November 21, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met.

In the September 18, 2008 issue of the Federal Register (73 FR 54226), we published an interim final rule with comment period that revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. The interim final rule makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private-fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost- sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, the interim final rule sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. This correcting amendment corrects technical and typographical errors identified in the September 18, 2008 interim final rule.

The Bureau of Land Management published a Notice of Federal Competitive Coal Lease Sale Offer in the Federal Register on October 31, 2008 [73 FR 64981]. The DATES section of this notice incorrectly listed January 14, 2008 instead of January 14, 2009. The lease sale will be held at 10 a.m., Wednesday, January 14, 2009. Sealed bids must be received on or before 10 a.m., Wednesday, January 14, 2009.

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.

We, the Fish and Wildlife Service (Service), announce the availability of our final comprehensive conservation plan (CCP) and finding of no significant impact (FONSI) for Shell Keys National Wildlife Refuge (NWR). In the final CCP, we describe how we will manage this refuge for the next 15 years.

The National Aeronautics and Space Administration, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).

This is an amendment of the Presidential declaration of a major disaster for the State of Illinois (FEMA-1800-DR), dated 10/03/ 2008. Incident: Severe Storms and Flooding. Incident Period: 09/13/2008 through 10/05/2008.

The Department of the Navy published a document in the Federal Register on October 30, 2008, announcing its intent to prepare an Environmental Impact Statement for the Proposed Acquisition of Lands and Establishment of Airspace Contiguous to the Marine Corps Air Ground Combat Center, Twentynine Palms, California. The original publication contained incorrect dates.

The Gulf of Mexico Fishery Management Council will convene a joint meeting of the Standing and Special Mackerel Scientific and Statistical Committees (SSC).

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of seventeen additional entities and twenty-six additional individuals whose property and interests in property have been blocked pursuant to the Foreign Narcotics Kingpin Designation Act (``Kingpin Act'') (21 U.S.C. 1901-1908, 8 U.S.C. 1182).

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Mortgagees servicing HUD insured mortgages are required to document all loss mitigation efforts for delinquent loans and to submit the documentation to HUD if requested.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

FRA announces the thirty-seventh meeting of the RSAC, a Federal advisory committee that develops railroad safety regulations through a consensus process. The RSAC meeting topics will include opening remarks from the FRA Administrator, and status reports will be provided by the Passenger Safety, Locomotive Safety Standards, Railroad Bridge Safety, Medical Standards, Railroad Operating Rules, and Track Safety Standards Working Groups. FRA may offer several tasks pertaining to the mandates contained in the Rail Safety Improvement Act of 2008. Subjects to be addressed by these tasks include hours of service recordkeeping and reporting, implementing regulations for Positive Train Control systems, hours of service limitations and fatigue management for employees of intercity and commuter passenger railroads, certification of conductors, and potentially other topics. This agenda is subject to change.

This action adds to the Procurement List services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes from the Procurement List products previously furnished by such agencies.

In accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), the Department of Labor (the Department) conducts a preclearance consultation program so that the general public and other federal agencies can comment on proposed and continuing collections of information. This program helps to ensure that the data the Department gathers arrive in the desired format, that the reporting burden on the public (time and financial resources) is minimized, that the public understands the collection instruments, and that the Department can accurately assess the impact of collection requirements on respondents. By this notice, the Department is soliciting comments on the information collection provisions of regulations pertaining to section 101(f) of the Employee Retirement Income Security Act of 1974, as amended (ERISA). The statute and the regulatory provisions codified at 29 CFR 2520.101-4 require the administrator of a defined benefit plan which is a multiemployer plan to furnish an annual plan funding notice to each plan participant and beneficiary, each labor organization representing such participants or beneficiaries, each employer that has an obligation to contribute under the plan, and the Pension Benefit Guaranty Corporation. A copy of the information collection request (ICR) can be obtained by contacting the office shown in the addresses section of this notice. ICRs submitted to OMB also are available at https://www.RegInfo.gov.

In accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), the Department of Labor (the Department) conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This program helps to ensure that the data the Department gathers can be provided in the desired format, that the reporting burden on the public (time and financial resources) is minimized, that the public understands the Department's collection instruments, and that the Department can accurately assess the impact of collection requirements on respondents. By this notice, the Department is soliciting comments concerning the information collection provisions of the regulation pertaining to section 401(c) of the Employee Retirement Income Security Act of 1974, as amended (ERISA). The statute and the regulatory provisions codified at 29 CFR 2550.401c-1 require insurers that issue certain types of insurance policies to employee benefit plans to make specific one-time and annual disclosures to such plans if assets of the plan are held in the insurer's general account. A copy of the ICR may be obtained by contacting the office listed in the ADDRESSES section of this notice.

Section 211(o) of the Clean Air Act (CAA or the Act) requires the Administrator of the Environmental Protection Agency (EPA) to annually determine a renewable fuel standard (RFS) which is applicable to refiners, importers and certain blenders of gasoline, and publish the standard in the Federal Register. On the basis of this standard, each obligated party determines the volume of renewable fuel that it must ensure is consumed as motor vehicle fuel. This standard is calculated as a percentage, by dividing the amount of renewable fuel that the Act requires to be used in a given year by the amount of gasoline expected to be used during that year, including certain adjustments specified by the Act. In this notice we are publishing an RFS of 10.21% for 2009. This standard is intended to lead to the use of 11.1 billion gallons of renewable fuel in 2009, as required by the Energy Independence and Security Act of 2007 (EISA). As discussed below, we expect the 11.1 billion gallons of renewable fuel required in 2009 to include approximately 0.5 billion gallons of biodiesel and renewable diesel.

The Securities and Exchange Commission (``Commission'') is proposing a Roadmap for the potential use of financial statements prepared in accordance with International Financial Reporting Standards (``IFRS'') as issued by the International Accounting Standards Board by U.S. issuers for purposes of their filings with the Commission. This Roadmap sets forth several milestones that, if achieved, could lead to the required use of IFRS by U.S. issuers in 2014 if the Commission believes it to be in the public interest and for the protection of investors. This Roadmap also includes discussion of various areas of consideration for market participants related to the eventual use of IFRS in the United States. As part of the Roadmap, the Commission is proposing amendments to various regulations, rules and forms that would permit early use of IFRS by a limited number of U.S. issuers where this would enhance the comparability of financial information to investors. Only an issuer whose industry uses IFRS as the basis of financial reporting more than any other set of standards would be eligible to elect to use IFRS, beginning with filings in 2010.

The Federal Aviation Administration (FAA) announces its findings on the Noise Compatibility Program submitted by the Piedmont Triad Airport Authority (PTAA) under the provisions of 49 U.S.C. (the Aviation Safety and Noise Abatement Act, hereinafter referred to as ``the Act'') and 14 CFR part 150. These findings are made in recognition of the description of Federal and nonfederal responsibilities in Senate Report No. 96-52 (1980). On June 10, 2008, the FAA determined that the noise exposure maps submitted by the Piedmont Triad Airport Authority (PTAA) under Part 150 were in compliance with applicable requirements. On November 7, 2008, the FAA approved the Piedmont Triad International Airport noise compatibility program. All of the recommendations of the program were approved.

The FAA proposes to rule and invite public comment on the release of land at the Eagle County Regional Airport under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).