November 2008 – Federal Register Recent Federal Regulation Documents

Notice is hereby given, in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770, 5 U.S.C. App 1, section 10), of the tenth, eleventh, and twelfth meetings of the Negotiated Rulemaking Advisory Committee for Off-Road Vehicle Management at Cape Hatteras National Seashore. (See DATES section.)

The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.

The Agricultural Marketing Service (AMS) is amending the Cotton Board Rules and Regulations by increasing the value assigned to imported cotton for calculating supplemental assessments collected for use by the Cotton Research and Promotion Program. An amendment is required to adjust the assessments collected on imported cotton and the cotton content of imported products to be the same as those paid on domestically produced cotton. In addition, AMS is removing Harmonized Tariff Schedule (HTS) numbers that were absorbed into other HTS categories since the last assessment adjustment.

This regulation establishes tolerances for residues of ipconazole from seed treatment in or on cotton, peanut, soybean, dry shelled pea and bean (Subgroup 6C), cereal grains (Group 15) except rice, and forage, fodder, and straw of cereal grains (Group 16) except rice. Chemtura Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also finalizes the calendar year (CY) 2008 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2009. In addition, as required by the statute, it announces that the physician fee schedule update is 1.1 percent for CY 2009, the preliminary estimate for the sustainable growth rate for CY 2009 is 7.4 percent, and the conversion factor (CF) for CY 2009 is $36.0666. This final rule with comment period also implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). (See the Table of Contents for a listing of the specific issues addressed in this rule.)

The Consumer Product Safety Act (``CPSA''), at section 14(a) as amended by section 102(a) of the Consumer Product Safety Improvement Act of 2008 (``CPSIA''), Public Law 110-314, requires that, for products manufactured on or after November 12, 2008, manufacturers (including importers) and private labelers of the products certify that the products comply with all applicable CPSA consumer product safety rules and similar rules, bans, standards and regulations under any other laws administered by the Commission by issuing a certificate that accompanies the product and can be furnished to certain parties. The certificate must specify each such rule, ban, standard, or regulation with which the product must comply. In general, the certification must be based on a test of each product or upon a reasonable testing program. Certificates and certification for certain children's products must be based on testing by third party laboratories whose accreditation to do so has been accepted by the Commission. The third party testing requirements become effective on a rolling schedule as the Commission issues specific laboratory accreditation requirements. Section 14(a)(4) of the CPSA gives the Commission the authority where there is more than one manufacturer, importer, or private labeler to designate one or more of such entities as the person(s) who shall issue the required certificate and to relieve all others of that responsibility. The final rule published today limits the parties who must certify to the U.S. importer and, in the case of domestically produced products, the U.S. manufacturer. It also specifies the requirements that an electronic certificate must meet.

This is a final 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.

This proposed rule would adjust the North and South Atlantic swordfish quotas for the 2008 fishing year (January 1, 2008, through December 31, 2008) to account for underharvests, and to transfer 18.8 metric tons (mt) dressed weight (dw) to Canada per the 2006 International Commission for the Conservation of Atlantic Tunas (ICCAT) recommendations 06-02 and 06-03. The North Atlantic 2008 directed baseline quotas plus the 2007 underharvest would be divided equally between the semiannual periods of January through May and June through December. In addition, NMFS proposes to modify the vessel chartering regulations to potentially allow Atlantic Highly Migratory Species (HMS) limited access permit (LAP) holders to charter foreign vessels under a chartering arrangement where catches taken would count against U.S. Atlantic HMS quotas or entitlements.

NMFS is closing the commercial fishery for porbeagle sharks in the Atlantic Ocean and Gulf of Mexico. This action is necessary because the porbeagle shark quotas for the 2008 fishing season have reached or are projected to have reached at least 80 percent of the available quota.

The Nuclear Regulatory Commission (NRC) is correcting a document that appeared in the Federal Register on November 6, 2008 (73 FR 66000). The NRC is considering the issues raised in a petition for rulemaking submitted by Anthony R. Pietrangelo, on behalf of the Nuclear Energy Institute, in the ongoing ``Risk-Informed Redefinition of Large Break Loss-of-Coolant Accident (LOCA) Emergency Core Cooling System (ECCS) Requirements'' rulemaking. This document corrects an erroneous NRC docket number and date.

This action will establish Class E airspace at Lake Havasu, AZ. Additional controlled airspace is necessary to accommodate aircraft using VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Lake Havasu City Airport, Lake Havasu, AZ. This action also will revoke Class E airspace at the old Lake Havasu Airport, Lake Havasu, AZ, as that airport has been abandoned. This will improve the safety and management of aircraft operations at Lake Havasu City Airport, Lake Havasu, AZ.

The Commander, Fifth Coast Guard District, has approved a temporary deviation from the regulations governing the operation of the Norfolk Southern Railroad (NS V2.8) Bridge, at mile 2.7, across the Elizabeth RiverEastern Branch at Norfolk, VA. Under this temporary deviation, the drawbridge may remain in the closed position on specific dates and times to facilitate mechanical repairs.

The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.

NMFS issues this final rule to implement the annual harvest guideline (HG) for Pacific mackerel in the U.S. exclusive economic zone (EEZ) off the Pacific coast for the fishing season of July 1, 2008, through June 30, 2009. This HG has been calculated according to the regulations implementing the Coastal Pelagic Species (CPS) Fishery Management Plan (FMP) and establishes allowable harvest levels for Pacific mackerel off the Pacific coast. The HG for the 2008-2009 fishing season is 40,000 metric tons (mt). If this total is reached, Pacific mackerel fishing will be closed to directed harvest and only incidental harvest will be allowed at a 45 percent by weight incidental catch rate when landed with other CPS, except that up to one mt of Pacific mackerel can be landed without landing any other CPS.

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement a number of changes made by the Medicare Improvement for Patients and Providers Act of 2008. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2009. In addition, this final rule with comment period updates the revised Medicare ambulatory surgical center (ASC) payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In this final rule with comment period, we set forth the applicable relative payment weights and amounts for services furnished in ASCs, specific HCPCS codes to which these changes apply, and other pertinent ratesetting information for the CY 2009 ASC payment system. These changes are applicable to services furnished on or after January 1, 2009. In this document, we are responding to public comments on a proposed rule and finalizing updates to the ASC Conditions for Coverage to reflect current ASC practices and new requirements in the conditions to promote and protect patient health and safety. Further, this final rule also clarifies policy statements included in responses to public comments set forth in the preamble of the March 30, 2007 final rule regarding the Secretary's ability to terminate Medicare providers and suppliers (that is, transplant centers) during an appeal of a determination that affects participation in the Medicare program.

The Bureau of Land Management (BLM) is finalizing regulations to set out the policies and procedures for the implementation of a commercial leasing program for the management of federally-owned oil shale and any associated minerals located on Federal lands. The Energy Policy Act of 2005 (EP Act) directs the Secretary of the Interior (Secretary) to: Make public lands available for conducting oil shale research and development activities; Complete a Programmatic Environmental Impact Statement (PEIS) for a commercial leasing program for both oil shale and tar sands resources on the BLM-administered lands in Colorado, Utah, and Wyoming; and Issue regulations establishing a commercial oil shale leasing program. These final regulations incorporate specific provisions of the Mineral Leasing Act of 1920 (MLA) and the EP Act relating to: Oil shale lease size; Acreage limitations; Rental; and Lease diligence. These regulations also address the diligent development requirements of the EP Act by establishing work requirements and milestones to ensure diligent development of leases. The rule also provides for other standard components of a BLM mineral leasing program, including lease administration and operations.

This action establishes a low altitude Global Positioning System (GPS)/Global Navigation Satellite System (GNSS) area navigation route, designated T-254, in the vicinity of the Houston, TX, terminal area. This route allows for more efficient utilization of airspace and enhances the management of aircraft operations in the vicinity of Houston, TX.

The Rural Utilities Service (RUS), an agency delivering the United States Department of Agriculture's (USDA) Rural Development Utilities Programs, hereinafter referred to as Rural Development or the Agency, is amending its regulations to administer the Household Water Well System Grant Program. This action implements provisions of the 2008 Farm Bill for limits on loans that nonprofit organizations may make to homeowners for private well systems. The 2008 Farm Bill raises the loan limit to $11,000 from $8,000. The intended effect is to make part 1776 current with statutory authority. The Agency will also amend the regulation to enable existing grant recipients to amend their grant agreements for the new $11,000 loan limit. In the final rule section of the Federal Register, the Agency is publishing this action as a direct final rule without prior proposal because Rural Development views this as a non-controversial action and expects no adverse comments. If no adverse comments are received in response to the direct final rule, no further action will be taken on this proposed rule, and the action will become effective at the time specified in the direct final rule. If the Agency receives adverse comments, a timely document will be published withdrawing the direct final rule, and all public comments received will be addressed in a subsequent final rule based on this action.

Through this notice, the Federal Transit Administration (FTA) proposes to amend its school bus operations regulations. Most notably, FTA proposes to clarify several definitions, amend the school bus operations complaint procedures, and implement Section 3023(f) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU). FTA seeks comment on this notice from interested parties.

This final rule amends existing deep gas royalty relief regulations to reflect statutory changes enacted in the Energy Policy Act of 2005. It provides additional royalty relief for certain ultra- deep wells on Outer Continental Shelf leases in shallow water in the Gulf of Mexico. It extends both the existing and the additional deep gas royalty relief to Outer Continental Shelf leases in deeper water than before. Finally, this final rule applies discretionary royalty relief procedures that have been used by deepwater leases in the Gulf of Mexico to leases offshore of Alaska.

In this document, the Federal Communications Commission (Commission) retains the current site-based licensing paradigm for the 900 MHz B/ILT spectrum, and declines to adopt competitive bidding rules or geographic service areas for the licensing of 900 MHz B/ILT ``white space;'' adopts interference protection rules applicable to all licensees operating in the 900 MHz B/ILT spectrum; and lifts, on a rolling basis, the freeze placed on applications for new 900 MHz B/ILT licenses in September 2004, the lift being tied to the completion of rebanding in each 800 MHz National Public Safety Planning Advisory Committee (NPSPAC) region. The Commission takes these actions to balance the needs of incumbent 900 MHz B/ILT licensees and commercial providers that operate in the spectrum.

The Office of Foreign Assets Control (``OFAC'') of the U.S. Department of the Treasury is soliciting comments on the effectiveness of OFAC's licensing procedures for the exportation of agricultural commodities, medicine, and medical devices to Sudan and Iran. Pursuant to section 906(c) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (Title IX of Pub. L. 106-387, 22 U.S.C. 7201 et seq.) (the ``Act''), OFAC is required to submit a biennial report to the Congress on the operation of licensing procedures for such exports.

NMFS proposes 2009 specifications and management measures for Atlantic mackerel, squid, and butterfish (MSB). This action proposes to maintain quotas for Atlantic mackerel (mackerel), Illex squid (Illex), and butterfish at the same levels as 2008, while increasing the quota for Loligo squid (Loligo). Additionally, this action proposes to increase the incidental possession limit for mackerel and requests public comment concerning the possibility of an inseason adjustment to increase the mackerel quota, if landings approach proposed harvest limits. These proposed specifications and management measures promote the utilization and conservation of the MSB resource.

NMFS publishes regulations to require operators of domestic fishing vessel with a freeboard of four feet or over to provide a U.S. Coast Guard-approved pilot ladder as a safe and enforceable means for authorized personnel to board fishing vessels in carrying out their duties under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the Atlantic Tunas Convention Act, and other applicable fisheries laws and treaties. This action is necessary to provide for the safety of personnel boarding domestic fishing vessels, as current standards have proven to be inadequate. These final regulations establish a safer and more enforceable national standard for ladders used by authorized officers for boarding domestic fishing vessels subject to Federal regulation.

The Assistant Administrator for Fisheries (AA), NOAA, announces temporary restrictions consistent with the requirements of the Atlantic Large Whale Take Reduction Plan's (ALWTRP) implementing regulations. These regulations apply to lobster trap/pot and anchored gillnet fishermen in an area totaling approximately 1,575 nm\2\ (5,402.3 km\2\), east of Portland, Maine, for 15 days. The purpose of this action is to provide protection to an aggregation of northern right whales (right whales).