Notices. Notice of closed meeting

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BILLING CODE 3710-AJ-M DEPARTMENT OF DEFENSE Department of the Navy Meeting of the Chief of Naval Operations

(CNO)Executive Panel AGENCY: Department of the Navy, DOD. ACTION: Notice of closed meeting. SUMMARY: The CNO Executive Panel will report on the findings and recommendations of the Global Governance Subcommittee to the Chief of Naval Operations. The meeting will consist of discussions of the U.S. Navy's emerging missions and relationships with non-military organizations. DATES: The meeting will be held May 30, 2006 from 1 p.m. to 2:30 p.m. ADDRESSES: The meeting will be held at the Chief of Naval Operations office, Room 4E662, 2000 Navy Pentagon, Washington, DC 20350. FOR FURTHER INFORMATION CONTACT: CDR Chris Corgnati, CNO Executive Panel, 4825 Mark Center Drive, Alexandria, VA 22311, 703-681-6206. SUPPLEMENTARY INFORMATION: Pursuant to the provisions of the Federal Advisory Committee Act (5 U.S.C. App. 2), these matters constitute classified information that is specifically authorized by Executive Order to be kept secret in the interest of national defense and are, in fact, properly classified pursuant to such Executive Order. Accordingly, the Secretary of the Navy has determined in writing that the public interest requires that all sessions of this meeting be closed to the public because they will be concerned with matters listed in section 552b(c)(1) of title 5, United States Code. Dated: May 22, 2006. M.A. Harvison, Lieutenant, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. E6-8132 Filed 5-25-06; 8:45 am] BILLING CODE 3810-FF-P DEPARTMENT OF DEFENSE Department of the Navy Meeting of the Naval Research Advisory Committee AGENCY: Department of the Navy, DOD. ACTION: Notice of closed meetings. SUMMARY: The Naval Research Advisory Committee will meet to discuss classified information from government organizations and proprietary information from commercial organizations. All sessions of the meetings will be devoted to briefings, discussions and technical examination of information related to Distributed Operations and Software-Intensive Systems. Discussions will focus on the assessment of the emergent concept of Marine Corps Distributed Operations and determine appropriate options for associated training, key upstream investments, technology monitoring, and go/no-go assessment points; and probable time frames for exploration and implementation. The sessions will also identify, review, and assess challenges with the utilization and field computer-based acquisition tools in the context of Software-Intensive Systems across multiple organizations. DATES: The meetings will be held on Monday, June 12, 2006 through Friday, June 16, 2006, from 8 a.m. to 5 p.m.; Monday, June 19, 2006 through Thursday, June 22, 2006, from 8 a.m. to 5 p.m.; and Friday, June 23, 2006, from 8 a.m. to 11 a.m. ADDRESSES: The meetings will be held at the Space and Naval Warfare Systems Center, San Diego, CA 92152. FOR FURTHER INFORMATION CONTACT: Dr. Sujata Millick, Program Director, Naval Research Advisory Committee, 875 North Randolph Street, Arlington, VA 22203-1995, 703-696-6769. SUPPLEMENTARY INFORMATION: This notice is provided in accordance with the provisions of the Federal Advisory Committee Act (5 U.S.C. App. 2). All sessions of the meeting will be devoted to executive sessions that will include discussions and technical examination of information related to distributed operations and software-intensive systems. These briefings and discussions will contain proprietary information and classified information that is specifically authorized under criteria established by Executive Order to be kept secret in the interest of national defense and are, in fact, properly classified pursuant to such Executive Order. The proprietary, classified and non-classified matters to be discussed are so inextricably intertwined as to preclude opening any portions of the meetings. In accordance with 5 U.S.C. App. 2, section 10(d), the Secretary of the Navy has determined in writing that the public interest requires that all sessions of the meetings be closed to the public because they will be concerned with matters listed in 5 U.S.C. section 552b(c)(1) and (4). Dated: May 22, 2006. M.A. Harvison, Lieutenant, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer. [FR Doc. E6-8131 Filed 5-25-06; 8:45 am] BILLING CODE 3810-FF-P 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 June 26, 2006. ADDRESSES: Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Rachel Potter, Desk Officer, Department of Education, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503 or faxed to

(202)395-6974. 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: May 22, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Institute of Education Sciences *Type of Review:* Revision. *Title:* National Assessment of Educational Progress—2007 Reading and Writing. *Frequency:* One time. *Affected Public:* Individuals or household; State, Local, or Tribal Gov't, SEAs or LEAs. *Reporting and Recordkeeping Hour Burden:* *Responses:* 580,392. *Burden Hours:* 148,353. *Abstract:* This is the first of two clearance packages for the National Assessment of Educational Progress

(NAEP)2007 assessment activities. This package covers reading and writing background questionnaires for students, teachers, school administrators, and Students with Disabilities/Limited English Proficient (SD/LEP) staff. 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 3123. 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. E6-8163 Filed 5-25-06; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Rocky Flats 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), Rocky Flats. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the **Federal Register** . DATES: Thursday, June 22, 2006, 6 p.m. to 9 p.m. ADDRESSES: College Hill Library, Room L-211, Front Range Community College, 3705 W. 112th Avenue, Westminster, Colorado. FOR FURTHER INFORMATION CONTACT: Ken Korkia, Executive Director, Rocky Flats Citizens Advisory Board, 12101 Airport Way, Unit B, Broomfield, CO 80021; telephone

(303)966-7855; fax

(303)966-7856. 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. Presentation of the Board's Legacy Report to the Community. 2. Statements of Appreciation to the Board. 3. Vote to Close Board Operations. *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 agenda items should contact Ken Korkia at the address or telephone number listed above. Requests must be received at least five days prior to the meeting and reasonable provisions 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 office of the Rocky Flats Citizens Advisory Board, 12101 Airport Way, Unit B, Broomfield, CO 80021; telephone

(303)966-7855. Hours of operations are 7:30 a.m. to 4 p.m., Monday through Friday. Minutes will also be made available by writing or calling Ken Korkia at the address or telephone number listed above. Board meeting minutes are posted on RFCAB's Web site within one month following each meeting at: *http://www.rfcab.org/Minutes.HTML* . Issued at Washington, DC on May 18, 2006. Carol Matthews, Acting Advisory Committee Management Officer. [FR Doc. E6-8138 Filed 5-25-06; 8:45 am] BILLING CODE 6450-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL06-61-000, EL06-71-000] Before Commissioners: Joseph T. Kelliher, Chairman; Nora Mead Brownell, and Suedeen G. Kelly; Associated Electric Cooperative, Inc., Complainant v. Southwest Power Pool, Inc., Respondent; Order Denying Complaint and Instituting Section 206 Proceeding Issued May 19, 2006. 1. Associated Electric Cooperative, Inc. (Associated Electric) filed a complaint against Southwest Power Pool, Inc. (SPP), arguing that SPP violated its Open Access Transmission Tariff

(OATT)in granting a rollover request by American Electric Power Service Corporation, as agent for the subsidiaries of the American Electric Power Company, Inc. d/b/a AEPM (collectively, AEP) for 250 megawatts

(MW)of long-term firm point-to-point transmission service from the Union Electric Company d/b/a Ameren UE (Ameren UE) transmission system to the Central and South West Services, Inc.

(CSW)transmission system. In this order, the Commission denies Associated Electric's complaint. In this order, the Commission also institutes a proceeding pursuant to section 206 of the Federal Power Act

(FPA)1 to determine whether certain language in section 2.2 of SPP's existing OATT may be unjust, unreasonable, or unduly discriminatory or preferential. SPP is directed to file comments on this matter within 30 days of the issuance date of this order. 1 16 U.S.C. 824e (2000). Associated Electric's Complaint 2. Associated Electric contends that it is not possible for SPP to grant AEP's rollover request for 250 MW of long-term firm service to begin on June 1, 2005, because SPP no longer has the rights to the underlying contract path needed to provide such service. Associated Electric states that the preceding AEP service arrangements to be rolled over relied on a contract path provided by an Interchange Agreement dated September 22, 1971, as amended December 31, 1996, among Associated Electric, Kansas Gas and Electric Company, Public Service Company of Oklahoma, and Union Electric Company for the Missouri-Kansas-Oklahoma 345kV interconnection (MoKanOk Line), which agreement was terminated effective June 1, 2005, 2 the same day AEP's requested service was to begin. 2 *See Union Electric Co.* , 112 FERC ¶ 61,089, *order denying clarification* , 113 FERC ¶ 61,320 (2005). 3. Associated Electric states that without the MoKanOk Line available to SPP to support AEP's rollover request, SPP should not have granted AEP's request without first determining if sufficient Available Flowgate Capacity

(AFC)existed to continue to provide the service. 3 Associated Electric further states that, alternatively, SPP should have considered AEP's request for a new transmission service request and processed it pursuant to the procedures for handling new service requests under SPP's OATT. 3 Associated Electric argues that the initial 1998 Transmission Agreements for the 250 MW of service and subsequent service requests plainly indicate that SPP's grant of AEP's requested rollover is dependent upon the MoKanOk Line. Complaint at 13-17. 4. Associated Electric states that SPP was obliged under section 15.2 (Determination of Available Transmission Capability), section 19.1 (Additional Study Procedures for Firm Point-to-Point Transmission Service Requests—Notice of Need for System Impact Study), and Attachment D (Methodology for Completing a System Impact Study) of SPP's OATT, to perform a study to determine whether sufficient transmission capability existed to accommodate AEP's service request. Associated Electric contends that by rolling over AEP's service without first determining the sufficiency of AFC, SPP has adversely affected the reliability of Associated Electric's system and neighboring systems. Associated Electric, however, is unable to quantify the financial impact of SPP's action. 4 4 Complaint at 39. 5. Associated Electric alleges that SPP's reliance on section 2.2 (Reservation Priority for Existing Firm Service Customers) of its OATT was misplaced because the cost of Associated Electric's portion of the MoKanOk Line was not included as part of the SPP firm transmission service rates that AEP had been paying. 6. Associated Electric requests that the Commission

(1)determine it was inappropriate for SPP to grant AEP's rollover request without studying the AFC in the region;

(2)order SPP to conduct a study of the AFC on SPP and neighboring transmission systems, including Associated Electric, to determine if there is sufficient AFC to support AEP's request;

(3)order SPP to rescind AEP's service and treat it as a new request, if SPP is unable to demonstrate sufficient AFC; and

(4)order SPP to coordinate with the neighboring transmission system owners with respect to all future awards of transmission capacity under its OATT that may effect neighboring systems. Notice of Filing and Responsive Pleadings 7. Notice of the complaint was published in the **Federal Register** , 71 FR 16,137 (2006), with comments, interventions, and protests due on or before April 10, 2006. Lafayette Utilities System, Ameren Services Company, Western Farmers Electric Cooperative, and AEP filed timely motions to intervene. Xcel Energy Service Inc.

(Xcel)filed an out-of-time motion to intervene. SPP filed an answer in opposition to the complaint. SPP's Answer 8. SPP requests that the Commission dismiss the complaint and deny Associated Electric's claim for relief. SPP states that it was required to allow the rollover of existing firm service requested by AEP. It explains that section 2.2 of its OATT obliges it to allow all existing firm service to roll over service, subject only to allocations of capacity if there are competing reservation requests, which SPP states was not the case here. With respect to Associated Electric's contention that SPP's reliance on section 2.2 was misplaced, SPP maintains that Associated Electric misinterprets section 2.2. 9. This reservation priority only applies to the facilities of the Transmission Owner(s) where such facility costs have been included as part of the firm service rates that the firm service customer has been paying. 10. SPP states that this language is only applicable if there are competing requests for service which prevent SPP from allowing the full rollover. It explains that the language only limits the amount of capacity that a customer may obtain if there are competing requests, according to SPP. 11. SPP further states that section 2.2 does not require a study, and, in fact, the Commission has expressly told the transmission provider that it should not be performing studies to determine if it can accommodate the rollover. 5 With respect to section 15.2, SPP states that it is only required to perform individual system impact studies if it determines that there is insufficient transmission capacity. SPP contends that it is given discretion as to whether or not to conduct such a study elsewhere in its OATT. 6 SPP states that, in this particular case, SPP previously had concluded that there was sufficient transmission capacity to fulfill AEP's service request. SPP states that it based its decision to use its transmission system on its ongoing plans and models, which indicated adequate capacity to support the request. SPP further states that it has seen no evidence of any adverse effect on Associated Electric's reliability, nor does it have any knowledge that service to Associated Electric's loads is in jeopardy. 5 Answer at 10 (citing *Constellation Power Source, Inc.* v. *Am. Elec. Power Serv. Corp.* , 102 FERC ¶ 61,142 (2003); *Tenaska Power Servs. Co* . v. *Sw. Power Pool, Inc.* , 102 FERC ¶ 61,140 (2003); *Exelon Generation Co., LLC* v. *Sw. Power Pool, Inc.* , 101 FERC ¶ 61,226 (2002)). 6 Answer at 11 (citing to OATT §§ 17.5, 19.1). 12. SPP avers that Associated Electric assumes the service to AEP is tied to a specific path involving the 345 kV MoKanOk Line. However, SPP explains that it is providing the service with a contract path using only SPP transmission facilities which interconnect directly with AmerenUE's transmission facilities, thereby allowing the service without the MoKanOk Line. 7 Indeed, SPP explains that “[c]urrently, including the AEP transaction, SPP has 680 MWs of transactions flowing from AmerenUE or the Midwest ISO into SPP's region. This includes 105 MW of Aquila-MPS service that was not SPP's responsibility at the time it accepted the AEPM reservation. Therefore, SPP has the ability to satisfy the entire AEP rollover request over a contract path involving SPP facilities, thus rendering service over the MoKanOk Line unnecessary.” 8 The sole issue, according to SPP, is whether SPP could provide the rollover service under its OATT to allow imports directly from the AmerenUE system. SPP maintains that its grant of transmission service to AEP was not contingent on the use of the MoKanOk Line. Therefore, SPP concludes that Associated Electric's arguments concerning the MoKanOk Line provide interesting historical perspective, but are not particularly relevant. 7 SPP states that it had interconnections with AmerenUE, involving 1018 MW of contract path capacity, at the time of SPP's acceptance of the AEP reservation. SPP states that subsequently the SPP interconnection with AmerenUE has increased to 1688 MW of contract path capacity. Answer at 12-13. 8 SPP Answer at 13. Discussion Procedural Matters 13. Pursuant to Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2005), the timely, unopposed motions to intervene serve to make the entities that filed them parties to this proceeding. We will grant Xcel's motion to intervene out-of-time, given its interest in this proceeding, the early stage of this proceeding, and the absence of any undue prejudice or delay. Commission Determination 14. We will deny Associated Electric's complaint. Contrary to Associated Electric's arguments, SPP properly applied section 2.2 of its OATT in granting AEP's rollover request. 9 The Commission has consistently held that under section 2.2 all firm service customers (requirements and transmission-only with contract terms of one year or more) have the right to continue to take transmission service from their existing transmission providers when their contracts expire, roll over, or are renewed. 10 SPP correctly implemented section 2.2 of its OATT and granted AEP's rollover request. 9 In relevant part, section 2.2 of SPP's OATT provides that “[e]xisting firm service customers (wholesale requirements and transmission-only, with a contract term of one-year or more, and retail) of the Transmission Owner(s) or Transmission Provider have the right to continue to take transmission service from the Transmission Provider when the contract expires, rolls over or is renewed.” 10 The right to rollover applies regardless of whether there is a competing request for transmission service. If there is a competing request, the existing transmission customer must agree to accept a contract term at least as long as that offered by the potential customer and to pay the current just and reasonable rate, as approved by the Commission, for such service. Here, there were no competing requests for transmission service. In this regard, we reject Associated Electric's argument that SPP also violated section 2.2 “because reservation priority pursuant to Section 2.2 is only to be awarded with respect to the transmission owner's transmission facilities where the cost of those facilities has been included as part of the firm service rates that the customer has been paying.” Complaint at 41. That portion of section 2.2 applies only in the event of competing requests, of which there are none in this proceeding, and thus is irrelevant to the issue raised in this proceeding. 15. As we explained in a prior SPP order, “[u]nder Section 2.2, SPP is obligated to maintain available transmission capacity for its existing long-term transmission customers with rollover rights * * * until the time expires for those customers to exercise their rollover rights.” 11 In explaining SPP's obligation to maintain available transmission capacity to provide the rollover right, the Commission rejected SPP arguments that it could not provide the requested rollover service “due to changes to existing firm uses on its system including native load growth, changes in external trading patterns, generation dispatch modeling assumptions, and loop flow changes.” 12 In this proceeding, SPP, consistent with Commission precedent, maintained available transmission capacity to provide AEP's requested rollover, and Associated Electric's unsupported allegations to the contrary are unavailing. 13 11 Exelon Generation Co., 99 FERC ¶ 61,235 at P 26 (2002). 12 *Id.* SPP, as the Commission has consistently held, could restrict a transmission customer's rollover rights only in certain limited circumstances. Absent the limited circumstances that the Commission has identified for a transmission provider to restrict a transmission customer's rollover, and Associated Electric does not argue that those circumstances exist, SPP had no basis to deny AEP's rollover request. 13 SPP also could not deny AEP's rollover request on a claim that there was insufficient capacity on a third-party's transmission system. See Commonwealth Edison Co., 95 FERC ¶ 61,252 at 61,875

(2001)(“A transmission provider may not condition a transmission customer's rights to roll over transmission service on the transmission provider's system at the end of an existing service agreement based on whether there is enough transmission capacity available on a third-party's transmission system.”). 16. Moreover, contrary to Associated Electric's complaint, section 2.2 contains no requirement that SPP perform any studies before granting a rollover request. 14 As explained above, SPP has an ongoing obligation to plan its system and maintain available transmission capacity to provide existing transmission customers' rollover requests. To impose a study obligation on transmission providers, as Associated Electric argues, would provide transmission providers the opportunity to stall rollover requests and undermine the purpose of section 2.2 of ensuring that transmission customers may continue to receive transmission service. 14 AEP's rollover request is subject to section 2.2 of SPP's OATT and is not a request for new transmission service. AEP is requesting that it continue to receive the same service that it previously received. In any event, as SPP points out, even if it were treated as a new transmission request, studies would only be needed if the transmission provider determined that sufficient capacity did not exist to provide the service. See SPP Answer at 11. That is not the case here. 17. Finally, we reject Associated Electric's arguments with respect to loop flow. SPP is obligated under its OATT to offer to provide transmission service on its system if there is available transmission capacity. SPP has complied with the requirements of section 2.2 and provided rollover service to AEP. To the extent that Associated Electric faces loop flows on its system as a result of this transaction or any other transaction, the Commission's policy is that owners and controllers of the transmission facilities must attempt to resolve the matter on a consensual, regional basis. 15 The possibility that Associated Electric may face loop flows as a result of the AEP rollover transaction is no basis for SPP to deny AEP's request. In this regard, we note that Associated Electric, to date, has chosen not to join the SPP Regional Transmission Organization or any other regional entities that would provide solutions for loop flow problems. 15 *See, e.g., Southern California Edison Co.* , 70 FERC ¶ 61,087 at 61,241-42 (1995). 18. Accordingly, we will deny Associate Electric's complaint. 19. In addition, pursuant to section 206 of the FPA, we find that the language in the last three sentences of section 2.2 of SPP's existing OATT may not be just and reasonable, 16 and may be unjust, unreasonable, unduly discriminatory or preferential, or otherwise unlawful, because the language may place limitations on customers' rollover rights that are contrary to Commission policy. Once a transmission provider evaluates the impact on its system of serving a customer, Commission policy requires the transmission provider to plan and operate its transmission system with the expectation that it will continue to provide service to the customer should the customer request rollover. 17 The Commission has explained that a transmission provider can deny a customer the ability to roll over its long-term firm service contract only if the transmission provider includes in the original service agreement a specific limitation based on reasonably forecasted native load needs for the transmission capacity provided under the contract at the end of the contract term. 18 The Commission also has explained that a transmission provider may limit the terms under which a new long-term agreement may be rolled over if it has a pre-existing contract obligation that commences in the future. 19 If the transmission system becomes constrained (for reasons other than reasonably forecasted native load growth or pre-existing contract obligations that commence in the future) such that the transmission provider cannot satisfy all existing long-term customers, then the obligation is on the transmission provider either to curtail service to all affected customers (not just the later-accepted firm customers) pursuant to the provisions of its OATT or to build more capacity to relieve the constraint. 20 16 These sentences provide: This reservation priority only applies to the facilities of the Transmission Owner(s) where such facility costs have been included as part of the firm service rates that the firm service customer has been paying. If competing existing firm service requirements customers apply for service that cannot be fully provided, the priority rights will be ranked in accordance with first-come, first-served principles. If firm service customers tie, then the capacity for which they receive priority rights under this tariff shall be apportioned on a pro rata basis. 17 *See, e.g., Southern Company Services, Inc.* , 103 FERC ¶ 61,117 at P 5 (2003). 18 *See, e.g., Southern Company Services, Inc.* , 110 FERC ¶ 61,379 (2005). 19 *Id.* 20 *Id.* 20. The limitations included in section 2.2 of SPP's existing OATT (the last three sentences) appear to go beyond those allowed by the Commission. Consequently, we will institute an investigation, under section 206 of the FPA, in Docket No. EL06-71-000, into the justness and reasonableness of this language, and direct SPP to file comments on this matter within 30 days of the issuance date of this order. 21. In cases where, as here, the Commission institutes a section 206 investigation on its own motion, section 206(b) of the FPA requires that the Commission establish a refund effective date that is no earlier than publication of notice of the Commission's initiation of its investigation in the **Federal Register** , and no later than five months subsequent to that date. In order to give maximum protection to customers, and consistent with our precedent, 21 we will establish a refund effective date at the earliest date allowed. This date will be the date on which notice of our investigation in Docket No. EL06-71-000 is published in the **Federal Register** . 21 *See, e.g., PJM Interconnection, L.L.C.* , 90 FERC ¶ 61,137 (2000); *Cambridge Elec. Light Co.* , 75 FERC ¶ 61,177, *clarified* , 76 FERC ¶ 61,020 (1996); *Canal Elec. Co.* , 46 FERC ¶ 61,153, *reh'g denied* , 47 FERC ¶ 61,275 (1989). *The Commission orders:*

(A)Associated Electric's complaint is hereby denied, as discussed in the body of this order.

(B)Pursuant to the authority contained in and subject to the jurisdiction conferred by the Federal Energy Regulatory Commission by section 402(a) of the Department of Energy Organization Act, particularly section 206 thereof, and pursuant to the Commission's Rules of Practice and Procedure and the regulations under the Federal Power Act (18 CFR chapter I), an investigation is hereby instituted, in Docket No. EL06-71-000, concerning the justness and reasonableness of the last three sentences of section 2.2 of SPP's existing OATT.

(C)The Secretary shall promptly publish in the **Federal Register** a notice of the Commission's initiation of the proceeding ordered in Ordering Paragraph

(B)above, under section 206 of the Federal Power Act, in Docket No. EL06-71-000.

(D)The refund effective date in Docket No. EL06-71-000, established pursuant to section 206(b) of the Federal Power Act, shall be the date of publication in the **Federal Register** of the notice in Ordering Paragraph

(C)above. By the Commission. Magalie R. Salas, Secretary. [FR Doc. E6-8099 Filed 5-25-06; 8:45 am] BILLING CODE 6717-01-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6675-6] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167. An explanation of the ratings assigned to draft environmental impact statements

(EISs)was published in the **Federal Register** dated April 7, 2006 (71 FR 17845). Draft EISs *EIS No. 20060042, ERP No. D-NPS-E65079-TN,* Great Smoky Mountains National Park General Management Plan Amendment, Implementation, Elkmont Historic District, Sevier County, TN. *Summary:* EPA does not object to the proposed action. Rating LO. *EIS No. 20060090, ERP No. D-AFS-F65061-WI,* Fishbone Project Area, Vegetation and Road Management, Implementation, Washburn Ranger District, Chequamegon-Nicolet National Forest, Bayfield County, WI. *Summary:* EPA supports the preferred alternative, but recommends that the Final EIS include additional information on cumulative impacts to sensitive species. Rating EC2. *EIS No. 20060110, ERP No. D-AFS-J65459-MT,* Whitetail-Pipestone Travel Management, Develop Site-Specific Travel Management Plan, Jefferson and Butte Ranger Districts, Beaverhead-Deerlodge National Forest, Jefferson and Silver Bow Counties, MT. *Summary:* EPA expressed environmental concerns about adverse impacts from roads and motorized use to water quality, aquatic habitat and wildlife. The final EIS should consider modifying the preferred alternative to further reduce sedimentation from road erosion by decreasing road densities and stream crossings and improving road conditions. Rating EC2. Final EISs *EIS No. 20050495, ERP No. F-SFW-E65074-NC,* Roanake River National Wildlife Refuge, Comprehensive Conservation Plan, To Determine and Evaluate a Range of Reasonable Management Alternative, Bertie County, NC. *Summary:* No formal comment letter was sent to the preparing agency. *EIS No. 20060102, ERP No. F-NOA-D81036-WV,* Canaan Valley Institute Office Complex, Proposes to Construct: Offices, Classrooms, Laboratories, 250-Seat Auditorium, Parking Facilities, Outdoor Classrooms and Interpretive Areas, U.S. Army COE Section 404 Permit, Southeast of the Towns of Davis and Thomas, Tucker County, WV. *Summary:* EPA does not object to the proposed action. Dated: May 23, 2006. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E6-8147 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6675-5] Environmental Impacts Statements; Notice of Availability *Responsible Agency:* Office of Federal Activities, General Information

(202)564-7167 or *http://www.epa.gov/compliance/nepa/.* Weekly receipt of Environmental Impact Statements Filed May 15, 2006 through May 19, 2006 Pursuant to 40 CFR 1506.9. *EIS No. 20060197, Final EIS, FHW, CO,* US Highway 160, Transportation Improvements from Junction US 160/550 Durango—East to Bayfield, U.S. Army COE Section 404 Permit, La Plata County, CO, Wait Period Ends: June 26, 2006, Contact: Joseph R. Duran 720-963-3006. *EIS No. 20060198, Final EIS, AFS, MT,* Helena National Forest Noxious Weed Treatment Project, Implementation, Lewis and Clark, Broadwater, Powell, Jefferson and Meagher Counties, MT, Wait Period Ends: June 26, 2006, Contact: Dennis Heffner 406-495-3727. *EIS No. 20060199, Final EIS, AFS, MI,* Huron-Manistee National Forests, Land and Resource Management Plan, Implementation, Several Counties, MI, Wait Period Ends: June 26, 2006, Contact: Jeffery G. Pullen 231-775-3183. *EIS No. 20060200, Draft EIS, COE, 00, Programmatic* —Ohio River Mainstem System Study, System Investment Plan

(SIP)for Maintaining Safe, Environmentally Sustainable and Reliable Navigation on the Ohio River, IL, IN, OH, KY, PA and WV, Comment Period Ends: July 18, 2006, Contact: Veronica Rife 502-315-6785. *EIS No. 20060201, Final EIS, NRS, AR,* Little Red River Irrigation Project, Develop a Water Management Plan for Irrigation Purposes in Seary, U.S. Army COE Section 404 Permit, Raft Creek, White County, AR, Wait Period Ends: June 26, 2006, Contact: Belinda Bell 501-301-3149. *EIS No. 20060202, Final EIS, NOA, 00,* Snapper Grouper Fishery, Amendment 13C to the Fishery Management Plan, Phase Out Overfishing of Snowy Grouper, Golden Tilefish, Vermilion Snapper and Sea Bass, Implementation, South Atlantic Region , Wait Period Ends: June 26, 2006, Contact: Dr. Roy E. Crabtree 727-824-5301. *EIS No. 20060203, Draft EIS, BLM, WY,* Maysdorf Coal Lease by Application

(LBA)Tract, (Federal Coal Application WYW154432), Implementation, Campbell Counties, WY, Comment Period Ends: July 25, 2006, Contact: Nancy Doelger 307-261-7627. *EIS No. 20060204, Draft EIS, AFS, OR,* Mt. Hood National Forest and Columbia River Gorge National Scenic Area, Site-Specific Invasive Plant Treatments, Forest Plan Amendments #16, Mt. Hood National Forest and Columbia River Gorge National Scenic Area, Clackamas, Hood River, Multnomah and Wasco Counties, OR, Comment Period Ends: July 13, 2006, Contact: Jennie O'Connor 503-668-1645. *EIS No. 20060205, Draft EIS, AFS, PA,* Allegheny National Forest, Proposed Revised Land and Resource Management Plan, Implementation, Elk, Forest, McKean and Warren Counties, PA, Comment Period Ends: August 28, 2006, Contact: William Connelly 814-723-5150. *EIS No. 20060206, Draft EIS, FRC, MS,* Clean Energy Liquefied Natural Gas

(LNG)Import Terminal and Natural Gas Pipeline Facilities, Construction and Operation, US Army COE Section 10 and 404 Permits, (FERC/EIS-0192D), Port of Pascagoula, Jackson County, MS, Comment Period Ends: July 10, 2006, Contact: Todd Sedmak 1-866-208-3372. *EIS No. 20060207, Draft EIS, FRC, MS,* Casotte Landing Liquefied Natural Gas

(LNG)Import and Interstate Natural Gas Transmission Facilities, Construction and Operation, U.S. Army COE Section 404 Permit, (FERC/EIS-0193D), near the City of Pascagoula, Jackson County, MS, Comment Period Ends: July 10, 2006, Contact: Todd Sedmak 1-866-208-3372. *EIS No. 20060208, Draft EIS, AFS, 00,* Heavenly Mountain Resort Master Plan Amendment 2005 (MPA 05), Improve and Enhance the Resorts Over Winter and Summer Recreation Opportunities, Special-Use-Permit, Lake Tahoe Basin, El Dorado County, CA and Douglas County, NV, Comment Period Ends: July 17, 2006, Contact: Matt Dickinson 530-543-2769. *EIS No. 20060209, Draft EIS, NPS, PA,* Flight 93 National Memorial, Designation of Crash Site to Commemorate the Passengers and Crew of Flight 93, Implementation, Stonycreek Township, Somerset County, PA, Comment Period Ends: July 17, 2006, Contact: Jeff Reinbold 814-443-4557. *EIS No. 20060210, Final EIS, UAF, AZ,* Barry M. Goldwater Range (BMGR), Integrated Natural Resources Management Plan (INRMP), Implementation, Yuma, Pima, and Maricopa Counties, AZ, Wait Period Ends: June 26, 2006, Contact: Carol Heathington 623-856-8492. *EIS No. 20060211, Draft EIS, DOE, 00,* Strategic Petroleum Reserve Expansion, Site Selection of Five New Sites: Chacahoula and Clovelly, in Lafourche Parish, LA; Burinsburg, Claiborne County, MS; Richton, Perry County, MS; and Stratton Ridge, Brazoria County, TX and Existing Site Bayou Choctaw, Iberville Parish, LA, West Hackberry, Cameron and Calcasieu Parishes, LA; and Big Hill, Jefferson County, TX, Comment Period Ends: July 10, 2006, Contact: Donald Silawsky 202-586-1892. *EIS No. 20060212, Draft EIS, AFS, CA,* Freeman Project, Reduce Hazardous Fuel and Improving Forest Health, Implementation, Lake Recreation Area, Beckworth Ranger District, Plumas National Forest, Plumas County, CA, Comment Period Ends: July 10, 2006, Contact: Sabrina Stadler 530-836-7141. *EIS No. 20060213, Draft EIS, CGD, MA,* Northeast Gateway Deepwater Port License Application to Import Liquefied Natural Gas

(LNG)(USCG-2005-22219), Massachusetts Bay, City of Gloucester, MA, Comment Period Ends: July 10, 2006, Contact: Mark Prescott 202-267-0225. *EIS No. 20060214, Final EIS, NRC, NY,* Generic—License Renewal of Nuclear Plants for Nine Mile Point Nuclear Station, Units 1 and 2, Supplement 24 to NUREG 1437, Implementation, Lake Ontario, Oswego County, NY, Wait Period Ends: June 26, 2006, Contact: Samuel Hernandez 301-415-4049. *EIS No. 20060215, Final EIS, AFS, AK,* Whistle Stop Project, Provide Access to Backcountry Recreation Area on National Forest, System

(NFS)Lands, on the Kenai Peninsula between Portage and Moose Pass, Chugach National Forest, Kenai Peninsula Borough, AK , Wait Period Ends: June 26, 2006, Contact: Adam McClory 907-754-2352. *EIS No. 20060216, Final EIS, IBR, 00, Programmatic* —Platte River Recovery Implementation Program, Assessing Alternatives for the Implementation of a Basinwide, Cooperative, Endangered Species Recovery Program, Four Target Species: Whooping Crane, Interior Least Tern, Pipping Plover and Pallid Sturgeon, NE, WY, and CO, Wait Period Ends: June 26, 2006, Contact: Curt Brown 303-445-2096. Amended Notices *EIS No. 20060191, Final EIS, FAA, FL,* Panama City-Bay County International Airport (PFN), Proposed Relocation to a New Site, NPDES Permit and U.S. Army COE Section 404 Permit, Bay County, FL, Wait Period Ends: July 5, 2006, Contact: Virginia Lane 407-872-6331 Ext. 129. Revision to FR Notice Published May 19, 2006: Comment Period Extended from June 19, 2006 to July 5, 2006. Dated: May 23, 2006. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E6-8146 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2006-0299; FRL-8066-7] Notice of Filing of a Pesticide Petition for the Establishment of a Temporary Exemption from the Requirement of a Tolerance for the Residues of the Plant-Incorporated Protectants Bacillus Thuringiensis Cry2Ab2 Protein and the Genetic Material for Its Production in Corn in or on All Corn Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of a temporary exemption from the requirement of a tolerance for the residues of the plant-incorporated protectants *Bacillus thuringiensis* Cry2Ab2 and the genetic material necessary for its production in corn in or on all corn commodities. DATES: Comments must be received on or before June 26, 2006. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPP-2006-0299, and pesticide petition number

(PP)5G7005 by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2006-0299. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov,* or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)305-5805. FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:

(703)308-8715; e-mail address: *mendelsohn.mike@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: • Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). • Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. II. What Action is the Agency Taking? EPA is printing a summary of the pesticide petition received under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. EPA has determined that this pesticide petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petition. Additional data may be needed before EPA rules on this pesticide petition. Pursuant to 40 CFR 180.7(f), a summary of the petition included in this notice, prepared by the petitioner is available on EPA's Electronic Docket at *http://www.regulations.gov* . To locate this information on the homepage of EPA's Electronic Docket, select “Quick Search” and type the OPP docket ID number. Once the search has located the docket, clicking on the “Docket ID” will bring up a list of all documents in the docket for the pesticide including the petition summary. New Exemption from Tolerance *(PP) 5G7005* . Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, proposes to establish a temporary exemption from the requirement of a tolerance for residues of the plant-incorporated protectants *Bacillus thuringiensis* Cry2Ab2 protein and the genetic material necessary for its production in corn in or on all corn commodities. Because this petition is a request for an exemption from the requirement of a tolerance without numerical limitations, no analytical method is required. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 18, 2006. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. E6-8040 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2006-0300; FRL-8066-5] Notice of Filing of a Pesticide Petition for the Establishment of a Temporary Exemption from the Requirement of a Tolerance for the Residues of the Plant-Incorporated Protectants Bacillus Thuringiensis Cry1A.105 Protein and the Genetic Material for Its Production in Corn in or on All Corn Commodities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of a temporary exemption from the requirement of a tolerance for the residues of the plant-incorporated protectants *Bacillus thuringiensis* Cry1A.105 protein and the genetic material necessary for its production in corn in or on all corn commodities. DATES: Comments must be received on or before June 26, 2006. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPP-2006-0300, and pesticide petition number

(PP)5G6940 by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2006-0300. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov,* or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(CFR)part or section number. • Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. II. What Action is the Agency Taking? EPA is printing a summary of the pesticide petition received under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, proposing the establishment of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. EPA has determined that this pesticide petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petition. Additional data may be needed before EPA rules on this pesticide petition. Pursuant to 40 CFR 180.7(f), a summary of the petition included in this notice, prepared by the petitioner is available on EPA's Electronic Docket at *http://www.regulations.gov* . To locate this information on the homepage of EPA's Electronic Docket, select “Quick Search” and type the OPP docket ID number. Once the search has located the docket, clicking on the “Docket ID” will bring up a list of all documents in the docket for the pesticide including the petition summary. New Exemption from Tolerance *PP 5G6940* . Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167, proposes to establish a temporary exemption from the requirement of a tolerance for residues of the plant-incorporated protectants *Bacillus thuringiensis* Cry1A.105 protein and the genetic material necessary for its production in corn in or on all corn commodities. Because this petition is a request for an exemption from the requirement of a tolerance without numerical limitations, no analytical method is required. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 18, 2006. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. E6-8041 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2006-0298; FRL-8066-8] Experimental Use Permit; Receipt of Application AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces receipt of an application 524-EUP-OT from Monsanto Company requesting an experimental use permit

(EUP)for the plant-incorporated protectants *Bacillus thuringiensis* Cry1A.105 protein and the genetic material necessary (vector PV-ZMIR245) for its production in MON 89034 corn, *Bacillus thuringiensis* Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in MON 89034 corn, and *Bacillus thuringiensis* Cry3Bb1 protein and the genetic material necessary (vector PV-ZMIR39) for its production in MON 88017 corn. The Agency has determined that the application may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11(a), the Agency is soliciting comments on this application. DATES: Comments must be received on or before June 26, 2006. ADDRESSES: Submit your comments, identified by docket identification

(ID)number EPA-HQ-OPP-2006-0298, by one of the following methods: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs

(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building); 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is

(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2006-0298. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The Federal regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation for this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is

(703)308-8715; e-mail address: *mendelsohn.mike@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons interested in agricultural biotechnology or those who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI). In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations

(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background The 524-EUP-OT application is for 4,897 acres of MON 89034, 1,727 acres of MON 89034 x MON 88017, 1,661 acres of MON 88017, and 992 non-plant-incorporated protectant border acres. MON 89034 contains the lepidopteran protecting *Bacillus thuringiensis* Cry1A.105 protein and the genetic material necessary (vector PV-ZMIR245) for its production in MON 89034 corn and *Bacillus thuringiensis* Cry2Ab2 protein and the genetic material necessary (vector PV-ZMIR245) for its production in MON 89034 corn. MON 88017 contains the corn rootworm protecting *Bacillus thuringiensis* Cry3Bb1 protein and the genetic material necessary (vector PV-ZMIR39) for its production in MON 88017 corn. Proposed shipment/use dates are July 1, 2006 through June 30, 2008. Five trial protocols will be conducted, including: • Breeding and observation nursery. • Inbred seed increase production. • Line *per se* hybrid yield and herbicide tolerance trials. • Insect efficacy trials. • Product characterization and performance trials. • Insect resistance management trials, benefit trials, and seed treatment trials. States and Commonwealth involved include: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Washington, and Wisconsin. III. What Action is the Agency Taking? Following the review of the Monsanto Company application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the **Federal Register** . IV. What is the Agency's Authority for Taking this Action? The Agency's authority for taking this action is under FIFRA section 5. List of Subjects Environmental protection, Experimental use permits. Dated: May 18, 2006. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. E6-8042 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [Docket Nos. EPA-R04-SFUND-2006-0457; EPA-RO4-SFUND-2006-0458; FRL-8174-6] P & W Electric Superfund Site; Yorkville, Gibson County, TN; Notice of Settlement AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of proposed settlements. SUMMARY: Under section 122(h)(1) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLS), the United States Environmental Protection Agency has entered into two proposed settlements for the reimbursement of past response costs concerning the P & W Superfund Site located in Yorkville, Gibson County, Tennessee. DATES: The Agency will consider public comments on the settlements until June 26, 2006. The Agency will consider all comments received and may modify or withdraw its consent to the settlements if comments received disclose facts or considerations which indicate that the settlements are inappropriate, improper, or inadequate. ADDRESSES: Copies of the settlements are available from Ms. Paula V. Batchelor. Submit your comments, identified by Docket ID No. EPA-RO4-SFUND-2006-0457 and ID No. EPA-R04-SFUND-2006-0458 or Site name P & W Electric Superfund Site by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • E-mail: *Batchelor.Paula@epa.gov.* • Fax: 404/562-8842/Attn Paula V. Batchelor. Mail: Ms. Paula V. Batchelor, U.S. EPA Region 4, WMD-SEIMB, 61 Forsyth Street, SW., Atlanta, Georgia 30303. In addition, please mail a copy of your comments on the information collection provisions to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attn: Desk Officer for EPA, 725 17th St. NW., Washington, DC 20503. *Instructions:* Direct your comments to Docket ID No. EPA-R04-SFUND-2006-0457 and EPA-R04-SFUND-2006-0458. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information

(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at the U.S. EPA Region 4 office located at 61 Forsyth Street, SW., Atlanta, Georgia 30303. Regional office is open from 7 a.m. until 6:30 p.m. Monday through Friday, excluding legal holidays. Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication. FOR FURTHER INFORMATION CONTACT: Paula V. Batchelor at 404/562-8887. Dated: May 10, 2006. Greg Armstrong, Acting Chief, Superfund Enforcement & Information Management Branch, Waste Management Division. [FR Doc. E6-8143 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8174-7] Final Reissuance of General NPDES Permit

(GP)for Offshore Oil and Gas Exploration Facilities on the Outer Continental Shelf and Contiguous State Waters (NPDES Permit Number AKG-28-0000) AGENCY: Environmental Protection Agency. ACTION: Final Notice of reissuance of the general NPDES permit. SUMMARY: On April 5, 2004, EPA proposed to reissue the general permit

(GP)for offshore oil and gas exploration facilities on the Outer Continental Shelf

(OCS)areas designated as the Beaufort and Chukchi Seas and contiguous State waters, pursuant to the provisions of the Clean Water Act

(CWA)33 U.S.C. 1251 *et seq.* There was a 45 day comment period during which written comments on the draft permit were submitted to EPA. On June 24, 2005, EPA extended the area of coverage to include the Hope Basin and Norton Sound Planning Areas including contiguous State waters that are within the Minerals Management Services current 5-year oil and gas leasing program and proposed to reissue the GP. There was an additional 30 day comment period. During the two comment periods, EPA received six comment letters on the GP. A Response to Comments was prepared by EPA along with the final GP. DATES: The general permit will be effective June 26, 2006. ADDRESSES: Copies of the GP and Response to Comments are available upon request. Written requests may be submitted to EPA, Region 10, 1200 Sixth Avenue OWW-130, Seattle, WA 98101. Electronic requests may be mailed to: *washington.audrey@epa.gov* or *vidanage.sonia@epa.gov.* FOR FURTHER INFORMATION CONTACT: The GP, Fact Sheet and Response to Comments may be found on the Region 10 Web site at *http://www.epa.gov/r10earth/waterpermits.htm* under the General Permits section. Requests by phone may be made to Audrey Washington at

(206)553-0523 or to Sonia Vidanage at

(206)553-1019. SUPPLEMENTARY INFORMATION: *Executive Order 12866:* The Office of Management and Budget exempted this action from the review requirements of Executive Order 12866 pursuant to section 6 of that order. The State of Alaska, Department of Environmental Conservation (ADEC), has certified that the subject dischargers comply with the applicable provisions of section 208(e), 301, 302, 306 and 307 of the Clean Water Act, and that the general permit is in compliance with the Standards of the Alaska Coastal Management Program. *Regulatory Flexibility Act (RFA):* Under the RFA, 5 U.S.C. 601 *et seq.* , a Federal agency must prepare an initial regulatory flexibility analysis “for any proposed rule” for which the agency “is required by section 553 of the Administrative Procedure Act (APA), or any other law, to publish general notice of proposed rule making. The RFA exempts from this requirement any rule that the issuing agency certifies “will not, if promulgated, have a significant economic impact of a substantial number of small entities.” EPA has concluded that NPDES general permits are permits, not rulemakings, under the APA and thus not subject to APA rulemaking requirements or RFA. Dated: May 16, 2006. Michael F. Gearheard, Director, Office of Water & Watersheds, Region 10. [FR Doc. E6-8184 Filed 5-25-06; 8:45 am] BILLING CODE 6560-50-P FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Proposed Collection Renewals; Comment Request AGENCY: Federal Deposit Insurance Corporation (FDIC). ACTION: Notice and request for comment. SUMMARY: The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on continuing information collections, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). Currently, the FDIC is soliciting comments concerning the following continuing collections of information titled: 1. Application Pursuant to Section 19 of the Federal Deposit Insurance Act (3064-0018); 2. Home Mortgage Disclosure Act

(HMDA)(3064-0046); 3. Public Disclosure by Banks (3064-0090); 4. Notice Required of Government Securities Dealers or Brokers (Insured State Nonmember Banks) (3064-0093); 5. Procedures for Monitoring Bank Protection Act Compliance (3064-0095); 6. Activities and Investments of Insured State Banks (3064-0111); 7. Foreign Banks (3064-0114); 8. Certification of Eligibility Under the Affordable Housing Program (3064-0116); 9. Notice Regarding Unauthorized Access to Customer Information (3064-0145); 10. Mutual-to-Stock Conversions of State Savings Banks (3064-0117); 11. Privacy of Consumer Financial Information (3064-0136); and 12. Applicant Background Questionnaire (3064-0138). DATES: Comments must be submitted on or before July 25, 2006. ADDRESSES: Interested parties are invited to submit written comments by any of the following methods. All comments should refer to the name and number of the collection: • *http://www.FDIC.gov/regulations/laws/federalnotices/propose.html* . • *E-mail: comments@fdic.gov* . Include the name and number of the collection in the subject line of the message. • *Mail:* Gary A. Kuiper (202.898.3877), Counsel, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429. • *Hand Delivery:* Comments may be hand-delivered to the guard station at the rear of the 550 17th Street Building (located on F Street), on business days between 7 a.m. and 5 p.m. A copy of the comments may also be submitted to the OMB Desk Officer for the FDIC, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Gary A. Kuiper, at the address identified above, for collections numbered 1-9; Steve Hanft, at the address identified above, for collections numbered 10-12. SUPPLEMENTARY INFORMATION: Proposal to renew the following currently approved collections of information: 1. *Title:* Application Pursuant to Section 19 of the Federal Deposit Insurance Act. *OMB Number:* 3064-0018. *Form Number:* FDIC 6710/07. *Frequency of Response:* On occasion. *Affected Public:* Insured depository institutions. *Estimated Number of Respondents:* 14. *Estimated Time per Response:* 16 hours. *Total Annual Burden:* 224 hours. *General Description of Collection:* Section 19 of the Federal Deposit Insurance Act (12 U.S.C. Section 1829) requires the FDIC's consent prior to any participation in the affairs of an insured depository institution by a person who has been convicted of crimes involving dishonesty or breach of trust. To obtain that consent, an insured depository institution must submit an application to the FDIC for approval on Form FDIC 6710/07. 2. *Title:* Home Mortgage Disclosure Act (HMDA). *OMB Number:* 3064-0046. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Estimated Number of Responses:* 1,890,384. *Estimated Time per Response:* 5 minutes. *Total Annual Burden:* 157,532 hours. *General Description of Collection:* To permit the FDIC to detect discrimination in residential mortgage lending, certain insured state nonmember banks are required by FDIC regulation 12 CFR part 338 to maintain various data on home loan applicants. 3. *Title:* Public Disclosure by Banks. *OMB Number:* 3064-0090. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Estimated Number of Respondents:* 5,500. *Estimated Time per Response:* 0.5 hours. *Total Annual Burden:* 2,750 hours. *General Description of Collection:* 12 CFR part 350 requires a bank to notify the general public, and in some instances shareholders, that financial disclosure statements are available on request. Required disclosures consist of financial reports for the current and preceding year, which can be photocopied directly from the year-end call reports. Also, on a case-by-case basis, the FDIC may require that descriptions of enforcement actions be included in disclosure statements. The regulation allows, but does not require, the inclusion of management discussions and analysis. 4. *Title:* Notices Required of Government Securities Dealers or Brokers (Insured State Nonmember Banks). *OMB Number:* 3064-0093. *Form Number:* G-FIN; G-FINW; G-FIN4; & G-FIN5. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks acting as government securities brokers and dealers. *Estimated Number of Respondents:* 180. *Estimated Time per Response:* 1 hour. *Total Annual Burden:* 180 hours. *General Description of Collection:* The Government Securities Act of 1986 requires all financial institutions acting as government securities brokers and dealers to notify their federal regulatory agencies of their broker-dealer activities, unless exempted from the notice requirement by Treasury Department regulation. 5. *Title:* Procedures for Monitoring Bank Protection Act Compliance. *OMB Number:* 3064-0095. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Estimated Number of Respondents:* 5,250. *Estimated Time per Response:* 0.5 hours. *Total Annual Burden:* 2,625 hours. *General Description of Collection:* The Bank Protection Act of 1968 (12 U.S.C. 1881-1884) requires each Federal supervisory agency to promulgate rules establishing minimum standards for security devices and procedures to discourage financial crime and to assist in the identification of persons who commit such crimes. To avoid the necessity of constantly updating a technology-based regulation, the FDIC takes a flexible approach to implementing this statute. It requires each insured nonmember bank to designate a security officer who will administer a written security program. The security program shall:

(1)Establish procedures for opening and closing for business and for safekeeping valuables;

(2)establish procedures that will assist in identifying persons committing crimes against the bank;

(3)provide for initial and periodic training of employees in their responsibilities under the security program; and

(4)provide for selecting, testing, operating and maintaining security devices as prescribed in the regulation. In addition, the FDIC requires the security officer to report at least annually to the bank's board of directors on the effectiveness of the security program 6. *Title:* Activities and Investments of Insured State Banks. *OMB Number:* 3064-0111. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Estimated Number of Respondents:* 20. *Estimated Time per Response:* 8 hours. *Total Annual Burden:* 160 hours. *General Description of Collection:* With certain exceptions, section 24 of the FDI Act (12 U.S.C. 1831a) limits the direct equity investments of state chartered banks to equity investments that are permissible for national banks. In addition, the statute prohibits an insured state bank from directly engaging as principal in any activity that is not permissible for a national bank or indirectly through a subsidiary in an activity that is not permissible for a subsidiary of a national bank unless the bank meets it minimum capital requirements and the FDIC determines that the activity does not pose a significant risk to the deposit insurance fund. The FDIC can make such a determination for exception by regulation or by an order. 12 CFR part 362 is the FDIC's implementing regulation for Section 24. It details the activities that insured state banks or their subsidiaries may engage in, under certain criteria and conditions, and identifies the information that banks must furnish to the FDIC in order to obtain the FDIC's approval or nonobjection. 7. *Title:* Foreign Banks. *OMB Number:* 3064-0114. *Form Number:* None. *Frequency of Response:* On occasion. *Number of Responses per Respondent:* Varies with circumstances. *Affected Public:* Certain U.S. branches of foreign banks. *Estimated Number of Respondents:* 12. *Estimated Time per Response:* Ranges from 1/4 hour to 10 hours. *Total Annual Burden:* 1,572 hours. *General Description of Collection:* The collection of information consists of

(a)applications to operate as a noninsured state-licensed branch of a foreign bank;

(b)applications from an insured state licensed branch of a foreign bank to conduct activities which are not permissible for a federally-licensed branch;

(c)internal recordkeeping by insured branches of foreign banks; and

(d)reporting requirements relating to an insured branch(s pledge of assets to the FDIC. 8. *Title:* Certification of Eligibility Under the Affordable Housing Program. *OMB Number:* 3064-0116. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Individuals wishing to purchase affordable housing properties from the FDIC. *Estimated Number of Respondents:* 12. *Estimated Time per Response:* 1 hour. *Total Annual Burden:* 12 hours. *General Description of Collection:* This collection of information certifies income eligibility under the affordable housing program. The certification assists the FDIC in determining an individual(s eligibility for purchasing affordable housing properties from the FDIC. 9. *Title:* Notice Regarding Unauthorized Access to Customer Information. *OMB Number:* 3064-0145. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Number of Respondents:* 5,500. *Estimated Time per Response:* *Developing notices:* 20 hrs. × 5,500 = 110,000 hours. *Notifying customers:* 24 hrs. × 110 = 2,640 hours. *Total Estimated Annual Burden:* 112,640 hours. *General Description of Collection:* This collection reflects the FDIC's expectations regarding a response program that financial institutions should develop to address unauthorized access to or use of customer information that could result in substantial harm or inconvenience to a customer. The information collections require financial institutions to:

(1)Develop notices to customers; and

(2)in certain circumstances, determine which customers should receive the notices and send the notices to customers. 10. *Title:* Mutual-to-Stock Conversions of State Savings Banks. *OMB Number:* 3064-0117. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state chartered savings banks that are not members of the Federal Reserve System proposing to convert from mutual to stock form of ownership. *Estimated Number of Respondents:* 10. *Estimated Time per Response:* 50 hours. *Total Annual Burden:* 500 hours. *General Description of Collection:* 12 CFR 303.161 and 333.4 require state savings banks that are not members of the Federal Reserve System to file with the FDIC a notice of intent to convert to stock form and provide copies of documents filed with State and Federal banking and or securities regulators in connection with the proposed conversion. 11. *Title:* Privacy of Consumer Financial Information. *OMB Number:* 3064-0136. *Form Number:* None. *Frequency of Response:* On occasion. *Affected Public:* Insured state nonmember banks. *Estimated annual number of institution respondents:* Initial notice, 208; annual notice and change in terms, 5,138; opt-out notice, 873. *Estimated average time per response per institution:* Initial notice, 80 hours; annual notice and change in terms, 8 hours; opt-out notice, 8 hours. *Subtotal, annual burden hours for institutions:* 64,728 hours. *General Description of Collection:* The elements of this information collection are required under section 504 of the Gramm-Leach-Bliley Act, Public Law 106-102. The collection mandates notice requirements and restrictions on a financial institution's ability to disclose nonpublic personal information about consumers to nonaffiliated third parties. 12. *Title:* Applicant Background Questionnaire. *OMB Number:* 3064-0138. *Form Number:* FDIC 2100/14. *Frequency of Response:* On occasion. *Affected Public:* FDIC job applicants who are not current FDIC employees. *Estimated Number of Respondents:* 10,000. *Estimated Time per Response:* 3 minutes. *Total Annual Burden:* 500 hours. *General Description of Collection:* The FDIC Applicant Background Questionnaire is completed voluntarily by FDIC job applicants who are not current FDIC employees. Responses to questions on the survey provide information on gender, age, disability, race/national origin, and to the applicant's source of vacancy announcement information. Data is used by the Office of Diversity and Economic Opportunity and the Personnel Services Branch to evaluate the effectiveness of various recruitment methods used by the FDIC to ensure that the agency meets workforce diversity objectives. Request for Comment Comments are invited on:

(a)Whether these collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility;

(b)the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used;

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

(d)ways to minimize the burden of the information collections on respondents, including through the use of automated collection techniques or other forms of information technology. At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the collections should be modified prior to submission to OMB for review and approval. Comments submitted in response to this notice also will be summarized or included in the FDIC's requests to OMB for renewal of these collections. All comments will become a matter of public record. Dated at Washington, DC, this 23rd day of May, 2006. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. E6-8182 Filed 5-25-06; 8:45 am] BILLING CODE 6714-01-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 June 9, 2006. **A. Federal Reserve Bank of New York** (Anne McEwen, Financial Specialist) 33 Liberty Street, New York, New York 10045-0001: *1. Mario and Dawn Martinez* , both of Sundown, New York; to acquire voting shares of Catskill Hudson Bancorp, Inc., Rock Hill, New York, and thereby indirectly acquire voting shares of Community Bank of Sullivan County, Rock Hill, New York. Board of Governors of the Federal Reserve System, May 22, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6-8083 Filed 5-25-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *http://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 June 19, 2006. **A. Federal Reserve Bank of Cleveland** (Cindy West, Manager) 1455 East Sixth Street, Cleveland, Ohio 44101-2566: *1. Sir Barton Bancorp, Inc.* , Lexington, Kentucky; to become a bank holding company by acquiring 100 percent of the voting shares of First National Bank of Lexington, Lexington, Kentucky. **B. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Minnesota Bancshares, Inc.* , Minneapolis, Minnesota; to become a bank holding company by acquiring 100 percent of the voting shares of Heron Lake State Bank, Heron Lake, Minnesota. In connection with this application, Applicant also has applied to acquire Heron Lake Agency, Inc., Heron Lake, Minnesota, and thereby engage in the sale of insurance in a town with a population not exceeding 5,000, pursuant to section 225.28(b)(11)(iii)(A) of Regulation Y. Board of Governors of the Federal Reserve System, May 22, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6-8084 Filed 5-25-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR part 225) to engage *de novo* , or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *http://www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 9, 2006. **A. Federal Reserve Bank of New York** (Anne McEwen, Financial Specialist) 33 Liberty Street, New York, New York 10045-0001: *1. Allied Irish Banks, P.L.C.* , Dublin, Ireland; to engage *de novo* through its subsidiary Goodbody Securities, Inc., New York, New York, in securities brokerage and private placement services, pursuant to sections 225.28(b)(7)(i) and (b)(7)(iii) of Regulation Y. Board of Governors of the Federal Reserve System, May 22, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6-8082 Filed 5-25-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage *de novo* , or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 23, 2006. **A. Federal Reserve Bank of New York** (Anne McEwen, Financial Specialist) 33 Liberty Street, New York, New York 10045-0001: *1. Emigrant Bancorp, Inc., and New York Private Bank & Trust Corporation* , both of New York, New York; to engage *de novo* through their subsidiary, New York Private Bank & Trust, FSB, Wilmington, Delaware, in operating a savings association, pursuant to section 225.28(b)(4)(ii) of Regulation Y. Board of Governors of the Federal Reserve System, May 23, 2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6-8137 Filed 5-25-06; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-372(S), CMS-2746, CMS-10190, CMS-10183, CMS-2744, CMS-10194, and CMS-10184] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

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

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

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Annual Report on Home and Community-Based Services Waivers and Supporting Regulations in 42 CFR 440.180 and 441.300-310; *Use:* States with an approved waiver under section 1915(c) of the Act are required to submit a report annually in order for CMS to:

(1)Verify that State assurances regarding waiver cost-neutrality are met; and

(2)determine the waiver's impact on the type, amount, and cost of services provided under the State Plan and health and welfare of recipients. *Form Number:* CMS-372(S) (OMB#: 0938-0272); *Frequency:* Annually; *Affected Public:* State, Local or Tribal Government; *Number of Respondents:* 50; *Total Annual Responses:* 287; *Total Annual Hours:* 21,525. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* End Stage Renal Disease Death Notification Public Law 95-292; 42 CFR 405.2133, 45 CFR 5-5b; 20 CFR parts 401 and 422E; *Use:* The ESRD Death Notification (CMS-2746) is completed by all Medicare-approved ESRD facilities upon the death of an ESRD patient. Its primary purpose is to collect fact of death and cause of death of ESRD patients. Certain other identifying information (e.g., name, Medicare claim number, and date of birth) is required for matching purposes. Federal regulations require that the ESRD Networks examine the mortality rates of every Medicare-approved facility within its area of responsibility. The Death Form provides the necessary data to assist the ESRD Networks in making decisions that result in improved patient care and in cost-effective distribution of ESRD resources. The data is used by the ESRD Networks to verify facility deaths and to monitor facility performance. *Form Number:* CMS-2746 (OMB#: 0938-0448); *Frequency:* On occasion, weekly; *Affected Public:* Business or other for-profit, Not-for-profit institutions, Federal government; *Number of Respondents:* 4,719; *Total Annual Responses:* 75,504; *Total Annual Hours:* 37,752. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* State Plan Preprints to Implement Sections of the Deficit Reduction Act

(DRA)of 2006; *Use:* This information collection is requested in order that States can submit State Plan preprints to CMS for review and approval to implement the Medicaid program. The DRA provides States with the flexibility to request through the use of State Plan preprints changes in benefit packages, cost sharing, non-emergency medical transportation services, etc. CMS will send State Medicaid Director letters and State Plan preprints to States in an effort to request these changes, if they so choose, and to make the process as simple as possible.; *Form Number:* CMS-10190 (OMB#: 0938-0993); *Frequency:* Other: One-time; *Affected Public:* State, Local or Tribal Government; *Number of Respondents:* 56; *Total Annual Responses:* 56; *Total Annual Hours:* 56. 4. *Type of Information Collection Request:* New Collection; *Title of Information Collection:* National Evaluation of the Demonstration to Improve the Direct Service Community Workforce; *Use:* The purpose of this research is to perform a national evaluation of the impact of ten demonstration grants awarded by CMS. These demonstration grants support various interventions to improve the recruitment and retention of direct service workers. The data will permit the national evaluation to compare and contrast the processes and outcomes of the ten demonstration projects. The evaluation will provide an understanding of which types of interventions are most likely to be effective under a range of circumstances. The data collections consist of six components. From participating sites this will include: 200 agencies, 4,000 direct service workers, and 4,000 consumers. From control sites this will include 50 agencies, 1,333 direct service workers, and 1,333 consumers. All data will be collected using mail surveys; *Form Number:* CMS-10183 (OMB#: 0938-NEW); *Frequency:* Other: One-time; *Affected Public:* Individuals or Households, Business or other for-profit, and Not-for-profit institutions; *Number of Respondents:* 10,916; *Total Annual Responses:* 10,916; *Total Annual Hours:* 10,916. 5. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* End Stage Renal Disease Medical Information ESRD Facility Survey; *Use:* The ESRD Facility Survey is completed by all Medicare-approved ESRD facilities once a year. The survey was designed to collect information concerning treatment trends, utilization of services and patterns of practice in treating ESRD patients. The aggregate patient information is collected from each Medicare-approved provider of dialysis and kidney transplant services. The information is used to assess and evaluate the local, regional and national levels of medical and social impact of ESRD care and are used extensively by researchers and suppliers of services for trend analysis. The information is available on the CMS Dialysis Facility Compare website and will enable patients to make informed decisions about their care by comparing dialysis facilities in their area. The ESRD Facility Survey Public Use File is also posted at: *http://www.cms.hhs.gov/ESRDGeneralInformation/02_Data.asp#TopOfPage ; Form Number:* CMS-2744 (OMB#: 0938-0447); *Frequency:* Reporting—Annually; *Affected Public:* Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 4,800; *Total Annual Responses:* 4,800; *Total Annual Hours:* 38,400. 6. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Mail Survey of Medicare Advantage Special Needs Plans (SNPs)/Focus Groups with Enrollees of Medicare Advantage SNPs; *Use:* CMS is conducting an evaluation of Medicare Advantage Special Needs Plans (SNPs), which includes developing profiles of all SNPs that describe the structure and operation of these plans. A one-time short mail questionnaire will gather information about SNPs that is not available from other sources, such as reason for becoming a SNP, and information on care coordination. One-time 90-minute focus groups conducted during site visits to 15 SNPs will provide information on beneficiary experiences in SNPs, including decision to enroll and use of special services.; *Form Number:* CMS-10194 (OMB#: 0938-NEW); *Frequency:* Reporting—One-time; *Affected Public:* Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 350; *Total Annual Responses:* 350; *Total Annual Hours:* 395. 7. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Payment Error Rate Measurement of Eligibility in Medicaid and the State Children's Health Insurance Program (SCHIP); *Use:* The Improper Payments Information Act

(IPIA)of 2002 requires CMS to produce national error rates for Medicaid and the State Children's Health Insurance Program (SCHIP). To comply with the IPIA, CMS will use a national contracting strategy to produce error rates for Medicaid and SCHIP fee-for-service and managed care improper payments. The Federal contractor will review states on a rotational basis so that each state will be measured for improper payments, in each program, once and only once every three years. As outlined in the October 5, 2005, interim final rule (70 FR 58260), CMS convened an eligibility workgroup comprised of the Department of Health and Human Services, the Office of Management and Budget

(OMB)and representatives from two states. The Office of Inspector General

(OIG)participated in an advisory capacity. The workgroup was charged to make recommendations for measuring Medicaid and SCHIP improper payments based on eligibility errors within the confines of current statute, with minimal impact on states' resources and considering public comments on the August 27, 2004, proposed rule and the October 5, 2005, interim final rule. Based on the eligibility workgroup's recommendations and public comments, we developed an eligibility review methodology that we expect will provide consistency in the reviews of active (i.e., beneficiaries receiving Medicaid or SCHIP) and negative cases (i.e., beneficiaries whose benefits were denied or terminated) as well as achieve the confidence and precision requirements at the national level required by the IPIA.; *Form Number:* CMS-10184 (OMB#: 0938-NEW); *Frequency:* Reporting—On occasion and Monthly; *Affected Public:* Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 34; *Total Annual Responses:* 715; Total Annual Hours: 448,120. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on July 25, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: May 18, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-7933 Filed 5-25-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Awareness on Embryo Adoption and/or Donation AGENCY: Office of Public Health and Science, Office of the Secretary, DHHS. ACTION: Notice. *Announcement Type:* This is the initial announcement of a competitive funding opportunity for cooperative agreement projects. *Funding Opportunity Number:* OPHS-2006-EA. CFDA Number: 93.007. DATES: Applications are due no later than June 26, 2006. A Letter of Intent

(LOI)is requested on or before June 12, 2006. SUMMARY: The Office of Public Health and Science

(OPHS)announces the availability of Fiscal Year

(FY)2006 funds to support a total of three to four new cooperative agreement grant projects, with the goal of increasing public awareness of embryo donation and/or adoption. Approximately $1,000,000 in funding is available on a competitive basis for cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. The OPHS intends to fund at least one project in each of three distinct categories (professional meeting(s); training for professionals to equip them with the skills necessary to provide information and education; and an evidence-based assessment of the emerging field of embryo donation and/or adoption) with the goal of increasing public awareness regarding embryo donation and/or adoption. Entities may apply for more than one category; however, a separate application is required for each category identified in this announcement. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children. I. Funding Opportunity Description The Office of Public Health and Science

(OPHS)of the Department of Health and Human Services

(DHHS)announces the availability of funds for FY 2006 and requests applications for cooperative agreement projects that will contribute to increasing public awareness of embryo donation and/or adoption. The OPHS is under the direction of the Assistant Secretary for Health (ASH), who serves as the Senior Advisor on public health and science issues to the Secretary of the Department of Health and Human Services (DHHS). The Office serves as the focal point for leadership and coordination across the Department in public health and science; provides direction to program offices within OPHS; and provides advice and counsel on public health and science issues to the Secretary. The increasing success of assisted reproductive technologies

(ART)has resulted in a situation in which an infertile couple typically creates several embryos through in-vitro fertilization (IVF). During IVF treatments, couples may produce many embryos in an attempt to conceive with several being cryopreserved (frozen) for future use. If a couple conceives without using all of the stored embryos, they may choose to have the remaining unused embryos donated for donation and adoption allowing other infertile couples the experience of pregnancy and birth. Embryo donation and/or adoption is a relatively new process in which individuals who have extra frozen embryos agree to release the embryos for transfer to the uterus of another woman, either known or anonymous to the donor(s) for the purpose of the recipient(s) attempting to bear a child and be that child's parent. Legislative History Public Law 109-149, the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, which includes appropriations for DHHS, authorizes the Secretary to conduct a public awareness campaign to educate Americans about the existence of frozen embryos available for donation and/or adoption. The FY 2006 Senate Committee on Appropriations Report (S. Rep. 109-103) contains the following statement: The Committee continues to believe that increasing public awareness of embryo donation and adoption remains an important goal. The Committee has provided $2,000,000 for the Department's embryo adoption awareness campaign, which is $1,008,000 more than the comparable fiscal year 2005 funding level and the administration request. The FY 2006 House Committee on Appropriations Report (H. Rep. 109-143) contains the following statement: The Committee provides $992,000 for the embryo adoption awareness campaign, which is the same as the Administration request and the comparable fiscal year 2005 level. These funds will be used for a competitive grant program to continue embryo adoption public awareness activities. The Conference Report (H.R. Conf. Rep. 109-337) accompanying the FY 2006 Appropriations for the Departments of Labor, Health and Human Services and Education and Related Agencies bill did not include a statement addressing embryo adoption and/or donation awareness activities; however, the budget table accompanying the conference report allocated $2 million. Review of Grant Materials Grantees shall submit all materials proposed for use in the funded project (including, but not limited to, Web sites, videos, training materials, brochures, fact sheets, press releases, agendas, curricula, reports, journal articles, promotional pieces, advertisements, PSA's, articles, mailings) to the OPHS Project Officer for review and approval prior to use in the funded program. The review shall ensure that materials are consistent with the requirements of this announcement and other applicable grant requirements. Grant Attribution The OPHS is interested in making available to the public the results and accomplishments of activities that it funds. Therefore, grantees will be required to place an acknowledgment of OPHS grant support and a disclaimer, as appropriate, on any publication written or published with such support and, if feasible, on any publication reporting the results of or describing a grant-supported activity. II. Award Information *Funding Instrument Type:* Cooperative Agreement. *Anticipated Total Funding:* $1,000,000. *Anticipated Number of Awards:* A total of 3-4. OPHS anticipates funding one or two projects in each category. *Expected Amounts of Individual Awards:* $250,000-350,000. *Floor of Award Range:* None. *Ceiling of Award Range:* $350,000 for the first 12 month budget period. OPHS will not accept and review applications with budgets greater than the ceiling of the award range. *Project Periods for Awards:* 24 months. The projects will be awarded for a project period of 24 months. The initial grant award will be for a 12-month budget period. The award of continuation funding beyond each 12-month budget period will be subject to the availability of funds, satisfactory progress on the part of the grantee, and a determination that continued funding would be in the best interest of the government. Applications are encouraged from organizations which are currently operating programs that have the capability of expanding and enhancing public awareness of embryo donation and/or adoption, and that have the capability to conduct a rigorous evaluation of the funded project. A cooperative agreement is a grant award instrument establishing an “assistance” relationship between OPHS and a recipient, in which substantial programmatic involvement with the recipient is anticipated during the performance of the activity. The recipient will have lead responsibilities in all aspects of the project, including any modifications to the project, conduct of the project, and preparation of any publications. The OPHS project officer will collaborate with the recipients, as appropriate, and provide consultation, assistance, and support in planning, implementing, and evaluating all aspects of the proposed project plan. OPHS will have substantial programmatic involvement during conduct of the project, through technical assistance, advice and coordination. Substantial involvement as a partner would include, for example, assisting in planning an agenda, selecting speakers, organizing a symposium, determining the content of a training curricula and related educational materials, determining the topics or data to reviewed as part of an assessment, and determining the acceptability of articles or reports. OPHS will provide assistance in the preparation and review of any reports that may be disseminated as part of a funded project. III. Eligibility Information 1. Eligible Applicants Eligible applicants must demonstrate previous experience with embryo donation and/or adoption and be knowledgeable in all elements of the process of embryo donation and/or adoption. Only agencies and organizations, not individuals, are eligible to apply. Eligible applicants include public agencies, non-profit organizations, and for-profit organizations. One agency must be identified as the applicant organization and will have legal responsibility for the project. Additional agencies and organizations can be included as co-participants, subgrantees, subcontractors, or collaborators if they will assist in providing expertise and in helping to meet the needs of the recipients. Any public or private nonprofit organization or agency is eligible to apply for a cooperative agreement grant. However, only those organizations or agencies which demonstrate the capability of providing the proposed services and meet the requirements of this announcement are considered for awards. Faith-based and community-based organizations that meet the eligibility requirements are encouraged to apply for these embryo donation and/or adoption public awareness cooperative agreement projects. Please note, however, that cooperative agreement funds may not be used for inherently religious activities, such as worship, religious instruction, and proselytization. If an organization engages in such activities, they must be offered separately in time or location from the cooperative agreement program and participation must be voluntary for program beneficiaries. A cooperative agreement program, in providing services and outreach related to program services, cannot discriminate against current or prospective program beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in a religious practice. Applicants should note that section 74.81 of the DHHS grants administration regulations (45 CFR part 74) indicates that, except for awards under certain Asmall business@ programs, no grant funds may be paid as profit to any recipient even if the recipient is a commercial organization. Profit is any amount in excess of allowable direct and indirect costs. 2. Cost Sharing or Matching None. 3. Other Applicants are required to have a Dun and Bradstreet Data Universal Numbering System

(DUNS)number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access *http://www.dunandbradstreet.com* or call 1-866-705-5711. For more information, see the OPA Web site at: *http://opa.osophs.dhhs.gov/duns.html.* IV. Application and Submission Information 1. Address To Request Application Package Application kits may be requested from, and applications submitted to the Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, Maryland 20852, 240-453-8822. Application kits are also available online at: *https://egrants.osophs.dhhs.gov* or the Grants.gov Web site portal ( *http://www.grant.gov* ) or by fax at 240-453-8823. 2. Content and Form of Application Submission The OPHS requests that you send a Letter of Intent

(LOI)if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, estimate the potential review workload, and allow OPHS to plan the review process. The information will be used to determine the number of expert reviewers needed to evaluate the applications. The narrative should be not more than two double-spaced pages, printed on one side, with one-inch margins, and in 12-point font, unreduced. The LOI should include the following information: *“Attention: Embryo Adoption Public Awareness Campaign Letter of Intent for Category #__;”* name and address of the applicant institution; name, address and telephone number of the contact person; and specific objectives to be addressed by the proposed project. Applications must be prepared on the forms supplied (OPHS-1) and in the manner prescribed in the application kits provided by the OPHS. The application must be signed by an individual authorized to act for the applicant agency and to assume responsibility for the obligations imposed by the terms and conditions of the grant award. To be considered for funding, applicants must submit one signed original of the application and two photocopies in one package, including all forms and attachments. Please label the application envelope: *“Attention: Embryo Adoption Public Awareness Campaign Category #__.”* The application should be typed and should be no more than 50 double-spaced pages (excluding attachments), printed on one side, with one-inch margins, and in 12-point font, unreduced. All pages, including appendices should be numbered sequentially and stapled, or otherwise secured, in the upper left corner. Applications must include a one-page abstract of the proposed project. The abstract will be used to provide reviewers with an overview of the application, and will form the basis for the applications summary in grants management documents. Program Requirements/Application Content This notice solicits applications for cooperative agreement grant projects in three distinct categories:

(1)Professional meeting(s) with the goal of increasing public awareness about embryo donation and/or adoption;

(2)Training for professionals who work in ART and/or embryo donation and/or adoption in order to equip them with the skills necessary to provide information and education to the public; and

(3)Evidence-based assessment of the emerging field of embryo donation and/or adoption in order to identify the most pressing information gaps for efficient and effective campaigns to increase public awareness of embryo donation and/or adoption. Category #1—Professional Meeting(s) on Embryo Donation and/or Adoption The OPHS is interested in supporting a professional meeting (or a series of meetings) that further the goal of increasing public awareness of embryo donation and/or adoption by gaining visibility and fostering collaboration among professionals who are committed to addressing areas of development in the field of embryo donation and/or adoption. For the purpose of this announcement, such a meeting (or meetings) is defined as a gathering, symposium, seminar, conference, workshop or any other organized, formal meeting where people assemble to coordinate, exchange, and disseminate information or explore or clarify the subject of embryo donation and/or adoption. Among the goals of such a professional meeting would be to foster multi-disciplinary and multi-sector interactions that will stimulate development in communications and increase public awareness regarding the practice of embryo donation and/or adoption. A professional meeting is expected to actively foster an environment conducive to collaboration among a variety of professionals in the field. The types of meeting activities eligible for support include, but are not limited to:

(1)A meeting where issues or challenges in the delivery of information on embryo donation and/or adoption are defined and an agenda or strategy for studying them is developed;

(2)a meeting where technical, medical, legal, ethical, social, and/or policy issues of major importance in the field are addressed or new ideas are developed; and

(3)dissemination conferences where critical information is summarized and communicated broadly to organizations and individuals that have the capability to use the information to develop, deliver or improve public awareness campaigns on embryo donation and/or adoption. OPHS is especially interested in supporting a project that demonstrates strategies which include plans for disseminating conference materials beyond the participants attending the event. Such strategies might include, but are not limited to, submitting articles for publication, posting information on a Web site, and seeking formal opportunities to discuss conference information with others. Applicants should include a brief summary of the proposed meeting(s), including proposed dates, location, type of participants, goals and specific topics to be covered. The summary should include the objectives, specific program and logistical arrangements for the meeting. Applicants should describe the format and agenda, including the principal topics to be covered, problems to be addressed, and developments or contributions the meeting might stimulate regarding public awareness of embryo donation and/or adoption. Applicants are expected to provide a detailed justification for the meeting, including the professional need, timeliness and usefulness of the meeting to the embryo donation and/or adoption community. The grant application should describe the composition and role of an organizing committee, and provide the names and credentials of proposed key participants in the meeting, including the basis for their selection and documentation of their interest in participating. The applications should also describe the expected size and composition of the audience, as well as the method for selection. The OPHS is also interested in description of plans for publicizing the meeting and publication of proceedings or other methods of disseminating information during or after the meeting(s). Category #2—Training Regarding Embryo Donation and/or Adoption The OPHS is interested in supporting training for health, social service and other involved professionals (e.g., physicians, nurses, embryologists, counselors, social workers, clinic staff, etc.) that address the complex legal, medical, psychosocial, ethical and practical issues that confront embryo donors and recipients. OPHS anticipates funding one applicant to establish a training project that focuses on embryo donation and/or adoption information and education services. The successful applicant will provide training that will enhance and support quality services and public awareness of embryo donation and/or adoption in the United States. The purpose of the training program to be funded under this announcement is to ensure that professionals working in the area of embryo donation and/or adoption have the knowledge, skills, and abilities necessary to effectively provide information and education services regarding embryo donation and/or adoption to the public. The successful applicant will use evidence-based information and approaches in all aspects of training and act as a resource on embryo donation and/or adoption to other entities interested in increasing public awareness of embryo donation and/or adoption. Embryo donation and/or adoption is an emerging field and the practice of embryo donation and/or adoption is complicated by the different attitudes and expectations that professionals, as well as potential donors and recipients, have about this option. Many clinical settings may not be aware of or comfortable with providing information to their patients about embryo donation and/or adoption. Current and future efforts will add significantly to the body of knowledge related to embryo donation and/or adoption, providing evidence-based information that will enable providers to develop effective programs. This emerging body of knowledge should also provide the basis for training content. The applicant must be able to incorporate current, evidence-based information as it becomes available in all phases of training design, delivery, and evaluation. Applicant organizations must demonstrate significant experience in the design, development, implementation, successful completion, and evaluation of training activities. In addition, the successful applicant must demonstrate skill and experience in providing training to diverse groups. The successful applicant will provide evidence of familiarity with embryo donation and/or adoption and the ability to translate evidence-based information into training activities. The training project is intended to serve a national network for interested professionals, both medical and social service providers, as well as other professionals that may have an interest. Eligible activities include, but are not limited to:

(1)Conducting training events that focus on information, education, and clinical services that will enhance and support public awareness of embryo donation and/or adoption;

(2)developing strategies to translate evidence-based information on embryo donation and/or adoption into effective educational and clinical practice through training;

(3)identifying or developing and disseminating training materials and resources related to embryo donation and/or adoption;

(4)supporting appropriate speakers at training events; and

(5)building the capacity of professionals to educate and serve individuals who are interested in embryo donation and/or adoption. The applicant funded under this announcement will be expected to conduct training activities with continuing education content relevant to the medical, legal, psychosocial, ethical and practical issues involved with embryo donation. This continuing education content may be offered to professionals working with populations who may be interested in embryo donation and/or adoption. Training provided is intended to enhance the ability of multiple levels of providers to share information about and assist couples with embryo donation and/or adoption. Training content and design should be adjusted to the skill and practice role of the target audience. Continuing education credits must be available for training activities provided under this announcement. The content and number of offerings should be based on an assessment of the need and offerings should be designed and delivered in a manner appropriate to the content and professional preparation of the participants. Distance learning components may be part of the training offerings. Category #3—Evidence-Based Assessment of Embryo Donation and/or Adoption Public Awareness OPHS is interested in supporting a project that will advance our understanding of embryo donation and/or adoption in the United States, and will also improve strategies for communicating information that will ultimately increase public awareness of embryo donation and/or adoption. One of the purposes of such a project is to serve as a resource for the efficient translation of knowledge generated through this and other related projects to the practice efforts in the field of embryo donation and/or adoption. This work will contribute to a longer-term strategy to address the complex issues associated with embryo donation and/or adoption. OPHS is interested in a project that will analyze necessary data and information to assess progress toward the goal of improving public awareness of embryo donation and/or adoption. One of the purposes of this project is to facilitate information exchange among professionals in the field of embryo donation and adoption. The types of activities eligible for support include, but are not limited to:

(1)The development and distribution of periodic publications ( *e.g.* , “Updates” or “Issues in Brief”) to highlight findings, collaborations, presentations, publications, and other noteworthy items generated by embryo donation and/or adoption grantees and other entities engaged in efforts to increase public awareness of embryo donation and/or adoption; and/or

(2)analyses on key issues in order to increase the availability of data and evidence-based information which will be useful to professionals in improving or increasing public awareness about embryo donation and/or adoption. Applicants should describe the set of information needs in the area of embryo donation and/or adoption public awareness, and propose a coherent program of quantitative and/or qualitative analysis or assessment designed to fill these needs in a practical and creative manner. The principal purpose of this project is not to collect original data; however, if it is relevant and can be demonstrated that appropriate data do not exist elsewhere, some collection of original data is not precluded. Applicants must provide a plan on how information from the project will be disseminated. Application Narrative In the narrative section of the application, applicants are advised to describe the strategies and processes that they will use. The applicant should document its capacity to undertake a project in one of the identified categories that is focused on increasing public awareness of embryo donation and/or adoption. Applicants are encouraged to present a description of approaches that may be used, as well as any supplemental materials. Moreover, applicants are advised to demonstrate a familiarity with and understanding of professionally recognized standards or practices (both medical and legal issues) pertaining to embryo donation and/or adoption, as well as supportive services for potential donor or recipient couples. The applicant organization should clearly demonstrate its professional knowledge and experience in embryo donation and/or adoption. Applicants should include information about their history in working with embryo donation and/or adoption, and the organization's capacity to further the goal of increasing public awareness of embryo donation and/or adoption. As part of the project narrative, applicants are advised to describe the methods they will use to recruit, select, train and evaluate individuals who will implement the project. Applicants, in the project narrative, are encouraged to present a plan for evaluation of the project. The evaluation plan should be two tiered to address:

(1)Process, including the planning, content and quality of the products ( *e.g.* , videos, pamphlets, journal articles, presentations, survey instruments, focus groups projects, pilot test reports, conference proceedings, etc.) produced and

(2)participant satisfaction and/or project effectiveness, as appropriate. Applicants that do not have the in-house capacity to conduct an evaluation are advised to propose contracting with a third party evaluator to conduct the evaluation. Applicants should prepare a project description statement in accordance with the following general instructions and use the information provided in this section and the evaluation criteria section to develop the application content. Applications will be evaluated on the criteria listed, so it is important to follow them in describing your program plan. The narrative should contain the following sections in the order presented below: 1. *Project Summary/Abstract:* Provide a summary of the project description not to exceed one page. Care should be taken to produce an abstract/summary that accurately and concisely reflects the proposed project since the abstract will be used to provide reviewers with an overview of the application, will form the basis for an application summary in official documents, and it may be posted on the OPHS Web site. It should describe the objectives of the project, the approach to be used and the results or benefits expected. 2. *Objectives and Need for Assistance:* Clearly identify the physical, economic, social, legal, financial, institutional, and/or other problem(s) requiring a solution. The need for assistance must be demonstrated and the principal and subordinate objectives of the project must be clearly stated; supporting documentation, such as letters of support and testimonials from concerned interests other than the applicant, may be included. Any relevant data based on studies should be included or referred to in the endnotes/footnotes. In developing the project description, the applicant may volunteer to provide information on the total range of related projects being conducted or supported (or to be initiated), some of which may be outside the scope of the program announcement. Describe the specific geographic region that will be served by the organization. This section should include a justification for the selection of the region, based on, for example, geographic size or the number and types of ART centers in the area. There are no geographic restrictions on where the prospective projects may be conducted. The OPHS will accept applications for projects of national, regional, or local scope. The rationale for the project scope must be justified in detail. 3. *Approach:* Outline a plan of action, which describes the scope and detail of how the proposed work will be accomplished. Account for all functions or activities identified in the application. Cite factors that might accelerate or decelerate the work, and state your reason for taking the proposed approach rather than others. Describe any unusual features of the project such as design or technological innovations, reductions in cost or time, or extraordinary social and community involvement. Provide quantitative monthly or quarterly projections of the accomplishments to be achieved for each function or activity in such terms as the number of program activities to be held, or appropriate measurable outcomes. When accomplishments cannot be quantified by activity or function, list them in chronological order to show the schedule of accomplishments and their target dates. 4. *Evaluation:* Provide a narrative addressing how the results of the project and the conduct of the project will be evaluated. In addressing the evaluation of results, state how you will determine the extent to which the project has achieved its stated objectives and the extent to which the accomplishment of objectives can be attributed to the project. Discuss the criteria to be used to evaluate results, and explain the methodology that will be used to determine if the needs identified and discussed are being met and if the project results and benefits are being achieved. With respect to the conduct of the project, define the procedures to be employed to determine whether the project is being conducted in a manner consistent with the work plan presented and discuss the impact of the project's various activities on the project's effectiveness. 5. *Organizational Profiles:* Provide information on the applicant organization and cooperating partners such as organizational charts, financial statements, audit reports or statements from CPAs/Licensed Public Accountants, Employer Identification Numbers, names of bond carriers, contact persons and telephone numbers, and other documentation of professional accreditation, information on compliance with Federal/State/local government standards, documentation of experience in the program area, and other pertinent information. 6. *Budget and Budget Justification:* Provide a narrative budget justification that describes how the categorical costs are derived. Discuss the necessity, reasonableness, and allocability of the proposed costs. Identify the project director or principal investigator, if known. For each staff person, provide the title, time commitment to the project (in months), time commitment to the project (as a percentage or full-time equivalent), annual salary, grant salary, and wage rates. Do not include the costs of consultants or personnel costs of delegate agencies or of specific project(s) or businesses to be financed by the applicant. Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, FICA, retirement insurance, and taxes, unless treated as part of an approved indirect cost rate. Include information on the costs of project-related travel by employees of the applicant organization (does not include costs of consultant travel). For each trip, show the total number of traveler(s), travel destination, duration of trip, per diem, mileage allowances, if privately owned vehicles will be used, and other transportation costs and subsistence allowances. For each type of equipment requested, provide a description of the equipment, the cost per unit, the number of units, the total cost, and a plan for use on the project, as well as use or disposal of the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy or section of its policy which includes the equipment definition. Specify general categories of supplies and their costs. Show computations and provide other information, which supports the amount requested. Include information on the costs of all contracts for services and goods except for those, which belong under other categories such as equipment, supplies, construction, etc. Third-party evaluation contracts (if applicable) and contracts with secondary recipient organizations, including delegate agencies and specific project(s) or businesses to be financed by the applicant, should be included under this category. Whenever the applicant intends to delegate part of the project to another agency, the applicant must provide a detailed budget and budget narrative for each delegate agency, by agency title, along with the required supporting information. 3. Submission Dates and Times Applications must be submitted to the OPHS Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852. Letters of Intent should also be sent to this address. Submission Mechanisms The Office of Public Health and Science

(OPHS)provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines described below will not be accepted for review. Applications which do not conform to the requirements of the grant announcement will not be accepted for review and will be returned to the applicant. Applications may only be submitted electronically via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the OPHS eGrants system or the Grants.gov Web site Portal is encouraged. Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement using one of the electronic submission mechanisms specified below. All required hardcopy original signatures and mail-in items must be received by the OPHS Office of Grants Management no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the DATES section of the announcement. Applications will not be considered valid until all electronic application components, hardcopy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible. Applicants are encouraged to initiate electronic applications early in the application development process, and to submit early on the due date or before. This will aid in addressing any problems with submissions prior to the application deadline. Electronic Submissions Via the Grants.gov Web site Portal The Grants.gov Web site Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, *http://www.grants.gov* . In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the grant announcement, as well as the application guidance provided within the Grants.gov application package, to determine such requirements. Any required hard copy materials, or documents that require a signature, must be submitted separately via mail to the OPHS Office of Grants Management, and, if required, must contain the original signature of an individual authorized to act for the applicant agency and the obligations imposed by the terms and conditions of the grant award. Electronic applications submitted via the Grants.gov Web site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. All required mail-in items must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. Upon completion of a successful electronic application submission via the Grants.gov Web site Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation for their records, as well as a copy of the entire application package. All applications submitted via the Grants.gov Web site Portal will be validated by Grants.gov. Any applications deemed “Invalid” by the Grants.gov Web site Portal will not be transferred to the OPHS eGrants system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Web site Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard copy materials. Once the application is validated by Grants.gov, it will be electronically transferred to the OPHS eGrants system for processing. Upon receipt of both the electronic application from the Grants.gov Web site Portal, and the required hardcopy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Web site Portal. Applicants should contact Grants.gov regarding any questions or concerns regarding the electronic application process conducted through the Grants.gov Web site Portal. Electronic Submissions Via the OPHS eGrants System The OPHS electronic grants management system, eGrants, provides for applications to be submitted electronically. Information about this system is available on the OPHS eGrants Web site, *https://egrants.osophs.dhhs.gov* , or may be requested from the OPHS Office of Grants Management at

(240)453-8822. When submitting applications via the OPHS eGrants system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms ( *e.g.* , Program Certifications) with the original signature of an individual authorized to act for the applicant agency. Electronic applications submitted via the OPHS eGrants system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however these mail-in items must be entered on the eGrants Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. Upon completion of a successful electronic application submission, the OPHS eGrants system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission including all electronic application components, required hardcopy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted. As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of their application in the OPHS eGrants system to ensure that all signatures and mail-in items are received. Mailed or Hand-Delivered Hard Copy Applications Applicants who submit applications in hard copy (via mail or hand-delivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award. Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS-1. Applications that do not meet the deadline will be returned to the applicant unread. 4. Intergovernmental Review This program is not subject to the intergovernmental review requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs,” as implemented by 45 CFR part 100. 5. Funding Restrictions The allowability, allocability, reasonableness and necessity of direct and indirect costs that may be charged to OPHS grants are outlined in the following documents: OMB Circular A-21 (Institutions of Higher Education); OMB Circular A-87 (State and Local Governments); OMB Circular A-122 (Nonprofit Organizations); and 45 CFR part 74, Appendix E (Hospitals). Copies of the Office of Management and Budget

(OMB)Circulars are available on the Internet at *http://www.whitehouse.gov/omb/grants/grants_circulars.html.* Applicants for cooperative agreements are expected to anticipate and justify their funding needs and the activities to be carried out with those funds in preparing the budget and accompanying narrative portions of their applications. If applicants are uncertain whether a particular cost is allowable, they should contact the OPHS Office of Grants Management at 240-453-8822 for further information. V. Application Review Information 1. Criteria Each application for a cooperative agreement grant project will be evaluated individually according to the following criteria by a panel of independent reviewers appointed by the OPHS. Before the review panel convenes, each application will be screened for applicant organization eligibility, as well as to make sure the application contains all of the essential elements. Applicants that meet the requirements of this program announcement will be notified by the Office of Grants Management. A panel of at least three reviewers will use the evaluation criteria listed below to determine the strengths and weaknesses of each application, provide comments and assign numerical scores. Applicants should address each criterion in the project application. The point values (summing up to 100) indicate the maximum numerical weight each criterion will be accorded in the review process. Criterion 1: Objectives and Need for Assistance (30 Points) Applicants must demonstrate a clear understanding of the legislative goals and demonstrate how their approach to the project design will contribute to achieve the legislative goals. Applicants must also demonstrate an understanding of the information and skills needed by the designated staff, as well as of the intended audience. Applicants should provide letters of commitment or Memoranda of Understanding from organizations, agencies and consultants that will be partners or collaborators in the proposed project. These documents should describe the role of the agency, organization or consultant and detail specific tasks to be performed. Specific review criteria include:

(1)Extent to which the application reflects an understanding of the legislative goals of the public awareness campaign for embryo donation and/or adoption, and implementation will contribute to achieving the legislative goals;

(2)Extent to which the application clearly describes and documents an understanding of the need for assistance to support and/or enhance existing efforts regarding public awareness of embryo donation and/or adoption;

(3)Extent to which the application reflects a knowledge and understanding of the challenges involved with embryo donation and/or adoption, and in increasing public awareness about embryo donation and/or adoption;

(4)Extent to which the application reflects a knowledge and understanding of the medical and legal framework of embryo donation and/or adoption, and the services and resources in the geographic area in which the proposed project will be conducted;

(5)Extent to which the application explains how the proposed project will contribute to increased knowledge of the problems, issues, and effective strategies and best practices in the field of embryo donation and/or adoption; and

(6)Extent to which the application presents a vision of how the project will advance embryo donation and/or adoption public awareness, and discusses broad contextual factors that will facilitate or impede increasing public awareness of embryo donation and/or adoption. Criterion 2: Approach (30 Points) In this section, applicants are expected to define goals and specific, measurable objectives for the project. Goals are an end product of an effective project. Objectives are measurable steps for reaching goals. Applicants are advised to describe a preliminary, yet appropriate and feasible plan of action pertaining to the scope of the proposed project and provide details on how the proposed project will be accomplished. If the project involves partnerships with other agencies and organizations, then the roles of each partner should be clearly specified. Applicants are required to describe how the project will be evaluated to determine the extent to which it has achieved its stated goals and objectives. Applicants are expected to present a project design that includes detailed procedures for documenting project activities that is sufficient to implement the goals and provide for an evaluation. The evaluation design is expected to include process and outcome analyses, if feasible. Applicants are expected to report on their evaluation results in their final report to the OPHS upon completion of the project period. Applicants are required to describe the activities that they will develop pursuant to the project. Applicants should discuss the intended audiences for these activities ( *e.g.* , ART centers, adoption organizations, practitioners, professional organizations that work with infertile couples, potential recipients, or donors) and present a dissemination plan specifying the venues for conveying the information. This criterion consists of four broad topics:

(A)Project design,

(B)implementation,

(C)evaluation, and

(D)dissemination. Specific review criteria include:

(A)Design of the Project

(1)Extent to which the application reflects a familiarity with and understanding of professionally-recognized standards and/or other relevant Federal or State requirements pertaining to embryo donation and/or adoption.

(2)Extent to which the proposed project goals, objectives and outcomes are clearly specified and measurable, and reflect an understanding of the context in which embryo donation and/or adoption operates; and

(3)Extent to which the application presents an approach that is:

(a)Competency based,

(b)consistent with the nationally recognized guidelines, and

(c)can be evaluated.

(B)Implementation

(1)Extent to which the application clearly describes and provides a justification for the selection of the geographic region that will be served by the project;

(2)Extent to which the application presents an appropriate, feasible and realistic plan for conducting the project;

(3)Extent to which the application presents an appropriate, feasible and realistic plan for recruiting, selecting, and training individuals to conduct the project;

(4)Extent to which the application provides an appropriate, feasible and realistic plan for documenting project activities and results, that can be used to describe and evaluate the project, and participant satisfaction; and

(5)Extent to which the proposed project will establish and coordinate linkages with other appropriate agencies and organizations.

(C)Evaluation

(1)Extent to which the methods of evaluation are feasible, comprehensive and appropriate to the goals, objectives and context of the project;

(2)Extent to which the applicant provides an appropriate, feasible and realistic plan for evaluating the project, including performance feedback and assessment of program progress that can be used as a basis for program adjustments;

(3)Extent to which the methods of evaluation include process and outcome analyses, as appropriate, for assessing the effectiveness of program strategies and the implementation process; and

(4)Extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the program and will produce quantitative and qualitative results.

(D)Dissemination

(1)Extent to which the application provides an appropriate, feasible and realistic plan for dissemination of information and related educational materials;

(2)Extent to which the intended audience is clearly identified and defined and is appropriate to the goals of the proposed program;

(3)Extent to which the program's products will be useful to the respective audiences;

(4)Extent to which the applicant presents a realistic schedule for developing these products, and provides a dissemination plan that is appropriate in scope and budget to each of the audiences; and

(5)Extent to which the products to be developed during the program are described clearly and will address the goal of dissemination of information and are designed to support evidence-based improvements of practices in the field. Criterion 3: Organizational Profile (20 Points) Applicants need to demonstrate that they have the capacity to implement the proposed program. Capacity includes:

(1)Previous experience with similar projects;

(2)experience with the target audience;

(3)qualifications and experience of the project leadership;

(4)experience and commitment of any consultants and subcontractors; and,

(5)appropriateness of the organizational structure. This criterion consists of three broad topics:

(A)management plan,

(B)staff qualifications, and

(C)organizational capacity and resources. Applicants are expected to present a sound and feasible management plan for implementing the proposed program. This section should detail how the program will be structured and managed, how the timeliness of activities will be ensured, how quality control will be maintained, and how costs will be controlled. The role and responsibilities of the lead agency should be clearly defined and, if appropriate, applicants should discuss the management and coordination of activities carried out by any partners, subcontractors and consultants. Applicants should include a list of organizations and consultants who will work with the project, along with a short description of the nature of their contribution or effort. Applicants are also expected to produce a time line that presents a reasonable schedule of target dates, and accomplishments. The time line should include the sequence and timing of the major tasks and subtasks, important milestones, reports, and completion dates. The application should also discuss factors that may affect project implementation or the outcomes and present realistic strategies for the resolution of these difficulties. Applicants must provide evidence that project staff have the requisite experience, and expertise to carry out the proposed project on time, within budget, and with a high degree of quality. Include information on staff knowledge of the medical and legal issues concerning embryo donation and/or adoption, and experience working in this area. Brief resumes of current and proposed staff, as well as job descriptions, should be included. Resumes must indicate the position that the individual will fill, and each position description must specifically describe the job as it relates to the proposed project. Applicants must show that they have the organizational capacity and resources to successfully carry out the project on time and to a high standard of quality, including the capacity to resolve a variety of technical and management problems that may occur. If the proposed project involves partnering and/or subcontracting with other agencies/organizations, then the application should include an organizational capability statement for each participating organization documenting the ability of the partners and/or subcontractors to fulfill their assigned roles and functions. Specific review criteria include:

(A)Management Plan

(1)Extent to which the management plan presents a realistic approach to achieving the objectives of the proposed project on time and within budget, including clearly defined responsibilities, time lines and milestones for accomplishing project tasks;

(2)Extent to which the role and responsibilities of the lead agency are clearly defined and the time commitments of the project director and other key project personnel (including consultants) are appropriate and adequate to meet the objectives of the proposed project; and

(3)Extent to which the applicant discusses factors that may affect the development and implementation of the project and presents realistic strategies for the resolution of these difficulties.

(B)Staff Qualifications

(1)Extent to which the proposed project director, key project staff and consultants have the necessary technical skill, knowledge and experience to successfully carry out their responsibilities; and

(2)Extent to which staffing is adequate for the proposed project, including administration, program services, data processing and analysis, evaluation, reporting and implementation of the project.

(C)Organizational Capacity and Resources

(1)Extent to which the applicant and partnering organizations collectively have experience in embryo donation and/or adoption consistent with professionally recognized guidelines;

(2)Extent to which the applicant has experience in developing and implementing similar projects; and

(3)Extent to which the applicant has adequate organizational resources for the proposed project, including administration, program operations, data processing and analysis, and evaluation. Criterion 4: Budget and Budget Justification (20 Points) Applicants are expected to present a detailed budget for both the first and second year budget periods. The budget is should present reasonable project costs, appropriately allocated across component areas and sufficient to accomplish the objectives. Consideration shall be given to project delays due to start-up when preparing the budget. Applicants are expected to allocate sufficient funds in the budget to provide for two meetings each year with the Project Officer in Rockville, Maryland, and regular conference calls for programmatic collaboration during the performance of the project. Specific review criteria include:

(1)Extent to which applicant demonstrates that the project costs and budget information submitted for the proposed program are reasonable and justified in terms of the proposed tasks and the anticipated results and benefits; and,

(2)Extent to which the fiscal control and accounting procedures are adequate to ensure prudent use, proper and timely disbursement and an accurate accounting of funds received under this announcement. Review and Selection Process Each application submitted to the OPHS Office of Grants Management will be screened to determine whether it was received by the closing date and time. The results of a competitive review are a primary factor in making funding decisions. In addition, Federal staff will conduct administrative reviews of the applications and, in light of the results of the competitive review, will recommend applications for funding to the ASH. The ASH may also solicit and consider comments from Office of Public Health and Science staff and others within DHHS in making funding decisions. Final grant awards decisions will be made by the ASH. The ASH will fund those projects which will, in his/her judgment, best promote the purposes of this program, within the limits of funds available for such projects. VI. Award Administration Information 1. Award Notices The OPHS does not release information about individual applications during the review process. When final decisions have been made, successful applicants will be notified by letter of the outcome of the final funding decisions. The official document notifying an applicant that a project as been approved for funding is the Notice of Grant Award (NGA), signed by the OPHS Grants Management Officer, which sets forth the amount of funds granted, the terms and conditions of the award, the effective date of the grant, the budget period for which initial support will be given, and the total project period for which support is contemplated. The ASH will notify an organization in writing when its application will not be funded. Every effort will be made to notify all unsuccessful applicants as soon as possible after final decisions are made. 2. Administrative and National Policy Requirements In accepting this award, the grantee stipulates that the award and any activities thereunder are subject to all provisions in 45 CFR parts 74 (non-governmental) and 92 (governmental) currently in effect or implemented during the period of the grant. The DHHS Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, grantees shall clearly state the percentage and dollar amount of the total costs of the program or project which will be financed with Federal money and the percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources. 3. Reporting Requirements A successful applicant under this notice will submit:

(a)Progress reports;

(b)annual Financial Status Reports; and

(c)a final performance report, including an evaluation report, and Financial Status Report. Reporting formats are established in accordance with provisions of the general regulations which apply under 45 CFR parts 74 and 92. Applicants must submit all required reports in a timely manner, in recommended formats and submit a final report on the project, including any information on evaluation results, at the completion of the project period. The final performance report should contain an overview of the program from start to finish, including information on:

(a)Summary of the project,

(b)state of the major goals and objectives of the project,

(c)list of significant accomplishments,

(d)description of innovative features,

(e)statement of significant problems encountered and solutions developed,

(f)a complete written disclosure of any invention, curriculum, publication, video, pamphlet conceived or produced as part of the grant funded project,

(g)a copy of any products developed in association with the project. The final evaluation report should reflect an assessment of the program. It should describe factors contributing to both program success and problem areas. The report should include a description of the project's objectives, interventions, evaluation model and hypotheses, findings and conclusions. The report should include a summary of the program statistics and findings. It should discuss the implications of project findings as they relate to the project objectives, as well as a set of recommendations based on the findings (where appropriate). The appendices to the evaluation report should include any data collection instruments and relevant references. Copies of any published articles, based on the project or project evaluation findings are also requested. Agencies receiving $500,000 or more in total Federal funds are required to undergo an annual audit as described in OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.” VII. Agency Contacts Office of Grants Management Contact: Robin Fuller Department of Health and Human Services, Office of Public Health and Science, OPHS Grants Management Office, 1101 Wootton Parkway, Suite 550, Rockville, Maryland, 20852. E-mail: *rfuller@osophs.dhhs.gov* ; telephone: 240-453-8822. *Program Office Contact:* Evelyn Kappeler, Department of Health and Human Services, Office of Public Health and Science, Office of Population Affairs, 1101 Wootton Parkway, Suite 750, Rockville, Maryland, 20852. E-mail: *Ekappeler@osophs.dhhs.gov* ; telephone: 240-453-2837. Dated: May 19, 2006. John O. Agwunobi, Assistant Secretary for Health, Office of Public Health and Science. [FR Doc. E6-8081 Filed 5-25-06; 8:45 am] BILLING CODE 4150-28-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): HIV III—OPT-Out Testing in Emergency Department Settings, Program Announcement

(PA)PS06-003 and Formative Internet-Based Interventions Research To Improve the Health and Reduce HIV Transmission Among HIV Positive Persons, PA PS06-004 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): HIV III—OPT-Out Testing in Emergency Department Settings, PA PS06-003 and Formative Internet-Based Interventions Research to Improve the Health and Reduce HIV Transmission Among HIV Positive Persons, PA PS06-004. *Time and Date:* 8 a.m.-5 p.m., June 22, 2006 (Closed). *Place:* Marriott Suites Midtown, 35 14th Street, Atlanta, GA 30309, Telephone 404-876-8888. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)

(PA)PS06-003 and “Formative Internet-Based Interventions Research to Improve the Health and Reduce HIV Transmission Among HIV Positive Persons,” PA PS06-004. *For Further Information Contact:* Chris Langub, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404-639-4640. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 19, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8127 Filed 5-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): HIV II—Identifying Ground-Breaking Behavioral Interventions To Prevent HIV Transmission, Program Announcement

(PA)PS06-005; Reducing Sexual Risk HIV Acquisition and Transmission, PA PS06-007 and HIV Prevention Intervention Research With HIV Positive Incarcerated Populations, PA PS06-011 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): HIV II—Identifying Ground-Breaking Behavioral Interventions to Prevent HIV Transmission, PA PS06-005; Reducing Sexual Risk HIV Acquisition and Transmission, PA PS06-007 and HIV Prevention Intervention Research with HIV Positive Incarcerated Populations, PA PS06-011. *Time and Date:* 8 a.m.-5 p.m., June 21, 2006 (Closed). *Place:* Marriott Suites Midtown, 35 14th Street, Atlanta, GA 30309, Telephone 404.876.8888. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)

(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to “HIV II—Identifying Ground-Breaking Behavioral Interventions to Prevent HIV Transmission,” PA PS06-005; “Reducing Sexual Risk HIV Acquisition and Transmission,” PA PS06-007 and “HIV Prevention Intervention Research with HIV Positive Incarcerated Populations,” PA PS06-011. *For Further Information Contact:* Chris Langub, Ph.D., Scientific Review Administrator, National Institute for Occupational Safety and Health, CDC, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.4640. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 18, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8128 Filed 5-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): HIV I—Use of Respondent-Driven Sampling To Reach Bisexually Active MSM Program Announcement

(PA)PS06-008; Reducing Sexual Risk for HIV Acquisition and Transmissions Among African American MSM, PA PS06-006; Strategies for Identifying At-Risk African American Men Who Have Sex With Men, PA PS06-009 and Research To Evaluate an Effective Community Level Intervention Adapted for Black Men Who Have Sex With Men, PA PS06-010 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): HIV I—Use of Respondent-Driven Sampling to Reach Bisexually Active MSM, PA PS06-008; Reducing Sexual Risk for HIV Acquisition and Transmissions Among African American MSM, PA PS06-006; Strategies for Identifying At-Risk African American Men Who Have Sex With Men, PA PS06-009 and Research to Evaluate an Effective Community Level Intervention Adapted for Black Men Who Have Sex With Men, PA PS06-010. *Time and Date:* 8 a.m.-5 p.m., June 20, 2006 (Closed). *Place:* Marriott Suites Midtown, 35 14th Street, Atlanta, GA 30309, Telephone 404.876.8888. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to “Use of Respondent-Driven Sampling to Reach Bisexually Active MSM,” PA PS06-008; “Reducing Sexual Risk for HIV Acquisition and Transmissions Among African American MSM,” PA PS06-006; “Strategies for Identifying At-Risk African American Men Who Have Sex With Men,” PA PS06-009 and “Research to Evaluate an Effective Community Level Intervention Adapted for Black Men Who Have Sex With Men,” PA PS06-010. *For Further Information Contact:* Jim Newhall, Ph.D., Scientific Review Administrator, Office of Public Health Research, CDC, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.4641. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 19, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8130 Filed 5-25-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health, Safety and Occupational Health Study Section In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following committee meeting. *Name:* Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH). *Times and Dates:* 8 a.m.-5 p.m., June 13, 2006. 8:30 a.m.-5 p.m., June 14, 2006. *Place:* Embassy Suites Hotel, 8978 International Drive, Orlando, Florida 32819, Telephone 407.352.1400, Fax 407.363.1120. *Status:* Open 8 a.m.-8:30 a.m., June 13, 2006. Closed 8:30 a.m.-5 p.m., June 13, 2006. Closed 8:30 a.m.-5 p.m., June 14, 2006. *Purpose:* The Safety and Occupational Health Study Section will review, discuss, and evaluate grant application(s) received in response to the Institute's standard grants review and funding cycles pertaining to research issues in occupational safety and health and allied areas. It is the intent of the Institute to support broad-based research endeavors in keeping their program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funding will promote these program goals. *Matters to be Discussed:* The meeting will convene in open session from 8 a.m.-8:30 a.m. on June 13, 2006, to address matters related to the conduct of Study Section business. The remainder of the meeting will proceed in closed session. The purpose of the closed session is for the study section to consider safety and occupational health-related grant applications. These portions of the meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, Centers for Disease Control and Prevention, pursuant to section 10(d) Public Law 92-463. Agenda items are subject to change as priorities dictate. *For Further Information Contact:* Price Connor, Ph.D., NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E-20, Atlanta, Georgia 30333, telephone 404.498.2511, fax 404.498.2569. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 22, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-8126 Filed 5-25-06; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-668B, CMS-R-284, CMS-R-205, CMS-10187, and CMS-10116] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

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

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Post Clinical Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 493.1771, 493.1773, and 493.1777; *Use:* To provide an opportunity and a mechanism for Clinical Laboratory Improvement Amendments of 1988

(CLIA)laboratories surveyed by CMS or CMS' agents to express their satisfaction and concerns about the CLIA survey process.; *Form Number:* CMS-668B (OMB#: 0938-0653); *Frequency:* Recordkeeping, Reporting—Biennially; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 21,000; *Total Annual Responses:* 10,500; *Total Annual Hours:* 2,625. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Medicaid Statistical Information System; *Use:* State data are reported by the Federally mandated electronic process, known as Medicaid Statistical Information System (MSIS). These data are the basis of actuarial forecasts for Medicaid service utilization and costs; of analysis and cost savings estimates required for legislative initiatives relating to Medicaid; and for responding to requests for information from CMS components, the Department, Congress and other customers.; *Form Number:* CMS-R-284 (OMB#: 0938-0345); *Frequency:* Quarterly; *Affected Public:* State, Local or Tribal Government; *Number of Respondents:* 53; *Total Annual Responses:* 212; *Total Annual Hours:* 2,120. 3. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Information Collection Requirements Referenced in HIPAA, Title 1 for the Individual Market, supporting regulations at 45 CFR 148.120, 148.122, 148.124, 148.126, and 148.128, and Forms/instructions; *Use:* The provisions of Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) amend the Public Health Service Act (PHS Act) and are designed to make it easier for people to get access to health care coverage, reduce the limitations that can be put on the coverage, and limit the issuers' ability to terminate coverage. This information collection requirement will ensure that issuers in the individual market comply with Title 1 of HIPAA, provide individuals with certificates of creditable coverage necessary to demonstrate prior creditable coverage, file the necessary documentation with CMS for review in States that have Federal direct enforcement, and ensure States' flexibility to implement State alternative mechanisms. Individuals and their dependents need certificates of creditable coverage to take advantage of the rights they have under HIPAA. States and CMS need the information supplied by issuers to properly perform their regulatory functions under HIPAA and or existing State law.; *Form Number:* CMS-R-205 (OMB#: 0938-0703); *Frequency:* Recordkeeping, Third party disclosure, and Reporting—On Occasion; *Affected Public:* Individuals or Households, Business or other for-profit, Not-for-profit institutions and Federal, State, Local or Tribal Government; *Number of Respondents:* 1,042; *Total Annual Responses:* 2,987,501; *Total Annual Hours:* 868,147. 4. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Evaluation of the Demonstration of Coverage of Chiropractic Services Under Medicare; *Use:* Section 651 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003, authorizes a two-year demonstration “to evaluate the feasibility and advisability of covering chiropractic services under Medicare”. The Demonstration aims to evaluate both the costs and the benefits of expanded coverage for chiropractic services. The evaluation will examine the achievements as well as the difficulties inherent in demonstration implementation. The study includes a descriptive evaluation of the program, a survey of a total of 2,000 beneficiaries using expanded services, analyses of medical claims to determine service utilization and expenditures, as well as the cost impact on the Medicare program. These data will allow the researchers to examine use, effectiveness, and satisfaction of Medicare beneficiaries with the chiropractic services they receive in relation to their demographic and clinical characteristics. The results will help CMS to understand the user's experience with chiropractic services and with this Medicare demonstration.; *Form Number:* CMS-10187 (OMB#: 0938-New); *Frequency:* Reporting—Monthly; *Affected Public:* Individuals or Households; *Number of Respondents:* 2000; *Total Annual Responses:* 2000; *Total Annual Hours:* 667. 5. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Conditions of Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles (CMS-3017-IFC); *Use:* CMS-3017-IFC (Conditions for Payment of Power Mobility Devices, including Power Wheelchairs and Power-Operated Vehicles) provides further guidance with respect to the prescribing of and payment for Power Mobility Devices (PMDs). This rule defines the term power mobility devices

(PMDs)as power wheelchairs and power operated vehicles (POVs or scooters). This rule conforms our regulations to section 302(a)(2)(E)(iv) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA mandated:

(1)A face-to-face examination of the individual be conducted by a physician (as defined in section 1861(r)(1) of the Social Security Act (the Act)), a physician assistant, a nurse practitioner or a clinical nurse specialist (as those terms are defined in section 1861(aa)(5) of the Act; and

(2)that payment may not be made for a power wheelchair unless the physician or treating practitioner has written a prescription for the item. With this information collection request, CMS is seeking approval for the collection requirements associated with CMS-3017-IFC (70 FR 50940).; *Form Number:* CMS-10116 (OMB#: 0938-0971); *Frequency:* Recordkeeping and Reporting—On occasion; *Affected Public:* Business or other for-profit, Not-for-profit institutions, Federal government, State, Local, or Tribal governments; *Number of Respondents:* 17,000; *Total Annual Responses:* 37,400; *Total Annual Hours:* 37,400. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

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

(202)395-6974. Dated: May 15, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-7944 Filed 5-25-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-4117-FN] Medicare Program; Approval of URAC for Deeming Authority for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. SUMMARY: This final notice announces the approval of URAC for deeming authority as a national accreditation organization for health maintenance organizations and local preferred provider organizations participating in the Medicare Advantage program, for a term of 6 years upon publication of this notice in the **Federal Register.** This notice describes the processes and criteria used in evaluating the application. We did not receive any public comments during the public comment period, which ended on April 28, 2006. FOR FURTHER INFORMATION CONTACT: Shaheen Halim, Ph.D.,

(410)786-0641. I. Background Under the Medicare program, eligible beneficiaries may receive covered services through a managed care organization

(MCO)that has a Medicare Advantage

(MA)(formerly, Medicare+Choice) contract with the Centers for Medicare & Medicaid Services (CMS). The regulations specifying the Medicare requirements that must be met in order for an MCO to enter into an MA contract with CMS are located at 42 CFR part 422. These regulations implement Part C of Title XVIII of the Social Security Act (the Act), which specifies the services that an MCO must provide and the requirements that the organization must meet to be an MA contractor. Other relevant sections of the Act are Parts A and B of Title XVIII and Part A of Title XI pertaining to the provision of services by Medicare-certified providers and suppliers. Generally, for an organization to enter into an MA contract, the organization must be licensed by the State as a risk-bearing organization as set forth in part 422 of our regulations. Additionally, the organization must file an application demonstrating that it meets other Medicare requirements in part 422 of our regulations. Following approval of the contract, we engage in routine monitoring and oversight audits of the MA organization to ensure continuing compliance. The monitoring and oversight audit process is comprehensive and uses a written protocol that itemizes the Medicare requirements the MA organization must meet. As an alternative for meeting some Medicare requirements, an MA organization may be exempt from our monitoring of certain requirements in subsets listed in section 1852(e)(4)(B) of the Act as a result of an MA organization's accreditation by a CMS-approved accrediting organization (AO). In essence, the Secretary “deems” that the Medicare requirements are met based on a determination that the AO's standards are at least as stringent as Medicare requirements. An organization that applies for MA deeming authority is generally recognized by the industry as an entity that accredits MCOs that are licensed as a health maintenance organization

(HMO)or a preferred provider organization (PPO). As we specify at § 422.157(b)(2) of our regulations, the term for which an AO may be approved by us may not exceed 6 years. For continuing approval, the AO must re-apply to us. II. Deeming Application Approval Process Section 1852(e)(4)(C) of the Act requires that within 210 days of receipt of an application, the Secretary shall determine whether the applicant meets criteria specified in section 1865(b)(2) of the Act. Under these criteria, the Secretary will consider for a national accreditation body, its requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting activities, its monitoring procedures for provider entities found out of compliance with the conditions or requirements, and its ability to provide the Secretary with necessary data for validation. Section 1865(b)(3)(A) of the Act further requires that we publish a notice identifying receipt of an organization's application identifying the national accreditation body making the request, and providing at least a 30-day public comment period. We must publish a finding of approval or denial of the application within 210 days from the receipt of the completed application. III. Provisions of the Proposed Notice On March 24, 2006, we published a proposed notice in the **Federal Register** (71 FR 14922) announcing URAC's October 12, 2005 application for deeming authority for MA HMOs and local PPOs in the following six areas: • Quality improvement. • Antidiscrimination. • Access to services. • Confidentiality and accuracy of enrollee records. • Information on advance directives. • Provider participation rules. In the proposed notice, we described our evaluation criteria. Under § 422.158(a), this includes but is not limited to, the following: • The equivalency of URAC's requirements for HMOs and PPOs to our comparable MA organization requirements. • URAC's survey process, to determine the following: + The frequency of surveys. + The types of forms, guidelines, and instructions used by surveyors. + Descriptions of the accreditation decision making process, deficiency notification and monitoring process, and compliance enforcement process. • Detailed information about individuals who perform accreditation surveys including— + Size and composition of the survey team; + Education and experience requirements for the surveyors; + In-service training required for surveyor personnel; + Surveyor performance evaluation systems; and + Conflict of interest policies relating to individuals in the survey and accreditation decision process. • Descriptions of the organization's— + Data management and analysis system; + Policies and procedures for investigating and responding to complaints against accredited organizations; + Types and categories of accreditation offered and MA organizations currently accredited within those types and categories. In accordance with § 422.158(b) of our regulations, the applicant must provide documentation relating to— • Its ability to provide data in a CMS compatible format; • The adequacy of personnel and other resources necessary to perform the required surveys and other activities; and • Assurances that it will comply with ongoing responsibility requirements specified in § 422.157(c) of our regulations. We also must have an opportunity to observe the applicant using the accreditation processes under which it intends to deem compliance. Those observational site visits allow us to verify that the information presented in the application is correct and to make a determination on the application. In accordance with section 1865(b)(3)(A) of the Act, the proposed notice solicited public comment on the ability of URAC's accreditation program to meet or exceed the Medicare requirements for which it seeks authority to deem. We did not receive any public comments in response to the proposed notice. IV. Evaluation of Application for Deeming Authority Following the receipt of URAC's application for deeming authority on October 12, 2005, for MA organizations that are licensed as either HMOs or PPOs, we began our review and evaluation under § 422.158(a) of the regulations. Our review and evaluation included, but was not limited to, the information and criteria provided in sections II and III of this final notice. Additionally, we observed on-site application of URAC's accreditation processes twice at two separate managed care organizations. Following these two observational opportunities, we determined that URAC's criteria and methods of evaluating MA plans meet or exceed ours. We grant approval of URAC's application for deeming authority for MA HMOs and local PPOs for a term of 6 years beginning upon publication of this final notice. V. Executive Order 12866 Statement In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget. Authority: Sections 1852 and 1865 of the Social Security Act (42 U.S.C. 1395w-22 and 1395bb). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: May 17, 2006. Mark B. McClellan, Administrator, Centers for Medicare & Medicare Services. [FR Doc. E6-8135 Filed 5-25-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1324-N] Medicare Program; Public Meeting in Calendar Year 2006 for New Clinical Laboratory Tests for Payment Determinations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces a public meeting to discuss payment determinations for specific new Physicians' Current Procedural Terminology

(CPT)codes for clinical laboratory tests. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for calendar year 2007, which will be effective on January 1, 2007. Discussion is directed toward technical issues relating to payment determinations for a specified list of new clinical laboratory codes. The development of the codes for clinical laboratory tests is performed by the CPT Editorial Panel and will not be discussed at the public meeting. DATES: The public meeting announced in this notice is scheduled for Monday, July 17, 2006 from 10 a.m. to 3 p.m. ADDRESSES: The public meeting will be held in the main auditorium of the central building of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. FOR FURTHER INFORMATION CONTACT: Anita Greenberg,

(410)786-4601. SUPPLEMENTARY INFORMATION: I. Background Section 531(b) of the Medicare, Medicaid, and State Child Health Insurance Program Benefits Improvement and Protection Act of 2000 (BIPA), Pub. L. 106-554, mandated procedures that permit public consultation for payment determinations for new clinical laboratory tests under Part B of title XVIII of the Social Security Act (the Act) in a manner consistent with the procedures established for implementing coding modifications for International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). The procedures and public meeting announced in this notice for new clinical laboratory tests are in accordance with the procedures published on November 23, 2001 in the **Federal Register** (66 FR 58743) to implement section 531(b) of BIPA. Also, section 942(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. 108-173, added section 1833(h)(8)(B)(iii) to the Act to require that we convene a public meeting to receive comments and recommendations (and data on which recommendations are based) for establishing payment amounts for new clinical laboratory tests. A newly created CPT code can either represent a refinement or modification of existing test methods, or a substantially new test method. The newly created CPT codes for calendar year 2007 will be listed on our Web site *http://www.cms.hhs.gov/ClinicalLabFeeSched* on or after June 19, 2006. The first method, called cross-walking, is used when a new test is determined to be similar to an existing test, multiple existing test codes, or a portion of an existing test code. The new test code is then assigned the related existing local fee schedule amounts and resulting national limitation amount. The second method, called gap-filling, is used when no comparable, existing test is available. When using this method, instructions are provided to each Medicare carrier to determine a payment amount for its geographic area(s) for use in the first year, and the carrier-specific amounts are used to establish a national limitation amount for following years. For each new clinical laboratory test code, a determination must be made to either cross-walk or to gap-fill, and if cross-walking is appropriate, to identify which tests to cross-walk. II. Format This meeting is open to the public. For registration information, see section III. The on-site check-in for visitors will be held from 9:30 a.m. to 10 a.m., followed by opening remarks. Registered persons from the public may discuss and recommend payment determinations for specific new CPT codes for the 2007 Clinical Laboratory Fee Schedule. The public meeting is intended to provide expert input on the nature of new clinical laboratory tests and receive recommendations to either cross-walk or gap-fill for payment. Decisions regarding payment for the newly created Physicians' Current Procedural Terminology

(CPT)codes will not be made at this meeting. A summary of the new codes and the payment recommendations that are presented during the public meeting will be posted on our Web site by September 8, 2006 and can be accessed at *http://www.cms.hhs.gov/ClinicalLabFeeSched.* In addition, the summary of the meeting will list additional comments received on or before 15 days after the meeting. The summary will also display our tentative payment determinations, and interested parties may submit written comments on the tentative payment determinations by September 22, 2006 to the following address: Centers for Medicare & Medicaid Services (CMS), Center for Medicare Management, Mailstop: C4-07-07, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Oral presentations must be brief, and must be accompanied by three written copies. Presenters may also make copies available for approximately 50 meeting participants. Presenters should address the new test code(s) and descriptor(s), the test purpose and method, costs and charges, and present a recommendation with rationale for one of two methods (cross-walking or gap-fill) for determining payment for new clinical laboratory codes. III. Registration Instructions CMM is coordinating the meeting registration. Beginning June 19, 2006, registration may be completed on-line at *http://www.cms.hhs.gov/ClinicalLabFeeSched.* The following information must be submitted when registering: Name; company name; address; telephone number(s); and E-mail address(es). When registering, individuals who want to make a presentation must also specify which new clinical laboratory test code(s) they will be presenting. A confirmation will be sent upon receipt of the registration. Individuals may also register by calling Anita Greenberg at

(410)786-4601. *Registration Deadline:* Individuals must register by July 12, 2006. IV. Security, Building, and Parking Guidelines The meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, participants must bring a government-issued photo identification and a copy of their written meeting registration confirmation. Persons without proper identification may be denied access to the building. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting each day. Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, are subject to inspection. V. Special Accommodations Individuals attending the meeting who are hearing or visually impaired and have special requirements, or a condition that requires special assistance, should provide the information upon registering for the meeting. Authority: Sections 1102, 1833, and 1871 of the Social Security Act (42 U.S.C. 1302, 42 U.S.C. 13951, and 42 U.S.C. 1395hh). (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program.) Dated: April 19, 2006. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E6-7503 Filed 5-25-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0184] Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Investigational Device Exemptions Reports and Records. DATES: Submit written or electronic comments on the collection of information by July 25, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Investigational Device Exemptions Reports and Records—21 CFR 812 (OMB Control Number 0910-0078) Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) establishes the statutory authority to collect information regarding investigational devices, and establishes rules under which new medical devices may be tested using human subjects in a clinical setting. The Food and Drug Administration Modernization Act of 1997 added section 520(g)(6) to the act and permitted changes to be made to either the investigational device or to the clinical protocol without FDA approval of an investigational device exemption

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

(IRB)information, and statement on the extent that good manufacturing practices will be followed. The most likely respondents to this information collection will primarily be medical device manufacturers, investigators, hospitals, health maintenance organizations, and businesses. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 812.10 1 1 1 1 1 812.20, 812.25, and 812.27 600 0.5 275 80 22,000 812.35 and 812.150 (reports for significant risk studies) 600 7.8 4700 6 28,200 812.150 (reports for non-significant risk studies) 600 0.017 10 6 60 812.36(c) 1 1 1 120 120 812.36(f) 1 2 2 20 40 Total 50,421 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 2.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 812.140 Original 600 0.5 275 10 2,750 812.140 Supplemental 600 7 4,700 1 4,700 812.140 Non-significant 600 1 600 6 3,600 Total 11,050 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-8125 Filed 5-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice The Food and Drug Administration

(FDA)is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the **Federal Register** of April 19, 2006 (71 FR 20111). The amendment is being made to reflect a change in the *Procedure* portion of the document, specifically due to a change in the scheduling of the oral presentations from the public. There are no other changes. FOR FURTHER INFORMATION CONTACT: Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of April 19, 2006, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee would be held on June 2, 2006, from 8:30 a.m. to 3:30 p.m. On page 20111, in the second and third columns, the *Procedure* portion is amended to read as follows: *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 19, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of the committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 19, 2006. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: May 18, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-8088 Filed 5-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Tetrahalogenated Compounds Useful as Inhibitors *Description of Technology:* Cancer is the second leading cause of death in United States and it is estimated that there will be approximately 600,000 deaths caused by cancer in 2006. A major drawback of the existing chemotherapies is the cytotoxic side-effects that are associated with them. Thus, there is a need to develop new therapeutic approaches with reduced side-effects. Anti-angiogenic therapy is a recent approach in cancer therapeutics targeting the formation of blood vessels that are necessary for tumor growth. Recently, the anti-angiogenic molecule bevacizumab (Avastin) has gained approval from the FDA for the first-line treatment of metastatic colon cancer in combination with standard chemotherapy. Another promising anti-angiogenic molecule is thalidomide. Thalidomide has been approved as an anti-cancer agent and for other use in Europe and Australia. However, its use as a drug has been limited by its effect as a teratogen, necessitating the development of new thalidomide analogs with improved efficacy and reduced toxicity. This technology describes synthesis of several tetrahalogenated thalidomide derivatives that are potentially more anti-angiogenic than thalidomide. More specifically, two series of analogs based on two major common pharmacophores have been synthesized. One series preserves the thalidomide common structure, while the other series contains a different common structure (tetrafluorobenzamides). Several analogs from both series have shown significant anti-angiogenic properties, *in vitro.* This technology has therapeutic potential for a broad spectrum of cancer related diseases alone, or in combination with existing therapies. *Applications:* Novel tetrahalogenated thalidomide analogs containing the thalidomide pharmacophore with improved anti-angiogenic activity; Novel tetrahalogenated thalidomide analogs containing a different common structure (tetrafluorobenzamides) with considerable anti-angiogenic activity; Use of the compounds for the treatment of several cancers; Use of the compounds for the treatment other diseases including autoimmune diseases. *Market:* 600,000 deaths from cancer related diseases estimated in 2006. The technology platform involving novel anti-angiogenic small molecule cancer therapy technology has a potential market of more than 2 billion U.S. dollars. The technology platform has additional market in treating several other clinical problems such as autoimmune diseases. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors: William D. Figg* (NCI), Erin Lepper (SAIC), *et al.* *Publications:* SS Ng *et al.* , “Antitumor effects of thalidomide analogs in human prostate cancer xenografts implanted in immunodeficient mice,” *Clin Cancer Res.* 2004 Jun 15; 10 (12 Pt 1):4192-7. WL Dahut *et al.* , “Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer,” *J Clin Oncol.* 2004 Jul 1; 22 (13): 2532-9. S Kumar *et al.* , “Antimyeloma activity of two novel N-substituted and tetraflourinated thalidomide analogs,” *Leukemia* 2005 Jul; 19 (7):1253-61. *Patent Status:* U.S. Provisional Application filed 13 Apr 2006 (HHS Reference No. E-080-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* David A. Lambertson, PhD.; 301-435-4632; *lambertsond@od.nih.gov.* *Collaborative Research Opportunity:* The National Cancer Institute, Center for Cancer Research, Medical Oncology Branch, Molecular Pharmacology Section is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize tetrafluorinated compounds as anti-cancer therapeutics. Please contact Dr. W. Figg at 301-402-3623 for more information. Anti-Notch-1 Monoclonal Antibodies for Inducing Cellular Differentiation and Apoptosis *Description of Technology:* As cancer cells progress towards more aggressive forms, they often become highly resistant to drug or radiation-induced apoptosis, generally through the loss of function p53, a gene which can trigger apoptosis in response to DNA damage. Thus, novel strategies to induce apoptosis in tumor cells, especially p53-deficient cells, is an attractive and an active area of research. Using a model constituted by a p53-deficient mouse leukemia cell line, PHS scientists found that:

(1)Antisense synthetic DNA oligonucleotides and stable incorporation of an antisense gene (a model for gene therapy) targeting notch-1, when given together with a differentiation-inducing antitumor drug, cause the cells to respond by massive apoptosis rather than differentiation;

(2)stable incorporation of an antisense notch-1 gene increases apoptosis in these cells even in the absence of any antitumor drugs. This suggests that antisense Notch-1 treatment, by antisense oligonucleotides or by gene therapy, may be used alone or together with anti-cancer drugs to cause apoptosis in tumor cells. This invention provides compositions, pharmaceutical compositions, and methods for stimulating/increasing cell differentiation, and is particularly related to the treatment of tumors which have increased Notch-1 expression. A polyclonal and/or monoclonal antibody generated against human Notch-1 Epidermal Growth Factor (“EGF”) that recognizes an extracellular epitope of Notch-1 and that stimulates target cell differentiation in the presence of a differentiation inducing agent is disclosed as is the hybridoma which produces these antibodies. *Inventors:* Lucio L Miele and Chana Y. Fuchs (FDA). *Patent Status:* PCT Application No. PCT/US99/23162 filed 01 Oct 1999, which published as WO 00/20576 on 13 Apr 2000 (HHS Reference No. E-176-1998/1-PCT-01); U.S. Patent Application No. 11/069,208 filed 28 Feb 2005, claiming priority to 02 Oct 1998 (HHS Reference No. E-176-1998/1-US-08). *Licensing Contact:* David A. Lambertson, PhD.; 301-435-4632; *lambertsond@od.nih.gov* . Novel Bis-Acridones as Anti-Tumor Agents: Potential for Treating Drug Resistant Tumors *Description of Technology:* Cancer is the second leading cause of death in United States and it is estimated that there will be approximately 600,000 deaths caused by cancer in 2006. Current chemotherapies are mostly based on the use of small molecules. A major drawback of these existing chemotherapies is the acquired or inherent resistance of certain tumors against these drugs. Treating resistant tumors has been a major challenge in the successful management of cancer, necessitating the development of new therapies to treat resistant tumors and thus expanding the life expectancy of cancer patients. The present invention discloses novel derivatives of Bis-acridones and related molecules and their pharmaceutically acceptable salts and their use as anti-tumor agents. Some of the derivatives have high anti-tumor activity both *in vitro* and *in vivo.* In addition to its anti-tumor activity these above mentioned compounds have been shown to be potent irreversible inhibitors of P-glycoprotein, a member of the ABC transporter protein family that has a major role in conferring multi-drug resistance. Therefore, these compounds have the potential of being used in combination with traditional chemotherapy to treat drug resistant tumors. In addition, to its anti-neoplastic property some of the derivatives of this family of compounds have been shown to have anti-HIV property. *Inventors:* Christopher J. Michejda *et al.* (NCI). *Publications:* WM Cholody *et al.* , “Bisimidazoacridones and related compounds: New antineoplastic agents with high selectivity against colon tumors,” *J Med Chem* . 1995 Aug 4; 38 (16): 3043-52. JA Turpin *et al.* , “Inhibition of acute-, latent-, and chronic-phase human immunodeficiency virus type 1 (HIV-1) replication by a bistriazoloacridone analog that selectively inhibits HIV-1 transcription,” *Antimicrob Agents Chemother.* 1998 Mar; 42 (3):487-94. *Patent Status:* U.S. Patent No. 5,508,289 issued 16 Apr 1996 (HHS Reference No. E-106-1994/0-US-01); European Patent No. 0750612 issued. *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Michelle A. Booden, PhD.; 301-451-7337; *boodenm@mail.nih.gov.* *Collaborative Research Opportunity:* The National Cancer Institute, Center for Cancer Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize certain derivatives of Bis-acridones and related molecules as well as their pharmaceutically acceptable salts as anti-tumor agents. Please contact Kathy Higinbotham at 301-846-5465 or *higinbok@mail.nih.gov* for more information. Dated: May 19, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-8167 Filed 5-25-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Antibodies That Specifically Recognize S100A15, a Protein Involved in Epidermal Differentiation and Inflammation *Description of Technology:* This technology describes rabbit polyclonal antibodies that recognize the human and mouse S100A15 proteins. S100A15 is involved in epidermal differentiation and inflammation, and is dysregulated in skin tumors and inflammatory psoriasis. *Applications:* Diagnostic tool for evaluation of agents that alter skin pathology; research tool to probe the role of S100A15 during epidermal maturation, skin carcinogenesis, and inflammation; diagnostic tool for the clinical evaluation of skin tumors and inflammatory diseases such as psoriasis. *Development Status:* Early stage. *Inventors:* Ronald Wolf, Stuart H. Yuspa, Paul Goldsmith, and Christopher J. Voscopoulos (NCI). *Publication:* R. Wolf *et al.* , “The mouse S100A15 ortholog parallels genomic organization, structure, gene expression, and protein-processing pattern of the human S100A7/A15 subfamily during epidermal maturation,” *J Invest Dermatol* advance online publication 09 March 2006, doi: 10.1038/sj.jid.5700210. *Patent Status:* HHS Reference No. E-145-2006/0—Research Tool. *Licensing Status:* Available for non-exclusive licensing under a Biological Materials License. *Licensing Contact:* Marlene K. Astor, JD, MS, MIP; 301/435-4426; *ms482m@nih.gov.* Potent Pharmacophoric Delta- and Mu-Opioid Receptor Antagonists and Conversion of Endomorphin Mu-Opioid Agonists to Antagonists *Description of Technology:* The inhibition (antagonism) of mu-opioid receptors is a critical human health topic, since this receptor is the key element in the neural reward pathway in the central nervous system responsible for craving and addiction to food, alcohol or various drugs, such as morphine and its derivatives. Furthermore, antagonists to these receptors are absent in nature. This invention provides compositions for new modified opioid antagonists. For example, a series of dimeric *N,N* -dimethyl-Dmt-Tic (2',6'-dimethyl- l -tyrosyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid) analogues were covalently linked tail-to-tail through diaminoalkane, and symmetric or asymmetric 3,6-diaminoalkyl-2(1 *H* )-pyrazinone moieties. The latter compounds exhibit dual antagonism toward delta- and mu-opioid receptors providing a means to simultaneously regulate two independent opioid receptors to combat addiction, tolerance, and alcohol dependency. Dmt is the essential pluripotent amino acid residue that regulates binding to all opioid receptor molecules, which are classified into delta, mu, and kappa subtypes depending on the type of interacting opioid. Compounds from another class of mu-opioid antagonists were also prepared, including [ *N* -allyl-Dmt1]endomorphin-1 ( *N* -allyl-Dmt-Pro-Trp-Phe-NH2) and [ *N* -allyl-Dmt1]endomorphin-2 ( *N* -allyl-Dmt-Pro-Phe-Phe-NH2). The former set of dimeric compounds readily pass through the epithelial barriers in the gut and brain when injected systematically or taken orally. Additionally, these bivalent ligands would be attractive in drug design due to their stability to proteolytic degradation. That they are also slightly more hydrophobic may increase potency by their ability to transit membranes. *Application:* Potential opiate, food and alcohol addiction therapeutics. *Development Status:* Early stage. *Inventors:* Lawrence H. Lazarus (NIEHS) *et al.* *Publications:* T Li *et al.* , “Potent Dmt-Tic pharmacophoric delta- and mu-opioid receptor antagonists,”

(2005)*J Med Chem.* 48:8035-44. T Li *et al.* , “New series of potent delta-opioid antagonists containing the H-Dmt-Tic-NH-hexyl-NH-R motif,”

(2005)*Bioorg Med Chem Lett.* 15:5517-20. *Patent Status:* U.S. Provisional Application No. 60/714,071 filed 04 Feb 2005 (HHS Reference No. E-305-2005/0-US-01). *Licensing Status:* This technology is available for exclusive, co-exclusive, or nonexclusive licensing. *Licensing Contact:* Marlene K. Astor, JD, MS, MIP; 301/435-4426; *ms482m@nih.gov.* *Collaborative Research Opportunity:* The National Institute of Environmental Health Sciences, Laboratory of Pharmacology and Chemistry, Medicinal Chemistry Group, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John S. Penta, PhD. at 919-541-3696 or *penta@niehs.nih.gov* for more information. Novel Glycated Peptides and Proteins as Biomarkers for Diabetes Control *Description of Technology:* A primary goal of diabetes therapy is to improve control of blood glucose levels (known as glycemic control) in patients. Prospective studies of both Type 1 and Type 2 diabetes indicate that careful glycemic control significantly reduces the risk of microvascular, neurological, and cardiovascular complications of diabetes. The current method to monitor glycemic control is by measurement of the relative concentration of glycated red-cell hemoglobin (HbA1C). However, levels of HbA1C, an intracellular protein, reflect glycemic control over a timeframe of several months. They are also susceptible to a variety of perturbing factors such as hematologic disorders, kidney disease, aspirin or penicillin use, or alcohol intake. This technology describes a family of novel glycated peptide and protein biomarkers for glycemic control, as well as a method to monitor glycemic control in diabetic patients. In contrast to HbA1C, which is an intracellular protein, the glycated proteins described in this invention are found in blood plasma, and might reflect changes in glycemic control more rapidly, and with more sensitivity. A test developed using this technology could be envisioned to supplement or replace current monitoring of glycemic control by HbA1C. Also described are methods for making antibodies and aptamers that bind the described glycated peptides and proteins, and a database listing glycated peptide concentrations in diabetic and control samples. *Applications:* Diagnostic tool to monitor glycemic control in diabetic or at-risk individuals; markers to track development of diabetes complications. *Development Status:* Early stage. *Inventors:* Perry J. Blackshear (NIEHS). *Patent Status:* U.S. Provisional Application No. 60/779,710 filed 06 Mar 2006 (HHS Reference No. E-057-2005/0-US-01). *Licensing Status:* This technology is available for exclusive, co-exclusive, or nonexclusive licensing. *Licensing Contact:* Marlene K. Astor, JD, MS, MIP; 301/435-4426; *ms482m@nih.gov.* *Collaborative Research Opportunity:* The National Institute of Environmental Health Sciences, Office of Clinical Research, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact John S. Penta, PhD. at 919-541-3696 or *penta@niehs.nih.gov* for more information. Dated: May 18, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-8168 Filed 5-25-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Influenza DNA Vaccine That Protects Against Lethal H5N1 Challenge *Description of Technology:* Concerns about a potential influenza pandemic and its prevention dominate health news, with new cases of bird (avian) influenza (H5N1 strain) cases being reported on a daily basis. Vaccination is one of the most effective ways to minimize suffering and death from influenza. Currently, there is not an effective vaccine to protect against the H5N1 strain, thought to be a leading pandemic candidate. The technology described here relates to a DNA influenza vaccine encoding the matrix 2

(M2)protein, which is highly conserved among different influenza strains. The M2 component can be used either alone or in combination with other influenza components. Specifically, mouse studies showed that the use of M2 from H1N1 strain protected against a lethal challenge with H5N1 strain. The current technology offers several advantages over traditional influenza vaccine approaches, including

(a)ease and speed of production without need for eggs,

(b)no surveillance to determine dominant strain(s), and

(c)no potential for antigenic shift as observed for the components (HA and NA) of current influenza vaccines. *Inventors:* Suzanne L. Epstein *et al.* (CBER/FDA). *Patent Status:* U.S. Provisional Application No. 60/785,152 filed March 27, 2006 (HHS Reference No. E-076-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, PhD.; 301/435-5515; *anos@mail.nih.gov* . *Collaborative Research Opportunity:* The Food and Drug Administration's Center for Biologics Evaluation and Research

(CBER)is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Beatrice Droke at 301/827-7008 or *bdroke@oc.fda.gov* for more information. Methods for Inhibiting HIV and Other Viral Infections by Modulating Ceramide Metabolism *Description of Technology:* This invention provides methods of inhibiting or preventing HIV-1 infections by inducing either the de novo biosynthesis of ceramide, or by activating enzymes ( *e.g.* , sphingomyelinase) involved in the generation of ceramide at the plasma membrane, or by direct incorporation of exogenous ceramide into target cell membranes. The invention describes methods for administration a retinamide compound particularly an N-(aryl) retinamide compound such as N-(4-hydroxyphenyl) retinamide (4-HPR) resulting in increased plasma membrane ceramide levels, which results in the inhibition of HIV-1 infection in monocyte/macrophages by perturbing membrane organization. In addition, because of its low toxicity in non-tumor cells, 4-HPR and related compounds are particularly suitable for long-term preventative or therapeutic administration to subjects suffering from an HIV infection or who are at risk of contracting an HIV infection. Thus, this invention provides a novel means of treating or inhibiting HIV and other viral infections by administering a retinamide compound to a patient suffering from or susceptible to such a viral infection. *Inventors:* Robert P. Blumenthal *et al.* (NCI). *Publications:* 1. C.M. Finnegan *et al.* , “Ceramide, a target for antiretroviral therapy,” Proc. Natl. Acad. Sci. USA. (2004 Oct 26) 101(43):15452-15457. 2. C.M. Finnegan and R. Blumenthal, “Fenretinide inhibits HIV infection by promoting viral endocytosis,” Antiviral Res. (2006 Feb) 69(2):116-123. *Patent Status:* U.S. Provisional Application No. 60/528,411 filed December 9, 2003 (HHS Reference No. E-265-2003/0-US-01); PCT Application No. PCT/US2004/41512 filed December 9, 2004, which published as WO 2005/072091 on August 11, 2005 (HHS Reference No. E-265-2003/0-PCT-02). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Sally Hu, PhD., M.B.A.; 301/435-5606; *hus@mail.nih.gov* *Collaborative Research Opportunity:* The National Cancer Institute, Center for Cancer Research Nanobiology Program, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the clinical potential of sphingolipid-based antiviral therapies. Please contact Melissa Maderia at *maderiam@mail.nih.gov* or by phone at 301/846-5465 for more information. Methods and Compositions for the Inhibition of HIV-1 Replication *Description of Technology:* This invention relates to methods and compositions for the attenuation of HIV-1 replication in human cells, and especially in CD4+ human peripheral blood mononuclear cells, such as blood monocyte-derived macrophages by targeting a host cell protein. HIV-1 infected macrophages typically resist cell death, support viral replication, and facilitate HIV-1 transmission. We found that the gene encoding cyclin-dependent kinase inhibitor 1A (CDKN1A) is consistently expressed following virus binding, and re-expressed at the peak of HIV-1 replication. The protein encoded by this gene, also known as p21, is associated with cell cycle regulation, anti-apoptotic response and cell differentiation. Increased levels of p21 may enhance survival and long-term persistence of HIV-1 infected macrophages. Following identification of p21 as a candidate molecule in facilitating viral replication, efforts to curtail its role were investigated as a mode of blunting infection in macrophages. RNA interference (siRNA) represents a tool to regulate gene expression and when siRNA specific for p21 or p21-specific oligonucleotides were transfected into primary macrophages to silence the expression of p21, HIV infection was aborted, thereby validating p21 as a cellular factor essential to productive HIV infection in this population. Extending these observations, a pharmacologic agent known to influence p21 expression, the synthetic triterpenoid and peroxisome proliferator-activated receptor gamma (PPARg) ligand, 2-cyano-3,12-dioxooleana-1,9-dien-28-oic acid

(CDDO)or its derivative di-CDDO, was shown to moderate virally-induced p21 expression and concurrently dampen HIV infection. CDDO is part of a class of synthetic triterpenoids based on natural products resembling steroids in their biogenesis and in their pleiotropic actions. A newly developed CDDO derivative, which is orally bioavailable, also suppresses HIV. These results, coupled with the evidence that macrophage p21 is a requisite macrophage facilitator of viral replication, intensify the interest to further develop these compounds as antiretroviral agents. The anti-retroviral effect of CDDO was evident when peripheral blood mononuclear cells

(PBMC)were infected with a T-tropic

(X4)or dual tropic viral

(R5X4)strain of HIV-1. These studies suggest that these triterpenoids may aid in the control of retroviral replication. Neither p21 oligonucleotides nor CDDO were toxic to the cultured macrophages or peripheral blood mononuclear cells. Thus, p21 inhibitors could be safe and effective anti-HIV therapeutic candidates to be used independently and/or in conjunction with current anti-retroviral therapy. In this regard, CDDO will be entered into human trials for the first time in the near future for its anti-cancer indications, thereby determining its maximally tolerated dose for use in subsequent HIV/AIDS clinical trials. Current anti-retroviral therapy, often characterized by high toxicity and the emergence of drug resistant virus strains, may be augmented through the identification of these and other new anti-viral agents targeting host cellular molecules less prone to mutational events. *Inventors:* Sharon M. Wahl, Nancy Vazquez-Maldonado, Teresa Greenwell-Wild (NIDCR). *Publications:* 1. S.M. Wahl *et al.* , “HIV accomplices and adversaries in macrophage infection,” J. Leukoc. Biol. 2006, in press. 2. N. Vazquez *et al.* , “Human immunodeficiency virus type 1-induced macrophage gene expression includes the p21 gene, a target for viral regulation,” J. Virol. (2005 Apr) 79(7):4479-4491. *Patent Status:* U.S. Provisional Application No. 60/516,794 filed November 4, 2003 (HHS Reference No. E-114-2003/0-US-01); PCT Application No. PCT/US2004/36492 filed November 3, 2004, which published as WO 2005/046732 on May 26, 2005 (HHS Reference No. E-114-2003/0-PCT-02) *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Sally Hu, PhD., M.B.A.; 301/435-5606; *hus@mail.nih.gov* *Collaborative Research Opportunity:* The National Institute of Dental and Craniofacial Research, Oral Infection and Immunity Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact David W. Bradley, PhD., at *bradleyda@nidcr.nih.gov* or by phone at 301/402-0540 for more information. Dated: May 18, 2006. David R. Sadowski, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-8176 Filed 5-25-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center on Minority Health and Health Disparities; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Council on Minority Health and Health Disparities. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Advisory Council on Minority Health and Health Disparities. *Date:* June 13, 2006. *Closed:* 8:30 a.m. to 10 a.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Suite 800, Bethesda, MD 20892. *Open:* 10 a.m. to 5 p.m. *Agenda:* The agenda will include Opening Remarks, Administrative Matters, Director's Report, NCMHD, IC Strategic Plan Report, NIH Minority Research Training Programs Update, NCMHD Program Highlights, and other business of the Council. *Place:* National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Suite 800, Bethesda, MD 20892. *Contact Person:* Donna Brooks, Asst. Director for Administration, National Center on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., Suite 800, Bethesda, MD 20892. 301-435-2135. *brooksd@ncmhd.nih.gov.* Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Dated: May 18, 2006. Anna Snouffer, Acting Director, Office of the Federal Advisory Committee Policy. [FR Doc. 06-4893 Filed 5-25-06; 8:45 am]

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