December 27, 2011 – Federal Register Recent Federal Regulation Documents

The Commodity Futures Trading Commission (CFTC) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq., Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the rule requiring notification of pending legal proceedings pursuant to 17 CFR 1.60.

This notice announces receipt of and publishes a petition for waiver from Samsung Electronics America, Inc. (Samsung). The petition for waiver (hereafter ``petition'') requests a waiver from the U.S. Department of Energy (DOE) test procedure applicable to commercial package air-source central air conditioners and heat pumps. The petition is specific to the variable capacity Digital Variable Multi (DVM) (commercial) multi-split heat pump models specified in Samsung's petition. Through this document, DOE: (1) Solicits comments, data, and information with respect to the Samsung petition; and (2) announces the grant of an interim waiver to Samsung from the existing DOE test procedure for the subject commercial multi-split air conditioners and heat pumps.

NMFS proposes 2012 and 2013 harvest specifications, apportionments, and prohibited species catch (PSC) allowances for the groundfish fisheries of the Bering Sea and Aleutian Islands (BSAI) management area. This action is necessary to establish harvest limits for groundfish during the 2012 and 2013 fishing years, and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area. The intended effect of this action is to conserve and manage the groundfish resources in the BSAI in accordance with the Magnuson-Stevens Fishery Conservation and Management Act.

In accordance with the Marine Mammal Protection Act (MMPA), notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to Cape Wind Associates (CWA) to take marine mammals, by harassment, incidental to pre-construction high resolution survey activities in Nantucket Sound.

Distribution pipeline operators were required to have prepared and implemented distribution integrity management plans (DIMP) by August 2, 2011. Federal and state regulators have begun inspecting those plans and their implementation. This webinar will be the first opportunity for the regulators to share their findings broadly with the regulated community. The webinar will also include discussion of analyses of the initial submissions of data concerning mechanical fitting failures in distribution pipelines.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Pipeline Hazardous Materials Safety Administration will submit a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to the Office of Management and Budget (OMB) for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the object ``Woman in Blue, Against Blue Water'' by Edvard Munch, imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit object at the Metropolitan Museum of Art, New York, N.Y., from on or about January 9, 2012, until on or about January 9, 2014, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.

The EPA Environmental Laboratory Advisory Board, as previously announced, holds teleconference meetings on the third Wednesday of each month at 1 p.m. Eastern Time, and two face-to-face meetings each calendar year. For 2012, teleconference only meetings will be February 15, 2012 at 1 p.m. Eastern Time; March 21, 2012 at 1 p.m. Eastern Time; April 18, 2012 at 1 p.m. Eastern Time; May 16, 2012 at 1 p.m. Eastern Time; June 20, 2012 at 1 p.m. Eastern Time; July 18, 2012 at 1 p.m. Eastern Time; September 19, 2012 at 1 p.m. Eastern Time; October 17, 2012 at 1 p.m. Eastern Time; November 21, 2012 at 1 p.m. Eastern Time; and December 19, 2012 at 1 p.m. Eastern Time to discuss the ideas and views presented at the previous ELAB meetings, as well as new business. Items to be discussed by ELAB over these coming meetings include: (1) Issues in continuing the expansion of national environmental accreditation; (2) ELAB support to the Agency on issues relating to measurement and monitoring for all programs; and (3) follow-up on some of ELAB's past recommendations and issues. In addition to these teleconferences, ELAB will be hosting its two face-to-face meetings on January 30, 2012 at the Hyatt Regency Sarasota in Sarasota, FL at 8 a.m. Eastern Time and on August 6, 2012 at the Hyatt Regency Capitol Hill in Washington, DC at 9 a.m. Eastern Time. Teleconference lines will also be available for these meetings. Written comments on laboratory accreditation issues and/or environmental monitoring, or measurement issues are encouraged. These comments and should be sent to Ms. Lara P. Autry, Designated Federal Officer, US EPA, Mail Code E243-05, 109 T. W. Alexander Drive, Research Triangle Park, NC 27709, or email her at autry.lara@epa.gov. Members of the public are invited to listen to the teleconference calls, and time permitting, will be allowed to comment on issues discussed during the ELAB meetings. Those persons interested in attending should call Lara P. Autry on (919) 541-5544 to obtain teleconference information. For information on access or services for individuals with disabilities or to request accommodation of a disability, please contact Lara P. Autry on the number above, preferably at least 10 days prior to the meeting, to give the Agency as much time as possible to process your request.

On October 26, 2011, EPA published its final 2010 Effluent Guidelines Program Plan (``final 2010 Plan'') and announced its 2011 Effluent Guidelines Reviews, as required under the Clean Water Act (CWA). Since publication, the Agency has received several requests for additional time to submit comments. EPA is therefore re-opening the comment period and will accept public comments on both actions for an additional 60 days.

EPA is approving the Clean Air Act (CAA) section 111(d)/129 state plan (the Plan) submitted by the Florida Department of Environmental Protection (FDEP) for the State of Florida on December 21, 2010, for implementing and enforcing the Emissions Guidelines (EGs) applicable to existing Hospital/Medical/Infectious Waste Incinerators (HMIWIs). These EGs apply to devices that combust any amount of hospital waste and/or medical/infectious waste.

The Department of Commerce (United States Patent and Trademark Office) is requesting nominations of individuals to serve on the National Medal of Technology and Innovation Nomination Evaluation Committee. The United States Patent and Trademark Office will consider all timely nominations received in response to this notice as well as from other sources.

A determination has been made that a number of foreign entities and one foreign person have engaged in activities that warrant the imposition of measures pursuant to Section 3 of the Iran, North Korea, and Syria Nonproliferation Act. The Act provides for penalties on entities and individuals for the transfer to or acquisition from Iran since January 1, 1999, the transfer to or acquisition from Syria since January 1, 2005, or the transfer to or acquisition from North Korea since January 1, 2006, of goods, services, or technology controlled under multilateral control lists (Missile Technology Control Regime, Australia Group, Chemical Weapons Convention, Nuclear Suppliers Group, Wassenaar Arrangement) or otherwise having the potential to make a material contribution to the development of weapons of mass destruction (WMD) or cruise or ballistic missile systems. The latter category includes (a) items of the same kind as those on multilateral lists but falling below the control list parameters, when it is determined that such items have the potential of making a material contribution to WMD or cruise or ballistic missile systems, (b) other items with the potential of making such a material contribution, when added through case-by-case decisions, and (c) items on U.S. national control lists for WMD/missile reasons that are not on multilateral lists.

The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

In accordance with relevant provisions of the Harmonized Tariff Schedule of the United States (HTS), the Office of the United States Trade Representative (USTR) is providing notice of its determination of the trade surplus in certain sugar and syrup goods and sugar-containing products of Chile, Morocco, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, and Peru. As described below, the level of a country's trade surplus in these goods relates to the quantity of sugar and syrup goods and sugar-containing products for which the United States grants preferential tariff treatment under (i) the United StatesChile Free Trade Agreement (Chile FTA), in the case of Chile; (ii) the United StatesMorocco Free Trade Agreement (Morocco FTA), in the case of Morocco; (iii) the Dominican RepublicCentral AmericaUnited States Free Trade Agreement (CAFTA-DR), in the case of Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua, and (iv) the United StatesPeru Trade Promotion Agreement (Peru TPA), in the case of Peru.

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 (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/ 176,373, filed January 14, 2000 and currently abandoned [HHS Ref. No. E-176-1999/0-US-01]; PCT Application PCT/US01/00981, filed January 12, 2001 and currently expired [HHS Ref. No. E-176-1999/0-PCT-02]; U.S. Patent Application No. 10/169,975, filed July 12, 2002 and issued as U.S. Patent No. 7,087,589 on August 8, 2006 [HHS Ref. No. E-176-1999/0- US-06]; U.S. Patent Application No. 11/500,860, filed August 8, 2006 and issued as U.S. Patent No. 7,790,735 on September 14, 2006 [HHS Ref. No. E-176-1999/0-US-07]; Australian Patent Application No. 2001230913, filed January 12, 2001 and issued as Australian Patent No. 2001230913 on October 13, 2005 [HHS Ref. No. E-176-1999/0-AU-03]; Canadian Patent Application No. 2,397,366, filed January 12, 2001 and issued as Canadian Patent No. 2,397,366 on March 15, 2011 [HHS Ref. No. E-176- 1999/0-CA-04]; European Patent Application No. 01903043.6, filed January 12, 2001 and issued as European Patent No. 1252160 on August 6, 2006 and currently abandoned [HHS Ref. No. E-176-1999/0-EP-05]; and UK Patent Application No. 01903043.6, filed January 12, 2001 and issued as UK Patent No. 1252160 on August 16, 2006 [HHS Ref. No. E-176-1999/0-GB- 08], entitled ``Methanocarba Cycloalkyl Nucleoside Analogues'' to Cornovus Pharmaceuticals, Inc., a company incorporated under the laws of the State of Delaware having its headquarters in Farmington, Connecticut. The United States of America is the assignee of the rights of the above inventions. The prospective exclusive evaluation option license territory may be ``worldwide'', and the field of use may be limited to ``The use of (1'S,2R,3S,4'R,5'S)-4- (6-amino-2-chloro-9H-purin-9-yl)-1-[phosphoryloxymethyl] bicycle[3.1.0]hexane-2,3-diol) (MRS2339) to treat and/or prevent cardiac diseases in humans.'' Upon the expiration or termination of the exclusive evaluation option license, Cornovus Pharmaceuticals, Inc. will have the right to execute an exclusive patent commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the evaluation license.