Notices. Notice to alter a system of records

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BILLING CODE 6730-01-M FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated.

The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 20, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. CMJ Interests, LP* , Hinesville, Georgia, Carolyn L. Jones as general partner; to acquire voting shares of Coastal Bankshares, Inc., and thereby indirectly acquire voting shares of The Coastal Bank, both of Savannah, Georgia.

Board of Governors of the Federal Reserve System, October 31, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-18560 Filed 11-02-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843).

Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 27, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1.

SouthEast Bancshares, Inc.* ; to become a bank holding company by acquiring 100 percent of the voting shares of SouthEast Bank & Trust, both of Athens, Tennessee. **B. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. John T. Vucurevich Foundation* , Rapid City, South Dakota, to become a bank holding company by acquiring 100 percent of the voting shares of United Bancorporation, Osseo, Wisconsin, and thereby indirectly Lincoln County Bank, Merrill, Wisconsin, United Bank, Osseo, Wisconsin;

Bank of Poynette, Poynette, Wisconsin; Cambridge State Bank, Cambridge, Wisconsin; and Midwest Bancorporation, Billings, Montana, and thereby indirectly acquire voting shares of Clarke County State Bank, Osceola, Iowa; Farmers & Merchants State Bank, Iroquois, South Dakota, and Farmers State Bank, Stickney, South Dakota. **C. Federal Reserve Bank of Dallas** (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272: *1. Olney Bancshares of Texas, Inc.* , Olney, Texas, and Olney Bancorp of Delaware, Inc., Wilmington, Delaware; to acquire 100 percent of the voting shares of InterBank, Inc., Sayre, Oklahoma, and thereby indirectly acquire voting shares of InterBank, Elk City, Oklahoma.

Board of Governors of the Federal Reserve System, October 30, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-18541 Filed 11-2-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

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 November 30, 2006. **A. Federal Reserve Bank of Richmond** (A. Linwood Gill, III, Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528: *1.

TrustAtlantic Financial Corporation* , Raleigh, North Carolina; to become a bank holding company by acquiring 100 percent of the voting shares of Millennia Community Bank, Greenville, North Carolina. **B. Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Greene Investment Co.* , Jefferson, Iowa; to merge with Audubon Investment Company, Carroll, Iowa, and thereby indirectly acquire Audubon State Bank, Audubon, Iowa. *2.

PrivateBancorp, Inc.* , Chicago, Illinois; to acquire 100 percent of the voting shares of The PrivateBank, N.A. (in organization) Milwaukee, Wisconsin. Board of Governors of the Federal Reserve System, October 31, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-18562 Filed 11-02-06; 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 November 30, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. IBERIABANK Corporation* , Lafayette, Louisiana; to merge with Pocahontas Bancorp, Inc., and thereby indirectly acquire First Community Bank, both of Jonesboro, Arkansas, and engage in operating a savings association, pursuant to section 225.28(b)(4)(ii) of Regulation Y. **B.

Federal Reserve Bank of Chicago** (Patrick M. Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Bankers' Bancorp, Inc.* , Springfield, Illinois to acquire 100 percent of the voting shares of Bankers' Banc Investment Services, LLC, St. Louis, Missouri, and thereby indirectly acquire voting shares of First St. Louis Capital Markets, Inc., and its subsidiary, First St. Louis Securities, Inc., both of St. Louis, Missouri, and thereby engage in securities brokerage, private placement services, and underwriting government obligations and money market instruments, pursuant to sections 225.28(b)(7)(i), (b)(7)(iii), and (b)(8)(i) of Regulation Y.Comments regarding this application should be received not later than November 20, 2006.

Board of Governors of the Federal Reserve System, October 31, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-18561 Filed 11-2-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Privacy Act of 1974 AGENCY: Federal Retirement Thrift Investment Board. ACTION: Notice to alter a system of records. SUMMARY: The Federal Retirement Thrift Investment Board (Agency) proposes to alter a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

This proposed change is necessary due to new communication technologies and is required in order to assist the Agency in implementing its Continuity of Operations Plan. DATES: *Effective Date:* This proposed action will be effective without further notice on December 4, 2006 unless comments are received which result in a contrary determination. ADDRESSES: Comments may be sent to Stephen D. Suetterlein, Associate General Counsel, Federal Retirement Thrift Investment Board, 1250 H Street, NW., Washington, DC 20005.

The Agency's fax number is

(202)942-1676. FOR FURTHER INFORMATION CONTACT: Stephen D. Suetterlein on

(202)942-1660. SUPPLEMENTARY INFORMATION: The Agency's systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the **Federal Register** and are available from the address above. The proposed system reports, as required by 5 U.S.C. 552a(r), of the Privacy Act of 1974, as amended, were submitted to the House Committee on Government Reform, the Senate Committee on Homeland Security and Government Affairs, and the Office of Management and Budget

(OMB)pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427). Thomas K. Emswiler, General Counsel, Federal Retirement Thrift Investment Board. FRTIB-9 System Name: Employee Locator Card Files (May 7, 1990, 55 FR 18949-01). Changes: System name: Delete entry and replace with “Organization Management and Locator System.” System location: Delete entry and replace with: “Federal Retirement Thrift Investment Board, 1250 H Street, NW., Washington DC 20005.” Categories of individuals covered by the system: Delete entry and replace with: “Civilian and contractor personnel working for the Agency; former employees; applicants for civilian employment, volunteers, and individuals designated as emergency points of contact.” Categories of records in the system: Delete entry and replace with: “This system contains information regarding the organizational location, telephone extension, and e-mail address of individual Agency employees and contractors. The system also contains the home address, telephone number, cell phone number, and e-mail address of the individual, and the name, address, and telephone number of an individual to contact in the event of a medical or other emergency involving the employee.” Authority for maintenance of the system: Purpose(s): Delete the entry and replace with: “Information is used to prepare organizational charts and directories, recall rosters, emergency notification rosters, and social rosters; notify personnel of arrival of visitors; locate individuals on routine and/or emergency matters; locate individuals during medical emergencies, facility evacuations and similar threat situations; provide mail distribution and forwarding addresses; compile a social roster for official and non-official functions; send personal greetings and invitations; and, similar administrative uses requiring personnel data.” Routine uses of records maintained in the system, including categories of users and the purposes of such uses: Delete the entry and replace with: “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the Agency as a routine use pursuant to 5 U.S.C. 552a(b)(b)(3) as follows: a. By the Agency in the production of summary descriptive statistics and analytical studies in support of the function for which the records are collected and maintained, or for related work force studies. While published statistics and studies do not contain individual identifiers, in some instances the selection of the elements of data included in the study may be structured in such a way as to make the data individually identifiable by inference. b. To disclose, in response to a request for discovery or for appearance of a witness, information that is relevant to the subject matter involved in a pending judicial or administrative proceeding.” Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Delete entry and replace with: “Storage: Electronic data bases and paper records. Retrievability: Records are retrieved by the name of the individual on whom they are maintained. Safeguards: Records are maintained in secured areas and electronic systems and are available only to authorized personnel whose duties require access. Retention and disposal: Records are maintained as long as the individual is an employee or contractor for the Agency. Expired records are destroyed by burning or shredding or purging from the Agency's electronic record keeping systems.” System manager and address: Delete the entry and replace with: “Office directors maintain records pertaining to that director's employees or contractor personnel. The Director, Automated Systems, maintains the Agency's electronic emergency notification roster. The Chief Financial Officer maintains all other records in FRTIB-9. Any of these individuals may be contacted in writing at 1250 H Street, NW., Washington, DC 20005.” Notification procedure: Delete the entry and replace with: “Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to their Office Director; the Director, Automated Systems; or the Chief Financial Officer at Federal Retirement Thrift Investment Board, 1250 H Street, NW., Washington, DC 20005. Individuals must supply their full name for their records to be located and identified.” Record access procedures: Delete the entry and replace with: “Individuals wishing to request access to records about them should contact the Office Director; Director, Automated Systems; or Chief Financial Officer. Individuals must supply their full name for their records to be located and identified.” Contesting record procedures: Delete the entry and replace with: “Individuals wishing to request amendment of their records under the provisions of the Privacy Act should contact the respective system manager. Individuals must furnish full name for their records to be located and identified.” Record source categories: Systems exempted from certain provisions of the act: [FR Doc. E6-18546 Filed 11-2-06; 8:45 am] BILLING CODE 6760-01-P GENERAL SERVICES ADMINISTRATION Privacy Act of 1974; Privacy Act System of Records AGENCY: General Services Administration ACTION: Final Notice SUMMARY: The General Services Administration

(GSA)is publishing a final notice for the Government-wide system of records, GSA SmartPay® Purchase Charge Card Program (GSA/GOVT-6). This final notice incorporates changes from feedback received to the notice originally published for public comment on June 16, 2006, proposing the establishment of the SmartPay® Purchase Charge Care Program as a system of records under the Privacy Act of 1974, 5 U.S.C. 552a. The feedback was provided by Federal agencies’ program coordinators and were minor in nature, consisting of requests for clarification of terms and inclusion of certain examples, *i.e.* , an explanation of what constitutes an “expert, consultant, or contractor” in routine use h., and inclusion of “Approving Agency Officials and Federal agency/organization program coordinators” to clarify the types of Federal employees covered by the system. Additionally, minor editorial changes were made to ensure clarity. All changes were agreed to by the individuals who provided the feedback. **SUPPLEMENTARY INFORMATION:** The GSA SmartPay® Purchase Charge Card Program (GSA/GOVT-6) system of records, for which GSA has Government-wide responsibility, assembles and maintains charge card related information and ensures the efficient and cost effective operation, control, and management of commercial purchasing activities by Federal agencies. The system includes personal information of individuals to enhance the Federal government’s ability to monitor official purchases, payments, and expenses involving purchase charge card transactions. DATES: The system of records will become effective on the date of publication of this notice. FOR FURTHER INFORMATION: Write the Director, Support Services Division, Federal Acquisition Service, General Services Administration, 1901 South Bell Street, Arlington VA 22202; or call the GSA Privacy Act Officer

(CIB)on

(202)501-1452. Dated: October 27, 2006. Cheryl M. Paige Acting Director, Office of Information Management. GSA/GOVT-6 System name: GSA SmartPay® Purchase Charge Card Program System location: System records are located at the Federal agency for which an individual is authorized to perform purchase charge card transactions. Records necessary for a contractor to perform under a Federal agency contract are located at the contractor's facility. Contact the System Manager for additional information. Categories of individuals covered by the system: Individuals covered by the system are Federal Agency Approving Officials; Federal Agency/Organization Program Coordinators; and Federal employees, contractors, and other individuals who apply for and/or use government-assigned purchase charge cards. Categories of Records in the System: The system provides control over expenditure of funds through the use of Federal government purchase cards. System records include: a. Personal information on individuals who apply for and use Federal government charge cards including name and Social Security Number or other personal identifier ( *e.g.* , employee ID). The system also includes information of a non-personal nature such as agency of employment, business address (city, state, country, and zip code), title or position, business telephone, business fax number, and e-mail address. b. Account processing and management information, including purchase authorizations and vouchers, charge card applications, charge card receipts, terms and conditions for card use, charge card transactions, contractor monthly reports showing charges to individual account numbers, account balances, and other data needed to authorize, account for, and pay authorized purchase card expenses. Authorities for maintenance of the system: E.O. 9397; E.O. 12931; 40 U.S.C. Sec. 501-502. Purpose: To establish and maintain a system for operating, controlling, and managing the purchase charge card program involving commercial purchases by authorized Federal government employees and contractors. Routine uses of the system records, including categories of users and their purpose for using the system: System information may be accessed and used by authorized Federal agency employees or contractors to conduct official duties associated with the management and operation of the purchase charge card program. Information from this system also may be disclosed as a routine use: a. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order, where an agency becomes aware of a violation or potential violation of civil or criminal law or regulation. b. To an appeal, grievance, or formal complaints examiner; equal employment opportunity investigator; arbitrator; or other official engaged in investigating, or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record. c. To officials of labor organizations recognized under Pub. L. 95-454, when necessary to their duties of exclusive representation on personnel policies, practices, and matters affecting working conditions. d. To another Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; clarifying a job; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision. e. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), the Government Accountability Office

(GAO)or other Federal agency when the information is required for program evaluation purposes. f. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record. g. To the National Archives and Records Administration

(NARA)for records management purposes. h. To an expert, consultant, or contractor in the performance of a Federal duty to which the information is relevant, including individuals, organizations, private or public agencies, or other entities or individuals with whom a Federal agency/organization has a contract or agreement to perform such services, including issuance of charge cards, as that agency/organization may deem practicable for the purposes of laws administered by the agency/organization, in order for the contractor, subcontractor, public or private agency, or other entity or individual with whom the agency/organization has an agreement or contract to perform the services of the contract or agreement. This routine use includes disclosures by the individual or entity performing the service for the Federal agency/organization to any secondary entity or individual to perform an activity that is necessary for individuals, organizations, private or public agencies, or other entities or individuals with whom the agency/organization has a contract or agreement to provide the service to the agency/organization. i. To GSA in the form of listings, reports, and records of all transportation related transactions, including refunds and adjustments, by the contractor to enable audits of transportation related charges to the Government. j. To GSA contract agents assigned to participating agencies for billing of purchase expenses. k. To agency finance offices for debt collection purposes. Policies and practices for storing, retrieving, accessing, retaining, and disposing of system records: Storage: Information may be collected on paper or electronically and may be stored on paper or on electronic media, as appropriate. Retrievability: Records may be retrieved by name, Social Security Number, credit card number, and/or other personal identifier ( *e.g.* , employee ID) or appropriate type of designation. Safeguards: System records are safeguarded in accordance with the requirements of the Privacy Act, the Computer Security Act, and OMB Circular A-130. Technical, administrative, and personnel security measures are implemented to ensure confidentiality and integrity of the system data stored, processed, and transmitted. Paper records are stored in secure cabinets or rooms to which only authorized individuals have access. Electronic records are protected by passwords and other appropriate security measures. Retention and disposal: Disposition of records is according to the National Archives and Records Administration

(NARA)guidelines, as set forth in the handbook, GSA Records Maintenance and Disposition System (OAD P 1820.2A and CIO P 1820.1), authorized GSA records schedules, and by individual agencies. System manager and address: Director, Office of Commercial Acquisition (FC), General Services Administration, 1901 South Bell Street, Arlington VA 22202. Also, officials responsible for individual agency purchase card programs using the SmartPay® system ( *e.g.* , Federal Agency/Organization Program Coordinators). Notification procedure: Individuals may obtain information about their records from the purchase charge card program manager of the agency for which they transact purchases. Record access procedures: Requests from individuals for access to their records should be addressed to their agency's purchase charge card program manager or to the finance office of the agency for which the individual transacts purchases. Contesting record procedures: Individuals may access their records, contest the contents, and appeal determinations according to their agency’s rules. Record source categories: Information is obtained from individuals submitting charge card applications, monthly contractor reports, purchase records, managers, other agencies, non-Federal sources such as private firms, and other agency systems containing information pertaining to the purchase charge card program. [FR Doc. E6-18600 Filed 11-02-06; 8:45 am] BILLING CODE 6820-34-S OFFICE OF GOVERNMENT ETHICS Proposed Collection; Comment Request for Unmodified SF 278 Executive Branch Personnel Public Financial Disclosure Report AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: The Office of Government Ethics is publishing this first round notice and seeking comment on the Standard Form

(SF)278 because it intends to submit the form for extension of approval (up to three years) by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act. OGE is making no changes to the SF 278 at this time. As in the past, OGE will ask agencies to notify filers of two updates to the information contained in the existing SF 278. DATES: Written comments by the public and the agencies on this proposed extension are invited and must be received by January 2, 2007. ADDRESSES: You may submit comments to OGE on this paperwork notice by any of the following methods: • *E-mail: usoge@oge.gov.* (Include reference to “SF 278 Paperwork Comment” in the subject line of the message). • *Fax:* 202-482-9237. • *Mail* , Hand Delivery/Courier: Office of Government Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917, *Attention:* Paul D. Ledvina, Records Officer, Information Resources Management Division. FOR FURTHER INFORMATION CONTACT: Mr. Ledvina at the Office of Government Ethics; *telephone:* 202-482-9281; *TDD:* 202-482-9293; *fax:* 202-482-9237; *e-mail: pdledvin@oge.gov.* A copy of a blank SF 278 may be obtained, without charge, by contacting Mr. Ledvina. Also, a copy of a blank SF 278 is available through the Forms, Publications & Other Ethics Documents section of OGE's Web site at *www.usoge.gov.* SUPPLEMENTARY INFORMATION: The Office of Government Ethics intends to submit, after this notice and comment period, the unmodified Standard Form 278 Executive Branch Personnel Public Financial Disclosure Report (OMB control number 3209-0001) for extension of approval for (up to) three years by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). The current paperwork approval for the SF 278 expires at the end of November 2006. The Office of Government Ethics, as the supervising ethics office for the executive branch of the Federal Government under the Ethics in Government Act (the Ethics Act), is the sponsoring agency for the Standard Form 278. OGE will not seek General Services Administration

(GSA)standard forms clearance for this extension because no modification to this standard form is proposed. In accordance with section 102 of the Ethics Act, 5 U.S.C. app. section 102, and OGE's implementing financial disclosure regulations at 5 CFR part 2634, the SF 278 collects pertinent financial information from certain officers and high-level employees in the executive branch for conflicts of interest review and public disclosure. The SF 278 is also completed by individuals who are nominated by the President for high-level executive branch positions requiring Senate confirmation and new entrants to other public reporting positions in the executive branch. The financial information collected under the statute and regulations relates to: assets and income; transactions; gifts, reimbursements and travel expenses; liabilities; agreements or arrangements; outside positions; and compensation over $5,000 paid by a source—all subject to various reporting thresholds and exclusions. Current Version of the SF 278 The Office of Government Ethics is proposing no modifications to the SF 278 at this time. OGE will continue to make the unmodified SF 278 available to departments and agencies and their reporting employees through the Forms, Publications & Other Ethics Documents section of OGE's Web site. This provides filers with two electronic options for preparing their report on a computer (as well as a downloadable blank form). There is also a link on the OGE Web site to another electronic version of the SF 278 maintained by the Department of Defense. In addition, GSA separately maintains two electronic versions of the form on its Web site ( *www.gsa.gov* ); paper forms can also be ordered through GSA. The Office of Government Ethics has determined that at this time, electronic filing of the SF 278 using an Internet-based system will not be permitted. A printout and manual signature of the form are still required unless otherwise specifically approved by OGE. Further developments on electronic filing may be forthcoming as part of a broader E-Gov initiative. Agency Notification of Updates There are two ways in which the content of the current SF 278 report form is affected. The first concerns adjustments in the gifts/reimbursements reporting thresholds. The second involves revised routine use language contained in the Privacy Act Statement of the form. OGE is proposing no revisions to the SF 278, but will continue to ask executive branch departments and agencies to inform SF 278 filers, through cover memorandum or otherwise, of these two updates when the existing March 2000 edition of the SF 278 report forms are provided for completion. See OGE's August 25, 2003 memorandum to designated agency ethics officials (DO-03-015), posted in the “DAEOgrams” section of the OGE Web site. Information regarding these changes is also posted along with the SF 278 in the forms section of OGE's Web site. In addition, OGE will post on its Web site an updated summary of one of the Privacy Act routine uses on the report form (see discussion below). Gifts/Reimbursements Reporting Thresholds Every three years OGE issues final rule amendments that revise the executive branch financial disclosure regulation to increase the aggregation and exception thresholds for reporting of gifts, reimbursements and travel expenses for the public and confidential report systems. See 5 U.S.C. app. section 102(a)(2)(A) & (B). The OGE aggregation threshold limits the total value of gifts and reimbursements from any one source. The exception threshold limits the value of individual gifts that must be counted toward the aggregation threshold. OGE's threshold adjustments are tied to the “minimal value” threshold of the Foreign Gifts and Decorations Act, as determined by GSA under 5 U.S.C. 7342. Since 2002, OGE has asked agencies to notify filers of the SF 278 of the updated adjustments to the reporting thresholds for gifts and reimbursements. Effective January 1, 2005, GSA raised the “minimal value” threshold under 5 U.S.C. 7342 to $305 or less for the three-year period 2005-2007. See 70 FR 2317-2318 (part V) (January 12, 2005). Following GSA's action, OGE advised agencies of the adjusted thresholds and revised its financial disclosure regulation to reflect the increase in the thresholds for SF 278 reporting of gifts and travel reimbursements received from any one source to “more than $305” for the aggregation level for reporting and to “$122 or less” for the *de minimis* aggregation exception threshold. See March 17, 2005 memorandum to designated agency ethics officials (DO-05-007) and 70 FR 12111-12112 (March 11, 2005). Both GSA and OGE rulemakings and OGE's memorandum are posted on the OGE Web site. Privacy Act Statement In addition, OGE has updated the OGE/GOVT-1 Privacy Act system of records notice (covering SF 278 Public Financial Disclosure Reports and other name-retrieved ethics program records). See 68 FR 3097-3109 (January 22, 2003), as corrected at 68 FR 24744 (May 8, 2003). As a result, the Privacy Act Statement, which includes summaries of the routine uses on page 11 of the instructions on the SF 278, is affected. As explained in the above-noted OGE memorandum DO-03-015 and the SF 278 notice posted on OGE's Web site, the system notice update added three new routine uses applicable to SF 278 reports. Moreover, OGE will also ask agencies to inform filers of an update needed to the summary of the sixth listed routine use on the form in their periodic notifications to filers of changes to the SF 278. See revised routine use “h” at 68 FR 3100 for the OGE/GOVT-1 records system notice. OGE has already updated that same sixth routine use summary for two of its other forms, the OGE Form 201 and the OGE Optional Form 450-A, and is preparing to do so for the proposed future modified OGE Form 450 for use starting in 2007. The first two forms are posted in the forms section of the OGE Web site; see the paperwork notices in 2005 and 2006 for the latter form posted in the Laws & Regulations section of OGE's Web site. A summary of the updates relevant to that SF 278 statement will be included with the paperwork clearance submission to OMB. SF 278 Filers The SF 278 is completed by candidates, nominees, new entrants, incumbents and terminees of certain high-level positions in the executive branch of the Federal Government. These reports are routinely reviewed by the agencies concerned. The Office of Government Ethics, along with the agencies concerned, conducts the review of the SF 278 reports of Presidential nominees subject to Senate confirmation and incumbents in and terminees from such positions. Reporting Burden The Office of Government Ethics estimates, based on the agency ethics program questionnaire responses for 2003-2005, that an average of some 23,971 SF 278 report forms are filed annually at departments and agencies throughout the executive branch. Most of those executive branch filers are current Federal employees at the time they file. However, an estimated 4.9 percent, or some 1,175 of the branchwide total SF 278 filers are members of the public, including private citizen Presidential nominees to positions subject to Senate confirmation (and their private representatives-lawyers, accountants, brokers and bankers), other private citizen prospective new entrants to reportable positions, and those who file termination reports from such positions after their Government service ends, and Presidential and Vice Presidential candidates. The OGE estimate covers the next three years, 2007-2009, including a significant increase in reports anticipated with the fall 2008 Presidential election and following transition. The estimated average amount of time to complete the report form, including review of the instructions and gathering of needed information, remains the same as previously reported, at three hours. Thus, the overall estimated annual public burden for the SF 278 for the private citizen/representative nominee and terminee report forms processed in executive branch agencies, and those report forms processed by the OGE, including private citizen Presidential and Vice Presidential candidates report forms, is 3,525 hours. The prior paperwork burden estimate for the 2003-2005 period was 1,347 hours. This estimate was based upon an annual average of 449 SF 278 forms, those received only at OGE from private citizen/representative nominee and terminee filers, and Presidential and Vice Presidential candidates. The burden estimate for 2007-2009 is adjusted to cover private citizen filers in departments and agencies throughout the executive branch. Consideration of Comments Public comment is invited on each aspect of the SF 278 Public Financial Disclosure Report as set forth in this notice, including specifically views on the need for and practical utility of this collection of information, the accuracy of OGE's burden estimate, the potential for enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). Any comments received in response to this notice will be summarized for, and may be included with, OGE's request to OMB for paperwork approval for this information collection. Comments will also become a matter of public record. After reviewing any comments received, OGE will also publish a second round notice in the **Federal Register** to inform the public and the agencies at the time it submits the request for OMB paperwork approval. Approved: October 26, 2006. Robert I. Cusick, Director, Office of Government Ethics. [FR Doc. E6-18554 Filed 11-2-06; 8:45 am] BILLING CODE 6345-02-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-234] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* Extension of a currently approved collection. *Title of Information Collection:* Subpart D—Private Contracts and Supporting Regulations in 42 CFR 405.410, 405.430, 405.435, 405.440, 405.445, and 405.455. *Use:* Under the section 4507 of the Balanced Budget Act of 1997, CMS is required to permit certain physicians and practitioners to opt out of Medicare and furnish covered services to Medicare beneficiaries through private contracts. *Form Number:* CMS-R-234 (OMB#: 0938-0730). *Frequency:* Reporting—Biennially. *Affected Public:* Business or other for-profits. *Number of Respondents:* 26,820. *Total Annual Responses:* 26,820. *Total Annual Hours:* 7,197. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on January 2, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: October 24, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-18412 Filed 11-2-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-64, CMS-3070G-I, CMS-576A, and CMS-304/304A] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved information collection. *Title of Information Collection:* Indirect Medical Education

(IME)and Supporting Regulations 42 CFR 412.105; Direct Graduate Medical Education

(GME)and Supporting Regulations in 42 CFR 413.75-413.73. *Use:* The collection of information on interns and residents

(IR)is needed to properly calculate Medicare program payments to hospitals that incur indirect and direct costs for medical education. The agency's Intern and Resident Information System

(IRIS)and similar contractor systems use the information for producing reports of duplicate full-time equivalent IR counts for IME and GME. The contractors also use this information to ensure that hospitals are properly reimbursed for IME and GME, and help eliminate duplicate reporting of IR counts which inflate payments. The collection of this information affects 1,215 hospitals which participate in approved medical education programs. *Form Number:* CMS-R-64 (OMB#: 0938-0456). *Frequency:* Recordkeeping and Reporting—Annually. *Affected Public:* Not-for-profit and Business or other for-profit institutions. *Number of Respondents:* 1,215. *Total Annual Responses:* 1,215. *Total Annual Hours:* 2,430. 2. *Type of Information Collection Request:* Extension of a currently approved information collection. *Title of Information Collection* : Intermediate Care Facility for the Mentally Retarded or Persons with Related Conditions ICF/MR Survey Report Form and Supporting Regulations at 42 CFR 442.30, 483.410, 483.420, 483.440, 483.50, and 483.460. *Use* : The survey forms are needed to ensure provider compliance. In order to participate in the Medicaid program as an ICF/MR, providers must meet Federal standards. The survey report form is used to record providers' level of compliance with the individual standard requirements and report it to the Federal government. *Form Number:* CMS-3070G-I (OMB#: 0938-0062). *Frequency:* Recordkeeping and Reporting—Annually. *Affected Public:* Business or other for-profit and Not-for-profit institutions. *Number of Respondents:* 6,428. *Total Annual Responses:* 6,428. *Total Annual Hours:* 19,284. 3. *Type of Information Collection Request:* Extension of a currently approved collection. *Title of Information Collection:* Organ Procurement Organization's

(OPOs)Health Insurance Benefits Agreement and Supporting Regulations at 42 CFR 486.301-486.348. *Use:* The information provided on this form serves as a basis for continuing the agreements with CMS and the 58 OPOs for participation in the Medicare and Medicaid programs and for reimbursement of service. *Form Number:* CMS-576A (OMB#: 0938-0512. *Frequency:* Reporting—Every 4 years and as needed. *Affected Public:* Business or other for-profit and Not-for-profit institutions. *Number of Respondents:* 58. *Total Annual Responses:* 58. *Total Annual Hours:* 116. 4. *Type of Information Collection Request:* Extension of a currently approved information collection. *Title of Information Collection:* Reconciliation of State Invoice and Prior Quarter Adjustment Statement. *Use:* Section 1927 of the Social Security Act requires drug labelers to enter into and have in effect a rebate agreement with CMS for States to receive funding for drugs dispensed to Medicaid recipients. Drug manufacturers must complete and submit to States the CMS-304 form to explain any rebate payment adjustments for the current quarter, and complete and submit the CMS-304A form to States to explain rebate payment adjustments to any prior quarters. Both forms are used to reconcile drug rebate payments made by manufacturers with the States invoices of rebates due. *Form Number:* CMS-304/304A (OMB#: 0938-0676). *Frequency:* Recordkeeping and Reporting—Quarterly. *Affected Public:* Business or other for-profit. *Number of Respondents:* 550. *Total Annual Responses:* 3,740. *Total Annual Hours:* 139,480. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974. Dated: October 24, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-18413 Filed 11-2-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0425] Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on premarket notification. DATES: Submit written or electronic comments on the collection of information by January 2, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Premarket Notification—21 CFR Part 807; Subpart E—(OMB Control Number 0910-0120) Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) and the implementing regulation under part 807 (21 CFR part 807, subpart E) require a person who intends to market a medical device to submit a premarket notification submission to FDA at least 90 days before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use. Based on the information provided in the notification, FDA must determine whether the new device is substantially equivalent to a legally marketed device, as defined in § 807.92(a)(3). If the device is determined to be not substantially equivalent to a legally marketed device, it must have an approved premarket approval application (PMA), Product Development Protocol or be reclassified into class I or class II before being marketed. The FDA makes the final decision of whether a device is equivalent or not equivalent. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) added section 510(o) to the act to establish new regulatory requirements for reprocessed single-use devices (SUDs). MDUFMA was signed into law on October 26, 2002. Section 510(o) of the act requires that FDA review the types of reprocessed SUDs subject to premarket notification requirements and identify which of these devices require the submission of validation data to ensure their substantial equivalence to predicate devices. Section 510(o) also requires that FDA review critical and semicritical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require the submission of premarket notifications to ensure their substantial equivalence to predicate devices. FDA has identified the reprocessed SUDs that require the submission of validation data to date. The requirement to submit validation data for certain reprocessed SUDs has been incorporated into the premarket notification program. As with all other devices, new premarket notifications for reprocessed SUDs will be required as new manufacturers enter the market or manufacturers with cleared premarket notifications make significant changes to their device. The burden estimates below include the burden for submitting premarket notifications for reprocessed SUDs with the burden for all other devices. FDA may amend the lists of reprocessed SUDs that require the submission of premarket notifications with validation data as necessary. Section 807.81 states when a premarket notification is required. A premarket notification is required to be submitted by a person who is: • Introducing a device to the market for the first time; • Introducing or reintroducing a device which is significantly changed or modified in design, components, method of manufacturer, or the intended use that could affect the safety and effectiveness of the device. Section 807.87 specifies information required in a premarket notification submission. Section 204 of the Food and Drug Administration Modernization Act (FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions including premarket notifications or other requirements. FDA has published and updated the list of recognized standards regularly since enactment of FDAMA and has allowed 510(k) submitters to certify conformance to recognized standards to meet the requirements of § 807.87. Certification of conformance to a recognized standard may allow a manufacturer to submit an abbreviated 510(k). FDA is now seeking approval of a form (Form FDA 3654) that will standardize certification of conformance to a recognized standard. FDA believes that use of this form will simplify the certification process for 510(k) submitters and the review process for FDA. Form FDA 3514, a summary cover sheet form, has been created to assist respondents in categorizing 510(k) information for submission to FDA. This form also assists respondents in categorizing information for other FDA medical device programs such as PMAs, investigational device exemptions, and humanitarian device exemptions. The total burden (1,000 hours) for Form FDA 3514 has been included in this information collection. Form FDA 3654 is used in the following information collections: 0910-0078, 0910-0231, and 0910-0332, but the burden is approved under this information collection (0910-0120). Under § 807.87(h), each 510(k) submitter must include in the 510(k) either a summary of the information in the 510(k) (510(k) summary) or a statement certifying that the submitter will make available upon request the information in the 510(k) (510(k) statement). If the 510(k) submitter includes a 510(k) statement in the submission, § 807.93 requires that the official correspondent of the firm make available within 30 days of a request all information included in the submitted premarket notification on safety and effectiveness. This information will be provided to any person within 30 days of a request if the device described in the premarket notification submission is determined to be substantially equivalent. The information provided will be a duplicate of the premarket notification submission including any safety and effectiveness information, but excluding all patient identifiers and trade secret and confidential information. The most likely respondents to this information collection will primarily be medical device manufacturers including reprocessors of SUDs, and initial importers of devices. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section Form FDA Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 807, subpart E (807.81 and 807.87/510(k)) 3,700 1 3,700 80 296,000 3514 2,000 1 2,000 0.5 1,000 3654 150 1 150 1 150 Totals 297,150 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section Form FDA Number No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 807.93 2,000 10 20,000 0.5 10,000 Total 10,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA has based these estimates on conversations with industry and trade association representatives, and from internal review of the documents listed in tables 1 and 2. Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18553 Filed 11-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0247] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Device User Fee Cover Sheet AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(CBER)to initiate the administrative screening of new medical device applications and supplemental applications. According to the FDA database system, there are an estimated 4,600 manufacturers of products subject to MDUFMA. However, not all manufacturers will have any cover sheet submissions in a given year and some may have multiple cover sheet submissions. The total number of annual responses is based on the number of coversheet submissions received by FDA in fiscal year

(FY)2005. CDRH received 4,436 annual responses that included the following: 43 premarket approval applications, 4,071 premarket notifications, 22 modular premarket applications, 1 product development protocol, 1 premarket report, 15 panel track supplements, 174 real-time supplements, and 109 180-day supplements. CBER received 106 annual responses that included the following: 2 premarket approval applications, 16 biologics license applications, 84 premarket notifications, 1 modular premarket application, 2 180-day supplements, and 1 real-time supplement. The number of received annual responses in FY 2005 included the cover sheets for applications that were qualified for small businesses and fee waivers or reductions. The estimated hours per response are based on past FDA experience with the various cover sheet submissions, and range from 5 to 30 minutes. The hours per response are based on the average of these estimates. In the **Federal Register** of June 29, 2006 (71 FR 37082), FDA published a 60-day notice soliciting comments on the proposed collection of information. In response to that notice, one comment was received regarding the MDUFMA cover sheet. FDA responded as follows “The current layout of the online form is to ensure information and questions presented on the Web site are easy to read for all users. When this system was constructed, the Food and Drug Administration was limited to the format and the layout of questions and answers. FDA took an already approved form and created an interactive system that determines the payments of requested applications based on the answers to the questions. The questions are sequential. After completing the first question, the system decides and chooses the next question for the customers. This **Federal Register** notice renews the current construction. Careful consideration during the next review will be given and FDA will certainly consider the commenter's suggestion of saving screen refresh time.” As noted previously, FDA will be glad to take under consideration the commenter's template and the ability to download the form, when the next update or review is initiated. You can, however, retrieve an existing cover sheet by logging into the system, and clicking on the name of the cover sheet. The retrieved form is a photo shot html format. Thus, no changes can be made directly onto the form. To print the cover sheet, please select “Print Cover Sheet” on the bottom of the form. Currently, the printed cover sheet contains all information on one page. Again, FDA will be glad to consider this request during the next review. The current cover sheet is designed to contain all information on one page. By creating more room on the left margin, the form may extend to two pages. Having instructions 1 through 6 on the cover sheet seems redundant. However, at the time, when creating the interactive system, FDA took into consideration that once a cover sheet is completed and ready to mail, all information would be displayed on the same page. Instructions 1 through 6 are very important information for all customers to follow in order to expedite the application review process. The instructions printed on the cover sheet provide easy access for all customers to learn about them, especially for new users. FDA will continue to use the current form. For other questions regarding submitted cover sheets, please contact the User Fee Hotline at 301-827-9539, or e-mail the User Fee Financial Support Team at *userfees@fda.gov* . The most likely respondents would be medical device manufacturers. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Form FDA No. No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3601 4,600 1 4,600 0.30 1,380 Total 1,380 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18557 Filed 11-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0427] Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for reporting and recordkeeping, general and specific requirements, and the availability of sample electronic products for manufacturers and distributors of electronic products. DATES: Submit written or electronic comments on the collection of information by January 2, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products (OMB Control Number 0910-0025)—Extension Under sections 532 through 542 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA has the responsibility to protect the public from unnecessary exposure of radiation from electronic products. The regulations issued under these authorities are listed in the Code of Federal Regulations, title 21, chapter I, subpart J. Specifically, subpart A regulations, 21 CFR 5.10(a)(3), 5.25(b), 5.35(a)(4), and 5.600 through 5.606, delegate administrative authorities to FDA. Section 532 of the act directs the Secretary of the Department of Health and Human Services (the Secretary), to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of electronic product radiation from electronic products. The program is designed to protect the public health and safety from electronic radiation, and the act authorizes the Secretary to procure (by negotiation or otherwise) electronic products for research and testing purposes and to sell or otherwise dispose of such products. Section 534(g) of the act directs the Secretary to review and evaluate industry testing programs on a continuing basis; and section 535(e) and

(f)of the act directs the Secretary to immediately notify manufacturers of, and ensure correction of, radiation defects or noncompliances with performance standards. Section 537(b) of the act contains the authority to require manufacturers of electronic products to establish and maintain records (including testing records), make reports, and provide information to determine whether the manufacturer has acted in compliance. Parts 1002 through 1010 (21 CFR parts 1002 through 1010) specify reports to be provided by manufacturers and distributors to FDA and records to be maintained in the event of an investigation of a safety concern or a product recall. FDA conducts laboratory compliance testing of products covered by regulations for product standards in parts 1020, 1030, 1040, and 1050 (21 CFR parts 1020, 1030, 1040, and 1050). FDA details product-specific performance standards that specify information to be supplied with the product or require specific reports. The information collections are either specifically called for in the act or were developed to aid the agency in performing its obligations under the act. The data reported to FDA and the records maintained are used by FDA and the industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. This information refers to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data provided to users and others are intended to encourage actions to reduce or eliminate radiation exposures. FDA uses the following forms to aid respondents in the submission of information for this information collection: FDA Form 2579 “Report of Assembly of a Diagnostic X-ray System” FDA Form 2767 “Notice of Availability of Sample Electronic Product” FDA Form 2877 “Declaration for Imported Electronic Products Subject To Radiation Control Standards” FDA Form 3649 “Accidental Radiation Occurrence” FDA Form 3626 “A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components” FDA Form 3627 “Diagnostic X-ray CT Products Radiation Safety Report” FDA Form 3628 “General Annual Report (Includes Medical, Analytical, and Industrial X-ray Products Annual Report)” FDA Form 3629 “Abbreviated Report” FDA Form 3630 “Guide for Preparing Product Reports on Sunlamps and Sunlamp Products” FDA Form 3631 “Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products” FDA Form 3632 “Guide for Preparing Product Reports on Lasers and Products Containing Lasers” FDA Form 3633 “General Variance Request” FDA Form 3634 “Television Products Annual Report” FDA Form 3635 “Laser Light Show Notification” FDA Form 3636 “Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products” FDA Form 3637 “Laser Original Equipment Manufacturer

(OEM)Report” FDA Form 3638 “Guide for Filing Annual Reports for X-ray Components and Systems” FDA Form 3639 “Guidance for the Submission of Cabinet X-ray System Reports Pursuant to 21 CFR 1020.40” FDA Form 3640 “Reporting Guide for Laser Light Shows and Displays” FDA Form 3147 “Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device” FDA Form 3641 “Cabinet X-ray Annual Report” FDA Form 3642 “General Correspondence” FDA Form 3643 “Microwave Oven Products Annual Report” FDA Form 3644 “Guide for Preparing Product Reports for Ultrasonic Therapy Products” FDA Form 3645 “Guide for Preparing Annual Reports for Ultrasonic Therapy Products” FDA Form 3646 “Mercury Vapor Lamp Products Radiation Safety Report” FDA Form 3647 “Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps” The most likely respondents to this information collection will be electronic product and x-ray manufacturers, importers, and assemblers. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section FDA Form Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1002.3 10 1 10 12 120 1002.10 3626—Diagnostic X-Ray 3627—CT X-Ray 3639—Cabinet X-Ray 3632—Laser 3640—Laser Light Show 3630—Sunlamp 3646—Mercury Vapor Lamp 3644—Ultrasonic Therapy 540 1.6 850 24 20,400 1002.11 1,000 1.5 1,500 0.5 750 1002.12 3629—Abbreviated Report 150 1 150 5 750 1002.13 3628—General 3634—TV 3638—Diagnostic X-Ray 3641—Cabinet X-Ray 3643—Microwave Oven 3636—Laser 3631—Sunlamp 3647—Mercury Vapor Lamp 3645—Ultrasonic Therapy 900 1 900 26 23,400 1002.13 250 2.4 600 0.5 300 1002.20 3649—ARO 40 1 40 2 80 1002.41(a) 1 1 1 1 1 1002.50(a) and 1002.51 3642—General Correspondence 10 1.5 15 1 15 1005.10 2767—Sample Product 145 11.03 1,600 0.09 144 1005.25(b) 1 1 1 1 1 2877—Imports Declaration 600 32 19,200 0.2 3,840 1010.2 and 1010.3 1 1 1 5 5 1010.4(b) 3633—General Variance Request 3147—Laser Show Variance Request 3635—Laser Show Notification 1 1 1 120 120 1010.5(c) and

(d)2 1 2 22 44 1010.13 1 1 1 10 10 1020.20(c)(4) 1 1 1 1 1 1020.30(d), (d)(1), and (d)(2) 2579—Assembler Report 2,345 8.96 21,000 0.30 6,300 1020.30(g) 200 1.33 265 35 9,275 1020.30(h)(1) through (h)(4), 1020.32(a)(1) and

(g)200 1.33 265 35 9,275 1020.30(h)(5) and (h)(6) and 1020.32(j)(4) 20 5 100 180 18,000 1020.32(g) and 1020.33(c), (d), (g)(4), (j)(3), and (j)(4) 9 1.00 9 40 360 1020.40(c)(9)(i) and (c)(9)(ii) 8 1.00 8 40 320 1030.10(c)(4) 41 1.61 66 20 1,320 1030.10(c)(5)(i) through (c)(5)(iv) 41 1.61 66 20 1,320 1030.10(c)(6)(iii) and (c)(6)(iv) 1 1 1 1 1 1040.10(a)(3)(i) 3637—OEM Report 83 1 83 3 249 1040.10(h)(1)(i) through (h)(1)(vi) 805 1.00 805 8 6,440 1040.10(h)(2)(i) and (h)(2)(ii) 100 1.00 100 8 800 1040.11(a)(2) 190 1.00 190 10 1,900 1040.20 (d)(1)(ii)-(vi), (e)(1), and (e)(2) 110 1.00 110 10 1,100 1040.30(c)(1)(ii) 1 1.00 1 1 1 1040.30(c)(2) 7 1.00 7 1 7 1050.10(d)(1)-(d)(4) and (f)(1)-(f)(2)(iii) 10 1.00 10 56 560 Total 107,209 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505 1002.40 and 1002.41 2,950 49.2 145,140 2.4 7,080 1020.30(g) 22 1 22 0.5 11 1040.10(a)(3)(ii) 83 1 83 1.0 83 Totals 235,679 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The information collection, OMB control number 0910-0564 (i.e. FDA Form 3626) has been consolidated under this information collection thus, requiring an adjustment of the burden estimate. The burden estimates were derived by consultation with FDA and industry personnel and actual data collected from industry. An evaluation of the type and scope of information requested was also used to derive some time estimates. For example, disclosure information primarily requires time only to update and maintain existing manuals. Initial development of manuals has been performed except for new firms entering the industry. When information is generally provided to users, assemblers, or dealers in the same manual, they have been grouped together in the “Estimated Annual Reporting Burden” table. The following information collection requirements are not subject to review by OMB because they do not constitute a “collection of information” under the PRA: Sections 1002.31(c); 1003.10(a), (b), and (c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through (d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b); 1004.2(a) through (i); 1004.3(a) through (i); 1004.4(a) through (h); 1005.21(a) through (c); and 1005.22(b). These requirements “apply to the collection of information during the conduct of general investigations or audits” (5 CFR 1320.4(b)). The following labeling requirements are also not subject to review under the PRA because they are a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2)): Sections 21 CFR 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1). Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18559 Filed 11-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0326] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 4, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices: Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (OMB Control Number 0910-0510)—Extension The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA adds a new paragraph “g” to section 704 of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons or APs) to conduct inspections of eligible manufacturers of class II or class III devices. This is a voluntary program. FDA has a guidance document that provides information for those interested in participating in this program. The guidance is entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.” In the **Federal Register** of August 24, 2006 (71 FR 50067), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents are expected to be businesses or other for profit organizations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Information Collection No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Request for Accreditation 3 1 3 80 240 Total Hours 240 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on conversations with industry, trade association representatives, and internal FDA estimates. Once an organization is accredited, it will not be required to reapply. Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18603 Filed 11-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 016” (Recognition List Number: 016), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 016” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT ). Submit electronic comments by e-mail: *standards@cdrh.fda.gov* . This document may also be accessed on FDA's Web site at *http://www.fda.gov/cdrh/fedregin.html* . See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 016 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the **Federal Register** of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. FDA has modified its initial list of recognized standards in the following **Federal Register** notices: **Table 1.** Federal Register Cite October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language”

(HTML)and “portable document format”

(PDF)versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Web site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 016 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 016” to identify these current modifications. In table 1 of this document, FDA describes the following modifications:

(1)The withdrawal of standards and their replacement by others,

(2)the correction of errors made by FDA in listing previously recognized standards, and

(3)the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. **Table 2.** Old Item No. Standard Change Replacement Item No. A. Anesthesia 39 CGA V-5: 2005, Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) Withdrawn and replaced with newer version 68 53 ASTM F1464-93 (2005), Standard Specification for Oxygen Concentrators for Domiciliary Use Withdrawn and replaced with newer version 69 65 ISO 21647: 2005, Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors Devices affected, Code of Federal Regulations citation, and relevant guidance B. Biocompatibility 107 ASTM F1877-05, Standard Practice for Characterization of Particles Withdrawn and replaced with newer version 114 108 ASTM F1905-98 (2003), Standard Practice for Selecting Tests for Determining the Propensity of Materials for Cause Immunotoxicity Title C. Dental/Ear, Nose, and Throat

(ENT)49 ANSI/ADA Specification No. 17: 1983 (R1999), Denture Base Temporary Relining Resins Withdrawn and replaced with newer version 130 64 ISO 3107: 2004, Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol Cements Withdrawn and replaced with newer version 131 66 ISO 4049: 1988, Dentistry—Resin-Based Filling Materials Withdrawn. Refer to item no. 99 70 ISO 6874: 2005, Dental Resin-Based Pit and Fissure Sealants Withdrawn and replaced with newer version 132 71 ISO 6876: 2001, Dental Root Canal Sealing Materials Withdrawn and replaced with newer version 133 74 ISO 7494-1: 2004, Dentistry—Dental Units—Part 1: General Requirements and Test Methods Withdrawn and replaced with newer version 134 114 ANSI/ADA Specification No. 48: 1989, Visible Curing Units Title 116 ISO 10139-1: 2005, Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term Use Withdrawn and replaced with newer version 135 D. General Hospital/General Plastic Surgery 83 ASTM D6319-00a (2005), Standard Specification for Nitrile Examination Gloves for Medical Application Withdrawn and replaced with newer version 167 87 ASTM D3577-06, Standard Specification for Rubber Surgical Gloves Withdrawn and replaced with newer version 168 106 ASTM D3772-01 (2005), Standard Specification for Natural Rubber Finger Cots Withdrawn and replaced with newer version 169 E. In Vitro Diagnostics 003 CLSI/NCCLS GP10-A 1995, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic

(ROC)Plots; Approved Guideline Contact person 004 CLSI/NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline Contact person 007 CLSI/NCCLS LA1-A2 1994, Assessing the Quality of Radioimmunoassay Systems—2d ed.; Approved Guideline Contact person 012 CLSI/NCCLS C12-A, Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard Contact person 013 CLSI/NCCLS C21-A, Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard Contact person 015 CLSI/NCCLS C25-A, Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline Contact person 016 CLSI/NCCLS C27-A, Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline Contact person 018 CLSI/NCCLS C30-A, Ancillary (Bedside) Blood Glucose Testing Contact person 038 CLSI/NCCLS I/LA10-A, Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline Contact person 039 CLSI/NCCLS I/LA17-A, Assessing the Quality of Systems for Alpha-Fetoprotein

(AFP)Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline Contact person 043 CLSI/NCCLS LA4-A3, Blood Collection on Filter Paper for Neonatal Screening Programs; Approved Standard—3d ed. Contact person 048 CLSI/NCCLS T/DM6-A, Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline Contact person 051 CLSI/NCCLS GP 27-A, Using Proficiency Testing

(PT)to Improve the Clinical Laboratory; Approved Guideline Contact person 052 CLSI/NCCLS NRSCL 8-A, Terminology and Definitions for Use in National Committee for Clinical Laboratory Standards (NCCLS) Documents; Approved Standard Contact person 055 CLSI/NCCLS H18-A2, Procedures for the Handling and Processing of Blood Specimens; Approved Guideline Contact person 059 CLSI/NCCLS AUTO2-A, Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard Contact person F. Materials 40 ASTM F2063-05, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants Withdrawn and replaced with newer version 122 48 ASTM F899-02, Standard Specification for Stainless Steel for Surgical Instruments Contact person 60 ISO 5832-5: 2005, Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy Withdrawn and replaced with newer version 123 65 ISO 5834-2: 2006, Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded Forms Withdrawn and replaced with newer version 127 67 ISO 7153-1: 1991/Amd. 1: 1999, Surgical Instruments—Metallic Materials—Part 1: Stainless Steel Contact person 70 ASTM F2052-06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment Withdrawn and replaced with newer version 124 72 ASTM F2213-06, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment Withdrawn and replaced with newer version 128 85 ASTM F1854-01, Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Contact person 86 ASTM F1926-03, Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings Contact person 88 ASTM F2024-00, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings Contact person 89 ASTM F1873-98, Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Contact person 94 ASTM F601-03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Contact person 99 ASTM F2004-05, Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Withdrawn and replaced with newer version 125 103 ASTM F1801-97 (2004), Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Contact person 106 ASTM F648-04, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Contact person 109 ASTM F561-05a, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids Withdrawn and replaced with newer version 126 111 ASTM F1160-05, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Contact person 112 ASTM F1044-05, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Contact person 113 ASTM F1147-05, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Contact person 117 ASTM F86-04, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Contact person G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology 28 ANSI/AAMI RD16: 1996/A1: 2002/(R)2005, Hemodialyzers Reaffirmation 29 ANSI/AAMI RD17: 1994/A1: 2002/(R)2005, Hemodialyzer Blood Tubing Reaffirmation 31 ANSI/AAMI ID54: 1996/(R)2005, Enteral Feeding Set Adapters and Connectors Reaffirmation H. Ophthalmic 20 ISO 11979-1: 1999, Ophthalmic Implants—Intraocular Lenses—Part 1: Vocabulary Contact person 22 ISO 11979-3: 1999, Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test Methods Contact person 32 ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube Shafts Withdrawn and transferred to Radiology I. Orthopedic/Physical Medicine 85 ISO 14630: 2005, Non-Active Surgical Implants—General Requirements Withdrawn and replaced with newer version 194 141 ASTM F1612-95 (2005), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With Torsion Withdrawn and replaced with newer version 195 142 ASTM F1672-95 (2005), Standard Specification for Resurfacing Patellar Prosthesis Withdrawn and replaced with newer version 196 150 ASTM F983-86 (2005), Standard Practice for Permanent Marking of Orthopaedic Implant Components Withdrawn and replaced with newer version 197 162 ASTM F564-02 (2006), Standard Specification and Test Methods for Metallic Bone Staples Withdrawn and replaced with newer version 201 174 ASTM F382-99

(2003)e1, Standard Specification and Test Method for Metallic Bone Plates Withdrawn and replaced with newer version 198 176 ASTM F565-04, Standard Practice for Care and Handling of Orthopedic Implants and Instruments Withdrawn and replaced with newer version 199 193 ASTM F2083-06, Standard Specification for Total Knee Prosthesis Withdrawn and replaced with newer version 200 J. Radiology 32 (Opthalmic) ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube Shafts Transferred from Ophthalmic, type of standard, and contact person 144 92 IEC 61674 (1997-10), Medical Electrical Cquipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic Imaging Withdrawn and replaced 145 93 IEC 61674 (2002), Amendment 1, Medical Electrical Equipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic Imaging Withdrawn and replaced 145 118 IEC 60601-2-17 (2005), Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment Withdrawn and replaced with newer version 146 135 IEC 60601-2-5 (2005), Medical Electrical Equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment ed. 2.0 Withdrawn and replaced with newer version 147 8 IEC 60336 (2005), Medical Electrical Equipment—X-Ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots Withdrawn and replaced with newer version 149 K. Sterility 74 ANSI/AAMI ST 60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements Withdrawn 103 ISO 11607-2000, Packaging for Terminally Sterilized Medical Devices Withdrawn III. Listing of New Entries The listing of new entries and consensus standards, added as modifications to the list of recognized standards under Recognition List Number: 016, follows: **Table 3.** Item No. Title of Standard Reference No. and Date A. Dental/ENT 136 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices ASTM F2504-05 B. General Hospital/General Plastic Surgery 160 Sterile Single-Use Syringes, With or Without Needle, for Insulin ISO 8537: 1991/Amendment 1: 2000 161 Sterile, Single-Use Intravascular Catheters—Part 1: General Requirements ISO 10555-1: 1996/Amendment 1: 1999, Amendment 2: 2004 162 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles ISO 8536-1: 2000/Amendment 1: 2004 163 Stainless Steel Needle Tubing for the Manufacture of Medical Devices ISO 9626: 1991/Amendment 1: 2001 164 Sterile, Single-Use Intravascular Catheters—Part 5: Over-Needle Peripheral Catheters ISO 10555-5: 1996/Amendment 1: 1999, Corrigendum 1: 2002 165 Standard Specification for Polychloroprene Examination Gloves for Medical Application ASTM D6977-04 166 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps ASTM F2132-01 C. In Vitro Diagnostics 124 Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline CLSI/NCCLS I/LA24-A 125 Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline CLSI M28-A2, Vol. 25, No. 16 126 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes CLSI M24-A, Vol. 23, No. 18 D. OB-GYN/Gastroenterology 38 Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics ISO 8600-3: 1997/Amendment 1: 2003 39 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics ISO 8600-5: 2005 40 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: Vocabulary ISO 8600-6: 2005 E. Radiology 145 Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic Imaging IEC 61674 (1997), (2002), Amendment 1 148 Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601-2-37 (2005), Amendment 2 F. Software 8 Medical Device Software—Software Life Cycle Processes IEC 62304 ed. 1.0

(2006)G. Sterility 193 Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems, 3d ed. ANSI/AAMI/ISO 11607-1: 2006 194 Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes, 1st ed. ANSI/AAMI/ISO 11607-2: 2006 195 Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements, 2d ed. ANSI/AAMI/ISO 11140-1: 2005 IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Web site at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm* . FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the **Federal Register** , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the **Federal Register** once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT ). To be properly considered such recommendations should contain, at a minimum, the following information:

(1)Title of the standard,

(2)any reference number and date,

(3)name and address of the national or international standards development organization,

(4)a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and

(5)a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the **Federal Register** , this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 016” will be available on the CDRH home page. You may access the CDRH home page at *http://www.fda.gov/cdrh* . You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at *http://www.fda.gov/cdrh/stdsprog.html* . This **Federal Register** document on modifications in FDA's recognition of consensus standards is available at *http://www.fda.gov/cdrh/fedregin.html* . VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT ) 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. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 016. These modifications to the list of recognized standards are effective upon publication of this notice in the **Federal Register** . Dated: October 27, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-18604 Filed 11-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)-443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)—Extension Section 602 of Pub. L. 102-585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) “Limitation on Prices of Drugs Purchased by Covered Entities.” Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B drug discount program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to develop audit guidelines and because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs

(OPA)has developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities. *Audit Guidelines:* A manufacturer will be permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or

(B)has occurred. The manufacturer must notify the covered entity in writing when it believes the covered entity has violated the provisions of 340B. If the problem cannot be resolved, the manufacturer must then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA OPA for review. The office will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to the HRSA OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General. *Dispute Resolution Guidelines:* Because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA OPA has developed an informal dispute resolution process which can be used if an entity or manufacturer is believed to be in violation of section 340B. Prior to filing a request for resolution of a dispute with the HRSA OPA, the parties must attempt, in good faith, to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to the HRSA OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. The estimates of annualized burden are as follows: Reporting requirement Number of respondents Responses per respondent Total responses Hours per response Total burden hours Audits Audit Notification of Entity* 2 1 2 4 8 Audit Work Plan 1 1 1 8 8 Audit Report 1 1 1 1 1 Entity Response 0 0 0 0 0 Dispute Resolution Mediation Request 2 4 8 10 80 Rebuttal 2 1 2 16 32 Total Reporting 8 14 129 Recordkeeping Requirement Dispute Records 10 1 10 .5 5 Total Recordkeeping 10 5 * Prepared by the manufacturer. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: October 26, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-18508 Filed 11-2-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the meeting of the National Cancer Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. A portion of the meeting will be closed to the public in accordance with the provisions set forth in section 552b(6), as amended. The discussions could disclose personal information concerning NCI Staff and/or its contractors, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Advisory Board. *Open:* November 30, 2006, 8:30 a.m. to 4:45 p.m. *Agenda:* Program reports and presentations; Business of the Board. *Place:* National Cancer Institute, 9000 Rockville Pike, Building 31, C Wing, 6th Floor, Conference Room 10, Bethesda, MD 20892. *Contact Person:* Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,

(301)496-5147. *Name of Committee:* National Cancer Advisory Board. *Closed:* November 30, 2006, 4:45 p.m. to 5:30 p.m. *Agenda:* Review intramural program site visit outcomes; Discussion of confidential personnel issues. *Contact Person:* Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,

(301)496-5147. *Name of Committee:* National Cancer Advisory Board. *Open:* December 1, 2006, 8:30 a.m. to 12 p.m. *Agenda:* Program reports and presentations; Business of the Board. *Contact Person:* Dr. Paulette S. Gray, Executive Secretary, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,

(301)496-5147. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute's/Center's home page: *deainfo.nci.nih.gov/advisory/ncab.htm* where an agenda and any additional information for the meeting will be posted when available. (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: October 26, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-9034 Filed 11-2-06; 8:45 am]

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