Notices. Notice for Comments SUMMARY: GSA is proposing a change to the Centralized Household Goods Traffic Management Program (CHAMP) and the Household Goods Standard Tender of Service (HTOS) to implement a mileage based Fuel Cost Price Adjustment on the shipment of household goods effective May 1, 2007

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6725-01-P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the **Federal Register** . Copies of agreements are available through the Commission's Office of Agreements (202-523-5793 or *tradeanalysis@fmc.gov* ). *Agreement No.:* 010099-046. *Title:* International Council of Containership Operators. *Parties:* A.P.

Moller-Maersk A/S; ANL Container Line Pty Ltd.; American President Lines, Ltd.; APL Co. Pte. Ltd.; APL Limited; Atlantic Container Line AB; China Shipping Container Lines Co., Ltd.; CMA CGM, S.A.; Companhia Libra de Navegacao; COSCO Container Lines Company Limited; Crowley Maritime Corporation; Delmas SAS; Evergreen Marine Corporation (Taiwan), Ltd.; Hamburg-Süd KG; Hanjin Shipping Co., Ltd.; Hapag-Lloyd AG; Hapag-Lloyd USA LLC; Hyundai Merchant Marine Co., Ltd.; Kawasaki Kisen Kaisha, Ltd.;

Malaysia International Shipping Corporation Berhad; Mediterranean Shipping Company S.A.; Mitsui O.S.K. Lines, Ltd.; Montemar Maritima S.A.; Neptune Orient Lines, Ltd.; Nippon Yusen Kaisha; Norasia Container Line Limited; Orient Overseas Container Line, Limited; Pacific International Lines

(Pte)Ltd.; Safmarine Container Line N.V.; United Arab Shipping Company (S.A.G.); Wan Hai Lines Ltd.; Yang Ming Transport Marine Corp.; and Zim Integrated Shipping Services Ltd. *Filing Party:* John Longstreth, Esq.; Preston Gates Ellis & Rouvelas Meeds LLP; 1735 New York Avenue; Suite 500; Washington, DC 20006-5209. *Synopsis:* The amendment changes CP Ships USA LLC's corporate name to Hapag-Lloyd USA LLC. *Agreement No.:* 011547-022. *Title:* Eastern Mediterranean Discussion Agreement. *Parties:* COSCO Container Lines Co. Ltd.; China Shipping Container Lines Co., Ltd.; and Zim Integrated Shipping Services, Ltd. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. *Synopsis:* The amendment removes Turkon Container Transportation and Shipping, Inc. as a party to the agreement. *Agreement No.:* 011984. *Title:* CSAV/NYK Venezuela Space Charter Agreement. *Parties:* Compania Sud Americana de Vapores S.A. and Nippon Yusen Kaisha. *Filing Party:* Marc J. Fink, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. *Synopsis:* The agreement authorizes CSAV to charter space to NYK for the carriage of motor vehicles on car carriers from Baltimore to ports in Venezuela through January 10, 2007. By order of the Federal Maritime Commission. Dated: December 15, 2006. Karen V. Gregory, Assistant Secretary. [FR Doc. E6-21757 Filed 12-19-06; 8:45 am] BILLING CODE 6730-01-P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Applicants Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as a Non-Vessel—Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. Chapter 409 and 46 CFR part 515). Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573. Non-Vessel—Operating Common Carrier Ocean Transportation Intermediary Applicants: Platinum Moving Services, LLC, 2 Cessna Court, Gaithersburg, MD 20879. Officers: Raquel Fazio, Manager (Qualifying Individual), Eduardo Jorge Fazio, Gen. Manager. APL Logistics Ltd., 456 Alexandra Road, #06-00, NOL Building, Singapore 119962, Officers: Ian Moore, Manager Product Development (Qualifying Individual), Cheng Wai Keung, Director. Duncan International Shipping, 1082 Rodgers Avenue, Brooklyn, NY 11226, Noel N. Griffith, Sole Proprietor. Sola Forwarding Inc., 70 Bowery Street, Suite 204, New York, NY 10013, Officers: Kit Yee Man, Vice President (Qualifying Individual), Kenneth Tran, President. La Solucion Cargo Express Inc., 3900 S.W. 52nd Ave., #401, Hollywood, FL 33023. Officer: Hermogenes R. Simo, President (Qualifying Individual). Oconca Logistics

(USA)Inc., 175-01 Rockaway Blvd., Suite 218, Jamaica, NY 11434. Officers: Xiao Jun He, Vice President (Qualifying Individual), Yuan Li, President. Non-Vessel—Operating Common Carrier and Ocean Freight Forwarder Transportation Intermediary Applicants: Logitech Shipping, Inc., 838 Pine Avenue, #108, Long Beach, CA 90813. Officer: Johnny Moegelvang Hyldmar, President (Qualifying Individual). Ocean Express Marine USA Inc., 33 Arbor Drive, Howell, NJ 07731 Officer: Hassanein Moustafa Mohamed Youssef, President (Qualifying Individual). PRO Cargo Solutions, Inc., 23924 Pennsylvania Ave., Suite #3, Lomita, CA 90717. Officer: Su Gyung Kim, President (Qualifying Individual). Sea & Air Global Inc., 811 N. Catalina Avenue, #3012, Redondo Beach, CA 90277. Officer: Laurent Saluzeat, President (Qualifying Individual). Ocean Freight Forwarder—Ocean Transportation Intermediary Applicants: EFM Management, Inc., 2551 Santa Fe Avenue, Redondo Beach, CA 90278. Officer: Steve Botting, Vice President (Qualifying Individual). Freight Yours, Inc., 1164 West Duarte Road, #12A, Arcadia, CA 91007. Officers: Roberta Lee, CEO (Qualifying Individual), Cecilia Lee, Secretary. SMSI International Inc., 7566 Pinewood Tr., West Bloomfield, WI 48322, Officer: Yevgeniy Eposhteyn, Vice President (Qualifying Individual). Dated: December 15, 2006. Karen V. Gregory, Assistant Secretary. [FR Doc. E6-21756 Filed 12-19-06; 8:45 am] BILLING CODE 6730-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than January 5, 2007. **A. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Thomas M. Marcuccilli and James C. Marcuccilli,* both of Fort Wayne, Indiana, and their immediate families; Sandra Joan Marcuccilli, Fort Wayne, Indiana; Dr. Meagan M. Marcuccilli, Irvine, California; Meredith A. Marcuccilli, Cincinnati, Ohio; Kathryn L. Marcuccilli, South Bend, Indiana; Patrice Marcuccilli, Fort Wayne, Indiana; Morgan Marcuccilli, Vallejo, California; Kristin Marcuccilli, South Bend, Indiana and Thomas P. Marcuccilli, Chicago, Illinois; to retain voting shares of STAR Financial Group, Inc., Fort Wayne, Indiana, and thereby indirectly acquire STAR Financial Bank, Fort Wayne, Indiana. Board of Governors of the Federal Reserve System, December 15, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-21745 Filed 12-19-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 16, 2007. **A. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. First Busey Corporation* , Urbana, Illinois, to merge with Main Street Trust, Inc., Champaign, Illinois, and thereby indirectly acquire Main Street Bank & Trust, Champaign, Illinois. **B. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: *1. First Banks, Inc.* , Hazelwood, Missouri, and The San Francisco Company, St. Louis, Missouri; to acquire 100 percent of the voting shares of Royal Oaks Bancshares, Inc., Houston, Texas, and thereby indirectly acquire Royal Oaks Bank, SSB, Houston, Texas. Board of Governors of the Federal Reserve System, December 15, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-21744 Filed 12-19-06; 8:45 am] BILLING CODE 6210-01-S GENERAL SERVICES ADMINSTRATION Implementation of a mileage based Fuel Cost Price Adjustment (Surcharge) for Household Goods AGENCY: Federal Acquisition Service, GSA ACTION: Notice for Comments SUMMARY: GSA is proposing a change to the Centralized Household Goods Traffic Management Program (CHAMP) and the Household Goods Standard Tender of Service

(HTOS)to implement a mileage based Fuel Cost Price Adjustment on the shipment of household goods effective May 1, 2007. DATES: Interested parties should submit written comments before January 10, 2007. ADDRESSES: Mail comments to General Services Administration, Federal Acquisition Service, Travel and Transportation Management Division (6FBDX), 1500 East Bannister Road, Building 6, Kansas City, Missouri 64131. Comments may be sent via email to *reg6.transportation@gsa.gov* . FOR FURTHER INFORMATION CONTACT: Brian Kellhofer, Transportation Programs Branch, by telephone at 816-823-3646 or via email at *brian.kellhofer@gsa.gov* . SUPPLEMENTARY INFORMATION: A. Background GSA’s CHAMP uses the Domestic Household Goods Government Rate Tender (415-G) published by the American Moving and Storage Association

(AMSA)through its Household Goods Carriers” Bureau Committee. The tender contains a Fuel Cost Price Adjustment (Surcharge) provision identified in Item 16, which GSA has utilized since May 2000. The current Fuel Cost Price Adjustment calculation is based on the net transportation charges of the line haul and the delivery in and delivery out of storage in transit (SIT). The Fuel Cost Price Adjustment is designed to compensate the Transportation Service Provider

(TSP)when the cost of diesel fuel exceeds $1.399. When applicable, a percentage as identified in Item 16 is taken against the net line haul charges. GSA is proposing changing the Fuel Cost Price Adjustment methodology from a percentage based to a mileage based calculation. The mileage based Fuel Cost Price Adjustment will be calculated on the distance between the shipment’s origin and destination, and if applicable, the distance for delivery in or delivery out of storage in transit (SIT), using the billable mileage as currently identified by ALK Technologies. When the cost of diesel fuel exceeds $1.399, as identified by the Department of Energy

(DOE)on the first Monday of every month, with an effective date of the 15th day of the same month, the TSP may calculate a fuel surcharge based on the difference between the DOE price and the trigger price of $1.40. Effective May 1, 2007, this will be accomplished by first taking the number of billable miles and dividing it by 4.5 to identify the number of gallons of fuel used. The total will then be multiplied by the cost difference between the DOE price and $1.399. Beginning May 1, 2008, the number of billable miles will be divided by five

(5)to identify the number of gallons of fuel used. B. Substantive Changes The implementation of the mileage based Fuel Cost Price Adjustment reflects a more accurate view of additional cost incurred by TSPs for the increases in the fuel costs. It eliminates weight pricing and aligns the fuel cost with the distance the shipment travels and the fuel usage. As a result of this change, agencies should realize transportation cost savings. Dated: December 14, 2006. Tauna T. Delmonico Director, Travel and Transportation Management Division (FBL), GSA [FR Doc. E6-21732 Filed 12-19-06; 8:45 am] BILLING CODE 6820-89-S GENERAL SERVICES ADMINISTRATION 2006-N01 No FEAR Act Notice AGENCY: General Services Administration ACTION: Notice. SUMMARY: The General Services Administration is publishing this notice to inform Federal employees, former Federal employees and applicants for Federal employment of the rights and protections available to them under Federal antidiscrimination and whistleblower protection laws. FOR FURTHER INFORMATION CONTACT: Jearline Nicome at

(202)501-2143. No FEAR Act Notice The General Services Administration is committed to ensuring that Federal employees, former Federal employees and applicants are notified of the rights and protections available to them under Federal antidiscrimination and whistleblower protection laws. On May 15, 2002, Congress enacted the “Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002,” which is now known as the No FEAR Act. One purpose of the Act is to “require that Federal agencies be accountable for violations of antidiscrimination and whistleblower protection laws.” Public Law 107-174, Summary. In support of this purpose, Congress found that “agencies cannot be run effectively if those agencies practice or tolerate discrimination.” Public Law 107-174, Title I, General Provisions, section 101(1). The Act also requires this agency to provide this notice to Federal employees, former Federal employees and applicants for Federal employment to inform you of the rights and protections available to you under Federal antidiscrimination and whistleblower protection laws. Antidiscrimination Laws A Federal agency cannot discriminate against an employee or applicant with respect to the terms, conditions or privileges of employment on the basis of race, color, religion, sex, national origin, age, disability, marital status or political affiliation. Discrimination on these bases is prohibited by one or more of the following statutes: 5 U.S.C. 2302(b)(1), 29 U.S.C. 206(d), 29 U.S.C. 631, 29 U.S.C. 633a, 29 U.S.C. 791 and 42 U.S.C. 2000e-16. Although not covered by the No Fear Act, discrimination on the basis of sexual orientation is prohibited by Executive Order 11478, as amended by Executive Order 13087. If you believe that you have been the victim of unlawful discrimination on the basis of race, color, religion, sex, national origin or disability, you must contact an Equal Employment Opportunity

(EEO)counselor within 45 calendar days of the alleged discriminatory action, or, in the case of a personnel action, within 45 calendar days of the effective date of the action, before you can file a formal complaint of discrimination with your agency. See, *e.g.* 29 CFR 1614. If you believe that you have been the victim of unlawful discrimination on the basis of age, you must either contact an EEO counselor as noted above or give notice of intent to sue to the Equal Employment Opportunity Commission

(EEOC)within 180 calendar days of the alleged discriminatory action. If you are alleging discrimination based on marital status or political affiliation, you may file a written complaint with the U.S. Office of Special Counsel

(OSC)(see contact information below). In the alternative (or in some cases, in addition), you may pursue a discrimination complaint by filing a grievance through your agency’s administrative or negotiated grievance procedures, if such procedures apply and are available. Whistleblower Protection Laws A Federal employee with authority to take, direct others to take, recommend or approve any personnel action must not use that authority to take or fail to take, or threaten to take or fail to take, a personnel action against an employee or applicant because of disclosure of information by that individual that is reasonably believed to evidence violations of law, rule or regulation; gross mismanagement; gross waste of funds; an abuse of authority; or a substantial and specific danger to public health or safety, unless disclosure of such information is specifically prohibited by law and such information is specifically required by Executive order to be kept secret in the interest of national defense or the conduct of foreign affairs. Retaliation against an employee or applicant for making a protected disclosure is prohibited by 5 U.S.C. 2302(b)(8). If you believe that you have been the victim of whistleblower retaliation, you may file a written complaint (Form OSC-11) with the U.S. Office of Special Counsel at 1730 M Street NW., Suite 218, Washington, DC 20036-4505 or online through the OSC Web site-- *http://www.osc.gov* . Retaliation for Engaging in Protected Activity A Federal agency cannot retaliate against an employee or applicant because that individual exercises his or her rights under any of the Federal antidiscrimination or whistleblower protection laws listed above. If you believe that you are the victim of retaliation for engaging in protected activity, you must follow, as appropriate, the procedures described in the Antidiscrimination Laws and Whistleblower Protection Laws sections or, if applicable, the administrative or negotiated grievance procedures in order to pursue any legal remedy. Disciplinary Actions Under the existing laws, each agency retains the right, where appropriate, to discipline a Federal employee for conduct that is inconsistent with Federal Antidiscrimination and Whistleblower Protection Laws up to and including removal. If OSC has initiated an investigation under 5 U.S.C. 1214, however, according to 5 U.S.C. 1214(f), agencies must seek approval from the Special Counsel to discipline employees for, among other activities, engaging in prohibited retaliation. Nothing in the No FEAR Act alters existing laws or permits an agency to take unfounded disciplinary action against a Federal employee or to violate the procedural rights of a Federal employee who has been accused of discrimination. Additional Information For further information regarding the No FEAR Act regulations, refer to 5 CFR part 724, as well as the appropriate offices within your agency ( *e.g.* , EEO/civil rights office, human resources office or legal office). Additional information regarding Federal antidiscrimination, whistleblower protection and retaliation laws can be found at the EEOC Web site-- *http://www.eeoc.gov* and the OSC Web site-- *http://www.osc.gov* . Attentiveness to ensuring a work environment that is free from discrimination and reprisal is essential to maintain our world class workplace. Existing Rights Unchanged Please be aware that, pursuant to section 205 of the No FEAR Act, neither the Act nor this notice creates, expands or reduces any rights otherwise available to any employee, former employee or applicant under the laws of the United States, including the provisions of law specified in 5 U.S.C. 2302(d). Dated: December 5, 2006 Lurita Doan Administrator,General Services Administration [FR Doc. E6-21733 Filed 12-19-06; 8:45 am] BILLING CODE 6820-34-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0028] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed 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;

(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. Written comments should be received within 60 days of this notice. Proposed Project Evaluation of Customer Satisfaction with the Agency for Toxic Substances and Disease Registry Internet Home Page and Links (OMB No. 0923-0028)—Extension—Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC). Background and Brief Description ATSDR considers evaluation to be a critical component for enhancing program effectiveness and improving resource management. ATSDR's mandate under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended, is to assess the presence and nature of health hazards at specific Superfund sites. To help prevent or reduce further exposure and the illnesses that result from such exposures. ATSDR, the lead Agency within the Public Health Service for implementing the health-related provisions of CERCLA and its 1986 amendments, the Superfund Amendments and Re-authorization Act (SARA), ATSDR received additional responsibilities in environmental public health. This act broadened ATSDR's responsibilities in the areas of health assessments, establishment and maintenance of toxicologic databases, information dissemination, and medical education. Furthermore, in accordance with the Government Performance and Results Act of 1993 (Pub. L. 103-62), the e-Government Act of 2002, and the Federal Enterprise Architecture are key elements of the Presidents Management Agenda. These “e-government” initiatives have required staff at all levels of the Federal government with the improvement of program effectiveness and public accountability by promoting new focuses on results, service quality, and customer satisfaction. These staff are further charged with responsibility to articulate clearly the results of their programs in terms that are understandable to their customers, their stakeholders, and the American taxpayer. This project addresses these concerns and serves to improve ATSDR's health promotion agenda by providing data on which to assess and improve the usefulness and usability of information provided via Internet. ATSDRs extension (continuation) efforts will follow the guidance articulated in our reinstatement application submitted and approved in 2003. Our current survey, the “ATSDR Web Site User Satisfaction Survey,” was combined in the past under project 0920-0449 “Evaluation of Customer Satisfaction of the CDC and ATSDR Internet Home Page and Links.” Having our own survey would allow us to tailor the survey to our needs, manage the project effectively, and ensure that we collect the necessary information to evaluate customer satisfaction of our Web site. The 2003 reinstatement request was further modified by our most recent I-83c submission adding five replicate product-specific surveys to the OMB 0923-0028 inventory for this project. ATSDR is requesting an extension without change for the following surveys: • ATSDR Web Site User Satisfaction Survey

(WSUS)• Toxicological Profiles User Satisfaction Survey

(TPUS)• ToxFAQs TM User Satisfaction Survey

(TFUS)• Public Health Statements User Satisfaction Survey (PHSUS) • Toxicology Curriculum for Communities Training Manual User Satisfaction Survey (TCCUS) • ToxProfiles TM CD-ROM User Satisfaction Survey (TP-CDUS) ATSDR has designed this site to serve the general-public, persons at risk for exposure to hazardous substances, collaborating organizations, state and local governments, and health professionals. As a “Support Delivery of Services” tool, the ATSDR Web site presents information focused on prevention of exposure and adverse human health effects and diminished quality of life associated with exposure to hazardous substances from waste sites, unplanned releases, and other sources of pollution present in the environment. Furthermore, as a Web based delivery tool it advances the agencies health promotional messages, product outreach activities, and future survey options currently under consideration. Therefore, it is critical that ATSDR have the capacity to answer whether or not these expenditures elicit the desired effects or impact. The results of this project will ensure that these audiences will continue to find our knowledge products and informational pieces easy to access, clear, informative and useful. Specifically, this project will continue to examine whether current and future informational updates are presented in an appropriate technological format and whether it meets the needs, wants, and preferences of visitors (“customers”) to the ATSDR Web site. This extension request is for a three-year period. The survey questions have been held to the absolute minimum required for the use of the data. There are no costs to the respondents other than their time. Estimate of Annualized Burden Hours: Respondents & percent of form name use Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) ATSDR Web site Visitors (50%) WSUS 1,000 1 5/60 83 ATSDR Web site Visitors (15%) TPUS 300 1 5/60 25 ATSDR Web site Visitors (15%) TFUS 300 1 5/60 25 ATSDR Web site Visitors (5%) PHSUS 100 1 5/60 8 ATSDR Web site Visitors (8%) TCCUS 160 1 5/60 13 ATSDR Web site Visitors (7%) TP-CDUS 140 1 5/60 12 Total 166 Dated: December 14, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21718 Filed 12-19-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-06BU] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

(a)Whether the proposed 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;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(GDL)laws and the ways that parents can influence their children's safe driving are necessary. In preparation for a national campaign to educate parents about their role in their teens' driver education, it is necessary to determine the most effective messages and channels through which to communicate with parents. Ogilvy Public Relations Worldwide, on behalf of CDC, will conduct two studies to assess the appropriateness and impact of messages and creative materials intended to

(a)increase parental involvement in their teen's driving education and experience, and

(b)encourage teens to adopt safer driving practices. The first information collection will be accomplished through focus group testing of campaign messages and materials with representatives from our target audiences, parents and teens, in two cities in the U.S. The findings will provide valuable information regarding parents' and teens' levels of awareness and concern about safe driving; motivators for behavior change, especially GDL compliance; and message/channel preferences. The information collected will be used to develop final creative materials to implement the teen safe driving campaign in pilot cities. The second information collection will be accomplished through pilot city testing, which will evaluate knowledge, attitude and behaviors of intended audiences both pre- and post-communications campaign. The campaign will target parents of newly-licensed drivers. It will encourage parents to understand state regulations regarding new drivers, talk with their teens about safe driving practices, and both manage and monitor their teens' driving behavior. Testing will be conducted through brief telephone surveys intended to assess knowledge, attitudes and behaviors of parents and teens related to safe driving practices, GDL laws, and parental management of new drivers before and after the campaign; with the goal of observing a marked increase in parental management at the time of the post-campaign survey. CDC anticipates screening 1,777 individuals and that 45% of these will qualify for the survey testing. Pending CDC's decision whether or not to include teens in survey testing, the breakdown of the groups shown in the tables below may change. However, the total number of respondents and screeners will remain the same. There is no cost to the respondents other than their time. Estimated Annualized Burden Hours: Phase 1.—Focus Group Testing Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden per response (in hours) Annual total burden requested (in hours) Rejected Screeners 152 1.0 1/60 2 Accepted Screeners 48 1.0 5/60 4 Parents 32 1.0 2.0 64 Teens 16 1.0 2.0 32 Total 102 Phase 2.—Pre- and Post-Intervention Pilot City Survey Testing [based on two cities] Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden per response (in hours) Estimated annual total burden hours requested Screeners 1,777 2.0 1/60 59 Parents 600 2.0 15/60 300 Teens 200 2.0 15/60 100 Total 459 Dated: December 13, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21719 Filed 12-19-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0237] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(1)A drug and a device;

(2)a device and a biological;

(3)a biological and a drug; or

(4)a drug, a device, and a biological. The second purpose of this regulation is to enhance the efficiency of agency management and operations by providing procedures for classifying and determining which agency component is designated to have primary jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute. The regulation establishes a procedure by which an applicant may obtain an assignment or designation determination. The regulation requires that the request include the identity of the applicant, a comprehensive description of the product and its proposed use, and the applicant's recommendation as to which agency component should have primary jurisdiction, with an accompanying statement of reasons. The information submitted would be used by FDA as the basis for making the assignment or designation decision. Most information required by the regulation is already required for premarket applications affecting drugs, devices, biologicals, and combination products. The respondents will be businesses or other for-profit organizations. In the **Federal Register** of June 22, 2006 (71 FR 35916), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Part 3 43 1 43 24 1,032 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-21636 Filed 12-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0202] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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. DATES: Fax written comments on the collection of information by January 19, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—21 CFR 1.278 to 1.285 (OMB Control Number 0910-0520)—Extension The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(m)), which requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 to 1.282 of FDA's regulations (21 CFR 1.278 to 1.282) set forth the requirements for submitting prior notice; §§ 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for requesting FDA review after an article of food has been refused admission under section 801(m)(1) of the act or placed under hold under section 801(l) of the act; and § 1.285(i) (21 CFR 1.285(i)) sets forth the procedure for post-hold submissions. Advance notice of imported food allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. Any person with knowledge of the required information may submit prior notice for an article of food. Thus, the respondents to this information collection may include importers, owners, ultimate consignees, shippers, and carriers. FDA's regulations require that prior notice of imported food be submitted electronically using CBP's Automated Broker Interface of the Automated Commercial System (ABI/ACS) (§ 1.280(a)(1)) or the FDA Prior Notice

(PN)System Interface (Form FDA 3540) (§ 1.280(a)(2)). The term “Form FDA 3540” refers to the electronic system known as the FDA PN System Interface, which is available at *http://www.access.fda.gov* . Prior notice must be submitted electronically using either ABI/ACS or the FDA PN System Interface. Information collected by FDA in the prior notice submission includes: The submitter and transmitter (if different from the submitter); entry type and CBP identifier; the article of food, including complete FDA product code; the manufacturer, for an article of food no longer in its natural state; the grower, if known, for an article of food that is in its natural state; the FDA Country of Production; the shipper, except for food imported by international mail; the country from which the article of food is shipped or, if the food is imported by international mail, the anticipated date of mailing and country from which the food is mailed; the anticipated arrival information or, if the food is imported by international mail, the U.S. recipient; the importer, owner, and ultimate consignee, except for food imported by international mail or transshipped through the United States; the carrier and mode of transportation, except for food imported by international mail; and planned shipment information, except for food imported by international mail (§ 1.281). Much of the information collected for prior notice is identical to the information collected for FDA's importer's entry notice, which has been approved under OMB control number 0910-0046. The information in FDA's importer's entry notice is collected electronically via CBP's ABI/ACS at the same time the respondent files an entry for import with CBP. To avoid double-counting the burden hours already counted in the importer's entry notice information collection, the burden hour analysis in table 1 of this document reflects the reduced burden for prior notice submitted through ABI/ACS in the column labeled “Hours per Response.” In addition to submitting a prior notice, a submitter should cancel a prior notice and must resubmit the information if information changes after FDA has confirmed a prior notice submission for review (e.g., if the identity of the manufacturer changes) (§ 1.282). However, changes in the estimated quantity, anticipated arrival information, or planned shipment information do not require resubmission of prior notice after FDA has confirmed a prior notice submission for review (§ 1.282(a)(1)(i) to 1.282(a)(1)(iii)). In the event that an article of food has been refused admission under section 801(m)(1) of the act or placed under hold under section 801(l) of the act, §§ 1.283(d) and 1.285(j) set forth the procedure for requesting FDA review and the information required to be included in a request for review. In the event that an article of food has been placed under hold under section 801(l) of the act, § 1.285(i) sets forth the procedure for and the information to be included in a post-hold submission. In the **Federal Register** of May 31, 2006 (71 FR 30940), FDA published a 60-day notice requesting public comment on the information collection provisions. FDA received two timely letters in response, each containing one or more comments. To the extent that the comments suggest changes to the requirements of the prior notice interim final rule (21 CFR Part 1, subpart I), such a request is outside the scope of the four collection of information topics on which the notice solicits comments and, thus, will not be addressed here. The interim final rule established a 75-day comment period. In order to ensure that those commenting on the interim final rule had the benefit of FDA's outreach and educational efforts and had experience with the systems, timeframes, and data elements of the prior notice system, FDA reopened the comment period for 30 days on April 14, 2004 (69 FR 19763), and for an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 days. The prior notice final rule currently is being developed and will publish in the near future. The agency's responses to the comments received in response to the 60-day notice published May 31, 2006, reference provisions found in the prior notice interim final rule and will not address any changes being considered for the final rule. (Comment) One comment stated that prior notice information provided to FDA has no practical utility for goods transshipped through the United States, from one point in Canada to another point in Canada, when the goods are shipped by a Customs-Trade Partnership Against Terrorism (C-TPAT) or Partners In Protection

(PIP)certified exporter, and carried by a C-TPAT certified carrier, with a C-TPAT approved bolt seal on the container. The comment argued that because these goods do not enter U.S. commerce and the parties responsible for the goods (the exporter and carrier) are classified as “low risk,” the shipments have already been determined to be “low risk,” and thus, prior notice review by FDA is not necessary and the prior notice information provided to FDA has no practical utility. The comment also noted that Free and Secure Trade

(FAST)approved drivers are now accepted by the U.S. Department of Homeland Security for the transportation of dangerous goods (including explosives) into and through the United States and argued that FAST approved drivers for shipments of food products transshipped through the United States should make it unnecessary to provide prior notice information for the shipment. (Response) FDA does not agree that obtaining prior notice information is unnecessary if shipments can be characterized as “low risk.” Prior notice is a statutory requirement under section 801(m) of the act. As explained in the prior notice interim final rule, section 801(m) of the act applies to all food imported or offered for import into the United States except as outlined in 21 CFR 1.277(b) (68 FR 58974 at 58993), including “low-risk” shipments. (Comment) Another comment asserted that transhipments, including both those originating in Canada and entering the United States for purposes of export to a third country, as well as Canadian shipments routed through the United States and returned to Canada, are transported under bond and information about the transshipments is entered in ABI/ACS. This comment further asserted that ABI/ACS captures the information necessary to identify transhipments that may pose a risk as defined by FDA. The comment suggested that it would minimize the burden of the collection of information if exporters of transhipments through the United States would be required to provide only the information originally required in ABI/ACS and not be required to enter additional information for FDA prior notice purposes. (Response) FDA disagrees. ABI/ACS information submitted during entry cannot substitute for the submission of prior notice because it does not meet the requirements of the Bioterrorism Act, such as providing FDA with certain specified information before the food arrives in the United States. As we explained in the prior notice interim final rule, entry may be made up to 15 days after a food arrives in the United States and does not contain all of the information required in a prior notice, such as the country from which the article is shipped (68 FR 58974 at 58975-58976). The information in a prior notice is necessary for FDA to determine whether it should examine the food at the U.S. port of arrival. Moreover, the comment implies that these shipments should be exempt from prior notice requirements because the shipments are under strict CBP control and are secured by a bond, i.e., that these shipments are low-risk. As we explained previously, section 801(m) of the act requires prior notice for all food imported or offered for import into the United States except as outlined in 21 CFR 1.277(b). FDA notes, however, the policy established in the March 2005 revision to the prior notice interim final rule CPG, which addresses imported food arriving from and exiting to the same country. It describes the situations and conditions under which FDA and CBP should typically consider not taking regulatory action despite the fact that prior notice is not submitted. (Comment) One comment noted that “Standard Manifest” data elements must be transmitted to CBP prior to arrival in order to clear a regular shipment, and the “Preferred Manifest” data elements must be transmitted to CBP in order to clear a low risk FAST/C-TPAT shipment. In addition to these CBP transmissions, a separate prior notice transmission to FDA, with a different data set, is required to meet the prior notice requirements. The comment suggested that, to minimize the burden of the collection of information on respondents, FDA and CBP should work together to develop integrated data elements for both regular and FAST/C-TPAT shipments which would meet both FDA and CBP requirements, and the information required should be submitted once and then transferred to the other agency as required. (Response) FDA disagrees. FDA's Bioterrorism Act and CBP's Trade Act of 2002 have different statutory requirements. For example under section 801(m) of the act, FDA, not CBP, must receive prior notice. In implementing these laws, the agencies require different information and use different targeting and screening tools. FDA and CBP have discussed interfacing with the Automated Manifest System

(AMS)(the module of ACS through which carriers, port authorities, or service bureaus transmit electronically the cargo declaration portion of the inward foreign manifest to CBP) for manifest data and determined that the general cargo data in AMS are not suitable to accommodate the detailed information requirements of section 801(m) of the act. For example, AMS does not collect the country of origin. In addition, its collection of the identities of the article of food and its manufacturer differs from the way those are collected under the prior notice interim final and final rules in such a way that the data would not meet our needs in carrying out the purpose of section 801(m) of the act. Therefore, the information collection burden may not necessarily be reduced as the comment suggests because manifest data could not substitute for certain prior notice requirements. (Comment) Another comment suggested that both the FDA and CBP systems be simplified to more efficiently enter data that are common to all products in the shipment. For instance, information such as importer and shipper, which is common to all products in a shipment, should only need to be entered once. (Response) The Bioterrorism Act requires notice for each article of food and requires in that notice, for each article of food, certain information. As stated in the interim final rule, an “article” refers to a single food that is associated with the same complete FDA Product Code, the same package size, and the same manufacturer or grower (68 FR 58974 at 59003). This is consistent with how entry is filed with CBP. An article of food is a unique item related to a specific manufacturer or grower and a specific process or size. All of these pieces of information are critical for a risk-based assessment of the food. The ABI/ACS system provides the capability to submit information for multiple food items as lines in a single entry, when entry level information is consistent for a number of articles in a shipment. For example, shipment level information, such as estimated time of arrival, can be captured once for all articles within a shipment. The ability to minimize data entry by copying specific information from one article, or line, to another depends upon the sophistication of the software being used by the submitter to create the submission to CBP. The FDA PN System Interface allows for simplified submission of similar articles of food by allowing the submitter to easily repeat common information (e.g., FDA product code, manufacturer, etc.) while entering different quantities (e.g., amount and package size). Both systems thus significantly reduce the amount of repetitive entry. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. FDA Form No. No. of Respondents Annual Frequency per Respondent Total Annual Responses Hours per Response Total Hours Prior Notice Submissions *Prior Notice submitted through ABI/ACS* 1.280 to 1.281 None 6,500 949.50 6,171,750 0.167 1,030,682 2 *Prior Notice submitted through PN System Interface* 1.280 to 1.281 FDA 3540 3 214,400 8.33 1,785,952 0.384 685,806 New Prior Notice Submissions Subtotal 1,716,488 Prior Notice Cancellations *Prior Notice cancelled through ABI/ACS* 1.282 FDA 3540 6,500 3.34 21,710 0.25 5,428 *Prior Notice cancelled through PN System Interface* 1.282 and 1.283(a)(5) FDA 3540 214,400 0.31 66,464 0.25 16,616 Prior Notice Cancellations Subtotal 22,044 Prior Notice Requests for Review and Post-hold Submissions 1.283(d) and 1.285(j), None 1 1 1 8 8 1.285(i) None 1 1 1 1 1 Prior Notice Requests for Review and Post-hold Submissions Subtotal 9 Total Hours Annually 1,738,541 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer's entry notice information collection approved under OMB control number 0910-0046 are not included in this total. 3 The term “Form FDA 3540” refers to the electronic system known as the FDA PN System Interface, which is available at *http://www.access.fda.gov* . This estimate is based on FDA's experience and the average number of prior notice submissions, cancellations, and requests for review received in the past 3 years. FDA received 282,244 prior notices through ABI/ACS during December 2003; 6,865,722 during 2004; and 6,171,939 during 2005. Based on this experience, FDA estimates that approximately 6,500 users of ABI/ACS will submit an average of 949.5 prior notices annually, for a total of 6,171,750 prior notices received annually through ABI/ACS. FDA estimates the reporting burden for a prior notice submitted through ABI/ACS to be 10 minutes, or 0.167 hours, per notice, for a total burden of 1,030,682 hours. This estimate takes into consideration the burden hours already counted in the information collection approval for FDA's importer's entry notice, as previously discussed in this document. FDA received 35,308 prior notices through the PN System Interface during December 2003; 1,425,825 during 2004; and 1,786,896 during 2005. Based on this experience, FDA estimates that approximately 214,400 registered users of the PN System Interface will submit an average of 8.33 prior notices annually, for a total of 1,785,952 prior notices received annually through the PN System Interface. FDA estimates the reporting burden for a prior notice submitted through the PN System Interface to be 23 minutes, or 0.384 hours, per notice, for a total burden of 685,806 hours. FDA received no cancellations of prior notices through ABI/ACS during December 2003; 16,624 during 2004; and 21,720 during 2005. Based on this experience, FDA estimates that approximately 6,500 users of ABI/ACS will submit an average of 3.34 cancellations annually, for a total of 21,710 cancellations received annually through ABI/ACS. FDA estimates the reporting burden for a cancellation submitted through ABI/ACS to be 15 minutes, or 0.25 hours, per cancellation, for a total burden of 5,428 hours. FDA received 1,539 cancellations of prior notices through the PN System Interface during December 2003; 64,918 during 2004; and 65,491 during 2005. Based on this experience, FDA estimates that approximately 214,400 registered users of the PN System Interface will submit an average of 0.31 cancellations annually, for a total of 66,464 cancellations received annually through the PN System Interface. FDA estimates the reporting burden for a cancellation submitted through the PN System Interface to be 15 minutes, or 0.25 hours, per cancellation, for a total burden of 16,616 hours. FDA has not received any requests for review under §§ 1.283(d) or 1.285(j) in the last 3 years (December 2003 through 2005); therefore, the agency estimates no more than one request for review will be submitted annually. FDA estimates that it will take a requestor about 8 hours to prepare the factual and legal information necessary to prepare a request for review. Thus, FDA has estimated a total reporting burden of 8 hours. FDA has not received any post-hold submissions under § 1.285(i) in the last 3 years (December 2003 through 2005); therefore, the agency estimates no more than one post-hold submission will be submitted annually. FDA estimates that it will take about 1 hour to prepare the written notification described in § 1.285(i)(2)(i). Thus, FDA has estimated a total reporting burden of 1 hour. In cases where a regulation implements a statutory information collection requirement, only the additional burden attributable to the regulation, if any, has been included in FDA's burden estimate. Dated: December 13, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-21737 Filed 12-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0478] Marketed Unapproved Drugs; Public Workshop; Change of Meeting Location and Time AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a change of location and time for the upcoming public workshop on marketed unapproved drugs. Registration for the public workshop is closed. A new address and time are given for those persons who have previously registered with FDA. DATES: The public workshop will be held on January 9, 2007, from 8:30 a.m. to 4:30 p.m. ADDRESSES: The public workshop will be held in the Universities at Shady Grove, Conference Center Auditorium, bldg. 1, 9640 Gudelsky Dr., Rockville, MD. Directions and information on parking, hotels, and transportation options can be found at *http://www.shadygrove.umd.edu/conference* . The agenda for the workshop will be posted at *http://www.fda.gov/cder/drug/unapproved_drugs* . FOR FURTHER INFORMATION CONTACT: Karen Kirchberg, Center for Drug Evaluation and Research (HFD-330), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-8916, e-mail: *Karen.Kirchberg@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of November 1, 2006 (71 FR 64284), FDA issued a notice announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. The November 1, 2006, notice invited individuals interested in attending the workshop to register and submit topics for discussion by November 15, 2006. Registration for the workshop is closed. Attendance at the workshop is limited to those persons who have previously registered with FDA. Because of a greater than anticipated response for attending the public workshop, FDA is announcing in this notice a new location and time. II. New Location and Time for the Public Workshop The new location will be the Universities at Shady Grove, Conference Center Auditorium (see ADDRESSES ). Directions and information on parking, hotels, and transportation options can be found at *http://www.shadygrove.umd.edu/conference* . The new time will be 8:30 a.m. to 4:30 p.m. Dated: December 14, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-21738 Filed 12-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: 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. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Production, Recovery and Purification Process for Plasmid DNA Clinical Manufacturing *Description of Technology:* Available for licensing from NIH is a method for large scale production, recovery, and purification process for plasmid DNA manufacturing meeting human clinical trial requirements. DNA plasmid recovery and purification methods can separate plasmid from contamination from a variety of sources including cellular debris and proteins as well as genomic DNA and RNA. Traditionally, DNA plasmid recovery methods utilizing column chromatography have had poor results such as product elutes with broad smears rather than sharp peaks, product elutes appearing in the flow through thereby preventing isolation from lysate components, and monomeric supercoiled plasmids are not separated from other forms of plasmids. To overcome these shortcomings, a fermentation, recovery, purification, and formulation process for the production of plasmid has been developed. The overall recovery of this process is greater than 400 mg of formulated final product per kilogram (wet weight) of E. coli cell paste. *Applications:*

(1)Produce clinical grade plasmid DNA for clinical trials;

(2)Therapeutic reagents. *Market:* This technology has potential uses in drug manufacturing and clinical studies. In the United States alone, there were approximately over 40,000 clinical trials conducted. The potential market is worth several billion dollars. *Inventors:* Yueqing Xie *et al.* (NCI/SAIC). *Related Publications:* 1. N Horn *et al.* U.S. Patent No. 5,707,812, Purification of plasmid DNA during column chromatography. 2. R Lemmens *et al.* Supercoiled plasmid DNA: selective purification by thiophilic/aromatic adsorption. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Feb 5;784(2):291-300. 3. J Urthaler *et al.* Application of monoliths for plasmid DNA purification development and transfer to production. J Chromatogr A 2005 Feb 11;1065(1):93-106. *Patent Status:* HHS Reference No. E-033-2007/0—Research Tool. *Licensing Status:* This technology is available as a non-exclusive license. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov.* *Collaborative Research Opportunity:* The National Cancer Institute—Frederick is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Production, Recovery and Purification Process for Plasmid DNA Clinical Manufacturing. Please contact Betty Tong, PhD at *tongb@mail.nih.gov* for more information. Chitosan as a Universal Vaccine Adjuvant, Antigen Depot and Cytokine Depot *Description of Technology:* This technology describes the use of chitosan depots with appropriate antigens and/or cytokines for generating an immune response in a subject. Such depots are made by mixing one or more antigens and/or cytokines with chitosan or a chitosan derivative. Similar compositions are described wherein chitosan or a derivative forms a micro-or nanoparticle, which have resulted in a more immunogenic presentation of antigen compared to antigen in solution. Using a representative antigen, the inventors showed that mice vaccinated with the subject depots had increased humoral and cellular immune responses compared to mice vaccinated with antigen alone. 1 Furthermore, comparative mouse studies showed the antigen-specific immune response generated with chitosan depots of this invention to be equipotent to incomplete Freund's adjuvant

(IFA)and superior to aluminum hydroxide, a widely used adjuvant for licensed and routinely administered vaccines. 1 Thus, this technology improves upon commonly used adjuvant technology and is widely applicable. This technology is the first to show that subcutaneous administrations of chitosan and an appropriate antigen, with no other component, can be used for enhancing immune responses. In additional studies, the inventors showed that chitosan is able to maintain a depot of recombinant cytokine. A single subcutaneous injection of chitosan-cytokine outperforms daily injections of recombinant cytokine in both the expansion of draining lymph nodes and in the antigen presenting ability of lymph node cells. This technology is the first to show that chitosan can maintain a depot of cytokine which results in a significant enhancement of the functional effects of a cytokine. This technology can be used for vaccines and immunotherapies against various infectious agents and cancer. *Applications:* Vaccine adjuvant; Immunogenic depots, including vaccine and cytokine. *Development Status:* Animal (mouse) data available. *Inventor:* Jeffrey Schlom *et al.* (NCI). *Reference:* 1 DA Zaharoff, CJ Rogers, KW Hance, J Schlom, JW Greiner. Chitosan solution enhances both humoral and cell-mediated immune responses to subcutaneous vaccination. Vaccine (accepted November 2006). *Patent Status:* U.S. Provisional Application No. 60/846,481 filed 22 Sep 2006 (HHS Reference No. E-311-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, PhD; 301/435-5515; *anos@mail.nih.gov* *Collaborative Research Opportunity:* The NCI Laboratory of Tumor Immunology and Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize chitosan-mediated immunopotentiation of vaccines and immunotherapies. Please contact Betty Tong, PhD at 301-594-4263 or *tongb@mail.nih.gov* for more information. Preparative Two Dimensional Gel Electrophoresis System *Description of Technology:* The National Institute of Environmental Health Sciences has developed procedures and a prototype device for isolation of proteins from complex mixtures for protein identification. The system serves as a one-step purification method for isolation of biologically relevant proteins affected by disease or experimental treatment and has been described in *Electrophoresis* 15, 735-745, 1994. The system includes a preparative isoelectric focusing device for separation of proteins by charge, a glass mold for preparative polyacrylamide gel separation by mass and a protocol for use. The commercial advantage of the Preparative Two Dimensional Gel Electrophoresis system is to separate and isolate sufficient amounts of individual protein for sequencing in a powerful one-step purification method. The Preparative Two Dimensional Gel Electrophoresis system can resolve individual proteins by charge and mass from up to 1 to 2 mg of unpurified starting material from protein mixtures. Current devices for two dimensional gel electrophoresis are generally for analytical scale work and are not physically or procedurally adapted to accommodate preparative sample loads. Although other preparative electrophoresis devices do exist, they separate by either mass or charge alone and function as stand-alone units without ready integration into additional systems for resolution of individual proteins. *Applications:* Protein sequencing, protein immunization for antibody production, immunostaining and other modes of protein characterization. *Development Status:* The system has been tested and is operational; however some refinements in protein resolution are still possible which may involve procedural, reagent or equipment modifications. *Inventors: B. Alex Merrick* ( *NIEHS* ), Rachel Patterson (NIEHS), Robert Hall (NIEHS), Chaoying He (NIEHS), James Selkirk (NIEHS). *Publication:* BA Merrick, RM Patterson, LL Witcher, C He, JK Selkirk. Separation and sequencing of familiar and novel murine proteins using preparative two-dimensional gel electrophoresis. *Electrophoresis.* 1994 May;15(5):735-745. *Patent Status:* U.S. Patent No. 5,534,121 issued 09 July 1996, claiming priority to 16 May 1994 (HHS Reference No. E-066-1994/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Michael A. Shmilovich; 301/435-5019; *shmilovm@mail.nih.gov.* *Collaborative Research Opportunity:* The NIEHS National Center for Toxicogenomics, Proteomics Group, may consider statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this preparative two-dimensional gel electrophoresis system. Please contact John Penta, NIEHS Office of Translational Research, at 919/541-3696 or *penta@niehs.nih.gov* for additional information. Dated: December 8, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-21665 Filed 12-19-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: 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. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine *Description of Technology:* This invention is a method of immunization against typhoid fever using a conjugate vaccine comprising the capsular polysaccharide of *Salmonella typhi,* Vi, conjugated through an adipic dihydrazide linker to nontoxic recombinant exoprotein A

(rEPA)from *Pseudomonas aeruginosa.* The three licensed vaccines against typhoid fever, attenuated *S. typhi* Ty21a, killed whole cell vaccines and Vi polysaccharide, have limited efficacy, in particular for children under 5 years of age, which make an improved vaccine desirable. It is generally recognized that an effective vaccine against *Salmonella typhi* is one that increases serum anti-Vi IgG eight-fold six weeks after immunization. The conjugate vaccine of the invention increases anti-Vi IgG, 48-fold, 252-fold and 400-fold in adults, in 5-14 years old and 2-4 years old children, respectively. Thus this is a highly effective vaccine suitable for children and should find utility in endemic regions and as a traveler's vaccine. The route of administration can also be combined with routine immunization. In 2-5 years old, the protection against typhoid fever is 90% for 4 years. In school age children and in adults the protection could mount to completer protection according to the immunogenicity data. *Application:* Immunization against *Salmonella typhi* for long term prevention of typhoid fever in all ages. *Developmental Status:* Conjugates have been synthesized and clinical studies have been performed. The synthesis of the conjugates is described by Kossaczka *et al.* in Infect Immun. 1997 June;65(7):2088-2093. Phase III clinical studies are described by Mai *et al.* in N Engl J Med. 2003 October 2; 349(14):1390-1391. Dosage studies are described by Canh *et al.* in Infect Immun. 2004 Nov;72(11):6586-6588. A safety and immunogenicity study in infants are underway. The aim is to administer the conjugate vaccine with routine infant immunization. Preliminary results shows the vaccine is safe in 2 months old infants. *Inventors:* Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins (NICHD). *Patent Status:* U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS Reference No. E-020-1999/0-US-02); U.S. Patent Application No. 10/866,343 filed 10 Jun 2004 (HHS Reference No. E-020-1999/0-US-03). *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . *Collaborative Research Opportunity:* The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine. Please contact Betty Tong, PhD at 301-594-4263 for more information. Vaccine Against Escherichia Coli O157 Infection, Composed of Detoxified LPS Conjugated to Proteins *Description of Technology:* This invention is a conjugate vaccine to prevent infection by *E. coli* O157:H7, particularly in young children under 5 years of age. *E. coli* O157:H7 is an emerging human pathogen which causes a spectrum of illnesses with high morbidity and mortality, ranging from diarrhea to hemorrhagic colitis and hemolytic-uremic syndrome (HUS). Infection with *E. coli* O157:H7 occurs as a result of consumption of water, vegetables, fruits or meat contaminated by feces from infected animals, such as cattle. The most recent large outbreak in the U.S. was from contaminated bag spinach. The conjugate is composed of the O-specific polysaccharide isolated from *E. coli* O157, or other Shiga-toxin producing bacteria, conjugated to carrier proteins, such as non-toxic *P. aeruginosa* exotoxin A or Shiga toxin 1. A Phase I clinical trial, involving adult humans, showed the vaccine is safe and highly immunogenic. Adults, after one injection containing 25 μg of antigen, responded with high titers of bactericidal antibodies. Similarly in a phase II study, fifty 2 to 5 years-old children in U.S. were injected with the conjugate vaccines. There were only mild local adverse reactions. More than 90% children responded with greater than 10 fold rise of *E. coli* O157 antibodies of bactericidal ability. Thus the conjugates of the invention are promising vaccines, especially for children and the elderly, who are most likely to suffer serious consequences from infection. *Application:* Prevention of *E. coli* O157 infection. *Development Status:* Clinical studies have been performed and are described in Konadu *et al.* , J Infect Dis. 1998 Feb;177(2):383-387 and Ahmed *et al.* , J Infect Dis. 2006 Feb;193(2):515-526. *Inventors:* Shousun C. Szu, Edward Konadu, and John B. Robbins (NICHD). *Patent Status:* U.S. Patent 6,858,211 issued 22 Feb 2005 (HHS Reference No. E-158-1998/0-US-06); U.S. Patent Application No. 10/987,428 filed 12 Nov 2004 (HHS Reference No. E-158-1998/0-US-07). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Vaccine for *E. coli* O157 for Children and Adults. Please contact Betty Tong, PhD at 301-594-4263, *tongb@mail.nih.gov* for more information. Dated: December 8, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-21666 Filed 12-19-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Alternative Medicine; Notice of Meeting Pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussion could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Advisory Council for Complementary and Alternative Medicine. *Date:* February 2, 2007. *Closed:* 9 a.m. to 12 p.m. *Agenda:* To review and evaluate grant applications and/or proposals. *Open:* 1 p.m. to 4:30 p.m. *Agenda:* Opening remarks by the Acting Director of National Center for Complementary and Alternative Medicine, presentations of new research initiatives, and other council related business. *Place:* National Institutes of Health, Neuroscience Building, 6001 Executive Boulevard, Rooms C & D, Rockville, MD 20852. *Contact Person:* Martin H. Goldrosen, Executive Secretary, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892.

(301)594-2014. The public comments session is scheduled from 4-4:30 p.m., but could change depending on the actual time spent on each agenda item. Each speaker will be permitted 5 minutes for their presentation. Interested individuals and representatives of organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-594-2014, Fax: 301-480-9970. Letters of intent to present comments, along with a brief description of the organization represented, should be received no later than 5 p.m. on January 31, 2007. Only one representative of an organization may present oral comments. Any person attending the meeting who does not request an opportunity to speak in advance of the meeting may be considered for oral presentation, if time permits, and at the discretion of the Chairperson. In addition, written comments may be submitted to Dr. Martin H. Goldrosen at the address listed above up to ten calendar days (February 12, 2007) following the meeting. Copies of the meeting agenda and roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-594-2014, Fax 301-480-9970, or via e-mail at *naccames@mail.nih.gov.* In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government I.D. will need to show a photo I.D. and sign-in at the security desk upon entering the building. Dated: December 13, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-9773 Filed 12-19-06; 8:45 am]

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46 CFR 515
12 CFR 225
Pub. L. 107-174
29 CFR 1614
5 CFR 724
Pub. L. 103-62
Pub. L. 101-629
Pub. L. 107-250
21 CFR 1

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Notice for Comments SUMMARY: GSA is proposing a change to the Centralized Household Goods Traffic Management Program (CHAMP) and the Household Goods Standard Tender of Service (HTOS) to implement a mileage based Fuel Cost Price Adjustment on the shipment of household goods effective May 1, 2007

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