September 1, 2009 – Federal Register Recent Federal Regulation Documents

The U.S. Travel and Tourism Advisory Board (Board) will hold a meeting to discuss topics related to the travel and tourism industry. The Board was re-chartered on September 21, 2007, to advise the Secretary of Commerce on matters relating to the travel and tourism industry.

The Acting Regional Administrator of EPA Region III is hereby granting a project waiver of the Buy American requirements of ARRA Section 1605 under the authority of Section 1605(b)(2) [manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality] to the Town of Cape Charles for the purchase of membrane filtrations cassettes, which are an integral component of the Membrane Bioreactor (MBR) wastewater treatment process, at its Wastewater Treatment Plant (WWTP). Cape Charles indicates that the MBR treatment process is necessary to achieve the wastewater treatment levels required by the National Pollutant Discharge Elimination System (NPDES) permits issued for this WWTP. The membrane filtration equipment under consideration is manufactured by a company located in Canada and no United States manufacturer produces an alternative that meets Cape Charles's technical specifications. This is a project specific waiver and only applies to the use of the specified product for the ARRA funded project being proposed. Any other ARRA project that may wish to use the same product must apply for a separate waiver based on the specific project circumstances. The Acting Regional Administrator is making this determination based on the review and recommendations of the EPA Region III, Water Protection Division, Office of Infrastructure and Assistance. Cape Charles has provided sufficient documentation to support its request.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit the following continuing Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on February 28, 2010. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added certain qualifying children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of final guidelines regarding the addition of children's hospitals that meet certain requirements, specifically: (1) The process for the registration of children's hospitals to the 340B Program; and (2) the obligation of manufacturers to provide the statutorily mandated discount to those children's hospitals.

Notice is hereby given that, pursuant to 19 CFR 151.13, Camin Cargo Control, Inc., 2844 Sharon Street, Suite B, Kenner, LA 70062, has been approved to gauge petroleum, petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.13. Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to cbp.labhq@dhs.gov. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. https://cbp.gov/xp/cgov/import/operations support/labsscientificsvcs/commercialgaugers/.

Notice is hereby given that, pursuant to 19 CFR 151.12 and 19 CFR 151.13, SGS North America, Inc., 614 Heron Drive, Bridgeport, NJ 08014, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquires regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to cbp.labhq@dhs.gov. Please reference the Web site listed below for a complete listing of CBP approved gaugers and accredited laboratories. https://cbp.gov/xp/cgov/import/operationssupport/labsscientifi c svcs/commercialgaugers/.

The Food and Drug Administration (FDA) has determined the regulatory review period for TAPENTADOL HYDROCHLORIDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of fruit From Thailand.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the labeling requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA). Separate guidance on labeling requirements for nonprescription (over- the-counter) human drugs marketed without an approved application, issued by FDA's Center for Drug Evaluation and Research, is announced elsewhere in this issue of the Federal Register.

We are advising the public of our determination that a papaya line developed by the University of Florida, designated as transformation event X17-2, which has been genetically engineered for resistance to the papaya ringspot virus, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by the University of Florida in its petition for a determination of nonregulated status, our analysis of other scientific data, our response to comments received from the public on the petition for nonregulated status for papaya line X17-2, and our associated environmental assessment. This notice also announces the availability of our written determination of nonregulated status and finding of no significant impact.

HUD is amending HUD/PIH-5 to reflect changes in the following sections, which impact participants and program administrators of the Public Housing, Disaster Housing Assistance, Housing Choice Voucher (HCV), Section 8 Moderate Rehabilitation programs; and the various rental assistance programs for the Office of Housing: Categories of Individuals Covered by the System, Categories of Records in the System, Purposes of the System, and Routine Uses of Records Maintained in the System, Including Categories of Users and Purposes of Such Users. These sections are revised to reflect the present status of the information contained in the system. A more detailed description of the present system is contained in the Supplemental Information section.

NMFS announces the approval of Amendment 33 to the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (FMP). Amendment 33 amends the FMP to allow NMFS to reduce the amount of fees collected under the Crab Rationalization Program to the amount needed to finance the Federal loan program for quota share purchase. The amendment provides NMFS with the flexibility to reserve only the amount of fees necessary to support the loan program, including no fees if none are needed. This FMP amendment does not require modifications to Federal regulations.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a new collection for the Food and Nutrition Service Evaluation of the Fresh Fruit and Vegetable Program (FFVP) to examine how the Fresh Fruit and Vegetable Program is currently being implemented and to estimate program impacts on participating students.

The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 221: Aircraft Secondary Barriers and Alternative Flight Deck Security Procedures.

These special conditions are issued for the Cessna Aircraft Company, model 525C airplane. This airplane will have a novel or unusual design feature(s) associated with a Single Point Refuel/Defuel system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.