2007 – Federal Register Recent Federal Regulation Documents

Results 3,201 - 3,250 of 31,104
Paperwork Reduction Act of 1995, as Amended by Public Law 104-13; Proposed Collection, Comment Request
Document Number: E7-22604
Type: Notice
Date: 2007-11-20
Agency: Tennessee Valley Authority, Agencies and Commissions
The proposed information collection described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). The Tennessee Valley Authority is soliciting public comments on this proposed collection as provided by 5 CFR 1320.8(d)(1). Requests for information, including copies of the information collection proposed and supporting documentation, should be directed to the Agency Clearance Officer: Alice D. Witt, Tennessee Valley Authority, 1101 Market Street (EB 5B), Chattanooga, Tennessee 37402- 2801; (423) 751-6832. (SC: 000YRFB). Comments should be sent to the Agency Clearance Officer no later than January 22, 2008.
Civilian Board of Contract Appeals; Information Collection; Civilian Board of Contract Appeals Rules of Procedure
Document Number: E7-22603
Type: Notice
Date: 2007-11-20
Agency: General Services Administration, Agencies and Commissions
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement regarding the Civilian Board of Contract Appeals (CBCA) Rules of Procedure. The clearance currently expires on January 31, 2008. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.
Federal Economic Statistics Advisory Committee; Notice of Open Meeting and Agenda
Document Number: E7-22585
Type: Notice
Date: 2007-11-20
Agency: Department of Labor, Bureau of Labor Statistics, Labor Statistics Bureau
Removal of Thresholds for the List I Chemicals Pseudoephedrine and Phenylpropanolamine
Document Number: E7-22560
Type: Proposed Rule
Date: 2007-11-20
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) is proposing to remove the thresholds for importation, exportation, and domestic distributions of the List I chemicals pseudoephedrine and phenylpropanolamine. This rulemaking is being conducted as part of DEA's implementation of the Combat Methamphetamine Epidemic Act of 2005 and is needed to implement the Act's requirements for import and production quotas and to address the potential diversion of these chemicals. DEA is also clarifying that all transactions of drug products containing ephedrine, pseudoephedrine, and phenylpropanolamine, except retail transactions, are considered to be regulated transactions.
Elimination of FERC Form No. 423
Document Number: E7-22550
Type: Proposed Rule
Date: 2007-11-20
Agency: Department of Energy, Federal Energy Regulatory Commission
In this Notice of Proposed Rulemaking, the Federal Energy Regulatory Commission (Commission) is proposing to amend its regulations to eliminate the FERC Form No. 423, Monthly Report of Cost and Quality of Fuels for Electric Plants. The Commission's infrequent use of the information no longer justifies the burden and cost of collecting it. Conversely, the Energy Information Administration has expressed a need for this information and, upon cessation of the Commission's collection, proposes to collect the information, as part of its newly proposed EIA-923.
Airworthiness Directives; Bell Helicopter Textron, Inc. Model 204B, 205A, 205A-1, 205B, 210, 212, 412, 412EP, and 412CF Helicopters
Document Number: E7-22439
Type: Rule
Date: 2007-11-20
Agency: Federal Aviation Administration, Department of Transportation
This document publishes in the Federal Register an amendment adopting Airworthiness Directive (AD) 2007-19-53, which was sent previously to all known U.S. owners and operators of the specified Bell Helicopter Textron, Inc. (BHTI) model helicopters by individual letters. This AD requires replacing each affected tail rotor blade (blade) with an airworthy blade with a serial number not listed in the applicability of this AD. This AD is prompted by three incidents in which blade tip weights were slung from the blades during flight causing significant vibration. The actions specified by this AD are intended to prevent loss of a blade tip weight, loss of a blade, and subsequent loss of control of the helicopter.
Airworthiness Directives; Bell Helicopter Textron Canada Limited Model 206A, 206B, 206L, 206L-1, 206L-3, 206L-4, 222, 222B, 222U, 230, 407, 427, and 430 Helicopters
Document Number: E7-22416
Type: Rule
Date: 2007-11-20
Agency: Federal Aviation Administration, Department of Transportation
This document publishes in the Federal Register an amendment adopting Airworthiness Directive (AD) 2007-19-52, which was sent previously to all known U.S. owners and operators of the specified Bell Helicopter Textron Canada Limited (BHTC) model helicopters by individual letters. This AD requires replacing each affected tail rotor blade (blade) with an airworthy blade with a serial number not listed in the Rotor Blades, Inc. (RBI), attachment to the BHTC Alert Service Bulletin (ASB), listed in the applicability section of this AD. This amendment is prompted by three incidents in which blade tip weights were slung from blades during flight causing significant vibration. The actions specified are intended to prevent loss of a blade tip weight, loss of a blade, and subsequent loss of control of the helicopter.
Airworthiness Directives; Cessna Aircraft Company, Model 525B Airplanes
Document Number: E7-22304
Type: Rule
Date: 2007-11-20
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Cessna Aircraft Company (Cessna) Model 525B airplanes. This AD requires you to incorporate electrical power relay circuit protection kit part number (P/N) SB525B-24-02. This AD results from both the need to protect aircraft wiring left unprotected in the original design and a report of a Model 525B airplane experiencing in-flight loss of numerous systems, tripped circuit breakers, and burned wiring adjacent to the power distribution panel. We are issuing this AD to correct an incorrect wiring installation and to provide short-circuit protection for all wiring from the aircraft power distribution system. This condition could result in burned wiring and loss of various aircraft electrical systems.
Airworthiness Directives; Diamond Aircraft Industries Model DA 42 Airplanes
Document Number: E7-22177
Type: Rule
Date: 2007-11-20
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Airworthiness Directives; Aeromot-Industria Mecanico Metalurgica Ltda. Model AMT-100/200/200S/300 Gliders
Document Number: E7-22176
Type: Rule
Date: 2007-11-20
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
National Farm-City Week, 2007
Document Number: 07-5792
Type: Proclamation
Date: 2007-11-20
Agency: Executive Office of the President, Presidential Documents
Sunshine Federal Register Notice
Document Number: 07-5772
Type: Notice
Date: 2007-11-20
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Senior Executive Service Performance Review Board; Update
Document Number: 07-5771
Type: Notice
Date: 2007-11-20
Agency: Agency for International Development, Agencies and Commissions
This notice is hereby given of the appointment of members of the updated USAID OIG SES Performance Review Board.
Oversales and Denied Boarding Compensation
Document Number: 07-5761
Type: Proposed Rule
Date: 2007-11-20
Agency: Office of the Secretary, Department of Transportation
The Department of Transportation (DOT or Department) is proposing to amend its rules relating to oversales and denied boarding compensation to increase the limits on the compensation paid to ``bumped'' passengers, to cover flights by certain U.S. and foreign air carriers operated with aircraft seating 30 to 60 passengers, which are currently exempt from the rule, and to make other changes. Such changes in the rule, if adopted, would be intended to maintain consumer protection commensurate with developments in the aviation industry.
Enhancing Airline Passenger Protections
Document Number: 07-5760
Type: Proposed Rule
Date: 2007-11-20
Agency: Office of the Secretary, Department of Transportation
The Department of Transportation (DOT or Department) is seeking comment on whether it should adopt a rule to enhance airline passenger protections in the following seven ways: require carriers to adopt contingency plans for lengthy tarmac delays and incorporate them in their contracts of carriage, require carriers to respond to consumer problems, deem operating a chronically delayed flight to be unfair and deceptive, require carriers to publish delay data, require carriers to publish complaint data, require on-time performance reporting for international flights, and require carriers to audit their compliance with their customer service plans. We are proposing that most of these measures cover certificated or commuter air carriers that operate domestic scheduled passenger service using any aircraft with more than 30 passenger seats. We are proposing that one measure cover the largest U.S. and foreign carriers and that two other measures cover the largest U.S. carriers.
Revision of Airline Service Quality Performance Reports and Disclosure Requirements
Document Number: 07-5759
Type: Proposed Rule
Date: 2007-11-20
Agency: Office of the Secretary, Department of Transportation
The U.S. Department of Transportation (DOT) is proposing to collect additional data elements when flights are cancelled, diverted, or experience gate returns. The additional proposed data elements would fill in data gaps giving the Department, the industry, and the public a more accurate portrayal of on-ground delays after flights depart the gate but prior to the time they take off and after flights land but before they reach the gate.
36(b)(1) Arms Sales Notification
Document Number: 07-5757
Type: Notice
Date: 2007-11-20
Agency: Office of the Secretary, Department of Defense
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
36(b)(1) Arms Sales Notification
Document Number: 07-5756
Type: Notice
Date: 2007-11-20
Agency: Office of the Secretary, Department of Defense
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Meeting of the Defense Policy Board Advisory Committee
Document Number: 07-5755
Type: Notice
Date: 2007-11-20
Agency: Office of the Secretary, Department of Defense
The Defense Policy Board Advisory Committee will meet in closed session on December 11, 2007 from 0800 hrs until 2030 and December 12, 2007 from 0730 hrs until 1430 at the Pentagon. The purpose of the meeting is to provide the Secretary of Defense, Deputy Secretary of Defense and Under Secretary of Defense for Policy with independent, informed advice on major matters of defense policy. The Board will hold classified discussions on national security matters. In accordance with Section 10(d) of the Federal Advisory Committee Act, Public Law No. 92-463, as amended [5 U.S.C. 552B(c)(1)(1982)], and that accordingly this meeting will be closed to the public.
Umatilla National Forest, Grant County, OR Farley Analysis Area Vegetation Management Project
Document Number: 07-5754
Type: Notice
Date: 2007-11-20
Agency: Department of Agriculture, Forest Service
The U.S. Department of AgricultureForest Service proposes to conduct vegetation management activities on approximately 17,500 acres of upland forest sites in the Farley Analysis Area to restore sustainable forest conditions in the Desolation Creek watershed. The proposed action will use a range of mechanical harvest and non-harvest thinning and prescribed fire activities to alter species composition, stand structure, and fire regime condition class to re-create conditions that are consistent with the historic range of variability for forests of the Blue Mountains of northeastern Oregon, and to capture the commercial value of forest raw materials for the benefit of local economies. The Farley Analysis Area encompasses the Desolation Creek watershed which covers 69,672 acres of diverse mountainous, mostly forested landscapes ranging in elevation from 7,765 ft at its headwaters to 2810 ft at its confluence with the North Fork John Day River near Dale, Oregon. It includes both National Forest and privately-owned lands; private lands comprise about 18 percent of the total area, mostly at lower elevations at the western end of the watershed. Development and implementation of these actions will be conducted in accordance with the National Forest Management Act, National Environmental Policy Act, Council on Environmental Quality regulations, Clean Water Act, Clean Air Act, Endangered Species Act, and with the Umatilla National Forest Land and Resource Management Plan and scientific recommendations of the Interior Columbia Basin Ecosystem Management Project.
Notice of New Fee Site; Federal Lands Recreation Enhancement Act, (Title VIII, Pub. L. 108-447)
Document Number: 07-5753
Type: Notice
Date: 2007-11-20
Agency: Department of Agriculture, Forest Service
The Coronado National Forest proposes to begin charging a new $150.00 per day fee for rental of the Rockfellow House located 10 miles west of Sunsites, Arizona. Rental of the Cabin includes overnight use. Rental of the cabin and other facilities within the Arizona National Forests has shown that the public appreciates and enjoys the availability of historic rental facilities. Funds from the rentals will be used for the continued operation and maintenance of the Rockfellow House.
Agency Information Collection Activities: Submitted for Office of Management and Budget (OMB) Review; Comment Request
Document Number: 07-5746
Type: Notice
Date: 2007-11-20
Agency: Geological Survey, Department of the Interior
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements for ``Consolidated consumers' Report (Form 9-4117-MA).'' This notice also provides the public a second opportunity to comment on the paperwork burden of this form.
Appendix to Chemical Facility Anti-Terrorism Standards
Document Number: 07-5585
Type: Rule
Date: 2007-11-20
Agency: Department of Homeland Security
This final rule revises the list of chemicals of interest, or COI, which the Department of Homeland Security (DHS or the Department) included as Appendix A to the Chemical Facility Anti-Terrorism Standards Interim Final Rule. Appendix A lists chemicals of interest and screening threshold quantities, or STQs. Any facility that possesses (or later comes into possession of) the listed chemicals in quantities that meet or exceed the STQ for any applicable security issue must complete and submit a Top-Screen. This will assist the Department in determining whether a facility presents a high level of security risk. In this final rule, DHS, among other things: (i) Adjusts the STQs for certain COI; (ii) defines the specific security issue or issues implicated by each chemical of interest, and in some cases, establishes different STQs for COI based upon the security issue presented; and (iii) adds provisions that instruct facilities on how to calculate the quantities of COI that they have in their possession. These refinements to Appendix A will assist the Department in more precisely identifying facilities that may be designated as high risk, while reducing the burden on facilities that possess chemicals in smaller amounts.
Reader Aids
Document Number: FR-2007-11-19-ReaderAids
Type: Reader Aids
Date: 2007-11-19
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-22637
Type: Notice
Date: 2007-11-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Certain Chemical Substances; Withdrawal of Significant New Use Rules
Document Number: E7-22614
Type: Rule
Date: 2007-11-19
Agency: Environmental Protection Agency
EPA is withdrawing two significant new use rules (SNURs) promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for substances which were the subject of premanufacture notices (PMNs), i.e., dodecandioic acid, 1, 12-dihydrazide (CAS No. 4080-98-2; PMNs P-01-759 and P-05-555) and thiophene, 2,5-dibromo-3-hexyl- (CAS No. 116971-11-0; PMN P-07-283). EPA published the SNURs using direct final rulemaking procedures. EPA received notices of intent to submit adverse comments on these rules. Therefore, the Agency is withdrawing these SNURs, as required under the expedited SNUR rulemaking process. EPA also intends to publish in the Federal Register, under separate notice and comment rulemaking procedures, proposed SNURs for these two substances.
Notice of Extension of Information Collection for Public Comment; Consolidated Plan and Annual Performance Report
Document Number: E7-22610
Type: Notice
Date: 2007-11-19
Agency: Department of Housing and Urban Development
The proposed extension of information collection requirements for Consolidated Planning for Community Planning and Development (CPD) programs described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Radio Broadcasting Services; AM or FM Proposals To Change the Community of License
Document Number: E7-22602
Type: Notice
Date: 2007-11-19
Agency: Federal Communications Commission, Agencies and Commissions
The following applicants filed AM or FM proposals to change the community of license: ATLANTIC COAST RADIO, LLC, Station WLOB-FM, Facility ID 9180, BPH-20070924AGC, To GRAY, ME, From RUMFORD, ME; CHRISTYAHNA BROADCASTING, INC., Station NEW, Facility ID 160820, BNP- 20070926AMO, To SANTEE, CA, From LEMON GROVE, CA; COLLEGE CREEK MEDIA, LLC, Station KYEN, Facility ID 164151, BMPH-20071010ACF, To SEVERENCE, CO, From CHEYENNE, WY; MITCHELL COMMUNITY BROADCASTING CO., Station WPHZ, Facility ID 43248, BPH-20070831ACV, To ORLEANS, IN, From MITCHELL, IN; SHOECRAFT BROADCASTING, INC., Station KIKO, Facility ID 72477, BP-20071002ADQ, To QUEEN CREEK, AZ, From MIAMI, AZ; THE LAST BASTION STATION TRUST, LLC, AS TRUSTEE, Station WCLZ, Facility ID 56569, BPH-20070917ABH, To NORTH YARMOUTH, ME, From BRUNSWICK, ME; TICHENOR LICENSE CORPORATION, Station KPTY, Facility ID 57806, BPH- 20070914ACP, To DEER PARK, TX, From MISSOURI CITY, TX; UNIVISION RADIO HOUSTON LICENSE CORPORATION, Station KLTN, Facility ID 65310, BPH- 20070914ACQ, To MISSOURI CITY, TX, From HOUSTON, TX.
Submission for OMB Review; Comment Request
Document Number: E7-22601
Type: Notice
Date: 2007-11-19
Agency: Department of the Treasury, Department of Treasury
Submission for OMB Review; Comment Request
Document Number: E7-22600
Type: Notice
Date: 2007-11-19
Agency: Department of the Treasury, Department of Treasury
Board of Scientific Counselors, National Center for Environmental Research (NCER) Standing Subcommittee Meeting-2007
Document Number: E7-22598
Type: Notice
Date: 2007-11-19
Agency: Environmental Protection Agency
Pursuant to the Federal Advisory Committee Act, Public Law 92- 463, the Environmental Protection Agency, Office of Research and Development (ORD), gives notice of a meeting of the Board of Scientific Counselors (BOSC) National Center for Environmental Research (NCER) Standing Subcommittee.
National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Pilot Study for the National Children's Study
Document Number: E7-22597
Type: Notice
Date: 2007-11-19
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Pilot Study for the National Children's Study, Type of Information Collection Request: NEW, Affected entities: Households and individuals. Types of respondents: People potentially affected by this action are pregnant women, women age 18-49 years of age, their husbands or partners, and their children who live in selected areas within the seven (7) National Children's Study Vanguard sites enumerated below. A small number of health care professionals, community leaders, and child care personnel are also potential respondents. Frequency of Response: On occasion. See burden table for estimated number of annual responses for each respondent. Need and use of information collection: The purpose of this Study is to pilot test protocols, policies, and procedures for the National Children's Study (NCS) with the goal of improving the efficiency of study procedures and enhancing the subsequent implementation of the NCS. The NCS is a long- term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. The Act specifies a broad definition of environment, including biologic, chemical, physical, and psycho-social factors and authorizes NICHD to plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of those exposures on child health and human development. This data collection will test procedures for population-based sampling and recruitment of pregnant women and women of child-bearing age, test study logistics, and estimates of subject burden, and evaluate data collection strategies including interviews and acquisition of biologic and environmental samples. In addition, participants will also be asked to provide qualitative and quantitative input on their feelings regarding participation in this Study, to enhance the lessons that can be learned and applied to improve the efficiency of the full NCS. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: https://nationalchildrensstudy.gov. This Pilot Study will be carried out in the seven NCS ``Vanguard'' locations previously selected as the initial study sites. These sites are Orange County, CA; Duplin County, NC; Queens County, NY; Montgomery County, PA; Salt Lake County, UT; Waukesha County, WI; and the aggregate of Lincoln, Pipestone, and Yellow Medicine Counties, MN and Brookings County, SD. This data collection is intended to begin with household enumeration and enrollment of women, proceed through pregnancy and birth, and continue with follow-up of children for up to 21 years. This application is for the first three years of data collection, which includes data collection through the visits at which some of the children will be 24 months old. Details of data collections beyond this period will be addressed at the time of renewal or in future applications. Women who are pregnant will be eligible for participation if, at the time of household enumeration and screening, they are within the first trimester of pregnancy. Women who are not pregnant will be eligible if, at the time of household enumeration and screening, they are 18-49 years of age, are neither surgically nor medically sterile, and can participate in the consent process. A subset of age-eligible women with a high likelihood of pregnancy (e.g., planning to become pregnant) will be enrolled to enable assessment of peri-conceptional exposures, should they become pregnant. The remainder of the study population will comprise women enrolled early in pregnancy. The seven centers combined will follow approximately 1000 infants born to women enrolled in the first year of this Pilot Study. Infants born to women enrolled in this Pilot Study but born after the eligibility period for the Pilot will be eligible for enrollment in the full NCS. The schedule of participant contacts for this data collection includes home visits, clinic visits, and phone contacts, and is described in the NCS Research Plan: https://nationalchildrensstudy.gov. Home visits before and during pregnancy will include collection of interview data, environmental specimens such as air and dust samples, maternal and paternal biospecimens such as blood and hair samples, and a brief physical examination including anthropometric measures and blood pressure. During pregnancy, women will receive up to three fetal ultrasounds to assess fetal growth. At birth, cord blood and placental samples will be collected and the infant will receive a brief developmental assessment. During infancy, home visits will include collection of interview data, environmental specimens, biospecimens from the infant and parents, a brief physical examination of the infant, and assessment of infant development and parental-infant interactions. Burden statement: The public burden for this Study will vary depending on the eligibility and pregnancy status of potential participants at the time of household screening. Women who are not pregnant at the time of screening will have varying burden depending on their likelihood of pregnancy and, should they become pregnant, the time to pregnancy. The burden for women enrolled during pregnancy will depend on when during pregnancy they are identified and enrolled in the Study. The table provides an annualized average burden per person for each stage of the Pilot Study over the three year period of the Study.
Prospective Grant of Exclusive License: Use of Anti-TAG72 Monoclonal Antibodies as a Tumor-Specific Imaging Agent and Drug Delivery Therapeutic
Document Number: E7-22595
Type: Notice
Date: 2007-11-19
Agency: Department of Health and Human Services, National Institutes of Health
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 patent license to practice the inventions embodied in the following patents or patent applications U.S. Provisional Patent Application Nos. 60/106,534 and 60/106,757 filed October 31, 1998 and November 2, 1998; U.S. Patent No. 6,818,749 issued November 16, 2004; and U.S. Patent Application 10/927,433 filed August 25, 2004 as well as issued and pending foreign counterparts [HHS Ref. No. E-259-1998/0, /1, and /2]; U.S. Provisional Patent Application No. 60/498,903 filed August 29, 2003 and U.S. Patent Application No. 10/570,220 filed February 28, 2006 as well as issued and pending foreign counterparts [HHS Ref. No. E-323-2003/0]; U.S. Patent Application Nos. 07/510,697 filed July 17, 1990; 07/964,536 filed October 20, 1992; 08/261,354 filed June 16, 1994 and issued as U.S. Patent No. 5,976,531 on November 2, 1999; 08/487,743 filed June 7, 1995; 08/961,309 filed June 30, 1997 and issued as U.S. Patent No. 6,495,137 on December 17, 2002; and 10/ 255,478 filed September 25, 2002 and issued as U.S. Patent No. 7,179,899 on February 20, 2007 as well as issued and pending foreign counterparts [HHS Ref. E-347-2003/0, /1, /2, and /3]; U.S. Patent Application Nos. 07/259,943 filed October 19, 1988; 07/261,942 filed January 28, 1988; 07/424,362 filed October 19, 1989; 08/017,570 filed February 16 and issued as U.S. Patent No. 5,472,693 on December 5, 1995, 1993; 08/040,687 filed March 31, 1993 and issued as U.S. Patent No. 6,051,225 on April 18, 2000; 08/822,028 filed March 24, 1997 and issued as U.S. Patent No. 5,993,813 on November 30, 1999; 08/479,285 filed June 7, 1997 and issued as U.S. Patent No. 6,207,815 on March 27, 2001; 08/823,105 filed March 24, 1997; and 09/503,653 filed February 14, 2000 and issued as U.S. Patent No. 6,641,999 on November 4, 2003 as well as issued and pending foreign counterparts [HHS Ref. D-003-1992/0, /1, /2, /3, and /4]; U.S. Patent Application Nos. 07/259,943 filed December 11, 1992; 08/263,911 filed June 21, 1994 and issued as U.S. Patent No. 5,877,291 on March 2, 1999; 08/263,911 filed June 21, 1994; 08/481,006 filed June 6, 1995 and issued as U.S. Patent No. 5,892,020 on April 6, 1999 as well as issued and pending foreign counterparts [HHS Ref. D-004-1992/0 and /1]; U.S. Provisional Patent Application No. 60/030,173; U.S. Patent Application Nos. 09/025,203 filed February 18, 1998 and issued as U.S. Patent No. 6,348,581 on February 19, 2002; 09/998,817 filed October 31, 2001 and issued as U.S. Patent No. 6,753,420 on June 22, 2004; 09/999,021 October 31, 2001 and issued as U.S. Patent No. 6,737,060 on May 18, 2004; 09/999,025 filed October 31, 2001 and issued as U.S. Patent No. 6,737,061 on May 18, 2004; 09/999,040 filed October 31, 2001 and issued as U.S. Patent No. 6,753,152 issued June 22, 2004; 10/040,997 filed October 31, 2001 and issued as U.S. Patent No. 6,752,990 on June 22, 2004 as well as issued and pending foreign counterparts [HHS Ref. D- 001-1996/0 and /1] to Enlyton, Ltd., which is located in Columbus, Ohio. 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 use of Anti-TAG72 monoclonal antibodies with (i) Licensee's proprietary fluorescence-based, tumor- specific imaging agent for use in tumor localization and visualization; (ii) Licensee's proprietary tumor-specific imaging agent for use in positron emission tomography (``PET'') for tumor localization and visualization; and (iii) Licensee's proprietary tumor-specific agent coupled with a proprietary compound for therapeutic use in targeted drug therapy. For the avoidance of doubt, gamma emitting isotopes are specially excluded from the field of use.
National Institute of Environmental Health Sciences; Division of Extramural Research and Training; Submission for OMB Review; Comment Request; Program Assessment and Evaluations for NIEHS-Asthma Research
Document Number: E7-22594
Type: Notice
Date: 2007-11-19
Agency: Department of Health and Human Services, National Institutes of Health
Under the provision of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 9, 2007, page 26399 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: Program Assessment and Evaluations for NIEHSAsthma Research. Type of Information Collection Request: NEW. New and Use of Information Collection: National Institute of Environmental Health Sciences, Division of Extramural Research and Training (DERT). DERT, with contract support from Battelle Centers for Public Health Research and Evaluation, is examining the impact of its research portfolio. Focusing specifically on one portion of the research portfolioasthma researchDERT proposes to supplement extant data sources with a primary data collection activity. The purpose of the proposed primary data collection is to obtain information from grantees regarding the impact of their funded asthma research in the short-, intermediate-, and long-term. This will be done through a survey of grantees that includes questions about the impact of funding on career development, the field of asthma research, public attitudes, commercial product development, clinical practice, business and industry practices, and long-term human and environmental health. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: Individuals receiving asthma funding. A 15-minute, close- ended, multi-mode (web and paper) survey will be administered to the universe of NIEHS-funded asthma researchers (N=179) and comparison agency asthma researchers (N=1371). Comparison agencies include other NIH institutes (NICHD, NIAID, NIA, NHLBI), the CDC, AHRQ, and the EPA. The survey development process included formative interviews with a small sample of NIEHS asthma researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1550; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 15 minutes; and Estimated Total Annual Burden Hours Requested: 387.5. The annualized cost to respondents is estimated at $13,039.38. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Proposed Agency Information Collection Activities; Comment Request
Document Number: E7-22593
Type: Notice
Date: 2007-11-19
Agency: Federal Railroad Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking approval of the following information collection activities. Before submitting these information collection requirements for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.
National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Formative Research and Pilot Studies for the National Children's Study
Document Number: E7-22592
Type: Notice
Date: 2007-11-19
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Formative Research and Pilot Studies for the National Children's Study. Type of Information Collection Request: NEW. Need and use of information collection: The NICHD seeks to obtain OMB's generic approval to conduct pilot and formative research to be used in the development of instruments, materials, and procedures for the National Children's Study (NCS). The NCS is a long- term cohort study of environmental influences on child health and development authorized under the Children's Health Act of 2000. The Act specifies a broad definition of environment, including biologic, chemical, physical, and psycho-social factors and authorizes the NICHD to plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of those exposures on child health and human development. Further details pertaining to the NCS background and planning, including the NCS Research Plan, can be found at: https://nationalchildrensstudy.gov. The proposed data collection program will include community outreach materials, medical provider and participant materials, questionnaires and measures, use of technology such as Interactive Voice Recognition (IVR), and other aspects related to data collection. Activities will include small focused studies to test data collection items and methods on a specific or targeted population, validation of questionnaires for targeted populations, focus groups within the NCS communities to test forms and procedures, cognitive interviews to test data items, and the use of materials on targeted populations such as medical providers and hospitals, and materials translated into other languages. These activities will be conducted over the life of the study to develop procedures and materials for each stage of data collection. The results of these pilot tests will be used to maximize the efficiency of study procedures, materials, and methods for community outreach, engagement of the medical community, for recruiting and retaining study subjects prospectively across study visits and to ensure that data collection methodologies are efficient and valid for all potential participants. Without this information, NCS will be hampered in its efforts to effectively publicize the NCS, gain public and professional support, and effectively recruit and retain respondents and collect data over the life of the Study. Affected entities: Individuals. Types of respondents: People potentially affected by this action are pregnant women or women of childbearing age, their husbands or partners, health care professionals, and community leaders. The annual reporting burden is as follows: Estimated Number of Respondents: 3,150. Frequency of Response: On occasion (see Burden table). The Estimated Number of Responses per Respondent: 1. Average Burden Hours Per Response: Varies with study type. Estimated Total Annual Burden Hours Requested: 5,825. The estimated annualized cost to respondents is $114,250 (based on rates listed in the burden table). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Use of Government Sources by Contractors (OMB Control Number 0704-0252)
Document Number: E7-22591
Type: Notice
Date: 2007-11-19
Agency: Defense Acquisition Regulations System, Department of Defense
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; (b) the accuracy of the estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through February 29, 2008. DoD proposes that OMB extend its approval for use for three additional years.
Adequacy Status of the Vancouver, WA, Carbon Monoxide, Second 10-year Limited Maintenance Plan (2006-2016)
Document Number: E7-22589
Type: Notice
Date: 2007-11-19
Agency: Environmental Protection Agency
In this notice, EPA is notifying the public that we have found the Vancouver, Washington, carbon monoxide, second 10-year limited maintenance plan (2006-2016) adequate for transportation conformity purposes. On March 2, 1999, the DC Circuit Court ruled that submitted State Implementation Plans (SIPs) cannot be used for conformity determinations until EPA has found them adequate. As a result of this adequacy finding, the area automatically meets the budget test for future transportation conformity. This affects future transportation conformity determinations prepared, reviewed and approved by the Southwest Washington Regional Transportation Council, Washington State Department of Transportation, Federal Highway Administration and the Federal Transit Administration.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Registration of Cosmetic Product Establishments
Document Number: E7-22588
Type: Notice
Date: 2007-11-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
Document Number: E7-22587
Type: Notice
Date: 2007-11-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act
Document Number: E7-22586
Type: Notice
Date: 2007-11-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Transportation Worker Identification Credential (TWIC); Enrollment Date for the Port of Lake Charles, LA
Document Number: E7-22584
Type: Notice
Date: 2007-11-19
Agency: Department of Homeland Security, Transportation Security Administration
The Department of Homeland Security (DHS) through the Transportation Security Administration (TSA) issues this notice of the dates for the beginning of the initial enrollment for the Transportation Worker Identification Credential (TWIC) for the Port of Lake Charles, LA.
Request for Comments Concerning Compliance With Telecommunications Trade Agreements
Document Number: E7-22583
Type: Notice
Date: 2007-11-19
Agency: Office of the United States Trade Representative, Trade Representative, Office of United States, Executive Office of the President
Pursuant to section 1377 of the Omnibus Trade and Competitiveness Act of 1988 (19 U.S.C. 3106) (``section 1377''), the Office of the United States Trade Representative (``USTR'') is reviewing and requests comments on: The operation, effectiveness, and implementation of and compliance with the following agreements regarding telecommunications products and services of the United States: the World Trade Organization (``WTO'') Agreement; the North American Free Trade Agreement (``NAFTA''); U.S. free trade agreements (``FTAs'') with Australia, Bahrain, Chile, Morocco, and Singapore; the Dominican RepublicCentral AmericaUnited States Free Trade Agreement (``CAFTA-DR''); and any other FTA or telecommunications trade agreement coming into force on or before January 1, 2008. The USTR will conclude the review by March 31, 2008.
Agency Forms Submitted for OMB Review, Request for Comments
Document Number: E7-22582
Type: Notice
Date: 2007-11-19
Agency: Railroad Retirement Board, Agencies and Commissions
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request a revision to a currently approved collection of information: 3220-0151, Representative Payee Monitoring consisting of Form(s) G-99a, Representative Payee Report and G-99c, Representative Payee Evaluation Report. Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collection of information to determine (1) The practical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if RRB and OIRA receive them within 30 days of publication date. Under Section 12 of the Railroad Retirement Act (RRA), the RRB may pay annuity benefits to a representative payee when an employee, spouse or survivor annuitant is incompetent or a minor. The RRB is responsible for determining if direct payment to an annuitant or a representative payee would best serve the annuitant's best interest. The accountability requirements authorizing the RRB to conduct periodic monitoring of representative payees, including a written accounting of benefit payments received, are prescribed in 20 CFR 266.7. The RRB utilizes the following forms to conduct its representative payee monitoring program. Form G-99a, Representative Payee Report, is used to obtain information needed to determine whether the benefit payments certified to the representative payee have been used for the annuitant's current maintenance and personal needs and whether the representative payee continues to be concerned with the annuitant's welfare. RRB Form G-99c, Representative Payee Evaluation Report, is used to obtain more detailed information from a representative payee who fails to complete and return Form G-99a, or in situations when the returned Form G-99a indicates the possible misuse of funds by the representative payee. Form G-99c contains specific questions concerning the representative payee's performance and is used by the RRB to determine whether or not the representative payee should continue in that capacity. Completion of the forms in this collection is required to retain benefits. Previous Requests for Comments: The RRB has already published the initial 60-day notice (72 FR 48696 on August 24, 2007) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
Notice of Final Federal Agency Actions on Proposed Highway in California
Document Number: E7-22580
Type: Notice
Date: 2007-11-19
Agency: Federal Highway Administration, Department of Transportation
This notice announces actions taken by the California Department of Transportation (Caltrans) pursuant to its assigned responsibilities under 23 U.S.C. 327 that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, State Route 91 from post miles 15.6-21.6 in Riverside County, California. Those actions grant licenses, permits, and approvals for the project.
Proposed Collection; Comment Request for Notice 2005-04
Document Number: E7-22579
Type: Notice
Date: 2007-11-19
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
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 Notice 2005-04, Fuel Tax Guidance, and Request for comments.
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