2007 – Federal Register Recent Federal Regulation Documents
Results 401 - 450 of 5,969
Ethalfluralin; Pesticide Tolerance
This regulation establishes tolerances for residues of ethalfluralin in or on dill, dried leaves; dill, fresh leaves; mustard, seed; potato; and rapeseed, seed. It also removes the current tolerance for residues of ethalfluralin on canola seed since residues on canola are covered by the rapeseed tolerance, thus making the canola tolerance unnecessary. Interregional Research Project Number 4 (IR-4) requested the new tolerances and removal of the canola tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Disclosure of Termination Information
This is a proposed rule to implement section 506 of the Pension Protection Act of 2006 (Pub. L. 109-280) which amends sections 4041 and 4042 of ERISA. These amendments require that a plan administrator disclose information it has submitted to PBGC in connection with a distress termination filing, and that a plan administrator or plan sponsor disclose information it has submitted to PBGC in connection with a PBGC-initiated termination. The new provisions also require PBGC to disclose the administrative record in a PBGC-initiated termination. The disclosures must be made to an affected party upon request.
Dichlorvos (DDVP); Order Denying NRDC's Petition to Revoke All Tolerances
In this Order, EPA denies a petition requesting that EPA revoke all pesticide tolerances for dichlorvos (DDVP) under section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The petition was filed on June 2, 2006, by the Natural Resources Defense Council (NRDC).
Safety Zone, Chicago Harbor, Navy Pier East, Chicago, IL
The Coast Guard will enforce the Navy Pier East Safety Zone in Chicago Harbor on December 4, 2007. This action is necessary to protect vessels and people from the hazards associated with fireworks displays. This safety zone will restrict vessel traffic from a portion of the Captain of the Port Lake Michigan Zone.
Safety Zone: Wantagh Parkway 3 Bridge over the Sloop Channel, Town of Hempstead, New York
The Coast Guard is extending the effective period of a temporary safety zone previously established on the waters surrounding the Wantagh Parkway Number 3 Bridge across the Sloop Channel in Town of Hempstead, New York. The extended effective period of this zone is necessary to protect vessels transiting in the area from hazards imposed by construction barges and equipment that are being utilized to construct a new bascule bridge over the Sloop Channel. Entry into this zone is prohibited unless authorized by the Captain of the Port Long Island Sound, New Haven, Connecticut.
Drawbridge Operation Regulations; Cheesequake Creek, Morgan, NJ
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the New Jersey Transit Rail Operation (NJTRO) Railroad Bridge across Cheesequake Creek, mile 0.2, at Morgan, New Jersey. Under this temporary deviation, the bridge may remain in the closed position from January 2, 2008 through March 31, 2008. Vessels that can pass under the draw without a bridge opening may do so at all times. This deviation is necessary to facilitate scheduled bridge maintenance.
Drawbridge Operation Regulations; Biscayne Bay, Atlantic Intracoastal Waterway, Miami River, and Miami Beach Channel, Miami-Dade County, FL
The Coast Guard proposes to change the regulations governing the operation of the east and west spans of the Venetian Causeway bridges across the Miami Beach Channel on the Atlantic Intracoastal Waterway, the Miami Avenue bridge and the Brickell Avenue bridge across the Miami River, Miami-Dade County. This proposed rule would allow these bridges to remain in the closed position for periods of time during the last Sunday in January during the running of an annual marathon.
Change in Deadline for Rulemaking to Address the Control of Emissions From New Marine Compression-Ignition Engines at or Above 30 Liters per Cylinder
A February 2003 final rule established the first U.S. emission standards for new compression-ignition Category 3 marine engines, those with a per-cylinder displacement at or above 30 liters. It also established a deadline of April 27, 2007 for EPA to promulgate a second set of emission standards for these engines. This rulemaking schedule was intended to allow time to consider the state of technology for deeper emission reductions and the status of international action for more stringent standards. Since 2003 we have continued to gain a greater understanding of technical issues and assess the continuing efforts of manufacturers to apply advanced emission control technologies to these engines. In addition, we have continued to work with and through the International Maritime Organization toward more stringent emission standards that would apply to all new marine diesel engines on ships engaged in international transportation. Much of the information necessary to develop more stringent Category 3 marine diesel engines standards has become available only recently and we expect more information to come to light in the course of the current negotiations underway as part of the international process. EPA is therefore adopting a new deadline for the rulemaking to consider the next tier of Category 3 marine diesel engine standards. Under this new schedule, EPA would adopt a final rule by December 17, 2009. EPA has started this rulemaking process by publishing an Advance Notice of Proposed Rulemaking elsewhere in today's Federal Register.
Extension of the Presumptive Period for Compensation for Gulf War Veterans
This document affirms an amendment to the Department of Veterans Affairs (VA) adjudication regulation regarding compensation for disabilities resulting from undiagnosed illnesses suffered by veterans who served in the Persian Gulf War. This amendment is necessary to extend the presumptive period for qualifying chronic disabilities resulting from undiagnosed illnesses that must become manifest to a compensable degree in order that entitlement for compensation be established. The intended effect of this amendment is to provide consistency in VA adjudication policy and preserve certain rights afforded to Persian Gulf War veterans and ensure fairness for current and future Persian Gulf War veterans.
United States Standards for Grades of Sweet Cherries
The Agricultural Marketing Service (AMS) is withdrawing the notice soliciting comments on its proposal to amend the voluntary United States Standards for Grades of Sweet Cherries. After reviewing and considering the comments received, the agency has decided not to proceed with this action.
Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida; Decreased Assessment Rate
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule which decreased the assessment rate established for the Citrus Administrative Committee (Committee) for the 2007-08 and subsequent fiscal periods from $0.008 to $0.0072 per \4/5\ bushel carton of oranges, grapefruit, tangerines, and tangelos handled. The Committee locally administers the marketing order which regulates the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida. Assessments upon Florida citrus handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins August 1 and ends July 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Revisions of Regulations Concerning Procedures for Filing Appeals to Denial in Whole or Part of Initial FOIA Requests
The National Labor Relations Board (NLRB) is amending regulations concerning the procedures for filing an appeal to adverse FOIA determinations. The revisions require that appeals be filed within 28 calendar days of the service of the notification of the adverse determination.
New Animal Drugs For Use in Animal Feeds; Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in two-way Type B and Type C medicated feeds containing monensin and tylosin to cattle fed in confinement for slaughter and a revision to bacterial pathogen nomenclature.
New Animal Drugs For Use in Animal Feeds; Monensin USP
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.
Oral Dosage Form New Animal Drugs; Carprofen
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Belcher Pharmaceuticals, Inc. The ANADA provides for veterinary prescription use of carprofen caplets in dogs.
Approval of Implementation Plans; Ohio; Clean Air Interstate Rule
Due to the receipt of an adverse comment, the EPA is withdrawing the October 16, 2007 (72 FR 58546), direct final rule approving the State of Ohio's September 26, 2007, request to revise the Ohio State Implementation Plan (SIP) by incorporating provisions related to the implementation of EPA's Clean Air Interstate Rule (CAIR). In the direct final rule, EPA stated that if adverse comments were submitted by November 15, 2007, the rule would be withdrawn and not take effect. On November 9, 2007, EPA received a comment. EPA believes this comment is adverse and, therefore, EPA is withdrawing the direct final rule. EPA will address the comment in a subsequent final action based upon the proposed action also published on October 16, 2007 (72 FR 58571). EPA will not institute a second comment period on this action.
Approval and Promulgation of Air Quality Implementation Plans; Maryland, Pennsylvania, Virginia, West Virginia; Redesignation of 8-Hour Ozone Nonattainment Areas to Attainment and Approval of the Areas' Maintenance Plans and 2002 Base-Year Inventories; Correction
This document corrects an error in the part 81 tables of a series of final rules pertaining to EPA's approval of ozone redesignation requests for Kent and Queen Anne, Erie, Fredericksburg, Shenandoah, Charleston, Parkersburg-Marietta, Steubenville-Weirton, Wheeling, and Huntington-Ashland 8-hour ozone nonattainment areas. The requests to redesignate the areas from nonattainment to attainment were submitted by Maryland, Pennsylvania, Virginia, and West Virginia.
Approval and Promulgation of Air Quality Implementation Plans; Minnesota
EPA is proposing to approve State Implementation Plan (SIP) revisions to the sulfur dioxide (SO2) requirements for Northern States Power Company, doing business as Xcel Energy, Inver Hills Generating Plant (Inver Hills), located in Inver Grove Heights, Dakota County, Minnesota. The revisions make the limits of the sulfur content in its fuel and its sulfur dioxide emissions more stringent, and prohibit the burning of residual fuel oil. The revisions allow the facility to use simpler methods to analyze the sulfur content of its fuel. Because the sulfur dioxide emission limits are being reduced, the air quality of Dakota County will be protected.
Approval and Promulgation of Air Quality Implementation Plans; Minnesota
EPA is approving State Implementation Plan (SIP) revisions to sulfur dioxide (SO2) requirements for Northern States Power Company, doing business as Xcel Energy, Inver Hills Generating Plant (Inver Hills), located in Inver Grove Heights, Dakota County, Minnesota. The revisions make the limits of the sulfur content in its fuel and its sulfur dioxide emissions more stringent, and prohibit the burning of residual fuel oil. The revisions allow the facility to use simpler methods to analyze the sulfur content of its fuel. Because the sulfur dioxide emission limits are being reduced, the air quality of Dakota County will be protected.
Change in Address for the Department of Transportation (DOT) and DOT Migration to the Federal Docket Management System (FDMS)
This action updates the Department of Transportation (DOT) addresses, changes references from the Docket Management System to the Federal Docket Management System (FDMS), and removes obsolete information listed in FAA regulations as a result of DOT's relocation, migration to the Federal electronic docket system, and closure of the DOT Branch Library. The intended effect of this action is to ensure that the regulated public is informed of address changes, electronic docket changes, and other administrative matters.
Approval and Promulgation of Air Quality Implementation Plans; Virginia; Amendments Extending the Applicability of Four Consumer and Commercial Product Regulations to the Fredericksburg Volatile Organic Compound (VOC) Emissions Control Area
EPA is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia. This revision consists of amendments to extend the geographic applicability of four consumer and commercial product regulationsPortable Fuel Container Spillage, Mobile Equipment Repair and Refinishing Operations, Architectural and Industrial Maintenance Coatings, and Consumer Productsto the Fredericksburg VOC Emissions Control Area. These amendments are necessary to implement VOC contingency measures within the Fredericksburg Area. The revision also incorporates by reference two additional test methods and procedures needed for Virginia's Architectural and Industrial Maintenance Coatings Rule. EPA is approving this revision to the Virginia SIP in accordance with the requirements of the Clean Air Act (CAA).
Homeliving Programs
Under the No Child Left Behind Act of 2001, the Secretary of the Interior is publishing final regulations addressing homeliving programs administered under the Bureau of Indian Education-funded school system.
Bacillus Thuringiensis Vip3Aa20 Protein and the Genetic Material Necessary for its Production in Corn; Extension of Temporary Exemption From the Requirement of a Tolerance
This regulation extends the temporary exemption from the requirement of a tolerance for residues of Bacillus thuringiensis Vip3Aa20 protein in corn when applied or used as a plant-incorporated protectant. Syngenta Seeds, Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting that the temporary tolerance exemption be extended. This regulation eliminates the need to establish a maximum permissible level for residues of the Bacillus thuringiensis Vip3Aa20 protein in corn when applied or used as a plant- incorporated protectant on field corn, sweet corn, and popcorn. The temporary tolerance exemption expires on October 31, 2009.
Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes
This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement.
Risk-Based Capital Regulation-Loss Severity Amendments
The Office of Federal Housing Oversight (OFHEO) is amending Appendix A to Subpart B of 12 CFR part 1750 Risk-Based Capital (Risk- Based Capital Regulation). The amendments are intended to enhance the accuracy and transparency of the calculation of the risk-based capital requirement for the Federal National Mortgage Association (Fannie Mae) and the Federal Home Loan Mortgage Corporation (Freddie Mac) (collectively the Enterprises). OFHEO proposes to amend further the Risk-Based Capital Regulation to change the loss severity equations that understate losses on defaulted single-family conventional and government guaranteed loans. OFHEO also proposes to amend the treatment of Federal Housing Administration (FHA) insurance in the Risk-Based Capital Regulation in order to conform the treatment to current law.
Notification of U.S. Fish Quotas and an Effort Allocation in the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area
NMFS announces that fish quotas and an effort allocation are available for harvest by U.S. fishermen in the Northwest Atlantic Fisheries Organization (NAFO) Regulatory Area. This action is necessary to make available to U.S. fishermen a fishing privilege on an equitable basis.
Fisheries of the Northeastern United States; Regulatory Amendment to Modify Recordkeeping and Reporting and Observer Requirements; Correction
On April 23, 2007, NMFS published in the Federal Register a final rule to implement measures requiring observers for participating hagfish vessels in the Federal Register as part of the hagfish information collection program. On June 13, 2007, NMFS published a separate final rule that inadvertently deleted these regulations implemented in the April 23, 2007, rule. This correcting amendment corrects this error by reinstating the language regarding hagfish observer requirements.
Fisheries of the Northeastern United States; Summer Flounder Fishery; Commercial Quota Harvested for Connecticut
NMFS announces that the 2007 summer flounder commercial quota allocated to the State of Connecticut has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in Connecticut for the remainder of calendar year 2007, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise Connecticut that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no commercial quota is available for landing summer flounder in Connecticut.
Reasonable Charges for Medical Care or Services
This final rule amends the Department of Veterans Affairs (VA) medical regulations concerning ``reasonable charges'' for medical care or services provided or furnished by VA to certain veterans for nonservice-connected disabilities. It changes the process for determining interim billing charges when a new Diagnosis Related Group (DRG) code or Current Procedural Terminology/Healthcare Common Procedure Coding System (CPT/HCPCS) code identifier is assigned to a particular type or item of medical care or service and VA has not yet established a charge for the new identifier. This process is designed to provide interim billing charges that are very close to what the new billing charges would be when the charges for the new identifiers are established in accordance with the regulations. This final rule also changes the regulations by removing all of the provisions for discounts of billed charges. This will eliminate or reduce duplicate discounting and thereby prevent unintended underpayments to the government.
Disclosure to Shareholders; Annual Report to Shareholders
The Farm Credit Administration (FCA, Agency, we) issues this final rule amending our regulations to allow Farm Credit System (System) institutions 90 calendar days to prepare and distribute annual reports to shareholders, while retaining the 75 calendar day requirement for electronic reporting and distribution to the FCA.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List
This document corrects the direct final notice of deletion of the Standard Auto Bumper Site from the National Priorities List, published in the Federal Register of August 27, 2007. This correction clarifies that all Institutional Controls (ICs) are in place and recorded at the site.
Approval and Promulgation of Implementation Plans; State of Missouri; General Conformity
EPA is taking direct final action to approve a revision to the Missouri State Implementation Plan (SIP) to amend the General Conformity Rule to include de minimis emission levels for Particulate Matter 2.5 (PM2.5). This update ensures consistency with the Federal General Conformity Rule.
Approval and Promulgation of Implementation Plans; State of Missouri; General Conformity
EPA is proposing to approve a revision to the Missouri State Implementation Plan (SIP) to amend the General Conformity Rule to include de minimus emission levels for Particulate Matter 2.5 (PM2.5). This update ensures consistency with the Federal General Conformity Rule.
Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Approval of Construction Permit Waiver
EPA is proposing to approve revisions to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) on May 1, 2007. The WDNR has submitted for approval into its SIP a revision which allows the State to issue a waiver to a source allowing it to commence construction prior to a construction permit being issued, in certain cases. This provision is only allowed for minor sources which meet specific criteria, and WDNR must follow established procedures to grant a waiver. In addition, the revision also contains changes to Wisconsin's fee provisions to allow a fee to be charged for the waiver. EPA is proposing to approve this revision because it is consistent with Federal regulations governing state permit programs.
Expanded Definition of Byproduct Material; Notification of Waiver Termination
This document announces that on November 30, 2007, in accordance with Section 651(e) of the Energy Policy Act of 2005 and the provisions of the ``Plan for the Transition of Regulatory Authority Resulting from the Expanded Definition of Byproduct Material'' (transition plan) issued by the U.S. Nuclear Regulatory Commission (Commission or NRC) on October 19, 2007 (72 FR 59157), the Commission determined that the States listed below have a program to license byproduct material, as defined in Sections 11e.(3) and (4) of the Atomic Energy Act of 1954, as amended, that is adequate to protect the public health and safety. This determination is based on certifications provided to the Commission by Governors of these States.
Occupational Dose Records, Labeling Containers, and the Total Effective Dose Equivalent
The Nuclear Regulatory Commission (NRC or Commission) is amending its regulations related to the reporting of annual dose to workers, the definition of Total Effective Dose Equivalent (TEDE), the labeling of certain containers holding licensed material, and the determination of cumulative occupational radiation dose. This final rule limits the routine reporting of annual doses to those workers whose annual dose exceeds a specific dose threshold or who request a report. This final rule also modifies the labeling requirements for certain containers holding licensed material within posted areas in nuclear power facilities. This final rule also amends the definition of TEDE to be consistent with current Commission policy. Finally, this rule removes the requirement that licensees attempt to obtain cumulative exposure records for workers unless these individuals are being authorized to receive a planned special exposure. These revisions reduce the administrative and information collection burdens on NRC and Agreement State licensees without affecting the level of protection for either the health and safety of workers and the public, or for the environment.
Airworthiness Directives; Boeing Model 747-400 and 747-400D Series Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Boeing Model 747-400 and 747-400D series airplanes. This proposed AD would require a general visual inspection of the power feeder wire bundle of the auxiliary power unit (APU) where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube. This proposed AD would also require related investigative and corrective actions if necessary. This proposed AD results from a report that the power feeder wire bundle of the APU was found touching the hydraulic system return tube during inspection of an airplane. We are proposing this AD to prevent insufficient clearance between the wire bundle and hydraulic tube that could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire in an area outside of the smoke detection and fire extinguishing zone; this condition could result in an uncontrolled fire on the airplane.
Airworthiness Directives; Cirrus Design Corporation Models SR20 and SR22 Airplanes
We are revising an earlier proposed airworthiness directive (AD) that applies to certain Cirrus Design Corporation (CDC) Models SR20 and SR22 airplanes. The earlier NPRM would have required you to inspect and, as necessary, adjust the aileron and rudder rigging and would have required you to modify, inspect, and, as necessary, adjust the rudder-aileron interconnect system. The earlier NPRM resulted from a jamming of the aileron and rudder controls on a Model SR20 airplane, which resulted in loss of rudder and aileron flight controls. Since issuance of the NPRM, CDC revised the service information as a result of comments received on the NPRM, and the FAA has determined the changes to the service information are necessary to address the unsafe condition. The changes in the revised service information include the addition of airplanes to the Applicability; a requirement to check rudder, aileron, and rudder-aileron interconnect rigging; a requirement to replace the attaching hardware and clamp at the end of the rudder- aileron interconnect arm; and an increase in work-hours to do the proposed actions. This proposed AD would require you to use the revised service information and would require you to report any out-of-rig condition found. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these additional actions.
Drawbridge Operation Regulations; Pinellas Bayway Structure “E” (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, FL
The Coast Guard proposes to change the drawbridge regulation of the Pinellas Bayway Structure ``E'' (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, Florida. This rule is needed to provide vehicular traffic relief during heavy vehicular traffic periods flowing into a nearby county park while still meeting the reasonable needs of mariners.
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and- comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.
Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This Rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Federal Motor Vehicle Safety Standards; Cargo Carrying Capacity
In this final rule, we (NHTSA) address the problem of motor home and recreation vehicle trailer overloading by amending the Federal Motor Vehicle Safety Standards (FMVSS) on tire selection and rims. This final rule requires manufacturers of all motor homes and recreation vehicle trailers to provide information to consumers in a label that informs the consumer about the vehicle's load carrying capacity. This information is helpful both at the time the consumer is making a purchase decision and as the consumer uses his or her vehicle. We also require that the size of tires on motor homes and recreation vehicle trailers be the same as the size of the tires listed on the tire information label. In addition, this rule provides regulatory relief for dealers from a labeling requirement in the safety standard on tire selection and rims for light vehicles. The standard's requirement can currently require dealers which add even small amounts of weight to re-label the vehicles. Under today's amendment, any party that adds weight to a completed vehicle exceeding the lesser of 1.5 percent of the vehicle's gross vehicle weight rating or 100 pounds (before first sale to the retail customer) is required to disclose this extra weight on labels affixed to the vehicles. Lesser amounts of weight may be added without changing or adding labels. It is our belief that this rule complements the efforts of the recreation vehicle industry to provide consumers with information in order to help reduce overloading motor homes and recreation vehicle trailers. This rulemaking was initiated in response to a petition from Ms. Justine May.
Magnuson-Stevens Act Provisions; Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Biennial Specifications and Management Measures; Inseason Adjustments
This final rule announces inseason changes to management measures in the commercial Pacific Coast groundfish fishery. These actions, which are authorized by the Pacific Coast Groundfish Fishery Management Plan (FMP), are intended to allow fisheries to access more abundant groundfish stocks while protecting overfished and depleted stocks.
Medicare Program, Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III), Correction
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on September 5, 2007 entitled ``Medicare Program, Physicians'' Referrals to Health Care Entities With Which They Have Financial Relationships (Phase III).''
Medicaid Program; Optional State Plan Case Management Services
This interim final rule with comment period revises current Medicaid regulations to incorporate changes made by section 6052 of the Deficit Reduction Act of 2005. In addition, it incorporates provisions of the Consolidated Omnibus Budget Reconciliation Act of 1985, the Omnibus Budget Reconciliation Act of 1986, the Tax Reform Act of 1986, the Omnibus Budget Reconciliation Act of 1987, and the Technical and Miscellaneous Revenue Act of 1988, concerning case management and targeted case management services. This interim final rule with comment period will provide for optional coverage of case management services or targeted case management services furnished according to section 1905(a)(19) and section 1915(g) of the Social Security Act. This interim final rule with comment period clarifies the situations in which Medicaid will pay for case management activities and also clarifies when payment will not be consistent with proper and efficient operation of the Medicaid program, and is not available.
Federal Motor Vehicle Safety Standards; Lamps, Reflective Devices, and Associated Equipment
This document amends the Federal Motor Vehicle Safety Standard (FMVSS) No. 108 on lamps, reflective devices, and associated equipment by reorganizing the regulatory text so that it provides a more straightforward and logical presentation of the applicable regulatory requirements, which includes the agency's interpretation of the existing requirements. It also greatly reduces the need to consult relevant third-party standards by including applicable requirements directly into the main body of Standard No. 108, rather than incorporating such provisions by reference. This final rule does not impose any new substantive requirements on manufacturers. In addition, this document amends 49 CFR Part 564, Replaceable Light Source Information, by adding a newly created Appendix C, which relocates figures addressing sealed beam headlamps that currently reside in FMVSS No. 108 and a relevant Society of Automotive Engineers (SAE) standard there. We believe few lighting manufacturers still produce sealed beam headlamps, and their diminishing use is unlikely to draw new manufacturers of this type of lamp. Accordingly, we see no drawbacks to consolidating the information regarding sealed beam light sources with other light source information currently located in 49 CFR Part 564.
Definition of “Positional Isomer” as It Pertains to the Control of Schedule I Controlled Substances
On May 25, 2006, DEA published a Notice of Proposed Rulemaking which proposed the addition of a specific definition for the term ``positional isomer'' to allow for the systematic determination of which isomers of schedule I substances would be considered to be ``positional,'' and therefore, subject to schedule I control. This rulemaking finalizes that definition. The Controlled Substances Act (CSA) and its implementing regulations specify which hallucinogenic substances are considered schedule I controlled substances. The CSA states that all salts, isomers, and salts of isomers of these substances are also schedule I controlled substances. In non-technical terms, an isomer of a substance is a different compound, but a compound which has the same number and kind of atoms. The terms ``optical isomer'' and ``geometric isomer'' are specific scientific terms and it is easy to determine whether one substance is an optical or geometric isomer of another. The term ``positional isomer,'' however, is subject to scientific interpretation. The addition of a definition for the term ``positional isomer'' will assist legitimate research[ers] and industry in determining the control status of materials that are ``positional isomers'' of schedule I hallucinogens. While the DEA will remain the authority for ultimately determining the control status of a given material, providing a specific definition for ``positional isomer'' will ensure consistent criteria are utilized in making these determinations. This rule does not change existing laws, regulations, policies, processes, and procedures regarding the determination of control status for schedule I hallucinogenic substances. This rule merely makes available to the public the longstanding definition of ``positional isomer'' which DEA has used when making these scheduling determinations. This rule is relevant only to specialized forensic or research chemists. Most of these individuals are existing DEA registrants who are authorized by the DEA to handle schedule I hallucinogenic substances.
Recruitment, Relocation, and Retention Incentives
The Office of Personnel Management is issuing final regulations on recruitment, relocation, and retention incentives. The final regulations revise the interim regulations by making a number of technical modifications, corrections, and clarifications. The final regulations continue to provide agencies with additional flexibility to help recruit and retain Federal employees and better meet agency strategic human capital needs.
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