29733
Type: Rule
Date: 2008-12-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard moves that the procedures for Operation of Drawbridges across the Wabash River be revised to reflect the needs of navigation. There were no comments or related materials received from the public for the Notice of Final Rulemaking docket number USCG-2008-0100 that preceded this Final Rule.
Chief of Engineers Environmental Advisory Board
Document Number: E8-29732
Type: Notice
Date: 2008-12-16
Agency: Department of Defense, Department of the Army, Corps of Engineers, Engineers Corps, Army Department
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following committee meeting: Name of Committee: Chief of Engineers Environmental Advisory Board (EAB). Topic: The EAB will discuss national considerations related to ecosystem restoration through integrated water resources management with emphasis on building collaborative partnerships, and the implementation of the Environmental Operating Principles. Date of Meeting: January 15, 2009. Place: Marines' Memorial Club and Hotel, 609 Sutter Street, San Francisco, CA Time: 9 a.m. to 12 p.m. Thirty minutes will be set side for public comment. Members of the public who wish to speak are asked to register prior to the start of the meeting. Registration will begin at 8:30. Statements are limited to 3 minutes.
Intent To Prepare a Draft Environmental Impact Statement for the Proposed Arboretum Project, in Rancho Cordova, Sacramento County, CA, Permit Application Number SPK-2007-00133
Document Number: E8-29730
Type: Notice
Date: 2008-12-16
Agency: Department of Defense, Department of the Army, Corps of Engineers, Engineers Corps, Army Department
The U.S. Army Corps of Engineers, Sacramento District, (Corps) will prepare an Environmental Impact Statement (EIS) for The Arboretum project, a mixed-use residential and commercial development in Rancho Cordova, Sacramento County, CA. Lewis Operating Corp. has applied for a Department of the Army permit to fill approximately 31.78 acres of waters of the United States, including wetlands, to construct the project.
Apache-Sitgreaves National Forests; Arizona; Revised Land and Resource Management Plan
Document Number: E8-29729
Type: Notice
Date: 2008-12-16
Agency: Department of Agriculture, Forest Service
The Forest Service is revising the Apache-Sitgreaves National Forests' Land and Resource Management Plan (hereafter referred to as the forest plan). This notice describes the documents available for review and how to obtain them; summarizes the need to change the forest plan; provides information concerning public participation and collaboration, including the process for submitting comments; provides an estimated schedule for the planning process, including the time available for comments; and includes names and addresses for agency officials who can provide additional information.
Conaway Hip-Hugger; Denial of Petition for Rulemaking
Document Number: E8-29728
Type: Proposed Rule
Date: 2008-12-16
Agency: National Highway Traffic Safety Administration, Department of Transportation
This notice denies a petition for rulemaking submitted by Mr. Brian J. Conaway, which, among other things, requested that the NHTSA amend the language and definitions in Federal Motor Vehicle Safety Standard (FMVSS) No. 213, ``Child restraint systems,'' to apply the standard to products that are not yet defined by the standard, such as belt positioning devices. Alternatively, the petitioner asked the agency to adopt a new definition, which would allow his product, the Hip-Hugger, to be recognized and defined as a child restraint device under FMVSS No. 213. NHTSA is denying the petition because it does not see a safety need to apply a FMVSS to seat belt positioners and it does not believe that a denial would hamper child restraint system innovation or design. Furthermore, the agency is concerned that applying FMVSS No. 213 to seat belt positioners may actually degrade child occupant protection by promoting premature graduation to lap/ shoulder belts.
Houston/Galveston Navigation Safety Advisory Committee Vacancies
Document Number: E8-29727
Type: Notice
Date: 2008-12-16
Agency: Coast Guard, Department of Homeland Security
The U.S. Coast Guard seeks applications for membership on the Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC). This committee advises and makes recommendations to the Coast Guard on matters relating to the safe navigation of vessels to and from the Ports of Galveston, Houston, and Texas City, and throughout Galveston Bay, Texas.
Withdrawal of Regulatory Guide
Document Number: E8-29724
Type: Notice
Date: 2008-12-16
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Endangered and Threatened Wildlife and Plants; Initiation of 5-Year Reviews of 7 Listed Species
Document Number: E8-29720
Type: Notice
Date: 2008-12-16
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, initiate 5-year reviews of the endangered Appalachian monkeyface (Quadrula sparsa), the northeast population of the roseate tern (Sterna dougalii dougalli), and the shale barren rock-cress (Arabis serotina), and the threatened Cheat Mountain salamander (Plethodon nettingi), the Madison cave isopod (Antrolana lira), the sensitive joint-vetch (Aeschynomene virginica), and the Virginia sneezeweed (Helenium virginicum), under the Endangered Species Act of 1973, as amended (Act). We request any new information on these species that may have a bearing on their classification as endangered or threatened. Based on the results of these 5-year reviews, we will make a finding on whether these species are properly classified under the Act.
New Hampshire Disaster Number NH-00005
Document Number: E8-29719
Type: Notice
Date: 2008-12-16
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Hampshire (FEMA-1799-DR), dated 10/03/2008. Incident: Severe Storms and Flooding. Incident Period: 09/06/2008 through 09/07/2008.
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29718
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, LLC for competitive oil and gas lease WYW153113 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29717
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, LLC for competitive oil and gas lease WYW155731 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29716
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, LLC for competitive oil and gas lease WYW153114 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29715
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, L.L.C. for competitive oil and gas lease WYW153112 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29714
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, LLC for competitive oil and gas lease WYW153111 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Notice of Consideration of Energy Efficiency and Smart Grid Standards
Document Number: E8-29713
Type: Notice
Date: 2008-12-16
Agency: Tennessee Valley Authority, Agencies and Commissions
The Tennessee Valley Authority (TVA) is considering adopting for itself and the distributors of TVA power certain energy efficiency and Smart Grid standards. The standards being considered are the Integrated Resource Planning, Rate Design Modifications to Promote Energy Efficiency Investments, Consideration of Smart Grid Investments, and Smart Grid Information standards listed in section 111(d) of the Public Utility Regulatory Act of 1978 (Pub. L. 95-617) as amended by the Energy Independence and Security Act of 2007 (Pub. L. 110-140). The standards will be considered on the basis of their effect on conservation of energy, efficient use of facilities and resources, equity among electric consumers, and the objectives of the Tennessee Valley Authority Act. Comments are requested from the public on whether TVA should adopt these standards or any variations on them.
Airworthiness Directives; Honeywell International Inc., T5313 and T5317 Series Turboshaft Engines
Document Number: E8-29712
Type: Proposed Rule
Date: 2008-12-16
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for Honeywell International Inc., T5313 and T5317 series turboshaft engines. This proposed AD would require initial and repetitive visual inspections and initial and repetitive ultrasonic inspections. This proposed AD results from eight instances of cracks in combustion chamber housings (CCHs). Two of the instances resulted in an engine shutdown during flight. We are proposing this AD to detect cracks in the CCH, which could result in rupture of the CCH, leading to loss of engine power and damage to the helicopter.
Washington, DC Metropolitan Area Special Flight Rules Area
Document Number: E8-29711
Type: Rule
Date: 2008-12-16
Agency: Federal Aviation Administration, Department of Transportation
This action codifies special flight rules and airspace and flight restrictions for certain aircraft operations in the Washington, DC Metropolitan Area. The FAA takes this action in the interest of national security. This action is necessary to enable the Department of Homeland Security (DHS) and the Department of Defense (DOD) to effectively execute their respective constitutional and Congressionally-mandated duties to secure, protect, and defend the United States.
Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting
Document Number: E8-29709
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
Revisions to the EDA Regulations
Document Number: E8-29708
Type: Rule
Date: 2008-12-16
Agency: Department of Commerce, Economic Development Administration
On October 22, 2008, the Economic Development Administration (``EDA'') published an interim final rule in the Federal Register. This document extends the deadline for submitting public comments on the interim final rule from December 22, 2008 until January 22, 2009. The extension of the public comment period is necessary to provide additional time for the submission of public comments and to allow for EDA's additional consideration of matters pertaining to the effective implementation of the interim final rule.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: E8-29707
Type: Notice
Date: 2008-12-16
Agency: Federal Reserve System, Agencies and Commissions
Wyoming: Notice of Proposed Reinstatement of Terminated Oil and Gas Lease
Document Number: E8-29705
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement from Chesapeake Exploration, L.L.C. for competitive oil and gas lease WYW172444 for land in Converse County, Wyoming. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Interagency Cooperation Under the Endangered Species Act
Document Number: E8-29701
Type: Rule
Date: 2008-12-16
Agency: Department of Commerce, National Oceanic and Atmospheric Administration, Fish and Wildlife Service, Department of the Interior
With this final rule, the United States Fish and Wildlife Service and the National Marine Fisheries Service (collectively, ``Services'' or ``we'') amend regulations governing interagency cooperation under the Endangered Species Act of 1973, as amended (ESA). This rule clarifies several definitions, provides assistance as to when consultation under section 7 is necessary, and establishes time frames for the informal consultation process.
Notice of Intent To Seek Approval To Extend an Information Collection
Document Number: E8-29700
Type: Notice
Date: 2008-12-16
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is announcing plans to request clearance of this collection. In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting that OMB approve clearance of this collection for no longer than three years.
National Assessment Governing Board; Proposed Information Collection
Document Number: E8-29699
Type: Notice
Date: 2008-12-16
Agency: Department of Education
The National Assessment Governing Board, 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 Governing Board is soliciting comments concerning a survey of higher education institutions it is conducting in connection with designing the National Assessment of Educational Progress (NAEP) to report on the preparedness of 12th grade students for placement into entry-level college-credit coursework.
Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System
Document Number: E8-29698
Type: Proposed Rule
Date: 2008-12-16
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is proposing to expand the applicability of notice of arrival and departure (NOAD) and automatic identification system (AIS) requirements to more commercial vessels. This proposed rule would expand the applicability of notice of arrival (NOA) requirements to additional vessels, establish a separate requirement for certain vessels to submit notices of departure (NOD), set forth a mandatory method for electronic submission of NOA and NOD, and modify related reporting content, timeframes, and procedures. This proposed rule would also expand the applicability of AIS requirements, beyond Vessel Traffic Service (VTS) areas, to all U.S. navigable waters and require AIS carriage for additional commercial vessels. These proposed changes would improve navigation safety, enhance the Coast Guard's ability to identify and track vessels, heighten our overall maritime domain awareness, and thus help us address threats to maritime transportation safety and security and mitigate the possible harm from such threats.
TIAA-CREF Life Funds, et al.
Document Number: E8-29697
Type: Notice
Date: 2008-12-16
Agency: Securities and Exchange Commission, Agencies and Commissions
Lamb Promotion and Research Program: Procedures To Request Conduct of a Referendum
Document Number: E8-29694
Type: Rule
Date: 2008-12-16
Agency: Agricultural Marketing Service, Department of Agriculture
This final rule amends the regulations issued under the Lamb Promotion, Research, and Information Order (Order) pursuant to administrative changes to Web addresses and office locations within the USDA's Agricultural Marketing Service.
Notice of Opportunity To Participate in the Lamb Promotion, Research, and Information Program Referendum
Document Number: E8-29693
Type: Notice
Date: 2008-12-16
Agency: Agricultural Marketing Service, Department of Agriculture
The Agricultural Marketing Service (AMS) is announcing that a referendum will be conducted under the Lamb Promotion, Research, and Information Order (Order) to determine whether those persons voting favor the continuance of the Order.
Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl; Availability
Document Number: E8-29692
Type: Notice
Date: 2008-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.'' The recommendation provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules.
Draft Guidance for Industry on Changes to Approved New Animal Drug Applications-New Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability
Document Number: E8-29691
Type: Notice
Date: 2008-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs''. This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).
Qualification of Drivers; Exemption Applications; Vision
Document Number: E8-29690
Type: Notice
Date: 2008-12-16
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 13 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Qualification of Drivers; Exemption Applications; Vision
Document Number: E8-29689
Type: Notice
Date: 2008-12-16
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 13 individuals. FMCSA has statutory authority to exempt individuals from the vision requirement if the exemptions granted will not compromise safety. The Agency has concluded that granting these exemption renewals will provide a level of safety that is equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
Guidance for Industry on Orally Disintegrating Tablets; Availability
Document Number: E8-29688
Type: Notice
Date: 2008-12-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Disintegrating Tablets.'' The guidance provides pharmaceutical manufacturers of new and generic products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate proposed products as ODTs.
Annual Surveys in the Manufacturing Area
Document Number: E8-29687
Type: Notice
Date: 2008-12-16
Agency: Department of Commerce, Bureau of the Census, Census Bureau
The Bureau of the Census (Census Bureau) is conducting the 2008 Annual Surveys in the Manufacturing Area. The 2008 Annual Surveys consist of the Current Industrial Reports surveys, the Annual Survey of Manufactures, and the Business Research and Development (R&D) and Innovation Survey. We have determined that annual data collected from these surveys are needed to aid the efficient performance of essential governmental functions and have significant application to the needs of the public and industry. The data derived from these surveys, most of which have been conducted for many years, are not publicly available from non-governmental or other governmental sources.
Proposed Wind Energy Project, Searchlight, NV
Document Number: E8-29686
Type: Notice
Date: 2008-12-16
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321 et seq., the Bureau of Land Management (BLM), Las Vegas Field Office will prepare an EIS for a wind energy project located on public lands in Clark County, Nevada.
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