Notices. Notice of request for comments regarding a renewal to an existing OMB clearance

7,388 words·~34 min read·/register/2006/02/01/06-910

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

BILLING CODE 6712-01-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 an agreement 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.:* 011375-065. *Title:* Trans-Atlantic Conference Agreement. *Parties:* Atlantic Container Line AB;

A.P. Moller-Maersk A/S; Mediterranean Shipping Company, S.A.; Nippon Yusen Kaisha; Orient Overseas Container Line Limited; and P&O Nedlloyd Limited. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW; Suite 900; Washington, DC 20036. *Synopsis:* The amendment deletes Hapag-Lloyd Container Linie GmbH as a party to the agreement. *Agreement No.:* 011574-013. *Title:* Pacific Islands Discussion Agreement. *Parties:* Hamburg-Süd; Polynesia Line Ltd.; FESCO Ocean Management Limited d/b/a FESCO Australia North America Line;

Australia-New Zealand Direct Line, a division of CP Ships

(UK)Ltd.; CMA-CGM S.A.; and Compagnie Maritime Marfret, S.A. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell, LLP; 1850 M Street, NW; Suite 900; Washington, DC 20036. *Synopsis:* The amendment deletes P&O Nedlloyd Limited as a party to the agreement. *Agreement No.:* 011584-006. *Title:* NYK/WWL/NSCSA Cooperative Working Agreement. *Parties:* Nippon Yusen Kaisha; Wallenius Wilhelmsen Lines AS; and National Shipping Company of Saudi Arabia. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW; Suite 900; Washington, DC 20036. *Synopsis:* The agreement changes the name of Wallenius Wilhelmsen Lines AS to Wallenius Wilhelmsen Logistics AS and restates the agreement to reflect the change throughout. *Agreement No.:* 011705-005. *Title:* Grand Alliance-CP Ships Atlantic Agreement. *Parties:* Hapag-Lloyd Container Linie GmbH; Nippon Yusen Kaisha; Orient Overseas Container Line Limited, Orient Overseas Container Line, Inc., and Orient Overseas Container Line (Europe) Limited (acting as one party); P&O Nedlloyd Limited/P&O Nedlloyd BV; and CP Ships USA, LLC. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW; Suite 900; Washington, D.C. 20036. *Synopsis:* The amendment revises the service loops, vessel contributions, and space allocations under the agreement. The parties request expedited review. *Agreement No.:* 011935. *Title:* CSAV/NYK South America Space Charter Agreement. *Parties:* Compania Sud Americana de Vapores S.A. and Nippon Yusen Kaisha. *Filing Party:* Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW; Suite 900; Washington, DC 20036. *Synopsis:* The agreement authorizes CSAV to charter space to NYK on its ro-ro vessels in service from Baltimore, MD, to ports in Chile. By order of the Federal Maritime Commission. Dated: January 27, 2006. Bryant L. VanBrakle, Secretary. [FR Doc. E6-1358 Filed 1-31-06; 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. app. 1718 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 Logicargo Corp., 1209 Uniroyal Drive, Laredo, TX 78045. Officers: Alejandro Zamudio, President (Qualifying Individual), Eduardo Betesh, vice President. Patron Star Corporatio, 425 S. San Gabriel Boulevard, Suite #200, San Gabriel, CA 91776. Officer: An-Ning Dai, President (Qualifying Individual). Non-Vessel-Operating Common Carrier and Ocean Freight Forwarder Transportation Intermediary Applicant JCI Logistics LLC, 2940 Husking Peg Lane, Geneva, IL 60134. Officer: Paul Curry, President (Qualifying Individual). Ocean Freight Forwarder—Ocean Transportation Intermediary Applicant Tri-Ocean Logistics, Inc., 20B Dreyer Avenue, Staten Island, NY 10314. Officers: Victor Rao, President (Qualifying Individual), Wilma Rodriguez-Rao, Vice President. Dated: January 27, 2006. Bryant L. VanBrakle, Secretary. [FR Doc. E6-1363 Filed 1-31-06; 8:45 am] BILLING CODE 6730-01-P 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 Web site at *http://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 February 27, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30303: *1. Seacoast Banking Corporation of Florida* , Stuart, Florida; to merge with Big Lake Financial Corporation, and thereby indirectly acquire voting shares of Big Lake National Bank, Okeechobee, Florida. **B. Federal Reserve Bank of San Francisco** (Tracy Basinger, Director, Regional and Community Bank Group) 101 Market Street, San Francisco, California 94105-1579: *1. Western Alliance Bancorporation* , Las Vegas, Nevada; to merge with Intermountain First Bancorp, Las Vegas, Nevada, and thereby indirectly acquire voting shares of Nevada First Bank, Las Vegas, Nevada. Board of Governors of the Federal Reserve System, January 27, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-1325 Filed 1-31-06; 8:45 am] BILLING CODE 6210-01-S GENERAL SERVICES ADMINISTRATION [OMB Control No. 3090-0277] Office of Citizen Services and Communications; Information Collection; Market Research Collection AGENCY: Office of Citizen Services and Communications, General Services Administration (GSA). ACTION: Notice of request for comments regarding a renewal to an existing OMB clearance. SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration has submitted to the Office of Management and Budget

(OMB)a request to review and approve a renewal of a currently approved information collection requirement regarding Market Research for the Office of Citizen Services and Communications. A request for public comments was published at 70 FR 69154, November 14, 2005. No comments were received. This information collection will be used to determine the utility and ease of use of GSA's Web site, *http://www.gsa.gov* . The respondents include individuals and representatives from businesses currently holding GSA contracts. 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; ways to enhance the quality, utility, and clarity of the information to be collected. DATES: Submit comments on or before: March 3, 2006. FOR FURTHER INFORMATION CONTACT: Ms. Jocelyn Johnson, Office of Citizen Services and Communications, at telephone

(202)208-0043, or via e-mail to *jocelyn.johnson@gsa.gov.* ADDRESSES: Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to Ms. Jeanette Thornton, GSA Desk Officer, OMB, Room 10236, NEOB, Washington, DC 20503, and a copy to the Regulatory Secretariat (VIR), General Services Administration, Room 4035, 1800 F Street, NW., Washington, DC 20405. Please cite OMB Control No. 3090-0277, Market Research Collection for the Office of Citizen Services and Communications, in all correspondence. SUPPLEMENTARY INFORMATION: A. Purpose The General Services Administration will be requesting the Office of Management and Budget

(OMB)to review and approve information collection 3090-0277 concerning Market Research Collection for the Office of Citizen Services and Communications. The purpose of this information collection is to inform GSA on how to best provide service and relevance to the American public via GSA's Web site *http://www.gsa.gov.* The information collected from an online survey, focus groups, and Web site usability testing will be used to refine the *http://www.gsa.gov* Web site. The questions to be asked are non-invasive and do not address or probe sensitive issues. It is important for the GSA to gain information from the many diffuse groups it serves; therefore, the GSA will be questioning individuals and households, and businesses and other for-profit groups. B. Annual Reporting Burden *Respondents:* 190. *Responses Per Respondent:* 1. *Total Responses:* 190. *Hours Per Response:* 72.6 minutes. *Total Burden Hours:* 230. *Obtaining Copies of Proposals:* Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (VIR), 1800 F Street, NW., Room 4035, Washington, DC 20405, telephone

(202)208-7312. Please cite OMB Control No. 3090-0277, Market Research Collection for the Office of Citizen Services and Communications, in all correspondence. Dated: January 23, 2006. Michael W. Carleton, Chief Information Officer. [FR Doc. E6-1217 Filed 1-31-06; 8:45 am] BILLING CODE 6820-CX-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Termination, By Expiration, of Declaration of Emergency Justifying Emergency Use Authorization of Anthrax Vaccine Adsorbed AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination, by expiration, of the declaration of emergency justifying emergency use authorization of Anthrax Vaccine Adsorbed

(AVA)that was issued by the former Secretary of Health and Human Services Secretary Tommy G. Thompson (the former HHS Secretary) on January 14, 2005. The declaration of emergency terminated by expiration on January 14, 2006, which is the end of the 1-year period that began on the date that the declaration was made. Under the act, advance notice of the termination of the declaration was provided to the Department of Defense. DATES: The Notice is effective as of February 1, 2006. FOR FURTHER INFORMATION CONTACT: Boris Lushniak, Office of Counterterrorism Policy and Planning (HF-29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4067. SUPPLEMENTARY INFORMATION: I. Background On December 10, 2004, the Deputy Secretary of Defense determined, under section 564(b)(1)(B) of the act (21 U.S.C. 360bbb-3(b)(1)(B)), that there was a significant potential for a military emergency involving a heightened risk to U.S. military forces of attack with anthrax. On the basis of such determination and under section 564(b)(1) of the act, the former HHS Secretary declared an emergency justifying the authorization of the emergency use of Anthrax Vaccine Adsorbed. A notice of the determination of the Deputy Secretary of Defense and the declaration of the former HHS Secretary was published in the ** Federal Register ** of February 2, 2005 (70 FR 5452). II. Advance Notice of Termination Under section 564(b)(3) of the act, the FDA Commissioner provided advance notice of the termination of the former HHS Secretary's declaration of emergency to the Department of Defense. The January 2006 letter notifying the Department of Defense of the termination of the declaration of emergency follows: William Winkenwerder, Jr., M.D., Assistant Secretary of Defense for Health Affairs, The Pentagon, Washington, D.C. 20301-1200 Dear Dr. Winkenwerder: This letter is to provide advance notice of the termination of the above-referenced declaration of emergency that was issued by Secretary of Health and Human Services Tommy G. Thompson on January 14, 2005, pursuant to section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360bbb-3. In accordance with section 564(b)(2)(A)(ii) of the Act, the declaration of emergency will terminate by expiration on January 14, 2006, which is the end of the one year period that began on the date that the declaration was made. This advance notice of termination will be published in the **Federal Register** , pursuant to section 564(b)(4) of the Act. Sincerely, Andrew C. von Eschenbach, M.D. Acting Commissioner of Food and Drugs Dated: January 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1311 Filed 1-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0445] Determination of Regulatory Review Period for Purposes of Patent Extension; HUMIRA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for HUMIRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biological product HUMIRA (adalimumab). HUMIRA is indicated for reducing signs and symptoms, including major clinical response, inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for HUMIRA (U.S. Patent No. 6,090,382) from Abbott Biotechnology Ltd., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated April 8, 2005, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of HUMIRA represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for HUMIRA is 1,722 days. Of this time, 1,443 days occurred during the testing phase of the regulatory review period, while 279 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective* : April 16, 1998. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on April 16, 1998. 2. *The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262)* : March 28, 2002. FDA has verified the applicant's claim that the product license application

(BLA)for HUMIRA (BLA 125057) was initially submitted on March 28, 2002. 3. *The date the application was approved* : December 31, 2002. FDA has verified the applicant's claim that BLA 125057 was approved on December 31, 2002. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 326 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 3, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 31, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management (see ADDRESSES ). Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 5, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-1313 Filed 2-1-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pediatric Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services, when that research is also regulated by FDA. *Date and Time* : The meeting will be held on Wednesday, March 22, 2006, from 8 a.m. to 6 p.m. *Location* : Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Jan N. Johannessen, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, rm. 14C-06) Rockville, MD 20857, 301-827-6687, e-mail: *Jan.Johannessen@fda.hhs.gov* or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up to date information on this meeting. *Agenda* : The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in Section 17 of the Best Pharmaceuticals for Children Act (BPCA), on adverse event reports possibly related to clofarabine (CLOLAR), irbesartan (AVAPRO), sibutramine (MERIDIA), and the mixed salts amphetamine product (ADDERALL). In continuation of a prior committee discussion of adverse events for the class of methylphenidate products used to treat attention deficit hyperactivity disorder (ADHD), the committee will hear and discuss neuropsychiatric adverse events possibly related to other approved ADHD medications. The presentations will focus on neuropsychiatric adverse event reports and clinical trial data from approved ADHD medications. The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications. The background material will become available no later than the day before the meeting and will be posted under the Pediatric Advisory Committee Docket site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . (Click on the year 2006 and scroll down to Pediatric Advisory Committee meetings.) *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 8, 2006. Oral presentations from the public will be scheduled on March 22, 2006, between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by March 8, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please notify Jan N. Johannessen at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-1223 Filed 1-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Psychopharmacologic Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on March 23, 2006, from 8 a.m. to 5 p.m. *Location* : Hilton Washington DC North/Gaithersburg,The Ballrooms, 620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-8900. *Contact Person* : Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, Fax: 301-827-6776, e-mail: *ReeseCi@cder.fda.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. Please call the Information Line for up-to-date information on this meeting. The background material will become available no later than the day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . Click on the year 2006 and scroll down to the “Psychopharmacologic Drugs Advisory Committee” meeting. *Agenda* : The committee will discuss new drug application

(NDA)20-717, S-019, PROVIGIL (100 milligrams (mg), 200 mg, 85 mg, 170 mg, 255 mg, 340 mg, and 425 mg) Tablets, Cephalon, Inc.; the proposed indication is for the treatment of attention deficit hyperactivity disorder (ADHD). *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by March 15, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 15, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cicely Reese at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-1222 Filed 1-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Vaccines and Related Biological Products Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held via teleconference on February 17, 2006, from 1 p.m. to 5:30 p.m. *Location* : National Institutes of Health

(NIH)campus, Food and Drug Administration, Bldg. 29B, conference rooms A and B, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend. A speakerphone will be provided at the specified location for public participation in this meeting. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the internet at *http://www.nih.gov/about/visitor/index.htm* . (FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web sites after this document publishes in the **Federal Register** .) Visitors must show two forms of identification such as a Federal employee badge, driver's license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave. (the medical center metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at *http://www.nih.gov/about/visitorsecurity.htm* . Due to the limited available parking, visitors are encouraged to use public transportation. *Contact Person* : Christine Walsh or Denise Royster, Food and Drug Administration, Center for Biologics Evaluation and Research (HFM-71), 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will review and discuss the selection of strains to be included in the influenza virus vaccine for the 2006-2007 season. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 10, 2006. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 10, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-1224 Filed 1-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; The Leukocyte Antibodies Prevalence

(LAP)Study SUMMARY: 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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget

(OMB)for review and approval. *Proposed Collection: Title:* The Leukocyte Antibodies Prevalence

(LAP)Study. *Type of Information Collection Request: NEW* . *Need and Use of Information Collection:* The two current hypotheses for pathogenesis of transfusion-related acute lung injury (TRALI) include the development of acute pulmonary insufficiency from immune and non-immune causes. The immune mediated mechanism postulates that passively transferred anti-leukocyte antibodies from blood donors are responsible for TRALI. The donor antibodies implicated in TRALI include antibodies directed towards HLA class I and class II antigens, and anti-neutrophil antibodies. The LAP Study is a cross-sectional multi-center study to measure the prevalence of HLA and neutrophil antibodies in blood donors with or without a history of blood transfusion or pregnancy, and the development of a repository of blood samples obtained from these donors. Specifically, 7,900 adult blood donors across six blood centers participating in the Retrovirus Epidemiology Donor Study II (REDS-II) will be enrolled in the study. Eligible donors will be asked to complete a short questionnaire on their transfusion history (ever, and date of last transfusion) and, for female donors, questions on pregnancy history (ever, number and outcome of pregnancies, last pregnancy). Each donor will also be asked to provide a sample of blood which will be tested for the presence of HLA class I and class II antibodies. This data will help us evaluate variations in HLA antibody prevalence based on blood transfusion and pregnancy history and time since the last immunizing event. Further, neutrophil specific antibodies will be measured in those blood donors who have HLA antibodies. Also, donors with neutrophil antibodies will be tested to determine their neutrophil phenotype using routine serologic and DNA methods, since individuals homozygous for certain neutrophil antigens are more prone to develop certain neutrophil antibodies. The results from testing HLA positive donors for neutrophil antibodies in this primary study could be used to develop an optimal testing strategy for large number of donors using the stored repository samples. These data will provide the basis for calculating donor loss in the event that a TRALI prevention strategy is implemented that includes deferring donors with a history of transfusion or pregnancy or those with HLA or neutrophil antibodies. The second major goal of this study is to develop a repository of blood samples from well characterized blood donors whose detailed transfusion and pregnancy histories are known. Repository samples will be stored indefinitely. Although future research on repository samples is yet to be determined, they may be tested for studies designed to help transfusion safety and transfusion biology. *Frequency of Response:* Once. *Affected Public:* Individuals. *Type of Respondents:* Adult Blood Donors. The annual reporting burden is a follows: *Estimated Number of Respondents:* 7,900; *Estimated Number of Responses per Respondent:* 1; *Average Burden of Hours per Response:* 0.17; and *Estimated Total Annual Burden Hours Requested:* 1343. The annualized cost to respondents is estimated at: $24,174 (based on $18 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Adult Blood Donors 7,900 1 0.17 1343 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions used;

(3)Ways to enhance the quality, utility, and clarity of the information collected; and

(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two Rockledge Center, Room 10142, 6701 Rockledge Drive, MSC 7950, Bethesda, MD 20892-7950, or call 301-435-0075, or e-mail your request to *nemog@nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: January 20, 2006. Charles M. Peterson, Director, DBDR, National Institutes of Health. [FR Doc. E6-1269 Filed 1-31-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: FDA Approvable Human DNA Diagnostic Test for Endometriosis AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent Application Number 60/654,331 filed February 18, 2005, entitled “Identification of Molecular Markers for Endometriosis in Blood Lymphocytes Using DNA Microarrays,” to Ortho-Clinical Diagnostics, having a place of business in Raritan, NJ 08869. The contemplated exclusive license may be limited to an FDA approvable human DNA diagnostic test for endometriosis. The United States of America is the assignee of the patent rights in this invention. DATES: Only written comments and/or application for a license which are received by the National Institutes of Health on or before April 3, 2006 will be considered. ADDRESSES: Requests for a copy of the patent, inquires, comments, and other materials relating to the contemplated license should be directed to: Marlene Astor, Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 301-435-4426; Facsimile: 301-402-0220; e-mail: *ms482m@nih.gov.* SUPPLEMENTARY INFORMATION: Endometriosis is a common, non-malignant gynecological disease that affects up to twenty percent (20%) of women during their reproductive years. Endometriosis is characterized by the growth of endometrial tissue outside the uterus. This growth of tissue causes recurring severe pain and can lead to infertility. As the current procedure used for diagnosis is invasive and not entirely accurate, there is a need for a fast, accurate, and minimally invasive test to test for endometriosis. Using DNA microarray analysis of blood lymphocytes, the inventors have identified two gene markers expressed in blood that are able to discriminate between those women who have endometriosis and those that don't. This new technology would be minimally invasive and quick using a blood sample from a patient. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. Dated: January 23, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-1277 Filed 1-31-06; 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. Rapid Anti-Depressant Response Produced by Low Dose Treatment with Anti-Muscarinic Drugs Maura Furey and Wayne Drevets (NIMH). U.S. Patent Application No. 11/137,114 filed 25 May 2005 (HHS Reference No. E-175-2004/0-US-01). *Licensing Contact:* Norbert Pontzer; 301/435-5502; *pontzern@mail.nih.gov.* Available for licensing are new methods of rapidly treating depression. The drugs currently used to treat depression work by increasing the activity at serotonin, norepinephrine and perhaps dopamine receptors in the CNS. However these drugs are effective in only 60-70% of patients, require 3-4 weeks of treatment before clinical improvement and have many side effects. These inventors have shown that in human patients, the administration of anti-muscarinic agents produces a rapid, prolonged alleviation of depressive symptoms. Beginning the day following administration of the anti-muscarinic agent, a majority of patients show significant improvements in mood, anxiety, sleep and other depressive symptoms that last days or weeks. The very slow dissociation of some muscarinic agents from their receptors may account for the prolonged therapeutic effects. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Dated: January 23, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-1286 Filed 1-31-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health State-of-the-Science Conference: Cesarean Delivery on Maternal Request; Notice Notice is hereby given of the National Institutes of Health

(NIH)“State-of-the-Science Conference: Cesarean Delivery on Maternal Request” to be held March 27-29, 2006, in the NIH Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. The conference will begin at 8:30 a.m. on March 27 and 28, and at 9 a.m. on March 29, and will be open to the public. Despite the national goal of reducing rates of cesarean delivery to 15 percent of births established as part of Healthy People 2010, cesarean delivery rates have continued to increase. In 2003, 1.1 million or 27.5 percent of births in the U.S. were by cesarean delivery. An estimated 2.5 percent of births that year were cesarean deliveries performed on request, in the absence of medical necessity, and the rate of cesareans on request appears to be growing rapidly over time. The potential benefits of elective cesarean delivery as compared to vaginal delivery are not fully understood but are thought to include decreased risk of urinary incontinence, pelvic organ prolapse, anal sphincter damage and fecal incontinence. Elective cesarean delivery also has the benefit of flexible timing for mother and physician. However, like any major surgical procedure, there are risks associated with cesarean delivery. Risks that are known to be higher for cesarean deliveries than for vaginal delivery include adverse reactions to anesthesia, breathing problems, bleeding, infection, urinary tract injury, and injury to the baby. In addition, recovery time following cesarean delivery is typically longer than for vaginal delivery. Given these risks, any decision to deliver by cesarean delivery when vaginal delivery is also available should be informed by the best possible information regarding potential health outcomes, good and bad, for both mother and baby. Toward that end, the National Institute of Child Health and Human Development and the Office of Medical Applications of Research of the National Institutes of Health will convene a State-of-the-Science Conference from March 27 to 29, 2006, to assess the available scientific evidence relevant to the following questions: • What is the trend and incidence of cesarean delivery over time in the United States and in other countries? • What are the short-term (under one year) and long-term benefits and harms to mother and baby associated with cesarean by request versus attempted vaginal delivery? • What factors influence benefits and harms? • What future research directions need to be considered to get evidence for making appropriate decisions regarding cesarean on request or attempted vaginal delivery? An impartial, independent panel will be charged with reviewing the available published literature in advance of the conference, including a systematic literature review commissioned through the Agency for Healthcare Research and Quality. The first day and a half of the conference will consist of presentations by expert researchers and practitioners, and public discussions. On Wednesday, March 29, the panel will present a statement of its collective assessment of the evidence to answer each of the questions above. The panel will also hold a press conference to address questions from the media. The draft statement will be published online later that day, and the final version will be released approximately six weeks later. The primary sponsors of this meeting are the National Institute of Child Health and Human Development and the NIH Office of Medical Applications of Research. Advance information about the conference and conference registration materials may be obtained from American Institutes for Research of Silver Spring, Maryland, by calling 888-644-2667, or by sending e-mail to *consensus@mail.nih.gov* . American Institutes for Research's mailing address is 10720 Columbia Pike, Silver Spring, MD 20901. Registration information is also available on the NIH Consensus Development Program Web site at *http://consensus.nih.gov* . Please Note: The NIH has recently instituted new security measures to ensure the safety of NIH employees and property. All visitors must be prepared to show a photo ID upon request. Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter NIH buildings. For more information about the new security measures at NIH, please visit the Web site at *http://www.nih.gov/about/visitorsecurity.htm* . Dated: January 24, 2006. Raynard S. Kington, Deputy Director, National Institutes of Health. [FR Doc. E6-1272 Filed 1-31-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed 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 following meeting. 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Special Emphasis Panel, SBIR Topic 204, “Plant Genomic Models for Establishing Physiological Relevance of Bioactive Components as Cancer Protectants”. *Date:* March 9, 2006. *Time:* 10:15 a.m. to 11:30 a.m. *Agenda:* To review and evaluate contract proposals. *Place:* National Institutes of Health, 6116 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). *Contact Person:* Marvin L. Salin, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, 6116 Executive Boulevard, Room 7073, MSC8329, Bethesda, MD 20892-8329, 301-496-0694, *msalin@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: January 24, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-910 Filed 1-31-06; 8:45 am]

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