Notices. Notice of intent to fund down the grant slate for the Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships
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BILLING CODE 3710-08-M DEPARTMENT OF EDUCATION Submission for OMB Review; Comment Request AGENCY: Department of Education. SUMMARY: The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before May 23, 2007. ADDRESSES: Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention:
Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, Washington, DC 20503. Commenters are encouraged to submit responses electronically by e-mail to *oira_submission@omb.eop.gov* or via fax to
(202)395-6974. Commenters should include the following subject line in their response “Comment: [insert OMB number], [insert abbreviated collection name, *e.g.* , “Upward Bound Evaluation”]. Persons submitting comments electronically should not submit paper copies. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget
(OMB)provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following:
(1)Type of review requested, *e.g.* new, revision, extension, existing or reinstatement;
(2)Title;
(3)Summary of the collection;
(4)Description of the need for, and proposed use of, the information;
(5)Respondents and frequency of collection; and
(6)Reporting and/or Recordkeeping burden. OMB invites public comment. Dated: April 17, 2007. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Federal Student Aid *Type of Review:* Revision. *Title:* Fiscal Operations Report for 2006-2007 and Application to Participate for 2008-2009 (FISAP) and Reallocation Form E40-4P. *Frequency:* Annually. *Affected Public:* Not-for-profit institutions; Businesses or other for-profit; State, Local, or Tribal Gov't, SEAs or LEAs. *Reporting and Recordkeeping Hour Burden:* *Responses:* 5,798. *Burden Hours:* 27,936. *Abstract:* This application data will be used to compute the amount of funds needed by each school for the 2008-2009 award year. The Fiscal Operations Report data will be used to assess program effectiveness, account for funds expended during the 2006-2007 award year, and as part of the school funding process. The Reallocation form is part of the FISAP on the web. Schools will use it in the summer to return unexpended funds for 2006-2007 and request supplemental FWS funds for 2007-2008. Requests for copies of the information collection submission for OMB review may be accessed from *http://edicsweb.ed.gov* , by selecting the “Browse Pending Collections” link and by clicking on link number 3279. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to *ICDocketMgr@ed.gov* or faxed to 202-245-6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to *ICDocketMgr@ed.gov.* Individuals who use a telecommunications device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8339. [FR Doc. E7-7629 Filed 4-20-07; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF EDUCATION [CFDA No. 84.336C] Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships AGENCY: Office of Postsecondary Education, Department of Education. ACTION: Notice of intent to fund down the grant slate for the Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships. SUMMARY: The Secretary intends to use the grant slate developed for the Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships in fiscal year
(FY)2005 to make new grant awards in FY 2007. The Secretary takes this action because a significant number of high-quality applications remain on the FY 2005 grant slate. FOR FURTHER INFORMATION CONTACT: Luretha Kelley, U.S. Department of Education, Office of Postsecondary Education, 1990 K Street, NW., room 7906, Washington, DC 20006. Telephone:
(202)502-7645, Fax: 202-502-7699 or e-mail: *luretha.kelley@ed.gov* . If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service
(FRS)at 1-800-877-8339. Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT . SUPPLEMENTARY INFORMATION: Background On March 21, 2005, we published a notice in the **Federal Register** (70 FR 13486) inviting applications for new awards under the Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships. We received a significant number of applications in this competition and made 20 new grant awards. Because such a large number of high-quality applications were received, many applications that were awarded high scores by peer reviewers did not receive funding in FY 2005. The Department estimates that there will be approximately $2.6 million available for new awards under this program in FY 2007. In order to conserve funding that would have been required for a peer review of new applications submitted under the program, we intend to select grantees in FY 2007 from the existing slate of applicants. This slate was developed during the FY 2005 competition using the selection criteria in the March 21, 2005 notice. No changes to the selection criteria will be required by this action. Electronic Access to This Document You may view this document, as well as all other documents of this Department published in the **Federal Register** , in text or Adobe Portable Document Format
(PDF)on the Internet at the following site: *http://www.ed.gov/news/fedregister* . To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at
(202)512-1530. Note: The official version of this document is the document published in the **Federal Register** . Free Internet access to the official edition of the **Federal Register** and the Code of Federal Regulations is available on GPO Access at: *http://www.gpoaccess.gov/nara/index.html* . Program Authority: 20 U.S.C. 1024. Dated: April 18, 2007. James F. Manning, Delegated the Authority of Assistant Secretary for Postsecondary Education. [FR Doc. E7-7684 Filed 4-20-07; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Nevada AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada Test Site. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the **Federal Register** . DATES: Wednesday, May 9, 2007, 5 p.m. ADDRESSES: 7710 West Cheyenne Avenue, Conference Room #130, Las Vegas, Nevada. FOR FURTHER INFORMATION CONTACT: Kelly Snyder, Deputy Designated Federal Officer, P.O. Box 98518, Las Vegas, Nevada 89193. Phone:
(702)295-2836; E-mail: *snyderk@nv.doe.gov.* SUPPLEMENTARY INFORMATION: *Purpose of the Board:* The purpose of the Board is to make recommendations to DOE in the areas of environmental restoration, waste management, and related activities. *Tentative Agenda:* 1. Briefing on Role in Environmental Management Activities, Nevada Division of Environmental Protection. 2. Updates by the Board's working committees. *Public Participation:* The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral presentations pertaining to agenda items should contact Kelly Snyder at the telephone number listed above. The request must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comment will be provided a maximum of five minutes to present their comments. *Minutes:* The minutes of this meeting will be available for public review and copying at the U.S. Department of Energy's Freedom of Information Public Reading Room, 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585 between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. Minutes will also be available by writing to Kelly Snyder at the address listed above. Issued at Washington, DC on April 17, 2007. Rachel Samuel, Deputy Advisory Committee Management Officer. [FR Doc. E7-7652 Filed 4-20-07; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Oak Ridge Reservation AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the **Federal Register** . DATES: Wednesday, May 9, 2007, 6 p.m. ADDRESSES: DOE Information Center, 475 Oak Ridge Turnpike, Oak Ridge, Tennessee. FOR FURTHER INFORMATION CONTACT: Pat Halsey, Federal Coordinator, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831. Phone
(865)576-4025; Fax
(865)576-5333 or e-mail: *halseypj@oro.doe.gov* or check the Web site at *www.oakridge.doe.gov/em/ssab* . SUPPLEMENTARY INFORMATION: *Purpose of the Board:* The purpose of the Board is to make recommendations to DOE in the areas of environmental restoration, waste management, and related activities. *Tentative Agenda:* 6 p.m. Board Business Meeting. 6:30 p.m. 2006 Remediation Effectiveness Report/CERCLA Five-Year Review for the Department of Energy, Oak Ridge Reservation. *Public Participation:* The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Pat Halsey at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comment will be provided a maximum of five minutes to present their comments. *Minutes:* Minutes of this meeting will be available for public review and copying at the Department of Energy's Information Center at 475 Oak Ridge Turnpike, Oak Ridge, TN between 8 a.m. and 5 p.m., Monday through Friday, or by writing to Pat Halsey, Department of Energy Oak Ridge Operations Office, P.O. Box 2001, EM-90, Oak Ridge, TN 37831, or by calling her at
(865)576-4025. Issued at Washington, DC on April 17, 2007. Rachel M. Samuel, Deputy Advisory Committee Management Officer. [FR Doc. E7-7654 Filed 4-20-07; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Office of Science; High Energy Physics Advisory Panel AGENCY: Department of Energy. ACTION: Notice of open meeting. SUMMARY: This notice announces a meeting of the High Energy Physics Advisory Panel (HEPAP). Federal Advisory Committee Act (Public Law 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the **Federal Register** . DATES: Friday, July 13, 2007; 9 a.m. to 6:30 p.m. and Saturday, July 14, 2007; 8:30 a.m. to 1 p.m. ADDRESSES: Hotel Palomar, 2121 P St, NW., Washington, DC. FOR FURTHER INFORMATION CONTACT: John Kogut, Executive Secretary; High Energy Physics Advisory Panel; U.S. Department of Energy; SC-25/Germantown Building, 1000 Independence Avenue, SW., Washington, DC 20585-1290; Telephone: 301-903-1298. SUPPLEMENTARY INFORMATION: *Purpose of Meeting:* To provide advice and guidance on a continuing basis with respect to the high energy physics research program. *Tentative Agenda:* Agenda will include discussions of the following: Friday, July 13, 2007, and Saturday, July 14, 2007. • Discussion of Department of Energy High Energy Physics Program • Discussion of National Science Foundation Elementary Particle Physics Program • Reports on and Discussions of Topics of General Interest in High Energy Physics • Public Comment (10-minute rule) *Public Participation:* The meeting is open to the public. If you would like to file a written statement with the Panel, you may do so either before or after the meeting. If you would like to make oral statements regarding any of these items on the agenda, you should contact John Kogut, 301-903-1298 or *John.Kogut@science.doe.gov* (e-mail). You must make your request for an oral statement at least 5 business days before the meeting. Reasonable provision will be made to include the scheduled oral statements on the agenda. The Chairperson of the Panel will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule. *Minutes:* The minutes of the meeting will be available for public review and copying within 90 days at the Freedom of Information Public Reading Room; Room 1E-190; Forrestal Building; 1000 Independence Avenue, SW.; Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except Federal holidays. Issued at Washington, DC on April 17, 2007. R. Samuel, Deputy Advisory Committee Management Officer. [FR Doc. E7-7645 Filed 4-20-07; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 April 13, 2007. Take notice that the Commission received the following electric corporate filings: *Docket Numbers:* EC07-77-000. *Applicants:* Progress Ventures, Inc.; Constellation Energy Commodities Group, Inc. *Description:* Progress Ventures Inc. and Constellation Energy submit an Application for approval of the disposition of jurisdictional facilities. *Filed Date:* 04/05/2007. *Accession Number:* 20070411-0071. *Comment Date:* 5 p.m. Eastern Time on Thursday, April 26, 2007. *Docket Numbers:* EC07-78-000. *Applicants:* Blue Canyon Windpower, LLC; Blue Canyon Windpower II LLC; Flat Rock Windpower LLC; Flat Rock Windpower II LLC; High Prairie Wind Farm II, LLC; High Trail Wind Farm, LLC; Old Trail Wind Farm, LLC; Telocaset Wind Power Partners, LLC; GS Wind Holdings, LLC; EDP-Energias De Portugal, S.A. *Description:* Wind Project Companies et al submit their joint application for authorization for disposition of jurisdictional facilities and on 4/12/07 amended their filing. *Filed Date:* 04/10/2007; 04/10/07. *Accession Number:* 20070412-0176. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER01-1699-006. *Applicants:* Pilot Power Group, Inc. *Description:* Pilot Power Group, Inc submits its updated market analysis in compliance with the Commission's letter order issued 4/30/01. *Filed Date:* 04/11/2007. *Accession Number:* 20070412-0089. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 2, 2007. *Docket Numbers:* ER03-879-005; ER03-880-005; ER03-882-005. *Applicants:* D.E. Shaw Plasma Power, L.L.C.; D.E. Shaw Plasma Trading, L.L.C.; D. E. Shaw & Co. Energy, L.L.C. *Description:* D.E. Shaw Plasma Power, L.L.C., *et al.* submit a Notice of Non-Material Change in Status. *Filed Date:* 04/11/2007. *Accession Number:* 20070411-5104. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 2, 2007. *Docket Numbers:* ER03-985-002. *Applicants:* El Cap II, LLC. *Description:* El Cap II, LLC re-submits revisions to their 4/2/07 filing of Substitute First Revised Sheet 1 to FERC Electric Rate Schedule 1. *Filed Date:* 04/09/2007. *Accession Number:* 20070412-0075. *Comment Date:* 5 p.m. Eastern Time on Monday, April 30, 2007. *Docket Numbers:* ER06-1349-001. *Applicants:* Southwest Power Pool, Inc. *Description:* Southwest Power Pool, Inc re-submits the revised and re-executed Service Agreements as an amendment to the 8/9/06 filing for Firm Point-to Point Transmission Service with Kansas Municipal Energy Agency. *Filed Date:* 04/05/2007. *Accession Number:* 20070411-0069. *Comment Date:* 5 p.m. Eastern Time on Thursday, April 26, 2007. *Docket Numbers:* ER06-1367-002; ER07-239-001; ER99-1714-005. *Applicants:* BG Dighton Power, LLC; BG Energy Merchants, LLC; Lake Road Generating Company, L.P. *Description:* BG Dighton Power, LLC, BG Energy Merchants, LLC & Lake Road Generating, LP submit notification of change in status to inform the Commission of a non-material departure from the characteristics relied upon. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0101. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER06-706-002. *Applicants:* Entergy Services, Inc. *Description:* Entergy Arkansas, Inc submits report of refunds pursuant to FERC's 3/16/07 Letter Order. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0098. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER07-219-001. *Applicants:* ISO New England Inc. *Description:* ISO New England, Inc. submit its report on requests for cost-based reliability agreements that have been received in anticipation of the elimination of the Peaking Unit Safe Harbor mechanism pursuant to FERC's 1/12/07 Order. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0100. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER07-361-002. *Applicants:* Central Illinois Light Company; Central Illinois Public Service Company; Illinois Power Company. *Description:* Central Illinois Light Company dba AmerenCILCO et al submits an explanation in response to FERC's 3/12/07 letter seeking additional information about the reconfiguration of the Balancing Authorities. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0088. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER07-732-000. *Applicants:* Lake Road Generating Company, L.P. *Description:* Lake Road Generating Company, LP submits an Amendment to its market-based rate schedule, FERC Electric Tariff 1. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0086. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER07-734-000. *Applicants:* Southwest Power Pool, Inc. *Description:* Southwest Power Pool, Inc submits an executed Meter Agent Services Agreement with Kansas Electric Power Cooperative et al. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0097. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. *Docket Numbers:* ER07-735-000. *Applicants:* Exel Power Sources, LLC. *Description:* Exel Power Sources, LLC submits a Petition for acceptance of Initial Tariff, Waivers and Blanket Authority and request for acceptance of FERC Electric Tariff, Original Volume 1 etc. *Filed Date:* 04/10/2007. *Accession Number:* 20070412-0087. *Comment Date:* 5 p.m. Eastern Time on Tuesday, May 1, 2007. Take notice that the Commission received the following public utility holding company filings: *Docket Numbers:* PH07-10-000. *Applicants:* Goldman Sachs Group, Inc. *Description:* FERC Form 65 A Exemption Notification of The Goldman Sachs Group, Inc. *Filed Date:* 04/11/2007. *Accession Number:* 20070411-5060. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 2, 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 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. Kimberly D. Bose, Secretary. [FR Doc. E7-7607 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 April 16, 2007. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER03-421-012. *Applicants:* PPL Wallingford Energy LLC; PPL EnergyPlus, LLC. *Description:* PPL Wallingford Energy LLC and PPL EnergyPlus, LLC submit a compliance Filing pursuant to the Commission's 3/23/07 order. *Filed Date:* 4/12/2007. *Accession Number:* 20070412-5031. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 3, 2007. *Docket Numbers:* ER03-1398-005. *Applicants:* South Carolina Electric & Gas Company. *Description:* South Carolina Electric & Gas Co submits a compliance filing as required by the March 7, 2007 Order. *Filed Date:* 4/6/2007. *Accession Number:* 20070411-0070. *Comment Date:* 5 p.m. Eastern Time on Friday, April 27, 2007. *Docket Numbers:* ER07-721-000. *Applicants:* Idaho Power Company. *Description:* Idaho Power Co. submits its Standard Large Generator Interconnection Agreement filed with Telocaset Wind Power Partners, LLC. *Filed Date:* 4/6/2007. *Accession Number:* 20070411-0068. *Comment Date:* 5 p.m. Eastern Time on Friday, April 27, 2007. *Docket Numbers:* ER07-733-000. *Applicants:* Central Illinois Public Service Company; Central Illinois Light Company; Illinois Power Company; Union Electric Company; Ameren Illinois Utilities. *Description:* Ameren Services Co's et al. submits an application to make sales to affiliates for capacity for the period of 6/1/07-9/30/07. *Filed Date:* 4/11/2007. *Accession Number:* 20070412-0096. *Comment Date:* 5 p.m. Eastern Time on Wednesday, May 2, 2007. *Docket Numbers:* ER07-739-000. *Applicants:* Aquila Long Term, Inc. *Description:* Aquila Long Term, Inc submits a Notice of Cancellation of its FERC Electric Tariff, Original Volume 1, effective 6/11/07. *Filed Date:* 4/12/2007. *Accession Number:* 20070413-0145. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 3, 2007. *Docket Numbers:* ER07-740-000. *Applicants:* Southwestern Electric Power Company. *Description:* Southwestern Electric Power Co submits a Power Supply Agreement for the Requirements Service dated 9/30/05 with Hope Water & Light Commission, Rate Schedule 210. *Filed Date:* 4/12/2007. *Accession Number:* 20070413-0146. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 3, 2007. *Docket Numbers:* ER07-741-000. *Applicants:* Southwestern Electric Power Company. *Description:* Southwestern Electric Power Co submits a Power Supply Agreement for Requirements Service dated 12/13/06 with the City of Bentonville, Arkansas, Rate Schedule 211. *Filed Date:* 4/12/2007. *Accession Number:* 20070413-0147. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 3, 2007. *Docket Numbers:* ER07-742-000. *Applicants:* MidAmerican Energy Company. *Description:* MidAmerican Energy Company submits the Confirmation Letter dated 4/9/07 with the City of Eldridge, Iowa and request waiver of the regulations. *Filed Date:* 4/12/2007. *Accession Number:* 20070413-0148. *Comment Date:* 5 p.m. Eastern Time on Thursday, May 3, 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. Philis J. Posey, Deputy Secretary. [FR Doc. E7-7630 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2230-034-AK] City and Borough of Sitka, AK; Notice of Availability of Environmental Assessment April 17, 2007. In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's regulations, 18 CFR part 380 (Order No. 486, 52 FR 47879), the Office of Energy Projects has reviewed the application for a new license for the Blue Lake Hydroelectric Project, located on Sawmill Creek, near the City of Sitka, Alaska, and has prepared an Environmental Assessment (EA). In the EA, Commission staff analyze potential environmental effects of relicensing the project and conclude that issuing a new license for the project, with appropriate environmental measures, would not constitute a major federal action significantly affecting the quality of the human environment. A copy of the EA is on file with the Commission and is available for public inspection. The EA 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, contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll-free at 1-866-208-3676, or for TTY,
(202)502-8659. Any comments should be filed within 30 days from the issuance date of this notice, and should be addressed to the Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Room 1-A, Washington, DC 20426. Please affix “Blue Lake Project No. 2230-034” to all comments. Comments may be filed electronically via Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “eFiling” link. For further information, contact Tom Dean at
(202)502-6041. Kimberly D. Bose, Secretary. [FR Doc. E7-7662 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Application of Operating Plan and Soliciting Comments, Motions To Intervene, and Protests April 17, 2007. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection: a. *Application Type:* Amendment of license for a change in water surface elevation limits for the upper reservoir. b. *Project No.:* 2360-167. c. *Date Filed:* October 19, 2006. d. *Applicant:* ALLETE, Inc. e. *Name of Project:* St. Louis Project. f. *Location:* The project consisting of five headwater reservoirs and four hydroelectric developments is located in the St. Louis River Basin, in St. Louis and Carlton Counties, Minnesota, and in part on the Fond du Lac Indian reservation. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791a-825r. h. *Applicant Contact:* Mr. Thomas R. Hughes, Supervisor Hydro Operations, 30 West Superior Street, Duluth, MN 55802. Tel:
(218)722-5642, extension 2130. i. *FERC Contact:* Any questions on this notice should be addressed to Vedula Sarma at
(202)502-6190 or *vedula.sarma@ferc.gov* . j. *Deadline for filing comments and/or motions:* May 18, 2007. All documents (original and eight copies) should be filed with: Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. The Commission's Rules of Practice and Procedure require all interveners filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervener 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. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. k. *Description of Request:* Pursuant Article 413 of the license, the licensee filed for Commission approval an Operating Plan for the St. Louis Project. The licensee says that based on consultations with the Federal and State resource agencies and non-governmental organizations, the Plan reflects minor changes to the currently authorized ramping rates, minimum flows and headwater refill elevation at Whiteface development. l. *Locations of the Application:* A copy of the application is available for inspection and reproduction at the Commission's 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. You may also register online at *http://www.ferc.gov/docs-filing/esubscription.asp* to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, call 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. 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. Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. 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. q. 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 at *http://www.ferc.gov* under the “e-Filing” link. Kimberly D. Bose, Secretary. [FR Doc. E7-7663 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests April 17, 2007. Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection: a. *Type of Application:* Competing Preliminary Permit. b. *Project No.:* 12779-000. c. *Date Filed:* February 27, 2007. d. *Applicant:* Pacific Gas and Electric Company. e. *Name of Project:* PG&E Humboldt WaveConnect Project. f. *Location:* The project would be located in the Pacific Ocean off the coast of Humboldt County, California. g. *Filed Pursuant to:* Federal Power Act, 16 U.S.C. 791(a)-825(r). h. *Applicant Contacts:* Mr. Roy Kuga, Vice President—Energy Supply, Pacific Gas and Electric Company, P.O. Box 770000, MC N13-1360, San Francisco, CA 94177, telephone: (415)-973-3806, and Ms. Annette Faraglia, Esq., Pacific Gas and Electric Company, Law Department, P.O. Box 7442, MC B30A-2479, San Francisco, CA 94120, telephone: (415)-973-7145. i. *FERC Contact:* Mr. Chris Yeakel, (202)-502-8132. j. *Deadline for filing motions to intervene, protests and comments:* 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-12779-000) 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. *Competing Application:* Project No. 12780-000, Date Filed: February 28, 2007 Notice Issued: April 6, 2007, Due Date: June 5, 2007. l. *Description of Project:* The proposed project would consist of:
(1)8-200 wave-energy conversion buoys with a generating capacity of 200 kilowatts to 1 megawatt each consisting of;
(2)integrated generators;
(3)anchoring devices; and
(4)interconnection transmission lines. The anticipated annual generation of the project will be approximately 175 gigawatt-hours. m. *Locations of Application:* 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. n. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission. o. 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. p. 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. q. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “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. 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 motion to intervene must also be served upon each representative of the Applicant specified in 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 the “e-Filing” link. The Commission strongly encourages electronic filings. r. 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. E7-7664 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-the Record Communications; Public Notice April 17, 2007. This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications. Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication. Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010. Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v). The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These 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, please contact FERC, Online Support at *FERCOnlineSupport@ferc.gov* or toll free at
(866)208-3676, or for TTY, contact
(202)502-8659. Docket No. Date received Presenter or requester Prohibited: 1. P-1494-000 4-12-07 Jim Thompson. 2. P-1494-307 4-16-07 Burl Lane. 1 Exempt: 1. CP06-54-000 4-2-07 Hon. Richard Blumenthal. 2. CP07-67-000, PF06-22-000 4-11-07 Robbie Cumberland, Jr. 2 3. CP06-354-000 3-29-07 Scott Parker. 4. CP06-354-000 4-12-07 Robert Unternaehrer. 3 5. CP06-365-000 4-2-07 Hon. Ron Wyden. 6. PF07-1-000, PF07-4-000 4-13-07 George M. Moore. 7. PF07-4-000 4-12-07 Karen Gustin. 8. PF07-4-000 4-12-07 Tom Robinson. 4 1 E-mail communication. 2 One of twelve letters from students from Dundalk High School submitted in this docket. 3 Record of phone call to FERC staff. 4 One of three pre-filing comment forms and two additional comments that were a part of one fax submittal. Kimberly D. Bose, Secretary. [FR Doc. E7-7661 Filed 4-20-07; 8:45 am] BILLING CODE 6717-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 8, 2007. **A. Federal Reserve Bank of Dallas** (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272: *1. Harry Lynn and Oksana Williams* , Plano, Texas; to acquire additional voting shares of Snook Bancshares, Inc., Snook, Texas, and indirectly acquire additional voting shares of First Bank of Snook, Snook, Texas. Board of Governors of the Federal Reserve System, April 18, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-7657 Filed 4-20-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 18, 2007. **A. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Broadway Bancorp, Inc.* , Chicago, Illinois; to become a bank holding company by acquiring 100 percent of the voting shares of Broadway Bank, Chicago, Illinois. *2. St. Anne Bancorp, Inc.* , St. Anne, Illinois; to become a bank holding company by acquiring 100 percent of the voting shares of National Bank of Saint Anne, Saint Anne, Illinois. **B. Federal Reserve Bank of Kansas City** (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. Young Partners, L.P., and Young Corporation* ; to indirectly acquire, and Citizens Bancshares Co., all of Chillicothe, Missouri, to directly acquire, additional voting shares for a total of 22.1 percent of the voting shares of First Community Bancshares, Inc., Overland Park, Kansas, and thereby indirectly acquire additional voting shares of First Community Bank, Lee's Summit, Missouri. Board of Governors of the Federal Reserve System, April 18, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-7656 Filed 4-20-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Vaccine Advisory Committee AGENCY: Department of Health and Human Services, Office of the Secretary. ACTION: Notice. SUMMARY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services
(DHHS)is hereby giving notice that the National Vaccine Advisory Committee
(NVAC)will hold a meeting by conference call. The meeting is open to the public. DATES: The meeting will be held on May 11, 2007, from 1 p.m. to 2:30 p.m. ADDRESSES: This meeting will be held by conference call. FOR FURTHER INFORMATION CONTACT: Ms. Emma English, Program Analyst, National Vaccine Program Office, Department of Health and Human Services, Room 443-H Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201;
(202)690-5566, *nvpo@hhs.gov.* SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public Service Act (42 U.S.C. Section 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Assistant Secretary for Health, as the Director of the National Vaccine Program, on matters related to the program's responsibilities. This is a special meeting of the NVAC. Discussions will surround a draft document titled “The Promise and Challenge of Adolescent Immunization,” prepared at the request of the Assistant Secretary for Health by the Committee's Adolescent Immunization Working Group. The Committee will review the draft document and the Committee will vote to either endorse the document as an official NVAC report or request that further revisions be made to the document by the Working Group. A copy of this draft document can be found on the World Wide Web ( *http://www.hhs.gov/nvpo* ) or by contacting the contact person identified above. For this special meeting, remote participation will be made available via a toll-free call-in phone number. This call-in number can be obtained from the contact person identified above and will be operator assisted to provide members of the public the opportunity to provide comments to the Committees. Members of the public will have the opportunity to provide comments at the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed written comment made available to the Committee members should submit materials to the Executive Secretary, NVAC, through the contact person listed above prior to close of business May 7, 2007. Any written materials submitted by the public that are to be discussed by the Committee will be made available via the World Wide Web ( *http://www.hhs.gov/nvpo* ) prior to the meeting. Dated: April 17, 2007. Raymond Strikas, Medical Advisor, National Vaccine Program Office. [FR Doc. E7-7682 Filed 4-20-07; 8:45 am] BILLING CODE 4150-44-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Assistant Secretary for Preparedness and Response; HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats AGENCY: Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services ACTION: Notice. SUMMARY: The United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)—chemical, biological, radiological, or nuclear (CBRN)—by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. The HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) has taken a holistic, end-to-end approach that considers multiple aspects of the medical countermeasures mission including research, development, acquisition, storage, maintenance, deployment, and guidance for utilization. Phase one of this approach established the *HHS PHEMCE Strategy for Chemical, Biological, Radiological, and Nuclear Threats (HHS PHEMCE Strategy).* The HHS PHEMCE Strategy, published in the **Federal Register** on March 20, 2007, described a framework of strategic policy goals and objectives for identifying medical countermeasure requirements and establishing priorities for medical countermeasure evaluation, development and acquisition. These strategic policy goals and objectives were used to establish the Four Pillars upon which this *HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan (HHS PHEMCE Implementation Plan)* is based. The *HHS PHEMCE Implementation Plan* considers the full spectrum of medical countermeasures-related activities, including research, development, acquisition, storage/maintenance, deployment, and utilization. The *HHS PHEMCE Implementation Plan* is consistent with the President's *Biodefense for the 21st Century* and is aligned with the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction.* DATES: This notice is effective as of April 16, 2007. FOR FURTHER INFORMATION CONTACT: Dr. Susan Coller, Policy Analyst, Office of Public Health Emergency Medical Countermeasures, Office of the Assistant Secretary for Preparedness and Response at 330 Independence Ave., SW., Room G640, Washington, DC 20201 or by phone 202-260-1200. HHS PHEMCE Approach to Medical Countermeasures The United States faces serious public health threats from the deliberate use of chemical, biological, radiological, or nuclear
(CBRN)threat agents by hostile states or terrorists, and from naturally emerging infectious diseases that have the potential to cause illness on a scale that would impact national security. Within the Federal government, the mission of the Department of Health and Human Services
(HHS)is to protect the civilian population by providing leadership in research, development, acquisition, deployment, and guidance for effective use of medical countermeasures for mitigation of CBRN events. This key role was identified in the * National Strategy to Combat Weapons of Mass Destruction * , 1 *Biodefense for the 21st Century,* 2 and the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction* , 3 which together comprise the national blueprint for addressing CBRN defense. 1 *www.whitehouse.gov/news/releases/2002/12/WMDStrategy.pdf.* 2 *www.whitehouse.gov/homeland/20040430.html.* 3 *www.whitehouse.gov/news/releases/2007/02/20070207-2.html.* The HHS Public Health Emergency Medical Countermeasures Enterprise (HHS PHEMCE) leads the mission to develop and acquire medical countermeasures that will improve public health emergency preparedness as well as prevent and mitigate the adverse health consequences associated with CBRN and naturally occurring threats. HHS PHEMCE is a coordinated, intra-agency effort led by the Office of the Assistant Secretary for Preparedness and Response
(ASPR)and includes three HHS internal agencies: The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Additionally, HHS PHEMCE collaborates with its *ex officio* members: The Department of Defense (DOD), the Department of Homeland Security (DHS), the Department of Veterans Affairs
(VA)and other interagency stakeholders as appropriate. The *HHS PHEMCE Implementation Plan for CBRN Threats* addresses twelve biological threat agents, a class of chemical threats (volatile nerve agents) and radiological and nuclear threats. The medical countermeasure programs described will involve the full range of activities from research through advanced development, acquisition, storage, maintenance, deployment and utilization and will include all of the PHEMCE. However, the detailed focus of this Plan will be on the acquisition phase using the remaining funds available under Project BioShield, recognizing that significant efforts both upstream and downstream of the acquisition will be required to ensure the successful development, maintenance and utilization of these critical response assets, that may be needed in the event of a public health emergency. The *HHS PHEMCE Implementation Plan for CBRN Threats* excludes pandemic influenza, which is addressed in the *HHS Pandemic Influenza Plan.* The *HHS Pandemic Influenza Plan* includes an overview of the threat of pandemic influenza, a description of the relationship of the *HHS Pandemic Influenza Plan* to other Federal plans, and an outline of key roles and responsibilities during a pandemic. It is aligned with the *National Strategy for Pandemic Influenza* , issued by President George W. Bush on November 1, 2005, and the *Implementation Plan for the National Strategy for Pandemic Influenza* , which guides the Nation's preparedness and response to an influenza pandemic. Significant progress has been made in the development and acquisition of medical countermeasures for pandemic influenza. Additional detailed information is available at *http://www.pandemicflu.gov.* Current State of Medical Countermeasure Preparedness To date, HHS has significantly expanded national medical countermeasure preparedness utilizing significant investments from throughout the HHS PHEMCE, including NIH research and development; CDC Division of the Strategic National Stockpile
(DSNS)acquisition, storage, and maintenance of medical countermeasures; and substantive technical and regulatory support provided by FDA to product developers. Funding support by the NIH for basic research, product development, and clinical research of CBRN medical countermeasures has increased dramatically between Fiscal Year 2001 (FY 2001) to FY 2006. Funding for the DSNS has increased more than ten-fold in that same period, providing for the acquisition and stockpiling of medical countermeasures and supplies to protect the American public. Furthermore, the Project BioShield Act of 2004 (Pub. L. 108-276) 4 (Project BioShield) was enacted to accelerate the acquisition and availability of safe and effective medical countermeasures to protect the United States from CBRN threats. Project BioShield created a $5.6 billion Special Reserve Fund
(SRF)for use over 10 years (FY 2004-FY 2013) to acquire appropriate medical countermeasures for DSNS. 4 *http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=108_cong_public_laws&docid=f:publ276.108.pdf.* During its first two years of implementation, Project BioShield acquisitions were guided by requirements derived from interagency deliberations in 2003 that involved Cabinet-level Departments and the Executive Office of the President. Under this initial strategy, HHS pursued acquisitions for those highest priority threats for which there were candidate products at relatively advanced stages of development and for which there were opportunities to have a significant impact on improving preparedness. These products included medical countermeasures for anthrax, smallpox, botulinum toxins, and radiological/nuclear agents—the four threat agents initially determined by DHS to pose a material threat to national security. 5 Acquisitions under Project BioShield to date include the currently licensed anthrax vaccine, anthrax therapeutics (monoclonal and human immune globulin), a pediatric formulation of potassium iodide to protect against absorption of radioactive iodine, calcium and zinc diethylenetriaminepentaacetate (DTPA), chelating agents to treat ingestion of certain radiological particles, and botulinum antitoxin. 5 The Project BioShield Annual Report to Congress July 2004-July 2006 is available at *http://www.hhs.gov/aspr/ophemc/bioshield/bioshieldreport/index.html* Additional acquisitions of medical countermeasures for the DSNS have also provided a substantial preparedness level for a number of material threats. Specifically, DSNS inventory includes smallpox vaccine to immunize every American and Vaccinia Immune Globulin to treat complications that may arise from smallpox vaccination; anthrax therapeutics and a substantial level of antibiotics to provide treatment (thousands of doses) or prophylaxis (millions of doses) for bacterial threat agents anthrax, plague and tularemia; thousands of treatment courses of the chelating agent Prussian Blue (which mitigates internal absorption of cesium-137, a component of dirty bombs); enough potassium iodide tablets (which protects against radioactive iodine) for over one million people; thousands of courses of growth factors that could be useful for addressing the hematopoietic effects of acute radiation syndrome (ARS); CHEMPACKs (pre-positioned antidotes for volatile nerve agent exposure) distributed throughout the country; and general supplies that will be required to treat the complex array of medical problems following a nuclear attack, including antibiotics, anti-nausea drugs, and large quantities of supplies to treat burn and blast injuries. Some of these stockpiled products are licensed, approved, or cleared by FDA for use as medical countermeasures. Others are investigational and would need to be used under an Investigational New Drug application or an Emergency Use Authorization 6 . In 2002, DSNS began participating in the Shelf Life Extension Program
(SLEP)with FDA. SLEP allows the extension of the expiration date of certain drugs in DSNS where adequate supporting data exist, so that critical medical countermeasures that are still safe and effective can continue to be used. 6 See *http://www.FDA.gov* for further information regarding the Investigational New Drug application and the Emergency Use Authorization HHS has also acted to improve and strengthen the underlying national response capacity and distribution efficiency that is required to take full advantage of these stockpiled medical countermeasures. HHS has specifically worked to prepare public health systems for bioterrorism and other mass casualty incidents; expand America's public health laboratory capacity, a crucial element in detecting and understanding any disease outbreak; expand and improve communications capacity within the public health structure to make public communications clearer and faster in an emergency; enhance food defense and safety activities at the FDA; expand the biodefense research program at NIH; and address response capacity for at-risk populations including children, pregnant women, senior citizens and other individuals who have special needs in the event of a public health emergency, as determined by the Secretary. 7 7 As defined in the Pandemic and All-Hazards Preparedness Act (P.L.109-417), which is available at *http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ417.109.pdf.* Development of the HHS PHEMCE Implementation Plan For Chemical, Biological, Radiological and Nuclear Threats HHS approached the development of the *HHS PHEMCE Implementation Plan* recognizing that the past investments outlined above have resulted in an armamentarium of medical countermeasures in DSNS that provides a substantial preparedness level for a number of CBRN threats. HHS recognizes that while it was important to achieve the current level of preparedness, it is equally as important to maintain and improve this capability. HHS PHEMCE has taken a holistic, end-to-end approach that considers multiple aspects of the medical countermeasures mission including research, development, acquisition, storage, maintenance, deployment, and guidance for utilization. Phase One of this approach established the *HHS Public Health Emergency Medical Countermeasures Enterprise Strategy for Chemical Biological, Radiological and Nuclear Threats (HHS PHEMCE Strategy* ). 8 The September 2006 BioShield Stakeholders Workshop brought together stakeholders from all aspects of the mission to discuss the framework and approach for the *HHS PHEMCE Strategy.* The valuable input solicited from stakeholders at the Workshop, combined with the responses received to the medical countermeasures Request for Information issued in October 2006 9 and through the **Federal Register** , was incorporated into the *HHS PHEMCE Strategy.* 8 Available at *http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2007_register&docid=%5bDOCID:fr20mr07-65.* 9 *http://www.fbo.gov/servlet/Docments/R/589030.* *The HHS PHEMCE Strategy* , published in the **Federal Register** on March 20, 2007, described a framework of strategic policy goals and objectives for identifying medical countermeasure requirements and establishing priorities for medical countermeasure evaluation, development and acquisition. These strategic policy goals and objectives were used to establish the Four Pillars upon which this *HHS PHEMCE Implementation Plan* is based. Pillar One: Identify and Assess CBRN Threats DHS leads the Federal response to National Response Plan incidents, conducts integrated assessments of the risks posed by CBRN agents, and issues Material Threat Determinations
(MTDs)as to which CBRN pose a material threat sufficient to affect U.S. national security. 10 The Secretary of Homeland Security has issued MTDs for threat agents (Table 1) and has conducted Population Threat Assessments
(PTA)to estimate the number of individuals who might be exposed to each of these threats in plausible, high-consequence scenarios. A Population Threat Assessment has been conducted for volatile nerve agents. 10 Material Threat Determinations are authorized under section 319 F-2(c)(2) of the Public Health Service Act, as added by section 3 of the Project BioShield Act and are a legally required precursor to procurements under that authority. In the future, additional MTDs may be issued if technology advances or if our understanding of the potential threats changes. The PHEMCE strategy is to have specific medical countermeasures that address each of the threats for which an MTD has been issued while also providing broad spectrum medical countermeasures to address as many as is practicable of those threats that did not rise to the level of an MTD. EN23AP07.000 Pillar Two: Assess Medical/Public Health Consequences The information supporting the MTDs and PTAs regarding population exposures from high consequence scenarios provided by DHS is used by HHS to inform subsequent medical and public health consequence assessments using multiple sources of information, including modeling. HHS uses modeling to help to explore potential outcomes when medical countermeasures are employed in operationally realistic timelines. The HHS assessments provide public health impact estimates for a given threat scenario and use of medical countermeasures for each threat agent. Pillar Three: Establish Medical Countermeasure Requirements That Incorporate Assessments of Current Levels of Preparedness, Concepts of Utilization, and Product Specifications Our current state of preparedness and medical countermeasure requirements have been assessed for these fourteen CBRN threats. To establish medical countermeasure requirements for the top priority threat agents, HHS combines the threat prioritization and medical and public health consequence assessments, along with subject matter expert evaluations, domestic and international intelligence information, and information on current State, local and tribal response capabilities. Pillar Four: Identify and Prioritize Near-, Mid-, and Long-Term Development and Acquisition Programs, Informed by Assessment of the Maturity of the Product Development Pipeline and Estimated Costs The mission to develop and acquire agent-specific medical countermeasures for the entire U.S. population for all fourteen threats and broad spectrum medical countermeasures against the remaining current and future threats encompasses a vast range of activities and dictates priority-setting. The process for setting the priorities for the portfolio of investments ultimately outlined in this plan required careful consideration and deliberation. Specifically, HHS PHEMCE evaluated three possible approaches during the priority setting process. The first option was to focus only on a single, highest priority threat. In line with this, all available acquisition dollars would be spent trying to fully address the requirements for this one agent with the aim of eliminating it as a material threat to national security. The second option was to divide the available resources equally among the known fourteen threats. The third option, and the approach that the PHEMCE ultimately pursued, was to prioritize strategic policy decisions, framed by the *HHS PHEMCE Strategy* , which will most effectively improve overall public health preparedness. This decision-making process to set priorities included extensive discussion with Federal government subject matter experts 11 and was guided by the principles of the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction.* As a result, HHS has prioritized the medical countermeasures programs—including, research, development, and acquisition in the near-term, mid-term and long-term—that were determined to provide the greatest opportunities to improve public health emergency preparedness across the threat spectrum. 11 Including subject matter experts from HHS (CDC, FDA, and NIH), DOD, DHS, VA, and the respective HHS PHEMCE Chemical, Biologics, Radiological and Nuclear Working Groups. The key elements that established the foundation for the priority-setting decisions were as follows: Prevention Versus Mitigation and Treatment HHS has generally adopted a strategy of developing and acquiring medical countermeasures for post-event response to CBRN threats. Preventive measures are appropriate only for threats of such potential catastrophic consequence that a pre-event strategy will be examined in order to reduce vulnerability and mitigate post-event consequences. Therapeutics and diagnostics or the use of post-event prophylaxis will be the preferred strategy for all other threats. Priority will be placed on medical countermeasures that focus on post-event prophylaxis or post-exposure treatment. Concept of Operations In alignment with the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction* , HHS will prioritize the development and acquisition of medical countermeasures that are associated with an effective concept of operations (CONOPs). These CONOPs include a deployment strategy and utilization policy that is supportable by the present and future programmed distribution capabilities of Federal, State, local, and tribal public health emergency responders to rapidly ship and distribute critical items following a CBRN event. Within HHS, ASPR coordinates with the CDC Coordinating Office for Terrorism Preparedness and Emergency Response (COPTER) in determining processes, procedures, tactics, and techniques for how DSNS deploys countermeasures 12 and the utilization strategies for those materials and medical countermeasures. ASPR's Office of Preparedness and Emergency Operations
(OPEO)works with its response partners, using event and response modeling, to outline how the current DSNS inventory will be used. These approaches are exercised with interagency partners to ensure that the plans are based on realistic and achievable timelines. 12 The authority of the Secretary of HHS to deploy the SNS is codified at 42 U.S.C. § 247d-6b. The CONOPs for a particular threat scenario and medical countermeasure are a crucial component in setting specific product requirements and contribute directly to the acquisition strategy. While there is much in common in medical countermeasure development for civilian and military medical countermeasures, CONOPs for HHS and DOD, respectively, have differences which must be considered in the requirements and acquisitions processes. HHS is committed to continuing to work with all its emergency responder partners to improve public health response capabilities. Broad Spectrum Medical Countermeasures and Platform Technologies A fixed defense 13 or “one-bug, one-drug” approach for medical countermeasure development is determined to be effective and viable for some of the highest priority threats such as smallpox and anthrax. As the list of material threats increases, and technology advances, HHS will be focusing its medical countermeasure research, development and acquisition efforts on broad spectrum and platform approaches. 13 Relman DA. Bioterrorism—Preparing to Fight the Next War, NEJM, 2006, 354(2):113-115. In the context of defense against biological threats, a fixed defense is a medical countermeasure intended for use against a specific organism and not useful in scenarios that employ a different organism. Preparing for New Threats In order to address emerging, enhanced, and advanced threats, 14 HHS will be investing in research and development on innovative approaches and platform technologies. 15 These technologies will facilitate rapid identification and characterization of novel threat agents, thereby creating the capability to rapidly produce relevant medical countermeasures. This policy is aligned with the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction* which targets the use of existing, proven approaches for developing medical countermeasures to address challenges posed by traditional CBRN agents while calling for a flexible capability to develop new medical countermeasures. These latter activities emphasize the need to capitalize upon the development of innovative and future technologies that will enhance our ability to respond swiftly and effectively to potential, emerging, and future unknown CBRN threats. This will require targeted, balanced, and sustained investments to support fundamental basic research to discover new technologies and update platforms as well as applied research for technology development to deliver new medical capabilities and countermeasures. 14 As defined in the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction:* Enhanced Agents are traditional agents that have been modified or selected to enhance their ability to harm human populations or circumvent current countermeasures, such as a bacterium that has been modified to resist antibiotic treatment; Emerging Agents are previously unrecognized pathogens that might be naturally occurring and present a serious risk to human populations, such as the virus responsible for Severe Acute Respiratory Syndrome (SARS); and Advanced Agents are novel pathogens or other materials of biological nature that have been artificially engineered in the laboratory to bypass traditional countermeasures or produce a more severe or otherwise enhanced spectrum of disease. 15 Examples of platform technologies include strategies that permit rapid commercial scale production of threat-specific countermeasures or expression systems that permit rapid production of new vaccines. Top Priority Medical Countermeasure Research, Development, and Acquisition Programs to Increase Public Health Emergency Preparedness Following the principles and processes described above, HHS has assessed the top priority CBRN threats from a medical countermeasure perspective and has developed medical countermeasure acquisition priorities for the near-term (FY 2007-FY 2008), the mid-term (FY 2009-FY 2013), and, in less detail, the long-term (beyond FY 2013). 16 This prioritization spans the CBRN threat spectrum and best utilizes available resources in addressing the highest priority threats to maximize risk mitigation. Table 2 arrays the top priority medical countermeasure programs against the specific threat agents addressed by the program. The broad spectrum antibiotic, broad spectrum antiviral, and diagnostics programs address multiple threat agents, while other programs are, of necessity, agent-specific. 16 SRF that supports Project BioShield released $3.4 billion for use between FY 2004-2008 and the remaining $2.2 billion will be available for use between FY 2009-2013. Medical countermeasure requirements are based primarily on the number of persons exposed to clinically significant levels of a threat agent in a single-event, plausible, high-consequence scenario. In setting appropriate targets for an acquisition program, a number of factors in addition to the single event, exposure-based medical countermeasure requirement could be considered, including: • Multiple events • Citizens concerned about exposure 17 17 Non-exposed population seeking medical care for non-specific symptoms or concerns about exposure. • The lack of availability of rapid, point-of-care diagnostics • Potential nationwide demand after a single large-scale event • Pre-positioning of individual medical countermeasures to meet specific response time requirements • Economies of scale for production 18 18 A production process in which an increase in the number of units produced causes a decrease in the average cost of each unit. • Providing a target acquisition size sufficient to drive industrial development of the medical countermeasure. HHS will continue to coordinate medical countermeasure development and acquisition efforts with DOD; however, separate development and acquisition programs may be necessary in situations where military requirements differ from civilian requirements, including with regard to concepts of use of particular countermeasures. Consistent with the National Strategy for *Medical Countermeasures against Weapons of Mass Destruction* , the Secretary of Health and Human Services is tasked with civilian medical countermeasure preparedness, and it is National policy that “the Secretary of Defense shall retain the exclusive responsibility for research, development and acquisition of medical countermeasures to prevent or mitigate the health effects of WMD threats * * * to the Armed Forces.” 19 19 *www.whitehouse.gov/ news/releases/2007/ 02/20070207-2.html* . BILLING CODE 4150-37-P EN23AP07.001 Strategies for Addressing High Priority Medical Countermeasures Research and Development NIH is the lead agency within the Federal Government for conducting and supporting biomedical research relating to causes, diagnosis, treatment, control, and prevention of diseases. NIH will align research and development efforts with the PHEMCE priority medical countermeasure programs. In addition, NIH will support Research and Development for next-generation products to replace currently-held medical countermeasures in DSNS, as needed. These next generation products include medical countermeasures with broad spectrum activity against a wide variety of threat agents; broad spectrum technologies that enhance effectiveness of multiple classes of medical countermeasures; and broad spectrum platforms that permit more rapid generation of required medical countermeasures. Continued research and development efforts will ensure a sustainable, continuous stream of promising medical countermeasures in the pipeline that are aligned with top priority HHS PHEMCE requirements for future acquisitions and/or replacement of DSNS inventory. NIH's long-term focus is on platform technologies and broad spectrum medical countermeasures that will allow for the rapid introduction of additional response capabilities for emerging infectious agents. Advanced Development 20 20 The Pandemic and All-Hazards Preparedness Act (Pub. L. 109-417) definition of advanced research and development: “with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly are conducted after basic research and preclinical development of the product; and are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act or under section 351 of this Act.” The use of advanced development efforts that support multiple candidates for each medical countermeasure need is a key element to mitigating risk in the Project BioShield acquisition phase of the product development pathway. The Pandemic and All-Hazards Preparedness Act (Pub. L. 109-417) established the Biomedical Advanced Research and Development Authority (BARDA). Utilizing those tools, HHS plans to promote innovation, reduce risk to both medical countermeasure developers and the Government, and invest in medical countermeasure advanced development that will carry products through the crucial middle phase 21 of drug development between basic research and acquisition of final products. HHS anticipates that available funding through these authorities, in FY 2007 and beyond, will be aligned with the highest priority medical countermeasure development programs. Finally, Advanced Development activities will depend on congressional approval of the President's FY 2008 budget request of $189 million. The future funding levels for BARDA remain to be determined. 21 Often referred to as the “Valley of Death.” Projected Acquisitions The HHS PHEMCE will consider opportunities for acquiring medical countermeasures using both DSNS appropriations as well as SRF monies under Project BioShield. Acquisitions under DSNS will be limited to commercially available products. Current funding levels were considered in projecting acquisition forecasts. While BARDA funding has been established to support the advanced development of medical countermeasures, Project BioShield acquisition contracts may still include late-stage development costs for scale-up manufacturing, clinical trials, and pivotal animal efficacy studies, in addition to final production and delivery. The near-term is defined as FY 2007-FY 2008, which is the time frame of allocation of approximately half of the Project BioShield SRF. The mid-term is defined as FY 2009-FY 2013, which is the remainder of the ten year duration of the Special Reserve Fund. Medical countermeasures will be procured in the near-term and mid-term using both the SRF as well as from the DSNS appropriations. During the near-term, HHS also will pursue acquiring a number of medical countermeasures for which utilization of the Project BioShield Special Reserve Fund has been approved, but for which funds have not yet been fully obligated. Table 3 summarizes the proposed near-term and mid-term acquisitions for the priority medical countermeasures. In some cases, the estimated funding ranges indicated are based on identified potential medical countermeasure candidates currently under development; whereas in other cases the estimated ranges are based on industry standard information for vaccine and drug development costs. Descriptions of the acquisitions for priority medical countermeasures follow Table 3. EN23AP07.002 PROJECTED NEAR-TERM (FY 2007-FY 2008) Medical Countermeasure Development and Acquisition Programs To Enhance Preparedness Programs for Biological Threats Broad Spectrum Antibiotic(s) MTD: *Bacillus anthracis and multi-drug resistant bacillus anthracis, burkholderia mallei, burkholderia pseudomallei, franciscella tularensis, rickettsia prowazekii, yersinia pestis.* Many of MTDs address bacterial species that can be treated using antibiotics. Broad spectrum antibiotics, therefore, will continue to be a critical component of strategy HHS will take to maintain and improve public health preparedness. For each biological threat agent or class of agents, however, there is a limited array of antibiotics with demonstrated efficacy. In the near-term, HHS will continually evaluate the antibiotics in the DSNS and, as needed, will acquire commercially available antibiotics using DSNS appropriations. Anthrax Vaccine(s) MTD: *Bacillus anthracis, multi-drug resistant bacillus anthracis.* Antibiotics represent the first line of defense to protect the nation following an anthrax attack. However, anthrax vaccines are also an essential element of our national preparedness. Vaccines may be given as post-exposure prophylaxis in combination with antibiotics to potentially provide longer-term protection; this combination may also allow for a reduction in the duration of the antibiotic regimen. Vaccines can also provide pre-event protection to the relatively small population that is at high risk of frequent occupational exposure to *Bacillus anthracis.* In December 2006, a contract for the development and acquisition of a recombinant Protective Antigen
(rPA)anthrax vaccine was terminated by HHS; however, the Department remains committed to acquiring next-generation anthrax vaccines that will be part of a balanced and diversified portfolio of medical countermeasures. HHS has developed a comprehensive strategy for advanced development and acquisition of current and next generation anthrax vaccines and anticipates that these activities will be pursued in the near-term. Smallpox Vaccine(s) MTD: *Variola virus.* HHS has made significant progress in providing smallpox vaccine to the DSNS. In addition, a requirement has been established for a smallpox vaccine to protect immunocompromised persons for whom use of the existing smallpox vaccines is medically contraindicated in the absence of smallpox exposure. One candidate next-generation smallpox vaccine, modified vaccinia Ankara (MVA), is based on a strain of the vaccinia virus that, in contrast to current smallpox vaccines such as Dryvax, does not replicate effectively in human cells and, therefore, may cause fewer side effects. The MVA development programs were supported by the National Institute of Allergy and Infectious Diseases (NIAID) with milestone-driven contract awards in 2003 and 2004. HHS is well-advanced in the pre-award stage of an MVA vaccine acquisition program. Programs for Radiological and Nuclear Threats ARS/Hematopoietic Syndrome Medical Countermeasure(s) MTD: *Radiological/nuclear agents.* HHS regards radiological and nuclear agents as a significant threat to national security and is committed to purchasing safe and efficacious medical countermeasures to treat Acute Radiation Syndrome (ARS). In March 2007, HHS withdrew the ARS RFP because it was determined, after extensive scientific and technical expert evaluation, that no competing offeror had a product that met USG requirements for a Project BioShield acquisition. HHS will continue to pursue an initial acquisition of a safe and effective medical countermeasure to treat ARS. In moving forward to meet this goal, HHS will make use of scientific developments that have occurred since the previous RFP closed, as well as new authorities provided by the Pandemic and All-Hazards Preparedness Act that could accelerate the advanced development of promising countermeasures. HHS supports further development of the radiological and nuclear medical countermeasure pipeline. The NIAID's Radiation Countermeasures Research Program has funded numerous projects, including: ARS medical countermeasure screening programs in cell-based and rodent models at multiple institutions around the country; development of three Good Laboratory Practices
(GLP)animal testing facilities to evaluate the efficacy of medical countermeasures against ARS; eight Centers for Medical Countermeasures against Radiation at academic institutions around the country; and intramural research programs at the DOD Armed Forces Radiobiology Research Institute (AFRRI) and the National Cancer Institute. PROJECTED MID-TERM (FY 2009-FY 2013) Medical Countermeasure Development and Acquisition Programs To Enhance Preparedness HHS will pursue the following medical countermeasure acquisitions in the mid-term using the remaining SRF and pending availability of other funding for those acquisitions that do not use the SRF. These anticipated acquisitions are also predicated on the availability of products at the appropriate developmental stage that meet U.S. Government civilian requirements. Programs for Biological Threats The ideal medical countermeasures for biological agents will be highly effective for post-exposure prophylaxis as well as early symptomatic treatment, will display an excellent safety profile and could be easily self-administered. Broad Spectrum Antibiotic(s) MTD: *Bacillus anthracis, multi-drug resistant bacillus anthracis. burkholderia mallei, burkholderia pseudomallei, francisella tularensis, rickettsia prowazekii, yersinia pestis.* In addition to the near-term strategy for acquisition of commercially available antibiotics, HHS anticipates maintaining a robust basic research and development program along with advanced development for broad spectrum antimicrobials that will specifically provide support for regulatory approval for clinical indications that address bacterial agent MTDs. In order to better balance antimicrobial DSNS holdings in light of newer MTDs, HHS will pursue a potential acquisition of additional broad spectrum antimicrobials in the mid-term. Diagnostics (Point-of-Care) MTD: *All biological threat agents.* Following a terrorist event, clinical diagnostic assays ( *in vitro* diagnostics, IVDs) are critical tools for distinguishing infected (symptomatic) individuals needing treatment from potentially exposed but asymptomatic individuals needing post-exposure prophylaxis. Overall, the requirements for diagnostic assays to facilitate a response to a bioterrorism event will focus on rapid, point-of-care assays. Rapid triaging of the symptomatic patients will be required to provide, as necessary, treatment, isolation and implementation of universal precautions for infectious diseases and may also be useful in the allocation of limited critical therapeutic materials to only those patients in need. Multiplexed, adaptive platforms that confer flexibility, offer alternative commercial opportunities, and allow for the rapid introduction of additional tests for emerging infectious agents are highly desired. These IVDs used for clinical purposes are distinguished from detection assays used for environmental samples (air, water, food, surface swabs) in that they are required to be approved or cleared by the FDA. To date, limited incentives have been available to sustain commercial market production of IVDs; however, once specific requirements in this area are developed and prioritized, HHS will pursue a potential mid-term acquisition of biological agent diagnostics to enhance public health preparedness capability. Anthrax Antitoxin MTD: *Bacillus anthracis, multi-drug resistant bacillus anthracis.* The primary mortality and morbidity of anthrax disease is mediated through toxins produced by the bacteria, B. *anthracis.* Antibiotics (currently within DSNS) target the B. *anthracis* bacteria itself; while vaccines (discussed under Near-Term Acquisitions) provide long-term protection from disease. Antitoxins are required to neutralize the effects of the toxins and may contribute to a more successful therapeutic outcome. Given the current status of anthrax antitoxins and animal model development, HHS will continue its phased acquisition program and will pursue a mid-term acquisition of additional anthrax antitoxin to allow HHS to more fully meet medical countermeasure requirements, including to address the threat from MDR anthrax. Filovirus Medical Countermeasure(s) MTD: *Ebola virus, marburg virus.* Infection with filoviruses produces an aggressive disease that is highly lethal. Currently, no FDA-approved filovirus-specific medical countermeasures exist. An antiviral is preferred to treat infected patients and to provide pre-exposure prophylaxis to health care workers and personal contacts. A vaccine will be useful for civilian populations if it provides rapid onset of protective immunity. HHS will continue to invest in research and development and will pursue an acquisition for filovirus medical countermeasures in the mid-term. Smallpox Antiviral MTD: *Variola virus.* Currently there is no treatment available for smallpox disease once the symptoms manifest. An effective antiviral treatment could mitigate the effects of smallpox disease. It is likely that such an antiviral may also be effective against other pox viruses. Given the current status of the most advanced products as well as the status of animal model development, HHS will pursue a mid-term acquisition of a smallpox antiviral for the treatment of smallpox. The ideal antiviral will be highly effective post-exposure as well as an effective treatment early in the symptomatic phase of the disease. Programs for Radiological and Nuclear Threats ARS/DEARE Medical Countermeasure(s) MTD: *Radiological/nuclear agents.* Acute Radiation Syndrome
(ARS)often called radiation sickness, results when humans are exposed to a large dose of ionizing radiation. ARS develops in the timeframe of hours to weeks, and the Delayed Effects of Acute Radiation Exposure (DEARE) injury in weeks to months following radiation exposure. HHS will pursue one or more ARS/DEARE medical countermeasure acquisition(s) in the mid-term to continue the phased acquisition strategy launched in the near-term. Biodosimetry and Bioassay MTD: *Radiological/nuclear agents.* Biodosimetry and radionuclide bioassay capabilities are essential for medical management of ARS/DEARE following acute radiation exposure and are integral to triage and management processes. HHS anticipates that rapid biodosimetry assays for on-scene triage should be available for acquisition in the mid-term. A system of biodosimetry and radionuclide bioassay laboratories is also proposed to increase overall national capacity. While the diagnostics portion of this requirement may be funded through the Project BioShield SRF, appropriate funding to establish this laboratory network is yet to be determined. Radionuclide-Specific Medical Countermeasure(s) MTD: *Radiological/nuclear agents.* Radionuclide-specific medical countermeasures are a key component to managing the medical consequences of radiation dispersal device
(RDD)events, both explosive and non-explosive, as well as nuclear power plant events. In the near term, HHS will continue to fund the development of improved formulations of diethylenetriaminepentaacetate
(DTPA)and other novel decorporating agents that remove radioactive particles from the body. If continued progress is made on the radionuclide-specific countermeasures currently under development, it is conceivable that oral formulations of DTPA (which would considerably ease the logistical requirements for rapid delivery of this medical countermeasure) and/or other novel decorporating agents could be available for acquisition in the mid-term. Programs for Chemical Threats Enterprise CHEMPACKs PTA: *Volatile nerve agents.* The CHEMPACK program is an ongoing initiative of the DSNS, begun in 2003, that provides antidotes (three countermeasures used concomitantly) to volatile nerve agents for pre-positioning by State, local, and/or tribal officials throughout the U.S. In its current form, the program will receive continued funding in the near-term for procurement and fielding of additional CHEMPACKs, replacement of expired product, and administrative support. The proposed Enterprise CHEMPACK program would build upon the existing system, improving it by adding an education, training and exercise component and by optimizing the pre-positioning of antidotes. In the near-term, HHS will begin performing the operations analysis that is prerequisite to such improvements. It is anticipated that acquisition of some next-generation replacement products and the implementation of changes to improve the program could occur in the mid-term, pending availability of DSNS funds. PROJECTED LONG-TERM (BEYOND FY 2013) Medical Countermeasure Development and Acquisition Programs To Enhance Preparedness Program for Biological Threats Broad Spectrum Antiviral(s) MTD: *Ebola Virus, Junin Virus, Marburg Virus, Variola Virus.* Three families of viruses are represented among the existing MTDs: *Poxviridae* (variola virus), *Filoviridae* (Ebola and Marburg viruses), and *Arenaviridae* (Junin virus). These different viral families have diverse biological and pathological characteristics and cause unique diseases in humans. All of these viruses can be disseminated via aerosolization, a feature which enhances their potential use as bioterrorism agents. There are no approved antiviral drugs available for either post-exposure prophylaxis or for therapeutic use for any of these viral diseases. Overall, the development of broad spectrum medical countermeasures that can address several threat agents would maximize the efficiency and flexibility of the DSNS, thereby reducing storage and maintenance costs. HHS will prioritize research and development funding in this area in the near- and mid-terms. Due to its relative immaturity in the development pipeline, it is unlikely that a broad spectrum antiviral will be acquisition-ready until after FY 2013. Program for Chemical Threats Volatile Nerve Agent Single Antidote PTA: *Volatile Nerve Agents.* The optimal medical defense against volatile nerve agents would be a single, rapidly effective countermeasure that could be used, for example, via intranasal or inhaled routes and by untrained persons at risk or by first responders dealing with large numbers of exposed individuals. HHS will continue research and development funding in this area in the near- and mid-terms. Given the current immature status of the development pipeline, a single antidote for volatile nerve agents would likely not be available for acquisition until the long-term timeframe. Conclusion This *HHS PHEMCE Implementation Plan* identifies top priorities for medical countermeasure research, development and acquisition programs that HHS has determined, in collaboration with interagency partners, to have the greatest potential to improve public health emergency preparedness. It is anticipated that this plan will be reviewed at least biennially to encompass potential changes in assessments of the threat, consequences (particularly with regard to the evolution of CONOPs), and maturity of the medical countermeasure development pipeline. The prioritization of medical countermeasure programs described in this *HHS PHEMCE Implementation Plan* represents the current thinking of HHS informed by material threat determinations, population threat assessments, or the assessments of medical and public health consequences. DHS is conducting an integrated CBRN threat assessment, to be completed in June 2008 that will further inform the next version of the *HHS PHEMCE Implementation Plan.* Additionally, future versions are anticipated to incorporate more detailed assessments of potential multipliers of medical countermeasure requirements, based on the potential for enhanced, emerging, or advanced biological agents, multiple and simultaneous CBRN events and other factors informed by scientific and threat analysis. As State, local, and tribal medical countermeasure delivery capabilities and event response planning evolve, they will also open new flexibilities with respect to the types of medical countermeasures that can be incorporated into Federal planning efforts, and will influence HHS assessments of potential medical and public health consequences following CBRN events. The development and acquisition strategies to most effectively improve preparedness resulted from critical evaluation of the status of medical countermeasure development pipelines. HHS recognizes that developing, acquiring, and utilizing medical countermeasures to prepare for and respond to CBRN events requires significant resources and unprecedented cooperation among many stakeholders, including Federal counterparts outside HHS; private industry (domestic and international); State, local and tribal governments; first responders and healthcare workers; academia; and the public. HHS will build upon its 2006 RFI for medical countermeasures against CBRN threats, including the technology readiness levels
(TRLs)defined in that RFI, to continue to explore new, more efficient ways to reach out to the academic and medical countermeasure development communities to ensure that future versions of the *HHS PHEMCE Implementation Plan* are informed by the latest breakthroughs in the field. In addition, while this *HHS PHEMCE Implementation Plan* focuses on the further enhancement of public health emergency preparedness, HHS is simultaneously evaluating the costs and benefits associated with the mid- and long-term maintenance of existing and projected stockpiles of medical countermeasures. HHS anticipates that such an evaluation will be detailed in a future version of the *HHS PHEMCE Implementation Plan.* Finally, Advanced Development activities will depend upon congressional approval of the President's FY 2008 budget request and will increase the chance of programmatic success. Through the Pandemic and All-Hazards Preparedness Act, HHS now has the authority to promote innovation, increase the potential for success for both medical countermeasure developers and the Government, and invest in medical countermeasure advanced development that will carry products across the so-called “Valley of Death” to meet medical countermeasure requirements. It is anticipated that future versions of the *HHS PHEMCE Implementation Plan* will more fully incorporate implementation of these authorities and funding levels that may be appropriated in support of the robust advanced development programs that are critical to mission success. The prioritization of medical countermeasures to improve public health preparedness reflected in *this HHS PHEMCE Implementation Plan* was an interagency process led by HHS and involving significant collaboration with DHS, DOD, VA, and others. The *HHS PHEMCE Implementation Plan* has also benefited tremendously from the information provided by Stakeholders, particularly at the BioShield Stakeholders Workshop held in September 2006, and from the many formal comments received in response to the **Federal Register** notice of the draft *HHS PHEMCE Strategy.* Notice of the issuance of this *HHS PHEMCE Implementation Plan* will be posted in the **Federal Register** and HHS welcomes comments from stakeholders. The *HHS PHEMCE Implementation Plan* will be a feature of the upcoming HHS Public Health Emergency Medical Countermeasures Enterprise Stakeholders Workshop to be held in Washington, DC, July 31—August 2, 2007. HHS is committed to improving transparency and continuing to find the most appropriate venues to work with stakeholders who are likewise committed to meeting the goals of this critical mission of preparing the nation for the adverse health consequences of public health emergencies. Improving preparedness will be an ongoing process as science advances, innovations mature, and the threat scope changes. HHS resources beyond the SRF, when it ends in FY 2013, will continue to be strategically invested in programs throughout the medical countermeasure development and acquisition pipeline to achieve this goal. It is anticipated that targets for the timeframe beyond FY 2013 will be articulated with increasing clarity and granularity with each successive revision of the *HHS PHEMCE Implementation Plan.* Finally, to successfully execute the program objectives outlined in the *HHS PHEMCE Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats* , ASPR will strengthen and build upon its achievements to develop, recruit, and support a world-class workforce. To realize this goal, ASPR will intensify its efforts to attract and expedite hiring of qualified candidates; focus and align training, education, and career development; recognize staff accomplishments; and foster learning and growth with improved knowledge management. Dated: April 17, 2007. Gerald Parker, Principal Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services. [FR Doc. 07-1983 Filed 4-18-07; 12:17 pm]
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statutes-at-large
CFR
- Protests other than under Rule 208 (Rule 211).§ 385.211
- Filings and Other Submissions.§ 385.2001
- Method of notice; dates established in notice (Rule 210).§ 385.210
- Rules governing off-the-record communications (Rule 2201).§ 385.2201
- Service (Rule 2010).§ 385.2010
- Transactions requiring prior notice.§ 225.41
8 references not yet in our index
- 20 USC 1024
- Pub. L. 92-463
- 18 CFR 380
- 16 USC 791a-825r
- 40 CFR 1501.6
- 12 CFR 225
- Pub. L. 108-276
- Pub. L. 109-417
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cites case law
Notices
Notice of intent to fund down the grant slate for the Teacher Quality Enhancement Grants Program—Recruitment Grants for States and Partnerships
Cite20 USC 1024
Pub. L.Pub. L. 92-463
Cite18 CFR 380
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