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Code · REGISTER · 2006-10-26 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice; extension of expiration date

12,904 words·~59 min read·/register/2006/10/26/06-8897·

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

BILLING CODE 6750-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-000] 30-Day Notice; Agency Information Collection Activities: Proposed Collection; Comment Request *Agency:* Office of the Secretary. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection 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. *Type of Information Collection Request:* Regular, New Collection. *Title of Information Collection:* The Effect of Reducing Falls on Acute and Long-Term Care Expenses. *Form/OMB No.:* OS-0990-New. Attention: ASPE is planning to conduct a demonstration and evaluation of a multi-factorial fall prevention program to measure its impact on health outcomes for the elderly as well as acute and long-term care use and cost. This will be accomplished by obtaining a sample of individuals with private long-term care insurance who are age 75 and over. *Frequency:* One Time On Occasion. *Affected Public:* Individual or Households. *Annual Number of Respondents:* 9720. *Total Annual Responses:* 9,600. *Average Burden Per Response:* 3.54 min. *Total Annual Hours:* 4305. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to Sherette.funncoleman@hhs.gov, or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: *OMB Desk Officer:* John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-New), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: October 23, 2006. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E6-17943 Filed 10-25-06; 8:45 am] BILLING CODE 4151-05-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0535] Agency Information Collection Activities; Announcement of Office of Management and Budget; Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of expiration date. SUMMARY: The Food and Drug Administration
(FDA)is announcing that, under the Paperwork Reduction Act of 1995 (the PRA), the Office of Management and Budget
(OMB)has extended the expiration date to May 1, 2007, for the use of the prior version of Form FDA 3500A for “MedWatch: Food and Drug Administration Medical Products Reporting Program” (the MedWatch Program). FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the **Federal Register** of August 16, 2005 (70 FR 48157), FDA announced that a proposed collection of information entitled “MedWatch: Food and Drug Administration Medical Products Reporting Program” had been submitted to OMB for approval under the PRA. The collection of information included the use of two forms used in the MedWatch Program—Form FDA 3500 and Form FDA 3500A. In that notice, we responded to public comments pertaining to proposed revisions to Form FDA 3500 and Form FDA 3500A. Several comments from industry stated that considerable resources would be required to modify computer systems and processes to begin using the mandatory reporting form—Form FDA 3500A. In response to these comments, we stated: “[T]o allow mandatory reporters time to make the necessary changes to their computer systems and processes to conform to the revised Form FDA 3500A, FDA is granting a grace period of 1 year. During this transition period FDA will accept both the newly effective Form FDA 3500A and the prior version of the form.” In the **Federal Register** of December 7, 2005 (70 FR 72843), FDA announced that OMB had approved the information collection for the MedWatch Program as submitted to OMB on August 16, 2005. In that notice, we stated: “As requested by the agency, in addition to the approval of the revised forms, the existing forms are approved for continued use for the next 12 months to allow for the industry to make necessary changes to their computerized systems.” In response to several recent requests from industry that we grant more time to make necessary changes to computerized systems, we requested and OMB has agreed to extend approval to use the prior version of Form FDA 3500A until May 1, 2007. The expiration date for the newly revised Form FDA 3500A remains unchanged—October 31, 2008. The prior version of Form FDA 3500A is available for downloading at *http://www.fda.gov/medwatch/getforms.htm* , and the expiration date on the form has been revised to May 1, 2007. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Dated: October 19, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-17907 Filed 10-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Dental Products Panel of the Medical Devices Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on November 9, 2006, from 8 a.m. to 5 p.m. *Location* : Holiday Inn, Walker/Whetstone Rooms, Two Montgomery Village Ave., Gaithersburg, MD. *Contact Person* : Michael J. Ryan, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 175, e-mail at: *michael.ryan@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512518. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss, make recommendations, and vote on a premarket approval application for a collagen material, which contains a bone morphogenetic protein, for oral maxillofacial bone grafting procedures. Background information, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at *http://www.fda.gov/cdrh/panel* (click on Upcoming CDRH Advisory Panel/Committee Meetings). *Procedure* : On November 9, 2006, from 8:30 a.m. to 5 p.m., the meeting will be open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before November 2, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of 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 November 2, 2006. *Closed Committee Deliberations* : On November 9, 2006, from 8 a.m. to 8:30 a.m., the meeting will be closed to the public to permit FDA to present to the committee trade secret and/or confidential commercial information regarding pending and future agency issues (5 U.S.C. 552b(c)(4)) for the next year. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, 301-827-7291, at least 7 days in advance of the meeting. FDA regrets that it was unable to publish this notice 15 days prior to the Dental Products Panel of the Medical Devices Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Dental Products Panel of the Medical Devices Advisory Committee were available at this time, the Commissioner of Food and Drugs concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-17932 Filed 10-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pediatric Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. The committee also advises and makes recommendations to the Secretary of Health and Human Services under 21 CFR 50.54 and 45 CFR 46.407 on research involving children as subjects that is conducted or supported by the Department of Health and Human Services, when that research is also regulated by FDA. *Date and Time* : The meeting will be held on November 16, 2006, from 8 a.m. to 4 p.m. *Location* : Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Jan Johannessen, Office of Science and Health Coordination, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, rm. 14B-08), Rockville, MD 20857, 301-827-6687, e-mail: *Jan.Johannessen@fda.hhs.gov* or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732310001. Please call the Information Line for up to date information on this meeting. *Agenda* : The Pediatric Advisory Committee will hear and discuss a report by the agency, as mandated in section 17 of the Best Pharmaceuticals for Children Act, on adverse event reports for ertapenem (INVANZ), gemcitabine (GEMZAR), glimepiride (AMARYL), insulin aspart recombinant (NOVOLOG), linezolid (ZYVOX), meloxicam (MOBIC), ondansetron (ZOFRAN), oxcarbazepine (TRILEPTAL), ritonavir (NORVIR), rosiglitazone (AVANDIA), sirolimus (RAPAMUNE). The committee will also receive updates to adverse event reports for atorvastatin (LIPITOR), citalopram (CELEXA), oseltamivir (TAMIFLU), oxybutynin (DITROPAN), and simvastatin (ZOCOR), which were requested by the Pediatric Advisory Committee or its predecessor, the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, when the reports were first presented. The background material will become available no later than 1 business day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . (Click on the year 2006 and scroll down to Pediatric Advisory Committee link.) *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 November 1, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. on November 16, 2006. 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 by November 1, 2006. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Jan N. Johannessen at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: October 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-17965 Filed 10-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0408] Draft Guidance for Industry and Food and Drug Administration Staff; Annual Reports for Approved Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the draft guidance entitled “Annual Reports for Approved Premarket Approval Applications.” This draft guidance document outlines the information required by a certain FDA regulation in periodic reports (usually referred to as annual reports) and FDA's recommendations for the level of detail that manufacturers should provide. This draft guidance is not final nor is it in effect at this time. DATES: Submit written or electronic comments on this draft guidance by January 24, 2007. Submit written or electronic comments on the collection of information by December 26, 2006. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Annual Reports for Approved Premarket Approval Applications” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance and the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: *For device issues* : Laura Byrd, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186. *For biologics issues* : Leonard Wilson, Center for Biologics Evaluation and Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373. SUPPLEMENTARY INFORMATION: I. Background This draft guidance document outlines the information required by § 814.84(b) (21 CFR 814.84(b)) in periodic reports (usually referred to as annual reports) and FDA's recommendations for the level of detail that manufacturers should provide. We also outline the principles and procedures that the Center for Devices and Radiological Health
(CDRH)and the Center for Biologics Evaluation and Research
(CBER)follow when we review these reports, identify the steps FDA staff generally take when reviewing annual reports, the resources available to assist staff in conducting their reviews, and the possible outcomes of a review. This draft guidance is not final nor is it in effect at this time. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on “Annual Reports for Approved Premarket Approval Applications.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Annual Reports for Approved Premarket Approval Applications” you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number
(1585)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. *Title* : Annual Reports for Approved Premarket Approval Applications. *Description* : Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) are also subject to periodic reports imposed by the premarket approval application
(PMA)approval order (§ 814.82(a) (21 CFR 814.82(a)) and § 814.84(b)). FDA typically specifies that an applicant submit a report 1 year from the date of approval of the original PMA and annually thereafter. Therefore the periodic report is usually referred to as the annual report. Although this draft guidance addresses “annual reports,” there may be circumstances where FDA specifies more frequent periodic reports. FDA believes this draft guidance will also be relevant to the more frequent reports. This draft guidance document describes FDA's recommendation for the level of detail that should be provided in the annual report. This draft guidance suggests that an annual report should include a cover letter that includes the following information:
(1)PMA number;
(2)device name (including any model names and numbers);
(3)company name;
(4)date of report;
(5)reporting period; and
(5)approval date. This draft guidance recommends that the annual report also include information regarding manufacturing, design, or labeling changes made during the reporting period, in which the following information should be included:
(1)The change made;
(2)the rationale for making the change;
(3)any validation or other testing that was performed, including a description of the method and acceptance criteria; and
(4)the implementation date. This guidance recommends creating a separate table for manufacturing changes, design changes, and labeling changes. Furthermore, if any manufacturing, design, or labeling change is associated with any written communication to practitioners or patients, this draft guidance recommends that the applicant include a copy of the communication in the annual report. For manufacturing, design, or labeling changes not reported in a PMA Supplement or a 30-day notice, this draft guidance recommends including a brief summary of the risk analysis performed to assess the effect of the changes made during the reporting period. If the risk analysis was performed in conformance to any consensus standards, these should be identified. If system-level testing of the cumulative changes were not conducted, then the risk analysis should also assess whether incremental testing was adequate to assure continued safety and effectiveness of the device in the absence of system level testing. If any changes to the design, manufacture, or labeling that have been made during the reporting period are associated with medical device reporting requirements, failures, or recalls of any kind, corrective actions (21 CFR 820.100), complaints, or in response to FDA warning letters or inspection findings (FDA Form 483), this draft guidance recommends that the applicant do the following:
(1)Describe their investigation of the cause or source of the problem; and
(2)explain their decision to change the device design, labeling, or manufacturing process by describing how the actions taken have corrected the problem and mitigated the harm. This draft guidance also recommends including a discussion of how the results and conclusions in clinical investigations or nonclinical laboratory studies or reports in scientific literature could impact the known safety and effectiveness profile of the device. If changes to the device or its labeling are based on clinical investigations or nonclinical laboratory studies or reports in scientific literature, this draft guidance recommends informing FDA of a plan for submitting a PMA Supplement or 30-day notice for these changes; or in the alternative, explaining why such a submission is not appropriate. To help FDA assess the public health impact of the information provided in annual reports, this draft guidance also asks applicants to provide data about the number of devices shipped or sold during the reporting period. For device implants, data regarding the number of devices actually implanted should be provided, if it is available. Finally, this draft guidance suggests that a redacted copy of the annual report may be provided in order to be publicly posted on FDA's Web site. This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in §§ 814.82(a)(7) and 814.84(b) have been approved under OMB Control No. 0910-0231. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** Information Collection Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Annual Report Cover Letter 434 1 434 0.5 217 Rationale for Changes 434 1 434 3 1,302 Summary of Risk Analysis 434 1 434 4 1,736 Evaluation of Clinical Investigations, Non-Clinical Laboratory Studies, or Scientific Literature 434 1 434 7 3,038 Information on Devices Shipped, Sold, or Implanted 434 1 434 5 2,170 Redacted Copy of Annual Report 434 1 434 4 1,736 Total 434 1 434 29.5 10,199 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The industry-wide burden estimate is based on an FDA actual average fiscal year
(FY)annual rate of receipt of 434 annual reports, using FY 2003 through 2005 data. The burden data for annual reports is based on FDA estimates. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 17, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6-17908 Filed 10-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Cancellation: Change of Meeting Date AGENCY: Health Resources and Services Administration; HHS. ACTION: Meeting notice: cancellation and change of meeting date. SUMMARY: The Health Resources and Services Administration published a document in the **Federal Register** of September 22, 2006, regarding a meeting date for the Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children. The meeting scheduled for November 2-3, 2006, has been cancelled. Correction In the **Federal Register** of September 22, 2006, in FR Doc. 06-8018, on page 55494, correct the “Dates and Times” section to read: *Dates and Times:* December 18, 2006, 9 a.m. to 5 p.m., December 19, 2006, 8:30 a.m. to 3 p.m. *Place:* Hilton Washington Hotel, Monroe Room, 1919 Connecticut Avenue, NW., Washington, DC 20009. Dated: October 20, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-17931 Filed 10-25-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Health Information National Trends Survey 2007 (HINTS 2007) *Summary:* In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health
(NIH)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget
(OMB)for review and approval. Proposed Collection *Title:* Health Information National Trends Survey 2007 (HINTS 2007). *Type of Information Collection Request:* New. *Need and Use of Information Collection:* Building on the first two rounds of HINTS data collection, HINTS 2007 will continue to provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer, including cancer prevention, early detection, diagnosis, treatment, and prognosis. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained. HINTS is intended to be the foundation of NCI's effort to build on the opportunities presented by a national shift in communication context, and by so doing, improve the nation's ability to reduce the national cancer burden. Data will be used
(1)To understand individuals sources of and access to cancer-related information;
(2)to measure progress in improving cancer knowledge and communication to the general public;
(3)to develop appropriate messages for the public about cancer prevention, detection, diagnosis, treatment, and survivorship; and
(4)to identify research gaps and guide decisions about NCI's research efforts in health promotion and health communication. *Frequency of Response:* One time. *Affected Public:* Individuals. *Type of Respondents:* U.S. Adults. The annual reporting burden is as follows: *Estimated Number of Respondents:* 10,599. *Estimated Number of Responses per Respondent:* 1. *Average Burden Hours per Response:* .33. *Estimated Total Annual Burden Hours Requested:* 3,576. The annualized cost to respondents is estimated at: $35,760. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondent Estimated number of respondents Frequency of response Average hours per response Annual hour burden Pilot RDD Screener 250 1 .0833 21 Pilot RDD Interview * 150 1 .4167 63 Pilot Mail Survey 150 1 .3333 50 RDD Screener 5,833 1 .0833 486 RDD Interview * 3,500 1 .4167 1,458 Mail Survey 3,660 1 .3333 1,219 Telephone Screener for Followup of Mail 956 1 .0833 80 Telephone Interview for Follow-up of Mail * 478 1 .4167 199 Totals 3,576 * Pilot survey and HINTS 2007 RDD interview respondents are a subset of the RDD screener respondents. Similarly, the telephone interview respondents in the followup of mail nonrespondents are a subset of the telephone screener respondents in the followup of mail nonrespondents. N = 10,849. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;
(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Bradford W. Hesse, Ph.D., Project Officer, National Cancer Institute, NIH, EPN 4068, 6130 Executive Boulevard MSC 7365, Bethesda, Maryland 20892-7365, or call non-toll-free number 301-594-9904, or FAX your request to 301-480-2198, or E-mail your request, including your address, to *hesseb@mail.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: October 18, 2006. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E6-17964 Filed 10-25-06; 8:45 am] BILLING CODE 4101-01-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. Manganese Superoxide Dimutase VAL16ALA Polymorphism Predicts Resistance to Doxorubicin Cancer Therapy *Description of Technology:* Cancer is the second leading cause of death in the United States and it is estimated that there will be approximately 600,000 deaths caused by cancer in 2006. Major drawbacks of the existing cancer therapies are the interindividial differences in the response and the cytotoxic side-effects that are associated with them. Thus, there is a need to develop new therapeutic approaches to optimize treatment and increase patient survival. This technology describes the identification of a manganese superoxide dismutase (MnSOD) polymorphism as a novel biomarker for the prognosis of doxorubicin therapeutic response in breast cancer patients, wherein a Val16Ala polymorphism of MnSOD is indicative of patient survival. More specifically, patients undergoing doxorubicin combination therapy with Val/Val, Val/Ala, and Ala/Ala genotypes had 95.2%, 79%, and 45.5% survival rates, respectively, in a case study of 70 unselected breast cancer patients. Carriers of the Ala/Ala genotype had a highly significantly poorer breast cancer-specific survival in a multivariate Cox regression analysis than carriers of the Val/Val genotype. This technology can be developed into an assay to screen for breast cancer patients who will be responsive to doxorubicin treatment. Further, as the MnSOD polymorphism is common in the population (15% to 20% of patients have the Ala/Ala genotype), it is a common risk factor for doxorubicin therapy. This technology can potentially be utilized as a screening tool applicable for all cancer types treated with doxorubicin. *Applications:*
(1)A novel genetic marker that can predict breast cancer patient survival with doxorubicin treatment;
(2)A screening test based on MnSOD Val16Ala genotype that predicts patient response to doxorubicin cancer therapy, wherein treatment can be subsequently individualized according to patient MnSOD genotype. *Development Status:* Future studies include determining the mechanism in which the polymorphism modulates doxorubicin toxicity. *Inventors:* Stefan Ambs and Brenda Boersma (NCI). *Patent Status:* U.S. Provisional Application No. 60/799,788 filed 11 May 2006 (HHS Reference No. E-137-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Jennifer Wong; 301/435-4633; *wongje@mail.nih.gov* . *Collaborative Research Opportunity:* The Laboratory of Human Carcinogenesis, Center for Cancer Research, National Cancer Institute, National Institutes of Health, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize MnSOD genotyping assays to assess a patient's response to doxorubicin combination therapy. Please contact Betty Tong, Ph.D. at 301-594-4263 or *tongb@mail.nih.gov* for more information. A Novel Magnetic Resonance Radio-Frequency Coil Array that Eliminates Inductive Coupling *Description of Technology:* Parallel magnetic resonance imaging
(MRI)techniques employ RF coil arrays for faster data acquisition, and have been shown to reduce the overall length of MRI procedures, improve signal-to-noise ratio
(SNR)and image quality, thus making MRI more attractive and less costly. Elimination of inductive coupling is an essential step in designing RF coil arrays for parallel MRI. If mutual inductance remains among coils in the RF coil array, the MR signal obtained from one coil may disturb the flux in another coil, making it difficult to match the impedance of each individual element to the input impedance its preamplifier. This non-optimal matching can lead to degradation of MR signal thereby yielding images with low quality. The most common strategy for inductive decoupling involves the use of preamplifiers with very low input impedance and decoupling networks with lumped elements. However, the construction of preamplifiers with low input impedance is not easy to accomplish, and these preamplifiers impose technical restrictions on coil design, requiring the use of overlapping loops to further minimize the amount of mutual inductance between the coils. The present invention describes a novel RF coil circuitry scheme to remove inductive coupling and to overcome the limitations of having to use overlapping geometries and low-impedance preamplifiers. The coil array employs a transformer to match the input impedance of the preamplifier. The signal that reaches the preamplifier is coupled in an inductive fashion to the RF coil decoupling network through the transformer's primary coil. Because primary and secondary coils in the transformer are isolated, the preamplifier circuit (and the MRI scanner electronics) is electrically isolated from the MR pickup coil. This arrangement provides a perfect electrical balance and isolation between the array channels, thus making it unnecessary to use traps and balluns in the circuit. At 7T, a 4-channel small animal coil array implementing the novel circuitry provided images with excellent SNR and demonstrated isolation of all individual RF coils and immunity to standing waves and other parasitic signals. *Applications:*
(1)MR imaging of humans, including imaging of brain;
(2)MR imaging of animals, including non-human primates and rodents;
(3)Functional imaging of humans and animals. *Advantages:*
(1)Allows for increased flexibility of coil design including geometries that require array with overlapping receiver coil loops;
(2)Can provide high level of mutual inductance decoupling within coils in the array;
(3)Isolates the grounds from coil to coil, and cancels all ground loops related to the coil array;
(4)Greatly increases the signal to noise ratio in MR imaging. *Development Status:* Early stage; Working model made and tested, improved model for animals under testing. *Inventors:* George C. Nascimento and Afonso C. Silva (NINDS). *Patent Status:* U.S. Provisional Application No. 60/789,934 filed 30 Mar 2006 (HHS Reference No. E-099-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Chekesha S. Clingman, Ph.D.; 301/435-5018; *clingmac@mail.nih.gov.* PDE11A as a Novel Therapeutic Target for Inherited Form of Cushing Syndrome and Endocrine Tumors *Description of Technology:* Cushing Syndrome, a disorder associated with excess production of a steroid hormone, cortisol, affects up to 10 per 15 million people every year. Cushing Syndrome may be caused by several reasons such as cortisol-producing endocrine tumors and can be inherited in some instances. Surgery of the adrenal tumor is the most common method of treatment. New diagnostic and therapeutic approaches need to be developed for successful management of the disease. This technology describes the clinical identification of a new disease termed “isolated micronodular adrenocortical disease” (iMAD), as well as the role of PDE11A gene in this disease. Additionally, the technology also identifies particular sequence variants of the PDE11A gene associated with abnormal or altered function of the gene, PDE11A as a potential novel drug target for the treatment of bilateral adrenal hyperplasia, and possibly other endocrine tumors and malignancies. *Applications and Modality:*
(1)Identification of PDE11A gene and sequence variants for the diagnosis of “isolated micronodular adrenocortical disease” (iMAD), a form of Cushing Syndrome and endocrine tumors, *i.e.* , as diagnostic tool.
(2)Identification of PDE11A as a potential novel drug target for the treatment of bilateral adrenal hyperplasia and other endocrine and non-endocrine tumors and malignancies. *Market:*
(1)5 to 10 per 15 million 10 to 15 million new cases of Cushing Syndrome every year;
(2)27,000 new cases of endocrine tumors every year;
(3)The technology involving PDE11A genes for the diagnosis and treatment of endocrine tumors including Cushing syndrome;
(4)The endocrine drug market is more than 40 billion U.S. dollars. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventor: Dr. Constantine A. Stratakis* (NICHD). *Publication:* A Horvath *et al.* A genome-wide scan identifies mutations in the gene encoding phosphodiesterase 11A4 (PDE11A) in individuals with adrenocortical hyperplasia. Nat Genet. 2006 Jul;38(7):794-800. Epub 2006 Jun 11, doi:10.1038/ng1809. [ *PubMed abs* ] *Patent Status:* U.S. Provisional Application No. 60/761,446 filed 24 Jan 2006 entitled “PDE11A mutations in Adrenal Diseases” (HHS Reference No. E-027-2006/0-US-01). *Licensing Status:* Available for exclusive and non-exclusive license. *Licensing Contact:* Mojdeh Bahar; 301/435-2950; *baharm@mail.nih.gov* . *Collaborative Research Opportunity:* The NICHD Heritable Disorders Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize testing for PDE11A genetic or functional defects in endocrine disease, and endocrine and other tumors or cancers. Please contact Betty Tong, Ph.D. at 301-594-4263 or *tongb@mail.nih.gov* for more information. 2-Amino- O 4 -Substituted Pteridines: Improved Chemotherapy Adjuvants *Description of Technology: O* 6 -Benzylguanine derivatives, some *O* 6 -benzylpyrimidines, and related compounds are known to be inactivators of the human DNA repair protein *O* 6 -alkylguanine-DNA alkyltransferase (alkyltransferase). This repair protein is the primary source of resistance many tumor cells develop when exposed to chemotherapeutic agents that modify the *O* 6 -position of DNA guanine residues. Therefore, inactivation of this protein can bring about a significant improvement in the therapeutic effectiveness of these chemotherapy drugs. The prototype inactivator *O* 6 -benzylguanine is currently in clinical trials in the United States as an adjuvant in combination with the chloroethylating agent 1, 3-bis (2-chloroethyl)-1-nitrosourea
(BCNU)and the methylating agent temozolomide. A similar alkyltransferase inactivator, *O* 6 -(4-bromothenyl) guanine is in clinical trials in the UK. This technology is directed to the discovery of a new class of potent alkyltransferase inactivators, 2-amino- *O* 4 -benzylpteridine derivatives targeted for use in cancer treatment in combination with chemotherapeutic agents such as 1, 3-bis (2-chloroethyl)-1-nitrosurea
(BCNU)or temozolomide. The derivatives of the present invention inactivate the *O* 6 -alkylguanine-DNA-alkyltransferase repair protein and thus enhance activity of such chemotherapeutic agents. Some of the derivatives are water soluble and possess tumor cell selectivity in particular by inactivating alkyltransferase in tumor cells that overexpress folic acid receptors. The 2-amino- *O* 4 -benzylpteridine derivatives represent a promising new class of alkyltransferase inactivator with representatives that may be great candidates as chemotherapy adjuvants. *Applications and Modality:*
(1)New small molecules as alkyltransferase inactivators based on 2-amino- *O* 4 -benzylpteridine compounds;
(2)Promising candidates as chemotherapy adjuvants for the treatment of cancer;
(3)Therapeutic application for drug resistant tumors where acquired resistance is caused by *O* 6 -alkylguanine-DNA alkyltransferase. *Market:*
(1)600,000 deaths from cancer related diseases estimated in 2006;
(2)This technology involving small molecule therapeutics for the treatment of several cancers has a potential market of several billion U.S. dollars. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors: Robert C. Moschel*
(NCI)*et al.* *Publication:* ME Nelson, NA Loktionova, AE Pegg, RC Moschel. 2-amino- *O* 4 -benzylpteridine derivatives: potent inactivators of *O* 6 -alkylguanine-DNA alkyltransferase. J Med Chem. 2004 Jul 15;47(15):3887-3891. Epub 2004 Jun 18, doi 10.1021/jm049758+ S0022-2623(04)09758-4. *Patent Status:* U.S. Provisional Application No. 60/534,519 filed 06 Jan 2004 (HHS Reference No. E-274-2003/0-US-01); U.S. Patent Application No. 10/585,566 filed 06 Jul 2006 (HHS Reference No. E-274-2003/0-US-03); Foreign equivalents. *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Adaku Madu, J.D.; 301/435-5560; *madua@mail.nih.gov.* Retrovirus-Like Particles as Vaccines and Immunogens *Description of Technology:* This technology describes retrovirus-like particles and their production from retroviral constructs in which the gene encoding all but seven amino acids of the nucleocapsid
(NC)protein was deleted. NC is critical for both genomic RNA packaging into the virion and viral integration into the host cell. Therefore, this deletion functionally eliminates two essential steps in retrovirus replication, thereby resulting in non-infectious retrovirus-like particles that maintain their full complement of antigenic proteins. Furthermore, efficient formation of these particles requires inhibition of the protease enzymatic activity, either by mutation to the protease gene in the construct or by protease inhibitor thereby ensuring the production of non-infectious retrovirus-like particles by altering two independent targets. These particles can be used in vaccines or immunogenic compositions. Specific examples using HIV-1 constructs are given. *Applications:* Retroviral vaccine; Immunogenic compositions. *Development Status:* In vitro data available. *Inventor:* David E. Ott (NCI). *Publications:* 1. DE Ott *et al.* Elimination of protease activity restores efficient virion production to a human immunodeficiency virus type 1 nucleocapsid deletion mutant. J Virol. 2003 May;77(10):5547-5556. [ *PubMed abs* ] 2. DE Ott *et al.* Redundant roles for nucleocapsid and matrix RNA-binding sequences in human immunodeficiency virus type 1 assembly. J Virol. 2005 Nov;79(22), 13839-13847. [ *PubMed abs* ] Patent Status: U.S. Patent Application No. 11/413,614 filed 27 Apr 2006 (HHS Reference No. E-236-2003/0-US-02). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The NCI, CCR, AIDS Vaccine Program is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize whole retrovirus-like particle vaccines. Please contact Betty Tong, Ph.D. at 301-594-4263 or tongb@mail.nih.gov for more information. Dated: October 19, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-17966 Filed 10-25-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2006-24851] Draft Environmental Assessment, Draft Finding of No Significant Impact, and Draft Memorandum of Agreement for the Decommissioning and Excessing of the U.S. Coast Guard Cutters STORIS (WMEC-38) and ACUSHNET (WMEC-167) AGENCY: Coast Guard, DHS. ACTION: Notice of availability and request for comments. SUMMARY: The U.S. Coast Guard
(USCG)announces the availability of, and seeks comment on, the Environmental Assessment and Draft Finding of No Significant Impact for the proposed decommissioning of the USCG cutters STORIS (WMEC-38) and ACUSHNET (WMEC-167) in Ketchikan and Kodiak, Alaska. The USCG is also announcing the availability and seeking comment on a related Draft Memorandum of Agreement
(MOA)with the Alaska State Historic Preservation Office (AK SHPO) and the General Services Administration (GSA). DATES: Comments and related material must reach Coast Guard Headquarters on or before November 27, 2006. ADDRESSES: Please submit comments by only one of the following means:
(1)By e-mail to Susan Hathaway at *Susan.G.Hathaway@uscg.mil.*
(2)By conventional mail delivery to Susan Hathaway, Headquarters, United States Coast Guard, Assistant Commandant for Engineering and Logistics, Environmental Management (CG-443), 2100 Second St., SW., Rm. 6109, Washington, DC 20593.
(3)By fax to Susan Hathaway at
(202)475-5956.
(4)Through the Web Site for the Docket Management System at *http://dms.dot.gov.* The Docket Management Facility maintains the public docket. Comments will become part of this docket and will be available for inspection or copying at the Nassif Building, 400 Seventh Street, SW., Room PL-401, Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except for Federal holidays. You may also view this docket, including this notice and comments, on the Internet at *http://dms.dot.gov.* Click on Simple Search and enter the docket number (24851). FOR FURTHER INFORMATION CONTACT: By mail: Susan Hathaway, Headquarters, United States Coast Guard, Assistant Commandant for Engineering and Logistics, Environmental Management (CG-443), 2100 Second St., SW., Rm. 6109, Washington, DC 20593; by telephone:
(202)475-5688; by fax:
(202)475-5956; or by e-mail: *Susan.G.Hathaway@uscg.mil.* To view and download the Environmental Assessment (EA), Draft Finding of No Significant Impact (FONSI), and Memorandum of Agreement (MOA), please go to *http://www.uscg.mil/systems/gse/NEPAhot.htm* and scroll to ACUSHNET and STORIS Decommissioning EA for Public Review. The EA, Draft FONSI, and MOA can also be viewed and downloaded from the Docket Management System at *http://dms.dot.gov.* Click on Simple Search and enter the docket number (24851). The Draft FONSI is after the cover sheet at the front of the EA and the MOA is Appendix D of the EA. SUPPLEMENTARY INFORMATION: Request for Comments We encourage you to submit comments on the EA, Draft FONSI, and MOA. If you do so, please include your name and address, identify the docket number for this notice (USCG-2006-24851), and give the reasons for each comment. You may submit your comments by mail, hand delivery, fax, or electronic means to the Docket Management Facility at the addresses under ADDRESSES but please submit your comments by only one means. If you submit them by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments received during the comment period. Proposed Action After over 60 years of continuous service, the USCGCs STORIS (WMEC-38) and ACUSHNET (WMEC-167) have reached the end of their service lives. The USCG intends to decommission the USCGC STORIS (WMEC-38) in 2007 and the USCGC ACUSHNET (WMEC-167) between 2008 and 2010, and report the vessels as excess personal property to the U.S. General Services Administration
(GSA)pursuant to the Federal Property and Administrative Services Act of 1949 and its implementing regulations at Title 41, Code of Federal Regulations (CFR), part 102-36 (41 CFR part 102-36). Preparation of the EA for the decommissioning of the USCGCs STORIS (WMEC-38) and ACUSHNET (WMEC-167) is being conducted in accordance with the National Environmental Policy Act
(NEPA)of 1969 (Section 102[2][c]) and its implementing regulations at 40 CFR Part 1500. Environmental Assessment An EA has been prepared that identifies and examines alternatives including a no action alternative and the preferred alternative, the decommissioning and subsequent reporting of the vessels to GSA, as well as a third possible outcome, that is beyond the control of the Coast Guard and entails passage by Congress of specific legislation that directs the vessels' disposition. The EA assesses the potential environmental impacts of these alternatives and the additional possibility of specific legislation. As the Coast Guard has determined that the vessels are historic for purposes of Section 106 of the National Historic Preservation Act of 1966, the Coast Guard has engaged in Section 106 consultation with the Alaska State Historic Preservation Office (AK SHPO) in developing a MOA on the Coast Guard's intended action of decommissioning of the USCGCs STORIS (WMEC-38) and ACUSHNET (WMEC-167) and then reporting the vessels as excess personal property to GSA. GSA also participated in the development of the MOA. The Draft FONSI records the USCG's determination that the Proposed Action would have no significant impact on the environment. The USCG will consider all comments received by the close of business on November 27, 2006. Dated: October 19, 2006. Captain Douglas J. Wisniewski, Acting Director of Enforcement and Incident Management Directorate, U.S. Coast Guard. [FR Doc. E6-17900 Filed 10-25-06; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1663-DR] Alaska; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Alaska (FEMA-1663-DR), dated October 16, 2006, and related determinations. DATES: *Effective Date:* October 16, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 16, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Alaska resulting from severe storms, flooding, landslides, and mudslides during the period of August 15-25, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Alaska. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance under Section 408 of the Stafford Act is later warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency
(FEMA)hereby gives notice that pursuant to the authority vested in the Director, under Executive Order 12148, as amended, William M. Lokey, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Alaska to have been affected adversely by this declared major disaster: The Chugach Regional Education Attendance Area, Denali Borough, and Matanuska-Susitna Borough for Public Assistance. All boroughs and Regional Education Attendance Areas in the State of Alaska are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17961 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1664-DR] Hawaii; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Hawaii (FEMA-1664-DR), dated October 17, 2006, and related determinations. DATES: *Effective Date:* October 17, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 17, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Hawaii resulting from an earthquake that occurred on October 15, 2006, and related aftershocks, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Hawaii. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide assistance for debris removal and emergency protective measures (Categories A and B) under the Public Assistance program in the designated areas, as well as Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate, subject to completion of Preliminary Damage Assessments (PDAs), unless you determine that the incident is of such unusual severity and magnitude that PDAs are not required to determine the need for supplemental Federal assistance pursuant to 44 CFR 206.33(d). Direct Federal assistance is authorized. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance is later warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency
(FEMA)hereby gives notice that pursuant to the authority vested in the Director, Department of Homeland Security, under Executive Order 12148, as amended, Michael L. Karl of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Hawaii to have been affected adversely by this declared major disaster: The counties of Hawaii, Honolulu, Kauai, and Maui and the City of Honolulu for debris removal and emergency protective measures (Categories A and B), including direct Federal assistance, under the Public Assistance program. All counties within the State of Hawaii are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individual and Household Housing; 97.049, Individual and Household Disaster Housing Operations; 97.050, Individual and Household Program-Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17985 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1662-DR] Indiana; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Indiana (FEMA-1662-DR), dated October 6, 2006, and related determinations. EFFECTIVE DATE: October 6, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 6, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Indiana resulting from severe storms and flooding during the period of September 12-14, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Indiana. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later requested and warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency
(FEMA)hereby gives notice that pursuant to the authority vested in the Director, under Executive Order 12148, as amended, Lawrence Sommers, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Indiana to have been affected adversely by this declared major disaster: Lake and Vanderburgh Counties for Individual Assistance. All counties within the State of Indiana are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17975 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1659-DR] New Mexico; Amendment No. 4 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the State of New Mexico (FEMA-1659-DR), dated August 30, 2006, and related determinations. DATES: *Effective Date:* October 13, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of New Mexico is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of August 30, 2006: Rio Arriba and Taos Counties for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: § 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17960 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-3268-EM] New York; Amendment No.1 to Notice of an Emergency Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This notice amends the notice of an emergency declaration for the State of New York (FEMA-3268-EM), dated October 15, 2006, and related determinations. EFFECTIVE DATE: October 16, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA)hereby gives notice that pursuant to the authority vested in the Director, under Executive Order 12148, as amended, Peter J. Martinasco, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. This action terminates my appointment of Marianne C. Jackson as Federal Coordinating Officer for this disaster. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17958 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-3268-EM] New York; Emergency and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of an emergency for the State of New York (FEMA-3268-EM), dated October 15, 2006, and related determinations. DATES: *Effective Date:* October 15, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 15, 2006, the President declared an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the emergency conditions in certain areas of the State of New York resulting from a lake effect snowstorm beginning on October 12, 2006, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act). Therefore, I declare that such an emergency exists in the State of New York. You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives, protect property and public health and safety, and lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for debris removal and emergency protective measures (Categories A and B) under the Public Assistance program, including incidental snow removal necessary to complete debris removal or emergency protective measures. This assistance excludes regular time costs for subgrantees' regular employees. In addition, you are authorized to provide such other forms of assistance under Title V of the Stafford Act as you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency
(FEMA)hereby gives notice that pursuant to the authority vested in the Director, Department of Homeland Security, under Executive Order 12148, as amended, Marianne C. Jackson, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency. I do hereby determine the following areas of the State of New York to have been affected adversely by this declared emergency: Erie, Genesee, Niagara, and Orleans Counties for debris removal and emergency protective measures (Categories A and B) under the Public Assistance program, including incidental snow removal necessary to complete debris removal or emergency protective measures. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program—Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17983 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1661-DR] Virginia; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-1661-DR), dated September 22, 2006, and related determinations. EFFECTIVE DATE: October 18, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 22, 2006: Greensville, King and Queen, and Lunenburg Counties for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17957 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1661-DR] Virginia; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-1661-DR), dated September 22, 2006, and related determinations. DATES: *Effective Date:* October 6, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472,
(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of September 22, 2006: The independent City of Newport News for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers
(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Under Secretary for Federal Emergency Management and Director of FEMA. [FR Doc. E6-17963 Filed 10-25-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Intent To Prepare a Comprehensive Conservation Plan for Cape Meares, Oregon Islands and Three Arch Rocks National Wildlife Refuges AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent and announcement of five public open house meetings. SUMMARY: This notice advises the public that the U.S. Fish and Wildlife Service (Service) intends to prepare a Comprehensive Conservation Plan
(CCP)for the Cape Meares, Oregon Islands and Three Arch Rocks National Wildlife Refuges (Refuges); and announces five public open house meetings. The Refuges are located in Clatsop, Tillamook, Lincoln, Lane, Coos and Curry Counties in Oregon. We are furnishing this notice to advise the public and other agencies of our intentions and obtain public comments, suggestions, and information on the scope of issues to include in the CCP. DATES: Please provide written comments on the scope of the CCP by December 11, 2006. Five public open house meetings will be held to begin the CCP planning process; see SUPPLEMENTARY INFORMATION for dates, times, and locations. ADDRESSES: Address comments, questions, and requests for further information to Project Leader, Oregon Coast National Wildlife Refuge Complex, 2127 SE Marine Science Drive, Newport, OR 97365. Comments may be faxed to the Refuge Complex office at
(541)867-4551, or e-mailed to *FW1PlanningComments@fws.gov.* Additional information concerning the Refuges is available on the Internet at *http://www.fws.gov/oregoncoast/.* Addresses for the public meeting locations are listed under SUPPLEMENTARY INFORMATION . FOR FURTHER INFORMATION CONTACT: Roy W. Lowe, Project Leader, Oregon Coast National Wildlife Refuge Complex, phone
(541)867-4550. SUPPLEMENTARY INFORMATION: The National Wildlife Refuge System Administration Act of 1966 (Refuge Administration Act), as amended (16 U.S.C. 668dd-668ee), requires all lands within the National Wildlife Refuge System to be managed in accordance with an approved CCP. A CCP guides a refuge's management decisions, and identifies long-range refuge goals, objectives, and strategies for achieving the purposes for which the refuge was established. During the CCP planning process many elements will be considered, including wildlife and habitat protection and management, and public use opportunities. Public input during the planning process is essential. The CCP for the Cape Meares, Oregon Islands, and Three Arch Rocks Refuges will describe the purposes and desired conditions for the Refuges and the long-term conservation goals, objectives, and strategies for fulfilling the purposes and achieving those conditions. The Service will prepare an environmental document for compliance with the National Environmental Policy Act
(NEPA)of 1969, as amended, and NEPA's implementing procedures. Background Cape Meares National Wildlife Refuge is located on the Oregon coast between Tillamook Bay and Netarts Bay, and was established in 1938 through the acquisition of excess lands from the U.S. Coast Guard. The Refuge is comprised of two units separated by Cape Meares State Scenic Viewpoint, which is managed by Oregon Parks and Recreation Department (OPRD). Cape Meares Refuge includes vertical coastal cliffs, rock outcroppings, and rolling headlands, with an old-growth forest dominated by Sitka spruce and western hemlock. A smaller section of old-growth blowdown forest in early seral stage is also present within the Refuge boundary adjacent to a clearcut. Management programs at the Cape Meares Refuge are primarily focused on preserving the old growth forest, maintaining the integrity of a Research Natural Area, protecting seabird nesting colonies and a peregrine falcon eyrie, and providing opportunities for the public to learn about wildlife resources through wildlife viewing and interpretation on adjacent OPRD lands. Public use on the Cape Meares Refuge is managed cooperatively by the OPRD and the Service through a Memorandum of Agreement. The Oregon Islands Refuge is located along 320 miles of the Oregon coast, and includes 1,853 rocks, islands and reefs, and two headlands (Coquille Point in Coos County, and Crook Point in Curry County). In 1970, 1978 and 1996, the rocks, islands and reefs within the Refuge were designated wilderness, with the exception of Tillamook Rock. The rocks, reefs and islands of Oregon Islands Refuge and wilderness lands were acquired to serve as a refuge and breeding ground for birds and marine mammals. The Coquille Point headland was acquired in 1991 to: Provide a buffer zone between the Refuge's offshore islands and mainland development; protect a bluff zone for the wildlife species that are dependent on it; and provide one of the best opportunities along the Oregon coast for wildlife observation. The Crook Point headland was acquired in 2000 to provide permanent protection to one of the few remaining undisturbed headlands on the Oregon coast, resulting in increased protection for major near shore seabird breeding colonies and pinniped pupping and haulout sites within the Oregon Islands Refuge. A relatively undisturbed intertidal zone, unique geological formations, rare plants, and cultural resource sites on the mainland are also protected within the Refuge. The Three Arch Rocks Refuge is located a half-mile west of the town of Oceanside, and is comprised of nine rocks and islands encompassing 15 acres of seabird and marine mammal habitat. The Refuge was established in 1907 and was accorded Wilderness status in 1970. The Refuge is closed to public use to protect seabirds, marine mammals, and their habitats from human disturbance. A seasonal closure of the waters within 500 feet of the Refuge is enforced yearly from May 1 through September 15. Interpretation, wildlife photography, and wildlife observation are all existing public uses of Three Arch Rocks Refuge, which occur offsite at both Cape Meares State Scenic Viewpoint and from Oceanside Beach State Recreation Area. Preliminary Issues, Concerns, and Opportunities Preliminary issues, concerns, and opportunities that have been identified and may be addressed in the CCP, are briefly summarized below. Additional issues will be identified during public scoping. During the CCP planning process, the Service will analyze methods for protecting the resources of the Cape Meares Refuge in the long term, while continuing to provide quality opportunities for wildlife-dependent recreation in partnership with OPRD, volunteers, and a Friends group. At the Oregon Islands and Three Arch Rocks Refuges, the Service will identify and consider a wide range of techniques and partnerships in the CCP, for protection of the sensitive and irreplaceable wildlife, habitat, and cultural resources contained within these Refuges. Opportunities for the public to enjoy the Refuges will be examined. The Service will also evaluate the extensive inventory, monitoring, and research needs of these Refuges, within the context of Refuge needs and priorities, and in the wider context of regional, national, and international conservation priorities, and will analyze and determine methods for prioritizing and accomplishing these needs. Public Meetings Five public open house meetings will be held in November 2006. The public open house meetings will be held on weeknights between 6:30 p.m. and 8:30 p.m. Addresses and dates for the public meetings follow. 1. November 1, 2006, Newport High School, Boone Center Room, 322 NE Eads St., Newport, OR 97365. 2. November 6, 2006, Oceanside Community Center, 1550 Pacific St., Oceanside, OR 97134. 3. November 8, 2006, Cannon Beach Elementary School, 268 Beaver, Cannon Beach, OR 97110. 4. November 14, 2006, Brookings High School Auditorium, 564 Fern St., Brookings, OR 97415. 5. November 15, 2006, Bandon High School Cafeteria, 550 Ninth Street, SW., Bandon, OR 97411. Opportunities for public input will be announced throughout the CCP planning process. All comments received from individuals become part of the official public record. Requests for such comments will be handled in accordance with the Freedom of Information Act, NEPA, and Service and Departmental policies and procedures. Dated: September 25, 2006. David J. Wesley, Acting Regional Director, Region 1, Portland, Oregon. [FR Doc. E6-17940 Filed 10-25-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Pea Island National Wildlife Refuge AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability of the Final Comprehensive Conservation Plan and Finding of No Significant Impact for Pea Island National Wildlife Refuge in Dare County, North Carolina. SUMMARY: The Fish and Wildlife Service announces that a Final Comprehensive Conservation Plan and Finding of No Significant Impact for Pea Island National Wildlife Refuge are available for distribution. The plan was prepared pursuant to the National Wildlife Refuge System Improvement Act of 1997 and in accordance with the National Environmental Policy Act of 1969. It describes how the refuge will be managed for the next 15 years. The compatibility determinations for recreational hunting, fishing, wildlife observation, wildlife photography, and environmental education and interpretation are also available within the plan. ADDRESSES: A copy of the plan may be obtained by writing to: Bonnie Strawser, P.O. Box 1969, Manteo, North Carolina 27954, or by electronic mail to: *bonnie_strawser@fw.gov.* The plan may also be accessed and downloaded from the Service Web site *http://southeast.fws.gov/planning/.* SUPPLEMENTARY INFORMATION: The availability of the Draft Comprehensive Conservation Plan and Environmental Assessment for a 30-day public review and comment period was announced in the **Federal Register** on February 6, 2006 (71 FR 6089). The draft plan and environmental assessment identified and evaluated five alternatives for managing the refuge over the next 15 years. Based on the environmental assessment and the comments received, the Service adopted Alternative 2 as its preferred Alternative. This alternative was considered to be the most effective for meeting the purposes of the refuge and the mission of the National Wildlife Refuge System. Under this alternative, the refuge will continue to manage very intensively the water levels of the impoundments and the vegetation to create optimum habitat for migrating waterfowl, shorebirds, wading birds, and aquatic organisms. The refuge will continue to allow five of the six priority public uses of the Refuge System, as identified in the National Wildlife Refuge System Improvement Act of 1997. These uses are: fishing, wildlife observation, wildlife photography, and environmental education and interpretation. Pea Island National Wildlife Refuge, in northeastern North Carolina, consists of approximately 5,800 acres of ocean beach, barrier dunes, salt marshes, fresh and brackish water ponds and impoundments, as well as tidal creeks and bays. These habitats support a variety of wildlife species including waterfowl, shorebirds, wading birds, sea turtles, and neotropical migratory songbirds. Authority: This notice is published under the authority of the National Wildlife Refuge System Improvement Act of 1997, Public Law 105-57. Dated: May 3, 2006. Cynthia K. Dohner, Acting Regional Director. Editorial Note: This document was received at the Office of the Federal Register on October 23, 2006. [FR Doc. 06-8897 Filed 10-25-06: 8:45 am]
Connectionstraces to 11
10 references not yet in our index
  • 45 CFR 46.407
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
  • 21 CFR 820.100
  • 41 CFR 102
  • 40 CFR 1500
  • 42 USC 5121-5206
  • 44 CFR 206.33(d)
  • 16 USC 668dd-668ee
  • Pub. L. 105-57
Citation graph
cites case law
Notices
Notice; extension of expiration date
U.S.C.§ 552b
C.F.R.§ 50.54
C.F.R.§ 814.84
C.F.R.§ 10.115
U.S.C.§ 3502
U.S.C.§ 3506
U.S.C.§ 360e
C.F.R.§ 814.82
U.S.C.§ 207
Cite45 CFR 46.407
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Cites 21 · showing 12Cited by 0 across 0 sources
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