Notices. Notice of availability and public hearing

35,053 words·~159 min read·/register/2007/10/26/07-5310

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

BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR08-2-000] Acacia Natural Gas Corporation; Notice of Petition for Rate Approval October 18, 2007. Take notice that on October 12, 2007, Acacia Natural Gas Corporation (Acacia) filed a petition for rate approval for NGPA section 311 maximum interruptible transportation rates equal to 12.23 cents per MMBtu, pursuant to section 284.123(b)(2) of the Commission's regulations, with a proposed effective date of January 1, 2008.

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:* 5 p.m. October 31, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21150 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER07-1175-001] Ameren Illinois Transmission Company; Notice of Filing October 18, 2007. Take notice that on October 3, 2007, pursuant to the Federal Energy Regulatory Commission's September 17, 2007, letter order, Ameren Illinois Transmission Company (Ameren Transco) filed a certificate of concurrence Ameren Transco designating the Joint Ownership Agreement, accepted as Rate Schedule No. 1. 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. On or before the comment date, it is not necessary to 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:* 5 p.m. Eastern Time on October 31, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21154 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ID-4025-001] Brown, D. Tim; Notice of Filing October 18, 2007. Take notice that on October 15, 2007, Tim D. Brown filed an application for approval to hold interlocking positions, pursuant to section 45.8 of the Commission's regulation, 18 CFR 45.8 (2007). 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 p.m. Eastern Time on November 14, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21155 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL08-4-000] Entergy Gulf States, Inc.; Notice of Filing October 18, 2007. Take notice that on October 12, 2007, Entergy Gulf States, Inc., on behalf of Gulf States Louisiana, L.L.C. and Entergy Texas, Inc., filed a petition for declaratory order regarding payment of dividends from paid-in capital. 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. On or before the comment date, it is not necessary to 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:* 5 p.m. Eastern Time on November 2, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21153 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-6-000 and Docket No. PF07-4-000] Midcontinent Express Pipeline LLC; Notice of Application October 23, 2007. Take notice that on October 9, 2007, and supplemented on October 19, 2007, Midcontinent Express Pipeline LLC (Midcontinent), 747 East 22nd Street, Lombard, Illinois 60148, filed an abbreviated application pursuant to section 7(c) of the Natural Gas Act

(NGA)and Part 157 of the Commission's regulations, for a certificate of public convenience and necessity to construct and operate a new 502-mile natural gas pipeline system from southeastern Oklahoma to western Alabama. This filing 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, please contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll free at

(866)208-3676, or for TTY, contact

(202)502-8659. Midcontinent requests:

(1)Authorization to construct a new natural gas pipeline system consisting of 502 miles of primarily 30-inch to 42-inch diameter pipeline, a booster compressor station (9,470 hp), and 4 mainline compressor stations (102,250 hp), which will originate in southeastern Oklahoma, continue through Texas, Louisiana, Mississippi, and terminate in western Alabama;

(2)authorization to lease up to 800,000 Dth/d in the Enogex Inc. intrastate system in Oklahoma to be connected at the origin of the Midcontinent system;

(3)approval of Midcontinent's pro forma tariff and proposed recourse rates; and

(4)issuance of a blanket construction certificate pursuant to Subpart F of Part 157 and a blanket transportation certificate pursuant to Subpart G of Part 284. On October 9, 2007, Enogex Inc. filed a related application, in Docket No. CP08-9-000, seeking a limited-jurisdiction certificate authorizing Enogex to lease up to 800,000 Dth/d of its intrastate pipeline capacity to Midcontinent. Midcontinent proposes phased in-service dates and recourse rates. Midcontinent has committed to lease 275,334 Dth/d of capacity on the Enogex system but requests authority to increase the lease capacity up to 800,000 Dth/d at any time during the first 5 years after the project's in-service date. Midcontinent also requests that it be allowed up to 5 years after the project's in-service date in which to construct 2 of the requested mainline compressor stations. The project will have two zones. Without the 2 delayed-construction compressor stations, Zone 1 will have a capacity of 1,400,000 Dth/d and Zone 2 capacity will be 1,000,000 Dth/d. Construction of the final 2 compressor stations will provide an additional 100,000 Dth/d of capacity in Zone 1 and an additional 200,000 Dth/d in Zone 2. Estimated initial project cost is $1.28 billion without the final 2 compressor stations, rising to $1.34 billion with the final 2 compressor stations. Midcontinent requests a preliminary determination on non-environmental issues by March 2008, and a final order by July 2008, in order to commence construction by August 1, 2008. Midcontinent anticipates placing some pipeline facilities in-service on October 31, 2008, with all of the proposed facilities, except the final 2 compressor stations, going into service on February 28, 2009. Any questions regarding the application are to be directed to Bruce H. Newsome, Vice President, Regulatory, Midcontinent Express Pipeline LLC, 747 East 22nd Street, Lombard, Illinois 60148-5072, telephone:

(630)691-3526 or e-mail: *bruce_newsome@kindermorgan.com* . On February 22, 2007, the Commission staff granted Midcontinent's request to utilize the National Environmental Policy Act

(NEPA)Pre-Filing Process and assigned Docket No. PF07-4-000 to staff activities involving the project. Now, as of the filing of this application on October 9, 2007, the NEPA Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP08-6-000, as noted in the caption of this notice. Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment

(EA)and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement

(FEIS)or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA. 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 on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant. 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. 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 the original and 14 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street, NE., Washington, DC 20426. *Comment Date:* November 13, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21229 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF07-3011-000] Southeastern Power Administration; Notice of Filing October 18, 2007. Take notice that on September 13, 2007, the Deputy Secretary, U.S. Department of Energy, pursuant to the authority vested in the Deputy Secretary by the Department of Energy's Delegation Order Nos. 00-001.00C and 00-037.00, and by sections 302(a) and 301(b) of the Department of Energy Organization Act (Pub. L. 95091), submitted for confirmation and approval on a final basis, Rate Schedules SOCO-1-C, SOCO-2-C, SOCO-3-C, SOCO-4-C, ALA-1-L, MISS-1-L, Duke-1-C, Duke-2-C, Duke-3-C, Duke-4-C, Santee-1-C, Santee-2-C, Santee-3-C, Santee-4-C, SCE&G-1-C, SCE&G-2-C, SCE&G-3-C, SCE&G-4-C, Pump-1-A, Pump-2, Replacement-1, and Regulation-1, effective October 1, 2007 and ending September 30, 2012. 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. On or before the comment date, it is not necessary to 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:* 5 p.m. Eastern Time on November 19, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21158 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RC08-1-000] Southeastern Power Administration; Notice of Filing October 19, 2007. Take notice that on October 15, 2007, Southeastern Power Administration (Southeastern) filed an appeal of the September 25, 2007 decision of the North American Electric Reliability Corporation

(NERC)to include Southeastern Power Administration on the NERC compliance registry within the SERC Reliability Corporation for the function of transmission operator and resource planner. Southeastern states that it has the responsibility to market the electric power generated at reservoir projects owned and operated by the U.S. Army Corps of Engineers in the southeast and neither owns or operates a generation or transmission system. Southeastern asks the Commission to reverse the NERC's decision to register Southeastern as a transmission operator and resource planner. 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. On or before the comment date, it is not necessary to 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:* 5 p.m. Eastern Time on November 14, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21159 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-5-000] Southern Natural Gas Company; Magnolia Enterprise Holdings, Inc.; Notice of Application October 19, 2007. Take notice that on October 5, 2007, Southern Natural Gas Company (Southern), P.O. Box 2563, Birmingham, Alabama 35202-2563, filed an application in Docket No. CP08-5-000 pursuant to section 7 of the Natural Gas Act (NGA), for approval to abandon and lease certain pipeline and appurtenant facilities and authorization to construct, install and operate a new compressor unit on its Cypress Pipeline and related appurtenant facilities. Magnolia Enterprise Holdings, Inc. (MEHI), Ten Peachtree Place, Location 1466, Atlanta, Georgia 30309, filed a request in the same application pursuant to section 7 of the NGA, for authorization to acquire certain pipeline, measurement and compression facilities and to lease those facilities back to Southern, all as more fully set forth in the application which is on file with the Commission and open to public inspection. It is stated that pursuant to the terms of a Purchase and Sale Agreement between Southern and AGL Resources, Inc., MEHI's parent company, Southern requests authorization to abandon by sale to MEHI an undivided interest of the following: Twin 30 Pipelines extending from Southern's interconnection with Elba Island to Port Wentworth, Georgia in Chatham County, Georgia and Jasper County, South Carolina; 10 miles of Southern's 20-inch Wrens to Savannah Second Loop Line from the interconnection with the Twin 30 Pipelines at Port Wentworth, Georgia, to the Rincon Gate in Effingham County, Georgia; The Cypress Pipeline from the take off point on the Wrens Savannah Lines to the interconnection with Atlanta Gas Light Company's

(AGLC)Brunswick Pipeline in Glynn County, Georgia, including, as applicable, the compressor facilities to be constructed on that portion of the Cypress Pipeline; and Southern's Brunswick Pipeline from the Jackson Measurement Station at Milepost 53.8 to Milepost 0.0. It is stated that upon closing of the sale of the facilities, MEHI and Southern request authorization for MEHI to lease to Southern the facilities, including the compression facilities to be constructed, and AGLC's Brunswick Pipeline that it proposes to sell to MEHI so that Southern may operate and maintain the facilities as part of its interstate gas pipeline system under the terms of Southern's tariff. In addition, it is stated that MEHI requests pregranted abandonment authority to sell the AGLC Brunswick Pipeline back to AGLC upon termination of the lease. This filing 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 Telephone: 202-502-6652; Toll-free: 1-866-208-3676; or for TTY, contact

(202)502-8659. Any initial questions regarding Southern's proposal in this application should be directed to Patricia S. Francis, Senior Counsel, Southern Natural Gas Company, P.O. Box 2563, Birmingham, Alabama 35202-2563, or call

(205)325-7696. Any initial questions regarding EMHI's proposal in this application should be directed to Shannon Omia Pierce, Senior Regulatory Counsel, AGL Resources, Inc., Ten Peachtree Place, 15th floor, Atlanta, Georgia 30309, or call

(404)584-3394. Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment

(EA)and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement

(FEIS)or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA. 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 proceeding 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 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 commentors 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 commentors will not be required to serve copies of filed documents on all other parties. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the applicant. However, the non-party commentors 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. The Commission strongly encourages electronic filings of comments, protests, and interventions 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:* November 9, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21160 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF07-4021-000] Southwestern Power Administration; Notice of Filing October 18, 2007. Take notice that on September 17, 2007, the Deputy Secretary, U.S. Department of Energy, pursuant to the authority vested on the Deputy Secretary by the Department of Energy's Delegation Order Nos. 00-001.00C and 00-037.00, and by sections 301(b), 302(a), 402(e), 641, 642, 643 and 644 of the Department of Energy Organization Act (Pub. L. 95091), submitted for confirmation and approval on a final basis, the annual power rate increase for the sale of power and energy by the Southwestern Power Administration from the Sam Rayburn Dam to the Sam Rayburn Dam Electric Cooperative, Inc., under Contract No. DE-PM-75-92SW00215, effective October 1, 2007 and ending September 30, 2012. 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. On or before the comment date, it is not necessary to 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:* 5 p.m. Eastern Time on November 19, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21151 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP08-10-000] Trunkline Gas Company, LLC; Notice of Request Under Blanket Authorization October 19, 2007. Take notice that on October 16, 2007, Trunkline Gas Company LLC (Trunkline), P. O. Box 4967, Houston, Texas 77210-4967, filed in Docket No. CP08-10-000 a prior notice request pursuant to sections 157.205(b), 157.208(c), and 157.212 of the Commission's regulations under the Natural Gas Act (NGA), and Trunkline's blanket certificate issued in Docket No. CP83-84-000 on October 1, 1983. 1 Trunkline seeks authorization to construct, own, and operate a new receipt point to receive revaporized liquefied natural (LNG)gas in Beauregard Parish, Louisiana, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be 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, contact FERC at *FERCOnlineSupport@ferc.gov* or call toll-free,

(886)208-3676 or TYY,

(202)502-8659. 1 22 FERC ¶ 62,044 (1983). Specifically, Trunkline proposes design and construct two 24-inch tap assemblies, valves, overpressure protection equipment, a remote terminal unit and approximately 400 feet of 24-inch pipe to receive LNG from Creole Trail LNG, L.P. LNG import terminal by way of the Cheniere Pipeline facilities. 2 2 *See Creole Trail LNG, L.P., et al.* , 115 FERC ¶ 61,331 (2006). Any questions regarding this application should be directed to Stephen T. Veatch, Regulatory Affairs, Trunkline Gas Company, LLC, 5444 Westheimer Road, Houston, TX, 77056, or call (713)989-2024 or (713)989-7660. Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the Natural Gas Act

(NGA)(18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)

(iii)and the instructions on the Commission's Web site ( *http://www.ferc.gov* ) under the “e-Filing” link. *Comment Date:* December, 18, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21162 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP08-27-000] Southern California Generation Coalition, Complainant, v. Southern California Gas Company, Respondent; Notice of Complaint October 23, 2007. Take notice that on October 22, 2007, the Southern California Generation Coalition

(SCGC)filed a formal complaint against Southern California Gas Company (SoCalGas) pursuant to section 5 of the Natural Gas Act (NGA), 15 U.S.C. 171d, and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206. SCGC alleges that SoCalGas has received California Public Utilities Commission

(CPUC)approval to charge and, absent Commission intervention, will charge and intrastate fee for access to its intrastate pipeline system in violation of the Supremacy Clause of the United States Constitution, the NGA, the Commission's rules and regulations and under the NGA, and Commission precedent. SCGC certifies that copies of the complaint were served on counsel for SoCalGas as listed in the CPUC proceeding because SoCalGas is not listed on the Commission's list of Corporate Officials. 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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants. 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 p.m. Eastern Time on November 13, 2007. Kimberly D. Bose, Secretary. [FR Doc. E7-21228 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 October 23, 2007. Take notice that the Commission received the following electric corporate filings: *Docket Numbers:* EC08-8-000. *Applicants:* Consolidated Water Power Company; NewPage Energy Services, LLC; Stora Enso Oyj, Stora Enso North America, Inc.; Stora Enso North America Corp.; NewPage Group, Inc; NewPage Holding Corporation; NewPage Corporation. *Description:* The NewPage Companies submits a joint application for authorization under Section 203 of the Federal Power Act. *Filed Date:* 10/17/2007. *Accession Number:* 20071018-0196. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. Take notice that the Commission received the following exempt wholesale generator filings: *Docket Numbers:* EG08-9-000. *Applicants:* Wharton County Generation, LLC. *Description:* Wharton County Notice of Self-Certification of EWG Status. *Filed Date:* 10/19/2007. *Accession Number:* 20071019-5096. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER97-420-015. *Applicants:* ProLiance Energy, LLC. *Description:* ProLiance Energy, LLC submits a change in status notification. *Filed Date:* 10/16/2007. *Accession Number:* 20071018-0081. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 6, 2007. *Docket Numbers:* ER04-157-024; ER04-714-014. *Applicants:* Bangor Hydro-Electric Company; Florida Power & Light Company New England. *Description:* Fitchburg Gas & Electric Light Company Revised Refund Report Pursuant to FERC Order Dated July 26, 2007. *Filed Date:* 10/18/2007. *Accession Number:* 20071018-5057. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER07-1022-002. *Applicants:* Duke Energy Carolinas, LLC. *Description:* Duke Energy Carolinas, LLC. submits Substitute Original Sheet 4 to FERC Electric Tariff, Fifth Revised Volume 3 *et al.* to be effective 9/18/07. *Filed Date:* 10/17/2007. *Accession Number:* 20071018-0080. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER07-1201-001. *Applicants:* Southwest Power Pool, Inc. *Description:* Southwest Power Pool Inc submits Exhibit I a partially executed Network Integration Transmission Service Agreement with Transmission Provider and American Electric Power Service Corporation. *Filed Date:* 10/18/2007. *Accession Number:* 20071019-0036. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER07-1205-001. *Applicants:* PJM Interconnection, LLC. *Description:* PJM Interconnection, LLC responds to FERC's 9/21/07 deficiency letter re their 7/26/07 filing of an executed interconnection service agreement with WM Renewable Energy, LLC. *Filed Date:* 10/22/2007. *Accession Number:* 20071023-0034. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 13, 2007. *Docket Numbers:* ER07-1247-002. *Applicants:* FC Energy Services Company, LLC. *Description:* FC Energy Services Company, LLC submits an amendment to its proposed market based rate tariff, entitled FERC Electric Tariff 1. *Filed Date:* 10/19/2007. *Accession Number:* 20071022-0087. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. *Docket Numbers:* ER07-1258-002. *Applicants:* Rocky Mountain Power, LLC. *Description:* Rocky Mountain Power, LLC submits Substitute Original Sheet 1 and Second Substitute Original Sheet 2 to its revised tariff to delete the following provisions prohibition on affiliate sales, etc. *Filed Date:* 10/22/2007. *Accession Number:* 20071023-0033. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 13, 2007. *Docket Numbers:* ER07-1259-002. *Applicants:* San Joaquin Cogen, LLC. *Description:* San Joaquin Cogen, LLC submits its Second Substitute Original Sheet 1-3 to its FERC Electric Tariff, First Revised Volume 1, etc. *Filed Date:* 10/22/2007. *Accession Number:* 20071023-0031. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 13, 2007. *Docket Numbers:* ER07-1268-001. *Applicants:* PacifiCorp. *Description:* PacifiCorp submits Exhibits A and B two supplements to the 10/1/98 Facilities Agreement with Southern Utah Power Systems, *et al.* *Filed Date:* 10/18/2007. *Accession Number:* 20071022-0089. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER07-1309-001. *Applicants:* Dynegy Oakland, LLC. *Description:* Dynegy Oakland, LLC. submits revised tariff sheets to its Reliability Must-Run Agreement with the California ISO. *Filed Date:* 10/17/2007. *Accession Number:* 20071019-0039. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER07-1317-001. *Applicants:* Citizens Electric Company of Lewisburg, PA. *Description:* Citizens' Electric Co. of Lewisburg, PA submits a Supplement to the Petition for Acceptance of Initial Tariff, Waivers and Blanket Authority. *Filed Date:* 10/17/2007. *Accession Number:* 20071018-0079. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER07-1331-002. *Applicants:* Indianapolis Power & Light Company. *Description:* Indianapolis Power & Light Company submits the corrected designation of First Revised Rate Schedule 21; Original Sheet 1 through 11. *Filed Date:* 10/19/2007. *Accession Number:* 20071023-0032. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. *Docket Numbers:* ER07-1341-002. *Applicants:* York Generation Company, LLC. *Description:* York Generation Company, LLC supplements the notice of succession filed on 9/4/07 & supplemented 10/1/07, etc. *Filed Date:* 10/19/2007. *Accession Number:* 20071022-0088. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. *Docket Numbers:* ER07-1382-001. *Applicants:* Duke Energy Carolinas, LLC. *Description:* Duke Energy Carolinas, LLC.submits an errata to its filing of a non-firm Transmission Service Agreement with Cargill Power Markets, LLC. *Filed Date:* 10/17/2007. *Accession Number:* 20071019-0038. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER08-1-001. *Applicants:* Yuma Power Limited Liability Company. *Description:* Yuma Power Limited Liability Co submits its proposed Rate Schedule No. 1, revised Original Sheet no. 2 on 10/3/07 and 10/16/07 its 10/1/07 and this filing. *Filed Date:* 10/03/2007; 10/16/2007. *Accession Number:* 20071003-0229; 20071018-0083. *Comment Date:* 5 p.m. Eastern Time on Monday, October 29, 2007. *Docket Numbers:* ER08-65-000. *Applicants:* Westar Energy, Inc. *Description:* Westar Energy, Inc. submits a Notice of Cancellation of a Generating Municipal Electric Service Agreement with the City of Girard, Kansas. *Filed Date:* 10/17/2007. *Accession Number:* 20071018-0082. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER08-67-000. *Applicants:* Ameren Services Company. *Description:* Ameren Services Co et al submit an executed service agreement fore Wholesale Distribution Service with the City of Farmington, Missouri. *Filed Date:* 10/17/2007. *Accession Number:* 20071019-0037. *Comment Date:* 5 p.m. Eastern Time on Wednesday, November 7, 2007. *Docket Numbers:* ER08-69-000. *Applicants:* ISO New England, Inc. *Description:* ISO New England, Inc., *et al.* jointly submits its revised tariff sheets & supporting testimony of Hung-po Chao, the Director of the ISO's Internal Market Monitoring Unit, reflecting proposed revisions to Market Rule 1. *Filed Date:* 10/18/2007. *Accession Number:* 20071022-0091. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER08-70-000. *Applicants:* FirstEnergy Service Company. *Description:* FirstEnergy Services Company et al submits its Notice of Cancellation of Appendix 8 to Schedule E of the Central Area Power Coordinating Group Basic Operating Agreement. *Filed Date:* 10/18/2007. *Accession Number:* 20071022-0092. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER08-71-000; ER08-72-000. *Applicants:* Powerex Corporation and Northwestern Corporation *Description:* Powerex Corp et al submits an executed Agreement for Regulating Reserve Services. *Filed Date:* 10/18/2007. *Accession Number:* 20071022-0093. *Comment Date:* 5 p.m. Eastern Time on Thursday, November 8, 2007. *Docket Numbers:* ER08-73-000. *Applicants:* California Independent System Operator Corporation *Description:* California ISO submits proposed amendments to its FERC Electric Tariff to implement its Market Redesign and Technology Upgrade. *Filed Date:* 10/19/2007. *Accession Number:* 20071023-0030. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. *Docket Numbers:* ER08-74-000. *Applicants:* North American Energy Credit and Clearing. *Description:* North American Energy Credit and Clearing—Finance ,LLC. submits its petition for acceptance of initial rate tariff, waivers and blanket authority. *Filed Date:* 10/19/2007. *Accession Number:* 20071023-0029. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. *Docket Numbers:* ER08-76-000. *Applicants:* South Glen Falls Energy, LLC. *Description:* South Glen Falls Energy, LLC. submits a notice of cancellation of their market based rate tariff, FERC Electric Tariff, Third Revised Volume 1. *Filed Date:* 10/22/2007. *Accession Number:* 20071023-0035. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 13, 2007. Take notice that the Commission received the following electric securities filings: *Docket Numbers:* ES08-3-000. *Applicants:* Kansas City Power & Light Company. *Description:* Application of Kansas City Power & Light Company for Authorization under section 204(A) to Issue Short Term Debt. *Filed Date:* 10/22/2007. *Accession Number:* 20071022-5110. *Comment Date:* 5 p.m. Eastern Time on Tuesday, November 13, 2007. Take notice that the Commission received the following PURPA 210(m)(3) filings: *Docket Numbers:* QM08-2-000. *Applicants:* PECO Energy Company. *Description:* Application of PECO Energy Company to terminate purchase obligation. *Filed Date:* 10/19/2007. *Accession Number:* 20071022-0151. *Comment Date:* 5 p.m. Eastern Time on Friday, November 16, 2007. Take notice that the Commission received the following electric reliability filings: *Docket Numbers:* RR06-1-011. *Applicants:* North American Electric Reliability Corporation. *Description:* Compliance Filing of the North American Electric Reliability Corp in Response to September 20, 2007 Order. *Filed Date:* 10/19/2007. *Accession Number:* 20071019-5078. *Comment Date:* 5 p.m. Eastern Time on Friday, November 9, 2007. 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 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. Nathaniel J. Davis, Sr., Acting Deputy Director. [FR Doc. E7-21227 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2197-073; Project No. 2206-030] Alcoa Power Generating, Inc., North Carolina; Progress Energy Carolinas, North Carolina; Notice of Public Meetings on Draft Environmental Impact Statement October 23, 2007. The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff will conduct two public meetings on the draft environmental impact statement

(DEIS)for the Yadkin Hydroelectric Project and the Yadkin-Pee Dee River Hydroelectric Project. The times and locations of these meetings are as follows: *Yadkin Project Meeting* *Date:* November 14, 2007. *Time:* 7 to 9:30 p.m. (EST). *Place:* James Varick Auditorium. *Address:* Livingstone College, 701 West Monroe Street, Salisbury, NC 28144. *Yadkin-Pee Dee Project Meeting* *Date:* November 15, 2007. *Time:* 7 to 9:30 p.m. (EST). *Place:* Cole Auditorium. *Address:* Richmond Community College, 1042 West Hamlet Ave., Hamlet, NC 28345. The purpose of these meetings is to solicit comments on the DEIS prepared for the relicensing applications of the Yadkin and Yadkin-Pee Dee River Projects. The DEIS was issued and publicly noticed on September 28, 2007, and is available for review on the Commission's Web site at *http://www.ferc.gov* , using the “eLibrary” link. Enter the docket number (either P-2197or P-2206) 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. The Yadkin Project is located on the Yadkin River in Davidson, Davie, Montgomery, Rowan, and Stanly Counties, North Carolina. The Yadkin-Pee Dee River Project is located on the Yadkin and Pee Dee Rivers in Anson, Montgomery, Richmond, and Stanly Counties, North Carolina. There are no federal lands affected by these projects. These meetings are open to the public. All local, state, and federal agencies, Indian Tribes, and other interested parties are invited to participate. Transcripts of the meetings will be prepared. The deadline for filing comments on the DEIS is December 8, 2007. Comments should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments should reference either Project No. 2197-073 (Yadkin Project) or Project No. 2206-030 (Yadkin-Pee Dee River Project). 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 instructions on the Commission's Web site at *http://www.ferc.gov* under the eLibrary link. For further information, contact Stephen Bowler at

(202)502-6861 or *stephen.bowler@ferc.gov* or Lee Emery at

(202)5028379 or *lee.emery@ferc.gov* . Kimberly D. Bose, Secretary. [FR Doc. E7-21232 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12842-000] FFP Project 19, LLC; Notice of Application Accepted for Filing and Soliciting Motions To Intervene, Protests, and Comments October 18, 2007. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection: a. *Type of Application:* Preliminary Permit. b. *Project No.:* 12842-000. c. *Date filed:* July 25, 2007. d. *Applicant:* FFP Project 19, LLC. e. *Name of Project:* Brilliant Point Project. f. *Location:* The project would be located on the Mississippi River in St James Parish, Louisiana. The project uses no dam or impoundment. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791(a)—825(r). h. *Applicant Contact:* Mr. Dan Irvin, FFP Project 19, LLC, 69 Bridge Street, Manchester, MA 01944, phone

(978)232-3536. i. *FERC Contact:* Robert Bell,

(202)502-6062. j. *Deadline for filing comments, protests, and motions to intervene:* 60 days from the issuance date of this notice. All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. 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. The Commission strongly encourages electronic filings. Please include the project number (P-12842-000) on any comments or motions filed. The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in 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. k. *Description of Project:* The proposed project consists of:

(1)2,600 proposed 20 kilowatt Free Flow generating units having a total installed capacity of 56 megawatts,

(2)a proposed transmission line; and

(3)appurtenant facilities. The FFP Project 19, LLC, project would have an average annual generation of 227.76 gigawatt-hours and be sold to a local utility. l. *Locations of Applications:* A copy of the application is available for inspection and reproduction at the Commission in the Public Reference Room, located at 888 First Street NE., Room 2A, Washington DC 20426, or by calling

(202)502-8371. This filing may also 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, call toll-free 1-866-208-3676 or e-mail *FERCOnlineSupport@ferc.gov.* For TTY, call

(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission. n. *Competing Preliminary Permit* —Anyone desiring to file a competing application for preliminary permit for a proposed project must submit the competing application itself, or a notice of intent to file such an application, to the Commission on or before the specified comment date for the particular application (see 18 CFR 4.36). Submission of a timely notice of intent allows an interested person to file the competing preliminary permit application no later than 30 days after the specified comment date for the particular application. A competing preliminary permit application must conform with 18 CFR 4.30 and 4.36. o. *Competing Development Application* —Any qualified development applicant desiring to file a competing development application must submit to the Commission, on or before a specified comment date for the particular application, either a competing development application or a notice of intent to file such an application. Submission of a timely notice of intent to file a development application allows an interested person to file the competing application no later than 120 days after the specified comment date for the particular application. A competing license application must conform with 18 CFR 4.30 and 4.36. p. *Notice of Intent* —A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit, if such an application may be filed, either a preliminary permit application or a development application (specify which type of application). A notice of intent must be served on the applicant(s) named in this public notice. q. *Proposed Scope of Studies under Permit* —A preliminary permit, if issued, does not authorize construction. The term of the proposed preliminary permit would be 36 months. The work proposed under the preliminary permit would include economic analysis, preparation of preliminary engineering plans, and a study of environmental impacts. Based on the results of these studies, the Applicant would decide whether to proceed with the preparation of a development application to construct and operate the project. r. *Comments, Protests, or Motions to Intervene* —Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application. 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 “e-filing” link. The Commission strongly encourages electronic filing. s. *Filing and Service of Responsive Documents* —Any filings must bear in all capital letters the title “COMMENTS”, “COMPETING APPLICATION”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. Any of the above-named documents must be filed by providing the original and the number of copies provided by the Commission's regulations to: The Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. t. *Agency Comments* —Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives. Kimberly D. Bose, Secretary. [FR Doc. E7-21156 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12843-000] FFP Project 23, LLC; Notice of Application Accepted for Filing and Soliciting Motions To Intervene, Protests, and Comments October 18, 2007. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection: a. *Type of Application:* Preliminary Permit. b. *Project No.:* 12843-000. c. *Date filed:* July 25, 2007. d. *Applicant:* FFP Project 23, LLC. e. *Name of Project:* White Alder Project. f. *Location:* The project would be located on the Mississippi River in St. Gabriel and Iberville Parishes, Louisiana. The project uses no dam or impoundment. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791(a)-825(r). h. *Applicant Contact:* Mr. Dan Irvin, FFP Project 23, LLC, 69 Bridge Street, Manchester, MA 01944, phone

(978)232-3536. i. *FERC Contact:* Robert Bell,

(202)502-6062. j. *Deadline for filing comments, protests, and motions to intervene:* 60 days from the issuance date of this notice. All documents (original and eight copies) should be filed with: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. 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. The Commission strongly encourages electronic filings. Please include the project number (P-12843-000) on any comments or motions filed. The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in 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. k. *Description of Project:* The proposed project consists of:

(1)2,550 proposed 20 kilowatt Free Flow generating units having a total installed capacity of 51 megawatts,

(2)a proposed transmission line; and

(3)appurtenant facilities. The FFP Project 23, LLC, project would have an average annual generation of 223.38 gigawatt-hours and be sold to a local utility. l. *Locations of Applications:* A copy of the application is available for inspection and reproduction at the Commission in the Public Reference Room, located at 888 First Street, NE., Room 2A, Washington DC 20426, or by calling

(202)502-8659. A copy is also available for inspection and reproduction at the address in item h above. m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission. n. *Competing Preliminary Permit:* Anyone desiring to file a competing application for preliminary permit for a proposed project must submit the competing application itself, or a notice of intent to file such an application, to the Commission on or before the specified comment date for the particular application (see 18 CFR 4.36). Submission of a timely notice of intent allows an interested person to file the competing preliminary permit application no later than 30 days after the specified comment date for the particular application. A competing preliminary permit application must conform with 18 CFR 4.30 and 4.36. o. *Competing Development Application:* Any qualified development applicant desiring to file a competing development application must submit to the Commission, on or before a specified comment date for the particular application, either a competing development application or a notice of intent to file such an application. Submission of a timely notice of intent to file a development application allows an interested person to file the competing application no later than 120 days after the specified comment date for the particular application. A competing license application must conform with 18 CFR 4.30 and 4.36. p. *Notice of Intent:* A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit, if such an application may be filed, either a preliminary permit application or a development application (specify which type of application). A notice of intent must be served on the applicant(s) named in this public notice. q. *Proposed Scope of Studies Under Permit:* A preliminary permit, if issued, does not authorize construction. The term of the proposed preliminary permit would be 36 months. The work proposed under the preliminary permit would include economic analysis, preparation of preliminary engineering plans, and a study of environmental impacts. Based on the results of these studies, the Applicant would decide whether to proceed with the preparation of a development application to construct and operate the project. r. *Comments, Protests, or Motions To Intervene:* Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application. 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 “e-filing” link. The Commission strongly encourages electronic filing. s. *Filing and Service of Responsive Documents:* Any filings must bear in all capital letters the title “COMMENTS”, “COMPETING APPLICATION”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. Any of the above-named documents must be filed by providing the original and the number of copies provided by the Commission's regulations to: The Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. t. *Agency Comments:* Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives. Kimberly D. Bose, Secretary. [FR Doc. E7-21157 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12829-000; Project No. 12852-000] Free Flow Power Corporation; FFP Project 8 LLC; Notice of Competing Applications Accepted for Filing and Soliciting Comments, Motions to Intervene, and Protests October 19, 2007. Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection: a. *Type of Applications:* Preliminary Permit (Competing). b. *Applicants, Project Numbers, and Dates Filed:* Free Flow Power Corporation, filed the application for Project No. 12829-000 on July 23, 2007. FFP Project 8, LLC filed the application for Project No.12852-000 on July 25, 2007. c. Name of the project is Greenville Bend Project. The project would be located on the Mississippi River in Orleans and Jefferson Counties, Louisiana. The project would use no dam or impoundment. d. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791a—825r. e. *Applicants Contacts:* For the Free Flow Power Corporation: Mr. Dan Irvin, Free Flow Power Corporation, 69 Bridge Street, Manchester, MA 01944, phone

(978)232-3536. FFP Project 8, LLC:Mr. Dan Irvin, FFP Project 7, LLC, 69 Bridge Street, Manchester, MA 01944, phone

(978)232-3536. f. *FERC Contact:* Robert Bell,

(202)502-6062. g. *Deadline for filing comments, protests, and motions to intervene:* 60 days from the issuance date of this notice. All documents (original and eight copies) should be filed with: Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. 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. The Commission strongly encourages electronic filings. Please include the project number (P-12829-000 or P-12852-000) on any comments or motions filed. The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person in 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. h. *Description of Projects:* The project proposed by Free Flow Power Corporation would consist of:

(1)1,450 proposed 20 kilowatt Free Flow generating units having a total installed capacity of 19 megawatts,

(2)a proposed transmission line; and

(3)appurtenant facilities. The Free Flow Power Corporation, project would have an average annual generation of 127.02 gigawatt-hours and be sold to a local utility. *The project proposed by FFP Project 8, LLC would consist of:*

(1)1,450 proposed 20 kilowatt Free Flow generating units having a total installed capacity of 29 megawatts,

(2)a proposed transmission line; and

(3)appurtenant facilities. The FFP Project 8, LLC, project would have an average annual generation of 127.02 gigawatt-hours and be sold to a local utility. i. The filings are 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, call toll-free 1-866-208-3676 or e-mail *FERCONLINESUPPORT@FERC.GOV.* For TTY, call

(202)502-8659. A copy is also available for inspection and reproduction at the address in item e above. j. Competing Preliminary Permit—Anyone desiring to file a competing application for preliminary permit for a proposed project must submit the competing application itself, or a notice of intent to file such an application, to the Commission on or before the specified comment date for the particular application (see 18 CFR 4.36). Submission of a timely notice of intent allows an interested person to file the competing preliminary permit application no later than 30 days after the specified comment date for the particular application. A competing preliminary permit application must conform with 18 CFR 4.30 and 4.36. k. Competing Development Application—Any qualified development applicant desiring to file a competing development application must submit to the Commission, on or before a specified comment date for the particular application, either a competing development application or a notice of intent to file such an application. Submission of a timely notice of intent to file a development application allows an interested person to file the competing application no later than 120 days after the specified comment date for the particular application. A competing license application must conform with 18 CFR 4.30 and 4.36. l. Notice of Intent—A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit, if such an application may be filed, either a preliminary permit application or a development application (specify which type of application). A notice of intent must be served on the applicant(s) named in this public notice. m. Proposed Scope of Studies under Permit—A preliminary permit, if issued, does not authorize construction. The term of the proposed preliminary permit would be 36 months. The work proposed under the preliminary permit would include economic analysis, preparation of preliminary engineering plans, and a study of environmental impacts. Based on the results of these studies, the Applicant would decide whether to proceed with the preparation of a development application to construct and operate the project. n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application. o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “NOTICE OF INTENT TO FILE COMPETING APPLICATION”, “COMPETING APPLICATION”, “PROTEST”, and “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. Any of the above-named documents must be filed by providing the original and the number of copies provided by the Commission's regulations to: The Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. An additional copy must be sent to Director, Division of Hydropower Administration and Compliance, Federal Energy Regulatory Commission, at the above-mentioned address. A copy of any notice of intent, competing application or motion to intervene must also be served upon each representative of the Applicant specified in the particular application. p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives. Kimberly D. Bose, Secretary. [FR Doc. E7-21161 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RP07-666-000; RP07-667-000] Colorado Interstate Gas Company; Notice of Technical Conference October 22, 2007. Take notice that the Commission will convene a technical conference in the above-referenced proceeding on Thursday, November 15, 2007, at 10 a.m. (EDT), in a room to be designated at the offices of the Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426. The Commission's September 27, 2007 Order 1 directed that a technical conference be held to address the issues raised by Colorado Interstate Gas Company's

(CIG)August 31, 2007, tariff filings to revise its fuel tracking mechanism and to update the calculation of its cash-out Index Price and cash-out System Index Price (collectively, cash-out prices). 1 Colorado Interstate Gas Co., 120 FERC ¶ 61,287 (2007). Commission Staff and parties will have the opportunity to discuss all of the issues raised by CIG's proposals to modify its fuel and LUF mechanism and to adjust its cash-out price calculations. Specifically, CIG should be prepared to address all the concerns raised in the protests, and if necessary, to provide additional technical, engineering and operational support for its proposals. Any party proposing alternatives to CIG's proposals should also be prepared to similarly support its position. FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an e-mail to *accessibility@ferc.gov* or call toll free

(866)208-3372 (voice) or 202-502-8659 (TTY), or send a fax to 202-208-2106 with the required accommodations. All interested persons are permitted to attend. For further information please contact Debbie-Anne Reese at

(202)502-8758 or e-mail *Debbie-Anne.Reese@ferc.gov* . Kimberly D. Bose, Secretary. [FR Doc. E7-21223 Filed 10-25-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Western Area Power Administration Big Stone II Power Plant and Transmission Project Supplemental Draft Environmental Impact Statement (DOE/EIS-0377) AGENCY: Western Area Power Administration, DOE. ACTION: Notice of availability and public hearing. SUMMARY: Western Area Power Administration (Western) announces the availability of the Supplemental Draft Big Stone II Power Plant and Transmission Project (Project) Environmental Impact Statement (Supplemental Draft EIS) for public review and comment. The U.S. Department of Agriculture Rural Utilities Service

(RUS)and U.S. Department of Defense, U.S. Army Corps of Engineers (USACE), are participating as cooperating agencies in the EIS process. The Supplemental Draft EIS addresses the environmental impacts of a different back-up water supply plan that uses groundwater instead of surface water along with associated cooling alternatives for the proposed Big Stone II power plant's back-up water supply. The National Environmental Policy Act

(NEPA)requires Western to make the Supplemental Draft EIS available to interested members of the public, groups, and Federal, State, local, and tribal agencies for review and comment to assure they have an opportunity to provide input to the Federal decision making process. Comments on the Supplemental Draft EIS may be provided in writing or at the hearing scheduled during the review period. DATES: Western invites the public to comment on the Supplemental Draft EIS during the 45-day public review and comment period, which begins on October 26, 2007, and ends on Monday, December 10, 2007. Western will hold one public hearing on November 13, 2007, at 7 p.m., at the Milbank Chamber of Commerce in Milbank, South Dakota. ADDRESSES: The hearing will be held at the Milbank Chamber of Commerce, 1001 E. 4th Ave., Milbank, South Dakota. Written comments on the Supplemental Draft EIS should be mailed, faxed, or e-mailed to: Ms. Nancy Werdel, NEPA Document Manager, Big Stone II EIS, A7400, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, fax

(720)962-7263 or 7269, e-mail *BigStoneEIS@wapa.gov* . FOR FURTHER INFORMATION CONTACT: For further information or to request a copy or summary of the Supplemental Draft EIS, please write Ms. Nancy Werdel, NEPA Document Manager, Big Stone II EIS, A7400, Western Area Power Administration, P.O. Box 281213, Lakewood, CO 80228-8213, fax

(720)962-7263 or 7269, e-mail *BigStoneEIS@wapa.gov* , or telephone her at

(800)336-7288. For general information on DOE's NEPA review process, please contact: Carol M. Borgstrom, Director, Office of NEPA Policy and Compliance, GC-20, U.S. Department of Energy, Washington, DC 20585,

(202)586-4600 or

(800)472-2756. SUPPLEMENTARY INFORMATION: In May 2006, Western Area Power Administration (Western) issued the Big Stone II Power Plant and Transmission Project Draft Environmental Impact Statement (Draft EIS). The Draft EIS described the details of the Proposed Action to construct a nominal 600-megawatt (MW), coal-fired, baseload electric generating facility and associated transmission line and substation upgrades, known as the Big Stone II Project (proposed Project). The primary source of water for the existing plant and the proposed Big Stone II plant would be withdrawals from Big Stone Lake. The proposed Project described in the Draft EIS included construction of a 450-acre surface water pond as the source of back-up water. The 450-acre surface water pond would have been filled with water from Big Stone Lake during normal operating conditions and used in the event of a drought or operational constraints, when sufficient quantities of water could not be pumped from Big Stone Lake. The Rural Utilities Service

(RUS)and the U.S. Army Corps of Engineers (USACE) are participating as cooperating agencies in the EIS process. The purpose of the Supplemental Draft EIS is to present and analyze the environmental impacts of using groundwater instead of surface water for the proposed Big Stone II power plant's back-up water supply along with different cooling alternatives. Changes to the proposed Project are based on comments received on the Draft EIS concerning wetland impacts from construction of the 450-acre water storage pond and additional construction costs associated with the pond. The Council on Environmental Quality NEPA regulations (40 CFR 1502.9) and DOE NEPA regulations (10 CFR 1021.314) require that a supplement to a draft environmental impact statement be prepared if there are substantial changes to the Proposed Action or significant new circumstances or information relevant to environmental concerns, and contribute to the impacts of the Proposed Action. Western determined that the use of groundwater as the back-up water supply would significantly change the environmental impacts of the proposed Project as presented in the Draft EIS and required the preparation of a Supplemental Draft EIS. The Supplemental Draft EIS considers two cooling technology alternatives with groundwater as the back-up water supply. Groundwater would be produced from the Veblen Aquifer. Both alternatives would use surface water from Big Stone Lake as the primary water source. Alternative 2 (wet cooling with groundwater back-up water supply), the Revised Proposed Action, retains the original wet cooling system technology identified in the Draft EIS but uses groundwater supply as its back-up water supply. Alternative 3 (wet/dry cooling with groundwater back-up water supply) would use a combined wet/dry cooling system. The dry portion would use an air-cooled condenser as a heat transfer mechanism and the wet portion of the system would be used in parallel to the dry system, as needed, to achieve full unit output on warmer days. Both alternatives would require installation of groundwater production wells and a pipeline system to convey groundwater to the proposed plant site. Other changes described in the Supplemental Draft EIS include plant water usage, water treatment, and wastewater management. There are no other significant changes to the Proposed Action as described in Section 2.2 of the Draft EIS. The Supplemental Draft EIS evaluates the environmental impacts of the proposed Project on air quality, water resources (groundwater, floodplains, surface water), geology, minerals, paleontological resources, soils, biological resources (vegetation, wildlife, fisheries, special status species, wetland/riparian areas), cultural and historical resources, land use (land use planning, public facilities, recreation, agricultural practices and prime and unique farmland), infrastructure, public health, waste management, visual resources, noise, social and economic values, environmental justice, and cumulative impacts. Western maintains a mailing list of those interested in the Big Stone II Project EIS. Copies of the complete Supplemental Draft EIS or the Executive Summary have been distributed to all persons and groups on the mailing list that requested a copy. A distribution has been made to various libraries in the proposed Project area. Oral comments on the Supplemental Draft EIS will be accepted only during the public hearing scheduled for the date and location provided above. Those wishing to make oral comments may do so at the scheduled public hearing. Speakers will be asked to register at the door prior to the beginning of the hearing. Speakers are encouraged to provide a written version of their oral comments for the record. Each speaker will be allowed 5 minutes to present comments unless more time is requested and available. Comments will be recorded by a court reporter at the hearing and will become part of the public hearing record. Western will conduct an open house information session 2 hours prior to the public hearing to field questions and provide information to the public. Copies of the Supplemental Draft EIS are available for public review at the offices and public libraries listed below: Public Libraries Ortonville Public Library, 412 Second Street Northwest, Ortonville, Minnesota. Morris Public Library, 102 East 6th Street, Morris, Minnesota. Granite Falls Public Library, 155 7th Avenue, Granite Falls, Minnesota. Appleton Public Library, 322 W. Schlieman Avenue, Appleton, Minnesota. Canby Public Library, 110 Oscar Avenue North, Canby, Minnesota. Willmar Public Library, 410 5th Street Southwest, Willmar, Minnesota. Kerkhoven Public Library, 208 10th Street North, Kerkhoven, Minnesota. Benson Public Library, 200 13th Street South, Benson, Minnesota. Grant County Public Library, 207 Park Avenue East, Milbank, South Dakota. Watertown Regional Library, 611 Bruhn Avenue NE., Watertown, South Dakota. The Draft EIS is also available at DOE Reading Rooms at the following addresses: U.S. Department of Energy, Forrestal Building, Reading Room 1E-190, 1000 Independence Avenue, SW., Washington, DC 20585; Western Area Power Administration, Corporate Services Office, 12155 West Alameda Parkway, Lakewood, Colorado 80228; and Western Area Power Administration, Upper Great Plains Customer Service Region, South Dakota Maintenance Office, 200 4th Street, SW., Huron, South Dakota 57350. Western will consider all written comments postmarked or received during the public comment period in preparing the Final EIS. Decisions by each of the involved Federal agencies will be made after considering comments on the Draft, Supplemental Draft, and Final EIS. The decisions to be made by Western, RUS, and USACE regarding the proposed Big Stone II Power Plant and Transmission Project will be issued following the Final EIS in the form of separate records of decision for each agency. Dated: October 19, 2007. Timothy J. Meeks, Administrator. [FR Doc. E7-21088 Filed 10-25-07; 8:45 am] BILLING CODE 6450-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8487-8] Science Advisory Board Staff Office; Request for Additional Expertise for the Science Advisory Board Asbestos Expert Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board

(SAB)Staff Office is seeking public nominations of additional experts in the formation of the Asbestos Expert Panel in the areas of biostatistics, statistical modeling, epidemiology, meta-analysis, Bayesian analysis and toxicology of inhaled particles. Previous nominations of individuals for this asbestos panel need not be re-submitted, as they will still be considered. DATES: New nominations should be submitted by November 16, 2007. FOR FURTHER INFORMATION CONTACT: Members of the public who wish to obtain further information regarding this announcement may contact Ms. Vivian Turner, Designated Federal Officer, by telephone:

(202)343-9697 or e-mail at: *turner.vivian@epa.gov.* The SAB Mailing address is: U.S. EPA Science Advisory Board (1400F), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460. General information about the SAB as well as any updates concerning this request for nominations may be found on the SAB Web site at: *http://www.epa.gov/sab.* SUPPLEMENTARY INFORMATION: EPA's Office of Solid Waste and Emergency Response (OSWER) requested the Science Advisory Board

(SAB)provide technical advice on the proposed methodology to estimate cancer potency from inhalation exposure to asbestos. In 71 FR 48926-48927, the SAB announced the formation of an Asbestos Expert Panel and solicited nominations for members to that Panel. In response to that **Federal Register** Notice, the SAB Staff Office received nominations in the areas of clinical and pulmonary medicine, epidemiology, occupational and public health, pathology, inhalation toxicology; biology, mineralogy; environmental fate and transport, environmental sampling and detection methods, biostatistics, statistical modeling and risk assessment. The Science Advisory Board Staff Office is now seeking additional nominations for nationally and internationally recognized non-EPA scientists who have expert knowledge in biostatistics, statistical modeling, epidemiology, meta-analysis, Bayesian analysis and toxicology of inhaled particles. The SAB is a chartered Federal Advisory Committee, established by 42 U.S.C. 4365, to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical bases for EPA policies and actions. The SAB expert panel will provide technical advice to EPA through the chartered SAB. The SAB Asbestos Panel will comply with the provisions of the Federal Advisory Committee Act

(FACA)and all appropriate SAB procedural policies. *Request for Nominations:* The SAB Staff Office is requesting nominations for nationally and internationally recognized non-EPA scientists with demonstrated expertise in biostatistics, statistical modeling, epidemiology, meta-analysis, Bayesian analysis and toxicology of inhaled particles. The previously submitted nominations of individuals for this Asbestos Expert Panel need not be re-submitted, as they will still be considered. *Process and Deadline for Submitting Nominations:* Any interested person or organization may nominate individuals qualified in the areas of expertise described above to serve on the SAB Asbestos Expert Panel. Nominations may be submitted in electronic format through the *Form for Nominating Individuals to Panels of the EPA Science Advisory Board* which can be accessed through a link on the blue navigational bar on the SAB Web site at: *http://www.epa.gov/sab.* Please follow the instructions for submitting nominations carefully, and include all of the information requested on that form. The nominating form requests contact information of the person making the nomination; contact information for the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's curriculum vita; and a biographical sketch of the nominee indicating current position, educational background, research activities, and recent service on other national advisory committees or national professional organizations. Anyone unable to submit nominations using the electronic form, or who may have questions concerning the nomination process or any other aspect of this notice may contact Ms. Vivian Turner, DFO, at the contact information. Nominations should be submitted in time to arrive no later than November 16, 2007. The process for forming an SAB panel is described in the *Overview of the Panel Formation Process at the Environmental Protection Agency, Science Advisory Board* (EPA-SAB-EC-COM-02-010), on the SAB Web site at: *http://www.epa.gov/sab/pdf/ec02010.pdf.* The SAB Staff Office will acknowledge receipt of nominations and inform nominees of the panel for which they have been nominated. From the nominees identified by respondents to this **Federal Register** notice (termed the “Widecast”), the SAB Staff Office will develop a smaller subset (known as the “Short List”) for more detailed consideration. The Short List will be posted on the SAB Web site at: *http://www.epa.gov/sab* and will include the nominee's name and biographical sketch. Public comments on the Short List will be accepted for 21 calendar days. During this comment period, the public will be requested to provide information, analysis or other documentation on nominees that the SAB Staff Office should consider in evaluating candidates for the panel. For the SAB, a balanced panel is characterized by inclusion of nominees who possess the necessary domains of knowledge, the relevant scientific perspectives (which, among other factors, can be influenced by work history and affiliation), and the collective breadth of experience to adequately address the charge. Public responses to the Short List will be considered in the selection of the panel members, along with information provided by nominees and information independently gathered by SAB Staff (e.g., financial disclosure information and computer searches to evaluate a nominee's prior involvement with the topic under review). Specific criteria to be used in evaluating Short List nominees include:

(a)Scientific and/or technical expertise, knowledge, and experience (primary factors);

(b)absence of financial conflicts of interest;

(c)scientific credibility and impartiality;

(d)availability and willingness to serve; and

(e)ability to work constructively and effectively on committees. Dated: October 19, 2007. Anthony F. Maciorowski, Deputy Director, EPA Science Advisory Board Staff Office. [FR Doc. E7-21092 Filed 10-25-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL6692-4] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167. An explanation of the ratings assigned to draft environmental impact statements

(EISs)was published in FR dated April 6, 2007 (72 FR 17156). Draft EISs *EIS No. 20070285, ERP No. D-COE-K35044-CA* , Berth 136-147 [TraPac] Container Terminal Project, Upgrade Existing Wharf Facilities, Install a Buffer Area between the Terminal and Community, US Army COE Section 10 and 404 Permit, West Basin Portion of the Port of Los Angeles, CA. *Summary:* EPA expressed environmental concerns because the preferred alternative may not represent the least environmentally damaging practicable alternative, as required under the Clean Water Act Section 404(b)(1) Guidelines. EPA also expressed environmental concerns about impacts to air quality and minority and low-income communities, and requested that the Final EIS discuss mitigation in more detail. Rating EC2. *EIS No. 20070296, ERP No. D-AFS-K65332-CA* , Eldorado National Forest Public Wheeled Motorized Travel Management Project, Proposes to Regulate Unmanaged Public Wheeled Motor Vehicle, Implementation, Alpine, Amador, El Dorado and Placer Counties, CA. *Summary:* EPA expressed environmental concerns about impacts to water quality, meadows, riparian areas, critical habitat, and watersheds, and requested additional information on the above issues, monitoring and enforcement commitments. Rating EC2. *EIS No. 20070297, ERP No. D-AFS-J65486-UT* , Big Creek Vegetation Treatment Project, To Treat 4,800 Acres of Aspen Conifer and Sagebrush Communities, Ogden Ranger District, Wasatch-Cache National Forest, Rich County, UT. *Summary:* While EPA does not object to the proposed action, it requested clarification of impacts to migratory birds, regeneration of big sagebrush, and mitigation of impacts from illegal ORV use. Rating LO. *EIS No. 20070315, ERP No. D-NOA-L91029-AK* , Alaska Eskimo Whaling Commission for a Subsistence Hunt on Bowhead Whale for the Years 2008 through 2012 for Issuing Annual Quotas, Proposes to Authorize Subsistence Harvests of the Western Arctic Stock of Bowhead Whales, Bering, Chukchi and Beaufort Seas, AK. *Summary:* While EPA does not object to the proposed action, it requested clarification on the exchange of non-food portions of the whales between native villages as a commodity. Rating LO . *EIS No. 20070365, ERP No. D-USA-A15000-00* , PROGRAMMATIC—Army Growth and Force Structure Realignment, Implementation, Nationwide. *Summary:* EPA does not object to the proposed action. Rating LO. *EIS No. 20070393, ERP No. DS-AFS-J65424-MT* , Fishtrap Project, Updated Information on Past Maintenance/Restorative Treatments within Old Growth Stands, 200 Timber Harvest, Prescribed Burning, Road Construction and Other Restoration Activities, Lolo National Forest, Plains/Thompson Falls Ranger District, Sanders County, MT. *Summary:* EPA does not object to the proposed action. Rating LO. Final EISs *EIS No. 20070260, ERP No. F-COE-K36142-CA* , PROGRAMMATIC—San Luis Obispo Creek Watershed, Waterway Management Plan, Stream Maintenance and Management Plan, City of San Luis Obispo and County of San Luis Obispo, Community of Avila Beach, San Luis Obispo County, CA. *Summary:* EPA's previous issues have been resolved; therefore, EPA does not object to the proposed action. *EIS No. 20070292, ERP No. F-COE-K36055-CA* , San Luis Rey Flood Control Project, Operation and Maintenance of the Vegetation and Sediment Management, from College Blvd to the Pacific Ocean, San Diego County, CA. *Summary:* EPA continues to have environmental concerns because the preferred alternative may not represent the least environmentally damaging practicable alternative, as required under the Clean Water Act section 404(b)(1) Guidelines. *EIS No. 20070318, ERP No. F-FHW-K40257-CA* , Los Banos Bypass Project, Construct from CA-152 in Merced County beginning near Volta Road west to Los Banos, bypassing Los Banos, ending near the Santa Fe Grade Road, U.S. Army COE Section 404 Permit, Merced County, CA. *Summary:* EPA continues to have environmental concerns about the proposed project related to induced growth. Also, EPA recommends that the project sponsor develop a strategy to facilitate protection of valuable habitat areas. *EIS No. 20070379, ERP No. F-AFS-L65525-AK* , Baht Timber Sale Project, Proposes to Harvest Timber and Temporary Road Construction on Zarembo Island, Wrangell Ranger District, Tongass National Forest, AK. *Summary:* EPA continues to have concerns about potential impacts to water quality and impacts to old growth habitat, and recommends water quality monitoring, preservation of riparian buffers and reduced new road construction. *EIS No. 20070402, ERP No. F-FRC-K03030-00* , Phoenix Expansion Project, Construction and Operation of Existing Natural Gas Transmission Pipeline, Right-of-Way Grant and Temporary Use Permit, San Juan and McKinley Counties, NM and Pinal and Maricopa Counties, AZ. *Summary:* No formal comment letter was sent to the preparing agency. *EIS No. 20070058, ERP No. FA-FHW-E40325-NC* , Western Section of the Winston-Salem Northern Beltway, Updated Information, U.S. 158 north to U.S. 52, TIP Project No. R-2247, Forsyth County, NC. (THIS EIS #20070058 AND EIS #20070057 ARE COMBINED IN A SINGLE DOCUMENT.) *Summary:* EPA continues to have environmental concerns about the large bypass regarding 7-8 linear miles of stream impacts, sedimentation and erosion control, terrestrial forest habitat losses and impacts to migratory birds. EPA requests that the Record of Decision disclose plans to mitigate these adverse impacts. *EIS No. 20070384, ERP No. FS-FHW-E40714-GA* , U.S. 411 Connector, From U.S. 411/GA-20 Interchange with U.S. 41 to U.S. 411 Interchange with I-75, Updated Information, Funding and U.S. Army COE Section 404 Permit, Bartow County, GA. *Summary:* EPA continues to have environmental concerns about the preferred alternative regarding impacts to jurisdictional wetlands, regulatory floodplains, and the loss of upland forest habitat. However, EPA supports the mitigation measures and monitoring programs as described in the Final Supplemental EIS. Dated: October 23, 2007. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E7-21089 Filed 10-25-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6692-3] Environmental Impacts Statements; Notice of Availability *Responsible Agency:* Office of Federal Activities, General Information

(202)564-7167 or *http://www.epa.gov/compliance/nepa/.* Weekly receipt of Environmental Impact Statements Filed 10/15/2007 through 10/19/2007. Pursuant to 40 CFR 1506.9. *EIS No. 20070435, Draft EIS, BLM, UT,* Richfield Field Office Resource Management Plan, Implementation, Future Management of the Public Lands and Resource, Glen Canyon National Recreation Area, Capitol Reef and Canyonlands National Parks, Sanpete, Sevier, Piute, Wayne and Garfield Counties, UT. *Comment Period Ends:* 01/24/2008. *Contact:* Wayne Wetzel, 435-896-1500. *EIS No. 20070436, Draft EIS, FHW, ME,* Wiscasset Route 1 Corridor Study Project, To Relieve Traffic Congestion and Improve Safety, U.S. Army COE section 404 Permit, Wiscasset and Edgecomb Counties, ME. *Comment Period Ends:* 12/21/2007. *Contact:* Mark Asselmann, 207622-8350. *EIS No. 20070437, Draft EIS, NPS, HI,* PROGRAMMATIC EIS—Ala Kahakai National Historic Trail Comprehensive Management Plan, To Provide Long-Term Direction for Natural and Cultural Resource, Island of Hawii, HI. *Comment Period Ends:* 12/26/2007. *Contact:* Aric Arakaki 808-326-6012. *EIS No. 20070438, Final Supplement, NOA, NC,* Atlantic Sea Scallop Fishery Management Plan (FMP), Amendment 11, Implementation to Control Capacity and Mortality in the General Category Scallop Fishery, Gulf of Maine, Georges Bank, NC. *Wait Period Ends:* 11/26/2007. *Contact:* Patricia A. Kurkal, 978-281-9250. *EIS No. 20070439, Draft EIS, BOP, AL,* Aliceville, Alabama Area, Proposed Federal Correctional Complex, To Address the Growing Federal Inmate Population, Pickens County, AL. *Comment Period Ends:* 12/10/2007. *Contact:* Pamela J. Candler, 202-514-6470. *EIS No. 20070440, Draft EIS, FHW, UT,* Mountain View Corridor

(MVC)Project, Proposed Transportation Improvement 2030 Travel Demand in Western Salt Lake County south of I-80 and west of Bangerter Highway and in northwestern Utah County of I-15, south of the Salt Lake County Line, and north of Utah Lake, Salt Lake and Utah County, UT. *Comment Period Ends:* 12/24/2007. *Contact:* Edward Woolford, P.E. 801-963-0182. *EIS No. 20070441, Draft Supplement, IBR, CA,* PROGRAMMATIC—Environmental Water Account

(EWA)Project, Updated Information to Provide an Evaluation of 2004 Final EIS/EIR Environmental Water Account

(EWA)and Effects Associated with Extending the Current EWA's through 2011, CALFED Bay-Delta Programs, Endangered Species Act section 7 and U.S. Army COE Section 10 Permit, CA. *Comment Period Ends:* 12/10/2007. *Contact:* Ms. Sammie Cervantes, 916-978-5104. *EIS No. 20070442, Final EIS, FHW, CA,* Interstate 5/Cosumnes River Boulevard Interchange Project, Extension of Cosumnes River Boulevard from Franklin Boulevard to Freeport Boulevard with an Interchange at Interstate 5, South of the Pocket/Meadowview Road Interchange and North of the Laguna Boulevard Interchange, City of Sacramento, Sacramento County, CA. *Wait Period Ends:* 11/26/2007. *Contact:* Cesar E. Perez, 916-498-5065. *EIS No. 20070443, Draft Supplement, FTA, CA,* Third Street Light Rail Phase 2, Updated Information on the Central Subway Project Area, Funding, San Francisco Municipal Transportation Agency, in the City and County San Francisco, CA. *Comment Period Ends:* 12/10/2007. *Contact:* Ray Sukys, 415-744-3133. *EIS No. 20070444, Final EIS, USA, GA,* Fort Benning U.S. Army Infantry Center, Base Realignment and Closure

(BRAC)2005 and Transformation Actions, Implementation, Chattahoochee and Muscogee Counties, GA. *Wait Period Ends:* 11/26/2007. *Contact:* John Brent, 706-545-2180. *EIS No. 20070445, Draft EIS, USN, 00,* Shock Trail of the MESA VERDE (LPD 19), San Antonio (LPD 17) Class Ship designated as the Shock Ship for Proposed Shock Trail, Possible Offshore Locations are Naval Station Norfolk, VA; Naval Station Mayport, FL; and Naval Air Station Pensacola, FL. *Comment Period Ends:* 12/10/2007. *Contact:* Donald Shaver, 703-412-7521. *EIS No. 20070446, Final EIS, FHW, IN,* I-69 Evansville to Indianapolis Project, I-69 Tier 2 Section 1: Evansville to Oakland City, from 1-64 to IN-64, Preferred Alternative is 4, Gibson and Warrick Counties, IN. *Wait Period Ends:* 11/26/2007. *Contact:* Anthony DeSimone, 317-226-5307. *EIS No. 20070447, Draft EIS, FHW, CA,* Marin-Sonoma Narrows

(MSN)HOV Widening Project, Propose to Relieve Recurrent Congestion along U.S. 101 south of the Route 37 Interchange in the City of Novato (Marin County) and ends north of the Corona Road Overcrossing in the City of Petaluma (Sonoma County), Marin and Sonoma Counties, CA. *Comment Period Ends:* 12/14/2007. *Contact:* Cesar E. Perez, 916-498-5065. *EIS No. 20070448, Final EIS, USA, 00,* PROGRAMMATIC—Army Growth and Force Structure Realignment, Implementation, Nationwide. *Wait Period Ends:* 11/26/2007. *Contact:* Mike Ackerman, 410-436-2522. *EIS No. 20070449, Final EIS, BLM, ID,* Smoky Canyon Mine Panels F & G, Proposed Mine Expansion, Caribou County, ID. *Wait Period Ends:* 11/26/2007. *Contact:* Bill Stout 208-478-6367. *EIS No. 20070450, Draft Supplement, WPA, 00,* Big Stone II Power Plant and Transmission Project, Addresses the Impacts of Changes to the Proposed Action relative to Cooling Alternatives and the Use of Groundwater as Backup Water Source, U.S. Army COE Section 10 and 404 Permits, Grant County, SD and Big Stone County, MN. *Comment Period Ends:* 12/10/2007. *Contact:* Nancy Werdel, 720-962-7251. *EIS No. 20070451, Draft EIS, AFS, UT,* Indian Springs Road Realignment, Reducing Adverse Impacts to Watershed and Fisheries, U.S. Army COE Section 404 Permit, Uinta National Forest, Heber Ranger District, Wasatch County, UT. *Comment Period Ends:* 12/10/2007. *Contact:* Jim Percy, 435-654-0470. Dated: October 23, 2007. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E7-21102 Filed 10-25-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [Docket# EPA-RO4-SFUND-2007-1052; FRL-8487-9] B&B Manufacturing Superfund Site; Mobile, Mobile County, AL; Notice of Settlements AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of settlements. SUMMARY: Under Section 122(h) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency has entered into three separate settlements for reimbursement of past response costs concerning the B&B Manufacturing Superfund Site located in Mobile, Mobile County, Alabama. DATES: The Agency will consider public comments on the settlements until November 26, 2007. The Agency will consider all comments received and may modify or withdraw its consent to the settlements if comments received disclose facts or considerations which indicate that the settlements are inappropriate, improper, or inadequate. ADDRESSES: Copies of the settlements are available from Ms. Paula V. Batchelor. Submit your comments, identified by Docket ID No. EPA-RO4-SFUND-2007-1052 or Site name B&B Manufacturing Superfund Site by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: Batchelor.Paula@epa.gov.* • *Fax:* 404/562-8842/Attn: Paula V. Batchelor. *Mail:* Ms. Paula V. Batchelor, U.S. EPA Region 4, SD-SEIMB, 61 Forsyth Street, SW., Atlanta, Georgia 30303. “In addition, please mail a copy of your comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW., Washington, DC 20503. *Instructions:* Direct your comments to Docket ID No. EPA-RO4-SFUND-2007-1052. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the U.S. EPA Region 4 office located at 61 Forsyth Street, SW., Atlanta, Georgia 30303. Regional office is open from 7 a.m. until 6:30 p.m. Monday through Friday, excluding legal holidays. Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication. FOR FURTHER INFORMATION CONTACT: Paula V. Batchelor at 404/562-8887. Dated: October 11, 2007. Rosalind H. Brown, Chief, Superfund Enforcement & Information Management Branch, Superfund Division. [FR Doc. E7-21094 Filed 10-25-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board Through an Expedited Review Procedure AGENCY: Department of Health and Human Services, Office of the Secretary. ACTION: Notice. SUMMARY: The Office for Human Research Protections

(OHRP)is requesting written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board

(IRB)through an expedited review procedure, last published in the **Federal Register** on November 9, 1998 (63 FR 60364). On that date, the Office for Protection from Research Risks (OPRR), now OHRP, and the Food and Drug Administration

(FDA)simultaneously published identical lists of categories of research activities involving human subjects which may be reviewed by the IRB through an expedited review procedure. It has come to OHRP's attention that there has been confusion in the research community about expedited review category 5. OHRP is proposing to amend expedited review category 5 to clarify that the category includes research involving materials that were previously collected for either nonresearch or research purposes, provided that any materials collected for research were not collected for the currently proposed research. Expedited review category 5 also includes research involving materials that will be collected solely for nonresearch purposes. In addition, OHRP is requesting comments on the entire expedited review list that was last published in the **Federal Register** on November 9, 1998 (63 FR 60364) to determine if other changes are needed. As part of its charge to provide expert advice and recommendations to the Secretary of Health and Human Services (the Secretary) and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects, the Secretary's Advisory Committee on Human Research Protections (SACHRP), through its Subcommittee on Subpart A, considered whether the current expedited review categories should be modified. On March 14, 2007, SACHRP submitted recommendations regarding expedited review to the Secretary, and on June 18, 2007, the Secretary sent a letter to the SACHRP chairperson, stating that HHS would give serious consideration to these recommendations. In regard to the current expedited review categories, SACHRP recommended that expedited review category 7 should be revised as described in Section V below. Therefore, in addition to requesting comments on the entire expedited review list that was published in the **Federal Register** on November 9, 1998 (63 FR 60364), OHRP is also specifically requesting comments on SACHRP's recommended revision of expedited review category 7. As required under 21 CFR 56.110(a), FDA also will publish in the **Federal Register** a list of categories of research that may be reviewed by the IRB through an expedited review procedure. FDA intends to issue the list concurrently with OHRP's issuance of its final notice, and in compliance with 21 CFR 10.115 (good guidance practice regulations). This approach maintains FDA's practice of moving in tandem on this issue with OHRP. DATES: Submit written or electronic comments by December 26, 2007. ADDRESSES: Submit written comments to EXPEDITED REVIEW, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to *expeditedreviewohrp@hhs.gov* , or via facsimile at 301-402-2071. Comments received within the comment period, including any personal information provided, will be made available to the public upon request. FOR FURTHER INFORMATION CONTACT: Mr. Glen Drew, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 1-866-447-4777 or by e-mail to: *glen.drew@hhs.gov.* SUPPLEMENTARY INFORMATION: I. Expedited Review Procedures The Department of Health and Human Services

(HHS)human subjects protection regulations at 45 CFR 46.110 permit expedited review procedures for certain kinds of human subjects research that have been found by an IRB to involve no more than minimal risk to research subjects, or for minor changes in previously IRB-approved research during the period (of one year or less) for which approval is authorized. An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB, in accordance with the requirements at 45 CFR 46.110. The HHS regulations at 45 CFR 46.110 also give the Secretary the authority to amend and republish the list of research categories that may be reviewed by the IRB through an expedited review procedure, after consultation with other departments and agencies. This same section of the HHS regulations also requires that an amended expedited review list be published by the Secretary in the **Federal Register** . As required by HHS regulations at 45 CFR 46.110, this proposed amendment of expedited review category 5 was developed after consulting with the other Federal departments and agencies that have promulgated the Federal Policy for the Protection of Human Subjects. II. Background on the Expedited Review List The first expedited review list was published by the Secretary in 1981 (46 FR 8392). On November 10, 1997, OPRR, now OHRP, and FDA published identical proposed revisions to the 1981 expedited review list (published for OPRR at 62 FR 60607). The category of research in question, expedited review category 5, was addressed in the proposed categories 4 and 5 in the November 10, 1997 **Federal Register** Notices requesting public comment. In those Notices, proposed categories 4 and 5 were presented as follows:

(4)Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens) where these materials, in their entirety, have been collected prior to the research, for a purpose other than the proposed research.

(5)Research involving solely

(a)prospectively collected identifiable residual or discarded specimens, or

(b)prospectively collected identifiable data, documents, or records, where

(a)or

(b)has been generated for nonresearch purposes. In addition, a chart included in OPRR's and FDA's November 10, 1997 **Federal Register** Notices, comparing the proposed expedited review list with the 1981 list, indicated that the proposed category 4 (see above) was intended to replace expedited review category 8 on the 1981 list. Category 8 on the 1981 list stated, “the study of existing data, documents, records, pathological specimens, or diagnostic specimens.” The comments received on OPRR's and FDA's November 10, 1997 **Federal Register** Notices overwhelmingly supported the proposed revision to the expedited review list. With minor modifications to the 1997 proposed expedited review list, on November 9, 1998, OPRR and FDA simultaneously published identical revised lists of categories of research activities that may be reviewed by the IRB through the expedited review procedure (published for OPRR at 63 FR 60364, and for FDA at 63 FR 60353). In regard to expedited review category 5, the OPRR and FDA November 9, 1998 **Federal Register** Notices described this category of research as:

(5)Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) The preamble of the OPRR November 9, 1998 **Federal Register** Notice explained that: Categories four

(4)and five

(5)on the proposed list have been combined into one new category five

(5)on the 1998 list. This new section is added in response to comments that raised questions about the relationship of proposed categories four

(4)and five

(5)to exempt research and about separating out existing and prospectively collected materials. The term “nonresearch purposes” was maintained in new category five

(5)to describe the origins of the research material * * * Similarly, the FDA November 9, 1998 **Federal Register** Notice explained that: Categories four and five on the proposed list have been combined into one new category, category five, addressing research involving materials collected or which will be collected solely for nonresearch purposes. This new category five was formed in response to comments that raised questions about why the two categories separated out existing and prospectively collected materials. The term “nonresearch purposes” was maintained in new category five to describe the origins of the research materials. III. Clarification on the Scope of Expedited Review Category Five

(5)Needed The description of expedited review category 5 and the preamble language as published in the November 9, 1998 OPRR and FDA **Federal Register** Notices has caused confusion in the research community about whether this expedited review category includes research involving materials that were originally collected for either nonresearch or research purposes, or is limited to research involving materials that were originally collected solely for nonresearch purposes. As evidence of this confusion, in their 1999 report, *Research Involving Human Biological Materials: Ethical Issues and Policy Guidance,* the National Bioethics Advisory Commission

(NBAC)stated: NBAC finds that there is no need to distinguish between collections originally created for clinical purposes and those created for research purposes. In both cases, research on the collected materials should be eligible for expedited review if the research presents no more than a minimal risk to the study subjects. As a result of this finding, NBAC recommended that “OPRR should revise its guidance to make clear that all minimal-risk research involving human biological materials—regardless of how they were collected—should be eligible for expedited IRB review.” In response to NBAC's 1999 report, HHS convened a multi-agency Working Group to analyze the appropriateness, feasibility, and practical implications of implementing NBAC's recommendations and to develop a set of proposed HHS activities to enhance the protection of human subjects in research involving human biological materials. In regard to the NBAC recommendation above, the HHS Working Group stated: The Working Group concurs with Recommendation 2 and agrees with NBAC that, for purposes of determining eligibility for expedited IRB review, it is not necessary to draw a distinction between samples originally collected for clinical purposes and those obtained for research purposes. The Working Group also agrees with NBAC's observation that current guidance regarding the types of research that IRBs may review through expedited procedures (63 FR 60364 [HHS] and 60353 [FDA], November 9, 1998) appears to exclude research utilizing existing specimens previously collected for research purposes. It is the understanding of the Working Group that this apparent exclusion is not intentional but rather resulted from a copy editing oversight * * * IV. OHRP Assessment After reviewing OPRR's and FDA's 1997 and 1998 **Federal Register** notices concerning revisions to the 1981 expedited review list, NBAC's recommendation, and the HHS Working Group's response, OHRP has concluded that expedited review category 5 was intended to, and should, include research involving existing information or specimens that were previously collected for *nonresearch* purposes, as well as research involving existing information or specimens that were previously collected for *research* purposes—provided they were not collected for the currently proposed research. OHRP notes that neither OPRR's nor FDA's November 10, 1997 **Federal Register** Notice indicated that the proposed expedited review category 4 was intended to narrow category 8 on the 1981 list to exclude existing specimens that were collected for research purposes, provided the materials were collected for a research purpose other than the proposed research. Because proposed category 4 would have applied to research involving existing identifiable information or specimens that had been previously collected for *either research or nonresearch purposes,* provided they were not collected for the currently proposed research, OHRP has concluded that the term “nonresearch purposes” was retained in the final version of category 5 to describe the origins of the prospectively collected material only, not the origins of the previously collected material. However, this intent was not made clear in either OPRR's or FDA's November 9, 1998 **Federal Register** Notice. V. OHRP Request for Comments For the reasons described in Section IV, OHRP is proposing to revise expedited review category 5 as set forth below. Remove

(5)in its entirety, and add, in its place:

(5)Research involving materials (data, documents, records, or specimens) that

(a)have previously been collected for nonresearch purposes;

(b)have previously been collected for research purposes, provided the materials were not collected for the currently proposed research; or

(c)will be collected solely for nonresearch purposes. Note: Some research under section

(a)or

(b)of this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt. OHRP is also requesting comments on the entire expedited review list that was last published in the **Federal Register** on November 9, 1998 (63 FR 60364) to determine if other changes are needed. The following is the current expedited review list, as published in the **Federal Register** on November 9, 1998:

(1)Clinical studies of drugs and medical devices only when condition

(a)or

(b)is met.

(a)Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(b)Research on medical devices for which

(i)an investigational device exemption application (21 CFR Part 812) is not required; or

(ii)the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

(2)Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a)from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b)from other adults and children, 2 considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

(3)Prospective collection of biological specimens for research purposes by noninvasive means. *Examples:*

(a)Hair and nail clippings in a nondisfiguring manner;

(b)deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;

(c)permanent teeth if routine patient care indicates a need for extraction;

(d)excreta and external secretions (including sweat);

(e)uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;

(f)placenta removed at delivery;

(g)amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;

(h)supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

(i)mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

(j)sputum collected after saline mist nebulization.

(4)Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) *Examples:*

(a)Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy;

(b)weighing or testing sensory acuity;

(c)magnetic resonance imaging;

(d)electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;

(e)moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(5)Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

(6)Collection of data from voice, video, digital, or image recordings made for research purposes.

(7)Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

(8)Continuing review of research previously approved by the convened IRB as follows:

(a)Where

(i)the research is permanently closed to the enrollment of new subjects;

(ii)all subjects have completed all research-related interventions; and

(iii)the research remains active only for long-term follow-up of subjects; or

(b)where no subjects have been enrolled and no additional risks have been identified; or

(c)where the remaining research activities are limited to data analysis.

(9)Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two

(2)through eight

(8)do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. In addition to requesting comments on all of the expedited review categories listed above, OHRP specifically requests comments on a recommendation by SACHRP to revise expedited review category 7 as follows: Research

(a)on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, affective states, interpersonal relationships, identity, language, communication, cultural beliefs or practices, and social behavior); or

(b)employing methods commonly used in social, behavioral, epidemiologic, health services and educational research (including, but not limited to, survey, interview, oral history, participant observation, ethnographic, focus group, program evaluation, human factors evaluation, or quality assurance methods). (Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) Dated: October 22, 2007. Ivor A. Pritchard, Acting Director, Office for Human Research Protections. [FR Doc. E7-21126 Filed 10-25-07; 8:45 am] BILLING CODE 4150-36-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH-091] Notice of Public Meeting AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention

(CDC)announces the following meeting on updating the NIOSH publication “Occupational Exposure Sampling Strategies Manual”. The document can be found at *http://www.cdc.gov/niosh/docs/77-173/* . Instructions are provided for submitting comments. *Public Meeting Dates and Times:* November 8, 2007, 8:30 a.m. to 4:30 p.m. EST and November 9, 2007, 8:30 a.m. to 12 p.m. EST. *Place:* Washington Court Hotel, 525 New Jersey Avenue, NW., Washington, DC 20001. *Purpose of Meeting:* To obtain input from stakeholders on their needs for information and guidance to be included in a revision of the “Occupational Exposure Sampling Strategies Manual” (OESSM), which is sometimes referred to as “Leidel, Busch and Lynch” or “The NIOSH Yellow Book” [ *http://www.cdc.gov/niosh/77-173.html* ]. *Status:* The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. Persons wanting to attend and contribute comments at the meeting are requested to register at *http://www.team-psa.com/niosh-OESSM07/home.asp* no later than November 1, 2007. Unreserved walk-in attendees will be accommodated on the day of the meeting if space is available. The meeting has several scheduled presentations and panels that will include time for questions and answers. In addition, two breakout sessions will be held to solicit discussion and input on specific occupational exposure issues. Presentations, questions, and oral comments given at the meeting will be recorded and included in the docket. Written comments will also be accepted at the meeting. Written comments may also be submitted to Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091 and must be submitted by November 30, 2007 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-091. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, relevant to the current practice, limitations, and needs for development of occupational exposure assessment practices and policies. NIOSH will use this information to assess the needs and scientific basis for revisions to its guidance and recommendations in occupational exposure assessment. *Contact Person for Technical Information:* Paul Middendorf, telephone (513)533-8606, M/S C-9, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226. *Contact Person for Submitting Comments/Meeting Attendance:* Diane Miller, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone 513/533-8611. All material submitted to the Agency should reference docket number NIOSH-091. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Dated: October 18, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-21078 Filed 10-25-07; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-2088-92 and CMS-10244] Agency Information Collection Activities: Submission for OMB Review; Comment Request *Agency:* Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

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

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension without change of a currently approved collection; *Title of Information Collection:* Outpatient Rehabilitation Provider Cost Report; *Use:* In accordance with sections 1815(a), 1833(e) and 1861(v)(1)(A)(ii) of the Social Security Act, providers of service in the Medicare program are required to submit annual information to achieve reimbursement for health care services rendered to Medicare beneficiaries. Section 42 CFR 413.20(b) requires that cost reports be required from providers on an annual basis. Such cost reports are required to be filed with the provider's fiscal intermediary. The CMS 2088-92 cost report is needed to determine the amount of reimbursable cost that is due these providers for furnishing medical services to Medicare beneficiaries. *Form Number:* CMS-2088-92 (OMB#: 0938-0037); *Frequency:* Reporting—Yearly; *Affected Public:* Business or other for-profits and Not-for-profit institutions; *Number of Respondents:* 623; *Total Annual Responses:* 623; *Total Annual Hours:* 62,300. 2. *Type of Information Collection Request:* New Collection; * Title of Information Collection: * Medicaid State Program Integrity Assessment (SPIA); *Use:* Under the provisions of the Deficit Reduction Act

(DRA)of 2005, Congress directed CMS to establish the Medicaid Integrity Program (MIP), CMS' first national strategy to combat Medicaid fraud, waste, and abuse. CMS has two broad responsibilities under the MIP:

(1)Reviewing the actions of individuals or entities providing services or furnishing items under Medicaid; conducting audits of claims submitted for payment; identifying overpayments; and educating providers and others on payment integrity and quality of care; and

(2)Providing effective support and assistance to States to combat Medicaid fraud, waste, and abuse. In order to fulfill the second of these requirements, CMS plans to develop a Medicaid State Program Integrity Assessment

(SPIA)system. CMS is seeking approval from the Office of Management and Budget

(OMB)to collect information from the States on an annual basis for input into a national SPIA system. Through the SPIA system, CMS will identify current Medicaid program integrity

(PI)information, develop profiles for each State based on these data, determine areas to provide States with technical support and assistance, and use the data to develop performance measures to assess States' performance in an ongoing manner. Based on comments received during the 60-day comment period, we revised the supporting statement timeline and the instrument (Appendix B). In addition, we added a draft MIP glossary (Appendix C); *Form Number:* CMS-10244 (OMB#: 0938-NEW); *Frequency:* Reporting: Yearly; *Affected Public:* State, Local or Tribal Governments; *Number of Respondents:* 56; *Total Annual Responses:* 56; *Total Annual Hours:* 1,400. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on November 26, 2007: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:

(202)395-6974 Dated: October 19, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-21116 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-262 and CMS-10142] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

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

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

(2)the accuracy of the estimated burden;

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

(PBP)and Formulary Submission for Medicare Advantage

(MA)Plans and Prescription Drug Plans (PDP); *Use:* Under the Medicare Modernization Act (MMA), Medicare Advantage

(MA)and Prescription Drug Plan

(PDP)organizations are required to submit plan benefit packages for all Medicare beneficiaries residing in their service area. The plan benefit package submission consists of the formulary file, Plan Benefit Package

(PBP)software, and supporting documentation as necessary. MA and PDP organizations will generate a formulary to illustrate their list of drugs, including information on prior authorization, step therapy, tiering, and quantity limits. Additionally, the PBP software will be used to describe their organization's plan benefit packages, including information on premiums, cost sharing, authorization rules, and supplemental benefits. CMS uses the formulary and PBP data to review and approve the plan benefit packages proposed by each MA and PDP organization. CMS requires that MA and PDP organizations submit a completed formulary and PBP as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to CMS for review and approval. Based on operational changes and policy clarifications to the Medicare program and continued input and feedback by the industry, CMS has made the necessary changes to the plan benefit package submission. *Form Number:* CMS-R-262 (OMB#: 0938-0763); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 475 *Total Annual Responses:* 4987.5; Total Annual Hours: 11,400. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Bid Pricing Tool

(BPT)for Medicare Advantage

(MA)Plans and Prescription Drug Plans (PDPs); *Use:* Under the Medicare Prescription Drug, Improvement, and Modernization (MMA), Medicare Advantage organizations

(MAO)and Prescription Drug Plans

(PDP)are required to submit an actuarial pricing “bid” for each plan offered to Medicare beneficiaries. CMS requires that MAOs and PDPs complete the BPT as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to CMS for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan's bid, enrollee premiums, and payment rates. Refer to “Attachment C” for a summary of changes. *Form Number:* CMS-10142 (OMB#: 0938-0944); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 550 *Total Annual Responses:* 6,050; *Total Annual Hours:* 42,350. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on December 26, 2007: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: October 19, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-21123 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-2276-PN] Medicare and Medicaid Programs; Application by the Community Health Accreditation Program for Continued Deeming Authority for Home Health Agencies AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. SUMMARY: This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 26, 2007. ADDRESSES: In commenting, please refer to file code CMS-2276-PN. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking* . Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2276-PN, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2276-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-9994 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Cindy Melanson,

(410)786-0310. Patricia Chmielewski,

(410)786-6899. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-2276-PN and the specific “issue identifier” that precedes the section on which you choose to comment. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking* . Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency

(HHA)provided certain requirements are met. Sections 1861(m) and (o), and 1891 of the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as an HHA. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 484 specify the conditions that an HHA must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for Home Health Care. Generally, in order to enter into a provider agreement with the Medicare program, an HHA must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 484 of our CMS regulations. Thereafter, the HHA is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies. Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at §§ 488.4 and 488.8(d)(3). The regulations at § 488.8(d)(3) require accrediting organizations to reapply for continued deeming authority every six years or sooner as determined by us. Community Health Accreditation Program's (CHAP's) term of approval as a recognized accreditation program for HHA's expires March 31, 2008. II. Approval of Deeming Organizations Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. The purpose of this proposed notice is to inform the public of CHAP's request for continued deeming authority for HHAs. This notice also solicits public comment on whether CHAP's requirements meet or exceed the Medicare conditions for participation for HHAs. III. Evaluation of Deeming Authority Request CHAP submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for HHAs. This application was determined to be complete on September 3, 2007. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accrediting organizations), our review and evaluation of CHAP will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of CHAP's standards for an HHA as compared with CMS' HHA conditions of participation. • CHAP's survey process to determine the following: —The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. —The comparability of CHAP's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. —CHAP's processes and procedures for monitoring HHAs found out of compliance with CHAP's program requirements. These monitoring procedures are used only when CHAP identifies noncompliance. If noncompliance is identified through validation reviews, the State survey agency monitors corrections as specified at § 488.7(d). —CHAP's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. —CHAP's capacity to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process. —The adequacy of CHAP's staff and other resources, and its financial viability. —CHAP's capacity to adequately fund required surveys. —CHAP's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. —CHAP's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans). IV. Response to Public Comments and Notice Upon Completion of Evaluation Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the **Federal Register** announcing the result of our evaluation. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice. In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 5, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-20574 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-2277-PN] Medicare and Medicaid Programs; Application by The Joint Commission for Continued Deeming Authority for Home Health Agencies AGENCY: Centers for Medicare and Medicaid Services, HHS. ACTION: Proposed notice. SUMMARY: This proposed notice with comment period acknowledges the receipt of a deeming application from The Joint Commission for continued recognition as a national accrediting organization for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 26, 2007. ADDRESSES: In commenting, please refer to file code CMS-2277-PN. Because of staff and resource limitations, we cannot accept comments by facsimile

(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2277-PN, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-2277-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number

(410)786-0310. Patricia Chmielewski,

(410)786-6899. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this proposed notice to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-2277-PN and the specific “issue identifier” that precedes the section on which you choose to comment. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking.* Click on the link “Electronic Comments on CMS Regulations” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency

(HHA)provided certain requirements are met. Sections 1861(m) and (o), and 1891 of the Social Security Act (the Act) establish distinct criteria for facilities seeking designation as an HHA. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 484 specify the conditions that an HHA must meet in order to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for home health care. Generally, in order to enter into a provider agreement with the Medicare program, an HHA must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 484 of our regulations. Thereafter, the HHA is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements. There is an alternative, however, to surveys by State agencies. Section 1865(b)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation. If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for deeming authority under part 488, subpart A must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the reapproval of accrediting organizations are set forth at §§ 488.4 and 488.8(d)(3). The regulations at § 488.8(d)(3) require accrediting organizations to reapply for continued deeming authority every six years or sooner as determined by us. The Joint Commission's term of approval as a recognized accreditation program for HHAs expires March 31, 2008. II. Approval of Deeming Organizations Section 1865(b)(2) of the Act and our regulations at § 488.8(a) require that our findings concerning review and reapproval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. The purpose of this proposed notice is to inform the public of The Joint Commission's request for continued deeming authority for HHAs. This notice also solicits public comment on whether The Joint Commission's requirements meet or exceed the Medicare conditions for participation for HHAs. III. Evaluation of Deeming Authority Request The Joint Commission submitted all the necessary materials to enable us to make a determination concerning its request for reapproval as a deeming organization for HHAs. This application was determined to be complete on September 3, 2007. Under section 1865(b)(2) of the Act and our regulations at § 488.8 (Federal review of accrediting organizations), our review and evaluation of The Joint Commission will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of The Joint Commission standards for an HHA as compared with CMS' HHA conditions of participation. • The Joint Commission's survey process to determine the following: —The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. —The comparability of The Joint Commission's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities. —The Joint Commission's processes and procedures for monitoring HHAs found out of compliance with The Joint Commission program requirements. These monitoring procedures are used only when The Joint Commission identifies noncompliance. If noncompliance is identified through validation reviews, the State survey agency monitors corrections as specified at § 488.7(d). —The Joint Commission's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner. —The Joint Commission's capacity to provide us with electronic data in ASCII comparable code, and reports necessary for effective validation and assessment of the organization's survey process. —The adequacy of The Joint Commission's staff and other resources, and its financial viability. —The Joint Commission's capacity to adequately fund required surveys. —The Joint Commission's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. —The Joint Commission's agreement to provide us with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans). IV. Response to Public Comments and Notice Upon Completion of Evaluation Because of the large number of public comments we normally receive on **Federal Register** documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the **Federal Register** announcing the result of our evaluation. V. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 35). VI. Regulatory Impact Statement In accordance with the provisions of Executive Order 12866, the Office of Management and Budget did not review this proposed notice. In accordance with Executive Order 13132, we have determined that this proposed notice would not have a significant effect on the rights of States, local or tribal governments. Authority: Section 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; No. 93.773 Medicare—Hospital Insurance Program; and No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 5, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-20579 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3181-FN] Medicare Program: Approval of Application by the American Diabetes Association

(ADA)for Continued Recognition as a National Accreditation Organization That Accredits Entities To Furnish Outpatient Diabetes Self-Management Training AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. SUMMARY: This final notice announces the approval of the American Diabetes Association

(ADA)as a national accreditation organization for the purpose of determining that an entity meets the necessary quality standards to furnish outpatient diabetes self-management training services under Part B of the Medicare program. Therefore, diabetes self-management training

(DSMT)programs accredited by the ADA will receive deemed status under the Medicare program. DATES: *Effective Date:* This accreditation is effective on October 27, 2007. FOR FURTHER INFORMATION CONTACT: Joan A. Brooks,

(410)786-5526. SUPPLEMENTARY INFORMATION: I. Background To participate in the Medicare program, diabetes self-management training

(DSMT)programs must meet conditions for coverage specified in our regulations at 42 CFR part 410, subpart H. One requirement is that entities must satisfy required quality standards. Currently, one way of satisfying the quality standards under § 410.145 is to be approved by an approved accrediting body. The regulations pertaining to the application procedures for national accreditation organizations for DSMT are at § 410.142. After we approve and recognize the accreditation organization, it may accredit an entity to meet one of the sets of quality standards described in § 410.144. II. Review Process In evaluating an application from an accrediting organization, we consider the following factors under section 1865(b)(2) of the Social Security Act (the Act): • Accreditation requirements. • Survey procedures. • Ability to provide adequate resources for conducting required surveys and to supply information for use in enforcement activities. • Monitoring procedures. • Ability to provide us with the necessary data for validation. We are required by § 410.142(d) to publish a proposed notice in the **Federal Register** after the receipt of a written request for approval from a national accreditation organization. After review of the national accreditation organization's application, the regulations require that we publish a notice of our approval or disapproval after we receive a complete package of the information and the organization's deeming application. III. Analysis of and Responses to Public Comments and Provisions of the Final Notice We received a complete application from the American Diabetes Association

(ADA)on March 3, 2007. On May 25, 2007, we published a proposed notice in the **Federal Register** , (72 FR 29325) announcing the application of the ADA for continued approval as an accreditation organization for diabetes self-management training programs. *Comment:* We received one comment on our proposed notice, which was supportive of the ADA's application. Although the comment supported ADA, the commenter expressed concern that some of ADA's accrediting requirements do not reflect the current state of health care practice for many DSMT programs. Specifically, the commenter expressed concern about the requirements pertaining to data collection, documentation, location requirements, and fees. The commenter stated that accreditation requirements can be burdensome for small DSMT practices that may operate outside of a large hospital-based setting. The commenter further specified that some large hospitals' DSMT programs have closed in recent years, due to a variety of factors that include the burdensome administrative requirements of accreditation combined with overall low reimbursement for DSMT services. *Response:* Although reimbursement issues are not within the scope of this final notice, we recognize these are issues of concern. Some reimbursement issues associated with DMST are— • Entities' failure to meet the required number of participants for group training; • Entities' failure to meet the requirement for both a registered dietician

(RD)and a registered nurse

(RN)on the training team; and • Entities' failure to bill correctly. Recent revisions made to the National Standards for Diabetes Self-Management Education Programs (NSDSMEP) include: 1) a reduction in the number of participants required for group training (from 15 to 10); and 2) a change in the instructional requirements that DSMT programs must meet. Previously, a DSMT entity was required to have both a RD and a RN conduct training. The recent revisions to the NSDSMEP changed this requirement. An entity may now have either a RD or a RN conduct training. This revision should help to alleviate some of the administrative burdens faced by entities when administering the DSMT benefit. Additionally, we have revised Chapter 18 of the CMS Claims Processing Manual, and Chapter 15 of the CMS Benefits Policy Manual to clarify the instructions for filing specific claims. Our findings indicate that the ADA continues to use one of the sets of quality standards described in § 410.144. It also continues to meet the CMS criteria as “a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes” to accredit entities to furnish training as specified in § 410.142(a). The ADA began its Education Recognition Program

(ERP)in 1986. At that time they formally recognized diabetes self-management education programs that meet the NSDSMEP. These standards, created by the National Diabetes Advisory Board (NDAB), were designed to promote quality diabetes self-management education nationwide for every person with diabetes. A Task Force consisting of the ADA, the American Association of Diabetes Educators, the American Dietetic Association, the Veteran's Health Service, the National Certification Board for Diabetes Educators, the Centers for Disease Control and Prevention, the Department of Veterans Affairs, the Diabetes Research and Training Centers, the Indian Health Service, and the National Certification Board for Diabetes Educators was convened on March 31, 2006 and again on September 19, 2006 as part of the update process. The revised standards were approved on March 25, 2007 and was published in the June 2007 issue of Diabetes Care, Volume 30, Number 6. The task force reviewed the standards for their appropriateness, relevancy, scientific basis, specificity, and ability to be implemented in multiple settings. The current NSDSMEP standards (7th Edition) were effectuated in June 2007 and reflect the changing approaches in diabetes training and education. We reviewed ADA's materials and the findings presented by the Iowa Foundation for Medicare Care (IFMC, Contract #GS-35F-5831 H/HHDM 500-2006-0015IG), which was under contract with CMS to validate ADA's accreditation policies. IFMC surveyed a sample of ADA's accredited facilities. Based on these reviews, we have determined that the ADA's deeming authority has been exercised in compliance with § 410.142. Therefore, ADA's continued recognition as a national accrediting organization is approved and is effective for 6 years, beginning October 27, 2007. Authority: Sections 1865 of the Social Security Act (42 U.S.C. 1395bb). (Catalog of Federal Domestic Program No. 93.773, Medicare—Hospital Insurance Program; and No. 93.774, Medicare-Supplementary Medical Insurance Program) Dated: September 6, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-20495 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1389-N] Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 3, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public. DATES: *Meeting Date:* Monday, December 3, 2007, from 8:30 a.m. to 5 p.m., e.s.t. *Deadline for Registration without Oral Presentation:* Thursday, November 29, 2007, 12 noon, e.s.t. *Deadline for Registration with Oral Presentations:* Friday, November 16, 2007, 12 noon, e.s.t. *Deadline for Submission of Oral Remarks and Written Comments:* Wednesday, November 21, 2007, 12 noon, e.s.t. *Deadline for Requesting Special Accommodations:* Monday, November 26, 2007, 12 noon, e.s.t. ADDRESSES: *Meeting Location:* The meeting will be held in Room 705A in the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. *Submission of Testimony:* Testimonies should be mailed to Kelly Buchanan, Designated Federal Official (DFO), Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Mail stop C4-13-07, Baltimore, MD 21244-1850, or contact the DFO via e-mail at *PPAC@cms.hhs.gov.* FOR FURTHER INFORMATION CONTACT: Kelly Buchanan, DFO,

(410)786-6132, or e-mail *PPAC@cms.hhs.gov.* News media representatives must contact the CMS Press Office,

(202)690-6145. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free),

(410)786-9379 local) or the Internet at *http://www.cms.hhs.gov/home/regsguidance.asp* for additional information and updates on committee activities. SUPPLEMENTARY INFORMATION: I. Background In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before **Federal Register** publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)not later than December 31 of each year. The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists, and chiropractors. Members serve for overlapping 4-year terms. Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Section 1868(a)(3) of the Act provides for payment of expenses and per diem for Council members in the same manner as members of other advisory committees appointed by the Secretary. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership. The Council held its first meeting on May 11, 1992. The current members are: Anthony Senagore, M.D., Chairperson; Jose Azocar, M.D.; M. Leroy Sprang, M.D.; Karen S. Williams, M.D.; Peter Grimm, D.O.; Jonathon E. Siff, M.D., MBA; John E. Arradondo, M.D., MPH; Helena Wachslicht Rodbard, M.D.; Vincent J. Bufalino, M.D.; Tye J. Ouzounian, M.D.; Geraldine O'Shea, D.O.; Arthur D. Snow, Jr., M.D.; Gregory J. Przybylski, M.D.; Jeffrey A. Ross, DPM, M.D.; and Roger L. Jordan, O.D. II. Meeting Format and Agenda The meeting will commence with the Council's Executive Director providing a status report, and the CMS responses to the recommendations made by the Council at the August 27, 2007 meeting, as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics: • Stark Update. • Overview of Medicare Demonstration Projects. • Physician Fee Schedule Final Rule. • Outpatient Prospective Payment System (OPPS)/Ambulatory Surgical Center

(ASC)Final Rule. • 9th Scope of Work/Quality Improvement Organization

(QIO)Program. For additional information and clarification on these topics, contact the DFO as provided in the FOR FURTHER INFORMATION CONTACT section of this notice. Individual physicians or medical organizations that represent physicians wishing to present a 5-minute oral testimony on agenda issues must register with the DFO by the date listed in the DATES section of this notice. Testimony is limited to agenda topics only. The number of oral testimonies may be limited by the time available. A written copy of the presenter's oral remarks must be submitted to the DFO for distribution to Council members for review before the meeting by the date listed in the DATES section of this notice. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution by the date listed in the DATES section of this notice. III. Meeting Registration and Security Information The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting the DFO at the address listed in the ADDRESSES section of this notice or by telephone at

(410)786-6132 by the date specified in the DATES section of this notice. Since this meeting will be held in a Federal Government Building, the Hubert H. Humphrey Building, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. To gain access to the building, participants will be required to show a government-issued photo identification (for example, driver's license or passport), and must be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the Hubert H. Humphrey Building and will not be permitted to attend the Council meeting. All persons entering the building must pass through a metal detector. In addition, all items brought to the Hubert H. Humphrey Building, whether personal or for the purpose of presentation, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for the purpose of presentation. Individuals requiring sign language interpretation or other special accommodation must contact the DFO via the contact information specified in the FOR FURTHER INFORMATION CONTACT section of this notice by the date listed in the DATES section of this notice. Authority: (Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)).) Dated: October 5, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-20484 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-7006-N] Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education, December 4, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Panel on December 4, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public. DATES: *Meeting Date:* December 4, 2007 from 9 a.m. to 3:30 p.m., e.d.t. *Deadline for Meeting Registration, Presentations, and Comments:* November 27, 2007, 12 noon, e.d.t. *Deadline for Requesting Special Accommodations:* November 19, 2007, 12 noon, e.d.t. ADDRESSES: *Meeting Location:* Doubletree Hotel 1515 Rhode Island Avenue, NW., Washington, DC 20005,

(202)232-7000. *Meeting Registration, Presentations, and Written Comments:* Lynne Johnson, Designated Federal Official, Division of Forum and Conference Development, Office of External Affairs, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mailstop S1-05-06, Baltimore, MD 21244-1850 or contact Ms. Johnson via e-mail at *Lynne.Johnson@cms.hhs.gov.* *Registration:* The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting Lynne Johnson at the address listed in the ADDRESSES section of this notice or by telephone at

(410)786-0090, by 12 noon, e.d.t., on November 27, 2007. FOR FURTHER INFORMATION CONTACT: Lynne Johnson,

(410)786-0090. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet ( *http://www.cms.hhs.gov/FACA/04_APME.asp* ) for additional information and updates on committee activities. Press inquiries are handled through the CMS Press Office at

(202)690-6145. SUPPLEMENTARY INFORMATION: Section 9(a)(2) of the Federal Advisory Committee Act authorizes the Secretary to establish an advisory panel if the Secretary determines that the panel is “in the public interest in connection with the performance of duties imposed * * * by law.” Such duties are imposed by section 1804 of the Social Security Act (the Act), requiring the Secretary to provide informational materials to Medicare beneficiaries about the Medicare program, and section 1851(d) of the Act, requiring the Secretary to provide for “activities * * * to broadly disseminate information to medicare beneficiaries * * * on the coverage options provided under [Medicare Advantage] in order to promote an active, informed selection among such options.” The Advisory Panel is also authorized by 1114(f) of the Social Security Act, 42 U.S.C. 1311(f), and section 222 of the Public Health Service Act, 42 U.S.C. 217a. The Secretary signed the charter establishing this Panel on January 21, 1999 (64 FR 7899) and approved the renewal of the charter on November 14, 2006. The establishment of the charter and the renewal of the charter were announced in the February 17, 1999 **Federal Register** (64 FR 7899), and the March 23, 2007 **Federal Register** (72 FR 13796), respectively. The Panel advises and makes recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The goals of the Panel are as follows: • To develop and implement a national Medicare education program that describes the options for selecting a health plan under Medicare. • To enhance the Federal government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships. • To expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program. • To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance. The current members of the Panel are: Anita B. Boles, Independent Consultant, Health Communications; Gwendolyn T. Bronson, SHINE/SHIP Counselor, Massachusetts SHINE Program; Dr. Yanira Cruz, President and Chief Executive Officer, National Hispanic Council on Aging; Clayton Fong, President and Chief Executive Officer, National Asian Pacific Center on Aging; Nan Kirsten-Forte, Executive Vice President, Consumer Services, WebMD; Dr. Jessie C. Gruman, President and Chief Executive Officer, Center for the Advancement of Health; Dr. David Lansky, Director, Health Program, Markle Foundation; Dr. Daniel Lyons, Senior Vice President, Government Programs, Independence Blue Cross; Dr. Frank B. McArdle, Manager, Hewitt Research Office, Hewitt Associates; Traci McClellan, J.D., Executive Director, National Indian Council on Aging; Dr. Keith Mueller, Professor and Section Head, Health Services Research and Rural Health Policy, University of Nebraska; Lee Partridge, Senior Health Policy Advisor, National Partnership for Women and Families; Rebecca Snead, Executive Vice President/Chief Executive Officer, National Alliance of State Pharmacy Associations; William A. Steel, President, The National Grange; Marvin Tuttle, Jr., CAE, Executive Director and Chief Executive Officer, Financial Planning Association; Catherine Valenti, Chairperson and Chief Executive Officer, Caring Voice Coalition; and Grant Wedner, Vice President, Partnerships and Corporate Development, Daily Strength, Inc. The agenda for the December 4, 2007 meeting will include the following: • Recap of the previous (September 20, 2007) meeting. • Medicare Enrollment, Outreach, Education, and Partnering Activities Update. • Public Comment. • Listening Session with CMS Leadership. • Next Steps. Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to Lynne Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make a presentation may submit written comments to Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3). (Catalog of Federal Domestic Assistance Program No. 93.733, Medicare—Hospital Insurance Program; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: October 19, 2007. Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E7-21080 Filed 10-25-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N-0205] Exocrine Pancreatic Insufficiency Drug Products; Extension to Obtain Marketing Approval AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that it intends to continue to exercise enforcement discretion to ensure the continued availability of exocrine pancreatic insufficiency drug products after April 28, 2008. FDA intends to exercise its enforcement discretion with respect to unapproved pancreatic enzyme drug products until April 28, 2010, if the manufacturers have investigational new drug applications

(INDs)on active status on or before April 28, 2008, and have submitted new drug applications

(NDAs)on or before April 28, 2009. FDA is granting this extension to ensure the availability of exocrine pancreatic insufficiency drug products during the additional time needed by manufacturers to obtain marketing approval. DATES: The period during which FDA intends to exercise its enforcement discretion against unapproved pancreatic insufficiency drug products is extended to April 28, 2010, if the manufacturer has an active IND on or before April 28, 2008, and has submitted an NDA on or before April 28, 2009. FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In the **Federal Register** of April 28, 2004 (69 FR 23410) (the 2004 notice), FDA announced that all exocrine pancreatic insufficiency drug products are new drugs and announced the conditions for continued marketing of the drug products. The 2004 notice covered pancreatic enzyme preparations containing the ingredients pancreatin and pancrelipase. Both ingredients are extracted mainly from hog pancreas and contain principally the enzymes amylase, protease, and lipase. Pancreatic extract drug products are indicated as replacement therapy to treat conditions associated with exocrine pancreatic insufficiency, including cystic fibrosis, chronic pancreatitis, pancreatic tumors, or pancreatectomy. Pancreatic extract drug products have been marketed in the United States for many years. Marketing of some versions of these products predates the 1938 passage of the Federal Food, Drug, and Cosmetic Act (the act). Over the years, other pancreatic extract drug products have entered the market. Various dosage forms of pancreatic enzyme drug products are currently marketed as prescription drug products: Uncoated tablets, powders, capsules, enteric-coated tablets, and encapsulated enteric-coated microspheres. Some pancreatic extract drug products were marketed over-the-counter (OTC). As part of the OTC drug review, FDA evaluated the safety and effectiveness of drug products used to treat exocrine pancreatic insufficiency. FDA's review of data and information on pancreatic extract drug products found significant variations in bioavailability among the various dosage forms and among products from different manufacturers of the same dosage form. Available data have shown that the formulation, dosage, and manufacturing process of pancreatic enzyme drug products have a critical effect on the safe and effective use of these drugs. FDA concluded that preclearance of each product to standardize enzyme bioactivity would be necessary. FDA also determined that continuous physician monitoring of patients is a collateral measure necessary to the safe and effective use of pancreatic enzyme drug products, requiring that these products be available by prescription only and that the products be approved through the new drug approval process to standardize enzyme activity (56 FR 32282, July 15, 1991; 60 FR 20162, April 24, 1995). The 2004 notice reiterated FDA's determination that all pancreatic extract drug products are new drugs under section 201(p) of the act (21 U.S.C. 321(p)), requiring approved NDAs under section 505 of the act (21 U.S.C. 355) and 21 CFR part 314. The document stated that FDA expects to receive only NDAs, including applications submitted under section 505(b)(2) of the act, for these products. To assist manufacturers of pancreatic extract drug products in preparing and submitting documentation to meet NDA requirements for the drug products, FDA announced the availability of a draft guidance for industry entitled “Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs” in the **Federal Register** of April 28, 2004 (69 FR 23414). In response, FDA received a number of comments which the agency considered in finalizing the guidance. In the **Federal Register** of April 14, 2006 (71 FR 19524), FDA announced the availability of the final guidance (available on the Internet at *http://www.fda.gov/cder/guidance/index.htm* ). FDA stated in the 2004 notice that pancreatic extract drug products are used to treat exocrine pancreatic insufficiency, a condition in which symptoms are due to deficient secretion of pancreatic enzymes (i.e., lipase, protease, amylase) essential for normal digestion and absorption, and no alternative drug is relied upon by the medical community to treat the lack of lipase, protease, and amylase caused by exocrine pancreatic insufficiency. The severity of the conditions varies from patient to patient as does the dosage requirement of pancreatic enzyme replacement therapy needed to relieve the symptoms of pancreatic insufficiency. Pancreatic enzyme therapy is a daily requirement for patients with exocrine pancreatic insufficiency and is needed for survival for many of these patients (e.g., cystic fibrosis patients). The appropriate daily dose of pancreatic enzymes must be individualized and adjusted when clinically indicated. To meet the needs of patients requiring pancreatic enzyme replacement therapy, drug products with varying dosage forms, enzyme content, and activity need to remain available for patient use. Only one product, Cotazym, sponsored by Organon, Inc., is the subject of an approved NDA and that product is not currently being marketed. The 2004 notice advised that FDA intended to exercise its enforcement discretion until April 28, 2008, as to unapproved pancreatic enzyme drug products that were marketed on or before April 28, 2004. FDA determined that pancreatic enzyme drug products are medically necessary and, accordingly, FDA intended to exercise its enforcement discretion so that pancreatic extract drug products would remain available during the period necessary for manufacturers to conduct the required studies, prepare applications, and have the applications approved. This provision for the exercise of enforcement discretion applied only to pancreatic enzyme products marketed on or before the publication of the April 28, 2004, **Federal Register** document. The document stated that after April 28, 2008, any pancreatic enzyme drug product that is introduced or delivered for introduction into interstate commerce without an approved application will be subject to regulatory action, unless there has been a finding by FDA under a citizen petition submitted for that product that the product is not subject to the new drug requirements of the act. The deadline for filing a citizen petition was June 28, 2004. No one submitted a citizen petition in response to the 2004 notice. In response to the 2004 notice, a number of manufacturers of pancreatic extract drug products have indicated that they need an extension of time to obtain approved applications. The manufacturers contend that additional time is needed because of numerous problems encountered during the drug development process, predominantly manufacturing issues, and difficulty conducting all of the required studies needed for NDA filing and approval. The agency has carefully considered the requests and concludes that additional time is justified to ensure the continued availability of pancreatic extract drug products after April 28, 2008. As these pancreatic extract drugs are naturally-derived products of porcine origin, manufacturers must conform with currently accepted standards for protein therapeutic products. The justification for this extension is based upon chemistry, manufacturing, and control issues that previously have not been well-understood and have been found to be particularly challenging for these enzyme preparations derived from porcine pancreas. These issues include the following: • Control and evaluation of variability of pancreatic source materials used in drug substance manufacture; • Measurement of viral loads, viral inactivation, and resultant risk assessment and mitigation strategies as described in International Conference on Harmonisation guidance Q5A; • Development and implementation of validated purity and identity drug substance and product release and stability testing methodologies for the very complex protein mixtures derived from porcine pancreas; • Required modification and validation of the traditional lipase potency assay methodology based upon recent scientific studies; and • Maintenance and confirmation of drug product stability without the use of overages to increase the dating period. By this notice, FDA is extending the period during which it intends to exercise its enforcement discretion as to certain unapproved pancreatic enzyme products until April 28, 2010. This extension of the period during which FDA intends to exercise its enforcement discretion applies to any manufacturer of pancreatic extract drug products marketed on or before publication of the 2004 notice, if the manufacturer has an active IND for its pancreatic extract product on or before April 28, 2008, has submitted an NDA on or before April 28, 2009, and is pursuing approval of its application with due diligence as determined by FDA. In determining the due diligence of an applicant, FDA will examine the facts and circumstances of the applicant's actions during the drug development and review period to determine whether the applicant exhibited the degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, an applicant during this period. FDA will take into consideration whether the applicant is conducting its clinical trials in a manner and at a rate sufficient for NDA submission on or before April 28, 2009, the adequacy and completeness of any required or necessary documents submitted by the applicant to FDA, the speed and thoroughness with which the applicant responds to any FDA requests for information or notifications of deficiencies, and any other relevant evidence of whether the applicant is making a genuine effort to meet the deadlines set out in this notice and obtain FDA approval for its products. FDA believes that establishing certain milestones will ensure that manufacturers are actively pursuing an NDA approval. Under those circumstances, extending the period of enforcement discretion as described in this notice will provide sufficient time for manufacturers to obtain approval of NDAs. Therefore, the agency does not anticipate that any further extensions will be needed. The agency, however, does not intend to exercise its enforcement discretion as described in this notice if the following conditions exist:

(1)A person manufacturing or shipping an unapproved product covered by this notice is violating other provisions of the act or

(2)there is significant new information related to a safety risk associated with a specific product covered by this notice. FDA intends to take regulatory action, including but not limited to initiating seizure, injunction, or other judicial or administrative proceedings, against manufacturers that are marketing unapproved pancreatic insufficiency drug products and are not actively pursuing approval. Actively pursuing approval means that the manufacturer has an active IND on or before April 28, 2008, and has submitted an NDA on or before April 28, 2009. 1 The agency may choose not to issue a warning letter or any further warning prior to taking a regulatory action against a firm that is marketing an unapproved exocrine pancreatic insufficiency drug product and not actively pursuing approval. 1 If FDA decides to take enforcement action against a firm's unapproved exocrine pancreatic insufficiency drug product, the agency may at the same time take action relating to any and all of the firm's other violations. For example, if a firm continues to market an unapproved exocrine pancreatic insufficiency drug product but fails to actively pursue approval, to preserve limited agency resources, FDA may take enforcement action relating to any and all of the firm's other unapproved drugs that require applications (see, e.g., *United States* v. *Sage Pharmaceuticals* , 210 F. 3d 475, 479-480 (5th Cir. 2000) (permitting the agency to combine all violations of the act in one proceeding, rather than taking action against multiple violations of the act in “piecemeal fashion”)). This notice is issued under sections 502 and 505 of the act (21 U.S.C. 352) and under authority delegated to the Assistant Commissioner for Policy. Dated: October 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21082 Filed 10-25-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0364] Draft Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions and Answers; 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 “Impact-Resistant Lenses: Questions and Answers.” This draft guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to testing. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 24, 2008. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Impact-Resistant Lenses: Questions and Answers” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to either *http://www.fda.gov/dockets/ecomments* or *http://www.regulations.gov* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: John Stigi, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150. SUPPLEMENTARY INFORMATION: I. Background Eyeglasses and sunglasses are medical devices and are subject to device regulations, including § 801.410 (21 CFR 801.410). This draft guidance document revises the original guidance document entitled “Impact-Resistant Lenses: Questions and Answers” (FDA 87-4002), issued September 1987. This draft guidance document also contains detailed and updated discussions of the following:

(1)Lens blanks;

(2)semi-finished, finished, and plano lenses; and

(3)import entry inspections. To reduce the number of eye injuries, eyeglasses and sunglasses must be fitted with impact-resistant lenses capable of withstanding the impact test described under § 801.410(d)(2). This draft guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing. 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 impact-resistant lenses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Impact-Resistant Lenses: Questions and Answers,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number

(23)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, ** Federal Register** reprints, information on premarket submissions (including lists of approved 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 801.109 have been approved under OMB Control No. 0910-0485; the collections of information in 21 CFR 807.87 have been approved under OMB Control No. 0910-0120; and the collections of information in 21 CFR part 820 have been approved under OMB Control No. 0910-0073. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21122 Filed 10-25-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; the Multi-Ethnic Study of Atherosclerosis

(MESA)Event Surveillance *Summary:* Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health

(NIH)has submitted to the Office of Management and Budget

(OMB)a request for review and approval the information collection listed below. This proposed information collection was previously published in the **Federal Register** on August 21, 2007, pages 46640-46641, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. *Proposed Collection: Title:* The Multi-Ethnic Study of Atherosclerosis

(MESA)Event Surveillance. *Type of Information Collection Request:* Renewal (OMB No. 0925-0493). *Need and Use of Information Collection:* This project identifies and quantifies factors associated with the presence and progression of subclinical cardiovascular disease (CVD)—that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. *Frequency of Response:* The participants will be contacted annually. *Affected Public:* Individuals or households; Businesses or other for profit; Small businesses or organizations. *Type of Respondents:* Individuals or households; physicians. The annual reporting burden is as follows: *Estimated Number of Respondents:* 550; *Estimated Number of Responses per Respondent:* 1.0; *Average Burden Hours Per Response:* .2; and *Estimated Total Annual Burden Hours Requested:* 36.7. The annualized cost to respondents is estimated at $5,595, assuming respondents time at the rate of $18.65 per hour and physician time at the rate of $75 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimates of Hour Burden Type of respondent Number of respondents Frequency of response Average time per response (hours) Annual hour burden Physicians 250 1 0.20 16.7 Proxies 300 1 0.20 20 Total 550 1 0.20 36.7 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:

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

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

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

(4)Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Jean Olson, Epidemiology Branch, Division of Prevention and Population Sciences, NHLBI, NIH, II Rockledge Centre, 6701 Rockledge Drive, Suite 10018, MSC # 7936, Bethesda, MD, 20892-7936, or call 301-435-0397 (non-toll-free number), or e-mail your request, including your address to: *OlsonJ@nhlbi.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: October 16, 2007. Mike Lauer, Director, Division of Prevention and Population Sciences, NHLBI, National Institutes of Health. Dated: October 18, 2007. Suzanne Freeman, OMB Clearance Officer, NHLBI, National Institutes of Health. [FR Doc. E7-21103 Filed 10-25-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Cell-Nanofiber Composite Based Engineered Cartilage *Description of Invention:* Available for licensing and commercial development is a tissue-engineered cartilage derived from a cellular composite made from a biodegradable, biocompatible polymeric nanofibrous matrix having dispersed chondrocytes or adult mesenchymal stem cells. More particularly, tissue-engineered cartilage can be prepared where the cartilage has a biodegradable and biocompatible nanofibrous polymer matrix prepared by electrospinning and a plurality of chondocytes or mesenchymal stem cells dispersed in the pores of the matrix. The tissue-engineered cartilage possesses compressive strength properties similar to natural cartilage. The electrospinning process is a simple, economical means to produce biomaterial matrices or scaffolds of ultra-fine fibers derived from a variety of biodegradable polymers (Li WJ, *et al. J. Biomed. Mater. Res.* 2002; 60:613-21). Nanofibrous scaffolds

(NFSs)formed by electrospinning, by virtue of structural similarity to natural extracellular matrix (ECM), may represent promising structures for tissue engineering applications. Electrospun three-dimensional NFSs are characterized by high porosity with a wide distribution of pore diameter, high-surface area to volume ratio and morphological similarities to natural collagen fibrils (Li WJ, *et al. J. Biomed. Mater. Res.* 2002; 60:613-21). These physical characteristics promote favorable biological responses of seeded cells in vitro and in vivo, including enhanced cell attachment, proliferation, maintenance of the chondrocytic phenotype (Li WJ, *et al. J. Biomed. Mater. Res.* 2003; 67A: 1105-14), and support of chondrogenic differentiation (Li WJ, *et al. Biomaterials* 2005; 26:599-609) as well as other connective tissue linage differentiation (Li WJ, *et al. Biomaterials* 2005; 26:5158-5166). The invention based on cell-nanofiber composite represents a candidate engineered tissue for cell-based approaches to cartilage repair. *Application:* Cartilage repair and methods for making tissue-engineered cartilage. *Developmental Status:* Electrospinning method is fully developed and cartilage has been synthesized. *Inventors:* Wan-Ju Li and Rocky Tuan (NIAMS). *Publications:* The invention is further described in: 1. W-J Li *et al.* Engineering controllable anisotropy in electrospun biodegradable nanofibrous scaffolds for musculoskeletal tissue engineering. J Biomech. 2007;40(8):1686-1693. Epub 2006 Oct 23, doi:10.1016/jbiomech.2006.09.004. 2. W-J Li *et al.* Fabrication and characterization of six electrospun poly(alpha-hydroxy ester)-based fibrous scaffolds for tissue engineering applications. Acta Biomater. 2006 Jul;2(4):377-385. Epub 2006 May 6, doi:10.1016/j.actbio.2006.02.005. 3. CK Kuo *et al.* Cartilage tissue engineering: its potential and uses. Curr Opin Rheumatol. 2006 Jan;18(1):64-73. Review. 4. W-J Li *et al.* Multilineage differentiation of human mesenchymal stem cells in a three-dimensional nanofibrous scaffold. Biomaterials. 2005 Sep;26(25):5158-5166. *Patent Status:* U.S. Provisional Application No. 60/690,998 filed 15 Jun 2005 (HHS Reference No. E-116-2005/0-US-01). PCT Application No. PCT/US2006/0237477 filed 15 Jun 2006 (HHS Reference No. E-116-2005/0-PCT-02). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; soukasp@mail.nih.gov. Cell-Nanofiber Composite and Cell-Nanofiber Composite Amalgam Based Engineered Intervertebral Disc *Description of Invention:* Diseased or damaged musculoskeletal tissues are often replaced by an artificial material, cadaver tissue or donated, allogenic tissue. Tissue engineering offers an attractive alternative whereby a live, natural tissue is generated from a construct made up of a patient's own cells or an acceptable/compatible cell source in combination with a biodegradable scaffold for replacement of defective tissue. Degeneration of the intervertebral disc

(IVD)is a common and significant source of morbidity in our society. Approximately 8 of 10 adults at some point in their life will experience an episode of significant low back pain, with the majority improving without any formal treatment. However, for the subject requiring surgical management current interventions focus on fusion of the involved IVD levels, which eliminates pain but does not attempt to restore disc function. Approximately 200,000 spinal fusions were performed in the United States in 2002 to treat pain associated with lumbar disc degeneration. Spinal fusion however is thought to significantly alter the biomechanics of the disc and lead to further degeneration, or adjacent segment disease. Therefore, in the past decade there has been mounting interest in the concept of IVD replacement. The replacement of the IVD holds tremendous potential as an alternative to spinal fusion for the treatment of degenerative disc disease by offering a safer alternative to current spinal fusion practices. At the present time, several disc replacement implants are at different stages of preclinical and clinical testing. These disc replacement technologies are designed to address flexion, extension, and lateral bending motions; however, they do little to address compressive forces and their longevity is limited due to their inability to biointegrate. Therefore, a cell-based tissue engineering approach offers the most promising alternative to replace the degenerated IVD. Current treatment for injuries that penetrate subchondral bone include subchondral drilling, periosteal tissue grafting, osteochondral allografting, chondrogenic cell and transplantation; but are limited due to suboptimal integration with host tissues. The present invention claims tissue engineered intervertebral discs comprising a nanofibrous polymer hydrogel amalgam having cells dispersed therein, methods of fabricating tissue engineered intervertebral discs by culturing a mixture of stem cells or intervertebral disc cells and a electrospun nanofibrous polymer hydrogel amalgam in a suitable bioreactor, and methods of treatment comprising implantation of tissue engineered intervertebral disc into a subject. *Application:* Intervertebral disc bio-constructs and electrospinning methods for fabrication of the discs. *Developmental Status:* Prototype devices have been fabricated and preclinical studies have been performed. *Inventors:* Wan-Ju Li, Leon Nesti, Rocky Tuan (NIAMS). *Patent Status:* U.S. Provisional Application No. 60/847,839 filed 27 Sep 2006 (HHS Reference No. E-309-2006/0-US-01). U.S. Provisional Application No. 60/848,284 filed 28 Sep 2006 (HHS Reference No. E-309-2006/1-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . Bioreactor Device and Method and System for Fabricating Tissue *Description of Technology* : Available for licensing and commercial development is a millifluidic bioreactor system for culturing, testing, and fabricating natural or engineered cells and tissues. The system consists of a millifluidic bioreactor device and methods for sample culture. Biologic samples that can be utilized include cells, scaffolds, tissue explants, and organoids. The system is microchip controlled and can be operated in closed-loop, providing controlled delivery of medium and biofactors in a sterile temperature regulated environment under tabletop or incubator use. Sample perfusion can be applied periodically or continuously, in a bidirectional or unidirectional manner, and medium re-circulated. *Advantages:* The device is small in size, and of conventional culture plate format. Provides the ability to grow larger biologic samples than microfluidic systems, while utilizing smaller medium volumes than conventional bioreactors. The bioreactor culture chamber is adapted to contain sample volumes on a milliliter scale (10 [mu]L to 1 mL, with a preferred size of 100 [mu]L), significantly larger than chamber volumes in microfluidic systems (on the order of 1 [mu]L). Typical microfluidic systems are designed to culture cells and not larger tissue samples. The integrated medium reservoirs and bioreactor chamber design provide for,

(1)concentration of biofactors produced by the biologic sample, and

(2)the use of smaller amounts of exogenous biofactor supplements in the culture medium. The local medium volume (within the vicinity of the sample) is less than twice the sample volume. The total medium volume utilized is small, preferably 2 ml, significantly smaller than conventional bioreactors (typically using 500-1000 mL). Provides for real-time monitoring of sample growth and function in response to stimuli via an optical port and embedded sensors. The optical port provides for microscopy and spectroscopy measurements using transmitted, reflected, or emitted (e.g., fluorescent, chemiluminescent) light. The embedded sensors provide for measurement of culture fluid pressure and sample pH, oxygen tension, and temperature. Capable of providing external stimulation to the biologic sample, including mechanical forces (e.g. fluid shear, hydrostatic pressure, matrix compression, microgravity via clinorotation), electrical fields (e.g., AC currents), and biofactors (e.g., growth factors, cytokines) while monitoring their effect in real-time via the embedded sensors, optical port, and medium sampling port. Monitoring of biologic sample response to external stimulation can be performed non-invasively and non-destructively through the embedded sensors, optical port, and medium sampling port. Testing of tissue mechanical and electrical properties (e.g., stiffness, permeability, loss modulus via stress or creep test, electrical impedance) can be performed over time without removing the sample from the bioreactor device. The bioreactor sample chamber can be constructed with multiple levels fed via separate perfusion circuits, facilitating the growth and production of multiphasic tissues. *Application:* Cartilage repair and methods for making tissue-engineered cartilage. *Development Stage:* Electrospinning method is fully developed and cartilage has been synthesized. *Inventors:* Juan M. Taboas (NIAMS), Rocky S. Tuan (NIAMS), et al. *Patent Status:* U.S. Provisional Application No. 60/701,186 filed 20 Jul 2005 (HHS Reference No. E-042-2005/0-US-01). PCT Application No. PCT/US2006/028417 filed 20 Jul 2006, which published as WO 2007/012071 on 25 Jan 2007 (HHS Reference No. E-042-2005/0-PCT-02). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . Dated: October 22, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-21100 Filed 10-25-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Public Teleconference Regarding Licensing and Collaborative Research Opportunities for: Treatment of Autoimmune and Allergic Disorders (NIAID) AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. Technology Summary These technologies relate to compositions and methods useful in treating autoimmune diseases generally, and Multiple Sclerosis specifically. Technology Description Scientists at the NIH have discovered a method for the treatment or prevention of autoimmune diseases, allergic or atopic disorders, and graft rejections. This method selectively induces apoptosis of disease causing T lymphocytes, while sparing the majority of T-cells. Cell death is achieved by the cyclical administration of disease specific antigens and IL-2. Further, the NIH scientists have developed compositions and methods for clinical assessment, diagnosis and treatment of Multiple Sclerosis (MS). The compositions are molecules related to the human proteolipid protein (PLP), and the 21.5 kDA fetal isoform of human myelin basic protein (MBP), including nucleic acids and polypeptides. The polypeptides can be used to assay T-cells for responsiveness to MBP and PLP epitopes. They are further useful as therapeutic agents for treating MS by inducing T-cell apoptosis. The inventors have demonstrated that treatment with MP4, a protein chimera of MBP, and a modified form of PLP, termed PLP4, prevented clinical symptoms of MS in both rodent and non-human primates. They have also completed primate toxicity tests demonstrating the compounds are non-toxic. Novel application of these methods described in these technologies include: Infusion of autoimmune disease antigen peptides reduces the severity of allergic diseases. Pre-immunization prior to engraftment with foreign tissues prolongs graft survival time. With molecular identification of allergy-evoking antigens, it will be possible to immunize in cycle with IL-4 to induce apoptosis of T cells involved in allergic disorders. It is envisioned that autoimmune diseases such as multiple sclerosis, rheumatic fever, lupus and others can be treated using IL-2 and the relevant peptide to cause apoptosis of the T cells responsible for the disease. The fact that interleukin-2 and 4 participates in the death of a subpopulation of T lymphocytes cells capable of causing diseases while leaving the majority of T lymphocyte cells substantially unaffected enhances the therapeutic value of these inventions. The use of a novel therapeutic agent, i.e., MP4, in the treatment of MS. Competitive Advantage of Our Technology Autoimmune diseases result from a dysfunction of the immune system in which the body attacks its own organs, tissues and cells. More than 80 clinically distinct autoimmune diseases have been identified, including: type-1 diabetes (300,000-500,000 cases in the U.S.); systemic lupus erythematosus (240,000 cases in the U.S.); multiple sclerosis (250,000 to 350,000); rheumatoid arthritis (2.1 million cases in the U.S.); inflammatory bowel diseases, including both Crohn's disease and ulcerative colitis (800,000 in the U.S.); hemolytic anemia; Graves' disease; scleroderma; psoriasis (2% to 4% of the U.S. population); Sjörgen's syndrome, Immune Thrombocytopenic Purpura (ITP). Collectively, autoimmune diseases afflict 14-22 million Americans or 5% to 8% of the United States population. Treatment of autoimmune diseases generally involves suppressing the immune system, and depending on the particular disease, different treatments are used. To demonstrate the diversity among these treatments consider the following: immunosuppressants such as azathioprine, chlorambucil, cyclophosphamide, cyclosporine or methostrexate are among the category of therapeutic agents employed in treating some autoimmune diseases. Corticosteroids such as prednisone are also used for both their immunosuppressive effect and anti-inflammatory activities. Tumor Necrosis Factor Antagonists, such as Etanercept and Infliximab are also used in treating some autoimmune disorders. Finally, Platelet transfusion and Plasmapheresis are used to treat a few autoimmune disorders. MS is an autoimmune disease affecting the central nervous system, characterized by disseminated patches of demyelination in the brain and spinal cord, resulting in multiple and varied neurologic symptoms and signs, usually with remissions and exacerbations. The currently approved drugs for MS are different recombinant forms of interferons and are primarily used for the treatment of RRMS. Antegren, which blocks cellular adhesion, is currently in the pipeline and will be useful in treating SPMS patients. There is a current theoretical patient population of approx 368,000 patients with MS in the U.S. and approx. 450,000 in Western Europe. Considering an estimated yearly growth rate of this market of 0.9%, this number will increase to approximately 390,000 by 2010 and approximately 400,000 by 2013 in the U.S. alone. The total U.S. sales in 2003 for the top MS drugs, i.e., Rebif, Avonex, Betaseron, and Copaxone, was about $1.7 billion. However, within a six-month period, 6-10% of the patients have to discontinue interferon therapy. These patients are likely to switch to new therapies as they become available. Thus, this is the patient population that will benefit from the compositions discovered at the NIH, i.e., MP4 therapy. Patent Estate This technology consists of the following patents and patent applications: 1. U.S. Patent No. 6,083,503, entitled “Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection” (E-137-1991/0-US-03); 2. U.S. Patent No. 5,989,546, entitled “Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses” (E-137-1991/0-US-04); 3. U.S. Patent No. 5,935,575, entitled “Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders” (E-151-1992/0-US-11); 4. U.S. Patent Application No. 08/431,644 entitled “Modified Myelin Basic Protein Molecules” (E-033-1996/0-US-01); and 5. U.S. Patent Application No. 08/482,114 entitled “Modified Proteolipid Protein Molecules” (E-128-1996/1-US-01). Next Step: Teleconference There will be a teleconference where the principal investigator will explain this technology. Licensing and collaborative research opportunities will also be discussed. If you are interested in participating in this teleconference please call or e-mail Mojdeh Bahar;

(301)435-2950; *baharm@mail.nih.gov.* OTT will then e-mail you the date, time and number for the teleconference. Dated: October 22, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-21104 Filed 10-25-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Alternative Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Center for Complementary and Alternative Medicine Special Emphasis Panel, Developmental Center for Research on Complementary and Alternative Medicine. *Date:* November 12-14, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Courtyard Marriott at Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878. *Contact Person:* Martina Schmidt, PhD., Scientific Review Administrator, Office of Scientific Review, National Center for Complementary & Alternative Medicine, NIH, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892, 301-594-3456, *schmidma@mail.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Dated: October 22, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-5310 Filed 10-25-07; 8:45 am]

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