September 26, 2006 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE-New Drug Application 21-506
The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
National Environmental Policy Act; Constellation Program
Pursuant to the National Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), the Council on Environmental Quality Regulations for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-1508), NASA's NEPA policy and procedures (14 CFR part 1216, subpart 1216.3), and Executive Order 12114, NASA intends to prepare a Programmatic EIS for the implementation of the Constellation Program. The Constellation Program encompasses NASA's initial efforts to extend a human presence throughout the Solar System as President George W. Bush outlined in his Vision for Space Exploration. Major elements of the Constellation Program are currently focused on providing the capability to transport humans and cargo first to the International Space Station (ISS), and then at a later date to the Moon in support of lunar exploration missions. These activities would provide the framework for future human exploration of the Moon, Mars and other destinations in the Solar System in the decades to come. The design, development, test, and production of the vehicles needed to transport humans and cargo, the design and development of the infrastructure necessary to support their use in missions, and the early mission applications of these vehicles form the basis of the Proposed Action and alternatives to be analyzed in the Constellation Programmatic EIS. The No Action Alternative is to not implement the Constellation Program. Present plans call for operational missions to the ISS no later than 2014 and human missions to the Moon no later than 2020. Launches are proposed to take place from John F. Kennedy Space Center (KSC), Florida. Analysis of potential landing areas for returning spacecraft is at a very early stage. NASA will hold public scoping meetings as part of the NEPA process associated with development of the Programmatic EIS. Public meeting locations and dates identified at this time are provided under SUPPLEMENTARY INFORMATION below.
National Environmental Policy Act; Advanced Radioisotope Power Systems
Pursuant to the National Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), the Council on Environmental Quality Regulations for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-1508), and NASA policy and procedures (14 CFR part 1216 subpart 1216.3), NASA has prepared and issued an FPEIS for the proposed development of two new types of advanced Radioisotope Power Systems (RPSs), the Multi-Mission Radioisotope Thermoelectric Generator (MMRTG) and the Stirling Radioisotope Generator (SRG). The purpose of this Proposed Action is to develop advanced power systems, specifically the MMRTG and the SRG, that would be able to function in the environments encountered in space and on the surfaces of planets, moons, and other solar system bodies that have an atmosphere thus enabling a broad range of long-term space exploration missions. Included in this Proposed Action are NASA's long-term research and development (R&D) activities focused on alternative radioisotope power systems and power conversion technologies. The long- term R&D activities could include, but not necessarily be limited to, improvements to further increase the versatility of future RPS designs, expanding their capability and the environments in which they can operate. The long-term R&D activities are also expected to include activities to develop RPS designs with smaller electrical outputs and efforts to reduce the mass of power conversion systems to further improve specific power (watts of electrical power per unit of mass). Such long-term R&D activities do not involve the use of radioactive material. The only alternative to the Proposed Action considered in detail is the No Action Alternative, where NASA would discontinue development efforts for the production of the MMRTG and the SRG and would continue to consider the use of currently available RPSs, such as the General Purpose Heat SourceRadioisotope Thermoelectric Generator (GPHS-RTG), for future exploration missions. As with the Proposed Action, NASA's long-term R&D activities on alternative radioisotope power systems and power conversion technologies would continue. The Proposed Action is NASA's preferred alternative.
Notice of Availability of a Final Record of Decision on the Issuance of Permits
The U.S. Fish and Wildlife Service and the National Marine Fisheries Service (Services) announce the availability of a Final Record of Decision on the issuance of incidental take permits to the state of Washington under section 10 of the Endangered Species Act for the Washington Forest Practices Habitat Conservation Plan (HCP). The two incidental take permits (one from each of the Services) authorize incidental take of aquatic species (16 listed fish species, 54 unlisted fish species, and 7 unlisted amphibian species) from covered forest practices implemented under the HCP. These forest practices affect approximately 9 million acres of non-Federal and non-tribal lands in Washington State. The permits were issued on June 5, 2006, and will remain in effect for 50 years.
Marine Protected Areas Federal Advisory Committee; Public Meeting
Notice is hereby given of the next meeting of the Marine Protected Areas Federal Advisory Committee (Committee) in Newport, Oregon.
Marine Protected Areas Federal Advisory Committee
The Department of Commerce is seeking nominations for membership on the Marine Protected Areas Federal Advisory Committee (Committee). The Marine Protected Areas Federal Advisory Committee was established to advise the Secretary of Commerce and the Secretary of the Interior in implementing Section 4 of Executive Order 13158, specifically on strategies and priorities for developing the national system of marine protected areas (MPAs) and on practical approaches to further enhance and expand protection of new and existing MPAs. Nominations are sought for highly qualified non-Federal scientists, resource managers, and people representing other interests or organizations involved with or affected by marine conservation including in the Great Lakes. Fifteen members of the Committee have terms that expire October 31, 2007, and nominations are sought to fill these vacancies. Individuals seeking membership on the Committee should possess demonstrable expertise in a related field or represent a stakeholder interest affected by MPAs. Nominees also will be evaluated based on the following factors: Marine policy experience, leadership and organization skills, region of country represented, and diversity characteristics. The membership reflects the Departments' commitment to attaining balance and diversity. The full text of the Committee Charter and its current membership can be viewed at the Agency's Web page at https://mpa.gov/fac.html.
Freeport McMoRan Energy L.L.C. Main Pass Energy Hub Liquefied Natural Gas Deepwater Port License Application Amendment; Final Public Hearings, Environmental Assessment and Draft Finding of No Significant Impact
The Maritime Administration (MARAD) and U.S. Coast Guard announce the availability of the Environmental Assessment (EA) and Draft Finding of No Significant Impact (FONSI) on the Main Pass Energy Hub (MPEH) Deepwater Port Amended License Application. We are also announcing the dates and locations of public hearings for input regarding the approval or denial of the license application. The application and the amendment describe a project that would be located in the Gulf of Mexico in Main Pass Lease Block 299 (MP 299), approximately 16 miles southeast of Venice, Louisiana. Draft and final Environmental Impact Statements (EIS) evaluating the original application were published on June 17, 2005 and March 14, 2006, respectively. The Main Pass Energy Hub Deepwater Port License Application originally proposed the use of ``open-loop'' open rack vaporization (ORV). In the amended application, the applicant is proposing a ``closed-loop'' system using submerged combustion vaporization with selective catalytic reduction (SCV/SCR). Though similar, a more generic SCV/SCR system was analyzed in detail in the Final EIS (FEIS) as an alternative. The amended application provides expanded and refined design information regarding the proposed changes. The EA was prepared to provide analysis of the actual SCV/SCR design now being proposed and to determine if there were any significant impacts resulting from this change in proposed regassification technology in addition to or different from those previously assessed in the FEIS. The original application and environmental analysis contained in the FEIS still apply, including facilities, offshore and onshore pipelines, and salt cavern gas storage. Previous comments on the FEIS and application will continue to be considered in this process and need not be repeated. Based upon the EA, we have determined that the project changes as proposed in this amended application will not have a significant impact on the environment and we are therefore issuing a Draft Finding of No Significant Impact (FONSI) for public review and comment.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Proposed Collection; Comment Request
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Representative Fee Request. A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Stainless Steel Bar from India: Notice of Initiation of Antidumping Duty New Shipper Review
The Department of Commerce has received a request for a new shipper review of the antidumping duty order on stainless steel bar from India. In accordance with section 751(a)(2)(B) of the Tariff Act of 1930, as amended, and 19 CFR 351.214(d), we are initiating an antidumping new shipper review of Ambica Steels Limited.
Proposed Collection; Comment Request
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Pharmacy Billing Requirements. A copy of the proposed information collection request can be obtained by contacting the office listed below in the addressee section of this Notice.
Determination under the Textile and Apparel Commercial Availability Provision of the Dominican Republic-Central America-United States Free Trade Agreement (CAFTA-DR Agreement)
The Committee for the Implementation of Textile Agreements (CITA) has determined that certain 2-way stretch woven fabrics, as specified below, are not available in commercial quantities in a timely manner in the CAFTA-DR region. The product will be added to the list in Annex 3.25 of the CAFTA-DR in unrestricted quantities.
Proposed Information Collection; Comment Request; Economic Performance in the Commercial Stone Crab and Lobster Fisheries in Florida
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.
Culturally Significant Object Imported for Exhibition Determinations: “Lucio Fontana: Venice/New York”
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, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the object to be included in the exhibition ``Lucio Fontana: Venice/New York,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The object is imported pursuant to loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the Solomon R. Guggenheim Museum, New York, New York, from on or about October 10, 2006, until on or about January 21, 2007, and at possible additional venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.
National and Governmental Advisory Committees to the U.S. Representative to the Commission for Environmental Cooperation
Under the Federal Advisory Committee Act, Pub. L. 92463, EPA gives notice of a meeting of the National Advisory Committee (NAC) and Governmental Advisory Committee (GAC) to the U.S. Representative to the North American Commission for Environmental Cooperation (CEC). The National and Governmental Advisory Committees advise the EPA Administrator in his capacity as the U.S. Representative to the CEC Council. The Committees are authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC), North American Free Trade Agreement Implementation Act, Pub. L. 103-182, and as directed by Executive Order 12915, entitled ``Federal Implementation of the North American Agreement on Environmental Cooperation.'' The NAC is composed of 12 members representing academia, environmental non- governmental organizations, and private industry. The GAC consists of 12 members representing state, local, and tribal governments. The Committees are responsible for providing advice to the U.S. Representative on a wide range of strategic, scientific, technological, regulatory, and economic issues related to implementation and further elaboration of the NAAEC. The purpose of the meeting is to review the CEC's Draft Operational Plan and Budget. A copy of the agenda for the meeting will be posted at https://www.epa.gov/ocem/nacgac-page.htm.
Notice of Listing of Grants for Research Projects
Section 52.1(b) of the regulations governing grants for research projects, codified at 42 CFR part 52, authorizes the Secretary of Health and Human Services to publish periodically a list of all of the research project grant programs to which the research project grant regulations apply. This Notice provides the most recent list of the programs covered by the regulations and supersedes the prior Notice published on November 25, 2003 (68 FR 66114-66117).
The No FEAR Act Notice
The Surface Transportation Board (Board) gives notice of the ``Notification and Federal Employee Antidiscrimination Act of 2002,'' the No FEAR Act, to former and current STB employees and to applicants for STB employment.
Notice of Request for Renewal of a Previously Approved Collection
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), this notice announces the U.S. Department of Transportation's (DOT) intention to request extension of a previously approved information collection.
Notice To Extend Public Comment Period for Reopened Public Scoping Process for the Proposed Clark, Lincoln, and White Pine Counties Groundwater Development Project
Public comment period is being extended on the Proposed Clark, Lincoln, and White Pine Counties Groundwater Development Project. The comment period is being extended due to extensive public comment and a high level of public interest.
Notice of Request for Renewal of a Previously Approved Collection
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), this notice announces the U.S. Department of Transportation's (DOT) intention to request renewal of a previously approved information collection.
Renewal of Cultural Property Advisory Committee Charter
The Charter of the Department of State's Cultural Property Advisory Committee (CPAC) has been renewed for an additional two years. The Charter of the Cultural Property Advisory Committee is being renewed for a two-year period. The Committee was established by the Convention on Cultural Property Implementation Act of 1983, 19 U.S.C. 2601 et seq. It reviews requests from other countries seeking U.S. import restrictions on archaeological or ethnological material the pillage of which places a country's cultural heritage in jeopardy. The Committee makes findings and recommendations to the Secretary of State, who, on behalf of the President, determines whether to impose the import restrictions. The membership of the Committee consists of private sector experts in archaeology, anthropology, or ethnology; experts in the international sale of cultural property; and representatives of museums and of the general public.
National Energy Technology Laboratory; Notice of Intent To Grant Exclusive or Partially Exclusive Patent License
Notice is hereby given of intent to grant to Johnson Matthey Inc. of Malvern, PA, an exclusive or partially exclusive license to practice the invention described in the U.S. patent number 7,033,419, ``Method for High Temperature Mercury Capture from Gas Streams.'' The invention is owned by the United States of America, as represented by the Department of Energy (DOE). The proposed license will be exclusive or partially exclusive, subject to a license and other rights retained by the U.S. Government, and other terms and conditions to be negotiated.
Agency Information Collection
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995), intends to propose an information collection package with the Office of Management and Budget (OMB) concerning the Work Authorization System, as prescribed in DOE O 412. 1A, in order to authorize and control work performed by designated Management and Operating (M&O) contractors and other contractors as determined by the senior procurement executive, consistent with the budget execution and program evaluation requirements of the DOE Planning, Programming, Budget, and Evaluation process. Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Notice of Invitation for Coal Exploration License Application, Wyoming
Pursuant to section 2(b) of the Mineral Leasing Act of 1920, as amended by section 4 of the Federal Coal Leasing Amendments Act of 1976, 90 Stat. 1083, 30 U.S.C. 201(b), and to the regulations adopted as 43 Code of Federal Regulations (CFR) 3410, all interested qualified parties, as provided in 43 CFR 3472.1, are hereby invited to participate with Ark Land Company on a pro rata cost sharing basis in a program for the exploration of coal deposits owned by the United States of America in the following-described lands in Campbell County, Wyoming:
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