January 16, 2008 – Federal Register Recent Federal Regulation Documents

Oral Dosage Form New Animal Drugs; Firocoxib Tablets
Document Number: E8-730
Type: Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.
Proposed Flood Elevation Determinations
Document Number: E8-725
Type: Proposed Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Proposed Flood Elevation Determinations
Document Number: E8-724
Type: Proposed Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Proposed Flood Elevation Determinations
Document Number: E8-722
Type: Proposed Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Proposed Flood Elevation Determinations; Correction
Document Number: E8-721
Type: Proposed Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security, Department of Homeland Securtiy
This document corrects the table to a proposed rule published in the Federal Register of September 11, 2007. This correction clarifies the table representing the flooding source(s), location of referenced elevation, the effective and modified elevation in feet and the communities affected for Graham County, North Carolina, and Incorporated Areas; specifically, for flooding source ``Cochran Creek,'' than was previously published.
Changes in Flood Elevation Determinations
Document Number: E8-706
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.
Changes in Flood Elevation Determinations
Document Number: E8-703
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.
Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
Document Number: E8-702
Type: Proposed Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA) to codify the agency's longstanding view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review of such change. FDA is proposing to reaffirm its longstanding position that a supplemental application submitted under those provisions is appropriate to amend the labeling for an approved product only to reflect newly acquired information, as well as to clarify that such a supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or device. The amendments proposed by this document are intended to reflect the agency's existing practices with respect to supplemental applications submitted to FDA.
Changes in Flood Elevation Determinations
Document Number: E8-700
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
Document Number: E8-699
Type: Rule
Date: 2008-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.
Final Flood Elevation Determinations
Document Number: E8-695
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Final Flood Elevation Determinations
Document Number: E8-692
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
Base (1% annual chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Suspension of Community Eligibility
Document Number: E8-690
Type: Rule
Date: 2008-01-16
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.
Acetamiprid; Pesticide Tolerance
Document Number: E8-683
Type: Rule
Date: 2008-01-16
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of acetamiprid in or on bushberry subgroup 13-07B; caneberry subgroup 13- 07A; low growing berry subgroup 13-07G; onion, bulb, subgroup 3-07A; and onion, green, subgroup 3-07B. Nippon Soda Co., Ltd. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Proposed Clarification for Chemical Identification Describing Activated Phosphors for TSCA Inventory Purposes
Document Number: E8-681
Type: Proposed Rule
Date: 2008-01-16
Agency: Environmental Protection Agency
This document proposes a clarification under which activated phosphors that are not on the Toxic Substances Control Act (TSCA) section 8(b) Chemical Substance Inventory (TSCA Inventory) would be considered to be new chemical substances under TSCA section 5, thus would be subject to the notification requirements under TSCA section 5(a) new chemical notification requirements. In certain letters and other interpretations issued by EPA from 1978 to 2003, it appears that the Agency erroneously indicated that activated phosphors constitute solid mixtures for purposes of the TSCA Inventory, and thus that they were not separately reportable as chemical substances under TSCA section 5(a) new chemical notification requirements. This proposed clarification is necessary because EPA's interpretations in this area have not been consistent. Given this past inconsistency, EPA is seeking comment on its proposed clarfication.
Mandipropamid; Pesticide Tolerance
Document Number: E8-677
Type: Rule
Date: 2008-01-16
Agency: Environmental Protection Agency
This regulation establishes a tolerance for residues of mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]- alpha-(2-propynyloxy)-benzeneacetamide in or on Brassica, head and stem, subgroup 5A; Brassica, leafy greens, subgroup 5B; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; okra; vegetable, leafy except brassica, group 4; vegetable, tuberous and corm, subgroup 1C; grape; grape, raisin; onion, dry bulb; onion, green; and potato, wet peel. Syngenta Crop Protection Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Class 9 Bonded Warehouse Procedures
Document Number: E8-522
Type: Proposed Rule
Date: 2008-01-16
Agency: Department of Homeland Security, Department of the Treasury, Bureau of Customs and Border Protection
This document proposes amendments to title 19 of the Code of Federal Regulations, with respect to the requirements applicable to the operation of Class 9 bonded warehouses, which are also known as ``duty- free sales enterprises'' or ``duty-free stores.'' The proposed amendments would extend the blanket withdrawal procedure for Class 9 bonded warehouses to cover vessel supplies under certain circumstances and expand and create a uniform time period for Class 9 proprietors to file an entry, provide written confirmation of certain shortages, overages, and damages, and to pay duties, taxes, and interest on overages and shortages. In addition, the proposed amendments would permit Class 9 warehouses to utilize technological systems more effectively. The proposed changes would facilitate the efficient operation of Class 9 warehouses and also ensure adequate records are maintained for U.S. Customs and Border Protection (``CBP'') trade enforcement purposes.
Endangered and Threatened Wildlife and Plants; Final Rule To List Six Foreign Birds as Endangered
Document Number: E8-492
Type: Rule
Date: 2008-01-16
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), determine endangered status for six avian speciesblack stilt (Himantopus novaezelandiae), caerulean paradise-flycatcher (Eutrichomyias rowleyi), giant ibis (Pseudibis gigantea), Gurney's pitta (Pitta gurneyi), long- legged thicketbird (Trichocichla rufa), and Socorro mockingbird (Mimus graysoni)under the Endangered Species Act of 1973, as amended (Act). This rule implements the protection of the Act for these six species.
Airworthiness Directives; Pilatus Aircraft Limited Model PC-12, PC-12/45, and PC-12/47 Airplanes
Document Number: E8-479
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued 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:
Airworthiness Directives; EMBRAER Model EMB-135BJ Airplanes
Document Number: E8-470
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This 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:
Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 170 and ERJ 190 Airplanes
Document Number: E8-469
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This 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:
Airworthiness Directives; Airbus Model A310 Series Airplanes
Document Number: E8-370
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
The FAA is superseding an existing airworthiness directive (AD), that applies to certain Airbus Model A310 series airplanes. That AD currently requires modification of certain wires in the right-hand (RH) wing. This new AD requires further modification by installing an additional protection sleeve and segregating route 2S in the RH pylon area. This AD results from analysis of wire routing that revealed that route 2S of the fuel electrical circuit, located in the RH wing, does not provide adequate separation of fuel quantity indication wires from wires carrying 115-volt alternating current (AC). We are issuing this AD to ensure that fuel quantity indication wires are properly separated from wires carrying 115-volt AC. Improper separation of such wires, in the event of wire damage, could lead to a short circuit and a possible ignition source, which could result in a fire in the airplane.
Airworthiness Directives; EMBRAER Model EMB-120, -120ER, -120FC, -120QC, and -120RT Airplanes
Document Number: E8-170
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This 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:
Preventing Undue Discrimination and Preference in Transmission Service
Document Number: E8-144
Type: Rule
Date: 2008-01-16
Agency: Department of Energy, Federal Energy Regulatory Commission
The Federal Energy Regulatory Commission affirms its basic determinations in Order No. 890, granting rehearing and clarification regarding certain revisions to its regulations and the pro forma open- access transmission tariff, or OATT, adopted in Order Nos. 888 and 889 to ensure that transmission services are provided on a basis that is just, reasonable, and not unduly discriminatory. The reforms affirmed in this order are designed to: (1) Strengthen the pro forma OATT to ensure that it achieves its original purpose of remedying undue discrimination; (2) provide greater specificity to reduce opportunities for undue discrimination and facilitate the Commission's enforcement; and (3) increase transparency in the rules applicable to planning and use of the transmission system.
Airworthiness Directives; Airbus Model A300 Airplanes; and Model A300 B4-600, B4-600R, and F4-600R Series Airplanes, and Model C4-605R Variant F Airplanes (Collectively Called A300-600 Series Airplanes)
Document Number: E7-25503
Type: Rule
Date: 2008-01-16
Agency: Federal Aviation Administration, Department of Transportation
The FAA is superseding an existing airworthiness directive (AD), which applies to all Airbus Model A300 B2 and B4 series airplanes; and all Model A300 B4-600, B4-600R, and F4-600R (collectively called A300-600) series airplanes. That AD currently requires repetitive inspections to detect cracking of the upper radius of the forward fitting of frame 47, and repair if necessary. This new AD retains those requirements, but reduces inspection thresholds and repetitive intervals, and adds related investigative and corrective actions. This AD also provides an optional terminating action for the repetitive inspections only for airplanes with cracking that is within certain limits, and a post-repair inspection program following the optional terminating action. This AD results from reports of additional cracking in airplanes that were inspected in accordance with the existing AD. We are issuing this AD to detect and correct fatigue cracking of the left and right upper radius at frame 47, which could propagate and result in reduced structural integrity of the airplane.
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