Notices. Notice

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BILLING CODE 4154-07-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the President's Council on Physical Fitness and Sports AGENCY: Office of Public Health and Science, Office of the Secretary, DHHS. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services

(DHHS)is hereby giving notice that the President's Council on Physical Fitness and Sports will hold a meeting. This meeting is open to the public. A description of the Council's functions is included with this notice. DATES: November 15, 2006, from 8:30 a.m. to 4 p.m. ADDRESSES: Department of Health and Human Services, Hubert H. Humphrey Building, Room 800, 200 Independence Avenue, SW., Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Melissa Johnson, Executive Director, President's Council on Physical Fitness and Sports, Hubert H. Humphrey Building, Room 738H, 200 Independence Avenue, SW., Washington, DC 20201,

(202)690-5187. SUPPLEMENTARY INFORMATION: The President's Council on Physical Fitness and Sports (PCPFS) was established originally by Executive Order 10673, dated July 16, 1956. PCPFS was established by President Eisenhower after published reports indicated that American boys and girls were unfit compared to the children of Western Europe. The Council has undergone two name changes and several reorganizations since its inception. Authorization to continue Council operations has been given at appropriate intervals by subsequent Executive Orders. Authority to continue Council operations was most recently directed by Executive Order 13385, dated September 29, 2005. Presently, the PCPFS serves as a program office that is located organizationally in the Office of Public Health and Science within the Office of the Secretary in the U.S. Department of Health and Human Services. On June 6, 2002, President Bush signed Executive Order 13256 to reestablish the PCPFS. Executive Order 13256 was established to expand the focus of the Council. This directive instructed the Secretary to develop and coordinate a national program to enhance physical activity and sports participation. The Council currently operates under the stipulations of the new directive. The primary functions of the Council include to:

(1)Advise the President, through the Secretary, on the progress made in carrying out the provisions of the enacted directive and recommend actions to accelerate progress;

(2)advise the Secretary on ways and means to enhance opportunities for participation in physical fitness and sports, and, where possible, to promote and assist in the facilitation and/or implementation of such measures;

(3)to advise the Secretary regarding opportunities to extend and improve physical activity/fitness and sports programs and services at the national, State and local levels; and

(4)to monitor the need for the enhancement of programs and educational and promotional materials sponsored, overseen, or disseminated by the Council, and advise the Secretary, as necessary, concerning such needs. The PCPFS holds at a minimum, one meeting in the calendar year to

(1)assess ongoing Council activities and

(2)discuss and plan future projects and programs. Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the meeting. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Dated: October 25, 2006. Melissa Johnson, Executive Director, President's Council on Physical Fitness and Sports. [FR Doc. E6-18244 Filed 10-30-06; 8:45 am] BILLING CODE 4150-35-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0220] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices 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 November 30, 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, 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. Administrative Detention and Banned Medical Devices—(OMB Control Number 0910-0114)—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 334(g)), where officers or employees (FDA investigators), duly designated by the Secretary of Health and Human Services, may detain during establishment inspections devices that are believed to be adulterated or misbranded. In the **Federal Register** of March 9, 1979 (44 FR 13234), FDA issued, under § 800.55 (21 CFR 800.55), a final regulation on administrative detention procedures, under section 304(g) of the act, which includes certain reporting requirements (§ 800.55(g)(1) and (g)(2)) and recordkeeping requirements (§ 800.55(k)). Under § 800.55(g), an appellant of a detention order must show documentation of ownership if devices are detained at a place other than that of the appellant. Under § 800.55(k), the owner or other responsible person must supply records about how the devices may have become adulterated or misbranded, as well as records of distribution of the detained devices. These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. FDA also has the statutory authority under section 516 of the act (21 U.S.C. 360f), to ban devices that present substantial deception, or unreasonable and substantial risk of illness or injury, or unreasonable, direct, and substantial danger to the health of individuals. The final regulation for banned devices (part 895 (21 CFR part 895)), issued in the **Federal Register** of May 18, 1979 (44 FR 29214), contained certain reporting requirements (§§ 895.21(d) and 895.22(a)). In the **Federal Register** of June 7, 2006 (71 FR 32987), FDA published a 60-day notice requesting public comments on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 800.55(g) 1 1 1 25 25 895.21(d) and 895.22(a) 26 1 26 16 416 Total 441 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 per Recordkeeper Total Annual Records Hours per Record Total Hours 800.55(k) 1 1 1 20 20 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's estimate of the burden under the administrative detention provision is based on FDA's discussion with the last firm whose devices had been detained. Historically, FDA has had very few or no annual responses for this information collection. Dated: October 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18190 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0426] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602) 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 the proposed collection of information that will permit an applicant to certify that it qualifies as a “small business” within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA). 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. MDUFMA Small Business Qualification Certification (Form FDA 3602)—(OMB Control Number 0910-0508)—Extension MDUFMA amends the Federal Food, Drug, and Cosmetic Act to provide for user fees for certain medical device applications. FDA published a **Federal Register** notice on August 2, 2006 (71 FR 43784 through 43786), announcing fees for fiscal year

(FY)2007. To avoid harming small businesses, MDUFMA provides for reduced or waived fees for applicants who qualify as a “small business.” This means there are two levels of fees, a standard fee, and a reduced or waived small business fee. For FY 2006, you can qualify for a small business fee discount under MDUFMA if you reported gross receipts or sales of no more than $100 million on your Federal income tax return for the most recent tax year. If you have any affiliates, partners, or parent firms, you must add their gross receipts or sales to yours, and the total must be no more than $100 million. If your gross receipts or sales are no more than $30 million (including all of your affiliates, partners, and parent firms), you will also qualify for a waiver of the fee for your first

(ever)premarket application (premarket approval (PMA), product development protocol (PDP), biologic license application (BLA), or Premarket Report). An applicant must pay the full standard fee unless it provides evidence demonstrating to FDA that it meets the “small business” criteria. The evidence required by MDUFMA is a copy of the most recent Federal income tax return of the applicant, and any affiliate, partner, or parent firm. FDA will review these materials and decide whether an applicant is a “small business” within the meaning of MDUFMA. Form FDA 3602 is available in a guidance document entitled “Guidance for Industry and FDA: FY 2006 MDUFMA Small Business Qualification Worksheet and Certification.” This guidance describes the criteria FDA will use to decide whether an entity qualifies as a MDUFMA small business and will help prospective applicants understand what they need to do to meet the small business criteria for FY 2006 and subsequent fiscal years. *Description of Respondents* : Respondents will 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 FDA Form Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3602 2,000 1 2,000 1 2,000 Total 2,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden is based on the number of applications received in the last 3 years. Dated: October 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18198 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0184] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records 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

(IDE)supplement. An IDE allows a device, which would otherwise be subject to provisions of the act, such as premarket notification or premarket approval, to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. The purpose of part 812 (21 CFR part 812) is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use. The IDE regulation is designed to encourage the development of useful medical devices, and allow investigators the maximum freedom possible, without jeopardizing the health and safety of the public or violating ethical standards. To do this, the regulation provides for different levels of regulatory control depending on the level of potential risk the investigational device presents to human subjects. Investigations of significant risk devices, ones that present a potential for serious harm to the rights, safety, or welfare of human subjects, are subject to the full requirements of the IDE regulation. Nonsignificant risk device investigations, ones that do not present a potential for serious harm, are subject to the reduced burden of the abbreviated requirements. The regulation also includes provisions for treatment IDEs. The purpose of these provisions is to facilitate the availability, as early in the device development process as possible, of promising new devices to patients with life-threatening or serious conditions for which no comparable or satisfactory alternative therapy is available. Section 812.10 allows the sponsor of the IDE to request a waiver to all of the requirements of part 812. This information is needed for FDA to determine if waiver of the requirements of part 812 will impact the public's health and safety. Sections 812.20, 812.25, and 812.27 consist of the information necessary to file an IDE application with FDA. The submission of an IDE application to FDA is required only for significant risk device investigations. Section 812.20 lists the data requirements for the original IDE application; § 812.25 lists the contents of the investigational plan; and § 812.27 lists the data relating to previous investigations or testing. The information in this original IDE application is evaluated by the Center for Devices and Radiological Health to determine whether the proposed investigation will reasonably protect the public health and safety, and for FDA to make a determination to approve the IDE. Once FDA approves an IDE application, a sponsor must submit certain requests and reports. Under § 812.35, a sponsor who wishes to make a change in the investigation which affects the scientific soundness of the study or the rights, safety, or welfare of the subjects is required to submit a request for the change to FDA. Under § 812.150, a sponsor is required to submit reports to FDA. These requests and reports are submitted to FDA as supplemental applications. This information is needed for FDA to assure protection of human subjects and to allow review of the study's progress. Section 812.36(c) identifies the information necessary to file a treatment IDE application. FDA uses this information to determine if wider distribution of the device is in the interests of the public health. Section 812.36(f) identifies the reports required to allow FDA to monitor the size and scope of the treatment IDE, to assess the sponsor's due diligence in obtaining marketing clearance of the device and to ensure the integrity of the controlled clinical trials. Section 812.140 lists the recordkeeping requirements for investigators and sponsors. FDA requires this information for tracking and oversight purposes. Investigators are required to maintain records, including correspondence and reports concerning the study; records of receipt, use, or disposition of devices; records of each subject's case history and exposure to the device; informed consent documentation; study protocol and documentation of any deviation from the protocol. Sponsors are required to maintain records including correspondence and reports concerning the study; records of shipment and disposition; signed investigator agreements; adverse device effects information; and, for a nonsignificant risk device study, an explanation of the nonsignificant risk determination, records on device name and intended use, study objectives, investigator information, investigational review board

(IRB)information, and statement on the extent that good manufacturing practices will be followed. The most likely respondents to this information collection will primarily be medical device manufacturers, investigators, hospitals, health maintenance organizations, and businesses. In the **Federal Register** of May 26, 2006 (71 FR 30425), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 812.10 1 1 1 1 1 812.20, 812.25, and 812.27 600 0.5 275 80 22,000 812.35 and 812.150 (reports for significant risk studies) 600 7.8 4,700 6 28,200 812.150 (reports for nonsignificant risk studies) 600 0.017 10 6 60 812.36(c) 1 1 1 120 120 812.36(f) 1 2 2 20 40 Total 50,421 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 812.140 Original 600 0.5 275 10 2,750 812.140 Supplemental 600 7 4,700 1 4,700 812.140 Nonsignificant 600 1 600 6 3,600 Total 11,050 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: October 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18200 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0239] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infectious Disease Issues in Xenotransplantation 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

(PHS)act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301 *et seq.* ). The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and the general public. The PHS guideline is intended to address public health issues raised by xenotransplantation, through identification of general principles of prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to the public health. The collection of information described in this guideline is intended to provide general guidance to sponsors in the following ways:

(1)The development of xenotransplantation clinical protocols,

(2)the preparation of submissions to FDA, and

(3)the conduct of xenotransplantation clinical trials. Also, the collection of information will help ensure that the sponsor maintains important information in a cross-referenced system that links the relevant records of the xenotransplantation product recipient, xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures. The PHS guideline describes an occupational health service program for the protection of health care workers involved in xenotransplantation procedures, caring for xenotransplantation product recipients, and performing associated laboratory testing. The guideline also describes a public health need for a national xenotransplantation database, which is currently under development by PHS. The PHS guideline is intended to protect the public health and to help ensure the safety of using xenotransplantation products in humans by preventing the introduction, transmission, and spread of infectious diseases associated with xenotransplantation. The PHS guideline also recommends that certain specimens and records be maintained for 50 years beyond the date of the xenotransplantation. These include the following information, as recommended by the specific PHS guideline sections:

(1)Records linking each xenotransplantation product recipient with relevant health records of the source animal, herd, or colony, and the specific organ, tissue, or cell type included in or used in the manufacture of the product (3.2.7.1);

(2)aliquots of serum samples from randomly selected animal and specific disease investigations (3.4.3.1);

(3)source animal biological specimens designated for PHS use (3.7.1); animal health records (3.7.2), including necropsy results (3.6.4); and

(4)recipients' biological specimens (4.1.2). The retention period is intended to assist health care practitioners and officials in surveillance and in tracking the source of an infection, disease, or illness that might emerge in the recipient, the source animal, or the animal herd or colony after a xenotransplantation. The recommendation for maintaining records for 50 years is based on clinical experience with several human viruses that have presented problems in human to human transplantation and are therefore thought to share certain characteristics with viruses that may pose potential risks in xenotransplantation. These characteristics include long latency periods and the ability to establish persistent infections. Several also share the possibility of transmission among individuals through intimate contact with human body fluids. Human immunodeficiency virus

(HIV)and Human T-lymphotropic virus are human retroviruses. Retroviruses contain ribonucleic acid

(RNA)that is reverse-transcribed into deoxyribonucleic acid

(DNA)using an enzyme provided by the virus and the human cell machinery. That viral DNA can then be integrated into the human cellular DNA. Both viruses establish persistent infections and have long latency periods before the onset of disease, 10 years and 40 to 60 years, respectively. The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for Hepatitis C. In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and nosocomial exposures. Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications

(INDs)and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated 12 respondents who are sponsors of INDs that include protocols for xenotransplantation in humans. Other respondents for this collection of information are an estimated 18 source animal facilities that provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These 18 source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The total annual reporting and recordkeeping burden is estimated to be approximately 156 hours. The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting and recordkeeping tasks described in the guideline. FDA does not expect the level of clinical studies using xenotransplantation to increase significantly in the next few years. FDA is requesting an extension of OMB approval for the following reporting and recordkeeping recommendations in the PHS guideline: **Table 1.—Reporting Recommendations** PHS Guideline Section Description 3.2.7.2 Notify sponsor or FDA of new archive site when the source animal facility or sponsor ceases operations 3.4 Standard operating procedures

(SOPs)of source animal facility should be available to review bodies 3.5.1 Include increased infectious risk in informed consent if source animal quarantine period of 3 weeks is shortened 3.5.4 Sponsor to make linked records described in section 3.2.7 available for review 3.5.5 Source animal facility to notify clinical center when infectious agent is identified in source animal or herd after xenotransplantation product procurement **Table 2.—Recordkeeping Recommendations** PHS Guideline Section Description 3.2.7 Establish records linking each xenotransplantation product recipient with relevant records 4.3 Sponsor to maintain cross-referenced system that links all relevant records (recipient, product, source animal, animal procurement center, and nosocomial exposures) 3.4.2 Document results of monitoring program used to detect introduction of infectious agents which may not be apparent clinically 3.4.3.2 Document full necropsy investigations including evaluation for infectious etiologies 3.5.1 Justify shortening a source animal's quarantine period of 3 weeks prior to xenotransplantation product procurement 3.5.2 Document absence of infectious agent in xenotransplantation product if its presence elsewhere in source animal does not preclude using it 3.5.4 Add summary of individual source animal record to permanent medical record of the xenotransplantation product recipient 3.6.4 Document complete necropsy results on source animals (50-year record retention) 3.7 Link xenotransplantation product recipients to individual source animal records and archived biologic specimens 4.2.3.2 Record base-line sera of xenotransplantation health care workers and specific nosocomial exposure 4.2.3.3 and 4.3.2 Keep a log of health care workers' significant nosocomial exposure(s) 4.3.1 Document each xenotransplant procedure 5.2 Document location and nature of archived PHS specimens in health care records of xenotransplantation product recipient and source animal FDA estimates the burden for this collection of information as follows: **Table 3.—Estimated Annual Reporting Burden** 1 PHS Guideline Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3.2.7.2 2 1 1 1 0.5 0.5 3.4 3 12 0.33 4 0.08 0.32 3.5.1 4 12 0.08 (0-1) 1 0.25 0.25 3.5.4 5 12 1 12 0.5 6.0 3.5.5 4 18 0.06 (0-1) 1 0.2 0.2 Total 7.27 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 No animal facility or sponsor has ceased operations in the last 3 years, however, we are using 1 respondent for estimation purposes. 3 FDA's records indicate that an average of 4 INDs are expected to be submitted per year. 4 To our knowledge, has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 5 Based on an estimate of 36 patients treated over a 3 year period, the average number of xenotransplantation product recipients per year is estimated to be 12. **Table 4.—Estimated Annual Recordkeeping Burden** 1 PHS Guideline Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 3.2.7 2 1 1 1 16 16 4.3 3 12 1 12 0.83 9.96 3.4.2 4 12 11 132 0.25 33 3.4.3.2 5 18 4 72 0.3 21.6 3.5.1 6 12 0.08 (0-1) 1 0.5 0.5 3.5.2 6 12 0.08 (0-1) 1 0.25 0.25 3.5.4 12 1 12 0.17 2.04 3.6.4 7 12 2 24 0.25 6 3.7 7 18 1.33 24 0.08 1.92 4.2.3.2 8 12 25 300 0.17 51 4.2.3.2 6 12 0.08 (0-1) 1 0.17 0.17 4.2.3.3 and 4.3.2 6 12 0.08 (0-1) 1 0.17 0.17 4.3.1 12 1 12 0.25 3 5.2 9 12 3 36 0.08 2.88 Total 148.49 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 A 1-time burden for new respondents to set up a recordkeeping system linking all relevant records. FDA estimates 1 new sponsor annually. 3 FDA estimates there is minimal recordkeeping burden associated with maintaining the record system. 4 Monitoring for sentinel animals (subset representative of herd) plus all source animals. There are approximately 6 sentinel animals per herd x 1 herd per facility x 18 facilities = 108 sentinel animals. There are approximately 24 source animals per year (see footnote 7 of this table); 108 + 24 = 132 monitoring records to document. 5 Necropsy for animal deaths of unknown cause estimated to be approximately 4 per herd per year x 1 herd per facility x 18 facilities = 72. 6 Has not occurred in the past 3 years and is expected to continue to be a rare occurrence. 7 On average 2 source animals are used for preparing xenotransplantation product material for one recipient. The average number of source animals is 2 source animals per recipient x 12 recipients annually = 24 source animals per year (see footnote 5 of table 3 of this document). 8 FDA estimates there are approximately 12 clinical centers doing xenotransplantation procedures x approximately 25 health care workers involved per center = 300 health care workers. 9 24 source animal records + 12 recipient records = 36 total records. Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Since these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 4 can be found under existing regulations and approved under the OMB control numbers as follows:

(1)“Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved through September 30, 2008, under OMB control number 0910-0139;

(2)“Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved through May 31, 2009, under OMB control number 0910-0014; and

(3)information included in a license application, 21 CFR 601.2, approved through September 30, 2008, under OMB control number 0910-0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product (e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.) However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 4. In table 5 of this document, FDA identifies those information collection activities that are already encompassed by existing regulations or are consistent with voluntary standards that reflect industry's usual and customary business practice. **Table 5.—Collection of Information Required by Current Regulations and Standards** PHS Guideline Section Description of Collection of Information Activity 21 CFR Section (Unless Otherwise Stated) 2.2.1 Document off-site collaborations 312.52 2.5 Sponsor ensure counseling patient, family, and contacts 312.62(c) 3.1.1 and 3.1.6 Document well-characterized health history and lineage of source animals 312.23(a)(7)(a) and 211.84 3.1.8 Registration with and import permit from the Centers for Disease Control and Prevention 42 CFR 71.53 3.2.2 Document collaboration with accredited microbiology labs 312.52 3.2.3 Procedures to ensure the humane care of animals 9 CFR parts 1, 2, and 3 and PHS Policy 1 3.2.4 Procedures consistent for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) and consistent with the National Research Council's (NRC's) guide AAALAC international rules of accreditation 2 and NRC guide 3 3.2.5, 3.4, and 3.4.1 Herd health maintenance and surveillance to be documented, available, and in accordance with documented procedures; record standard veterinary care 211.100 and 211.122 3.2.6 Animal facility SOPs PHS Policy 1 3.3.3 Validate assay methods 211.160(a) 3.6.1 Procurement and processing of xenografts using documented aseptic conditions 211.100 and 211.122 3.6.2 Develop, implement, and enforce SOPs for procurement and screening processes 211.84(d) and 211.122(c) 3.6.4 Communicate to FDA animal necropsy findings pertinent to health of recipient 312.32(c) 3.7.1 PHS specimens to be linked to health records; provide to FDA justification for types of tissues, cells, and plasma, and quantities of plasma and leukocytes collected 312.23(a)(6) 4.1.1 Surveillance of xenotransplant recipient; sponsor ensures documentation of surveillance program lifelong (justify > 2 years (yrs.)); investigator case histories (2 yrs. after investigation is discontinued) 312.23(a)(6)(iii)(f) and (g), and 312.62(b) and

(c)4.1.2 Sponsor to justify amount and type of reserve samples 211.122 4.1.2.2 System for prompt retrieval of PHS specimens and linkage to medical records (recipient and source animal) 312.57(a) 4.1.2.3 Notify FDA of a clinical episode potentially representing a xenogeneic infection 312.32 4.2.2.1 Document collaborations (transfer of obligation) 312.52 4.2.3.1 Develop educational materials (sponsor provides investigators with information needed to conduct investigation properly) 312.50 4.3 Sponsor to keep records of receipt, shipment, and disposition of investigative drug; investigator to keep records of case histories 312.57 and 312.62(b) 1 The “Public Health Service Policy on Humane Care and Use of Laboratory Animals” ( *http://www.grants.nih.gov/grants/olaw/references/phspol.htm* ). 2 AAALAC international rules of accreditation ( *http://www.aaalac.org/accreditation/rules.cfm* ). (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site address after this document publishes in the Federal Register .) 3 NRC's “Guide for the Care and Use of Laboratory Animals” (1996). In the **Federal Register** of June 22, 2006 (71 FR 35911), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Dated: October 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18203 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0421] Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A 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 the information collection requirements relating to the reporting of biological product deviations in manufacturing, and Forms FDA 3486 and 3486A. 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: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: 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. Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A (OMB Control Number 0910-0458)—Extension Under section 351 of the Public Health Service Act (42 U.S.C. 262), all biological products, including human blood and blood components, offered for sale in interstate commerce must be licensed and meet standards designed to ensure the continued safety, purity, and potency of such products. In addition, the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not conform with Current Good Manufacturing Practice

(CGMP)assuring that they meet the requirements of the act. All establishments manufacturing biological products including human blood and blood components must comply with the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts 211, 606, and 820)). Transfusion services are required under 42 CFR 493.1271 to comply with 21 CFR parts 606 and 640 as they pertain to the performance of manufacturing activities. FDA regards biological product deviation

(BPD)reporting to be an essential tool in its directive to protect public health by establishing and maintaining surveillance programs that provide timely and useful information. Section 600.14 requires the manufacturer who holds the biological product license, for other than human blood and blood components, and who had control over the product when the deviation occurred, to report to the Center for Biologics Evaluation and Research

(CBER)or to the Center for Drugs Evaluation and Research

(CDER)as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Section 606.171 requires a licensed manufacturer of human blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, to report to CBER as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. The BPD reporting under 21 CFR 1271.350(b) for human cells, tissues, and cellular and tissue-based products is approved under OMB control number 0910-0559 (expires November 30, 2007). Form FDA 3486 is used to submit BPDs under these regulations. Respondents to this collection of information are the licensed manufacturers of biological products other than human blood and blood components, licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered blood establishments, and transfusion services. Based on information from FDA's database, there are an estimated 147 licensed manufacturers of biological products other than human blood and blood components, 194 licensed manufacturers of human blood and blood components, including Source Plasma, and 1,230 unlicensed registered blood establishments. Based on the Center for Medicare and Medicaid Services records, there are an estimated 4,980 transfusion services. The number of licensed manufacturers and total annual responses under § 600.14 include the estimates for both CBER and CDER. The number of total annual responses is based on the number of BPD reports FDA received in fiscal year 2005. The rate of submission is not expected to change significantly in the next few years. Based on information from industry, the estimated average time to complete a deviation report is 2 hours. The availability of the standardized report form, Form FDA 3486, and the ability to submit this report electronically to CBER (CDER does not currently accept electronic filings) further streamlines the report submission process. CBER is developing an addendum to Form FDA 3486. The web-based addendum (Form FDA 3486A) would request additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information requested would include information not contained in the Form FDA 3486 such as:

(1)Distribution pattern,

(2)method of consignee notification,

(3)consignee(s) of products for further manufacture,

(4)additional product information, and

(5)updated product disposition. This information would be requested by CBER through e-mail notification to the submitter of the BPD report. This information would be used by CBER for purposes of recall classification. We plan to use Form FDA 3486A for only biological products regulated by CBER. We do not plan to use this form for biological products regulated by CDER because they receive very few BPD reports and do not accept electronic filings. CBER estimates that 5 percent of the total BPD reports submitted to CBER would need additional information submitted in the addendum. CBER estimates it would take between 15 to 45 minutes to complete the addendum. For calculation purposes, CBER is using one-half hour. Activities such as investigating, changing standard operating procedures or processes, and followup are currently required under 21 CFR parts 211 (approved under OMB control no. 0910-0139, expires September 30, 2008), 606 (approved under OMB control no. 0910-0116, expires December 31, 2008), and 820 (approved under OMB control no. 0910-0073, expires September 30, 2007) and, therefore, are not included in the burden calculation for the separate requirement of submitting a BPD report to FDA. 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 Responses Total Hours 600.14 3486 147 2.73 401 2.0 802 606.171 2 3486 194 169.89 32,958 2.0 65,916 606.171 3 3486 6,210 1.50 9,311 2.0 18,622 3486A 4 6,551 0.33 2,133 0.5 1,067 Total 86,407 1 There are no capital costs or maintenance costs associated with this collection of information. 2 Licensed manufacturers of human blood and blood components, including Source Plasma. 3 Unlicensed registered blood establishments and transfusion services (1,230 + 4,980 = 6,210). 4 Five percent of the total annual responses to CBER (42,653 x 0.05 = 2,133). Dated: October 25, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-18313 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Vaccines and Related Biological Products Advisory Committee *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held via teleconference on November 16, 2006 from 1 p.m. to 5 p.m. *Location* : NIH campus, Food and Drug Administration Bldg. 29B, Conference Room C, 8800 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the above location. A speakerphone will be provided at the specified location for public participation in this meeting. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the internet at *http://www.nih.gov/about/visitor/index.htm* . Visitors must show two forms of identification such as a Federal employee badge, driver's license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Drive entrance of the campus which is located on Wisconsin Ave. (the medical center metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at *http://www.nih.gov/about/visitorsecurity.htm* . Due to the limited available parking, visitors are encouraged to use public transportation. *Contact Person* : Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will hear an overview on the operations of the Laboratory of Bacterial Toxins, Division of Bacterial, Parasitic, and Allergenic Products; and the Laboratory of Vector Borne Virus Diseases, the Laboratory of Hepatitis Viruses, and the Laboratory of Respiratory Viral Diseases, Division of Viral Products, Office of Vaccines Research and Review, CBER, and in closed session will discuss the reports from the laboratory site visits of December 6, 2005, January 11, 2006, and June 29, 2006. *Procedure* : On November 16, 2006, from 1 p.m. to 3:55 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by November 9, 2006. Oral presentations from the public will be scheduled between approximately 2:55 p.m. to 3:55 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before November 9, 2006 and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. *Closed Committee Deliberations* : On November 16, 2006 from 3:55 p.m. to 5 p.m. the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss a review of internal research programs in the Office of Vaccines Research and Review, Division of Viral Products and Division of Bacterial Parasitic and Allergenic Products, Center for Biologics Evaluation and Research. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 26, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-18314 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0363] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the draft guidance entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). This draft guidance is not final, nor is it being implemented at this time. DATES: Submit written or electronic comments on this draft guidance by January 29, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141. SUPPLEMENTARY INFORMATION: I. Background Absorbable hemostatic devices are primarily applied during surgical procedures in order to control bleeding that is not readily controlled via conventional means, such as cautery or ligation. At other times, an absorbable hemostatic device may be applied due to the inaccessibility of a site to conventional hemostatic methods. On July 24, 2003, the General and Plastic Surgery Devices Panel considered the types of information the agency should include in a class II special controls guidance document for the absorbable hemostatic device and recommended that the device be reclassified from class III into class II. FDA considered the Panel's recommendations, and elsewhere in this issue of the **Federal Register** , is proposing to reclassify the absorbable hemostatic device into class II. If this reclassification rule is finalized, FDA intends that this guidance document will serve as the special control for this device. Following the effective date of any final reclassification rule based on this proposal, any firm submitting a premarket notification (510(k)) for an absorbable hemostatic device would need to address the issues covered in the special controls guidance document. However, the firm need only show that its device meets the recommendations of the guidance document or in some other way provides equivalent assurances of safety and effectiveness. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the absorbable hemostatic device. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled “Class II Special Controls Document: Absorbable Hemostatic Device,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document, or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1558 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved submissions, approved applications, and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to the review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the draft guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910-0120). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 19, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-18318 Filed 10-30-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on

(240)276-1243. Comments are invited on:

(a)Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Cross-Site Assessment of the Residential Treatment for Pregnant and Postpartum Women

(PPW)and Their Children Program—(OMB No. 0930-0269)—Revision The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), is funding additional Services Grants for Residential Treatment for Pregnant and Postpartum Women (PPW). The purpose of the PPW is to expand the availability of comprehensive, high quality residential treatment services for pregnant and postpartum women who suffer from alcohol and other drug use problems, and for their infants and children impacted by the perinatal and environmental effects of maternal substance use and abuse. Section 508 [290bb-1] of the Public Health Service Act mandates the evaluation and dissemination of findings of residential treatment programs for pregnant and postpartum women. This cross-site accountability assessment will assess project activities implemented for these services. The grantees were brought to consensus surrounding an evaluation design and methods of data collection with accompanying instruments, via the work of the project officer and consultant experts in the field. The data collection instruments will be used for program and treatment planning, local evaluations, and for this cross-site accountability evaluation. For mothers, administration of data collection instruments will occur at intake, 6 months post-intake, discharge, and 4 months post-discharge. 1 The following four different interview instruments will be used for mothers: 1 The 4 month post-discharge administration replaces the 12-month post-admission administration approved by OMB for the pilot study. This modification was made because it is believed that post-discharge followup information will be more informative and will have more cases than 12 months post-admission. 1. Child Data Collection Tool, Part 1 (child's personal background) and Part 2 (child's medical background); 2. Ferrans and Powers Quality of Life Index© Generic Version—III; 3. BASIS-24® (pilot study used BASIS-32®)—behavioral health assessment; and 4. Allen Barriers to Treatment Instrument. For all children under 18 years, program staff will collect information from observation, interview, and records review. For infants and children, data collection will occur at a time within 30 days of the mother's intake or the child's birth, 3 months post-intake/birth, 6 months post-intake/birth, discharge, and 4 months post-discharge. 1 Children's data collection tools include the following: 1. Child Well-Being Scales (staff observation and records review for all children); 2. Denver Developmental Screening Inventory II (ages 0 to 6 years, 0 days); 3. Middle Childhood Developmental Assessment Guide (ages 6 to 10); 4. Adolescent Childhood Development Assessment Guide (ages 11 to 17); and 5. CRAFFT substance abuse screening instrument (ages 11-17). In addition, records review will be conducted by program staff on all program participants. First, at each data collection period except for 4 months post-discharge, staff will complete the Women's Medical Record Audit and the Child's Medical Record Audit (or the Newborn's Medical Record Audit at delivery.) Second, staff will complete the Women's Discharge Tool and the Children's Discharge Tool at discharge. All data will be collected using a combination of observation, records review, self-administered paper-and-pencil questionnaires, and personal interviews. CSAT will use this data for this evaluation to inform public policy, research, and programming as they relate to the provision of women's services. Data produced by this study will provide direction to the type of technical assistance that will be required by service providers of women's programming. In addition, the data will be used by individual grantees to support progress report efforts. The following table shows the estimated annual response burden for this collection. Estimates of Burden Hours Form name/type of administration Number of respondents Responses per respondent Total responses Hours per response Total hour burden Women Interviews Child Data Collection Tool (Personal Interview) 963 4 3,852 0.75 2,889 Allen Barriers to Treatment Instrument (Self-administered paper & pencil) 963 4 3,852 0.28 1,091 Quality of Life Inventory (Self-administered paper & pencil) 963 4 3,852 0.25 963 BASIS-24 (Personal Interview) 963 4 3,852 0.17 642 Total for Women 963 15,408 5,585 Child Interviews/Observations Denver Developmental Screening Inventory II (ages 0m to 6y, 0m) (Personal Interview & Observation) 1,926 5 9,630 0.50 4,815 CRAFFT (ages 11-17) (Personal Interview) 1,225 5 6,125 0.17 1,021 Middle Childhood Developmental Guide (ages 6 to 10) (Personal Interview) 657 5 3,285 0.33 1,095 Adolescent Development Guide (ages 11 to 17) (Personal Interview) 1,225 5 6,125 0.33 2,042 Total for Children 3,852 25,165 8,973 Observation/Records Review by Staff at 8 Facilities Child Well-Being Scales (age 0-17) (Observation & Records Review) 8 3,852 X 5 19,260 0.33 6,420 Women's Medical Record Audit (Records Review) 8 963 X 3 2,889 0.25 722 Children's Medical Record Audit (Records Review) 8 2,812 X 1 (intake) 3,852 X 3 (follow-up) 14,368 0.25 3,592 Newborns' Medical Record Audit (Records Review) 8 1,040 X 1 1,040 0.08 87 Women's Discharge Tool (Records Review) 8 963 X 1 963 0.58 562 Children's Discharge Tool (Records Review) 8 3,852 X 1 3,852 0.58 2,247 Total for Staff: 8 42,372 2.08 13,630 3-Year Total 4,823 82,945 28,188 Average Annual 1,608 27,648 9,396 Note: For mothers, administration of data collection instruments will occur at:

(1)Intake,

(2)6 months post-intake,

(3)discharge, and

(4)4 months post-discharge. For the Child Data Collection Tool, each mother will respond for each of her estimated 4 children at intake only. For infants and children, data collection will occur at:

(1)a time within 30 days of the mother's intake or the child's birth,

(2)3 months post-intake/birth,

(3)6 months post-intake/birth,

(4)discharge, and

(5)4 months post-discharge. It is estimated that 27 percent (1,040) of the children (3,852) will be delivered while the woman is in the treatment facility. For these infants, the Newborn's Medical Record Audit will be completed at delivery, and the Children's Medical Record Audit will be completed at 3 months post-admission, 6 months post-admission, and at discharge. Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, 1 Choke Cherry Road, Rockville, MD 20850. Written comments should be received by January 2, 2007. Dated: October 4, 2006. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E6-18266 Filed 10-30-06; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2006-26114] National Boating Safety Activities: Funding for National Nonprofit Public Service Organizations AGENCY: Coast Guard, DHS. ACTION: Notice of funds availability. SUMMARY: The Coast Guard seeks applications for fiscal year 2007 grants and cooperative agreements from national, nongovernmental, nonprofit public service organizations. The Boating Safety Financial Assistance Program is listed in section 97.012 of the Catalog of Federal Domestic Assistance. These grants and cooperative agreements would be used to fund projects on various subjects promoting recreational boating safety on a national scope. This notice provides information about the grant and cooperative agreement application process and some of the subjects of particular interest to the Coast Guard. DATES: Application packages may be obtained on or after November 1, 2006. Proposals for the fiscal year 2007 grant cycle must be received before 3 p.m. Eastern time, January 22, 2007. ADDRESSES: Application packages may be obtained by calling the Coast Guard at 202-372-1060. Submit proposals to: Commandant (G-PCB-1), U.S. Coast Guard Headquarters, 2100 Second Street SW., Room 3100, Washington, DC 20593-0001. This notice is available from the Coast Guard and on the Internet at *http://dms.dot.gov* in docket USCG-2006-26114 or at the Web site for the Office of Boating Safety at *http://www.uscgboating.org.* FOR FURTHER INFORMATION CONTACT: Ms. Vickie Hartberger, Office of Boating Safety, U.S. Coast Guard (G-PCB-1/ Room 3100), 2100 Second Street, SW., Washington, DC 20593-0001; 202-372-1060; e-mail *Vickie.L.Hartberger@uscg.mil.* The points of contact for the seven project areas of particular interest are listed at the end of the description of each project area. SUPPLEMENTARY INFORMATION: Title 46, United States Code, Section 13103, allocates funds available from the Aquatic Resources Trust Fund for recreational boating safety grants. The majority of funds are allocated to the states, and up to 5 percent of these funds may be distributed by the Coast Guard for grants and cooperative agreements for national recreational boating safety activities of national nonprofit public service organizations. It is anticipated that approximately $5,400,000 will be made available for fiscal year 2007. Thirty awards totaling $4,615,400 were made in fiscal year 2006, ranging from $10,000 to $550,000. Nothing in this announcement should be construed as committing the Coast Guard to dividing available funds among qualified applicants or awarding any specified amount. It is anticipated that several awards will be made by the U.S. Coast Guard. Applicants must be national, nongovernmental, nonprofit public service organizations and must establish that their activities are, in fact, national in scope. An application package may be obtained by writing or calling the point of contact listed in ADDRESSES on or after November 1, 2006. The application package contains all necessary forms, an explanation of how the grant program is administered, and a checklist for submitting a grant application. Specific information on organization eligibility, proposal requirements, award procedures, and financial administration procedures may be obtained by contacting the person listed in FOR FURTHER INFORMATION CONTACT . Prospective grantees may propose up to a 5-year grant with 12-month (fiscal year) increments identified. In effect, an award would be made for the first year and thereafter renewal is optional. Each annual increment would not be guaranteed. Under a continuation (multi-year) type of award, the Coast Guard agrees to support a grant project at a specific level of effort for a specified period of time, with a statement of intention to provide additional future support, provided funds are available, the project continues to support the needs of the government, and the achieved results warrant further support. Award of continuation grants will be made on a strict case-by-case basis to assist planning in certain large scale projects and ensure continuity. Procedures also provide for awarding noncompetitive grants or cooperative agreements on a case-by-case basis. This authority is judiciously used to fund recurring annual projects or events which can only be carried out by one organization, and projects that present targets of opportunity for timely action on new or emerging program requirements or issues. The following list includes items of specific interest to the Coast Guard; however, potential applicants should not be constrained by the list. We welcome any initiative that supports the mission of the Coast Guard Office of Boating Safety that is to ensure the public has a safe, enjoyable and secure recreational boating experience by implementing programs that minimize the loss of life, personal injury, and property damage, and the goal of the Recreational Boating Safety Program which is achieving a reduction in recreational boating injuries and fatalities by: • Improving the reliability of boating accident reporting, which assists in identifying causal factors that could then be addressed through education and/or regulation; • Increasing Awareness of Safe Boating Practices; • Increasing lifejacket wear; • Decreasing the number of alcohol-related accidents; • Increasing operator compliance with navigation rules; • Increasing operator compliance with USCG safety equipment carriage requirements; • Tracking completion of advanced boating education courses with the future goal of using this data to increase said training; or • Tracking and increasing the number of National Association of State Boating Law Administrators (NASBLA)-approved boating safety education certificates issued annually. Some project areas of continuing and particular interest for grant funding include the following: 1. *Develop and Conduct a National Year-Round Safe Boating Campaign* that focuses on providing support to address areas that have been identified through the Coast Guard's Strategic Planning Process. The Coast Guard seeks a grantee to plan, develop and implement a 2008 National Safe Boating Campaign that promotes a concentrated effort to target specific boater market segments and recreational boating safety topics. This year-round campaign must coincide with the objectives of the National Recreational Boating Safety Program. The nationwide activities of this public awareness campaign should be based on the support of the volunteers and professional groups at the grassroots (local) level. Key to this collaborative effort is how it will complement the Coast Guard's national outreach initiatives. The major focus of the effort will be to modify the behavior of all boaters with special focus on boat operators being responsible for their own safety as well as the safety of their passengers. Significant emphasis should be placed on Personal Flotation Device

(PFD)wear, boater education, safety and security issues, propeller injury prevention, and the dangers of carbon monoxide, as well as boating under the influence of alcohol or drugs. Efforts will also be coordinated, year-round, with other national safety initiatives and special media events. Point of Contact: Ms. Jo Calkin, 202-372-1065. 2. *Develop and Conduct a National Recreational Boating Safety Outreach and Awareness Conference.* The Coast Guard seeks a grantee to plan, implement, oversee, and conduct a National Recreational Boating Safety Outreach and Awareness Conference that supports the organizational objectives of the National Recreational Boating Safety Program. The overall conference focus should have promotional strategies with special emphasis on boat operators being responsible for their own safety as well as the safety of their passengers. Significant emphasis should be placed on offering multiple subjects that afford the participants professional development opportunities and educational enhancement. Subjects should focus on, but not be limited to: PFD wear, safety and security issues, propeller injury prevention, the dangers of carbon monoxide, boater education, vessel safety, outreach and awareness efforts, as well as boating under the influence of alcohol or drugs. Point of Contact: Ms. Jo Calkin, 202-372-1065. 3. *Federal/State Cooperative Partnering Efforts.* The Coast Guard seeks a grantee to provide programs to measurably enhance uniformity and reciprocity in State boating safety laws/regulations and other state boating safety efforts. The grantee would provide a forum to encourage such uniformity and reciprocity among jurisdictions, and closer cooperation and assistance in developing, administering, and enforcing State laws and regulations pertaining to boating safety. The grantee would further provide a forum to encourage sufficient patrol and other activities to ensure adequate enforcement of state boating safety laws and regulations, provision of an adequate U.S. Coast Guard

(USCG)recognized State boating safety education program, enhanced maintenance of USCG approved vessel numbering system and enhanced implementation of a USCG approved marine casualty reporting system. Point of Contact: Ms. Audrey Pickup, 202-372-1063. 4. *Develop and Conduct Boating Accident Investigation Seminars.* The Coast Guard seeks a grantee to develop, provide instructional material, and conduct training courses nationwide for boating accident investigators, including four courses at the U.S. Coast Guard's Maritime Law Enforcement Academy in Charleston, South Carolina. Point of Contact: Mr. Rick Gipe, 202-372-1074. 5. *National Estimate of Personal Flotation Devices

(PFDs)Wear Rate.* The Coast Guard seeks a grantee to provide reliable and valid national estimates of personal flotation device (PFD or lifejacket) wear by recreational boaters. Wear rates of PFDs should be based on actual observations taken from a representative sample of boaters across a range of water venues that include lakes, rivers, and bays. It is essential that observation methods remain as close as possible to those used in previous years so the number of boats, types of boats, length of boats, operation and activity of boats, as well as the age and gender of the boaters observed remain consistent. Using the design of the National PFD Wear Rate Study as a base, a supplemental observational study is solicited to determine if PFD wear rates are higher in an area after the roll-out of the annual Safe Boating Campaign. The grantee shall conduct observations in areas around the country that have relatively high boating activity in the summer and therefore may be expected to have a reasonable level of activity to make conclusions about changes in wear rates more stable. Observation data for 2007 will be collected for inclusion in the baseline measure. In the summer of 2008, the post-campaign measurement will be conducted. Point of Contact: Mr. Bruce Schmidt, 202-372-1059. 6. *Voluntary Standards Development Support* . The Coast Guard seeks a grantee to carry out a program to encourage active participation by members of the public and other qualified persons in the development of technically sound voluntary safety standards for boats and associated equipment. Point of Contact: Mr. Po Chang, 202-372-1075. 7. *PFD Wear Rate Strategy for Anglers.* The Coast Guard seeks a grantee to develop and implement a national outreach and awareness strategy designed to raise the level of boating safety consciousness among anglers. This year-round strategic effort must support the organizational objectives of the National Recreational Boating Safety Program as well as have the capacity to be implemented into the Coast Guard national outreach initiatives. The major focus will be to specifically target the behavior of anglers while boating with a significant emphasis on their responsibility as boat operators to wear a lifejacket/PFD as well as ensure that all passengers do the same. Point of Contact: Ms. Jo Calkin, 202-372-1065. We encourage proposals addressing other boating safety concerns. Potential grantees should focus on partnership, *e.g.* , exploring other sources, linkages, in-kind contributions, cost sharing, and partnering with other organizations or corporations. The primary goal of the National Recreational Boating Safety Program is to reduce fatalities to specific levels for each upcoming year. With your application, we encourage you to list and describe the tools you will use to measure your grant's performance toward achieving this goal or toward achieving a specific objective that will result in the achievement of this goal. For some examples of tools, we invite you to explore this CDC Web site: *http://www.cdc.gov/ncipe/ pub-res/demonstr.htm.* This announcement is available on the *http://www.grants.gov* Web site; we are also publishing the information in the **Federal Register** again this year to provide information to the public in a timely manner. Dated: October 20, 2006. Brian M. Salerno, Rear Admiral, U.S. Coast Guard, Director of Inspections and Compliance. [FR Doc. E6-18265 Filed 10-30-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration New Agency Information Collection Activity Under OMB Review: TSA Web Site Usability Development: Focus Groups and Online Survey AGENCY: Transportation Security Administration, DHS. ACTION: Notice. SUMMARY: This notice announces that the Transportation Security Administration

(TSA)has forwarded the new Information Collection Request

(ICR)abstracted below to the Office of Management and Budget

(OMB)for review and approval under the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. TSA published a **Federal Register** notice, with a 60-day comment period soliciting comments, of the following collection of information on June 9, 2006, 71 FR 33478. DATES: Send your comments by November 30, 2006. A comment to OMB is most effective if OMB receives it within 30 days of publication. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to Nathan Lesser, Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. FOR FURTHER INFORMATION CONTACT: Katrina Kletzly, Attorney-Advisor, Office of the Chief Counsel, TSA-2, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220; telephone

(571)227-1995; facsimile

(571)227-1381. SUPPLEMENTARY INFORMATION: Comments Invited In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

(1)Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden;

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

(4)Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Information Collection Requirement *Title:* TSA Web Site Usability Development: Focus Groups and Online Survey. *Type of Request:* New collection. *OMB Control Number:* Not yet assigned. *Form(s):* NA. *Affected Public:* Visitors to the TSA Web site; travelers at airports who volunteer for focus groups. *Abstract:* In order to provide a useful public Web site, TSA seeks to administer two data collections, “Web site Focus Groups” and “Web site Online Survey,” to obtain feedback concerning the usability, content, focus and user satisfaction of TSA's Web site. TSA will use the data obtained through these collection methods to deliver effective and engaging information to meet customers' needs and continuously improve TSA's Web site usability. TSA intends to conduct 15 Web site focus groups annually, each with a target of 10 total participants and an estimate of a 1 hour burden per respondent. TSA estimates a maximum total annual burden of 150 hours (10 participant hours per focus group session times 15 focus group sessions equals 150 hours total). TSA also intends to conduct voluntary Web site surveys to collect data for improved content and usability, which will be available via the TSA Web site ( *http://www.tsa.gov* ). Surveys will comprise an approximate five-minute burden per respondent and an aggregate burden of 34 hours per year, based on an estimated 400 online surveys voluntarily completed per year (400 surveys times 5 minutes per survey equals 2000 minutes total, which is then divided by 60 minutes, resulting in 34 hours total). *Number of Respondents:* 550. *Estimated Annual Burden Hours:* An estimated 184 hours annually. Issued in Arlington, Virginia, on October 24, 2006. Peter Pietra, Director of Privacy Policy and Compliance. [FR Doc. E6-18212 Filed 10-30-06; 8:45 am] BILLING CODE 9110-05-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [ID100 1220MA 024D 252X; DBG071002] Notice of Public Meeting: Resource Advisory Council to the Boise District, Bureau of Land Management, U.S. Department of the Interior AGENCY: Bureau of Land Management, U.S. Department of the Interior. ACTION: Notice of public meeting. SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management

(BLM)Boise District Resource Advisory Council (RAC), will meet as indicated below. DATES: The meeting will be held November 21, 2006, beginning at 8 a.m. and adjourning at 5 p.m. A field trip is scheduled for the morning hours, departing from the BLM Boise District Offices. Selected recreation areas will be evaluated located in the Owyhee Field Office. The afternoon session will be held at the American Legion-Community Center, Phipps Watson Hall, Marsing, ID. Public comment periods will be held after topics on the agenda. FOR FURTHER INFORMATION CONTACT: MJ Byrne, Public Affairs Officer and RAC Coordinator, BLM Boise District, 3948 Development Ave., Boise, ID 83705, Telephone

(208)384-3393. SUPPLEMENTARY INFORMATION: The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in southwestern Idaho. The agenda and meeting topics will include the following: • Field Trip to assess selected recreation areas in the Owyhee Field Office; • Introduction of newly appointed RAC members; • Review of Action Items from previous RAC meeting; • Hot Topics; • Review and discussion of issue papers sent to RAC of planned activities in the District and three Field Offices; • Subcommittee Reports: ○ OHV & Transportation Management; ○ Sage Grouse Habitat Management; ○ Resource Management Plans

(RMPs)—Bruneau Field Office' Draft RMP-EIS Alternatives —Update on Draft EIS for the NCA-RMP ○ River and Recreation Management —Update on new Recreation RAC Subcommittee formation Agenda items and location may change due to changing circumstances, including wildfire emergencies. All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM Coordinator as provided above. Expedited publication is requested to give the public adequate notice. Dated: October 24, 2006. Jerry L. Taylor, District Manager. [FR Doc. E6-18273 Filed 10-30-06; 8:45 am] BILLING CODE 4310-GG-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [NM-920-1310-07; NMNM 98210] Notice of Proposed Reinstatement of Terminated Oil and Gas Lease NMNM 98210 AGENCY: Bureau of Land Management, Interior. ACTION: Notice of Reinstatement of Terminated Oil and Gas Lease. SUMMARY: Under the Class II provisions of Title IV, Public Law 97-451, and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management

(BLM)received a petition for reinstatement of oil and gas lease NMNM 98210 from the lessee, Chesapeak Permian, L.P., for lands in Roosevelt County, New Mexico. The petition was filed on time and it was accompanied by all the rentals due since the date the lease terminated under the law. FOR FURTHER INFORMATION CONTACT: Bernadine T. Martinez, BLM, New Mexico State Office, at

(505)438-7530. SUPPLEMENTARY INFORMATION: No lease has been issued that affect the lands. The lessee agrees to new lease terms for rentals and royalties of $10.00 per acre or fraction thereof, per year, and 16 2/3 percent, respectively. The lessee paid the required $500.00 administrative fee for the reinstatement of the lease and $166.00 cost for publishing this Notice in the **Federal Register** . The lessee met all the requirements for reinstatement of the lease as set out in sections 31(d) and

(e)of the Mineral Leasing Act of 1920 (30 U.S.C. 188). We are proposing to reinstate lease NMNM 98210, effective the date of termination, March 1, 2006, under the original terms and conditions of the lease and the increased rental and royalty rates cited above. Dated: October 20, 2006. Bernadine T. Martinez, Land Law Examiner, NMSO. [FR Doc. E6-18235 Filed 10-30-06; 8:45 am] BILLING CODE 4310-FB-P DEPARTMENT OF THE INTERIOR Minerals Management Service Notice and Agenda for Meeting of the Royalty Policy Committee AGENCY: Minerals Management Service (MMS), Interior. ACTION: Notice of meeting. SUMMARY: Agenda items for the meeting of the Royalty Policy Committee

(RPC)will include remarks from the Director, MMS, and the Associate Director, Minerals Revenue Management (MRM), as well as updates from the following subcommittees: Coal, Federal Oil and Gas Valuation, and Oil and Gas Royalty Reporting. The RPC membership includes representatives from states, Indian tribes, individual Indian mineral owner organizations, minerals industry associations, the general public, and other Federal departments. DATES: Tuesday, November 14, 2006, from 8:30 a.m. to 4:30 p.m., mountain time. ADDRESSES: The meeting will be held at the Sheraton Denver West, 360 Union Boulevard, Lakewood, Colorado, telephone 303-987-2000 or 1-800-325-3535. FOR FURTHER INFORMATION CONTACT: Gina Dan, Minerals Revenue Management, Minerals Management Service, P.O. Box 25165, MS 300B2, Denver, Colorado 80225-0165, telephone number

(303)231-3392, fax number

(303)231-3780, e-mail *gina.dan@mms.gov.* SUPPLEMENTARY INFORMATION: The RPC provides advice to the Secretary and top Department officials on minerals policy, operational issues, and the performance of discretionary functions under the laws governing the Department's management of Federal and Indian mineral leases and revenues. The RPC reviews and comments on revenue management and other mineral-related policies and provides a forum to convey views representative of mineral lessees, operators, revenue payors, revenue recipients, governmental agencies, and the interested public. Dates and locations of future meetings will be published in the **Federal Register** and posted on our Internet site at *http://www.mms.gov/mmab/RoyaltyPolicyCommittee/rpc_homepage.htm.* Meetings will be open to the public without advanced registration on a space-available basis. To the extent time permits, the public may make statements during the meetings, and file written statements with the RPC for its consideration. Copies of these written statements should be submitted to Gina Dan by November 6, 2006. Transcripts of this meeting will be available for public inspection and copying at our offices located in Building 85, Denver Federal Center, West 6th Ave. and Kipling Blvd., Denver, Colorado 80225. These meetings are conducted under the authority of the Federal Advisory Committee Act (Public Law 92-463, 5 U.S.C., Appendix 1) and the Office of Management and Budget (Circular No. A-63, revised). Dated: October 24, 2006. Lucy Querques Denett, Associate Director, Minerals Revenue Management. [FR Doc. E6-18372 Filed 10-30-06; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF THE INTERIOR National Park Service National Register of Historic Places; Notification of Pending Nominations and Related Actions Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before October 14, 2006. Pursuant to section 60.13 of 36 CFR part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St. NW., 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service,1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447. Written or faxed comments should be submitted by November 15, 2006. John W. Roberts, Acting Chief, National Register/National Historic Landmarks Program. CALIFORNIA Lake County Rattlesnake Island, 12900 Sulphur Bank Mine Rd., Clearlake Oaks, 06001047 COLORADO El Paso County Edgeplain, 1106 N. Nevada Ave., Colorado Springs, 06001048 Rice, Ida M., House, 1196 N. Cascade Ave., Colorado Springs, 06001049 DELAWARE Sussex County Roosevelt Inlet Shipwreck, Lower Delaware Bay, Lewes, 06001056 KANSAS Butler County Oldham, James T., House, 321 S. Denver St., El Dorado, 06001054 Ness County Tilley, Henry, House, 108 W. 2nd St., Ransom, 06001053 Osborne County Natoma Presbyterian Church, 408 N. 3rd St., Natoma, 06001052 Riley County Community House, 120 N. 4th St., Manhattan, 06001051 Smith County Allen's Market, 2938 E. Douglas Ave., Wichita, 06001050 MASSACHUSETTS Franklin County Colrain Center Historic District, Main, Greenfield, Jacksonville Rds., Streeter Ln, River and Coburn Sts., Colrain, 06001057 NEBRASKA Custer County Broken Bow Commercial Square Historic District, Five blks in downtown Broken Bow centered around public square, Broken Bow, 06001058 Dawes County Chadron Commercial Historic District, Main St. & 2nd St., Chadron, 06001059 NEVADA Clark County Woodlawn Cemetery, 1500 Las Vegas Blvd N, Las Vegas, 06001060 PENNSYLVANIA Dauphin County Derry Session House and Enclosure, 248 E. Derry Rd., Hershey, 06001061 Erie County Academy Hall, On the campus of Edinboro University, Jct. of Highland and Normal Sts, Edinboro, 06001055 RHODE ISLAND Providence County Pascoag Grammar School, 265 Sayles Ave., Burrillville, 06001062 TEXAS Harris County First Evangelical Church, 1311 Holman St., Houston, 06001066 Orange Show, 2401 Munger St., Houston, 06001063 Kleberg County Nance-Jones House, 426 E. Johnston Ave., Kingsville, 06001064 Tarrant County Eighth Avenue Historic District, Bounded by 8th Ave., Pennsylvania Ave., 9th Ave., and Pruitt St., Fort Worth, 06001065 UTAH Garfield County Panguitch Historic District, Roughly bounded by 500 North, 400 East, 500 South, and 300 West, Panguitch, 06001068 Salt Lake County Ashby Apartments, 358 E. 100 South, Salt Lake City, 06001067 WISCONSIN Walworth County Sheboygan Light, Power and Railway Company Car #26, 2015 Division St., East Troy, 06001069 [FR Doc. E6-18302 Filed 10-30-06; 8:45 am] BILLING CODE 4312-51-P DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to issuing a registration under this Section to a bulk manufacturer of a controlled substance in schedule I or II and prior to issuing a regulation under 21 U.S.C. 952(a)(2)(B) authorizing the importation of such a substance, provide manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. Therefore, in accordance with 21 CFR 1301.34(a), this is notice that on July 19, 2006, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78664, made application by renewal to the Drug Enforcement Administration

(DEA)to be registered as an importer of the basic classes of controlled substances listed in schedule I and II: Drug Schedule Cathinone

(1235)I Methcathinone

(1237)I N-Ethylamphetamine

(1475)I Gamma Hydroxybutyric Acid

(2010)I Ibogaine

(7260)I Alpha-methyltryptamine

(7432)I Dimethyltryptamine

(7435)I Tetrahydrocannabinols

(7370)I Mescaline

(7381)I 4-Bromo-2,5-dimethoxyamphetamine

(7391)I 4-Bromo-2,5-dimethoxyphenethylamine

(7392)I 4-Methyl-2,5-dimethoxyamphetamine

(7395)I 2,5-Dimethoxyamphetamine

(7396)I 3,4-Methylenedioxyamphetamine

(7400)I 3,4-Methylenedioxy-N-ethylamphetamine

(7404)I 3,4-Methylenedioxymethamphetamine

(7405)I 4-Methoxyamphetamine

(7411)I Psilocybin

(7437)I Psilocyn

(7438)I Etorphine (except HCI)

(9056)I Heroin

(9200)I Pholcodine

(9314)I Amphetamine

(1100)II Methamphetamine

(1105)II Methylphenidate

(1724)II Amobarbital

(2125)II Pentobarbital

(2270)II Cocaine

(9041)II Codeine

(9050)II Dihydrocodeine

(9120)II Oxycodone

(9143)II Hydromorphone

(9150)II Benzoylecgonine

(9180)II Ethylmorphine

(9190)II Meperidine

(9230)II Methadone

(9250)II Dextropropoxyphene bulk

(9273)(non-dosage form) II Morphine

(9300)II Thebaine

(9333)II Levo-alphacetylmethadol

(9648)II Oxymorphone

(9652)II The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic classes of controlled substances may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than November 30, 2006. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d),

(e)and (f). As noted in a previous notice published in the **Federal Register** on September 23, 1975, (40 FR 43745-46), all applicants for registration to import a basic class of any controlled substance listed in schedule I or II are, and will continue to be required to demonstrate to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a), 21 U.S.C. 823(a), and 21 CFR 1301.34(b), (c), (d),

(e)and

(DEA)to be registered as an importer of Phenylacetone (8501), a basic class of controlled substance listed in schedule II. The company plans to import Phenylacetone to manufacture Amphetamine. Any manufacturer who is presently, or is applying to be, registered with DEA to manufacture such basic class of controlled substance may file comments or objections to the issuance of the proposed registration and may, at the same time, file a written request for a hearing on such application pursuant to 21 CFR 1301.43 and in such form as prescribed by 21 CFR 1316.47. Any such written comments or objections being sent via regular mail should be addressed, in quintuplicate, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL; or any being sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, Virginia 22301; and must be filed no later than November 30, 2006. This procedure is to be conducted simultaneously with and independent of the procedures described in 21 CFR 1301.34(b), (c), (d),

(e)and

(f)are satisfied. Dated: October 24, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. E6-18251 Filed 10-30-06; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF LABOR Employment Standards Administration Proposed Collection; Comment Request ACTION: Notice. SUMMARY: The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Davis-Bacon and Related Act/Contract Work Hours and Safety Standards Act Reporting Requirements—Regulations, 29 CFR Part 5. A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice. DATES: Written comments must be submitted to the office listed in the addresses section below on or before January 2, 2007. ADDRESSES: Ms. Hazel M. Bell, U.S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone

(202)693-0418, fax

(202)693-1451, E-mail *bell.hazel@dol.gov.* Please use only one method of transmission for comments (mail, fax, or E-mail). SUPPLEMENTARY INFORMATION: *I. Background:* Regulations 29 CFR Part 5 prescribes labor standards for federally financed and assisted construction contracts subject to the Davis-Bacon (DBA), 40 U.S.C. 3141 *et seq.* , the Davis-Bacon Related Acts (DBRA), and labor standards for all contracts subject to the Contract Work Hours and Safety Standards Act (CWHSSA), 40 U.S.C. 3701 *et seq.* The DB and DBRA require payment of locally prevailing wages and fringe benefits, as determined by the Department of Labor (DOL), to laborers and mechanics on most federally financed or assisted construction projects. See 40 U.S.C. § 3142(a) and 29 CFR 5.5(2)(1). The CWHSSA requires the payment of one and one-half times the basic rate of pay hours worked over forty in a week on most Federal contracts involving the employment of laborers or mechanics. See 40 U.S.C. 3702(c) and 29 CFR 5.5(b)(1). The requirements of this information collection consist of:

(A)reports of conformed classifications and wage rates, and

(B)requests for approval of unfunded fringe benefit plans. This information collection is currently approved for use through May 31, 2007. II. *Review Focus:* The Department of Labor is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submissions of responses. III. *Current Actions:* The Department of Labor seeks approval for the extension of this information collection in order to ensure that federal contractors are in compliance with the DBA, DBRA, and CWHSSA. *Type of Review:* Extension. *Agency:* Employment Standards Administration. *Title:* Davis-Bacon and Related Acts/Contract Work Hours and Safety Standards Act Reporting Requirements-Regulations, 29 CFR Part 5. *OMB Number:* 1215-0140. *Affected Public:* Business or other for-profit; Federal Government; State, Local or Tribal Government. Requirement Number of respondents Number of responses Estimated time per response Burden hours Conformance Reports 3,000 3,000 15 minutes 750 Unfunded Fringe Benefit Plans 6 6 6 hours 6 Total 3,006 3,006 756 *Frequency:* On Occasion. *Estimated Total Burden Hours:* 756. *Total Burden Cost (capital/startup):* $0. *Total Burden Cost (operating/maintenance):* $1,263. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record. Dated: October 26, 2006. Ruben Wiley, Chief, Branch of Management Review and Internal Control, Division of Financial Management, Office of Management, Administration and Planning, Employment Standards Administration. [FR Doc. E6-18282 Filed 10-30-06; 8:45 am] BILLING CODE 4510-27-P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection; Comment Request Annual Report for Multiple Employer Welfare Arrangements (Form M-1) ACTION: Notice. SUMMARY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and the public understand the Department's information collection requirements and provide the requested data in the desired format. Currently, the Employee Benefits Security Administration

(EBSA)is soliciting comments concerning a proposed extension of the current approval of an information collection entitled Annual Report for Multiple Employer Welfare Arrangements (Form M-1), contained in the Department's regulation at 29 CFR 2520.101-2, Multiple Employer Welfare Arrangements and Certain Other Entities that Offer or Provide Medical Care to the Employees of Two or More Employers. A copy of the Department's information collection request

(ICR)may be obtained by contacting the office listed in the addresses section of this notice. DATES: Written comments must be submitted to the office shown in the addresses section below on or before January 2, 2007. ADDRESSES: Direct all written comments to Susan G. Lahne, Office of Policy and Research, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5647, Washington, DC 20210. Telephone:

(202)693-8410; Fax:

(202)219-4745. These are not toll-free numbers. Comments may also be submitted electronically to the following Internet e-mail address: *ebsa.opr@dol.gov* . SUPPLEMENTARY INFORMATION: I. Background The Health Insurance Portability and Accountability Act of 1996 (HIPAA), codified as Part 7 of Title I of the Employee Retirement Security Act of 1974 (ERISA), was enacted to improve the portability and continuity of health care coverage for participants and beneficiaries of group health plans. In the interest of assuring compliance with Part 7, section 101(g) of ERISA, added by HIPAA, further permits the Secretary of Labor (the Secretary) to require multiple employer welfare arrangements (MEWAs), as defined in section 3(40) of ERISA, to report to the Secretary in such form and manner as the Secretary might determine. The Department published a final rule providing for such reporting on an annual basis, together with a form (Form M-1) to be used by MEWAs for the annual report. The reporting requirement enables the Secretary to determine whether the requirements of Part 7 of ERISA are being carried out. EBSA submitted an ICR for the information collection in Form M-1 to the Office of Management and Budget

(OMB)for review and clearance in connection with publication of the final rule, and OMB approved the information collection under OMB control number 1210-0116. This approval is scheduled to expire on January 31, 2007. After considering any comments received in response to this notice, EBSA intends to submit an ICR to OMB to request continuing approval. The public is not required to respond to an information collection unless it displays a valid control number. No change to the existing ICR is being proposed or made at this time. II. Desired Focus of Comments The Department is particularly interested in comments that: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., by permitting electronic submission of responses. III. Current Action This notice requests comments on an extension of OMB's approval of the information collection included in Form M-1. The Department is not proposing or implementing changes to the existing ICR at this time. A summary of the ICR and the current burden estimates follows: *Type of Review:* Extension of a currently approved collection of information. *Agency:* Employee Benefits Security Administration, Department of Labor. *Title:* Annual Report for Multiple Employer Welfare Arrangements and Certain Entities Claiming Exception (Form M-1). *OMB Number:* 1210-0116. *Affected Public:* Business or other for-profit; Not-for-profit institutions. *Respondents:* 741. *Frequency of Response:* Annually. *Responses:* 3,718. *Estimated Total Burden Hours:* 2,336. *Total Burden Cost (Operating and Maintenance):* $143,650. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record. Joseph S. Piacentini, Director, Office of Policy and Research, Employee Benefits Security Administration. [FR Doc. E6-18230 Filed 10-30-06; 8:45 am] BILLING CODE 4510-29-P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection; Comment Request; Employee Benefit Plan Claims Procedures Under ERISA AGENCY: Employee Benefits Security Administration, Department of Labor. ACTION: Notice. SUMMARY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and the public understand the Department's information collection requirements and provide the requested data in the desired format. Currently, the Employee Benefits Security Administration

(EBSA)is soliciting comments on a proposed extension of the current approval of information collection provisions incorporated in the regulation pertaining to employee benefit plan claims procedures under the Employee Retirement Income Security Act of 1974 (ERISA). A copy of the information collection request

(ICR)may be obtained by contacting the office listed in the ADDRESSES section of this notice. DATES: Written comments must be submitted on or before January 2, 2007. ADDRESSES: Direct all written comments to Susan G. Lahne, Office of Policy and Research, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5647, Washington, DC 20210. Telephone:

(202)693-8410; Fax:

(202)219-4745. These are not toll-free numbers. Comments may also be submitted electronically to the following Internet e-mail address: *ebsa.opr@dol.gov.* SUPPLEMENTARY INFORMATION: I. Background Section 503 of ERISA requires each employee benefit plan to provide, pursuant to regulations promulgated by the Secretary of Labor, notice in writing to any participant or beneficiary whose claim for benefits under the plan has been denied. The notice must set forth the specific reasons for the denial and must be written in a manner calculated to be understood by the claimant. Plans must also give a participant or beneficiary whose claim has been denied a reasonable opportunity to obtain a full and fair review of any benefit claim denial by the appropriate named fiduciary. The Department issued a regulation pertaining to benefit claims procedures in 1977 and amended that regulation in a Notice of Final Rulemaking

(NFRM)published on November 21, 2000 (65 FR 70246). The regulation pertaining to benefit claims procedures is codified at 29 CFR 2560.503-1. The regulation requires plans to establish reasonable claims procedures that meet specified standards governing the timing and content of notices and disclosures. EBSA submitted an ICR for the information collections in 29 CFR 2560.503-1 to the Office of Management and Budget

(OMB)for review and clearance in connection with publication of the NFRM, and OMB approved the information collections under OMB control number 1210-0053. That approval is scheduled to expire on February 28, 2007. After considering comments received in response to this notice, the Department intends to submit an ICR to OMB to request continuing approval. The public is not required to respond to an information collection unless it displays a valid control number. No change to the existing ICR is being proposed or made at this time. II. Desired Focus of Comments The Department of Labor (Department) is particularly interested in comments that • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. III. Current Action This notice requests comments on an extension of OMB's approval of the information collections included in 29 CFR 2560.503-1. The Department is not proposing or implementing changes to the existing ICR at this time. A summary of the ICR and the current burden estimates follows: *Agency:* Employee Benefits Security Administration, Department of Labor. *Title:* Employee Benefit Plan Claims Procedures under ERISA. *Type of Review:* Extension of a currently approved collection of information. *OMB Number:* 1210-0053. *Affected Public:* Business or other for-profit; Not-for-profit institutions. *Respondents:* 6,700,000. *Responses:* 118,000,000. *Estimated Total Burden Hours:* 333,000. *Estimated Total Burden Cost (Operating and Maintenance):* $90,000,000. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record. Joseph S. Piacentini, Director, Office of Policy and Research, Employee Benefits Security Administration. [FR Doc. E6-18231 Filed 10-30-06; 8:45 am] BILLING CODE 4510-29-P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection; Comment Request; ERISA Investment Manager Electronic Registration AGENCY: Employee Benefits Security Administration, Department of Labor. ACTION: Notice. SUMMARY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and the public understand the Department's information collection requirements and provide the requested data in the desired format. Currently, the Employee Benefits Security Administration

(EBSA)is soliciting comments on a proposed extension of the current approval of information collection provisions incorporated in the regulation pertaining to electronic registration of investment managers under ERISA. A copy of the information collection request

(ICR)can be obtained by contacting the office shown in the Addresses section of this notice. DATES: Written comments must be submitted to the office shown in the Addresses section on or before January 2, 2007. ADDRESSES: Direct all written comments to Susan G. Lahne, Office of Policy and Research, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5647, Washington, DC 20210. Telephone:

(202)693-8410; Fax:

(202)219-4745. These are not toll-free numbers. Comments may also be submitted electronically to the following Internet e-mail address: *ebsa.opr@dol.gov.* SUPPLEMENTARY INFORMATION: I. Background Section 3(38)(B) of the Employee Retirement Income Security Act of 1974 (ERISA) imposes certain registration requirements on an investment adviser that wishes to be considered an investment manager under ERISA. In 1997, section 3(38) was amended to permit advisers to satisfy the registration requirements by registering electronically with the Investment Adviser Registration Depository

(IARD)established and maintained by the Securities Exchange Commission (SEC). The Department promulgated a final regulation (69 FR 52120, August 24, 2004) to implement the statutory change. The final regulation is codified at 29 CFR 2510.3-38. EBSA submitted an ICR requesting OMB approval of the information collection contained in 29 CFR 2510.3-38 when the proposed regulation was published, and OMB approved the information collection under OMB control number 1210-0125. The approval is scheduled to expire on January 31, 2007. The Department intends, following receipt of comments pursuant to this notice, to submit an ICR to OMB requesting an extension of its approval of this information collection. The public is not required to respond to an information collection unless it displays a valid OMB control number. No change to the existing ICR is being proposed or made at this time. II. Desired Focus of Comments The Department is particularly interested in comments that: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , by permitting electronic submissions of responses. III. Current Actions This notice requests comments on an extension of OMB's approval of the information collections included in 29 CFR 2510.3-38. The Department is not proposing or implementing changes to the existing ICR at this time. A summary of the ICR and the current burden estimates follows: *Agency:* Employee Benefits Security Administration, Department of Labor. *Title:* ERISA Investment Manager Electronic Registration. *Type of Review:* Extension of a currently approved collection of information. *OMB Number:* 1210-0125. *Affected Public:* Business or other for-profit; Not-for-profit institutions. *Respondents:* 500. *Responses:* 500. *Estimated Total Burden Hours:* 1,000. *Estimated Total Burden Cost (Operating and Maintenance):* $50,000. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval; they will also become a matter of public record. Joseph S. Piacentini, Director, Office of Policy and Research, Employee Benefits Security Administration. [FR Doc. E6-18232 Filed 10-30-06; 8:45 am] BILLING CODE 4510-29-P DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection; Comment Request; Summary Plan Description Requirements Under ERISA AGENCY: Employee Benefits Security Administration, Department of Labor. ACTION: Notice. SUMMARY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and the public understand the Department's information collection requirements and provide the requested data in the desired format. Currently, the Employee Benefits Security Administration

(EBSA)is soliciting comments on a proposed extension of the current approval of information collection provisions in the regulation pertaining to summary plan description requirements under ERISA. A copy of the information collection request

(ICR)can be obtained by contacting the individual shown in the Addresses section of this notice. DATES: Written comments must be submitted to the office shown in the Addresses section on or before January 2, 2007. ADDRESSES: Direct all written comments to Susan G. Lahne, Office of Policy and Research, Employee Benefits Security Administration, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5647, Washington, DC 20210. Telephone:

(202)693-8410; Fax:

(202)219-4745. These are not toll-free numbers. Comments may also be submitted electronically to the following Internet e-mail address: *ebsa.opr@dol.gov* . SUPPLEMENTARY INFORMATION: I. Background Section 104(b) of the Employee Retirement Income Security Act of 1974 (ERISA) requires the administrator of an employee benefit plan to furnish plan participants and certain beneficiaries with a Summary Plan Description

(SPD)that describes, in language understandable to an average plan participant, the benefits, rights, and obligations of participants in the plan. The information required to be contained in the SPD is set forth in section 102(b) of ERISA. To the extent that there is a material modification in the terms of the plan or a change in the required content of the SPD, section 104(b)(1) of ERISA requires the administrator to furnish participants and specified beneficiaries a summary of material modifications

(SMM)or summary of material reductions (SMR). The Department of Labor (Department) has issued regulations providing guidance on compliance with the requirements to furnish SPDs, SMMs, and SMRs. These regulations, which are codified at 29 CFR 2520.102-2,102-3, and 29 CFR 104b-2 and 104b-3, contain information collections for which the Department has obtained OMB approval under the OMB Control No. 1210-0039. The current approval is scheduled to expire on January 31, 2007, and the Department intends, following receipt of comments pursuant to this notice, to submit an ICR to OMB requesting an extension of its approval of these information collections. The public is not required to respond to an information collection unless it displays a valid control number. No change to the existing ICR is being proposed or made at this time. II. Desired Focus of Comments The Department is particularly interested in comments that: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., by permitting electronic submissions of responses. III. Current Actions This notice requests comments on an extension of OMB's approval of the information collections included in 29 CFR 2520.102-2,102-3, and 29 CFR 104b-2 and 104b-3. The Department is not proposing or implementing changes to the existing ICR at this time. A summary of the ICR and the current burden estimates follows: *Agency:* Employee Benefits Security Administration, Department of Labor. *Title:* Summary Plan Description Requirements under ERISA. *Type of Review:* Extension of a currently approved collection of information. *OMB Number:* 1210-0039. *Affected Public:* Business or other for-profit; Not-for-profit institutions. *Respondents:* 900,000. *Responses:* 50,000,000. *Estimated Total Burden Hours:* 1,100,000. *Estimated Total Burden Cost (Operating and Maintenance):* $400,000,000. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval; they will also become a matter of public record. Joseph S. Piacentini, Director, Office of Policy and Research, Employee Benefits Security Administration. [FR Doc. E6-18233 Filed 10-30-06; 8:45 am] BILLING CODE 4510-29-P DEPARTMENT OF LABOR Employee Benefits Security Administration [Application Nos. D-08295 and D-10365] RIN 1210-ZA10 Prohibited Transaction Exemption

(PTE)2006-16; Class Exemption To Permit Certain Loans of Securities by Employee Benefit Plans AGENCY: Employee Benefits Security Administration, Department of Labor. ACTION: Adoption of Amendment and Revocation of PTEs 81-6 and 82-63. SUMMARY: This document amends and replaces Prohibited Transaction Exemption

(PTE)81-6 (46 FR 7527, January 23, 1981) and PTE 82-63 (47 FR 14804, April 6, 1982). PTE 81-6 exempts the lending of securities by employee benefit plans to certain banks and broker-dealers, and PTE 82-63 exempts certain compensation arrangements for the provision of securities lending services by a plan fiduciary to an employee benefit plan. The final amendment incorporates the exemptions into one renumbered exemption, and expands the relief that was provided in PTEs 81-6 and 82-63 to include additional parties and additional forms of collateral subject to the specified conditions. The exemption affects participants and beneficiaries of employee benefit plans, persons who lend securities on behalf of such plans, and parties in interest who engage in securities lending transactions with such plans. DATES: The effective date of this amendment is January 2, 2007. The revocation of PTEs 81-6 and 82-63 is effective on January 2, 2007. FOR FURTHER INFORMATION CONTACT: Allison Padams Lavigne, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor,

(202)693-8540 (This is not a toll-free number.) SUPPLEMENTARY INFORMATION: On October 23, 2003, the Department proposed a notice in the **Federal Register** of a proposed class exemption to amend PTEs 81-6 and 82-63 by incorporating PTEs 81-6 and 82-63 into a new class exemption and expanding the existing relief from the restrictions of sections 406(a)(1)(A) through

(D)and 406(b)(1) of ERISA and the taxes imposed by section 4975(a) and

(b)of the Code by reason of section 4975(c)(1)(A) through

(E)of the Code to additional parties under modified conditions. 1 The notice also proposed the revocation of PTEs 81-6 and 82-63. The proposal was published in response to two exemption applications. One application was submitted by the American Bankers Association

(ABA)(D-08295), and the second application was submitted by the Robert Morris Associates, now known as the Risk Management Association

(RMA)(D-10365). The applications were filed pursuant to section 408(a) of ERISA and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR 2570, subpart B (55 FR 32836, August 10, 1990). 1 Section 102 of Reorganization Plan No. 4 of 1978 (5 U.S.C. App. 1 (1996)) generally transferred the authority of the Secretary of the Treasury to issue exemptions under Code section 4975(c)(2) to the Secretary of Labor. The notice of pendency gave interested persons an opportunity to comment or request a public hearing on the proposal. The Department received six public comments. No request for a hearing was received. Upon consideration of the comments received, the Department has determined to grant the proposed class exemption, subject to certain modifications. These modifications and the comments are discussed below. Executive Order 12866 Under Executive Order 12866, the Department must determine whether the regulatory action is “significant” and therefore subject to the requirements of the Executive Order and subject to review by the Office of Management and Budget (OMB). Under section 3(f), the order defines a “significant regulatory action” as an action that is likely to result in a rule

(1)having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as “economically significant”);

(2)creating serious inconsistency or otherwise interfering with an action taken or planned by another agency;

(3)materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4)raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This class exemption has been drafted and reviewed in accordance with Executive Order 12866, section 1(b), Principles of Regulation. The Department has determined that this exemption is not a “significant regulatory action” under section 3(f) of the Executive Order. Accordingly, it does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. Paperwork Reduction Act As part of its continuing effort to reduce paperwork and respondent burden, the Department of Labor conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)). This helps to ensure that requested data will be provided in the desired format, that the reporting burden (time and financial resources) imposed on respondents is minimized, that the public can clearly understand the Department's collection instruments, and that the Department can properly assess the impact of its collection requirements on respondents. The Department previously solicited comments concerning the information collection request

(ICR)included in the Proposed Amendment to PTE 81-6 and Proposed Restatement and Redesignation of PTE 82-63 (the Proposal) when that document was published in the **Federal Register** on October 23, 2003 (68 FR 60715). The ICR re-stated and combined then-existing ICRs previously approved under OMB Control Numbers 1210-0065 (PTE 81-6) and 1210-0062 (PTE-82-63) and requested approval for the program changes set forth in the Proposal, as well as an adjustment in the burden estimates based on updated information. The ICR was reviewed by OMB and approved on April 11, 2004, under the control number 1210-0065, and that approval is currently scheduled to expire on December 31, 2006. The class exemption published in this notice has been revised from the Proposal in two basic ways. First, the categories of eligible foreign banks and broker dealers have been broadened to include foreign banks and broker dealers located in additional specified foreign countries, provided that such entities meet the additional specified conditions. Second, the permitted types of collateral for loans of securities by plans to eligible banks and broker dealers have been enlarged to include additional types of collateral. Currently, the Department is soliciting comments concerning revisions in the burden estimates for the ICR resulting from these modifications and from further changes in the Department's assumptions and estimation methodology, which are due to better understanding of the existing market for foreign and domestic securities lending. After consideration of any public comments received in response to this solicitation, the Department intends to submit an ICR to OMB for review of the paperwork burden modifications and changes described in this section. Under 5 CFR 1320.5(b), an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection displays a valid control number. The Department will publish notice in the **Federal Register** of OMB's decision upon review of the Department's ICR. A copy of the ICR may be obtained by contacting Susan G. Lahne, Office of Policy and Research, U.S. Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue, NW., Room N-5647, Washington, DC 20210. Telephone:

(202)693-8410; Fax:

(202)219-5333. These are not toll-free numbers. The ICR also may be viewed via the internet at *http://www.reginfo.gov/public/do/PRAMain* . The Department and OMB are particularly interested in comments that: • Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; • Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; • Enhance the quality, utility, and clarity of the information to be collected; and • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , by permitting electronic submission of responses. Comments should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503; Attention: Desk Officer for the Employee Benefits Security Administration. Although comments may be submitted through January 2, 2007, OMB requests that comments be received within 30 days of publication of this class exemption to ensure their consideration. The Department has consulted with industry experts and has received additional information on the nature and operation of the foreign and domestic securities lending markets. Based on this new information, the Department is revising its prior paperwork burden analysis to reflect its better understanding of the likely impact of the exemption. In its prior paperwork burden analysis, the Department based its estimates conservatively on the assumption that all domestic broker dealers and banks with trust powers would take advantage of the exemption. This led to an estimate of 13,900 domestic entities that would be respondents to the information collections of the Proposal. Given the highly sophisticated nature of the securities lending market in general and the specific limitations of the exemption in particular, including the required indemnification agreements, equity capital minimums, and levels of collateralization, the Department believes that its original estimate overstated the likely incidence of reliance. The Department now assumes that the exemption will be relied upon only by the limited group of large, sophisticated domestic broker dealers and banks currently active in the securities lending market, which the Department estimates at approximately 140 separate entities. In addition, the Department estimates that in total 60 foreign broker dealers and banks will begin to rely upon the exemption in its final form, including the 13 entities located in the United Kingdom that were previously included in the Department's paperwork burden analysis for the Proposal. This produces a total estimate of 200 respondents. Given the nature of securities lending practices, which require expert knowledge, efficient and sophisticated communications systems, and careful monitoring and control of the timing of securities loan transactions, the Department further believes that each of the borrowing entities will establish securities lending relationships with only a limited number of plans. For purposes of this estimate, the Department has assumed that each borrower will sign a contract with no more than 10 employee benefit plans. The specific information collections of this exemption have not changed from the Proposal. As described in the prior ICR, the exemption provides that, before a plan can lend securities, the borrower must provide the plan with a financial statement. In addition, the agreements regarding the loan transaction or series of transactions and the compensation arrangement for the Lending Fiduciary must be described in a written document. The Department continues to assume that these documents are routinely prepared by the respondent entities in-house as part of usual and customary business practice. The Department has therefore treated the preparation and review of these documents as an hour burden for purposes of this analysis; the cost burden derives solely from material and postage costs for distribution. These costs were estimated at $4.00 per priority or overnight domestic mailing of the documents. Discussions with industry experts indicated that nearly all of the foreign-based institutions likely to rely on the exemption have established domestic branches. The Department assumes, therefore, that all mailings will be handled by the domestic-based operations and that there will be few, if any, respondents using foreign mail services. The Department has also assumed that the respondents, all of which are large, sophisticated financial entities, will generally communicate by electronic means. Because electronic communications will be undertaken through existing electronic systems and databases, the Department has not added any additional burden for documents that are assumed to be distributed by electronic means. *Financial statements.* The Department assumes that each of the 200 respondents will provide each plan with which it has a master lending agreement (10 plans each) with a new financial statement on a quarterly basis, resulting in an estimate of 8,000 financial statements distributed annually (200 respondents × 10 plans × 4 quarterly financial statements). No preparation burden for these statements is assumed, however, since the financial statements will have been prepared for other purposes. The Department has assumed that only 10 percent of the respondents will distribute the financial statements in paper by mail. For the 800 financial statements that are therefore assumed to be distributed annually by mail (10 percent of 8,000 = 800), the Department assumes an hour burden of 5 minutes per statement, consisting of the preparation of an overnight or priority delivery package, resulting in an annual hour burden of 67 hours of clerical time (800 mailings × 5 min./60 min.). For these purposes, each statement is assumed, based on financial statements filed with the Securities and Exchange Commission, to consist of 10 pages. For the 800 financial statements delivered via mail, the Department further assumes a total annual cost of $3,200 (800 mailings × $4.00 per mailing). For the remaining 90 percent of the financial statements distributed annually, or 7,200 statements (8,000 − 800 = 7,200), the Department has assumed electronic distribution and has not estimated any additional distribution burden. *Lending and compensation agreements.* The Department assumes that each respondent will use master agreements for both the lending agreement and the lending fiduciary compensation agreement and will review and distribute them on an annual basis. For purposes of burden analysis, the Department has assumed that each respondent will annually require 30 minutes to review each of these two agreements for compliance (1 hour total per respondent), resulting in an annual hour burden of 200 hours (200 respondents × 1 hour per respondent). The respondents are further assumed to require 5 minutes to package and mail the agreements. Because of the nature of these agreements, the Department assumes that the respondents will provide each of their plan partners with a single mailing annually containing both the lending agreement and the compensation agreement for that partner and that all agreements will be distributed in paper form by priority or overnight mail. The total time for preparation is 167 hours (200 respondents × 10 lending partners × 5 minutes per agreement)/60). The cost for the distribution of these 2,000 documents (2,000 = 200 respondents × 10 lending partners each) by overnight or priority mail is estimated at $8,000. The total annual hour burden for this information collection, based on these assumptions, is therefore 434 hours (67 hours + 200 hours + 167 hours). The equivalent cost of the annual hour burden is estimated at $21,514, based on $16,600 for legal staff review of the agreements (200 hours × $83 per hour = $16,600) and $4,914 for clerical time to prepare and distribute the documents (234 hours × $21 per hour = $4,914). The total annual cost burden for this information collection is estimated at $11,200 ($8,000 for the agreements + $3,200 for the financial statements = $11,200). The following summarizes the Department's paperwork burden estimates for this information collection: *Type of Review:* Revision of a currently approved collection. *Agency:* Employee Benefits Security Administration, Department of Labor. *Title:* Securities Lending Prohibited Transaction Exemption. *OMB Number:* 1210-0065. *Affected Public:* Business or other for-profit, Not-for-profit institutions. *Total Respondents:* 200. *Frequency:* On occasion. *Total Responses:* 2,000. *Estimated Total Burden Hours:* 434. *Estimated Burden Cost:* $11,200. Discussion of Comments Received The Department received six comments regarding the proposed class exemption. The commenters requested specific modifications to the proposal in the following areas: 1. Definition of “Foreign Broker-Dealer” and “Foreign Bank” One commenter asked the Department to expand the definition of Foreign Broker-Dealers and Foreign Banks to include those foreign broker-dealers or foreign banks that are located in a foreign country in which a foreign broker-dealer or a foreign bank has received an individual exemption involving the lending of securities by plans. The commenter notes that, in each of these exemptions, the foreign banks and foreign broker-dealers were under their country's governmental regulation and oversight, which provided a sufficient level of protection for plans. Another commenter asked the Department to expand relief to include broker-dealers and banks of Germany and the Netherlands within the definitions of Foreign Bank and Foreign Broker-Dealer. In the alternative, the commenter requested that relief be extended to broker-dealers and banks of Germany and the Netherlands, provided that the Lending Fiduciary is a U.S. Broker-Dealer or U.S. Bank and such fiduciary indemnifies the plan against losses that arise from a borrower's default. This commenter states that this type of indemnification agreement is present in most securities lending transactions. The Department notes that the terms and conditions of the individual exemptions generally require that the foreign borrower be affiliated with a U.S. Bank or a U.S. Broker-Dealer that indemnifies the plan in the United States against potential loss resulting from a borrower's default. In addition, those exemptions require that the collateral be maintained in the United States in U.S. dollars or U.S. denominated securities. The Department notes that while these conditions were appropriate and protective of the plan in the context of an individual exemption, they may not be feasible in the context of a class exemption. 2 Thus, for purposes of the class exemption, it may be difficult for a plan to readily assess the risk of lending securities to broker-dealers and banks located in the various foreign jurisdictions. The Department believes that the presence of governmental regulation and oversight by the foreign countries that were involved in the individual exemptions, and an indemnification by a U.S. regulated entity, provide a significant degree of protection for plans. Accordingly, the Department has determined to expand the definition of Foreign Broker-Dealer (as defined in section V(c)) and Foreign Bank (as defined in section V(d)) under limited circumstances. 2 The terms and conditions of the individual exemptions generally involve the lending of securities by a plan to a foreign affiliate of a U.S. broker-dealer or U.S. bank and require the U.S. affiliate to indemnify the plan in the United States against any potential losses arising from a default. In addition, these exemptions require that the collateral be maintained in U.S. dollars or U.S. denominated securities and be held in the U.S. The proposed class exemption did not contain an affiliate requirement and permitted non-U.S. forms of collateral that may be maintained outside the U.S. Under the final exemption, the definition of Foreign Broker-Dealer has been expanded to include those broker-dealers registered and regulated under the relevant securities laws of a governmental entity of a country other than the United States where such securities laws were applicable to a broker-dealer that received:

(i)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a broker-dealer or

(ii)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended, (61 FR 39988 (July 31, 1996); 67 FR 44622 (July 3, 2002)) involving the loan of securities by a plan to a broker-dealer. The term “Foreign Bank” has been expanded to include those banks subject to regulation by the relevant governmental banking agency(ies) of a country other than the United States, where the regulation and oversight of these banking agencies were applicable to a bank that received:

(i)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a bank or

(ii)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended, (61 FR 39988 (July 31, 1996); 67 FR 44622 (July 3, 2002)) involving the loan of securities by a plan to a bank. 3 3 To date, individual exemptions have been granted and transactions have received final authorization under PTE 96-62, as amended, that involve securities loans by plans to broker-dealers and banks regulated under the applicable laws of Japan, Germany, the Netherlands, Sweden, Switzerland, France, Australia, Canada and the United Kingdom. Thus, any broker-dealer or bank that is subject to government regulation in any one of these countries would be able to utilize the relief provided in this exemption, if all applicable conditions are met. In this regard, if in the future, the Department grants individual exemptions or final authorizations under PTE 96-62 for transactions involving securities loans by plans to broker-dealers or banks regulated under the applicable laws of additional foreign countries, broker-dealers and banks subject to such government regulation would be able to utilize the final exemption provided all applicable conditions are met. However, to further protect the plans from any unnecessary costs and risks associated with the lending of securities in the different foreign jurisdictions, a new condition has been added to section III(c) of the exemption. This condition requires, in the case of a securities lending transaction involving a Foreign Broker-Dealer or a Foreign Bank that is described above (as defined in section V(c)(2) and V(d)(2) of the exemption), the Lending Fiduciary to be a U.S. Bank or U.S. Broker-Dealer that indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under this provision) which the plan may incur or suffer directly arising out of a borrower default. In this regard, it is the Department's understanding that in a default situation, the plan will be able to recover the money it is owed under this indemnification agreement from the lending fiduciary in the United States. Another commenter asked the Department to expand the definition of borrower to include Canadian broker-dealers and Canadian banks. The commenter described a strong similarity in the type of government oversight between broker-dealers and banks in Canada and the United States. In particular, the commenter described the regulation of Canadian broker-dealers. In Canada, securities regulation is within the jurisdiction of the Provinces. In Ontario, the Ontario Securities Commission

(OSC)is responsible for regulating the securities markets with the purpose of protecting investors, ensuring optimal allocation of financial resources and maintaining public confidence in the markets. The OSC regulates market participants by notices and orders. It has an enforcement role in the market. It has the power to ensure that trading activities are carried out in accordance with applicable regulations. It can investigate, prosecute and impose penalties on individuals who do not comply with such regulations. Other provincial securities commissions operate similarly. All powers of all the commissions are subject to the oversight of the Ministers of Finance in each Province. In addition, the commenter notes that the Canadian Securities Administration

(CSA)reviews the activities of the provincial securities commissions to ensure consistency in the regulatory framework among the Provinces. The commenter adds that Canadian broker-dealers are subject to oversight by self-regulatory organizations (SRO's), which are subject to the supervision of the provincial commissions. According to the commenter, the Market Regulation Services is the independent regulation services provider for Canadian equity markets and is a recognized SRO by the CSA. Its mandate is to foster and protect investor confidence and market integrity through the administration, interpretation and enforcement of a common set of market integrity principles. The commenter also described the regulation of Canadian banks. The commenter noted that the Office of Superintendent of Financial Institutions

(OSFI)regulates Canadian banks. OSFI is an independent agency of the Government of Canada and reports to the Minister of Finance. Its principal role is to safeguard depositors and other banking clients. OSFI imposes capital requirements to ensure that Canadian banks are able to meet their financial obligations as well as strict reporting, managing, accounting and auditing requirements. Lastly, the commenter represented that under Canadian law, counterparties may agree to submit to the jurisdiction of the courts of the United States and the judgments of the courts in the United States are readily enforceable in Canada. Based on the representations of the commenter regarding the regulatory supervision of Canadian broker-dealers and banks, the Department has expanded the definition of “Foreign Broker-Dealer” to include any broker-dealer that:

(i)Is regulated by a securities commission of a Province of Canada that is a “member” of the Canadian Securities Administration, and

(ii)is subject to the oversight of a Canadian SRO; and has expanded the definition of “Foreign Bank” to include any bank that is regulated by the Office of the Superintendent of Financial Institutions in Canada. Finally, one commenter requested that plans be permitted to loan securities to entities other than those permitted under the proposed exemption, provided that all obligations of the borrower are fully guaranteed by an entity that could have borrowed the securities itself. To the extent the commenter is referring to entities other than broker-dealers and banks for which the Department has previously granted relief, this comment raises issues that are beyond the scope of our original consideration, and the commenter has not provided sufficient information for the Department to consider this request. Accordingly, the Department has determined not to adopt this comment. 2. Level of Foreign Collateral That Must Be Pledged One commenter expressed support for the collateral requirements found in the proposed exemption. Three commenters (including the Applicant) requested that the collateralization requirements (described in section II(b) of the proposed exemption) be made consistent with those in SEC Rule 15c3-3 (17 CFR 240.15c3-3). 4 The Applicant states that regulatory and market developments have occurred since the Applicant first filed its exemption application. The Applicant expressed concern that, if the exemption requires different collateralization levels for plans than what is required for other investors by Rule 15c3-3, plans would be placed at a competitive disadvantage. Another commenter suggested that the level of collateralization required in SEC Rule 15c3-3 be required for those transactions in which the lending fiduciary is a U.S. Bank and such lending fiduciary indemnifies the plan against losses resulting from the borrower's default. According to the commenter, most securities lending transactions include these types of indemnification arrangements. Lastly, a commenter suggested that the collateralization requirements stated in the proposed exemption only be modified for those transactions involving plans with total assets in excess of $500 million. 4 On April 16, 2003, the SEC issued the Order Regarding the Collateral Broker-Dealers Must Pledge When Borrowing Customer Securities (Release No. 47683). Rule 15c3-3 specifies the types and amount of collateral that may be offered by broker-dealers who borrow fully paid and excess margin securities from customers. For purposes of this exemption, the term “Rule 15c3-3” shall also refer to the SEC Order contained in Release No. 47683. Rule 15c3-3 requires 100% collateralization if the collateral and securities are denominated in the same currency; 101% if the collateral and securities are denominated in a different currency ( *i.e.* , Euros, British pounds, Swiss francs, Canadian dollars, and Japanese yen); and 105% if the collateral and securities are denominated in a different currency and such currency is other than those specified above. On the basis of the comments, the Department has determined to adopt the collateralization requirements in Rule 15c3-3 for certain transactions where the lending fiduciary is a U.S. Broker-Dealer or U.S. Bank, and such fiduciary indemnifies the plan against loss in the event of borrower default. Specifically, the Department has expanded section II(b) of the exemption to provide that: In the case of a securities lending transaction in which the Lending Fiduciary is a U.S. Bank or U.S. Broker-Dealer, and such Lending Fiduciary indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default, the plan receives from the borrower by the close of the Lending Fiduciary's business on the day in which the securities lent are delivered to the borrower: “Foreign Collateral” having, as of the close of business on the preceding business day, a market value or, in the case of bank letters of credit, a stated amount, equal to not less than:

(i)100 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in section V(k)) on which the securities are primarily traded if the collateral posted is denominated in the same currency as the securities lent; or

(ii)101 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in section V(k)) on which the securities are primarily traded if the collateral posted is in a different currency than the securities lent and such currency is denominated in Euros, British pounds, Japanese yen, Swiss francs or Canadian dollars; or

(iii)105 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in section V(k)) if the collateral posted is in a different currency than the securities lent and is denominated in a currency other than those specified above. Lastly, the Department believes that the Lending Fiduciary indemnification requirement discussed above provides a sufficient safeguard to protect a plan's interest under the revised collateralization levels making the $500 million plan asset test unnecessary. Accordingly, the Department has not modified the exemption in this respect. 3. Expand The Types of Collateral Permitted Under The Exemption Several commenters requested that the class exemption permit plans to accept the types of collateral permitted under SEC Rule 15c3-3. Another commenter requested that the definition of foreign collateral be broadened to include equity securities and fixed income securities. *Rule 15c3-3 permits the following forms of collateral:* 1. Government securities as defined in section 3(42)(A) and

(B)of the Securities Exchange Act of 1934 (the Exchange Act) (15 U.S.C. 78c(42)(A) and (B)) may be pledged when borrowing any securities. 2. Government securities as defined in section 3(42)(C) of the Exchange Act (15 U.S.C. 78c(42)(C)) and issued or guaranteed as to principal or interest by the following corporations may be pledged when borrowing any securities:

(i)Federal Home Loan Mortgage Corporation,

(ii)the Federal National Mortgage Corporation,

(iii)the Student Loan Marketing Association and

(iv)the Financing Corporation. 3. Securities issued by, or guaranteed as to principal and interest by, the following Multinational Banks—the obligations of which are backed by participating countries, including the United States—may be pledged when borrowing any securities:

(i)International Bank for Reconstruction and Development,

(ii)the Inter-American Development Bank,

(iii)the Asian Development Bank,

(iv)the African Development Bank,

(v)the European Bank for Reconstruction and Development, and

(vi)the International Finance Corporation. 4. Mortgage-backed securities that meet the definition of a “mortgage related security” as defined by section 3(a)(41) of the Exchange Act (15 U.S.C. 78c(a)(41)) may be pledged when borrowing any securities. 5. Negotiable certificates of deposit and bankers acceptances issued by a “bank” as that term is defined in section 3(a)(6) of the Exchange Act (15 U.S.C. 78c(a)(6)), and which are payable in the United States and deemed to have a “ready market” as that term is defined in 17 CFR 240.15c3-1, may be pledged when borrowing any securities. 6. Foreign sovereign debt securities may be pledged when borrowing any securities, provided that:

(i)At least one nationally recognized statistical rating agency (NRSRO) has rated in one of its two highest rating categories either the issue, the issuer or guarantor, or other outstanding unsecured long-term debt securities issued or guaranteed by the issuer or guarantor; and

(ii)if the securities pledged are denominated in a different currency than those borrowed, the broker-dealer shall provide collateral in an amount that exceeds the minimum collateralization requirements in paragraph (b)(3) of Rule 15c3-3 (100%) by 1% when the collateral is denominated in the Euro, British pound, Swiss franc, Canadian dollar or Japanese yen, or by 5% when it is denominated in another currency. 7. Foreign sovereign debt securities that do not meet the NRSRO rating condition set forth in Item 6 above may be pledged only when borrowing non-equity securities issued by a person organized or incorporated in the same jurisdiction (including other debt securities issued by the foreign sovereign); provided that, if such foreign sovereign debt securities have been assigned a rating lower than the securities borrowed, such foreign sovereign debt securities must be rated in one of the four highest rating categories by at least one NRSRO. If the securities pledged are denominated in a different currency than those borrowed, the broker-dealer shall provide collateral in an amount that exceeds the minimum collateralization requirement in paragraph (b)(3) of Rule 15c3-3 by 1% when the collateral is denominated in the Euro, British pound, Swiss franc, Canadian dollar or Japanese yen, or by 5% when it is denominated in another currency. 8. The Euro, British pound, Swiss franc, Canadian dollar or Japanese yen may be pledged when borrowing any securities, provided that, when the securities borrowed are denominated in a different currency than that pledged, the broker-dealer shall provide collateral in an amount that exceeds the minimum collateralization requirement in paragraph (b)(3) of Rule 15c3-3 by 1%. Any other foreign currency may be pledged when borrowing any non-equity securities denominated in the same currency. 9. Non-governmental debt securities may be pledged when borrowing any securities, provided that, in the relevant cash market they are not traded flat or in default as to principal or interest, and are rated in one of the two highest rating categories by at least one NRSRO. If such securities are not denominated in U.S. dollars or in the currency of the securities being borrowed, the broker-dealer shall provide collateral in an amount that exceeds the minimum collateralization requirement in paragraph (b)(3) of Rule 15c3-3 by 1% when the securities pledged are denominated in the Euro, British pound, Swiss franc, Canadian dollar or Japanese yen, or by 5% when they are denominated in any other currency. The Department agrees with the commenters that the types of the collateral allowed under the class exemption should be expanded. Although the SEC concluded that the designation of additional categories of permissible collateral will add liquidity to the securities lending market and lower borrowing costs for broker-dealers, the Department does not believe that the commenters have made a sufficient showing that adopting all the categories of collateral described in Rule 15c3-3 would be protective of the interests of participants and beneficiaries if a borrower were to default. In this regard, the Department notes that the collateral described in categories 1 and 2 of Rule 15c3-3 satisfies the definition of “U.S. Collateral” under the proposed exemption. For the sake of clarity, the Department has revised the definition of “U.S. Collateral” to specifically include: Government securities as defined in section 3(42)(A) and

(B)of the Securities Exchange Act of 1934 (the Exchange Act); and Government securities as defined in section 3(42)(C) of the Exchange Act and issued or guaranteed as to principal or interest by the following corporations:

(i)Federal Home Loan Mortgage Corporation,

(ii)the Federal National Mortgage Corporation,

(iii)the Student Loan Marketing Association and

(iv)the Financing Corporation. Additionally, the Department believes that it would be appropriate to expand the definition of “U.S. Collateral” to include: “Mortgage-backed securities” as described in category 4 of Rule 15c3-3, and “negotiable certificates of deposit and banker acceptances” as described in category 5 of Rule 15c3-3. Further, the Department has determined that it would be appropriate to expand the definition of “Foreign Collateral” to include all other types of collateral that are specified under Rule 15c3-3, as amended by the SEC from time to time, provided the Lending Fiduciary is a U.S. Broker-Dealer or U.S. Bank, and such entity provides the plan with an indemnification with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs which a plan may incur or suffer directly arising out of a borrower default. In the absence of an indemnification by a U.S. Broker-Dealer or U.S. Bank, the definition of “Foreign Collateral” in the final exemption has been revised to include the types of collateral described in categories 3 of Rule 15c3-3, rated foreign sovereign debt described in category 6, and the British pound, the Canadian dollar, the Swiss franc, the Japanese yen or the Euro. In response to a comment, the Department has determined not to revise the exemption to include equity securities and fixed-income securities as these items appear to be outside the scope of Rule 15c3-3, and the Department has insufficient information about how these items would function as collateral. 4. Issues Relating to the Lending Fiduciary's Indemnification of the Plan From Loss Upon a Borrower's Default Two commenters requested that the Department revise the indemnification provision of section III(b) to limit the lending fiduciary's indemnification obligation to losses resulting from a borrower's default, and not from any shortfall in the earnings on the collateral. The Department notes that the indemnification by the Lending Fiduciary is only applicable when the borrower defaults and there is a difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under this provision) which the plan may incur or suffer directly arising out of a borrower default. The indemnification requirement, under the proposal, was never intended to encompass losses arising out of the investment of the collateral by a Lending Fiduciary or other party. Accordingly, the Department has clarified section III(b)(2) of the exemption to reflect this intent. Another commenter asked the Department to expand section III(b)(2) of the proposed exemption to permit a parent corporation (which may or may not be domiciled in the United States) of a U.S. subsidiary acting as a Lending Fiduciary to provide the indemnity in lieu of the Lending Fiduciary itself. The Department believes that this request raises issues that are beyond the scope of the proposed exemption and has determined not to modify the exemption as requested by the commenter. One commenter requested clarification regarding the scope of the indemnification provisions under the exemption. Specifically, the commenter questioned whether, in accordance with the provisions in an indemnification agreement, a Lending Fiduciary can stand in the shoes of the plan, and seek recovery from the borrower. Nothing in the final exemption would preclude a Lending Fiduciary from entering into an indemnification agreement that permits the Lending Fiduciary to seek recovery against a defaulting borrower after the Lending Fiduciary has made the plan whole pursuant to the indemnification agreement. 5. Miscellaneous Comments Another commenter questioned whether the exemption would apply to repurchase agreements (repos). The commenter states that in the context of securities loans that are structured and documented as repos, a Master Repurchase Agreement is utilized instead of a Master Securities Lending Agreement. Except for the difference in the form of the arrangement, such an agreement contains all of the same information and substantive requirements that would be found in a typical Master Securities Lending Agreement. The commenter indicates that the Master Repurchase Agreement contains terms and conditions that satisfy all of the substantive requirements of the exemption, including the requirement that the securities be returned at termination of the loan ( *i.e.* , repurchase transaction) in consideration for the return of the cash, the requirement that any interest or dividends on the securities lent ( *i.e.* , sold) be paid by the securities borrower ( *i.e.* , the purchaser) to the securities lender ( *i.e.* , the seller) as and when paid, and the requirement that the securities lender ( *i.e.* , the seller) receive reasonable compensation for the loan of the securities (which may consist of the ability to retain investment earnings on the cash collateral in excess of a pre-specified rebate amount). The Department notes that the exemption permits securities loans that are structured as repos, provided that all of the other terms and conditions of the exemption are otherwise met. For the sake of clarity, the Department has added a definition of the terms “lending of securities” or “loan of securities” to include securities loans that are structured as repurchase agreements, provided that all terms of the exemption are otherwise met (section V(l) of the exemption). Another commenter expressed concern that the exemption prevents plans from lending certain fixed income securities when a plan accepts foreign collateral by requiring the collateralization level for foreign collateral to be determined by reference to the market value of the securities lent on a “recognized securities exchange,” or an “automated trading system.” ( *See* section II(b)(1)(B) and II(b)(2)(B))) The commenter requests that market value be determined in the same manner as set out under the 2000 version of the Master Securities Loan Agreement which was jointly published by the commenter and the Securities Industry Association. The Department believes that the objective standard contained in the proposal is an important safeguard, and is not persuaded by the comment. One commenter requested that the Department clarify section IV(c) of the proposal. Section IV(c) of the proposal requires that the compensation be reasonable and be paid to the Lending Fiduciary in accordance with the terms of a written instrument, which may be in the form of a master agreement covering a series of securities lending transactions. The commenter was concerned that this provision could require that the aggregate compensation for all loans be reasonable. Thus, if one loan's compensation failed, then all loans would fail this condition. The Department intended that this condition apply on a loan-by-loan basis. Thus, the failure of one loan to meet this requirement would not cause all loans entered into pursuant to a master agreement to fail such requirement. A commenter requested clarification on whether the exemption covers “fee-for-hold” arrangements. The commenter describes “fee-for-holds” as the following. The borrower pays a fee in exchange for the guaranteed availability of a particular security for a specified period of time or until the arrangement is terminated by either party. If a fee-for-hold arrangement is in place and the holding borrower chooses to borrow any such held securities, the fee-for-hold arrangement with respect to such securities terminates and the borrower will enter into a securities loan arrangement. These arrangements may take two forms:

(1)The plan may grant the borrower the right of first refusal essentially giving the borrower an option to borrow the securities if the lending plan is approached by another party seeking to borrow the same held securities; or

(2)the plan may grant the borrower the exclusive right to borrow the securities. The commenter stated that title to the securities does not transfer until securities are actually delivered. The borrower pays a fee related to the type, quantity and duration of the fee-for-hold arrangement. Once loaned, the lending fee paid is based on market conditions at the time of the loan. The plan may terminate the arrangement at any time so that it may dispose of the securities at any time. The Department is of the view that these arrangements are within the scope of the exemption, provided that all terms and conditions are otherwise met. One commenter requested that relief be extended to transactions covered by the Federal Employee's Retirement System Act of 1986 (FERSA). The Department notes that relief from the prohibited transaction provisions of FERSA is provided for transactions described in section I(c) of the final amendment by reason of PTE T88-1, as amended (53 FR 52838 (December 29, 1988), 57 FR 8689 (March 11, 1992).) No additional exemptive relief is necessary under the final amendment for those prohibited transactions described in FERSA which parallel those described in section 406(a) of ERISA, if the plan receives no less than adequate consideration. In this regard, PTE T88-1, as amended, adopted six prohibited transaction class exemptions (including PTE 82-63) for purposes of section 8477(c)(2) of FERSA. The amendment to PTE T88-1 extended such relief to any amendments of these class exemptions which are granted by the Department pursuant to section 408(a) of ERISA unless the Department determines that PTE T88-1, as amended does not apply to such amendment. Accordingly, the Department determines that PTE T88-1, as amended shall apply to this final amendment for purposes of FERSA. One commenter noted that the requirements in section II(d) that the loan agreement identify the currency in which payment of any fees will be made to the plan would be burdensome. The commenter noted that, in the context of securities loans secured by cash collateral, it is industry practice that the lender pays a rebate to the borrower rather than receiving a fee. Secondly, it is industry practice that the borrower's rebate will be in the same currency as the currency of the cash collateral. In addition, many loans are covered by a master agreement and, in the context of a securities loan secured by non-cash collateral, parties may need to offer different forms of collateral on a loan-by-loan basis. Thus, the commenter requests that the parties be permitted to specify the currency of the fees in the loan confirmation. The Department concurs with the comment, and has modified the final exemption accordingly. A commenter asked the Department to clarify how the final exemption would apply to securities loans that were entered into pursuant to PTEs 81-6 and 82-63 prior to the effective date of the final exemption. The Department notes that loan transactions entered into prior to the effective date of this exemption would be covered by PTE 81-6 and PTE 82-63, provided all conditions of the exemption are met. Transactions entered into on or after the effective date of the final exemption would be covered by this exemption, provided that the conditions therein are met. The Department notes that the conditions of PTE 81-6 and PTE 82-63 have been incorporated into this class exemption. Description of the Exemption Section I of the exemption describes the transactions that are covered by the exemption. Section I(a) tracks the language of PTE 81-6 by permitting the lending of securities that are assets of an employee benefit plan to a U.S. Broker-Dealer or U.S. Bank, if the general conditions set forth in section II are met. However, the conditions contained in PTE 81-6 have been amended to permit additional types of collateral to be used for the securities loan. Section I(b) of the exemption expands PTE 81-6 by permitting the lending of securities that are assets of an employee benefit plan to a Foreign Broker-Dealer or a Foreign Bank. A Foreign Broker-Dealer or a Foreign Bank must meet both the general conditions set forth in section II of the proposed exemption, as well as the specific conditions described in section III. Under the final exemption, a Foreign Broker-Dealer is defined in section V(c) as a broker-dealer that has, as of the last day of its most recent fiscal year, equity capital that is the equivalent of no less than $200 million and is: (1)(i) Registered and regulated under the laws of the Financial Services Authority in the United Kingdom, or (ii)(a) registered and regulated under the laws of a securities commission of a Province of Canada that is a member of the Canadian Securities Administration, and

(b)is subject to the oversight of a Canadian self-regulatory authority; or

(2)registered and regulated, under the relevant securities laws of a governmental entity of a country other than the United States, and such securities laws and regulation were applicable to a broker-dealer that received:

(i)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a broker-dealer or

(ii)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended involving the loan of securities by a plan to a broker-dealer. Section V(d) of the final exemption defines the term “Foreign Bank” to mean: An institution that has, substantially similar powers to a bank as defined in section 202(a)(2) of the Investment Advisers Act, has as of the last day of its most recent fiscal year, equity capital which is the equivalent of no less than $200 million, and is subject to:

(1)Regulation by the Financial Services Authority in the United Kingdom or the Office of the Superintendent of Financial Institutions in Canada, or

(2)regulation by the relevant governmental banking agency(ies) of a country other than the United States, and the regulation and oversight of these banking agencies were applicable to a bank that received:

(i)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a bank or

(ii)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended involving the loan of securities by a plan to a bank. Section I(c) permits the payment to a lending fiduciary of compensation for services rendered in connection with loans of plan assets that are securities, provided that the conditions set forth in section IV are met. The conditions found in section IV mirror the conditions that were found in PTE 82-63. Although the relief provided by section I(c) would apply to a broader range of lending activities, no changes have been made with respect to any of the conditions that are contained in PTE 82-63. Section II(a) of the final exemption remains as proposed and requires that neither the borrower nor any affiliate of the borrower have or exercise discretionary authority or control with respect to the investment of the plan assets involved in the transaction, or render investment advice (within the meaning of 29 CFR 2510.3-21(c)) with respect to those assets. Under the final exemption, section II(b)requires that the plan receive from the borrower by the close of the Lending Fiduciary's business on the day in which the securities lent are delivered to the borrower,

(1)“U.S. Collateral” having, as of the close of business on the preceding business day, a market value or, in the case of bank letters of credit, a stated amount, equal to not less than 100 percent of the then market value of the securities lent; or

(2)“Foreign Collateral” having as of the close of business on the preceding business day, a market value or, in the case of bank letters of credit, a stated amount, equal to not less than:

(i)102 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in section V(k)) on which the securities are primarily traded if the collateral posted is denominated in the same currency as the securities lent, or(ii) 105 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in V(k)) on which the securities are primarily traded if the collateral posted is denominated in a different currency than the securities. In addition, section II(b) has been expanded to include new collateralization requirements in the case of a securities lending transaction in which the Lending Fiduciary is a U.S. Bank or U.S. Broker-Dealer, and such Lending Fiduciary indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default. For those securities transactions involving such an indemnification, the plan may receive from the borrower by the close of the Lending Fiduciary's business on the day in which the securities lent are delivered to the borrower: Foreign Collateral having, as of the close of business on the preceding day, a market value or in the case of bank letters of credit, a stated amount, equal to not less than:

(iii)105 percent of the then market value of the securities lent as valued on a recognized securities exchange or an automated trading system (as defined in section V(k)) if the collateral posted is in a different currency than the securities lent and is denominated in a currency other than those specified above. 5 5 The Department notes that this requirement would not preclude the Lending Fiduciary from requiring additional collateral should the circumstances so warrant. The final exemption contains a revised definition of “U.S. Collateral” that incorporates additional forms of collateral described in Rule 15c3-3. The term “U.S. Collateral” is defined in section V(e) as:

(1)U.S. currency,

(2)“government securities” as defined in section 3(a)(42)(A) and

(B)of the Securities Exchange Act of 1934 (the Exchange Act),

(3)“government securities” as defined in section 3(a)(42)(C) of the Exchange Act issued or guaranteed as to principal or interest by the following corporations: The Federal Home Loan Mortgage Corporation, the Federal National Mortgage Association, the Student Loan Marketing Association and the Financing Corporation,

(4)mortgage-backed securities meeting the definition of a “mortgage related security” set forth in section 3(a)(41) of the Exchange Act,

(5)negotiable certificates of deposit and bankers' acceptances issued by a “bank” as that term is defined in section 3(a)(6) of the Exchange Act, and which are payable in the United States and deemed to have a “ready market” as that term is defined in 17 CFR 240.15c3-1, or

(6)irrevocable letters of credit issued by a U.S. Bank other than the borrower or an affiliate thereof, or any combination thereof. The final exemption contains a revised definition of “Foreign Collateral” that permits U.S. Banks, U.S. Broker-Dealers, Foreign Banks and Foreign Broker-Dealers to accept a broader range of collateral. The term “Foreign Collateral” is defined in section V(f) as:

(1)Securities issued by or guaranteed as to principal and interest by the following Multilateral Development Banks—the obligations of which are backed by the participating countries, including the United States: The International Bank for Reconstruction and Development, the Inter-American Development Bank, the Asian Development Bank, the African Development Bank, the European Bank for Reconstruction and Development and the International Finance Corporation.

(2)Foreign sovereign debt securities provided that at least one nationally recognized statistical rating organization has rated in one of its two highest categories either the issue, the issuer or guarantor;

(3)the British pound, Canadian dollar, Swiss franc, Japanese yen or the Euro;

(4)irrevocable letters of credit issued by a Foreign Bank, other than the borrower or an affiliate thereof, which has a counterparty rating of investment grade or better as determined by a nationally recognized statistical rating organization; or

(5)any type of collateral described in Rule 15c3-3 of the Exchange Act, as amended from time to time, provided that the lending fiduciary is a U.S. Bank or U.S. Broker-Dealer and such fiduciary indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs which a plan may incur or suffer directly arising out of a borrower default. The Department notes that section II(c) of the exemption remains unchanged from the proposal and requires that plans receive collateral from borrowers by physical delivery, by wire transfer or by book entry in a securities depository located in the United States. For borrowers that are Foreign Banks and Foreign Broker-Dealers, the exemption requires that the plan receive either collateral by physical delivery, by wire entry or by book entry in a securities depository located in the United States or held on behalf of the plan at an Eligible Securities Depository as defined in section V(i)of the exemption. Section II(d) of the exemption has been modified in light of the expanded definition of “Foreign Broker-Dealer” and “Foreign Bank.” That section requires that the borrower furnish the Lending Fiduciary with its most recent available audited statement of the borrower's financial condition, as audited by a United States certified public accounting firm or in the case of a borrower that is a Foreign Broker-Dealer or Foreign Bank, a firm which is eligible or authorized to issue audited financial statements in conformity with accounting principles generally accepted in the primary jurisdiction that governs the borrowing Foreign Broker-Dealer or Foreign Bank. Under section II(e) of the exemption, the loan must be made pursuant to a written loan agreement. Section II(e) further requires that the securities lending agreement must give the plan a continuing security interest in, title to, or the rights of a secured creditor with respect to the collateral received by the plan. In section

(f)of the exemption, the plan may receive a reasonable fee in connection with the securities loan or have the opportunity to derive compensation through the investment of the currency collateral. The plan may pay a loan rebate or similar fee to the borrower where the plan invests the currency collateral. Section II(g) of the exemption requires that the fees and other consideration received by the plan in connection with the loan of securities must be reasonable. The identity of the currency in which payment of fees and rebates will be made must be disclosed to the plan either in the written loan agreement or the loan confirmation as agreed to by the borrower and the plan (or Lending Fiduciary) prior to the making of the loan. Under the exemption, section II(h) requires that the plan receive the equivalent of all distributions made to holders of the borrower securities during the term of the loan including, but not limited to, dividends, interest payments, shares of stock as a result of stock splits and rights to purchase additional securities. Section II(i) requires that, if the market value of the collateral at the close of trading on a business day is less than the applicable percentage of the market value of the borrowed securities at the close of trading on that day, then the borrower shall deliver, by the close of business on the following business day, an additional amount of U.S. Collateral or Foreign Collateral, the market value of which, together with the market value of all previously delivered collateral, equals at least the applicable percentage of the market value of all borrowed securities as of such preceding day. Notwithstanding the foregoing, part of the U.S. Collateral or Foreign Collateral may be returned to the borrower if the market value of the collateral exceeds the applicable percentage described in this exemption as long as the market value of the remaining collateral equals the applicable percentage described in the exemption of the market value of the borrowed securities. Under section II(j) of the exemption, a plan may terminate a loan at any time. Section II(k) of the exemption permits a plan to purchase securities identical to the loaned securities if the borrower does not return the loaned securities, and obligates the borrower to pay to the plan any amount of remaining obligation and expenses not covered by the collateral. Section II(l) of the exemption states that if a borrower fails to comply with any provision of a loan agreement which requires compliance with this exemption, the plan fiduciary who caused the plan to engage in such transaction shall not be deemed to have caused the plan to engage in a transaction prohibited by section 406(a)(1)(A) through

(D)of ERISA solely by reason of the borrower's failure to comply with the conditions of the exemption. Section III of the exemption contains conditions that are applicable to securities lending transactions with Foreign Broker-Dealers and Foreign Banks. Section III(a) requires that the lending fiduciary maintain the situs of the loan agreement in accordance with the indicia of ownership requirements under section 404(b) of ERISA and the regulations promulgated under 29 CFR 2550.404(b)-1. Further, section III(b) requires that a foreign borrower agree to submit to the jurisdiction of the district courts of the United States, and agree that the plan may in its sole discretion enforce the agreement in a U.S. court. It is the Department's understanding that in the event the borrower were to default, the plan would be able to secure a judgment in the United States which would be enforceable in a UK or a Canadian court. As an alternative to the requirement that the Foreign Broker-Dealer or Foreign Bank must agree to submit to the jurisdiction of the United States courts, the lending fiduciary may, if a U.S. Bank or U.S. Broker-Dealer, indemnify the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction cost incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under the exemption) which the plan may incur or suffer directly arising out of a borrower's default. The final exemption contains a new condition in section III(c) which requires that in the case of a securities lending transaction involving a Foreign Broker-Dealer or a Foreign Bank that is described in section V(c)(2) or V(d)(2), the Lending Fiduciary must be a U.S. Bank or U.S. Broker-Dealer and prior to entering into the loan transaction, such fiduciary must agree to indemnify the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under this provision) which the plan may incur or suffer directly arising out of a borrower default. It is the Department's understanding that, in the event of a borrower default, the plan would be able to recover from the lending fiduciary, in the United States, the amount it is entitled to under the indemnification agreement. As in the proposal, section IV of the exemption incorporates the conditions of PTE 82-63. Section V of the exemption contains the definitions. Unless noted above, the definitions of the exemption remain as they were in the proposed exemption. The Department has added section VI that specifies the effective dates of the final exemption and the revocation of PTEs 81-6 and 82-63. Lastly, the Department notes that section 611(d)(1) of the Pension Protection Act of 2006 (Pub. L. 109-280) (the PPA) amended the Employee Retirement Income Security Act of 1974 (ERISA) in part, by adding a new section 408(b)(17) which provides relief from ERISA section 406(a)(1)(A),

(B)and

(D)for any transaction between a plan and a person that is a party in interest other than fiduciary (or an affiliate) who has or exercises any discretionary authority or control with respect to the investment of the plan assets involved in the transaction or renders investment advice (within the meaning of section 3(21)(A)(ii)) with respect to those assets, solely by reason of providing services to the plan or solely by reason of a relationship to such a service provider described in ERISA section 3(14)(F), (G),

(H)or (I), or both, but only if in connection with such transaction the plan receives no less, nor pays more, than adequate consideration. 6 The Department notes that to the extent that a transaction involving a loan of securities by a plan to a party in interest meets the requirements of ERISA section 408(b)(17), such transaction does not need to comply with the terms of this class exemption. The Department further notes that the new section 408(b)(17) will not be available for the payment of compensation to a plan's securities lending agent. In this regard, see 408(b)(2) of ERISA and section I(c) of this final exemption for relief permitting the payment of compensation related to foreign securities lending services. 6 Section 611(d)(2) of the PPA provided similar exemptive relief in amending section 4975 of the Code to add the new section 4975(c)(20). General Information The attention of interested persons is directed to the following:

(1)The fact that a transaction is the subject of an exemption under section 408(a) of ERISA and section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions of ERISA and the Code. These provisions include any prohibited transaction provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of ERISA which, among other things, require a fiduciary to discharge his duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with section 404(a)(1)(B) of ERISA; nor does it affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;

(2)In accordance with section 408(a) of ERISA and section 4975(c)(2) of the Code, and based on the entire record, the Department finds that the exemption is administratively feasible, in the interests of the plan(s) and of its participants and beneficiaries, and protective of the rights of the participants and beneficiaries of the plan;

(3)This exemption is supplemental to, and not in derogation of, any other provisions of ERISA and the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and

(4)The class exemption is applicable to a particular transaction only if the transaction satisfies the conditions specified in the class exemption. Exemption Accordingly, the following exemption is granted under the authority of section 408(a) of ERISA and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, August 10, 1990). I. Transactions

(a)Effective January 2, 2007, the restrictions of section 406(a)(1)(A) through

(D)of ERISA and the taxes imposed by section 4975(a) and

(b)of the Code by reason of section 4975(c)(1)(A) through

(D)of the Code shall not apply to the lending of securities that are assets of an employee benefit plan to a “U.S. Broker-Dealer” or to a “U.S. Bank,” provided that the conditions set forth in section II below are met.

(b)Effective January 2, 2007, the restrictions of section 406(a)(1)(A) through

(D)of ERISA and the taxes imposed by section 4975(a) and

(b)of the Code by reason of section 4975(c)(1)(A) through

(D)of the Code shall not apply to the lending of securities that are assets of an employee benefit plan to a “Foreign Broker-Dealer” or “Foreign Bank”, provided that the conditions set forth in sections II and III below are met.

(c)Effective January 2, 2007, the restrictions of section 406(b)(1) of ERISA and the taxes imposed by section 4975(a) and

(b)of the Code by reason of section 4975(c)(1)(E) of the Code shall not apply to the payment to a fiduciary (the Lending Fiduciary) of compensation for services rendered in connection with loans of plan assets that are securities, provided that the conditions set forth in section IV below are met. II. General Conditions For Transactions Described in Sections I(a) and I(b)

(a)Neither the borrower nor any affiliate of the borrower has or exercises discretionary authority or control with respect to the investment of the plan assets involved in the transaction, or renders investment advice (within the meaning of 29 CFR 2510.3-21(c)) with respect to those assets;

(b)The plan receives from the borrower by the close of the Lending Fiduciary's business on the day in which the securities lent are delivered to the borrower,

(2)“Foreign Collateral” having as of the close of business on the preceding business day, a market value or, in the case of bank letters of credit, a stated amount, equal to not less than:

(ii)105 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in V(k)) on which the securities are primarily traded if the collateral posted is denominated in a different currency than the securities lent. Notwithstanding the foregoing, if the Lending Fiduciary is a U.S. Bank or U.S. Broker-Dealer, and such Lending Fiduciary indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default, the plan receives from the borrower by the close of the Lending Fiduciary's business on the day in which the securities lent are delivered to the borrower, “Foreign Collateral” having as of the close of business on the preceding business day, a market value or, in the case of bank letters of credit, a stated amount, equal to not less than:

(ii)101 percent of the then market value of the securities lent as valued on a recognized securities exchange (as defined in section V(j)) or an automated trading system (as defined in V(k)) on which the securities are primarily traded if the collateral posted is denominated in a different currency than the securities lent and such currency is denominated in Euros, British pounds, Japanese yen, Swiss francs or Canadian dollars; or

(2)If the borrower is a Foreign Bank or Foreign Broker-Dealer, the plan receives U.S. Collateral or Foreign Collateral from the borrower by the close of the Lending Fiduciary's business on the day in which the securities are delivered to the borrower. Such collateral is received by the plan either by physical delivery, wire transfer or by book entry in a securities depository located in the United States or held on behalf of the plan at an Eligible Securities Depository. The indicia of ownership of such collateral shall be maintained in accordance with section 404(b) of ERISA and 29 CFR 2550.404b-1.

(d)Prior to making of any such loan, the borrower shall have furnished the Lending Fiduciary with:

(1)The most recent available audited statement of the borrower's financial condition, as audited by a United States certified public accounting firm or in the case of a borrower that is a Foreign Broker-Dealer or Foreign Bank, a firm which is eligible or authorized to issue audited financial statements in conformity with accounting principles generally accepted in the primary jurisdiction that governs the borrowing Foreign Broker-Dealer or Foreign Bank;

(2)The most recent available unaudited statement of its financial condition (if the unaudited statement is more recent than such audited financial statement); and

(3)A representation that, at the time the loan is negotiated, there has been no material adverse change in its financial condition since the date of the most recent financial statement furnished to the plan that has not been disclosed to the Lending Fiduciary. Such representations may be made by the borrower's agreement that each loan shall constitute a representation by the borrower that there has been no such material adverse change.

(e)The loan is made pursuant to a written loan agreement, the terms of which are at least as favorable to the plan as an arm's-length transaction with an unrelated party would be. Such loan agreement states that the plan has a continuing security interest in, title to, or the rights of a secured creditor with respect to the collateral. Such agreement may be in the form of a master agreement covering a series of securities lending transactions.

(f)In return for lending securities, the plan:

(1)Receives a reasonable fee (in connection with the securities lending transaction), and/or

(2)Has the opportunity to derive compensation through the investment of the currency collateral. Where the plan has that opportunity, the plan may pay a loan rebate or similar fee to the borrower, if such fee is not greater than the plan would pay in a comparable transaction with an unrelated party.

(g)All fees and other consideration received by the plan in connection with the loan of securities are reasonable. The identity of the currency in which the payment of fees and rebates will be made shall be disclosed to the plan either in the written loan agreement or the loan confirmation as agreed to by the borrower and the plan (or Lending Fiduciary) prior to the making of the loan.

(h)The plan receives the equivalent of all distributions made to holders of the borrowed securities during the term of the loan including, but not limited to, dividends, interest payments, shares of stock as a result of stock splits and rights to purchase additional securities;

(i)If the market value of the collateral at the close of trading on a business day is less than the applicable percentage of the market value of the borrowed securities at the close of trading on that day (as described in section II(b) of this exemption), then the borrower shall deliver, by the close of business on the following business day, an additional amount of U.S. Collateral or Foreign Collateral the market value of which, together with the market value of all previously delivered collateral, equals at least the applicable percentage of the market value of all the borrowed securities as of such preceding day. Notwithstanding the foregoing, part of the U.S. Collateral or Foreign Collateral may be returned to the borrower if the market value of the collateral exceeds the applicable percentage (described in section II(b)) of the exemption) of the market value of the borrowed securities, as long as the market value of the remaining U.S. Collateral or Foreign Collateral equals at least the applicable percentage of the market value of the borrowed securities;

(j)The loan may be terminated by the plan at any time, whereupon the borrower shall deliver certificates for securities identical to the borrowed securities (or the equivalent thereof in the event of reorganization, recapitalization or merger of the issuer of the borrowed securities) to the plan within the lesser of:

(1)The customary delivery period for such securities,

(2)Five business days, or

(3)The time negotiated for such delivery by the plan and the borrower.

(k)In the event that the loan is terminated, and the borrower fails to return the borrowed securities or the equivalent thereof within the applicable time described in section II(j) above, the plan may, under the terms of the loan agreement:

(1)Purchase securities identical to the borrowed securities (or their equivalent as described above) and may apply the collateral to the payment of the purchase price, any other obligations of the borrower under the agreement, and any expenses associated with the sale and/or purchase, and

(2)The borrower is obligated, under the terms of the loan agreement, to pay, and does pay to the plan the amount of any remaining obligations and expenses not covered by the collateral, including reasonable attorney's fees incurred by the plan for legal action arising out of default on the loans, plus interest at a reasonable rate. Notwithstanding the foregoing, the borrower may, in the event the borrower fails to return borrowed securities as described above, replace collateral, other than U.S. currency, with an amount of U.S. currency that is not less than the then current market value of the collateral, provided such replacement is approved by the Lending Fiduciary.

(l)If the borrower fails to comply with any provision of a loan agreement which requires compliance with this exemption, the plan fiduciary who caused the plan to engage in such transaction shall not be deemed to have caused the plan to engage in a transaction prohibited by section 406(a)(1)(A) through

(D)of ERISA solely by reason of the borrower's failure to comply with the conditions of the exemption. III. Specific Conditions For Transactions Described in Section I(b)

(a)The Lending Fiduciary maintains the written documentation for the loan agreement at a site within the jurisdiction of the courts of the United States.

(b)Prior to entering into a transaction involving a Foreign Broker-Dealer that is described in section V(c)(1) or a Foreign Bank that is described in section V(d)(1) either:

(1)The Foreign Broker-Dealer or Foreign Bank agrees to submit to the jurisdiction of the United States; agrees to appoint an agent for service of process in the United States, which may be an affiliate (the Process Agent); consents to service of process on the Process Agent; and agrees that any enforcement by a plan of its rights under the securities lending agreement will, at the option of the plan, occur exclusively in the United States courts; or

(2)The Lending Fiduciary, if a U.S. Bank or U.S. Broker-Dealer, agrees to indemnify the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under this provision) which the plan may incur or suffer directly arising out of a borrower default by the Foreign Broker-Dealer or Foreign Bank.

(c)In the case of a securities lending transaction involving a Foreign Broker-Dealer that is described in section V(c)(2) or a Foreign Bank that is described in section V(d)(2), the Lending Fiduciary must be a U.S. Bank or U.S. Broker-Dealer, and prior to entering into the loan transaction, such fiduciary must agree to indemnify the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs incurred (including attorney's fees of such plan arising out of the default on the loans or the failure to indemnify properly under this provision) which the plan may incur or suffer directly arising out of a borrower default by the Foreign Broker-Dealer or Foreign Bank. IV. Specific Conditions for Transactions Described in Section I(c)

(a)The loan of securities is not prohibited by section 406(a) of ERISA or otherwise satisfies the conditions of this exemption.

(b)The Lending Fiduciary is authorized to engage in securities lending transactions on behalf of the plan.

(c)The compensation is reasonable and is paid in accordance with the terms of a written instrument, which may be in the form of a master agreement covering a series of securities lending transactions.

(d)Except as otherwise provided in section IV(f), the arrangement under which the compensation is paid:

(1)Is subject to the prior written authorization of a plan fiduciary (the “authorizing fiduciary”), who is (other than in the case of a plan covering only employees of the Lending Fiduciary or any affiliates of such fiduciary) independent of the Lending Fiduciary and of any affiliate thereof, and

(2)May be terminated by the authorizing fiduciary within:

(A)The time negotiated for such notice of termination by the plan and the Lending Fiduciary, or

(B)five business days, whichever is less, in either case without penalty to the plan.

(e)No such authorization is made or renewed unless the Lending Fiduciary shall have furnished the authorizing fiduciary with any reasonably available information which the Lending Fiduciary reasonably believes to be necessary to determine whether such authorization should be made or renewed, and any other reasonably available information regarding the matter that the authorizing fiduciary may reasonably request.

(f)(Special Rule for Commingled Investment Funds) In the case of a pooled separate account maintained by an insurance company qualified to do business in a State or a common or collective trust fund maintained by a bank or trust company supervised by a State or Federal agency, the requirements of section IV(d) of this exemption shall not apply, provided that:

(1)The information described in section IV(e) (including information with respect to any material change in the arrangement) shall be furnished by the Lending Fiduciary to the authorizing fiduciary described in section IV(d) with respect to each plan whose assets are invested in the account or fund, not less than 30 days prior to implementation of the arrangement or material change thereto, and, where requested, upon the reasonable request of the authorizing fiduciary;

(2)In the event any such authorizing fiduciary submits a notice in writing to the Lending Fiduciary objecting to the implementation of, material change in, or continuation of the arrangement, the plan on whose behalf the objection was tendered is given the opportunity to terminate its investment in the account or fund, without penalty to the plan, within such time as may be necessary to effect such withdrawal in an orderly manner that is equitable to all withdrawing plans and to the non-withdrawing plans. In the case of a plan that elects to withdraw pursuant to the foregoing, such withdrawal shall be effected prior to the implementation of, or material change in, the arrangement; but an existing arrangement need not be discontinued by reason of a plan electing to withdraw; and

(3)In the case of a plan whose assets are proposed to be invested in the account or fund subsequent to the implementation of the compensation arrangement and which has not authorized the arrangement in the manner described in sections IV(f)(1) and IV(f)(2), the plan's investment in the account or fund shall be authorized in the manner described in section IV(d)(1). V. Definitions For purposes of this exemption:

(a)The term “U.S. Broker-Dealer” means a broker-dealer registered under the Securities Exchange Act of 1934 (the 1934 Act or the Exchange Act) or exempted from registration under section 15(a)(1) of the 1934 Act as a dealer in exempted government securities (as defined in section 3(a)(12) of the 1934 Act).

(b)The term “U.S. Bank” means a bank as defined in section 202(a)(2) of the Investment Advisers Act.

(c)The term “Foreign Broker-Dealer” means a broker-dealer that has, as of the last day of its most recent fiscal year, equity capital that is equivalent of no less than $200 million and is:

(i)Registered and regulated under the laws of the Financial Services Authority in the United Kingdom, or (ii)(a) registered and regulated by a securities commission of a Province of Canada that is a member of the Canadian Securities Administration, and

(b)is subject to the oversight of a Canadian self-regulatory authority; or

(2)registered and regulated under the relevant securities laws of a governmental entity of a country other than the United States, and such securities laws and regulation were applicable to a broker-dealer that received:

(i)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a broker-dealer or

(ii)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended, involving the loan of securities by a plan to a broker-dealer.

(d)The term “Foreign Bank” means an institution that has substantially similar powers to a bank as defined in section 202(a)(2) of the Investment Advisers Act, has as of the last day of its most recent fiscal year, equity capital which is equivalent of no less than $200 million, and is subject to:

(1)Regulation by the Financial Services Authority in the United Kingdom or the Office of the Superintendent of Financial Institutions in Canada, or

(a)An individual exemption, granted by the Department under section 408(a) of ERISA, involving the loan of securities by a plan to a bank or

(b)a final authorization by the Department to engage in an otherwise prohibited transaction pursuant to PTE 96-62, as amended, involving the loan of securities by a plan to a bank.

(e)The term “U.S. Collateral” means:

(1)U.S. currency;

(2)“government securities” as defined in section 3(a)(42)(A) and

(B)of the Exchange Act;

(4)mortgage-backed securities meeting the definition of a “mortgage related security” set forth in section 3(a)(41) of the Exchange Act;

(5)negotiable certificates of deposit and bankers acceptances issued by a “bank” as that term is defined in section 3(a)(6) of the Exchange Act, and which are payable in the United States and deemed to have a “ready market” as that term is defined in 17 CFR 240.15c3-1; or

(6)irrevocable letters of credit issued by a U.S. Bank other than the borrower or an affiliate thereof, or any combination, thereof.

(f)The term “Foreign Collateral” means:

(2)foreign sovereign debt securities provided that at least one nationally recognized statistical rating organization has rated in one of its two highest categories either the issue, the issuer or guarantor;

(3)the British pound, the Canadian dollar, the Swiss franc, the Japanese yen or the Euro;

(5)any type of collateral described in Rule 15c3-3 of the Exchange Act as amended from time to time provided that the lending fiduciary is a U.S. Bank or U.S. Broker-Dealer and such fiduciary indemnifies the plan with respect to the difference, if any, between the replacement cost of the borrowed securities and the market value of the collateral on the date of a borrower default plus interest and any transaction costs which a plan may incur or suffer directly arising out of a borrower default. Notwithstanding the foregoing, collateral described in any of the categories enumerated in section V(e) will be considered U.S. Collateral for purposes of the exemption.

(g)The term “affiliate” of another person means:

(1)Any person directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with such person;

(2)Any officer, director, partner, employee, or relative (as defined in section 3(15) of ERISA) of such other person; and

(3)Any corporation or partnership of which such other person is an officer, director, partner or employee.

(h)The term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.

(i)The term “Eligible Securities Depository” means an eligible securities depository as that term is defined under Rule 17f-7 of the Investment Company Act of 1940 [15 U.S.C. 80a], as such definition may be amended from time to time.

(j)The term “recognized securities exchange” means a U.S. securities exchange that is registered as a “national securities exchange” under section 6 of the Exchange Act of 1934 (15 U.S.C. 78f) or a designated offshore securities market as defined in Regulation S of the Securities Act of 1933 [17 CFR part 230.902(B)], as such definition may be amended from time to time, which performs with respect to securities, the functions commonly performed by a stock exchange within the meaning of the definitions under the applicable securities laws ( *e.g.* , 17 CFR part 240.3b-16).

(k)The term “automated trading system” means an electronic trading system that functions in a manner intended to simulate a securities exchange by electronically matching orders on an agency basis from multiple buyers and sellers such as an “alternative trading system” within the meaning of SEC's Reg. ATS [17 CFR part 242.300] as such definition may be amended from time to time, or an “automated quotation system” as described in section 3(a)(51)(A)(ii) of the Securities and Exchange Act of 1934 [15 U.S.C. 78c(a)(51)(A)(ii)].

(l)The term “lending of securities” or “loan of securities” shall include securities loans that are structured as repurchase agreements provided, that all terms of the exemption are otherwise met. VI. Effective Dates

(a)This exemption is effective on January 2, 2007.

(b)PTEs 81-6 and 82-63 are revoked effective January 2, 2007. Signed at Washington, DC, this 25th day of October, 2006. Ivan L. Strasfeld, Director, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor. [FR Doc. E6-18238 Filed 10-30-06; 8:45 am] BILLING CODE 4510-29-P DEPARTMENT OF LABOR Employment and Training Administration Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers (TA-W) number and alternative trade adjustment assistance

(ATAA)by (TA-W) number issued during the period of October 2 through October 6, 2006. In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met. I. Section (a)(2)(A) all of the following must be satisfied: A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated; B. The sales or production, or both, of such firm or subdivision have decreased absolutely; and C. Increased imports of articles like or directly competitive with articles produced by such firm or subdivision have contributed importantly to such workers' separation or threat of separation and to the decline in sales or production of such firm or subdivision; or II. Section (a)(2)(B) both of the following must be satisfied: A. A significant number or proportion of the workers in such workers' firm, or an appropriate subdivision of the firm, have become totally or partially separated, or are threatened to become totally or partially separated; B. There has been a shift in production by such workers' firm or subdivision to a foreign country of articles like or directly competitive with articles which are produced by such firm or subdivision; and C. One of the following must be satisfied: 1. The country to which the workers' firm has shifted production of the articles is a party to a free trade agreement with the United States; 2. The country to which the workers' firm has shifted production of the articles to a beneficiary country under the Andean Trade Preference Act, African Growth and Opportunity Act, or the Caribbean Basin Economic Recovery Act; or 3. There has been or is likely to be an increase in imports of articles that are like or directly competitive with articles which are or were produced by such firm or subdivision. Also, in order for an affirmative determination to be made for secondarily affected workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.

(1)Significant number or proportion of the workers in the workers' firm or an appropriate subdivision of the firm have become totally or partially separated, or are threatened to become totally or partially separated;

(2)The workers' firm (or subdivision) is a supplier or downstream producer to a firm (or subdivision) that employed a group of workers who received a certification of eligibility to apply for trade adjustment assistance benefits and such supply or production is related to the article that was the basis for such certification; and

(3)Either—

(A)The workers' firm is a supplier and the component parts it supplied for the firm (or subdivision) described in paragraph

(2)accounted for at least 20 percent of the production or sales of the workers' firm; or

(B)A loss of business by the workers' firm with the firm (or subdivision) described in paragraph

(2)contributed importantly to the workers' separation or threat of separation. In order for the Division of Trade Adjustment Assistance to issue a certification of eligibility to apply for Alternative Trade Adjustment Assistance

(ATAA)for older workers, the group eligibility requirements of Section 246(a)(3)(A)(ii) of the Trade Act must be met. 1. Whether a significant number of workers in the workers' firm are 50 years of age or older. 2. Whether the workers in the workers' firm possess skills that are not easily transferable. 3. The competitive conditions within the workers' industry ( *i.e.* , conditions within the industry are adverse). Affirmative Determinations for Worker Adjustment Assistance The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination. The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (downstream producer for a firm whose workers are certified eligible to apply for TAA based on increased imports from or a shift in production to Mexico or Canada) of the Trade Act have been met. *None.* Affirmative Determinations for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination. The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *TA-W-60,003; Central Products Co., Brighton, CO:* *September 1, 2005* . *TA-W-60,084; Hekman Furniture Co., Grand Rapids, MI:* *September 13, 2005.* *TA-W-60,177; Hooker Furniture Corp., Martinsville, VA:* *September 29, 2005.* *TA-W-59,980; Mechanical Products Manufacturing, Co., Lucasville, OH: August 18, 2005.* The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *TA-W-60,026; BSN-Jobst, Inc., Rutherford College, NC: September 6, 2005.* *TA-W-60,085; Parker Hannifin Corp., Sarasota, FL: September 13, 2005.* *TA-W-60,096; General Electric, Bloomington, IL: September 15, 2005.* *TA-W-60,097; Eaton Corporation, Hutchinson, KS: September 13, 2005.* *TA-W-60,136; Owens Brockway, Godfrey, IL: September 25, 2005.* *TA-W-60,167; Andrew Corporation (AFMA), Amesbury, MA: September 26, 2005.* *TA-W-59828; Pfizer, Inc., Kalamazoo, MI: July 27, 2005.* *TA-W-60,069; Cooper Standard Automotive, Auburn, IN: September 8, 2005* *TA-W-60,079; Allied Motion Technologies, Owosso, MI: September 13, 2005.* *TA-W-60,095; Regal Electronics, Inc., Pocahontas, AR: September 15, 2005.* *TA-W-60,130; AJS Controls, Inc., Sidney, NY: September 21, 2005.* The following certifications have been issued. The requirements of Section 222(b) (supplier to a firm whose workers are certified eligible to apply for TAA) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *None.* The following certifications have been issued. The requirements of Section 222(b) (downstream producer for a firm whose workers are certified eligible to apply for TAA based on increased imports from or a shift in production to Mexico or Canada) and Section 246(a)(3)(A)(ii) of the Trade Act have been met. *None.* Negative Determinations for Alternative Trade Adjustment Assistance In the following cases, it has been determined that the requirements of 246(a)(3)(A)(ii) have not been met for the reasons specified. The Department as determined that criterion

(1)of Section 246 has not been met. Workers at the firm are 50 years of age or older. *None.* The Department as determined that criterion

(2)of Section 246 has not been met. Workers at the firm possess skills that are easily transferable. *None.* The Department as determined that criterion

(3)of Section 246 has not been met. Competition conditions within the workers' industry are not adverse. *None.* Negative Determinations for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified. Since the workers of the firm are denied eligibility to apply for TAA, the workers cannot be certified eligible for ATAA. The investigation revealed that criteria (a)(2)(A)(I.A.) and (a)(2)(B)(II.A.) (employment decline) have not been met. *TA-W-60,162; Ison Transport Inc., Ontonagon, MI.* The investigation revealed that criteria (a)(2)(A)(I.B.) (Sales or production, or both, did not decline) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met. *None.* The investigation revealed that criteria (a)(2)(A)(I.C.) (increased imports) and (a)(2)(B)(II.B.) (shift in production to a foreign country) have not been met. *TA-W-59761; Ace Products, LLC, Conneautville, PA.* *TA-W-59970; TDE Group, Inc., Somerset, KY.* *TA-W-59989; Canam Metal Products, Inc., Colton, CA.* *TA-W-60,056; Short Bark Industries, Tellico Plains, TN.* The investigation revealed that the predominate cause of worker separations is unrelated to criteria (a)(2)(A)(I.C.) (increased imports) and (a)(2)(B)(II.C) (shift in production to a foreign country under a free trade agreement or a beneficiary country under a preferential trade agreement, or there has been or is likely to be an increase in imports). *None.* The workers' firm does not produce an article as required for certification under Section 222 of the Trade Act of 1974. *TA-W-59,993; Fenton Gift Shops, Inc., Williamstown, WV.* *TA-W-60,045; International Business Machines Corp., Rocklin, CA.* *TA-W-60,058; Akzo Nobel, Inc., Georgetown, SC.* *TA-W-60,103; Xerox Corporation, Wilsonville, OR.* *TA-W-60,154; Lucas Ford Lincoln Mercury, Southold, NY.* The investigation revealed that criteria of Section 222(b)(2) has not been met. The workers' firm (or subdivision) is not a supplier to or a downstream producer for a firm whose workers were certified eligible to apply for TAA. *None.* I hereby certify that the aforementioned determinations were issued during the period of October 2 through October 6, 2006. Copies of these determinations are available for inspection in Room C-5311, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 during normal business hours or will be mailed to persons who write to the above address. Dated: October 12, 2006. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18226 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-59,846] Coville, Inc. Winston-Salem, NC; Dismissal of Application for Reconsideration Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Coville, Inc., Winston-Salem, North Carolina. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued. TA-W-59,846; Coville, Inc., Winston-Salem, North Carolina, (October 18, 2006). Signed at Washington, DC this 23rd day of October 2006. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18218 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-59,627] Liebert Corporation; Irvine, CA; Dismissal of Application for Reconsideration Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Liebert Corporation, Irvine, California. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued. TA-W-59,627; Liebert Corporation, Irvine, California, (October 18, 2006). Signed at Washington, DC this 23rd day of October 2006. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18217 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-60,219] Marathon Electric, a Subsidiary of Regal-Beloit Corporation; Lima, OH; Notice of Termination of Investigation Pursuant to section 221 of the Trade Act of 1974, as amended, an investigation was initiated on October 6, 2006 in response to a worker petition filed by an IUE-CWA Region 7 official on behalf of workers of Marathon Electric, a subsidiary of Regal-Beloit Corporation, Lima, Ohio. The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated. Signed at Washington, DC, this 20th day of October 2006. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18215 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-59,715] Salisbury Manufacturing Corporation, Mohican Mills, Salisbury, NC; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with Section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and Section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance on August 21, 2006, applicable to workers of Salisbury Manufacturing Corporation located in Salisbury, North Carolina. The notice was published in the **Federal Register** on September 13, 2006 (71 FR 54094-54096). At the request of a company official, the Department reviewed the certification for workers of the subject firm. The workers produce airline blankets. The company informed the Department that some of the workers wages were reported to the Unemployment Insurance

(UI)tax account for a sister company, Mohican Mills. The intent of the certification is to provide coverage to all workers of the subject firm impacted by increased imports. Accordingly, the Department is amending the certification to include workers of Salisbury Manufacturing Corporation, Salisbury, North Carolina, whose wages are reported by Mohican Mills. The amended notice applicable to TA-W-59,715 is hereby issued as follows: “All workers of Salisbury Manufacturing Corporation, Mohican Mills, Salisbury, North Carolina, who became totally or partially separated from employment on or after June 28, 2005 through August 21, 2008, are eligible to apply for adjustment assistance under Section 223 of the Trade Act of 1974, and are also eligible to apply for alternative trade adjustment assistance under section 246 of the Trade Act of 1974.” Signed in Washington, DC, this 10th day of October, 2006. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18227 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-59,988] Smith Die & Mold, Inc., Port Huron, MI; Notice of Termination of Investigation Pursuant to Section 221 of the Trade Act of 1974, as amended, an investigation was initiated on August 31, 2006 in response to a petition filed by a company official on behalf of workers at Smith Die & Mold Inc., Port Huron, Michigan. The workers at the subject facility produce industrial molds used for injection molded plastic. The petitioner has requested that the petition be withdrawn. Consequently, the investigation has been terminated. Signed in Washington, DC, this 10th day of October, 2006. Richard Church, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18228 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration Investigations Regarding Certifications of Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance Petitions have been filed with the Secretary of Labor under section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to section 221(a) of the Act. The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved. The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 13, 2006. Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 13, 2006. The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room C-5311, 200 Constitution Avenue, NW., Washington, DC 20210. Signed at Washington, DC this 10th day of October 2006. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. Appendix [TAA petitions instituted between 10/2/06 and 10/6/06] TA-W Subject firm (petitioners) Location Date of institution Date of petition 60172 Sunshine Scholl Uniforms

(Wkrs)Medley, FL 10/02/06 09/27/06 60173 LeRocato Manufacturing, Inc. (State) Plainfield, CT 10/02/06 09/29/06 60174 Tyson Frest Foods

(Wkrs)Wallula, WA 10/02/06 09/28/06 60175 Terrisol Corp.

(Comp)Troutman, NC 10/02/06 09/29/06 60176 Flextronics

(Wkrs)San Jose, CA 10/02/06 09/29/06 60177 Hooker Furniture Corp.

(Comp)Martinsville, VA 10/02/06 09/29/06 60178 Trafalga (State) Norwalk, CT 10/02/06 09/29/06 60179 Tenneco—Napoleon (Union) Napoleon, OH 10/02/06 10/02/06 60180 Cadence Innovation (State) Chesterfield, MI 10/02/06 10/02/06 60181 Custom Fashions, Inc.

(Comp)Tupelo, MS 10/02/06 10/02/06 60182 Oak Lawn Packaging, Inc. (State) Fort Smith, AR 10/03/06 10/02/06 60183 Signature Fruit Company, LLC (Union) Modesto, CA 10/03/06 09/28/06 60184 Bellsouth Telecommunications

(Wkrs)Paducah, KY 10/03/06 10/02/06 60185 Southern Steel and Wire Co. (State) Fort Smith, AR 10/03/06 10/02/06 60186 Deltak, LLC (State) Plymouth, MN 10/03/06 10/02/06 60187 PCC Airfoils, LLC

(Comp)Douglas, GA 10/03/06 10/02/06 60188 Jackson furniture Industries

(Comp)Cleveland, TN 10/03/06 09/15/06 60189 Sebago/Wolverine (State) Portland, ME 10/03/06 10/02/06 60190 Cooper Power Tools, Inc. (Union) Dayton, OH 10/03/06 09/27/06 60191 Hamilton Beach/Proctor-Silex, Inc.

(Comp)Southern Pines, NC 10/03/06 10/02/06 60192 Black and Decker

(Comp)Charlotte, NC 10/03/06 09/20/06 60193 Ilpea (State) Ft. Smith, AR 10/03/06 09/29/06 60194 Innovex, Inc. (State) Litchfield, MN 10/03/06 10/03/06 60195 Kidde Residential and Commercial

(Comp)Mebane, NC 10/03/06 10/01/06 60196 TRW Automotive (State) Rushford, MN 10/03/06 10/03/06 60197 C and C Smith Lumber Co., Inc.

(Comp)Summerhill, PA 10/03/06 10/03/06 60198 Westark Diversified Enterprise (State) Ft. Smith, AR 10/03/06 10/02/06 60199 Airtex Products

(Wkrs)Fairfield, IL 10/04/06 10/03/06 60200 Fiskars Brands, Inc.

(Comp)Spencer, WI 10/04/06 10/04/06 60201 Weyerhaeuser Raymond Lumber Mill (Union) Raymond, WA 10/04/06 10/04/06 60202 Goodyear Tire and Rubber Co.

(USWA)St. Marys, OH 10/04/06 09/28/06 60203 Performance Fibers

(Comp)Scottsboro, AL 10/04/06 10/04/06 60204 FAG Bearings

(Comp)Joplin, MO 10/04/06 10/02/06 60205 General Motors Vehicle Manufacturing

(Wkrs)Oklahoma City, OK 10/05/06 09/27/06 60206 Kentucky Derby Hosiery Co., Inc.

(Comp)Mt. Airy, NC 10/05/06 10/02/06 60207 Lego Systems, Inc.

(Comp)Enfield, CT 10/05/06 10/04/06 60208 Bauhaus USA, Inc.

(Wkrs)Sherman, MS 10/05/06 10/04/06 60209 Cowan Plastic Products Corp. (State) Providence, RI 10/05/06 10/04/06 60210 Gutmann Leather, LLC

(Comp)Chicago, IL 10/05/06 10/04/06 60211 American Dryer Corporation

(Wkrs)Fall River, MA 10/05/06 10/05/06 60212 Standex Electronics

(Wkrs)Douglas, AZ 10/05/06 10/04/06 60213 InkCycle (State) Lenexa, KS 10/06/06 10/06/06 60214 Multy Industries USA, Inc.

(Comp)Atlanta, GA 10/06/06 10/05/06 60215 Gold Star Coatings (State) West Branch, MI 10/06/06 10/06/06 60216 Component Concepts, Inc.

(Wkrs)Thomasville, NC 10/06/06 10/06/06 60217 Z-Star Industries, Inc.

(Comp)Watertown, NY 10/06/06 10/05/06 60218 Alcoa Global Fasteners, Inc.

(Comp)Stoughton, MA 10/06/06 09/25/06 60219 Marathon Electric

(CWA)Lima, OH 10/06/06 10/06/06 60220 Ferrero International S.A. (State) Caguas, PR 10/06/06 10/02/06 [FR Doc. E6-18225 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-60,031] Velcorex, Inc., A Division of Dollus Mieg Company; Orangeburg, SC; Dismissal of Application for Reconsideration Pursuant to 29 CFR 90.18(C) an application for administrative reconsideration was filed with the Director of the Division of Trade Adjustment Assistance for workers at Velcorex, Inc., a division of Dollus Mieg Company, Orangeburg, South Carolina. The application did not contain new information supporting a conclusion that the determination was erroneous, and also did not provide a justification for reconsideration of the determination that was based on either mistaken facts or a misinterpretation of facts or of the law. Therefore, dismissal of the application was issued. TA-W-60,031; Velcorex, Inc., A division of Dollus Mieg Company, Orangeburg, South Carolina, (October 18, 2006). Signed at Washington, DC this 23rd day of October 2006. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18219 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration [TA-W-58,623; TA-W-58,623CC; TA-W-58,623DD] Westpoint Home, Inc., Formerly Westpoint Stevens, Inc. Corporate Office Including On-Site Leased Workers of Ambassador Personnel in the Corporate Office, Claims Department; West Point, Georgia; Including Employees of Westpoint Home, Inc., Formerly Westpoint Stevens, Inc., Corporate Office, West Point, Georgia Employees Working at the Following Locations: Cotton Department Valley, Alabama, Records Center West Point, Georgia; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance In accordance with section 223 of the Trade Act of 1974 (19 U.S.C. 2273), and section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor issued a Notice of Determination Regarding Eligibility to Apply for Worker Adjustment Assistance on February 21, 2006, applicable to workers of WestPoint Home, Inc., formerly WestPoint Stevens, Inc., Corporate Office West Point, Georgia. The notice was published in the **Federal Register** on March 22, 2006 (71 FR 14549). At the request of a company official, the Department reviewed the certification for workers of the subject firm. New information shows that worker separations have occurred involving employees of the Corporate Office, West Point, Georgia of WestPoint Home, Inc., formerly WestPoint Stevens, Inc. located in the Cotton Department, Valley, Alabama and the Records Center, West Point, Georgia. The workers provided support services for the manufacture of comforters, sheets, pillowcases, towels and blankets produced by WestPoint Home, Inc., formerly WestPoint Stevens, Inc. Information also shows that leased workers of Ambassador Personnel were employed on-site at the West Point, Georgia location of WestPoint Home, Inc., formerly WestPoint Stevens, Inc., Corporate Office, Claims Department. In addition, in accordance with section 246 of the Trade Act of 1974 (26 U.S.C. 2813), as amended, the Department of Labor herein presents the results of its investigation regarding certification of eligibility to apply for alternative trade adjustment assistance

(ATAA)for older workers. The Department has determined in this case the requirements of section 246 have been met. A significant number of workers at the firm are age 50 or over and possess skills that are not easily transferable. Competitive conditions within the industry are adverse. Based on these findings, the Department is amending this certification to include employees of the Corporate Office, West Point, Georgia facility WestPoint Home, Inc., formerly WestPoint Stevens, Inc. located at the Cotton Department, Valley, Alabama and the Records Center, West Point, Georgia. The intent of the Department's certification is to include all workers of WestPoint Home, Inc., formerly WestPoint Stevens, Inc., Corporate Office, West Point, Georgia who were adversely affected by increased company and customer imports. The amended notice applicable to TA-W-58,623 is hereby issued as follows: “All workers of WestPoint Home, Inc., formerly WestPoint Stevens, Inc., Corporate Office, including on-site leased workers of Ambassador Personnel, who reported to the Corporate Office, Claims Department, West Point, Georgia (TA-W-58,623), including employees reporting to this office but working at the Cotton Department, Valley, Alabama (TA-W-58,623CC) and the Records Center, West Point, Georgia (TA-W-58,623DD), who became totally or partially separated from employment on or after January 12, 2005, through February 21, 2008, are eligible to apply for adjustment assistance under section 223 of the Trade Act of 1974 and are also eligible to apply for alternative trade adjustment assistance under section 246 of the Trade Act of 1974.” Signed at Washington, DC this 24th day of October 2006. Elliott S. Kushner, Certifying Officer, Division of Trade Adjustment Assistance. [FR Doc. E6-18216 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P DEPARTMENT OF LABOR Employment and Training Administration Investigations Regarding Certifications of Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment Assistance Petitions have been filed with the Secretary of Labor under Section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to Section 221(a) of the Act. The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved. The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 13, 2006. Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Division of Trade Adjustment Assistance, at the address shown below, not later than November 13, 2006. The petitions filed in this case are available for inspection at the Office of the Director, Division of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room C-5311, 200 Constitution Avenue, NW., Washington, DC 20210. Signed at Washington, DC this 17th day of October 2006. Linda G. Poole, Certifying Officer, Division of Trade Adjustment Assistance. Appendix [TAA petitions instituted between 10/10/06 and 10/13/06] TA-W Subject firm (petitioners) Location Date of institution Date of petition 60221 Whittier Wood Products

(Comp)Eugene, OR 10/10/06 10/06/06 60222 Textile, Inc.

(Comp)Ronda, NC 10/10/06 09/12/06 60223 Zippo Manufacturing Company

(Comp)Bradford, MA 10/10/06 10/09/06 60224 Misty Mountain Threadworks, Inc.

(Comp)Banner Elk, NC 10/10/06 09/28/06 60225 ITW Paslode (State) Augusta, AR 10/10/06 10/09/06 60226 Washington Mutual LFC

(Wkrs)Bethel Park, PA 10/10/06 10/10/06 60227 Amcor Pet Packaging

(Wkrs)Erie, PA 10/10/06 10/09/06 60228 Eudyna Devices USA, Inc. (State) San Jose, CA 10/10/06 10/10/06 60229 City Machine Tool and Die Co., Inc.

(Comp)Muncie, IN 10/10/06 10/10/06 60230 Creative Engineered Polymer Products, LLC (Union) Crestline, OH 10/11/06 10/10/06 60231 Molly West Hand Bound Books

(Wkrs)Emeryville, CA 10/11/06 10/10/06 60232 Sildler, Inc.

(COMP)LaOtto, IN 10/11/06 09/26/06 60233 Cencorp, LLC

(Comp)Longmont, CO 10/12/06 10/11/06 60234 Maytag Searcy Laundry Products

(Comp)Searcy, AR 10/12/06 10/11/06 60235 Agmapore (State) Tolleson, AZ 10/12/06 09/13/06 60236 Tracewell Electronics (Union) Cuba, NY 10/12/06 10/06/06 60237 Woodsmiths Company

(The)(State) Lenoir, NC 10/12/06 10/04/06 60238 Ossure—Generation II (State) Bothell, WA 10/12/06 10/10/06 60239 Fischbein-Inglett and Company (State) Augusta, GA 10/12/06 10/11/06 60240 Georgia Pacific Corporation (Union) Camas, WA 10/12/06 10/10/06 60241 Ingenix

(Wkrs)Louisville, KY 10/12/06 10/12/06 60242 Thornton Fashion Designs, Inc.

(Wkrs)San Francisco, CA 10/13/06 10/01/06 60243 Oakwood Metal Fabricating

(Comp)Taylor, MI 10/13/06 10/12/06 60244 Mosey Manufacturing Co., Inc.

(Comp)Richmond, IN 10/13/06 10/12/06 [FR Doc. E6-18221 Filed 10-30-06; 8:45 am] BILLING CODE 4510-30-P MILLENNIUM CHALLENGE CORPORATION [MCC FR 06-17] Notice of the November 8, 2006 Millennium Challenge Corporation Board of Directors Meeting; Sunshine Act Meeting AGENCY: Millennium Challenge Corporation. Time and Date: 10 a.m. to 12 p.m., Wednesday, November 8, 2006. Place: Department of State, 2201 C Street, NW., Washington, DC 20520. FOR FURTHER INFORMATION CONTACT: Information on the meeting may be obtained from Suzi M. Morris via e-mail at *Board@mcc.gov* or by telephone at

(202)521-3600. Status: Meeting will be closed to the public. Matters to be Considered: The Board of Directors (the “Board”) of the Millennium Challenge Corporation (“MCC”) will hold a meeting to consider the selection of countries that will be eligible for FY 2007 Millennium Challenge Account (“MCA”) assistance under Section 607 of the Millennium Challenge Act of 2003 (the “Act”), codified at 22 U.S.C. 7706, or Threshold Program assistance under section 616 of the Act; discuss progress on proposed Compacts with certain MCA-eligible countries; discuss MCC's proposed policy on suspension and termination of assistance and eligibility; and certain administrative matters. The agenda items are expected to involve the consideration of classified information and the meeting will be closed to the public. Dated: October 27, 2006. William Geoff Anderson, Jr., Vice President and General Counsel (Acting), Millennium Challenge Corporation. [FR Doc. 06-9014 Filed 10-27-06; 3:38 pm]

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