2009 – Federal Register Recent Federal Regulation Documents
Results 6,701 - 6,750 of 30,932
Guidance for Industry and Food and Drug Administration Staff; Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007.'' The purpose of this guidance is to explain recent changes in the device registration and listing program to owner/operators and official correspondents of device establishments and to help them fulfill these new requirements. The guidance also describes the information that owner/operators of device establishments must submit to register their establishments and list their devices electronically, using FDA Form No. 3673. Those owner/operators seeking a waiver from the electronic submission requirement must submit their requests in writing to FDA with a complete explanation of why their registration and listing information cannot reasonably be submitted electronically. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Notice of Public Meeting: Resource Advisory Councils, Nevada
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972 (FACA), the Department of the Interior, Bureau of Land Management (BLM) Nevada will hold a joint meeting of its three Resource Advisory Councils (RACs), the Sierra Front-Northwestern Great Basin RAC, the Northeastern Great Basin RAC, and the Mojave-Southern Great Basin RAC in Elko, Nevada. The meeting is open to the public and a public comment period will be available.
Endangered and Threatened Wildlife and Plants; Permit Application, Northern Spotted Owl, Oregon
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the public comment period for the Oregon Department of Forestry's (ODF) enhancement of survival permit (permit) application under the Endangered Species Act of 1973, as amended. The permit application includes a proposed programmatic safe harbor agreement (Agreement) between ODF, the U.S. Department of AgricultureNatural Resources Conservation Service (NRCS), and the Service. The requested permit would authorize ODF to extend incidental take coverage with assurances through issuance of Certificates of Inclusion to eligible landowners willing to carry out habitat management measures expected to benefit the northern spotted owl (Strix occidentalis caurina), which is federally listed as threatened. We are reopening the comment period for 30 days. The original notice of availability was published in the Federal Register on July 21, 2009 (74 FR 35883), and contains additional information regarding the permit application. Previous comments need not be resubmitted.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Announcement of the Formaldehyde Expert Panel Meeting: Amended Notice
This notice announces the availability of web conferencing and an updated draft agenda for the RoC expert panel meeting on formaldehyde. The NTP has reserved web conferencing for the first 50 registrants; individuals who want to access the meeting remotely must pre-register by October 21, 2009. The web conferencing will be available during the public sessions of the meeting. The expert panel will meet on November 2-4, 2009, starting at 8:30 AM Eastern Standard Time, at the Hilton Raleigh-Durham Airport at Research Triangle Park Hotel, 4810 Page Creek Lane, Durham, NC 27703. Information regarding the formaldehyde expert panel meeting was announced in the Federal Register (74 FR 44845) published on August 31, 2009, and is available on the RoC Web site (https://ntp.niehs.nih.gov/go/29679). The guidelines and deadlines published in the August 31 Federal Register notice for submitting written public comments or making an oral presentation at the meeting in North Carolina still apply.
Federal Sport Fish Restoration; California Department of Fish and Game Fish Hatchery and Stocking Program
The U.S. Fish and Wildlife Service (FWS) announces the availability of the draft EIR/EIS for the California Department of Fish and Game's (CDFG) Fish Hatchery and Stocking Program (Program). FWS is lead agency, under the National Environmental Policy Act (NEPA) of 1969, as amended, for the draft EIR/EIS jointly prepared with CDFG. Under the Sport Fish Restoration Act (SFRA), FWS proposes to fund actions associated with the operation of CDFG's 14 trout hatcheries and the Mad River Hatchery for the anadromous steelhead, and stocking from the 15 hatcheries. The Federal action does not include funding CDFG's other anadromous fish hatcheries and associated stocking, nor its issuance of private stocking permits. SFRA funding may also support CDFG's Fishing in the City and Classroom Aquarium Education Programs. CDFG is the lead agency under the California Environmental Quality Act (CEQA) and proposes to implement hatchery operations and stocking funded by FWS, as well as all other components of the CDFG Program, including anadromous fish hatchery operations and associated stocking, and issuance of stocking permits to private parties seeking to stock fish in California's inland waters. We invite and encourage interested persons to review the draft EIR/EIS and submit written comments
Agency Information Collection Activities; Proposed Collection; Comment Request; National Estuary Program (Renewal); EPA ICR No. 1500.07, OMB Control No. 2040-0138
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on 01/31/2010. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.
Special Conditions: Boeing Model 747-8/-8F Airplanes, Structural Design Requirements for Four-Post Main Landing Gear System
These special conditions are issued for the Boeing Model 747- 8/-8F airplane. This airplane will have novel or unusual design features associated with a four-post main landing gear system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions: Boeing Model 747-8/-8F Series Airplanes; Design Roll Maneuver Requirement
This notice proposes special conditions for the Boeing Model 747-8/-8F airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. These design features include an electronic flight control system that provides roll control of the airplane through pilot inputs to the flight computers. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards. Additional special conditions will be issued for other novel or unusual design features of the Boeing 747-8/-8F airplanes.
Certain Cut-to-Length Carbon-Quality Steel Plate from the Republic of Korea: Correction to the Preliminary Results of Antidumping Duty Administrative Review and Intent to Rescind Administrative Review in Part
On September 24, 2009, the Department of Commerce published in the Federal Register the preliminary results of the administrative review of the antidumping duty order on certain cut-to-length carbon- quality steel plate from the Republic of Korea for the period of review February 1, 2008, through January 31, 2009. The notice contained two incorrect citations to memoranda. The correct citations are indicated below.
ODS Nutrient Biomarkers Analytical Methodology: Vitamin D Workshop; Notice
Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to others, and available as a dietary supplement. It is also produced endogenously when ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D obtained from sun exposure, food, and supplements is biologically inert and must undergo two hydroxylations in the body for activation. The first occurs in the liver and converts vitamin D to 25-hydroxyvitamin D [25(OH)D], also known as calcidiol. The second occurs primarily in the kidney and forms the physiologically active 1,25-dihydroxyvitamin D [1,25(OH)2D], also known as calcitriol.
Aquatic Nuisance Species Task Force Meeting
This notice announces a meeting of the Aquatic Nuisance Species (ANS) Task Force. The meeting is open to the public. The meeting topics are identified in the SUPPLEMENTARY INFORMATION section.
Notice 1 Receipt of Petition for Decision That Nonconforming 2009 Harley Davidson FX, FL, XL and VR Series Motorcycles Are Eligible for Importation
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2009 Harley Davidson FX, FL, XL and VR Series 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 (1) 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, and (2) they are capable of being readily altered to conform to the standards.
Establishment of the Happy Canyon of Santa Barbara Viticultural Area (2007R-311P)
This Treasury decision establishes the 23,941-acre ``Happy Canyon of Santa Barbara'' American viticultural area in Santa Barbara County, California. This viticultural area lies within the larger Santa Ynez Valley viticultural area and the multicounty Central Coast viticultural area. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Endangered and Threatened Wildlife and Plants; Revised Designation of Critical Habitat for the California Red-Legged Frog (Rana aurora draytonii)
We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on our September 16, 2008, and April 28, 2009, proposal to revise the designation of critical habitat for the California red-legged frog under the Endangered Species Act of 1973, as amended (Act). We also announce the availability of a revised draft economic analysis (DEA). We are reopening the comment period to allow all interested parties an opportunity to comment simultaneously on the proposed revision of critical habitat and the associated revised DEA. Comments previously submitted on this rulemaking do not need to be resubmitted. These comments have already been incorporated into the public record and will be fully considered in preparation of the final rule.
Open Meeting of the OTS Minority Depository Institutions Advisory Committee
The OTS Minority Depository Institutions Advisory Committee (MDIAC) will convene a meeting on Friday, November 6, 2009, at the Office of Thrift Supervision Central Region Office, at 9 a.m. Central Time. The meeting will be open to the public.
Open Meeting of the OTS Mutual Savings Association Advisory Committee
The OTS Mutual Savings Associations Advisory Committee (MSAAC) will convene a meeting on Wednesday, October 28, 2009, in the Chicago Office of the Office of Thrift Supervision, One South Wacker Drive, Suite 2000, Chicago, Illinois beginning at 8:30 a.m. Central Time. The meeting will be open to the public.
Notice of Meeting of the Ocean Research and Resources Advisory Panel
The Ocean Research and Resources Advisory Panel (ORRAP) will meet to discuss National Ocean Research Leadership Council (NORLC) and Interagency Committee on Ocean Science and Resource Management Integration (ICOSRMI) activities. All sessions of the meeting will remain open to the public.
Southeast Oregon Resource Advisory Council
Pursuant to the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the U.S. Department of the Interior, Bureau of Land Management (BLM) Southeast Oregon Resource Advisory Council (SEORAC) will meet as indicated below:
Proposed Information Collection Activities
The Recovery Accountability and Transparency Board (Board) invites comments on the proposed information collection request as required by the Paperwork Reduction Act of 1995.
Notice of Enforcement of Regulation
The Coast Guard will enforce the special local regulations in the navigable waters of San Francisco Bay for the annual U.S. Navy and City of San Francisco sponsored Fleet Week Parade of Navy Ships, Blue Angels Flight Demonstrations, and Ship Tours to be held from October 8, 2009 through October 12, 2009. This action is necessary to ensure the safety of event participants and spectators. During the enforcement period, no persons or vessels may enter the regulated area without permission of the Captain of the Port (COTP) or his designated representative.
Anchorage Regulations; Port of New York
This document confirms that the direct final rule entitled ``Anchorage Regulations; Port of New York,'' published July 1, 2009, in the Federal Register (74 FR 31354), became effective September 29, 2009.
Anchorages; New and Revised Anchorages in the Captain of the Port Portland, OR, Area of Responsibility
The Coast Guard is establishing a new anchorage, modifying existing anchorages, and revising the regulations governing anchorages in the Captain of the Port Portland, Oregon, area of responsibility. These changes are necessary to ensure that there are sufficient anchorage opportunities in that area, and to clarify the locations of those anchorage opportunities. In addition, the changes will help prevent conflicts with navigable channels and other uses of anchorage waters.
Determination of Total Amounts of Fiscal Year 2010 Tariff-Rate Quotas for Raw Cane Sugar and Certain Sugars, Syrups and Molasses; Correction
The Foreign Agricultural Service published a document in the Federal Register of September 29, 2009, providing notice of the establishment of the Fiscal Year (FY 2010) in-quota aggregate quantity of the raw, as well as, refined and specialty sugar Tariff-Rate Quotas (TRQ) as required under the U.S. World Trade Organization (WTO) commitments. The document contained an incorrect date.
Endangered Species; File No. 14634
Notice is hereby given that Douglas Peterson, PhD, University of Georgia, Warnell School of Forest Resources, Athens, GA 30602, has applied in due form for a permit to take shortnose sturgeon (Acipenser brevirostrum) for purposes of scientific research.
Marine Mammals; File No. 14802
Notice is hereby given that the Oregon Coast Aquarium, 2820 S.E. Ferry Slip Road, Newport, OR 97365, has applied in due form for a permit to import up to eight non-releasable harbor seals (Phoca vitulina) for the purposes of public display.
Privacy Act; Implementation
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of the Treasury exempts a new Internal Revenue Service (IRS) system of records entitled ``Treasury/IRS 50.222Tax Exempt/Government Entities (TE/GE) Case Management Records'' from certain provisions of the Privacy Act.
Indian Gaming
This publishes notice of an Amendment to a Compact between the Nottawaseppi Huron Band of Pottawatomi Indians and the State of Michigan providing for the Conduct of Tribal Class III Gaming by the Nottawaseppi Huron Band of Pottawatomi Indians taking effect.
Indian Gaming
This notice publishes the Approval of the Eighth Amendment to the Tribal/State Compact for Class III Gaming between the Tulalip Tribe of Washington and the State of Washington.
FHA-Insured Mortgage Loan Servicing Involving the Loss Mitigation Programs
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. The Department is soliciting public comments on the subject proposal.
Interoperability Requirements, Standards, or Performance Specifications for Automated Toll Collection Systems
The FHWA is adding a new part to the Code of Federal Regulations, to add regulations specifying the interoperability requirements for automated toll collection systems for the facilities that are tolled under any of the tolling programs contained in section 1604 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU). Specifically, this rulemaking requires facilities operating with authority under section 1604 of SAFETEA-LU to use electronic toll collection (ETC) systems and to maximize their system's interoperability with other toll facilities. Although a nationwide interoperability standard has not yet been established, this rule seeks to accelerate progress toward achieving nationwide interoperability by requiring these facilities to upgrade their ETC systems to the national standards whenever adopted.
Colorado River Basin Salinity Control Advisory Council
The Colorado River Basin Salinity Control Advisory Council (Council) was established by the Colorado River Basin Salinity Control Act of 1974 (Public Law 93-320) (Act) to receive reports and advise federal agencies on implementing the Act. In accordance with the Federal Advisory Committee Act, the Bureau of Reclamation announces that the Council will meet as detailed below.
Agency Information Collection Activities: Customs Declaration (Form 6059B)
As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Customs Declaration. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)).
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