December 4, 2006 – Federal Register Recent Federal Regulation Documents

To comply with the Paperwork Reduction Act of 1995 (PRA), MMS is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements in the regulations under 30 CFR 250, Subpart Q, ``Decommissioning Activities.''

This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Washington, dated 11/22/2006. Incident: Fire. Incident Period: 07/24/2006 and continuing.

This is a notice of an Administrative declaration of a disaster for the State of Mississippi dated 11/22/2006. Incident: Severe Storms and Flooding. Incident Period: 11/15/2006 through 11/16/2006.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning Disaster Assistance Registration applications.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Beneficiary Database (MBD),'' System No. 09-70-0536, established at 66 Federal Register (FR) 63392 (December 6, 2001), and modified at 71 FR 11420 (March 7, 2006). The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) authorizes Medicare payment to Part D sponsors (including Medicare Advantage prescription drug plan sponsors) that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 CFR Parts 417, 422 and 423. The MBD will include data necessary to process certain activities associated with the new Part D benefit including, but not limited to, the following activities: (1) Determination of the status of Medicare beneficiaries who are eligible for the Low Income Subsidy Program (LIS) and are deemed to receive certain drug benefits; and (2) auto-assignment/auto- enrollment of beneficiaries as required by the MMA, and regulation, to include all LIS and deemed individuals who are not voluntarily enrolled in a drug plan, will automatically be assigned to a Prescription Drug Plan (PDP) or Medicare Advantage (MA) Prescription Drug Plan (MA-PD). We propose to broaden the scope of the disclosure provisions of this system by adding a new routine use to permit the release of Part D enrollment data maintained in the MBD to support Patient Assistance Programs (PAP) and other groups providing pharmaceutical assistance to the Medicare beneficiary. The new routine use will be published as routine use number 8. Specifically, the new routine use will facilitate the sharing of information between PAPs and Part D plans to meet the MMA provisions for drug utilization reviews, drug medication therapy management, and quality of care that can only be addressed through the cooperation between the PAP and the Part D Plan. Information may be released to these organizations upon a specific request, and only if the requester meets the following requirements. They must (1) Provide an attestation or other qualifying information that they are providing pharmaceutical assistance to Medicare beneficiaries; (2) submit a finder file identifying Medicare beneficiaries receiving pharmaceutical assistance and/or services; (3) safeguard the confidentiality of any CMS data received and prevent unauthorized access; and, (4) complete a written statement attesting to the information recipient's understanding of and willingness to abide by CMS provisions regarding Privacy protections and information security. Recipients of CMS data must complete the Coordination of Benefits PAP Data Sharing Agreement prior to the release of CMS data. The finder file submitted by the PAP must provide the following data elements: (a) First initial of the first name, (b) first 6 letters of the last name, (c) social security number or health insurance claims number, (d) date of birth, and (e) sex. Part D data maintained in the MBD that will be released to a PAP or a group providing pharmaceutical assistance will consist of the verification of Medicare status and the identification of the current Part D Plan selected by the Medicare beneficiary. We will delete published routine use number 8 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of published routine uses number 10 and 11 authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which shall refer to specific beneficiary/recipient practices that result in unnecessary cost to all federally-funded health benefit programs. The primary purpose of this modified system is to provide CMS with a singular, authoritative, database of comprehensive enrollment data on individuals in the Medicare program to support ongoing and expanded program administration, service delivery modalities, and payment coverage options. This collection will contain a complete ``beneficiary insurance profile'' that reflects the individual's Medicare health insurance coverage and Medicare health plan and demonstration enrollment. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or a CMS grantee; (2) assist another Federal or State agency, agency of a State government, an agency established by State law, or its fiscal agent; (3) support providers and suppliers of services for administration of Title XVIII; (4) assist third parties where the contact is expected to have information relating to the individual's capacity to manage his or her own affairs; (5) support Quality Improvement Organizations (QIO); (6) assist other insurers for processing individual insurance claims; (7) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (8) support Patient Assistance Programs and other groups providing pharmaceutical assistance or services to Medicare beneficiaries; (9) support litigation involving the agency; and (10) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATES section for comment period.

This notice announces the Occupational Safety and Health Administration's final decision expanding the recognition of TUV Rheinland of North America, Inc., (TUV) as a Nationally Recognized Testing Laboratory under 29 CFR 1910.7.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of sulfamethazine soluble powder to create a solution administered as a drench to swine or cattle, or in the drinking water of chickens, turkeys, swine, or cattle for the treatment of coccidiosis or various bacterial diseases.

Section 601 of the Pension Protection Act of 2006 (the PPA) (Pub. L. 109-280) amended section 408 of the Employee Retirement Income Security Act of 1974 (ERISA) and section 4975 of the Internal Revenue Code (the Code) to add a prohibited transaction exemption for the provision of investment advice to participants and beneficiaries of individual account plans that permit the direction of assets in their accounts, and for certain related transactions, if the investment advice is provided under an ``eligible investment advice arrangement,'' as defined in the statute. The purpose of this notice is to request information from the public relating to the requirements in the new provisions that a computer model which serves as the basis for an eligible investment advice arrangement be certified as meeting specific criteria, and that information regarding certain fees and compensation be provided to participants and beneficiaries.

This proposal would amend existing FDIC ethics regulations involving extensions of credit, ownership of stock, and definitions. This proposal would implement the Preserving Independence of Financial Institution Examinations Act of 2003, which amended sections 212 and 213 of title 18 of the United States Code. These sections continue generally to impose criminal penalties on examiners borrowing from banks they have examined, and financial institutions extending a loan to anyone who examines or has authority to examine that institution. The statutory amendment, however, decriminalizes extensions of credit to examiners for credit cards and for primary residential home loans from institutions that they examine or have authority to examine if these loans are made on the same terms and conditions as are available to other cardholders and borrowers and satisfy other criteria contained in the statute as amended. Additionally, the proposed regulation would clarify and make minor revisions to definitions and restrictions for FDIC employees' acquisition, ownership, or control of securities of FDIC-insured depository institutions and certain holding companies.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The NADA provides for the use of a florfenicol Type A medicated article by veterinary feed directive to formulate swine feed used for the control of respiratory disease.

This document contains a correction to notice of proposed rulemaking by cross-reference to temporary regulations that were published in the Federal Register on Thursday, November 2, 2006 (71 FR 64496) relating to the disclosure of reportable transactions by material advisors.

The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Seaway Regulations and Rules in various categories. The proposed changes will update the following sections of the Regulation and Rules: Condition of Vessels; Preclearance and Security for Tolls; Seaway Navigation; Dangerous Cargo; and, General. These proposed amendments are necessary to take account of updated procedures and will enhance the safety of transits through the Seaway. Several of the proposed amendments are merely editorial or for clarification of existing requirements.

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 a discrepancy between the design documentation and the Technical Service Manual. In 1981, a castellated nut with cotter pin was introduced to secure the rudder, replacing the self-locking nut through PZL-Bielsko Bulletin No. BE-06/50-3/81. This change has not been introduced to the Technical Service Manual and use of a self-locking nut, in accordance with the Manual, is still possible. We are issuing this AD to require actions that are intended to address the unsafe condition described in the MCAI.

The FAA is superseding an existing airworthiness directive (AD) for certain IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M- A5, V2530-A5, and V2533-A5 turbofan engines. That AD currently requires initial and repetitive inspections of the master magnetic chip detector (MCD) or the No. 1, 2, 3 bearing chamber MCD. This AD requires the same MCD inspections. This AD also requires removing certain No. 3 bearings and removing certain high pressure compressure (HPC) stubshaft assemblies as mandatory terminating actions to the repetitive MCD inspections. This AD results from IAE developing a terminating action to the repetitive inspections of the chip detectors, and from expanding the applicability to include additional serial-numbered engines with certain No. 3 bearings installed. We are issuing this AD to prevent failure of the No. 3 bearing, which could result in an in-flight shutdown (IFSD) and smoke in the cockpit and cabin.

The Environmental Protection Agency, Region 8 (EPA) announces the deletion of portions of the Ellsworth Air Force Base (AFB) Site located in Meade and Pennington Counties, South Dakota, from the National Priorities List (NPL). All areas originally proposed for deletion under the Notice of Intent to Partially Delete published in the Federal Register on June 28, 2006 (71 FR 36736) are being deleted. The NPL constitutes Appendix B to the National Oil and Hazardous Substances Pollution Contingency Plan, 40 CFR Part 300, which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA has determined, with the concurrence of the State of South Dakota through the Department of Environment and Natural Resources that the parcels pose no significant threat to public health, welfare or the environment and, therefore, no further response action pursuant to CERCLA is appropriate. This partial deletion pertains to surface soil, unsaturated subsurface soil, surface water, and sediments at Operable Units 2, 3, 4, 5, 6, 7, 8, 9, 10 and 12, and excludes the ground water medium at these parcels. The ground water medium at the Ellsworth AFB Site (OU-11, Basewide Ground Water), and the soil medium (surface and unsaturated subsurface soils) at OU-1, Fire Protection Training Area, will remain on the NPL and response activities will continue for those OUs. Two additional areas not associated with an operable unit, the Gateway Lake Ash Study Area and the Pride Hangar Study Area, are currently under investigation and are also not part of this partial deletion.

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 fuel manifold leakage that could result in engine fire, in-flight shutdown or damage to the airframe. This AD requires actions that are intended to address the unsafe condition described in the MCAI.

The Coast Guard revises its drawbridge regulations by lengthening the period for which a deviation from published bridge opening requirements is authorized, and by reorganizing and clarifying some provisions. These changes promote intermodal mobility, safety, and security while balancing the reasonable needs of land and marine traffic.

This action corrects an error in the location name (Kokhanok) contained in a Final Rule that was published in the Federal Register on Tuesday, October 10, 2006 (71 FR 59372). Airspace Docket No. 06-AAL-19.

NMFS is reopening directed fishing for Greenland turbot for vessels using hook-and-line gear in the Bering Sea subarea in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to fully use the 2006 total allowable catch (TAC) of Greenland turbot for vessels using hook-and-line gear in the Bering Sea subarea in the Bering Sea and Aleutian Islands (BSAI).