February 10, 2012 – Federal Register Recent Federal Regulation Documents

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 objects to be included in the exhibition ``Nomads and Networks: The Ancient Art and Culture of Kazakhstan,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Institute for the Study of the Ancient World, New York University, New York, New York, from on or about March 6, 2012, until on or about June 3, 2012, 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 BLM published a Notice of Intent (NOI) on December 9, 2011 [76 FR 77008]. This Notice of Correction changes/clarifies the names of the regions that are coordinating the Environmental Impact Statements (EISs) and Supplemental EISs, extends the scoping period, and adds 11 Forest Service Land Management Plans (LMPs) to this process. The Eastern Region referred to in the previous NOI is now known as the Rocky Mountain Region; while the Western Region referred to in the previous NOI is now known as the Great Basin Region. The added Forest Service LMPs include: Rocky Mountain Region [cir] ColoradoRoutt National Forest Plan (1998) [cir] UtahAshley National Forest Plan (1986) [cir] UtahManti-Lasal National Forest Plan (1986) [cir] UtahWasatch-Cache National Forest Plan (2003) [cir] WyomingBridger-Teton National Forest Plan (1990) [cir] WyomingMedicine Bow National Forest Plan (2004) Great Basin Region [cir] IdahoBoise National Forest Plan (2003) [cir] IdahoChallis National Forest Plan (1987) [cir] IdahoSalmon National Forest Plan (1988) [cir] IdahoTarghee National Forest Plan (1997) [cir] MontanaBeaverhead-Deerlodge National Forest Plan (2009)

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment for a proposed controlled field release of a genetically engineered clone of a Eucalyptus hybrid. The purpose of the field release is to assess the effectiveness of gene constructs intended to confer cold tolerance, to test the efficacy of genes introduced to alter lignin biosynthesis, to test the efficacy of genes designed to alter growth, and to test the efficacy of genes designed to alter flowering. We are making the environmental assessment available to the public for review and comment.

We propose to adopt a new airworthiness directive (AD) for Eurocopter Deutschland GMBH (ECD) Model MBB-BK 117 C-1 and C-2 helicopters. This proposed AD would require installing a placard that corresponds to the maximum permissible flight altitude, amending the Rotorcraft Flight Manual (RFM) to revise the maximum permissible operating altitude, and inserting revised performance charts into the RFM. The proposed AD would also require a repetitive maintenance ``MAX N1 CHECK'' to determine the appropriate maximum altitudes. The AD would also require, if the engine or a fuel control unit (FCU) or module 2 or 3 is replaced, repeating the maintenance ``MAX N1 CHECK.'' Finally, the proposed AD specifies that modifying both engines would provide terminating action for the proposed AD requirements. This proposed AD is prompted by the failure of a ``few'' engines to reach the specified one-engine-inoperative (OEI) rating at altitudes above 10,000 feet. The proposed actions are intended to prevent flights at altitudes where the full OEI engine power cannot be reached and subsequent loss of control of the helicopter if an OEI operation is required.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), National Aeronautics and Space Administration (NASA) is publishing this notice to advise the public of the availability of its analysis of FY 2010 Service Contract inventory and the FY 2011 Service Contract Inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2011. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). NASA has posted its analysis of the FY 2010 inventory, the FY 2011 inventory and a summary of the FY 2011 inventory on the NASA Office of Procurement homepage at the following link: https://www.hq.nasa.gov/office/ procurement/scinventory/. Point of contact for this initiative is Sandra Morris (202) 358- 0532, Sandra.Morris@nasa.gov.

In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Commodity Futures Trading Commission is publishing this notice to advise the public of the availability of the FY 2011 Service Contract inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2011. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP) and the revised guidance issued on 11/8/2011. OFPP's November 5, 2010 guidance is available at https://www.whitehouse.gov/sites/default/files/omb/ procurement/memo/service-contract-inventories-guidance-110520 10.pdf. Commodity Futures Trading Commission has posted its inventory and a summary of the inventory on the CFTC homepage at the following link: https://www.cftc.gov/About/CFTCReports/index.htm.

Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

NMFS issues this final rule to implement management measures described in Amendment 32 to the Fishery Management Plan (FMP) for the Reef Fish Resources of the Gulf of Mexico (Amendment 32) prepared by the Gulf of Mexico Fishery Management Council (Council). This rule adjusts the commercial gag quota and recreational annual catch target (ACT) for 2012 through 2015 and subsequent fishing years, consistent with the gag rebuilding plan established in Amendment 32; adjusts the shallow-water grouper (SWG) quota; adjusts the commercial and recreational sector annual catch limits (ACLs) for gag and red grouper; adjusts the commercial ACL for SWG; establishes a formula-based method for setting gag and red grouper multi-use allocation for the grouper/ tilefish individual fishing quota (IFQ) program in the Gulf of Mexico (Gulf); sets the recreational gag fishing season from July 1 through October 31; reduces the gag commercial size limit to 22 inches (59 cm) total length (TL); and modifies the gag and red grouper accountability measures (AMs). In addition, Amendment 32 establishes gag commercial ACTs and a 10-year gag rebuilding plan consistent with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This final rule is intended to end overfishing of gag, allow the gag stock to rebuild, and adjust red grouper management measures to allow the harvest of optimum yield (OY).

In this document, the Commission's Wireless Telecommunications and Wireline Competition Bureaus announce a reverse auction to award $300 million in one-time Mobility Fund Phase I support scheduled to commence on September 27, 2012. This document also seeks comment on competitive bidding procedures for Auction 901 and other program requirements.

Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

The Department of Commerce is currently seeking applications for public or semi-public organizations or entities, including ports, to serve as members of the Advisory Committee on Supply Chain Competitiveness (Committee). Representatives of ports are particularly encouraged to apply. The purpose of the Committee is to advise the Secretary on the necessary elements of a comprehensive, holistic national freight infrastructure and a national freight policy designed to support U.S. export growth and competitiveness, foster national economic competitiveness, and improve U.S. supply chain competitiveness in the domestic and global economy.

In response to a request from an interested party, Eurodif S.A. and AREVA NP Inc. (collectively, AREVA), the Department of Commerce (Department) initiated a changed circumstances review (CCR) of the antidumping duty order of low enriched uranium (LEU) from France.\1\ We preliminarily determine that it is appropriate to issue a one-time amendment to the scope of the order to extend by 18 months the deadline otherwise applicable to AREVA for the re-exportation of one entry of LEU. We invite interested parties to comment on these preliminary results. Parties who submit comments in these reviews are requested to submit with each argument (1) a statement of the issue and (2) a brief summary of the argument.

This notice announces that EPA Region 10 has issued two final permit decisions granting Clean Air Act Outer Continental Shelf (OCS) permit applications, one from Shell Gulf of Mexico, Inc., for operation of the Discoverer drillship in the Chukchi Sea and one from Shell Offshore, Inc. (collectively, ``Shell''), for operation of the Discoverer drillship in the Beaufort Sea.

The Office of Rare Diseases Research (ORDR), an organizational component of the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), is inviting patient organizations without a patient registry and those with established patient registries to be considered for participation in a two-year pilot project to establish the Global Rare Diseases Patient Registry and Data Repository (GRDR), and to submit background information about their organization for consideration by the project's selection committee. More information may be found at https:// rarediseases.info.nih.gov/GRDR. The goal of the GRDR is to enable data analysis within and across many rare diseases and to facilitate clinical trials and other studies. An interface will be developed to accept de-identified patient data from existing patient registries to promote data sharing. The GRDR will serve rare disease patients and their advocacy groups seeking help and information. It will also serve investigators conducting research, clinicians treating patients, epidemiologists analyzing disease data, and investigators seeking patients for new clinical trials and initiating natural history studies. A researcher portal will allow authorized researchers to gain access to de-identified patient data to identify potential study candidates and to learn about the natural history of disease. Because the GRDR will contain only de-identified data, investigators will recruit prospective participants through the patient organizations. Direct contact with the prospective participants would occur only after the patient has granted permission. In order to aggregate data from different registries to facilitate pan-disease analysis, data must be captured and collected in a standardized manner. Use of Common Data Elements (CDEs) facilitates the standardization of data collection and allows for harmonization, sharing, and exchange of information across registries. ORDR has developed a set of minimal CDEs that have been accepted and adopted by numerous national and international patient advocacy groups and professional organizations globally. To develop organ systems and disease specific CDEs, ORDR is coordinating and collaborating with the various NIH components, patient advocacy groups, and professional organizations that already have developed similar CDEs or are in the process of developing them. The purpose of this pilot program is to test the different functionalities of the GRDR. A total of 24 organizations will be selected. Twelve organizations with established registries and 12 organizations that have no registry will be chosen to participate. The 12 patient organizations without patient registries will be selected to assist in testing the GRDR and in the implementation of the ORDR Common Data Elements (CDEs) when establishing new patient registries. These organizations will participate in the development and promotion of a new patient registry for their rare disease. The GRDR program will fund the development and hosting of the registry during the pilot program. Thereafter, the patient registry is expected to be self-sustainable. The 12 established patient registries will be selected to integrate their de-identified data into the GRDR to evaluate the data mapping and data export/import processes. The GRDR team will assist these patient organizations in mapping their existing registry data to the CDEs. Participating organizations (with patient registries) must have a means to export their de-identified registry data into a specified data format that will facilitate loading the data into the GRDR on a regular basis. A HIPAA compliant server infrastructure and secure file transmission protocols will be implemented to protect patient privacy. The Global Unique Identifiers (GUID) program developed by the National Database for Autism Research (NDAR) will be used to assign unique patient identifiers. This will help eliminate duplication and enable integration with tissue repositories in a de-identified manner. Participating registries will gain access to all collected patient and biospecimen information to stimulate collaboration to accelerate the development of therapeutics, drugs and hopefully cures for the rare diseases. During the two-year pilot project, a web-based template will be developed to assist other patient groups that wish to establish their own patient registry. A HIPAA compliant hosting facility will provide a secure environment to protect properly consented de-identified patient information. Background: The GRDR project is a follow-up to the January 2010 ORDR workshop, ``Advancing Rare Disease Research: the Intersection of Patient Registries, Biospecimen Repositories, and Clinical Data.'' Information on this workshop can be found at https:// rarediseases.info.nih.gov/PATIENTREGISTRIESWORKSHOP/. The ORDR, in collaboration with PatientCrossroads, Children's Hospital of Philadelphia, and Medscape, launched a pilot project to establish the GRDR to collect patient clinical information without personal identifiers (de-identified information compiled by the federal common rule and HIPPA regulations) for research. The PatientCrossroads registry platform, utilized by many rare disease organizations to collect patient self-report medical history and diagnostic testing information, will be deployed for the 12 new registries. PatientCrossroads will provide all technology, hosting, and management of the GRDR program. Medical oversight and recommendations of CDEs for each participating registry will be provided by Children's Hospital of Philadelphia. Medscape will provide input and recommendations on marketing, promotion, Continuing Medical Education (CME) and physician training programs. Although any given condition is rare and there might be few patients with each disease, the cumulative public health burden of rare diseases is significant, with great unmet medical needs collectively. Because rare diseases are so uncommon, no single institution, and in many cases no single country, has sufficient numbers of patients to conduct clinical trials and translational research studies. Geographic dispersion of patients has been a major impediment to patient recruitment into clinical trials. Best estimates are that fewer than 20% of rare diseases have patient registries. Most of these are operated by patients' organizations or academic researchers. Most registries are country- specific, but there are some international efforts. For registry developers and those responsible for providing oversight and maintenance, there is a need for an established forum to share experiences. Each time a new registry is developed, it is started from scratch using a different platform with no ability to ``talk'' to other registries, share data, and exchange information. There is a consensus in the community that there is a need for an infrastructure for rare disease patient registries. In recognition of both barriers and public health imperatives to advance knowledge regarding optimal methods of improving health and well-being of rare disease patients, the ORDR has embarked on an initiative to establish an infrastructure for an Internet-based, federated global patient registry with the capability to link to patient clinical information to biospecimens. This global registry will develop or utilize existing common data elements, standards, and vocabularies that would provide a forum for exchange of data, experiences, and knowledge. The future goal is to create a partnership with different sectors of the community including advocacy, research, and industry organizations. This joint effort will reduce the costs of developing and maintaining an international registry for many of the rare disease patient advocacy groups. A federated model requires that individual registries are developed, and those already in existence are enhanced to ensure that they are interoperablei.e., data are defined in the same way, use the same standards, and use the same vocabulary. Similar to the open-source software community, ORDR believes that an open-science community for rare diseases is needed. Such a community would ensure that the conditions necessary for data exchange are addressed by defining common data-sets, data standards, and vocabulary, and provide a forum for exchange of experience and knowledge. The goal is to increase data compatibility, broaden accessibility, and collect patient data and biospecimen information to accelerate the development of therapeutics, drugs, and cures for the rare diseases. This global rare disease registry infrastructure will draw new interest in rare diseases from academic researchers and the pharmaceutical industry because it will assist in the recruitment of patient participants much faster and at much lower cost and enable the design of more effective clinical trials. Going forward, ORDR expects the GRDR to sustain itself as a public-private partnership. Because of the importance of biospecimens as research tool to accelerate research and better facilitate the understanding of the underlying pathogenesis of rare diseases, GRDR will have the capability of linking patient data and medical information to donated biospecimens using a double coded voluntary unique patient identifiers such as the GUID system, which has been developed by National Database for Autism Research (NDAR), a project which recently was chosen as finalist in the HHSinnovates program. For more information, go to https:// jamia.bmjjournals.com/content/17/6/689.full.pdf. The link to biospecimens will be interfaced with the patient registry-associated biorepositories and with the Rare Disease Human Biospecimens/ Repositories (RD-HUB), and found at https:// biospecimens.ordr.info.nih.gov/. Information Requested: Patient advocacy organizations without a patient registry and those with established patient registries that wish to be considered by the selection committee for the GRDR pilot project are encouraged to submit contact and background information about their organization and the rare disease(s) or condition(s) that they represent. The information provided should address the eligibility and selection criteria below. Organizations must meet the following eligibility criteria to submit a response.

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on July 31, 2012. 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.

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.

The Department of Commerce, 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.

The Caribbean Fishery Management Council's Scientific and Statistical Committee (SSC) and the Advisory Panel (AP) will hold meetings.

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 Qualified Electing Fund Elections.