September 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register of October 31, 2006 (71 FR 63728) to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). FDA is reopening the comment period to update comments and to receive any new information. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.

In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations under section 6707A of the Internal Revenue Code (Code), which provide the rules relating to the assessment of penalties under section 6707A for the failure to include on any return or statement any information required to be disclosed under section 6011 with respect to a reportable transaction. The text of those temporary regulations also serves as the text of these proposed regulations.

NMFS withdraws regulations that placed limits on charter vessel anglers, including a one-halibut daily bag limit in International Pacific Halibut Commission Area 2C. The U.S. District Court for the District of Columbia issued a Temporary Restraining Order (TRO) on June 10, 2008 (amended on June 13, 2008), and a Preliminary Injunction (PI) on June 20, 2008, enjoining and restraining NMFS from giving any effect to or otherwise taking any action to enforce the one- halibut daily bag limit restriction for charter vessel anglers. The TRO (as amended) and the PI direct that the daily bag limit should revert to the two-fish daily bag limit with one fish no more than 32 inches (81.3 cm) head-on length that was in place prior to the one-fish daily bag limit. This action ensures that regulatory text provides accurate information to the regulated public. The intended effect is to make regulatory requirements consistent with a duly issued court order.

NMFS is reallocating the projected unused amount of Pacific cod from catcher vessels greater than or equal to 60 feet ([gteqt] 18.3 meters (m)) length overall (LOA) using hook-and-line gear and Pacific cod from vessels using jig gear to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to allow the 2008 total allowable catch (TAC) of Pacific cod to be harvested.

We are amending the regulations to remove a zone in New Mexico from the list of accredited-free zones for bovine tuberculosis and reclassify the entire State as modified accredited advanced. Because two affected herds have been detected in New Mexico's accredited-free zone since May 2007, the zone no longer meets our requirements for accredited-free status. This action is necessary to reduce the likelihood of the spread of bovine tuberculosis within the United States.

We are superseding an existing airworthiness directive (AD) for Bell Helicopter Textron Canada (Bell) Model 222, 222B, 222U, 230, and 430 helicopters. That AD currently requires visually inspecting the main rotor hydraulic actuator support (support) to verify the presence of all dowel pins and sealant between the support and transmission and verifying the proper torque of each attaching nut (nut). This AD requires the same actions as the existing AD and also requires repetitive actions at intervals not to exceed 600 hours time-in-service (TIS) or 12 months, whichever occurs first. This AD is prompted by the discovery that a 12-month compliance requirement was correctly included in an Emergency AD (EAD) that we issued but was inadvertently omitted when we published the Final rule; request for comments following the issuance of the EAD. The actions specified by this AD are intended to prevent failure of the support and subsequent loss of control of the helicopter.

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.

NMFS approves and implements new management measures for the monkfish fishery recommended in Framework Adjustment 6 (Framework 6) to the Monkfish Fishery Management Plan (FMP), which has been submitted jointly by the New England (NEFMC) and Mid-Atlantic Fishery Management Councils (Councils). This action eliminates the backstop provision adopted in Framework Adjustment 4 (Framework 4) to the FMP, which was implemented in October 2007. This provision would have adjusted, and possibly closed, the directed monkfish fishery in fishing year (FY) 2009 if the landings in FY 2007 exceeded the target total allowable catch (TTAC) by more than 30 percent. Given that both stocks are rebuilt according to the most recent assessment, the backstop provision is no longer deemed necessary.

This rule relaxes the size requirement prescribed under the Washington potato marketing order. The marketing order regulates the handling of Irish potatoes grown in Washington, and is administered locally by the State of Washington Potato Committee (Committee). This rule decreases the minimum size required for all fresh market red, yellow fleshed, and white types of potatoes from 1 inch (25.4 mm) to \3/4\ inch (19.1 mm) in diameter, if the potatoes otherwise meet the requirements of U.S. No. 1 grade. This rule will also decrease the minimum size requirement from July 1 through September 30 of each year for imported red-skinned, round type potatoes under the import regulations as required by section 8e of the Agricultural Marketing Agreement Act of 1937. The Committee recommended this change in response to the recently revised U.S. Standards for Grades of Potatoes which added a definition for Creamer potatoes. This change is intended to provide potato handlers with greater marketing flexibility, growers with increased returns, consumers with a greater supply of small potatoes, and to bring the section 8e potato import regulation into conformity with the marketing order.

We are adopting amendments to the rule that exempts a foreign private issuer from having to register a class of equity securities under Section 12(g) of the Securities Exchange Act of 1934 (``Exchange Act'') based on the submission to the Commission of certain information published by the issuer outside the United States. The exemption allows a foreign private issuer to have its equity securities traded in the U.S. over-the-counter market without registration under Section 12(g). The adopted rule amendments will eliminate the current written application and paper submission requirements under Rule 12g3-2(b) by automatically exempting from Exchange Act Section 12(g) a foreign private issuer that meets specified conditions. Those conditions will require an issuer to maintain a listing of its equity securities in its primary trading market located outside the United States, and require it to publish electronically in English specified non-United States disclosure documents. As a result, the adopted amendments should make it easier for U.S. investors to gain access to a foreign private issuer's material non-United States disclosure documents and thereby to make better informed decisions regarding whether to invest in that issuer's equity securities through the over-the-counter market in the United States or otherwise. As is currently the case, issuers must continue to register their securities under the Exchange Act to have them listed on a national securities exchange or traded on the OTC Bulletin Board.

EPA is revoking certain tolerances for the herbicides benfluralin and napropamide and the insecticides carbaryl and diazinon. Also, EPA is modifying certain tolerances for the herbicides fluometuron, glyphosate, norflurazon, and pyrazon and the insecticides carbaryl, diazinon, dicrotophos, formetanate hydrochloride, and tau- fluvalinate. In addition, EPA is establishing new tolerances for the herbicides fluometuron, glyphosate, metolachlor, and pyrazon and the insecticides carbaryl and formetanate hydrochloride. The regulatory actions finalized in this document are in follow-up to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA), section 408(q).

This action proposes to establish Class E airspace at Death Valley, CA. Controlled airspace is necessary to facilitate vectoring of Instrument Flight Rules (IFR) traffic from en route airspace to Las Vegas, NV. The FAA is proposing this action to enhance the safety and management of IFR aircraft operations near Las Vegas, NV.

The Office of the Comptroller of the Currency (OCC) is adopting as final and without change the interim final assessments rule issued on February 19, 2008. The interim final rule added two new asset-size categories to the table in 12 CFR 8.2(a) used to calculate each national bank's semiannual assessment. The addition of these categories is warranted to take account of significant structural changes in the national banking system since 1992, when the table was last revised, and has enabled the OCC to realign assessments to better reflect industry structure and OCC's corresponding expenses of operations. No comments were received in response to the request for comment on the interim final rule.

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.

This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry2Ae in or on cotton and its food and feed commodities when used as a Plant-Incorporated Protectant (PIP) in accordance with the terms of Experimental Use Permit 264-EUP-143. Bayer CropScience LP submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus thuringiensis Cry2Ae. The temporary tolerance exemption expires on December 31, 2012.

We are amending our regulation governing the use of the Automated Clearing House (ACH) system by Federal agencies. The rule adopts, with some exceptions, the ACH Rules developed by NACHAThe Electronic Payments Association (NACHA) as the rules governing the use of the ACH Network by Federal agencies. We are issuing this rule to address changes to the ACH Rules set forth in NACHA's 2006 ACH Rules book and 2007 ACH Rules book. We are adopting all of the changes that NACHA published in the 2006 ACH Rules book and 2007 ACH Rules book, except certain changes to the self- audit provisions of the ACH Rules, which we have previously determined are not appropriate for the Federal government. This rule follows publication of a January 9, 2008 proposed rule and adopts the provisions of the proposed rule without change. In addition, the rule provides two exceptions to existing deposit account requirements. Generally, an ACH credit entry representing a Federal payment other than a vendor payment must be deposited into a deposit account at a financial institution in the name of the recipient. On April 25, 2005, Treasury waived this requirement in order to allow some or all of the amount to be reimbursed to a Federal employee for official travel credit card charges to be disbursed directly to the credit card issuing bank. The rule codifies this waiver. The rule also provides an exception from existing deposit account requirements in cases where a Federal payment is to be disbursed through a debit card, stored value card, prepaid card or similar payment card program established by the Financial Management Service (Service).

This regulation amends the established tolerances for combined residues of hexythiazox in or on citrus dried pulp; citrus oil; pome fruit, crop group 11; wet apple pomace; and meat byproducts of cattle, goat, horse, and sheep. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the C season allowance of the 2008 total allowable catch (TAC) of pollock for Statistical Area 610 in the GOA.

EPA is proposing to approve revisions to the North Carolina State Implementation Plan (SIP) submitted by the State of North Carolina in three submittals dated November 30, 2005, March 16, 2007, and June 20, 2008. The proposed revisions modify North Carolina's Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR) permitting regulations in the SIP to address changes to the federal New Source Review (NSR) regulations, which were promulgated by EPA on December 31, 2002, and reconsidered with minor changes on November 7, 2003 (collectively, these two final actions are referred to as the ``2002 NSR Reform Rules''). In addition, the proposed revisions address an update to the NSR regulations promulgated by EPA on November 29, 2005 (``Ozone Implementation NSR update'') relating to the implementation of the 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS). The proposed revisions include provisions for baseline emissions calculations, an actual-to-projected- actual methodology for calculating emissions changes, options for plantwide applicability limits (PALs), recordkeeping and reporting requirements, and provisions recognizing nitrogen oxides (NOX) as a precursor to ozone. The June 20, 2008, SIP submittal also contains proposed revisions that are not related to EPA's 2002 NSR Reform Rules. EPA will propose action on those revisions in a separate Federal Register notice.

This rule reinstates the continuing assessment rate established for the Area No. 3 Colorado Potato Administrative Committee (Committee) for the 2008-2009 and subsequent fiscal periods at $0.02 per hundredweight of potatoes handled. The Committee locally administers the marketing order regulating the handling of potatoes grown in northern Colorado. The continuing assessment rate was suspended for the 2006-2007 and subsequent fiscal periods to bring the monetary reserve within the program limit of two fiscal periods' operating expenses. Assessments upon potato handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period began on July 1 and ends June 30. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

On June 20, 2008, FEMA published in the Federal Register a proposed rule that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 73 FR 35114. The table provided here represents the flooding source, location of referenced elevation, effective and modified elevation, and communities affected for Plymouth County, Massachusetts (All Jurisdictions). Specifically, it addresses flooding source ``Atlantic Ocean.''

On June 20, 2008, FEMA published in the Federal Register a proposed rule that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 73 FR 35114. The table provided here represents the flooding source, location of referenced elevation, effective and modified elevation, and communities affected for Bristol County, Massachusetts (All Jurisdictions). Specifically, it addresses flooding source ``Buzzards Bay.''

This document contains proposed regulations on the public approval requirements under section 147(f) of the Internal Revenue Code (Code) applicable to tax-exempt private activity bonds issued by State and local governments. The proposed regulations affect State and local governmental issuers of tax-exempt private activity bonds. This document also provides notice of a public hearing on these proposed regulations.

The FAA is adopting a new airworthiness directive (AD) for certain Harco Labs, Inc. part numbers 100435-39, 100435-39-001, 100435- 40, and 100435-40-001 pitot/angle of attack (AOA) probes installed on, but not limited to Eclipse Aviation Inc. Model EA500 airplanes. This AD requires you to incorporate information into the Limitations section of the airplane flight manual (AFM) that will allow operation only under day visual flight rules (VFR) and allow only a VFR flight plan. This AD also requires you to test the pitot/AOA probes for heater performance and replace the pitot/AOA probe if it fails the heater performance test. This AD results from several reports of airspeed disagree caution indication due to blockage from freezing condensation within the pitot/ AOA system. We are issuing this AD to detect and correct improperly performing pitot/AOA probe heaters, which could result in blockage within the pitot/AOA system from condensation freezing with consequent incorrect indication of impact air pressure (airspeed/AOA). This blockage could lead to the stall warning becoming unreliable and the stick pusher, overspeed warning, autopilot, and yaw damper to malfunction.

We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to remove the Lahontan cutthroat trout (Oncorhynchus clarkii henshawi) from the Federal List of Threatened and Endangered Wildlife (List) under the Endangered Species Act of 1973, as amended (Act). We find that the petition does not present substantial scientific or commercial information indicating that removing Lahontan cutthroat trout from the List may be warranted. Therefore, we will not initiate a status review in response to this petition. However, we are currently conducting a 5-year review of this species under section 4(c)(2)(A) of the Act. This review was initiated on February 14, 2007, and will consider information that has become available since the last status review. We ask the public to submit to us any new information that becomes available concerning the status of, or threats to, the Lahontan cutthroat trout or its habitat at any time.