January 16, 2009 – Federal Register Recent Federal Regulation Documents

This document contains corrections to the final rule which was published in the Federal Register on December 19, 2008. 73 FR 77473. The pertinent regulations relate to the collection of biometric identifiers during the inspection of aliens at United States ports of entry.

EPA is proposing to allocate essential use allowances for import and production of Class I ozone-depleting substances (ODSs) for calendar year 2009. Essential use allowances enable a person to obtain controlled Class I ODSs as part of an exemption to the regulatory ban on the production and import of these chemicals, which became effective as of January 1, 1996. EPA allocates essential use allowances for exempted production or import of a specific quantity of Class I substances solely for the designated essential purpose. The proposed allocation in this action is 63.0 metric tons (MT) of chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for 2009.

Section 702 of the Consolidated Natural Resources Act of 2008 (CNRA) extends the immigration laws of the United States to the Commonwealth of the Northern Mariana Islands (CNMI) and provides for a visa waiver program for travel to Guam and the CNMI. This rule implements section 702 of the CNRA by amending U.S. Customs and Border Protection (CBP) regulations to replace the current Guam Visa Waiver Program with a new Guam-CNMI Visa Waiver Program. Accordingly, this interim final rule sets forth the requirements for nonimmigrant visitors who seek admission for business or pleasure and solely for entry into and stay on Guam or the CNMI without a visa for a period of authorized stay of no longer than forty-five days. In addition, this rule establishes six ports of entry in the CNMI in order to administer and enforce the Guam-CNMI Visa Waiver Program and to allow for immigration inspections in the CNMI, including arrival and departure controls, under the Immigration and Nationality Act (INA).

The Department of Homeland Security (DHS) is giving concurrent notice of a revised and updated system of records pursuant to the Privacy Act of 1974 for the Department of Homeland Security Law Enforcement Authority in Support of the Protection of Property Owned or Occupied by the Department of Homeland Security system of records and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

NMFS is prohibiting directed fishing for the A season allowance of the 2009 Pacific cod sideboard limits apportioned to non- American Fisheries Act (AFA) crab vessels catching Pacific cod for processing by the inshore component in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2009 Pacific cod sideboard limits apportioned to non-AFA crab vessels catching Pacific cod for processing by the inshore component in the Central Regulatory Area of the GOA.

With this amendment, the Department of Homeland Security (DHS) corrects an inadvertent error that was made to the Final Rule titled ``Changes to Requirements Affecting H-2B Nonimmigrants and Their Employers'' that was published in the Federal Register on December 19, 2008, at 73 FR 78104.

We are reopening the comment period for our proposed rule that would revise our regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms. This action will allow interested persons additional time to prepare and submit comments.

The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance.

This interim final rule with comment period implements certain provisions of section 154 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) related to the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program. Specifically, this rule: Implements certain MIPPA provisions that delay implementation of Round 1 of the program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships.

To make Detached Address Labels (DALs) accompanying saturation mailings of Periodicals or Standard Mail[reg] flats more compatible with our processing equipment, they must be automation-compatible and have a correct delivery point POSTNET(tm) barcode or Intelligent Mail[reg] barcode with an 11-digit routing code. This requirement does not apply to DALs with simplified addresses. Also, for consistency, we are requiring return addresses on DALs.

This final rule amends the U.S. Customs and Border Protection (CBP) regulations to reflect the imposition of import restrictions on certain archaeological material from the People's Republic of China (China). These restrictions are being imposed pursuant to an agreement between the United States and China that has been entered into under the authority of the Convention on Cultural Property Implementation Act in accordance with the United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property. The final rule amends CBP regulations by adding China to the list of countries for which a bilateral agreement has been entered into for imposing cultural property import restrictions. The final rule also contains the designated list that describes the types of archaeological articles to which the restrictions apply.

NMFS proposes a temporary Secretarial interim action under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson- Stevens Act) to implement measures intended to immediately reduce overfishing in the Northeast (NE) multispecies fishery, while addressing the need to help sustain fishing communities, without compromising rebuilding objectives. Measures proposed for the commercial fishery include the following: A differential days-at-sea (DAS) area north of 41[deg]30' N. lat., whereby a vessel would be charged 2 days for every day fished; a large Southern New England (SNE) Closure Area; and modified groundfish trip limits. This action does not change the scheduled DAS reduction in the NE Multispecies Fishery Management Plan (FMP), which would result in an approximate 18-percent reduction in DAS. For private recreational vessels fishing in the Exclusive Economic Zone (EEZ) and for federally permitted charter/party vessels, this action would extend in time a seasonal prohibition on the possession of Gulf of Maine (GOM) cod, and prohibit the possession of SNE winter flounder. For federally permitted charter/party vessels, this action would implement a trip limit for Georges Bank (GB) cod. In addition, this action proposes to mitigate some of the negative short- term economic impacts of the FMP by making modifications to the DAS Leasing Program, the Regular B DAS Program, and the DAS Transfer Program; continuing the Eastern U.S./Canada Haddock Special Access Program (SAP); and implementing a reduction in the haddock minimum size to 18 inches (45 cm). Finally, this action would specify management measures for the U.S./Canada Management Area for fishing year (FY) 2009.

Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans prescribes interest assumptions for valuing and paying certain benefits under terminating single-employer plans. This final rule amends the benefit payments regulation to adopt interest assumptions for plans with valuation dates in February 2009. As discussed below, this final rule does not address the interest assumptions under PBGC's regulation on Allocation of Assets in Single-Employer Plans. Interest assumptions are also published on PBGC's Web site (https://www.pbgc.gov).

The Natural Resources Conservation Service (NRCS), an agency of the U.S. Department of Agriculture (USDA) is issuing an interim final rule for technical service provider (TSP) assistance as authorized under the Food Security Act of 1985, as amended by the Food, Conservation, and Energy Act of 2008. This interim final rule amends the Technical Service Provider (TSP) regulations to address changes made by the Food, Conservation, and Energy Act of 2008. The Secretary of Agriculture has delegated to NRCS the responsibility for administering the authority for technical service provider assistance.

This action proposes to amend Class E airspace at Natchitoches, LA. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Natchitoches Regional Airport, Natchitoches, LA. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Natchitoches Regional Airport.

The EPA proposes to revise the rule for implementing the 1997 8-hour ozone national ambient air quality standard (NAAQS) for several of the limited portions of the rule vacated by the U.S. Circuit Court of Appeals for the District of Columbia. The proposal addresses the classification system for the subset of initial 8-hour ozone nonattainment areas that the implementation rule originally covered under Clean Air Act (CAA or Act) title I, part D, subpart 1. The proposal also addresses how 1-hour ozone contingency measures that apply for failure to attain or make reasonable progress toward attainment of the 1-hour standard should apply under the anti- backsliding provisions of the implementation rule. In addition, the proposal removes language relating to the vacated provisions of the rule that provided exemptions from the requirements of nonattainment new source review (NSR) and CAA section 185 penalty fees under the 1- hour standard. The EPA plans to issue a separate proposed rule providing additional guidance as to how these two requirements (185 fees and NSR) now apply. In addition, this proposal includes the deletion of an obsolete provision in the 1-hour ozone standard itself.

The Coast Guard is amending its oil pollution prevention equipment regulations to make them consistent with new International Maritime Organization (IMO) guidelines and specifications issued under the International Convention for the Prevention of Pollution from Ships (MARPOL) Annex I. These revisions will implement MARPOL Annex I regulations and are intended to reduce the amount of oil discharged from vessels and eliminate the use of ozone-depleting solvents in equipment tests. This interim rule will require all vessels replacing or installing oil separators and bilge alarms to install equipment that meets revised standards and it will require newly constructed vessels carrying oil in bulk to install monitoring systems that meet the revised standards. We have delayed the implementation of three paragraphs involving vessels constructed and equipment installed on or after January 1, 2005. We seek comments on these three paragraphs and will consider those comments before issuing a final rule.

This interim final rule with comment period revises the regulations governing the Medicare prescription drug benefit program (Part D). This regulation makes conforming changes to reflect revisions to the rules governing Part D that were made as a result of provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. These MIPPA provisions change the definition of a covered Part D drug, and add new requirements that apply to Part D formularies.

This final rule adopts modifications to two of the code set standards adopted in the Transactions and Code Sets final rule published in the Federal Register pursuant to certain provisions of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, this final rule modifies the standard medical data code sets (hereinafter ``code sets'') for coding diagnoses and inpatient hospital procedures by concurrently adopting the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, as maintained and distributed by the U.S. Department of Health and Human Services (HHS), hereinafter referred to as ICD-10-CM, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, as maintained and distributed by the HHS, hereinafter referred to as ICD-10-PCS. These new codes replace the International Classification of Diseases, 9th Revision, Clinical Modification, Volumes 1 and 2, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volumes 1 and 2, and the International Classification of Diseases, 9th Revision, Clinical Modification, Volume 3, including the Official ICD-9-CM Guidelines for Coding and Reporting, hereinafter referred to as ICD-9-CM Volume 3, for diagnosis and procedure codes, respectively.

The Office of Management and Budget (OMB) has approved under the Paperwork Reduction Act (PRA) information collection requirements contained in recently revised final regulations published by the Department of Labor in the Federal Register on December 19, 2008. The PRA requires this notice to set forth the effectiveness of information collection requirements contained in a final rule.

The National Oceanic and Atmospheric Administration (NOAA) publishes this rule to finalize the regulations for the Channel Islands National Marine Sanctuary (CINMS or Sanctuary). This final rule revises the regulations to implement prohibitions on: Exploring for, developing, or producing minerals within the Sanctuary; abandoning matter on or in Sanctuary submerged lands; taking marine mammals, sea turtles, or seabirds within or above the Sanctuary; possessing within the Sanctuary any marine mammal, sea turtle, or seabird; marking, defacing, damaging, moving, removing, or tampering with Sanctuary signs, monuments, boundary markers, or similar items; introducing or otherwise releasing from within or into the Sanctuary an introduced species; and operating motorized personal watercraft within waters of the Sanctuary that are coextensive with the Channel Islands National Park. NOAA also makes additional changes to the grammar and wording of several sections of the regulations to ensure clarity. Finally, NOAA publishes the Sanctuary's revised terms of designation.

This final rule adopts, with minor modifications, an interim final rule issued by PHMSA on March 28, 2008, conforming PHMSA's administrative procedures with the Pipeline Inspection, Protection, Enforcement, and Safety Act of 2006 by establishing the procedures PHMSA will follow for issuing safety orders and handling requests for special permits, including emergency special permits. The rule also notifies operators about electronic docket information availability; updates addresses for filing reports, telephone numbers, and routing symbols; and clarifies the time period for processing requests for written interpretations of the regulations. This final rule makes minor amendments and technical corrections to the regulatory text in response to written public comments received after issuance of the interim final rule.

We are adopting a new rule that defines the terms ``annuity contract'' and ``optional annuity contract'' under the Securities Act of 1933. The rule is intended to clarify the status under the federal securities laws of indexed annuities, under which payments to the purchaser are dependent on the performance of a securities index. The rule applies on a prospective basis to contracts issued on or after the effective date of the rule. We are also adopting a new rule that exempts insurance companies from filing reports under the Securities Exchange Act of 1934 with respect to indexed annuities and other securities that are registered under the Securities Act, provided that certain conditions are satisfied, including that the securities are regulated under state insurance law, the issuing insurance company and its financial condition are subject to supervision and examination by a state insurance regulator, and the securities are not publicly traded.

This proposed rule would revise requirements that the Mine Safety and Health Administration (MSHA) and the National Institute for Occupational Safety and Health (NIOSH) apply to approve sampling devices that monitor miner exposure to respirable coal mine dust. The proposal would establish criteria for approval of a new type of technology, the ``continuous personal dust monitor,'' which would be worn by the miner and would report exposure to dust levels continuously during the shift. In addition, the proposal would update application requirements for the existing ``coal mine dust personal sampler unit'' to reflect improvements in this sampler over the past 15 years. This rulemaking is limited to approval requirements and does not address requirements concerning how sampling devices must be used to determine compliance, e.g., who and when to sample. Those requirements are addressed in existing 30 CFR parts 70, 71, and 90.

FMCSA discontinues the administrative requirement that applicants seeking for-hire authority to transport passengers over regular routes submit a detailed description and a map of the route(s) over which they propose to operate. The Agency will register such carriers as regular-route carriers without requiring the designation of specific regular routes and fixed end-points. Once motor carriers have obtained regular-route, for-hire operating authority from FMCSA, they will no longer need to seek additional FMCSA approval in order to change or add routes. Each registered regular-route motor carrier of passengers will continue to be subject to the full safety oversight and enforcement programs of FMCSA and its State and local partners.