January 3, 2005 – Federal Register Recent Federal Regulation Documents
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Government-Owned Inventions; Availability for Licensing
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.
Submission for OMB review; comment request; California Health Interview Survey 2005
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on August 5, 2004, p. 47450 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: California Health Interview Survey 2005. Type of Information Collection Request: New. Need and Use of Information Collection. The NCI has sponsored two Cancer Control Modules to the California Health Interview Survey (CHIS), and will be sponsoring a third to be admitted in 2005. The CHIS is a telephone survey designed to provide population-based, standardized health- related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2005, the third bi-annual survey, is planned for administration to 55,000 adult Californians. The cancer control module, which is similar to that administered in CHIS 2001 and CHIS 2003, will allow NCI to examine trends in breast cancer screening and diagnosis, as well as to study other cancer-related topics, such as diet, physical activity and obesity. Because California is the most populous and the most racially and ethnically diverse state in the nation, the CHIS 2005 sample will yield adequate numbers of respondents in key ethnic and racial groups, including African Americans, Latinos, Asians, and American Indian/ Alaska Natives. The Latino group will include large numbers of Mexican- origin, Central Americans, South Americans, and other Latino subgroups; the Asian group will include large numbers of respondents in the Chinese, Filipino, Japanese, Vietnamese, and Korean subgroups. NCI will compare the CHIS and National Health Interview Survey (NHIS) data in order to conduct comparative analyses and better estimate cancer risk factors and screening among racial/ethnic minority populations. The CHIS sample size also permits NCI to create estimates for ethnic subdomains of the population, for which NHIS has insufficient numbers for analysis. Frequency of Response: One-time. Affected Public: Individuals. Type of Respondents: Adults (persons 18 years of age and older). The annual reporting burden is as follows:
Prospective Grant of an Exclusive License: “Vasostatin as Marrow Protectant” and “Use of Calreticulin and Calreticulin Fragments To Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor Growth”
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,596,690 B2 entitled ``Vasostatin as Marrow Protectant'' (DHHS Reference E-230-2000/0); U.S. Patent Application No. 09/807,148 filed April 5, 2001, entitled ``Use of Calreticulin and Calreticulin fragments to inhibit endothelial cell growth and angiogenesis and suppress tumor growth'' (DHHS Reference E- 082-1998/0-US-03); PCT Application No. PCT/US99/23240 filed October 5, 1999 entitled ``Use of Calreticulin and Calreticulin fragments to inhibit endothelial cell growth and angiogenesis and suppress tumor growth'' (DHHS Reference E-082-1998/0-PCT-02); to BioAccelerate, Inc., a venture capital group controlling the following twelve companies: Bioenvision, Enhance Biotech, Evolve Oncology, CNS Thera, Innova Lifestyle, Inncardio, Anvira, Neuro Bioscience, Biocardio, Oncbio, Innovative Oncology and Genar Oncology. 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 development and sale of a pharmaceutical product useful in protecting bone marrow stem cells from the toxic effects of chemotherapy and radiotherapy.
Government-Owned Inventions; Availability for Licensing
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.
Pipeline Safety: Random Drug Testing Rate
Each year pipeline operators randomly select employees to test for prohibited drugs. The number of selections may not be less than the minimum annual percentage rate the Research and Special Programs Administration's (RSPA) Office of Pipeline Safety (OPS) determines, either 50 percent or 25 percent of covered employees, based on the industry's positive rate of random tests. In accordance with applicable standards, RSPA/OPS has determined that the positive rate of random drug tests reported by operators this calendar year for testing done in calendar year 2003 is less than 1.0 percent. Therefore, in calendar year 2005, the minimum annual percentage rate for random drug testing is 25 percent of covered employees.
Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB Review
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register notice with a 60-day comment period was published on Monday, October 18, 2004, FR Doc. 04-23253.
Civil Monetary Penalties-Adjustments for Inflation; Correction
This document contains corrections to the final regulations published in the Federal Register on December 23, 2003. The regulations related to inflation adjustments in fines and other civil monetary penalties that are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended.
WTO Dispute Settlement Proceeding Regarding Section 776 of the Tariff Act of 1930 and Antidumping Duty Investigation on Stainless Steel Bar From the United Kingdom
The Office of the United States Trade Representative (``USTR'') is providing notice that the European Communities (``EC'') has requested dispute settlement consultations under the Marrakesh Agreement Establishing the World Trade Organization (``WTO Agreement'') regarding the U.S. antidumping duty (``AD'') investigation on stainless steel bar from the United Kingdom. That request may be found at https:// www.wto.org contained in a document designated as WT/DS319/1. USTR invites written comments from the public concerning the issues raised in this dispute.
WTO Dispute Settlement Proceeding Regarding the American JOBS Creation Act of 2004
The Office of the United States Trade Representative (``USTR'') is providing notice that the European Communities has requested dispute settlement consultations under the Marrakesh Agreement Establishing the World Trade Organization (``WTO Agreement''). That request may be found at https://www.wto.org contained in a document designated as WT/DS108/27. USTR invites written comments from the public concerning the issues raised in this dispute.
Statement of Policy Regarding Treasurers Subject to Enforcement Proceedings
The Commission is issuing a Policy Statement to clarify when, in the course of an enforcement proceeding (known as a Matter Under Review or ``MUR''), a treasurer is subject to Commission action in his or her official or personal capacity, or both. Under this policy, when the Commission investigates alleged violations of the Federal Election Campaign Act, as amended, the Presidential Election Campaign Fund Act, and the Presidential Primary Matching Payment Account Act (collectively ``the Act'' or ``FECA'') involving a political committee, the treasurer will typically be subject to Commission action only in his or her official capacity. However, when information indicates that a treasurer has knowingly and willfully violated a provision of the Act or regulations, or has recklessly failed to fulfill duties specifically imposed on treasurers by the Act, or has intentionally deprived himself or herself of the operative facts giving rise to the violation, the Commission will consider the treasurer to have acted in a personal capacity and make findings (and pursue conciliation) accordingly. This Policy Statement also addresses situations in which treasurers are subject to Commission action in both their official and personal capacities, and situations where successor treasurers are named. The goal in adopting this policy is to clarify when a treasurer is subject to Commission action in a personal or official capacity, while at the same time preserving the Commission's ability to obtain an appropriate remedy that will satisfactorily resolve enforcement matters, or to seek relief in court, if necessary, against a live person. Importantly, the policy is grounded in the statutory obligations specifically imposed on treasurers and well-established legal distinctions between official and personal capacity proceedings.
Airworthiness Directives; Boeing Model 747-200B, 747-200C, 747-200F, 747-300, and 747SR Series Airplanes Equipped with General Electric (GE) CF6-45 or -50 Series Engines
The FAA proposes to adopt a new airworthiness directive (AD) for certain Boeing Model 747-200B, 747-200C, 747-200F, 747-300, and 747SR series airplanes, equipped with GE CF6-45 or -50 series engines. This proposed AD would require modifying the side cowl assemblies on the engines by replacing existing wear plates with new extended wear plates and installing new stop fittings. This proposed AD is prompted by reports of a gap at the interface of the lower portion of the side cowl and the aft flange of the thrust reverser. We are proposing this AD to prevent an excessive quantity of air from entering the fire zone that surrounds the engine, which in the event of an engine fire, could result in an inability to control or extinguish the fire.
Airworthiness Directives; Boeing Model 767-200, -300, and -300F Series Airplanes
This document corrects an error that appeared in airworthiness directive (AD) 2004-22-25, which was published in the Federal Register on November 9, 2004 (69 FR 64839). The error resulted in the incorrect reference to cable spacers. This AD is applicable to certain Boeing Model 767-200, -300, and -300F series airplanes. This AD requires a one-time inspection for discrepancies of all wire bundles, including certain power feeder cables, of the electrical system in the forward cargo compartment ceiling at certain stations; and corrective actions if necessary.
Notice of Utah Resource Advisory Council and Grand Staircase-Escalante National Monument Advisory Committee Meetings
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Utah Resource Advisory Council (RAC) and the Grand Staircase-Escalante National Monument Advisory Committee (GSENMAC) will meet as indicated below.
Notice of Lincoln County Resource Advisory Committee Meeting
Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393) the Kootenai National Forest's Lincoln County Resource Advisory Committee will meet on Wednesday January 12, 2005 at 6 p.m. at the Supervisor's Office in Libby, Montana for a business meeting. The meeting is open to the public.
Tuolumne County Resource Advisory Committee
The Tuolumne County Resource Advisory Committee (RAC) will meet on January 24, 2005 at the City of Sonora Fire Department, in Sonora, California. The purpose of the meeting is to review the Five- Year Vegetation management Plan, considerations for the leveraging of funds, and environmental requirements for non-Forest Service projects.
Southwest Oregon Provincial Advisory Committee; Notice of Meeting
The Southwest Oregon Provincial Advisory Committee will meet on Tuesday, January 11th, 2005 to discuss topics including the Josephine County Fire Plan, Northern Spotted Owl Five Year Review, and fire plan working group report. The meeting will be held at the Josephine County Fairgrounds Art Building, 1451 Fairgrounds Road, Grants Pass, Oregon. It begins at 9 a.m., ends at 5 p.m.; the open public forum begins at 11:30 a.m. Written comments may be submitted prior to the meeting and delivered to Designated Federal Official, Scott Conroy at the Rogue River-Siskiyou National Forest, PO Box 520, Medford, OR 97501.
Establishing a Docket for the Development of Plasma Standards Public Workshop; Notice
The Food and Drug Administration (FDA) is announcing the opening of a docket to receive information and comments on the August 31 and September 1, 2004, public workshop entitled ``Development of Plasma Standards'' (the workshop). We are opening the docket to gather additional information from interested parties on the subjects of plasma collection, freezing, and storage, and for interested parties to provide comments on the presentations and discussions that took place during the workshop.
Guidance for Industry on Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees.'' The guidance describes the agency's current policy on what should be contained in separate marketing applications and what should be combined into one application for purposes of assessing user fees and a definition of ``clinical data'' for user fee purposes.
Airworthiness Directives; Saab Model SAAB SF340A and SAAB 340B Series Airplanes
This document corrects a typographical error that appeared in airworthiness directive (AD) 2004-24-06 that was published in the Federal Register on November 30, 2004 (69 FR 69505). The typographical error resulted in incorrect reference to certain main landing gear (MLG) part numbers as retract actuator bracket attachment bolt (RABAB) part numbers. This AD is applicable to certain Saab Model SAAB SF340A and SAAB 340B series airplanes. This AD requires replacement of the RABAB of the MLG with a new RABAB; reidentification of the MLG shock strut; an inspection for corrosion, fretting, or other damage of certain RABABs; and applicable corrective actions.
Migratory Birds Notice of Inquiry Proceeding
The document gives parties an opportunity to comment on a report that Avatar Environmental, LLC, prepared as part of the Federal Communications Commission's Migratory Birds Notice of Inquiry proceeding. Avatar's report is entitled Notice of Inquiry Comment Review Avian/Communication Tower Collisions, Final, Prepared for Federal Communications Commission. The public notice also sets forth the due dates for the filing of comments and reply comments.
Environmental Impact Statement: Municipality of Anchorage & Matanuska-Susitna Borough, AK
The FHWA is issuing this notice to advise the public that an environmental impact statement (EIS) will be prepared for a proposed bridge across Knik Arm between the Municipality of Anchorage (MOA) and the Matanuska-Susitna (MatSu) Borough in Alaska. Scoping meetings for the proposed Knik Arm Crossing project will be held in Anchorage and Wasilla, Alaska during the Winter/Spring of 2005.
Notice of Meeting of the Pinedale Anticline Working Group's Wildlife Task Group
In accordance with the Federal Land Policy and Management Act (1976) and the Federal Advisory Committee Act (1972), the U.S. Department of the Interior, Bureau of Land Management (BLM) Pinedale Anticline Working Group (PAWG) Wildlife Task Group (subcommittee) will meet in Pinedale, Wyoming, for a business meeting. Task Group meetings are open to the public.
Notice of Meeting of the Pinedale Anticline Working Group's Cultural and Historic Task Group
In accordance with the Federal Land Policy and Management Act (1976) and the Federal Advisory Committee Act (1972), the U.S. Department of the Interior, Bureau of Land Management (BLM) Pinedale Anticline Working Group (PAWG) Cultural and Historic Task Group (subcommittee) will meet in Pinedale, Wyoming, for a business meeting. Task Group meetings are open to the public.
Filing of Plats of Survey: Oregon/Washington
The plats of survey of the following described lands were officially filed in the Oregon State Office, Portland, Oregon, on October 13, 2004.
Airworthiness Directives; Bell Helicopter Textron Canada Model 222, 222B, 222U, 230, and 430 Helicopters
This amendment adopts a new airworthiness directive (AD) for the specified Bell Helicopter Textron (BHTC) model helicopters. This action requires certain checks and inspections of the tail rotor blades. If a crack is found, before further flight, this AD requires replacing the tail rotor blade (blade) with an airworthy blade. This amendment is prompted by three reports of cracked blades found during scheduled inspections. The actions specified in this AD are intended to detect a crack in the blade and prevent loss of a blade and subsequent loss of control of the helicopter.
Safety Zones: Fireworks Displays in the Captain of the Port Portland Zone
The Coast Guard is establishing a temporary safety zone on the waters of the Columbia River during a New Year's fireworks display. The Captain of the Port, Portland, Oregon, is taking this action to safeguard watercraft and their occupants from safety hazards associated with this display. Entry into this safety zone is prohibited unless authorized by the Captain of the Port.
Flavored Malt Beverage and Related Regulatory Amendments (2002R-044P)
The Department of the Treasury and its Alcohol and Tobacco Tax and Trade Bureau adopt as a final rule certain proposed changes to the regulations concerning the production, taxation, composition, labeling, and advertising of beer and malt beverages. This final rule permits the addition of flavors and other nonbeverage materials containing alcohol to beers and malt beverages, but, in general, limits the alcohol contribution from such flavors and other nonbeverage materials to not more than 49% of the alcohol content of the product. However, if a malt beverage contains more than 6% alcohol by volume, not more than 1.5% of the volume of the finished product may consist of alcohol derived from flavors and other nonbeverage ingredients that contain alcohol. This final rule also amends the regulations relating to the labeling and advertising of malt beverages, and adopts a formula requirement for beers. We issue this final rule to clarify the status of flavored malt beverages under the provisions of the Internal Revenue Code of 1986 and the Federal Alcohol Administration Act related to the production, composition, taxation, labeling, and advertising of alcohol beverages. This final rule also will ensure that consumers are adequately informed about the identity of flavored malt beverages.
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