2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled ``PET DrugsCurrent Good Manufacturing Practice (CGMP).''

The FAA is superseding an existing airworthiness directive (AD), which applies to certain Boeing Model 747 airplanes. The existing AD currently requires repetitive inspections for cracking, and repair as necessary, of lower lobe body frames (sections 42 and 46) of the fuselage. The existing AD also provides for optional modification of the frames, which terminates the repetitive inspections. This new AD requires additional repetitive inspections for cracking of certain fuselage frames, and corrective actions if necessary. This AD results from a new report of a crack found in a body frame with a tapered side guide bracket at fuselage station 1800, located on the left side between stringers 39 and 40; the frame was severed. We are issuing this AD to detect and correct the loss of structural integrity of the fuselage, which could result in rapid depressurization of the airplane.

The U.S. Secretary of Education (Secretary) issues final requirements for School Improvement Grants authorized under section 1003(g) of Title I of the ESEA, and funded through both the Department of Education Appropriations Act, 2009 and the ARRA. The final requirements govern the process that a State educational agency (SEA) uses to award school improvement funds to local educational agencies (LEAs) with the persistently lowest-achieving Title I schools that demonstrate the greatest need for the funds and the strongest commitment to use those funds to raise substantially the achievement of the students attending those schools. Under the final requirements, an LEA may also use school improvement funds to serve persistently lowest- achieving secondary schools that are eligible for, but do not receive, Title I funds and Title I schools in improvement, corrective action, and restructuring that are not among the persistently lowest-achieving schools. The final requirements require an SEA to award school improvement funds to eligible LEAs in amounts sufficient to enable the persistently lowest-achieving schools to implement one of four specific school intervention models.

The Wassenaar Arrangement (WA) Task Force on Editorial Issues (TFEI) made revisions, editorial in nature, to clarify, remove extraneous text or correct text that appears in Export Control Classification Numbers (ECCNs) on the Commerce Control List of the Export Administration Regulations. The TFEI revisions (over 2,000) were agreed upon by the WA in December 2007. The WA implementation rules for 2007 and 2008 contain only the TFEI revisions that coincided with the revisions to ECCNs affected by the 2007 and 2008 WA agreements. This rule implements the remaining TFEI revisions.

This document makes amendments to the Federal Acquisition Regulation in order to make editorial changes.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to permit the contractor to measure accrued PRB costs using either the criteria in Internal Revenue Code (IRC) 419 or the criteria in Financial Accounting Standard (FAS) 106.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to require Internet Protocol Version 6 (IPv6) compliant products be included in all new information technology (IT) acquisitions using Internet Protocol (IP). IP is one of the primary mechanisms that define how and where information moves across networks. The widely-used IP industry standard is IP Version 4 (IPv4). The Office of Management and Budget (OMB) Memorandum M-05-22, dated August 2, 2005, requires all new IT procurements, to the maximum extent practicable, to include IPv6 capable products and standards.

The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (the Councils) are issuing a final rule amending the Federal Acquisition Regulation (FAR) to delete FAR Subpart 22.16 and the corresponding clause at FAR 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees, which implemented Executive Order (E.O.) 13201 of February 17, 2001, of the same title. E.O. 13201 required contractors to post a notice informing employees of their rights concerning payment of union dues or fees and detailed that employees could not be required to join unions or maintain membership in unions to retain their jobs. E.O. 13201 was revoked by E.O. 13496 of January 30, 2009, Notification of Employee Rights Under Federal Labor Laws.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated 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:

The Federal Maritime Commission repeals the marine terminal agreements exemption, which exempted such agreements from the Shipping Act's 45-day statutory waiting period, and amends the Commission's regulations to transfer an existing definition of the marine terminal conference agreement to another section. This rule also corrects a typographical error.

The Coast Guard is adopting the subject interim rule published in the Federal Register August 20, 2009, as a final rule without change. Due to the physical location of Pier 91, Large Passenger Cruise Vessels are required to maneuver near a prominent marina frequented by a large recreational vessel community and near other numerous large commercial fishing vessels located at adjacent piers, posing a high safety and security risk when Large Passenger Cruise Vessels are entering and departing the cruise terminal. Due to the inherent safety and security risks associated with the movement of a cruise ship into or out of this especially tight berth at Pier 91, coupled with the large recreational boating community and commercial traffic in the area, the Coast Guard Captain of the Port Puget Sound finds it necessary to enact these safety and security zones.

This regulation establishes tolerances for residues of clothianidin in or on multiple commodities which are identified and discussed later in this document. This regulation additionally increases established tolerances in or on cotton, gin byproducts; cotton, undelinted seed and potato, granules/flakes and deletes tolerances in or on several commodities that will be superseded by this action. Valent U.S.A. Corporation, Bayer CropScience and Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

U.S. Citizenship and Immigration Services (USCIS) announces the reopening and extension of the public comment period for the interim rule entitled ``Commonwealth of the Northern Mariana Islands Transitional Worker Classification.'' The interim rule was initially published on October 27, 2009 and intended to become effective on November 27, 2009. On November 25, the United States District Court for the District of Columbia enjoined implementation of the rule until DHS considers public comments and issues a final rule. To provide the public and the CNMI with optimum opportunity to comment on the proposed transitional worker classification provisions, USCIS is reopening the comment period for an additional 30 days. USCIS will consider comments received during the entire public comment period in its development of the final rule.

This final rule amends regulations of the Bureau of Economic Analysis (BEA) setting forth reporting requirements for the BE-605 quarterly survey of foreign direct investment in the United States. The survey obtains quarterly sample data on transactions and positions between foreign-owned U.S. business enterprises (U.S. affiliates) and their ``affiliated foreign groups'' (i.e., their foreign parents and foreign affiliates of their foreign parents).

We are adopting as a final rule, without change, an interim rule that amended the swine health protection regulations to clarify the applicability of the regulations regarding the treatment of garbage that consists of industrially processed materials. The interim rule made clear that such materials are subject to the same treatment requirements as other regulated garbage, except for materials that meet the definition of processed product that we added to the regulations in the interim rule. The interim rule was necessary to ensure that garbage fed to swine has been treated to inactivate disease organisms that pose a risk to the U.S. swine industry.

On October 28, 2009, the U.S. Small Business Administration (SBA or Agency) proposed changes to its 8(a) Business Development (8(a) BD) and Small Disadvantaged Business (SDB) programs as well as its size regulations. The rule proposes to make a number of changes to the regulations governing the 8(a) BD and SDB programs, and several changes to SBA's size regulations. Some of the changes involve technical issues. Other changes are more substantive and result from SBA's experience in implementing the current regulations. SBA requested comments on the various approaches for the proposed changes in the proposed rulemaking. The proposed rule provided a 60-day comment period closing on December 28, 2009.

We, the U.S. Fish and Wildlife Service (Service), propose to revise the designated critical habitat for the Santa Ana sucker (Catostomus santaanae). The areas identified in this proposed rule constitute a revision of the areas designated as critical habitat for the Santa Ana sucker on January 4, 2005. In the 2005 final rule, we designated 8,305 ac (3,361 ha) of critical habitat in Los Angeles County. Approximately 9,605 acres (ac) (3,887 hectares (ha)) of habitat in the Santa Ana River (San Bernardino, Riverside, and Orange Counties) and the San Gabriel River and Big Tujunga Creek (Los Angeles County) in southern California fall within the boundaries of the proposed revised critical habitat designation.

This final rule will implement the procedures that the Department of Health and Human Services will follow at the Administrative Law Judge and Medicare Appeals Council levels in deciding appeals brought by individuals who have enrolled in the Medicare prescription drug benefit program. In addition, it will implement the reopening procedures that will be followed at all levels of appeal.

NCUA is issuing proposed amendments to its rule governing corporate credit unions contained in part 704. The major revisions involve corporate credit union capital, investments, asset-liability management, governance, and credit union service organization (CUSO) activities. The amendments would establish a new capital scheme, including risk-based capital requirements; impose new prompt corrective action requirements; place various new limits on corporate investments; impose new asset-liability management controls; amend some corporate governance provisions; and limit a corporate CUSO to categories of services preapproved by NCUA. In addition, this proposal contains conforming amendments to part 702, Prompt Corrective Action (for natural person credit unions); part 703, Investments and Deposit Activities (for federal credit unions); part 747, Administrative Actions, Adjudicative Hearings, Rules of Practice and Procedure, and Investigations; and part 709, Involuntary Liquidation of Federal Credit Unions and Adjudication of Creditor Claims Involving Federally Insured Credit Unions. These amendments will strengthen individual corporates and the corporate credit union system as a whole.

This document amends title 19 of the Code of Federal Regulations (CFR) to reflect that U.S. Customs and Border Protection (CBP) has added preclearance stations in Halifax, Canada and Shannon, Ireland. CBP officers at preclearance stations conduct inspections and examinations to ensure compliance with U.S. customs, immigration, and agriculture laws, as well as other laws enforced by CBP at the U.S. border. Such inspections and examinations prior to arrival in the United States generally enable passengers to exit the domestic terminal or connect directly to a U.S. domestic flight without undergoing further CBP processing.

The Commander, Seventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Dunedin Causeway bridge across the Gulf Intracoastal Waterway, mile 141.9, at Dunedin, FL. The deviation is necessary to facilitate rehabilitation of the bascule leaves of the bridge. This deviation allows the bridge to conduct single leaf operations while repairs are conducted with a three hour notice for double leaf operations.

EPA, Region 5 is issuing a Notice of Intent to Delete the Kerr-McGee Reed-Keppler Park Superfund Site (Site) located in West Chicago, Illinois, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of Illinois, through the Illinois Environmental Protection Agency (IEPA), have determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.

This final rule sets forth the policies and procedures implementing the Agricultural Management Assistance Program (AMA). The Natural Resources Conservation Service (NRCS), on behalf of the Commodity Credit Corporation (CCC), published an interim final rule with request for comment on November 20, 2008 (73 FR 70245). NRCS

The States of Mississippi, Montana, Oklahoma, Pennsylvania, Texas, and Utah have requested that we, the U.S. Fish and Wildlife Service, delegate permitting for falconry to the State, as provided under the regulations at 50 CFR 21.29. We have reviewed regulations and supporting materials provided by the States, and have concluded that their regulations comply with the Federal regulations. We change the falconry regulations accordingly.

Pursuant to section 215 of the Federal Power Act, the Commission approves six Modeling, Data, and Analysis Reliability Standards submitted to the Commission for approval by the North American Electric Reliability Corporation, the Electric Reliability Organization certified by the Commission. The approved Reliability Standards require certain users, owners, and operators of the Bulk- Power System to develop consistent methodologies for the calculation of available transfer capability or available flowgate capability. Pursuant to section 215(d)(5) of the FPA and Sec. 39.5(f) of our regulations, the Commission also directs the ERO to develop certain modifications to the MOD Reliability Standards. Finally, the Commission directs NERC to retire the existing MOD Reliability Standards replaced by the versions approved here.