June 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined that DELALUTIN (hydroxyprogesterone caproate) injection, 125 milligrams (mg)/milliliter (mL) and 250 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 hydroxyprogesterone caproate injection, 125 mg/mL and 250 mg/mL, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for hydroxyprogesterone caproate, future applicants are advised that they may not be able to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 25, 2010, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Hewlett-Packard Company of Palo Alto, California and Hewlett-Packard Development Company, L.P. of Houston, Texas. A letter supplementing the complaint was filed on June 16, 2010. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain inkjet ink cartridges with printheads and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 6,234,598 (``the `598 patent''); 6,309,053 (``the `053 patent''); 6,398,347 (``the `347 patent''); 6,412,917 (``the `917 patent''); 6,481,817 (``the `817 patent''); and 6,402,279 (``the `279 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.

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 8857, Request for Innocent Spouse Relief.

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 5330, Return of Excise Taxes Related to Employee Benefit Plans.

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 1120-C, U.S. Income Tax Return for Cooperative Associations.

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: Extension of airbrakes above 360 KIAS [knots indicated air speed]/0.79 Mi [Mach indicated] results in aerodynamic driven vibration of the airbrake which, if not limited per Revision 14 to the AFM [airplane flight manual], can lead to high cycle fatigue failure of the airbrake in board hinge. The unsafe condition is high cycle fatigue of the airbrake in-board hinge, which can result in loss of the airbrake, which in turn can lead to reduced controllability of the airplane. The proposed AD would require actions that are intended

The FAA proposes to supersede an existing airworthiness directive (AD) that applies to all of the McDonnell Douglas Corporation airplanes identified above. The existing AD currently requires revising the maintenance program to incorporate new airworthiness limitations for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 requirements. This proposed AD would add requirements to revise the maintenance program to incorporate specific Critical Design Configuration Control Limitations (CDCCL) information and install fuel tank float switch in-line fuses. This proposed AD would also add two Airworthiness Limitations inspections (ALIs). This proposed AD results from a design review of the fuel tank systems. We are proposing this AD to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

The Coast Guard proposes that operating procedures on the Rob Roy Drawbridge across the Arkansas Waterway at mile 67.4 at Pine Bluff, AR be revised in the Code of Federal Regulations to reflect that vessel operators contact the remote drawbridge operator via microphone keying on VHF-FM Channel 12 when requesting a draw opening. This keying activates an indicator on the remote drawbridge operator's console and sends an acknowledgement tone back to the vessel and the remote drawbridge operator then establishes normal verbal radio communications. This protocol is used to isolate and differentiate these radio communications from the railroad communications that the remote drawbridge operator receives, thus ensuring that vessel calls receive immediate attention.

The Coast Guard is establishing a temporary safety zone for a swimming event in the Captain of the Port Buffalo zone. This rule is intended to restrict vessels from areas of water during events that pose a hazard to public safety. The safety zone established by this rule is necessary to protect participants and vessels from the hazards associated with a swimming event.

In December 2009, the Governments of the United States and Turkey agreed to establish a U.S.-Turkey Business Council. This notice announces the opportunity for appointment as private sector members to the U.S. Section of the Council.

The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of five individuals and three entities 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 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 Notice 2007-19, as Amended and Supplemented by Notice 2007-31, Statute of Limitations on Assessment Concerning Certain Individuals Filing Income Tax Returns With the U.S. Virgin Islands.

The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD)/Approved Resource Management Plan (RMP) for the Canyons of the Ancients National Monument located in Montezuma and Dolores counties in southwest Colorado. The Colorado State Director signed the ROD on June 14, 2010, which constitutes the final decision of the BLM and makes the Approved RMP effective immediately.

Under section 8 of RESPA and HUD's implementing RESPA regulations, services performed by real estate brokers and agents as additional settlement services in a real estate transaction are compensable if the services are actual, necessary and distinct from the primary services provided by the real estate broker or agent, the services are not nominal, and the payment is not a duplicative charge. A referral is not a compensable service for which a broker or agent may receive compensation. This rule interprets section 8 of RESPA and HUD's regulations as they apply to the compensation provided by home warranty companies to real estate brokers and agents. Although interpretive rules are exempt from public comment under the Administrative Procedure Act, HUD nevertheless welcomes public comment on this interpretation.

The National Marine Fisheries Service (NMFS) publishes its proposed List of Fisheries (LOF) for 2011, as required by the Marine Mammal Protection Act (MMPA). The proposed LOF for 2011 reflects new information on interactions between commercial fisheries and marine mammals. NMFS must classify each commercial fishery on the LOF into one of three categories under the MMPA based upon the level of serious injury and mortality of marine mammals that occurs incidental to each fishery. The classification of a fishery in the LOF determines whether participants in that fishery are subject to certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan requirements.

The Olympic Peninsula Resource Advisory Committee will meet this July in Montesano, Washington. The purpose of this meeting will be to review project proposals and provide recommendations for Title II projects to be funded by the Secure Rural Schools and Community Self- Determination Act.

This document contains proposed rules that would amend the project review regulations of the Susquehanna River Basin Commission (Commission) to: Include subsidiary allocations for public water supply systems under the scope of withdrawals requiring review and approval; improve notice procedures for all project applications; clarify requirements for grandfathered projects increasing their withdrawals from an existing source or initiating a new withdrawal; refine the provisions governing transfer and re-issuance of approvals; clarify the Executive Director's authority to grant, deny, suspend, rescind, modify or condition an Approval by Rule; include decisional criteria for diversions into the basin; amend administrative appeal procedures to broaden available remedies and streamline the appeal process; and make other minor regulatory clarifications to the text of the regulations.