July 21, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (198) entitled ``Draft Guidance for Industry on Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is an annex to a VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' VICH GL3(R), that published in the Federal Register of November 23, 2007 (72 FR 65751). This draft VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).

The Department of the Treasury's Office of Foreign Assets Control (``OFAC'') is amending the Persons Contributing to the Conflict in C[ocirc]te d'Ivoire Sanctions Regulations, 31 CFR part 543 (the ``Regulations''), to change the heading of the Regulations.

The Coast Guard is establishing a safety zone on the navigable waters of San Diego Bay in support of the Access Destinations Fireworks. This temporary safety zone is necessary to provide for the safety of the crew, spectators, and other users and vessels of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this temporary safety zone unless authorized by the Captain of the Port or his designated representative.

The Coast Guard is establishing a temporary safety zone on Lake Huron, St. Ignace, MI. This zone is intended to restrict vessels from a portion of Lake Huron during the Friends of Fireworks Celebration fireworks displays taking place July 11 through September 5, 2009. This temporary safety zone is necessary to protect spectators and vessels from the hazards associated with fireworks displays.

On July 13, 2009, the Maritime Administration and the U.S. Coast Guard (USCG) published in the Federal Register a notice of availability of the Final Environmental Impact Statement (FEIS) for the Port Dolphin Energy LLC, Port Dolphin Energy Liquefied Natural Gas Deepwater Port license application. The notice incorrectly listed the project's docket number as USCG-2006-28532. The correct docket number is USCG-2007-28532. This number should be included on all comments submitted regarding the Port Dolphin Deepwater Port license application. Additionally, the closing date for the comment period was incorrectly listed. The correct date on which comments must be received is August 27, 2009.

The Assistant Secretary for Special Education and Rehabilitative Services announces two priorities under the RRTC program administered by NIDRR. The Assistant Secretary may use one or both of these priorities for competitions in fiscal year (FY) 2009 and later years. We take this action to focus research attention on areas of national need. We intend these priorities to improve rehabilitation services and outcomes for individuals with disabilities.

The Coast Guard is increasing the rates for pilotage service on the Great Lakes by an average of 10.77% over the rates that took effect February 4, 2009. This increase reflects an August 1, 2009, increase in benchmark contractual wages and benefits, as well as an increase in the ratio of pilots to ``bridge hours.'' The Coast Guard intends the final rule to generate sufficient revenue to cover allowable expenses, target pilot compensation, and returns on investment. The final rule promotes the Coast Guard strategic goal of maritime safety.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed 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:

This notice amends the notice of a major disaster declaration for the State of West Virginia (FEMA-1838-DR), dated May 15, 2009, and related determinations.

This notice amends the notice of a major disaster declaration for the State of South Dakota (FEMA-1844-DR), dated June 16, 2009, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Illinois (FEMA-1850-DR), dated July 2, 2009, and related determinations.

The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1041-T, Allocation of Estimated Tax Payments to Beneficiaries.

This notice is provided in accordance with IRC section 6039G, as amended, by the Health Insurance Portability and Accountability Act (HIPPA) of 1996. This listing contains the name of each individual losing their United States citizenship (within the meaning of section 877(a)) with respect to whom the Secretary received information during the quarter ending June 30, 2009.

The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 940, Employer's Annual Federal Unemployment (FUTA) Tax Return, and Form 940-PR, Planilla Para La Declaracion Anual Del PatronoLa Contribucion Federal Para El Desempleo (FUTA).

Section 106 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) requires the Consumer Product Safety Commission (``CPSC'' or ``Commission'') to examine and assess, in consultation with consumer groups, juvenile product manufacturers, and independent child product engineers and experts, the effectiveness of ASTM F963-07, ``Standard Consumer Safety Specification for Toy Safety,'' or its successor standard (except for section 4.2 and Annex 4), as it relates safety requirements, safety labeling requirements, and test methods related to: (1) Internal harm or injury hazards caused by the ingestion or inhalation of magnets in children's products; (2) toxic substances; (3) toys with spherical ends; (4) hemispheric-shaped objects; (5) cords, straps, and elastics; and (6) battery-operated toys. This notice is issued to facilitate the receipt of any written submissions on these matters as part of the consultative process required by section 106 of the CPSIA. The Commission invites comments concerning the issues discussed in this notice.

The Commander, Eighth Coast Guard District has issued a temporary deviation from the regulation governing the operations of the Burlington Northern Santa Fe Railroad Bridge, Mile 88.8, at Beardstown, Illinois across the Illinois Waterway. The deviation is necessary to allow time for upgrade of the lift drive mechanism which only can be done when the bridge is in the closed-to-navigation position. This deviation allows the bridge to remain closed-to-navigation during the 60-hour period July 27-29, 2009.

The National Marine Fisheries Service (NMFS) proposes to amend the regulations implementing the Harbor Porpoise Take Reduction Plan

The FAA is adopting a new airworthiness directive (AD) for Honeywell International Inc., T5313 and T5317 series turboshaft engines. This AD requires initial and repetitive visual inspections and initial and repetitive ultrasonic inspections of combustion chamber housings (CCHs) for cracks. This AD results from eight instances of cracks in CCHs. Two of the instances resulted in an engine shutdown during flight. We are issuing this AD to detect cracks in the CCH, which could result in rupture of the CCH, leading to loss of engine power and damage to the helicopter.

The OCC, Board, FDIC, OTS, FCA, and NCUA (collectively, the Agencies) are issuing final revisions to the Interagency Questions and Answers Regarding Flood Insurance (Interagency Questions and Answers). The Agencies are also soliciting comments on proposed revisions to the Interagency Questions and Answers. To help financial institutions meet their responsibilities under Federal flood insurance legislation and to increase public understanding of the flood insurance regulation, the Agencies are finalizing new and revised guidance, as well as proposing

The FAA is superseding an existing airworthiness directive (AD), which applies to certain Airbus Model A310 series airplanes. That AD currently requires repetitive inspections of the fuselage skin to detect corrosion or fatigue cracking around and under the chafing plates of the wing root; repetitive inspections for fatigue cracking of frame 39, stringer 35; and corrective actions if necessary. The existing AD also provides for an optional terminating action for certain repetitive inspections, except for certain areas where corrosion was detected and reworked. This new AD reduces the intervals for accomplishing repetitive inspections in a certain area. This AD results from mandatory continuing airworthiness information originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. We are issuing this AD to detect and correct fatigue cracks and corrosion around and under the chafing plates of the wing root, which could result in reduced structural integrity of the airplane.