March 26, 2013 – Federal Register Recent Federal Regulation Documents

HHS gives notice of a determination concerning a petition to add a class of employees from General Steel Industries in Granite City, Illinois, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On March 6, 2013, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

We propose to adopt a new airworthiness directive (AD) for Hartzell Propeller, Inc. propeller models HC-(1, D)2(X, V, MV)20-7, HC- (1, D)2(X, V, MV)20-8 and HC-(1, D)3(X, V, MV)20-8. This proposed AD was prompted by failures of the propeller hydraulic bladder diaphragm and resulting engine oil leak. This proposed AD would require replacement of the propeller hydraulic bladder diaphragm. We are proposing this AD to prevent propeller hydraulic bladder diaphragm rupture, loss of engine oil, damage to the engine, and loss of the airplane.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to Aura BioSciences to practice the inventions embodied in U.S. Provisional Patent Application No. 60/928,495 entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 8, 2007 [HHS Ref. No. E-186-2007/0-US-01], U.S. Provisional Patent Application No. 61/065,897 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed February 14, 2008 [HHS Ref. No. E-186-2007/1-US-01], PCT Application No. PCT/US2008/ 062296 ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-PCT-01], Australian Patent Application No. 2008251615 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-AU-02], Canadian Patent Application No. 2,686,990 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-CA- 03], European Patent Application No. 08747407.8 entitled ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed May 1, 2008 [HHS Ref. No. E-186-2007/2-EP-04], U.S. Patent Application No. 12/598,684 entitled, ``Papillomavirus Pseudoviruses for Detection and Therapy of Tumors'' filed February 8, 2010 [HHS Ref. No. E-186-2007/2-US-05], and US Patent Application No. 13/763,365 entitled, ``Papilloma Pseudovirus for Detection and Therapy of Tumors'' filed February 8, 2013 [HHS Ref. No. E-186-2007/2-US-06] and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development and use of the Licensed Patent Rights in combination with Licensee's proprietary nanosphere encapsulation technology for the treatment, diagnosis and imaging of cancer tumors and metastases as well as their respective pre-cursor dysplasia states. Licensee's proprietary nanosphere encapsulation technology is understood to consist of: (1) Methods for manipulating the outer proteins of human papillomavirus-derived nanoparticles to create particles targeted to solid tumors and distant metastases; and (2) enhancements for the delivery of particles created by Licensee's proprietary technology.

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 (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to practice the inventions embodied in U.S. Patent No. 7,854,899, (E-098-2004/0) filed 08/26/2004 and issued 12/20/2010 entitled ``Template Methods and Device for Preparing Sample Arrays''; by Hewitt et al. (NCI); and U.S. Patent No. 6,951,761 9 (E- 064-2001/0) filed 08/30/2002 and issued 11/04/2005 ``Measurements of Multiple Molecules Using a Cryoarray'' by Star et al. (NIDDK) to Micatu, Inc. having a place of business at 231 West Water Street, Elmira, NY 14901. The patent rights in this invention have been assigned to the United States of America.

Notice is hereby given, pursuant to CBP regulations, that AmSpec Services, LLC, has been approved to gauge and accredited to test petroleum and petroleum products, organic chemicals and vegetable oils for customs purposes for the next three years as of September 21, 2012.

The Department of Veterans Affairs (VA) is withdrawing VA's proposed rulemaking, published in the Federal Register on September 27, 2012, which proposed to amend its regulations that govern VA payments to State homes for bed holds on behalf of veterans. Specifically, the regulation proposed to remove a 30-day residency requirement before VA would make such payments. VA received no significant adverse comments concerning the proposed rule or its companion substantially identical direct final rule published on the same date in the Federal Register. In a companion document in this issue of the Federal Register, we are confirming that the direct final rule became effective on November 26, 2012. Accordingly, this document withdraws as unnecessary the proposed rule.

Notice is hereby given that Yoko Mitani, Ph.D., Hokkaido University, 3-1-1 Minato-cho, Hakodate, Hokkaido 041-8611, Japan, has applied in due form for a permit to conduct research on gray (Eschrichtius robustus) and killer (Orcinus orca) whales.

The Food and Drug Administration (FDA) has determined that QUESTRAN (cholestyramine for oral suspension, USP), equivalent to (EQ) 4 grams (g), and QUESTRAN LIGHT (cholestyramine for oral suspension, USP), EQ 4 g, 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 applications (ANDAs) that refer to these drugs, and it will allow FDA to approve ANDAs that refer to these drugs as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Coast Guard is establishing a temporary safety zone in the navigable waters of the San Francisco Bay near Hunters Point in San Francisco, CA in support of the San Francisco Police Department's maritime interdiction training exercises. This safety zone is established to ensure the safety of the exercise participants and mariners transiting the area. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.

The Coast Guard proposes to issue a special local regulation on the waters of the Wando River, Cooper River, and Charleston Harbor in Charleston, SC during the Low Country Splash in Charleston, SC, on June 1, 2013. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. The special local regulation will temporarily restrict vessel traffic in a portion of the Wando River and Charleston Harbor, preventing non-participant vessels from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.

The United States Department of Commerce, International Trade Administration.

The FAA is issuing this notice to advise the public of the sixth meeting of the RTCA Special Committee 226, Audio Systems and Equipment.