Notices. Notice of filing dates for special election
13,894 words·~63 min read·
/register/2006/01/09/06-174A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4000-01-M DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR06-8-000] Dow Intrastate Gas Company; Notice of Petition for Rate Approval December 29, 2005. Take notice that on December 15, 2005, Dow Intrastate Gas Company (DIGCO) filed a petition for rate approval pursuant to § 284.123(b)(2) of the Commission's regulations. DIGCO states that it proposes a maximum interruptible rate of $0.0388 per MMBtu, plus a 0.004 percent in-kind fuel reimbursement for the transportation of natural gas under section 311(a)(2) of the Natural Gas Policy Act of 1978.
Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate.
Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* .
Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* January 19, 2006. Magalie R. Salas, Secretary. [FR Doc. E6-53 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR06-7-000] ETC Katy Pipeline, Ltd.; Notice of Petition for Rate Approval December 29, 2005. Take notice that on December 8, 2005, ETC Katy Pipeline, Ltd.
(ETC)filed, pursuant to section 284.123(b)(1)(i)(A) of the Commission's regulations, an election to use rates contained in its effective State of Texas transportation rate schedule for comparable services under subpart C of part 284 of the Commission's regulations. ETC states that this rate will be applicable to the firm and interruptible transportation of natural gas under section 311(a)(2) of the Natural Gas Policy Act of 1978. Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* January 19, 2006. Magalie R. Salas, Secretary. [FR Doc. E6-52 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL06-27-000] The Goldman Sachs Group, Inc.; Notice of Filing December 20, 2005. Take notice that on December 12, 2005, The Goldman Sachs Group, Inc. (GS Group) tendered for filing a Petition for Declaratory Order stating that section 203 of the Federal Power Act, as amended, will not apply to certain acquisitions of utility and holding company securities. GS Group further states that accompanying this filing is an Application for Blanket Authorization to Acquire Utility and/or Holding Company Securities, pursuant to, amended section 203(a)(2) of the Federal Power Act, but that the Commission need not act on this latter Application if the Commission grants the declaratory relief. Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 pm Eastern Time on January 11, 2006. Magalie R. Salas, Secretary. [FR Doc. E6-49 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP06-152-000] Natural Gas Pipeline Company of America; Notice of Petition for Waiver and Request for Expedited Action December 29, 2005. Take notice that on December 23, 2005, Natural Gas Pipeline Company of America (Natural), pursuant to Rule 207 of the Federal Energy Regulatory Commission's Rules of Practice and Procedure, submitted a petition for waiver of tariff and request for expedited action to waive certain secondary point rights provisions set forth in section 5.5 of its General Terms and Conditions. Natural makes this request to provide shippers with added flexibility in responding to capacity constraints on Natural's Gulf Coast Line brought on by system testing and maintenance. Natural requests that the Commission grant this petition by January 20, 2006, so that shippers can utilize the waiver to set up February business, thereby mitigating the impact of the capacity reductions. Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed in accordance with the provisions of Section 154.210 of the Commission's regulations (18 CFR 154.210). Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov* . Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov* , using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* , or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Magalie R. Salas, Secretary. [FR Doc. E6-50 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP06-42-000, CP06-43-000] Northern Natural Gas Company, Targa Texas Field Services LP; Notice of Application and Petition for a Declaratory Order December 29, 2005. Take notice that on December 27, 2005, Northern Natural Gas Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124, filed in Docket No. CP06-42-000 an application pursuant to section 7(b) of the Natural Gas Act and part 157 of the Commission's Regulations, for permission and approval to abandon by sale various natural gas pipeline facilities located in various Texas counties to Targa Texas Field Services LP (Targa), 1000 Louisiana Street, Suite 4700, Houston, Texas 77002. On December 23, 2005, Targa filed in Docket No. CP06-43-000 a petition for a declaratory order with the Commission disclaiming jurisdiction for the facilities it intends to purchase from Northern. Northern's and Targa's applications are on file with the Commission and open to public inspection. These filings may also be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link, select “Docket #” and follow the instructions (call 202-502-8222 or for TTY, 202-502-8659). Northern proposes to abandon by sale to Targa approximately 101 miles of 16-, 10-, 8-, and 4-inch diameter pipeline, including all delivery and receipt points and appurtenant facilities in Schleicher, Irion, Reagan, Glasscock, and Midland Counties, Texas, for a price of $3,000,000 pursuant to their October 31, 2005, sales agreement. Concurrently, Targa petitions for a declaratory order disclaiming the Commission's jurisdiction over the facilities, rates, services, or operations (referred to as the Eldorado—Spraberry facilities) it would purchase from Northern. Northern states that Targa would integrate the Eldorado—Spraberry facilities into Targa's gathering system and offer gathering service to existing customers as well as to other parties who request service on these facilities. Any questions regarding this application should be directed to Michael T. Loeffler, Director, Certificates and Government Affairs for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124, at
(402)398-7103 or Dan Middlebrooks, Director Gas Supply—Texas, Targa Texas Field Services LP, 1000 Louisiana Street, Suite 4700, Houston, Texas 77002, at
(713)584-1047. There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding. However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest. Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. *Comment Date:* January 19, 2006. Magalie R. Salas, Secretary. [FR Doc. E6-51 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP05-410-001] Northern Natural Gas Company; Notice of Amendment of Application December 29, 2005. Take notice that on December 23, 2005 Northern Natural Gas Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124, filed with the Federal Energy Regulatory Commission an application under section 7 of the Natural Gas Act
(NGA)to amend its original application pending Commission approval in Docket No. CP05-410-000, all as more fully set forth in the application which is on file with the Commission and open to public inspection. This filing may be also viewed on the Web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, call
(202)502-8659 or TTY,
(202)208-3676. Northern states it is amending its original application requesting authorization to install the water handling facilities to increase the storage capacity at its Redfield Storage Field in Dallas County, Iowa, pursuant to section 7 of the NGA. This amendment is in addition to the authorization requested in the original application filed September 2, 2005. Any questions regarding this amendment should be directed to Michael T. Loeffler, Director of Certificates for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124,
(402)398-7103 or Bret Fritch, Senior Regulatory Analyst, at
(402)398-7140. There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding. However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest. Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. *Comment Date:* January 5, 2006. Magalie R. Salas, Secretary. [FR Doc. E6-54 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 December 28, 2005. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER04-691-068. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits Substitute Third Revised Sheet 50 et al to FERC Electric Tariff, Third Revised Volume No. 1. *Filed Date:* 12/20/2005. *Accession Number:* 20051223-0010. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER05-143-003. *Applicants:* Reliant Energy Florida, LLC. *Description:* Reliant Energy Florida LLC clarifies the change in contracted status of its Indian River Generating Facility. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0054. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER05-1495-001. *Applicants:* American Electric Power Service Corporation. *Description:* American Electric Power Service Corp as agent for Appalachian Power Co submits its compliance filing. *Filed Date:* 12/19/2005. *Accession Number:* 20051221-0094. *Comment Date:* 5 p.m. Eastern Time on Monday, January 9, 2006. *Docket Numbers:* ER06-71-001. *Applicants:* Southwestern Public Service Company. *Description:* Southwestern Public Service Co submits revisions to their FERC Electric Rate Schedule No. 118. *Filed Date:* 12/09/2005. *Accession Number:* 20051214-0016. *Comment Date:* 5 p.m. Eastern Time on Monday, January 9, 2006. *Docket Numbers:* ER06-109-001. *Applicants:* Southwest Power Pool, Inc. *Description:* Southwest Power Pool Inc submits an executed service agreement for long-term firm point to point transmission service with Southwestern Public Service Co et al. *Filed Date:* 12/19/2005. *Accession Number:* 20051221-0091. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 5, 2006. *Docket Numbers:* ER06-116-001. *Applicants:* Entergy Services, Inc. *Description:* Entergy Services Inc submits on behalf of Entergy Gulf States Inc, Exhibit C to the Rate Schedules providing for cost-based power sales for full requirements service to the City of Caldwell et al. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0052. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-117-000. *Applicants:* FirstEnergy Solutions Corp. *Description:* Notice of appearance of Michael L Kurtz, and Kurt J Boehm as counsel for Mittal Steel USA ISG, Inc. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0062. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-229-001. *Applicants:* Safeway Inc. *Description:* Safeway, Inc's sumbits Rate Schedule No.1 in accordance with FERC Order 614 guidelines. *Filed Date:* 12/20/2005. *Accession Number:* 20051223-0009. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-246-000. *Applicants:* Allegheny Power. *Description:* Allegheny Power submits a notice of cancellation of the Interconnection & Operating Agreement with Mill Run Windpower, LLC. *Filed Date:* 11/23/2005. *Accession Number:* 20051129-0128. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 5, 2006. *Docket Numbers:* ER06-247-000. *Applicants:* Allegheny Power. *Description:* Allegheny Power submits a notice of cancellation of the Power Resale Agreement, dated as of 3/18/87 between Monongahela Power Co & West Penn Power Co *et al.* *Filed Date:* 11/23/2005. *Accession Number:* 20051129-0129. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 5, 2006. *Docket Numbers:* ER06-248-000. *Applicants:* Allegheny Power. *Description:* Allegheny Power submits a notice of cancellation of the Interconnection and Operating Agreement with Industrial Power Generating Corp for Mountain View etc. *Filed Date:* 11/23/2005. *Accession Number:* 20051129-0130. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 5, 2006. *Docket Numbers:* ER06-343-000. *Applicants:* Northeast Utilities Service Company. *Description:* Northeast Utilities Service Co submits a Notice of Cancellation of NU Companies Service Agreement No.13 under ISO New England, Inc's FERC Electric Tariff No. 3. *Filed Date:* 12/19/2005. *Accession Number:* 20051221-0035. *Comment Date:* 5 p.m. Eastern Time on Monday, January 9, 2006. *Docket Numbers:* ER06-344-000. *Applicants:* Southwest Power Pool. *Description:* Southwest Power Pool, Inc submits revisions to Attachment AD of its Open Access Transmission Tariff to modify the Tariff Administration Agreement w/Southwestern Power Administration. *Filed Date:* 12/19/2005. *Accession Number:* 20051221-0036. *Comment Date:* 5 p.m. Eastern Time on Monday, January 09, 2006. *Docket Numbers:* ER06-345-000. *Applicants:* Arizona Public Service Company. *Description:* Arizona Public Service Co's compliance filing, in response to FERC's Order 2006-A. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0077. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-346-000. *Applicants:* Desert Generation & Transmission Co-operative, Inc. *Description:* Deseret Generation & Transmission Co-operative, Inc submits an Agreement for Large Industrial Rate with Bridger Valley Electric Association. *Filed Date:* 12/19/2005. *Accession Number:* 20051221-0038. *Comment Date:* 5 p.m. Eastern Time on Monday, January 09, 2006. *Docket Numbers:* ER06-347-000. *Applicants:* Arizona Public Service Company. *Description:* Arizona Public Service Co submits revisions to its Open Access Transmission Tariff to comply with FERC's Order 661-A. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0049. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-348-000. *Applicants:* DTE East China, LLC. *Description:* DTE East China LLC submits its proposed FERC Electric Tariff No. 5 which set the cost-based revenue requirement. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0048. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-349-000. *Applicants:* Florida Power & Light Company. *Description:* Florida Power & Light Co submits it Notice of Cancellation of 1st Revised Service Agreement No. 184 and 185 with Duke Energy Trading and Marketing LLC. *Filed Date:* 12/20/2005. *Accession Number: 20051223-0015.* *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-350-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator Inc submits revisions toAttachment (Grandfathered Agreement) of its Open Access Transmission and Energy Market Tariff. *Filed Date:* 12/20/2005. *Accession Number:* 20051223-0014. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-369-000. *Applicants:* Pacific Gas and Electric Company. *Description:* Pacific Gas and Electric Co submits temporary modifications to the Service Agreement No. 42 for Network Integration Transmission Service with the San Francisco Bay Area Rapid Transit District. *Filed Date:* 12/20/2005. *Accession Number:* 20051227-0225. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER06-370-000. *Applicants:* California Independent System Operator C orporation. *Description:* California Independent System Operator Corp submits an Amended and Restated Interconnected Control Area Operating Agreement with Sierra Pacific Power Co, effective 2/1/06. *Filed Date:* 12/20/2005. *Accession Number:* 20051228-0015. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. *Docket Numbers:* ER98-2782-010. *Applicants:* AG-Energy LP. *Description:* AG-Energy, LP, Power City Partners, LP et al notifies FERC of a non-material change in facts regarding their upstream ownership. *Filed Date:* 12/09/2005. *Accession Number:* 20051214-0015. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 5, 2006. *Docket Numbers:* ER99-3491-008; ER00-2184-006; ER00-2185-006; EL05-124-003. *Applicants:* PPL Montana, LLC; PPL Colstrip I, LLC; PPL Colstrip II, LLC. *Description:* PPL Montana LLC, PPL Colstrip I, LLC and PPL Colstrip II LLC submits informational filing. *Filed Date:* 12/20/2005. *Accession Number:* 20051222-0055. *Comment Date:* 5 p.m. Eastern Time on Tuesday, January 10, 2006. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at *http://www.ferc.gov* . To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Magalie R. Salas, Secretary. [FR Doc. E6-46 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 December 29, 2005. Take notice that the Commission received the following electric rate filings. *Docket Numbers:* ER01-2562-004. *Applicants:* Competitive Energy Services, LLC. *Description:* Competitive Energy Services, LLC submits its revised market-based rate tariff as instructed in Appendix B of the order on updated market power analyses. *Filed Date:* 12/21/2005. *Accession Number:* 20051227-0188. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER05-1502-002. *Applicants:* California Independent System Operator. *Description:* California Independent System Operator Corp submits its compliance filing to Commission's 11/21/05 Order. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0018. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER05-938-003. *Applicants:* Southern Company Services, Inc. *Description:* Southern Company Services, Inc submits the Compliance Refund Report pursuant to the Commission's letter order dated 12/2/05. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0007. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-27-001. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits proposed revisions to its Open Access Transmission and Energy Markets Tariff, FERC Electric Tariff, Third Revised Volume No. 1 etc. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0008. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-33-000. *Applicants:* Pacific Gas & Electric Company. *Description:* Pacific Gas & Electric Co submits proposed revisions to Rate Schedule No. 208 for the Reliability Must-Run Service Agreement with CASIO. *Filed Date:* 12/21/2005. *Accession Number:* 20051227-0249. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-351-000. *Applicants:* Arizona Public Service Company. *Description:* Arizona Public Service Co submits amended sheets to the IOA between APS and Gila River which is designated as Service Agreement No. 174 under its FERC Electric Tariff, Volume No. 2 *et al.* *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0041. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-353-000. *Applicants:* Duke Energy Corporation. *Description:* Duke Energy Corp, on behalf of Duke Electric Transmission submits an executed Network Integration Service Agreement for Network Integration Transmission Service with Piedmont Municipal Power Agency. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0016. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-355-000. *Applicants:* South Carolina Electric & Gas Corporation. *Description:* South Carolina Electric & Gas Co submits an Open Access Transmission Tariff by including Appendix 7 as an amendment to the OATT's Large Generator Interconnection Procedures etc. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0021. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-356-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits its proposed revisions to the Midwest ISO's Open Access Transmission and Energy Markets Tariff, FERC Electric Tariff, Third Revised Volume No. 1 etc. *Filed Date:* 12/21/2005. *Accession Number:* 20051223-0022. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-357-000. *Applicants:* Cleco Marketing & Trading LLC. *Description:* Cleco Marketing & Trading, LLC submits a notice of termination of its market-based wholesale sales rate schedule, FERC Electric Rate Schedule No. 1. *Filed Date:* 12/22/2005. *Accession Number:* 20051223-0056. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-358-000. *Applicants:* American Electric Power Service Corporation. *Description:* American Electric Power Service Corp agent for Kentucky Power Co submits a cost-based formula rate agreement for full requirements electric service ( including Appendices A through D) with the City of Olive Hill, KY. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0194. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-359-000. *Applicants:* Xcel Energy Operating Companies. *Description:* Xcel Energy submits the Fifth Revised Sheet Nos. 48-56 to the Restated Agreement to Coordinate Planning and Operations and Interchange Power and Energy w/ Northern States Power Co. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0195. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-360-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits the unexecuted Service Agreement for Sioux Falls Municipal Light & Power Department. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0191. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-361-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission Operator, Inc submits the unexecuted Service Agreement for Truman Public Utilities. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0196. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-362-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits the unexecuted Service Agreement for the University of North Dakota—Facilities. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0192. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-363-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits the unexecuted Service Agreement for East Grand Forks Water & Light Department. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0193. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-364-000. *Applicants:* Trans-Elect NTD Path 15, LLC. *Description:* Trans-Elect NTD Path 15, LLC submits First Revised Sheet No. 16 to FERC Electric Tariff, Original Volume No.1. *Filed Date:* 12/21/2005. *Accession Number:* 20051227-0190. *Comment Date:* 5 p.m. Eastern Time on Wednesday, January 11, 2006. *Docket Numbers:* ER06-365-000. *Applicants:* Entergy Services, Inc. *Description:* Entergy Services, Inc as agent for Entergy Operating Companies submits unexecuted Network Operating Agreements etc with City of Conway, Arkansas & the City of West Memphis, Arkansas. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0197. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-366-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc et al submits revisions to Schedule 23 to its Open Access Transmission and Energy Markets Tariff. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0189. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-371-000. *Applicants:* Avista Corporation. *Description:* Avista Corporation submits Rate Schedule FERC No. 227 an Interconnection & Transmission Service Agreement with Public Utility District No. 1 of Chelan County, Washington. *Filed Date:* 12/22/2005. *Accession Number:* 20051227-0221. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-372-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest Independent Transmission System Operator, Inc submits an unexecuted Attachment 2—Form of Schedule 23 Service Agreement on behalf of Granite Falls Municipal Utilities. *Filed Date:* 12/22/2005. *Accession Number:* 20051228-0062. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-373-000. *Applicants:* Midwest Independent Transmission System Operator, Inc. *Description:* Midwest ISO submits on behalf of East River Electric Power Cooperative unexecuted copies of Attachment 2—Form of Schedule 23 Service Agreement. *Filed Date:* 12/22/2005. *Accession Number:* 20051228-0064. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-374-000. *Applicants:* MidAmerican Energy Company. *Description:* MidAmerican Energy Co submits its Open Access Transmission Tariff for compliance with Order 661 and 661-A. *Filed Date:* 12/22/2005. *Accession Number:* 20051228-0063. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and § 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other and the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at *http://www.ferc.gov.* To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov.* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Magalie R. Salas, Secretary. [FR Doc. E6-55 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 December 30, 2005. Take notice that the Commission received the following electric rate filings *Docket Numbers:* ER01-3001-014. *Applicants:* New York Independent System Operator, Inc. *Description:* New York Independent Transmission System Operator, Inc submits corrected Ninth Biannual Compliance Report that addresses the Demand Response Programs and the Addition of New Generation. *Filed Date:* 12/23/2005. *Accession Number:* 20051230-0097. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER03-683-009. *Applicants:* California Independent System Operator Corporation. *Description:* California ISO submits supplemental Refund Report. *Filed Date:* 12/23/2005. *Accession Number:* 20051223-5041. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-278-001. *Applicants:* Nevada Hydro Company, Inc. *Description:* Nevada Hydro Co, Inc supplements its 12/1/05 filing of the Talega-Escondido Valley Serrano 500-kV Interconnect Project and the Lake Elsinore Advance Pump Storage Project. *Filed Date:* 12/22/2005. *Accession Number:* 20051230-0098. *Comment Date:* 5 p.m. Eastern Time on Thursday, January 12, 2006. *Docket Numbers:* ER06-368-000. *Applicants:* MidAmerican Energy Company. *Description:* MidAmerican Energy Co submits an agreement governing joint ownership of transmission facilities dated 11/17/05. *Filed Date:* 12/23/2005. *Accession Number:* 20051227-0248. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-376-000. *Applicants:* EL Paso Electric Company. *Description:* El Paso Electric Co submits a rate schedule under which it intends to continue service to its retail customer, Holloman Air Force Base in Alamogordo, New Mexico. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0066. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-377-000. *Applicants:* PJM Interconnection, L.L.C. *Description:* PJM Interconnection, LLC submits an executed Construction Service Agreement with Baileyville Wind Farm, LLC and Commonwealth Edison Company. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0260. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-378-000. *Applicants:* PJM Interconnection, L.L.C. *Description:* PJM Interconnection, LLC submits an executed Interconnection Service Agreement with Burlington County and Public Service Electric and Gas Co. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0259. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-379-000. *Applicants:* Commonwealth Edison Company. *Description:* Commonwealth Edison Co submits a Letter Agreement with Midwest Generation, LLC amending the Facilities, Interconnection and Easement Agreement for the Collins Generating Station dated 12/15/99. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0076. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-380-000. *Applicants:* Kentucky Utilities Company. *Description:* Kentucky Utilities Co submits an amendment to a contract with City of Owensboro, Kentucky. *Filed Date:* 12/23/2005. *Accession Number:* 20051229-0238. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-381-000. *Applicants:* Kentucky Utilities Company. Description: Kentucky Utilities Co submits an amendment to a contract with City of Corbin, Kentucky. *Filed Date:* 12/23/2005. *Accession Number:* 20051229-0232. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-382-000. *Applicants:* Kentucky Utilities Company. *Description:* Kentucky Utilities Co submits an amendment to a contract with the City of Nicholasville, Kentucky. *Filed Date:* 12/23/2005. *Accession Number:* 20051229-0236. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-383-000. *Applicants:* Kentucky Utilities Company. *Description:* Kentucky Utilities Co submits an amendment to a contract with City of Providence, Kentucky. *Filed Date:* 12/23/2005. *Accession Number:* 20051229-0234. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-384-000. *Applicants:* Montaup Electric Company. Description: New England Power Co provides a notice of termination of FERC Rate Schedule No. 106 contract between Montaup and Pittsfield Generating Co., LP. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0074. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-385-000. *Applicants:* PJM Interconnection, L.L.C. *Description:* PJM Interconnection, LLC submits a notice of cancellation of the agreement for dynamic scheduling transmission service for Wisconsin Electric Power Co. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0073. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-386-000. *Applicants:* Direct Energy Services, LLC. *Description:* Direct Energy Services, LLC submits Petition to amend market-based rate schedule & request for certain waiver and blanket approvals. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0072. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. *Docket Numbers:* ER06-387-000. *Applicants:* Geysers Power Company, LLC. *Description:* Geysers Power Co, LLC submits a Notice of Termination of its First Revised Rate Schedule FERC No. 4, the Reliability Must-Run Service Agreement with California Independent System Operator Corp, effective 1/1/06. *Filed Date:* 12/23/2005. *Accession Number:* 20051228-0071. *Comment Date:* 5 p.m. Eastern Time on Friday, January 13, 2006. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other and the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at *http://www.ferc.gov.* To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov.* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Magalie R. Salas, Secretary. [FR Doc. E6-56 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions December 28, 2005. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection. a. *Type of Application:* New Major License. b. *Project No.:* 2082-027. c. *Date Filed:* February 25, 2004. d. *Applicant:* PacifiCorp. e. *Name of Project:* Klamath Hydroelectric Project. f. *Location:* On the Klamath River in Klamath County, Oregon and on the Klamath River and Fall Creek in Siskiyou County, California. The project currently includes 219 acres of Federal lands administered by the Bureau of Reclamation and the Bureau of Land Management. g. *Filed Pursuant to:* Federal Power Act 16 U.S.C. 791 (a)-825(r). h. *Applicant Contact:* Cory Scott, Licensing Project Manager, PacifiCorp, 825 NE. Multnomah, Suite 1500, Portland, Oregon 97232,
(503)813-6011. i. *FERC Contact:* John Mudre,
(202)502-8902 or *john.mudre@ferc.gov* . j. Deadline for filing comments, recommendations, terms and conditions, and prescriptions is 60 days from the issuance of this notice; reply comments are due 105 days from the issuance date of this notice. All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency. Comments, recommendations, terms and conditions, and prescriptions may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. k. This application has been accepted, and is ready for environmental analysis at this time. l. The proposed Project consists of four existing generating developments (J.C. Boyle, Copco No. 1, Copco No. 2. and Iron Gate) along the mainstem of the Upper Klamath River, between RM 228 and RM 254, and one generating development (Fall Creek) on Fall Creek, a tributary to the Klamath River at about RM 196. The existing Spring Creek diversion is proposed for inclusion within the Fall Creek Development. The currently-licensed East Side, West Side, and Keno Developments are not included in the proposed Project. m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at 1-866-208-3676, or for TTY,
(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. All filings must:
(1)Bear in all capital letters the title “COMMENTS”, “REPLY COMMENTS”, “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “PRESCRIPTIONS;”
(2)set forth in the heading the name of the applicant and the project number of the application to which the filing responds;
(3)furnish the name, address, and telephone number of the person submitting the filing; and
(4)otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b), and 385.2010. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support. Magalie R. Salas, Secretary. [FR Doc. E6-47 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Request To Use Alternative Procedures in Preparing a License Application December 28, 2005. Take notice that the following request to use alternative procedures to prepare a license application has been filed with the Commission. a. *Type of Application:* Request to use alternative procedures to prepare a new license application. b. *Project No.:* 12478-000. c. *Date Filed:* December 7, 2005. d. *Applicant:* Gibson Dam Hydroelectric Company, LLC. e. *Name of Project:* Gibson Dam Hydroelectric Project. f. *Location:* On Sun River in Lewis and Clark County, Montana. The project would be located at the U.S. Bureau of Reclamation's Gibson Dam. The project would also occupy lands within the Lewis and Clark National Forest. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791(a)-825(r). h. *Applicant Contact:* Steve C. Marmon, Project Manager, Gibson Dam Hydroelectric Company, LLC, 3633 Alderwood Avenue, Bellingham, WA 98225;
(360)738,9999. i. *FERC Contact:* David Turner at
(202)502-6091; e-mail *David.Turner@ferc.gov.* j. *Deadline for Comments:* 30 days from the date of this notice. All documents (original and eight copies) should be filed with:Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. k. The project would be located at the U.S. Bureau of Reclamation Gibson Dam on the Sun River. The project would consist of a power house containing one 7 MW and two 1.5 MW horizontal Francis-type turbines. Two powerhouse alternatives are being considered: one near the base of the Gibson dam, the other near the Gibson Dam outlet works. Power would be transmitted via a 69 kV transmission along one of two possible routes originating from a step-up substation near the Forest Service boundary: a 18 mile long route along Sun River Canyon Road to the South Augusta Substation near Augusta, Montana; or a seven-mile-long cross country route to either the Northwest Energy substation or North Augusta substation north of Augusta, Montana. l. A copy of the request to use alternative procedures is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at 1-866-208-3676, or for TTY,
(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support. m. Gibson Dam Hydroelectric has demonstrated that it has made an effort to contact all Federal and state resources agencies, non-governmental organizations (NGO), and others affected by the project. Gibson Dam Hydroelectric has also demonstrated that a consensus exists that the use of alternative procedures is appropriate in this case. Gibson Dam Hydroelectric has submitted a communications protocol that is supported by the stakeholders. The purpose of this notice is to invite any additional comments on Gibson Dam Hydroelectric request to use the alternative procedures, pursuant to Section 4.34(i) of the Commission's regulations. Additional notices seeking comments on the specific project proposal, interventions and protests, and recommended terms and conditions will be issued at a later date. Gibson Dam Hydroelectric will complete and file a preliminary Environmental Assessment, in lieu of Exhibit E of the license application. This differs from the traditional process, in which an applicant consults with agencies, Indian tribes, NGOs, and other parties during preparation of the license application and before filing the application, but the Commission staff performs the environmental review after the application is filed. The alternative procedures are intended to simplify and expedite the licensing process by combining the pre-filing consultation and environmental review processes into a single process, to facilitate greater participation, and to improve communication and cooperation among the participants. Gibson Dam Hydroelectric issued an initial consultation document describing the proposed project on February 15, 2005. Agency and public meetings and a site visit for the project were conducted during the week of March 28, 2005. Magalie R. Salas, Secretary. [FR Doc. E6-48 Filed 1-6-06; 8:45 am] BILLING CODE 6717-01-P FEDERAL ELECTION COMMISSION [Notice 2005-31] Filing Dates for the California Special Election in the 50th Congressional District AGENCY: Federal Election Commission. ACTION: Notice of filing dates for special election. SUMMARY: California has scheduled a special general election on April 11, 2006, to fill the U.S. House of Representatives seat in the Fiftieth Congressional District vacated by Representative Randy “Duke” Cunningham. Under California law, a majority winner in a special election is declared elected. Should no candidate achieve a majority vote, a special runoff election will be held on June 6, 2006, among the top vote-getters of each qualified political party, including qualified independent candidates. Committees participating in the California special elections are required to file pre- and post-election reports. Filing dates for these reports are affected by whether one or two elections are held. FOR FURTHER INFORMATION CONTACT: Mr. Kevin R. Salley, Information Division, 999 E Street, NW., Washington, DC 20463; Telephone:
(202)694-1100; Toll Free
(800)424-9530. SUPPLEMENTARY INFORMATION: Principal Campaign Committees All principal campaign committees of candidates who participate in the California Special General and Special Runoff Elections shall file a 12-day Pre-General Report on March 30, 2006; a Pre-Runoff Report on May 25, 2006; and a consolidated Post-Runoff & July Quarterly Report on July 15, 2006. (See chart below for the closing date for each report). If only one election is held, all principal campaign committees of candidates in the Special General Election shall file a 12-day Pre-General Report on March 30, 2006; and a Post-General Report on May 11, 2006. (See chart below for the closing date for each report). Unauthorized Committees (PACs and Party Committees) Political committees filing on a quarterly basis in 2006 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the California Special General or Special Runoff Elections by the close of books for the applicable report(s). (See chart below for the closing date for each report). Committees filing monthly that support candidates in the California Special General or Special Runoff Election should continue to file according to the monthly reporting schedule. Disclosure of Electioneering Communications (Individuals and Other Unregistered Organizations) As required by the Bipartisan Campaign Reform Act of 2002, the Federal Election Commission promulgated new electioneering communications rules governing television and radio communications that refer to a clearly identified federal candidate and are distributed within 60 days prior to a special general election (including a special general runoff). 11 CFR 100.29. The statute and regulations require, among other things, that individuals and other groups not registered with the FEC who make electioneering communications costing more than $10,000 in the aggregate in a calendar year disclose that activity to the Commission within 24 hours of the distribution of the communication. See 11 CFR 104.20. The 60-day electioneering communications period in connection with the California Special General runs from February 10, 2006 through April 11, 2006. The 60-day electioneering communications period in connection with the California Special Runoff runs from April 7, 2006 through June 6, 2006. Calendar of Reporting Dates for California Special Election Report Close of books 1 Reg./Cert. & overnight mailing date Filing date If *Only* The Special General Is Held (04/11/06), Committees Involved Must File: Pre-General 03/22/06 03/27/06 03/30/06 April Quarterly 03/31/06 04/15/06 04/15/06 2 Post-General 05/01/06 05/11/06 05/11/06 July Quarterly 06/30/06 07/15/06 07/15/06 2 If Two Elections Are Held, Committees Involved *Only* In The Special General (04/11/06) Must File: Pre-General 03/22/06 03/27/06 03/30/06 April Quarterly 03/31/06 04/15/06 04/15/06 2 Committees Involved In The Special General (04/11/06) And Special Runoff (06/06/06) Must File: Pre-General 03/22/06 03/27/06 03/31/06 April Quarterly 03/31/06 04/15/06 04/15/06 2 Pre-Runoff 05/17/06 05/22/06 05/25/06 Post-Runoff & July Quarterly 3 06/30/06 07/15/06 07/15/06 2 Committees Involved *Only* In The Special Runoff (06/06/06) Must File: Pre-Runoff 05/17/06 05/22/06 05/25/06 Post-Runoff & July Quarterly 3 06/30/06 07/15/06 07/15/06 2 1 The period begins with the close of books of the last report filed by the committee. If the committee has filed no previous reports, the period begins with the date of the committee's first activity. 2 Notice that this deadline falls on a holiday or a weekend. Filing dates are not extended when they fall on nonworking days. 3 Committees should file a consolidated Post-Runoff and July Quarterly Report by the filing date of the July Quarterly Report. Dated: December 29, 2005. Scott E. Thomas, Chairman, Federal Election Commission. [FR Doc. E6-42 Filed 1-6-06; 8:45 am] BILLING CODE 6715-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0508] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Healthcare Practitioners Regarding Their Preferences for Public Health Notifications 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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of healthcare practitioners' preferences regarding public health notifications (PHNs). DATES: Submit written or electronic comments on the collection of information by March 10, 2006. 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, Office of Management Programs (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 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. Survey of Healthcare Practitioners Regarding Their Preferences for PHNs The PHN is one of the tools that the Center for Devices and Radiological Health
(CDRH)uses to get an important message to the user community about risks associated with use of medical devices. This particular tool is meant to serve a specific purpose not served by the other communication tools at our disposal—to be a source of information for healthcare practitioners, immediately recognizable as a statement from FDA, about a device risk with information on how to avoid or mitigate the risk. The purpose of this project is to evaluate the current notification format and distribution process for CDRH, with the goal of determining what is necessary to assure that the notifications reach, and are acted upon by, the target audience. The center needs to know that it is using the most effective approach to formatting and to disseminating PHNs to assure that they are received, recognized, understood, and acted upon quickly and effectively by medical practitioners and institutions. Considerations include, but are not limited to, design, terminology, nomenclature, distribution, utility of standardization, relationship with other medical product notifications (e.g., recalls), use of electronic transmission, and use of plain language. The intent of this project is to determine the preferences of the healthcare community for learning from FDA about risks associated with medical devices and to compare the current process against the approach identified by the research to be “preferred” with the intent of improving our format and process. CDRH will conduct a survey of a sample of healthcare providers who receive a new PHN from FDA. Most recently, FDA has been using intermediary organizations, such as professional associations, to help us distribute notifications to the appropriate target audiences and we are assuming that any new PHN will be disseminated in this way, using the appropriate association to distribute the PHN to their members. Generally, the PHN is distributed to the target audience electronically, either as a link embedded in a news article or sent directly via e-mail from either the professional association or FDA using the e-mail listing provided by the professional association. As part of the notification, we will provide a link to a Web-based questionnaire that will collect information related to the healthcare providers' preferences for learning about risks associated with medical devices. The information collected in this survey will help FDA identify the most effective format(s) and distribution method(s) for CDRH PHNs. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Survey of healthcare providers in relevant specialty 300 1 300 .1666 50 Survey of healthcare providers in another relevant specialty 300 1 300 .1666 50 Total 100 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions and completing the questionnaire. Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-72 Filed 1-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0507] Agency Emergency Processing Under Office of Management and Budget Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable 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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is preparing a guidance document explaining, that it is possible in certain circumstances for In Vitro Diagnostic
(IVD)device studies to be conducted using leftover specimens obtained without informed consent while protecting the human subjects who are the source of such specimens. This notice solicits comments on the proposed collection of information associated with the guidance document entitled “Guidance on Informed Consent for *In Vitro* Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.” DATES: Fax written comments on the collection of information by February 8, 2006. FDA is requesting approval of this emergency processing by January 17, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of this proposed collection of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. The Center for Devices and Radiological Health
(CDRH)intends to issue a guidance document that addresses an immediate need of the research community. CDRH's guidance will identify the circumstances when the agency intends to exercise enforcement discretion regarding the informed consent requirements. These requirements normally apply to all FDA-regulated clinical studies, including studies using only leftover human specimens that are not individually identifiable. The agency intends to issue this guidance because the existing requirements are bringing a halt to a class of very valuable research that can produce new diagnostic tests, without appreciably adding protection for human subjects. With respect to the following proposed collection of information, FDA invites comments on the following 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. Guidance on Informed Consent for *In Vitro* Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product development and the protection of public health, safety, and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and institutional review board
(IRB)review that apply to all FDA-regulated clinical investigations involving human subjects. In particular, informed consent requirements further both safety and ethical considerations by allowing potential subjects to consider both the physical and privacy risks they face if they agree to participate in a trial. Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations (see 21 CFR 812.3(p)). Many IVD device studies are exempt from most provisions of part 812 (21 CFR part 812), Investigational Device Exemptions (IDEs), under § 812.2(c)(3), but FDA's regulations for the protection of human subjects (parts 50 and 56 (21 CFR parts 50 and 56)) apply to all clinical investigations that are regulated by FDA (see §§ 50.1 and 56.101, and section 520(g)(3)(A) and (g)(3)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)(A) and (g)(3)(D))). FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants of human specimens collected for routine clinical care or analysis that would otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to waive informed consent for research involving leftover or unidentifiable specimens. FDA intends to notify the public, in a level 1 guidance document issued under the good guidances practices regulation (21 CFR 10.115), of the circumstances in which it intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs. In the guidance document, FDA recommends that sponsors of studies that meet the conditions maintain documentation of how these conditions were met and of the types of human subject protection procedures followed by the specimen provider to ensure that the subject cannot be identified. Sponsors that wish to follow the recommendations of the guidance will substitute use of records to demonstrate conformance to this enforcement discretion policy in place of the more detailed and patient-specific records for obtaining and documenting informed consent. Most fundamentally, this means collecting and maintaining information about the protections that are in place to prevent the identification of the specimens, since making sure that the specimens are not identifiable is key to obtaining FDA's enforcement discretion. FDA intends to exercise enforcement discretion when all the following are true: • The investigation meets the IDE exemption criteria at § 812.2(c)(3); • The study uses leftover specimens, that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded if not used in the study; • The specimens provided to the investigator are accompanied by only minimal clinical information such as age, gender, and existing laboratory result; • The specimens are not individually identifiable; • The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information; • The individuals caring for the patients are different from, and do not share information with, those conducting the investigation; and • The study has been reviewed by an IRB in accordance with 21 CFR part 56. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 No. of Recordkeepers Annual Frequency per Record Total Annual Records Hours per Record Total Hours 600 1 600 4 2,400 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The recommendations of this guidance impose a minimal burden on industry. FDA estimates that 600 studies will be affected annually. Each study will result in one recordkeeping per year, estimated to take 4 hours to complete. This results in a total recordkeeping burden of 2,400 hours (600 × 4 = 2,400). Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-73 Filed 1-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2005M-0320, 2005M-0289, 2005M-0387, 2005M-0270, 2005M-0379, 2005M-0388, 2005M-0284, 2005M-0283, 2005M-0328, 2005M-0308, 2005M-0380, 2005M-0321, 2005M-0339, 2005M-0359, 2005M-0382, 2005M-0381, 2005M-0378] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is publishing a list of premarket approval applications
(PMAs)that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the **Federal Register** . Instead, the agency now posts this information on the Internet on FDA's home page at *http://www.fda.gov* . FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the **Federal Register** , and FDA believes that the Internet is accessible to more people than the **Federal Register** . In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from July 1, 2005, through September 30, 2005. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. **Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2005, through September 30, 2005** PMA No./Docket No. Applicant Trade name Approval date P040043/2005M-0320 W.L. Gore & Associates, Inc. GORE TAG THORACIC ENDOPROSTHESIS March 23, 2005 P030035(S3)/2005M-0289 St. Jude Medical FRONTIER MODEL 5508L AND FRONTIER II MODEL 5586 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P) SUPPORTED ON THE MODEL 3510 PROGRAMMER PLATFORMS WITH THE MODEL 3307, V4.8M PROGRAMMER SOFTWARE April 29, 2005 P040005/2005M-0387 DakoCytomation Denmark A/S DAKOCYTOMATION HER2 FISH PHARMDX KIT May 3, 2005 P030049/2005M-0270 Bayer Healthcare, LLC ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL May 26, 2005 P040037/2005M-0379 W.L. Gore & Associates, Inc. VIABAHN ENDOPROSTHESIS June 14, 2005 P040011/2005M-0388 DakoCytomation California, Inc. DAKOCYTOMATION C-KIT PHARMDX June 27, 2005 P950042(S3)/2005M-0284 Xillix Technologies Corp. ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA June 30, 2005 P970003(S50)/2005M-0283 Cyberonics, Inc. VNS THERAPY SYSTEM July 15, 2005 P030004/2005M-0328 Micro Therapeutics, Inc. ONYX LIQUID EMBOLIC SYSTEM July 21, 2005 H050001/2005M-0308 Boston Scientific Smart WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER August 3, 2005 P030036/2005M-0380 Medtronic, Inc. MEDTRONIC SELECTSECURE August 3, 2005 P040021/2005M-0321 St. Jude Medical, Inc. SJM BIOCOR VALVE/SJM BICOR SUPRA VALVE August 5, 2005 P040039/2005M-0339 Orthometrix, Inc. ORBASONE PAIN RELIEF SYSTEM August 10, 2005 P040044/2005M-0359 Access Closure, Inc. MATRIX VSG SYSTEM MODEL MX-100 August 17, 2005 P930016(S21)/2005M-0382 Visx, Inc. STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING
(VSS)August 30, 2005 P040038/2005M-0381 Abbott Vascular Devices XACT CAROTID STENT SYSTEM September 6, 2005 P930014(S15)/2005M-0378 Alcon Laboratories ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS September 14, 2005 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: December 20, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-59 Filed 1-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies 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* : Cellular, Tissue and Gene Therapies Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on February 9, 2006, from 8 a.m. to approximately 5:30 p.m. and on February 10, 2006, from 8 a.m. to approximately 1 p.m. *Location* : Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Gail Dapolito or Rosanna L. Harvey, Food and Drug Administration, 1401 Rockville Pike (HFM-71), 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 301-451-2389. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On February 9, 2006, in open session, the committee will conduct a scientific discussion of potency measurements for cellular and gene transfer products. On February 10, in open session, the committee will
(1)Discuss the National Toxicology Program on Retroviral Mutagenesis and
(2)receive a brief update on the recent review of the research program of the Office of Cellular, Tissue and Gene Therapies, FDA. *Procedure* : On February 9, 2006, from 8 a.m. to approximately 5:30 p.m., and on February 10, 2006, from 8 a.m. to approximately 11:30 a.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 February 2, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2 p.m. on February 9, 2006, and between approximately 9:40 a.m. and 10:10 a.m. on February 10, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 2, 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 February 10, 2006, from approximately 11:30 a.m. to 1 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)); and where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the report of the Research Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee related to a review of the research program in the Office of Cellular, Tissue and Gene Therapies. 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 Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 3, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-71 Filed 1-6-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0468] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays; 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: Herpes Simplex Virus Types 1 and 2 Serological Assays.” This draft guidance document describes a means by which herpes simplex virus types 1 and/or 2 (HSV 1 and/or 2) serological assays 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 these devices from class III into class II (special controls). DATES: Submit written or electronic comments on this draft guidance by April 10, 2006. ADDRESSES: Submit written requests for single copies on a 3.5” diskette of the draft guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays” 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 301-443-8818. 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: Sally Hojvat, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2096. SUPPLEMENTARY INFORMATION: I. Background FDA developed this draft guidance document as a special control to support the classification of in vitro diagnostic devices for the laboratory diagnosis of herpes simplex virus
(HSV)infection into class II (special controls). HSV (types 1 and/or 2) serological assays are intended for testing specimens from individuals who have signs and symptoms of infection consistent with HSV 1 and/or 2; determining if an individual has been previously infected with HSV 1 and/or 2; or providing epidemiological information about these infections. The detection of these antibodies aids in the clinical diagnosis of an infection by HSV 1 and/or 2 in conjunction with other clinical laboratory findings. This draft guidance document identifies the classification regulation and product codes for HSV 1 and/or 2 serological assays. In addition, other sections of this guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these assays and lead to a timely premarket notification (510(k)) review and clearance. This document supplements other FDA documents regarding the specific content of a premarket notification submission. 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 class II special controls for HSV 1 and/or 2 serological assays. 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 To receive “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays” by fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number
(1305)followed by the pound sign (#). Follow the remaining voice prompts to complete your request. To receive “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays,” you may either send a fax request to 301-443-8818 to receive a hard copy of the document, or send an e-mail request to *gwa@cdrh.fda.gov* to receive a hard copy or an electronic copy. Please use the document number
(1305)to identify the guidance you are requesting. Persons interested in obtaining a copy of the draft guidance may also do so by using the Internet. 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 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 refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 807.87 have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR 801.109 have been approved under OMB Control No. 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. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: December 21, 2005. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. 06-174 Filed 1-6-06; 8:45 am]
Connectionstraces to 21
Traces to 21 documents
CFR
- Protests other than under Rule 208 (Rule 211).§ 385.211
- Protests, interventions, and comments.§ 154.210
- Intervention (Rule 214).§ 385.214
- Interventions and protests.§ 157.10
- Filings and Other Submissions.§ 385.2001
- Hearings on applications; consultation on terms and conditions; motions to intervene; alternative procedures.§ 4.34
- Electioneering communication (52 U.S.C. 30104(f)(3)).§ 100.29
- Reporting electioneering communications (52 U.S.C. 30104 (f)).§ 104.20
- Definitions.§ 812.3
- Good guidance practices.§ 10.115
- Procedures for review of a PMA.§ 814.44
- Administrative reconsideration of action.§ 10.33
- Information required in a premarket notification submission.§ 807.87
- Prescription devices.§ 801.109
U.S. Code
- Repealed. Aug. 26, 1935, ch. 687, title II, § 212, 49 Stat. 847§ 791
- Definitions§ 3502
- Federal agency responsibilities§ 3506
- Public information collection activities; submission to Director; approval and delegation§ 3507
- General provisions respecting control of devices intended for human use§ 360j
- Premarket approval§ 360e
- Open meetings§ 552b
5 references not yet in our index
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- 5 CFR 1320.13
- 21 CFR 812
- 21 CFR 56
Citation graph
cites case law
Notices
Notice of filing dates for special election
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Cite5 CFR 1320.13
Cites 26 · showing 12Cited by 0 across 0 sources