August 25, 2009 – Federal Register Recent Federal Regulation Documents

Medical Device Reporting: Electronic Submission Requirements
Document Number: Z9-19683
Type: Proposed Rule
Date: 2009-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
Amendments to Various National Indian Gaming Commission Regulations
Document Number: E9-20511
Type: Rule
Date: 2009-08-25
Agency: Department of the Interior, National Indian Gaming Commission
The National Indian Gaming Commission (``NIGC'') announces the extension of the effective date on the final rule concerning various amendments to the National Indian Gaming Commission regulations. The final rule was published in the Federal Register on July 27, 2009. The Commission has changed the effective date to December 31, 2009, in order to extend the transition time.
Fisheries Off West Coast States; Modifications of the West Coast Commercial and Recreational Salmon Fisheries; Inseason Actions #1, #2, and #3
Document Number: E9-20490
Type: Rule
Date: 2009-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NOAA Fisheries announces three inseason actions in the ocean salmon fisheries. Inseason action 1 modified the commercial fishery in the area from Cape Falcon, Oregon to Humbug Mountain, Oregon, and from Humbug Mountain, Oregon to the Oregon/California Border. Inseason action 2 modified the recreational fishery in the area from Cape Falcon, Oregon to Humbug Mountain, Oregon. Inseason action 3 modified the commercial fishery in the area from U.S./Canada Border to Cape Falcon, Oregon.
Magnuson-Stevens Act Provisions; Experimental Permitting Process, Exempted Fishing Permits, and Scientific Research Activity
Document Number: E9-20489
Type: Rule
Date: 2009-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues new and revised definitions for certain regulatory terms, and procedural and technical changes to the regulations
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Non-American Fisheries Act Crab Vessels Catching Pacific Cod for Processing by the Inshore Component in the Central Regulatory Area of the Gulf of Alaska
Document Number: E9-20422
Type: Rule
Date: 2009-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific cod by non- American Fisheries Act (AFA) crab vessels that are subject to sideboard limits catching Pacific cod for processing by the inshore component in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2009 Pacific cod sideboard limit established for non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Central Regulatory Area of the GOA.
Patient Safety and Quality Improvement: Civil Money Penalty Inflation Adjustment
Document Number: E9-20419
Type: Rule
Date: 2009-08-25
Agency: Office of the Secretary, Department of Health and Human Services
The Department of Health and Human Services amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are amending the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990. We are using direct final rulemaking for this action because we expect that there will be no significant adverse comment on the rule.
Patient Safety and Quality Improvement: Civil Money Penalty Inflation Adjustment
Document Number: E9-20418
Type: Proposed Rule
Date: 2009-08-25
Agency: Office of the Secretary, Department of Health and Human Services
The Department of Health and Human Services is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which amends the Patient Safety and Quality Improvement Rule by adjusting for inflation the maximum civil money penalty amount for violations of the confidentiality provisions of the Rule. We are proposing to amend the penalty amount to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990.
Defense Federal Acquisition Regulation Supplement; Technical Amendments
Document Number: E9-20416
Type: Rule
Date: 2009-08-25
Agency: Defense Acquisition Regulations System, Department of Defense
DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to update the list of DoD contracting activities and other references within the DFARS text.
Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Document Number: E9-20415
Type: Proposed Rule
Date: 2009-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its device classification regulations by correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays FDA was aware of were type 1 and type 2, and therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule.
Microbiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Document Number: E9-20411
Type: Rule
Date: 2009-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is implementing a direct final rule correcting the regulation classifying herpes simplex virus (HSV) serological assays by removing the reference to HSV serological assays other than type 1 and type 2. When reclassifying this device, FDA mistakenly distinguished between HSV serological assays type 1 and type 2 and all other HSV serological assays. At that time, and today, the only preamendments HSV serological assays which FDA was aware of were type 1 and type 2 and, therefore, the classification of HSV assays other than type 1 and type 2 was incorrect. FDA is correcting the classification of this device to eliminate possible confusion resulting from this error. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under FDA's usual procedure for notice and comment to provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw this direct final rule.
Implementation of Statutory Amendments Requiring the Qualification of Manufacturers and Importers of Processed Tobacco and Other Amendments Related To Permit Requirements, and the Expanded Definition of Roll-Your-Own Tobacco; Extension of Comment Period
Document Number: E9-20404
Type: Proposed Rule
Date: 2009-08-25
Agency: Alcohol and Tobacco Tax and Trade Bureau, Department of Treasury, Department of the Treasury, Alcohol, Tobacco, Firearms, and Explosives Bureau, Department of Justice
In response to a request filed on behalf of several industry members, the Alcohol and Tobacco Tax and Trade Bureau is reopening the comment period for Notice No. 95, a notice of proposed rulemaking published in the Federal Register on June 22, 2009. The proposed rule seeks comments on a concurrently published temporary rule implementing permit requirements for manufacturers and importers of processed tobacco and an expansion of the definition of roll-your-own tobacco adopted in the Children's Health Insurance Program Reauthorization Act of 2009. The text of the regulations contained in the temporary rule serves as the text of the proposed regulations.
Migratory Bird Hunting; Final Frameworks for Early-Season Migratory Bird Hunting Regulations
Document Number: E9-20400
Type: Rule
Date: 2009-08-25
Agency: Fish and Wildlife Service, Department of the Interior
This rule prescribes final early-season frameworks from which the States, Puerto Rico, and the Virgin Islands may select season dates, limits, and other options for the 2009-10 migratory bird hunting seasons. Early seasons are those that generally open prior to October 1, and include seasons in Alaska, Hawaii, Puerto Rico, and the Virgin Islands. The effect of this final rule is to facilitate the selection of hunting seasons by the States and Territories to further the annual establishment of the early-season migratory bird hunting regulations.
Revisions to Test Method for Determining Stack Gas Velocity Taking Into Account Velocity Decay Near the Stack Walls
Document Number: E9-20395
Type: Proposed Rule
Date: 2009-08-25
Agency: Environmental Protection Agency
EPA is proposing to revise the voluntary test method for determining stack gas velocity taking into account the velocity decay near the stack or duct walls. When the method was originally developed,
Approval and Promulgation of Implementation Plans; New York Reasonably Available Control Technology and Reasonably Available Control Measures
Document Number: E9-20394
Type: Proposed Rule
Date: 2009-08-25
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing action on portions of a State Implementation Plan revision submitted by New York State that are intended to meet some Clean Air Act requirements for attaining the 0.08 parts per million 8-hour ozone national ambient air quality standards. EPA is proposing to disapprove the reasonably available control technology requirement as it relates to the entire State of New York, including the New York portion of the New York- Northern New Jersey-Long Island, NY-NJ-CT and the Poughkeepsie 8-hour ozone moderate nonattainment areas.
New Entrant Safety Assurance Process: Implementation of Section 210(b) of the Motor Carrier Safety Improvement Act of 1999
Document Number: E9-20393
Type: Proposed Rule
Date: 2009-08-25
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
The Federal Motor Carrier Safety Administration (FMCSA) requests comment on the methods the Agency should consider implementing to provide further assurance that a new applicant carrier is knowledgeable about the applicable safety requirements before being granted New Entrant authority. We are considering whether to implement a proficiency examination as part of our revised New Entrant Safety Assurance Process and seek information concerning issues that should be considered in the development and use of such an examination. In addition, the Agency requests comments on other alternatives to a proficiency examination to complement the assurances already in place that new entrant carriers are knowledgeable about applicable safety requirements. This notice responds to issues raised by Advocates for Highway and Auto Safety (Advocates) regarding new entrant applicant knowledgeability.
Federal Motor Vehicle Safety Standards; Air Brake Systems
Document Number: E9-20387
Type: Rule
Date: 2009-08-25
Agency: National Highway Traffic Safety Administration, Department of Transportation
This document makes permanent an existing requirement that trailers with antilock brake systems (ABS) be equipped with an external malfunction indicator lamp. The indicator lamp requirement, which is included in the Federal motor vehicle safety standard that governs air- braked vehicles, was originally scheduled to sunset on March 1, 2009, but had previously been extended to September 1, 2009. The agency had established a sunset date for this requirement in light of the increasing numbers of post-2001 tractors which have an in-cab trailer ABS malfunction lamp, making the external trailer lamp redundant. We are making the requirement permanent in light of additional safety purposes served by the external lamp, including: it not only warns the driver of a malfunctioning trailer ABS, but, unlike the in-cab lamps, indicates which trailer in double and trailer applications has a malfunction, and it assists Federal and State roadside inspectors and maintenance personnel in identifying a malfunctioning trailer ABS. This rulemaking was conducted in response to petitions from the Commercial Vehicle Safety Alliance.
Federal Motor Vehicle Safety Standard No. 114, Theft Protection and Rollaway Prevention
Document Number: E9-20384
Type: Proposed Rule
Date: 2009-08-25
Agency: National Highway Traffic Safety Administration, Department of Transportation
NHTSA is proposing to place a requirement in the Federal motor vehicle safety standards that certain motor vehicles with an automatic transmission that includes a ``park'' position manufactured for sale after September 1, 2010 be equipped with a brake transmission shift interlock. This interlock will require that the service brake pedal be depressed before the transmission can be shifted out of ``park,'' and will function in any starting system key position.
Airworthiness Directives; Boeing Model 747 Airplanes
Document Number: E9-20382
Type: Proposed Rule
Date: 2009-08-25
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all Boeing Model 747 airplanes. This proposed AD would require one-time detailed and high frequency eddy current inspections for cracks in the wing and horizontal stabilizer side-of-body joints and the fuselage skin circumferential splices, and repair if necessary. This proposed AD would also require, for certain airplanes, repetitive detailed inspections for cracks of the fuselage skin circumferential splices, and repair if necessary. This proposed AD results from Boeing analysis indicating that the wing and horizontal stabilizer side-of-body joints, and the fuselage skin circumferential splices are susceptible to fatigue cracking due to high cyclic loads on the airplane. We are proposing this AD to detect and correct fatigue cracking at multiple adjacent locations in the subject areas, which could connect to form large cracks and result in reduced structural integrity leading to rapid decompression and consequent loss of control of the airplane.
Commission Guidance Regarding the Financial Accounting Standards Board's Accounting Standards Codification
Document Number: E9-20381
Type: Rule
Date: 2009-08-25
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (the ``Commission'') is publishing interpretive guidance regarding the release by the Financial Accounting Standards Board (``FASB'') of its FASB Accounting Standards Codification\TM\ (``FASB Codification'').
Privacy Act of 1974; Implementation
Document Number: E9-20364
Type: Rule
Date: 2009-08-25
Agency: Department of Justice
The Criminal Division (CRM), Department of Justice, issued a proposed rule to amend its Privacy Act regulations (Title 28 of the Code of Federal Regulations, Part 16), to revise the exemptions for the following newly modified Privacy Act system of records entitled ``Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System,'' JUSTICE/CRM-028, 74 FR 26598 (June 3, 2009). The ``Organized Crime Drug Enforcement Task Force Fusion Center and International Organized Crime Intelligence and Operations Center System,'' JUSTICE/ CRM-028, is exempt from the subsections of the Privacy Act listed below for the reasons set forth in the following text. Information in this system of records relates to matters of law enforcement, and the exemptions are necessary to avoid interference with law enforcement responsibilities and to protect the privacy of third parties.
Airworthiness Directives; Airbus Model A310 Airplanes
Document Number: E9-20352
Type: Proposed Rule
Date: 2009-08-25
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Trade Adjustment Assistance for Farmers
Document Number: E9-20345
Type: Proposed Rule
Date: 2009-08-25
Agency: Department of Agriculture, Foreign Agricultural Service
The American Recovery and Reinvestment Act of 2009 reauthorizes and modifies the Trade Adjustment Assistance for Farmers program as established by Subtitle C of Title I of the Trade Act of 2002, which amended the Trade Act of 1974. Under this program, the U.S. Department of Agriculture (USDA) provides technical assistance and cash benefits to eligible producers of raw agricultural commodities and fishermen (jointly referred to as ``producers'') when the Foreign Agricultural Service (FAS) Administrator determines that increased imports of raw agricultural commodities, aquaculture products, or wild- caught aquatic species (jointly referred to as ``agricultural commodities'') have contributed importantly to a greater than 15 percent decrease in the national average price, or quantity of production, or value of production, or cash receipts for the agricultural commodity specified in the certified petition compared to the average of the three preceding marketing years. The rule establishes the procedure by which a group can submit a petition for certification of eligibility and individual producers of agricultural commodities can apply for technical assistance and cash benefits for the development and implementation of approved business adjustment plans.
Track Safety Standards; Continuous Welded Rail (CWR)
Document Number: E9-20253
Type: Rule
Date: 2009-08-25
Agency: Federal Railroad Administration, Department of Transportation
FRA is amending the Federal Track Safety Standards to promote the safety of railroad operations over continuous welded rail (CWR). In particular, FRA is promulgating specific requirements for the qualification of persons designated to inspect CWR track, or supervise the installation, adjustment, or maintenance of CWR track. FRA is also clarifying the procedures associated with the submission of CWR plans to FRA by track owners. The final rule specifies that these plans should add focus on inspecting CWR for pull-apart prone conditions, and on CWR joint installation and maintenance procedures. This final rule will also make other changes to the requirements governing CWR.
Telemarketing Sales Rule Fees
Document Number: E9-20252
Type: Rule
Date: 2009-08-25
Agency: Rin 3084-Aa98, Federal Trade Commission, Agencies and Commissions
The Federal Trade Commission (the ``Commission'' or ``FTC'') is amending its Telemarketing Sales Rule (``TSR'') by updating the fees charged to entities accessing the National Do Not Call Registry (the ``Registry'') as required by the Do-Not-Call Registry Fee Extension Act of 2007.
Health Breach Notification Rule
Document Number: E9-20142
Type: Rule
Date: 2009-08-25
Agency: Federal Trade Commission, Agencies and Commissions
The Federal Trade Commission (``FTC'' or ``Commission'') is issuing this final rule, as required by the American Recovery and Reinvestment Act of 2009 (the ``Recovery Act'' or ``the Act''). The rule requires vendors of personal health records and related entities to notify consumers when the security of their individually identifiable health information has been breached.
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