September 14, 2010 – Federal Register Recent Federal Regulation Documents

This document announces that the EPA Administrator has responded to a petition asking EPA to object to a Clean Air Act (Act) operating permit issued by the Wisconsin Department of Natural Resources. Specifically, the Administrator granted in part and denied in part the petition submitted by David Bender of McGillivray Westerberg and Bender, LLC, on behalf of the Sierra Club, to object to the operating permit for Alliant EnergyWisconsin Power and Light Edgewater Generating Station. Pursuant to section 505(b)(2) of the Act, a petitioner may seek judicial review in the United States Court of Appeals for the appropriate circuit of those portions of the petition which EPA denied. Any petition for review shall be filed within 60 days from the date this notice appears in the Federal Register, pursuant to section 307 of the Act.

This is a notice of the Presidential declaration of an emergency for the Commonwealth of Massachusetts (FEMA-3315-EM), dated September 2, 2010, and related determinations.

The preamble to the proposed Transport Rule contains minor, technical errors that EPA is correcting in this action. In the portion of the preamble discussing in detail the proposed trading programs, EPA states clearly that it is proposing provisions that allow units to opt into these trading programs. Moreover, the proposed rule text for the Transport Rule includes detailed opt-in provisions for each proposed trading program. However, two sentences in other portions of the Transport Rule preamble erroneously state that the proposed trading programs do not allow units to opt in. In this proposed rule, EPA is correcting these technical errors.

EPA is proposing to approve the State Implementation Plan (SIP) revision submitted by the State of Montana on March 26, 2008. Montana submitted this SIP revision to meet Clean Air Act requirements for attaining the 15.0 micrograms per cubic meter ([mu]g/m3) annual fine Particulate Matter (PM2.5) national ambient air quality standard (NAAQS) for the Libby nonattainment area. The plan, herein called an ``attainment plan,'' includes an attainment demonstration, an analysis of Reasonably Available Control Technology and Reasonably Available Control Measures (RACT/RACM), base-year and projection year emission inventories, and contingency measures. The requirement for a Reasonable Further Progress (RFP) plan is satisfied because Montana projects that attainment with the 1997 PM2.5 NAAQS will occur in the Libby nonattainment area by April 2010. In addition, we are proposing to approve the PM10 SIP revisions to the Lincoln County Air Pollution Control Program submitted by Montana on June 26, 2006 for inclusion into Libby's attainment plan. This submittal contains provisions, including contingency measures, for controlling both PM10 and PM2.5 emissions from woodstoves, road dust, and outdoor burning. Finally, EPA is proposing to find on-road directly emitted PM2.5 and oxides of nitrogen (NOX) in the Libby, Montana nonattainment area insignificant for regional transportation conformity purposes. If this insignificance finding is finalized as proposed, the Libby, Montana nonattainment area will not have to perform a regional emissions analysis for either direct PM2.5 or NOX as part of future conformity determinations for the annual 1997 PM2.5 NAAQS.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Wah Chang facility, Albany, Oregon, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Wah Chang. Location: Albany, Oregon. Job Titles and/or Job Duties: All employees who worked in any buildings. Period of Employment: Operational period from January 1, 1971 through December 31, 1972, and the residual radioactivity period from January 1, 1973 through October 31, 2009.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 61/241,620 entitled ``Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0- US-01], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/ 0-US-01], U.S. Patent Application 60/160,071 entitled ``Immunoconjugates Having High Binding Affinity'' [HHS Ref. E-139-1999/ 0-US-01], U.S. Patent Application 60/067,175 entitled ``Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and Methods for Their Use'' [HHS Ref. E-021- 1998/0-US-01], U.S. Patent Application 60/010,166 entitled ``Molecular Cloning of Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref. E-002-1996/ 0-US-01], PCT Application PCT/US97/00224 entitled ``Mesothelin Antigen and Methods and Kits for Targeting It'' [HHS Ref. E-002-1996/1-PCT-01], U.S. Patent 5,747,654 entitled ``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' [HHS Ref. E-163- 1993/0-US-01], PCT application PCT/US96/16327 entitled ``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' [HHS Ref. E-163- 1993/2-PCT-01], U.S. Patent Application 07/596,291 entitled ``A Monoclonal Antibody'' [HHS reference E-195-1990/0-US-01], and all continuing applications and foreign counterparts, to Morphotek, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This document adopts modifications to the test method currently applied by U.S. Customs and Border Protection (``CBP'') for the testing of pressed and toughened (specially tempered) glassware, as set forth in Treasury Decision (T.D.) 94-26 which was published in the Federal Register on March 22, 1994. This document sets forth revised criteria for interpreting the results obtained from the cutting test for opaque glassware and provides an interpretation of breakage for that test. In addition, this document reinstates a previously used testing method, the center punch test, and provides a description of the center punch apparatus to be used for that test. The final CBP test method for pressed and toughened (specially tempered) glassware for tariff classification purposes is set forth in its entirety in this document.

The FAA is issuing this notice to advise the public that a Draft Re-Evaluation for an Environmental Impact Statement (EIS) has been prepared for Sikorsky Memorial Airport in Stratford, Connecticut.

The Mark Twain National Forest (MTNF) proposes to implement an integrated Forest-wide management strategy to control the spread of non-native invasive plants (NNIP) within the National Forest over the next 10 years, or until circumstances change to the point that the analysis is no longer valid. The proposal utilizes several management tools, including registered herbicides, bio-agents, and manual/ mechanical methods.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Del Norte Resource Advisory Committee (RAC) will meet in Crescent City, California. The committee meeting is authorized under the Secure Rural Schools and Community Self-Determination (SRS) Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act.

The Pacific Fishery Management Council's (Pacific Council) Coastal Pelagic Species Management Team (CPSMT) and Scientific and Statistical Committee's Subcommittee on Coastal Pelagic Species (SSC Subcommittee) will hold a joint meeting that is open to the public.

The Food and Drug Administration (FDA) is announcing that North American Bioproducts Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of penicillin G procaine as an antimicrobial processing aid in fuel- ethanol fermentations with respect to its consequent presence in by- product distiller grains used as an animal feed or feed ingredient.

The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations to remove portions reflecting approval of these NADAs.

The Food and Drug Administration (FDA) has determined that VESANOID (tretinoin) Capsules, 10 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of the abbreviated new drug application (ANDA) that refers to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Coast Guard announces two separate public meetings to receive comments on the study entitled ``Port Access Route Study: In the Approaches to Los Angeles-Long Beach and in the Santa Barbara Channel'' that was published in the Federal Register on Wednesday, April 7, 2010. As stated in that document, the Coast Guard is conducting a Port Access Route Study (PARS) to evaluate the continued applicability of and the potential need for modifications to the current vessel routing in the approaches to Los Angeles-Long Beach and in the Santa Barbara Channel.