Notices. Notice of Privacy Act system of records

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

BILLING CODE 6715-01-M FEDERAL MARITIME COMMISSION Notice of Request for Additional Information The Commission gives notice that it has requested that the parties to the below listed agreement provide additional information pursuant to section 6(d) of the Shipping Act of 1984, 46 U.S.C. app. 1701 *et seq.* This action prevents the agreement from becoming effective as originally scheduled. *Agreement No.:* 201172. *Title:* UMS-PHA Marine Terminal Agreement. *Parties:* Port of Houston Authority of Harris County, TX, and Universal Maritime Service Corporation.

Dated: September 22, 2006. By Order of the Federal Maritime Commission. 1 1 Chairman Blust and Commissioner Dye would not delay the subject agreement from becoming effective and would not seek additional information from the agreement parties. Bryant L. VanBrakle, Secretary. [FR Doc. E6-15910 Filed 9-27-06; 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 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 October 23, 2006. **A. Federal Reserve Bank of San Francisco** (Tracy Basinger, Director, Regional and Community Bank Group) 101 Market Street, San Francisco, California 94105-1579: *1.

Premier Commercial Bancorp* , Anaheim, California; to acquire 85.4 percent of the voting shares of Premier Commercial Bank, Arizona, N.A., Mesa, Arizona (in organization). Board of Governors of the Federal Reserve System, September 25, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-15929 Filed 9-27-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage *de novo* , or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies.

Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. 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 the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 13, 2006. **A. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Baytree Bancorp, Inc.* , Lake Forest, Illinois; to continue to engage *de novo* through its subsidiary, Baytree Bancorp, Investments, Inc., Lake Forest, Illinois, in riskless-principal transactions, pursuant to section 225.28(b)(7)(ii) of Regulation Y.

Board of Governors of the Federal Reserve System, September 25, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc.E6-15928 Filed 9-27-06; 8:45 am] BILLING CODE 6210-01-S GENERAL SERVICES ADMINISTRATION Privacy Act of 1974; Proposed Privacy Act System of Records AGENCY: General Services Administration. ACTION: Notice of Privacy Act system of records. SUMMARY: Pursuant to the Privacy Act of 1974, the General Services Administration

(GSA)proposes to establish a new system of records titled the Federal Personal Identity Verification Identity Management System (PIV IDMS) (GSA-GOVT-7). This system will support the implementation of Homeland Security Presidential Directive 12 (HSPD-12) by providing a GSA managed shared infrastructure and services for participating Federal agencies. HSPD-12 requires the use of a common identification credential for both logical and physical access to federally controlled facilities and information systems. This system will enhance security, increase efficiency, reduce identity fraud, and protect personal privacy. DATES: The established system of records will be effective 30 days after publication of this Notice. ADDRESSES: Comments may be submitted to the Director, HSPD-12 Managed Service Office, Federal Acquisition Service, General Services Administration, Suite 911, 2011 Crystal Drive, Arlington, VA 22202. FOR FURTHER INFORMATION CONTACT: Director, Identity Policy and Management, Office of Governmentwide Policy, Washington, DC 20405; or call 202-208-7655. SUPPLEMENTARY INFORMATION: The General Services Administration's Federal Acquisition Service

(FAS)is publishing a Privacy Act system of records notice to cover the collection, use, and maintenance of records relating to its administration of managed services in the collection and management of personally identifiable information for the purpose of issuing credentials (ID badges) to meet the requirements of Homeland Security Presidential Directive 12 for multiple agencies. Homeland Security Presidential Directive 12 (HSPD-12), issued on August 27, 2004, required the establishment of a standard for identification of Federal Government employees and contractors. HSPD-12 directs the use of a common identification credential for both logical and physical access to federally controlled facilities and information systems. This policy is intended to enhance security, increase efficiency, reduce identity fraud, and protect personal privacy. HSPD-12 requires that the Federal credential be secure and reliable. As directed by the Presidential Directive, the National Institute of Standards and Technology

(NIST)published the standard for secure and reliable forms of identification, Federal Information Processing Standard Publication 201 (FIPS 201), Personal Identity Verification

(PIV)of Federal Employees and Contractors, on February 25, 2005 and an update as FIPS 201-1 on June 26, 2006. HSPD-12 established four control objectives for Federal agencies to accomplish in implementing the directive: • Issue identification credentials based on sound criteria to verify an individual's identity; • Issue credentials that are strongly resistant to fraud, tampering, counterfeiting, and terrorist exploitation; • Provide for rapid, electronic authentication of personal identity; and • Issue credentials by providers whose reliability has been established through an official accreditation process. FIPS 201 has two parts: PIV I and PIV II. The requirements in PIV I support the control objectives and identity verification and security requirements described in FIPS 201, including the requirement for standard background investigation for all Federal employees and long-term contractors. PIV II specifies standards for PIV credentials to support technical interoperability and security for all HSPD-12 deployments. The Office of Management and Budget issued government-wide implementation guidance (M-05-24) for HSPD-12 on August 5, 2005. This implementation guidance required agencies to begin to issue identity credentials compliant with the PIV II requirements of FIPS 201 beginning October 27, 2006. OMB formed the HSPD-12 Executive Steering Committee

(ESC)in November 2005 to establish broad direction to assist agencies in meeting HSPD-12 implementation requirements. As a key initiative to assist government-wide implementation efforts, the ESC asked for lead agencies to provide common infrastructure for agencies to share in meeting implementation requirements. In response to the HSPD ESC direction, GSA established the HSPD-12 Managed Service Office

(MSO)to provide common, shared infrastructure and services to assist Federal agencies in the implementation of HSPD-12. GSA is offering the HSPD-12 managed services on a government-wide basis; any agency can sign up to use the shared infrastructure and services. The scope of the GSA HSPD-12 managed services consist of enrollment services, systems infrastructure through a centralized PIV Identity Management System (IDMS), card production facility, and card activation, finalization and issuance. GSA will initially provide the HSPD-12 managed services in four locations to demonstrate the initial operating capability in Atlanta, New York City, Seattle, and Washington DC. All other localities within a Federal presence will be serviced over time. The managed services provide for the enrollment of applicants in the PIV program in compliance with FIPS PIV I requirements, the issuance of PIV II compliant PIV cards and credentials, and the maintenance of systems records. The initial operating capability will be a combination of manual and automated processes. Following the initial operating capability, GSA will begin to roll out enrollment stations and operating capability to additional locations to service all user agencies. The managed service PIV enrollment process and IDMS records will cover all user agency employees, contractors and their employees, consultants, and volunteers who require long-term, routine access to federal facilities, systems, and networks. The personal information to be collected in the enrollment process will consist of data elements necessary to verify the identity of the individual and to perform background or other investigations concerning the individual. The PIV IDMS will collect data elements from the PIV card applicant, including: Name, date of birth, Social Security Number, organizational and employee affiliations, fingerprints, digital color photograph, work e-mail address, and phone number(s) as well additional verification and demographic information. These records also will be accessible to authorized personnel of participating Federal agencies for their PIV applicants. The Privacy Act embodies fair information principles in a statutory framework governing the means by which the United States Government collects, maintains, uses and disseminates personally identifiable information. The Privacy Act applies to information that a Federal agency maintains in a “system of records.” A “system of records” is a group of any records under the control of an agency from which the agency retrieves personal information by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The GSA HSPD-12 Identity Management System is such a system of records. GSA will provide controlled access to the records of the PIV IDMS to participating Federal agencies for their PIV applicants. Participating agencies will need to determine whether any updates to their existing Privacy Act System of Records Notices are required. Dated: September 21, 2006. Cheryl Paige, Acting Director, Office of Information Management. GSA/GOVT-7 System Name: Personal Identity Verification Identity Management System (PIV IDMS) Security Classification: Sensitive but unclassified. System Location: Records covered by this system are maintained by a contractor at the contractor's site. Categories Of Individuals Covered By The System: The PIV IDMS records will cover all participating agency employees, contractors and their employees, consultants, and volunteers who require routine, long-term access to federal facilities, information technology systems, and networks. The system also includes individuals authorized to perform or use services provided in agency facilities (e.g., Credit Union, Fitness Center, etc.). At their discretion, participating Federal agencies may include short-term employees and contractors in the PIV program and, therefore, inclusion in the PIV IDMS. Federal agencies shall make risk-based decisions to determine whether to issue PIV cards and require prerequisite background checks for short-term employees and contractors. The system does not apply to occasional visitors or short-term guests. GSA and participating agencies will issue temporary identification and credentials for this purpose. Categories Of Records In The System: Enrollment records maintained in the PIV IDMS on individuals applying for the PIV program and a PIV credential through the GSA HSPD-12 managed service include the following data fields: full name; Social Security Number; Applicant ID number, date of birth; current address; digital color photograph; fingerprints; biometric template (two fingerprints); organization/office of assignment; employee affiliation; work e-mail address; work telephone number(s); office address; copies of identity source documents; employee status; military status; foreign national status; federal emergency response official status; law enforcement official status; results of background check; Government agency code; and PIV card issuance location. Records in the PIV IDMS needed for credential management for enrolled individuals in the PIV program include: PIV card serial number; digital certificate(s) serial number; PIV card issuance and expiration dates; PIV card PIN; Cardholder Unique Identifier (CHUID); and card management keys. Agencies may also choose to collect the following data at PIV enrollment which would also be maintained in the PIV IDMS: physical characteristics (e.g., height, weight, and eye and hair color). Individuals enrolled in the PIV managed service will be issued a PIV card. The PIV card contains the following mandatory visual personally identifiable information: name, photograph, employee affiliation, organizational affiliation, PIV card expiration date, agency card serial number, and color-coding for employee affiliation. Agencies may choose to have the following optional personally identifiable information printed on the card: Cardholder physical characteristics (height, weight, and eye and hair color). The card also contains an integrated circuit chip which is encoded with the following mandatory data elements which comprise the standard data model for PIV logical credentials: PIV card PIN, cardholder unique identifier (CHUID), PIV authentication digital certificate, and two fingerprint biometric templates. The PIV data model may be optionally extended by agencies to include the following logical credentials: digital certificate for digital signature, digital certificate for key management, card authentication keys, and card management system keys. All PIV logical credentials can only be read by machine. Authority For Maintenance Of The System: 5 U.S.C. 301; Federal Information Security Management Act (Pub. L. 107-296, Sec. 3544); E-Government Act (Pub. L. 107-347, Sec. 203); Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et al) and Government Paperwork Elimination Act (Pub. L. 105-277, 44 U.S.C. 3504); Homeland Security Presidential Directive 12 (HSPD-12), Policy for a Common Identification Standard for Federal Employees and Contractors, August 27, 2004; Federal Property and Administrative Services Act of 1949, as amended. Purposes: The primary purposes of the system are: To ensure the safety and security of Federal facilities, systems, or information, and of facility occupants and users; to provide for interoperability and trust in allowing physical access to individuals entering Federal facilities; and to allow logical access to Federal information systems, networks, and resources on a government-wide basis. Routine Uses of Records Maintained in the System Including Categories of Users and the Purposes of Such Uses: In addition to those disclosures generally permitted under 5 U.S.C. Section 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside GSA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows: a. To the Department of Justice

(DOJ)when:

(1)The agency or any component thereof; or

(2)any employee of the agency in his or her official capacity;

(3)any employee of the agency in his or her individual capacity where agency or the Department of Justice has agreed to represent the employee; or

(1)The agency or any component thereof;

(2)any employee of the agency in his or her official capacity;

(3)any employee of the agency in his or her individual capacity where the agency or the Department of Justice has agreed to represent the employee; or

(4)the United States Government is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records and is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records. c. Except as noted on Forms SF 85, SF 85-P, and SF 86, when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate public authority, whether Federal, foreign, State, local, or tribal, or otherwise, responsible for enforcing, investigating or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative or prosecutorial responsibility of the receiving entity. d. To a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained. e. To the National Archives and Records Administration

(NARA)or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906. f. To agency contractors, grantees, or volunteers who have been engaged to assist the agency in the performance of a contract service, grant, cooperative agreement, or other activity related to this system of records and who need to have access to the records in order to perform their activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Federal Information Security Management Act (Pub. L. 107-296), and associated OMB policies, standards and guidance from the National Institute of Standards and Technology, and the General Services Administration. g. To a Federal agency, State, local, foreign, or tribal or other public authority, on request, in connection with the hiring or retention of an employee, the issuance or retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit, to the extent that the information is relevant and necessary to the requesting agency's decision. h. To the Office of Management and Budget

(OMB)when necessary to the review of private relief legislation pursuant to OMB Circular No. A-19. i. To a Federal, State, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947, as amended; the CIA Act of 1949, as amended; Executive Order 12333 or any successor order; and applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders, or directives. j. To designated agency personnel for controlled access to specific records for the purposes of performing authorized audit or authorized oversight and administrative functions. All access is controlled systematically through authentication using PIV credentials based on access and authorization rules for specific audit and administrative functions. k. To the Office of Personnel Management

(OPM)in accordance with the agency's responsibility for evaluation of Federal personnel management. l. To the Federal Bureau of Investigation for the FBI National Criminal History check. m. To a Federal, State, or local agency, or other appropriate entities or individuals, or through established liaison channels to selected foreign governments, in order to enable an intelligence agency to carry out its responsibilities under the National Security Act of 1947 as amended; the CIA Act of 1949 as amended; Executive Order 12333 or any successor order; and applicable national security directives, or classified implementing procedures approved by the Attorney General and promulgated pursuant to such statutes, orders or directives. Policies and Practices for Storing, Retrieving, Accessing, Retaining and Disposing of Records in the System: Storage: Records are stored in electronic media and in paper files. Retrievability: Records may be retrieved by name of the individual, Cardholder Unique Identification Number, Applicant ID, Social Security Number, and/or by any other unique individual identifier. Safeguards: Consistent with the requirements of the Federal Information Security Management Act (Pub. L. 107-296), and associated OMB policies, standards and guidance from the National Institute of Standards and Technology, and the General Services Administration, the GSA HSPD-12 managed service office protects all records from unauthorized access through appropriate administrative, physical, and technical safeguards. Access is restricted on a “need to know” basis, utilization of PIV Card access, secure VPN for web access, and locks on doors and approved storage containers. Buildings have security guards and secured doors. All entrances are monitored through electronic surveillance equipment. The hosting facility is supported by 24/7 onsite hosting and network monitoring by trained technical staff. Physical security controls include: Indoor and outdoor security monitoring and surveillance; badge and picture ID access screening; biometric access screening. Personally identifiable information is safeguarded and protected in conformance with all Federal statutory and OMB guidance requirements. All access has role-based restrictions, and individuals with access privileges have undergone vetting and suitability screening. All data is encrypted in transit. While it is not contemplated, any system records stored on mobile computers or mobile devices will be encrypted. GSA maintains an audit trail and performs random periodic reviews to identify unauthorized access. Persons given roles in the PIV process must be approved by the Government and complete training specific to their roles to ensure they are knowledgeable about how to protect personally identifiable information. Retention And Disposal: Disposition of records will be according to NARA disposition authority N1-269-06-1 (pending). System Manager And Address: Director, HSPD-12 Managed Service Office, Federal Acquisition Service (FAS), General Services Administration, Suite 911, 2011 Crystal Drive, Arlington, VA 22202. Notification Procedure: A request for access to records in this system may be made by writing to the System Manager. When requesting notification of or access to records covered by this Notice, an individual should provide his/her full name, date of birth, agency name, and work location. An individual requesting notification of records in person must provide identity documents sufficient to satisfy the custodian of the records that the requester is entitled to access, such as a government-issued photo ID. Record Access Procedures: Same as Notification Procedure above. Contesting Record Procedures: Same as Notification Procedure above. State clearly and concisely the information being contested, the reasons for contesting it, and the proposed amendment to the information sought. Record Source Categories: Employee, contractor, or applicant; sponsoring agency; former sponsoring agency; other Federal agencies; contract employer; former employer. Exemptions Claimed For The System: None. [FR Doc. E6-15901 Filed 9-27-06; 8:45 am] BILLING CODE 6820-34-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Chronic Fatigue Syndrome Advisory Committee AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science. ACTION: Notice. SUMMARY: As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public. DATES: The meeting will be held on Monday and Tuesday, November 20-21, 2006 from 9 a.m. to 5 p.m. each day. ADDRESSES: Department of Health and Human Services; Room 800 Hubert H. Humphrey Building; 200 Independence Avenue, SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: CDR John Eckert; Acting Executive Secretary, Chronic Fatigue Syndrome Advisory Committee; Department of Health and Human Services; 200 Independence Avenue, SW., Room 716G; Washington, DC 20201;

(202)690-7694. SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002 to advise, consult with, and make recommendations to the Secretary through the Assistant Secretary for Health, on a broad range of topics including

(1)The current state of knowledge and research about the epidemiology and risk factors relating to chronic fatigue syndrome, and identifying potential opportunities in these areas;

(2)current and proposed diagnosis and treatment methods for chronic fatigue syndrome; and

(3)development and implementation of programs to inform the public, health care professionals, and the biomedical, academic, and research communities about chronic fatigue syndrome advances. The agenda for this meeting is being developed and will be posed on the CFSAC Web site, *http://www.hhs.gov/advcomcfs,* when it is finalized. Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the meeting. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Pre-registration is required for public comment by November 13, 2006. Any individual who wishes to participate in the public comment session should call the telephone number listed in the contact information to register. Public comment will be limited to five minutes per speaker. Any member of the public who wishes to have printed material distributed to CFSAC members should submit materials to the Acting Executive Secretary, CFSAC, whose contact information is listed above prior to the close of business November 13, 2006. Dated: September 25, 2006. CDR John J. Eckert, Acting Executive Secretary, Chronic Fatigue Syndrome Advisory Committee. [FR Doc. E6-15924 Filed 9-27-06; 8:45 am] BILLING CODE 4150-42-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-224] Availability of Two Interaction Profiles [Final Documents] at http://www.atsdr.cdc.gov AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS). ACTION: Notice of availability. SUMMARY: This notice announces the availability of two interaction profiles prepared by ATSDR [final documents]. DATES: The interaction profiles will be available to the public on or about, October 1, 2006. ADDRESSES: The documents will also be available on ATSDR's Web site at *http://www.atsdr.cdc.gov.* FOR FURTHER INFORMATION CONTACT: Please submit questions regarding information contained in the profiles to Dr. Hana Pohl, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone

(888)422-8737. SUPPLEMENTARY INFORMATION: The interaction profiles were developed by ATSDR for hazardous substances at National Priority List

(NPL)sites under sections 104(i)(3) and

(5)of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA). This public law mandates that ATSDR shall assess whether adequate information on health effects is available for the priority hazardous substances. Where such information is not available or under development, ATSDR shall, in cooperation with the National Toxicology Program, initiate a program of research to determine these health effects. The Act further directs that where feasible, ATSDR shall develop methods to determine the health effects of substances in combination with other substances with which they are commonly found. To carry out these legislative mandates, ATSDR has developed a chemical mixtures program. As part of the mixtures program, ATSDR developed a guidance manual that outlines the latest methods for mixtures health assessment. In addition, a series of documents called interaction profiles are being developed for certain priority mixtures that are of special concern to ATSDR. The purpose of an interaction profile is to evaluate data on the toxicology of the “whole” priority mixture (if available) and on the joint toxic action of the chemicals in the mixture in order to recommend approaches for the exposure-based assessment of the potential hazard to public health. The documents were submitted to both the peer-review and the public review processes. Changes in the documents reflect those addressing the comments. The following documents will be available to the public on or about, October 1, 2006. Document 1 Interaction profile for atrazine deethylatrazine, diazinon, simazine, and nitrate. Document 2 Interaction profile for chlorpyrifos, lead, mercury, and methylmercury. Dated: September 21, 2006. Kenneth Rose, Acting Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E6-15946 Filed 9-27-06; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Development and Testing of a Coal Mine Safehouse, Program Announcement

(PA)04-038 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Development and Testing of a Coal Mine Safehouse, PA 04-038. *Time And Date:* 1 p.m.-3 p.m., October 20, 2006 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to Development and Testing of a Coal Mine Safehouse, Program Announcement PA 04-038. *For More Information Contact:* George Bokosh, Designated Federal Official, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone

(412)386-6465. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: September 21, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-15957 Filed 9-27-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Health Department Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH)/Agency for Toxic Substances and Disease Registry (ATSDR): Teleconference Meeting. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), The Centers for Disease Control and Prevention, NCEH/ATSDR announces the following subcommittee teleconference meeting: *Name:* Health Department Subcommittee (HDS). *Time and Date:* 1 p.m.-2:30 p.m., October 16, 2006. *Place:* Century Center, 1825 Century Boulevard, Atlanta, Georgia 30345. *Status:* Open to the public, teleconference access limited only by availability of telephone ports. *Purpose:* Under the charge of the Board of Scientific Counselors, NCEH/ATSDR the Health Department Subcommittee will provide the BSC, NCEH/ATSDR with advice and recommendations on local and state health department issues and concerns that pertain to the mandates and mission of NCEH/ATSDR. *Matters To Be Discussed:* The meeting agenda will include a follow-up on Workforce Recommendations; a selection of FY 2007/2008 Environmental Public Health Program Priorities; and the next steps for the Health Department Subcommittee. Items are subject to change as priorities dictate. *Supplementary Information:* This teleconference meeting is scheduled to begin at 1 p.m. Eastern Standard Time. To participate during the Public Comment period (2-2:10 p.m. Eastern Standard Time), dial

(877)315-6535 and enter conference code 383520. *For More Information Contact:* Individuals interested in attending the meeting, please contact Shirley D. Little, Committee Management Specialist, NCEH/ATSDR, 1600 Clifton Road, Mail Stop E-28, Atlanta, GA 30303; telephone

(404)498-0003, fax

(404)498-0059; E-mail: *slittle@cdc.gov.* The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. Dated: September 21, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-15949 Filed 9-27-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0378] Review of Agreements, Guidances, and Practices Specific to Assignment of Combination Products in Compliance With the Medical Device User Fee and Modernization Act of 2002; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Federal Food, Drug, and Cosmetic Act (the act) requires the Food and Drug Administration

(FDA)to review each agreement, guidance, or practice that is specific to the assignment of combination products to agency centers and to determine whether the agreement, guidance, or practice is consistent with the requirements of the act. In carrying out the review, the agency is to consult with stakeholders and directors of the agency centers, and then determine whether to continue in effect, modify, revise, or eliminate such an agreement, guidance, or practice. The agency has completed its initial review of relevant agreements, guidances, and practices, and has consulted with directors of the agency centers. This document provides the preliminary results of the agency's review and requests stakeholder comments to fulfill the act's requirement for stakeholder consultation prior to the agency's final determination whether to continue the agreements, guidance, or practices in effect, or to modify, revise, or eliminate them. DATES: Submit written or electronic comments by November 27, 2006. ADDRESSES: Submit written comments 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: Suzanne O'Shea, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD 20855, 301-427-1934, FAX: 301-427-1935, e-mail: *suzanne.oshea@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In October 2002, the Medical Device User Fee and Modernization Act (MDUFMA) added section 503(g)(4)(F) (21 U.S.C. 353(g)(4)(F)) to the act. This new provision requires the Secretary of the Department of Health and Human Services (the Secretary), acting through the Office of Combination Products (OCP), to review each agreement, guidance, or practice of the Secretary that is specific to the assignment of combination products to agency centers and to determine whether the agreement, guidance, or practice is consistent with the requirements of section 503(g) of the act. In carrying out such a review, OCP is to consult with stakeholders and the directors of the agency centers. After such consultation, OCP is to determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and publish in the **Federal Register** a notice of the availability of any modified or revised agreement, guidance, or practice. This notice provides the preliminary results of OCP's review of agreements, guidances, and practices that were in effect at the time section 503(g)(4)(F) of the act was enacted for their consistency with the act's requirement for the prompt assignment of combination products to agency centers on the basis of the products' primary mode of action (PMOA). 1 The directors of relevant agency centers have been consulted in this review. The agency now seeks stakeholder comment with respect to the following issues:

(1)Whether the agency has identified all agreements, guidances, and practices specific to the assignment of combination products that should have been included in this review;

(2)whether the agency's conclusions regarding the consistency of the agreements, guidances, and practices with the act's requirement that combination products be assigned promptly based on their PMOA is accurate; and

(3)whether the identified agreements, guidances, and practices should be continued in effect, modified, revised, or eliminated. 1 Section 503(g)(1) of the act requires that combination products be assigned to an agency center for regulation and review on the basis of the product's PMOA. In addition, section 503(g)(4)(B) of the act directs OCP to ensure the prompt assignment of combination products to agency centers. Upon receipt and review of stakeholder input, the agency will publish another **Federal Register** notice announcing its determinations and the availability of any modified or revised agreements, guidances, or practices. II. Primary Mode of Action—The Principle Underlying the Assignment of Combination Products to Agency Centers Section 503(g)(1) of the act requires that combination products be assigned to a lead agency center based upon the agency's determination of the product's PMOA. The agency published a final rule defining the PMOA of a combination product in the **Federal Register** of August 25, 2005 (70 FR 49848), after consulting with directors of the relevant agency centers and other agency officials, and obtaining stakeholder input through notice and comment rulemaking. As defined in the regulation, a combination product's PMOA is its single mode of action that provides the most important therapeutic action of the product (§ 3.2(m) (21 CFR 3.2(m))). The regulation includes an algorithm that will be followed when the most important therapeutic action of a combination product cannot be determined with reasonable certainty (§ 3.4(b)). The regulation is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms. The regulation went into effect on November 23, 2005. A copy of the final rule is available at *http://www.fda.gov/OHRMS/DOCKETS/98fr/05-16527.htm* . III. Agreements and Guidances Specific to the Assignment of Combination Products The agency has identified the three intercenter agreements

(ICAs)as the agreements or guidances specific to the assignment of combination products described in section 503(g)(4)(F) of the act. The three ICAs were entered into in 1991 by the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health

(CDRH)shortly after Congress introduced the concept of combination products in the Safe Medical Devices Act of 1990 (SMDA). Although the three ICAs (i.e., the CDER-CDRH ICA, the CBER-CDER ICA, and the CBER-CDRH ICA) differ in content, format, and scope, they are all specific to the assignment of combination products because they explain how various categories of both combination and single entity products were classified 2 and assigned 3 to an agency center at the time the documents were developed. The ICAs constitute guidance that is not binding on the public or the agency (§ 3.5(a)(2)). The ICAs are available at *http://www.fda.gov/oc/combination/intercenter.html* . 2 Classification refers to the determination of a product's regulatory identity as a drug, device, biological product, or combination product. 3 Assignment refers to the determination of the agency center that will have primary jurisdiction for the review and regulation of a product. The agency has reviewed the ICAs and preliminarily determined that they are generally consistent with the requirements of section 503(g) of the act in that the principles used to assign combination products described in the ICAs are based on a product's PMOA. The ICAs were developed following the enactment of the statutory PMOA criterion used to assign combination products to an agency center, and were developed using the PMOA principle. For example, the CDER-CDRH ICA assigns to CDRH products such as a “device incorporating a drug component with the combination product having the primary intended purpose of fulfilling a device function.” The premise underlying the assignment to CDRH is that the device component of such a product provides the most important therapeutic action of the product. This ICA assigns to CDER prefilled delivery systems, such as a “device with primary purpose of delivering or aiding in the delivery of a drug and distributed containing a drug.” The premise of this assignment to CDER is that the device's primary purpose in delivering or aiding in the delivery of a drug is subordinate to the most important therapeutic action provided by the drug product. Similarly, the CBER-CDER ICA assigns to CDER “combination products that consist of a biological component and a drug component where the biological component enhances the efficacy or ameliorates the toxicity of the drug product.” The premise underlying this assignment is that the drug product provides the most important therapeutic action of the product, while the biological product has a subordinate role in enhancing such action. FDA recognizes that, since the ICAs were written in 1991, new products have been developed, new uses for existing products have been devised, and additional laws, regulations, and guidances are in effect. During this period, FDA has continued to classify and assign many new products not specifically covered by the ICAs. In addition, some jurisdictional decisions made since 1991 cover products that appear to be part of a broad class of product included in an ICA, but are classified and/or assigned in a way different from the class of product because of the particular product's specific characteristics or use. Many of these decisions have been made through the formal Request for Designation

(RFD)process. For these reasons, the body of jurisdictional decisions has grown over time, and the ICAs have become incomplete statements. Moreover, in 2003 the agency administratively transferred many therapeutic biological products from CBER to CDER. For this reason, the CBER-CDER ICA is out of date. IV. Preliminary Proposal to Continue in Effect the CDER-CDRH and CBER-CDRH ICAs, and to Rescind the CBER-CDER ICA The agency believes it is very important to provide transparency in jurisdictional decisionmaking. Such transparency ensures predictability and consistency of decisions, and decreases ambiguity and uncertainty about agency perspectives. Moreover, as the bases for agency decisionmaking become clearer, the need for formal RFDs and informal inquiries covering specific products may diminish, which should conserve resources for the industry and the agency. A. CDER-CDRH and CBER-CDRH ICAs The agency has reviewed the CDER-CDRH and CBER-CDRH ICAs and preliminarily determined that they continue to provide helpful nonbinding guidance, and so proposes to continue them in effect, with the understanding that they should not be independently relied upon as the most current, complete jurisdictional statements. The agency considered updating the CDER-CDRH and CBER-CDRH ICAs as a way to continue to provide transparency to its jurisdictional decisionmaking. After consideration, however, the agency believes that the goal of transparency can be achieved more effectively by other means. The process of updating the ICAs would be time consuming, and given the quick pace of product development, the updated ICAs would soon be out of date as well. The agency believes that transparency is better served by articulating the principles upon which it bases determinations of a combination product's PMOA, and by frequently issuing jurisdictional information on particular classes of products as that information becomes available. The agency suggests that persons wishing to get the most current information about jurisdictional determinations consult the numerous other sources of information about jurisdictional determinations described in this document, as well as the ICAs. B. CBER-CDER ICA The 2003 administrative transfer of many therapeutic biological products from CBER to CDER has rendered the CBER-CDER ICA out of date. For this reason, the agency preliminarily proposes to rescind the CBER-CDER ICA. A statement of the current assignment of biological products to CBER and CDER is available at *http://www.fda.gov/oc/combination/transfer.html* . V. Actions Taken to Increase Transparency of Jurisdictional Decisionmaking Since the enactment of MDUFMA, the agency has implemented, or is developing, the following actions to increase the transparency of jurisdictional decisionmaking: A. Regulatory Definition of PMOA As described previously in this document, the agency recently published a final rule defining “primary mode of action,” which is the basis for assigning a combination product to a lead center for review. The regulation includes an algorithm that will be followed when the most important therapeutic action of a combination product cannot be determined with reasonable certainty. This clarification of the PMOA principle is expected to significantly increase the transparency of the reasoning underlying the agency's assignment of combination products to an agency center. B. Guidance for Industry and FDA Staff: How to Write a Request for Designation

(RFD)The goal of the guidance is to provide recommendations regarding the type of information a sponsor should submit in order for the agency to determine the regulatory identity of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate agency component for review and regulation. The guidance reflects the final rule defining the PMOA of a combination product, and is expected to increase the transparency of the RFD process by clarifying the kind of information that enables the agency to make a prompt and appropriate assignment decision. The guidance is available at *http://www.fda.gov/oc/combination/howtowrite.html* . C. Jurisdictional Determinations The agency has made available on the OCP Web site more than 220 capsular descriptions of prior RFD decisions. In selecting which jurisdictional determinations were appropriate to summarize and make public in this way, the agency considered the extent to which the product could be suitably described, the extent to which the existence and description of the product or similarly described products have been made public, and related factors. The agency will continue to update the list of capsular descriptions as new decisions are made and as information on these products becomes publicly available. The capsular descriptions are available at *http://www.fda.gov/oc/combination/determinations.html* . D. Jurisdictional Updates Jurisdictional updates are more detailed statements of the classification and assignment of various product classes. They reflect past agency decisions, and are not intended to be policy statements. Jurisdictional updates generally contain information about the basis for the assignment and classification decisions that have been made. The agency selects product classes to be the subject of jurisdictional updates based on the agency's perception of the current level of interest in the jurisdictional issue, the extent to which the class of products can be clearly described, the extent to which the existence and description of the class of products has been made public, and related factors. Additional jurisdictional updates will be issued as appropriate. Jurisdictional updates are available at *http://www.fda.gov/oc/combination/updates.html* . E. RFD Decision Letters The agency posts on the OCP Web site RFD decision letters for products that have been approved or cleared. These letters have been redacted to remove trade secret and confidential commercial information in accordance with the Freedom of Information Act. It should be noted that, in some cases, products undergo changes in name, sponsor, design, or other key aspects following the agency's issuance of an RFD decision. The agency will post RFD decision letters when it is certain that the covered product has been approved or cleared, but it should be recognized that the posting may be incomplete. Posting of these letters, which generally include the agency's reasoning behind the RFD decision, is intended to provide additional transparency on the jurisdictional process. The letters are available at *http://www.fda.gov/oc/combination/rfd.html* . F. Chemical Action In the course of assigning combination products to an agency center, OCP must often determine whether a product is a combination product—a determination that may turn on whether a constituent part of the product is properly classified as a device. Section 201(h) of the act (21 U.S.C. 321(h)) states that a device cannot achieve its primary intended purposes through chemical action within or on the body of man, or be dependent on being metabolized to achieve its primary intended purposes. The agency plans to develop guidance and/or regulations to further clarify what is meant by “chemical action within or on the body.” When final, such guidance and/or regulations should be helpful to sponsors in determining whether a product is a combination product. G. Devices Regulated by CBER Certain single entity (i.e., noncombination) devices are regulated under the device provisions of the act by CBER, rather than CDRH. One of the main purposes of the CBER-CDRH ICA is to identify categories of devices regulated by CBER. The agency believes, however, that additional guidance describing the assignment of devices that process human cellular and tissue products would be helpful. This product area was not fully envisioned at the time the CBER-CDRH ICA was developed. The agency plans to develop such guidance to assist sponsors in determining whether certain devices would be regulated by CDRH or CBER. H. Combination Product Regulation For some types of combination products, the CDER-CDRH ICA addresses good manufacturing practices, registration and listing, labeling, and other product regulation issues. The agency is developing guidance and/or regulations to address these and other significant areas of combination product regulation, and when final, these documents will ultimately update the limited information provided in the CDER-CDRH ICA on these topics. VI. Practices Specific to Assignment of Combination Products The agency has reviewed its practices specific to the assignment of combination products to ensure that they are in compliance with the requirement of section 503(g)(4)(B) of the act that the agency promptly assign a combination product to an agency center with primary jurisdiction in accordance with section 503(g)(1) of the act. The agency has refined its processing of jurisdictional requests to ensure that the agency makes its assignments promptly. For example, section 503(g)(4)(A) of the act requires OCP, in determining whether a product is appropriately classified as a combination product, to consult with the component within the Office of the Commissioner that is responsible for such determinations. In the **Federal Register** of June 23, 2003 (68 FR 37075), the agency issued a final rule announcing that to enhance the efficiency of agency operations, OCP assumed responsibility from the Office of the Ombudsman for designating the component of FDA with primary jurisdiction for the premarket review and regulation of any product requiring a jurisdictional determination under part 3 (21 CFR part 3). This change consolidated the jurisdiction program within OCP, eliminated the requirement for consultation about the classification of a product as a combination product, and made the RFD program more efficient to administer. The final rule also provided for the electronic submission of RFDs (§ 3.7(d)). Similarly, OCP has refined its internal processes and practices to ensure that all RFDs are resolved within the 60-day timeframe requirement of section 563(b) of the act (21 U.S.C. 360bbb-2(b)) (§ 3.8(b)). All RFDs submitted to OCP since its inception have been resolved within the 60-day period. Furthermore, all requests for reconsideration were responded to within the 15-day timeframe (§ 3.8(c)). For the period from the establishment of OCP through March 31, 2006, FDA's average RFD processing time for assignments of combination products is 37.7 days (median 40 days, range 11-59 days). Accordingly, the agency has preliminarily determined that its practices are consistent with the requirement contained in section 503(g)(4)(B) of the act that it promptly assign combination products to an agency center based on the product's PMOA. FDA plans to continue in effect the process improvements needed to maintain the prompt assignment of combination products, and plans to continue to work to refine its processes further. VII. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: September 22, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-15967 Filed 9-27-06; 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. Mammalian Cell Surface Display of Fvs for Rapid Antibody Maturation *Description of Technology:* This technology describes a new method of cell surface display of single chain antibodies for affinity maturation in a mammalian system. Cells expressing a rare mutant antibody with higher affinity were enriched about 240 fold by a single-pass cell sorting from a large excess of cells expressing wild-type antibodies with slightly lower affinity. Additionally, a highly enriched mutant with increased binding affinity for CD22 after a single selection of a combinatory library randomizing an intrinsic antibody hotspot was successfully obtained. The system is compatible with other mammalian expression systems and it is a rapid, simple and robust procedure. The method can be useful in isolating high affinity antibodies for cancer, AIDS and other diseases. *Applications:*

(1)A new method of displaying Fvs on human cells;

(2)A new method useful to isolate new high affinity antibodies for cancer, AIDS and other diseases. *Market:* The method has a potential several billion dollar market as it can be potentially used in immunotherapeutic approaches for the treatment of cancer, AIDS and other diseases. *Development Status:* The technology is currently in pre-clinical stage of development. *Inventors:* Drs. Ira Pastan and Mitchell Ho (NCI). *Publication:* Mo Ho, S Nagata, I Pastan. Isolation of anti-CD22 Fv with high affinity by Fv display on human cells. Proc Natl Acad Sci USA. Jun 20;103(25):9637-9642. Epub 2006 Jun 8, doi 10.1073/pnas.0603653103. *Patent Status:* U.S. Provisional Application No. 60/794,212 filed 21 Apr 2006 (HHS Reference No. E-200-2006/0-US-01) *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Jesse S. Kindra, J.D.; 301/435-5559; *kindraj@mail.nih.gov.* *Collaborative Research Opportunity:* The National Cancer Institute Laboratory of Molecular Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Mammalian Cell Surface Display of Fvs for Rapid Antibody Maturation. Please contact Betty Tong, PhD at 301-496-0477 or *tongb@mail.nih.gov* for more information. Methods of Identifying and Treating Tumors that Express Erythropoietin Receptor Protein (EPO R) *Description of Invention:* The inventors have discovered that EPO and EPOR are co-expressed in tumors of von Hippel-Lindau

(VHL)patients and in tumors of sporadic renal tumor patients. Ligands that bind to EPOR but do not activate the receptor can target specific tumor cells with minimal detrimental effect on normal cells. *Applications:*

(1)Treatment and diagnosis of renal tumors in sporadic and kidney dialysis patients;

(2)Treatment and diagnosis of multiple tumors in different organs in patients with von Hippel-Landau patients;

(3)Treatment and diagnosis of pheochromocytomas;

(4)Treatment and diagnosis of eye and CNS hemangioblastomas. *Inventors:* Zhengping Zhuang *et al.* (NINDS). *Patent Status:* International Patent Application No. PCT/US2005/033850 filed 20 Sep 2005, which published as WO 2006/034354 on 30 Mar 2006 (HHS Reference No. E-274-2004/0-US-02). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Thomas P. Clouse, J.D.; 301/435-4076; *clouset@mail.nih.gov.* *Collaborative Research Opportunity:* In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. For further information regarding collaborative research opportunities, please contact Dr. Martha Lubet at e-mail: *lubetm@mail.nih.gov* or telephone: 301/435-3120. Diagnostic and Therapeutic Use of SPANX-N Genes in Cancer and Fertility *Description of Technology:* Cancer is the second leading cause of death in United States and it is estimated that there will be approximately 600,000 deaths caused by cancer in 2006. In spite of the success of cancer screening and early diagnosis cancer still remains a life threatening disease. There is a great need for the development of new markers and new therapeutic strategies that would more accurately predict the outcome of the disease and aid in the proper management of cancer. Antibody-based strategies have taken a lead among the new cancer therapeutic approaches. This technology describes the identification of the link between expression of individual members of the SPANX-gene cluster and malignancies including prostate cancer. SPANX-genes consist of two subfamilies, SPANX-A/D and SPANX-N1/N5. The invention provides SPANX polypeptides, nucleic acids and antibodies that could be useful for detecting and treating prostate or other cancers. The SPANX-N genes are a family of related genes that are expressed in normal testis and in tumor cells in humans including melanoma, bladder carcinomas and myelomas. The SPANX cancer/testis antigens thus represent good candidates for diagnosis or treatment of several cancers. The present invention also describes a new approach for mutation screen of the SPANX gene cluster, including gene amplification, linking predisposition to prostate cancer with a specific architecture of the SPANX gene cluster. Additionally, due to the differential localization of SPANX-proteins in the spermatozoa, the mutational screen can be also used for diagnostics of infertility. Developed antibodies against SPANX-A/D and SPANX-N1/N5 proteins can be used for

(i)diagnostics of cancer,

(ii)diagnostics of infertility and iii) for the development of new contraceptives. *Applications:*

(1)Novel antibodies to SPANX-A/D and SPANX-N1/N5;

(2)New approach for mutation screen of SPANX gene cluster;

(3)Antibodies can be used for diagnosis and development of immunotherapeutics for several cancers including prostate;

(4)Compounds can also be used for the diagnosis of infertility and development of new contraceptives. *Market:*

(1)600,000 deaths from cancer related diseases estimated in 2006;

(2)The technology platform involving novel antibodies for the diagnosis and therapeutics of several cancers has a potential market of more than 7 billion U.S. dollars;

(3)The technology platform has additional market in fertility related diagnostics and therapeutics. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Natalay Kouprina

(NCI)*et al.* *Publications:* 1. N Kouprina *et al.* The SPANX gene family of cancer/testis-specific antigens: rapid evolution and amplification in African great apes and hominids. Proc Natl Acad Sci USA. 2004 Mar 2;101(9):3077-3082. Epub 2004 Feb 18, doi 10.1073/pnas.0308532100. 2. N Kouprina *et al.* Dynamic structure of the SPANX gene cluster mapped to the prostate cancer susceptibility locus HPCX at Xq27. Genome Res. 2005 Nov;15(11):1477-1486. 3. N Kouprina and V Larionov. TAR cloning: Insights into gene function, long-range haplotypes, and genome structure and evolution. Nature Reviews Genetics, 7: In press, 2006. 4. N Kouprina *et al.* SPANX-N gene cluster at Xq27: A new group of cancer-testis antigen genes encoding acrosomal proteins. Submitted to Cancer Research, 2006. *Patent Status:* U.S. Provisional Application No. 60/636,811 filed 15 Dec 2004 (HHS Reference No. E-212-2004/0-US-01); PCT Application No. PCT/US2005/045317 filed 15 Dec 2005, which published a WO 2006/065938 on 22 Jun 2006 (HHS Reference No. E-212-2004/1-PCT-01) *Licensing Status:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Mojdeh Bahar, J.D.; 301/435-2950; *baharm@mail.nih.gov* . *Collaborative Research Opportunity:* The National Cancer Institute Laboratory of Biosystems and Cancer is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this new diagnostic marker for malignancy and infertility and new targets for immuno-cancer therapy. Please contact Betty Tong, Ph.D. at 301-594-4263 or *tongb@mail.nih.gov* for more information. Cancer Peptides of NY-ESO-1/CAG-3 *Description of Technology:* The current invention embodies the identification, isolation and cloning of a gene encoding a novel tumor antigen, NY ESO-1/CAG-3, as well as cancer peptides thereof and antigenic cancer epitopes contained within the cancer peptides. This novel antigen is recognized by cytotoxic T lymphocyte clones derived from the TIL586 (tumor infiltrating lymphocyte) cell line in an HLA restricted manner. The inventors believe that cancer peptides which are encoded by the NY ESO-1/CAG-3 gene represent potential cancer vaccines, protecting an individual from development of cancer by inhibiting the growth of cells or tumors which express the NY ESO-1/CAG-3 antigen. Also embodied in the invention are pharmaceutical compositions comprising the NY ESO-1/CAG-3 antigen, peptide, or an antigenic cancer epitope thereof in combination with one or more immunostimulatory molecules. These compositions represent potential anticancer therapeutics, stimulating NY ESO-1/CAG-3-specific T cells to elicit an anti-cancer immunogenic response and thereby eliminating or reducing the cancer. While these vaccines and pharmaceutical compositions may be developed for use against a variety of cancers, data obtained to date indicate that they may be of particular value for use against melanoma. Methods for diagnosing cancer via the detection of NY ESO-1/CAG-3 are also embodied in the invention. *Inventors:* Steven A. Rosenberg

(NCI)*et al.* *Patent Status:* U.S. Patent No. 7,084,239 issued 01 Aug 2006 (HHS Reference No. E-265-1997/0-US-04). *Licensing Status:* Available for non-exclusive licensing or exclusive licensing. *Licensing Contact:* Jesse S. Kindra, J.D.; 301/435-5559; *kindraj@mail.nih.gov.* Dated: September 20, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-15975 Filed 9-27-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Clinical Center; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the NIH Advisory Board for Clinical Research, September 29, 2006, 10 a.m. to September 29, 2006, 2 p.m. National Institutes of Health, Building 10, 10 Center Drive, 4-2551, CRC Medical Board Room, Bethesda, MD 20892 which was published in the **Federal Register** on September 8, 2006, FR 06-7534. The open session will occur from 10 a.m.-1:30 p.m. The closed session will begin approximately at 1:30 p.m. and run until 2 p.m. The meeting will be held in the Clinical Center, Bldg. 10, Rm. 4-2551, CRC Medical Board Room. The meeting is partially Closed to the public. Dated: September 19, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-8329 Filed 9-27-06; 8:45 am]

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