November 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a final Compliance Policy Guide (CPG) 160.900 entitled ``Prescription Drug Marketing ActPedigree Requirements under 21 CFR Part 203'' (PDMA CPG). This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR Sec. Sec. 203.3(u) and 203.50. In addition, the FDA is announcing the availability of ``Guidance for Industry: Prescription Drug Marketing Act (PDMA) Pedigree Requirements Questions and Answers'' (PDMA Q & A). The PDMA Q & A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act (PDMA) pedigree requirements. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA.

NMFS is prohibiting gillnet fishing or gillnet possession in Atlantic Ocean waters west of 80[deg]00' W. long. between 29[deg]00' N. lat. (just south of New Smyrna Beach, Fla.) and 32[deg]00' N. lat. (the approximate state boundary between Georgia and South Carolina) and within 35 nautical miles of the South Carolina coast. An exemption to the prohibition on the possession of gillnet gear is provided for transiting through this area if gear is stowed in accordance with this rule. NMFS is taking this action to prevent a significant risk to the well being of endangered right whales from entanglement in gillnet gear in the core right whale calving area during the calving season.

The Food and Drug Administration (FDA) is amending the animal drug regulations to simplify the organization of special labeling requirements for formulations (Type A medicated articles, Type B and Type C medicated feeds) containing monensin sodium. This action is being taken to improve the clarity of the regulations.

EPA is promulgating amendments to the Toxic Substances Control Act (TSCA) section 12(b) export notification regulations at subpart D of 40 CFR part 707. One amendment changes the current annual notification requirement to a one-time requirement for exporters of chemical substances or mixtures (hereinafter referred to as ``chemicals'') for which certain actions have been taken under TSCA. Relatedly, for the same TSCA actions, EPA is changing the current requirement that the Agency notify foreign governments annually after the Agency's receipt of export notifications from exporters to a requirement that the Agency notify foreign governments once after it receives the first export notification from an exporter. EPA is also promulgating de minimis concentration levels below which notification will not be required for the export of any chemical for which export notification under TSCA section 12(b) is otherwise required, promulgating other minor amendments (to update the EPA addresses to which export notifications must be sent, to indicate that a single export notification may refer to more than one section of TSCA where the exported chemical is the subject of multiple TSCA actions, and to correct an error in 40 CFR 799.19 that currently omits mentioning multi-chemical test rules as being among those final TSCA section 4 actions that trigger export notification), and clarifying exporters' and EPA's obligations where an export notification-triggering action is taken with respect to a chemical previously or currently subject to export notification due to the existence of a previous triggering action.

This document contains final regulations that provide rules for determining bona fide residency in the following U.S. territories: American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the United States Virgin Islands under section 937(a) of the Internal Revenue Code.

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 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.

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).

We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding on a petition to list the island marble butterfly (Euchloe ausonides insulanus) under the Endangered Species Act of 1973, as amended (Act). After review of all available scientific and commercial information, we find that the petitioned action is not warranted. Furthermore, the Service and the National Park Service (NPS) have entered into a Conservation Agreement that implements conservation measures specifically addressing the needs of the island marble butterfly. We request that you submit any new information concerning the status of and threats to this subspecies whenever it becomes available. We will continue to collaborate with our partners to expand the conservation efforts that have been instituted by several landowners on currently occupied habitat.

We, the U.S. Fish and Wildlife Service (Service), are designating critical habitat for the Astragalus brauntonii (Braunton's milk-vetch) and Pentachaeta lyonii (Lyon's pentachaeta) pursuant to the Endangered Species Act of 1973, as amended (Act). For A. brauntonii, approximately 3,300 acres (ac) (1,337 hectares (ha)) fall within the boundaries of the critical habitat designation. The critical habitat for A. brauntonii is located in Ventura, Los Angeles, and Orange Counties, California. For P. lyonii, approximately 3,396 ac (1,372 ha) fall within the boundaries of the critical habitat designation. The critical habitat for P. lyonii is located in Ventura and Los Angeles Counties, California.

The Coast Guard is establishing a safety zone on the St. Louis River in Duluth, Minnesota. The purpose of the safety zone is to protect the boating public from dangers associated with the cleanup operation in and around Stryker Bay. Entry into this zone will be prohibited unless authorized by the Captain of the Port or his duly appointed representative.

The of State Louisiana has applied to EPA for Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA proposes to grant Final authorization to the State of Louisiana. In the ``Rules and Regulations'' section of this Federal Register, EPA is authorizing the changes by an immediate final rule. EPA did not make a proposal prior to the immediate final rule because we believe this action is not controversial and do not expect comments that oppose it. We have explained the reasons for this authorization in the preamble to the immediate final rule. Unless we get written comments which oppose this authorization during the comment period, the immediate final rule will become effective on the date it establishes, and we will not take further action on this proposal. If we receive comments that oppose this action, we will withdraw the immediate final rule and it will not take effect. We will then respond to public comments in a later final rule based on this proposal. You may not have another opportunity for comment. If you want to comment on this action, you must do so at this time.

We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a proposed amendment to the Indiana regulatory program (Indiana program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Indiana proposes revisions to its rules to allow commercial forestry (trees) to be planted on reclaimed prime farmland provided all remaining reclamation requirements for prime farmland are met. Indiana also proposes to restructure several of its provisions and make some minor language changes. Indiana intends to revise its program to improve operational efficiency. This document gives the times and locations that the Indiana program and proposed amendment to that program are available for your inspection, the comment period during which you may submit written comments on the amendment, and the procedures that we will follow for the public hearing, if one is requested.

The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that relaxed the minimum grade requirement prescribed under the Washington apricot marketing order for the 2006 shipping season. The marketing order regulates the handling of fresh apricots grown in designated counties in the State of Washington, and is administered locally by the Washington Apricot Marketing Committee (Committee). This rule continues in effect the action that relaxed the fresh apricot minimum grade requirement from Washington No. 1 grade to Washington No. 2 grade. Taking into consideration pre-harvest hail damage, this change was made for the purpose of increasing the supply of marketable fresh apricots while increasing the potential for higher producer returns.

The Commodity Credit Corporation (CCC) proposes to clarify Sugar Program regulations for the sugar marketing allotment program. This rule proposes to clarify eligibility requirements for processors to receive reassigned sugar marketing allocations deducted from other processors with insufficient supply to fill their allocations. The intent of this rule is to elaborate upon CCC's broad discretion to conduct allocation reassignments in the current regulations.

This final rule implements the Federal Civil Penalties Inflation Adjustment Act of 1990 as amended by the Debt Collection Improvement Act of 1996. The rule adjusts the amount of the statutory civil penalty for violation of the Seaway Regulations and Rules under the authority of the Ports and Waterways Safety Act of 1972, as amended (PWSA).

EPA is proposing to approve the State Implementation Plan (SIP) revision to the Low Enhanced Vehicle Inspection/Maintenance Program for the State of Louisiana. This revision addresses the exemption of the two newest model year gasoline-fueled passenger cars and gasoline-fueled trucks from On-Board Diagnostic (OBD) testing. We are taking this action in accordance to Section 110 of the Clean Air Act.

The FAA is adopting a new airworthiness directive (AD) for all BAE Systems (Operations) Limited Model BAe 146 and Avro 146-RJ airplanes equipped with certain hydraulic accumulators. This AD requires inspecting the hydraulic accumulators to identify certain serial numbers, and replacing any affected accumulator with a new or serviceable accumulator. Operators may delay doing the replacement by doing repetitive inspections of the affected hydraulic accumulators for signs of failure (leaking or cracking), and replacing any failed accumulator with a new or serviceable unit. This AD results from a report that one hydraulic accumulator failed in service, which caused the loss of the yellow hydraulic system when the airplane was configured for landing. We are issuing this AD to prevent damage to the pressure skin, failure of certain hydraulic systems, contamination of the cabin with hydraulic mist, increased workload for the flightcrew associated with the loss of one or more hydraulic circuits, and consequent reduced controllability of the airplane.

The Food and Drug Administration (FDA) is further delaying, until December 1, 2008, the applicability date of a certain requirement of a final rule published in the Federal Register of December 3, 1999 (64 FR 67720) (the final rule). The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA), and the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The provisions of the final rule became effective on December 4, 2000, except for certain provisions whose effective or applicability dates were delayed in five subsequent Federal Register notices, until December 1, 2006. The provision with the delayed applicability date would prohibit wholesale distribution of blood derivatives by registered blood establishments that meet the definition of a ``health care entity.'' In the Federal Register of February 1, 2006 (71 FR 5200), FDA published a proposed rule specific to the distribution of blood derivatives by registered blood establishments that qualify as health care entities (the proposed rule). The proposed rule would amend certain limited provisions of the final rule to allow certain registered blood establishments that qualify as health care entities to distribute blood derivatives. In response to the proposed rule, FDA received substantive comments. As explained in the SUPPLEMENTARY INFORMATION section of this document, further delaying the applicability of Sec. 203.3(q) (21 CFR 203.3(q)) to the wholesale distribution of blood derivatives by health care entities is necessary to give the agency additional time to address comments on the proposed rule, consider whether regulatory changes are appropriate, and, if so, to initiate such changes.

This notice proposes to establish Class D airspace at Castle Airport, Atwater, CA. A contract Airport Traffic Control Tower (ATCT) is being established at Castle Airport, Atwater, CA, which will meet criteria for Class D airspace. Class D airspace is required when the ATCT is open, and to contain and protect Standard Instrument Approach Procedures (SIAPs) and other Instrument Flight Rules (IFR) operations at the airport. This action would establish Class D airspace extending upward from the surface to 2,500 feet Mean Sea Level (MSL) within a 4.5 nautical mile radius of the airport.

This document amends the final rule published on the national plan for security control of air traffic during air defense emergencies to make administrative adjustments and includes correcting the effective date of the final rule, and removes references to State and regional disaster airlift (SARDA), rescinded by the Federal Aviation Administration on March 17, 2005.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to address requirements for the distribution of material inspection and receiving reports under DoD contracts. The proposed rule clarifies that copies of the Wide Area WorkFlow-Receipt and Acceptance (WAWF-RA) report must be distributed with a shipment, when WAWF-RA is used to satisfy material inspection and receiving report requirements.

DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update policy relating to trade agreements. The rule incorporates increased dollar thresholds for application of the World Trade Organization Government Procurement Agreement and the Free Trade Agreements, implements a new Free Trade Agreement with Morocco, and amends the list of end products subject to trade agreements.

This final rule revises the requirements for authority to manufacture and distribute postage evidencing systems. This final rule includes updating the regulations, removing obsolete text, and incorporating pertinent portions of the rules for postage meters (Postage Evidencing Systems) formerly contained in section P030 of the Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM) (Issue 58). This rule integrates the requirements that apply to the distribution and manufacture of PC Postage[supreg] products, a type of Postage Evidencing System. In addition, obsolete references to requirements for manually reset and mechanical meters are eliminated.

This action proposes special conditions for Boeing Model 737 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. 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.

EPA is taking direct final action to approve revisions to the Lake County Air Quality Management District (LCAQMD), Monterey Bay Unified Air Pollution Control District (MBUAPCD), San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD), and Ventura County Air Pollution Control District (VCAPCD) portions of the California State Implementation Plan (SIP). Under authority of the Clean Air Act as amended in 1990 (CAA or the Act), we are approving local rules that address particulate matter (PM-10) emissions from open burning, general area sources, cotton gins, incinerators, and fuel burning equipment.